Catheterization and Cardiovascular Interventions 00:00–00 (2015)
Core Curriculum The Requirement of Extracorporeal Circulation System for Transluminal Aortic Valve Replacement: Do We Really Need It in The Catheterization Laboratory? Konstantinos Toutouzas,* FSCAI, Andreas Synetos, MD, George Latsios, MD, Antonis Mastrokostopoulos, MD, Konstantinos Stathogiannis, MD, Maria Drakopoulou, MD, George Trantalis, MD, Eleftherios Tsiamis, MD, and Dimitrios Tousoulis, MD Transcatheter aortic valve replacement (TAVR) is the mainstay for treating high-risk patients with aortic stenosis. As the TAVR procedures worldwide keep increasing, it is inevitable that more issues and complications will arise. Such a complication that merits attention is the conversion of TAVR into open-heart surgery and the necessity this complication creates to have an extracorporeal circulation system in the catheterization laboratory. This review contains an analysis of all major randomized trials and registries on the number and cause of TAVR procedures that ended up in open-heart surgery and presents data to challenge the prerequisite of extracorporeal circulation system in the cath laboratory. VC 2015 Wiley Periodicals, Inc. Key words: TAVR; aortic stenosis; open heart surgery
INTRODUCTION
Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective method for the treatment of severe symptomatic aortic stenosis in patients at high risk and intermediate risk for conventional surgery (SAVR) [1–5]. The constantly increasing number of procedures performed, improve the accumulative experience and the safety of the procedure. This is evident from the results of large-scale randomized trials as well as from registries that represent the real world practice. The evidence from randomized studies [6–8] and national registries, including the learning phase of TAVR implantation, when operator experience, available sizes, and the design of the valves and/ or delivery systems used were different from the currently applied [9,10]. The indications, the requirements, and the methodology for the proper use of this method, based on the current evidence and practice have been reported on the 2012 Expert Consensus Document for TAVR [2]. The ongoing blooming of experimental and clinical research of this field has been supported by the “Valve Academic Research Consortium II (VARC-II)” which C 2015 Wiley Periodicals, Inc. V
homogenizes the definitions and simplifies the understanding of the end points of the research as well as the procedure itself [11]. Nowadays, TAVR is the standard of care for extremely high risk or “inoperable” patients and is a valid alternative to surgery for selected high-risk but “operable” patients with symptomatic aortic stenosis First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece Conflict of Interest: Dr Toutouzas is a proctor for Medtronic CoreValve. Konstantinos Toutouzas and Andreas Synetos contributed equally to this manuscript. *Correspondence to: Konstantinos Toutouzas, MD, 26 Karaoli and Dimitriou str. Holargos, 15562 Athens, Greece. E-mail: [email protected] Received 2 January 2015; Revision accepted 6 April 2015 DOI: 10.1002/ccd.25988 Published online 00 Month 2015 in Wiley Online Library (wileyonlinelibrary.com)
2
Toutouzas et al.
[1–3]. Expanding the indications of TAVR in patients with lower perioperative risk is considered by the rapid increase in the number of second-generation valves [2,12]. The ongoing evolution and spreading of the method is limited by the fact that it has to be performed in centers with a cardiothoracic department, in case of an emergency conversion to open-heart surgery [2]. Despite the well-established role of cardiothoracic surgeons on the management and decision making of these patients as part of the heart team, the necessity of the presence of the extracorporeal circulation system in the catheterization laboratory for the TAVR procedures is on debate [2,12]. In several countries, the extracorporeal circulation system is a prerequisite from the regulatory authorities and/or the companies supplying the valves for the acquirement of license to perform TAVR procedures. Emergency conversion from TAVR to open-heart surgery has been reported in 0.5 to 4.3% of patients, with a trend for lower conversion rate in TAVR procedures performed via the femoral artery compared with the transapical approach. In this review, we are performing an analysis of the largest registries and randomized trials on the incidence and the etiology of conversion to open surgery during the procedure of TAVR. According to this analysis, the presence of extracorporeal circulation system will be challenged. RANDOMIZED STUDIES
While registry reports are of crucial value to assess “real-world” practice, the randomized studies can provide more rigorous assessment regarding the safety and efficacy of a new therapy. During the last years, two large scaled randomized trials that compared TAVR with conservative treatment or with surgical aortic valve replacement were performed [13–16]. In the PARTNER trial, the first randomized study that showed that in high-risk patients with severe aortic stenosis, TAVR and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year using the SAPIEN device; in a total of 348 patients undergoing TAVR, 9 patients (2.6%) needed a conversion to surgery [14,17]. This relatively high percentage of conversion to surgery can be attributed to the learning curve of the procedure, as this study was performed in the very beginning of TAVR procedures, when experience was gained with the everyday practice [18]. A recent randomized study, performed at 45 clinical sites in the United States, assessed the safety and effectiveness of TAVR with CoreValve compared with surgical valve replacement in 795 patients with severe aortic stenosis who were at increased surgical risk. This study resulted in an increased survival at 1 year
after the procedure for the TAVR arm, and the survival benefit was consistent across almost all clinical subgroups. Out of the 390 patients that underwent TAVR, the need for conversion to open heart surgery was observed in two patients (0.51%) [13]. Importantly, in this trial the operators could include patients after the third procedure, thus incorporating their learning curve. REGISTRIES
In three large registries from Italy, the need for conversion to surgery during TAVR was lower. In the first Italian registry (a multicenter prospective cohort study), 514 patients were treated with the CoreValve device in 13 centers (using the subclavian approach in 54 cases), and conversion to open heart surgery was necessary in 5 patients (1.0%) [19]. The purpose of this registry was to report the initial experience using the subclavian access for TAVR. Overall survival and freedom from major cardiovascular events at 1 and 6 months were similar between patients treated through the subclavian approach and patients treated through the femoral approach, with a very high 6-month survival in both groups (88.6 vs. 93.3%, femoral vs. subclavian, respectively). The I-TA registry was a prospective, multicenter, registry with the participation of the majority of Italian cardiac surgery centers that started a transapical program included 774 patients undergoing transapical TAVR at each center using the SAPIEN or SAPIEN XT. Ten patients (1.2%) were converted to surgery due to apex-related complications, 2 patients required cardiopulmonary bypass (1 with conversion to median sternotomy); the remaining 8 were successfully treated off pump through the mini thoracotomy. Overall 1-year survival was 81.7%, 2-year survival was 76.1%, and 3year survival was 67.6% [20]. The FRANCE 2 registry evaluated data from a national multicenter registry of a 3,195 consecutive patients undergoing TAVR, in randomly selected centers. The SAPIEN device was used in 66.9% of patients and the CoreValve device in 33.1%. In 12 patients (0.4%), the procedure was converted to surgical aortic-valve replacement with small differences between the transfemoral and transapical approach (0.7%) and the subclavian approach (0%). Moreover, the percentage was similar for both devices used (0.4% both for SAPIEN and CoreValve), 30-day mortality rate was 9.7% a rate that was similar to those reported previously by other registries, ranging from 5.4 to 11.5%. The 1-year survival rate of 76.0% was nearly the same as the rates in the SOURCE, U.K. registries and in cohort A of the PARTNER trial [21]. The German Aortic Valve Registry (GARY) provides data on surgical and catheter-based aortic
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Extracorporeal Circulation during TAVR
procedures on an all-comers basis. The registry summarized the results of 6,523 SAVR without concomitant coronary bypass surgery and 3,464 with concomitant coronary bypass surgery, as well as 2,695 transvascular and 1,181 transapical TAVR procedures. TAVR patients were treated with balloon-expandable prostheses (n ¼ 2,061) or CoreValve (n ¼ 1,614). Only a minority was treated with second-generation prostheses from Symetis SA (n ¼ 53) or JenaValve (n ¼ 53). The remaining patients (n ¼ 94) received either devices under clinical evaluation or no device due to different reasons. The intraoperative complication rates were low. Conversion to sternotomy was necessary in 24 patients (2.0%) of the transapical and 38 patients (1.4%) of the transvascular cases. The in hospital mortality was 5.1% for the transvascular patients and 7.7% for the transapical patients. The authors do not mention whether there was a difference in conversion to surgery between the early phase of the learning curve or whether this percentage was constant throughout the inclusion period of the study population [22]. The United Kingdom Transcatheter Aortic Valve Implantation Registry (U.K. TAVR) is unique in that it has captured every TAVR performed at all the 25 active units within England and Wales, and thus includes the entire learning curve, thus incorporating the early experience of adopting centers. Data were collected prospectively on 870 patients undergoing TAVR procedures up until December 31, 2009. Conversion to an SAVR occurred in 6 patients (0.7%), and all had a SAPIEN implant via a transapical approach (2.2% of transapical implants). Survival at 30 days was 92.9%, and it was 78.6 and 73.7% at 1 and 2 years, respectively. In this cohort of patients, the 30-day mortality was 7.1%, which was comparable to other registries: Canadian registry, 10.4%, SOURCE (SAPIEN Aortic Bioprosthesis European Outcome) registry, 8.5%, PARTNER B cohort, 30-day mortality was 5%, and 5.2% in the PARTNER A cohort [10]. The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consisted of 1,038 patients enrolled at 32 centers. Patients were treated with the transapical approach (n ¼ 575) or the transfemoral approach (n ¼ 463). Conversion to open heart surgery was needed in 8 patients (1.7%) with the transfemoral approach and in 20 patients (3.5%) with TA approach [6,7]. The Medtronic Advance Trial with the Medtronic CoreValve prosthesis study was designed to evaluate the safety, efficacy, and clinical outcomes, using the VARC criteria, of the CoreValve system in 1,015 consecutive ‘‘real world’’ patients with severe aortic ste-
3
nosis. The need for conversion to open aortic valve replacement was 0.1% (1 patient) [12,23]. A multicenter prospective study performed in 137 centers of 10 European countries, the Transcatheter Valve Treatment Sentinel Pilot Registry was published and included a total of 4,571 patients that underwent TAVR between January 2011 and May 2012. SAPIEN XT valves were implanted in 2,604 patients (57.3%) and the rest were CoreValve. Valve selection was skewed towards small diameters with 23 mm SAPIEN XT and 26 mm CoreValve used in 44.2 and 40.8% of patients and intermediate diameter 26 mm SAPIEN XT and 29 mm CoreValve used in 48.7 and 53.1% of patients, respectively. The valve was successfully deployed in 96.5% of patients, without significant differences based on access site or valve type with surgical conversion occurring in 4.3% (194 patients, 159 of them with the transfemoral approach). Overall inhospital mortality was 7.4%, similar in SAPIEN XT and CoreValve, without significant differences (7.9 vs. 6.7%) [24]. An interesting study that analyzed patient characteristics, decision-making processes, and outcomes of TAVR performed in hospitals with versus those without on-site cardiac surgery was recently performed. Out of 1,432 patients enrolled in the German TAVR registry at 27 hospitals, 178 of them (12%) were treated in a hospital without and 1,254 patients in hospitals with on-site cardiac surgery. Conversion to open heart surgery was necessary in 4 (2.2%) in the first group versus 20 (1.6%) in the on-site cardiac surgery patients. Indications for emergency conversion in the in these four patients were annular rupture (n ¼ 1), aortic perforation (n ¼ 1), coronary obstruction (n ¼ 1), and prosthesis embolization (n ¼ 1). Three out of four emergency conversions were performed during a transapical TAVR procedure and only 1 during a transfemoral one. Two of the four patients died within 30 days after emergency conversion (mortality: 50%), while in the other group, nine of 20 patients requiring emergency conversion died postoperatively (mortality: 45%) [25]. An important study that included 411 patients that underwent TAVR in Germany (229 patients via a transapical and 190 via a transfemoral route) showed that 4.9% of the procedures needed emergency conversion to surgery, and this was more frequent in the transfemoral group compared to the transapical group. The reasons for the conversion to surgery were coronary obstruction with failed percutaneous coronary intervention, right or left ventricular perforation, aortic dissection, annulus rupture, severe paravalvular regurgitation, hemorrhagic shock due to bleeding from the left ventricular rupture site, malapposition of the
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
4
Toutouzas et al.
TABLE I. Most Important Registries and the Observed Conversion to Therapy Rates Pts
Conversion to surgery (N)
Conversion to surgery (%)
Conversion to surgery Transvascular approach (%)
France 2 Gary
3,195 3,876
12 62
0.4 1.6
0.7 1.4
Italian I-TA UK-TAVI Partner
514 774 870 348
5 10 6 9
1.0 1.2 0.7 2.6
1.1 Only trans apical 0
Source Advance U.S. CoreValve Greise et al
1,038 1,015 390 411
28 1 2 20
2.7 0.1 0.51 4.9
1.7 0.1 0.51 5.8
Sentinel
4,571
194
4.3
4.7
Registry/trial
Causes of conversion n.r. Device embolization, coronary occlusion, aortic dissection, annular rupture. n.r. Apex related complications Apex related complications Device embolization, large sigmoid septum, annulus size on TEE Valve embolization, coronary obstruction Coronary obstruction Hypotension after TEE coronary obstruction, ventricular perforation, aortic dissection, annulus rupture, severe paravalvular regurgitation, malapposition of the prosthetic valve Valve embolization, unsuccessful valve delivery
n.r: not recordable; pts: patients; TEE: Transesophageal echocardiography.
prosthetic valve, and mitral valve with apparatus damage by wire entrapment. Cardiopulmonary bypass was necessary for 80% of the patients that needed conversion to surgery [26]. A meta-analysis of 48 studies comprising 9,251 patients undergoing TAVR for native AV stenosis published between 2004 and 2011 showed that emergency conversion to surgery was required in 102 patients (1.1%) and this was marginally higher among those undergoing transapical TAVR as compared to those undergoing transfemoral TAVR (1.9 1.7% vs. 0.6 0.9%). In 41% of the reported cases, conversion to surgery was required for embolization/dislocation of the implanted valve prosthesis (n ¼ 36) with aortic dissection/perforation (n ¼ 14), ventricular/atrial wall perforation resulting in bleeding or tamponade (n ¼ 12), severe AV regurgitation (n ¼ 10), aortic valve annulus rupture (n ¼ 6), and coronary obstruction (n ¼ 5) and others (n ¼ 5) [27]. The prophylactic use of the heart-lung machine in patients undergoing TAVR was assessed in 43 high risk patients with preoperative cardiogenic shock or severe left ventricular systolic dysfunction. The aim of the extracorporeal circulation was to minimize the potential complications of the procedure, to stabilize the patients’ condition, to achieve haemodynamic stability during TAVR, and to avoid the possible need for manual cardiopulmonary resuscitation if ventricular fibrillation should occur during rapid pacing for balloon valvuloplasty and during valve deployment. Although 30 day mortality for all patients was 14%, this was present only to those with preoperative cardiogenic shock. Therefore, although the heart–lung machine is
rarely necessary, in this high risk population its use may increase safety and yield acceptable outcomes [28]. Table I summarizes the most important trials and registries that report the number of patients that needed conversion from TAVR to open heart surgery. OUTCOME OF CONVERSION
A recent detailed analysis of the causes, the procedural settings, and the outcome of conversion to open heart surgery was associated with a mortality of 45%. In this analysis from the German TAVR Registry, emergency conversion from TAVR to open cardiac surgery was required in 24 of 1,975 patients (1.2%). Although the mean time interval between abortions of TAVR to surgery was 19 min, with a range of 5–80 min, these patients showed increased mortality rates both within 72 hr from the surgery (29.2%) and within the first 30 days from the procedure (45%). Severe regurgitation and coronary issues were all successfully treated surgically with favorable immediate patient outcome in 30 days [29]. A similar approach was performed by a retrospective analysis of all procedure-related complications that required surgical interventions, whether immediate or delayed but within the initial hospital stay form a single center in Germany. Out of this cohort a total of 42 patients (1.8%) underwent conversion to sternotomy and 27 (1.2%) were dependent on the short-term use of the extracorporeal circulation system. Twenty-five (1.6%) of the cases converted to sternotomy were identified in the transfemoral group and 17 (2.3%) in the
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Extracorporeal Circulation during TAVR
transapical group. Although the conversion when necessary was performed within minutes, mortality rates were 19% in the operating rooms, and 61.9% in the first 30 days from the procedure [30]. In the single center German registry, the 20 patients that their TAVR procedure was converted urgently to surgery had a 30 days mortality of 35%, while this percentage reached 54% when sternotomy was required. Although no differences in survival were reported between the transfemoral and the transapical group, the need for urgent conversion to surgery decrease the mean survival time from 25.56 1.1 months to 4.56 1.6 months in the transfemoral group and from 22.9 1.1 months to 10.8 4.4 months in the transapical patients [26]. The meta-analysis of the 48 studies with 9,251 patients undergoing TAVR showed that mortality at 30 days was roughly 9-fold higher in patients who required a conversion to surgery compared with those patients who did not need emergency conversion (67.1 37.9% vs. 7.5 4.0%) [27]. DISCUSSION
Since 2002, when the first TAVR was performed, the penetration of this method has exponentially increased and nowadays, numerous procedures from different access routes and with a variety of prosthetic valves are performed worldwide. Further expansion of the method is limited by the prerequisite of the presence of a cardiothoracic department close to the cath laboratory. As the need for open cardiac conversion is still low in all registries, it seems difficult to identify definite independent risk factors for immediate conversion to open heart surgery during TAVR procedure. A further limitation for this is the inconsistency of the way that the causes for conversion to surgery are reported in the majority of the studies. However, the data from randomized trials and the major registries indicate several potential risk factors that need further investigation. Thus, first the early phase of the learning curve and secondly the transapical approach, seem to be associated with more acute complications requiring open heart conversion. The rest of the procedures in this high-risk population seem to be associated with low complication rates, requiring urgent cardiosurgical treatment. Furthermore, the treatment of lower risk patients and the advance of second-generation valves should further decrease the need for extracorporeal circulation system in the catheterization laboratory. Finally, the observation that urgent conversion to surgery especially in high risk patients has worse outcome when is performed by sternotomy, supports the
5
hypothesis that what we really need during a TAVR procedure is a left ventricular assist device for transient hemodynamic support, or a vascular surgeon for treating the possible vascular complications, and not necessarily a heart lung machine [26,31]. The presence of left ventricular assist device instead of having a group of experts waiting as a safety net for a possible complication could possible decrease the overall cost of the process and could lead to proper and more rational resource utilization. However, when surgery for failed TAVR is needed, outcomes are bleak with or without cardiopulmonary bypass.
CONCLUSION
In conclusion, although the rates of conversion to open heart surgery are low, the identification of risk factors for acute severe complications is essential for the risk stratification of patients undergoing TAVR. The requirement, however, of the extracorporeal circulation system in the catheterization laboratory during the TAVR procedure is challenged with these data. REFERENCES 1. Alli OO, Booker JD, Lennon RJ, Greason KL, Rihal CS, Holmes DR Jr. Transcatheter aortic valve implantation: Assessing the learning curve. JACC Cardiovasc Interv 2012;5:72–79. 2. Holmes DR Jr., Mack MJ, Kaul S, Agnihotri A, Alexander KP, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am College Cardiol 2012;59:1200–1254. 3. Lange R, Piazza N. Transcatheter aortic valve-in-surgical aortic valve implantation: Current status and future perspectives. Eur J Cardiothorac Surg 2013;44:403–406. 4. D’Errigo P, Barbanti M, Ranucci M, Onorati F, Covello RD, Rosato S, Tamburino C, Santini F, Santoro G, Seccareccia F. Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: Results from an intermediate risk propensity-matched population of the italian OBSERVANT study. Int J Cardiol 2014;167:1945–1952. 5. van Mieghem NM, Head SJ, van der Boon RM, Piazza N, de Jaegere PP, et al. The SURTAVI model: Proposal for a pragmatic risk stratification for patients with severe aortic stenosis. EuroIntervention 2014;8:258–266. 6. Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, et al. One-year outcomes of cohort 1 in the edwards SAPIEN aortic bioprosthesis european outcome (SOURCE) registry: The European registry of transcatheter aortic valve implantation using the edwards SAPIEN valve. Circulation 2011;124:425– 433. 7. Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, et al. Thirty-day results of the SAPIEN aortic bioprosthesis european outcome (SOURCE) registry: A European registry of transcatheter aortic valve implantation using the edwards SAPIEN valve. Circulation 2010;122:62–69. 8. Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, et al. Transcatheter aortic valve implantation: 3-year outcomes of selfexpanding CoreValve prosthesis. Eur Heart J 2012;33:969–976.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
6
Toutouzas et al.
9. Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, et al. Transcatheter aortic valve implantation: Early results of the FRANCE (French aortic national CoreValve and edwards) registry. Eur Heart J 2011;32:191–197. 10. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: The U.K. TAVI (united kingdom transcatheter aortic valve implantation) registry. J Am College Cardiol 2011;58: 2130–2138. 11. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: A consensus report from the valve academic research consortium. J Am College Cardiol 2011;57:253–269. 12. Haussig S, Schuler G, Linke A. Worldwide TAVI registries: What have we learned? Clin Res Cardiol 2014;103:603–612. 13. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, et al. Transcatheter aortic-valve replacement with a selfexpanding prosthesis. N Engl J Med 370:1790–1798. 14. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, et al. Transcatheter versus surgical aortic-valve replacement in highrisk patients. N Engl J Med 2011;364:2187–2198. 15. Piazza N, Kalesan B, van Mieghem N, Head S, Wenaweser P, et al. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv 6:443–451. 16. van Mieghem NM, Head SJ, van der Boon RM, Piazza N, de Jaegere PP, et al. The SURTAVI model: Proposal for a pragmatic risk stratification for patients with severe aortic stenosis. EuroIntervention, 8:258–266. 17. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363: 1597–1607. 18. Haussig S, Schuler G, Linke A. Worldwide TAVI registries: What have we learned? Clin Res Cardiol 2013;103:603–612. 19. Petronio AS, Carlo D, Bedogni M, Marzocchi F, Klugmann A, et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circulation 3:359–366. 20. D’Onofrio A, Salizzoni S, Agrifoglio M, Cota L, Luzi G, et al. Medium term outcomes of transapical aortic valve implantation: Results from the Italian registry of Trans-apical aortic valve implantation. Ann Thorac Surg 2013;96:830–835. discussion 836.
21. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1705–1715. 22. Hamm CW, Mollmann H, Holzhey D, Beckmann A, Veit C, et al. The German aortic valve registry (GARY): In-hospital outcome. Eur Heart J 2014;35:1588–1598. 23. Lange R, Bleiziffer S, Elhmidi Y, Piazza N. Transcatheter aortic valve implantation: The European experience. J Thorac Cardiovasc Surg 2013;145:S17–21. 24. Di Mario C, Eltchaninoff H, Moat N, Goicolea J, Ussia GP, et al. The 2011-12 pilot european sentinel registry of transcatheter aortic valve implantation: In-hospital results in 4,571 patients. EuroIntervention 2013;8:1362–1371. 25. Eggebrecht H, Mehta RH, Haude M, Sack S, Mudra H, et al. Transcatheter aortic valve implantation (TAVI) by centres with and without an on-site cardiac surgery programme: Preliminary experience from the German TAVI registry. EuroIntervention 2014;10:602–608. 26. Griese DP, Reents W, Diegeler A, Kerber S, Babin-Ebell J. Simple, effective and safe vascular access site closure with the double-ProGlide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2013;82:E734–741. 27. Eggebrecht H, Mehta RH, Kahlert P, Schymik G, Lefevre T, Lange R Macaya C Mandinov L Wendler O Thomas M. Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): Insights from the Edwards SAPIEN aortic bioprosthesis european outcome (SOURCE) registry. EuroIntervention 2013;10:975–981. 28. Drews T, Pasic M, Buz S, Dreysse S, Klein C, Kukucka M, Mladenow A, Hetzer R, Unbehaun A. Elective use of femorofemoral cardiopulmonary bypass during transcatheter aortic valve implantationdagger. Eur J Cardiothorac Surg 2014;47:24– 30. 29. Hein R, Abdel-Wahab M, Sievert H, Kuck KH, Voehringer M, et al. Outcome of patients after emergency conversion from transcatheter aortic valve implantation to surgery. EuroIntervention 2013;9:446–451. 30. Kiefer P, Seeburger J, Noack T, Schroter T, Linke A, Schuler G, Haensig M, Vollroth M, Mohr FW, Holzhey DM. The role of the heart team in complicated transcatheter aortic valve implantation: A 7-year single-centre experience. Eur J Cardiothorac Surg, Eur J Cardiothorac Surg 2014; Oct 13. pii: ezu379. 31. Seco M, Forrest P, Jackson SA, Martinez G, Andvik S, Bannon PG, Ng M, Fraser JF, Wilson MK, Vallely MP. Extracorporeal membrane oxygenation for very high-risk transcatheter aortic valve implantation. Heart Lung Circ 2014;23:957–962.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Core Curriculum The Requirement of Extracorporeal Circulation System for Transluminal Aortic Valve Replacement: Do We Really Need It in The Catheterization Laboratory? Konstantinos Toutouzas,* FSCAI, Andreas Synetos, MD, George Latsios, MD, Antonis Mastrokostopoulos, MD, Konstantinos Stathogiannis, MD, Maria Drakopoulou, MD, George Trantalis, MD, Eleftherios Tsiamis, MD, and Dimitrios Tousoulis, MD Transcatheter aortic valve replacement (TAVR) is the mainstay for treating high-risk patients with aortic stenosis. As the TAVR procedures worldwide keep increasing, it is inevitable that more issues and complications will arise. Such a complication that merits attention is the conversion of TAVR into open-heart surgery and the necessity this complication creates to have an extracorporeal circulation system in the catheterization laboratory. This review contains an analysis of all major randomized trials and registries on the number and cause of TAVR procedures that ended up in open-heart surgery and presents data to challenge the prerequisite of extracorporeal circulation system in the cath laboratory. VC 2015 Wiley Periodicals, Inc. Key words: TAVR; aortic stenosis; open heart surgery
INTRODUCTION
Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective method for the treatment of severe symptomatic aortic stenosis in patients at high risk and intermediate risk for conventional surgery (SAVR) [1–5]. The constantly increasing number of procedures performed, improve the accumulative experience and the safety of the procedure. This is evident from the results of large-scale randomized trials as well as from registries that represent the real world practice. The evidence from randomized studies [6–8] and national registries, including the learning phase of TAVR implantation, when operator experience, available sizes, and the design of the valves and/ or delivery systems used were different from the currently applied [9,10]. The indications, the requirements, and the methodology for the proper use of this method, based on the current evidence and practice have been reported on the 2012 Expert Consensus Document for TAVR [2]. The ongoing blooming of experimental and clinical research of this field has been supported by the “Valve Academic Research Consortium II (VARC-II)” which C 2015 Wiley Periodicals, Inc. V
homogenizes the definitions and simplifies the understanding of the end points of the research as well as the procedure itself [11]. Nowadays, TAVR is the standard of care for extremely high risk or “inoperable” patients and is a valid alternative to surgery for selected high-risk but “operable” patients with symptomatic aortic stenosis First Department of Cardiology, Hippokration Hospital, Athens Medical School, Athens, Greece Conflict of Interest: Dr Toutouzas is a proctor for Medtronic CoreValve. Konstantinos Toutouzas and Andreas Synetos contributed equally to this manuscript. *Correspondence to: Konstantinos Toutouzas, MD, 26 Karaoli and Dimitriou str. Holargos, 15562 Athens, Greece. E-mail: [email protected] Received 2 January 2015; Revision accepted 6 April 2015 DOI: 10.1002/ccd.25988 Published online 00 Month 2015 in Wiley Online Library (wileyonlinelibrary.com)
2
Toutouzas et al.
[1–3]. Expanding the indications of TAVR in patients with lower perioperative risk is considered by the rapid increase in the number of second-generation valves [2,12]. The ongoing evolution and spreading of the method is limited by the fact that it has to be performed in centers with a cardiothoracic department, in case of an emergency conversion to open-heart surgery [2]. Despite the well-established role of cardiothoracic surgeons on the management and decision making of these patients as part of the heart team, the necessity of the presence of the extracorporeal circulation system in the catheterization laboratory for the TAVR procedures is on debate [2,12]. In several countries, the extracorporeal circulation system is a prerequisite from the regulatory authorities and/or the companies supplying the valves for the acquirement of license to perform TAVR procedures. Emergency conversion from TAVR to open-heart surgery has been reported in 0.5 to 4.3% of patients, with a trend for lower conversion rate in TAVR procedures performed via the femoral artery compared with the transapical approach. In this review, we are performing an analysis of the largest registries and randomized trials on the incidence and the etiology of conversion to open surgery during the procedure of TAVR. According to this analysis, the presence of extracorporeal circulation system will be challenged. RANDOMIZED STUDIES
While registry reports are of crucial value to assess “real-world” practice, the randomized studies can provide more rigorous assessment regarding the safety and efficacy of a new therapy. During the last years, two large scaled randomized trials that compared TAVR with conservative treatment or with surgical aortic valve replacement were performed [13–16]. In the PARTNER trial, the first randomized study that showed that in high-risk patients with severe aortic stenosis, TAVR and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year using the SAPIEN device; in a total of 348 patients undergoing TAVR, 9 patients (2.6%) needed a conversion to surgery [14,17]. This relatively high percentage of conversion to surgery can be attributed to the learning curve of the procedure, as this study was performed in the very beginning of TAVR procedures, when experience was gained with the everyday practice [18]. A recent randomized study, performed at 45 clinical sites in the United States, assessed the safety and effectiveness of TAVR with CoreValve compared with surgical valve replacement in 795 patients with severe aortic stenosis who were at increased surgical risk. This study resulted in an increased survival at 1 year
after the procedure for the TAVR arm, and the survival benefit was consistent across almost all clinical subgroups. Out of the 390 patients that underwent TAVR, the need for conversion to open heart surgery was observed in two patients (0.51%) [13]. Importantly, in this trial the operators could include patients after the third procedure, thus incorporating their learning curve. REGISTRIES
In three large registries from Italy, the need for conversion to surgery during TAVR was lower. In the first Italian registry (a multicenter prospective cohort study), 514 patients were treated with the CoreValve device in 13 centers (using the subclavian approach in 54 cases), and conversion to open heart surgery was necessary in 5 patients (1.0%) [19]. The purpose of this registry was to report the initial experience using the subclavian access for TAVR. Overall survival and freedom from major cardiovascular events at 1 and 6 months were similar between patients treated through the subclavian approach and patients treated through the femoral approach, with a very high 6-month survival in both groups (88.6 vs. 93.3%, femoral vs. subclavian, respectively). The I-TA registry was a prospective, multicenter, registry with the participation of the majority of Italian cardiac surgery centers that started a transapical program included 774 patients undergoing transapical TAVR at each center using the SAPIEN or SAPIEN XT. Ten patients (1.2%) were converted to surgery due to apex-related complications, 2 patients required cardiopulmonary bypass (1 with conversion to median sternotomy); the remaining 8 were successfully treated off pump through the mini thoracotomy. Overall 1-year survival was 81.7%, 2-year survival was 76.1%, and 3year survival was 67.6% [20]. The FRANCE 2 registry evaluated data from a national multicenter registry of a 3,195 consecutive patients undergoing TAVR, in randomly selected centers. The SAPIEN device was used in 66.9% of patients and the CoreValve device in 33.1%. In 12 patients (0.4%), the procedure was converted to surgical aortic-valve replacement with small differences between the transfemoral and transapical approach (0.7%) and the subclavian approach (0%). Moreover, the percentage was similar for both devices used (0.4% both for SAPIEN and CoreValve), 30-day mortality rate was 9.7% a rate that was similar to those reported previously by other registries, ranging from 5.4 to 11.5%. The 1-year survival rate of 76.0% was nearly the same as the rates in the SOURCE, U.K. registries and in cohort A of the PARTNER trial [21]. The German Aortic Valve Registry (GARY) provides data on surgical and catheter-based aortic
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Extracorporeal Circulation during TAVR
procedures on an all-comers basis. The registry summarized the results of 6,523 SAVR without concomitant coronary bypass surgery and 3,464 with concomitant coronary bypass surgery, as well as 2,695 transvascular and 1,181 transapical TAVR procedures. TAVR patients were treated with balloon-expandable prostheses (n ¼ 2,061) or CoreValve (n ¼ 1,614). Only a minority was treated with second-generation prostheses from Symetis SA (n ¼ 53) or JenaValve (n ¼ 53). The remaining patients (n ¼ 94) received either devices under clinical evaluation or no device due to different reasons. The intraoperative complication rates were low. Conversion to sternotomy was necessary in 24 patients (2.0%) of the transapical and 38 patients (1.4%) of the transvascular cases. The in hospital mortality was 5.1% for the transvascular patients and 7.7% for the transapical patients. The authors do not mention whether there was a difference in conversion to surgery between the early phase of the learning curve or whether this percentage was constant throughout the inclusion period of the study population [22]. The United Kingdom Transcatheter Aortic Valve Implantation Registry (U.K. TAVR) is unique in that it has captured every TAVR performed at all the 25 active units within England and Wales, and thus includes the entire learning curve, thus incorporating the early experience of adopting centers. Data were collected prospectively on 870 patients undergoing TAVR procedures up until December 31, 2009. Conversion to an SAVR occurred in 6 patients (0.7%), and all had a SAPIEN implant via a transapical approach (2.2% of transapical implants). Survival at 30 days was 92.9%, and it was 78.6 and 73.7% at 1 and 2 years, respectively. In this cohort of patients, the 30-day mortality was 7.1%, which was comparable to other registries: Canadian registry, 10.4%, SOURCE (SAPIEN Aortic Bioprosthesis European Outcome) registry, 8.5%, PARTNER B cohort, 30-day mortality was 5%, and 5.2% in the PARTNER A cohort [10]. The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consisted of 1,038 patients enrolled at 32 centers. Patients were treated with the transapical approach (n ¼ 575) or the transfemoral approach (n ¼ 463). Conversion to open heart surgery was needed in 8 patients (1.7%) with the transfemoral approach and in 20 patients (3.5%) with TA approach [6,7]. The Medtronic Advance Trial with the Medtronic CoreValve prosthesis study was designed to evaluate the safety, efficacy, and clinical outcomes, using the VARC criteria, of the CoreValve system in 1,015 consecutive ‘‘real world’’ patients with severe aortic ste-
3
nosis. The need for conversion to open aortic valve replacement was 0.1% (1 patient) [12,23]. A multicenter prospective study performed in 137 centers of 10 European countries, the Transcatheter Valve Treatment Sentinel Pilot Registry was published and included a total of 4,571 patients that underwent TAVR between January 2011 and May 2012. SAPIEN XT valves were implanted in 2,604 patients (57.3%) and the rest were CoreValve. Valve selection was skewed towards small diameters with 23 mm SAPIEN XT and 26 mm CoreValve used in 44.2 and 40.8% of patients and intermediate diameter 26 mm SAPIEN XT and 29 mm CoreValve used in 48.7 and 53.1% of patients, respectively. The valve was successfully deployed in 96.5% of patients, without significant differences based on access site or valve type with surgical conversion occurring in 4.3% (194 patients, 159 of them with the transfemoral approach). Overall inhospital mortality was 7.4%, similar in SAPIEN XT and CoreValve, without significant differences (7.9 vs. 6.7%) [24]. An interesting study that analyzed patient characteristics, decision-making processes, and outcomes of TAVR performed in hospitals with versus those without on-site cardiac surgery was recently performed. Out of 1,432 patients enrolled in the German TAVR registry at 27 hospitals, 178 of them (12%) were treated in a hospital without and 1,254 patients in hospitals with on-site cardiac surgery. Conversion to open heart surgery was necessary in 4 (2.2%) in the first group versus 20 (1.6%) in the on-site cardiac surgery patients. Indications for emergency conversion in the in these four patients were annular rupture (n ¼ 1), aortic perforation (n ¼ 1), coronary obstruction (n ¼ 1), and prosthesis embolization (n ¼ 1). Three out of four emergency conversions were performed during a transapical TAVR procedure and only 1 during a transfemoral one. Two of the four patients died within 30 days after emergency conversion (mortality: 50%), while in the other group, nine of 20 patients requiring emergency conversion died postoperatively (mortality: 45%) [25]. An important study that included 411 patients that underwent TAVR in Germany (229 patients via a transapical and 190 via a transfemoral route) showed that 4.9% of the procedures needed emergency conversion to surgery, and this was more frequent in the transfemoral group compared to the transapical group. The reasons for the conversion to surgery were coronary obstruction with failed percutaneous coronary intervention, right or left ventricular perforation, aortic dissection, annulus rupture, severe paravalvular regurgitation, hemorrhagic shock due to bleeding from the left ventricular rupture site, malapposition of the
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
4
Toutouzas et al.
TABLE I. Most Important Registries and the Observed Conversion to Therapy Rates Pts
Conversion to surgery (N)
Conversion to surgery (%)
Conversion to surgery Transvascular approach (%)
France 2 Gary
3,195 3,876
12 62
0.4 1.6
0.7 1.4
Italian I-TA UK-TAVI Partner
514 774 870 348
5 10 6 9
1.0 1.2 0.7 2.6
1.1 Only trans apical 0
Source Advance U.S. CoreValve Greise et al
1,038 1,015 390 411
28 1 2 20
2.7 0.1 0.51 4.9
1.7 0.1 0.51 5.8
Sentinel
4,571
194
4.3
4.7
Registry/trial
Causes of conversion n.r. Device embolization, coronary occlusion, aortic dissection, annular rupture. n.r. Apex related complications Apex related complications Device embolization, large sigmoid septum, annulus size on TEE Valve embolization, coronary obstruction Coronary obstruction Hypotension after TEE coronary obstruction, ventricular perforation, aortic dissection, annulus rupture, severe paravalvular regurgitation, malapposition of the prosthetic valve Valve embolization, unsuccessful valve delivery
n.r: not recordable; pts: patients; TEE: Transesophageal echocardiography.
prosthetic valve, and mitral valve with apparatus damage by wire entrapment. Cardiopulmonary bypass was necessary for 80% of the patients that needed conversion to surgery [26]. A meta-analysis of 48 studies comprising 9,251 patients undergoing TAVR for native AV stenosis published between 2004 and 2011 showed that emergency conversion to surgery was required in 102 patients (1.1%) and this was marginally higher among those undergoing transapical TAVR as compared to those undergoing transfemoral TAVR (1.9 1.7% vs. 0.6 0.9%). In 41% of the reported cases, conversion to surgery was required for embolization/dislocation of the implanted valve prosthesis (n ¼ 36) with aortic dissection/perforation (n ¼ 14), ventricular/atrial wall perforation resulting in bleeding or tamponade (n ¼ 12), severe AV regurgitation (n ¼ 10), aortic valve annulus rupture (n ¼ 6), and coronary obstruction (n ¼ 5) and others (n ¼ 5) [27]. The prophylactic use of the heart-lung machine in patients undergoing TAVR was assessed in 43 high risk patients with preoperative cardiogenic shock or severe left ventricular systolic dysfunction. The aim of the extracorporeal circulation was to minimize the potential complications of the procedure, to stabilize the patients’ condition, to achieve haemodynamic stability during TAVR, and to avoid the possible need for manual cardiopulmonary resuscitation if ventricular fibrillation should occur during rapid pacing for balloon valvuloplasty and during valve deployment. Although 30 day mortality for all patients was 14%, this was present only to those with preoperative cardiogenic shock. Therefore, although the heart–lung machine is
rarely necessary, in this high risk population its use may increase safety and yield acceptable outcomes [28]. Table I summarizes the most important trials and registries that report the number of patients that needed conversion from TAVR to open heart surgery. OUTCOME OF CONVERSION
A recent detailed analysis of the causes, the procedural settings, and the outcome of conversion to open heart surgery was associated with a mortality of 45%. In this analysis from the German TAVR Registry, emergency conversion from TAVR to open cardiac surgery was required in 24 of 1,975 patients (1.2%). Although the mean time interval between abortions of TAVR to surgery was 19 min, with a range of 5–80 min, these patients showed increased mortality rates both within 72 hr from the surgery (29.2%) and within the first 30 days from the procedure (45%). Severe regurgitation and coronary issues were all successfully treated surgically with favorable immediate patient outcome in 30 days [29]. A similar approach was performed by a retrospective analysis of all procedure-related complications that required surgical interventions, whether immediate or delayed but within the initial hospital stay form a single center in Germany. Out of this cohort a total of 42 patients (1.8%) underwent conversion to sternotomy and 27 (1.2%) were dependent on the short-term use of the extracorporeal circulation system. Twenty-five (1.6%) of the cases converted to sternotomy were identified in the transfemoral group and 17 (2.3%) in the
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Extracorporeal Circulation during TAVR
transapical group. Although the conversion when necessary was performed within minutes, mortality rates were 19% in the operating rooms, and 61.9% in the first 30 days from the procedure [30]. In the single center German registry, the 20 patients that their TAVR procedure was converted urgently to surgery had a 30 days mortality of 35%, while this percentage reached 54% when sternotomy was required. Although no differences in survival were reported between the transfemoral and the transapical group, the need for urgent conversion to surgery decrease the mean survival time from 25.56 1.1 months to 4.56 1.6 months in the transfemoral group and from 22.9 1.1 months to 10.8 4.4 months in the transapical patients [26]. The meta-analysis of the 48 studies with 9,251 patients undergoing TAVR showed that mortality at 30 days was roughly 9-fold higher in patients who required a conversion to surgery compared with those patients who did not need emergency conversion (67.1 37.9% vs. 7.5 4.0%) [27]. DISCUSSION
Since 2002, when the first TAVR was performed, the penetration of this method has exponentially increased and nowadays, numerous procedures from different access routes and with a variety of prosthetic valves are performed worldwide. Further expansion of the method is limited by the prerequisite of the presence of a cardiothoracic department close to the cath laboratory. As the need for open cardiac conversion is still low in all registries, it seems difficult to identify definite independent risk factors for immediate conversion to open heart surgery during TAVR procedure. A further limitation for this is the inconsistency of the way that the causes for conversion to surgery are reported in the majority of the studies. However, the data from randomized trials and the major registries indicate several potential risk factors that need further investigation. Thus, first the early phase of the learning curve and secondly the transapical approach, seem to be associated with more acute complications requiring open heart conversion. The rest of the procedures in this high-risk population seem to be associated with low complication rates, requiring urgent cardiosurgical treatment. Furthermore, the treatment of lower risk patients and the advance of second-generation valves should further decrease the need for extracorporeal circulation system in the catheterization laboratory. Finally, the observation that urgent conversion to surgery especially in high risk patients has worse outcome when is performed by sternotomy, supports the
5
hypothesis that what we really need during a TAVR procedure is a left ventricular assist device for transient hemodynamic support, or a vascular surgeon for treating the possible vascular complications, and not necessarily a heart lung machine [26,31]. The presence of left ventricular assist device instead of having a group of experts waiting as a safety net for a possible complication could possible decrease the overall cost of the process and could lead to proper and more rational resource utilization. However, when surgery for failed TAVR is needed, outcomes are bleak with or without cardiopulmonary bypass.
CONCLUSION
In conclusion, although the rates of conversion to open heart surgery are low, the identification of risk factors for acute severe complications is essential for the risk stratification of patients undergoing TAVR. The requirement, however, of the extracorporeal circulation system in the catheterization laboratory during the TAVR procedure is challenged with these data. REFERENCES 1. Alli OO, Booker JD, Lennon RJ, Greason KL, Rihal CS, Holmes DR Jr. Transcatheter aortic valve implantation: Assessing the learning curve. JACC Cardiovasc Interv 2012;5:72–79. 2. Holmes DR Jr., Mack MJ, Kaul S, Agnihotri A, Alexander KP, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am College Cardiol 2012;59:1200–1254. 3. Lange R, Piazza N. Transcatheter aortic valve-in-surgical aortic valve implantation: Current status and future perspectives. Eur J Cardiothorac Surg 2013;44:403–406. 4. D’Errigo P, Barbanti M, Ranucci M, Onorati F, Covello RD, Rosato S, Tamburino C, Santini F, Santoro G, Seccareccia F. Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: Results from an intermediate risk propensity-matched population of the italian OBSERVANT study. Int J Cardiol 2014;167:1945–1952. 5. van Mieghem NM, Head SJ, van der Boon RM, Piazza N, de Jaegere PP, et al. The SURTAVI model: Proposal for a pragmatic risk stratification for patients with severe aortic stenosis. EuroIntervention 2014;8:258–266. 6. Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, et al. One-year outcomes of cohort 1 in the edwards SAPIEN aortic bioprosthesis european outcome (SOURCE) registry: The European registry of transcatheter aortic valve implantation using the edwards SAPIEN valve. Circulation 2011;124:425– 433. 7. Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, et al. Thirty-day results of the SAPIEN aortic bioprosthesis european outcome (SOURCE) registry: A European registry of transcatheter aortic valve implantation using the edwards SAPIEN valve. Circulation 2010;122:62–69. 8. Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, et al. Transcatheter aortic valve implantation: 3-year outcomes of selfexpanding CoreValve prosthesis. Eur Heart J 2012;33:969–976.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
6
Toutouzas et al.
9. Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, et al. Transcatheter aortic valve implantation: Early results of the FRANCE (French aortic national CoreValve and edwards) registry. Eur Heart J 2011;32:191–197. 10. Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: The U.K. TAVI (united kingdom transcatheter aortic valve implantation) registry. J Am College Cardiol 2011;58: 2130–2138. 11. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: A consensus report from the valve academic research consortium. J Am College Cardiol 2011;57:253–269. 12. Haussig S, Schuler G, Linke A. Worldwide TAVI registries: What have we learned? Clin Res Cardiol 2014;103:603–612. 13. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, et al. Transcatheter aortic-valve replacement with a selfexpanding prosthesis. N Engl J Med 370:1790–1798. 14. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, et al. Transcatheter versus surgical aortic-valve replacement in highrisk patients. N Engl J Med 2011;364:2187–2198. 15. Piazza N, Kalesan B, van Mieghem N, Head S, Wenaweser P, et al. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv 6:443–451. 16. van Mieghem NM, Head SJ, van der Boon RM, Piazza N, de Jaegere PP, et al. The SURTAVI model: Proposal for a pragmatic risk stratification for patients with severe aortic stenosis. EuroIntervention, 8:258–266. 17. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363: 1597–1607. 18. Haussig S, Schuler G, Linke A. Worldwide TAVI registries: What have we learned? Clin Res Cardiol 2013;103:603–612. 19. Petronio AS, Carlo D, Bedogni M, Marzocchi F, Klugmann A, et al. Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circulation 3:359–366. 20. D’Onofrio A, Salizzoni S, Agrifoglio M, Cota L, Luzi G, et al. Medium term outcomes of transapical aortic valve implantation: Results from the Italian registry of Trans-apical aortic valve implantation. Ann Thorac Surg 2013;96:830–835. discussion 836.
21. Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1705–1715. 22. Hamm CW, Mollmann H, Holzhey D, Beckmann A, Veit C, et al. The German aortic valve registry (GARY): In-hospital outcome. Eur Heart J 2014;35:1588–1598. 23. Lange R, Bleiziffer S, Elhmidi Y, Piazza N. Transcatheter aortic valve implantation: The European experience. J Thorac Cardiovasc Surg 2013;145:S17–21. 24. Di Mario C, Eltchaninoff H, Moat N, Goicolea J, Ussia GP, et al. The 2011-12 pilot european sentinel registry of transcatheter aortic valve implantation: In-hospital results in 4,571 patients. EuroIntervention 2013;8:1362–1371. 25. Eggebrecht H, Mehta RH, Haude M, Sack S, Mudra H, et al. Transcatheter aortic valve implantation (TAVI) by centres with and without an on-site cardiac surgery programme: Preliminary experience from the German TAVI registry. EuroIntervention 2014;10:602–608. 26. Griese DP, Reents W, Diegeler A, Kerber S, Babin-Ebell J. Simple, effective and safe vascular access site closure with the double-ProGlide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2013;82:E734–741. 27. Eggebrecht H, Mehta RH, Kahlert P, Schymik G, Lefevre T, Lange R Macaya C Mandinov L Wendler O Thomas M. Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): Insights from the Edwards SAPIEN aortic bioprosthesis european outcome (SOURCE) registry. EuroIntervention 2013;10:975–981. 28. Drews T, Pasic M, Buz S, Dreysse S, Klein C, Kukucka M, Mladenow A, Hetzer R, Unbehaun A. Elective use of femorofemoral cardiopulmonary bypass during transcatheter aortic valve implantationdagger. Eur J Cardiothorac Surg 2014;47:24– 30. 29. Hein R, Abdel-Wahab M, Sievert H, Kuck KH, Voehringer M, et al. Outcome of patients after emergency conversion from transcatheter aortic valve implantation to surgery. EuroIntervention 2013;9:446–451. 30. Kiefer P, Seeburger J, Noack T, Schroter T, Linke A, Schuler G, Haensig M, Vollroth M, Mohr FW, Holzhey DM. The role of the heart team in complicated transcatheter aortic valve implantation: A 7-year single-centre experience. Eur J Cardiothorac Surg, Eur J Cardiothorac Surg 2014; Oct 13. pii: ezu379. 31. Seco M, Forrest P, Jackson SA, Martinez G, Andvik S, Bannon PG, Ng M, Fraser JF, Wilson MK, Vallely MP. Extracorporeal membrane oxygenation for very high-risk transcatheter aortic valve implantation. Heart Lung Circ 2014;23:957–962.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
