[Atherectomy with a Novel Device Offering Wider Options]. / Atherektomie mit einem neuen System, das noch mehr kann.

Catheter-based atherectomy has been discussed for some years, although the conclusions have been controversial. Recent study data did show the feasibility of multifunctional atherectomy devices for complex lesion morphologies, with moderate material use. This is then thus an alternative to bypass surgery, although a direct comparison is lacking.The results of the ByCross approval study were compared to technical and clinical data from various atherectomy systems in terms of range of indication, limitations as defined by the manufacturer, the success and complication rate and the instructions for use. As in many recent studies, a residual stenosis ≤ 50% after atherectomy and ≤ 30% in the completion imaging was defined as the primary endpoint and proof of technical success.Lesions recruited for the ByCross study were more complex than in other studies, with respect to the lesion length (124.7 mm vs. 34 mm in the EASE study and 67.2 mm in the VISION study) and the degree of stenosis (99.4% vs. 88.5% in the EASE and 78,7% in the VISION study). Calcification was also more severe - as defined by the PACSS (Peripheral Artery Calcification Severity Score). ByCross allowed recanalisation of lesions without wire passage prior to atherectomy (26.82%), which is a must for all other systems. The variable tip diameter of the ByCross can achieve a lumen gain of 4.7 mm without tip or wire exchange or run time limits. The 0% rate of embolic events, which is unique for atherectomy device approval studies, can be explained by the working principle and the high aspiration rate. No vessel injuries occurred, and the 6-month follow-up results showed 0% revascularisation rate.New generation atherectomy systems offer safe and effective enlargement of the endovascular portfolio. The ByCross device is an atherectomy, thrombectomy and crossing device free from investment and has a wider range of indications for the iliac and the femorodistal segments, which supports ByCross atherectomy as an alternative for bypass surgery.

Safety and effectiveness of bycross rotational atherectomy and aspiration device: a prospective, multi-center pre-market approval study.

PURPOSE: To demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis. MATERIALS AND METHODS: From September 2018 until April 2019 39 patients with 41 femorodistal lesions including the femoropopliteal and distal popliteal segments were treated in a prospective, nonrandomized pre-market approval study with 6 months follow up using the ByCross® atherectomy device (ClinicalTrials.gov identifier NCT03724279). Adjunctive treatment with balloon dilatation or stenting was allowed by the protocol. Mean patient age was 72 years with 62% male. The average lesions length was 125 ± 118 mm (30 and 450 mm) with an average reference vessel diameter of 5.2 ± 0.85 mm and a mean stenosis of 96.4 ± 6.2% based on CT or MR angiography measurements. The primary performance endpoint was defined as acute procedural success with angiographically determined residual stenosis of ≤ 50% and of ≤ 30% after atherectomy or adjunctive treatment. The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Secondary endpoints were stenosis of the target lesions measured by duplex ultrasound (DUS) and the ankle-brachial pressure index (ABPI) at discharge, 30 and 180 days as well as any major adverse event (MAE) through 6 months. RESULTS: The acute procedural success was achieved in 39/41 (95.12%) lesions, partially without wire guidance (11/41 (26.82%)). No embolic protection was used, and adjunctive angioplasty and stenting was performed in 40/41 (97.56%) and 12/41 (29.26%) lesions, respectively without device related MAE's at 30 days. Mean level of stenosis was 5.7% at discharge and 21.7% at 6 months FU measured by DUS. Mean ABPI was 0.8, 1.0 and 0.8 at baseline, discharge, and 6 months FU respectively. CONCLUSIONS: Based on the high technical success rate and the low rates of MAE`s through six months, the BYCROSS® Atherectomy System has shown to be safe and effective for the crossing and atherectomy of complex lower-extremity arterial occlusions. TRIAL REGISTRATION: October 17, 2018,retrospectively registered. CLINICALTRIALS: gov Identifier: NCT03724279; https://clinicaltrials.gov/ct2/show/record/NCT03724279.

Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.

INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).

Inframalleolar access in endovenous treatment of venous ulcers and C5 disease with nonthermal nontumescent techniques.

PURPOSE: To evaluate the use of inframalleolar access for endovenous ablation when treating advanced venous disease with nonthermal nontumescent (NTNT) techniques. METHODS: This single-center retrospective study included 109 patients with advanced venous disease, treated using inframalleolar access between May 2018 and March 2020. NTNT techniques included ClariVein (Merit Medical Systems, South Jordan, Utah) and ScleroSafe (VVT Medical, Kefar Sava, Israel). Outcomes measured were postprocedure pain, leg edema, ulcer healing and recurrence rates, and venous insufficiency recurrence. RESULTS: Seventy-seven patients (70%) were treated with ClariVein and 32 (30%) with ScleroSafe. Postprocedure pain score (range, 0-10) after 1 week decreased from a preprocedure median of 5 (interquartile range, 3-6) to 1 ((interqartiel range, 0-2) (P = .0001). Complete wound healing was achieved in 38 patients (43.7%) after 30 days and in 71 patients (81.6%) after 90 days. One patient developed an ulcer recurrence and six developed venous insufficiency recurrence. There was no reported nerve or skin injuries. CONCLUSIONS: NTNT ablation techniques using inframalleolar access are effective and safe without risk of nerve damage. Their use facilitates ulcer healing and limits pain in patients with advanced disease.

Use of Multilayer Stent and Fenestrated Endograft in a Single Session to Treat Long-Segment Aorta.

A 72-year-old man with suprarenal aneurysm and 2 large penetrating ulcers (PAUs) in the descending aorta was referred for endovascular treatment. To avoid long-segment aortic coverage and the attendant risk of spinal ischemia, combination of 2 different stent technologies was used. A multilayer flow modulator was implanted in the thoracic aorta for the PAU, followed by implantation of a customized 4-vessel fenestrated stent graft for the suprarenal aneurysm. The patient remained well at 2 years with computed tomography evidence of exclusion of the suprarenal aneurysm and involution of the PAU.

Endovascular Hybrid Repair of True Ascending Aortic Aneurysms Using Double Graft Wrapping to Prepare a Landing Zone for Ascending Aortic Stent-Graft Placement: A Cohort Study.

Purpose: To describe a hybrid procedure that avoids cardiopulmonary bypass to treat patients with true ascending aortic aneurysms without a suitable proximal landing zone for endovascular repair. Material and Methods: Thirteen consecutive patients (mean age 75.9±6.5 years; 8 women) with true ascending aortic aneurysms were treated with the endovascular hybrid repair of true aortic aneurysms (EHTA) approach, which consists of a conventional sternotomy with double wrapping of the ascending aorta followed by staged stent-graft placement. Via sternotomy, a polypropylene mesh trimmed to downsize the aneurysm is placed around the dilated ascending aorta and sutured to the adventitia. A similarly trimmed polytetrafluoroethylene graft is placed loosely around the first wrap to avoid adhesions and secure the proximal landing zone. There is no need for cardiopulmonary bypass. A few days later, a standard thoracic stent-graft is deployed via either a transaxillary or transfemoral access; chimney or bypass grafts are used as needed to revascularize the supra-aortic vessels. Results: The ascending aortic diameter was reduced from a mean 5.7 cm (range 4.8-6.5) to 3.9 cm (range 3.2-4.3) after wrapping. The mean interval between surgery and stent-graft placement was 5 days. In this interval, 2 patients with significant reduction in the diameter of the ascending aorta elected to forego placement of a stent-graft. Of the 11 patients who underwent the full hybrid EHTA procedure, the ascending aortic stent-graft was combined with a chimney graft in the innominate artery in 4 cases. In 1 patient, a supra-aortic debranching procedure using a bifurcated Dacron graft to the innominate and left common carotid arteries was performed after wrapping with the polypropylene mesh. There was no mortality or neurological complication. A sternal wound infection required a prolonged hospital stay. At a mean follow-up of 13.8 months (range 3-24), there has been no death, type I endoleak, or sign of aneurysm enlargement on imaging. Conclusion: This technique permits complete endovascular exclusion of an ascending aortic aneurysm in a less invasive approach than standard open repair. Although this is only a small cohort of patients without long-term follow-up, it seems that this hybrid procedure is associated with low morbidity and mortality. It offers a beating-heart approach to treat true ascending aortic aneurysms in selected high-risk patients.

The V-Block Occlusion Stent and Sclerotherapy Device for Varicose Vein Treatment: A Retrospective Analysis.

BACKGROUND: The procedure aims to show our results with a novel nontumescent, nonthermal technique to treat varicose veins. The V-block occlusion stent is a minimally invasive device for treating reflux of the great saphenous vein (GSV). It is an office-based procedure that does not require tumescence anesthesia. The V-block stent is a self-expandable device that functions as a vein occluder and blood clot trap. Once the V-block is in place, further treatment of the saphenous vein such as ultrasound-guided sclerotherapy can be performed. The V-block device is intended to eliminate the possibility of forwarding passage of clot and sclerosant (embolization) to the deep and pulmonary circulations. METHODS: Patients were treated in an outpatient setting with the V-block occluding device. Follow-up was performed using duplex ultrasound to assess occlusion of the saphenous vein as well as the Aberdeen Varicose Vein Questionnaire and Venous Severity Scoring to determine changes in quality of life after the procedure. Patients were followed up at 1 week, 1 month, and 3 months after V-block placement. Duplex scanning was performed to confirm GSV occlusion at all follow-up visits. After deployment of the occlusion stent, a maximum of 2% polidocanol foam was injected with a double barrel syringe which simultaneously evacuated blood from the greater saphenous vein. Follow-up assessment for safety included evaluation of potential complications, device migration, and potential injury at the deployment site. RESULTS: Fifty-one symptomatic subjects with documented GSV reflux were enrolled in the study. Complete occlusion of the GSV was achieved in 98% of the patients during the 7-day postprocedural visit. There was no injury at the deployment site. No migration of the V-block device was observed. No deep vein thrombosis or any other complication was recorded. One patient of the 50 patients and 51 procedures experienced an adverse event, phlebitis that resolved under conservative therapy within 4 days with no residual effect. There was a significant improvement in the Aberdeen Vein quality of life measurements and the pain scores. After 3 years, 18 patients were willing to undergo a duplex follow-up examination. The occlusion rate after 3 years was 77.8. There were no device-related complications after this period. CONCLUSIONS: The study demonstrated a good safety and performance profile without any major adverse events. The primary end point of vein occlusion and obliteration was met.

Contemporary strategies for repair of complex thoracoabdominal aortic aneurysms: real-world experiences and multilayer stents as an alternative / Estratégias contemporâneas para reparo de aneurismas da aorta toracoabdominal: experiências reais e stents multilayer como alternativa

Abstract Thoracoabdominal aortic aneurysms (TAAA) present special challenges for repair due to their extent, their distinctive pathology, and the fact that they typically cross the ostia of one or more visceral branch vessels. Historically, the established treatment for TAAA was open surgical repair, with the first procedure reported in 1955. Endovascular repair of TAAA with fenestrated and/ or branched endografts, has been studied since the beginning of the current century as a means of mechanical aneurysm exclusion. More recently, flow modulator stents have been employed with the aim at reducing shear stress on aortic aneurysmal wall. In this review we present technical and main results of these techniques, based on literature review and personal experience.

Resumo Aneurismas da aorta toracoabdominal apresentam desafios especiais no seu reparo devido à sua extensão, patologia distinta, e pelo fato de que tipicamente eles atravessam o óstio de um ou mais vasos de ramos viscerais. Historicamente, o tratamento estabelecido para aneurismas da aorta toracoabdominal foi o reparo em cirurgia aberta, com o primeiro procedimento relatado em 1955. O reparo endovascular de aneurismas da aorta toracoabdominal com endoenxertos fenestrados e/ou ramificados tem sido estudado desde o início deste século como meio de exclusão mecânica do aneurisma. Mais recentemente, stents moduladores de fluxo têm sido empregados com o objetivo de reduzir o estresse de cisalhamento na parede do aneurisma de aorta. Nesta revisão, apresentamos os principais resultados obtidos com essas técnicas, com base em revisão de literatura e experiência pessoal.

Transcarotid Artery Revascularization With Flow Reversal.

PURPOSE: To report a study evaluating the safety and efficacy of stenting via direct carotid access with flow reversal using the ENROUTE Transcarotid Neuroprotection System. METHODS: Between March 2009 and June 2012, 75 patients (mean age 72.6 years; 45 men) underwent carotid artery stenting with the ENROUTE System; the majority of patients (63, 84%) were asymptomatic. The primary safety endpoint was the composite of major stroke, myocardial infarction, or death at 30 days. Efficacy outcomes included acute device success, procedure success, and tolerance to flow reversal. Fifty-six (74.7%) patients underwent diffusion-weighted magnetic resonance imaging (DW-MRI) before and after the procedure to assess the development of new ischemic brain lesions. RESULTS: Acute device and procedure success were achieved in 68 (90.6%) patients. The reverse flow circuit was established in 71 (94.6%) patients; only 5 patients demonstrated transient intolerance to flow reversal that did not interfere with completion of the procedure. The mean time on flow reversal was 19.1 minutes. In the DW-MRI substudy, 10 (17.9%) of 56 patients had ipsilateral new white lesions with a mean volume of 0.17 mL. At 30 days, no major stroke, myocardial infarction, or death occurred; 1 patient had experienced a minor stroke that was adjudicated as not related to either the device or procedure. CONCLUSION: Results of the PROOF study demonstrate the safety and efficacy of transcarotid revascularization with the ENROUTE Transcarotid Neuroprotection System.

Contemporary strategies for repair of complex thoracoabdominal aortic aneurysms: real-world experiences and multilayer stents as an alternative.

Thoracoabdominal aortic aneurysms (TAAA) present special challenges for repair due to their extent, their distinctive pathology, and the fact that they typically cross the ostia of one or more visceral branch vessels. Historically, the established treatment for TAAA was open surgical repair, with the first procedure reported in 1955. Endovascular repair of TAAA with fenestrated and/ or branched endografts, has been studied since the beginning of the current century as a means of mechanical aneurysm exclusion. More recently, flow modulator stents have been employed with the aim at reducing shear stress on aortic aneurysmal wall. In this review we present technical and main results of these techniques, based on literature review and personal experience.

Aneurismas da aorta toracoabdominal apresentam desafios especiais no seu reparo devido à sua extensão, patologia distinta, e pelo fato de que tipicamente eles atravessam o óstio de um ou mais vasos de ramos viscerais. Historicamente, o tratamento estabelecido para aneurismas da aorta toracoabdominal foi o reparo em cirurgia aberta, com o primeiro procedimento relatado em 1955. O reparo endovascular de aneurismas da aorta toracoabdominal com endoenxertos fenestrados e/ou ramificados tem sido estudado desde o início deste século como meio de exclusão mecânica do aneurisma. Mais recentemente, stents moduladores de fluxo têm sido empregados com o objetivo de reduzir o estresse de cisalhamento na parede do aneurisma de aorta. Nesta revisão, apresentamos os principais resultados obtidos com essas técnicas, com base em revisão de literatura e experiência pessoal.

Developments in parallel grafts for aortic arch lesions.

Due to the shortage of commercially available off the shelf aortic arch grafts since the last years parallel grafts or chimney grafts have played an increasing role in the treatment of patients with aortic arch lesions. Although there are still issues with type endoleaks and gutters between the chimney graft and the aortic stent-graft remaining. We report our results with the Medtronic thoracic graft in combination with long self-expanding parallel grafts, to ensure an overlapping zone of more than 7 cm between the different grafts. Alternatively, sandwich configurations are used where a direct contact between the parallel graft and the aortic wall is avoided. We have placed a total of 65 parallel grafts into supra-aortic branches. In 21 cases chimney grafts were placed into the carotid artery, in most cases into the left common carotid artery. In 36 cases chimney grafts were placed into left subclavian artery. A maximum number of 4 parallel grafts were placed for total endovascular debranching. In addition, in 8 patients a parallel graft had to be placed into the innominate artery. There was a patency of 69% for all subclavian artery chimney grafts versus 73% for carotid artery parallel grafts. Of note is a stroke rate of 5.2% in all these cases. Only 2 of the patients with an occluded left subclavian artery chimney graft required a bypass procedure for arm claudication or ischemia. We had a primary type I endoleak rate of 28%. In almost 25% secondary interventions were required mainly to treat type I leaks, in those cases where the leak did not resolve spontaneously. The overall mortality rate was 3.5%. The results of parallel graft in the aortic arch are promising, but of major concern is still the high rate of type I endoleaks as well as the neurological complication rate, most probably due to catheter manipulation in patients with severe atherosclerotic arch lesions.

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet).

OBJECTIVES: This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system-a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting. BACKGROUND: The risk of cerebral embolization persists throughout the carotid artery stenting procedure and remains during the stent healing period. METHODS: A total of 30 consecutive patients (age 71.6 ± 7.6 years, 63% male) meeting the conventional carotid artery stenting inclusion criteria were enrolled in 4 centers in Germany and Poland. RESULTS: The primary combined endpoint was the procedure success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted magnetic resonance imaging at 48 h post-procedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). Protection devices were used in all procedures. Procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 h occurred in 37.0% of patients and the average lesion volume was 0.039 ± 0.08 cm(3). The 30-day diffusion-weighted magnetic resonance imaging showed complete resolution of all but 1 periprocedural lesion and only 1 new minor (0.116 cm(3)) lesion in relation to the 48-h scan. CONCLUSIONS: The use of the CGuard system in patients undergoing carotid artery stenting is feasible. In addition, the benefit of using CGuard may extend throughout the stent healing period.

Endovascular repair of a complex giant infrarenal abdominal aortic aneurysm.

Giant aortic aneurysms (transverse diameter greater than 10.0 cm) are rare and open surgery is often the treatment of choice. We report an infrarenal saccular giant aortic aneurysm (measuring 25 cm in transverse diameter), which was treated with endovascular repair, with immediate technical success. No similar report of a giant infrarenal aortic aneurysm treated with an endovascular technique was found in the literature. High-risk patients could possibly benefit from the endovascular technique. Nevertheless, patient survival remains strongly influenced by comorbidities.

Endovascular treatment of spontaneous isolated common and external iliac artery dissections with preservation of pelvic blood flow.

Spontaneous isolated dissection of iliac arteries is very rare, with few reports in the literature. Medical, surgical, and endovascular treatment modalities have all been used to manage iliac artery dissections. We report a case of symptomatic, isolated, spontaneous dissection of the common iliac and external iliac arteries. Both dissections were successfully treated by separate percutaneous stent-graft placement, preserving hypogastric artery flow. This technique is interesting because it provides adequate sealing of proximal and distal dissection sites while preserving hypogastric artery and pelvic flow.