9.2 / IAGS 2019
Session 9: Emerging Therapies Session 2
Developments in Large Bore Closure
Problem Presenter: Robert M. Bersin, MD
Statement of the problem
Given the proven clinical advantages of percutaneous large bore (>10 Fr) closure over surgical exposure and repair, shown in the PEVAR trial, and the ever expanding list of interventional procedures employing large bore devices (TAVR, TEVAR, EVAR and LVADs), there has been explosive growth in the development and application of percutaneous large bore closure devices. The standard percutaneous approach has been with suture-based devices (Perclose and Prostar), which have overall technical success rates of 90%, but fail more frequently when there is anterior wall calcium and/or the patient is obese, and they have major vascular complication rates of 5.5%-8.5%. Device misfires and/or suture breaks are common, requiring use of an additional device to achieve hemostasis in 10%-15% of cases. Given these limitations of the suture-mediated devices, a number of non-suture based large bore closure devices have been developed, mostly based on bioresorbable platforms.
Gaps in knowledge
Four bioresorbable large bore closure devices (InSeal Medical InClosure, Vivasure Medical PerQseal, Transluminal Technologies velox LB, Teleflex MANTA) have human implant experience. Of these, only the MANTA device has undergone an IDE trial and received FDA approval. The remainder underwent FIH or CE mark trials. All trials to date have been single-armed and generally demonstrate safety with more rapid times to hemostasis (≤2 min) as compared to suture-mediated closure devices. One other hybrid suture-based plus bioresorbable device (Rex Medical Closer) has also demonstrated a rapid time to hemostasis (2 min) in anticoagulated patients. The MANTA IDE trial (SAFE MANTA) demonstrated the MANTA device has a VARC-2 MAE rate equivalent to the pooled literature MAE rate of the double Perclose technique (5.3% vs 5.5%). However, concern has been raised by some investigators that although the overall MAE rate is the same with MANTA and suture-mediated closure devices, the failure mode may be more catastrophic given the large mass of bioresorbable materials used to effect closure, which, if deployed intravascularly, may be immediately occlusive and result in acute limb ischemia rapidly.
Possible solutions and future directions
More research is needed to determine if bioresorbable VCDs work reliably in patients with anterior wall calcium and/or morbid obesity. We also need to know if bioresorbable VCDs lead to more vessel scarring, and if the failure mode is more catastrophic as a result of the size/mass of the devices when compared to suture-mediated devices. And finally, none of the current devices discussed have been specifically designed to address the unmet need for a large bore closure option for devices left in place post procedure (ie, VADs).