A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry.

The Chocolate BAR study is a prospective multicenter post-market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow-limiting dissection); secondary long-term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12-months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all-cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an "all-comers" population achieved excellent procedural outcomes with low dissection rates and bailout stent use.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

OBJECTIVES: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). BACKGROUND: Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. METHODS: The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. RESULTS: Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). CONCLUSIONS: The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Evaluating embolic reduction techniques concurrent to infrainguinal interventions: a single-center experience.

OBJECTIVE: To report a single-center retrospective evaluation of embolic reduction strategies concurrent to infrainguinal atherectomy intervention. METHODS: Fifty-five consecutive atherectomy patients from 2011 to 2012 treated with embolic reduction devices were analyzed. Embolic load was stratified by lesion type, atherectomy technique, debris capture effectiveness, and risk factor characteristics. Over 80% of lesions were complex. Baseline stenosis and average lesion length were 94.2 ± 6.4% and 172.8 ± 85.5 mm, respectively. Our embolic reduction strategy included a systematic approach using the Proteus device in all cases and then in combination with the SpiderFX for long or complex lesions. Debris was analyzed for count and aggregate surface area. RESULTS: Procedural success was 98.2%, with no in-hospital serious adverse events. The mean aggregated surface area of captured debris was 22 ± 20 mm². Thrombolysis with laser produced the highest amount of embolic load followed by laser, directional, and orbital atherectomy procedures (P<.05). Patients with restenotic/in-stent restenotic lesions produced larger amounts of debris (P<.05). No embolizations were recorded up to discharge. Proteus accounted for two-thirds of the debris captured in our study; its capture efficiency increased as device and lesion length met. An inverse relation was also found between lesion length and embolic protection device capture efficacy (TASC-II B vs D; P<.02). CONCLUSION: An embolic reduction strategy using the Proteus catheter alone, particularly when Proteus and lesion lengths meet, or with the SpiderFX in complex infrainguinal atherectomy procedures, can be an effective tool. Current findings suggest potential optimization of future "at risk" interventions.

Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II).

OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).

Use of orbital atherectomy treatment in a high-volume clinical practice modifies non-compliant plaque to deliver durable long-term results.

BACKGROUND: Resistant fibrotic calcified plaque is a major limitation in treating peripheral arterial disease (PAD). Percutaneous transluminal angioplasty (PTA) balloon pressures of 8-16 atm are typically required in these lesions. Ultrasound has detected significant dissection or plaque fracture immediately after balloon dilation in 76% of patients. Endovascular techniques are available that remove calcified plaque and alter lesion compliance, which minimizes dissection and stenting. A single-center experience evaluating the long-term durability of calcified plaque removal utilizing orbital atherectomy is presented. METHODS: Patients with PAD underwent primary intervention with orbital atherectomy followed by low-pressure balloon angioplasty. Lesion compliance markers, including balloon inflation pressures and times, dissection rates, and bail-out stent rates, were recorded. Twelve-month re-intervention rates were also tracked. RESULTS: Forty-six patients (57 lesions) were treated. Average age was 71 years and 74% of the patients were male. Rutherford classification was 3 to 5 for all patients. Lesion locations were in the common femoral artery (9%), superficial femoral artery (56%), popliteal artery (19%), and tibial/peritoneal arteries (16%). Average pretreatment stenosis was 90%. Adjunctive PTA was utilized in 82.5% of the lesions. Mean maximum inflation pressure was 5 atm for a mean of 2.3 minutes. Mean residual stenosis was 11%. One dissection occurred and no bailout stenting was required. Five patients (10.9%) returned for target lesion re-treatment. CONCLUSION: Orbital atherectomy modifies calcified lesion compliance in resistant peripheral arterial plaques as demonstrated by low balloon inflation pressures of short duration. Bail-out stenting was eliminated. Results were durable and the re-intervention rate was low.

Capture and removal of atheromatous plaque, from the lesion site, post directional atherectomy of long, in-stent restenotic superficial femoral artery lesions.

The clinical impact of embolic debris released during lower-limb interventions is a source of discussion and controversy. Yet, the sheer magnitude of their number, overall area, and morphology suggest significance, especially in complex and high-risk patients. Technologies designed for lowering embolic burden are required to improve peripheral vascular intervention (PVI) outcomes and to reduce complication rates in a timely and cost-effective manner. This work details capture and removal of atheromatous plaque during post-atherectomy dilatation of long, in-stent, restenotic superficial femoral artery (SFA) lesions in two complex comorbid patients. In both cases, embolic removal was obtained by deployment of an embolic protection device (EPD) prior to the main intervention and by postdilating the lesion using the Proteus aspiration balloon. Captured and removed particles were analyzed and compared for content, count, and dimensions from both the EPD and the Proteus device. Both cases were successfully resolved, as determined by angiography with no sequelae. In both procedures, Proteus surpassed the EPD in the magnitude of removed embolic shower. In case 1, the Proteus balloon captured 228 particles, with a mean major axial dimension of 0.4 ± 0.43 mm (range, 0.12-3.29 mm), while the distally positioned EPD captured 16 particles with a mean major axial dimension of 0.88 ± 1.25 mm. Similarly, 719 particles of a mean 0.24 ± 0.43 mm major axial dimension (range, 0.03-4.83 mm) were recovered in case 2. The capture efficiency presented by the Proteus device over the EPD suggests its potential to serve as a viable tool in complex PVIs, particularly in the dilatation of irregular atherectomized lesions.