Key result
Hybrid closure strategy is associated with similar femoral vascular complications vs non-hybrid strategy during TAVI.
Why the study?
A hybrid femoral closure strategy combining a suture-based and a collagen-based device has emerged as an alternative to the conventional double Perclose ProStyle technique during TAVI, but comparative vascular complication data were needed.
Does a hybrid percutaneous femoral closure strategy reduce vascular complications compared to a conventional non-hybrid strategy in patients undergoing transfemoral TAVI?
Observational (n=633)
No
Does a hybrid percutaneous femoral closure strategy reduce vascular complications compared to a conventional non-hybrid strategy in patients undergoing transfemoral TAVI?
A hybrid femoral closure strategy using one suture-based and one collagen-based device has a comparable vascular safety profile to the conventional double suture-based strategy in transfemoral TAVI.
Should not alter closure strategies in transfemoral TAVI; leaves open whether randomized trials would detect differences.
BACKGROUND: Percutaneous closure of femoral arterial access is a critical step in transcatheter aortic valve implantation (TAVI). A hybrid strategy combining a suture-based device (Perclose ProStyle) and a collagen-based device (Angio-Seal) has emerged as an alternative to the conventional double Perclose ProStyle technique. AIMS: The objective of the study is to compare femoral vascular complications between a hybrid strategy (1 Perclose ProStyle+ 1 Angio-Seal) and a non-hybrid strategy (2 Perclose ProStyle) in a large single-center experience. METHODS: This prospective, single-center, non-randomized study included 633 consecutive patients who underwent transfemoral TAVI at Timone University Hospital (Marseille, France) between November 2024 and March 2026. The choice of closure strategy was left to the operator's discretion. The primary endpoint was the occurrence of any femoral vascular complication (classified according to VARC-3 criteria). RESULTS: A total of 273 patients underwent hybrid closure, and 360 underwent non-hybrid closure. The overall rate of vascular complications was 4.9% (31/633), with no significant difference between groups (hybrid 4.8% vs. non-hybrid 5.0%; p = 1.000). There were no differences in major VARC-3 complications (2.2% vs. 1.9%, p = 1.000) or minor complications (2.6% vs. 3.1%, p = 0.899). In univariate analysis, preprocedural dual antiplatelet therapy was the main predictor of overall complications, hematoma, pseudoaneurysm, and minor VARC-3 complications. Dialysis was associated with major VARC-3 complications. CONCLUSION: The hybrid closure strategy (1 Perclose ProStyle + 1 Angio-Seal) demonstrates a vascular safety profile comparable to the conventional strategy (2 Perclose ProStyle) in transfemoral TAVI. Preprocedural antithrombotic therapy, rather than the closure device strategy, appears to be the main determinant of vascular complications.
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Roussel et al. (2026) conducted an observational in Transfemoral transcatheter aortic valve implantation (TAVI) (n=633). Hybrid closure strategy (1 Perclose ProStyle + 1 Angio-Seal) vs. Non-hybrid strategy (2 Perclose ProStyle) was evaluated on Occurrence of any femoral vascular complication (classified according to VARC-3 criteria) (p=1.000). A hybrid closure strategy (1 Perclose ProStyle + 1 Angio-Seal) resulted in a similar rate of femoral vascular complications compared to a non-hybrid strategy (4.8% vs. 5.0%; p=1.000) during TAVI.
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