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Transcatheter aortic valve implantation results are not superimposable to surgery in patients with aortic stenosis at low surgical risk
, 2, 2, 2, 2, 1, 1, 3, 1, 2, 4, 1
Affiliations- Department of Cardiovascular Disease, University of Rome La Sapienza, Rome, Italy
- Department of Cardiovascular Disease, University of Rome Tor Vergata, Rome, Italy
- Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiotherapy, University of Rome Tor Vergata, Rome, Italy
- Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
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Abstract
Background: The aim of this meta-analysis was to compare the impact of transcatheter aortic valve
implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in patients with severe aortic valve
stenosis (AS) at low surgical risk.
Methods: All randomized controlled trials (RCTs) and observational studies (Obs) published from
January 2014 until March 31st, 2020 were retrieved through the PubMed computerized database and at the
site https://www.clinicaltrials.com. The relative risk (RR) with the 95% confidence interval (CI) was used
to evaluate the effect of the intervention under comparison. The primary endpoints were all-cause 30-day
mortality and 1-year mortality. The 30-day safety endpoints were: stroke, acute kidney injury stage 2 or 3,
major bleeding, moderate/severe paravalvular leak, need for new permanent pacemaker (PM) implantation.
Results: After detailed review 9 studies, related to 4 RCTs and 5 Obs, were selected. The overall
analysis of RCTs plus Obs showed a significantly lower 30-day mortality for TAVI (RR = 0.55; 95% CI
0.45–0.68, p < 0.00001; I2 = 0%). However, an increased risk of new PM implantation (RR = 2.87;
95% CI 2.01–3.67, p < 0.00001, I2 = 0%) and of paravalvular leak (RR = 7.28; 95% CI 3.83–13.81,
p < 0.00001, I2 = 0%) was observed in TAVI compared to SAVR. On the contrary, a lower incidence
of major bleeding (RR = 0.38; 95% CI 0.27–0.54, p < 0.00001, I2 = 0%) and of acute kidney injury
was observed (RR = 0.33; 95% CI 0.19–0.56, p < 0.0001, I2 = 0%) in TAVI.
Conclusions: TAVI and SVAR in the treatment of AS in the patients at low surgical risk are not superimposable.
In particular, if 30-day and 1-year mortality, major bleeding and acute kidney injury were
significantly lower for TAVI, the need of new PM implantation and paravalvular leak were significantly
lower in SAVR. Consequently, we suggest the need of more trials to evaluate the effectiveness of TAVI as
routine therapeutic procedure in the treatment of patients with low surgical risk AS.
Abstract
Background: The aim of this meta-analysis was to compare the impact of transcatheter aortic valve
implantation (TAVI) vs. surgical aortic valve replacement (SAVR) in patients with severe aortic valve
stenosis (AS) at low surgical risk.
Methods: All randomized controlled trials (RCTs) and observational studies (Obs) published from
January 2014 until March 31st, 2020 were retrieved through the PubMed computerized database and at the
site https://www.clinicaltrials.com. The relative risk (RR) with the 95% confidence interval (CI) was used
to evaluate the effect of the intervention under comparison. The primary endpoints were all-cause 30-day
mortality and 1-year mortality. The 30-day safety endpoints were: stroke, acute kidney injury stage 2 or 3,
major bleeding, moderate/severe paravalvular leak, need for new permanent pacemaker (PM) implantation.
Results: After detailed review 9 studies, related to 4 RCTs and 5 Obs, were selected. The overall
analysis of RCTs plus Obs showed a significantly lower 30-day mortality for TAVI (RR = 0.55; 95% CI
0.45–0.68, p < 0.00001; I2 = 0%). However, an increased risk of new PM implantation (RR = 2.87;
95% CI 2.01–3.67, p < 0.00001, I2 = 0%) and of paravalvular leak (RR = 7.28; 95% CI 3.83–13.81,
p < 0.00001, I2 = 0%) was observed in TAVI compared to SAVR. On the contrary, a lower incidence
of major bleeding (RR = 0.38; 95% CI 0.27–0.54, p < 0.00001, I2 = 0%) and of acute kidney injury
was observed (RR = 0.33; 95% CI 0.19–0.56, p < 0.0001, I2 = 0%) in TAVI.
Conclusions: TAVI and SVAR in the treatment of AS in the patients at low surgical risk are not superimposable.
In particular, if 30-day and 1-year mortality, major bleeding and acute kidney injury were
significantly lower for TAVI, the need of new PM implantation and paravalvular leak were significantly
lower in SAVR. Consequently, we suggest the need of more trials to evaluate the effectiveness of TAVI as
routine therapeutic procedure in the treatment of patients with low surgical risk AS.
Keywords
transcatheter aortic valve interventions, transcatheter aortic valve implantation, aortic stenosis, prosthetic aortic valves, low surgical risk, meta-analysis
About this articleTitle
Transcatheter aortic valve implantation results are not superimposable to surgery in patients with aortic stenosis at low surgical risk
Journal
Issue
Article type
Original Article
Pages
595-605
Published online
2021-09-30
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1603
Article views/downloads
562
DOI
Pubmed
Bibliographic record
Cardiol J 2023;30(4):595-605.
Keywords
transcatheter aortic valve interventions
transcatheter aortic valve implantation
aortic stenosis
prosthetic aortic valves
low surgical risk
meta-analysis
Authors
Maria Cristina Acconcia
Marco Alfonso Perrone
Domenico Sergi
Marco Di Luozzo
Massimo Marchei
Pasquale De Vico
Antonio Sili Scavalli
Giuseppe Pannarale
Marcello Chiocchi
Carlo Gaudio
Francesco Romeo
Quintilio Caretta
Francesco Barillà
References (35)- 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. 2017; 135(25): e1159–e1195.
- Baumgartner H, Falk V, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017; 38(36): 2739–2791.
- Leon M, Smith C, Mack M, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016; 374(17): 1609–1620.
- Reardon M, Van Mieghem N, Popma J, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017; 376(14): 1321–1331.
- Thyregod HG, Steinbrüchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol. 2015; 65(20): 2184–2194.
- Søndergaard L, Steinbrüchel DA, Ihlemann N, et al. Two-Year outcomes in patients with severe aortic valve stenosis randomized to transcatheter versus surgical aortic valve replacement: the all-comers nordic aortic valve intervention randomized clinical trial. Circ Cardiovasc Interv. 2016; 9(6).
- Thyregod HG, Ihlemann N, Jørgensen TH, et al. Five-Year clinical and echocardiographic outcomes from the nordic aortic valve intervention (NOTION) randomized clinical trial in lower surgical risk patients. Circulation. 2019 [Epub ahead of print].
- Søndergaard L, Ihlemann N, Capodanno D, et al. Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol. 2019; 73(5): 546–553.
- Pibarot P, Salaun E, Dahou A, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019; 380(18): 1695–1705.
- Pibarot P, Salaun E, Dahou A, et al. Echocardiographic results of transcatheter versus surgical aortic valve replacement in low-risk patients: the PARTNER 3 trial. Circulation. 2020; 141(19): 1527–1537.
- Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019; 380(18): 1706–1715.
- Baron SJ, Magnuson EA, Lu M, et al. Health status after transcatheter versus surgical aortic valve replacement in low-risk patients with aortic stenosis. J Am Coll Cardiol. 2019; 74(23): 2833–2842.
- Serruys PW, Modolo R, Reardon M, et al. One-year outcomes of patients with severe aortic stenosis and an STS PROM of less than three percent in the SURTAVI trial. EuroIntervention. 2018; 14(8): 877–883.
- Bekeredjian R, Szabo G, Balaban Ü, et al. Patients at low surgical risk as defined by the Society of Thoracic Surgeons Score undergoing isolated interventional or surgical aortic valve implantation: in-hospital data and 1-year results from the German Aortic Valve Registry (GARY). Eur Heart J. 2019; 40(17): 1323–1330.
- Prendergast BD, Redwood SR. Transcatheter aortic valve replacement. Circulation. 2019; 139(24): 2724–2727.
- Prendergast BD, Baumgartner H, Delgado V, et al. Transcatheter heart valve interventions: where are we? Where are we going? Eur Heart J. 2019; 40(5): 422–440.
- O'Brien SM, Shahian DM, Filardo G, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2--isolated valve surgery. Ann Thorac Surg. 2009; 88(1 Suppl): S23–S42.
- Nashef SAM, Roques F, Sharples LD, et al. Risk factors and outcome in European cardiac surgery: analysis of the EuroSCORE multinational database of 19030 patients. Eur J Cardiothorac Surg. 1999; 15(6): 816–22; discussion 822.
- Roques F, Michel P, Goldstone AR, et al. The logistic EuroSCORE. Eur Heart J. 2003; 24(9): 881–882.
- Kappetein A, Head S, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document†. Eur Heart J. 2012; 33(19): 2403–2418.
- Review Manager (RevMan) [Computer program]. Version 5.3. Copenhagen: The Nordic Cochrane Centre, the Cochrane Collaboration, 2014.
- Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Cochrane, 2019. www.training.cochrane.org/handbook.
- Sterne JAC, Sutton AJ, Ioannidis JPA, et al. Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ. 2011; 343: d4002.
- Oh JK, Park SJ, Kim HoJ, et al. Transcatheter versus surgical aortic valve replacement in low-risk, elderly patients with severe aortic stenosis. J Am Coll Cardiol. 2019; 74(11): 1514–1515.
- Schaefer A, Schofer N, Goßling A, et al. Transcatheter aortic valve implantation versus surgical aortic valve replacement in low-risk patients: a propensity score-matched analysis. Eur J Cardiothorac Surg. 2019; 56(6): 1131–1139.
- Virtanen MPO, Eskola M, Jalava MP, et al. Comparison of outcomes after transcatheter aortic valve replacement vs surgical aortic valve replacement among patients with aortic stenosis at low operative risk. JAMA Netw Open. 2019; 2(6): e195742.
- Waksman R, Rogers T, Torguson R, et al. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol. 2018; 72(18): 2095–2105.
- Waksman R, Corso PJ, Torguson R, et al. TAVR in low-risk patients: 1-year results from the LRT trial. JACC Cardiovasc Interv. 2019; 12(10): 901–907.
- Bleakley C, Monaghan MJ. The pivotal role of imaging in TAVR procedures. Curr Cardiol Rep. 2018; 20(2): 9.
- Blanke P, Weir-McCall JR, Achenbach S, et al. Computed Tomography Imaging in the Context of Transcatheter Aortic Valve Implantation (TAVI)/Transcatheter Aortic Valve Replacement (TAVR): An Expert Consensus Document of the Society of Cardiovascular Computed Tomography. JACC Cardiovasc Imaging. 2019; 12(1): 1–24.
- Briere JB, Bowrin K, Taieb V, et al. Meta-analyses using real-world data to generate clinical and epidemiological evidence: a systematic literature review of existing recommendations. Curr Med Res Opin. 2018; 34(12): 2125–2130.
- Acconcia MC, Caretta Q, Monzo L, et al. Effectiveness of the new generation transcatheter aortic valve in the real life studies. Review and meta-analysis. Eur Rev Med Pharmacol Sci. 2019; 23(18): 8018–8027.
- Vlastra W, Chandrasekhar J, Muñoz-Garcia AJ, et al. Comparison of balloon-expandable vs. self-expandable valves in patients undergoing transfemoral transcatheter aortic valve implantation: from the CENTER-collaboration. Eur Heart J. 2019; 40(5): 456–465.
- Saturni S, Bellini F, Braido F, et al. Randomized Controlled Trials and real life studies. Approaches and methodologies: a clinical point of view. Pulm Pharmacol Ther. 2014; 27(2): 129–138.
- Sørensen HT, Lash TL, Rothman KJ. Beyond randomized controlled trials: a critical comparison of trials with nonrandomized studies. Hepatology. 2006; 44(5): 1075–1082.
