Use of Rotational Atherectomy-Assisted Balloon Angioplasty in the Treatment of Isolated Below-the-Knee Atherosclerotic Lesions in Patients with Chronic Limb-Threatening Ischemia.

The aim of the study is to evaluate the safety and effectiveness of rotational atherectomy-assisted balloon angioplasty (BTK-RA) for the treatment of isolated below the knee (BTK) atherosclerotic lesions and to compare the outcomes to plain old balloon angioplasty (POBA). Between January 2020 and September 2023, 96 consecutive patients with chronic limb threatening ischemia (CTLI) and isolated BTK-lesions underwent POBA (group A) or BTK-RA (group B). The primary outcome measures were: periprocedural technical success, primary patency, postoperative increase of the ankle branchial index (ABI), target lesion revascularization (TLR), limb salvage, minor amputation and death. Both techniques had similar technical success, operative time, intraprocedural complications and bailout stent implantations, independently of the operator's experience. Group B had significantly higher primary patency rates (93.5% vs. 72.0%, respectively, p = 0.006), TLR (2.1% vs. 24%, p = 0.057), lower in-hospital stay (2.0-3.0 vs. 4.0-6.0 days, respectively, p < 0.001) and higher postoperative ABI (0.8-0.2 vs. 0.7-0.1, respectively, p = 0.008), compared to group A. Significant differences (POBA n: 20, 40%, BTK-RA n = 3, 6.5%) were found in minor amputation rates between the two groups (p < 0.001), while the respective limb salvage rates were similar in both groups (94.0% vs. 97.8%, p = 0.35). The use of BTK-RA for the treatment of BTK-lesions in patients with CTLI showed significant clinical advantages in comparison to POBA.

Periprocedural Outcomes of Rotational Atherectomy-Assisted Balloon Angioplasty in Isolated Atherosclerotic Popliteal Artery Lesions: The ISO-POP Trial.

BACKGROUND: Treatment of calcified popliteal artery lesions represents an ongoing challenge for vascular specialists. Biomechanical forces of external compression, torsion and elongation that occur with locomotion in the popliteal segment can lead to stent fractures and occlusions. The aim of our study was to assess the procedural success rate of atherectomy in combination with balloon angioplasty for isolated calcified popliteal artery lesions. METHODS: Between January 2020 and December 2022, 62 patients with isolated atherosclerotic lesions of the popliteal artery underwent endovascular treatment by use of rotational atherectomy (Phoenix, Philips USA, (subgroup A) or Jetstream, Boston USA, (subgroup B), atherectomy systems) and additional balloon angioplasty in two vascular centers. The primary outcome measures were: 1. periprocedural clinical and technical success (<30% residual stenosis and no need for bailout stenting due to flow-limiting dissection) and 2. postprocedural increase in the ankle brachial index of more than 0.1. RESULTS: The overall rate of bailout stenting was 4.8%, whereas the procedural success rate was 98.4%. The rate of procedural complications included 3.7% and 5.7% peripheral embolizations in the subgroups A and B, respectively, and no vessel perforations were noted. All embolizations were successfully treated by catheter aspiration or capture in the pre-treatment placed filter system. In addition, 1 (3.7%) pseudoaneurysm in the groin was reported in subgroup A and treated by surgical means. Median ABI of the affected limbs improved from 0.55 (0.2) to 0.70 (0.2) in subgroup A and from 0.50 (0.2) to 0.95 (0.1) in subgroup B (DABI of 0.15 versus 0.45, p < 0.001). CONCLUSIONS: The combination of rotational atherectomy and balloon angioplasty in the popliteal artery showed reproducible outcomes in 2 centers, with low incidence of complications and low rates of bail-out stenting. These findings may contribute to more liberal use of such devices especially in segments with high risk for stent factures and occlusions.

Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.

BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

Technical performance and reproducibility following rotational atherectomy of femoropopliteal artery occlusive lesions: analysis of the multicenter MORPHEAS Registry.

BACKGROUND: The purpose of this study was to define patient and anatomical factors associated with technical results specific to rotational atherectomy. Controversy exists surrounding appropriate utilization of atherectomy to treat femoral-popliteal atherosclerosis. Importantly, the existence of different atherectomy devices and lack of technical reports highlighting variables that impact outcomes obscures the ability to assess perioperative performance. METHODS: The nonindustry sponsored, Multicentric National Registry on the use of rotational atherectomy in femoral-popliteal occlusive atherosclerotic disease (MORPHEAS) database was queried. The MORPHEAS investigators included experienced providers at four centers who previously had not utilized rotational atherectomy. The primary endpoint was flow-limiting dissection and/or >50% recoil resulting in stent-placement while a secondary endpoint included peripheral thromboembolism incidence. RESULTS: One hundred thirteen patients were enrolled. Only femoropopliteal occlusions were included in the analysis and anatomic distribution and calcification severity were depicted separately. The most common adjunctive therapy was drug-coated balloon angioplasty (84%; N.=96). Flow-limiting dissection was identified in 16% (N.=18) and thromboembolism occurred in 4% (N.=4). Diabetes increased risk of thromboembolism (P=0.03) while lesion length ≥8.0 cm (P=0.07) and SFA-popliteal adductor canal location (P=0.01) were associated with flow-limiting dissection. In multivariable analysis, SFA-popliteal adductor canal occlusion had a 4.7-fold risk of perioperative complications (OR=4.7, 95%CI: 1.1-21.0; P=0.04). CONCLUSIONS: Rotational atherectomy was characterized by reproducible performance among four centers; however, diabetic patients, as well as those with long-segment, heavily calcified SFA-popliteal adductor canal occlusion present greatest risk of complications.

Preservation of Clinically Relevant Accessory Renal Arteries in Infrarenal AAA Patients With Adequate Proximal Landing Zones Undergoing EVAR.

PURPOSE: To report techniques to preserve the flow to relevant accessory renal arteries (ARA) in patients undergoing infrarenal endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) with adequate landing zones. METHODS: ARAs that originate inferior to the lowest ipsilateral main renal artery, supply one-third of the renal parenchyma, and having a diameter >4 mm have significant clinical importance. Between May 2012 and January 2015, among 389 high-risk patients with infrarenal AAAs who underwent standard EVAR, 9 (2.3%) patients each presented with a coexistent clinically relevant ARA. Their perfusion was secured by placing covered stents in the target ARA, parallel and outside of the main abdominal, as chimney grafts. Evaluation of acute and chronic renal decline was based on the consensus definition of RIFLE criteria (risk, injury, failure, loss, and end-stage) and chronic kidney disease (CKD) staging system, respectively. RESULTS: The procedure was completed successfully in all cases. In the immediate postoperative period, no acute kidney injury was observed based on the RIFLE criteria. Eight of the 9 covered stents remained patent during a mean follow-up of 13.8 ± 6.2 months. A single covered stent occlusion was observed 30 days postoperatively with infarction of the caudal pole of the kidney. This patient developed renal function impairment based on the CKD staging system 12 months after the initial procedure. For the remaining 8 patients, improvement of one CKD stage (n=1) or no change (n=7) in the CKD stage was observed. CONCLUSION: In AAA patients unfit for surgical revascularization, EVAR is associated with a significant decline in renal function. For this reason, preservation of relevant coexistent ARAs using the chimney technique should be considered as an option.