Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry

Farhad Bakhtiary, Ali El-Sayed Ahmad, Rüdiger Autschbach, Peter Benedikt, Nikolaos Bonaros, Michael Borger, Oliver Dewald, Richard Feyrer, Hans-Joachim Geißler, Jürg Grünenfelder, Ka Yan Lam, Rainer Leyh, Andreas Liebold, Markus Czesla, Arash Mehdiani, Francesco Pollari, Saad Salamate, Justus Strauch, Andreas Vötsch, Alberto Weber, Daniel Wendt, Beate Botta, Peter Bramlage, Andreas Zierer, Farhad Bakhtiary, Ali El-Sayed Ahmad, Rüdiger Autschbach, Peter Benedikt, Nikolaos Bonaros, Michael Borger, Oliver Dewald, Richard Feyrer, Hans-Joachim Geißler, Jürg Grünenfelder, Ka Yan Lam, Rainer Leyh, Andreas Liebold, Markus Czesla, Arash Mehdiani, Francesco Pollari, Saad Salamate, Justus Strauch, Andreas Vötsch, Alberto Weber, Daniel Wendt, Beate Botta, Peter Bramlage, Andreas Zierer

Abstract

Background: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research.

Methods: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation.

Discussion: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses.

Trial registration: ClinicalTrials.gov identifier: NCT04053088 .

Keywords: Aortic valve disease; Comorbidities; Real-world setting; SAVR; Surgical aortic valve replacement.

Conflict of interest statement

Farhad Bakhtiary has received lecture fees and/or research support from Edwards Lifesciences.

Ali El-Sayed Ahmad has nothing to disclose with regard to commercial support.

Rüdiger Autschbach has no conflict of interest to disclose.

Peter Benedikt has no conflict of interest to disclose.

Nikolaos Bonaros has received lecture fees and/or research support from Edwards Lifesciences.

Michael Borger has received lecture fees and/or research support from Edwards Lifesciences.

Oliver Dewald has no conflict of interest to disclose.

Richard Feyrer has received proctoring fees from Edwards Lifesciences.

Hans-Joachim Geißler has no conflict of interest to disclose.

Jürg Grünenfelder has no conflict of interest to disclose.

Ka Yan Lam has not conflict of interest to disclose.

Rainer Leyh has no conflict of interest to disclose.

Andreas Liebold has received lecture and proctoring fees from Edwards Lifesciences.

Markus Czesla has no conflict of interest to disclose.

Arash Mehdiani has no conflict of interest to disclose.

Francesco Pollari has no conflict of interest to disclose.

Saad Salamate has no conflict of interest to disclose.

Justus Strauch has received research funding from Edwards Lifesciences.

Andreas Vötsch has received lecture fees and is a proctor for Edwards Lifesciences.

Alberto Weber has no conflict of interest to disclose.

Daniel Wendt has no conflict of interest to disclose.

Beate Botta: her institution has received research support from Edwards Lifesciences.

Peter Bramlage has received lecture fees and/or research support from Edwards Lifesciences.

Andreas Zierer has received lecture fees and/or research support from Edwards Lifesciences.

The institutions of these and those of the remaining authors representing study centers have received patient inclusion-based funding.

References

    1. Goldbarg SH, Elmariah S, Miller MA, Fuster V. Insights into degenerative aortic valve disease. J Am Coll Cardiol. 2007;50(13):1205–1213. doi: 10.1016/j.jacc.2007.06.024.
    1. Hu PP. TAVR and SAVR: current treatment of aortic stenosis. Clin Med Insights Cardiol. 2012;6:125–139. doi: 10.4137/CMC.S7540.
    1. Boon A, Cheriex E, Lodder J, Kessels F. Cardiac valve calcification: characteristics of patients with calcification of the mitral annulus or aortic valve. Heart. 1997;78(5):472–474. doi: 10.1136/hrt.78.5.472.
    1. Spadaccio C, Alkhamees K, Al-Attar N: Recent advances in aortic valve replacement. F1000Res 2019, 8.
    1. Najjar M, Yerebakan H, Sorabella RA, Donovan DJ, Kossar AP, Sreekanth S, Kurlansky P, Borger MA, Argenziano M, Smith CR, George I. Acute kidney injury following surgical aortic valve replacement. J Card Surg. 2015;30(8):631–639. doi: 10.1111/jocs.12586.
    1. Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020;75(Suppl 1):e143–e150.
    1. Clough RA, Leavitt BJ, Morton JR, Plume SK, Hernandez F, Nugent W, Lahey SJ, Ross CS, O'Connor GT. Group ftNNECDS: the effect of comorbid illness on mortality outcomes in cardiac surgery. Arch Surg. 2002;137(4):428–433. doi: 10.1001/archsurg.137.4.428.
    1. Pinon M, Paredes E, Acuna B, Raposeiras S, Casquero E, Ferrero A, Torres I, Legarra JJ, Pradas G, Barreiro-Morandeira F, et al. Frailty, disability and comorbidity: different domains lead to different effects after surgical aortic valve replacement in elderly patients. Interact Cardiovasc Thorac Surg. 2019;29(3):371–377. doi: 10.1093/icvts/ivz093.
    1. Gutmann A, Kaier K, Reinecke H, Frankenstein L, Zirlik A, Bothe W, von Zur MC, Zehender M, Reinöhl J, Bode C, et al. Impact of pulmonary hypertension on in-hospital outcome after surgical or transcatheter aortic valve replacement. EuroIntervention. 2017;13(7):804–810. doi: 10.4244/EIJ-D-16-00927.
    1. Thourani VH, Keeling WB, Sarin EL, Guyton RA, Kilgo PD, Dara AB, Puskas JD, Chen EP, Cooper WA, Vega JD, Morris CD, Halkos ME, Lattouf OM. Impact of preoperative renal dysfunction on long-term survival for patients undergoing aortic valve replacement. Ann Thorac Surg. 2011;91(6):1798–1806. doi: 10.1016/j.athoracsur.2011.02.015.
    1. Wukich DK. Diabetes and its negative impact on outcomes in orthopaedic surgery. World J Orthop. 2015;6(3):331–339. doi: 10.5312/wjo.v6.i3.331.
    1. Altaf A. Effect of diabetes mellitus on postoperative outcomes in patients undergoing emergency general surgery procedures. Biomed Res. 2019;30(5):747–752. doi: 10.35841/biomedicalresearch.30-19-333.
    1. Mendez-Bailon M, Lorenzo-Villalba N, Munoz-Rivas N, de Miguel-Yanes JM, De Miguel-Diez J, Comin-Colet J, Hernandez-Barrera V, Jimenez-Garcia R, Lopez-de-Andres A. Transcatheter aortic valve implantation and surgical aortic valve replacement among hospitalized patients with and without type 2 diabetes mellitus in Spain (2014-2015) Cardiovasc Diabetol. 2017;16(1):144. doi: 10.1186/s12933-017-0631-6.
    1. Bartus K, Sadowski J, Litwinowicz R, Filip G, Jasinski M, Deja M, Kusmierczyk M, Pawlak S, Jemielity M, Jagielak D, Hendzel P, Suwalski P, Tobota Z, Maruszewski B, Kapelak B. Changing trends in aortic valve procedures over the past ten years-from mechanical prosthesis via stented bioprosthesis to TAVI procedures-analysis of 50,846 aortic valve cases based on a polish National Cardiac Surgery Database. J Thorac Dis. 2019;11(6):2340–2349. doi: 10.21037/jtd.2019.06.04.
    1. Reichenspurner H, Weinhold C, Nollert G, Kaulbach HG, Vetter HO, Boehm DH, Reichart B. Comparison of porcine biological valves with pericardial valves--a 12-year clinical experience with 1123 bio-prostheses. Thorac Cardiovasc Surg. 1995;43(1):19–26. doi: 10.1055/s-2007-1013763.
    1. Patel KK, Shah SY, Arrigain S, Jolly S, Schold JD, Navaneethan SD, Griffin BP, Nally JV, Desai MY. Characteristics and outcomes of patients with aortic stenosis and chronic kidney disease. J Am Heart Assoc. 2019;8(3):e009980. doi: 10.1161/JAHA.118.009980.
    1. Briand M, Pibarot P, Despres JP, Voisine P, Dumesnil JG, Dagenais F, Mathieu P. Metabolic syndrome is associated with faster degeneration of bioprosthetic valves. Circulation. 2006;114(1 Suppl):I512–I517. doi: 10.1161/CIRCULATIONAHA.105.000422.
    1. Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149(1):340–345. doi: 10.1016/j.jtcvs.2014.09.062.
    1. Salaun E, Clavel MA, Rodes-Cabau J, Pibarot P. Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation. Heart. 2018;104(16):1323–1332. doi: 10.1136/heartjnl-2017-311582.
    1. Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR, on behalf of The COMMENCE Trial Investigators The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017;52(3):432–439. doi: 10.1093/ejcts/ezx158.
    1. Byass P. Towards a global agenda on ageing. Glob Health Action. 2008;1(1):1908. doi: 10.3402/gha.v1i0.1908.
    1. Maganti K, Rigolin VH, Sarano ME, Bonow RO. Valvular heart disease: diagnosis and management. Mayo Clin Proc. 2010;85(5):483–500. doi: 10.4065/mcp.2009.0706.
    1. Sun V, Burhenn PS, Lai L, Hurria A. The impact of comorbidity on surgical outcomes in older adults with cancer. Semin Oncol Nurs. 2017;33(1):80–86. doi: 10.1016/j.soncn.2016.11.008.
    1. Imamura K, Black N. Does comorbidity affect the outcome of surgery? Total hip replacement in the UK and Japan. Int J Qual Health Care. 1998;10(2):113–123. doi: 10.1093/intqhc/10.2.113.
    1. Piccirillo JF, Vlahiotis A, Barrett LB, Flood KL, Spitznagel EL, Steyerberg EW. The changing prevalence of comorbidity across the age spectrum. Crit Rev Oncol Hematol. 2008;67(2):124–132. doi: 10.1016/j.critrevonc.2008.01.013.
    1. Barth A, Yucel S, Ince H, Doblhammer G. Impact of transcatheter aortic valve implantation on the risk of mortality in patients with severe aortic valve diseases: a health insurance-based analysis. Open Heart. 2018;5(1):e000756. doi: 10.1136/openhrt-2017-000756.
    1. Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, Takkenberg JJ, David TE, Butchart EG, Adams DH, Shahian DM, Hagl S, Mayer JE, Lytle BW, STS. AATS. EACTS Guidelines for reporting mortality and morbidity after cardiac valve interventions. Ann Thorac Surg. 2008;85(4):1490–1495. doi: 10.1016/j.athoracsur.2007.12.082.
    1. Svensson LG, Adams DH, Bonow RO, Kouchoukos NT, Miller DC, O'Gara PT, Shahian DM, Schaff HV, Akins CW, Bavaria J, Blackstone EH, David TE, Desai ND, Dewey TM, D'Agostino RS, Gleason TG, Harrington KB, Kodali S, Kapadia S, Leon MB, Lima B, Lytle BW, Mack MJ, Reece TB, Reiss GR, Roselli E, Smith CR, Thourani VH, Tuzcu EM, Webb J, Williams MR. Aortic valve and ascending aorta guidelines for management and quality measures: executive summary. Ann Thorac Surg. 2013;95(4):1491–1505. doi: 10.1016/j.athoracsur.2012.12.027.
    1. Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG, Treede H, Sarano ME, Feldman T, Wijeysundera HC, Topilsky Y, Aupart M, Reardon MJ, Mackensen GB, Szeto WY, Kornowski R, Gammie JS, Yoganathan AP, Arbel Y, Borger MA, Simonato M, Reisman M, Makkar RR, Abizaid A, McCabe J, Dahle G, Aldea GS, Leipsic J, Pibarot P, Moat NE, Mack MJ, Kappetein AP, Leon MB, VIVID (Valve in Valve International Data) Investigators Standardized definition of structural valve degeneration for surgical and Transcatheter bioprosthetic aortic valves. Circulation. 2018;137(4):388–399. doi: 10.1161/CIRCULATIONAHA.117.030729.
    1. Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, et al. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Eur J Cardiothorac Surg. 2017;52(3):408–417. doi: 10.1093/ejcts/ezx244.
    1. Pibarot P, Borger MA, Clavel MA, Griffith B, Bavaria JE, Svensson LG, Thourani V. Study Design of the Prospective non-Randomized Single-arm Multicenter Evaluation of the durability of aortic bioprosthetic valves with RESILIA tissue in subjects under 65 years old (RESILIENCE trial) Structural Heart. 2019;4(1):46–52. doi: 10.1080/24748706.2019.1686554.
    1. Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwoger M, Laufer G, Binder K, Polvani G, Stefano P, Coscioni E, et al. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020;15(1):119. doi: 10.1186/s13019-020-01155-6.
    1. Foroutan F, Guyatt GH, O'Brien K, Bain E, Stein M, Bhagra S, Sit D, Kamran R, Chang Y, Devji T, et al. Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies. BMJ. 2016;354:i5065. doi: 10.1136/bmj.i5065.

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