Sebastian Sixt

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.

Results after balloon angioplasty or stenting of atherosclerotic subclavian artery obstruction

Endovascular therapy is an accepted treatment strategy in occlusive disease of the subclavian artery. The purpose of this study was to evaluate the technical and clinical long‐term outcome following either balloon angioplasty (plain balloon angioplasty (PTA)) or stenting.

The benefit of renal artery stenting in patients with atheromatous renovascular disease and advanced chronic kidney disease

Background: Around 16% of all patients who present with atheromatous renovascular disease (ARVD) in the United States undergo revascularization. Historically, patients with advanced chronic kidney disease (CKD) have been considered least likely to show improvement in renal functional terms, or survival. We aimed to investigate whether differences in outcomes after revascularization compared to medical management might be observed in ARVD patients if stratified by their CKD classes. Methods: Two prospective cohorts, a UK center with a traditionally conservative approach, and a German center who undertook a proactive revascularization approach, were compared. An improvement in renal function was defined as > 20% renal improvement at one years follow‐up. To improve validity and comparability, revascularized patients in the UK center were also used within analyses, Results: 347 (UK conservative group), 89 (UK revascularized group), and 472 (German center) patients were included in the analysis. When subdivided by CKD stage, patient ages between the two centers were comparable. Improvements in renal function were observed in twice as many patients who underwent revascularization as compared to medical treatment, particularly in the latter CKD stages, 15.2 (German revascularization) vs. 0% in CKD 1–2, 12.2 (UK), and 32.8 (German) revascularization vs. 14.1% in CKD3, and 53.1 and 53.8 vs. 28.3 in patients with CKD 4–5. The improvements in eGFR were 10.2 (16) and 8.1 (12.5) ml/min/year in the German and UK revascularized groups, respectively, vs. −0.05 (6.8) ml/min/year in the medical cohort in CKD 4–5. Improvements in blood pressure control were noted at 1 year overall and within each CKD category. Multivariate analysis revealed that revascularization independently reduced the risk of death by 45% in all patients combined (RR 0.55, P = 0.013). Conclusions: Although this study has significant methodological limitations, it does shows that percutaneous renal revascularization can improve renal function in advanced CKD (stages 4–5), and that this can provide a survival advantage in prospective analysis.

COLOR-CODED DUPLEX ULTRASOUND FOR DIAGNOSIS OF RENAL ARTERY STENOSIS AND AS FOLLOW-UP EXAMINATION AFTER REVASCULARIZATION

Currently, angiography is still considered to be the gold standard for the diagnosis of a renal artery stenosis (RAS). However, angiography is invasive and carries the potential risk of haematoma, pseudoaneurysm, contrast agent induced nephropathy, and athermanous embolization. Color‐coded duplex ultrasound is a noninvasive frequently repeatable bed‐side examination and is currently the only diagnostic method to reliably differentiate between a hemodynamically relevant or irrelevant stenosis using the side‐to‐side difference of the intrarenal resistance index (RI). There is a highly specific correlation between a side difference of the RI of >0.05 and an at least 70% angiographic diameter stenosis. All other duplex parameters like a peak systolic flow velocity >200 cm/sec or a renal aortic flow velocity ratio >3.5 are correlated to a 50 or 60% angiographic diameter stenosis and offer therefore indeed a high sensitivity in terms of detecting a RAS; however, the specificity detecting a hemodynamically relevant RAS is low. Provided that duplex ultrasound is performed by an experienced physician with an adequate machine it should be the preferred imaging method. The present article gives an overview about the literature related to duplex based diagnosis of RAS and as a follow‐up diagnostic procedure following RAS revascularization.

Retrograde Transpopliteal Recanalization of Chronic Superficial Femoral Artery Occlusion after Failed Re-Entry during Antegrade Subintimal Angioplasty

Purpose: To evaluate the acute success and clinical impact of retrograde transpopliteal access for subintimal recanalization of superficial femoral artery (SFA) and proximal popliteal artery (PA) occlusions after failed attempts to re-enter the true lumen in the antegrade femoral approach. Methods: From 2002 to 2007, 56 patients (43 men; mean age 68±9 years, range 43–87) with stable chronic peripheral artery disease (Rutherford category 2 to 5) were treated with antegrade subintimal angioplasty that could not be completed owing to re-entry failure. Mean occlusion length was 17±7 cm (range 4–32), including 13 TASC II A (23.2%), 10 TASC II B (17.8%), 16 TASC II C (28.5%), and 17 TASC II D (30.3%) lesions. After re-entry to the true lumen failed in the antegrade approach, including predilation of the false channel, all patients were turned to a prone position, and a 5-F or 6-F sheath was placed into the mid segment of the PA under fluoroscopic guidance. Retrograde wire passage was attempted with a 0.035-inch hydrophilic guidewire. Results: Fifty-five (98.2%) of 56 procedures were finished successfully with a residual stenosis of <30%; the 1 failure was due stent deformation within the occluded segment that could not be passed from either an antegrade or retrograde access. In all interventions, balloon angioplasty was performed; provisional stenting was done in 40 (71.4%). In 3 (5.3%) lesions, additional excimer laser atherectomy were performed. Six (10.7%) complications occurred, including 1 arteriovenous fistula from the PA to the popliteal vein and 1 sealing device induced PA occlusion. The mean ankle-brachial index increased from 0.44±0.26 to 0.86±0.23. The restenosis rate after 12 months was 54.9%. Conclusion: Failed antegrade attempts to recanalize chronic total occlusions of the SFA and proximal PA can be salvaged using a retrograde popliteal access, with a low complication rate, as an alternative to using a re-entry device. However, durability of the intervention using current interventional tools is limited.

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.

Recanalization of chronic occlusions of the superficial femoral artery using the outback™ re-entry catheter: A single centre experience†

Purpose: To report our experience with a catheter system (The Outback™ catheter) designed to allow fluoroscopically controlled re‐entry after subintimal guide wire passage during recanalization of chronically occluded femoro‐popliteal arteries. Methods: Between March 2007 and August 2008, 65 legs in 61 patients (60% male, mean age 73 (49–98 years) with chronic occlusion of the SFA and proximal popliteal artery were treated. Clinical presentation was severe intermittent claudication (Rutherford category 3, 59%), rest pain (Rutherford category 4, 16%), and minor ulcerations (Rutherford category 5, 25%). In all cases, the true lumen could not be entered by using standard antegrade catheter and guide wire techniques. Results: Median lesion length was 200 ± 102 mm. Recanalization of the arterial occlusion was successful in 57 of 65 treated lesions (88%). One patient died of myocardial infarction after delayed femoral bleeding possibly due to extensive recanalization attempts. There were no further procedure‐related complications. Conclusion: Use of the Outback™ re‐entry catheter system is a valuable option for interventional therapy of chronically occluded femoro‐popliteal arteries following failed standard antegrade recanalization attempt.

Safety and efficacy of the StarClose vascular closure system using 7-F and 8-F sheath sizes: a consecutive single-center analysis.

Purpose: To assess the safety and efficacy of the StarClose device following peripheral vascular interventions employing 7-F and 8-F femoral sheaths. Methods: From May 2006 to December 2007, 226 consecutive patients (143 men; mean age 69 years, range 36–92) underwent 231 groin punctures (150 with a 7-F sheath and 81 with an 8-F sheath) that were sealed with the StarClose Vascular Closure System. All the patients underwent duplex control of the puncture site 24 hours after deployment of the device to determine the presence of vascular complications (hematoma, pseudoaneurysm, arteriovenous fistula, and arterial/venous thrombosis or stenosis). Endpoints were major vascular complications during the hospital stay, device success (hemostasis using the StarClose device alone or with <5 minutes of adjunctive compression and freedom from major vascular complications), and procedure success (hemostasis established using any method and freedom from major vascular complications). Results: Procedural success was 96.0% (144/150) for the 7-F group and 97.5% (79/81) in the 8-F group. Device success was achieved in 91.3% (137/150) of the 7-F group and 90.1% (73/81) the 8-F group. Major vascular complications occurred in 4.1% (6/150) of the 7-F group: 1 patient developed massive retroperitoneal hematoma that required blood transfusion and surgical evacuation, 2 patients presented new ipsilateral lower extremity ischemia requiring revascularization, and 3 other patients developed pseudoaneurysm treated by ultrasound-guided compression or thrombin injection. In the 8-F group, only 2 (2.5%) patients had a major complication: 1 developed a high-grade stenosis of the punctured femoral artery that required angioplasty and the other developed massive retroperitoneal hematoma followed by blood transfusion and surgical evacuation. Minor complications occurred at a rate of 11.3% (17/150) in the 7-F group and 9.9% (8/81) in the 8-F group. Conclusion: Common femoral artery closure with the StarClose device following peripheral vascular procedures utilizing 7-F and 8-F sheath sizes is feasible, with few device-specific complications. A randomized trial of a larger number of patients comparing standard compression methods and StarClose is warranted.

New techniques for endovascular treatment of peripheral artery disease with focus on chronic critical limb ischemia

Chronic critical limb ischemia (CLI) represents the most advanced stage of peripheral arterial disease. CLI is associated with a high risk for limb loss and revascularization, either by surgical or endovascular means, is absolutely mandatory. With traditional techniques such as balloon angioplasty, limb salvage was reported in 80 to 90%. However, in case of failed revascularization attempt, limb loss was 40 to 50% and mortality approximately 20%. This review summarizes new developments in endovascular techniques which increase the acute and chronic success rate of endovascular procedures and therefore potentially further improve limb salvage rates. Special crossing and re-entry devices designed for femoro-popliteal application may even facilitate recanalization of long chronic occlusions. Improved stent design, atherectomy devices and drug coated balloons improve patency rates and may result in improved wound healing rates. Moreover, downsizing the catheter tools for infrapopliteal artery disease opens new horizons also for the treatment of complex below-the-knee lesions representing an increasing patient population due to the increasing prevalence of diabetes and end-stage renal failure.

Long term outcome after balloon angioplasty and stenting of subclavian artery obstruction : a single centre experience

INTRODUCTIONnPercutaneous transluminal angioplasty is an accepted and successful treatment strategy in obstructive disease of the subclavian artery. The purpose of this study was to evaluate the technical and clinical long-term outcome following endovascular therapy.nnnPATIENTS AND METHODSnWe retrospectively analyzed 99 patients (mean age of 65 +/- 10 years) with 100 interventions of the subclavian arteries and the brachiocephalic trunk with different aetiologies [atherosclerosis (90%); Takayasus arteritis (5%); thromboembolism (2%); external compression (1%); iatrogenic dissection (1%) and occlusion after graft implantation in type B dissection (1%)].nnnRESULTSnPrimary success rate was 97% (100% for stenoses and 90% for total occlusions). Treatment modalities included balloon angioplasty (PTA) alone (16%), stent implantation (78%), rotational thrombectomy (2%) and atherectomy (1%). The primary 1-year patency rate of the whole study cohort was 87% being not significantly lower after PTA (75%) compared to stent assisted angioplasty (89%). After thrombectomy and atherectomy no relevant restenosis were found. Multivariable analysis of 1-year restenosis-free survival revealed younger age (p = 0.03) and stenting (p = 0.04) as independent predictor. The blood pressure difference between both limbs at baseline was 42 +/- 24 mmHg and dropped to 10 +/- 14 mmHg after the intervention and 15 +/- 20 mmHg after 12 months, respectively (p = 0.01).nnnCONCLUSIONSnEndovascular therapy of subclavian artery obstructions of various aetiologies offers good acute success rates even in total occlusions. Long-term patency rate is in favour of stent placement.