Atherectomy System Research Articles

Acute Real-World Outcomes From the Phoenix Post-Approval Registry.

An evaluation of the 30-day safety and performance outcomes of the Phoenix atherectomy system (Philips Volcano Corporation) was performed in real-world patients with peripheral artery disease (PAD). The Phoenix Post-Approval Registry is an all-comer study that enrolled patients with infrainguinal PAD. Patients treated with the Phoenix atherectomy system were followed for 30 days to observe device-related complications. Outcomes evaluated include procedural (final target lesion(s) residual stenosis of ≤30% after treatment with Phoenix and any other adjunctive therapy) and technical success (defined as achieving a post-Phoenix [prior to any adjunctive therapy] residual diameter stenosis of ≤50%), target-vessel revascularization (TVR), target-lesion revascularization (TLR), target-limb amputation, ankle brachial index, Rutherford clinical category, and wound, ischemia, foot infection (WIfI) classification. Of the 500 patients enrolled, 259 had CLI, including 26.3% with Rutherford class 6. Procedural success rates were 97.3% for non-CLI patients and 98.2% for CLI patients. Technical success rates were 71.5% for non-CLI patients and 77.9% for CLI patients. Complication rates post Phoenix atherectomy were <1%. Through the 30-day follow-up, there were 6 patients (1.3%; 2 claudicants, 4 CLIs) who underwent TLR and 8 patients who underwent TVR. There were no major amputations in the non-CLI and CLI cohorts. In the CLI cohort, 16/235 (6.8%) underwent minor amputations. Higher stages of Rutherford class and WIfI classification were associated with amputations at 30 days. The Phoenix atherectomy system is a safe and effective treatment option in the acute setting for patients with PAD, including those with advanced Rutherford class. Randomized controlled trials are needed to confirm these results.

Single centre registry: Acute outcomes of coronary orbital atherectomy in calcified coronary arteries

The DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) is a catheter-based system designed for optimising PCI results in calcified coronary artery lesions. Calcification of coronary arteries remains one of the last frontiers in interventional cardiology. Interventions in these lesions are consistently associated with increased adverse acute and chronic outcomes e.g. Death, MI and TVR. These are attributed to failed stent delivery, stent malapposition, vessel dissection, stent thrombosis and in-stent restenosis.

Drug-coated balloon versus drug-eluting stent following orbital atherectomy for calcified coronary artery: one-year outcomes of a retrospective cohort study

Abstract Background Percutaneous coronary intervention (PCI) for calcified coronary artery remains challenging in the drug-eluting stent (DES) era. The effectiveness of drug-coated balloons (DCBs) and orbital atherectomy system (OAS) is unknown. Methods In this retrospective, single-center study, we compared the use of DCBs with second- and third-generation DESs following orbital atherectomy (OA) for calcified de novo coronary lesions. All patients underwent PCI with intravascular imaging. The primary endpoint was major cardiac event, that was a composite of cardiac death, death for unknown cause, non-fatal myocardial infarction, or target lesion revascularization at 1 year. Results Between June 2018 and December 2019, 107 patients with coronary lesions were enrolled in this study and divided into two groups: 23 patients in DCB group and 84 patients in DES group. The post-procedure segment percentage diameter stenosis was 23.1% (interquartile range [IQR], 17.7 to 32.5) with DCB versus 14.4% (IQR, 10.0 to 21.2) with DES (P&amp;lt;0.001). Overall adverse event rate for PCI procedure was low: one dissection with DES group, no persistent slow/no-flow, and no perforation with both group. The primary endpoint was not significantly different between 2 groups [DES: 6.0% (5/84), DCB: 0.0% (0/23), log-rank P=0.24]. Conclusions In calcified coronary artery disease, using DCB following OA is as safe and effective as using DES following OA with respect to 1-year clinical outcomes. Funding Acknowledgement Type of funding sources: None.

United States Investigational Device Exemption study of the Revolution Peripheral Atherectomy System

ObjectiveAtherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks including distal embolization and arterial perforation. This study aimed to examine the safety and effectiveness of a novel atherectomy system to treat femoropopliteal and below-knee peripheral arterial disease. MethodsThe Revolution Peripheral Atherectomy System (Rex Medical LP, Conshohocken, Pa) was studied in 121 patients with 148 femoropopliteal and below-knee lesions, enrolled at 17 United States institutions. Technical success was defined when the post-atherectomy angiographic stenosis was ≤50%, as assessed by an independent core laboratory. Major adverse events were adjudicated by an independent Clinical Events Committee. ResultsAmong 148 site-identified target lesions in 121 patients, 21.4% were in the superficial femoral artery, 13.7% involved the popliteal artery, and 67.9% were in tibial arteries; 3.1% involved more than one segment. Technical success was 90.2%, with stenoses decreasing from 73% ± 19% at baseline to 42% ± 14% after atherectomy. Adjunctive treatment after atherectomy included angioplasty with uncoated balloons in 91%, drug-coated balloons in 11%, bare stent deployment in 8%, and drug-eluting stent placement in 3%. Procedural success (<30% residual stenosis) was achieved in 93.7% of target lesions. Complications during the procedure included one target vessel perforation and two distal embolizations; each of which were adjudicated by the Clinical Events Committee as unrelated to the device and were not visualized angiographically by the core laboratory. Freedom from major adverse events was 97.3% through 30 days. The Kaplan-Meier estimates of primary, assisted primary, and secondary patency were 81.6%, 87.7%, and 91.6% at 6 months, respectively. ConclusionsThe use of the Revolution Peripheral Atherectomy System was associated with few procedural complications and a high rate of success at the index procedure and through 6 months.

Coronary orbital atherectomy using a five-French guiding catheter.

Recently, the efficacy was demonstratedof the Diamondback 360® Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St. Paul, MN, USA) for treating calcified coronary lesions in percutaneous coronary intervention (PCI). The safety and feasibility of OAS application through a 5-Fr guiding catheter (GC) which is less invasive and reduces access site complications were validated. This sequential, retrospective, observational study was conducted in a single center from September 2018 to May 2020. The primary endpoint was a successful PCI with the OAS. Secondary endpoints were major adverse complications related to PCI with the OAS, including coronary dissection, perforation, side branch loss, need for an unexpected cardiac assist device, access site complications, and major adverse cardiac and cerebrovascular events. 33 PCIs in 30 patients (mean age 72 ± 11years; male, 83.3%) were surveyed. All PCIs were successfully completed with OAS application through a 5-Fr GC. Coronary perforation after the OAS procedure occurred in one case (3.0%). Severe coronary dissection occurred in three cases (9.1%), and procedural myocardial infarction in two cases (6.1%). Regarding PCIs performed with the 5-Fr GC, the OAS is a safe and feasible strategy for calcified plaque modification.

Clinical Safety and Efficacy of Rotational Atherectomy in Japanese Patients with Peripheral Arterial Disease Presenting Femoropopliteal Lesions: The J-SUPREME and J-SUPREME II Trials

Purpose: The purpose of the J-SUPREME (J-S) and J-SUPREME II (J-SII) trials was to evaluate the performance of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in the superficial femoral and popliteal arteries. Materials and Methods: The J-S and J-SII trials were both prospective, multicenter, single-arm clinical trials. Patients in J-S underwent Jetstream atherectomy followed by percutaneous transluminal angioplasty (PTA), whereas those in J-SII had adjunctive drug-coated balloon (DCB) treatment following atherectomy. Patients were adults with Rutherford category 2, 3, or 4 and had stenotic, restenotic, or occlusive lesion(s) with a degree of stenosis ≥70 in the superficial femoral artery and/or proximal popliteal artery. In J-S, lesions were required to be calcified, and in J-SII lesions were required to be severely calcified. Results: A total of 50 patients were enrolled in J-S (mean age 72.3±8.7 years, lesion length 82.0±41.5 mm, 36% calcification PACSS Grade 3, 22% Grade 4) and 31 patients in J-SII (mean age 72.5±7.7 years, lesion length 122.6±55.6 mm, 19.4% calcification PACSS Grade 3, 77.4% Grade 4). No bailout stenting or bypass conversions were required. No major adverse events (MAEs) were reported for either trial through 1 month. The 6-month primary patency for J-S, with PTA alone following atherectomy, was 40.4% (19/47). The 6-month primary patency for J-SII, with DCB treatment following atherectomy, was 96.7% (29/30). At 6-month post-procedure, 79.2% (38/48) of patients in J-S, and 100% (30/30) of patients in J-SII had improved by at least 1 Rutherford category. Conclusion: J-SUPREME trial results demonstrate procedural safety and efficacy of the Jetstream Atherectomy System and J-SII showed sustained patency through 6 months following combination treatment with Jetstream atherectomy and DCB.

Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept

Effective treatment strategies and medical devices continue to be needed in Japan and the United States of America (US) to mitigate the growing burden of cardiovascular disease and coronary heart disease. Unfortunately, there can be a delay in gaining cardiovascular device approval in Japan after a device has already been approved and is in use in the US. The Harmonization by Doing (HBD) program; however, can eliminate this delay and reduce the cost of completing a clinical trial in Japan. The HBD proof-of-concept study, COAST, resulted in approval of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown simultaneously in Japan and the US on the same day. Subsequently, the Diamondback 360® Coronary OAS Classic Crown also received approval in Japan. The COAST study provides further evidence that global clinical trials via HBD for medical devices are practical and advantageous.

Clinical Experience of Percutaneous Coronary Intervention for Severely Calcified Coronary Artery Lesions with Orbital Atherectomy System.

Clinical Experience of Percutaneous Coronary Intervention for Severely Calcified Coronary Artery Lesions with Orbital Atherectomy System.

Intravascular Ultrasound Assessment and Correlation With Angiographic Findings of Arterial Dissections Following Auryon Laser Atherectomy and Adjunctive Balloon Angioplasty: Results of the iDissection Auryon Laser Study

Background Femoropopliteal arterial angiographic dissections with the use of the Auryon laser atherectomy system (previously the B-laser) have been infrequent and non–flow limiting. However, the pattern of these dissections (depth and arc) using intravascular ultrasound remains unknown. Materials and Methods We prospectively enrolled 29 patients in the iDissection Auryon study. The primary objective was to define the occurrence of new adventitial injury with intravascular ultrasound (IVUS). Secondary objectives included distal embolization and bailout stenting as judged by the operator because of 30% or more residual narrowing and/or NHLBI (National Heart, Lung, and Blood Institute) angiographic dissection C and higher. Core laboratory analysis was carried on all cases except for 1 patient (that crossed over to Jetstream atherectomy). Dissections were classified according to the iDissection classification as involving the intima (A), media (B), and adventitia (C) and ≤ 180-° arc (1) or >180-° arc (2). Overall, 22 of 29 patients had an embolic filter (per protocol). Results Median lesion and treated lengths were 100.0 and 150.0 mm, respectively. Vessel diameter by IVUS was 6.5 ± 1.5 mm. Chronic total occlusion (CTO) was present in 24.1% of cases. The arc of calcium was: no calcium in 27.6%, <90° in 13.8%, 90° to 180° in 20.7%, and >180° in 34.4%. Lesion severity was reduced to a median of 14% post laser and adjunctive percutaneous transluminal angioplasty (PTA) from a baseline of 76%. Bailout stenting occurred in 6 of 28 (21.4%) patients (3 for dissections, 2 for residual >30%, and 1 for both) and primary stenting in 1 of 28 (3.6%). By IVUS, there were 9 new dissections post laser (1 adventitial; 3≥180°) and 21 new dissections post laser and PTA (3 adventitial; 1≥180°). No distal embolization requiring treatment was seen and no macrodebris ≥2 mm was recovered in the filters. Conclusion The Auryon laser atherectomy system had minimal rate of adventitial injury despite complex disease with relatively low bailout stent rate and no clinically significant macrodebris.

Transradial Endovascular Intervention: Results From the Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study

Background/PurposeThe transradial approach has been proposed as an alternative to traditional transfemoral access for diagnostic and therapeutic purposes in several catheterization procedures. Historically, extended length devices for lower limb endovascular interventions have been limited. The aim of this study was to investigate the acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for the treatment of lower extremity peripheral artery disease (PAD). Methods/materialsREACH PVI was a multicenter, prospective, observational study (NCT03943160) including subjects with PAD and target lesion morphology appropriate for OA. All patients were followed post-procedure through the first standard of care follow-up visit. ResultsA total of 50 patients were enrolled. In most cases the indication for intervention was disabling claudication (74.0%). Overall, 50 target lesions were treated, 92.0% of lesions were femoropopliteal and 8.0% were infrapopliteal. The average lesion length was 98.3 ± 87.5 mm and 78.0% of the lesions were severely calcified. Balloon angioplasty was performed in 98.0% of target lesions, while a stent was deployed in 16.0%. Treatment success was 98.0%; in only one case the result was sub-optimal (>30% stenosis with stent placement) and a significant dissection was reported. No serious distal embolization, serious thrombus formation or serious acute vessel closure were observed intra- or post-procedurally. ConclusionsTransradial OA followed by percutaneous transluminal angioplasty for lower extremity PAD is feasible and demonstrates a favorable safety profile. Extended length devices such as the Extended Length Orbital Atherectomy System could further facilitate transradial endovascular procedures by increasing its spectrum of application.

Abstract No. 11 Single-center real-world experience of the novel 355 nm Auryon atherectomy device

Peripheral artery disease (PAD) affects more than 200 million adults in the world and is frequently associated with intermittent claudication. Open surgical approaches have been used in the past, but endovascular approaches have evolved as the first line of treatment. The present study details a single-center real-world case series assessing the safety and efficacy of the Auryon atherectomy system in patients with infrainguinal PAD.

Fractured Driveshaft Tip and Guidewire of Orbital Atherectomy System Retrieved With Micro Basket Catheter

Fractured Driveshaft Tip and Guidewire of Orbital Atherectomy System Retrieved With Micro Basket Catheter

Efficacy of Combination Atherectomy of Orbital Atherectomy System and Rotational Atherectomy for Severely Calcified Nodule

Provisional single drug-eluting stent (DES) strategy remains the standard of care in simple bifurcation lesions which comprise the vast majority of coronary bifurcations. Nevertheless, the presence of complex bifurcations which are defined based on the 1) Side Branch (SB) lesion length of >10 mm and 2) SB ostial diameter stenosis of >70% are approached with a 2-DES strategy upfront. The bifurcation angle will further define the most appropriate technique, with T-stenting more suitable in angulations close to 90°, Culotte and the family of Crush techniques more appropriate for acute angles of <75°. The Crush techniques which are composed of the classic Crush, mini-Crush and double kissing Crush (DK-Crush) share the core principle of protruding the SB DES within the Main Branch (MB) to minimize the risk of ostial SB restenosis, which remains the most prevalent etiology of stent failure during 2-stent approach in bifurcations. Proximal Side Optimization (PSO) is an additional technical consideration to further optimize the protruding SB struts enabling 1) optimal SB strut accommodation to the larger MB vessel diameter, 2) strut enlargement that will further facilitate effortless rewiring for kissing balloon inflation (KBI) avoiding unfavorable guide wire advancement in the peri-ostial SB area.

Successful Retrieval of a Fractured and Detached Crown From a Coronary Orbital Atherectomy System

We report a rare case of crown fracture and detachment from a coronary orbital atherectomy system. During orbital atherectomy in an angulated and calcified coronary vessel, the crown was completely detached and left distal to the stenosis. It was successfully retrieved using a gooseneck snare and a guide-extension catheter. (Level of Difficulty: Advanced.)

Use of the Orbital Atherectomy System in Isolated, Chronic Atherosclerotic Lesions of the Popliteal Artery

The treatment of isolated calcified lesions involving the popliteal artery are demanding and they often require stent placement to achieve acceptable luminal gain. This study evaluates the safety and performance of the orbital atherectomy system (Cardiovascular Systems Inc.) and percutaneous transluminal angioplasty with a drug-coated balloon (PTA-DCB) for the treatment of chronic atherosclerotic lesions within the popliteal artery segment. From November 2018 to November 2019, a series of six patients with Rutherford classification stage III peripheral arterial disease with isolated, focal, calcified occlusions of the popliteal artery were treated with orbital atherectomy followed by PTA-DCB. No embolic protection devices were used. The technical success rate was 100%, the primary patency rate was 100% at 7.0 (±4.2) months of follow-up. The Rutherford classification improved in all patients from stage III to stage II and the mean ankle brachial pressure index after the procedure was 0.97 (±0.08), with a preoperative mean ankle brachial pressure index of 0.69 (±0.21). In one instance, spasm was noted in a distal arterial bed and it was successfully treated with local nitroglycerine. No distal embolisation, perforation or aneurysmal degeneration was observed. During follow-up there were no deaths, major amputations or revascularisation of target lesions. The use of orbital atherectomy system in combination with PTA-DCB was found to be safe and effective in modifying focal, chronic, calcified plaques in the popliteal artery segment in these six cases.

Adverse Events and Modes of Failure Related to Rotational Atherectomy System: The Utility of the MAUDE Database

Background/purposeCoronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Methods/materialsWe queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis. ResultsPercentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery. ConclusionAn analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality.

Novel Micro Crown Orbital Atherectomy for Severe Lesion Calcification: Coronary Orbital Atherectomy System Study (COAST).

Percutaneous coronary intervention of severely calcified lesions carries a high risk of adverse events despite the use of contemporary devices. The Classic Crown Orbital Atherectomy System (OAS) was safe and effective for severely calcified lesion preparation in the ORBIT II study (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) but was not optimized for tight lesions. COAST (Coronary Orbital Atherectomy System Study) evaluated the safety and efficacy of calcified lesion preparation before stent implantation with the Diamondback 360 Micro Crown Coronary OAS, designed for use in tighter lesions. COAST was a prospective, multicenter, single-arm study that enrolled 100 patients with severely calcified de novo coronary lesions at 17 sites in the United States and Japan. The primary effectiveness end point was procedural success, defined as stent delivery with residual stenosis <50% without in-hospital major adverse cardiac events (MACE), and the primary safety end point was freedom from MACE (composite of cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. The OAS Micro Crown was inserted in all patients. A stent was delivered with a residual stenosis <50% in all except one patient (99.0%). Procedural success was achieved in 85 (85.0%) subjects versus 391 (88.9%) in ORBIT II (P=0.30), and freedom from MACE at 30 days was achieved in 85.0% versus 89.6% in ORBIT II (P=0.21). Freedom from MACE was 77.8% at 1 year. Prestent preparation of severely calcified lesions using the novel Micro Crown OAS resulted in similar rates of procedural success and freedom from MACE compared with the Classic Crown OAS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02132611.

Rationale and Design of a Prospective, Multicenter, Single-Arm Clinical Trial to Investigate the Safety and Effectiveness of Rotablator Atherectomy System as an Adjunctive Device for Endovascular Treatment of Occlusive Atherosclerotic Lesions in Below-the-Knee Arteries With Critical Limb Ischemia (RESCUE-BTK).

Background: Endovascular treatment with balloon angioplasty plays a major role in revascularization of below-the-knee (BTK) arteries in patients with critical limb ischemia (CLI). However, with severely calcified lesions, achieving optimal revascularization with balloon angioplasty alone is difficult. Therefore, we are evaluating the safety and effectiveness of the Rotablator atherectomy system as an adjunctive device in the treatment of severely calcified lesions in BTK arteries in the RESCUE-BTK trial, a multicenter, single-arm, open-label, exploratory investigator-initiated clinical study of medical devices. In this paper we describe the design of the trial.Methods and Results: Seventeen patients with CLI in whom balloon angioplasty has failed are enrolled in the study. The primary endpoint is the procedural success rate of balloon angioplasty after rotational atherectomy. Success is defined as the fulfillment of 3 requirements upon assessment by the core laboratory: (1) final residual diameter stenosis <50%; (2) the absence of a delay in flow or vessel perforation in the target artery, or both; and (3) brisk antegrade flow to the foot. Key secondary endpoints are the number of complications associated with the trial procedures and the limb salvage rate. Participants are followed-up for 6 months after the trial procedures.Conclusions: The RESCUE-BTK trial will clarify the safety and effectiveness of the adjunctive use of the Rotablator system in severely calcified lesions of BTK arteries in patients with CLI.

Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia

Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia

P963Coronary orbital atherectomy manufacturers and user facility device experience (MAUDE) database: a 5-year analysis of real-world complications

Abstract Background Coronary Orbital Atherectomy System was approved by the United States FDA (food and Drug Administration) on October 21st, 2013. The initial safety data were published in the ORBIT I trial. Purpose Evaluation of the reported real-life complications related to utilization of orbital coronary atherectomy system since its approval in the United States using the online FDA database. Methods The Manufacturer and User facility Device Experience (MAUDE) database was queried for all complication reports involving the orbital atherectomy (OA) “Diamondback 360 coronary orbital atherectomy system” from 1/1/2013 through 12/31/2018. All reports were searched for complications; mortality, perforation, dissections, device fragmentation, and the need for surgical intervention among reported procedures. Duplicate entries and data with no reporting on final procedure outcome were excluded. Results Over the allocated interval519 reports were identified. Seven reports were excluded (according to exclusion criteria). Over the period of slightly more than five years, coronary perforation was the most commonly reported complication mounting to 44.14% of all the reports (226 reports). Device fragmentation was reported in 18.94% of the reports (97 reports). Surgery was needed to retrieve device fragments in 13 cases (13.4% of all device fragmentation reports). Coronary dissection represented 16.21% of the reports (83 reports) and total surgical interventions were needed in 14.25% of the cases (73 reports). Finally, total reported deaths were 121 cases (23.63% of the total reports). Year 2013 2014 2015 2016 2017 2018 Number of reported complications 4 28 46 81 113 247 Percentage of reported complications Discussion The current analysis, representing data from real world reported complications to the FDA over a period of 5 years, shows that the most common reported complication during coronary orbital atherectomy was coronary perforations, followed by device breakings and fragmentation (which necessitated surgical intervention in almost 13.4% of those device fragmentation cases reported). It is hard to compare these data with published safety trials since the FDA database is involved in reporting complications and not total number of procedures. However the most striking complication involved device fragmentation, which was not seen or reported among the pivotal trials evaluating device safety. The current analysis may shed some light on a non reported complication among patients undergoing orbital atherectomy which might represent a gap between the device performance in real world as opposed to a well-designed study world.