Mechanical rotational thrombectomy in long femoropopliteal artery and bypass occlusions: risk factors for periprocedural peripheral embolization.

PURPOSE: We aimed to examine lesion characteristics influencing technical outcome and periprocedural peripheral embolization (PPE) during percutaneous mechanical rotational thrombectomy (PMT) of long femoropopliteal artery and bypass occlusions. METHODS: Retrospectively, 65 consecutive patients (43 male patients, mean age 70±12 years; Rutherford category I-III), undergoing PMT (Rotarex®, Straub Medical AG) with acutely/subacutely occluded femoropopliteal arteries/bypasses were included. Occlusions (mean length, 217±98 mm) were treated by PMT followed by percutaneous transluminal angioplasty (PTA) plus drug-coated balloon or PTA plus stenting/stentgrafting. Technical success was defined as residual stenosis <30%. Follow-up included duplex ultrasound and ankle-brachial index (ABI) after 12 months. Endpoints were technical success, complications, improvement of Rutherford category, ABI, and patency (re-stenosis <50%). The influence of lesion length, duration, and thrombus density (measured in preinterventional computed tomography angiography) on technical success and PPE was analyzed. RESULTS: Technical success was 18% (12/65) after PMT alone, 92% (60/65) after additional means. Four patients (6%) underwent bypass surgery and one patient (2%) amputation. PPE occurred in 11% (7/65). During the 12-month follow-up, three patients (5%) were lost to follow-up. ABI increased from baseline 0.5±0.12 to 0.81±0.14 (p = 0.001) and Rutherford category increased by at least one level in 57 patients at 12-month follow-up (clinical success, 88%). At 12 months, primary patency was 57.4% (95% CI, 45.8%-68.9%) and secondary patency was 75.0% (95% CI, 59.8%-72.3%). As risk factors for PPE, we identified lesion length >200 mm (15%; 6/39; OR 4.5; 95% CI, 0.5-40; p = 0.014) and thrombus density ≤45 HU (20%; 2/10; OR 3.0; 95% CI, 0.2-38.9; p = 0.05). No significant relation between risk factors and technical success was found. CONCLUSION: PMT followed by PTA or implantation of stent (grafts) appears to be effective and safe for revascularization of acute/subacute long occlusions. Thrombus density <45 HU and lesion length above 20 cm represent risk factors for PPE during PMT.

Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon for revascularization of complex femoro-popliteal lesions.

To evaluate technical success, safety and efficacy of post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon (PCB) for revascularization of complex femoro-popliteal lesions. Thirty patients (26 male, mean age 70 ± 7 years) suffering from peripheral artery disease (PAD) (Rutherford category II-III) underwent revascularization of chronic total occlusions (n = 22, 73%) or severe stenosis (n = 8, 27%) of the femoro-popliteal segment. Mean lesion length was 251 ± 85 mm. Lesions were treated by pre-dilatation (POBA), implantation of a helical interwoven stent and post-dilatation with a PCB. Technical success was defined as residual stenosis < 30%. Follow-up included clinical visits, duplex ultrasound and ABI at 6 and 12 months. Endpoints were patency (re-stenosis < 50%), complications, improvement of Rutherford category and ABI. Regarding patency two sub-groups were compared: long-("LL"; < 25 cm, n = 12, mean 175 ± 38 mm) and ultra-long lesions ("ULL"; ≥ 25 cm, n = 13, mean 322 ± 43 mm). Technical success was 100%. In 1/30 patients (3.3%), a minor complication occurred (embolism). The overall primary and secondary patency rates at 12 months were 80.0% (95% CI 72.5-96.9%) and 92.0% (95% CI 84.7-100%). In the LL-sub-group, primary patency was 100%, and in the ULL-sub-group, primary patency was 61.5% (95% CI 51.8-92.3%) (p = 0.056), and secondary patency 84.6% (95% CI 71.3-100%), respectively. Rutherford category increased by at least one category in 92% of patients, ABI increased from 0.52 ± 0.13 (baseline) to 0.9 ± 0.14 (12 months) (p = 0.001). Five patients underwent target lesion revascularization during follow-up (bypass: n = 1, endovascular: n = 4). No death was observed during follow-up. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated-balloon proved to be safe and effective with promising outcomes in long- and ultra-long lesions up to 12 months of follow-up.

Initial Experience with the E-liac® Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm.

PURPOSE: Occlusion of internal iliac arteries during endovascular treatment (EVAR) of abdominal aortic (AAA) and common iliac artery aneurysms might be associated with ischemic pelvic complications. This study evaluates technical and clinical success, safety and mid-term results of a novel iliac branch device (IBD) for revascularization of the internal iliac artery (IIA) during EVAR. MATERIALS AND METHODS: Retrospectively, we identified 21 men (mean age 73.3 ± 6.2 years) treated for aorto-iliac aneurysms by use of a novel IBD (E-liac®, Jotec Hechingen, Germany). We analyzed safety (30-day survival), technical (no type I and III endoleaks, "EL"), clinical (no ischemic complications) success, mid-term patency of this IBD, peri-procedural complications, occurrence of type II ELs, rate of re-interventions and additional treatment of the revascularized IIA for landing zone preparation. RESULTS: Twenty-three IBDs were implanted. Aneurysms of the ipsilateral IIA were present in 6/23 IIAs (26.1%). Super-selective branch embolization was performed in these patients and the landing zone for the iliac sidebranch stent-graft was within the superior gluteal artery. Mean follow-up was 341 days (range 4-1103 days). Technical success and 30-day survival were 100%. Clinical success was 95.2%. Primary patency of the IBDs was 100% at 12 months. Peri-procedural complications occurred in 3/21 patients (14.3%), none of them related to the IBD. AAA-related type II ELs were found in 6 patients (28.6%), IBD-related ELs in 4/23 IBDs (17.4%) (two type Ib, two type II endoleaks). Overall re-intervention rate was 23.8%, IBD-related 8.7%. CONCLUSION: Utilization of the E-liac® IBD is safe and effective for the treatment of aorto-iliac aneurysms.

Endovascular stent-based revascularization of malignant superior vena cava syndrome with concomitant implantation of a port device using a dual venous approach.

PURPOSE: The aim of this paper is to evaluate the safety and efficacy of endovascular revascularization of malignant superior vena cava syndrome (SVCS) and simultaneous implantation of a totally implantable venous access port (TIVAP) using a dual venous approach. MATERIALS AND METHODS: Retrospectively, 31 patients (mean age 67 ± 8 years) with malignant CVO who had undergone revascularization by implantation of a self-expanding stent into the superior vena cava (SVC) (Sinus XL®, OptiMed, Germany; n = 11 [Group1] and Protégé ™ EverFlex, Covidien, Ireland; n = 20 [Group 2]) via a transfemoral access were identified. Simultaneously, percutaneous access via a subclavian vein was used to (a) probe the lesion from above, (b) facilitate a through-and-through maneuver, and (c) implant a TIVAP. Primary endpoints with regard to the SVC syndrome were technical (residual stenosis < 30%) and clinical (relief of symptoms) success; with regard to TIVAP implantation technical success was defined as positioning of the functional catheter within the SVC. Secondary endpoints were complications as well as stent and TIVAP patency. RESULTS: Technical and clinical success rate were 100% for revascularization of the SVS and 100% for implantation of the TIVAP. One access site hematoma (minor complication, day 2) and one port-catheter-associated sepsis (major complication, day 18) were identified. Mean catheter days were 313 ± 370 days. Mean imaging follow-up was 184 ± 172 days. Estimated patency rates at 3, 6, and 12 months were 100% in Group 1 and 84, 84, and 56% in Group 2 (p = 0.338). CONCLUSION: Stent-based revascularization of malignant SVCS with concomitant implantation of a port device using a dual venous approach appears to be safe and effective.

Initial experience with the E-ventus® stent-graft for endovascular treatment of visceral artery aneurysms.

BACKGROUND: To evaluate the safety and efficacy of a novel balloon-expandable stent-graft for endovascular treatment of visceral artery aneurysms (VAA). METHODS: Between 9/2014 and 1/2017 seven patients (69±15 years) with true (N.=4) and false (N.=3) VAAs were treated by implantation of balloon-expandable stent-grafts (E-ventus®, Jotec, Hechingen, Germany) using a transfemoral (N.=2) or transbrachial (N.=5) vascular access. The stent-graft was placed without prior passing of the landing zone with a sheath. In 3 of 7 patients (42.9%) additional coil or plug embolization was performed to prevent retrograde VAA perfusion. Endpoints were technical success (defined as delivery and implantation of the stent-graft in the intended position with complete exclusion of the VAA), peri-procedural complications and patency. RESULTS: Mean diameters of true VAAs (splenic artery: N.=2, common hepatic artery: N.=1, celiac trunk: N.=1) were 26±9 and of false (common hepatic artery: N.=2, gastroduodenal artery: N.=1) 29±14 mm. False aneurysms presented as emergencies with active bleeding. Technical success was 100%. One peri-procedural complication was noted: pseudoaneurysm of the accessed brachial artery. After a mean follow-up of 187 days 6/7 stent-grafts (85.7%) were patent. One patient (fVAA) died two days after the emergency procedure owing to multi-organ failure which was assessed to be non-procedure-related. Another patient (fVAA) died 7 months from the procedure owing to cancer. CONCLUSIONS: Endovascular treatment of true and false visceral artery aneurysms by use of the E-ventus® stent-graft is safe and effective. Flexibility of the stent-graft and shaft allows for implantation without passing the lesion with a sheath, enabling treatment of distal as well as complex visceral lesions. Long-term results regarding patency in a larger patient cohort are needed to confirm these findings.

Accuracy of pre-interventional computed tomography angiography post-processing software and extravascularly calibrated devices to determine vessel diameters: comparison with an intravascularly located calibrated catheter.

Background Accurate vessel sizing might affect treatment outcome of endovascular therapy. Purpose To compare accuracy of peripheral vessel diameter measurements using pre-interventional computed tomography angiography post processing software (CTA-PPS) and extravascularly located calibrated devices used during digital subtraction angiography (DSA) with an intravascular scaled catheter (SC). Material and Methods In 33 patients (28 men, mean age = 72 ± 11 years) a SC was used during DSA of the femoro-popliteal territory. Simultaneously, one scaled radiopaque tape (SRT) was affixed to the lateral thigh, one scaled radiopaque ruler (SRR) was positioned on the angiography table. For each patient, diameters of five anatomic landmarks were measured on DSA images after calibration using different scaled devices and CTA-PPS. Diameters were compared to SC (reference) and between groups of non-obese (NOB) and obese (OB) patients. Results In total, 660 measurements were performed. Compared to the reference, SRT overestimated the diameter by 1.2% (range = -10-12, standard deviation [SD] = 4.1%, intraclass correlation coefficient [ICC] = 0.992, 95% confidence interval [CI] = 0.989-0.992, P = 0.01), the SRR and CTA-PPS underestimated it by 21.3% (range = 1-47, SD = 9.4%, ICC = 0.864, 95% CI = 0.11-0.963, P = 0.08) and 3.2% (range = 17-38, SD = 9.7%, ICC = 0.976, 95% CI = 0.964-0.983, P = 0.01), respectively. Underestimation using the SRR was greatest in the proximal superficial-femoral artery (31%) and lowest at the P2 level of the popliteal artery (15%). In the NOB group, diameter overestimation of the SRT was 0.8% (range = 4-7, SD = 4.2%, B = 0.071, 95% CI = 0.293-0.435, P = 0.08) compared to the OB group of 1.6% (range = -7-4, SD = 2.9%, B = 0.010, 95% CI = 0.474-0.454, P = 0.96). Diameter underestimation of the SRR was 17.3% (range = 13-21, SD = 3.1%, B = 0.946, 95% CI = 0.486-1.405, P = 0.002) in the NOB group, 23.3% (range = 11-36, SD = 6.6%, B = 0.870, 95% CI = 0.268-1.472, P = 0.007) in the OB group. Conclusion For calibrated measurements SRT and CTA-PPS prove accurate compared to the reference, while SRR does not. Obesity has a significant impact on underestimation of diameter if SRR is used.

Simultaneous Antegrade-Retrograde Subintimal Revascularization of a Femoropopliteal Chronic Total Occlusion by a Reentry Device-Facilitated Puncture of a Retrogradely Inserted Balloon.

PURPOSE: To report a rendezvous technique for subintimal revascularization of a chronic total occlusion (CTO) of the superficial femoral artery (SFA). TECHNIQUE: This maneuver is appropriate after failure to cross a long SFA CTO via intra- and subintimal approaches from the ipsilateral femoral as well as retrograde posterior tibial artery (PTA) access sites. After predilation of the subintimal space from the femoral access, a reentry device was placed at the level of the first popliteal artery segment. A balloon was delivered via the retrograde PTA access and inflated at the corresponding level of the reentry device. The balloon was punctured with the needle of the reentry device under fluoroscopic control, and a 0.014-inch guidewire was placed within the punctured balloon. The balloon and the antegrade guidewire were retracted from the retrograde access while the guidewire was gently pushed from the femoral site. Conventional balloon angioplasty of the SFA occlusion was performed via the femoral access, followed by overlapping stent-graft implantation. Complete revascularization of the CTO was documented. CONCLUSION: In selected cases a transfemoral reentry device-assisted puncture of a retrogradely inserted balloon within the subintimal space may facilitate a rendezvous and revascularization if standard techniques to cross long CTOs have failed.