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Dual ProGlide vs ProGlide and Angio-Seal for Femoral Access Hemostasis After Transcatheter Aortic Valve Replacement:
Chih-Fan Yeh1, Hsien-Li Kao1, Tsung-Yu Ko2
1Division of Cardiology, Department of Internal Medicine and Cardiovascular Centre, National Taiwan University Hospital, Taipei, Taiwan.
Insights
The hybrid Angio-Seal (AS) and Perclose ProGlide (PP) device strategy is safer and more effective for femoral access hemostasis after transcatheter aortic valve replacement (TAVR) compared to the dual PP approach, reducing vascular complications.
Area of Science:
- Cardiovascular Interventions
- Vascular Surgery
- Interventional Cardiology
Background:
- Vascular complications and device failures are significant concerns following transcatheter aortic valve replacement (TAVR).
- Effective vascular closure devices (VCDs) are crucial for minimizing morbidity and mortality associated with TAVR procedures.
Purpose of the Study:
- To compare the efficacy and safety of a hybrid closure strategy (Perclose ProGlide and Angio-Seal) versus a dual Perclose ProGlide strategy for femoral access hemostasis after TAVR.
- To evaluate rates of vascular complications, bleeding, and need for additional interventions in patients undergoing TAVR.
Main Methods:
- A randomized controlled trial involving 257 patients undergoing transfemoral TAVR.
- Comparison of dual Perclose ProGlide (PP) versus a hybrid approach combining 1 PP and 1 Angio-Seal (AS) for vascular closure.
- Primary endpoint: composite of TAVR access site-related vascular complications and life-threatening bleeding (Valve Academic Research Consortium 3 criteria).
Main Results:
- The hybrid AS+PP group showed significantly lower rates of the primary endpoint (18.2% vs. 29.8%, P=0.0381) and vascular complications.
- Additional VCD use (0.8% vs. 19.0%, P<0.0001) and modified VCD failure (9.9% vs. 33.1%, P<0.0001) were substantially reduced with the AS+PP strategy.
- Bleeding complication rates were similar between groups; however, interventions for complications led to smaller common femoral artery diameters.
Conclusions:
- The combined PP+AS strategy for large-bore femoral access hemostasis post-TAVR is more effective and safer than dual PP, significantly reducing vascular complications.
- Interventions to manage vascular complications following TAVR can lead to changes in common femoral artery diameter.
Background:
Vascular complications increase morbidity and mortality after transcatheter aortic valve replacements (TAVR), often related to failures in vascular closure devices (VCDs). We intended to compare the dual Perclose ProGlide (PP) strategy and the hybrid combination of PP and Angio-Seal (AS) for femoral access hemostasis after TAVR.
Methods:
A randomised controlled trial with 257 patients comparing dual PP with 1 PP and 1 AS (AS+PP) for vascular closure after transfemoral TAVR was conducted. The primary end point was the composite of TAVR access site-related vascular complications and life-threatening type 2/3 or 1 bleeding according to the Valve Academic Research Consortium 3. Secondary end points included additional VCD use and significant peripheral ischemia related to arteriotomy closure within 1 year. Modified VCD failure, defined as failure to achieve hemostasis within 5 minutes or requiring additional endovascular manoeuvres, was also recorded.
Results:
The AS+PP combination yielded lower rates of the primary end point (18.2% vs 29.8%; P = 0.0381), vascular complication (18.2% vs 29.8%; P = 0.0381), additional VCD use (0.8% vs 19.0%; P < 0.0001), and modified VCD failure (9.9% vs 33.1%; P < 0.0001) than the dual PP. Bleeding complication rates were similar between the 2 groups. Three-month follow-up vascular duplex tests showed similar common femoral artery (CFA) diameters and peak systolic velocities (PSVs) between the 2 groups, but those with additional intervention had higher PSVs and smaller CFA diameters than those without.
Conclusions:
Combined PP+AS for large-bore femoral access hemostasis after TAVR promises to be more effective and safer than dual PP in terms of vascular complications. Moreover, additional intervention for vascular complications resulted in smaller CFA diameters.
Clinical Trial Registration:
NCT05491070.
