Arne Schwindt

Use of Abdominal Chimney Grafts is Feasible and Safe: Short-term Results

Purpose: To present our initial experience with the use of chimney grafts in endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with challenging anatomy. Methods: Among 390 EVAR cases performed at our institution between November 2008 and February 2010, 15 patients (all men; mean age 81.8 years) underwent EVAR with synchronous placement of chimney grafts. The chimney technique involved placing covered stents parallel to the main aortic stent-graft to preserve or rescue flow to aortic branch vessels while extending the proximal fixation zone. All patients presented with pararenal aortic aneurysms with short necks (between 0 and 10 mm long) that required either suprarenal clamping to tailor a proximal anastomosis in open repair or suprarenal fixation to anchor an endoprosthesis. Chimney grafts were implanted into 10 left renal and 5 right renal arteries. Results: The immediate technical success was 100%. One early type II endoleak due to retrograde flow from the inferior mesenteric artery was detected and is under surveillance. Mean follow-up was 6.8 months (range 1–13). One chimney graft occluded 45 days postoperatively; the patient underwent open thrombectomy of the left renal artery and iliorenal bypass. The creatinine value at discharge was 1.6 mg/dL, and resting renal scintigraphy showed 36% perfusion for the left kidney and 64% for the right kidney. During follow-up, no patient required hemodialysis; no aneurysm-related deaths were noted. Conclusion: This limited experience demonstrates that the use of abdominal chimney grafts is feasible and safe. Long-term results in larger patient cohorts are needed evaluate the utility of this alternative endovascular technique.

Below knee bare nitinol stent placement in high-risk patients with critical limb ischemia is still durable after 24 months of follow-up

BACKGROUND This study evaluated the durability of nitinol stent placement in high-risk patients with chronic critical limb ischemia (CLI) and infrapopliteal lesions after suboptimal balloon angioplasty. METHODS Between January 2006 and January 2009, 53 high-risk patients (24 women; mean age, 71.8 +/- 5.1 years) with CLI underwent infragenicular stent placement with a 4F sheath-compatible self-expanding nitinol stent. Patients had three or more serious cardiopulmonary comorbidities, including chronic obstructive pulmonary disease, congestive heart failure, coronary artery occlusive disease, American Society of Anesthesiologists score >/=3, previous myocardial infarction, coronary stent or bypass, or infection after peripheral revascularization. Endovascular therapy was performed in 30 stenoses and 23 occlusions in 53 patients. The mean stenosis length was 5.5 +/- 1.9 cm. The mean occlusion length was 6.5 +/- 2.9 cm. The mean follow-up was 24.1 +/- 7.3 months and consisted of clinical examination, ankle-brachial index (ABI) measurements, and duplex ultrasound imaging. Digital subtraction angiography was performed if restenosis or reocclusion was suspected. RESULTS The technical success rate was 98.1%. The 24-month cumulative primary patency rate was 75.5%. During the follow-up, two patients underwent successful repeat angioplasty, and four patients required crural bypass. The 24-month secondary patency and freedom from amputation rates were 88.7% and 88.7%, respectively. The mean ABI increased significantly at 12 and 24 months (P < .001). Risk stratification to detect predictors that influenced the patency rate showed that proximal lesions had significant better patency than distal crural lesions (83.3% vs 65.2%, P = .04). The morphology of the lesions (stenoses vs occlusions, P = .88) did not seem to influence primary patency. Four patients died from nonprocedure-related causes during the follow-up, including lung cancer, myocardial infarction, and glioblastoma multiforme. No procedure-related deaths were recorded. CONCLUSIONS The 2-year outcome of our series underscores the value of infrapopliteal nitinol stent placement as a durable bailout treatment option in high-risk CLI patients with suboptimal angioplasty.

Use of iliac branch devices for endovascular repair of aneurysmal distal seal zones after EVAR.

Purpose: To assess the feasibility and midterm outcomes of iliac branch devices (IBD) for the treatment of aneurysmal distal seal zones after endovascular aneurysm repair (EVAR). Methods: Between January 2005 and January 2014, 188 patients with aortic aneurysms involving the iliac bifurcation underwent IBD implantation; of these, 18 consecutive patients (17 men; mean age 70±10 years) were treated for aneurysmal degeneration of 22 distal seal zones (mean 36±6-mm diameter) after EVAR. The main outcome measure was technical success. Further outcomes were primary and assisted primary patency of the internal iliac branch, types Ib/III endoleaks, reintervention, and all-cause mortality. Results: The technical success rate was 100%. The primary patency rate was 100% over a median follow-up of 15 months (interquartile range 4-25). None of the patients developed type Ib or III endoleak. During surveillance, two device-related reinterventions were performed (thrombectomy of an occluded external iliac artery and angioplasty with stenting of a stenotic common iliac artery). One patient died due to metastatic prostate cancer. Conclusion: Iliac side branch endografting showed excellent feasibility and encouraging midterm outcomes for the challenging endovascular repair of aneurysmal distal seal zones post EVAR.

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

Purpose: To evaluate the safety and effectiveness of the optical coherence tomography–guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). Methods: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. Results: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. Conclusion: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.

Combined Directional Atherectomy and Drug-Eluting Balloon Angioplasty for Isolated Popliteal Artery Lesions in Patients With Peripheral Artery Disease.

Purpose: To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. Methods: In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. Results: The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. Conclusion: In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint.

Endovascular Treatment of Profunda Femoris Artery Obstructive Disease: Nonsense or Useful Tool in Selected Cases?

BACKGROUND To evaluate the therapeutic value of endovascular techniques for the treatment of profunda femoris artery obstructive disease (PFAOD) in critical limb ischaemia (CLI) patients, with technically demanding open profunda repair. DESIGN Retrospective study of prospectively collected data of 15 consecutive CLI patients with technically demanding surgical treatment of PFAOD, that were treated by endovascular means in two European Centers of Vascular Surgery. MATERIALS All patients had critical limb ischaemia with a history of at least two previous vascular reconstructions in the ipsilateral groin and severe co-morbid conditions. All patients had good common femoral artery flow, long occlusion of the superficial femoral and popliteal arteries and impairment of crural arteries. METHODS Twelve patients underwent balloon angioplasty alone and, in the other three cases, an additional stent placement was necessary, due to flow-limiting dissection. The follow-up (mean 29.2+/-10 months) included a surveillance protocol with the best medical treatment and duplex scanning at 1, 3, 6, 12 months and yearly thereafter. RESULTS The endovascular approach was technically successful in all cases and the procedure-related morbidity and mortality rates were 0% for the entire follow-up period. The 3-year primary and secondary patency rates of the treated segment were 80% and 86.7%, respectively. The limb salvage rate was 93.3%. CONCLUSIONS The outcome of our series underscores the therapeutic value of balloon angioplasty in cases of severe PFAOD, as bailout treatment in critical limb ischaemia patients with technically demanding open profunda repair. This procedure can be repeated easily if significant restenosis occurs and provides a useful tool in selected cases.

Endovascular treatment as first line approach for infrarenal aortic occlusive disease

INTRODUCTION The purpose of this study was to report the early and late results of primary stenting for focal atherosclerotic lesions of the infrarenal aorta. METHODS A retrospective analysis of 52 consecutive patients treated for infrarenal occlusive aortic disease with primary stenting between January 2002 and November 2009 was performed. Original angiographic imaging, medical records, and noninvasive testing were reviewed. Primary stenting was the first line of treatment. Perioperative technical success and Kaplan-Meier estimates for patency and survival were calculated. RESULTS The majority of the patients (43) were treated for severe claudication (Rutherford III; 82.7%), 5 for ischemic rest pain (Rutherford IV; 9.6%), and 4 for minor tissue loss (Rutherford V; 7.7%). Aortic stenosis was found in 40 cases (76.9%) and occlusion in 12 (23%). Perioperative hemodynamic success was 100%. All patients had an improvement of ankle brachial index (ABI) >0.10. Clinical improvement was found in 96%. Early surgical revision was necessary for aortic rupture in 1 patient. One death occurred for pneumonia. The mean follow-up time was 39.4 ± 27.2 months. Ten reinterventions (19%) were needed for symptom recurrence. The estimated assisted primary patency at 9 years was 96% and the mean survival time was 86.6 months. CONCLUSION Primary stenting offers safe and durable results and should be considered as the first line of treatment for focal aortic lesions.

Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study.

AIMS Renal denervation has emerged as a treatment option for patients with drug-resistant hypertension. This study was designed to assess the safety and effectiveness of the OneShotª Renal Denervation System. METHODS AND RESULTS RAPID is a prospective, multicentre, single-arm study which enrolled 50 patients at 11 clinical sites in Europe and New Zealand. Eligible patients had an office systolic blood pressure (SBP) ≥160 mmHg and were on a stable regimen of ≥3 antihypertensive medications including a diuretic. The primary safety endpoints were acute procedural safety at discharge and chronic procedural safety at six months. The primary effectiveness endpoint was the rate of office SBP reduction ≥10 mmHg at six months compared to baseline. While not a predefined endpoint, change in 24-hour ambulatory BP was evaluated. The mean baseline office SBP and diastolic BP measurements were 181.6±20.8 and 95.5±15.5 mmHg, respectively. Patients were on a mean of 5.1 antihypertensive medications at baseline. The mean office BP decreased by -20/-8 mmHg (p<0.0001/p=0.0002), and -22/-8 mmHg (p<0.0001/p=0.0014), from baseline to six and 12 months, respectively. The 24-hour ABPM was also significantly reduced by -11/-6 mmHg at six months compared to baseline (p=0.0085/p=0.037). There were no serious adverse events (SAE) at discharge related to groin and vascular access complication or renal artery injury or SAE/adverse device effects at six months. CONCLUSIONS The results of the RAPID study demonstrate safe delivery of RF energy by the OneShot Renal Denervation System for renal sympathetic denervation and sustained efficacy, as evidenced by a significant reduction in office and 24-hour ABPM for six months, which was sustained up to 12 months. ClinicalTrials.gov Identifier: NCT01520506.

Crossing chronic total occlusions with the Ocelot system: the initial European experience.

AIMS The aim of the study was to determine the safety, efficacy and feasibility of a new chronic total occlusion (CTO) device using optical coherence tomography (OCT) technology, the Ocelot catheter (Avinger, Inc., Redwood City, CA, USA), for crossing of SFA CTOs following guidewire failure. METHODS AND RESULTS Prospective, multicentre, market preference testing. Thirty-three patients with confirmed CTO (99-100% stenosis by visual estimate) of their superficial femoral artery (SFA) were treated between September 28, 2011, and December 9, 2011, at three European centres. Ocelot crossed 94% (31/33) of CTOs, allowing guidewire placement in the distal true lumen. All (100%) lesions were treated without any major adverse safety events. Procedural time and contrast dose were significantly reduced (p<0.0001) when compared with a similar, non-OCT-guided CTO crossing device (Wildcat catheter; Avinger, Inc.). Overall physician feedback on the catheter performance was positive with an 87% average rating of excellent or good across seven categories. Performance ratings of Ocelots OCT imaging guidance were consistently positive with an 86% average rating of excellent or good across five OCT categories. CONCLUSIONS The Ocelot catheter combines advanced CTO crossing technology with real-time OCT guidance. When compared with a similar non-OCT-guided catheter, crossing efficacy and safety profile improved. Total procedure time and contrast volumes were significantly reduced. The Ocelot is a safe, efficient and effective tool for crossing CTOs.

Below-knee Bare Nitinol Stent Placement in High-risk Patients with Critical Limb Ischaemia and Unlimited Supragenicular Inflow as Treatment of Choice

PURPOSE To evaluate the effectiveness of nitinol stent placement in long infrapopliteal lesions in patients with critical limb ischaemia. MATERIALS AND METHODS Between January 2005 and January 2008, 34 high-risk patients (18 female; mean age: 73.8+/-6.1 years) with critical limb ischaemia underwent infragenicular stenting. They had serious cardiovascular co-morbidities (>3, such as chronic obstructive pulmonary disease (COPD), congestive heart failure and coronary artery occlusive disease), American Society of Anaesthesiologists score of 3 or more, previous myocardial infarction, coronary stent or bypass. The mean stenosis length was 6.5+/-0.9 cm (range: 2.2-8 cm), and the mean occlusion length was 7.5+/-2.9 cm (range: 3-9.6 cm). Primary stent implantation was performed for long stenosis or occlusion based on the TransAtlantic InterSociety Consensus (TASC) C and D classification, secondary stenting for flow-limiting dissections or elastic recoil after balloon dilatation. All patients who returned to the outpatient clinic were assessed for claudication by clinical examination, ankle-brachial index (ABI) measurements, colour flow and duplex Doppler ultrasound (US). Digital subtraction angiography was performed if restenosis or re-occlusion was identified by Doppler US or transcutaneous measurement of partial oxygen pressure (TcpO(2)) measurements, when appropriate. RESULTS The technical success rate was 97.1% (33 of 34 cases). The crude rate of primary patency rate was 91.1% during a follow-up period of 10.4+/-7.3 months. The mean ankle-brachial index increased significantly following intervention (0.45+/-0.25-0.92+/-0.13, p<0.001). Two patients underwent successful redo angioplasty after tibioperoneal interventions due to in-stent restenosis (>70%) with relevant limitation of pain-free walking distance. In another patient, bypass surgery to the anterior tibial artery 6 months after primary intervention was necessary due to rest pain. Two patients required surgical revision of the femoral artery after antegrade access. No procedure-related death was recorded in the entire follow-up period. CONCLUSIONS The mid-term outcome underscores infrapopliteal stent placement as a reliable treatment option in patients with critical limb ischaemia. In patients at high risk for crural bypass, with no flow-limiting supragenicular lesions, below-knee stent-supported angioplasty should be considered as a first choice of treatment.