Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial.

Autor:	Rodés-Cabau J; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Ribeiro HB; Interventional Cardiology Department, Heart Institute (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil (H.B.R., P.M.P., V.E.E.R., M.P.L.)., Mohammadi S; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Serra V; Cardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain (V.S., C.S.)., Al-Atassi T; Division of Cardiac Surgery, University of Ottawa Heart Institute, Ontario, Canada (T.A.-A.)., Iñiguez A; Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Spain (A.I., V.A.J.D.).; Cardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain (A.I., V.A.J.D.)., Vilalta V; Department of Interventional Cardiology, Germans Trias i Pujol University Hospital, Badalona, Spain (V.V.)., Nombela-Franco L; Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain (L.N.-F.)., Sáez de Ibarra Sánchez JI; Department of Cardiac Surgery, University Hospital de Son Espases, Mallorca, Spain (J.I.S.d.I.)., Auffret V; Department of Cardiology, Rennes University Hospital, Rennes, France (V.A.)., Forcillo J; Department of Cardiac Surgery, Centre Hospitalier Universitaire de Montreal, Montreal, Canada (J.F.)., Conradi L; Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany (L.C.)., Urena M; Department of Cardiology, Hospital Bichat Claude-Bernard, Paris, France (M.U.)., Moris C; Department of Cardiology, University Hospital Central de Asturias, Oviedo, Spain (C.M.)., Muñoz-Garcia A; Cardiology Department, University Hospital Virgen de la Victoria, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, (CIBERCV), Málaga, Spain (A.M.-G.)., Paradis JM; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Dumont E; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Kalavrouziotis D; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Maria Pomerantzeff P; Interventional Cardiology Department, Heart Institute (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil (H.B.R., P.M.P., V.E.E.R., M.P.L.)., Rosa VEE; Interventional Cardiology Department, Heart Institute (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil (H.B.R., P.M.P., V.E.E.R., M.P.L.)., Pezzute Lopes M; Interventional Cardiology Department, Heart Institute (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil (H.B.R., P.M.P., V.E.E.R., M.P.L.)., Sureda C; Cardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain (V.S., C.S.)., Diaz VAJ; Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Spain (A.I., V.A.J.D.).; Cardiovascular Research Group, Galicia Sur Health Research Institute (IIS Galicia Sur), SERGAS-UVIGO, Vigo, Spain (A.I., V.A.J.D.)., Giuliani C; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Avvedimento M; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Pelletier-Beaumont E; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.)., Pibarot P; Cardiology Department, Quebec Heart & Lung Institute, Laval University, Quebec City, Canada (J.R.-C., S.M., J.-M.P., E.D., D.K., C.G., M.A., E.P.-B., P.P.).
Jazyk:	angličtina
Zdroj:	Circulation [Circulation] 2024 Feb 27; Vol. 149 (9), pp. 644-655. Date of Electronic Publication: 2023 Oct 26.
DOI:	10.1161/CIRCULATIONAHA.123.067326
Abstrakt:	Background: The optimal treatment in patients with severe aortic stenosis and small aortic annulus (SAA) remains to be determined. This study aimed to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. Methods: This prospective multicenter international randomized trial was performed in 15 university hospitals. Participants were 151 patients with severe aortic stenosis and SAA (mean diameter <23 mm) randomized (1:1) to TAVR (n=77) versus SAVR (n=74). The primary outcome was impaired valve hemodynamics (ie, severe prosthesis patient mismatch or moderate-severe aortic regurgitation) at 60 days as evaluated by Doppler echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. Results: The mean age of the participants was 75.5±5.1 years, with 140 (93%) women, a median Society of Thoracic Surgeons predicted risk of mortality of 2.50% (interquartile range, 1.67%-3.28%), and a median annulus diameter of 21.1 mm (interquartile range, 20.4-22.0 mm). There were no differences between groups in the rate of severe prosthesis patient mismatch (TAVR, 4 [5.6%]; SAVR, 7 [10.3%]; P =0.30) and moderate-severe aortic regurgitation (none in both groups). No differences were found between groups in mortality rate (TAVR, 1 [1.3%]; SAVR, 1 [1.4%]; P =1.00) and stroke (TAVR, 0; SAVR, 2 [2.7%]; P =0.24) at 30 days. After a median follow-up of 2 (interquartile range, 1-4) years, there were no differences between groups in mortality rate (TAVR, 7 [9.1%]; SAVR, 6 [8.1%]; P =0.89), stroke (TAVR, 3 [3.9%]; SAVR, 3 [4.1%]; P =0.95), and cardiac hospitalization (TAVR, 15 [19.5%]; SAVR, 15 [20.3%]; P =0.80). Conclusions: In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups. These findings suggest that the 2 therapies represent a valid alternative for treating patients with severe aortic stenosis and SAA, and treatment selection should likely be individualized according to baseline characteristics, additional anatomical risk factors, and patient preference. However, the results of this study should be interpreted with caution because of the limited sample size leading to an underpowered study, and need to be confirmed in future larger studies. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03383445. Competing Interests: Disclosures Dr Rodés-Cabau has received institutional research grants from and is consultant for Edwards Lifesciences and Medtronic. Dr Ribeiro has received fees as a proctor from Medtronic, Edwards Lifesciences and Boston Scientific and research grant from Medtronic. Dr Al-Atassi has received honoraria/fees as a proctor from Edwards. Dr Nombela-Franco has received consulting fees from Edwards Lifesciences. Dr Conradi is a member of the Advisory Board of Medtronic, Abbott, and JenaValve; and has received consulting fees from Edwards Lifesciences, Boston Scientific, MicroPort, Venus Medtech, and PiCardia. Dr Moris received fees as a proctor from Medtronic and Boston Scientific. Dr Pibarot has received institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Novartis. The other authors report no conflicts.
Databáze:	MEDLINE
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