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 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.

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.

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.

One-year outcome after percutaneous rotational and aspiration atherectomy in infrainguinal arteries in patient with and without type 2 diabetes mellitus.

BACKGROUND: To compare the safety and efficacy of a rotational aspiration atherectomy system (Jetstream) for the treatment of infrainguinal arteries in diabetic versus nondiabetic patients. METHODS: A total of 172 patients with Rutherford stage 1-5 lower limb ischemia were treated with rotational aspiration atherectomy between February 2006 and February 2007. Of these, 80 patients with type 2 diabetes mellitus (DM: 46.5%) were compared with 92 nonDM (53.5%) patients. Overall, 210 target lesions (99 DM; 111 nonDM) were treated, located in the superficial femoral (67% DM; 61% nonDM), popliteal (25% DM; 30% nonDM), and tibial (8% DM; 9% nonDM) arteries. Lesion characteristics were comparable in both groups, mean lesion length was 28.5 mm (DM) and 26.2 mm (nonDM); total occlusions were present in 29% (DM) and 32% (nonDM), and 15% (DM) and 14% (nonDM) were restenotic. RESULTS: In the entire cohort, device success was 99% (all but two lesions). The major adverse event (MAE) rate (death, index limb amputation, myocardial infarction, target lesion revascularization [TLR] and target vessel revascularization) in DM at 30 days was 2.5% (n = 2 planned amputations) and 0% in nonDM. At 6 and 12 months, MAE in DM was seen in 13.8% (11/80) and 25% (20/80) compared with 21.7% (20/92) and 31.5% (29/92) in nonDM, respectively. TLR rate through 12 months was 20% (16/80) in DM and 28% in nonDM (26/92). Overall, 1 year restenosis rate was 38.2% based on duplex. The ankle-brachial index, mean Rutherford categories, and walking impairment questionnaire did not differ between groups at baseline and were increased significantly in both study cohorts at 12 months. CONCLUSION: Jetstream-assisted atherectomy in infrainguinal arteries is safe and effective in DM compared with nonDM patients. In this short-lesion cohort, vessel patency in diabetics was as good as for non-DM at 1 year. TLR and MAE were higher by trend in nonDM, although planned amputations were seen only in DM. The clinical benefit was similar in both groups.

Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study.

BACKGROUND: Functional mitral regurgitation (FMR), a well-recognized component of left ventricular remodeling, is associated with increased morbidity and mortality in heart failure patients. Percutaneous mitral annuloplasty has the potential to serve as a therapeutic adjunct to standard medical care. METHODS AND RESULTS: Patients with dilated cardiomyopathy, moderate to severe FMR, an ejection fraction <40%, and a 6-minute walk distance between 150 and 450 m were enrolled in the CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS). Percutaneous mitral annuloplasty was achieved through the coronary sinus with the CARILLON Mitral Contour System. Echocardiographic FMR grade, exercise tolerance, New York Heart Association class, and quality of life were assessed at baseline and 1 and 6 months. Of the 48 patients enrolled in the trial, 30 received the CARILLON device. Eighteen patients did not receive a device because of access issues, insufficient acute FMR reduction, or coronary artery compromise. The major adverse event rate was 13% at 30 days. At 6 months, the degree of FMR reduction among 5 different quantitative echocardiographic measures ranged from 22% to 32%. Six-minute walk distance improved from 307+/-87 m at baseline to 403+/-137 m at 6 months (P<0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47+/-16 points at baseline to 69+/-15 points at 6 months (P<0.001). CONCLUSIONS: Percutaneous reduction in FMR with a novel coronary sinus-based mitral annuloplasty device is feasible in patients with heart failure, is associated with a low rate of major adverse events, and is associated with improvement in quality of life and exercise tolerance.

One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial.

PURPOSE: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. METHODS: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51-93; 47% diabetics) with Rutherford class 1-5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0-5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. RESULTS: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59+/-0.21 at baseline to 0.82+/-0.27 (p<0.05) at 12 months. Mean Rutherford class improved from 3.0+/-0.9 at baseline to 1.5+/-1.3 at 1 year (p<0.05). CONCLUSION: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.

Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST).

BACKGROUND: Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year. METHODS AND RESULTS: Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease. CONCLUSIONS: In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.

Aneurysm hybrid treatment by simultaneous replacement of ascending aorta and aortic arch and endoluminal stenting of the descending aorta.

BACKGROUND: Resection of the descending thoracic aorta and replacement with a vascular prosthesis is associated with an increased risk of paraplegia, as opposed to endoluminal stenting. We report on the first case in which a thoracic aortic aneurysm was treated in a hybrid approach, combining surgery with the implantation of a new intraluminal stent during 1 procedure. METHODS: A 76-year-old man with long-standing hypertension suffered from acute chest pain. Magnetic resonance imaging (MRI) revealed a complex aortic aneurysm with increased diameters of the ascending aorta (55 mm), the aortic arch (75 mm), and the descending aorta (50 mm). Supracoronary replacement of the ascending aorta with a 30-mm prosthesis was carried out during cardiopulmonary bypass, cardioplegic arrest, and hypothermia (25 degrees C). Surgery and stenting were carried out during circulatory arrest and antegrade cerebral perfusion. Two stents (length: 23 cm and 17 cm) were placed in the descending aorta via the opened aortic arch under X-ray control, covering the left subclavian artery. Then aortic arch replacement was finished by anastomosing the distal end of the aortic prosthesis to the proximal stent's customized proximal end (Polyester cuff, length 25 mm/diameter 36 mm) together with the aortic wall. The brachiocephalic trunk and left carotid artery along with a vein graft to the left subclavian artery were implanted in the prosthesis. RESULTS: Postoperative course was uneventful except for a pericardial effusion. MRI revealed normal dimensions of the thoracic aorta with complete exclusion of the aneurysm and no leakage. CONCLUSION: Simultaneous replacement of ascending aorta and aortic arch with antegrade endoluminal stenting of the descending aorta using a new type of stent were safely and effectively performed in a patient with an aortic aneurysm.

Focal ischemia of the brain after neuroprotected carotid artery stenting.

OBJECTIVES: This study sought to assess the incidence of cerebral ischemia in nonselected patients undergoing neuroprotected carotid angioplasty and stenting (CAS) without preceding multiple-vessel diagnostic angiography. BACKGROUND: Protection devices to prevent distal embolization during CAS are presently under clinical investigation. Diffusion-weighted magnetic resonance imaging (MRI) visualizes recent ischemia of the brain and may aid in assessing the efficacy of protection devices. METHODS: Elective CAS was performed in 42 consecutive patients (15 female, 27 male; mean age, 67 +/- 9 years) using six different types of cerebral protection systems. All patients underwent MRI of the brain before and after a total of 44 interventions. RESULTS: Placement and retrieval of the devices and stent deployment was achieved in all procedures. New ischemic foci were seen on postinterventional MRI in 10 cases (22.7%). One patient had sustained a major stroke, whereas no adverse neurological sequelae were associated with the other nine procedures. In the latter, one to three foci (maximum area 43.0 mm(2)) were detected in cerebral regions subtended by the ipsilateral carotid artery in eight cases and by the contralateral carotid artery in one case. In the stroke patient, 12 ischemic foci (maximum area 84.5 mm(2)) were exclusively located in the contralateral hemisphere. Follow-up MRI at 4.1 months (median, n = 7) identified residuals of cerebral ischemia only in this patient. CONCLUSIONS: Neuroprotected CAS is associated in about 25% of cases with predominantly silent cerebral ischemia. Our findings suggest manipulation of endoluminal equipment in the supraaortic vessels to be a major risk factor for cerebral embolism during neuroprotected CAS.

Feasibility and efficacy of balloon-based neuroprotection during carotid artery stenting in a single-center setting.

We sought to prospectively assess the feasibility and in-hospital efficacy of the PercuSurge GuardWire temporary balloon-occlusive system for neuroprotection during carotid angioplasty and stenting (CAS).Carotid angioplasty and stenting harbors a risk of distal embolization. Cerebral protection devices are currently under clinical investigation.Ninety-six consecutive patients with carotid bifurcation disease underwent a total of 102 CAS procedures with the intention to use the GuardWire for neuroprotection. GuardWire deployment was achieved in 99 procedures performed in 93 patients (97%). Device failure (n = 3) and severe neurologic responses to balloon occlusion of the targeted carotid artery (n = 2) accounted for five additional procedures that were essentially concluded without neuroprotection, for a total of 94 procedures completed as intended in 88 patients (92% procedural feasibility rate). Carotid angioplasty and stenting was performed successfully in 94 patients (100 procedures). There were no in-hospital deaths; but three patients (3.1%) sustained strokes, and two patients experienced transient ischemic attacks, for a total periprocedural complication rate of 5.2%. One major stroke occurred with the GuardWire in place, whereas two minor strokes were observed in patients in whom the device could not be deployed. Thus, successful neuroprotected CAS without major neurologic events was achieved in 87 patients (91%). The GuardWire temporary balloon-occlusive system is feasible as an adjunct to CAS in the majority of patients. It is associated with a 3.1% rate of major periprocedural neurologic complications. Adverse neurologic reactions to balloon occlusion may prohibit effective use of the system in about 2% of patients.

Routine use of cerebral protection during carotid artery stenting: results of a multicenter registry of 753 patients.

PURPOSE: To evaluate the short-term outcome of patients who underwent carotid stenting with the routine use of cerebral protection devices. METHODS: In five centers, 808 successful stent procedures (of 815 attempted) were performed in 753 patients (557 [74%] men; mean [+/- SD] age, 70 +/- 8 years). Cerebral protection involved distal filter devices (n=640), occlusive distal balloons (n=144), or proximal balloon protection (n=24). RESULTS: The protection device was positioned successfully in 793 (98.2%) of the 808 attempted vessels. Neurologic complications occurred within 30 days after 46 procedures (5.6%), including seven major strokes, 17 minor strokes, and 22 transient ischemic attacks. There were four deaths (one following a major stroke). The 30-day incidence of stroke and death was 3.3% (27/815). The rate of stroke or death was 3.8% (8/213) for symptomatic lesions and 3.2% (19/602) for asymptomatic lesions (P=0.87), and 3.4% (25/729) in patients aged <80 years and 2% (2/86) in those aged > or =80 years (P=0.81). Protection device-related vascular complications, none of which led to neurologic symptoms, occurred after nine procedures (1.1%). CONCLUSION: In this uncontrolled study, routine cerebral protection during carotid artery stenting was technically feasible and clinically safe. The incidence of major neurologic complications in this study was lower than in previous reports of carotid artery stenting without cerebral protection.

Impact of asymptomatic cerebral lesions in diffusion-weighted magnetic resonance imaging after carotid artery stenting.

OBJECTIVES: This study sought to analyze the impact of new asymptomatic cerebral ischemic lesions, found in diffusion-weighted magnetic resonance imaging (DW-MRI) after carotid artery stenting (CAS) in relation to other risk factors for major adverse cerebral and cardiovascular events (MACCE) defined as death, stroke, and myocardial infarction. BACKGROUND: After CAS, new cerebral lesions have been reported in up to 70% of patients. The impact of asymptomatic lesions on prognosis after CAS has not been studied. METHODS: Eight hundred thirty-seven consecutive patients underwent CAS with cerebral embolic protection. In 728 patients (86.9%), a pre- and post-procedural DW-MRI was available; these patients were included in the analyses. Multivariate Cox regression analysis and Kaplan-Meier estimates were performed to identify independent risk factors for MACCE at follow-up. Clinical, procedural, and lesion characteristics and DW-MRI findings were included in the analyses. RESULTS: Post-procedure new cerebral ischemic lesions were detected in 32.8% (n = 241) of patients. Fifteen patients (1.79%) had a periprocedural MACCE and were therefore excluded from the analysis. At a mean follow-up of 766.8 ± 513.4 days (range 30 to 2,577 days), MACCE occurred in 45 patients (6.2%). Cox regression analysis and Kaplan-Meier estimates both identified diabetes as the only significant independent risk factor of MACCE. Asymptomatic cerebral lesions after CAS were not associated with MACCE. CONCLUSIONS: Beyond 30 days, diabetes is the only risk factor of MACCE at follow-up. Asymptomatic cerebral embolic events after CAS had no prognostic impact.

Direct Flow Medical valve.

AIMS: To study the feasibility and safety of the non-metallic, repositionable and retrievable percutaneous Direct Flow Medical (DFM) aortic valve. METHODS AND RESULTS: The first-generation (22 Fr) DFM valve has been evaluated in a prospective non-randomised trial in 31 high-risk patients with severe symptomatic aortic stenosis. The procedural success rate was 71%, 30-day mortality 12.9%. Survival at three years was 60% and all patients had none/trace aortic regurgitation at three years. Based on the initial experience, an 18 Fr device has been developed with several important revisions to improve the efficacy and safety of the procedure. Currently, it is being evaluated in a multicentre non-randomised trial which will include 100 patients. The primary endpoint is freedom from all-cause mortality at 30 days. CONCLUSIONS: The 22 Fr DFM valve has been successfully assessed in a first-in-man feasibility and safety trial. Up to three-year follow-up sustained clinical benefit and haemodynamic performance was demonstrated with no or trace aortic regurgitation in all patients. The 18 Fr DFM valve is under investigation in an on-going trial.

Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial.

OBJECTIVES: The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions. BACKGROUND: There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up. METHODS: The study extended the follow-up period of a prospective, randomized, multicenter, double-blind trial comparing polymer-free SES with placebo-coated BMS in the treatment of focal infrapopliteal de novo lesions. The main study endpoint was the event-free survival rate defined as freedom from target limb amputation, target vessel revascularization, myocardial infarction, and death. Secondary endpoints include amputation rates, target vessel revascularization, and changes in Rutherford-Becker class. RESULTS: The trial included 161 patients. The mean target lesion length was 31 ± 9 mm. Thirty-five (23.3%) patients died during a mean follow-up period of 1,016 ± 132 days. The event-free survival rate was 65.8% in the SES group and 44.6% in the BMS group (log-rank p = 0.02). Amputation rates were 2.6% and 12.2% (p = 0.03), and target vessel revascularization rates were 9.2% and 20% (p = 0.06), respectively. The median (interquartile range) improvement in Rutherford-Becker class was -2 (-3 to -1) in the SES group and -1 (-2 to 0) in the BMS group, respectively (p = 0.006). CONCLUSIONS: Long-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee-Randomised Double-Blind Study [YUKON-BTX]; NCT00664963).

Carotid artery stenting, what can be learned after more than 1,000 patients: a single centre single operator experience.

AIMS: The aim of the present study was to evaluate the outcome of carotid artery stenting (CAS) in a single, high-volume centre of a single operator and to analyse the circumstances under which complications occur. Recent trials comparing CAS with carotid endarterectomy demonstrated controversial results. The low experience of interventionists in performing CAS was a major limitation of these studies. The number of procedures needed to achieve optimal skills is unknown. METHODS AND RESULTS: From May 1997 until April 2010, 1,004 patients with symptomatic or asymptomatic carotid artery stenosis underwent CAS by a single operator. A cerebral protection device was in mandatory use since 2000. In-hospital complication rates were defined as the cumulative rate of death, myocardial infarction or stroke. Procedural success was achieved in 97.77% of patients. The perioperative complication rate was 1.69% including 0.2% deaths, 1.1% patients with minor stroke, 0.4% patients with major stroke. In 88% (15 out of 17) of the patients with complications, unfavourable anatomical or procedural factors could be identified. After the first 100 CAS performed,the complication rate was at 3% and significantly decreased to 1% after more than 500 procedures. Patients ≥80 years had a significantly higher complication rate. CONCLUSIONS: In a high-volume experienced centre, the in-hospital complication rate is low. Complications occurred almost exclusively in patients with unfavourable anatomical or procedural characteristics and seem to be avoidable in most patients. A learning curve was observed up to 500 procedures. Elderly patients have a higher complication rate.

The 1-year clinical impact of rotational aspiration atherectomy of infrainguinal lesions.

The present study was carried out to provide information about outcome of the Jetstream atherectomy device for treatment of infrainguinal arteries. From February 2006 to February 2007, 172 patients with Rutherford class 1 to 5 lower limb ischemia were enrolled at 9 study sites. The endpoints were evaluation of quality of life according to the walking impairment questionnaire (WIQ) besides technical parameters. In the total study cohort, the WIQ scale maintained improved up to 12-month follow-up. Furthermore, target lesion revascularization rate was 26% (42/162), ankle-brachial index (ABI) increased from 0.59 ± 0.21 at baseline to 0.82 ± 0.27 (P < 0.05), and mean Rutherford class dropped from 3.0 ± 0.9 at baseline to 1.5 ± 1.3 at 1 year (P < .05). The results of this prospective, multicenter, clinical study demonstrate that the Jetstream atherectomy device is a potential treatment alternative for the endovascular management to improve clinical outcome in patients with peripheral arterial occlusive disease.

Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: the Direct Flow Medical aortic valve.

OBJECTIVE: Transcatheter aortic valve implantation is considered an alternative for patients at high risk for conventional surgery. The Direct Flow Medical aortic valve (Direct Flow Medical, Inc, Santa Rosa, Calif) is a nonmetallic tissue valve prosthesis intended to treat patients with severe aortic stenosis at high risk for surgery. METHODS: Thirty-one patients at high surgical risk were enrolled in the trial (logistic EuroSCORE 28% ± 7%, Society of Thoracic Surgeons score 23% ± 9%). Twenty-two patients underwent successful retrograde transcatheter aortic valve implantation, and 9 patients did not undergo implantation owing to excessive calcifications or access issues. Mean preinterventional gradient and effective orifice area were 49 ± 14 mm Hg and 0.54 ± 0.16 cm(2), respectively, and 71% of patients were in New York Heart Association functional class III. RESULTS: Mean postprocedural gradient was 14.9 ± 5.5 mm Hg with an effective orifice area of 1.4 ± 0.31 cm(2). Two patients were converted to surgery and 2 patients died after implantation: 1 of myocardial infarction and 1 of congestive heart failure. One patient had a stroke 2 days after the procedure and 3 patients required a pacemaker. At 6 months the mean aortic valve gradient and effective orifice area were 19.8 mm Hg and 1.30 cm(2), respectively. The majority of patients had no paravalvular leak (58%) and 42% had grade 1/4 paravalvular leak; 69% were in New York Heart Association functional class I and 25% were in class II. The 3- and 6-month survivals were 87.1% and 80.6%, respectively (4/6 deaths in 31 patients). CONCLUSIONS: Transcatheter aortic valve implantation using the study valve appears safe and results are promising at 6 months. Severe leaflet and left ventricular outflow tract calcification affects procedural outcome; therefore, careful patient selection is crucial.

Endovascular reconstruction of the aortic bifurcation in patients with Leriche syndrome.

BACKGROUND: The Leriche syndrome with contiguous total occlusions of the infrarenal aorta and the iliac arteries is a variant of Trans-Atlantic Inter-Society Consensus (TASC) type D aortoiliac disease, for which surgery is the recommended treatment of choice. We sought to prospectively assess the feasibility and safety of an endovascular therapeutic approach. METHODS: Eleven consecutive patients with Leriche syndrome (eight men; 64 +/- 12 years) constituted the study cohort. The treatment strategy consisted of recanalization by transbrachial access of the occluded segments and subsequent transfemoral angioplasty with selective stent placement in the distal aorta and primary nitinol stent placement in the iliac arteries. RESULTS: Bilateral endovascular success was achieved in eight patients (73%), unilateral success in the other three patients. Seven patients received aortic stents; the total stented segment length in 19 iliac arteries successfully recanalized amounted to a median of 18 cm (range 12-26 cm). There was one periprocedural complication, an acute thrombotic aortoiliac occlusion managed by thrombolysis. One patient with unilateral endovascular success had to undergo femorofemoral crossover bypass grafting. At a median of 14 months, significant hemodynamic improvement was observed in successfully revascularized legs (ankle-brachial index, 0.79 +/- 0.20 vs. 0.48 +/- 0.08 at baseline; P = 0.0004); walking capacity as well as Rutherford category of peripheral arterial disease had improved in all patients. CONCLUSIONS: In this small series of patients with Leriche syndrome, the reconstruction of the totally occluded aortoiliac bifurcation by endoluminal means was shown to be feasible and safe and associated with excellent mid-term clinical outcomes.