Clinical outcomes of patients with and without chronic kidney disease undergoing endovascular revascularization of infrainguinal peripheral artery disease: Insights from the XLPAD registry.

OBJECTIVES: The purpose of the present study was to define clinical outcomes of chronic kidney disease (CKD) patients undergoing endovascular revascularization of infrainguinal peripheral artery disease (PAD). BACKGROUND: CKD is an established predictor of advanced PAD. However, clinical outcomes for these patients following endovascular revascularization remain inadequately defined. METHODS: Using the ongoing multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851), we analyzed all-cause death, target limb amputation, and need for repeat revascularization for patients with and without CKD undergoing infrainguinal endovascular revascularization between the years 2005 and 2018. RESULTS: Of 3,699 patients, 15.1% (n = 559) had baseline CKD. CKD patients had significantly higher incidence of heavily calcified lesions (48.4% vs. 38.1%, p < .001) and diffuse disease (66.9% vs. 61.5%, p = .007). Kaplan-Meier analysis showed significant differences between CKD and non-CKD patient outcomes at 12 months for freedom from target limb amputation (79.9% vs. 92.7%, p < .001) and all-cause death (90.1% vs. 97.6%, p < .001). However, freedom from target vessel revascularization was similar between the groups. After adjusting for baseline comorbidities in the CKD and non-CKD groups, the hazard ratios for target limb amputation and death at 12 months were 2.28 (95% confidence interval or CI 1.25-4.17, p < .001) and 4.38 (95% CI 2.58-7.45, p < .001), respectively. CONCLUSIONS: Following endovascular revascularization for infrainguinal PAD, CKD was an independent predictor of all-cause death and target limb amputation at 12 months.

IVUS Assessment of the Crossing Pathway of an Intraluminal Reentry Device Used in the Primary Treatment of Infrainguinal Chronic Total Occlusions.

Purpose: To examine with intravascular ultrasound (IVUS) the crossing pathways of the TruePath reentry device during primary antegrade recanalization of infrainguinal chronic total occlusions (CTOs). Methods: Between July 2017 and September 2018, a prospective multicenter study enrolled 143 consecutive patients (mean age 75±9 years; 101 men) with 146 CTOs treated in an antegrade approach using the TruePath reentry device with IVUS assessment of the crossing pathway in successful cases. Outcome measures were complete success (reentry device reached the distal true lumen), assisted success (reentry device use followed by a conventional guidewire to reach the distal true lumen), reentry device crossing route by IVUS assessment, and procedure- and device-related complications. Regression analyses were employed to identify any relevant associations between baseline patient variables and the outcome measures; results are presented as the odds ratio (ORs) and 95% confidence interval (CI). Results: Complete success was achieved in 82 (56.2%) lesions; any success (complete plus assisted) was documented in 117 (80.1%) lesions. Four (3%) perioperative device-related complications were observed. The crossing route was intraplaque for most of the total crossing distance in both complete success cases (95.3%±13.2%) and any success cases (94.8%±14.4%), with relatively short subintimal (3.6%±10.2% and 4.2%±11.2%, respectively) or intramedial (1.2%±5.8% and 1.0%±5.4%, respectively) crossing. CTO length was a significant risk factor for not achieving complete success (OR 1.74, 95% CI 1.13 to 2.68, p=0.012), and a history of failed revascularization was associated with not achieving any success (OR 6.40, 95% CI 1.28 to 28.9, p=0.038). Conclusion: The intraplaque route was the primary pathway taken by the TruePath reentry device as it crossed infrainguinal CTOs. Crossing rates were acceptable, with few device-related complications. However, a longer CTO length and a failed revascularization history negatively affected the success rate.

Dissections After Infrainguinal Percutaneous Transluminal Angioplasty: A Systematic Review and Current State of Clinical Evidence.

Purpose: To systematically review the literature and extract information on the definitions, prevalence, implications, and treatment of dissections after infrainguinal balloon angioplasty, with a goal of summarizing current data and identifying gaps in knowledge to help direct future research. Materials and Methods: A systematic review was performed according to the PRISMA guidelines. Medline (PubMed), Scopus, and Cochrane CENTRAL databases were reviewed for prospective and retrospective studies reporting dissection identification, characterization, incidence, severity, and/or outcomes after infrainguinal balloon angioplasty up to January 30, 2019. The electronic search resulted in 288 studies. From these, 153 full-text articles were assessed, and 51 published from 1964 to 2018 were selected as relevant to this systematic review. Because of the significant between-study differences in lesion characteristics, reporting methods, and lack of core laboratory adjudication, the findings were summarized from each study, but the results were not pooled. Results: The mechanism of percutaneous transluminal angioplasty (PTA) consists of adventitial stretching, medial necrosis, and controlled dissection or plaque fracture. PTA-induced dissections can precipitate pathological high and low shear hemodynamic defects and have been implicated as a contributing factor in procedural complications as well as restenosis at the treatment site. The development of significant dissection after PTA often leads to the use of adjunctive therapies, including stent placement. Despite the ubiquitous nature of dissection after balloon angioplasty (incidence 7.4% to 84%), limited data are available to categorize dissections in the peripheral arteries and direct subsequent treatments to improve vessel patency. With the increased utilization of drug-coated balloon angioplasty, understanding the outcomes of postangioplasty dissection has become increasingly important, as the decision to treat dissections with additional strategies has therapeutic and economic implications. Conclusion: All post-PTA dissections in the femoropopliteal arteries may benefit from a treatment approach that ensures optimal hemodynamics with long-term durability in treated lesions. Further understanding the importance of postangioplasty dissections, along with the development of new technologies, will help optimize the patency of endovascular interventions.

Initial Experience With the Outback Catheter for Targeted Reentry During Subintimal Angioplasty of the Infragenicular Arteries.

PURPOSE: To report use of the Outback reentry device for targeted distal reentry during subintimal recanalization of chronic total occlusions (CTOs) in the infragenicular arteries. METHODS: During an 18-month period, the Outback device was applied in 10 patients (mean age 71.8±18.8 years; 8 men) to achieve reentry at the infragenicular segment following either unsuccessful spontaneous reentry after subintimal crossing of a CTO or when a targeted reentry was desired. The mean occlusion length was 117.5±101.0 mm. Technical (device) success, overall procedure success, and reentry accuracy are reported, along with any major or minor complications. RESULTS: The device was technically successful in achieving reentry in 9 of 10 cases; overall procedure success was achieved in 8 owing to heavy calcifications in a distal posterior tibial artery and a distal popliteal artery. The reentry accuracy was 10.8±14.6 mm. There were no major complications and only 3 minor sequelae, including 2 dissections and 1 small perforation; all were treated successfully with stenting. CONCLUSION: The Outback device has a high technical success rate in achieving targeted true lumen reentry in infragenicular subintimal angioplasty when spontaneous reentry is not possible or a targeted reentry is desirable.

Outcomes After Endovascular Revascularization in Octogenarians and Non-Octogenarians With Critical Limb Ischemia.

PURPOSE: To determine the outcome and periprocedural risk of endovascular revascularization in octogenarians with critical limb ischemia (CLI) compared with their younger counterparts. METHODS: The multicenter, prospective registry for First-line Treatments in Patients With Critical Limb Ischemia (CRITISCH) enrolled 642 patients treated with endovascular techniques ( ClinicalTrials.gov identifier NCT01877252). The patients were dichotomized according to age <80 years (n=421; mean age 69 years, 292 men; group 1) or ≥80 years (n=221; mean age 85 years, 113 men; group 2). The groups had similar distributions in Rutherford categories 4 to 6, but group 1 had more men, smokers, diabetics, and patients on dialysis. The primary composite endpoint of the study was amputation and/or death. Key secondary endpoints were in-hospital mortality and major amputation, as well as major adverse limb events (MALE; any reintervention or major amputation involving the index limb) at 1 year. RESULTS: The in-hospital mortality was 1% in group 1 and 2% in group 2 (p=0.204) and the major amputation rates were 4% and 2% (p=0.169), respectively. Amputation-free survival at 1 year was 75% in group 1 and 77% in group 2 (p=0.340), whereas freedom from MALE was significantly different between the groups [62% group 1 vs 72% group 2; hazard ratio (HR) 1.45, 95% confidence interval (CI) 1.09 to 1.93, p=0.016). Limb salvage was 90% in group 1 and 95% in group 2 (HR 2.16, 95% CI 1.27 to 3.69, p=0.01). CONCLUSION: Octogenarians with CLI treated by endovascular means showed comparable early and 1-year amputation-free survival rates vs their younger counterparts, and limb salvage and freedom from MALE rates were even higher in octogenarians. APPENDIX: The CRITISCH collaborators are Farzin Adili, MD (Darmstadt), Kai Balzer, MD (Bonn), Arend Billing, MD (Offenbach), Dittmar Böckler, MD (Heidelberg), Daniel Brixner, MD (Offenbach), Sebastian E. Debus, MD (Hamburg), Hans-Henning Eckstein, MD (München), Hans-Joachim Florek, MD (Freital), Asimakis Gkremoutis, MD (Frankfurt), Reinhardt Grundmann, MD (Bad Krozingen), Thomas Hupp, MD (Stuttgart), Se-Won Hwang, MD (Muenster), Tobias Keck, MD (Lübeck), Wojciech, Klonek, MD (Cloppenburg), Werner Lang, MD (Erlangen), Björn May (Freital), Alexander Meyer, MD (Erlangen), Bernhard Mühling, MD (Biberach), Alexander Oberhuber, MD (Düsseldorf), Holger Reinecke, MD (Münster), Christian Reinhold, MD (Mönchengladbach), Ralf-Gerhard Ritter, MD (Bielefeld), Hubert Schelzig, MD (Düsseldorf), Christian Schlensack, MD (Tübingen), Thomas Schmitz-Rixen, MD (Frankfurt), Karl-Ludwig Schulte, MD (Berlin), Matthias Spohn, MD (Bamberg), Konstantinos Stavroulakis, MD (Münster), Martin Storck, MD (Karlsruhe), Matthias Trede, MD (Bremen), Barbara Weis-Müller, MD (Mönchengladbach), Heiner Wenk (Bremen), Thomas Zeller, MD (Bad Krozingen), Sven Zhorzel, MD (Munich), and Alexander Zimmermann, MD (Munich).

Transvenous Intravascular Ultrasound-Guided Endovascular Treatment for Chronic Total Occlusion of the Infrainguinal Arteries.

PURPOSE: To investigate the 1-year outcomes of transvenous intravascular ultrasound (IVUS)-guided endovascular therapy (EVT) for chronic total occlusion (CTO) of the lower extremity arteries. METHODS: Transvenous IVUS-guided EVT was performed in 44 patients (50 limbs) with CTO of the femoropopliteal arteries or tibioperoneal trunk. Treatment involved crossing a guidewire through the CTO under the guidance of both fluoroscopic and IVUS imaging, along with insertion of the IVUS catheter into a vein parallel to the target artery. Primary success rate, complications, and target lesion revascularization (TLR) at 12-month follow-up were investigated. RESULTS: Successful recanalization, defined as grade 3 flow (Thrombolysis in Myocardial Infarction score) and no flow-limiting dissection, was observed in 48 (96%) limbs. Two limbs with failed recanalization had a very long CTO lesion from the superficial femoral artery to below the knee. A bidirectional approach was selected in 11 (22%) limbs. Complications at the access site occurred in only 2 patients. The rate of freedom from TLR at 12 months was 77.9% (95% confidence interval 61.4 to 87.9). CONCLUSION: Transvenous IVUS-guided EVT is safe and can provide optimal short-term results for EVT of CTO in the infrainguinal arteries. IVUS-guided EVT may be one of the most effective treatment strategies for CTO of the femoropopliteal arteries or tibioperoneal trunk.

Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.

Objectives To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions. Methods This prospective, multicenter, nonrandomized investigational device exemption trial was conducted across 16 US and German centers between August 2010 and April 2013. Intention-to-treat enrollment was 128 patients (mean age: 71.8 years, 59% male) with 149 lesions (mean length: 34 mm, mean diameter stenosis: 89.5%), and the primary analysis per-protocol population consisted of 105 patients with 123 lesions. The primary efficacy endpoint, technical success, was the achievement of acute debulking with a post-atherectomy residual diameter stenosis ≤50% (before adjunctive therapy). The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Results For the primary analysis per-protocol population, the rate of lesion technical success was 95.1% (117/123), with the lower limit of the 95% CI 90.6%, meeting the prospectively established target performance goal of ≥86%. After post-atherectomy adjunctive therapy, residual stenosis was ≤30% for 99.2% (122/123) of lesions (mean final diameter stenosis 10.5%). Improvement of ≥1 Rutherford class occurred for 74.5% of patients through 30 days and for 80% through six months. MAEs were experienced by 5.7% (6/105) of patients through 30 days (with the upper limit of the 95% CI 11.0%, meeting the target performance goal of <20%), and 16.8% through six months. Six-month freedom from TLR and TVR was 88.0% and 86.1%, respectively. Conclusions Based on the high rate of technical success and the low rates of MAEs through six months, the Phoenix Atherectomy System is safe and effective for the debulking of lower-extremity arterial lesions. ClinicalTrials.gov identifier NCT01541774.

Targeted True Lumen Re-Entry With the Outback Catheter: Accuracy, Success, and Complications in 100 Peripheral Chronic Total Occlusions and Systematic Review of the Literature.

PURPOSE: To report a single-center experience with the Outback re-entry device for targeted distal true lumen re-entry during subintimal recanalization of chronic total occlusions (CTOs) and compare the results with a systematic review of the literature. METHODS: Between February 2011 and July 2013, 104 Outback devices were employed in 91 patients (mean age 64±9 years; 57 men) for subintimal recanalization of 100 vessels with CTOs after initial failure of spontaneous reentry. Fifty-two cases involved a retrograde approach to aortoiliac occlusions and 48 were re-entry attempts in infrainguinal CTOs. Outcome measures included complications and technical success, defined as successful targeted re-entry at the preplanned site of the distal true lumen. To evaluate device accuracy, the re-entry distance (between the point of true vessel reconstitution and the eventual re-entry point) was measured. RESULTS: Outback success was 93% (93/100); only 7 cases failed owing to heavy calcification (5/52 aortoiliac vs 2/48 infrainguinal, p=0.44). Re-entry was highly accurate, with a re-entry distance of ~1 cm in both subgroups (1.2±0.1 cm in aortoiliac vs 1.3±0.1 cm in infrainguinal, p=0.40). There were no major and 17 minor complications (9/52 aortoiliac vs 8/48 infrainguinal, p=0.93). Results are in line with the systematic review that identified 11 studies (only 1 randomized trial) involving mostly the femoropopliteal segment (119 aortoiliac and 464 infrainguinal segments). The pooled Outback success rate was 90% (95% confidence interval 85% to 94%) and the pooled complication rate was 4.3% (95% confidence interval 1.6% to 8.3%). CONCLUSION: The Outback device is safe and has a very high rate of achieving targeted true lumen re-entry, which minimizes the sacrifice of healthy vessel in the aortoiliac and infrainguinal arteries.

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease.

BACKGROUND: No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. OBJECTIVES: This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. METHODS: Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. RESULTS: A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). CONCLUSIONS: These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.

Endovascular Interventions to Superficial Femoral Artery Occlusion: Different Approaches, Technique, and Follow-up.

BACKGROUND: Superficial femoral artery lesion is one of the main causes for intermittent claudication or critical limb ischemia. Percutaneous transluminal angioplasty is one of the approved therapies for this medical entity. Anatomical factors should be considered in choosing the right approach and puncture.The purpose of this study is to discuss the anatomical, radiological, and technical factors which determine the preference of various approaches and to determine its safety, efficacy, and mid-term clinical and radiological outcome. METHODS: Retrospectively, data were collected from patients who underwent angioplasty to superficial femoral arteries for total occlusion from January 2015 and June 2018 in our center, we performed angioplasty to 59 occluded superficial femoral artery patients at our center. The ipsilateral femoral artery, ipsilateral popliteal artery, contralateral femoral artery, or upper limb approaches were used depending on the various anatomical factors determined by radiological imaging before the procedure. RESULTS: Acute success rate was 91.52%. There were no significant periprocedural complications. At the latest clinical follow-up of mean 25.8 months (10-51), a restenosis rate of 16.67% in infrainguinal arteries and 5.88% in suprainguinal arteries were noted. CONCLUSIONS: Percutaneous transluminal angioplasty of superficial femoral artery is a proven, viable, safer, and effective option, with good mid-term clinical results and patency rates. Different approaches to be chosen depends on the anatomical and technical factors to get the best possible outcome.