Hemodynamic comparison of CoreValve and SAPIEN-XT TAVI valves in Japanese patients
- 70 Downloads
Transcatheter aortic valve implantation (TAVI) is a viable treatment option for high-risk patients with severe aortic stenosis. In Japan, TAVI can be performed using first-generation self-expandable Medtronic CoreValve or balloon-expandable Edwards SAPIEN-XT from 2012. Since the durability and hemodynamic outcomes after transcatheter heart valve (THV) implantation in Japanese patients have not been clearly elucidated, we assessed serial changes in post-TAVI THV performances over a-3-year period by transthoracic echocardiography (TTE). From January 2012 to September 2014, among 83 patients with severe aortic stenosis, 26 underwent TAVI with CoreValve and 57 underwent TAVI with SAPIEN-XT. We assessed the serial changes in first post-implant (FPI) and 3-year post procedure THV hemodynamics by TTE. Valve performance was evaluated by serial assessment of aortic valve mean pressure gradient (PG) and aortic valve area (AVA) assessments. Three-year clinical outcomes were compared between the patients with CoreValve and those with SAPIEN-XT. Seventeen patients with CoreValve and 34 patients with SAPIEN-XT had FPI and 3-year TTEs. The AVA decreased significantly from FPI to 3-year follow-up among patients with SAPIEN-XT, but not among patients with CoreValve. The mean aortic PG decreased significantly from FPI to the 3-year follow-up point among patients with CoreValve; however, it was not significantly different from those with SAPIEN-XT. The absolute change in mean PG from FPI to the 3-year follow-up point decreased significantly among those with CoreValve compared to those with SAPIEN-XT. Clinical outcomes after TAVI were similar for both devices at 3-years after TAVI. In this study, long-term clinical outcomes for CoreValve and SAPIEN XT were similar. The 3-year THV performance of both devices was maintained after TAVI. Serial change in mean aortic PGs for CoreValve decreases significantly from FPI to the 3-year follow-up point compared to that for SAPIEN-XT.
KeywordsTranscatheter aortic valve implantation Aortic stenosis Durability Transcatheter heart valve performance
We thank Keiko Aso, who is a clinical research nurse at our hospital, for her enormous help with the data collection.
This research study did not receive any grants from any funding agency from public, commercial, or not-for-profit sectors.
Compliance with ethical standards
Conflict of interest
Dr. Saito is a clinical proctor for Edwards Lifesciences and Medtronic. The Authors declare that there is no conflict of interest.
- 1.Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria J, Herrmann H, Akin JJ, Anderson WN, Wang DC, Pocock SJ (2011) Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364:2187–2198CrossRefGoogle Scholar
- 2.Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK (2014) Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 370:1790–1798CrossRefGoogle Scholar
- 3.Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, Webb JG, Douglas PS, Anderson WN, Blackstone EH, Kodali SK, Makkar RR, Fontana GP, Kapadia S, Bavaria J, Hahn RT, Thourani VH, Babaliaros V, Pichard A, Herrmann HC, Brown DL, Williams M, Akin J, Davidson M, Svensson LG (2015) 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet (London, England) 385:2477–2484CrossRefGoogle Scholar
- 4.Reardon MJ, Adams DH, Kleiman NS, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Lee JS, Hermiller JB Jr, Chetcuti S, Heiser J, Merhi W, Zorn GL, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte JV, Resar JR, Aharonian V, Pfeffer T, Oh JK, Qiao H, Popma JJ (2015) 2-Year outcomes in patients undergoing surgical or self-expanding transcatheter aortic valve replacement. J Am Coll Cardiol 66:113–121CrossRefGoogle Scholar
- 5.Sawa Y, Saito S, Kobayashi J, Niinami H, Kuratani T, Maeda K, Kanzaki H, Komiyama N, Tanaka Y, Boyle A, Zhang A, Moore BJ, de Medeiros R (2014) First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis. Circ J 78:1083–1090CrossRefGoogle Scholar
- 9.Inohara T, Hayashida K, Watanabe Y, Yamamoto M, Takagi K, Yashima F, Arai T, Shimizu H, Chevalier B, Lefevre T, Fukuda K, Morice MC (2016) Streamlining the learning process for TAVI: Insight from a comparative analysis of the OCEAN-TAVI and the massy registries. Catheter Cardiovasc Interv 87:963–970CrossRefGoogle Scholar
- 10.Miyasaka M, Tada N, Taguri M, Kato S, Enta Y, Otomo T, Hata M, Watanabe Y, Naganuma T, Araki M, Yamanaka F, Shirai S, Ueno H, Mizutani K, Tabata M, Higashimori A, Takagi K, Yamamoto M, Hayashida K (2018) Incidence, predictors, and clinical impact of prosthesis-patient mismatch following transcatheter aortic valve replacement in asian patients: the OCEAN-TAVI Registry. JACC Cardiovasc Interv 11:771–780CrossRefGoogle Scholar
- 11.Zoghbi WA, Chambers JB, Dumesnil JG, Foster E, Gottdiener JS, Grayburn PA, Khandheria BK, Levine RA, Marx GR, Miller FA Jr, Nakatani S, Quinones MA, Rakowski H, Rodriguez LL, Swaminathan M, Waggoner AD, Weissman NJ, Zabalgoitia M (2009) Recommendations for evaluation of prosthetic valves with echocardiography and doppler ultrasound: a report From the American Society of Echocardiography's Guidelines and Standards Committee and the Task Force on Prosthetic Valves, developed in conjunction with the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association, the European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography and the Canadian Society of Echocardiography, endorsed by the American College of Cardiology Foundation, American Heart Association, European Association of Echocardiography, a registered branch of the European Society of Cardiology, the Japanese Society of Echocardiography, and Canadian Society of Echocardiography. J Am Soc Echocardiogr 22:975–1014 (quiz 1082–1084) CrossRefGoogle Scholar
- 12.Kappetein AP, Head SJ, Généreux P, Piazza N, Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation. J Am Coll Cardiol 60:1438–1454CrossRefGoogle Scholar
- 13.Daubert MA, Weissman NJ, Hahn RT, Pibarot P, Parvataneni R, Mack MJ, Svensson LG, Gopal D, Kapadia S, Siegel RJ, Kodali SK, Szeto WY, Makkar R, Leon MB, Douglas PS (2016) Long-term valve performance of TAVR and SAVR: a report from the PARTNER I trial. JACC Cardiovasc Imaging 10:15–25CrossRefGoogle Scholar
- 14.Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Osten M, Feindel CM, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson M, Thompson CR, Wood D, Toggweiler S, Gurvitch R, Lichtenstein SV, Doyle D, DeLarochelliere R, Teoh K, Chu V, Bainey K, Lachapelle K, Cheema A, Latter D, Dumesnil JG, Pibarot P, Horlick E (2012) Long-term outcomes after transcatheter aortic valve implantation: insights on prognostic factors and valve durability from the Canadian multicenter experience. J Am Coll Cardiol 60:1864–1875CrossRefGoogle Scholar
- 16.Sedaghat A, Sinning JM, Utzenrath M, Ghalati PF, Schmitz C, Werner N, Nickenig G, Grube E, Ensminger S, Steinseifer U, Kuetting M (2016) Hydrodynamic performance of the Medtronic CoreValve and the Edwards SAPIEN XT transcatheter heart valve in surgical bioprostheses: an in vitro valve-in-valve model. Ann Thorac Surg 101:118–124CrossRefGoogle Scholar
- 17.Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, Tarantini G, Sinning JM, Nickenig G, Capodanno D, Tamburino C, Latib A, Colombo A, Kapadia SR (2013) Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 61:1585–1595CrossRefGoogle Scholar
- 18.Barbanti M, Petronio AS, Ettori F, Latib A, Bedogni F, De Marco F, Poli A, Boschetti C, De Carlo M, Fiorina C, Colombo A, Brambilla N, Bruschi G, Martina P, Pandolfi C, Giannini C, Curello S, Sgroi C, Gulino S, Patane M, Ohno Y, Tamburino C, Attizzani GF, Imme S, Gentili A, Tamburino C (2015) 5-Year outcomes after transcatheter aortic valve implantation with CoreValve prosthesis. JACC Cardiovasc Interv 8:1084–1091CrossRefGoogle Scholar