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Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair.
Aglan, Amro; Maraey, Ahmed; Fath, Ayman R; Elsharnoby, Hadeer; Abdelmottaleb, Wael; Elzanaty, Ahmed M; Khalil, Mahmoud; Dani, Sourbha S; Saad, Marwan; Elgendy, Islam Y.
Afiliação
  • Aglan A; Department of Internal Medicine, Lahey Hospital and Medical Center, Beth Israel Lahey Health, Burlington, Massachusetts, USA.
  • Maraey A; Department of Internal Medicine, Carle Foundation Hospital, Urbana, Illinois, USA; Department of Cardiovascular Medicine, University of Toledo, Toledo, Ohio, USA.
  • Fath AR; Division of Cardiology, University of Texas Health Science Center at San Antonio, Texas, USA.
  • Elsharnoby H; Department of Internal Medicine, Carle Foundation Hospital, Urbana, Illinois, USA.
  • Abdelmottaleb W; Department of Internal Medicine, New York College of Medicine, Metropolitan Hospital, New York, New York, USA.
  • Elzanaty AM; Department of Cardiovascular Medicine, University of Toledo, Toledo, Ohio, USA.
  • Khalil M; Department of Cardiovascular Medicine, University of Connecticut, Farmington, Connecticut, USA.
  • Dani SS; Division of Cardiology, Lahey Hospital and Medical Center, Beth Israel Lahey Health, Burlington, Massachusetts, USA.
  • Saad M; Division of Cardiology, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
  • Elgendy IY; Division of Cardiovascular Medicine, Gill Heart Institute, University of Kentucky, Lexington, Kentucky, USA. Electronic address: iyelgendy@gmail.com.
JACC Cardiovasc Interv ; 17(4): 520-530, 2024 Feb 26.
Article em En | MEDLINE | ID: mdl-38418055
ABSTRACT

BACKGROUND:

Clinical trials have demonstrated the efficacy and safety of mitral transcatheter edge-to-edge repair (M-TEER) for selected patients with severe mitral regurgitation. However, the generalizability of trial results to real-world patients remains uncertain.

OBJECTIVES:

The authors aimed to compare baseline characteristics and in-hospital outcomes among trial participants with nonparticipants undergoing M-TEER.

METHODS:

Using the National Inpatient Sample database years 2016-2020, M-TEER admissions were identified and categorized into trial participants vs none. We also identified a cohort of trial noneligible patients based on clinical exclusion criteria from pivotal trials. Multivariate regression analysis was performed to compare in-hospital outcomes. The primary outcome was in-hospital mortality, and secondary outcomes included in-hospital complications, length of stay, and hospitalization cost.

RESULTS:

Among 38,770 M-TEER admissions from 2016 to 2020, 11,450 (29.5%) were trial participants, 22,975 (59.3%) were eligible nonparticipants, and 2,960 (7.6%) were noneligible. Baseline characteristics and comorbidity profiles were mostly similar between trial participants vs eligible nonparticipants. In-hospital mortality (adjusted OR [aOR] 0.98; 95% CI 0.60-1.62), cardiogenic shock (aOR 1.06; 95% CI 0.80-1.42), mechanical circulatory support (aOR 0.91; 95% CI 0.58-1.41), mechanical ventilation (aOR 1.03; 95% CI 0.74-1.42), and conversion to mitral valve surgery (aOR 1.08; 95% CI 0.57-2.03) were not different between both groups. Conversely, M-TEER for noneligible patients was associated with higher rates of mortality (aOR 6.27; 95% CI 3.75-10.45) and complications.

CONCLUSIONS:

The majority of real-world M-TEER patients would have been eligible for clinical trial participation and had comparable clinical profiles and in-hospital outcomes to trial participants. However, noneligible patients had worse in-hospital outcomes compared with trial participants.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Implante de Prótese de Valva Cardíaca / Insuficiência da Valva Mitral Limite: Humans Idioma: En Revista: JACC Cardiovasc Interv Assunto da revista: ANGIOLOGIA / CARDIOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Implante de Prótese de Valva Cardíaca / Insuficiência da Valva Mitral Limite: Humans Idioma: En Revista: JACC Cardiovasc Interv Assunto da revista: ANGIOLOGIA / CARDIOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos