Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation - CHOICE-CLOSURE

Nov 05, 2021
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Leipzig Heart Institute GmbH
Date Presented:
11/05/2021
Date Published:
11/05/2021
Date Updated:
11/05/2021
Original Posted Date:
11/05/2021
References

Contribution To Literature:

The CHOICE-CLOSURE trial showed that MANTA VCD had higher major/minor vascular complications compared with ProGlide for access closure among patients undergoing transfemoral TAVR despite a lower need for additional VCDs and shorter time to hemostasis.

Description:

The goal of the trial was to demonstrate the safety and efficacy of the MANTA vascular closure device (VCD) compared with ProGlide for access closure among patients undergoing transfemoral transcatheter aortic valve replacement (TAVR).

Study Design

All patients were randomized in a 1:1 open-label fashion to vascular closure with the MANTA VCD (n = 258) or ProGlide (n = 258).

The MANTA VCD consists of three parts that seal the arteriotomy: A luminal resorbable polymer toggle and an extraluminal, resorbable, bovine collagen plug are connected through a non-resorbable polyester suture and a stainless steel lock. It was available in two sizes: 14 French for 10-14 French arterial punctures, and 18 French for 15-22 French arterial punctures.

  • Total number of enrollees: 516
  • Duration of follow-up: 30 days
  • Mean patient age: 80.5 years
  • Percentage female: 45%

Inclusion criteria:

  • Patients with an indication for transfemoral TAVR, as judged by the local heart team
  • Transfemoral access route and a commercially available transcatheter aortic valve was selected by the local heart team

Exclusion criteria:

  • Vascular access site anatomy not suitable for percutaneous vascular closure
  • Vascular access site complications prior to the TAVR procedure
  • Known allergy or hypersensitivity to any VCD component
  • Unstable active bleeding/bleeding diathesis or significant unmanageable anemia
  • Absence of computed tomographic data of the access site before the procedure
  • Systemic infection or a local infection at or near the access site
  • Life expectancy of <6 months due to noncardiac conditions

Other salient features/characteristics:

  • Body mass index: 28.6 kg/m2
  • Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM): 4.1%
  • Known peripheral artery disease: 7.5%

Principal Findings:

The primary outcome, rate of access-site or access-related major and minor vascular complications (defined according to the Valve Academic Research Consortium-2 criteria) for MANTA vs. ProGlide, was: 19.4% vs. 12.0%, relative risk 1.61, 95% confidence interval 1.07-2.44 (p = 0.029).

  • Pseudoaneurysms: 6.2% vs. 1.2% (p = 0.005)
  • Clinically significant access-site hematomas: 15.5% vs. 7.4% (p = 0.006)

Secondary outcomes for MANTA vs. ProGlide:

  • Unplanned vascular surgery and/or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site: 10.5% vs. 8.1% (p = 0.45)
  • Need for blood transfusion for access-site or access-related bleeding or vascular complications: 3.9% vs. 1.2% (p = 0.09)
  • Use of an additional VCD to achieve complete hemostasis: 0.0% vs. 58.5% (p < 0.001)
  • Time to hemostasis: 80 vs. 240 seconds (p < 0.001)

Interpretation:

The results of this trial indicate that the MANTA VCD had higher major/minor vascular complications compared with ProGlide for access closure among patients undergoing transfemoral TAVR despite a lower need for additional VCDs and shorter time to hemostasis. This was driven by a higher rate of pseudoaneuryms and clinically significant hematomas; rates of endovascular ballooning and stenting were numerically higher as well.

This is an important trial for the field. Historically, closure has been achieved with two ProGlides (as “pre-closure”) for patients undergoing transfemoral TAVR. The MANTA device is US Food and Drug Administration (FDA) approved for use post-transfemoral TAVR (as a “post-closure” technique). This trial argues against the use of the MANTA device for routine transfemoral cases; it may have a role for bailout if both ProGlide sutures break after sheath removal.

References:

Abdel-Wahab M, Hartung P, Dumpies O, et al., on behalf of the CHOICE-CLOSURE Investigators. Comparison of a Pure Plug-Based versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial. Circulation 2021;Nov 5:[Epub ahead of print].

Presented by Dr. Mohamed Abdel-Wahab at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, Orlando, FL, November 5, 2021.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Interventions and Vascular Medicine

Keywords: Aneurysm, Aortic Valve Stenosis, Cardiac Surgical Procedures, Endovascular Procedures, Geriatrics, Heart Valve Diseases, Hematoma, Hemorrhage, Hemostasis, Peripheral Arterial Disease, Stents, Sutures, TCT21, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, Vascular Closure Devices


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