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DOI: 10.1055/s-0042-1757241
Rapid-Deployment Aortic Valve Replacement in a Real-World All-Comers Population
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Abstract
Background This study was conducted to evaluate the mid-term outcomes of rapid-deployment aortic valve replacement (AVR) using Edwards Intuity.
Methods A total of 215 patients underwent rapid-deployment AVR using Edwards Intuity at our institution. The median follow-up duration was 22 months (interquartile range, 8–36). Primary outcomes were overall survival, cumulative incidence of cardiac death, and major adverse cardiac events. Secondary outcomes were early and 1-year hemodynamic performances of the bioprosthetic valve.
Results The mean age was 68.6 ± 10.5 years, and EuroSCORE II was 3.09 ± 4.5. The study population included 113 patients (52.6%) with bicuspid valves (24 patients with type 0 bicuspid valves), 20 patients (9.3%) with pure aortic regurgitation, and 3 patients (1.4%) with infective endocarditis. Isolated AVR was performed in 70 patients (32.4%) and concomitant procedures were performed in 146 patients (67.6%), including aorta surgery (42.3%) and mitral valve procedure (22.3%). Operative mortality was 2.8%. Complete atrioventricular block occurred in 12 patients, but most of them were transient and only 3 patients received permanent pacemaker implantation before discharge. Overall survival at 3 years was 92.3%. Early hemodynamic data showed mean pressure gradients of 15.5 ± 5.0 and 12.7 ± 4.2 mm Hg in the 19 and 21 mm valve, respectively. One-year hemodynamics were also excellent with mean pressure gradients of 14.7 ± 5.3 and 10.7 ± 3.6 mm Hg in the 19 and 21 mm valve, respectively.
Conclusion Based on a real-world all-comers population, rapid-deployment AVR using Edwards Intuity could be performed for various indications, including bicuspid valve, pure aortic regurgitation, and infective endocarditis, and the clinical and hemodynamic outcomes were excellent.
Note
K.H.K. is an official proctor for Edwards Lifesciences.
Publication History
Received: 09 June 2022
Accepted: 23 August 2022
Article published online:
10 October 2022
© 2022. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
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References
- 1 Sohn SH, Jang MJ, Hwang HY, Kim KH. Rapid deployment or sutureless versus conventional bioprosthetic aortic valve replacement: a meta-analysis. J Thorac Cardiovasc Surg 2018; 155 (06) 2402-2412.e5
- 2 Accola KD, Chitwood Jr WR, Mumtaz MA, Barnhart GR. Step-by-step aortic valve replacement with a new rapid deployment valve. Ann Thorac Surg 2018; 105 (03) 966-971
- 3 Brown ML, McKellar SH, Sundt TM, Schaff HV. Ministernotomy versus conventional sternotomy for aortic valve replacement: a systematic review and meta-analysis. J Thorac Cardiovasc Surg 2009; 137 (03) 670-679.e5
- 4 Shalabi A, Spiegelstein D, Sternik L. et al. Sutureless versus stented valve in aortic valve replacement in patients with small annulus. Ann Thorac Surg 2016; 102 (01) 118-122
- 5 Kocher AA, Laufer G, Haverich A. et al. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg 2013; 145 (01) 110-115 , discussion 115–116
- 6 Laufer G, Haverich A, Andreas M. et al. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg 2017; 52 (02) 281-287
- 7 Barnhart GR, Accola KD, Grossi EA. et al; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg 2017; 153 (02) 241-251.e2
- 8 Sievers HH, Schmidtke C. A classification system for the bicuspid aortic valve from 304 surgical specimens. J Thorac Cardiovasc Surg 2007; 133 (05) 1226-1233
- 9 Sohn SH, Kim KH, Kang Y, Kim JS, Choi JW. Recovery from conduction abnormalities after aortic valve replacement using Edwards Intuity. Ann Thorac Surg 2021; 112 (04) 1356-1362
- 10 Akins CW, Miller DC, Turina MI. et al; STS, AATS, EACTS. Guidelines for reporting mortality and morbidity after cardiac valve interventions. Ann Thorac Surg 2008; 85 (04) 1490-1495
- 11 Arribas-Leal JM, Rivera-Caravaca JM, Aranda-Domene R. et al. Mid-term outcomes of rapid deployment aortic prostheses in patients with small aortic annulus. Interact Cardiovasc Thorac Surg 2021; 33 (05) 695-701
- 12 D'Onofrio A, Tessari C, Filippini C. et al. Early and mid-term results of rapid deployment valves: the Intuity Italian Registry (INTU-ITA). Ann Thorac Surg 2018; 106 (06) 1742-1749
- 13 Glauber M, Ferrarini M, Lio A, Miceli A. Dealing with a stenotic bicuspid aortic valve: is this still an off-label procedure for a sutureless valve?. J Thorac Cardiovasc Surg 2015; 150 (04) 858-859
- 14 Miceli A, Berretta P, Fiore A. et al. Sutureless and rapid deployment implantation in bicuspid aortic valve: results from the sutureless and rapid-deployment aortic valve replacement international registry. Ann Cardiothorac Surg 2020; 9 (04) 298-304
- 15 Regueiro A, Linke A, Latib A. et al. Association between transcatheter aortic valve replacement and subsequent infective endocarditis and in-hospital death. JAMA 2016; 316 (10) 1083-1092
- 16 Laufer G, Wiedemann D, Chitwood Jr WR. Rapid-deployment valves: finally the fog is lifting-benefits beyond crossclamp and bypass times. J Thorac Cardiovasc Surg 2017; 154 (05) 1527-1531
- 17 Herry M, Laghlam D, Touboul O. et al. Pacemaker implantation after aortic valve replacement: rapid-deployment Intuity® compared to conventional bioprostheses. Eur J Cardiothorac Surg 2020; 58 (02) 335-342
- 18 Andreas M, Coti I, Rosenhek R. et al. Intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures. Eur J Cardiothorac Surg 2019; 55 (03) 527-533
- 19 Romano MA, Koeckert M, Mumtaz MA. et al; TRANSFORM Trial Investigators. Permanent pacemaker implantation after rapid deployment aortic valve replacement. Ann Thorac Surg 2018; 106 (03) 685-690
- 20 Coti I, Schukro C, Drevinja F. et al. Conduction disturbances following surgical aortic valve replacement with a rapid-deployment bioprosthesis. J Thorac Cardiovasc Surg 2021; 162 (03) 803-811
- 21 Vogt F, Moscarelli M, Nicoletti A. et al. Sutureless aortic valve and pacemaker rate: from surgical tricks to clinical outcomes. Ann Thorac Surg 2019; 108 (01) 99-105
- 22 Haverich A, Wahlers TC, Borger MA. et al. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg 2014; 148 (06) 2854-2860
- 23 Young C, Laufer G, Kocher A. et al. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg 2018; 155 (02) 575-585
- 24 Ferrari E, Roduit C, Salamin P. et al. Rapid-deployment aortic valve replacement versus standard bioprosthesis implantation. J Card Surg 2017; 32 (06) 322-327
- 25 Rahmanian PB, Kaya S, Eghbalzadeh K, Menghesha H, Madershahian N, Wahlers T. Rapid deployment aortic valve replacement: excellent results and increased effective orifice areas. Ann Thorac Surg 2018; 105 (01) 24-30
- 26 Borger MA, Dohmen PM, Knosalla C. et al. Haemodynamic benefits of rapid deployment aortic valve replacement via a minimally invasive approach: 1-year results of a prospective multicentre randomized controlled trial. Eur J Cardiothorac Surg 2016; 50 (04) 713-720
- 27 Andreas M, Wallner S, Habertheuer A. et al. Conventional versus rapid-deployment aortic valve replacement: a single-centre comparison between the Edwards Magna valve and its rapid-deployment successor. Interact Cardiovasc Thorac Surg 2016; 22 (06) 799-805
- 28 Wahlers TCW, Andreas M, Rahmanian P. et al. Outcomes of a rapid deployment aortic valve versus its conventional counterpart: a propensity-matched analysis. Innovations (Phila) 2018; 13 (03) 177-183
- 29 Capelli C, Corsini C, Biscarini D. et al. Pledget-armed sutures affect the haemodynamic performance of biologic aortic valve substitutes: a preliminary experimental and computational study. Cardiovasc Eng Technol 2017; 8 (01) 17-29