Implantation depth of balloon‐expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events

Costanza Pellegrini; Markus Freißmuth; Tobias Rheude; David Graas; N. Patrick Mayr; Finn Syryca; Hector A. Alvarez‐Covarrubias; Andrei Fetcu; Carsten Lennerz; Heribert Schunkert; Adnan Kastrati; Erion Xhepa; Michael Joner

doi:10.1002/ccd.30870

October 25, 2023Catheterization and Cardiovascular InterventionsOpen Access

Implantation depth of balloon‐expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events

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Why the study?

Permanent pacemaker implantation remains a relevant complication after TAVI and its impact on outcome remains controversial.

Does higher prosthesis implantation depth reduce permanent pacemaker implantation at 30 days in patients undergoing transfemoral TAVI with the Sapien 3 prosthesis?

Structured PICO

Does higher prosthesis implantation depth reduce permanent pacemaker implantation at 30 days in patients undergoing transfemoral TAVI with the Sapien 3 prosthesis?

P

Population

849 patients without previous pacemaker undergoing transfemoral transcatheter aortic valve implantation (TAVI) with the balloon-expandable Sapien 3 prosthesis between 2014 and 2018.

I

Intervention

Higher prosthesis implantation depth (1st Quintile)

C

Comparator

Lower prosthesis implantation depth (5th Quintile)

O

Outcome

Permanent pacemaker implantation (PPI) at 30 dayssafety

Higher implantation of the Sapien 3 valve during TAVI is associated with a significantly reduced risk of permanent pacemaker implantation at 30 days.

Implication

Greater implantation depth was associated with higher PPI after S3 TAVI; hypothesis-generating, prospective confirmation needed before practice change.

Abstract

BACKGROUND: Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial. AIMS: This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis. METHODS: Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality. RESULTS: Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years. CONCLUSIONS: Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.