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Novel fast-track recovery protocol for alternative access transcatheter aortic valve replacement: application to non-femoral approaches

Novel fast-track recovery protocol for alternative access transcatheter aortic valve replacement:... OBJECTIVES: Although the transfemoral approach for transcatheter aortic valve replacement is the preferred choice, alternative access re- mains indicated for inadequate iliofemoral vessels. We report the successful implementation of a novel fast-track (FT) protocol for patients undergoing alternative access transcatheter aortic valve replacement compared with conventional controls. METHODS: Between September 2014 and January 2017, 31 and 23 patients underwent alternative access transcatheter aortic valve re- placement under FT and pre-fast-track (p-FT) protocols, respectively. Comparisons of outcomes (in terms of mortality, complications, re- admissions and resource utilization) were made before and after the implantation of the FT protocol in September 2015. RESULTS: Overall, mean age was 78.7 years in FT and 79.6 years in p-FT patients (P = 0.71). There were no significant differences in proced- ural (3.2% vs 13.0%, P = 0.301) or 90-day mortality (3.2% vs 17.4%, P = 0.151) between the FT and p-FT groups, respectively. Compared with p-FT patients, FT patients had significantly shorter intensive care unit stays (12 h vs 27 h, P = 0.006) and a trend towards more discharges within 3 days (41.9% vs 17.4%, P = 0.081). Resource utilization analyses projected a 56% and 17% reduction in the mean intensive care unit time (hours) per 100 patients and the total length of stay (days) per 100 patients, respectively, with respect to the FT approach. CONCLUSIONS: This pilot study demonstrates the feasibility and safety of the novel FT protocol for alternative access transcatheter aortic valve replacement, resulting in shorter intensive care unit stays, without increasing procedural complications or readmissions. With the ex- pected increase in transcatheter aortic valve replacement utilization, FT protocols should be integrated with a multidisciplinary heart team approach to enhance patient recovery and optimize resource utilization. Keywords: Cardiovascular diseases/therapy � Transcatheter aortic valve replacement � Heart team � Resource utilization the increasing feasibility of the TF approach in the light of con- INTRODUCTION temporary technological advances in valve technologies, includ- Within the last decade, transcatheter aortic valve replacement ing a smaller sheath size of newer generation valves [6–8]. (TAVR) has emerged as an established and viable treatment op- The recent results of the Placement of Aortic Transcatheter tion for patients with severe aortic stenosis who are deemed to Valve (PARTNER) 2 trial were also pivotal and showed that TF- be inoperable, at high risk or with an intermediate risk for surgi- TAVR resulted in lower mortality and stroke rates than conven- cal aortic valve replacement [1–3]. Over 250 000 TAVR proced- tional surgery, whereas transthoracic TAVR (non-femoral) did not ures have been performed worldwide since 2002 [1, 4, 5], with provide better results [1]. However, the TF approach is often pre- recent registry data indicating an 87% utilization rate of the cluded in patients with small, tortuous or calcified iliofemoral transfemoral (TF) approach [6]. This trend could be explained by vessels, for which alternative access sites are indicated. These ac- cess sites include transapical (TA), transaortic (TAo), trans- The first two authors are co-first authors. subclavian (SC), transcarotid and transcaval approaches [9–11]. The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery 939 Although enhanced operator experience and technical advance- surgical site and at the appropriate levels required for the TAo ment of TAVR devices have improved the overall outcomes of and TA approaches, and perineural catheters are placed for con- TAVR, with decreased vascular complications and procedural tinuous bupivacaine infusion at a rate of 6–10 ml/h for post-pro- mortality [7, 12], alternative access is still associated with cedural analgesia. The perioperative pain service manages the perineural infusions, and the catheters are removed on post-pro- increased cost, resource utilization, length of stay (LOS) and pro- cedural time compared with the conventional TF approach [13]. cedural Days 1 or 2, after the chest tubes are removed. The movement towards ‘minimalist approaches (MAs)’ and One of the immediate post-procedural goals is to extubate the ‘fast-track (FT) protocols’ for patients undergoing TF-TAVR has patients in the hybrid operating room soon after skin closure. gained appreciable momentum in recent years, partly due to This is made possible with customized anaesthetic drug selection concerns over increased resource utilization in spite of the heart and timing and is facilitated by regional analgesia (nerve blocks), as planned and conducted by a team of subspecialty-trained team approach [14, 15]. Some of these protocols include avoid- anaesthesiologists. ance of general anaesthesia (GA), use of low-dose or short-acting Restrictive fluid therapy is administered by the intensive care opioids and earlier extubation and ambulation. Moreover, the unit (ICU) team, limiting post-procedural fluid boluses and/or MA and FT protocols for TF-TAVR have been shown to provide vasopressor infusions, in direct communication and collaboration comparable outcomes to the conventional or ‘standard protocols’ while significantly cutting the overall costs, resource utilization with the surgical team. Adequate training is also given to the nursing staff in the ICU and step-down units. After taking the pa- and duration of hospitalization, all being critically important con- tients to the ICU, the urinary catheter and arterial line are quickly siderations in modern medicine, especially in the context of qual- removed after 2 h, and the patients are actively mobilized out of ity improvement and hospital reimbursements [16, 17]. bed within 4 h. ICU discharge goal is 6 h, if all the discharge crite- Although the non-femoral approaches have been associated ria are met. The ICU discharge criteria include intact neurological with worse outcomes and more resource utilization than the TF function, stable respiratory status, stable haemodynamics and no approach [13, 18], the advent of smaller delivery systems has bleeding from the access sites. A multidisciplinary ‘heart team’, allowed the SC approach to gain more popularity, with outcomes including cardiologists, cardiac surgeons, intensivists and anaes- comparable with that of the TF approach [8, 19–21]. It provides a thesiologists, collaborates closely to achieve a safe FT recovery feasible alternative when TF access is not possible, eliminates the for these patients. need for opening the chest cavity and, in most cases, is only lim- For the SC TAVRs, an alternative anaesthetic approach has ited by the diameter of the SC artery. Furthermore, it may be been designed by the regional anaesthesia team to avoid GA amenable to anaesthetic alternatives for GA. when possible. The goal is to provide surgical anaesthesia of the We implemented an FT protocol for TF-TAVR in October 2014 upper chest wall, ipsilateral axilla and upper extremity over 3–4 h, and recently adapted the programme for alternative access trans- with arm immobility while sparing the respiratory muscles. This catheter aortic valve replacement (AA-TAVR) in September 2015 is achieved by a combination of proximal brachial plexus blocks with our heart team approach. We sought to demonstrate the (usually via a retroclavicular approach), pectoral muscles I/II success of our pilot study and highlight the safety, efficacy, cost blocks and blocks of the supraclavicular nerves and the in- and resource utilization, including the outcomes of AA-TAVR be- tercostobrachial nerve. fore and after the implementation of our novel FT protocol. Data collection and outcomes MATERIALS AND METHODS Patient characteristics, periprocedural data and in-hospital out- Study population comes were recorded electronically at the time of presentation. Data were extracted from our electronic medical records, and Following approval from our institutional review board, we re- variables were defined and coded according to the Society of viewed all cases of AA-TAVR at our centre between September Thoracic Surgery (STS)/American College of Cardiology (ACC) 2014 and January 2017. A total of 54 patients were identified, Transcatheter Valve Therapy (TVT) registry v2.0 specifications un- including 31 FT and 23 pre-fast-track (p-FT) patients. less otherwise noted. Procedural mortality was defined as any death occurring in-house during the index admission or within Fast-track protocol 30 days of the procedure, if discharged. These inpatient data were then merged with our hospital cost data software system Our FT protocol for AA-TAVR was initiated in September 2015. using a combination of the medical record number and the ad- Patient selection algorithm is summarized in Fig. 1. The protocol mission date ±1 day for deterministic linkage. Our hospital uses a consists of the following: For TAVR, when the patient has inad- cost accounting system from Allscripts called EPSi that allocates equate iliofemoral vessels, computed tomography scan is used to all hospital patient costs by departments and services. EPSi is a reconstruct bilateral subclavian arteries. If the arteries are larger clinical and financial data repository, a management planning, than 5 mm, the SC approach is chosen. We prefer to utilize the analysis and cost-control tool that includes data on the hospital left SC as our first option. However, if the left SC is inadequate, costs and resource use of all hospitalizations. Outpatient costs we use the right SC as our second option. If bilateral SC arteries and professional billing costs (e.g. physician services) were are inadequate, we choose between TAo and TA. Transcarotid excluded, but some physician services were included if they were and transcaval are not used because of our lack of experience provided for under the hospital’s billed services (e.g. bundled with both approaches. payments for services that include physician care). Before the procedure, the regional anaesthesia team performs Primary outcomes of interest were procedural (i.e. in-hospital) ultrasound-guided proximal intercostal nerve blocks at the and 90-day mortality, ICU stay and hospital LOS. Secondary Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 ADULT CARDIAC 940 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery Figure 1: Patient selection criteria for the FT protocol. FT: fast-track; TAVR: transcatheter aortic valve replacement. outcomes of interest included permanent stroke and pacemaker Table 1: Baseline patient and echocardiographic character- implantation, residual aortic insufficiency, atrial fibrillation, new dia- istics in the pre-fast-track and fast-track protocols lysis dependence, ICU and 30-day readmission rates and direct and total hospitalization cost. Resource utilization was calculated by projecting percent reductions in the mean ICU time in hours, per Pre-fast-track Fast-track P-value (n = 23) (n = 31) 100 patients, and the total hospital LOS in days, per 100 patients. Patient characteristics Age (years) 79.6 ± 7.6 78.7 ± 8.7 0.708 Statistical analysis Female 11 (47.8) 17 (54.8) 0.784 Hypertension 21 (91.3) 29 (93.5) 1.000 To compare the FT group with the pFT group, normally distributed Diabetes mellitus 7 (30.4) 11 (35.5) 0.776 continuous variables were expressed as mean with standard devi- Dialysis dependent 2 (8.7) 2 (6.5) 1.000 Creatinine 1.19 ± 0.64 1.47 ± 1.41 0.374 ation and compared using the Student’s t-test. Non-normally dis- Peripheral artery disease 16 (69.6) 12 (38.7) 0.031 tributed variables were expressed as median and interquartile Previous stroke 3 (13) 5 (16.1) 1.000 range and compared using the Mann–Whitney U-tests. Categorical Infective endocarditis 2 (8.7) 1 (3.2) 0.578 variables were presented as number and percentages and com- History of smoking 4 (17.4) 8 (25.8) 0.757 COPD 10 (43.5) 5 (16.1) 0.035 pared using the v test or the Fisher’s exact test (for small cell sizes, Previous MI 8 (34.8) 10 (32.3) 1.000 i.e. for expected values <5). All analyses were done using IBM SPSS Atrial fibrillation 8 (34.8) 15 (48.4) 0.407 Statistics version 22.0 (IBM Corporation, Armonk, NY, USA), and a NYHA Class III/IV 21 (91.3) 13 (41.9) 0.001 P-value < _0.05 was the criterion for significance. Previous AVR 2 (8.7) 4 (12.9) 1.000 STS-PROM 7.98 ± 3.80 6.6 ± 3.40 0.178 Inoperable/STS-PROM >12% 4 (17.4) 2 (6.5) 0.390 Echocardiographic findings RESULTS Median ejection fraction (%) 60 (55–60) 55 (50–60) 0.499 V (m/s) 4.18 ± 0.56 3.98 ± 0.69 0.309 max Preprocedural characteristics Mean AV gradient (mmHg) 70.4 ± 20.5 69.9 ± 18.8 0.931 Aortic insufficiency 0.179 None 5 (21.7) 8 (25.8) Baselines characteristics of FT and p-FT patients are listed in Trace/trivial 5 (21.7) 3 (9.7) Table 1. There were 31 FT and 23 p-FT patients in this pilot study, Mild 11 (47.8) 11 (35.5) with a mean age of 78.7 ± 8.7 and 79.6 ± 7.6 years (P = 0.708), re- Moderate 1 (4.3) 8 (25.8) spectively. Most comorbidities, including diabetes mellitus, Severe 1 (4.3) 1 (3.2) hypertension, atrial fibrillation and previous stroke or myocardial infarction, were similar between the 2 groups. Compared with Continuous variables are presented as mean ± SD unless otherwise noted as median (IQR); categorical variables are summarized as n (%). the p-FT group, FT patients tended to have a lower burden of AV: aortic valve; AVR: aortic valve replacement; COPD: chronic ob- peripheral arterial disease, chronic obstructive pulmonary disease structive pulmonary disease; IQR: interquartile range; MI: myocardial and New York Heart Association Class III/IV. However, the mean infarction; NYHA: New York Heart Association; PROM: predicted risk of STS Predicted Risk of Mortality (STS-PROM) score was similar in mortality; SD: standard deviation; STS: Society of Thoracic Surgeons; both groups (6.60 ± 3.40% in FT vs 7.98 ± 3.80% in p-FT, V : peak aortic jet velocity. max P = 0.178). Similarly, baseline median ejection fraction (P = 0.499), Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery 941 mean peak aortic jet velocity (P = 0.309) and mean aortic valve gradients (P = 0.931), based on the preoperative echocardiog- Table 2: Procedural and postoperative outcomes of pa- raphy, were also similar between the 2 groups. Notably, there tients in the pre-fast-track and fast-track protocols were 2 and 4 inoperable cases (or patients with STS-PROM >12%) in the FT and p-FT groups, respectively. Pre-fast- Fast- P-value track (n = 23) track (n = 31) Procedural and postoperative outcomes Procedural details Urgent status 1 (4.3) 1 (3.2) 1.000 Median procedure 137 (104–165) 128 (92–160) 0.298 Compared with pre-FT patients, FT patients had a significantly length (min) higher proportion of SC access (77.4% vs 21.7%) but a lower pro- Valve in valve (elective) 1 (4.3) 2 (6.5) 1.000 portion of TAo access (22.6% vs 60.9%) in the TAVR performed General anaesthesia 23 (100) 30 (96.8) 1.000 (P < 0.001). Similarly, the valve types were significantly different CPB used 1 (4.3) 0 (0) 0.505 Procedural success 23 (100) 31 (100) 1.000 between the 2 groups (P < 0.001). There was also no difference in Alternative access approach 0.001 the median procedural lengths between the 2 groups (P = 0.298). Subclavian 5 (21.7) 24 (77.4) GA was used for all except 1 patient in the FT group. Moreover, Transaortic 14 (60.9) 7 (22.6) only 1 FT patient did not complete the protocol because of mul- Transapical 4 (17.4) 0 (0) Device types used 0.001 tiple comorbidities, including severe liver cirrhosis and a decubi- Sapien 3 (13) 1 (3.2) tus ulcer, which required an extended stay (Table 2). Sapien XT 10 (43.5) 2 (6.5) There were no significant differences in procedural mortality Sapien 3 3 (13) 20 (64.5) (3.2% vs 13.0%, P = 0.301) or 90-day mortality (3.2% vs 17.4%, CoreValve 7 (30.4) 8 (25.8) Postoperative outcomes P = 0.151) between the FT and the p-FT groups, respectively. Procedural mortality 3 (13) 1 (3.2) 0.301 Similarly, there were no significant differences in procedural 90-Day mortality 4 (17.4) 1 (3.2) 0.151 complications (such as new-onset atrial fibrillation and perman- New-onset dialysis 0 (0) 0 (0) ent pacemaker) or valve performance between the FT and the dependence p-FT groups. Compared with p-FT patients, FT patients had sig- Permanent stroke 0 (0) 0 (0) Permanent pacemaker 2 (8.7) 4 (12.9) 1.000 nificantly shorter median ICU stays (12 h vs 27 h, P = 0.006) and a New atrial fibrillation 2 (8.7) 1 (3.2) 0.569 trend towards more discharges within 3 days (41.9% vs 17.4%, Cardiac arrest 2 (8.7) 1 (3.2) 0.569 P = 0.081). Importantly, there were no ICU readmissions, post- Did not complete fast-track 0 (0) 1 (3.2) procedural strokes, new-onset dialysis dependence or residual Median ICU time (h) 27 (24–55) 12 (8–28) 0.006 ICU readmission 0 (0) 0 (0) moderate or severe aortic insufficiency in either group. Although Median LOS (days) 6 (4–6.5) 5 (3–7) 0.554 the 30-day readmission rate was 6.5% for the FT group and LOS < _ 4 days 6 (26.1) 14 (45.2) 0.098 13.0% for the p-FT group, it did not reach statistical significance LOS < _3 days 4 (17.4) 13 (41.9) 0.081 (P = 0.377). Post-TAVR echocardiography Trace/trivial 3 (13) 0 (0) Mild 0 (0) 2 (6.5) Cost and resource utilization Moderate/severe 0 (0) 0 (0) Discharged home 15 (65.2) 19 (61.3) 0.774 30-Day readmission 3 (13) 2 (6.5) 0.377 Resource utilization analyses projected a 56% and 17% reduction in the mean ICU time (h) per 100 patients and total LOS (days) Continuous variables are presented as mean ± SD unless otherwise per 100 patients, respectively. The overall median direct cost of noted as median (IQR); categorical variables are summarized as n (%). hospitalization, as measured by the overall relative median cost, One patient in the fast-track group underwent the procedure awake was 3% lower (P = 0.87), while the median total cost of hospital- under regional anaesthesia and sedation alone. ization was reduced by 2% (P = 0.690) after implementation of CPB: cardiopulmonary bypass; ICU: intensive care unit; IQR: interquar- the FT protocol, mostly due to shorter ICU stays and total LOS, as tile range; LOS: length of stay; SD: standard deviation; TAVR: transcath- eter aortic valve replacement. highlighted in Table 3. DISCUSSION total and direct cost of hospitalization—without increasing the To our knowledge, limited data exist on the FT protocols for AA- post-procedural complications or readmissions. TAVR in the current era [16]. Importantly, our pilot study had sev- TAVR has emerged as a viable alternative for inoperable, high or eral noteworthy findings. First, it demonstrated the safety and intermediate STS-risk patients with aortic stenosis [1, 5, 22]. feasibility of our novel FT protocol in patients undergoing AA- Traditionally, the main access site has been via the femoral artery, TAVR. Secondly, clinically observed procedural mortality had because it allows for total percutaneous access and has been shown decreased to about one-fourth, while 90-day mortality was al- to have superior outcomes to the non-TF approaches [23, 24]. most a fifth of that prior to FT protocol implementation, al- Unfortunately, certain characteristics, such as peripheral vascular disease and inadequate vessel calibre, still preclude the TF ap- though not statistically significant. Remarkably, there were no proach in selected patients, creating the need for alternative cases of post-procedural strokes, new-onset dialysis dependence or ICU readmissions. From a resource utilization standpoint, we approaches such as TA, TAo, SC, transcarotid and transcaval [9]. demonstrated a substantial reduction in the overall ICU time and Data from a large UK registry directly compared the TF approach hospital LOS among FT patients, with a trend towards earlier hos- with all the non-femoral approaches [8]. The TAo and TA pital discharge—which translated into an overall lower median approaches were found to have significantly worse short- and Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 ADULT CARDIAC 942 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery patients in the FT group had significantly shorter ICU stays and a trend towards more discharges within 3 days. This translated to Table 3: Cost and resource utilization among patients in the reduced cost and resource utilization and was in line with similar pre-fast-track and fast-track protocols studies except in TF-TAVR [14–17]. For instance, the ‘Vancouver TAVR clinical pathway’ proved successful for proper risk stratifi- Pre-fast-track Fast-track (n = 23) (n = 31) cation and LOS optimization in 144 consecutive patients undergoing TF-TAVR [15, 29]. Similarly, Babaliaros et al. [14] Total ICU hours 2003 1239 championed the concept with a comparison between their MA Mean (h) per patient 87 38.7 and the standard approach in 142 patients undergoing TF-TAVR. Hours per 100 patients 8709 3872 % Reduction 56% While both approaches had similar safety and efficacy outcomes, Total hospital days 160 179 the MA was associated with significant reduction of costs Mean (h) per patient 7 5.8 ($45 485 vs $55 377), ICU stays (22 h vs 28 h) and hospital LOS Days per 100 patients 696 577 (3 days vs 5 days), all P < 0.001. % Reduction 17% Total cost ($) Our pilot study highlights the pivotal role of a multidisciplinary Median cost (approximate) 56 550 32 000 heart team in determining the most appropriate mode of TAVR Median total cost/TIA 1.6 y (1.4–1.7) 1.5 y (1.4–2.1) access, taking into account the operator’s experience and centre’s % Reduction 2% facilities. Similarly, close interaction among the members of the Total direct cost ($) Median cost (approximate) 40 800 14 900 heart team is equally important. In our experience, several pa- Median direct cost/TIA 1.3 y (1.2, 1.4) 1.2 y (1.1, 1.6) tients were discharged on the post-procedural Day 1 with the SC % Reduction 3% approach, which did not occur with the other approaches. Moreover, we do not routinely perform the transcarotid or trans- Values presented as median (IQR). caval approach, given our lack of experience with these y represents the median cost per TIA patient in the preintervention approaches. Thus, as a team, we adopted the SC-first approach phase. Outpatient costs and professional billing costs (e.g. physician within our novel FT protocol. Taking the MA one step further, we services) were excluded, but some physician services were included if they were provided for under the hospital’s billed services (e.g. bundled also designed a uniquely tailored regional anaesthesia approach payments for services that include physician care). to avoid GA whenever possible, speed up recovery and improve ICU: intensive care unit; IQR: interquartile range; TIA: transient ischae- outcomes further. Although we only included our first awake SC- mic attack. TAVR patient in this study, we have since instituted this as our default alternative, with encouraging early results. long-term outcomes. However, the SC and TF approaches had Limitations comparable outcomes. A recent study further validated the safety and feasibility of the SC approach in 100 consecutive patients Despite its strengths, our study is subject to all the limitations in- with promising results [25]. A possible explanation as to why the herent to a single-centre, retrospective study. Our pilot study is SC approach offers better results than the other non-femoral the first of its kind to demonstrate the utility and safety of the FT approaches could be because of its peripheral and less invasive protocol in AA-TAVR, despite the small sample size which may nature, without the need for extensive cut-down or entering the not be generalizable to other populations. Only 10% of TAVRs chest cavity. are performed via alternative access, and with a case volume of Historically, FT protocols for cardiac surgery were first intro- 300 per year, our academic centre only sees about 30 patients duced in the early 90s with the advent of early ventilator weaning with alternative access. It could also be feasible that the im- and ambulation [26]. They have been shown to hasten the recov- proved outcomes may be associated with other policy changes ery of patients and improve cardiac performance as well as over- in our TAVR programme or because of the transition from a pri- all progression to a fully functional status [27]. The traditional marily descending aortic approach to a default strategy of the SC school of thought holds that monitoring patients for postopera- approach (i.e. selection bias, given our FT protocol) rather than tive complications deems conventional (non-FT) protocols indis- with the implementation of the protocol. This may require fur- pensable, for a more stable and controlled environment [16]. ther validation studies. Moreover, because of the smaller devices Furthermore, this specific patient population undergoing TAVR available, the FT group may have included fewer significant per- tends to be frailer than other cardiac patients, warranting extra ipheral vascular disease patients. Notably, there were also signifi- caution throughout the periprocedural period and creating reluc- cantly fewer patients with New York Heart Association Class III/ tance towards early discharge. Nonetheless, cost and resource IV in the FT groups. This imbalance may have influenced the re- utilization arise as important factors to be considered [28]. sults in favour of the FT group because we did not have enough Keeping these factors in mind, our institution started an FT power to address these using multivariable methods. Our univari- protocol for TF-TAVR patients in October 2014 and adapted a ate analysis showed that peripheral artery disease was marginally similar protocol for AA-TAVR patients in September 2015. associated with overall mortality, but there was no association In our pilot study, FT and p-FT patients had comparable out- with New York Heart Association Class III/IV and our outcomes comes. Clinically, procedural and 90-day mortality were lower in (P = 0.112). Concerning patient care, we initiated our TF FT the FT group, although limited by the small sample size and programme in November 2014, but our patient management did fewer number of events. Although ICU readmission rates have not change until the incorporation of alternative access FT. been reported to be between 2% and 5% in low-risk cardiac sur- Overall, the initial success of our novel FT protocol is worth con- gery patients [16], none of the patients in our series required an sidering on a wider scale and, to some extent, provides a frame- ICU readmission, despite their high-risk profile. Moreover, work for future studies that examine the feasibility and Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery 943 [12] Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M et al. cost-effectiveness of the FT protocols, especially in high-risk pa- Multicenter evaluation of a next-generation balloon-expandable trans- tients undergoing AA-TAVR in the current era. catheter aortic valve. J Am Coll Cardiol 2014;64:2235–43. [13] Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F et al. Outcomes following transcatheter aortic valve replacement in the CONCLUSION United States. JAMA 2013;310:2069–77. [14] Babaliaros V, Devireddy C, Lerakis S, Leonardi R, Iturra SA, Mavromatis K et al. Comparison of transfemoral transcatheter aortic valve replacement This small observational study demonstrated the safety of the performed in the catheterization laboratory (minimalist approach) ver- novel FT protocol for AA-TAVR, resulting in shorter ICU stays and sus hybrid operating room (standard approach): outcomes and cost ana- earlier hospital discharge, without increasing procedural compli- lysis. JACC Cardiovasc Interv 2014;7:898–904. cations or readmissions. With the expected increase in TAVR util- [15] Lauck SB, Wood DA, Achtem L, Baumbusch J, Boone RH, Cheung A et al. ization in the coming years, the FT protocols should be widely Risk stratification and clinical pathways to optimize length of stay after transcatheter aortic valve replacement. Can J Cardiol 2014;30:1583–7. considered and integrated closely with the multidisciplinary heart [16] Papadopoulos N, El-Sayed Ahmad A, Thudt M, Fichtlscherer S, team approach to enhance patient recovery and optimize re- Meybohm P, Reyher C et al. Successful fast track protocol implementa- source utilization. tion for patients undergoing transapical transcatheter aortic valve im- plantation. J Cardiothorac Surg 2016;11:55. [17] Marcantuono R, Gutsche J, Burke-Julien M, Anwaruddin S, Augoustides JG, Jones D et al. Rationale, development, implementation, and initial re- ACKNOWLEDGEMENTS sults of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR). Catheter Cardiovasc Interv 2015;85:648–54. We thank Sarah M. Dougherty for her help with cost analysis. [18] Kayatta MO, Thourani VH, Jensen HA, Condado JC, Sarin EL, Kilgo PD et al. Outcomes for transcatheter aortic valve replacement in nonagenar- Conflict of interest: none declared. ians. 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Transcaval access and closure for transcatheter aortic valve re- Vancouver transcatheter aortic valve replacement clinical pathway: min- placement: a prospective investigation. J Am Coll Cardiol 2017;69: imalist approach, standardized care, and discharge criteria to reduce 511–21. length of stay. Circ Cardiovasc Qual Outcomes 2016;9:312–21. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 ADULT CARDIAC http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Interactive Cardiovascular and Thoracic Surgery Oxford University Press

Novel fast-track recovery protocol for alternative access transcatheter aortic valve replacement: application to non-femoral approaches

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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1569-9285
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10.1093/icvts/ivx409
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Abstract

OBJECTIVES: Although the transfemoral approach for transcatheter aortic valve replacement is the preferred choice, alternative access re- mains indicated for inadequate iliofemoral vessels. We report the successful implementation of a novel fast-track (FT) protocol for patients undergoing alternative access transcatheter aortic valve replacement compared with conventional controls. METHODS: Between September 2014 and January 2017, 31 and 23 patients underwent alternative access transcatheter aortic valve re- placement under FT and pre-fast-track (p-FT) protocols, respectively. Comparisons of outcomes (in terms of mortality, complications, re- admissions and resource utilization) were made before and after the implantation of the FT protocol in September 2015. RESULTS: Overall, mean age was 78.7 years in FT and 79.6 years in p-FT patients (P = 0.71). There were no significant differences in proced- ural (3.2% vs 13.0%, P = 0.301) or 90-day mortality (3.2% vs 17.4%, P = 0.151) between the FT and p-FT groups, respectively. Compared with p-FT patients, FT patients had significantly shorter intensive care unit stays (12 h vs 27 h, P = 0.006) and a trend towards more discharges within 3 days (41.9% vs 17.4%, P = 0.081). Resource utilization analyses projected a 56% and 17% reduction in the mean intensive care unit time (hours) per 100 patients and the total length of stay (days) per 100 patients, respectively, with respect to the FT approach. CONCLUSIONS: This pilot study demonstrates the feasibility and safety of the novel FT protocol for alternative access transcatheter aortic valve replacement, resulting in shorter intensive care unit stays, without increasing procedural complications or readmissions. With the ex- pected increase in transcatheter aortic valve replacement utilization, FT protocols should be integrated with a multidisciplinary heart team approach to enhance patient recovery and optimize resource utilization. Keywords: Cardiovascular diseases/therapy � Transcatheter aortic valve replacement � Heart team � Resource utilization the increasing feasibility of the TF approach in the light of con- INTRODUCTION temporary technological advances in valve technologies, includ- Within the last decade, transcatheter aortic valve replacement ing a smaller sheath size of newer generation valves [6–8]. (TAVR) has emerged as an established and viable treatment op- The recent results of the Placement of Aortic Transcatheter tion for patients with severe aortic stenosis who are deemed to Valve (PARTNER) 2 trial were also pivotal and showed that TF- be inoperable, at high risk or with an intermediate risk for surgi- TAVR resulted in lower mortality and stroke rates than conven- cal aortic valve replacement [1–3]. Over 250 000 TAVR proced- tional surgery, whereas transthoracic TAVR (non-femoral) did not ures have been performed worldwide since 2002 [1, 4, 5], with provide better results [1]. However, the TF approach is often pre- recent registry data indicating an 87% utilization rate of the cluded in patients with small, tortuous or calcified iliofemoral transfemoral (TF) approach [6]. This trend could be explained by vessels, for which alternative access sites are indicated. These ac- cess sites include transapical (TA), transaortic (TAo), trans- The first two authors are co-first authors. subclavian (SC), transcarotid and transcaval approaches [9–11]. The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery 939 Although enhanced operator experience and technical advance- surgical site and at the appropriate levels required for the TAo ment of TAVR devices have improved the overall outcomes of and TA approaches, and perineural catheters are placed for con- TAVR, with decreased vascular complications and procedural tinuous bupivacaine infusion at a rate of 6–10 ml/h for post-pro- mortality [7, 12], alternative access is still associated with cedural analgesia. The perioperative pain service manages the perineural infusions, and the catheters are removed on post-pro- increased cost, resource utilization, length of stay (LOS) and pro- cedural time compared with the conventional TF approach [13]. cedural Days 1 or 2, after the chest tubes are removed. The movement towards ‘minimalist approaches (MAs)’ and One of the immediate post-procedural goals is to extubate the ‘fast-track (FT) protocols’ for patients undergoing TF-TAVR has patients in the hybrid operating room soon after skin closure. gained appreciable momentum in recent years, partly due to This is made possible with customized anaesthetic drug selection concerns over increased resource utilization in spite of the heart and timing and is facilitated by regional analgesia (nerve blocks), as planned and conducted by a team of subspecialty-trained team approach [14, 15]. Some of these protocols include avoid- anaesthesiologists. ance of general anaesthesia (GA), use of low-dose or short-acting Restrictive fluid therapy is administered by the intensive care opioids and earlier extubation and ambulation. Moreover, the unit (ICU) team, limiting post-procedural fluid boluses and/or MA and FT protocols for TF-TAVR have been shown to provide vasopressor infusions, in direct communication and collaboration comparable outcomes to the conventional or ‘standard protocols’ while significantly cutting the overall costs, resource utilization with the surgical team. Adequate training is also given to the nursing staff in the ICU and step-down units. After taking the pa- and duration of hospitalization, all being critically important con- tients to the ICU, the urinary catheter and arterial line are quickly siderations in modern medicine, especially in the context of qual- removed after 2 h, and the patients are actively mobilized out of ity improvement and hospital reimbursements [16, 17]. bed within 4 h. ICU discharge goal is 6 h, if all the discharge crite- Although the non-femoral approaches have been associated ria are met. The ICU discharge criteria include intact neurological with worse outcomes and more resource utilization than the TF function, stable respiratory status, stable haemodynamics and no approach [13, 18], the advent of smaller delivery systems has bleeding from the access sites. A multidisciplinary ‘heart team’, allowed the SC approach to gain more popularity, with outcomes including cardiologists, cardiac surgeons, intensivists and anaes- comparable with that of the TF approach [8, 19–21]. It provides a thesiologists, collaborates closely to achieve a safe FT recovery feasible alternative when TF access is not possible, eliminates the for these patients. need for opening the chest cavity and, in most cases, is only lim- For the SC TAVRs, an alternative anaesthetic approach has ited by the diameter of the SC artery. Furthermore, it may be been designed by the regional anaesthesia team to avoid GA amenable to anaesthetic alternatives for GA. when possible. The goal is to provide surgical anaesthesia of the We implemented an FT protocol for TF-TAVR in October 2014 upper chest wall, ipsilateral axilla and upper extremity over 3–4 h, and recently adapted the programme for alternative access trans- with arm immobility while sparing the respiratory muscles. This catheter aortic valve replacement (AA-TAVR) in September 2015 is achieved by a combination of proximal brachial plexus blocks with our heart team approach. We sought to demonstrate the (usually via a retroclavicular approach), pectoral muscles I/II success of our pilot study and highlight the safety, efficacy, cost blocks and blocks of the supraclavicular nerves and the in- and resource utilization, including the outcomes of AA-TAVR be- tercostobrachial nerve. fore and after the implementation of our novel FT protocol. Data collection and outcomes MATERIALS AND METHODS Patient characteristics, periprocedural data and in-hospital out- Study population comes were recorded electronically at the time of presentation. Data were extracted from our electronic medical records, and Following approval from our institutional review board, we re- variables were defined and coded according to the Society of viewed all cases of AA-TAVR at our centre between September Thoracic Surgery (STS)/American College of Cardiology (ACC) 2014 and January 2017. A total of 54 patients were identified, Transcatheter Valve Therapy (TVT) registry v2.0 specifications un- including 31 FT and 23 pre-fast-track (p-FT) patients. less otherwise noted. Procedural mortality was defined as any death occurring in-house during the index admission or within Fast-track protocol 30 days of the procedure, if discharged. These inpatient data were then merged with our hospital cost data software system Our FT protocol for AA-TAVR was initiated in September 2015. using a combination of the medical record number and the ad- Patient selection algorithm is summarized in Fig. 1. The protocol mission date ±1 day for deterministic linkage. Our hospital uses a consists of the following: For TAVR, when the patient has inad- cost accounting system from Allscripts called EPSi that allocates equate iliofemoral vessels, computed tomography scan is used to all hospital patient costs by departments and services. EPSi is a reconstruct bilateral subclavian arteries. If the arteries are larger clinical and financial data repository, a management planning, than 5 mm, the SC approach is chosen. We prefer to utilize the analysis and cost-control tool that includes data on the hospital left SC as our first option. However, if the left SC is inadequate, costs and resource use of all hospitalizations. Outpatient costs we use the right SC as our second option. If bilateral SC arteries and professional billing costs (e.g. physician services) were are inadequate, we choose between TAo and TA. Transcarotid excluded, but some physician services were included if they were and transcaval are not used because of our lack of experience provided for under the hospital’s billed services (e.g. bundled with both approaches. payments for services that include physician care). Before the procedure, the regional anaesthesia team performs Primary outcomes of interest were procedural (i.e. in-hospital) ultrasound-guided proximal intercostal nerve blocks at the and 90-day mortality, ICU stay and hospital LOS. Secondary Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 ADULT CARDIAC 940 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery Figure 1: Patient selection criteria for the FT protocol. FT: fast-track; TAVR: transcatheter aortic valve replacement. outcomes of interest included permanent stroke and pacemaker Table 1: Baseline patient and echocardiographic character- implantation, residual aortic insufficiency, atrial fibrillation, new dia- istics in the pre-fast-track and fast-track protocols lysis dependence, ICU and 30-day readmission rates and direct and total hospitalization cost. Resource utilization was calculated by projecting percent reductions in the mean ICU time in hours, per Pre-fast-track Fast-track P-value (n = 23) (n = 31) 100 patients, and the total hospital LOS in days, per 100 patients. Patient characteristics Age (years) 79.6 ± 7.6 78.7 ± 8.7 0.708 Statistical analysis Female 11 (47.8) 17 (54.8) 0.784 Hypertension 21 (91.3) 29 (93.5) 1.000 To compare the FT group with the pFT group, normally distributed Diabetes mellitus 7 (30.4) 11 (35.5) 0.776 continuous variables were expressed as mean with standard devi- Dialysis dependent 2 (8.7) 2 (6.5) 1.000 Creatinine 1.19 ± 0.64 1.47 ± 1.41 0.374 ation and compared using the Student’s t-test. Non-normally dis- Peripheral artery disease 16 (69.6) 12 (38.7) 0.031 tributed variables were expressed as median and interquartile Previous stroke 3 (13) 5 (16.1) 1.000 range and compared using the Mann–Whitney U-tests. Categorical Infective endocarditis 2 (8.7) 1 (3.2) 0.578 variables were presented as number and percentages and com- History of smoking 4 (17.4) 8 (25.8) 0.757 COPD 10 (43.5) 5 (16.1) 0.035 pared using the v test or the Fisher’s exact test (for small cell sizes, Previous MI 8 (34.8) 10 (32.3) 1.000 i.e. for expected values <5). All analyses were done using IBM SPSS Atrial fibrillation 8 (34.8) 15 (48.4) 0.407 Statistics version 22.0 (IBM Corporation, Armonk, NY, USA), and a NYHA Class III/IV 21 (91.3) 13 (41.9) 0.001 P-value < _0.05 was the criterion for significance. Previous AVR 2 (8.7) 4 (12.9) 1.000 STS-PROM 7.98 ± 3.80 6.6 ± 3.40 0.178 Inoperable/STS-PROM >12% 4 (17.4) 2 (6.5) 0.390 Echocardiographic findings RESULTS Median ejection fraction (%) 60 (55–60) 55 (50–60) 0.499 V (m/s) 4.18 ± 0.56 3.98 ± 0.69 0.309 max Preprocedural characteristics Mean AV gradient (mmHg) 70.4 ± 20.5 69.9 ± 18.8 0.931 Aortic insufficiency 0.179 None 5 (21.7) 8 (25.8) Baselines characteristics of FT and p-FT patients are listed in Trace/trivial 5 (21.7) 3 (9.7) Table 1. There were 31 FT and 23 p-FT patients in this pilot study, Mild 11 (47.8) 11 (35.5) with a mean age of 78.7 ± 8.7 and 79.6 ± 7.6 years (P = 0.708), re- Moderate 1 (4.3) 8 (25.8) spectively. Most comorbidities, including diabetes mellitus, Severe 1 (4.3) 1 (3.2) hypertension, atrial fibrillation and previous stroke or myocardial infarction, were similar between the 2 groups. Compared with Continuous variables are presented as mean ± SD unless otherwise noted as median (IQR); categorical variables are summarized as n (%). the p-FT group, FT patients tended to have a lower burden of AV: aortic valve; AVR: aortic valve replacement; COPD: chronic ob- peripheral arterial disease, chronic obstructive pulmonary disease structive pulmonary disease; IQR: interquartile range; MI: myocardial and New York Heart Association Class III/IV. However, the mean infarction; NYHA: New York Heart Association; PROM: predicted risk of STS Predicted Risk of Mortality (STS-PROM) score was similar in mortality; SD: standard deviation; STS: Society of Thoracic Surgeons; both groups (6.60 ± 3.40% in FT vs 7.98 ± 3.80% in p-FT, V : peak aortic jet velocity. max P = 0.178). Similarly, baseline median ejection fraction (P = 0.499), Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery 941 mean peak aortic jet velocity (P = 0.309) and mean aortic valve gradients (P = 0.931), based on the preoperative echocardiog- Table 2: Procedural and postoperative outcomes of pa- raphy, were also similar between the 2 groups. Notably, there tients in the pre-fast-track and fast-track protocols were 2 and 4 inoperable cases (or patients with STS-PROM >12%) in the FT and p-FT groups, respectively. Pre-fast- Fast- P-value track (n = 23) track (n = 31) Procedural and postoperative outcomes Procedural details Urgent status 1 (4.3) 1 (3.2) 1.000 Median procedure 137 (104–165) 128 (92–160) 0.298 Compared with pre-FT patients, FT patients had a significantly length (min) higher proportion of SC access (77.4% vs 21.7%) but a lower pro- Valve in valve (elective) 1 (4.3) 2 (6.5) 1.000 portion of TAo access (22.6% vs 60.9%) in the TAVR performed General anaesthesia 23 (100) 30 (96.8) 1.000 (P < 0.001). Similarly, the valve types were significantly different CPB used 1 (4.3) 0 (0) 0.505 Procedural success 23 (100) 31 (100) 1.000 between the 2 groups (P < 0.001). There was also no difference in Alternative access approach 0.001 the median procedural lengths between the 2 groups (P = 0.298). Subclavian 5 (21.7) 24 (77.4) GA was used for all except 1 patient in the FT group. Moreover, Transaortic 14 (60.9) 7 (22.6) only 1 FT patient did not complete the protocol because of mul- Transapical 4 (17.4) 0 (0) Device types used 0.001 tiple comorbidities, including severe liver cirrhosis and a decubi- Sapien 3 (13) 1 (3.2) tus ulcer, which required an extended stay (Table 2). Sapien XT 10 (43.5) 2 (6.5) There were no significant differences in procedural mortality Sapien 3 3 (13) 20 (64.5) (3.2% vs 13.0%, P = 0.301) or 90-day mortality (3.2% vs 17.4%, CoreValve 7 (30.4) 8 (25.8) Postoperative outcomes P = 0.151) between the FT and the p-FT groups, respectively. Procedural mortality 3 (13) 1 (3.2) 0.301 Similarly, there were no significant differences in procedural 90-Day mortality 4 (17.4) 1 (3.2) 0.151 complications (such as new-onset atrial fibrillation and perman- New-onset dialysis 0 (0) 0 (0) ent pacemaker) or valve performance between the FT and the dependence p-FT groups. Compared with p-FT patients, FT patients had sig- Permanent stroke 0 (0) 0 (0) Permanent pacemaker 2 (8.7) 4 (12.9) 1.000 nificantly shorter median ICU stays (12 h vs 27 h, P = 0.006) and a New atrial fibrillation 2 (8.7) 1 (3.2) 0.569 trend towards more discharges within 3 days (41.9% vs 17.4%, Cardiac arrest 2 (8.7) 1 (3.2) 0.569 P = 0.081). Importantly, there were no ICU readmissions, post- Did not complete fast-track 0 (0) 1 (3.2) procedural strokes, new-onset dialysis dependence or residual Median ICU time (h) 27 (24–55) 12 (8–28) 0.006 ICU readmission 0 (0) 0 (0) moderate or severe aortic insufficiency in either group. Although Median LOS (days) 6 (4–6.5) 5 (3–7) 0.554 the 30-day readmission rate was 6.5% for the FT group and LOS < _ 4 days 6 (26.1) 14 (45.2) 0.098 13.0% for the p-FT group, it did not reach statistical significance LOS < _3 days 4 (17.4) 13 (41.9) 0.081 (P = 0.377). Post-TAVR echocardiography Trace/trivial 3 (13) 0 (0) Mild 0 (0) 2 (6.5) Cost and resource utilization Moderate/severe 0 (0) 0 (0) Discharged home 15 (65.2) 19 (61.3) 0.774 30-Day readmission 3 (13) 2 (6.5) 0.377 Resource utilization analyses projected a 56% and 17% reduction in the mean ICU time (h) per 100 patients and total LOS (days) Continuous variables are presented as mean ± SD unless otherwise per 100 patients, respectively. The overall median direct cost of noted as median (IQR); categorical variables are summarized as n (%). hospitalization, as measured by the overall relative median cost, One patient in the fast-track group underwent the procedure awake was 3% lower (P = 0.87), while the median total cost of hospital- under regional anaesthesia and sedation alone. ization was reduced by 2% (P = 0.690) after implementation of CPB: cardiopulmonary bypass; ICU: intensive care unit; IQR: interquar- the FT protocol, mostly due to shorter ICU stays and total LOS, as tile range; LOS: length of stay; SD: standard deviation; TAVR: transcath- eter aortic valve replacement. highlighted in Table 3. DISCUSSION total and direct cost of hospitalization—without increasing the To our knowledge, limited data exist on the FT protocols for AA- post-procedural complications or readmissions. TAVR in the current era [16]. Importantly, our pilot study had sev- TAVR has emerged as a viable alternative for inoperable, high or eral noteworthy findings. First, it demonstrated the safety and intermediate STS-risk patients with aortic stenosis [1, 5, 22]. feasibility of our novel FT protocol in patients undergoing AA- Traditionally, the main access site has been via the femoral artery, TAVR. Secondly, clinically observed procedural mortality had because it allows for total percutaneous access and has been shown decreased to about one-fourth, while 90-day mortality was al- to have superior outcomes to the non-TF approaches [23, 24]. most a fifth of that prior to FT protocol implementation, al- Unfortunately, certain characteristics, such as peripheral vascular disease and inadequate vessel calibre, still preclude the TF ap- though not statistically significant. Remarkably, there were no proach in selected patients, creating the need for alternative cases of post-procedural strokes, new-onset dialysis dependence or ICU readmissions. From a resource utilization standpoint, we approaches such as TA, TAo, SC, transcarotid and transcaval [9]. demonstrated a substantial reduction in the overall ICU time and Data from a large UK registry directly compared the TF approach hospital LOS among FT patients, with a trend towards earlier hos- with all the non-femoral approaches [8]. The TAo and TA pital discharge—which translated into an overall lower median approaches were found to have significantly worse short- and Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 ADULT CARDIAC 942 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery patients in the FT group had significantly shorter ICU stays and a trend towards more discharges within 3 days. This translated to Table 3: Cost and resource utilization among patients in the reduced cost and resource utilization and was in line with similar pre-fast-track and fast-track protocols studies except in TF-TAVR [14–17]. For instance, the ‘Vancouver TAVR clinical pathway’ proved successful for proper risk stratifi- Pre-fast-track Fast-track (n = 23) (n = 31) cation and LOS optimization in 144 consecutive patients undergoing TF-TAVR [15, 29]. Similarly, Babaliaros et al. [14] Total ICU hours 2003 1239 championed the concept with a comparison between their MA Mean (h) per patient 87 38.7 and the standard approach in 142 patients undergoing TF-TAVR. Hours per 100 patients 8709 3872 % Reduction 56% While both approaches had similar safety and efficacy outcomes, Total hospital days 160 179 the MA was associated with significant reduction of costs Mean (h) per patient 7 5.8 ($45 485 vs $55 377), ICU stays (22 h vs 28 h) and hospital LOS Days per 100 patients 696 577 (3 days vs 5 days), all P < 0.001. % Reduction 17% Total cost ($) Our pilot study highlights the pivotal role of a multidisciplinary Median cost (approximate) 56 550 32 000 heart team in determining the most appropriate mode of TAVR Median total cost/TIA 1.6 y (1.4–1.7) 1.5 y (1.4–2.1) access, taking into account the operator’s experience and centre’s % Reduction 2% facilities. Similarly, close interaction among the members of the Total direct cost ($) Median cost (approximate) 40 800 14 900 heart team is equally important. In our experience, several pa- Median direct cost/TIA 1.3 y (1.2, 1.4) 1.2 y (1.1, 1.6) tients were discharged on the post-procedural Day 1 with the SC % Reduction 3% approach, which did not occur with the other approaches. Moreover, we do not routinely perform the transcarotid or trans- Values presented as median (IQR). caval approach, given our lack of experience with these y represents the median cost per TIA patient in the preintervention approaches. Thus, as a team, we adopted the SC-first approach phase. Outpatient costs and professional billing costs (e.g. physician within our novel FT protocol. Taking the MA one step further, we services) were excluded, but some physician services were included if they were provided for under the hospital’s billed services (e.g. bundled also designed a uniquely tailored regional anaesthesia approach payments for services that include physician care). to avoid GA whenever possible, speed up recovery and improve ICU: intensive care unit; IQR: interquartile range; TIA: transient ischae- outcomes further. Although we only included our first awake SC- mic attack. TAVR patient in this study, we have since instituted this as our default alternative, with encouraging early results. long-term outcomes. However, the SC and TF approaches had Limitations comparable outcomes. A recent study further validated the safety and feasibility of the SC approach in 100 consecutive patients Despite its strengths, our study is subject to all the limitations in- with promising results [25]. A possible explanation as to why the herent to a single-centre, retrospective study. Our pilot study is SC approach offers better results than the other non-femoral the first of its kind to demonstrate the utility and safety of the FT approaches could be because of its peripheral and less invasive protocol in AA-TAVR, despite the small sample size which may nature, without the need for extensive cut-down or entering the not be generalizable to other populations. Only 10% of TAVRs chest cavity. are performed via alternative access, and with a case volume of Historically, FT protocols for cardiac surgery were first intro- 300 per year, our academic centre only sees about 30 patients duced in the early 90s with the advent of early ventilator weaning with alternative access. It could also be feasible that the im- and ambulation [26]. They have been shown to hasten the recov- proved outcomes may be associated with other policy changes ery of patients and improve cardiac performance as well as over- in our TAVR programme or because of the transition from a pri- all progression to a fully functional status [27]. The traditional marily descending aortic approach to a default strategy of the SC school of thought holds that monitoring patients for postopera- approach (i.e. selection bias, given our FT protocol) rather than tive complications deems conventional (non-FT) protocols indis- with the implementation of the protocol. This may require fur- pensable, for a more stable and controlled environment [16]. ther validation studies. Moreover, because of the smaller devices Furthermore, this specific patient population undergoing TAVR available, the FT group may have included fewer significant per- tends to be frailer than other cardiac patients, warranting extra ipheral vascular disease patients. Notably, there were also signifi- caution throughout the periprocedural period and creating reluc- cantly fewer patients with New York Heart Association Class III/ tance towards early discharge. Nonetheless, cost and resource IV in the FT groups. This imbalance may have influenced the re- utilization arise as important factors to be considered [28]. sults in favour of the FT group because we did not have enough Keeping these factors in mind, our institution started an FT power to address these using multivariable methods. Our univari- protocol for TF-TAVR patients in October 2014 and adapted a ate analysis showed that peripheral artery disease was marginally similar protocol for AA-TAVR patients in September 2015. associated with overall mortality, but there was no association In our pilot study, FT and p-FT patients had comparable out- with New York Heart Association Class III/IV and our outcomes comes. Clinically, procedural and 90-day mortality were lower in (P = 0.112). Concerning patient care, we initiated our TF FT the FT group, although limited by the small sample size and programme in November 2014, but our patient management did fewer number of events. Although ICU readmission rates have not change until the incorporation of alternative access FT. been reported to be between 2% and 5% in low-risk cardiac sur- Overall, the initial success of our novel FT protocol is worth con- gery patients [16], none of the patients in our series required an sidering on a wider scale and, to some extent, provides a frame- ICU readmission, despite their high-risk profile. Moreover, work for future studies that examine the feasibility and Downloaded from https://academic.oup.com/icvts/article-abstract/26/6/938/4819232 by Ed 'DeepDyve' Gillespie user on 20 June 2018 A.A. Kolkailah et al. / Interactive CardioVascular and Thoracic Surgery 943 [12] Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M et al. cost-effectiveness of the FT protocols, especially in high-risk pa- Multicenter evaluation of a next-generation balloon-expandable trans- tients undergoing AA-TAVR in the current era. catheter aortic valve. J Am Coll Cardiol 2014;64:2235–43. [13] Mack MJ, Brennan JM, Brindis R, Carroll J, Edwards F, Grover F et al. Outcomes following transcatheter aortic valve replacement in the CONCLUSION United States. JAMA 2013;310:2069–77. [14] Babaliaros V, Devireddy C, Lerakis S, Leonardi R, Iturra SA, Mavromatis K et al. Comparison of transfemoral transcatheter aortic valve replacement This small observational study demonstrated the safety of the performed in the catheterization laboratory (minimalist approach) ver- novel FT protocol for AA-TAVR, resulting in shorter ICU stays and sus hybrid operating room (standard approach): outcomes and cost ana- earlier hospital discharge, without increasing procedural compli- lysis. JACC Cardiovasc Interv 2014;7:898–904. cations or readmissions. With the expected increase in TAVR util- [15] Lauck SB, Wood DA, Achtem L, Baumbusch J, Boone RH, Cheung A et al. ization in the coming years, the FT protocols should be widely Risk stratification and clinical pathways to optimize length of stay after transcatheter aortic valve replacement. Can J Cardiol 2014;30:1583–7. considered and integrated closely with the multidisciplinary heart [16] Papadopoulos N, El-Sayed Ahmad A, Thudt M, Fichtlscherer S, team approach to enhance patient recovery and optimize re- Meybohm P, Reyher C et al. Successful fast track protocol implementa- source utilization. tion for patients undergoing transapical transcatheter aortic valve im- plantation. J Cardiothorac Surg 2016;11:55. [17] Marcantuono R, Gutsche J, Burke-Julien M, Anwaruddin S, Augoustides JG, Jones D et al. Rationale, development, implementation, and initial re- ACKNOWLEDGEMENTS sults of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR). Catheter Cardiovasc Interv 2015;85:648–54. We thank Sarah M. Dougherty for her help with cost analysis. [18] Kayatta MO, Thourani VH, Jensen HA, Condado JC, Sarin EL, Kilgo PD et al. Outcomes for transcatheter aortic valve replacement in nonagenar- Conflict of interest: none declared. ians. 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Journal

Interactive Cardiovascular and Thoracic SurgeryOxford University Press

Published: Jun 1, 2018

Keywords: Cardiovascular diseases/therapy; Transcatheter aortic valve replacement; Heart team; Resource utilization

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