Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors

van Nieuwkerk, AC; Aarts, HM; Hemelrijk, KI; Cantón, T; Tchétché, D; de Brito, FS; Barbanti, M; Kornowski, R; Latib, A; D'Onofrio, A; Ribichini, F; Maneiro Melón, N; Dumonteil, N; Abizaid, A; Sartori, S; D'Errigo, P; Tarantini, G; Fabroni, M; Orvin, K; Pagnesi, M; Vicaino Arellano, M; Dangas, G; Mehran, R; Voskuil, M; Delewi, R

doi:10.1016/j.jcin.2023.10.011

Valvular & structural heart disease

Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors

JACC Cardiovasc IntervPublished 25 Dec 2023Pooled patient-level analysis of 10 clinical studies

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Authors' conclusion

Bleeding complications remain frequent and important in patients undergoing transfemoral TAVR. Increased mortality risk in major bleeding persists after the initial 30 days.

Study context

Population: Patients undergoing transfemoral transcatheter aortic valve replacement (TAVR), 2007–2022 (CENTER2 study)
Participants: 23,562 patients10 clinical studies

Outcome: Incidence of major bleeding
Follow-up: 30 days

Methodological detailspooled patient-level database

Pooled patient-level database

Main finding

As reported in the abstract

Bleeding within 30 days

Major bleeding

1,545 patients

6.6%

Minor bleeding

1,143 patients

4.7%

Observational data: associations, not effects.

Further findings

DAPT vs Single antiplatelet therapy

Outcome	DAPT	Single antiplatelet therapy	← Lower odds with DAPT ←→ Higher odds with DAPT →	OR (95% CI)	P value
Major bleeding, DAPTvs single antiplatelet therapy	12.2%	9.1%	0.512	1.40 (1.13–1.72)	P = 0.002
			0.512Odds ratio (log scale)

Major bleeding vs No major bleeding

Outcome	Major bleeding	No major bleeding	← Lower with major bleeding ←→ Higher with major bleeding →	Estimate	P value
30-day mortality, major bleedingvs none	14.1%	4.3%	0.20.5125	OR 3.66 (95% CI 3.11–4.31)	P < 0.001
1-year mortality, major bleedingvs none	27.8%	14.5%	0.20.5125	HR 1.50 (95% CI 1.41–1.59)	P < 0.001
			0.20.5125Ratio (log scale)

Minor bleeding vs No bleeding

Outcome	Minor bleeding	No bleeding	← Lower risk with minor bleeding ←→ Higher risk with minor bleeding →	HR (95% CI)	P value
1-year mortality, minor bleedingvs none	16.7%	14.5%	0.512	1.11 (0.93–1.32)	P = 0.27
			0.512Hazard ratio (log scale)

Temporal trend in major bleeding

Major bleeding decreased from 11.5% in 2007-2010 to 5.5% in 2019-2022: P for trend < 0.001

Predictors of major bleeding

Female sex and peripheral vascular disease

Original publication

Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors. JACC Cardiovasc Interv. Published 25 December 2023. doi:10.1016/j.jcin.2023.10.011

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