[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.

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.

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.

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.

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.

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.

Experience with the sandwich technique in endovascular thoracoabdominal aortic aneurysm repair.

BACKGROUND: The sandwich technique is an endovascular off-the-shelf solution for patients with thoracoabdominal aortic aneurysms (TAAAs). In a sandwich configuration, the chimney stent runs in the middle of a space created by two or three aortic endografts. METHODS: All patients with TAAAs who were treated with the sandwich technique were included in the study. Self-expanding Viabahn grafts (W. L. Gore and Associates Inc, Flagstaff, Ariz) were used as parallel grafts in the renal arteries and visceral vessels. Caudad-facing chimney grafts were used for the visceral arteries and cephalad-facing periscope grafts for the renal arteries. RESULTS: During the study period, 32 patients with TAAAs were treated with sandwich grafts. Indication for the procedure in 43% was an acute onset of symptoms, including two patients with a rupture and a retroperitoneal hematoma. Three patients required an additional debranching procedure. A total of 104 chimney grafts were implanted. Two patients died postoperatively because of the operation. Major adverse events were recorded in five patients, including one patient with persistent paraplegia and two with permanent renal failure requiring dialysis. The incidence of chimney graft occlusion was higher in patients with three or four parallel grafts than in those with two chimney grafts only. Patients with chronic dissections had a 12-times higher incidence of chimney graft occlusion than aneurysm patients. The number of patients with type I or III endoleaks was higher in the group with three or four parallel grafts. CONCLUSIONS: The sandwich technique is an off-the-shelf endovascular alternative to treat patients with TAAAs in an emergent setting. The combination of chimney grafts with a periscope configuration enables a rapid endovascular aneurysm exclusion with acceptable midterm results.

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).

Retrograde transpedal stenting of the tibioperoneal trunk in critical limb ischemia.

Management of critical limb ischemia (CLI) requires a combined treatment approach: optimal medical therapy and revascularization procedures are both essential for favorable outcome. With the development of endovascular interventions these new modalities took the primary role in limb revascularization, especially in CLI patients, where the culprit lesion is often located below the knee (BTK) level, making the surgical procedure unfeasible. In our present case report, we demonstrate a successful percutaneous recanalization of a surgically non-treatable tibioperoneal trunk occlusion. The procedure was performed with dual access from anterograde and retrograde transpedal approach, and modified "V stenting" technique was used. We describe feasibility of bail out stenting using retrograde posterior tibial artery access after failed retrograde guidewire externalization. Our report discusses the feasibility, safety, and efficacy of the retrograde approach applying 4F compatible devices.

Modified "stent-graft sandwich" technique for treatment of isolated common iliac artery aneurysm in patient with Marfan syndrome.

Isolated iliac artery aneurysms are rare in the general population (0.03%) and represent 2% of all abdominal aneurysms, and the association with Marfan syndrome is even rarer. We report a Marfan syndrome case with an isolated common iliac artery aneurysm treated by using a modified "stent-graft sandwich" technique, with preservation of the internal iliac artery perfusion. The modified "stent-graft sandwich" technique involves building an appropriate proximal neck just in the common iliac artery for fittingly housing two new stent-grafts inside, both deployed simultaneously and each one going to both distal iliac arteries (internal and external).

Endovascular treatment of late aortic perforation due to vena cava filter.

Perforation of inferior vena cava (IVC) by filter struts ranges from 9% to 24%, and clinical sequelae and complications are unpredictable. The aim of this article was to report an unusual case of late complication of IVC filter that caused an IVC wall perforation and penetration of the filter's hooks in the aorta, which was treated by endovascular procedure. Molding strut tip by balloon angioplasty, its accommodation with a bare stent, and its coverage and protection with an endoprosthesis is probably the first technique reported so far in this situation.

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.

Endovascular management of ascending aortic pathology.

BACKGROUND: Endovascular treatment of the ascending aorta is particularly challenging because of the anatomic features of this aortic segment. Only patients without connective tissue disorders, clinically relevant aortic regurgitation or stenosis, or concomitant coronary artery disease can be considered for an endovascular procedure. We report our results in a series of patients with aneurysms or intramural hematoma, penetrating ulcers, or floating thrombus who were scheduled for stent grafting. METHODS: Only patients with ascending aortic pathology who were unfit for open surgery were treated with an endograft. When preoperative computed tomography imaging showed severe calcification of the aortic arch or thrombus lining, temporary clamping of the carotid arteries before wire and catheter introduction was performed. An extracorporeal bypass from the right groin to both carotid arteries with a roller pump was established and maintained during the procedure. The endograft was placed across the aortic valve into the left ventricle and deployed in a retrograde fashion. At the end of the procedure, ventriculography and, if necessary, coronary angiography was performed to rule out any damage to the left ventricle or the valve apparatus. RESULT: Eleven patients were scheduled for stent graft exclusion of ascending aortic pathology. In five cases because of discrepancies in length measurements and sizing, the thoracic endograft was cut to length intraoperatively after partial deployment on the operating table and reloaded to avoid covering of the innominate artery. The mean length of the ascending aorta covered was longer in aneurysm patients than in those with dissection. An 81-year-old patient presented with a type Ia leak. The distal landing zone in one patient was enlarged by debranching. One patient died after wire perforation of the left ventricle, and one patient sustained a cerebral stroke. Combined morbidity and mortality was 18%, and the technical success rate was 91%. CONCLUSIONS: Stent grafting of the ascending aorta is technically feasible but should be reserved for selected high-risk patients only, preferably in centers where vascular specialists cooperate closely with interventional cardiologists. Cardiac surgery with cardiopulmonary bypass is still the gold standard to treat ascending aortic aneurysms. Stent graft exclusion of more advanced and complex ascending aortic pathology should be performed only in centers with the necessary experience in transvalvular cardiac procedures.

Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.

BACKGROUND: Randomized controlled trials have shown that periprocedural rates of stroke and death are higher with carotid artery stenting (CAS) than with carotid endarterectomy (CEA) in the treatment of carotid artery stenosis. Diffusion-weighted magnetic resonance imaging (DW-MRI) has shown higher rates of clinically silent new ischemic brain lesions when CAS is performed as compared with CEA. The Silk Road Medical Embolic PROtectiOn System: First-In-Man (PROOF) Study is a single-arm first-in-man study using the MICHI Neuroprotection System (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcervical access and cerebral embolic protection system. This system enables stent implantation under controlled blood flow reversal of the carotid artery, also known as Flow Altered Short Transcervical Carotid Artery Stenting (FAST-CAS). METHODS: Between March 2009 and February 2010, a total of 44 subjects were enrolled into the study. The primary composite endpoint was major stroke, myocardial infarction, or death within 30 days. Forty-three patients (97.7%) completed the study through the 30-day endpoint. One patient was lost to follow-up. In a subgroup of consecutive subjects, DW-MRI examinations were performed preprocedure and within 24 to 48 hours after the stent implantation. Blinded independent neuroradiologists reviewed all DW-MRI studies and confirmed the absence or presence of new ischemic brain lesions. RESULTS: All enrolled patients were successfully treated, and no major adverse events were seen through the follow-up period. Thirty-one subjects had DW-MRI examinations. Of these, five patients (16%) had evidence of new ischemic brain lesions but no clinical sequelae. Transient intolerance to reverse flow was reported in 9% of cases, but in all cases, a stent was successfully placed, and the intolerance was managed by minimizing the duration of reverse flow during the procedure. CONCLUSION: In this first-in-man experience, FAST-CAS using the MICHI Neuroprotection System was shown to be a safe and feasible method for carotid revascularization. DW-MRI findings suggest controlled reverse flow provides cerebral embolic protection similar to that seen with CEA.

A total laparoscopic technique for endovascular thoracic stent graft deployment.

BACKGROUND: Limitations of endovascular thoracic aneurysm treatment include small, tortuous, or severely calcified iliac arteries. We present our experience with a total laparoscopic access to deploy thoracic endografts. METHODS: A total laparoscopic left retrocolic approach was used in all cases. A Dacron conduit was laparoscopically sutured to either the iliac artery or to the aorta directly. The endograft was inserted through this conduit. After graft deployment, the Dacron prosthesis was tunneled to the groin and anastomosed with the femoral artery. RESULTS: The laparoscopic procedure could successfully be performed in 11 patients. In six cases, the aorta was used as an access and in five patients, the iliac arteries were preferred. In one of these cases, the right iliac artery was used for deployment of the endograft. After successful aorto- or ileo-femoral bypass grafting, all patients had an improvement of their ankle brachial index postoperatively. The mean operative time was almost four hours, including laparoscopy, laparoscopic anastomosis, endograft deployment, and femoral artery anastomosis or profundaplasty. CONCLUSION: Totally laparoscopic assisted graft implantation in aorta or iliac arteries provides a safe and effective access for the endovascular delivery system. However, further evaluation and long follow-up are necessary to ensure the potential advantages of this technique. It is a less invasive option to overcome access-related problems with thoracic endograft deployment, giving the patient the advantage of a totally minimal invasive procedure.