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Published on: May 26, 2023
Selection of Vascular Closure Devices in Transcatheter Aortic Valve Replacement: Systematic Review and Network
Tomoki Sakata1, Toshiki Kuno2, Tomohiro Fujisaki3
1Cardiovascular Research Institute, Icahn School of Medicine at Mount Sinai, New York, USA.
Insights
For transcatheter aortic valve replacement, Proglide and MANTA vascular closure devices show similar safety. Proglide is superior to Prostar, reducing major vascular complications and bleeding.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Vascular closure devices (VCDs) are essential for percutaneous transcatheter aortic valve replacement (TAVR).
- The comparative efficacy and safety of different VCDs (Prostar, Proglide, MANTA) remain insufficiently defined.
Approach:
- A network meta-analysis was conducted, searching PubMed and EMBASE for clinical studies up to January 2022.
- Included were studies comparing Prostar, Proglide, and MANTA VCDs in TAVR patients, excluding surgical cut-down or alternative access.
- Outcomes analyzed included vascular complications, bleeding, acute kidney injury, and mortality, defined by Valve Academic Research Consortium 2 criteria.
Key Points:
- Analysis of 11,344 patients revealed significantly lower rates of major vascular complications and bleeding with Proglide compared to Prostar.
- Proglide also demonstrated reduced acute kidney injury and red blood cell transfusion rates versus Prostar.
- No significant differences in major vascular complications or bleeding were observed between Proglide and MANTA devices.
Conclusions:
- In TAVR procedures, Proglide and MANTA vascular closure devices exhibit comparable safety and efficacy profiles.
- Proglide offers a superior safety profile compared to Prostar, particularly regarding major vascular complications and bleeding events.
- These findings aid in optimizing VCD selection for TAVR to improve patient outcomes and reduce periprocedural risks.
Abstract:
Various vascular closure devices (VCDs) are commonly used for percutaneous transcatheter aortic valve replacement (TAVR). However, superiority and safety profile among them remain unclear. We compared periprocedural complications among various VCDs in patients undergoing TAVR. PubMed and EMBASE were searched through January 2022 to identify clinical studies comparing any 2 VCDs of Prostar, Proglide and MANTA in patients who underwent TAVR. Studies using surgical cut-down or alternative access other than transfemoral approach were excluded. We analyzed the odds ratios (ORs) of vascular complications (VC), bleeding, acute kidney injury and all-cause mortality using a network meta-analysis. All outcomes were defined by Valve Academic Research Consortium 2 criteria. Two randomized controlled trials and 15 observational studies were identified, yielding a total of 11,344 patients including Prostar (n = 4499), Proglide (n = 5705), or MANTA group (n = 1140). The rates of major VC and life-threatening and major bleeding were significantly lower in Proglide compared to Prostar (OR [95 % CI] = 0.54 [0.32-0.89], 0.68 [0.52-0.90], and 0.49 [0.26-0.95], respectively). There was no significant difference in major VC and bleeding between Proglide and MANTA groups. Proglide was associated with a lower rate of acute kidney injury (0.56 [0.34-0.92]) and red blood cell transfusion (0.39 [0.16-0.98]) compared to Prostar. There was no significant difference in additional interventions and 30-day overall mortality among three groups. In this network meta-analysis of VCD in patients undergoing TAVR, MANTA and Proglide had comparable outcomes while Proglide appears superior to Prostar in terms of major VC and bleeding.
