Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial.

Background Paclitaxel drug-coated balloon (DCB) catheter angioplasty is the preferred treatment for revascularization of femoropopliteal lesions in peripheral artery disease, but mortality is a safety concern. Purpose To assess 2-year efficacy and safety of DCB angioplasty compared with conventional balloon angioplasty (also known as plain old balloon angioplasty or POBA). Materials and Methods This prospective, multicenter, randomized controlled trial enrolled consecutive participants with symptomatic superficial femoral and/or popliteal artery disease at 11 German centers between September 2015 and December 2016. Participants underwent DCB angioplasty or conventional balloon angioplasty. Primary outcome of 6-month late lumen loss showed superiority of DCB angioplasty over conventional balloon angioplasty. Evaluation at 2 years included secondary outcomes of primary patency and target lesion revascularization (TLR) estimated with Kaplan-Meier analysis, clinical and hemodynamic improvement, quality of life, target limb amputation, and all-cause mortality. Results A total of 171 participants (mean age, 69 years ± 8; 111 men) were evaluated. At 2 years, primary patency was achieved in 90.2% (95% confidence interval [CI]: 80.4%, 95.2%) of DCB angioplasty and 62.7% (95% CI: 50.0%, 73.0%) of conventional balloon angioplasty participants (P < .001). Freedom from TLR occurred in 97.2% (95% CI: 89.1%, 99.3%) of DCB angioplasty and 78% (95% CI: 66.5%, 86.0%) of conventional balloon angioplasty participants (P = .001). The groups did not differ in sustained improvement from baseline to 2 years in Rutherford-Becker category (row mean scores difference, 1.7; P = .19) and showed no difference in mean improvement in the Walking Impairment Questionnaire score (-0.8%; 95% CI: -11.8%, 10.2%; P = .88), EuroQol Group's five-dimension index of quality of life (-0.06; 95% CI: -0.17, 0.03; P = .20), or ankle-brachial index (0.03; 95% CI: -0.08, 0.14; P = .57). No major amputation was necessary. One DCB angioplasty and two conventional balloon angioplasty participants died (risk ratio, 0.48; 95% CI: 0.04, 5.10). Conclusion At 2 years after paclitaxel drug-coated balloon (DCB) angioplasty, primary patency and freedom from target lesion revascularization remained superior compared with conventional balloon angioplasty. DCB angioplasty resulted in sustained clinical and hemodynamic improvement with no increased risk of mortality. © RSNA, 2020 Online supplemental material in available for this article.

Meta-analysis of Individual Patient Data After Kissing Stent Treatment for Aortoiliac Occlusive Disease.

PURPOSE: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. MATERIALS AND METHODS: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. RESULTS: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p<0.005). Any previous endovascular intervention (HR 2.52, p=0.02) was the main predictor for loss of secondary patency; history of cardiovascular disease (HR 0.27, p=0.04) was the main predictor of sustained secondary patency. CONCLUSION: The kissing stent technique has a good safety profile and acceptable patency rates up to 2 years, even in TASC C and D lesions, supporting an endovascular-first approach for AIOD.

Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions - the BIOFLEX PEACE All-Comers Registry.

Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients with 186 femoropopliteal lesions were treated with the Pulsar-18 SE nitinol stent at 9 German sites. Mean lesion length was 116 ± 103 mm, and 41.9 % of the lesions were moderately or heavily calcified. Eighty lesions were concomitantly treated with drug-coated balloon (DCB). Main effectiveness outcome was primary patency at 12 months, and main safety outcome was freedom from the composite of device or procedure related death, major target limb amputation, and clinically driven target lesion revascularization (TLR) at 30 days and 6 months. Results: Kaplan-Meier estimate of primary patency was 89.1 %, 67.3 %, and 57.1 % at 6, 12, and 24 months. Freedom from TLR was 95.5 %, 91.4 %, and 85.2 % at 6, 12, and 24 months, respectively. Lesions, which were additionally treated with DCB (plus DCB-group), were longer (150 versus 82 mm on average, p < 0.0001), and associated with lower primary patency estimates than those without DCB angioplasty (stent-only-group) (log-rank p = 0.006). However, there was no difference in freedom from TLR between groups (log-rank p = 0.542). Improvement by ≥ 1 Rutherford category was achieved in 84.8 %, 81.0 %, and 81.7 % of patients at 6, 12, and 24 months, respectively. Walking distance and patient-reported pain improved persistently through 24 months (p < 0.001). Hemodynamic improvement was achieved in 68.2 %, 73.7 %, and 70.7 % of the patients at 6, 12, and 24 months, respectively. Conclusions: The Pulsar-18 self-expanding nitinol stent with optional drug-coated balloon angioplasty can be considered an efficacious and safe therapy option for endovascular treatment of femoropopliteal artery disease.

[Update on the current diagnosis and therapy of peripheral arterial occlusive disease]. / Update über die aktuelle Diagnostik und Therapie der peripheren arteriellen Verschlusskrankheit (pAVK).

Update on the current diagnosis and therapy of peripheral arterial occlusive disease Abstract. The prevalence of peripheral arterial disease (PAOD) increases with age and overall due to demographic trends. The symptoms severely reduce the quality of life. The 5-year mortality rate is even twice as high as in patients without PAOD. It is also higher than those of patients with coronary or cerebrovascular disease. Therefore it is important to identify those high-risk patients. Screening and diagnosing - not exclusion of the disease - is possible through clinical observation (pulse palpation) or with the help of simple equipment (messurement of the Ankle-Brachial-Index (ABI)) by any general practitoner. Further examination including imageing is done stepwise and with the goal of choice of best treatment. The most important part in all stages of PAOD is the treatment of cardiovascular risk factors. After lifestyle modification (smoking cessation, weight reduction and regular physical activity) several drug-assisted therapies should be considered e. g. to lower LDL-cholesterol levels < 1.8 mmol / L. and blood pressure < 130 / 80 mmHg combined with antiplatelet or anticoagulant agents.The first-line active treatment of claudicant patients is walking exercise. In patients with insufficient improvement in walking exercise and in patients with critical limb ischaemia, revasculatization is indicated. In recent years, the endovascular therapy possibilities have expended significantly through increasing experience and technological innovations also for occlusions in iliac arteries and long occlusions (> 25 cm) in the superficial femoral and popliteal artery, especially for patients with high perioperative risk. Some indications for primarly surgical therapy remain, for example long occlusions in femoro-popliteal arteries in patients with a low perioperative risk and stenosis / occlusions in the femoral bifurcation. The decision making for the optimal therapy for the patient should be taylored individually and interdisciplinary.

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial.

BACKGROUND: Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. METHODS AND RESULTS: One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related. CONCLUSIONS: DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01305070.

German Center Subanalysis of the LEVANT 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease.

PURPOSE: To report a subanalysis of the German centers enrolling patients in the prospective, global, multicenter, randomized LEVANT 2 pivotal trial (ClinicalTrials.gov identifier NCT01412541) of the Lutonix drug-coated balloon (DCB) for the treatment of femoropopliteal occlusive disease. METHODS: Among the 476 patients in LEVANT 2, 126 patients (mean age 67.1±9.6 years; 79 men) were enrolled at the 8 participating German sites between August 2011 and July 2012 and were randomized 2:1 to treatment with the Lutonix DCB (n=83) vs an uncoated balloon during percutaneous transluminal angioplasty (PTA, n=43). All patients had intermittent claudication or rest pain (Rutherford categories 2-4). Average lesion length was 58 mm and average treated length was 100 mm. Severe calcification was present in 11% of lesions, and 23% were total occlusions. The efficacy outcome was primary patency at 12 months, and the safety outcome was 12-month freedom from a composite of perioperative death, index limb-related death, amputation (below or above the ankle), and index limb revascularization. Secondary endpoints included target lesion revascularization (TLR), major adverse events, and functional outcomes. RESULTS: Demographic, clinical, and lesion characteristics were matched between Lutonix DCB and PTA groups, as were the final percent diameter stenosis (19%) and procedure success (91%). By Kaplan-Meier analysis, the 12-month primary patency rate was 80% vs 58% (p=0.015) and the composite safety endpoint rate was 94% vs 72% (p=0.001), respectively. Freedom from TLR was higher for DCBs (96%) vs PTA (82%, p=0.012). Major adverse events were similar for both groups. The benefit favoring DCB over PTA was observed in German men and women. Compared to the non-German LEVANT 2 cohort, there was a shorter time between insertion and inflation of treatment balloons (21.8 vs 39.5 seconds, p<0.001) in the German cohort. Balloons were inflated to higher pressures (9.0 vs 7.7 atm, p<0.001) but for a shorter period of time (130 vs 167 seconds, p<0.001), and although treated lesions in the German cohort had a higher baseline stenosis, final postprocedure diameter stenosis was lower (19% vs 22%, p=0.04) than in the non-German patients. CONCLUSION: Superiority of DCB over PTA in the German cohort of LEVANT 2 was demonstrated for primary patency, composite safety, and freedom from TLR. The benefit of DCB was also consistent for both genders. Geographic or regional differences in procedural variables may account for the different outcomes between the German and non-German cohorts.

Duplex ultrasound assessment of native stenoses in the superficial femoral and popliteal arteries: a comparative study examining the influence of multisegment lesions.

PURPOSE: To evaluate duplex ultrasonography (DUS) in the assessment of femoropopliteal stenoses comparing a single native stenosis (SNS) to multisegmental native stenoses (MNS). METHODS: Among the 1284 patients treated for atherosclerotic occlusive disease involving the femoropopliteal segment between November 2002 and November 2012, 139 patients (97 men; mean age 68±8 years) with 142 SNS or 143 MNS in 79 and 60 patients, respectively, were eligible for this retrospective analysis. The peak systolic velocity ratios with proximal (PSVRprox) and distal (PSVRdist) reference for the 285 lesions were compared with their respective angiographic stenosis grade as measured by 2 independent readers using quantitative vascular analysis to ensure objectivity. Receiver operating characteristic curve analysis was used to evaluate sensitivity, specificity, and the optimal thresholds of PSV and PSVR for detection of stenoses by grade (>50%, >70%, or >80% diameter stenosis). The area under the curve (AUC) values of dependent and independent receiver operating characteristic curves were compared. RESULTS: For SNS, correlation of PSVRprox to diameter stenosis (R=0.88) was higher (p<0.001) than the correlation for MNS (R=0.78). In the SNS group, the AUC for detecting a >50% (0.99±0.01), >70% (0.98±0.01), and >80% (0.96±0.01) stenosis with PSVRprox was significantly higher than in the MNS group [AUC50% 0.93±0.02 (p=0.01), AUC70% 0.92±0.02 (p=0.02), and AUC80% 0.87±0.03 (p=0.003)]. The optimal thresholds for detecting >50%, >70%, and >80% stenoses for SNS using PSVRprox were 2.6, 3.3, and 3.9, respectively. For MNS, the optimal thresholds of PSVRprox were 2.6, 3.4, and 3.9, respectively, with respective sensitivities of 87%, 81%, and 75%; respective specificities of 93%, 90%, and 82%; negative predictive values of 45%, 64%, and 74%; and positive predictive values of 99%, 95%, and 83%. CONCLUSION: DUS is an optimal tool for quantification of SNS. However, a multisegment setting has a significant negative impact on the quantification of femoropopliteal artery stenosis.

German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization.

PURPOSE: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants. METHODS: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047). CONCLUSION: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries.

BACKGROUND: Restenosis remains an unresolved problem despite different treatment modalities and new stent technology in femoropopliteal arteries. No standard therapy has proven to provide acceptable outcome data for this entity. Directional atherectomy alone did not result in satisfactory long-term patency rates. The outcome might be improved in conjunction with drug-coated balloon angioplasty. METHODS: In this retrospective study, restenotic lesions of the femoropopliteal arteries were treated with directed atherectomy in 89 lesions of consecutive patients (58% male; mean age, 69 ± 11 years). All patients received adjunctive treatment with conventional balloon percutaneous angioplasty (PTA; n = 60) or drug-coated balloon angioplasty (DCB; n = 29). RESULTS: Lesion location was in the stent (DCB [n = 27] vs PTA [n = 36]) and in native restenotic vessels (DCB [n = 2] vs PTA [n = 25]). The 1-year Kaplan-Meier freedom from restenosis estimates (95% confidence intervals) in the DCB and PTA groups were 84.7% (70.9%-98.5%) and 43.8% (30.5%-57.1%), respectively. In a multivariable Cox model for restenosis, DCB treatment had a hazard ratio (95% confidence interval) of 0.28 (0.12-0.66; P = .0036) compared with the PTA group. In the multivariable model for procedural success, the effect of treatment did not differ between PTA and DCB (P = .134). CONCLUSIONS: The combination of directed atherectomy with adjunctive DCB is associated with a better event-free survival at 12 months of follow-up compared with PTA after directed atherectomy.

New approach to protected percutaneous transluminal angioplasty in the lower limbs.

PURPOSE: To provide evidence for the safety and efficacy of the Proteus embolic capture balloon in lower limb interventions and to evaluate its indications for use. METHODS: The study was designed as a prospective, multicenter, non-randomized, single arm study enrolling 123 patients (78 men; mean age 68 years). The primary endpoint was rate of freedom from death, amputation, and target vessel revascularization (TVR) at 30 days post procedure. Follow-up was performed at 30 days and at 12 months. RESULTS: The freedom from death, amputation, and TVR rate was 95.9% (118/123). Procedure and device success rates were 98.7% (218/223) and 97.8% (156/158), respectively. TVR and death rates at 12 months were 18.8% and 4.1%, respectively. Histological analysis identified particles in 100% of the balloons. The median number of particles per subject was 339 (range 63-4361). Medians of particle size and total particle area were 0.8 (range 0.3-8.3) and 1.0 mm(2) (range 0.1-237) per balloon, respectively. Particles >1 mm were found in 37% (53/143) of the balloons analyzed. Higher mean number, length, and surface area of particles were found in long lesions (909±1057, 2.6±2.3 mm, and 18.2±44.2 mm(2), respectively; all p<0.0001 vs. short lesions). Additionally, longer particles were found in total occlusions (2.5±2.5 mm, p<0.0001), and a higher mean particle count was found in thrombotic lesions (1785±1821, p<0.05). De novo lesions had more thrombotic material than any other type of lesion. CONCLUSION: Proteus demonstrated good particle capture ability, making it a useful tool in situations where embolism is anticipated, such as complex lesions with calcified or thrombotic material and/or lesions with high plaque burden (i.e., long and totally occluded).

Endovascular repair of ascending aortic aneurysm by transapical approach and periscope technique.

PURPOSE: To demonstrate transapical stent-graft implantation for the treatment of an ascending aortic aneurysm simultaneously using the "periscope" technique for all supra-aortic branches. TECHNIQUE: The treatment plan is demonstrated in a 67-year-old man with prior ascending aortic replacement and known ascending aortic aneurysm who presented with acute severe chest pain. Computed tomographic angiography (CTA) revealed an 11-cm ruptured aneurysm of the ascending aorta distal to the prosthesis. Surgery was impossible due to direct contact of the aneurysm with the sternum. Conventional retrograde stent-graft implantation was infeasible because of a sharp kink of the descending thoracic aorta, so the stent-grafts were implanted via a transapical approach. To provide blood flow to the supra-aortic branches, periscope grafts oriented from the target vessels down the descending thoracic aorta were implanted in all branches before main stent-graft placement. Completion angiography and subsequent CTA documented satisfactory retrograde perfusion of the supra-aortic branches via the periscope grafts. CONCLUSION: A dual approach in terms of transapical stent-graft implantation and the periscope technique for perfusion of the supra-aortic branches may be an option for the treatment of inoperable aneurysms of the ascending aorta.

Endovascular treatment for extensive aortoiliac artery reconstruction: a single-center experience based on 1712 interventions.

PURPOSE: To determine the clinical and technical outcomes following endovascular therapy for aortoiliac occlusive disease, including complex reconstruction of the aortic bifurcation. METHODS: A retrospective database search identified 1184 consecutive patients (864 men; mean age 64±10 years) who underwent 1712 procedures to treat target lesions in the distal aorta and iliac arteries from September 1996 to December 2006. The intended strategy was to open only one femoral access site primarily, so a second puncture was needed only for the kissing balloon technique at the aortic bifurcation. The primary endpoint was a 1-year duplex-based primary patency; secondary endpoints included acute technical success (residual stenosis <30%), secondary patency, and target lesion revascularization (TLR). Results were stratified by lesion morphology, which was classified according to the TransAtlantic Inter-Society Consensus (TASC II) document. RESULTS: Most of the interventions were done in the iliac arteries (n=1337); 292 cases involved the aortic bifurcation, and 83 cases were in the distal aorta/aortic bifurcation. The mean follow-up was 3.24 years (range 0-12.7). In the entire study cohort, the 12- and 24-month restenosis, TLR, and primary/secondary patency rates did not differ among TASC II A-D subgroups. The symptom-driven TLR in the entire cohort was 8% and 9% at the 12- and 24-month follow-up, leading to secondary patency rates of 96% and 91% in the entire cohort. Outcomes for complex interventions in the distal aorta or aortic bifurcation did not differ significantly compared to the total cohort. The overall survival without restenosis, amputation, or surgery in TASC II subgroups A+B was higher (69.6%±1.5%) compared to TASC II C+D lesions (62.8%±1.9%, p=0.001). CONCLUSION: The indication for percutaneous intervention in aortoiliac occlusive disease can be extended to complex TASC C and D lesions in experienced endovascular centers, even if complex reconstruction of the distal aorta or the aortic bifurcation is indicated.

Angioplasty and provisional stent treatment of common femoral artery lesions.

PURPOSE: Isolated atherosclerotic common femoral artery (CFA) disease is a rare cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice, little is known about outcomes of percutaneous treatment. MATERIALS AND METHODS: A prospectively maintained single-center database was retrospectively analyzed for outcomes of consecutive patients undergoing isolated percutaneous revascularization of CFA disease between 1996 and 2007. In all cases, the intended strategy was balloon angioplasty with provisional stent placement in case of poor angioplasty results. Among 516 consecutive procedures involving the CFA, 419 were excluded because of nonatherosclerotic disease (n = 156) or treatment of additional vascular segments during the same procedure (n = 263). Procedural success (ie,<30% residual stenosis), in-hospital vascular complications (major [requiring surgical or percutaneous treatment] or minor [treated conservatively]), and 12-month restenosis and target lesion revascularization (TLR) rates were assessed for the remaining 97 interventions. RESULTS: CFA bifurcation lesions were present in 40 cases (41.2%) and required treatment of the deep femoral artery in 25 (25.8%). Chronic total CFA occlusions accounted for 11 cases (11.3%). Balloon angioplasty was performed in 96 cases (98.9%), and provisional stent placement was necessary in 37 (38.1%). The procedure was successful in 89 cases (91.8%). Minor and major vascular complications at 30 days occurred in three (3.1%) and four (4.1%) cases, respectively. At 12 months, restenosis greater than 50% and TLR were observed in 19.5% and 14.1% of procedures, respectively. CONCLUSIONS: This series shows that isolated CFA lesions may be safely and efficaciously treated with angioplasty and provisional stent placement.

Rotational and aspiration atherectomy for infrainguinal in-stent restenosis.

BACKGROUND: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. PATIENTS AND METHODS: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex. RESULTS: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. CONCLUSIONS: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

Erectile dysfunction: role of computed tomography cavernosography in the diagnosis and treatment planning of venous leak.

BACKGROUND: Venous leak appears to be the most common cause of vasculogenic erectile dysfunction (ED), which can be treated with venous embolization. Traditionally, conventional cavernosography was used for the diagnosis and treatment planning of venous leak. Recently, computed tomography (CT) cavernosography was introduced as a novel cross-sectional imaging method proposed to be advantageous over conventional cavernosography. We created a novel management algorithm for diagnosing venous leak including CT cavernosography as an imaging modality. In order to provide a broader basis for our management algorithm, a systematic literature review was conducted. MAIN BODY: In this article we systematically review relevant literature on using CT cavernosography for the diagnosis and treatment planning in ED patients with venous leak following the PRISMA selection process. Nine full-text articles were included in the review and assigned a level of evidence grade (all grade II). Two studies (2/9) compared the results of conventional cavernosography with those of CT cavernosography which was superior for site-specific venous leak identification (19.4% vs. 100%, respectively). CT cavernosography is a more detailed imaging method that is faster to perform, exposes the patient to less radiation, and requires less contrast material. In one study (1/9), CT cavernosography was used for diagnostic purposes only. Eight studies (8/9) cover both, diagnostic imaging and treatment planning including embolization (1/9) and sclerotherapy (2/9) of venous leak in patients with venogenic ED. Three studies (3/9) describe anatomical venous leak classifications that were established based on CT cavernosography findings for accurate mapping of superficial and/or deep venous leak and identification of mixed or more complex forms of venous leak present in up to 84% of patients. In addition to treatment planning, one study (1/9) used CT cavernosography also for follow-up imaging post treatment. CONCLUSION: CT cavernosography is superior to conventional cavernosography for diagnosis and treatment planning in patients with ED caused by venous leak (grade II levels of evidence). Consequently, CT cavernosography should be included in management algorithms for ED patients with suspected venous leak.

Elevated cardiac troponin T contributes to prediction of worse in-hospital outcomes after endovascular therapy for acute limb ischemia.

INTRODUCTION: The present study evaluated whether elevated cardiac troponin T (cTnT) was predictive of an increased risk for death or amputation in patients with acute lower limb ischemia (ALI). ALI is one of the most frequent causes of amputation, with mortality rates for ALI ranging from 15% to 20%. METHODS: This study included 254 consecutive ALI patients (155 men, 99 women; mean age, 71.6 ± 13.2 years) presenting with Rutherford categories I, IIA, or IIB according to the classification for ALI. RESULTS: ALI was caused by thromboembolism (29.5%), local arterial thrombosis (53.1%), or bypass graft occlusion (16.9%). Restoration of arterial blood flow was obtained by an endovascular approach, with a primary success rate of 98.4%. Rates were low for in-hospital mortality (3.9%) and amputation (5.1%). Patients who died or required amputation more frequently presented with elevated cTnT ≥0.01 ng/mL (52.2% vs 25.5%, P = .01) and impaired renal function (chronic kidney disease stage 3-5; 60.9% vs 38.1%; P = .04). After controlling for age, sex, C-reactive protein, renal function, presence or absence of coronary artery disease, and traditional vascular risk factors, as well as the interval between symptom onset and revascularization, the relationship between cTnT and a worse in-hospital outcome remained significant (hazard ratio, 3.4; 95% confidence interval, 1.3-8.5; P = .010). CONCLUSIONS: ALI patients frequently have elevated cTnT, which is associated with increased in-hospital mortality and amputation. Even small cTnT elevations predict a markedly increased risk of worse in-hospital outcome; however, the overall mortality and amputation rate in our study was low.

Initial experience with the 5 × 300-mm Proteus embolic capture angioplasty balloon in the treatment of peripheral vascular disease.

PURPOSE: To describe the use of the 5 × 300-mm Proteus embolic capture angioplasty (ECA) balloon catheter to reduce embolic burden in complex TASC II (TransAtlantic Inter-Society Consensus) C and D femoropopliteal interventions. METHODS: A non-randomized safety and feasibility study was conducted at 2 centers enrolling 15 subjects (9 women; mean age 72.5 ± 9.5 years, range 53-85) suffering from Rutherford-Becker category 2 to 4 occlusive disease. Of the 20 lesions in 15 limbs, 16 were TASC II D and 4 were TASC II C. Average baseline stenosis was 95%± 12%; 16 lesions were totally occluded. Half of the lesions were de novo, 5 were restenotic, and 5 were in-stent stenoses. Average lesion length was 284 ± 50 mm. In addition to using the ECA device, 18 of the target lesions were treated with stents and 4 with rotational thrombectomy devices. Distal angiography was performed before and after use of the ECA device to locate any periprocedural embolic events. RESULTS: Procedural success was achieved in 100% lesions. The ECA balloon was used for predilation in 11 lesions and for postdilation in 9. No distal embolization or flow-limiting vessel dissections were observed despite the complex nature of the cases. Three non-device-related complications were reported (pseudoaneurysm, myocardial infarction, acute renal failure) and resolved without sequelae within 30 days. Analysis of the particles recovered from 5 ECA balloons demonstrated a mean 257 ± 185 particles, with a mean major axial dimension of 0.54 ± 0.04 mm (range 0.11-7.54). There were a mean 7.67 ± 6.03 particles >2 mm in diameter, and all samples contained 1 to 3 particles >4 mm in diameter. CONCLUSION: In this small series, the 5 × 300-mm ECA embolic capture balloon catheter was an effective tool for avoiding embolic events in long peripheral lesions, with a good safety profile. The device might be considered as part of routine clinical practice for complex TASC II C/D femoropopliteal lesions.

Recanalization of femoropopliteal chronic total occlusions using the ENABLER-P Balloon Catheter System.

PURPOSE: To evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery. METHODS: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement of a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men; mean age 67 years (range 41-87) with femoropopliteal CTOs averaging 86 mm in length (range 10-340). The device was used in a variety of occlusions, including heavily calcified, long, and fibrotic lesions. After successful guidewire recanalization facilitated by the system, occluded arterial segments were treated conventionally with balloon angioplasty, atherectomy, and stents as appropriate. RESULTS: The primary endpoint of successful crossing was achieved in 86% (32/37) of the overall study population. The average activation time for successful crossing was 5.3 minutes (range 0.4-22). Of the 32 cases successfully crossed with the ENABLER-P System, all but 1 was successfully recanalized. One (3%) device-related complication occurred when the wire was advanced into a side branch when treating a 300-mm-long flush ostial SFA occlusion; the resulting perforation was managed with a covered stent without further sequelae. CONCLUSION: This novel system, which provides enhanced force to a standard guidewire tip for controlled intraluminal advancement, is a promising device for the treatment of peripheral CTOs.

Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial.

AIMS: Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery. METHODS AND RESULTS: 161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford-Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford-Becker classification after 1 year was -2 (-3 to -1) in the sirolimus-eluting stent group and -1 (-2 to 0) in the bare-metal stent group, respectively (P= 0.004). CONCLUSION: Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford-Becker classification reveal a significant advantage for the sirolimus-eluting stent.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

PURPOSE: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). MATERIALS AND METHODS: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. RESULTS: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). CONCLUSIONS: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).