TY - JOUR
AU - , van Straten, Albert H M
AB - Abstract View largeDownload slide View largeDownload slide OBJECTIVES Sutureless and rapid-deployment aortic valve prostheses are frequently used for the treatment of aortic stenosis. However, postoperative left bundle branch block (LBBB) and permanent pacemaker (PPM) implantation have emerged as frequent complications. The aim of this study was to compare the incidence of new-onset LBBB and PPM implantation after sutureless aortic valve replacement (sAVR) with stented bioprostheses, and the impact on postoperative survival. METHODS Patients undergoing isolated surgical aortic valve replacement (AVR) or concomitant AVR with coronary artery bypass surgery between January 2010 and July 2017 were included in the study. Two groups were defined: sAVR and conventional AVR (cAVR). The findings of preoperative electrocardiograms were compared with postoperative electrocardiogram findings for both groups. The incidence of new-onset LBBB and the requirement for PPM implantation were recorded. The effect of these conduction disorders on late survival was analysed. RESULTS A total of 987 patients were analysed, consisting of 132 sAVR and 855 cAVR patients. The sAVR group had an increased incidence of new-onset LBBB compared to the cAVR group (16.7% vs 2.3%, P < 0.001). A significantly higher rate of postoperative PPM implantation was found for sAVR patients compared to cAVR (6.8% vs 1.6%, P = 0.001). The multivariate Cox analysis revealed that neither postoperative new-onset LBBB nor PPM implantation was associated with increased mortality (hazard ratio 1.73, 95% confidence interval 0.74–4.03, P = 0.204). CONCLUSIONS sAVR is associated with an increased risk of new-onset LBBB and PPM requirement compared to cAVR. In this population, postoperative conduction disorders did not affect the mid-term survival. Sutureless valve, Aortic valve replacement, Survival, Conduction, Pacemaker, Minimal invasive INTRODUCTION Conventional aortic valve replacement (cAVR) is the therapy of choice in patients experiencing symptomatic severe aortic valve stenosis [1]. However, since transcatheter aortic valve implantation (TAVI) has become the standard treatment in high-risk patients and non-inferiority has been proven in intermediate-risk patients, the indications for this alternative treatment modality is growing [2]. On the other hand, the emergence of self-expandable sutureless bioprostheses facilitates the growth of less invasive surgery. Initially, these novel bioprostheses were used as an alternative treatment strategy in elderly and high-risk surgical patients. Because of the satisfying haemodynamic results, increasing numbers of sutureless valve implantation procedures were performed [3, 4]. However, early reports on the Perceval S (LivaNova PLC, London, UK) sutureless bioprosthesis suggest higher rates of conduction disorders requiring permanent pacemaker (PPM) implantation [5–9]. Moreover, it is known that left bundle branch block (LBBB) after TAVI is a predictor of cardiovascular morbidity and mortality [10–12]. Therefore, the question arises as whether similar findings could be found in patients undergoing surgical sutureless aortic valve surgery. Currently, data on this issue are scarce. Because PPM rates with conventional stented aortic bioprostheses are low [13, 14], it is desirable that novel bioprostheses have similar results. The aim of our study is (i) to compare the incidence of new-onset LBBB and PPM implantation between sutureless and stented aortic valve prostheses and (ii) to evaluate the impact of postoperative LBBB and PPM implantation on mortality. PATIENTS AND METHODS Study population The study population was made up of all consecutive patients who underwent isolated surgical aortic valve replacement (AVR) or concomitant AVR with coronary artery bypass surgery (CABG) between January 2010 and July 2017 at the Catharina Hospital, Eindhoven. Patients with preoperative PPM, active endocarditis or requiring concomitant arrhythmia and valve surgery were excluded from the study. The study population was classified according to the implanted bioprosthesis. In the sutureless AVR group (sAVR), patients received the Perceval S (LivaNova PLC, London, UK) sutureless valve prosthesis. In the cAVR group, patients underwent implantation of either the Carpentier Edwards Magna Ease (Edwards Lifesciences, Irvine, CA, USA) or the Trifecta valve (St. Jude Medical, St Paul, MN, USA) stented bioprostheses. The need for informed consent was waived by the ethics committee. The Perceval S sutureless valve The Perceval S prosthesis is a sutureless aortic valve prosthesis composed of a biological component of bovine pericardium, mounted in an elastic nitinol stent. The design features 2 ring segments and 9 vertical struts covered by a thin coating of Carbofilm™ that allows the prosthesis to anchor to the aortic root and the sinuses of Valsalva. Because of the elastic alloy, the prosthesis can be compressed before implantation and then released for deployment. Before the initial implantation, 3 guiding sutures are positioned at the nadir of each cusp, 2 mm under the leaflet hinge point. The prosthesis is collapsed using atraumatic device compression and loaded onto a holder. The valve is positioned and released in the aortic root, the stabilized seating of the prosthesis relies on radial forces and the self-anchoring property of the valve prosthesis. Surgical procedure Patients eligible for isolated AVR underwent either a partial upper J-sternotomy or a full sternotomy. General anaesthesia with orotracheal intubation and standard cardiopulmonary bypass were used in all patients. A transverse aortotomy was performed 0.5–1.0 cm distal to the sinotubular junction. The native aortic valve was excised, followed by decalcification and sizing using an obturator. The valve is available in 4 sizes: small (19–21 mm), medium (21–23 mm), large (23–25 mm) and extra large (25–27 mm). Implantation of the Perceval prosthesis was performed as previously described. To optimize the area of contact between the aortic annulus and the valve prosthesis, balloon dilatation of the prosthesis was performed at 4 atmospheres for 30 s and irrigated with warm saline after deployment. The valve position was visually checked, the aortotomy was closed in the usual fashion and all patients received temporary pacing wires. After release of the aortic cross-clamp, the valve function was assessed using transoesophageal echocardiography. Data collection and follow-up All baseline and procedural data were collected retrospectively from a central computerized registry of the Department of Cardiothoracic Surgery. The electrocardiogram (ECG) findings of each patient were reviewed preoperatively and postoperatively at discharge by 2 independent reviewers. In case of difference in the evaluation, agreement was reached after discussion between the 2 reviewers. The presence of (new-onset) first- or third-degree atrioventricular block, right bundle branch block (RBBB) or LBBB were defined according to the American Heart Association/American College of Cardiology/Heart Rhythm Society recommendations for the standardization and interpretation of ECGs [15]. LBBB was defined as a V1-negative QRS complex ≥120 ms with absent Q-waves and a notched or slurred R-wave in leads I, aVL, V5 and/or V6. RBBB was defined as a QRS complex ≥120 ms with a triphasic QRS complex in V1, together with a dominant S-wave in leads I and V6. The indication for PPM implantation was established by an electrophysiologist in the presence of high-degree atrioventricular block (Mobitz II or third degree), preferably existing for more than 14 days. The primary end point of the study was the incidence of postoperative LBBB and/or new-onset PPM implantation at the time of hospital discharge. This outcome was compared in the 2 groups and adjusted for covariables that could be associated with postoperative conduction disorders including age, sex and cross-clamp time. Adjustment was also performed for baseline characteristics that were significantly different between the study groups including diabetes and chronic obstructive pulmonary disease. For this purpose, the multivariable logistic regression analysis was thus performed. Patients with preoperative LBBB or PPM implantation were excluded from this logistic regression analysis. The secondary end point was overall mortality defined as all-cause mortality occurring during the follow-up period (mean 3.0 ± 2.0 years). Follow-up data concerning mortality were gathered using the databases of the civil registry. As the databases of our institution and that of the municipal administration are directly coupled, we receive (Gemeentelijke basisadministratie), daily updates of the mortality data (follow-up date 28 September 2017). Statistical analysis Continuous variables are expressed as mean ± standard deviation and compared using the Student’s t-test for independent samples. Categorical data are expressed as percentages and compared using the χ2 test. The univariate Cox’s regression analyses were performed to determine the effect of baseline variables on postoperative mortality. Patients with preoperative conduction disorders were excluded from this analysis. Hazard ratios (HRs) and 95% confidence intervals (CIs) were determined. Characteristics in the univariate analysis with a P-value <0.10, postoperative PPM implantation and new-onset LBBB, were entered into a multivariate Cox’s regression model to analyse the effect of conduction disorders on postoperative all-cause mortality. Patients with preoperative conduction disorders or PPM implantation were excluded from the Cox regression model. All statistical analyses were performed using the Statistical Package for Social Sciences, version 23.0 (IBM Corp., Armonk, NY, USA). RESULTS Postoperative conduction disorders The study population consisted of 987 patients. Patient characteristics are presented in Table 1. One hundred and thirty-two patients were included in the sAVR group, and the cAVR group consisted of 855 patients (n = 398, the Carpentier Edwards Magna Ease valve; n = 457, the Trifecta valve). Postoperative complications were not significantly different between the 2 groups (Table 2). ECGs at discharge were lacking in 24 (2.4%) patients. Overall, the postoperative PPM implantation rate was 2.2% (n = 22), and the incidence of new-onset LBBB was 4.3% (n = 41) (Fig. 1). The timing of the PPM implantation varied from 7 to 33 days postoperatively (median 13, interquartile range 10–16). The sAVR group (6.8%, n = 9) had a significantly higher postoperative PPM rate compared to the cAVR group (1.6%, n = 13, P = 0.001). The incidence of new-onset LBBB was also higher in the sAVR group (16.7% vs 2.3%, P < 0.001). The postoperative first-degree atrioventricular block and RBBB were comparable between the 2 groups (16.7% vs 15.0%, P = 0.355; 4.5% vs 2.2%, P = 0.098, respectively). Table 1: Clinical characteristics of the study population Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Demographics  Age (years) 75.0 ± 6.4 72.2 ± 7.4 <0.001  Male gender (%) 72 (54.5) 539 (63.0) 0.039  BSA (m2) 1.86 ± 0.18 1.92 ± 0.21 0.001  Isolated AVR (%) 73 (55.3) 447 (52.3) 0.290  AVR + CABG (%) 59 (44.7) 408 (47.7) 0.290  Logistic EuroSCOREa 8.9 ± 7.5 6.8 ± 5.8 <0.001  Hypertension (%) 71 (53.8) 513 (60.0) 0.105  Diabetes (%) 40 (30.3) 188 (22.0) 0.025  Peripheral arterial disease (%) 15 (11.4) 93 (10.9) 0.482  COPD (%) 2 (1.5) 96 (11.2) <0.001  Dialysis (%) 1 (0.8) 5 (0.6) 0.578  Cerebrovascular event (%) 10 (7.6) 52 (6.1) 0.309  Good LVF (%) 126 (95.5) 830 (97.1) 0.225  Haemoglobin (mmol/L) 8.1 ± 1.1 8.5 ± 0.9 <0.001  Creatinine (µmol/l) 88 ± 38 93 ± 50 0.321  Prior cardiac surgery (%) 2 (1.5) 0 (0.0) 0.018 Baseline electrocardiogram  First-degree AV block (%) 9 (6.8) 150 (17.5) 0.001  Atrial fibrillation (%) 7 (5.3) 49 (5.7) 0.519  Left bundle branch block (%) 11 (8.3) 42 (4.9) 0.084  Right bundle branch block (%) 7 (5.3) 42 (4.9) 0.490  PR interval (ms) 169 ± 31 175 ± 33 0.073  QRS duration (ms) 106 ± 32 101 ± 21 0.033 Operative data  Minimally invasive surgery (%) 15 (11.4) 82 (9.6) 0.307  Aortic cross-clamp time (min) 55 ± 20 77 ± 26 <0.001  CPB time (min) 82 ± 27 104 ± 37 <0.001 Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Demographics  Age (years) 75.0 ± 6.4 72.2 ± 7.4 <0.001  Male gender (%) 72 (54.5) 539 (63.0) 0.039  BSA (m2) 1.86 ± 0.18 1.92 ± 0.21 0.001  Isolated AVR (%) 73 (55.3) 447 (52.3) 0.290  AVR + CABG (%) 59 (44.7) 408 (47.7) 0.290  Logistic EuroSCOREa 8.9 ± 7.5 6.8 ± 5.8 <0.001  Hypertension (%) 71 (53.8) 513 (60.0) 0.105  Diabetes (%) 40 (30.3) 188 (22.0) 0.025  Peripheral arterial disease (%) 15 (11.4) 93 (10.9) 0.482  COPD (%) 2 (1.5) 96 (11.2) <0.001  Dialysis (%) 1 (0.8) 5 (0.6) 0.578  Cerebrovascular event (%) 10 (7.6) 52 (6.1) 0.309  Good LVF (%) 126 (95.5) 830 (97.1) 0.225  Haemoglobin (mmol/L) 8.1 ± 1.1 8.5 ± 0.9 <0.001  Creatinine (µmol/l) 88 ± 38 93 ± 50 0.321  Prior cardiac surgery (%) 2 (1.5) 0 (0.0) 0.018 Baseline electrocardiogram  First-degree AV block (%) 9 (6.8) 150 (17.5) 0.001  Atrial fibrillation (%) 7 (5.3) 49 (5.7) 0.519  Left bundle branch block (%) 11 (8.3) 42 (4.9) 0.084  Right bundle branch block (%) 7 (5.3) 42 (4.9) 0.490  PR interval (ms) 169 ± 31 175 ± 33 0.073  QRS duration (ms) 106 ± 32 101 ± 21 0.033 Operative data  Minimally invasive surgery (%) 15 (11.4) 82 (9.6) 0.307  Aortic cross-clamp time (min) 55 ± 20 77 ± 26 <0.001  CPB time (min) 82 ± 27 104 ± 37 <0.001 The results are presented as mean ± standard deviation or absolute n (%). a The logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a score system ranging from 0% to 100% used to predict 30-day mortality of cardiovascular surgery. AV: atrioventricular; AVR: aortic valve replacement; BSA: body surface area; CABG: coronary artery bypass grafting; COPD: chronic obstructive pulmonary disease; CPB: cardiopulmonary bypass; LVF: left ventricular function. Table 1: Clinical characteristics of the study population Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Demographics  Age (years) 75.0 ± 6.4 72.2 ± 7.4 <0.001  Male gender (%) 72 (54.5) 539 (63.0) 0.039  BSA (m2) 1.86 ± 0.18 1.92 ± 0.21 0.001  Isolated AVR (%) 73 (55.3) 447 (52.3) 0.290  AVR + CABG (%) 59 (44.7) 408 (47.7) 0.290  Logistic EuroSCOREa 8.9 ± 7.5 6.8 ± 5.8 <0.001  Hypertension (%) 71 (53.8) 513 (60.0) 0.105  Diabetes (%) 40 (30.3) 188 (22.0) 0.025  Peripheral arterial disease (%) 15 (11.4) 93 (10.9) 0.482  COPD (%) 2 (1.5) 96 (11.2) <0.001  Dialysis (%) 1 (0.8) 5 (0.6) 0.578  Cerebrovascular event (%) 10 (7.6) 52 (6.1) 0.309  Good LVF (%) 126 (95.5) 830 (97.1) 0.225  Haemoglobin (mmol/L) 8.1 ± 1.1 8.5 ± 0.9 <0.001  Creatinine (µmol/l) 88 ± 38 93 ± 50 0.321  Prior cardiac surgery (%) 2 (1.5) 0 (0.0) 0.018 Baseline electrocardiogram  First-degree AV block (%) 9 (6.8) 150 (17.5) 0.001  Atrial fibrillation (%) 7 (5.3) 49 (5.7) 0.519  Left bundle branch block (%) 11 (8.3) 42 (4.9) 0.084  Right bundle branch block (%) 7 (5.3) 42 (4.9) 0.490  PR interval (ms) 169 ± 31 175 ± 33 0.073  QRS duration (ms) 106 ± 32 101 ± 21 0.033 Operative data  Minimally invasive surgery (%) 15 (11.4) 82 (9.6) 0.307  Aortic cross-clamp time (min) 55 ± 20 77 ± 26 <0.001  CPB time (min) 82 ± 27 104 ± 37 <0.001 Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Demographics  Age (years) 75.0 ± 6.4 72.2 ± 7.4 <0.001  Male gender (%) 72 (54.5) 539 (63.0) 0.039  BSA (m2) 1.86 ± 0.18 1.92 ± 0.21 0.001  Isolated AVR (%) 73 (55.3) 447 (52.3) 0.290  AVR + CABG (%) 59 (44.7) 408 (47.7) 0.290  Logistic EuroSCOREa 8.9 ± 7.5 6.8 ± 5.8 <0.001  Hypertension (%) 71 (53.8) 513 (60.0) 0.105  Diabetes (%) 40 (30.3) 188 (22.0) 0.025  Peripheral arterial disease (%) 15 (11.4) 93 (10.9) 0.482  COPD (%) 2 (1.5) 96 (11.2) <0.001  Dialysis (%) 1 (0.8) 5 (0.6) 0.578  Cerebrovascular event (%) 10 (7.6) 52 (6.1) 0.309  Good LVF (%) 126 (95.5) 830 (97.1) 0.225  Haemoglobin (mmol/L) 8.1 ± 1.1 8.5 ± 0.9 <0.001  Creatinine (µmol/l) 88 ± 38 93 ± 50 0.321  Prior cardiac surgery (%) 2 (1.5) 0 (0.0) 0.018 Baseline electrocardiogram  First-degree AV block (%) 9 (6.8) 150 (17.5) 0.001  Atrial fibrillation (%) 7 (5.3) 49 (5.7) 0.519  Left bundle branch block (%) 11 (8.3) 42 (4.9) 0.084  Right bundle branch block (%) 7 (5.3) 42 (4.9) 0.490  PR interval (ms) 169 ± 31 175 ± 33 0.073  QRS duration (ms) 106 ± 32 101 ± 21 0.033 Operative data  Minimally invasive surgery (%) 15 (11.4) 82 (9.6) 0.307  Aortic cross-clamp time (min) 55 ± 20 77 ± 26 <0.001  CPB time (min) 82 ± 27 104 ± 37 <0.001 The results are presented as mean ± standard deviation or absolute n (%). a The logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a score system ranging from 0% to 100% used to predict 30-day mortality of cardiovascular surgery. AV: atrioventricular; AVR: aortic valve replacement; BSA: body surface area; CABG: coronary artery bypass grafting; COPD: chronic obstructive pulmonary disease; CPB: cardiopulmonary bypass; LVF: left ventricular function. Table 2: Postoperative data Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Rethoracotomy (%) 7 (5.3) 59 (6.9) 0.321 Myocardial infarction (%) 1 (0.8) 10 (1.2) 0.555 Cerebrovascular event (%) 1 (0.8) 18 (2.1) 0.254 Mortality (%) 7 (5.3) 85 (9.9) 0.055 Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Rethoracotomy (%) 7 (5.3) 59 (6.9) 0.321 Myocardial infarction (%) 1 (0.8) 10 (1.2) 0.555 Cerebrovascular event (%) 1 (0.8) 18 (2.1) 0.254 Mortality (%) 7 (5.3) 85 (9.9) 0.055 Data are presented as n (%). AVR: aortic valve replacement. Table 2: Postoperative data Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Rethoracotomy (%) 7 (5.3) 59 (6.9) 0.321 Myocardial infarction (%) 1 (0.8) 10 (1.2) 0.555 Cerebrovascular event (%) 1 (0.8) 18 (2.1) 0.254 Mortality (%) 7 (5.3) 85 (9.9) 0.055 Sutureless AVR (n = 132) Conventional AVR (n = 855) P-value Rethoracotomy (%) 7 (5.3) 59 (6.9) 0.321 Myocardial infarction (%) 1 (0.8) 10 (1.2) 0.555 Cerebrovascular event (%) 1 (0.8) 18 (2.1) 0.254 Mortality (%) 7 (5.3) 85 (9.9) 0.055 Data are presented as n (%). AVR: aortic valve replacement. Figure 1: View largeDownload slide Postoperative conductive disorders for the sutureless aortic valve replacement and conventional aortic valve replacement groups. Percentage of postoperative PM implantation, new-onset LBBB and new-onset RBBB compared between patients receiving sutureless aortic valve replacement or conventional aortic valve replacement. An asterisk indicates a P-value of <0.05. LBBB: left bundle branch block; PM: pacemaker; RBBB: right bundle branch block. Figure 1: View largeDownload slide Postoperative conductive disorders for the sutureless aortic valve replacement and conventional aortic valve replacement groups. Percentage of postoperative PM implantation, new-onset LBBB and new-onset RBBB compared between patients receiving sutureless aortic valve replacement or conventional aortic valve replacement. An asterisk indicates a P-value of <0.05. LBBB: left bundle branch block; PM: pacemaker; RBBB: right bundle branch block. To exclude the learning curve as a variable, we compared the early with the late experience in implanting the sAVR. In the first 40 patients, new-onset LBBB and PPM rates were comparable with the remaining 92 patients (17.5% vs 16.3%, P = 0.525; 7.5% vs 6.5%, P = 0.550, respectively). Table 3 shows the results of the multivariable logistic regression analysis for factors associated with PPM implantation. After adjustment for other confounding factors, the Perceval sutureless bioprosthesis remains significantly associated with a higher incidence of PPM implantation (odds ratio 12.955, 95% CI 6.691–25.086; P < 0.0001). Table 3: Multivariable logistic regression analysis for factors associated with PPM implantation Variables OR (95% CI) P-value Perceval S bioprosthesisa 12.955 (6.691–25.086) <0.0001 Age 0.999 (0.960–1.039) 0.941 Male gender 0.575 (0.314–1.054) 0.074 Diabetes 1.114 (0.593–2.091) 0.737 COPD 0.238 (0.032–1.772) 0.161 Cross-clamp time 1.018 (1.008–1.029) 0.001 Variables OR (95% CI) P-value Perceval S bioprosthesisa 12.955 (6.691–25.086) <0.0001 Age 0.999 (0.960–1.039) 0.941 Male gender 0.575 (0.314–1.054) 0.074 Diabetes 1.114 (0.593–2.091) 0.737 COPD 0.238 (0.032–1.772) 0.161 Cross-clamp time 1.018 (1.008–1.029) 0.001 a Reference is stented bioprosthesis. CI: confidence interval; COPD: chronic obstructive pulmonary disease; PPM: permanent pacemaker; OR: odds ratio. Table 3: Multivariable logistic regression analysis for factors associated with PPM implantation Variables OR (95% CI) P-value Perceval S bioprosthesisa 12.955 (6.691–25.086) <0.0001 Age 0.999 (0.960–1.039) 0.941 Male gender 0.575 (0.314–1.054) 0.074 Diabetes 1.114 (0.593–2.091) 0.737 COPD 0.238 (0.032–1.772) 0.161 Cross-clamp time 1.018 (1.008–1.029) 0.001 Variables OR (95% CI) P-value Perceval S bioprosthesisa 12.955 (6.691–25.086) <0.0001 Age 0.999 (0.960–1.039) 0.941 Male gender 0.575 (0.314–1.054) 0.074 Diabetes 1.114 (0.593–2.091) 0.737 COPD 0.238 (0.032–1.772) 0.161 Cross-clamp time 1.018 (1.008–1.029) 0.001 a Reference is stented bioprosthesis. CI: confidence interval; COPD: chronic obstructive pulmonary disease; PPM: permanent pacemaker; OR: odds ratio. Effect of conduction disorders on mortality Overall mortality of the entire study population was 9.3% (n = 92) with a mean follow-up period of 3.0 ± 2.0 years (range 0.01–7.7). Mortality for the cAVR group was 9.9% (n = 85) compared to an overall mortality of 5.3% (n = 7) for the sAVR group (P = 0.107). The univariate analysis revealed that postoperative PPM implantation, new-onset LBBB and RBBB were not individually associated with mortality (Table 4). However, the combined end point of PPM and new-onset LBBB was a possible predictor for decreased survival (HR 2.03, 95% CI 0.93–4.44; P = 0.077). In addition, the following parameters were entered into a multivariate Cox regression analysis: age, diabetes, peripheral arterial disease, dialysis, haemoglobin levels and minimally invasive surgery. For postoperative PPM and LBBB, an HR of 1.73 was found suggesting a correlation with postoperative mortality. Age, peripheral arterial disease and dialysis were found to be independent predictors for all-cause mortality (Table 5). Table 4: Univariate Cox regression analysis for all-cause mortality after surgical AVR Hazard ratio Confidence interval P-value Demographics  Age (years) 1.06 1.02–1.10 0.001  Male gender 1.39 0.86–2.25 0.175  BSA (m2) 0.86 0.28–2.66 0.793  Isolated AVR 0.69 0.44–1.09 0.110  Hypertension 1.31 0.82–2.10 0.266  Diabetes 1.64 1.01–2.67 0.044  Peripheral arterial disease 2.58 1.52–4.37 <0.001  COPD 1.54 0.83–2.85 0.174  Dialysis 4.47 1.09–18.28 0.037  Cerebrovascular event 1.55 0.67–3.57 0.305  Good LVF 0.65 0.21–2.06 0.463  Haemoglobin (mmol/l) 0.74 0.59–0.94 0.013 Baseline electrocardiogram  First-degree AV block 0.78 0.39–1.57 0.490  PR interval (ms) 1.00 0.99–1.01 0.818  QRS duration (ms) 1.01 1.00–1.02 0.342 Operative data  Minimally invasive surgery 0.28 0.07–1.16 0.079  Aortic cross-clamp time (min) 1.00 1.00–1.01 0.371  CPB time (min) 1.00 1.00–1.01 0.232  Postoperative PM implantation 1.85 0.45–7.56 0.331  Postoperative new-onset LBBB 1.97 0.79–4.89 0.146  Postoperative new-onset RBBB 1.68 0.41–6.88 0.470  Combined PM + LBBB 2.03 0.93–4.44 0.077 Hazard ratio Confidence interval P-value Demographics  Age (years) 1.06 1.02–1.10 0.001  Male gender 1.39 0.86–2.25 0.175  BSA (m2) 0.86 0.28–2.66 0.793  Isolated AVR 0.69 0.44–1.09 0.110  Hypertension 1.31 0.82–2.10 0.266  Diabetes 1.64 1.01–2.67 0.044  Peripheral arterial disease 2.58 1.52–4.37 <0.001  COPD 1.54 0.83–2.85 0.174  Dialysis 4.47 1.09–18.28 0.037  Cerebrovascular event 1.55 0.67–3.57 0.305  Good LVF 0.65 0.21–2.06 0.463  Haemoglobin (mmol/l) 0.74 0.59–0.94 0.013 Baseline electrocardiogram  First-degree AV block 0.78 0.39–1.57 0.490  PR interval (ms) 1.00 0.99–1.01 0.818  QRS duration (ms) 1.01 1.00–1.02 0.342 Operative data  Minimally invasive surgery 0.28 0.07–1.16 0.079  Aortic cross-clamp time (min) 1.00 1.00–1.01 0.371  CPB time (min) 1.00 1.00–1.01 0.232  Postoperative PM implantation 1.85 0.45–7.56 0.331  Postoperative new-onset LBBB 1.97 0.79–4.89 0.146  Postoperative new-onset RBBB 1.68 0.41–6.88 0.470  Combined PM + LBBB 2.03 0.93–4.44 0.077 Hazard ratio and 95% confidence interval are presented. AV: atrioventricular; AVR: aortic valve replacement; BSA: body surface area; COPD: chronic obstructive pulmonary disease; CPB: cardiopulmonary bypass; LBBB: left bundle branch block; LVF: left ventricular function; PM: pacemaker; RBBB: right bundle branch block. Table 4: Univariate Cox regression analysis for all-cause mortality after surgical AVR Hazard ratio Confidence interval P-value Demographics  Age (years) 1.06 1.02–1.10 0.001  Male gender 1.39 0.86–2.25 0.175  BSA (m2) 0.86 0.28–2.66 0.793  Isolated AVR 0.69 0.44–1.09 0.110  Hypertension 1.31 0.82–2.10 0.266  Diabetes 1.64 1.01–2.67 0.044  Peripheral arterial disease 2.58 1.52–4.37 <0.001  COPD 1.54 0.83–2.85 0.174  Dialysis 4.47 1.09–18.28 0.037  Cerebrovascular event 1.55 0.67–3.57 0.305  Good LVF 0.65 0.21–2.06 0.463  Haemoglobin (mmol/l) 0.74 0.59–0.94 0.013 Baseline electrocardiogram  First-degree AV block 0.78 0.39–1.57 0.490  PR interval (ms) 1.00 0.99–1.01 0.818  QRS duration (ms) 1.01 1.00–1.02 0.342 Operative data  Minimally invasive surgery 0.28 0.07–1.16 0.079  Aortic cross-clamp time (min) 1.00 1.00–1.01 0.371  CPB time (min) 1.00 1.00–1.01 0.232  Postoperative PM implantation 1.85 0.45–7.56 0.331  Postoperative new-onset LBBB 1.97 0.79–4.89 0.146  Postoperative new-onset RBBB 1.68 0.41–6.88 0.470  Combined PM + LBBB 2.03 0.93–4.44 0.077 Hazard ratio Confidence interval P-value Demographics  Age (years) 1.06 1.02–1.10 0.001  Male gender 1.39 0.86–2.25 0.175  BSA (m2) 0.86 0.28–2.66 0.793  Isolated AVR 0.69 0.44–1.09 0.110  Hypertension 1.31 0.82–2.10 0.266  Diabetes 1.64 1.01–2.67 0.044  Peripheral arterial disease 2.58 1.52–4.37 <0.001  COPD 1.54 0.83–2.85 0.174  Dialysis 4.47 1.09–18.28 0.037  Cerebrovascular event 1.55 0.67–3.57 0.305  Good LVF 0.65 0.21–2.06 0.463  Haemoglobin (mmol/l) 0.74 0.59–0.94 0.013 Baseline electrocardiogram  First-degree AV block 0.78 0.39–1.57 0.490  PR interval (ms) 1.00 0.99–1.01 0.818  QRS duration (ms) 1.01 1.00–1.02 0.342 Operative data  Minimally invasive surgery 0.28 0.07–1.16 0.079  Aortic cross-clamp time (min) 1.00 1.00–1.01 0.371  CPB time (min) 1.00 1.00–1.01 0.232  Postoperative PM implantation 1.85 0.45–7.56 0.331  Postoperative new-onset LBBB 1.97 0.79–4.89 0.146  Postoperative new-onset RBBB 1.68 0.41–6.88 0.470  Combined PM + LBBB 2.03 0.93–4.44 0.077 Hazard ratio and 95% confidence interval are presented. AV: atrioventricular; AVR: aortic valve replacement; BSA: body surface area; COPD: chronic obstructive pulmonary disease; CPB: cardiopulmonary bypass; LBBB: left bundle branch block; LVF: left ventricular function; PM: pacemaker; RBBB: right bundle branch block. Table 5: Multivariable Cox regression analysis for all-cause mortality after surgical AVR Variables Hazard ratio Confidence interval P-value Age (year) 1.05 1.01–1.10 0.009 Diabetes 1.46 0.87–2.45 0.152 Peripheral arterial disease 2.22 1.23–4.00 0.008 Dialysis 6.34 1.52–26.46 0.011 Haemoglobin (mmol/l) 0.89 0.68–1.15 0.370 Minimally invasive surgery 0.39 0.10–1.61 0.193 Combined PM + LBBB 1.73 0.74–4.03 0.204 Variables Hazard ratio Confidence interval P-value Age (year) 1.05 1.01–1.10 0.009 Diabetes 1.46 0.87–2.45 0.152 Peripheral arterial disease 2.22 1.23–4.00 0.008 Dialysis 6.34 1.52–26.46 0.011 Haemoglobin (mmol/l) 0.89 0.68–1.15 0.370 Minimally invasive surgery 0.39 0.10–1.61 0.193 Combined PM + LBBB 1.73 0.74–4.03 0.204 Hazard ratio and 95% confidence interval are presented. LBBB: left bundle branch block; PM: pacemaker. Table 5: Multivariable Cox regression analysis for all-cause mortality after surgical AVR Variables Hazard ratio Confidence interval P-value Age (year) 1.05 1.01–1.10 0.009 Diabetes 1.46 0.87–2.45 0.152 Peripheral arterial disease 2.22 1.23–4.00 0.008 Dialysis 6.34 1.52–26.46 0.011 Haemoglobin (mmol/l) 0.89 0.68–1.15 0.370 Minimally invasive surgery 0.39 0.10–1.61 0.193 Combined PM + LBBB 1.73 0.74–4.03 0.204 Variables Hazard ratio Confidence interval P-value Age (year) 1.05 1.01–1.10 0.009 Diabetes 1.46 0.87–2.45 0.152 Peripheral arterial disease 2.22 1.23–4.00 0.008 Dialysis 6.34 1.52–26.46 0.011 Haemoglobin (mmol/l) 0.89 0.68–1.15 0.370 Minimally invasive surgery 0.39 0.10–1.61 0.193 Combined PM + LBBB 1.73 0.74–4.03 0.204 Hazard ratio and 95% confidence interval are presented. LBBB: left bundle branch block; PM: pacemaker. DISCUSSION In this study, we found a significantly higher incidence of new-onset LBBB and postoperative PPM implantation in AVR with sutureless bioprostheses, compared to the AVR with stented bioprostheses. Even after adjustment for relevant variables, sAVR was associated with higher incidence of postoperative LBBB and new-onset PPM implantation. According to earlier studies [9], these conduction disorders tended to have a higher postoperative mortality rate. In this study, however, this was not found to be significant due to the limited number of events. Predictors of conduction disorders after sutureless aortic valve replacement Several studies have reported that the use of the Perceval S bioprostheses is associated with a high rate of new-onset LBBB and PPM implantation [5, 7–9, 16]. This is in contrast with cAVR, where we found the incidence of postoperative LBBB and PPM implantation to be only 2.3% and 1.6%, respectively. Bouhout et al. [8] proposed the compression of the conduction system due to radial forces during deployment of the valve as a possible explanation. This is in concordance with the presumed induced conduction abnormalities by expansion of the prosthesis following TAVI, which also results in higher postoperative PPM rates [17, 18]. In addition, balloon inflation following deployment as the decalcification strategy has been speculated to be a contributing factor in developing conduction disorders [19, 20]. Mild to moderate annular decalcification could result in the presence of calcification and fibrous tissue causing compression of the membranous septum after deployment of the valve [20]. A similar explanation can be made with regard to the use of transcatheter prostheses, where the lack of decalcification may result in high-pressure compression of the atrioventricular bundle. Complete decalcification of the aortic annulus is mandatory in both cAVR and sAVR. It is also suggested that lower positioning of the guiding sutures for placing the prosthesis could lead to intraventricular conduction abnormalities. Yanagawa et al. [21] reported a reduction in postoperative PPM rates from 28% to 0% after adjusting the implantation position and placing it a few millimetres higher than recommended by the manufacturer. In addition, it is plausible that higher PPM rates can be related to valve sizing, and the large intra-annular sealing collar of the Perceval prostheses. Therefore, it is hypothesized that increased PPM rates are associated with larger prostheses sizes due to larger sealing collars compared to smaller ones. However, the indication and timing of PPM vary between different clinical centres. Despite our conservative approach, a significantly increased rate of PPM implantation was still observed in the sAVR group, independent of surgical experience. Prognosis of conduction disorders As earlier reported by other authors [10], persistent LBBB is associated with higher mortality. Therefore, it is of great importance to evaluate the possible predicting factors after sAVR. It has been demonstrated that in patients undergoing TAVI, a new-onset LBBB is an independent predictor for all-cause mortality [10]. This is in concordance with the findings of our study that postoperative conduction disturbances might attenuate long-term survival irrespective of other known predicting factors. In general, it is known that patients requiring PPM are at risk of developing pacing-induced cardiomyopathy due to left ventricular dyssynchrony. However, we have not yet been able to reveal whether or not LBBB recovers over time or whether patients are still pacemaker dependent at the long-term follow-up. Despite the fact that the HR for new-onset LBBB and PPM implantation on late survival did not reach statistical significance, the trend is in concordance with findings from other studies, making the complication of a new-onset LBBB or implantation of a PPM an issue of concern. Limitations This is a retrospective cohort study with its inherent limitations. In our study, ECGs were analysed at discharge, and no electrocardiographic data were available at follow-up. The effect of possible temporary conduction disorders remains unknown and requires further investigation. Furthermore, only complete RBBB and LBBB were analysed. The number of patients with postoperative incomplete bundle branch blocks and the effect on postoperative mortality could not be extracted from our data. We were not able to retrieve the discharge ECG in 2.4% of the patients, which could have slightly influenced the results and the conclusions of the study. Moreover, although the technique of annular decalcification in both the patient groups is similar, the role of residual calcification and the degree of decalcification cannot be completely excluded. We observed a clear trend for reduced postoperative survival in patients with new-onset LBBB or PPM implantation. Because of the limited number of events, this did not meet statistical significance. However, in patients undergoing TAVI, the occurrence of LBBB is an independent predictor for mortality, which supports the findings of our study. Our study included patients undergoing combined AVR and CABG, a population that could have a different profile and outcome. However, the distribution of combined procedures is equal in both the study groups. In the Persist-AVR trial [22], which compares the outcome of sAVR with stented biological AVR, patients undergoing combined procedures were also included. The enrolment phase of this trial has been just accomplished. CONCLUSION In this study, sAVR is associated with an increased risk of new-onset LBBB and PPM implantation compared to conventional stented bioprostheses. Our data showed that postoperative new-onset LBBB and PPM implantation were not significant predictors of overall mortality in this population. However, with the emergence of innovative aortic bioprostheses, further research should focus on reducing the incidence of conduction disorders. Conflict of interest: none declared. REFERENCES 1 Nishimura RA , Otto CM , Bonow RO , Carabello BA , Erwin JP , Guyton RA et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association task force on practice guidelines . Circulation 2014 ; 129 : e521 – 643 . Google Scholar PubMed 2 Leon MB , Smith CR , Mack MJ , Makkar RR , Svensson LG , Kodali SK et al. ; PARTNER 2 Investigators. 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TI - Conduction disorders and impact on survival after sutureless aortic valve replacement compared to conventional stented bioprostheses
JF - European Journal of Cardio-Thoracic Surgery
DO - 10.1093/ejcts/ezy417
DA - 2019-06-01
UR - https://www.deepdyve.com/lp/oxford-university-press/conduction-disorders-and-impact-on-survival-after-sutureless-aortic-Nrv1gHlXmt
SP - 1168
VL - 55
IS - 6
DP - DeepDyve
ER -