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INTRODUCTION: With the introduction of transcatheter aortic valve implantation (TAVI), endovascular abdominal aortic aneurysm repair (EVAR), thoracic endovascular aortic aneurysm repair (TEVAR), and frequent use of left ventricular assist devices in complicated percutaneous coronary interventions, the use of large bore arterial access has become a necessity. In the index study, we compared the percutaneous closure of large arteriotomies with open surgical (OS) closure. METHODS: It was a prospective study in which we compared the technical success and vascular complication rate associated with the use of a suture-based vascular closure device (VCD): Perclose ProGlide (PP) with that of OS closure. The study was carried out at Command Hospital Air Force, Bengaluru, India, from January 1, 2016, to December 31, 2020. The inclusion criteria were any percutaneous intervention involving large bore arterial access (≥12 French (F) sheath). The exclusion criteria were any condition where a persistent need for vascular access at the end of the procedure was required. We noted the baseline characteristics and type of anesthesia for all patients. The primary outcome was technical success and major vascular complications, which included major local site bleeding: Bleeding Academic Research Consortium (BARC) 3 or more, failed hemostasis requiring a second intervention, and acute vessel occlusion. Total time taken for the procedure (TTP), time to ambulation (TTA), and time to discharge post-procedure (TTD) were noted for each patient. The secondary outcomes were any bleeding other than major, local hematoma sized >5 cm at 24 hours, pseudo aneurysm formation at 30 days, and acute limb ischemia at 30 days. RESULTS: A total of 120 patients (PP: 60 (males: 54, females: 6), OS: 60 (males: 50, females: 10)) were included in this study. The mean age of patients was comparable in both groups (PP: 71.8 ± 9.62 years and OS: 71.0 ± 7.76 years, p-value: 0.63). Total large arteriotomies (mean size: 18.03F ± 3.34) closed were 184 (PP: 90, OS: 94). The procedures performed were EVAR: 64 (PP: 30, OS: 34), TAVI: 38 (PP: 21, OS: 17), and TEVAR: 18 (PP: 9, OS: 9). All patients in PP group received dual ProGlide with preclose technique. All TEVAR procedures (total arteriotomies: 18) required a vascular sheath of ≥ 24F. There was no statistical difference between the mean size of sheaths used in the two groups. The technical success (PP: 95.55%, OS: 97.87%, 95% CI: -5.78%-10.98%, p-value: 0.48) and rate of major complications were similar in both groups. Three patients in the PP group who had failed hemostasis with two ProGlides were successfully managed with one additional Angioseal (6F) each. The occurrence of hematoma sized larger than 5 cm was significantly more in the PP group compared to the OS group (PP: 7 (7.78%), OS: 0 (0%), p-value: 0.006). While GA was used for all patients who underwent vascular closure with OS, only eight patients (13.33%) in the PP group required GA. The TTP, TTA, and TTD were significantly lower in the PP group as compared to the OS group. CONCLUSION: The percutaneous closure of large bore arteriotomies with suture-based VCDs is equally effective and is not associated with increased major vascular complications. In fact, the TTP, TTA, and TTD are significantly lower in the PP group which can translate to better patient comfort and lower costs.
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OBJECTIVE: To compare the outcome of suture mediated vascular closure device Perclose Proglide (PP) with manual compression (MC) following transfemoral access for coronary interventions (CI). METHODS: It is a retrospective, observational, single centre study from January 2018 to September 2019. Consecutive patients undergoing interventions through transfemoral access were divided into PP and MC groups. Those with less than 3 months follow up were excluded. Two groups were compared for baseline characteristics and various complications at 24 h and at 30 days. RESULTS: Out of 1743 patients studied, PP group included 1343 and MC group, 400 patients. Both groups were comparable in baseline characteristics, sheath size and use of antiplatelets and anticoagulation. PP group had significantly less minor bleeding (P = .01, CI 0.34-4.03) and hematoma (P = .0007, CI 0.95-5.10) at 24 h. At 30 days, minor bleeding (P < .0001, CI 0.97-4.25), hematoma (P = .0002, CI 1.05-4.93) and pseudo-aneurysm (P = .0095, CI 0.03-1.18) were also significantly less in PP group. Obesity (OR 3.5, CI 1.29-9.49) and hypertension (OR 2.41, CI 1.12-5.19) were associated with increased minor bleeding at 24 h. Device failure rate was 2.38%. CONCLUSIONS: PP device is safe, effective and is associated with fewer complications than MC in CI. Device failure rate is low. Obesity and hypertension are associated with increased minor bleeding in both groups.
