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Purpose: To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs)., Methods: A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates., Results: Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6- and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6- and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6- and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6- and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively., Conclusion: The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population., (Copyright © 2023 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA)., Materials and Methods: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2-4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR])., Results: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes., Conclusions: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)

Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA., Methods: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders., Results: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA., Conclusions: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To report our experience using a commercially available catheter-based system equipped with an intravascular ultrasound (IVUS) transducer to achieve controlled true lumen re-entry in patients undergoing subintimal angioplasty for chronic total occlusions (CTO) or aortic dissections., Methods: During an 8-month period, 10 patients (6 men; mean age 73.4 years) with lower extremity (LE) ischemia from CTOs (n=7) or true lumen collapse from aortic dissections (n=3) were treated. Subintimal access and controlled re-entry of the CTOs were performed with a commercially available 6.2-F dual-lumen catheter, which contained an integrated 64-element phased-array IVUS transducer and a deployable 24-G needle through which a guidewire was passed once the target lumen was reached. The occluded segments were balloon dilated; self-expanding nitinol stents were deployed. In the aortic dissections, fenestrations were performed using the same device, with the IVUS unit acting as the guide. The fenestrations were balloon dilated and stented to support the true lumen., Results: Time to effective re-entry ranged from 6 to 10 minutes (mean 7) in the CTOs; antegrade flow was restored in all 7 CTOs, and the patients were free of ischemic symptoms at up to 8-month follow-up. In the aortic dissection cases, the fenestrations equalized pressures between the lumens and restored flow into the compromised vessels. There were no complications related to the use of this device in any of the 10 patients., Conclusions: Our preliminary results demonstrate the feasibility of using this catheter-based system for subintimal recanalization with controlled re-entry in CTOs and for aortic flap fenestrations in aortic dissections. This approach can improve the technical success rate, reduce the time of the procedure, and minimize potential complications.

Angioplasty of chronic total occlusions (CTOs) has lower technical success rates with longer procedure times and poorer outcomes. Subintimal recanalization remains limited by the lack of controlled re-entry into the true lumen of the target vessel. We report our experience using a commercially available catheter-based system equipped with an intravascular ultrasound scanner to achieve controlled true lumen re-entry in patients with peripheral CTOs. In a 4-month period, 6 patients with lower extremity (LE) ischemia from CTOs were treated. Occluded segments were crossed subintimally, and controlled re-entry was secured using the CrossPoint TransAccess catheter. This 6.2 F dual-lumen catheter contains an integrated 64-element phased array intravascular ultrasound scanner enabling targeting of structures. Intravascular ultrasound-guided luminal re-entry was achieved by advancing a 24-gauge needle to a desired length and delivering a 0.014" guide wire into the target lumen. The occluded segments were balloon dilated and stented using self-expanding nitinol stents. Effective luminal re-entry and re-establishment of antegrade flow occurred in all 6 patients. Time to recanalization ranged from 5 to 10 minutes. All patients were free of ischemic symptoms at 1 to 5 month follow-up. There were no procedure-related complications. Our preliminary results demonstrate the feasibility of using this catheter system for subintimal recanalization with controlled re-entry in CTOs. This approach can improve the technical success rate, reduce the time of the procedure, and minimize potential complications.

Purpose: To report the results of endoluminal recanalization and stent placement in patients with chronic occlusions of the inferior vena cava (IVC)., Materials and Methods: Seventeen consecutive patients (12 male, five female patients; mean age, 40.6 years; age range, 15-77 years) with chronic IVC occlusions were treated during a 6-year period. The mean duration of symptoms was 32 months. Underlying active malignancy was the cause of occlusion in four patients. Five patients with superimposed acute thrombus underwent catheter-directed thrombolysis prior to IVC recanalization. Clinical patency was defined as absence or improvement of symptoms. Clinical follow-up was supplemented with ultrasonography, vena cavography, or both in 10 patients., Results: Technical success was achieved in 15 (88%) patients. Additional thrombolytic therapy and stent placement was needed in two patients to maintain patency at 4 and 6 months after the procedure. Twelve patients had IVCs that remained patent after a mean follow-up of 19 months for a primary patency rate of 80%. The primary assisted patency rate was 87% (13 of 15). There were four deaths owing to underlying disease 6-21 months after the procedures. There were no procedure-related complications., Conclusion: Endoluminal recanalization and stent placement in chronically occluded IVCs has a good intermediate-term outcome and should be considered in patients who have symptoms and who often do not have adequate alternative therapy.

Objectives: Our objectives were (1) to investigate the incidence and cause of symptomatic superior vena caval anastomotic stenosis and central venous thrombosis in patients receiving heart or heart-lung transplantation and (2) to explore percutaneous methods of thrombolysis and endoluminal intervention to treat these complications., Methods: Review of 1016 cases revealed three cases of superior vena cava syndrome. Anatomy, surgical technique, and medical risk factors were examined. Percutaneous treatments, including urokinase thrombolysis, mechanical thrombolysis, balloon angioplasty, and stent placement, were attempted., Results: All three of these patients underwent transplantation by means of the bicaval anastomotic technique. In addition, the diameters of the donor and recipient cavae were grossly mismatched in all three. Stenoses in all three patients were successfully treated percutaneously with balloon angioplasty and stent placement. Treatment of the accompanying large-volume thrombosis was problematic in these patients, and two had hemorrhagic complications of urokinase thrombolysis. A mechanical thrombolysis device was used successfully in the third patient., Conclusions: Anastomotic stricture and central venous thrombosis is an uncommon complication of the bicaval anastomotic technique of heart and heart-lung transplantation. Discrepancy between donor and recipient caval diameters appears to be the major risk factor. Endoluminal thrombolysis and stenting provides rapid and enduring relief of symptoms and precludes repeat sternotomy, cardiopulmonary bypass, and general anesthesia.