Endovascular treatment of complex femoro-popliteal lesions using plain angioplasty balloon and bare stents carries a high incidence of in-stent restenosis. Debulking using atherectomy device followed by angioplasty with drug coated balloon (DCB) has been proposed as an alternative option. However, few reports have published midterm outcomes and were focused on large inclusion criteria. The aim of this multicenter study was to report 12-month freedom from target lesion revascularization (TLR) following treatment of Trans-Atlantic Inter-Society Consensus (TASC) B and C femoro-popliteal lesions using JetStream® rotational plus aspiration atherectomy device and Ranger® DCB (Boston Scientific, Marlborough, MA, USA). Between March 2020 and December 2021, consecutive patients from 8 centers, with de novo and calcified TASC B and C lesions of superficial femoral artery and/or above-knee popliteal arteries were included. Intra-stent restenosis and recent (<1 month) occlusions were excluded. All patients had disabling intermittent claudication (Rutherford class 2 and 3). Procedure was 2 steps: atherectomy using Jetstream and postdilatation using drug-coated Ranger balloon. No embolic protection device was used. Patients who had target lesion stenting were excluded. Fifty-eight patients signed informed consent and underwent the procedure. Two patients underwent stenting of the target lesion. Two had failure to cross the lesion. Fifty-four patients had the full procedure [technical success 93% (54/58)]. Postoperative course was uneventful in all patients, and no embolic event was observed. During follow-up, 2 patients died, and 5 were lost to follow-up. Forty-seven patients had complete 12 months clinical and duplex follow-up. Two patients had target lesion restenosis, respectively, at 3 and 9 months, which were treated by balloon angioplasty. Kaplan-Meier 12-month freedom from TLR was 96% ± 3% (95% confidence interval 0.9-1). Treatment of complex femoro-popliteal lesions using rotational atherectomy and DCB without embolic protection is safe and effective with high technical success rate, no postoperative embolic events, and satisfactory 12-month freedom from TLR.Clinical ImpactThe Ellipse study was a multicenter prospective observational trial on the treatment of calcified TASC B and C lesions using Jetstream atherectomy and Ranger drug-coated balloon with no embolic protection. This technique resulted in 93% technical success and no distal embolization. Twelve-month freedom from target lesion revascularization, primary and secondary patency were, respectively, 96% ± 3%, 94% ± 4%, and 98% ± 2%. Rotational atherectomy plus drug coated balloon is a safe and effective treatment of complex calcified femoro-popliteal lesions. Embolic protection might not be necessary in selected patients, when lesions at high risk of distal embolization are excluded.

ObjectivesRotational atherectomy can offer a viable treatment for occlusive peripheral artery disease; maintaining the minimal invasiveness of an endovascular procedure, while allowing for a more complete lesion debridement compared with balloon angioplasty. This case report outlines a complication of guidewire entrapment associated with rotational atherectomy in the superficial femoral artery (SFA).MethodsA 57-year-old male underwent an atherectomy with Rotorex for left lower limb foot pain. During the procedure, the guidewire was suctioned into the atherectomy device, preventing any further advancement of the device and damaging the SFA and posterior tibial artery (PTA).ResultsThe atherectomy device was withdrawn and a new vascular access site was gained in the left PTA. A covered stent was inserted to treat the original SFA lesion, and balloon angioplasty was used to repair the device-induced damaged to the PTA.ConclusionWhile guidewire complications have been previously reported, this case report details the first reported case, to our knowledge, of guidewire entrapment while using a rotational atherectomy device. Knowledge of this possible complication of rotational atherectomy can aid in clinical decision making when choosing between treatments for peripheral vascular disease.

This article highlights four unique cases where rotational atherectomy (RA Rotapro, Boston Scientific) was used to cut and retrieve an entrapped coronary guidewire with parts extending into the aorta We discuss the technique and step by step approach to the retrieval procedure. Three of four cases described a guide wire entrapment in the right coronary artery (RCA), and one in the left anterior descending artery via retrograde route. In all cases the guide wire was intact within the intracoronary segment. In Case 1, the guide wire (Runthrough; Terumo) was entrapped in an acute marginal branch during chronic total occlusion (CTO) percutaneous coronary intervention. In Case 2, a whisper wire (Abbott) was entrapped during re-wiring of the right posterolateral branch through stent struts, the traction on the wire caused severe malformation of distal and proximal stents requiring second staged procedure to complete revascularization of the RCA CTO. In Case 3, a Runthrough wire was entrapped between two layers of stents and fractured at the proximal point with filaments extending into descending aorta. And in Case 4, a Pilot 200 (Abbott) wire was entrapped retrograde in the subintimal space via saphenous vein graft connection by tying a knot at the distal tip of the wire. In all four cases RA was used to successfully cut and remove the entrapped guide wires. Rotablation technique appears to be a safe and effective strategy for the management of entrapped coronary guidewire when conventional strategies fail.

Coronary calcifications, particularly in left main disease (LMD), are independently associated with adverse outcomes of percutaneous coronary intervention (PCI). Adequate lesion preparation is pivotal to achieve favorable short- and long-term outcomes. Rotational atherectomy devices have been used in contemporary practice to obtain adequate preparation of the calcified lesions. Recently, novel orbital atherectomy (OA) devices have been introduced to clinical practice to facilitate the preparation of the lesion. The objective of this study is to compare the short-term safety and efficacy of orbital and rotational atherectomy for LMD. we retrospectively evaluated a total of 55 consecutive patients who underwent the LM PCI supported by either OA or RA. The OA group consisted of 25 patients with a median SYNTAX Score of 28 (26-36). The Rota group consisted of 30 patients with a median SYNTAX Score of 28 (26-33.1) There were no statistical differences in MACCE between the RA and OA subpopulations when recorded in-hospital (6.7% vs. 10.3% p = 0.619) as well as in a 1-month follow-up after the procedure (12% vs. 16.6% p = 0.261). OA and RA seem to be similarly safe and effective strategies for preparating the lesion in the high-risk population with calcified LMD.

Treatment of Severely Calcified Complex Infrainguinal Lesions With the Novel ByCross Rotational Atherectomy Device: Results From a Prospective, Non-randomized CE-Mark Study

Effect of Procedural Volume on In-Hospital Outcomes After Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease (from the Japanese National Clinical Data [J-PCI Registry

The coronary artery calcium score is considered the most useful marker for predicting coronary events. The high score reflects heavy calcification in the vessel, which is more challenging to treat with the percutaneous intervention (PCI). To prepare this type of heavily calcified lesion intravascular lithotripsy (IVL) technology can be used prior to PCI, which is based on the concept of converting electrical energy into mechanical energy. It harmlessly and selectively disrupts both the shallow and deep deposits of calcium. The balloon-based catheters of this system emit sonic waves that transfer to the adjacent tissue resulting in improvement in vessel compliance with the slightest soft tissue loss. Therefore, making the treatment of calcified lesions more feasible, effective, and also simplify complex lesions. The lesions considered for lithotripsy-enhanced balloon dilation include calcified coronary lesions and peripheral vasculature lesions. This article reviews the use of IVL in calcified coronary artery disease, its advantages, and disadvantages while comparing it with other techniques like high-pressure balloons and rotational atherectomy devices. A thorough search of databases like PubMed and Google Scholar was performed, which uncovered 35 peer review articles. Keywords utilized in the data search were calcified coronary artery disease, coronary lithotripsy, calcification, and calcified atherosclerotic plaque. According to rotational atherectomy and intravascular lithotripsy trials, the latter was safer, mainly by decreasing atheromatous embolization risk. Deciphering these studies, it seems like IVL is better at parameters like procedural and clinical success rate, acute lumen gain, and less residual stenosis except in-hospital major adverse cardiovascular events (MACE), which was better in rotational atherectomy (RA). However, when lesion crossings are present, the atherectomy technique is still considered as first-line therapy. In clinical practice, despite these encouraging data for treating calcified lesions, IVL is grossly underutilized because of substantial costs and perceived significant procedural risk effects on the cardiac rhythm like causing 'shock topics' and asynchronous cardiac pacing. More longer-term clinical data and extensive researches are required to validate its safety and efficiency.

Calcified lesions still remain a technical challenge even in the treatment of infrainguinal artery disease. The aim of this retrospective, multicenter observational study was to investigate interventional outcomes of a high-speed rotational atherectomy device (Rotablator™) and to compare clinical outcomes in patients who underwent Rotablator and those who did not even after failed balloon angioplasty because of underlying calcified lesions. This study enrolled patients who underwent Rotablator (Rota group) and those who did not (Non-rota group) between January 2010 and 2014 December at 12 hospitals. A total of 67 limbs and 68 lesions in 65 patients were included (Rota group; 54 limbs and 55 lesions in 52 patients, Non-rota group; 13 limbs and 13 lesions in 13 patients). In the Rota group, a technical success rate was 94.5% with a complication rate of 1.8%, and all lesions underwent subsequent postdilatation following the adjunctive use of Rotablator, and approximately half of above-the-knee lesions underwent stent implantation. The Rota group had a significantly lower clinically driven reintervention rate at 12months than the Non-rota group (26.5% vs. 58.3%, respectively, p = 0.046). In addition, Rota group showed a trend toward a higher amputation-free survival compared to the Non-rota group at 1month (Rota; 98.0% vs. Non-rota; 84.6%, respectively, p = 0.10). Rotablator was used as an adjunctive device with a high technical success and a low complication rates, and Patients who underwent Rotablator yielded a significantly lower clinically driven reintervention rate at 12months compared to those who did not even after failed balloon angioplasty.

3:27 PM Abstract No. 311 Percutaneous mechanical atherothrombectomy using the RotarexS device in peripheral artery in-stent restenosis or occlusion: a French retrospective multicenter study on 128 patients

To ascertain the safety and mid-term outcomes of Rotarex®S rotational atherectomy plus thrombectomy device (Straub Medical AG, Wangs, Switzerland) with or without adjunctive treatment (e.g., percutaneous transluminal angioplasty, PTA/drug-coated balloon, DCB/stenting) in patients with in-stent restenosis (ISR) or occlusion in the iliac and/or infrainguinal arteries. French multicenter retrospective study of all patients treated by in-stent percutaneous mechanical debulking (PMD) of the lower limbs with Rotarex®S device between January 2013 and November 2018. The cohort consisted of 128 patients (88 men and 40 women), aged 39-94 years (mean, 66.7±12 years). All patients presented with cardio-vascular risk factors. Overall, 51.5% of patients had critical limb ischemia. The study demonstrated a technical success of 96.9% in the population with PMD and adjunctive PTA (95/128, 74.2%) or adjunctive DCB (16/128, 12.5%) or both (13/128, 10.2%). At 12-months follow-up, the primary clinical success/patency rate was 92.3% and the secondary clinical success/patency rate was 91.4%. Rate of limb salvage was 93.7%. Overall 32 (25%) reinterventions were reported with mean time from Rotarex®S treatment to reintervention of 7.1±8.2 months. Target lesion revascularization (TLR) was 19.5% (25/128). Seven (5.5%) patients developed distal embolism that responded to endovascular treatment. At mean follow-up, major adverse events (MAE) observed were death (18/128, 14.1%), myocardial infarction (MI) (9/128, 7.0%), stroke (2/128, 1.6%) and renal failure (3/128, 2.3%). Recanalization with Rotarex®S rotational atherectomy plus thrombectomy device is a practical choice for arterial ISR/occlusions of the iliac and/or infrainguinal arteries, regardless of the age of the thrombus, with satisfying TLR. Only adjunctive PTA is often necessary to further improve the recanalization.

The non-linear finite element method has been used for the analysis of a variety of non-traditional materials involving large deformations such as rubber, plastics, and soft tissues. In these types of nonlinear analysis, strain energy density functions are usually postulated that may incorporate dissipative internal variables to indicate micro-tearing and/or damage. One particular challenging area is plaque accumulation in cardiovascular and other arterial lumens that may partially or completely occlude blood flow, leading to coronary events such as stroke, myocardial infarction, or death. This paper describes the efficacy of a proposed high speed rotational atherectomy device for the removal of arterial plaque. The prototype design is based on the use of Finite Element Methods to evaluate the efficacy of a proposed high speed rotational atherectomy device for the removal of arterial plaque. Correlation between the numerical FEA model results and real world test results was achieved using a prototype device, a simulated arterial lumen with and without a fully deployed stent in the vascular lumen. The test results obtained by using the prototype high speed rotational atherectomy device to remove plaque in an arterial lumen with fully expanded stent are also presented in this paper.

Educational Exhibit Abstract No. 297 - Endovascular treatment options for chronic infrainguinal arterial occlusive disease: a pictorial essay

Atherosclerosis is a major cardiovascular disease involving accumulations of lipids, white blood cells, and other materials on the inside of artery walls. Since the calcification found in the advanced stage of atherosclerosis dramatically enhances the mechanical properties of the plaque, restoring the original lumen of the artery remains a challenge. High-speed rotational atherectomy, when performed with an ablating grinder to remove the plaque, produces much better results in the treatment of calcified plaque compared to other methods. However, the high-speed rotation of the Rotablator commercial rotational atherectomy device produces microcavitation, which should be avoided because of the serious complications it can cause. This research involves the development of a high-speed rotational ablation tool that does not generate microcavitation. It relies on surface modification to achieve the required surface roughness. The surface roughness of the tool for differential cutting was designed based on lubrication theory, and the surface of the tool was modified using Nd:YAG laser beam engraving. Electron microscope images and profiles indicated that the engraved surface of the tool had approximately 1μm of root mean square surface roughness. The ablation experiment was performed on hydroxyapatite/polylactide composite with an elastic modulus similar to that of calcified plaque. In addition, differential cutting was verified on silicone rubber with an elastic modulus similar to that of a normal artery. The tool performance and reliability were evaluated by measuring the ablation force exerted, the size of the debris generated during ablation, and through visual inspection of the silicone rubber surface.

Mechanism of lumen gain with a novel rotational aspiration atherectomy system for peripheral arterial disease: examination by intravascular ultrasound

Rotational atherectomy is used to penetrate resistant coronary lesions from standard balloon dilatation. These lesions may contain heavy calcification or metallic components from previously implanted stents. When the rotablator device is utilized to ablate an undilatable lesion containing metallic stent component, what happens to the rotablator burr after grinding through metal? Are there additional technical considerations of rotational atherectomy when used in metallic "ablation"? A challenging case of rotational ablation of a freshly placed coronary stent is presented requiring 2 burrs to penetrate the undilatable lesion overlaid by the stent. Comparative scanning electron microscopic (SEM) evaluations of 3 rotablator burrs are presented including the 2 used burrs and 1 brand new burr as control. SEM analyses including gross observations and detailed account of the diamond chips (DC) on the burr-surfaces were performed. The results showed that the 1st used burr received most of the damage and erosion from the high-speed impact with the metallic stent struts. Significant scratch marks were observed on the surface of the 1st used burr. Also, a significant number of the DC on the surface of the 1st used burr were found missing, as compared to the 2nd used burr or the brand new burr. The SEM findings of the rotablator burrs in this study suggest a mechanism for burr erosion when used in ablating metallic coronary stents. Also based on the SEM results, technical recommendations are discussed when the rotational atherectomy device is used to ablate metallic struts of coronary stents.

Use and Abuse of Atherectomy: Where Should it be Used?

Lower extremity peripheral arterial occlusive disease poses a unique challenge to traditional angioplasty-based endovascular therapies. The diffuse nature of lower extremity atherosclerotic disease, the presence of chronic total occlusions, poor distal runoff, and the presence of critical limb ischemia all have contributed to the disappointing results of balloon angioplasty for complex infrainguinal arterial disease. These challenges have spawned the development of a host of new technologies in an attempt to improve the safety and effectiveness of percutaneous revascularization for lower extremity peripheral arterial occlusive disease. This review summarizes the recent advances in available technologies, including novel angioplasty balloons; nitinol stents, stent grafts, and drug-eluting stents; excisional, laser, and rotational atherectomy devices; devices for crossing total occlusions; true-lumen reentry devices; thrombectomy catheters; and embolic protection devices.

Surgical Management of Complications of Percutaneous Coronary Rotational Atherectomy Interventions

To report our initial experience with a new rotary debulking device designed for treating long, diffusely diseased arterial segments. Ten symptomatic patients (8 men; mean age 63 years, range 34-76) with occluded superficial femoral (n = 6) or popliteal (n = 4) arteries were enrolled into a study to evaluate the debulking capabilities of a rotational atherectomy device. Occlusion length ranged from 4.0 to 16.1 cm (mean 11.1 +/- 4.10). The occlusions were treated with a low-speed, over-the-wire rotary device featuring a flexible, spiral "corkscrew" that embeds itself in the obstructive material while a rotary cutting catheter simultaneously cuts and captures the obstruction in a single pass. The device cut and retrieved material in a single pass from all segments without device-related complications. The captured material consisted of a mixture of atherosclerotic plaque and thrombus. Minimum lumen diameters (MLD) increased from 0.0 to 2.2 +/- 1.09 mm (p<0.05) after Xtrak treatment and to 4.09 +/- 1.20 mm (p<0.05) after adjunctive balloon dilation, which was used in 8 of 10 segments. All patients improved clinically after the procedure, with an increased the mean ankle-brachial index sustained at 6 months (0.69 +/- 0.32, p<0.05 compared to baseline and 1-month measurements). Six months after the procedure, 7 patients remained free of clinical symptoms, while 3 patients required a subsequent intervention. These initial results demonstrate that the Xtrak device can safely debulk long segments of diffusely diseased arteries in a single pass while simultaneously retrieving the occluding material. Supplementary angioplasty may be required in the majority of cases. Larger studies are required to determine whether debulking followed by balloon dilation improves the long-term prognosis in patients with chronic lower limb occlusions.

Coronary artery bypass grafting and percutaneous transluminal coronary angioplasty are now well established methods of myocardial revascularization. The choice of a method of revascularization depends on several clinical and angiographic parameters. Patients who derive the greatest benefit from coronary artery bypass grafting are those with left main coronary artery disease or those with three-vessel disease with left ventricular impairment. Patients with single-vessel disease achieve more symptomatic relief with coronary angioplasty than with medical therapy alone, but with no improvement in long-term mortality. In nondiabetic patients with multiple-vessel disease, angioplasty and bypass grafting likely yield similar results, and the choice of revascularization technique rests on weighing the more invasive nature of bypass grafting against the need for additional future revascularizations with angioplasty. Diabetic patients with multiple-vessel disease seem to achieve better outcomes with bypass grafting. Minimally invasive bypass surgery is an evolving technique. It is less invasive in nature but its applications are limited, and its advantages over traditional bypass grafting have not yet been shown. Stenting now plays a major role in percutaneous revascularization and is performed in more than two thirds of all interventional procedures. It improves both the short-term and the long-term outcomes of coronary angioplasty. Other novel percutaneous techniques such as directional or rotational atherectomy, laser angioplasty, or thrombectomy devices have not shown convincing superiority over coronary angioplasty alone. Transmyocardial laser revascularization can be performed surgically or percutaneously and may be beneficial in patients with angina refractory to traditional revascularization procedures.