Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
-
Randomized Controlled Trial Multicenter Study Comparative Study
Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial.
Purpose: To investigate the efficacy and sustainability of drug-coated balloon (DCB) treatment of femoropopliteal in-stent restenosis (ISR). Materials and Methods: An investigator-initiated, prospective, multicenter, 1:1 randomized study enrolled 88 patients for treatment of ISR with DCB (n=47; mean age 68.3±9.6 years; 26 men) or uncoated balloon (n=41; mean age 67.6±10.2 years; 26 men) angioplasty (ClinicalTrials.gov identifier NCT01594684). Additionally, the protocol provided for an observational arm composed of patients from either randomized arm who experienced recurrent ISR ≥30 days after the index treatment. ⋯ At ~2 years after treatment, a remarkable number (14/27, 52%) of TLRs were recorded in the single-dose DCB group. Conclusion: Treatment with DCBs resulted in significantly less 6-month LLL and fewer TLRs up to 24 months than treatment with uncoated balloons. The double dose for treating recurrent ISR did not cause recognizable adverse events or require TLR up to 24 months.
-
To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). ⋯ There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.
-
Multicenter Study
Association Between Extent of Stent-Graft Coverage and Thoracic Aortic Remodeling After Endovascular Repair of Type B Aortic Dissection.
Purpose: To examine the association between the extent of stent-graft coverage and thoracic aortic expansion after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection. Materials and Methods: A retrospective analysis was conducted of 201 patients (mean age 52.4±11.5 years; 178 men) with acute (135, 67.2%) or chronic (66, 32.8%) type B aortic dissection who underwent TEVAR at 4 medical centers. The mean stent-graft length was 157.1±33.3 mm. ⋯ Regression analysis showed no significant association between the risk of thoracic aortic expansion and the PSDA as a continuous variable (HR 0.97, 95% CI 0.91 to 1.03, p=0.288); however, analyzing the PSDA as a categorical variable indicated a significantly lower risk of thoracic aortic expansion for the PSDA >31.3% group (HR 0.46, 95% CI 0.22 to 0.95, p=0.036) after adjusting for a variety of demographic and anatomical characteristics. Conclusion: More extensive stent-graft coverage appears to improve thoracic aortic remodeling after TEVAR. However, the clinician should balance the benefit of extensive stent-graft coverage and its related risk of spinal cord ischemia.
-
Comparative Study
Off-the-Shelf Devices for Treatment of Thoracic Aortic Diseases: Midterm Follow-up of TEVAR With Chimneys or Physician-Made Fenestrations.
Purpose: To evaluate the midterm outcomes of thoracic endovascular aortic repair (TEVAR) using chimney grafts (ch-TEVAR) or thoracic stent-grafts with fenestrations made on the back table (f-TEVAR) to treat thoracic aortic dissection (TAD) and thoracic aortic aneurysm (TAA). Materials and Methods: A retrospective analysis was conducted of 474 consecutive patients (mean age 62.3±10.7 years; 346 men) treated with either f-TEVAR (n=110) or ch-TEVAR (n=364) for 352 TADs (81 f-TEVAR and 271 ch-TEVAR) or 122 TAAs (29 f-TEVAR and 93 ch-TEVAR) from 2008 to 2016. The primary endpoints at 30 days and during follow-up were overall mortality, aorta-related mortality, and major complications. ⋯ Conclusion: Off-the-shelf techniques employing chimney grafts and homemade fenestrations are both suitable options for TAD and TAA involving the supra-aortic branches, with a low incidence of reintervention. Fenestrated TEVAR seems to have more favorable short- and midterm outcomes. Further study of these off-the-shelf techniques for aortic arch repair is warranted.
-
Comparative Study
Utilization and Outcomes of Local Anesthesia and Peripheral Nerve Block for Hybrid Lower Extremity Revascularization.
Purpose: To investigate the utilization of local anesthesia or peripheral nerve block with monitored anesthesia care (LPMAC) and its impact on the perioperative outcomes of hybrid lower extremity revascularization (LER) compared with general anesthesia (GA). Materials and Methods: A search of the ACS-NSQIP database between 2005 and 2017 identified 9430 patients who underwent hybrid LER for peripheral artery disease. Excluding 449 ineligible cases left 8981 hybrid LER patients for analysis. ⋯ Conclusion: LPMAC is an infrequent anesthetic technique for hybrid LER and is primarily used for patients with a high burden of comorbidities. LPMAC is associated with reduced overall morbidity and operating time. Further studies are needed to identify which patients undergoing hybrid LER benefit most from LPMAC.