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.

Outcomes of translumbar embolization of type II endoleaks following endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Presence of an endoleak can compromise aneurysm exclusion after endovascular abdominal aortic aneurysm repair (EVAR). Type II endoleaks (T2Es) are most common and may cause sac expansion. We report outcomes of translumbar embolization (TLE) of T2Es following EVAR. METHODS: We conducted a retrospective chart review of patients with T2E after EVAR treated with TLE from 2011 to 2018 at a single academic institution. Treatment indications were the presence of persistent T2E and aneurysm growth ≥5 mm. Sac stabilization was defined as growth ≤5 mm throughout the follow-up period. RESULTS: Thirty consecutive patients were identified. The majority were men (n = 24), with a mean age of 74.3 years (95% confidence interval [CI], 70.9-77.6 years). The most common comorbidities were hypertension (83.3%) and coronary artery disease (54.0%). The mean maximal sac diameter at T2E discovery was 5.8 cm (95% CI, 5.4-6.2 cm). The mean time to intervention from endoleak discovery was 33.7 ± 28 months with a mean growth of 0.84 cm (95% CI, 0.48-1.2 cm) during that time period. The mean follow-up time after TLE was 19.1 months (95% CI, 11.1-27.2 months). Twenty-eight patients were treated with cyanoacrylate glue (CyG) alone, and two were treated with CyG plus coil embolization (CE). There was immediate complete endoleak resolution as assessed intraoperatively, and sac stabilization in 15 cases (50.0%). Eleven patients (36.7%) had evidence of persistent T2E on initial imaging after the embolization procedure; additional follow-up revealed eventual sac stabilization at a mean of 21.3 ± 7.2 months, and therefore, these patients did not require further intervention. In the remaining four cases (13.3%), there was persistent T2E after the initial TLE, requiring a second intervention. Repeat TLE stabilized growth in three of these four patients after a mean of 17.6 ± 12.9 months. One patient required open sacotomy and ligation of lumbar vessels due to continued persistence of the T2E and continued aneurysm growth. There were no ischemic complications related to the embolization procedures. Factors associated with persistent endoleak after initial embolization were larger aneurysm diameter at the time of initial endoleak identification (P < .001) and the use of antiplatelet agents (P < .02). The use of anticoagulation was not a significant risk factor for endoleak recurrence or aneurysm growth after TLE. CONCLUSIONS: TLE of T2E is a safe and effective treatment option for T2E with aneurysm growth following EVAR. Patients taking antiplatelet medication and those with larger aneurysms at the time of endoleak identification appear to be at increased risk for persistent endoleak and need for subsequent procedures following initial TLE. These patients may require more intensive monitoring and follow-up.

Early results for below-knee bypasses using Distaflo.

In patients who require lower extremity revascularization, prosthetic graft is a reasonable alternative in the absence of a suitable autologous vein conduit. However, prosthetic bypass grafts have limited patency, especially for infrageniculate reconstruction. Polytetrafluoroethylene grafts were geometrically modified at the distal end to increase their patency. The authors reviewed their experience with the Distaflo graft in patients who required lower extremity below-knee popliteal and tibial bypasses when no suitable autologous vein conduit was available. Chart review was conducted of the 57 patients who underwent 60 lower extremity bypasses over a 3-year period between June 2003 and April 2006. Twenty-four revascularizations were constructed to the tibial outflow sites, whereas the remaining grafts were placed to the below-knee (28) and above-knee (8) popliteal artery, respectively. Study endpoints were primary, assisted primary, secondary patency, and limb salvage at the time of follow-up. Distaflo bypass was performed at the infrageniculate level in 86.7% of cases (28 below-knee popliteal, 24 tibial). Mean follow-up time was 12 months (range, 0.5-37.5 months). At 1 year, primary, assisted primary, and secondary patencies and limb salvage rates for below-knee popliteal bypasses were 83.5%, 89.5%, 94.7%, and 94.4%, respectively. Primary, assisted primary, and secondary patencies and limb salvage rates for tibial bypasses were 44.4%, 44.4%, 63.2%, and 74.9%, respectively. Distaflo precuffed graft is a good alternative conduit for below-knee popliteal and tibial lower extremity reconstructions in the absence of an autologous vein and appears to have promising early patency and limb salvage rates even when used for tibial bypasses.

Postoperative infection associated with polyester patch angioplasty after carotid endarterectomy.

OBJECTIVES: Postoperative infection is one of the most dreaded complications associated with use of synthetic patches for carotid endarterectomy. Although polyester patches were used extensively for carotid patch angioplasty throughout the last decade, few reports detail cases of deep patch infection. We describe our experience with polyester patch infections after carotid endarterectomy. Patients and methods From January 1996 through December 2001 we treated polyester patch infections after carotid endarterectomy in 10 patients. RESULTS: The interval from primary carotid endarterectomy to presentation with infection ranged from 11 days to 30 months. All patients underwent repeat operation that involved tissue debridement, excision of the polyester patch, and either interposition grafting or patch angioplasty with autologous vein. No perioperative stroke or death occurred; however, 1 patient had transient hoarseness, and in 1 patient a pseudoaneurysm developed that required additional surgical repair with a saphenous vein interposition graft. All patients remain well and free of infection with follow-up as long as 56 months. CONCLUSIONS: Infection is a serious and rare complication of carotid patch angioplasty with polyester material. Nonetheless, it can be treated successfully with good results and acceptable morbidity with soft tissue debridement, prosthetic patch excision, and either patch angioplasty or interposition grafting with autologous vein.

Transcatheter embolization of extremity vascular malformations: the long-term success of multiple interventions.

Vascular malformations of the extremities present a difficult therapeutic challenge. Ligation of feeding vessels may lead to tissue necrosis and limb loss and can make subsequent attempts at transcatheter therapy impossible. The purpose of this study was to review our results with transcatheter embolization therapy in symptomatic vascular malformations in the upper and lower extremities in 50 patients. A retrospective review was conducted of a computerized database of all patients undergoing transcatheter therapy of peripheral vascular malformations at our institution. The mean age of the patients was 22 years (range 1-51 years), and 34% were male. The most common presenting symptoms included pain (80%), swelling (68%), ulceration or distal ischemia (18%), and hemorrhage (6%). Previous unsuccessful surgical treatment or embolization had been performed in 24% and 18% of patients, respectively. Predominantly venous lesions were treated by sclerotherapy with injection of ethanol. Arteriovenous and arterial lesions were treated by embolization via the arterial branch feeding vessels with cyanoacrylate. The most common vessels involved and treated were branches of the profunda femoris and tibial arteries (83% of lower extremity lesions), and branches of the brachial and radial arteries (82% of upper extremity lesions). Patients required a mean of 1.6 embolization procedures (range 1-5) over a mean period of 57 months. Sixteen patients (32%) underwent more than one embolization procedure. Of these, one was a planned staged procedure and 15 were performed secondary to residual or recurrent symptoms. Adjunctive surgical procedures were performed subsequent to embolization in three cases (6%). Ninety-two percent of patients remained asymptomatic or improved at a mean follow-up of 56 months. There was one case of limb loss (2%). Diffuse extremity vascular malformations are difficult to eradicate completely and recurrences are common. Although patients may require multiple embolization procedures and occasional adjunctive surgical resection, directed transcatheter embolization should be the treatment of choice for symptomatic extremity vascular malformations.