An international, two-center, pilot randomized controlled trial of 210 transcatheter aortic valve replacement (TAVR) patients found that the MANTA vascular closure device (VCD) was not superior to dual Perclose ProGlide (PP) closure with regard to access-site-related vascular complications for large-bore arteriotomy closure in TAVR, results released Wednesday show.
Despite advancements in TAVR over the last decade, vascular complications resulting from VCD failure remain common and are associated with increased morbidity and length of stay. Until recently, the suture-based dual PP closure technique was used to close large-bore arteriotomies in transfemoral TAVR. The novel MANTA VCD was designed specifically for closure of large-bore arteriotomies ranging from 12 to 25 French outer diameter arteriotomies. Randomized data comparing these two methods were lacking.
Maarten P. van Wiechen, MD, of Erasmus University Medical Center, Rotterdam, Netherlands, and co-investigators reported results from the MASH (MAntaTM vs Suture-based vascular closure after transcatHeter aortic valve replacement) trial in a manuscript published online Wednesday in JACC: Cardiovascular Interventions. This study was an international, two-center, pilot randomized controlled trial comparing the MANTA VCD to dual PP closure for large-bore TAVR arteriotomies. The primary outcome of interest was a composite of access-site-related major or minor vascular complications at 30-day follow-up post-TAVR. Secondary endpoints included clinically relevant access-site bleeding, time to hemostasis and modified VCD failure.
The study randomized 210 patients who underwent transfemoral TAVR between October 2018 and January 2020 to receive either the MANTA VCD or dual PP closure. Patients had a mean age of 81 years, 54% were men, and the patients had a mean Society of Thoracic Surgeons (STS) risk score of 2.7%.
With regard to the primary composite outcome, there were no differences between the two cohorts (10% vs. 4%; p=0.16). Furthermore, clinically significant access-site bleeding was similar between the two cohorts (9% vs. 6%; p=0.57). Modified VCD failure occurred less frequently in the MANTA group (20%, vs. 40%; p<0.01). Dual PP closure required additional closure devices more frequently, but the MANTA VCD more often required covered stents and surgical bailouts.
J. Dawn Abbott, MD, and Chirag Bavishi, MD, MPH, of Rhode Island Hospital, Providence, wrote an accompanying editorial to the study. They begin by congratulating the authors on performing the first randomized controlled trial comparing the MANTA VCD to dual PP closure in transfemoral TAVR large-bore arteriotomies.
They do point out that the study had major limitations, including sample size, low event rates, overall low surgical risk of the patients in the study and lack of cost-effectiveness analysis. The study also excluded patients deemed to have "unsuitable" anatomy for MANTA, emphasizing that one size does not fit all.
Furthermore, it is important to keep in mind the MANTA VCD can be 4 to 5 times more expensive that dual PP closure, which limits the argument for MANTA if safety outcomes are similar, the editorialists write.
Van Wiechen MP, Tchétché D, Ooms JF, et al. Suture- or Plug-Based Large Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial. JACC Cardiovasc Interv 2020 Dec 23. (Article in press).
Abbott JD, Bavishi C. In Search of an Ideal Vascular Closure Device for Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2020 Dec 23. (Article in press).