A Comparative Study of TAVR versus SAVR in Moderate and High-Risk Surgical Patients: Hospital Outcome and Midterm Results
Abstract
Background: Although the use of transcatheter aortic valve replacement (TAVR) has recently become an attractive strategy in prohibitive surgical high-risk patients undergoing aortic valve replacement (AVR), the most appropriate treatment option in patients with an intermediate- to high-risk profile— whether conventional surgery (SAVR) or TAVR—has been widely debated.
Methods: One hundred and forty-three consecutive patients with intermediate to high risk were prospectively enrolled and selected to undergo SAVR (Group 1 [G1], n = 63) or TAVR (Group 2 [G2], n = 80) following a multidisciplinary evaluation including frailty, anatomy, and degree of atherosclerotic disease of the aorta/peripheral vessels. The mean logistic EuroSCORE (G1 = 20.11 ± 7.144 versus G2 = 23.33 ± 8.97; P = .022), STS score (G1 = 5.722 ± 1.309 versus G2 = 5.958 ± 1.689; P = .347), and preoperative demographics such as sex, left ventricular ejection fraction (LVEF), body mass index (BMI), peripheral vascular disease, diabetes, atrial fibrillation, renal impairment and syncope were similar. Of note, chronic obstructive pulmonary disease was more frequent in TAVR patients (G2 [46.2%] versus G1 [19.0%]; P = .001), whereas pulmonary hypertension was more frequent in SAVR group (G1 [47.6%] versus G2 [17.5%]; P = .000). The SAVR was performed with either a mechanical or tissue valve; meanwhile, TAVR was performed with either Core valve prosthesis or Edwards-Sapiens XT valve.
Results: SAVR group showed higher incidence of some postoperative complications compared to TAVR, namely, postoperative bleeding (4.8% versus 0.0%; P = .048), tamponade (4.8% versus 0.0%; P = .048) and postoperative atrial fibrillation (34.9% versus 10.0%; P = .000), whereas TAVR group had a higher incidence of other sets of postoperative complications, namely, left bundle branch block (58.8% versus 4.8%; P = .000), need for permanent pacemaker implantation (25.0% versus 1.6%; P = .000) and peripheral vascular complications (15.0% versus 0.0%; P = .001). On the contrary, when the two groups were compared they did not show any significant difference regarding anemia requiring more than two units of blood transfusion, postoperative renal failure, stroke, myocardial infarction, and hospital mortality. P = .534, .873, .258, .373 and .072 respectively. Hospital mortality was similar among the two groups (G1 = 0% versus G2 = 5%; P = .072). At the 24-month follow-up, overall mortality, major adverse cardiac and cerebrovascular events were comparable between the two groups but prosthetic regurgitation was better in SAVR group (G2 = 8 patients [10.0%] versus G1 = 1 patient [1.6%] in SAVR group; P = .040).
Conclusion: In this study, we could not detect an advantage in survival when SAVR or TAVR were utilized in intermediate to high surgical risk patients needing aortic valve replacement for severe aortic stenosis.
References
Ben-Dor I, Pichard AD, Gonzalez MA, et al. 2010. Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation. Circulation 122:S37-42.
Cao C, Ang SC, Indraratna P, et al. 2013. Systematic review and meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis. Ann Cardiothorac Surg 2:10-23.
Colli A, D'Amico R, Kempfert J, et al. 2011. Transesophageal echocardiographic scoring for transcatheter aortic valve implantation: impact of aortic cusp calcification on postoperative aortic regurgitation. J Thorac Cardiovasc Surg 142:1229-35.
Cribier A, Eltchaninoff H, Bash A, et al. 2002. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106:3006-8.
Dewey TM, Brown DL, Das TS, et al. 2008. High-risk patients referred for transcatheter aortic valve implantation: management and outcomes, Ann Thorac Surg 86:1450-6.
D'Onofrio A, Messina A, Lorusso R, et al. 2012. Sutureless aortic valve replacement as an alternative treatment for patients belonging to the ‘gray zone' between transcatheter aortic valve implant-ation and conventional surgery: a propensity-matched, multicenter analysis. J Thorac Cardiovasc Surg 144:1010-6.
D’Onofrio A, Messina A, Lorusso R, et al. 2013. Conventional surgery, sutureless valves, and transapical aortic valve replacement: What is the best option for patients with aortic valve stenosis? A multicenter, propensity-matched analysis. J Thorac Cardiovasc Surg 146:1065-71.
Grossi EA, Schwartz CF, Yu PJ , et al. 2008 . High-risk aortic valve replacement: are the outcomes as bad as predicted? Ann Thorac Surg 85:102-6.
Holmes DR Jr, Mack MJ, Kaul S, et al. 2012. ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol 59:1200-54.
Kapadia SR, Goel SS, Svensson L, et al. 2009. Characterization and outcome of patients with severe symptomatic aortic stenosis referred for percutaneous aortic valve replacement. J Thorac Cardiovasc Surg 137:1430-5.
Kappetein AP, Head SJ, Généreux P, et al. 2012. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document, Eur Heart J 33:2403-18.
Kodali SK, Williams MR, Smith CR, et al. 2012. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 366:1686-95.
Lang RM, Bierig M, Devereux RB, et al. 2006. Recommendations for chamber quantification. Eur J Echocardiogr. 7:79-108.
Latib A, Maisano F, Bertoldi L, et al. 2012. Transcatheter vs surgical aortic valve replacement in intermediate- surgical-risk patients with aortic stenosis: a propensity score-matched case-control study. Am Heart J 164:910-7.
Ledwoch J, Franke J, Gerckens U, et al. 2013. Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve replacement: analysis from the German Transcatheter Aortic Valve Interventions Registry. Catheter Cardiovasc Interv, Wiley online library 82:E569-77.
Leon MB, Smith CR, Mack M, et al. 2010. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:1597-607.
Muneretto C, Bisleri G, Moggi A, et al. 2015. Treating the patients in the ‘grey-zone’ with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement. J Thorac Cardiovasc Surg 20: 90-5.
Nishimura RA, Otto CM, Bonow RO, et al. 2017. AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 136:12.
Piazza N, Kalesan B, van Mieghem N, et al. 2013. 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 6:443-51.
Rodés-Cabau J, Urena M, Nombela-Franco L. 2012. Indications for transcatheter aortic valve replacement based on the PARTNER trial. Rev Esp Cardiol (Engl Ed) 65:208-14.
Smith CR, Leon MB, Mack MJ, et al. 2011. PARTNER Trial Investigators.transcatheter versus surgical aortic valve replacement in high-risk patients. N Engl J Med 364:2187-98.
Thourani VH, Ailawadi G, Szeto WY, et al. 2011. Outcomes of surgical aortic valve replacement in high-risk patients: a multiinstitutional study. Ann Thorac Surg 91:49-55.
Turina J, Hess O, Sepulcri F, et al. 1987. Spontaneous course of aortic valve disease. Eur Heart J 8:471-83.
Vahanian A, Al fieri O, Andreotti F, et al. 2012. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 42:S1-44.
Zoghbi WA, Chambers JB, Dumesnil JG et al. 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.
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