Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review

Pacemaker implantation rate after transcatheter aortic valve implantation with early and... Abstract Aims The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. Methods and results According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3–37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7–26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI. Conclusion The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI. Transcatheter aortic valve implantation, Pacemaker , New-generation device, Systematic review Introduction Technological developments in transcatheter aortic valve implantation (TAVI) have facilitated the procedure and reduced significantly the incidence of vascular complications and paravalvular regurgitation, leading to an exponential increase of this therapy in patients with symptomatic severe aortic stenosis and contraindications or high risk for surgical aortic valve replacement and, recently, in patients with intermediate operative risk.1,2 However, there remain some concerns when considering TAVI for low operative risk patients. Compared with surgical aortic valve replacement, TAVI has been associated with higher rates of permanent pacemaker implantation (PPI) after the procedure.3,4 Current evidence indicates that several electrical, anatomical, and procedural factors are associated with the need for PPI after TAVI.5,6 For early-generation TAVI prostheses (Figure 1), age and pre-existent and procedure-induced conduction abnormalities and the use of a self-expandable prosthesis were the factors significantly associated with the increased risk of PPI.5,6 However, the incidence of PPI when using new-generation prostheses have not been extensively evaluated (Figure 1). In addition, the factors associated with the increased risk of PPI with these new devices have not been studied. Bearing in mind that the indication for TAVI is expanding towards younger and lower surgical risk patients, it is important to understand the patient and procedural characteristics associated with post-procedural PPI. In this systematic review, the incidence of PPI across different new-generation TAVI prostheses was analysed and compared with the incidence of PPI with the use of early-generation devices (as reported in the literature).6–8 In addition, the various electrical, anatomical, and procedural characteristics that are associated with PPI with the new-generation devices were reviewed. Figure 1 View largeDownload slide Early- and new-generation transcatheter aortic valves: (A) SAPIEN Edwards, (B) SAPIEN XT, (C) Medtronic CoreValve, (D) SAPIEN 3, (E) CoreValve Evolut R, (F) ACURATE transcatheter heart valve system, (G) Lotus valve, (H) Direct Flow Medical Transcatheter Aortic Valve System, (I) JenaValve, and (J) Portico. THV, transcatheter heart valve. Figure 1 View largeDownload slide Early- and new-generation transcatheter aortic valves: (A) SAPIEN Edwards, (B) SAPIEN XT, (C) Medtronic CoreValve, (D) SAPIEN 3, (E) CoreValve Evolut R, (F) ACURATE transcatheter heart valve system, (G) Lotus valve, (H) Direct Flow Medical Transcatheter Aortic Valve System, (I) JenaValve, and (J) Portico. THV, transcatheter heart valve. Methods Search strategy and selection criteria This systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist.9 Studies reporting on the rate of PPI after TAVI with new-generation prostheses (SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA; CoreValve Evolut R, Medtronic, Minneapolis, MN, USA; Lotus, Boston Scientific, Marlborough, MA, USA; Direct Flow Medical Transcatheter Aortic Valve System, Direct Flow Medical Inc., Santa Rosa, CA, USA; Portico, St. Jude Medical, St Paul, MN, USA; JenaValve, JenaValve Technology GmbH, Munich, Germany; and ACURATE transcatheter heart valve system, SYMETIS SA, Eclubens, Switzerland) were included. The PubMed database was searched entering the following keywords: ‘transcatheter aortic valve’, ‘TAVI’, ‘TAVR’, ‘aortic valve’, ‘transcatheter’, ‘pacemaker’. Original articles published between October 2010 and October 2017 were screened. Two investigators (P.v.R. and V.D.) independently reviewed the titles and abstracts of the original articles obtained in the initial search and selected the articles that reported on the PPI rate after implantation of new-generation transcatheter aortic valve prostheses, included ≥100 patients, and were published in English in a peer-reviewed journal. If considered eligible, the full article was scrutinized for inclusion, and the reference list and articles citing the included study (as provided by Google Scholar) were reviewed. To minimize the potential bias introduced by the experience and learning curve, studies including <100 patients treated with a new-generation transcatheter valve prosthesis, and studies that did not report on the PPI rate (or that clustered the PPI rate of earlier and new-generation prostheses) were excluded. In addition, for studies with overlapping patient populations, we selected the study with the largest population reporting on the PPI rate. Finally, abstracts and unpublished data presented at major international cardiology congresses were not considered for this analysis. The final search ended on 1 November 2017. To compare the post-procedural PPI incidence between new and early-generation (Edwards SAPIEN, SAPIEN XT, and Medtronic CoreValve) prostheses, recent systematic reviews and meta-analyses investigating the occurrence of a PPI after early-generation TAVI prostheses were considered.6–8 In addition, studies from the initial PubMed database search were rescreened for this specific purpose to find the possible studies that had not been included in the meta-analyses.6–8 Studies evaluating the incidence of PPI after early-generation prostheses were included by the same selection criteria as for the studies on new-generation prostheses. Data extraction For each original article included in the systematic review, the following characteristics were extracted: year of publication, design of the study, number of patients, age, gender, operative risk score [logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), or the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score], baseline heart rhythm (sinus rhythm, atrial fibrillation, and pacemaker rhythm), time of follow-up, and number of PPI after TAVI. In addition, the PPI rates that included pacemaker implantation prior to TAVI in the calculation were carefully scrutinized. Furthermore, data on several electrical, anatomical, and procedural factors that may influence the PPI rate were evaluated. Specifically, the electrical factors included the presence of different pre-existent conduction abnormalities: atrial fibrillation, atrioventricular (AV) block, PR interval duration, and right or left bundle branch block. The anatomical factors included the association between the calcification burden of the landing zone [left ventricular outflow tract (LVOT) and aortic valve] and the length of the membranous interventricular septum vs. the need for PPI. Finally, the procedural factors included the implantation depth of the device, coaxiality of the implantation, prosthesis oversizing, and the need for reballooning. Statistical analysis Categorical data are presented as frequencies and percentages. Frequencies of post-TAVI PPI are presented in a histogram using GraphPad Prism software (version 7.00, GraphPad Software, La Jolla, CA, USA). According to the post-TAVI PPI rates, quintiles were calculated using SPSS software (version 23.0; IBM Corp., Armonk, NY, USA). The studies within the highest and the lowest quintiles were evaluated and compared. Results After screening the titles and abstracts of 1406 original articles that were identified in the first search, 348 articles were examined for full text. Finally, 40 studies reporting on PPI after new-generation TAVI prostheses were included (Figure 2A). Figure 2 View largeDownload slide (A) Study selection: new-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. (B) Study selection: early-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using early-generation prostheses. Figure 2 View largeDownload slide (A) Study selection: new-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. (B) Study selection: early-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using early-generation prostheses. The characteristics of the study populations stratified according to the type of new-generation TAVI prosthesis are presented in Supplementary material online, Table S1A4,10–48 and the frequencies of post-TAVI PPI are plotted in Figure 3. For the Edwards SAPIEN 3 prosthesis, 7017 patients were evaluated in 17 studies, including the randomized Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial10 and three prospective registries.11–13 For this transcatheter valve prosthesis, the post-TAVI PPI rate ranged from 4.0%11 to 24%.14 Nine of the studies including patients treated with the SAPIEN 3 reported the criteria used for PPI (see Supplementary material online, Table S1A).11,13,15–21 For this device, reported mean time intervals between TAVI and the placement of a PPI were 3.5 ± 4.1 days,19 4.25 ± 3.3 days16 and 3.3 ± 3.0 days.14 Figure 3 View largeDownload slide Histograms showing the incidence of permanent pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. Figure 3 View largeDownload slide Histograms showing the incidence of permanent pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. For the Lotus valve, data for 2184 patients from 7 studies were available.22–28 The reported post-TAVI PPI rates ranged from 27.9%22 to 36.1%,28 and complete or second-degree Mobitz II AV blocks were the most frequent indications for PPI. Of the patients who were treated with PPI after the TAVI in the REPRISE II trial, 25% received the PPI on post-procedural Day 1, 37.5% between Day 1 and Day 3, and the remainder between Day 4 and Day 14.23 The median TAVI–PPI time interval in the UK Lotus Registry was 3.0 ± 3.4 days.27 For the Direct Flow Medical Valve (Direct Flow Medical Inc.), 5 studies totalling 724 patients were included.29–32,49 In the prospective DISCOVER study (Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18 Fr System for the Treatment of Patients with Severe Aortic Stenosis), the post-TAVI PPI rate was 17.0%.49 Naber et al.32 described the largest patient population treated with this device (n = 250) in the prospective, European multicentre registry and reported a post-TAVI PPI rate of 12.0%. The CoreValve Evolut R prosthesis was evaluated in 8 studies, including a total of 6017 patients. Post-TAVI PPI rates varied from 14.7%, as reported by Kalra et al.33 to 26.7% in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial.4 Data from the latest report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry revealed a post-TAVI PPI rate of 18.3% in 3810 patients who were treated with this device.34 Reported TAVI–PPI intervals were 2–3 days.33,35 The Portico prosthesis was evaluated in a prospective, multicentre study including 222 patients, and the reported incidence of PPI after TAVI was 13.5%.36 Only one study including patients treated with the JenaValve system fulfilled the inclusion criteria.37 Silaschi et al.,37 in their prospective multicentre study, showed a post-TAVI PPI rate of 14.4%. Finally, data from 795 patients treated with the ACURATE transcatheter heart valve system were evaluated.38,39,47,50 Toggweiler et al.47 reported a post-TAVI PPI rate of 2.3% in 175 patients. In the studies by Börgermann et al.38 (n = 500) and Hamm et al.39 (n = 120), the PPI rates were 10.2% and 9.6%, respectively. To compare these incidences with those reported by studies including only early-generation devices, the studies included in recent systematic reviews and meta-analyses were scrutinized.6–8 In addition, from the initial literature search, four additional studies not included in the systematic reviews and meta-analyses were included in this analysis.50–53 Twenty-seven studies evaluating the PPI incidence with the use of early-generation TAVI prostheses fulfilled the selection criteria and were finally included (Figure 2B, see Supplementary material online, Table S1B).40,50–71 For the early-generation SAPIEN devices, the post-TAVI PPI rate ranged from 2.3% in the PARTNER EU trial (n = 130)54 to 17.3% in the randomized controlled CHOICE trial (n = 121 SAPIEN XT vs. n = 120 CoreValve).50 However, this PPI rate increased up to 28.2% in a single-centre study, including 110 patients without a previous pacemaker who were treated with early-generation SAPIEN devices.55 Regarding the early generation of the CoreValve, the PPI rate ranged from 16.3% in the Italian CoreValve Registry56 to 37.7% in the CHOICE trial.50 Comparison of studies with high vs low permanent pacemaker implantation rate after new-generation prostheses The studies were categorized according to the post-TAVI PPI rate quintiles, and the studies within the lowest (<12.1%) and the highest (>26.0%) quintile were compared (Table 1).4,10,11,13,22–28,30,32,38,39,42,47,48 The number of patients within the group of the lowest PPI rate quintile was larger than the highest quintile group (5152 vs. 2323). Patients within the highest PPI rate quintile were more frequently women than the lowest quintile group (50.9% vs. 46.3%, P < 0.001). The proportion of patients who had atrial fibrillation was lower in the lowest PPI quintile group (29.3% vs. 31.9%, P = 0.029). No other significant differences were observed. Table 1 Studies according to the lowest and highest quintile of pacemaker implantation Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% ACC, American College of Cardiology; AF, atrial fibrillation; AV, atrioventricular; LBBB, left bundle branch block; ND, not determined; RBBB, right bundle branch block; STS, Society of Thoracic Surgeons; TVT, transcatheter valve therapy. Table 1 Studies according to the lowest and highest quintile of pacemaker implantation Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% ACC, American College of Cardiology; AF, atrial fibrillation; AV, atrioventricular; LBBB, left bundle branch block; ND, not determined; RBBB, right bundle branch block; STS, Society of Thoracic Surgeons; TVT, transcatheter valve therapy. Studies analysing factors associated with permanent pacemaker implantation following transcatheter aortic valve implantation with new-generation prostheses Several studies investigated the factors associated with PPI after new-generation TAVI prosthesis (Table 2).12,15–19,21–23,35,40 Among the several electrical factors that could influence the PPI rate, multivariate analyses evaluating the SAPIEN 3 valve identified the presence of pre-procedural conduction abnormalities such as the right bundle branch block (RBBB),16–19,40 prolonged PR interval,16,40 and atrial fibrillation17 to be associated with post-procedural PPI. For the Lotus valve, Dumonteil et al.23 showed that RBBB and first-degree AV block were independent electrical determinants of post-procedural PPI. Similarly, for the CoreValve Evolut R, Gomes et al.35 found that pre-existent RBBB was the electrical factor independently associated with the need for PPI. Table 2 Characteristics associated with permanent pacemaker implantation following transcatheter aortic valve implantation with new generation prostheses Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 AV, atrioventricular; COPD, chronic obstructive pulmonary disease; LVOT, left ventricular outflow tract; RBBB, right bundle branch block. Table 2 Characteristics associated with permanent pacemaker implantation following transcatheter aortic valve implantation with new generation prostheses Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 AV, atrioventricular; COPD, chronic obstructive pulmonary disease; LVOT, left ventricular outflow tract; RBBB, right bundle branch block. Regarding the anatomical factors potentially influencing the need for PPI, data from computed tomography scans performed in patients treated with the SAPIEN 3 showed that the amount of calcification in the device landing zone was independently associated with post-TAVI PPI.18,19 Similarly, for the Lotus valve, Dumonteil et al.23 showed an independent association between the amount of LVOT calcification as assessed with CT and increased risk of post-TAVI PPI. Furthermore, among the various procedural determinants, the implantation depth of the SAPIEN 3 was identified as an independent correlate of post-procedural PPI in several studies.15,17–19,21 Data from the REPRISE II study, including the extended cohort, showed that >10% overstretch of the LVOT was an independent procedural factor associated with increased post-TAVI PPI when a Lotus valve was implanted.23 In contrast, a deep implantation of the Louts valve (>5 mm deep into the LVOT) was associated with increased risk of PPI.23 When using the CoreValve Evolut R, Gomes et al.35 also showed that the implantation depth was a procedural factor independently associated with the need for PPI. The studies investigating the factors associated with PPI after early-generation TAVI prosthesis are provided in Supplementary material online, Table S2.3,29,55,61,65–69,72–74 Discussion In this systematic review, including 17 139 patients treated with new-generation TAVI prostheses, a wide range of post-TAVI PPI rates across various prostheses has been shown. The factors influencing this wide variability have not been fully elucidated, but the available evidence suggests that various electrical, anatomical, and procedural factors may explain these findings. Furthermore, it is important to note that some patients had a pacemaker prior to TAVI and the indication for PPI after TAVI varied significantly across the studies and not always fulfilled prevailing recommendations.75 Compared with early-generation devices, the PPI rates remain low with the balloon-expandable prostheses, whereas they have reduced with the new-generation of self-expandable CoreValve systems. Electrical factors associated with post-transcatheter aortic valve implantation permanent pacemaker implantation The aortic valve is in close anatomical relationship with the AV node and left bundle branch. The AV node is located in the right atrium in proximity to the septal part of the tricuspid valve and to the muscular ventricular septum in continuity with the aortic valve cusps.76 At a lower level of the conduction system, the LVOT is in close relationship with the left bundle branch.76 Direct mechanical trauma or compression of the AV node or the left bundle branch by balloon dilatation or prosthesis implantation can cause a high-degree AV block or LBBB during or after TAVI.6 Pre-existing damage of the conduction system, such as the RBBB, increases the risk of advanced conduction abnormalities after TAVI requiring PPI. Particularly, the presence of RBBB has been independently associated with the need for PPI in several studies using the SAPIEN 3,16–19,40 Lotus,23 and the CoreValve Evolut R35 prostheses. Auffret et al.,77 in their multicentre study including 3527 patients treated with TAVI, showed that 10% of the patients had pre-existing RBBB. The presence of RBBB at discharge was associated with the composite endpoint of sudden cardiac death and PPI with a hazard ratio of 2.68. Electrophysiological studies performed after TAVI have shown damage of the AV node, the His, and the infra-His system.78,79 In a study including 84 patients (33% treated with Edwards SAPIEN valve and 67% with the CoreValve system), the presence of persistent complete AV block during the procedure and postoperative high-degree AV block were the only factors associated with the need for PPI at follow-up, whereas the serial measurements of the HV interval could not predict the need for PPI.80 Compression of the left bundle branch by the prosthesis or periprocedural oedema of the LVOT in patients with pre-existent RBBB causes complete AV block. However, it remains difficult to predict whether the AV block will be permanent or transitory. When the damage of the left bundle branch is caused by oedema of the interventricular septum resulting from oversized balloons, the function of the left bundle branch may be recovered upon resolution of the oedema. However, there is no method to image the presence of oedema after TAVI and to predict the recovery of the left bundle branch function because the artefacts that the prosthetic frame causes on cardiovascular magnetic resonance preclude reliable assessment of this phenomenon. In addition, atrial fibrillation has been independently associated with the need for PPI in patients treated with the SAPIEN 3 (odds ratio 3.996, 95% confidence interval 1.567–10.192).17 In patients with atrial fibrillation treated with TAVI, Tovia-Brodie et al.79 used a heart rate <100 b.p.m. as a marker of intrinsic AV node dysfunction and demonstrated that 50% of these patients may show infranodal conduction disturbances on electrophysiological study. Anatomical factors associated with permanent pacemaker implantation after transcatheter aortic valve implantation The presence and distribution of calcifications underneath the aortic annulus plane and affecting the interventricular septum (landing zone) are the anatomical factors that have been associated with the need for PPI.18,19 Computed tomography used to size the aortic annulus and select the prosthesis size provides important information in this regard. Mauri et al.19 found a strong association between dense calcification in the LVOT under the left and right coronary cusps and the need for PPI after TAVI using the SAPIEN 3 valve. An asymmetrical calcium distribution may result in an oblique expansion of the prosthesis and uneven distribution of the mechanical stress on the AV conduction system. In patients undergoing TAVI with the Lotus valve, Dumonteil et al.23 showed that an increasing total volume of calcium in the LVOT was associated with the high risk of PPI (odds ratio 1.80 per 100 mm3 increase, 95% confidence interval 1.03–3.14). These findings suggest that it is important to assess the presence and distribution of the calcifications of the landing zone because careful procedural planning may reduce the risk of conduction abnormalities requiring PPI. By controlling the procedural factors associated with PPI after TAVI (modifiable factors), the PPI rate could decrease. Procedural factors associated with permanent pacemaker implantation after transcatheter aortic valve implantation Implantation depth into the LVOT is strongly associated with increased risk of PPI after TAVI, regardless of the prosthesis used. For the SAPIEN 3 valve, Mauri et al.19 showed that when >25.5% of the prosthesis frame is implanted into the ventricular side, the odds ratio of PPI was 15.7 (95% confidence interval 5.7–43.5) and the rate of PPI decreased from 19.2% to 9.2% when ≤21% of the prosthesis frame was implanted into the ventricular side (P = 0.038). Similarly, when using the CoreValve Evolut R, Gomes et al.35 demonstrated that there is an independent association between the implantation depth and the PPI rate. In addition, procedural overstretching of the LVOT resulting in more pressure on the surrounding conduction system appeared to be an independent predictor for a PPI after Lotus valve implantation in the 249 patients described by Dumonteil et al.23 The damage of the AV node and His bundle can occur as well during balloon valvuloplasty.78 In a series of 18 patients treated with the CoreValve system undergoing electrophysiological study before and after TAVI, Rubín et al.78 showed that the damage of the conduction system occurred during the balloon dilation of the valve in 43% of the patients. With the new TAVI prostheses, Abramowitz et al.41 demonstrated lower rate of PPI among patients in whom balloon dilation was not performed (11.5% vs. 14.3%). In addition, Toggweiler et al.47 hypothesized that the low PPI rate with the use of the ACURATE transcatheter heart valve system may be attributable to the relative low radial force that the inflow portion of this frame exerts on the surrounding AV conduction system. Furthermore, pre- and post-dilation occurred with balloons 1–2 mm smaller than the aortic annulus diameter, which may result in less damage of the conduction system.47 Future directions: integration of pre- and periprocedural data A wide range of PPI rates across the studies reflects the heterogeneous populations and procedural characteristics and therefore limits generalizability of the results. However, the results of this study suggest that careful pre-procedural evaluation of pre-existing conduction abnormalities and location of LVOT calcifications may assist procedural planning, particularly in terms of optimal prosthesis implantation depth into the LVOT, the need for balloon valvuloplasty, the balloon size, and the prosthesis type to minimize the risk of PPI. For example, in patients with pre-existing RBBB, atrial fibrillation and severe heterogeneous distribution of LVOT calcifications, a high prosthesis implant may reduce the risk of PPI. Understanding the design and conformation of the prostheses once deployed is also important to reduce the risk of PPI. The SAPIEN 3 prosthesis has a larger stent frame, but it also shortens significantly more from the ventricular side than the previous generations. In the SAPIEN 3 European approval trial, the recommendations on the positioning and deployment of the prostheses were slightly altered from those of the PARTNER II trial, and the central marker of the prosthesis should be positioned proximally to the base of the aortic cusps instead of placing it below the insertion point of the leaflets.10,11 This manoeuvre resulted in a significant decrease in PPI rate (from 13.3% to 4.0%). In addition, it would be important to study the time course of the conduction abnormalities induced after TAVI. Several studies have shown that these conduction disturbances are not permanent and patients may not be pacemaker dependent during follow-up.81–83 The study by Toggweiler et al.84, including 1064 patients treated with early- and new-generation devices, has shown that delayed high-degree AV block may occur up to 8 days post-procedure in 7% of patients. However, patients without conduction disorders immediately after TAVI did not show any delayed high-degree AV block, and therefore, the need for ECG monitoring beyond 48 h in those patients may not be needed.84 Currently, the prognostic implications for a PPI after TAVI are conflicting. The evidence arises mainly from early-generation prostheses. Pooled data from 9785 patients undergoing TAVI in the USA showed an increased 1-year mortality among patients who received a PPI after TAVI (hazard ratio 1.31, 95% confidence interval 1.09–1.58).5 In contrast, Urena et al.85 observed in 1556 patients that a PPI after TAVI has been associated with a lower risk of sudden cardiac death (hazard ratio 0.31, 95% confidence interval 0.11–0.85). In addition, a recent meta-analysis including 20 287 TAVI patients also did not observe an increased risk for all-cause and cardiovascular mortality in patients treated with a PPI.8 Of importance, PPI has been also associated with a significant decrease in the left ventricular function, which may impact on survival at long-term follow-up.5,8,85 For the new-generation TAVI devices, data regarding mortality or left ventricular function after a PPI are scarce. For the SAPIEN 3 prosthesis, Husser et al.17 observed a 30-day mortality of 3% in 34 patients (16.3% of the total 208 pacemaker naive patient cohort) who received a PPI, and this mortality rate was not significantly higher compared with the patients not treated with a PPI (P = 0.163).17 For the CoreValve Evolut R, Reardon et al.4 reported from the SURTAVI trial that there were no differences in 24-month mortality among patients who required a PPI compared with the counterparts who did not need PPI. However, this analysis involved both patients treated with the first-generation CoreValve (n = 724) as with the CoreValve Evolut R (n = 139).4 Conclusions The rate of PPI after TAVI with new-generation devices is highly variable and appears influenced by electrical factors (pre-existent conduction abnormalities), anatomical factors (calcification of the LVOT), and procedural factors (balloon valvuloplasty and depth of implantation). Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI. Furthermore, additional data on the time course of new-onset conduction abnormalities may help to refine the indication for PPI. Supplementary material Supplementary material is available at European Heart Journal online. Conflict of interest: The department of Cardiology received unrestricted research grants from Biotronik, Boston Scientific, Medtronic and Edwards Lifesciences. V.D. received speaker fees from Abbott Vascular. The remaining authors have nothing to disclose. References 1 Leon MB , Smith CR , Mack MJ , Makkar RR , Svensson LG , Kodali SK , Thourani VH , Tuzcu EM , Miller DC , Herrmann HC , Doshi D , Cohen DJ , Pichard AD , Kapadia S , Dewey T , Babaliaros V , Szeto WY , Williams MR , Kereiakes D , Zajarias A , Greason KL , Whisenant BK , Hodson RW , Moses JW , Trento A , Brown DL , Fearon WF , Pibarot P , Hahn RT , Jaber WA , Anderson WN , Alu MC , Webb JG. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients . N Engl J Med 2016 ; 374 : 1609 – 1620 . 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Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative) . Circulation 2011 ; 123 : 951 – 960 . Google Scholar CrossRef Search ADS 66 Calvi V , Conti S , Pruiti GP , Capodanno D , Puzzangara E , Tempio D , Di Grazia A , Ussia GP , Tamburino C. Incidence rate and predictors of permanent pacemaker implantation after transcatheter aortic valve implantation with self-expanding CoreValve prosthesis . J Interv Card Electrophysiol 2012 ; 34 : 189 – 195 . Google Scholar CrossRef Search ADS 67 Chorianopoulos E , Krumsdorf U , Pleger ST , Katus HA , Bekeredjian R. Incidence of late occurring bradyarrhythmias after TAVI with the self-expanding CoreValve((R)) aortic bioprosthesis . Clin Res Cardiol 2012 ; 101 : 349 – 355 . Google Scholar CrossRef Search ADS 68 De Carlo M , Giannini C , Bedogni F , Klugmann S , Brambilla N , De Marco F , Zucchelli G , Testa L , Oreglia J , Petronio AS. Safety of a conservative strategy of permanent pacemaker implantation after transcatheter aortic CoreValve implantation . Am Heart J 2012 ; 163 : 492 – 499 . Google Scholar CrossRef Search ADS 69 Munoz-Garcia AJ , Hernandez-Garcia JM , Jimenez-Navarro MF , Alonso-Briales JH , Dominguez-Franco AJ , Fernandez-Pastor J , Pena Hernandez J , Barrera Cordero A , Alzueta Rodriguez J , de Teresa-Galvan E. Factors predicting and having an impact on the need for a permanent pacemaker after CoreValve prosthesis implantation using the new Accutrak delivery catheter system . JACC Cardiovasc Interv 2012 ; 5 : 533 – 539 . Google Scholar CrossRef Search ADS 70 Simms AD , Hogarth AJ , Hudson EA , Worsnop VL , Blackman DJ , O’Regan DJ , Tayebjee MH. Ongoing requirement for pacing post-transcatheter aortic valve implantation and surgical aortic valve replacement . Interact Cardiovasc Thorac Surg 2013 ; 17 : 328 – 333 . Google Scholar CrossRef Search ADS 71 van der Boon RM , Van Mieghem NM , Theuns DA , Nuis RJ , Nauta ST , Serruys PW , Jordaens L , van Domburg RT , de Jaegere PP. Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System . Int J Cardiol 2013 ; 168 : 1269 – 1273 . Google Scholar CrossRef Search ADS 72 Schymik G , Tzamalis P , Bramlage P , Heimeshoff M , Wurth A , Wondraschek R , Gonska BD , Posival H , Schmitt C , Schrofel H , Luik A. Clinical impact of a new left bundle branch block following TAVI implantation: 1-year results of the TAVIK cohort . Clin Res Cardiol 2015 ; 104 : 351 – 362 . Google Scholar CrossRef Search ADS 73 Ledwoch J , Franke J , Gerckens U , Kuck KH , Linke A , Nickenig G , Krulls-Munch J , Vohringer M , Hambrecht R , Erbel R , Richardt G , Horack M , Zahn R , Senges J , Sievert H ; German Transcatheter Aortic Valve Interventions Registry Investigators . Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry . Catheter Cardiovasc Interv 2013 ; 82 : E569 – E577 . 74 Bleiziffer S , Ruge H , Horer J , Hutter A , Geisbusch S , Brockmann G , Mazzitelli D , Bauernschmitt R , Lange R. Predictors for new-onset complete heart block after transcatheter aortic valve implantation . JACC Cardiovasc Interv 2010 ; 3 : 524 – 530 . Google Scholar CrossRef Search ADS 75 Brignole M , Auricchio A , Baron-Esquivias G , Bordachar P , Boriani G , Breithardt OA , Cleland J , Deharo JC , Delgado V , Elliott PM , Gorenek B , Israel CW , Leclercq C , Linde C , Mont L , Padeletti L , Sutton R , Vardas PE ESC Committee for Practice Guidelines Zamorano JL , Achenbach S , Baumgartner H , Bax JJ , Bueno H , Dean V , Deaton C , Erol C , Fagard R , Ferrari R , Hasdai D , Hoes AW , Kirchhof P , Knuuti J , Kolh P , Lancellotti P , Linhart A , Nihoyannopoulos P , Piepoli MF , Ponikowski P , Sirnes PA , Tamargo JL , Tendera M , Torbicki A , Wijns W , Windecker S , Document R , Kirchhof P , Blomstrom-Lundqvist C , Badano LP , Aliyev F , Bansch D , Baumgartner H , Bsata W , Buser P , Charron P , Daubert JC , Dobreanu D , Faerestrand S , Hasdai D , Hoes AW , Le Heuzey JY , Mavrakis H , McDonagh T , Merino JL , Nawar MM , Nielsen JC , Pieske B , Poposka L , Ruschitzka F , Tendera M , Van Gelder IC , Wilson CM. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA) . Eur Heart J 2013 ; 34 : 2281 – 2329 . Google Scholar CrossRef Search ADS 76 Kawashima T , Sato F. Visualizing anatomical evidences on atrioventricular conduction system for TAVI . Int J Cardiol 2014 ; 174 : 1 – 6 . Google Scholar CrossRef Search ADS 77 Auffret V , Webb JG , Eltchaninoff H , Munoz-Garcia AJ , Himbert D , Tamburino C , Nombela-Franco L , Nietlispach F , Moris C , Ruel M , Dager AE , Serra V , Cheema AN , Amat-Santos IJ , de Brito FS Jr , Lemos PA , Abizaid A , Sarmento-Leite R , Dumont E , Barbanti M , Durand E , Alonso Briales JH , Vahanian A , Bouleti C , Imme S , Maisano F , Del Valle R , Benitez LM , Garcia Del Blanco B , Puri R , Philippon F , Urena M , Rodes-Cabau J. Clinical impact of baseline right bundle branch block in patients undergoing transcatheter aortic valve replacement . JACC Cardiovasc Interv 2017 ; 10 : 1564 – 1574 . Google Scholar CrossRef Search ADS 78 Rubin JM , Avanzas P , del Valle R , Renilla A , Rios E , Calvo D , Lozano I , Anguera I , Diaz-Molina B , Cequier A , Moris de la Tassa C. Atrioventricular conduction disturbance characterization in transcatheter aortic valve implantation with the CoreValve prosthesis . Circ Cardiovasc Interv 2011 ; 4 : 280 – 286 . Google Scholar CrossRef Search ADS 79 Tovia-Brodie O , Ben-Haim Y , Joffe E , Finkelstein A , Glick A , Rosso R , Belhassen B , Michowitz Y. The value of electrophysiologic study in decision-making regarding the need for pacemaker implantation after TAVI . J Interv Card Electrophysiol 2017 ; 48 : 121 – 130 . Google Scholar CrossRef Search ADS 80 Badenco N , Chong-Nguyen C , Maupain C , Himbert C , Duthoit G , Waintraub X , Chastre T , Gandjbakhch E , Hidden-Lucet F , Le Prince P , Collet JP , Frank R. Respective role of surface electrocardiogram and his bundle recordings to assess the risk of atrioventricular block after transcatheter aortic valve replacement . Int J Cardiol 2017 ; 236 : 216 – 220 . Google Scholar CrossRef Search ADS 81 Naveh S , Perlman GY , Elitsur Y , Planer D , Gilon D , Leibowitz D , Lotan C , Danenberg H , Alcalai R. Electrocardiographic predictors of long-term cardiac pacing dependency following transcatheter aortic valve implantation . J Cardiovasc Electrophysiol 2017 ; 28 : 216 – 223 . Google Scholar CrossRef Search ADS 82 Petronio AS , Sinning JM , Van Mieghem N , Zucchelli G , Nickenig G , Bekeredjian R , Bosmans J , Bedogni F , Branny M , Stangl K , Kovac J , Schiltgen M , Kraus S , de Jaegere P. Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the Medtronic CoreValve System: the CoreValve prospective, international, post-market ADVANCE-II Study . JACC Cardiovasc Interv 2015 ; 8 : 837 – 846 . Google Scholar CrossRef Search ADS 83 Renilla A , Rubin JM , Rozado J , Moris C. Long-term evolution of pacemaker dependency after percutaneous aortic valve implantation with the corevalve prosthesis . Int J Cardiol 2015 ; 201 : 61 – 63 . Google Scholar CrossRef Search ADS 84 Toggweiler S , Stortecky S , Holy E , Zuk K , Cuculi F , Nietlispach F , Sabti Z , Suciu R , Maier W , Jamshidi P , Maisano F , Windecker S , Kobza R , Wenaweser P , Luscher TF , Binder RK. The electrocardiogram after transcatheter aortic valve replacement determines the risk for post-procedural high-degree AV block and the need for telemetry monitoring . JACC Cardiovasc Interv 2016 ; 9 : 1269 – 1276 Google Scholar CrossRef Search ADS 85 Urena M , Webb JG , Tamburino C , Munoz-Garcia AJ , Cheema A , Dager AE , Serra V , Amat-Santos IJ , Barbanti M , Imme S , Briales JH , Benitez LM , Al Lawati H , Cucalon AM , Garcia Del Blanco B , Lopez J , Dumont E , Delarochelliere R , Ribeiro HB , Nombela-Franco L , Philippon F , Rodes-Cabau J. Permanent pacemaker implantation after transcatheter aortic valve implantation: impact on late clinical outcomes and left ventricular function . Circulation 2014 ; 129 : 1233 – 1243 . Google Scholar CrossRef Search ADS Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Heart Journal Oxford University Press

Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review

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Oxford University Press
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.
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0195-668X
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1522-9645
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10.1093/eurheartj/ehx785
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Abstract

Abstract Aims The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. Methods and results According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3–37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7–26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI. Conclusion The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI. Transcatheter aortic valve implantation, Pacemaker , New-generation device, Systematic review Introduction Technological developments in transcatheter aortic valve implantation (TAVI) have facilitated the procedure and reduced significantly the incidence of vascular complications and paravalvular regurgitation, leading to an exponential increase of this therapy in patients with symptomatic severe aortic stenosis and contraindications or high risk for surgical aortic valve replacement and, recently, in patients with intermediate operative risk.1,2 However, there remain some concerns when considering TAVI for low operative risk patients. Compared with surgical aortic valve replacement, TAVI has been associated with higher rates of permanent pacemaker implantation (PPI) after the procedure.3,4 Current evidence indicates that several electrical, anatomical, and procedural factors are associated with the need for PPI after TAVI.5,6 For early-generation TAVI prostheses (Figure 1), age and pre-existent and procedure-induced conduction abnormalities and the use of a self-expandable prosthesis were the factors significantly associated with the increased risk of PPI.5,6 However, the incidence of PPI when using new-generation prostheses have not been extensively evaluated (Figure 1). In addition, the factors associated with the increased risk of PPI with these new devices have not been studied. Bearing in mind that the indication for TAVI is expanding towards younger and lower surgical risk patients, it is important to understand the patient and procedural characteristics associated with post-procedural PPI. In this systematic review, the incidence of PPI across different new-generation TAVI prostheses was analysed and compared with the incidence of PPI with the use of early-generation devices (as reported in the literature).6–8 In addition, the various electrical, anatomical, and procedural characteristics that are associated with PPI with the new-generation devices were reviewed. Figure 1 View largeDownload slide Early- and new-generation transcatheter aortic valves: (A) SAPIEN Edwards, (B) SAPIEN XT, (C) Medtronic CoreValve, (D) SAPIEN 3, (E) CoreValve Evolut R, (F) ACURATE transcatheter heart valve system, (G) Lotus valve, (H) Direct Flow Medical Transcatheter Aortic Valve System, (I) JenaValve, and (J) Portico. THV, transcatheter heart valve. Figure 1 View largeDownload slide Early- and new-generation transcatheter aortic valves: (A) SAPIEN Edwards, (B) SAPIEN XT, (C) Medtronic CoreValve, (D) SAPIEN 3, (E) CoreValve Evolut R, (F) ACURATE transcatheter heart valve system, (G) Lotus valve, (H) Direct Flow Medical Transcatheter Aortic Valve System, (I) JenaValve, and (J) Portico. THV, transcatheter heart valve. Methods Search strategy and selection criteria This systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist.9 Studies reporting on the rate of PPI after TAVI with new-generation prostheses (SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA; CoreValve Evolut R, Medtronic, Minneapolis, MN, USA; Lotus, Boston Scientific, Marlborough, MA, USA; Direct Flow Medical Transcatheter Aortic Valve System, Direct Flow Medical Inc., Santa Rosa, CA, USA; Portico, St. Jude Medical, St Paul, MN, USA; JenaValve, JenaValve Technology GmbH, Munich, Germany; and ACURATE transcatheter heart valve system, SYMETIS SA, Eclubens, Switzerland) were included. The PubMed database was searched entering the following keywords: ‘transcatheter aortic valve’, ‘TAVI’, ‘TAVR’, ‘aortic valve’, ‘transcatheter’, ‘pacemaker’. Original articles published between October 2010 and October 2017 were screened. Two investigators (P.v.R. and V.D.) independently reviewed the titles and abstracts of the original articles obtained in the initial search and selected the articles that reported on the PPI rate after implantation of new-generation transcatheter aortic valve prostheses, included ≥100 patients, and were published in English in a peer-reviewed journal. If considered eligible, the full article was scrutinized for inclusion, and the reference list and articles citing the included study (as provided by Google Scholar) were reviewed. To minimize the potential bias introduced by the experience and learning curve, studies including <100 patients treated with a new-generation transcatheter valve prosthesis, and studies that did not report on the PPI rate (or that clustered the PPI rate of earlier and new-generation prostheses) were excluded. In addition, for studies with overlapping patient populations, we selected the study with the largest population reporting on the PPI rate. Finally, abstracts and unpublished data presented at major international cardiology congresses were not considered for this analysis. The final search ended on 1 November 2017. To compare the post-procedural PPI incidence between new and early-generation (Edwards SAPIEN, SAPIEN XT, and Medtronic CoreValve) prostheses, recent systematic reviews and meta-analyses investigating the occurrence of a PPI after early-generation TAVI prostheses were considered.6–8 In addition, studies from the initial PubMed database search were rescreened for this specific purpose to find the possible studies that had not been included in the meta-analyses.6–8 Studies evaluating the incidence of PPI after early-generation prostheses were included by the same selection criteria as for the studies on new-generation prostheses. Data extraction For each original article included in the systematic review, the following characteristics were extracted: year of publication, design of the study, number of patients, age, gender, operative risk score [logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), or the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score], baseline heart rhythm (sinus rhythm, atrial fibrillation, and pacemaker rhythm), time of follow-up, and number of PPI after TAVI. In addition, the PPI rates that included pacemaker implantation prior to TAVI in the calculation were carefully scrutinized. Furthermore, data on several electrical, anatomical, and procedural factors that may influence the PPI rate were evaluated. Specifically, the electrical factors included the presence of different pre-existent conduction abnormalities: atrial fibrillation, atrioventricular (AV) block, PR interval duration, and right or left bundle branch block. The anatomical factors included the association between the calcification burden of the landing zone [left ventricular outflow tract (LVOT) and aortic valve] and the length of the membranous interventricular septum vs. the need for PPI. Finally, the procedural factors included the implantation depth of the device, coaxiality of the implantation, prosthesis oversizing, and the need for reballooning. Statistical analysis Categorical data are presented as frequencies and percentages. Frequencies of post-TAVI PPI are presented in a histogram using GraphPad Prism software (version 7.00, GraphPad Software, La Jolla, CA, USA). According to the post-TAVI PPI rates, quintiles were calculated using SPSS software (version 23.0; IBM Corp., Armonk, NY, USA). The studies within the highest and the lowest quintiles were evaluated and compared. Results After screening the titles and abstracts of 1406 original articles that were identified in the first search, 348 articles were examined for full text. Finally, 40 studies reporting on PPI after new-generation TAVI prostheses were included (Figure 2A). Figure 2 View largeDownload slide (A) Study selection: new-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. (B) Study selection: early-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using early-generation prostheses. Figure 2 View largeDownload slide (A) Study selection: new-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. (B) Study selection: early-generation transcatheter heart valve prostheses. Flow chart displaying the results in each step of the systematic search to identify the studies reporting on the frequency of new pacemaker implantation after transcatheter aortic valve implantation using early-generation prostheses. The characteristics of the study populations stratified according to the type of new-generation TAVI prosthesis are presented in Supplementary material online, Table S1A4,10–48 and the frequencies of post-TAVI PPI are plotted in Figure 3. For the Edwards SAPIEN 3 prosthesis, 7017 patients were evaluated in 17 studies, including the randomized Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial10 and three prospective registries.11–13 For this transcatheter valve prosthesis, the post-TAVI PPI rate ranged from 4.0%11 to 24%.14 Nine of the studies including patients treated with the SAPIEN 3 reported the criteria used for PPI (see Supplementary material online, Table S1A).11,13,15–21 For this device, reported mean time intervals between TAVI and the placement of a PPI were 3.5 ± 4.1 days,19 4.25 ± 3.3 days16 and 3.3 ± 3.0 days.14 Figure 3 View largeDownload slide Histograms showing the incidence of permanent pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. Figure 3 View largeDownload slide Histograms showing the incidence of permanent pacemaker implantation after transcatheter aortic valve implantation using new-generation prostheses. For the Lotus valve, data for 2184 patients from 7 studies were available.22–28 The reported post-TAVI PPI rates ranged from 27.9%22 to 36.1%,28 and complete or second-degree Mobitz II AV blocks were the most frequent indications for PPI. Of the patients who were treated with PPI after the TAVI in the REPRISE II trial, 25% received the PPI on post-procedural Day 1, 37.5% between Day 1 and Day 3, and the remainder between Day 4 and Day 14.23 The median TAVI–PPI time interval in the UK Lotus Registry was 3.0 ± 3.4 days.27 For the Direct Flow Medical Valve (Direct Flow Medical Inc.), 5 studies totalling 724 patients were included.29–32,49 In the prospective DISCOVER study (Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18 Fr System for the Treatment of Patients with Severe Aortic Stenosis), the post-TAVI PPI rate was 17.0%.49 Naber et al.32 described the largest patient population treated with this device (n = 250) in the prospective, European multicentre registry and reported a post-TAVI PPI rate of 12.0%. The CoreValve Evolut R prosthesis was evaluated in 8 studies, including a total of 6017 patients. Post-TAVI PPI rates varied from 14.7%, as reported by Kalra et al.33 to 26.7% in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial.4 Data from the latest report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry revealed a post-TAVI PPI rate of 18.3% in 3810 patients who were treated with this device.34 Reported TAVI–PPI intervals were 2–3 days.33,35 The Portico prosthesis was evaluated in a prospective, multicentre study including 222 patients, and the reported incidence of PPI after TAVI was 13.5%.36 Only one study including patients treated with the JenaValve system fulfilled the inclusion criteria.37 Silaschi et al.,37 in their prospective multicentre study, showed a post-TAVI PPI rate of 14.4%. Finally, data from 795 patients treated with the ACURATE transcatheter heart valve system were evaluated.38,39,47,50 Toggweiler et al.47 reported a post-TAVI PPI rate of 2.3% in 175 patients. In the studies by Börgermann et al.38 (n = 500) and Hamm et al.39 (n = 120), the PPI rates were 10.2% and 9.6%, respectively. To compare these incidences with those reported by studies including only early-generation devices, the studies included in recent systematic reviews and meta-analyses were scrutinized.6–8 In addition, from the initial literature search, four additional studies not included in the systematic reviews and meta-analyses were included in this analysis.50–53 Twenty-seven studies evaluating the PPI incidence with the use of early-generation TAVI prostheses fulfilled the selection criteria and were finally included (Figure 2B, see Supplementary material online, Table S1B).40,50–71 For the early-generation SAPIEN devices, the post-TAVI PPI rate ranged from 2.3% in the PARTNER EU trial (n = 130)54 to 17.3% in the randomized controlled CHOICE trial (n = 121 SAPIEN XT vs. n = 120 CoreValve).50 However, this PPI rate increased up to 28.2% in a single-centre study, including 110 patients without a previous pacemaker who were treated with early-generation SAPIEN devices.55 Regarding the early generation of the CoreValve, the PPI rate ranged from 16.3% in the Italian CoreValve Registry56 to 37.7% in the CHOICE trial.50 Comparison of studies with high vs low permanent pacemaker implantation rate after new-generation prostheses The studies were categorized according to the post-TAVI PPI rate quintiles, and the studies within the lowest (<12.1%) and the highest (>26.0%) quintile were compared (Table 1).4,10,11,13,22–28,30,32,38,39,42,47,48 The number of patients within the group of the lowest PPI rate quintile was larger than the highest quintile group (5152 vs. 2323). Patients within the highest PPI rate quintile were more frequently women than the lowest quintile group (50.9% vs. 46.3%, P < 0.001). The proportion of patients who had atrial fibrillation was lower in the lowest PPI quintile group (29.3% vs. 31.9%, P = 0.029). No other significant differences were observed. Table 1 Studies according to the lowest and highest quintile of pacemaker implantation Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% ACC, American College of Cardiology; AF, atrial fibrillation; AV, atrioventricular; LBBB, left bundle branch block; ND, not determined; RBBB, right bundle branch block; STS, Society of Thoracic Surgeons; TVT, transcatheter valve therapy. Table 1 Studies according to the lowest and highest quintile of pacemaker implantation Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% Author/prosthesis Year Design Number of patients Follow-up Including previous pacemaker New pacemaker Age (years) Male Risk score AF LBBB RBBB Criteria for new pacemaker First quintile: PPI rate 0–12.1%  Toggweiler et al.47/ACURATE 2017 Observational 175 30 days Yes (8.0%) 2.3% 83 ± 6 42% STS score 4.1 ± 2.4 19% 7% 9% Complete AV block 75%; delayed high-degree AV block 25% No 2.5%  Vahanian et al.11/SAPIEN 3 2016 Prospective observational 101 30 days Yes (6.9%) 4.0% 84.4 ± 3.8 45.5% Logistic EuroSCORE 13.2 ± 3.8 22.9% ND ND Physician’s discretion, complete AV block 50%; second AV block 25%; atrial flutter+LBBB 25% No 4.3%  Rogers et al.48/SAPIEN 3 2017 Observational 183 30 days Yes (25.3%) 4.7% 81 ± 9 53.6% STS score 6.5 ± 6.3 39.3% ND ND  Hamm et al.39/ACURATE 2017 Prospective observational 120 217 ± 188  days Yes (4.2%) 9.6% 81.4 ± 3.8 33.3% Logistic EuroSCORE 15.0 ± 9.9 20.8% ND ND AV block 85.2%; bradyarrythmia’s 11.1%; sick sinus syndrome 3.7%  Börgermann et al.38/ACURATE 2017 Prospective observational 500 1 year ND 10.2% 80.8 ± 6.1 46.2% Logistic EuroSCORE 23.4 ± 14.3 ND ND ND  Kodali et al.10/SAPIEN 3 2016 Prospective randomized High/inoperable risk 583 30 days Yes (16.3%) 11.2% 13.3% 82.7 ± 8.1 58.0% Logistic EuroSCORE II 8.6 ± 7.1 43.7% ND ND Intermediate risk 1078 30 days Yes (13.3%) 10.1% 81.9 ± 6.6 61.8% Logistic EuroSCORE II 5.4 ± 4.5 36.1% ND ND  Giannini et al.30/Direct Flow Medical Valve 2017 Observational 115 1 year No (14.8%) 11.2% 82 ± 8 49.6% Logistic EuroSCORE 20 ± 13 20.0% 12.2% 9.2% Complete AV block 72.7%; second AV block 18.2%; new LBBB+bradycardia 9.1%  Jochheim et al.42/SAPIEN 3 2015 Observational 100 30 days ND 12.0% 79.3 ± 8.1 54% EuroSCORE II 5.6 ± 5.3 19.0% ND ND  Wendler et al.13/SAPIEN 3 2017 Prospective observational 1947 30 days Yes (11.8%) 12% 81.6 ± 6.6 51.9% Logistic EuroSCORE 18.3 ± 13.2. 21.8% ND ND Complete AV block 68.2%  Naber et al.32/ Direct Flow Medical Valve 2016 Observational 250 30 days Yes (7%) 12.0% 82.5 ± 5.5 61% Logistic EuroSCORE 18.3 ± 13.6 39% ND ND Complete AV block 70% Fifth quintile: PPI rate: 26.4–36.1%  Reardon et al.4/CoreValve Evolut R 2017 Prospective randomized 139 30 days Yes (9.8%) 26.7% 79.9 ± 6.2 57.8% Logistic EuroSCORE 11.9 ± 7.6 28.1% ND ND  De Backer et al.22/Lotus 2016 Prospective observational 154 30 days ND 27.9% 82.2 ± 5.9 41.6% EuroSCORE II 5.3 ± 3.1 34.4% ND ND Complete AV block 74.4%; second AV block 9.3%; new LBBB+bradycardia 13.9%; trifascular block 2, 3%  Falk et al.24/Lotus 2017 Prospective observational 996 30 days Yes (13.3%) No 30.0% 80.8 ± 6.5 49.2% EuroSCORE II 8.0 ± 8.4 33.9% ND ND 34.6%  Rampat et al.27/Lotus 2016 Prospective observational 228 30 days Yes (11.8%) 31.80% 81.4 ± 7.6 53.5% Logistic EuroSCORE 17.5 ± 12.4 23.2% ND ND Complete AV block 71.9%; first AV block+LBBB 17.2%; unspecified 10.9%  Montone et al.25/Lotus 2017 Prospective observational 225 30 days Yes (13.3%) 31.8% 82.6 ± 6.3 48.4% Logistic EuroSCORE 17.6  ±  6.7 24.4% ND ND Complete AV block 64.5%; second AV block 35.5%  Dumonteil et al.23/Lotus 2016 Prospective observational 249 1 year Yes (9.3%) 32.0% at 30 days 83.7 ± 5.3 47.8% EuroSCORE II 6.5 ± 6.3 35.4% 6.2% 11.5% 30 days results: complete AV block 81.9%; atrial fibrillation+bradycardia 5.5%; new LBBB+bradycardia 1.4%; LBBB+first AV block 4.2%; LBBB+second AV block 1.4%; Trifascular block 1.4%; LBBB and electrophysiology study showing severe infranodal disease 4.2% No  Pilgrim et al.26/Lotus 2016 Prospective observational 130 30 days Yes (10.7%) 34.3% 82.9 ± 5.4 53.6% Logistic EuroSCORE 14.95 ± 8.62 ND ND ND  Seeger et al.28/Lotus 2017 Prospective observational 202 24 months Yes (9.4%) 36.1% 81.2 ± 5.2 43.3% Logistic EuroSCORE 13.2 ± 12.1 36.6% ND ND No 39.9% ACC, American College of Cardiology; AF, atrial fibrillation; AV, atrioventricular; LBBB, left bundle branch block; ND, not determined; RBBB, right bundle branch block; STS, Society of Thoracic Surgeons; TVT, transcatheter valve therapy. Studies analysing factors associated with permanent pacemaker implantation following transcatheter aortic valve implantation with new-generation prostheses Several studies investigated the factors associated with PPI after new-generation TAVI prosthesis (Table 2).12,15–19,21–23,35,40 Among the several electrical factors that could influence the PPI rate, multivariate analyses evaluating the SAPIEN 3 valve identified the presence of pre-procedural conduction abnormalities such as the right bundle branch block (RBBB),16–19,40 prolonged PR interval,16,40 and atrial fibrillation17 to be associated with post-procedural PPI. For the Lotus valve, Dumonteil et al.23 showed that RBBB and first-degree AV block were independent electrical determinants of post-procedural PPI. Similarly, for the CoreValve Evolut R, Gomes et al.35 found that pre-existent RBBB was the electrical factor independently associated with the need for PPI. Table 2 Characteristics associated with permanent pacemaker implantation following transcatheter aortic valve implantation with new generation prostheses Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 AV, atrioventricular; COPD, chronic obstructive pulmonary disease; LVOT, left ventricular outflow tract; RBBB, right bundle branch block. Table 2 Characteristics associated with permanent pacemaker implantation following transcatheter aortic valve implantation with new generation prostheses Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 Author Year Total population including previous pacemaker Population excluding previous pacemaker New pacemaker Multivariate predictor Odds ratio 95% Confidence interval P-value Remarks SAPIEN 3  Mauri et al.19 2016 — 229 14.4% RBBB 16.9 3.0–95.5 0.001 9.2% pacemaker rate with a high implantation technique LVOT non coronary calcification >3.2 mm3 0.8 0.2–2.9 0.736 LVOT right coronary calcification >4.8 mm3 4.7 1.6–14.1 0.005 LVOT left coronary calcification >13.7 mm3 3.7 1.3–10.6 0.016 Implantation depth >25.5% ventricular part of the stent frame 15.7 5.7–43.5 <0.001  De Torres-Alba et al.15 2016 — 162 19.1%% Implantation depth (% of stent length in the aorta) 0.95 0.91–0.99 0.025 12.3% after higher implantation technique  Husser et al.17 2016 — 208 16% RBBB 11.965 3.406–42.026 <0.001 Atrial fibrillation 3.996 1.567–10.192 0.004 Heart rate on admission (per b.p.m. increase) 0.941 0.907–0.977 0.001 Unspecified intraventricular conduction abnormality 10.022 1.644–61.083 0.012 COPD 4.660 1.513–14.405 0.007 Implantation depth at the non-septal side (per % of frame below annulus) 1.066 1.066–1.127 0.022  Sawaya et al.40 2016 283 248 17.3% RBBB 4.9 1.88–12.95 0.001 PR duration (per 10 ms increment) 1.14 1.00–1.29 0.05 Device lack of coaxiality during implant (per 1 mm increment) 1.13 1.00–1.29 0.05  Schwerg et al.21 2016 — 131 18.3% Low TAVI implantation (<2 mm from central marker to aortic cusp) 15.9 1.5–163 0.019 Implantation height of > 2 mm from central marker to aortic cusp resulted in a 4.7% pacemaker rate  Maeno et al.18 2017 — 240 14.6 RBBB 14.3 5.01–40.9 <0.001 Non-coronary cusp device-landing zone calcium volume (mm3) 1.02 1.02–1.06 <0.001 Difference between membranous septal length and valve implantation (mm) 1.68 1.36–2.08 <0.001  Gonska et al.16 2017 — 283 18.4% First-degree AV block 3.9 1.73–9.10 <0.01 RBBB 4.5 1.50–13.21 <0.01  Webb et al.12 2014 150 — 13.3% Suggestion for higher implantation Lotus  Dumonteil et al.23 2017 249 226 32.0% RBBB 12.70 4.45–36.22 <0.001 LVOT area overstretch >10% 3.42 1.74–6.74 <0.001 First-degree AV block 2.49 1.13–5.47 0.02 LVOT total calcium volume (per 100 mm3 increase) 1.80 1.03–3.14 0.04  De Backer et al.22 2016 154 — 27.9% 12.8% pacemaker rate in case of a combined implantation depth below 4 mm and a device/ annulus ratio of 1.05. Evolut R  Gomes et al.35 2017 100 77 23.3% RBBB 4 <0.05 Implantation depth (mm) 1.2 <0.001 AV, atrioventricular; COPD, chronic obstructive pulmonary disease; LVOT, left ventricular outflow tract; RBBB, right bundle branch block. Regarding the anatomical factors potentially influencing the need for PPI, data from computed tomography scans performed in patients treated with the SAPIEN 3 showed that the amount of calcification in the device landing zone was independently associated with post-TAVI PPI.18,19 Similarly, for the Lotus valve, Dumonteil et al.23 showed an independent association between the amount of LVOT calcification as assessed with CT and increased risk of post-TAVI PPI. Furthermore, among the various procedural determinants, the implantation depth of the SAPIEN 3 was identified as an independent correlate of post-procedural PPI in several studies.15,17–19,21 Data from the REPRISE II study, including the extended cohort, showed that >10% overstretch of the LVOT was an independent procedural factor associated with increased post-TAVI PPI when a Lotus valve was implanted.23 In contrast, a deep implantation of the Louts valve (>5 mm deep into the LVOT) was associated with increased risk of PPI.23 When using the CoreValve Evolut R, Gomes et al.35 also showed that the implantation depth was a procedural factor independently associated with the need for PPI. The studies investigating the factors associated with PPI after early-generation TAVI prosthesis are provided in Supplementary material online, Table S2.3,29,55,61,65–69,72–74 Discussion In this systematic review, including 17 139 patients treated with new-generation TAVI prostheses, a wide range of post-TAVI PPI rates across various prostheses has been shown. The factors influencing this wide variability have not been fully elucidated, but the available evidence suggests that various electrical, anatomical, and procedural factors may explain these findings. Furthermore, it is important to note that some patients had a pacemaker prior to TAVI and the indication for PPI after TAVI varied significantly across the studies and not always fulfilled prevailing recommendations.75 Compared with early-generation devices, the PPI rates remain low with the balloon-expandable prostheses, whereas they have reduced with the new-generation of self-expandable CoreValve systems. Electrical factors associated with post-transcatheter aortic valve implantation permanent pacemaker implantation The aortic valve is in close anatomical relationship with the AV node and left bundle branch. The AV node is located in the right atrium in proximity to the septal part of the tricuspid valve and to the muscular ventricular septum in continuity with the aortic valve cusps.76 At a lower level of the conduction system, the LVOT is in close relationship with the left bundle branch.76 Direct mechanical trauma or compression of the AV node or the left bundle branch by balloon dilatation or prosthesis implantation can cause a high-degree AV block or LBBB during or after TAVI.6 Pre-existing damage of the conduction system, such as the RBBB, increases the risk of advanced conduction abnormalities after TAVI requiring PPI. Particularly, the presence of RBBB has been independently associated with the need for PPI in several studies using the SAPIEN 3,16–19,40 Lotus,23 and the CoreValve Evolut R35 prostheses. Auffret et al.,77 in their multicentre study including 3527 patients treated with TAVI, showed that 10% of the patients had pre-existing RBBB. The presence of RBBB at discharge was associated with the composite endpoint of sudden cardiac death and PPI with a hazard ratio of 2.68. Electrophysiological studies performed after TAVI have shown damage of the AV node, the His, and the infra-His system.78,79 In a study including 84 patients (33% treated with Edwards SAPIEN valve and 67% with the CoreValve system), the presence of persistent complete AV block during the procedure and postoperative high-degree AV block were the only factors associated with the need for PPI at follow-up, whereas the serial measurements of the HV interval could not predict the need for PPI.80 Compression of the left bundle branch by the prosthesis or periprocedural oedema of the LVOT in patients with pre-existent RBBB causes complete AV block. However, it remains difficult to predict whether the AV block will be permanent or transitory. When the damage of the left bundle branch is caused by oedema of the interventricular septum resulting from oversized balloons, the function of the left bundle branch may be recovered upon resolution of the oedema. However, there is no method to image the presence of oedema after TAVI and to predict the recovery of the left bundle branch function because the artefacts that the prosthetic frame causes on cardiovascular magnetic resonance preclude reliable assessment of this phenomenon. In addition, atrial fibrillation has been independently associated with the need for PPI in patients treated with the SAPIEN 3 (odds ratio 3.996, 95% confidence interval 1.567–10.192).17 In patients with atrial fibrillation treated with TAVI, Tovia-Brodie et al.79 used a heart rate <100 b.p.m. as a marker of intrinsic AV node dysfunction and demonstrated that 50% of these patients may show infranodal conduction disturbances on electrophysiological study. Anatomical factors associated with permanent pacemaker implantation after transcatheter aortic valve implantation The presence and distribution of calcifications underneath the aortic annulus plane and affecting the interventricular septum (landing zone) are the anatomical factors that have been associated with the need for PPI.18,19 Computed tomography used to size the aortic annulus and select the prosthesis size provides important information in this regard. Mauri et al.19 found a strong association between dense calcification in the LVOT under the left and right coronary cusps and the need for PPI after TAVI using the SAPIEN 3 valve. An asymmetrical calcium distribution may result in an oblique expansion of the prosthesis and uneven distribution of the mechanical stress on the AV conduction system. In patients undergoing TAVI with the Lotus valve, Dumonteil et al.23 showed that an increasing total volume of calcium in the LVOT was associated with the high risk of PPI (odds ratio 1.80 per 100 mm3 increase, 95% confidence interval 1.03–3.14). These findings suggest that it is important to assess the presence and distribution of the calcifications of the landing zone because careful procedural planning may reduce the risk of conduction abnormalities requiring PPI. By controlling the procedural factors associated with PPI after TAVI (modifiable factors), the PPI rate could decrease. Procedural factors associated with permanent pacemaker implantation after transcatheter aortic valve implantation Implantation depth into the LVOT is strongly associated with increased risk of PPI after TAVI, regardless of the prosthesis used. For the SAPIEN 3 valve, Mauri et al.19 showed that when >25.5% of the prosthesis frame is implanted into the ventricular side, the odds ratio of PPI was 15.7 (95% confidence interval 5.7–43.5) and the rate of PPI decreased from 19.2% to 9.2% when ≤21% of the prosthesis frame was implanted into the ventricular side (P = 0.038). Similarly, when using the CoreValve Evolut R, Gomes et al.35 demonstrated that there is an independent association between the implantation depth and the PPI rate. In addition, procedural overstretching of the LVOT resulting in more pressure on the surrounding conduction system appeared to be an independent predictor for a PPI after Lotus valve implantation in the 249 patients described by Dumonteil et al.23 The damage of the AV node and His bundle can occur as well during balloon valvuloplasty.78 In a series of 18 patients treated with the CoreValve system undergoing electrophysiological study before and after TAVI, Rubín et al.78 showed that the damage of the conduction system occurred during the balloon dilation of the valve in 43% of the patients. With the new TAVI prostheses, Abramowitz et al.41 demonstrated lower rate of PPI among patients in whom balloon dilation was not performed (11.5% vs. 14.3%). In addition, Toggweiler et al.47 hypothesized that the low PPI rate with the use of the ACURATE transcatheter heart valve system may be attributable to the relative low radial force that the inflow portion of this frame exerts on the surrounding AV conduction system. Furthermore, pre- and post-dilation occurred with balloons 1–2 mm smaller than the aortic annulus diameter, which may result in less damage of the conduction system.47 Future directions: integration of pre- and periprocedural data A wide range of PPI rates across the studies reflects the heterogeneous populations and procedural characteristics and therefore limits generalizability of the results. However, the results of this study suggest that careful pre-procedural evaluation of pre-existing conduction abnormalities and location of LVOT calcifications may assist procedural planning, particularly in terms of optimal prosthesis implantation depth into the LVOT, the need for balloon valvuloplasty, the balloon size, and the prosthesis type to minimize the risk of PPI. For example, in patients with pre-existing RBBB, atrial fibrillation and severe heterogeneous distribution of LVOT calcifications, a high prosthesis implant may reduce the risk of PPI. Understanding the design and conformation of the prostheses once deployed is also important to reduce the risk of PPI. The SAPIEN 3 prosthesis has a larger stent frame, but it also shortens significantly more from the ventricular side than the previous generations. In the SAPIEN 3 European approval trial, the recommendations on the positioning and deployment of the prostheses were slightly altered from those of the PARTNER II trial, and the central marker of the prosthesis should be positioned proximally to the base of the aortic cusps instead of placing it below the insertion point of the leaflets.10,11 This manoeuvre resulted in a significant decrease in PPI rate (from 13.3% to 4.0%). In addition, it would be important to study the time course of the conduction abnormalities induced after TAVI. Several studies have shown that these conduction disturbances are not permanent and patients may not be pacemaker dependent during follow-up.81–83 The study by Toggweiler et al.84, including 1064 patients treated with early- and new-generation devices, has shown that delayed high-degree AV block may occur up to 8 days post-procedure in 7% of patients. However, patients without conduction disorders immediately after TAVI did not show any delayed high-degree AV block, and therefore, the need for ECG monitoring beyond 48 h in those patients may not be needed.84 Currently, the prognostic implications for a PPI after TAVI are conflicting. The evidence arises mainly from early-generation prostheses. Pooled data from 9785 patients undergoing TAVI in the USA showed an increased 1-year mortality among patients who received a PPI after TAVI (hazard ratio 1.31, 95% confidence interval 1.09–1.58).5 In contrast, Urena et al.85 observed in 1556 patients that a PPI after TAVI has been associated with a lower risk of sudden cardiac death (hazard ratio 0.31, 95% confidence interval 0.11–0.85). In addition, a recent meta-analysis including 20 287 TAVI patients also did not observe an increased risk for all-cause and cardiovascular mortality in patients treated with a PPI.8 Of importance, PPI has been also associated with a significant decrease in the left ventricular function, which may impact on survival at long-term follow-up.5,8,85 For the new-generation TAVI devices, data regarding mortality or left ventricular function after a PPI are scarce. For the SAPIEN 3 prosthesis, Husser et al.17 observed a 30-day mortality of 3% in 34 patients (16.3% of the total 208 pacemaker naive patient cohort) who received a PPI, and this mortality rate was not significantly higher compared with the patients not treated with a PPI (P = 0.163).17 For the CoreValve Evolut R, Reardon et al.4 reported from the SURTAVI trial that there were no differences in 24-month mortality among patients who required a PPI compared with the counterparts who did not need PPI. However, this analysis involved both patients treated with the first-generation CoreValve (n = 724) as with the CoreValve Evolut R (n = 139).4 Conclusions The rate of PPI after TAVI with new-generation devices is highly variable and appears influenced by electrical factors (pre-existent conduction abnormalities), anatomical factors (calcification of the LVOT), and procedural factors (balloon valvuloplasty and depth of implantation). Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI. Furthermore, additional data on the time course of new-onset conduction abnormalities may help to refine the indication for PPI. Supplementary material Supplementary material is available at European Heart Journal online. Conflict of interest: The department of Cardiology received unrestricted research grants from Biotronik, Boston Scientific, Medtronic and Edwards Lifesciences. V.D. received speaker fees from Abbott Vascular. The remaining authors have nothing to disclose. References 1 Leon MB , Smith CR , Mack MJ , Makkar RR , Svensson LG , Kodali SK , Thourani VH , Tuzcu EM , Miller DC , Herrmann HC , Doshi D , Cohen DJ , Pichard AD , Kapadia S , Dewey T , Babaliaros V , Szeto WY , Williams MR , Kereiakes D , Zajarias A , Greason KL , Whisenant BK , Hodson RW , Moses JW , Trento A , Brown DL , Fearon WF , Pibarot P , Hahn RT , Jaber WA , Anderson WN , Alu MC , Webb JG. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients . N Engl J Med 2016 ; 374 : 1609 – 1620 . 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European Heart JournalOxford University Press

Published: Feb 6, 2018

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