A study published in Catheterization & Cardiovascular Interventions found that Proglide preclosure technique is a safe approach following removal of large bore venous access sheaths among patients receiving transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR).
Patients (N=354) at a single center who received TEER with MitraClip (n=287) or TMVR with Edwards Sapien Valves (n=67) between 2012 and 2019 were evaluated in this study. Investigators used a Perclose ProglideÔ device during the procedures. Clinical outcomes, 30-day mortality rates, and vascular access complications were evaluated up to 1 year postprocedure.
The patient population is aged mean 78±10.28 years, 55% are women, average BMI is 27.5±6.67, 93% of patients have hypertension, 69% have atrial fibrillation, 48% have coronary artery disease, 30% have a history of myocardial infarction, and 69% use aspirin.
Patients were hospitalized for an average of 6 days and a median of 3 days.
Among the TEER and TMVR cohorts, transfusion not related with vascular access (3.5% vs 10.4%, respectively), transfusion related with vascular access (1.05% vs 3.0%), small (<6 to >2 cm) hematoma (1.05% vs 4.5%), deep vein thrombosis (0.7% vs 0%), large (>6 cm) hematoma (0.35% vs 1.5%), and retroperitoneal hemorrhage (0.35% vs 0%) complications occurred.
The major bleeding event that occurred in the TEER group was spontaneous and likely related with thrombocytopenia. The other major bleed is in the TMVR group and was an arterial bleed that required stenting.
No infections, surgical repair of the access site, pseudoaneurysms, or arteriovenous malformation events occurred.
This study is limited by not having a comparator cohort and by the fact that routine vascular imaging follow-up was not performed. Subclinical complications could have been underreported.
“Randomized trials are needed to compare suture‐mediated versus other modalities of hemostasis,” the study authors wrote.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Mohammed M, Nona P, Asala EA, et al. Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair. Catheter Cardiovasc Interv. Published online May 14, 2022. doi:10.1002/ccd.30229