Aortic Valve Replacement vs Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis

Philippe Généreux; Marko Banovic; Duk-Hyun Kang; Gennaro Giustino; Bernard D Prendergast; Brian R Lindman; David E Newby; Philippe Pibarot; Björn Redfors; Neil J Craig; Jozef Bartunek; Allan Schwartz; Roxanna Seyedin; David J Cohen; Bernard Iung; Martin B Leon; Marc R Dweck

doi:10.1016/j.jacc.2024.11.006

Aortic Valve Replacement vs Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis

J Am Coll Cardiol. 2024 Nov 18:S0735-1097(24)10419-6. doi: 10.1016/j.jacc.2024.11.006. Online ahead of print.

Authors

Philippe Généreux¹, Marko Banovic², Duk-Hyun Kang³, Gennaro Giustino⁴, Bernard D Prendergast⁵, Brian R Lindman⁶, David E Newby⁷, Philippe Pibarot⁸, Björn Redfors⁹, Neil J Craig¹⁰, Jozef Bartunek¹¹, Allan Schwartz¹², Roxanna Seyedin¹³, David J Cohen¹⁴, Bernard Iung¹⁵, Martin B Leon¹⁶, Marc R Dweck⁷

Affiliations

¹ Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey, USA. Electronic address: philippe.genereux@atlantichealth.org.
² Belgrade Medical School, University of Belgrade, Belgrade, Serbia; Cardiology Department, University Clinical Center of Serbia, Belgrade, Serbia.
³ Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
⁴ Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey, USA.
⁵ Department of Cardiology, Guys and St Thomas' NHS Foundation Trust Hospital London, London, United Kingdom; Heart, Vascular and Thoracic Institute, Cleveland Clinic London, London, United Kingdom.
⁶ Structural Heart and Valve Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁷ British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.
⁸ Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.
⁹ Department of Molecular and Clinical Medicine, Institute of Medicine, Gothenburg University, Gothenburg, Sweden; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Population Health Sciences, Weill Cornell Medicine, New York, New York, USA.
¹⁰ Centre for Cardiovascular Sciences, University of Edinburgh, Edinburgh, United Kingdom.
¹¹ Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
¹² Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA.
¹³ Edwards Lifesciences, Irvine, California, USA.
¹⁴ St. Francis Hospital and Heart Center, Roslyn, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.
¹⁵ Bichat Hospital, Assistance Publique-Hôpitaux de Paris, and INSERM LVTS 1148, Université Paris-Cité, Paris, France.
¹⁶ Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA.

PMID: 39641732
DOI: 10.1016/j.jacc.2024.11.006

Abstract

Background: Current guidelines recommend a strategy of clinical surveillance (CS) for patients with asymptomatic severe aortic stenosis (AS) and a normal left ventricular ejection fraction.

Objectives: The aim of this study was to conduct a study-level meta-analysis of randomized controlled trials (RCTs) evaluating the effect of early aortic valve replacement (AVR) compared with CS in patients with asymptomatic severe AS.

Methods: Studies were quantitatively assessed in a meta-analysis using random-effects modeling. Prespecified outcomes included all-cause and cardiovascular mortality, unplanned cardiovascular or heart failure (HF) hospitalization, and stroke. The meta-analysis is registered at the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY202490002).

Results: Four RCTs were identified, including a total of 1,427 patients (719 in the early AVR group and 708 in the CS group). At an average follow-up time of 4.1 years, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization (pooled rate 14.6% vs 31.9%; HR: 0.40; 95% CI: 0.30-0.53; I² = 4%; P < 0.01) and stroke (pooled rate 4.5% vs 7.2%; HR: 0.62; 95% CI: 0.40-0.97; I² = 0%; P = 0.03). No differences in all-cause mortality (pooled rate 9.7% vs 13.7%; HR: 0.68; 95% CI: 0.40-1.17; I² = 61%; P = 0.17) and cardiovascular mortality (pooled rate 5.1% vs 8.3%; HR: 0.67; 95% CI: 0.35-1.29; I² = 50%; P = 0.23) were observed with early AVR compared with CS, although there was a high degree of heterogeneity among studies.

Conclusions: In this meta-analysis of 4 RCTs, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization and stroke and no differences in all-cause and cardiovascular mortality compared with CS.

Keywords: aortic stenosis; aortic valve replacement; meta-analysis; systematic review; transcatheter aortic valve implantation; transcatheter aortic valve replacement.