A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Management of patch infections after carotid endarterectomy and utility of femoral vein interposition bypass graft.

OBJECTIVE: Patch infection after carotid endarterectomy (CEA) is a rare but devastating complication. A variety of different treatment options are reported; however, there is currently no consensus on how to manage this highly morbid problem. The purpose of this study was to review our experience with management of infectious patch complications after CEA and to highlight utility of femoral vein interposition bypass grafting. METHODS: All CEA patch infection operations at the University of Florida from 2002 to 2017 were reviewed retrospectively. Preoperative history, intraoperative details, and postoperative complications were recorded. Bypass patency was verified with duplex ultrasound imaging (1 month, 6 months, annually). The primary end point was 30-day stroke or death; secondary end points included cranial nerve injury, reintervention, reinfection, and survival. Life tables were used to estimate end points. RESULTS: Twenty-nine patients (mean age, 70 ± 9 years; male, 76%) were identified. The index CEA occurred at a median of 15 months (interquartile range, 1-55 months) preoperatively (39% <2 months after the index procedure). A variety of patch materials were implicated (Dacron, n = 9; unknown/undocumented, n = 8; bovine pericardium, n = 5; expanded polytetrafluoroethylene, n = 3; unidentified nonbiologic prosthetic, n = 3; saphenous vein, n = 1). Carotid reintervention antecedent to the infected patch presentation occurred in 41% (incision and drainage, n = 10; carotid stent, n = 2; vein patch, n = 1). The most common infecting organisms were Staphylococcus and Streptococcus species (52%; n = 15). The most frequent presentation (46%; n = 13) was pericarotid abscess or phlegmon (pulsatile neck mass or pseudoaneurysm, 28% [n = 8]; carotid-cutaneous fistula, 28% [n = 8]). Reconstruction strategy included femoral vein interposition bypass in 24 patients (83%; nonreversed configuration, 16/24 [67%]), saphenous vein patch in 4 patients (14%), and femoral vein patch in 1 patient (3%). Median postoperative length of stay was 5 days (interquartile range, 4-8 days). Twelve patients (41%) experienced a complication, and the 30-day stroke/death rate was 7% (death, n = 1; stroke, n = 1). The single postoperative death occurred in a patient with history of congestive heart failure who developed a pulseless electrical activity arrest on postoperative day 11 that resulted in multiorgan system failure. Cranial nerve injury occurred in 28% (n = 8; cranial nerves X [3], VII [2], XII [2], and IX [1]), all of which resolved by last follow-up. In follow-up (mean clinical follow-up, 17 ± 14 months; mean survival time, 108 months [95% confidence interval, 81-135 months]), two (7%) complained of limb edema with femoral cutaneous nerve palsy that resolved by 3 months. One interposition bypass occluded at 3 months (asymptomatic); the remaining grafts remained patent with no restenosis, reinfection, or reintervention events. The 1- and 5-year survival was 87% ± 6% and 82% ± 8%, respectively. CONCLUSIONS: CEA patch infection can be successfully managed with femoral vein interposition bypass with acceptable postoperative outcomes. Excellent patency can be anticipated with good long-term survival. This strategy can be considered especially in cases with carotid size mismatch or if there is limited availability of alternative biologic conduits.