1. Self-expandable transcatheter heart valves for aortic stenosis. Short-term outcome and matched hemodynamic performance
- Author
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Itziar Gómez Salvador, Hipólito Gutiérrez, Manuel Carrasco-Moraleja, Sandra Santos-Martínez, Silvio Vera, Ignacio J. Amat-Santos, Roman Arnold, Guillermo Galeote, Victor Alfonso Jimenez-Diaz, Carlos Baladrón, José Antonio Baz, J. Alberto San Román, Pablo Catalá, Alfredo Redondo, Luis Nombela-Franco, Raúl Moreno, Tania Rodriguez-Gabella, Mario García-Gómez, Alex F Castro-Mejía, Ana Serrador, and Pilar Jiménez-Quevedo
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Population ,Hemodynamics ,Regurgitation (circulation) ,030204 cardiovascular system & hematology ,Prosthesis Design ,Ventricular Function, Left ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Cardiac skeleton ,Embolization ,education ,Body surface area ,education.field_of_study ,Ejection fraction ,business.industry ,Stroke Volume ,Aortic Valve Stenosis ,General Medicine ,medicine.disease ,Stenosis ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,Cardiology ,business - Abstract
Introduction and objectives Aortic self-expandable (SE) transcatheter aortic valve implantation (TAVI) devices are particularly useful for patients with aortic stenosis and small/tortuous vessels, small aortic annuli, or low coronary ostia. However, it is unclear whether the growing range of SE devices shows comparable hemodynamic and clinical outcomes. We aimed to determine the differential hemodynamic (residual valve area and regurgitation) and clinical outcomes of these devices in comparable scenarios. Methods All patients were enrolled from 4 institutions and were managed with 4 different SE TAVI devices. Baseline and follow-up clinical data were collected and echocardiographic tests blindly and centrally analyzed. Patients were compared according to valve type and a 1:1 matched comparison was performed according to degree of calcification, aortic annulus dimensions, left ventricular ejection fraction, and body surface area. Results In total, 514 patients were included (Evolut R/PRO, 217; ACURATE neo, 107; ALLEGRA, 102; Portico, 88). Surgical risk scores were comparable in the unmatched population. No differences were observed in the post-TAVI regurgitation rate and in in-hospital mortality (2.7%). The rate of pacemaker implantation at discharge was significantly different among devices (P=.049), with Portico showing the highest rate (23%) and ACURATE neo the lowest (9.5%); Evolut R/PRO and ALLEGRA had rates of 15.9% and 21.2%, respectively. The adjusted comparison showed worse residual TAVI gradients and aortic valve area with ACURATE neo vs ALLEGRA (P=.001) but the latter had higher risk of valve embolization and a tendency for more cerebrovascular events. Conclusions A matched comparison of 4 SE TAVI devices showed no differences regarding residual aortic regurgitation and in-hospital mortality.
- Published
- 2021