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Published on: June 3, 2018
Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs
Erez Marcusohn1, Majd Qasum1, Danny Epstein2
1Department of Cardiology, Rambam Health Care Campus, Haifa, Israel.
Insights
For Transcatheter Aortic Valve Implantation (TAVI) procedures, the ProGlide parallel suture technique and Prostar closure devices showed similar vascular complication rates. This finding is crucial for patient safety during TAVI interventions.
Area of Science:
- Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Transfemoral Transcatheter Aortic Valve Implantation (TAVI) relies on effective femoral artery closure.
- The choice of vascular access closure device can influence complication rates.
- Comparing ProGlide and Prostar devices is important for optimizing TAVI procedures.
Purpose of the Study:
- To compare vascular complication rates between ProGlide parallel suture and Prostar closure devices in TAVI patients.
- To evaluate differences in bleeding rates and in-hospital mortality between the two closure devices.
- To assess device performance in a higher-risk TAVI population.
Main Methods:
- Retrospective analysis of 191 patients undergoing transfemoral TAVI.
- Comparison of vascular access closure using ProGlide parallel suture versus Prostar devices.
- Statistical analysis including univariant analysis and propensity-score matching.
Main Results:
- No significant difference in Valve Academic Research Consortium (VARC)-2 major complications between ProGlide (4.7%) and Prostar (3.8%).
- Similar rates of closure device failure were observed for both devices.
- No differences in major/minor bleeding or in-hospital mortality between the ProGlide and Prostar groups.
Conclusions:
- The ProGlide parallel suture technique offers comparable vascular complication rates to the Prostar device in TAVI patients.
- Both devices demonstrate similar safety profiles regarding bleeding and mortality.
- The parallel suture technique is a viable option for femoral artery closure in TAVI procedures, including higher-risk patients.
Abstract:
Reliable femoral artery closure devices are essential for the success of trans-femoral Transcatheter Aortic Valve Implantation (TAVI) procedures. Accordingly, device choice might affect vascular complications and bleeding rates. This was a retrospective analysis, comparing vascular complication rates among patients who underwent trans-femoral TAVI with vascular access closure using either the ProGlide parallel suture or Prostar closure devices. We included 191 patients: 106 were treated with Prostar and 85 with ProGlide. The ProGlide group had higher rate of diabetes, chronic kidney disease, peripheral arterial disease, and significantly smaller femoral arteries that were treated via larger sheaths. Valve Academic Research Consortium (VARC)-2 major complications were similar between the groups. (4.7% for ProGlide vs 3.8% for Prostar, P=1), with similar incidence of closure device failure (2 vs 3, P=1). No differences were found after univariant analysis and propensity-score matching in the incidence of major and minor bleeding nor in the rate of in-hospital mortality between ProGlide and Prostar (4.7 vs 2.8%, P=.7, 1.2 vs 2.8%, P=.63, and 1.2 vs .0%, P=.45, respectively). Parallel suture technique using two ProGlide sutures showed comparable rates of vascular complications to the Prostar closure device in higher risk population of TAVI patients.
