Outcomes of RDAVR with Coronary Revascularization: 3-year Results from the German INCA Registry

Abstract

Background The long-term outcomes of combined rapid-deployment aortic valve replacement (RDAVR) with coronary artery bypass graft surgery (CABG) are not well explored. We report 3-year results from the INCA registry on combined RDAVR with CABG.

Methods INCA is a prospective, multicenter registry that enrolled 224 patients undergoing RDAVR with CABG at 10 cardiac institutions in Germany. Prosthetic valve hemodynamics, clinical outcomes, and quality of life (QoL) up to 3 years were assessed.

Results The mean age of patients was 73.6 ± 6.1 years, and the mean logistic EuroSCORE was 7.8 ± 6.0%. The mean number of distal arterial and venous anastomoses was 3.13 ± 1.56, aortic cross-clamp time was 79.4 ± 24.1 minutes, cardiopulmonary bypass time was 109.6 ± 34.5 minutes, and operation time was 224.2 ± 62.7 minutes. The majority of implanted valve size was 25 mm. At baseline, 11 patients (4.9.%) had a permanent pacemaker. Postoperatively, 17 patients (7.6%) required a new pacemaker implantation (5.4% valve-related). All-cause mortality at 30 days was 2.2%, and 11.2% at 3 years. Patient QoL (SF-12v2) was significantly restored and maintained for up to 3 years (p < 0.001). Five patients (0.9%) underwent reoperation related to endocarditis. The postimplant mean gradient was 9.2 ± 3.7 at discharge and 8.9 ± 4.6 mm Hg at 3 years.

Conclusion Combined RDAVR with CABG procedure is safe and effective over time. It offers stable and low transvalvular gradients with satisfactory clinical outcomes at 3 years. The pacemaker rate appears to be slightly increased, with no significant clinical effect at 3 years.

Keywords

rapid-deployment aortic valve replacement - structural valve degeneration - valve durability

Ethical Approval Statement

The study documents were submitted to the ethics committees responsible for each site and there were no objections to conducting the study. Formal written informed consent was obtained from every patient before enrolment.

Authors' Contribution

A.D., J.S., M.S., F.F., and A.L. were involved in the conception and design of the study. The idea was discussed and refined by the rest of the authors. D.M.V., J.G., R.G., P.M., M.K., R.M., G.W., T.W., and J.G. contributed significantly to study execution, acquisition of data, analysis, and interpretation. P.B. drafted the manuscript and all the other authors revised the article for important intellectual content. All the authors gave approval for the final version.

Data Availability Statement

All relevant data within this manuscript will be shared upon reasonable request to the corresponding author.

Publication History

Received: 30 July 2024

Accepted: 16 December 2024

Article published online:
27 January 2025

• References

• 1 Berretta P, Di Eusanio M. Aortic valve replacement with sutureless and rapid deployment aortic valve prostheses. J Geriatr Cardiol 2016; 13 (06) 504-510
• 2 Al-Sarraf N, Thalib L, Hughes A. et al. Cross-clamp time is an independent predictor of mortality and morbidity in low- and high-risk cardiac patients. Int J Surg 2011; 9 (01) 104-109
• 3 Salis S, Mazzanti VV, Merli G. et al. Cardiopulmonary bypass duration is an independent predictor of morbidity and mortality after cardiac surgery. J Cardiothorac Vasc Anesth 2008; 22 (06) 814-822
• 4 Pollari F, Santarpino G, Dell'Aquila AM. et al. Better short-term outcome by using sutureless valves: a propensity-matched score analysis. Ann Thorac Surg 2014; 98 (02) 611-616 , discussion 616–617
• 5 Gonzalez-Barbeito M, Arribas Leal JM, Jimenez Alfaro L. et al. Outcomes of rapid deployment aortic valve replacement with concomitant cardiac procedures. J Thorac Dis 2023; 15 (10) 5605-5612
• 6 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
• 7 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
• 8 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
• 9 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
• 10 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
• 11 Sakata T, De La Pena C, Ohira S. Rapid-deployment aortic valve replacement: patient selection and special considerations. Vasc Health Risk Manag 2023; 19: 169-180
• 12 Taghiyev ZT, Bechtel M, Schlömicher M. et al. Early-term results of rapid-deployment sortic valve replacement versus standard bioprosthesis implantation combined with coronary artery bypass grafting. Thorac Cardiovasc Surg 2023; 71 (07) 519-527
• 13 Barnhart GR, Shrestha ML. Current clinical evidence on rapid deployment aortic valve replacement: sutureless aortic bioprostheses. Innovations (Phila) 2016; 11 (01) 7-14
• 14 IBM SPSS Statistics for Windows. Version 28.0. Armonk, NY: IBM Corp; 2021
• 15 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
• 16 Bouhout I, Mazine A, Rivard L. et al. Conduction disorders after sutureless aortic valve replacement. Ann Thorac Surg 2017; 103 (04) 1254-1260
• 17 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
• 18 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
• 19 Matthews IG, Fazal IA, Bates MG, Turley AJ. In patients undergoing aortic valve replacement, what factors predict the requirement for permanent pacemaker implantation?. Interact Cardiovasc Thorac Surg 2011; 12 (03) 475-479
• 20 White A, Bozso SJ, Lakey O. et al. Rapid deployment valves versus conventional tissue valves for aortic valve replacement. J Thorac Cardiovasc Surg 2022; 163 (06) 2036-2042
• 21 Hartrumpf M, Kuehnel RU, Schroeter F. et al. Clinical short-term outcome and hemodynamic comparison of six contemporary bovine aortic valve prostheses. Thorac Cardiovasc Surg 2020; 68 (07) 557-566
• 22 Schlömicher M, Haldenwang PL, Moustafine V, Bechtel M, Strauch JT. Minimal access rapid deployment aortic valve replacement: initial single-center experience and 12-month outcomes. J Thorac Cardiovasc Surg 2015; 149 (02) 434-440
• 23 Borger MA, Moustafine V, Conradi L. et al. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann Thorac Surg 2015; 99 (01) 17-25