First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries.

PURPOSE: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. MATERIALS AND METHODS: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. RESULTS: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). CONCLUSION: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.

The Influence of 3D Printed Aortic Models on the Evolution of Physician Modified Stent Grafts for the Urgent Treatment of Thoraco-abdominal and Pararenal Aortic Pathologies.

OBJECTIVE: The aim was to describe the outcomes of high risk patients with symptomatic or contained rupture of pararenal (PRAs) and thoraco-abdominal aortic aneurysms (TAAAs) with anatomy unsuitable for commercially available stent grafts who underwent fenestrated endovascular aneurysm repair (FEVAR) using physician modified stent grafts (PMSGs) planned with 3D image analysis software (3DIMAS), and 3D printed aortic models (3DAMs). METHODS: Nineteen consecutive patients (17 male; mean age, 70 ± 9 years) underwent PMSG-FEVAR between 2015 and 2019. 3DAMs to plan the PMSGs were introduced in 2018. End points were all cause mortality, freedom from any endoleak, target vessel patency, and re-intervention. RESULTS: Seven patients (36.8%) were treated with PMSGs using 3DIMAS (three PRAs, three type IV, and one type III TAAAs), and 12 patients (63.2%) received PMSGs using 3DAMs (five PRAs, seven type IV TAAAs). Six patients presented with contained aortic rupture and 13 patients were treated for symptomatic aortic aneurysm. Mean aortic diameter was 72 ± 10 mm. The choice of stent graft for fenestration was the Valiant Captivia Closed Web (Medtronic), except for one patient. Sixteen (84.2%) stent grafts were manufactured with four fenestrations. Technical success was 100%. Seventy-one renovisceral branch vessels were targeted with fenestrations. Mean length of hospital stay was 17.3 ± 10.4 days. Thirty day mortality was 0%. Two patients developed reversible spinal cord injury. Mean follow up was 14.4 months (range 1-52 months). During follow up one non-aneurysm related death occurred, and two successful re-interventions were performed: one to re-establish renal artery patency, and one to treat a type 1c endoleak. CONCLUSION: PMSGs for urgent treatment of pararenal and thoraco-abdominal aortic aneurysms in high risk patients unsuitable for commercially available stent grafts are feasible and safe. 3D printing technology may improve urgent construction of patient specific devices for treatment of complex aortic pathologies and improve outcomes.

Current NAFLD guidelines for risk stratification in diabetic patients have poor diagnostic discrimination.

Patients with type 2 diabetes (T2D) are at risk for non-alcoholic fatty liver disease (NAFLD) and associated complications. This study evaluated the performance of international (EASL-EASD-EASO) and national (DGVS) guidelines for NAFLD risk stratification. Patients with T2D prospectively underwent ultrasound, liver stiffness measurement (LSM) and serum-based fibrosis markers. Guideline-based risk classification and referral rates for different screening approaches were compared and the diagnostic properties of simplified algorithms, genetic markers and a new NASH surrogate (FAST score) were evaluated. NAFLD risk was present in 184 of 204 screened patients (age 64.2 ± 10.7 years; BMI 32.6 ± 7.6 kg/m2). EASL-EASD-EASO recommended specialist referral for 60-77% depending on the fibrosis score used, only 6% were classified as low risk. The DGVS algorithm required LSM for 76%; 25% were referred for specialised care. The sensitivities of the diagnostic pathways were 47-96%. A simplified referral strategy revealed a sensitivity/specificity of 46/88% for fibrosis risk. Application of the FAST score reduced the referral rate to 35%. This study (a) underlines the high prevalence of fibrosis risk in T2D, (b) demonstrates very high referral rates for in-depth hepatological work-up, and (c) indicates that simpler referral algorithms may produce comparably good results and could facilitate NAFLD screening.

Retrograde Tibioperoneal Access for Complex Infrainguinal Occlusions: Short- and Long-Term Outcomes of 554 Endovascular Interventions.

OBJECTIVES: This study sought to report short- and long-term efficacy and safety outcomes of retrograde tibioperoneal access for endovascular treatment of chronic total occlusions (CTOs). BACKGROUND: Antegrade recanalization of peripheral CTO is associated with a high failure rate and retrograde puncture of tibioperoneal arteries has been adopted to overcome this limitation. METHODS: Within a retrospective single center cohort study, data of 554 infrainguinal occlusions were acquired in which a retrograde puncture of at least 1 infrapopliteal artery became necessary. Techniques used for access, retrograde lesion crossing, and antegrade treatment modalities were recorded. Next to short-term outcomes, long-term results through 4 years were described using survival analysis. RESULTS: The majority of patients (71.5%) had critical limb ischemia (CLI) and occlusion locations were the femoropopliteal segment (35.9%), infrapopliteal segment (42.6%), or both segments (21.5%). Retrograde access was most commonly performed via the proximal (28%) or distal (34%) anterior tibial artery. Retrograde access could be established in 98.6% and subsequent lesion crossing was successful in 95.1%. Complications due to distal puncture were rare (3.3%). At 1 year, freedom from target lesion revascularization and restenosis were 74.6 ± 3.7% and 67.5 ± 4.4% in claudicants and 62.2 ± 2.8% and 36.0 ± 4.4% in CLI patients, respectively. Late complications at the distal puncture site after a median follow-up time of 234 days comprised 1 stenosis, 7 occlusions, and 3 clinically nonrelevant arteriovenous fistula occurring only in CLI patients. CONCLUSIONS: Retrograde tibioperoneal access is a safe option for recanalization of complex CTOs after a failed antegrade approach. Complications at the puncture site were rare.

Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease.

BACKGROUND: Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES: The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS: Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. RESULTS: More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. CONCLUSIONS: Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441).

Drug-Coated Balloon Angioplasty in Atherosclerosis Patients With Popliteal Artery Involvement.

PURPOSE: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. METHODS: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. RESULTS: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). CONCLUSION: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.

Endovascular Treatment of Severely Calcified Femoropopliteal Lesions Using the "Pave-and-Crack" Technique: Technical Description and 12-Month Results.

PURPOSE: To report midterm results of the "pave-and-crack" technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent. METHODS: Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to "pave" the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was "cracked" before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method. RESULTS: Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%. CONCLUSION: Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal "pave-and-crack" technique.

Thrombectomy Devices in the Treatment of Acute Mesenteric Ischemia: Initial Single-Center Experience.

BACKGROUND: To report our preliminary experience with endovascular revascularization of patients with acute mesenteric ischemia (AMI), using thrombectomy devices. METHODS: It is a retrospective analysis of patients admitted to our hospital due to AMI and who were subjected to concomitant or exclusive endovascular treatment, from January 2011 to January 2016. Patients were admitted at the emergency department, underwent imaging investigation, and were referred to the endovascular specialist. Endovascular treatment was performed through left brachial artery access and selective catheterization and thrombectomy with a 6F Rotarex Debulking Device (Straub Medical, Wangs, Switzerland). Laparotomy was performed based on clinical and radiologic sings and at the discretion of the surgeon. Demographic, clinical/periprocedural, postoperative, complication, and adjunct intervention data were reviewed. Technical success was defined as recanalization of the Riolan's arcade on angiographic control. RESULTS: Twenty patients (mean age: 69.8 ± 11.3 years) underwent endovascular revascularization for AMI using thrombectomy devices, during the period of the study. Abdominal pain was the most common complain on admission (65%), with ileus (35%), sepsis (25%), and myocardial infarction as the main clinical referral presentation at admission. Fifteen patients (75%) had suggestive computer tomography (CT) signs of AMI on admission. Endovascular revascularization was successfully performed in all patients through the left brachial artery with a mean procedural time of 28 ± 17 min. Superior mesenteric artery (SMA) was the main vessel involved in 75% on a solely basis. The majority of the SMA occlusions were in the periosteal (30%) and proximal to middle colic artery offspring (35%). Primary use of thrombectomy devices was performed in all patients, associated with balloon angioplasty (7/20; 50%), stent deployment (5/20; 25%), intraoperative selective thrombolysis (4/20; 20%) and catheter-assisted aspiration in 10% (2/20) of patients. Average time between admission and computed tomography angiography was 1.5 ± 0.5 hr, between admission and angiographic procedure was 2.5 ± 1 hr, and between admission and surgery was 9 ± 5 hr. Following recanalization, 14 patients (70%) underwent open surgery. Laparotomy with intestinal resection (enterectomy, colectomy) and transit deviation was the most common procedure. Complications directly related to the endovascular procedure occurred in 2 patients, represented by self-limited small perforations. Overall 30-day mortality was 40% (n = 8). During the period of this study, no patient died as a result of complications related to the use of rotational thrombectomy. CONCLUSIONS: Endovascular treatment of the AMI with the use of thrombectomy devices proved to be technically feasible and reasonably fast procedure. Early diagnosis and adequate treatment remains the cornerstone of the treatment. Early surgical evaluation and close integration between surgical and endovascular specialists are crucial to faster treatment and consequently lower extensive surgical resections and mortality. Further studies are necessary on this field to confirm these findings.

Single-center experience with vascular closure devices in real-world endovascular peripheral interventions.

BACKGROUND: The aim of the current study was to evaluate the efficacy and safety of vascular closure devices (VCDs) in non-cardiac endovascular interventions. METHODS: Retrospective analysis of consecutive patients submitted to endovascular interventions, with deployment of 2327 vascular closure devices. Demographic, clinical/periprocedural, post-operative, complication and reintervention data were reviewed. RESULTS: A total of 2107 patients (1409 [66.9%] men) were included. Perclose ProGlide® (Abbott Vascular) was employed 1683 times (72.3%), Angio-Seal™ (St. Jude Medical Inc.) 463 (19.9%) and 181 (7.8%) Exoseal® (Cordis). Patients were 70.4±11 years old. Of all vascular approaches, 1794 were retrograde (77.1%) and 533 antegrade (22.9%), with sheath size ranging from 5 to 8 French. Overall success rate was 95.2% and did not significantly vary according to the device. Overall failure rate was 4.8%, with high puncture site, morbid obesity, previous total anticoagulation and severe calcification being related to worse efficiency results. Major complications occurred in 15 patients (0.6%). All patients were evaluated before discharge from the hospital, and were scheduled to return for ambulatory follow-up visits at 30 days postoperatively. Control duplex ultrasonography was performed on a regular basis, or within this period in case of clinical complain/signs. CONCLUSIONS: Vascular closure devices proved to be safe and effective in this study. Additional prospective randomized studies are recommended.

Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment.

PURPOSE: To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. METHODS: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. RESULTS: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. CONCLUSION: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.

Renal Sympathetic Denervation System via Intraluminal Ultrasonic Ablation: Therapeutic Intravascular Ultrasound Design and Preclinical Evaluation.

PURPOSE: To assess the safety and performance of a nonfocused and nonballooned ultrasonic (US) catheter-based renal sympathetic denervation (RDN) system in normotensive swine. MATERIALS AND METHODS: RDN with the therapeutic intravascular US catheter was evaluated in 3 experiments: (i) therapeutic intravascular US RDN vs a control group of untreated animals with follow-up of 30, 45, and 90 days (n = 6; n = 12 renal arteries for each group); (ii) therapeutic intravascular US RDN vs radiofrequency (RF) RDN in the contralateral artery in the same animal (n = 2; n = 4 renal arteries); and (iii) therapeutic intravascular US RDN in a recently stent-implanted renal artery (n = 2; n = 4 renal arteries). RESULTS: In the first experiment, therapeutic intravascular US RDN was safe, without angiographic evidence of dissection or renal artery stenosis. Neuronal tissue vacuolization, nuclei pyknosis, and perineuronal inflammation were evident after RDN, without renal artery wall damage. Norepinephrine levels were significantly lower after therapeutic intravascular US RDN after 30, 45, and 90 days compared with the control group (200.17 pg/mg ± 63.35, 184.75 pg/mg ± 44.51, and 203.43 pg/mg ± 58.54, respectively, vs 342.42 pg/mg ± 79.97). In the second experiment, deeper neuronal ablation penetrance was found with therapeutic intravascular US RDN vs RF RDN (maximal penetrance from endothelium of 7.0 mm vs 3.5 mm, respectively). There was less damage to the artery wall after therapeutic intravascular US RDN than with RF RDN, after which edema and injured endothelium were seen. In the third experiment, denervation inside the stent-implanted segments was feasible without damage to the renal artery wall or stent. CONCLUSIONS: The therapeutic intravascular US system performed safely and reduced norepinephrine levels. Deeper penetrance and better preservation of vessel wall were observed with therapeutic intravascular US RDN vs RF RDN. Neuronal ablations were observed in stent-implanted renal arteries.

The tibiopedal retrograde vascular access for challenging popliteal and below-the-knee chronic total occlusions: literature review and description of the technique.

In recent years, the retrograde tibiopedal approach is increasingly being used for revascularization of complex chronic total occlusions of infrainguinal arteries to bailout those cases where a guidewire was not possible to pass through the lesion from antegrade and therefore the treatment would have failed. The present popularity of this technique is in contrast to the paucity of data published so far. Nevertheless, from the reports that are available and from the authors' experience we conclude that it is not only a successful but also a safe technique. This article attempts to summarize the development of this technique, present the available data and to give some recommendations on how to perform a tibiopedal retrograde intervention.

Rotarex Mechanical Debulking in Acute and Subacute Arterial Lesions.

INTRODUCTION: Data regarding the effectiveness and safety of percutaneous mechanical thrombectomy (PMT) in contemporary routine care are scarce. MATERIALS AND METHODS: Consecutive patients undergoing PMT of native lower limb acutely/subacutely occluded arteries were included. RESULTS: In all, 525 consecutive patients were available for analysis with a mean age of 66.7 ± 10.7 years. Almost two-third (n = 324; 61.7%) were men with acutely (n = 211; 40.2%) or subacutely (n = 314; 59.8%) occluded lesions presenting mostly in Rutherford-Becker category (RBC): 3 (30.3%) and 4 (47.6%). Mean lesion length was 159 mm (range 22-279 mm), with moderate and severe calcification in 119 (23.3%) lesions. PMT was performed solely in 161(27.2%), PMT + balloon angioplasty in 232 (39.1%), provisional stenting in 169 (28.4%), and thrombolysis in 77 (13.9%) interventions. Procedural technical success rate was 97.7%, with improvement in RBC persisting in 74.1% of patients after 12 ± 2.4 months mean time follow-up. Overall 30 days major adverse events (MAEs) was 6.9% with a mortality rate of 1.1%. No death was directly related to the device. After 12 months, a promising overall target lesion revascularization (TLR; 10.1%), non-TLR (6.6%), and major amputation rates (2.3%) were found. One-year mortality was 8%. CONCLUSION: Treatment with PMT resulted in clinic and hemodynamic improvement in the majority of patients, thereby reducing the need for thrombolysis in a significant proportion of patients. Prospective studies in this issue are recommended.

Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries.

PURPOSE: To examine patient outcomes following the use of the Lutonix drug-coated balloon (DCB) in patients undergoing endovascular intervention in below-the-knee (BTK) arteries. METHODS: A retrospective chart review identified 248 patients who were treated for symptomatic peripheral artery disease with the Lutonix DCB between May 2013 and October 2014. Forty patients were lost to follow-up, leaving 208 patients (mean age 74.1±9.7 years; 138 men) with evaluable data for outcome analysis. The patient cohort suffered from either severe claudication (38.6%) or critical limb ischemia (CLI; 61.4%) in 220 limbs. Almost two-thirds (140, 63.6%) of the 220 target lesions were total occlusions, and 37 (17.8%) of all patients had occlusion of all 3 BTK vessels before intervention. RESULTS: Over a median 9-month follow-up, target lesion revascularization occurred in 15.9% of patients with an average time to first reintervention of 8 months. In total, 39 amputations were performed in 31 limbs. However, 17 of these amputations were preplanned minor amputations below the ankle; only 9 (4.1%) major amputations occurred corresponding to 6.6% of the CLI cohort. Freedom from the composite of death or major amputation was estimated as 92% and 85% at 6 and 12 months, respectively, by Kaplan-Meier analysis. In the full cohort, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, with 104 (80.0%) of those limbs showing an improvement of ≥2 categories. CONCLUSION: From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed.

Drug-Coated Balloons for Complex Femoropopliteal Lesions: 2-Year Results of a Real-World Registry.

OBJECTIVES: The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. BACKGROUND: Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. METHODS: Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. RESULTS: Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. CONCLUSIONS: These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

Midterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score-Matched Analysis.

PURPOSE: To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons. METHODS: A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥ 1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up. Propensity score-matched pairs were formed to compare each treatment with another using survival analysis. RESULTS: Survival curves of primary patency favored INS compared with SNS in 368 propensity score-matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 86.6%, 76.4%, and 68.9%, respectively, in the INS group vs 60.5%, 46.1%, and 42.1%, respectively, in the SNS group. No significant difference (p=0.232) was seen for the comparison of SNS vs DCB in 284 matched pairs over long-term follow-up (primary patency estimates at 1, 2, and 3 years were 79.8%, 53.8%, and 32.9%, respectively, in the DCB group vs 60.5%, 44.8%, and 40.3%, respectively, in the SNS group). Survival curves of primary patency favored INS over DCB in 254 matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 79.0%, 51.2%, and 30.1%, respectively, in the DCB group vs 89.0%, 76.9%, and 66.2%, respectively, in the INS group. CONCLUSION: Propensity score-based analysis of primary patency suggests profound differences in restenosis rates between various treatment modalities for femoropopliteal disease for over 3 years of follow-up.

Evaluation of the Biodegradable Igaki-Tamai Scaffold After Drug-Eluting Balloon Treatment of De Novo Superficial Femoral Artery Lesions: The GAIA-DEB Study.

PURPOSE: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. METHODS: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. RESULTS: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. CONCLUSION: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.

Postinterventional microembolism signals detected by transcranial Doppler ultrasound after carotid artery stenting.

BACKGROUND: The occurrence of early post-procedural complications after carotid artery stenting (CAS) can be attributed to embolization of thrombus or plaque particles released from the stented segment. Vascular emboli can be non-invasively detected by transcranial Doppler ultrasound as microembolic signals (MES). We performed this study to discover factors predicting MES detected by transcranial Doppler (TCD)-monitoring within the early post-interventional phase. PATIENTS AND METHODS: In 134 consecutive patients undergoing CAS, transcranial Doppler monitoring of the ipsilateral middle cerebral artery was performed for MES detection during the first post-interventional hour. To identify clinical, morphologic, and procedure-related parameters likely to predict the occurrence of post-interventional MES a logistic regression analysis was performed. RESULTS: In 134 patients (111 male, mean age 69.7 years) relevant MES were detected in 51 patients (38 %) with a median of 4 MES/h and a maximum of 62 MES/h. Three factors were observed to be associated with increased post-interventional MES-counts. These included symptomatic lesion (p < 0.05), elevated total cholesterol (p < 0.05), and aspirin monotherapy (p < 0.0005). In a binary logistic regression model, dual antiplatelet therapy (OR 5.6, p < 0.0005) and asymptomatic lesions (OR 2.6, p < 0.05) were revealed as independent predictors for the absence of post-interventional MES. CONCLUSIONS: Post-interventional MES were most likely in symptomatic lesions and patients with elevated cholesterol. The absence of an effective dual antiplatelet therapy and symptomatic lesions were revealed as independent predictors for post-interventional MES. An effective pre-interventional dual antiplatelet and lipid lowering therapy might improve the safety of CAS.

Late open conversion after endovascular aneurysm repair.

OBJECTIVES: Endovascular treatment of the infrarenal abdominal aorta (endovascular repair, EVAR) has emerged as an alternative to open surgery. However, a small subset of patients exists who undergo conversion either in the first 30 postoperative days or later during the course of postoperative surveillance. In the present study, we review our experience with late conversion operations. METHODS: Between December 2004 and August 2012, 411 EVARs were performed. During the same time interval, nine patients (males) with a mean age of 71 years (range, 59-79 years) required late open conversion. The median interval between EVAR and the conversion operation was 34 months (range 14-60 months). RESULTS: The indications for late conversion included persistent proximal type I endoleak (n = 2), type II endoleak with sac enlargement (n = 1), aneurysm rupture (n = 1), endotension (n = 2), stent-graft thrombosis (n = 1) and stent-graft infection (n = 2). Complete stent-graft explantation was performed in five patients. Eight patients underwent elective conversion. One patient presenting with rupture had an emergency operation. The 30-day mortality rate was 0%. CONCLUSIONS: Late open conversion after EVAR can be performed safely and successfully. Complete stent-graft explantation may be our preferred treatment option, but it is not always necessary, except in cases presenting with graft infection.