Atherectomy System Research Articles

Rotational atherectomy versus orbital atherectomy for the treatment of calcified coronary lesions: a systematic review and meta-analysis of 81,873 patients

Abstract Background Previous studies have suggested that pre-treatment of coronary artery calcification with rotational atherectomy (RA) prior to stent deployment can enhance procedural success, but this does not necessarily translate into improved clinical outcomes. Recently, the Orbital Atherectomy (OA) system has been introduced into clinical practice to enhance lesion preparation. Purpose Our study aims to evaluate the safety and efficacy of both RA and OA as pre-treatment strategies before stent deployment in patients with coronary artery calcification. Methods We conducted a comprehensive systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies. These were identified through systematic PubMed, Web of Science, Scopus, Embase, and Cochrane searches until January 2024. Dichotomous data were pooled using risk ratio (RR), and continuous data were pooled using mean difference (MD), both with a 95% confidence interval (CI), using Stata version 17. Results Our analysis included eleven studies encompassing 81,873 patients. No significant difference was observed between RA and OA in terms of major adverse cardiovascular events (MACE) (RR: 0.81 with 95% CI [0.64, 1.02], P= 0.07). However, OA was significantly associated with a decreased incidence of all-cause mortality (RR: 0.60 with 95% CI [0.52, 0.70], P< 0.01), target vessel revascularization (TVR) (RR: 0.43 with 95% CI [0.22, 0.82], P= 0.01), coronary artery bypass grafting (CABG) (RR: 0.78 with 95% CI [0.62, 0.97], P= 0.03), and fluoroscopy time (MD: -3.93 with 95% CI [-7.39, -0.48], P= 0.03). There was no significant difference between RA and OA in cardiac death (RR: 2.65 with 95% CI [0.94, 7.51], P= 0.07), target lesion revascularization (TLR) (RR: 0.57 with 95% CI [0.23, 1.41], P= 0.22), myocardial infarction (RR: 0.79 with 95% CI [0.62, 1.01], P= 0.06), stent thrombosis (RR: 0.33 with 95% CI [0.09, 1.23], P= 0.10), stroke (RR: 0.76 with 95% CI [0.57, 1.01], P= 0.06), re-admission (RR: 0.76 with 95% CI [0.48, 1.19], P= 0.23), vessel closure (RR: 0.78 with 95% CI [0.18, 3.33], P= 0.74), procedural duration (MD: -5.43 with 95% CI [-21.71, 10.84], P= 0.51), length of hospital stay (MD: 0.21 with 95% CI [-0.47, 0.90], P= 0.54), and contrast amount (MD: -3.68 with 95% CI [-9.37, 2.01], P= 0.21). Conclusion Both RA and OA as pre-treatment strategies before stent deployment demonstrate similar outcomes for numerous cardiovascular events. However, OA is associated with lower rates of all-cause mortality, TVR, CABG, and fluoroscopy time.

Technical aspects of the new BYCROSSTM atherectomy device - preliminary results after 28 patients.

Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients. We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSSTM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention. Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m2. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions. The BYCROSSTM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSSTM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.

Intravascular Lithotripsy: Approach to Advanced Calcified Coronary Artery Lesions, Current Understanding, and What Could Possibly Be Studied Next.

Calcified and resistant narrowing of arteries poses significant difficulty in performing percutaneous coronary interventions (PCIs), as they increase the risk of subpar outcomes leading to worse clinical outcomes. Despite the existence of dedicated technologies and devices, including various balloons and atherectomy systems, they often do not ensure sufficient plaque modification and ideal vessel preparation for optimal stent deployment. Intravascular lithotripsy (IVL), a technology originally developed for urological procedures, has recently been used to safely and selectively disrupt calcified depositions in both peripheral and coronary arteries by sonic waves that seamlessly transfer to nearby tissue, enhancing vessel compliance with minimal impact on soft tissues. In the coronary arteries, the use of IVL plays a role in the process of "vessel preparation" before the placement of stents, which is crucial for restoring blood flow in patients with severe coronary artery disease (CAD), and is considered a minimally invasive technique, reducing the need for open heart surgeries and associated risks and complications. Studies have shown that IVL can lead to improved procedural success rates and favorable long-term outcomes for patients with severely calcified coronary artery disease. With the advent of IVL, the disruption of severe calcification of coronary artery and stenotic lesions before stent implantations can be performed. Despite promising data for treating calcified lesions, IVL is significantly underutilized in clinical practice, long-term clinical data and extensive research are needed to validate its further safety and efficacy. In this article, we reviewed the literature discussing the use of IVL in the coronary arteries as an approach for addressing intravascular atherosclerotic plaques, particularly focusing on heavily calcified plaques that are resistant to standard initial PCI, while also evaluating its safety in comparison to alternative methods.

Intravascular Ultrasound Assessment of Arterial Dissections Following Rotarex Atherectomy: Results of the iDissection Rotarex Study

BackgroundThere are limited data on the mechanism of the Rotarex Rotational Excisional Atherectomy System in treating femoropopliteal arterial disease. The Rotarex iDissection study is a prospective, single center study evaluating the extent of excision and dissection in de novo and restenotic (not in-stent) lesions of the femoropopliteal arteries in symptomatic peripheral arterial disease patients. MethodsConsecutive patients with symptomatic peripheral arterial disease were prospectively enrolled in the Rotarex iDissection study at a single US center after obtaining informed consent. The study was approved by a central ethics committee. Quantitative vascular angiography and intravascular ultrasound images were analyzed by an independent core laboratory. The Eagle Eye Platinum ST intravascular ultrasound (Phillips) was used to identify the depth (A, B, C for intima, media, and adventitia, respectively) and arc of dissections (1 and 2 for <180° and ≥180°, respectively) using the iDissection classification. Statistical significance was determined by a P value <.05. ResultsA total of 19 patients (20 procedures) were enrolled by 1 endovascular specialist. There were 57.9% men with mean age of 71.1 ± 9.6 years. Of the patients, 31.6% had diabetes mellitus, and 84.2% were current or past smokers. Thirty percent of treated vessels were chronic total occlusions. A total of 10 patients received stents (2 covered stents due to perforation, 6 due to National Heart, Lung, and Blood Institute Type C dissections, and 2 were primary stenting). Two distal embolizations occurred; one was attributed to the Rotarex, and both were treated with no adverse consequences. Angiographic baseline stenosis was 74.7% ± 25.6%; after Rotarex, 48.7% ± 14.8%; and after percutaneous transluminal angioplasty (PTA), 16.0% ± 6.2%. Baseline minimal lumen diameter was 1.0 ± 1.0 mm; after Rotarex, 2.4 ± 1.1 mm; and after PTA, 4.4 ± 1.0 mm. Angiographically, there was 1 type A dissection at baseline; 1 A, 1 B, and 2 C after Rotarex, and 3 A and 5 C after final adjunctive PTA. Intravascular ultrasound revealed a reference diameter of 6.2 ± 1.0 mm; 70% of patients had adventitial dissections. The mean arc of calcium was 221° ± 39.4° (moderate to severe calcium). ConclusionsThe Rotarex device is an effective atherectomy device in treating complex femoropopliteal arterial disease. A high frequency of adventitial dissections is seen with the Rotarex. The long-term outcomes of this finding need to be further studied.

Usage of rotational atherectomy and drug-coated balloon angioplasty for isolated popliteal artery lesions: two-year results of a retrospective study

Objectives In this study, perioperative properties and early and mid-term clinical outcomes of endovascular revascularization with a combined usage of rotational atherectomy (RA) and drug-coated balloon angioplasty (DCB) angioplasty for isolated popliteal artery lesion were reported. Methods A total of 28 patients with isolated popliteal artery stenosis who underwent combined RA and DCB angioplasty between December 2018 and September 2022 were analyzed retrospectively. Temren atherectomy system (Invamed, Ankara, Turkey) and Extender paclitaxel-coated drug-coated balloon catheter (Invamed, Ankara, Turkey) were used in all cases. The main outcome was primary patency; secondary outcomes were technical success, freedom from amputation, and mortality. Results The mean age of patients was 64.2 ± 9.1 years and the majority of the patients were male (n = 20; 71.4%). Types of the lesions were total occlusion in 24 limbs and critical stenosis in 4 limbs. The mean total occlusion length was 65.2 ± 14.2 mm. Flow-limiting dissection was seen in lesions of 2 patients (7.1%) and treated with prolonged balloon dilatation without bail-out stenting requirement. Technical success defined as an adequate vascular lumen (less than 30% stenosis) was achieved in 26 (92.8%) with a mean follow-up of 17.2 ± 8.2 months. The mean primary patency rates at 12 months and 24 months were 92.3% ± 3.2 and 81.2% ± 3.2, respectively. Complications included 1 distal embolization following RA, 2 flow-limiting dissections, and 3 puncture site hematomas. Conclusions Endovascular procedures using combined RA and DCB angioplasty seem to be effective alternative treatment modalities for the treatment of popliteal artery lesions with high rates of primary patency and freedom from TLR.

Difference between antegrade and retrograde orbital atherectomy system debulking using an artificial pulsatile heart model.

Debulking devices are necessary to treat severe calcified lesions. OAS has a unique characteristic that the burr moves forward and backward. There are few studies reporting the differences of ablation style between only-antegrade and only-retrograde OAS. The aim of this study was to evaluate the difference of ablation style between only-antegrade and only-retrograde orbital atherectomy system (OAS) using an artificial pulsatile heart model (HEARTROID system®) and optical coherence tomography (OCT). The calcified lesion model was inserted into the mid of left anterior descending in the HEARTROID®. Only-antegrade and only-retrograde ablation of OAS were conducted for each five lesions. Pre-OCT, OCT after low speed debulking and OCT after high speed debulking were conducted. The width and the depth of debulked area, the debulked area and the direction of debulked area were investigated. In all of 210 cross-sections, 91 debulked cross sections were chosen for analysis. Only-antegrade group had 47 debulked cross-sections, and only-retrograde group 44 cross-sections. In the evaluation of OCT after high speed debulking, the debulked area (0.76 mm2 [0.58-0.91] vs. 0.53 mm2 [0.36-0.68], p < 0.001) and the depth of debulked area (0.76 mm [0.58-0.91] vs. 0.53 mm [0.36-0.68], p < 0.001) were significantly higher in only-antegrade group compared to only-retrograde group. The debulked bias and the width of debulked area are not significantly different between the two groups. Compared to only-retrograde debulking, only-antegrade debulking acquired larger debulked area because of larger cutting depth, although the debulked bias and the width of debulked area were comparable between the two groups.

Revascularization with BYCROSS atherectomy device- protocol of a prospective multicenter observational study

BackgroundThe BYCROSS™ device is a novel device intended for use in atherectomy of the peripheral arterial disease (PAD). With the BYCROSS™ atherectomy system, also prolonged calcifying lesions can be treated in a minimally invasive manner, which was previously reserved for bypass surgery. The aim of this study is to collect additional clinical data on safety and performance of the BYCROSS™ from patients undergoing revascularization of severely stenotic or occluded peripheral arterial vessels with the BYCROSS™.Methods and designThis is an investigator-initiated national prospective multicenter observational study in patients with PAD. Sixty patients (20 per center) with PAD with stenosis higher than 80% or complete occlusion (de novo or recurrent stenosis) of vessels below the aortic bifurcation (min 3 mm vessel diameter) will be recruited. Three vascular surgery centers are participating in the study. The primary efficacy endpoint is procedural success, defined as passage of the occlusion through the BYCROSS device, and safety outcomes, explicated as freedom from device-related serious adverse events (SADEs). Secondary endpoints include primary and secondary patency rates, change in Rutherford classification, and freedom from amputation at 3 and 12 months.DiscussionThe BYCROSS atherectomy system may be a novel device for the minimally invasive treatment of prolonged calcified lesions previously reserved for bypass surgery. This national prospective multicenter observational study could represent another step in demonstrating the efficancy and safety of this device for treatment of PAD.Trial registration#DRKS00029947 (who.int).Protocol approval id#22–0047(Ethics Committee at Ludwig-Maximilians-University Munich).

TCT-537 Safety and Clinical Outcomes of Rotapro Rotational Atherectomy System

TCT-537 Safety and Clinical Outcomes of Rotapro Rotational Atherectomy System

Insights From the FDA's MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease.

Rotational atherectomy has shown promise as an adjunctive therapy to percutaneous transluminal angioplasty (PTA) and stenting for the treatment of peripheral arterial disease (PAD). However, published data regarding the safety of these devices are limited. The Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database collects reports of adverse event for medical devices. We present 3 years of MAUDE adverse events data for the Jetstream Atherectomy System (Boston Scientific) for the treatment of PAD. We searched MAUDE from January 1, 2019 to December 31, 2021. Duplicate reports and those with insufficient information were excluded, leaving a total of 500 reports for analysis. Adverse events were categorized as either patient complication, device malfunction, or both. Adverse events were classified using the Cardiovascular and Interventional Radiological Society of Europe's (CIRSE) classification system for adverse events. The most common patient complications were embolism (22; 4.4%), dissection (17; 3.4%), vessel perforation (12; 2.4%), and device fracture in the patient (6; 1.2%). The most common modes of device failure were entrapment of the device on the guidewire (134; 27%), loss of blade rotation (116; 23%), loss of aspiration (99; 20%), and mechanical damage (57; 11%). As per the CIRSE adverse events classification, most events had no post-procedural sequelae (475; 95%), followed by those requiring prolonged observation (14; 2.8%), and post-procedural therapy without long-term sequelae (10; 2.0%). One hundred six devices (21%) were returned for manufacturer analysis. We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. This analysis provides further understanding of the safety profile and modes of failure of Jetstream, and could help guide improvements in product design and manufacturer-user training. There is greater need for root-cause analysis that can aided by returning devices to the manufacturer. We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. The MAUDE database is useful for capturing and characterizing modes of device failure/malfunction not typically described in conventional clinical studies. This may provide valuable information to help guide improvements in product design and manufacturer-user training. This information could also potentially be useful in helping establish manufacturer and product liability in the setting of medicolegal claims. We hope that by contributing to the growing understanding of the safety profile of the Jetstream Atherectomy System, our study may help physicians and patients come to more informed decisions regarding treatment options for PAD.

Atherectomy with a Novel Device Offering Wider Options

Catheter-based atherectomy has been discussed for some years, although the conclusions have been controversial. Recent study data did show the feasibility of multifunctional atherectomy devices for complex lesion morphologies, with moderate material use. This is then thus an alternative to bypass surgery, although a direct comparison is lacking.The results of the ByCross approval study were compared to technical and clinical data from various atherectomy systems in terms of range of indication, limitations as defined by the manufacturer, the success and complication rate and the instructions for use. As in many recent studies, a residual stenosis ≤50% after atherectomy and ≤30% in the completion imaging was defined as the primary endpoint and proof of technical success.Lesions recruited for the ByCross study were more complex than in other studies, with respect to the lesion length (124.7mm vs. 34mm in the EASE study and 67.2mm in the VISION study) and the degree of stenosis (99.4% vs. 88.5% in the EASE and 78,7% in the VISION study). Calcification was also more severe - as defined by the PACSS (Peripheral Artery Calcification Severity Score). ByCross allowed recanalisation of lesions without wire passage prior to atherectomy (26.82%), which is a must for all other systems. The variable tip diameter of the ByCross can achieve a lumen gain of 4.7mm without tip or wire exchange or run time limits. The 0% rate of embolic events, which is unique for atherectomy device approval studies, can be explained by the working principle and the high aspiration rate. No vessel injuries occurred, and the 6-month follow-up results showed 0% revascularisation rate.New generation atherectomy systems offer safe and effective enlargement of the endovascular portfolio. The ByCross device is an atherectomy, thrombectomy and crossing device free from investment and has a wider range of indications for the iliac and the femorodistal segments, which supports ByCross atherectomy as an alternative for bypass surgery.

Feasibility and outcome of the Rotapro system in treating severely calcified coronary lesions: The Rotapro study.

The Rotapro study was conducted to evaluate the safety and feasibility of the new Rotapro rotational atherectomy system (RAS) for lesion preparation in calcified coronary artery stenosis. Between 2015 and 2019 consecutive patients undergoing rotational atherectomy (RA) with the new Rotapro system and the conventional rotablator (Rotablator) were included from the Bad Krozingen Rotablation Registry. The primary endpoint was the incidence of in-hospital major adverse cardiovascular and cerebral event (MACCE) rate. Rotablation was performed in 3.6% of all patients (n = 597) treated by percutaneous coronary intervention. Procedural outcomes were compared according to the applied RAS (n = 246 Rotapro vs. n = 351 Rotablator). Overall technical success was achieved in 98.3% of patients. The primary endpoint of in-hospital MACCE was comparable between the Rotapro- and the Rotablator-group (3.7% vs. 5.7%, respectively, p = 0.254). The Rotapro group was associated with significant reductions of fluoroscopy time (30 vs. 38 min, p < 0.0001), procedural time (82.5 vs. 96 min, p = 0.0003), applied contrast volume (210 vs. 290 mL, p < 0.0001) and radiation dose (6129 vs. 9827 cGy*cm2, p < 0.0001) compared to the Rotablator group. The present study demonstrates the safety and efficacy of the new Rotapro system. Inhospital MACCE rates were comparable between both RAS, whereas Rotapro was associated with less fluoroscopy time, radiation dose as well as contrast use.

Acute and mid-term results of percutaneous coronary intervention for severely calcified coronary artery lesions with orbital atherectomy system.

Severely calcified lesions present many challenges for percutaneous coronary intervention (PCI). This study aimed to assess the safety and efficacy of the orbital atherectomy system (OAS) in treating calcified coronary lesions. The present study included 422 consecutive cases (546 lesions) who underwent PCI with OAS in Kyoto Katsura Hospital from February 2018 to December 2021. We assessed the following clinical outcomes after OAS was used for severely calcified lesions: procedure success, angiographic complications, in-hospital Major Adverse Cardiovascular Events (MACE), and mid-term results. The primary endpoint was the combination of incidence of MACE at 12 months, cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Of all the cases, 74% patients were men and the mean age was 76.5 years. In total, 81% of lesions were treated with drug-coated balloon, and 14% were implanted with stents. Procedural success rate was 96.3%. Coronary perforation occurred in 0.5% and persistent slow flow in 2% lesions. There was 1 cardiac death (0.5%), 43 periprocedural MIs (10.2%), and no TLR as in-hospital MACE. The incidence of MACE at 12 months was 8.4%, including 2.1% cardiac death and 6.9% TLR. In multivariate analysis, CKD, hemodialysis, and restenosis lesions were independently associated with MACE at 12 months. Periprocedural MI was not an independent predictor of MACE. This study suggested that OAS is a safe and effective treatment option for calcified coronary lesions with acceptable acute and mid-term results; thus, it can be an alternate for reducing calcified plaque.

Trends in outcomes associated with the use of Auryon atherectomy system in a real-world setting

BackgroundWhile endovascular approaches are considered first line treatment for stenosis or occlusion of the lower limb arteries, major dissections and embolic events remain procedural risks. Newer technologies are needed which limit these complications while achieving desired clinical outcomes. MethodsThe Auryon atherectomy system (AngioDynamics) consists of a 355-nm wavelength solid-state Nd:YAG short pulse laser combined with dedicated optical catheters. This single-center, retrospective chart review assessed the safety and efficacy of this device in patients with PAD treated at our center between March and December 2020. ResultsA total of 55 patients were included. Mean age was 73.7 ± 9.3 years with 63.6 % of patients being males. Lesions were above the knee only for 16.4 % of patients, below the knee only for 3.6 %, and both above and below the knee for 80.0 % of patients. One patient had in-stent restenosis. Chronic total occlusions and critical limb ischemia were present for 43.6 % of patients respectively. Procedural success, defined as <30 % residual stenosis without any complications, was achieved in 85.5 % of patients. Stenosis/re-occlusion occurred in 25.5 % of patients at a mean of 168.9 ± 73.4 days with resultant target lesion revascularization (TLR) at 218.3 ± 92.4 days. Four patients underwent minor amputations. No patients experienced procedure-related complications. One patient died unrelated to the procedure. ConclusionThe Auryon laser system was shown to be safe and effective in this real-world patient population with no procedural adverse events or deaths and improvements in patient outcomes.

Coronary Intra-orbital Atherectomy Complications and Procedural Failure: Insight From the Manufacturer and User Facility Device Experience (MAUDE) Database.

The Diamondback 360® Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St. Paul, MN) is the first and only orbital atherectomy system approved by the US FDA for the treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal. The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports on the Diamondback 360® Coronary from January 2019 to January 2022. A total of 566 events were reported during the study period. After the exclusion of duplicate reports, the final cohort included 547 reports. The most common mode of failure was break or separation of a device part (40.4%, n = 221) mainly due to breaking in the tip of the ViperWire(66.1%), driveshaft (22.7%), or crown (12.2%). The most common vessel associated with events was the left anterior descending artery (31.4%), followed by the right coronary artery (26.9%), left circumflex (21.6%), and left main coronary artery (6.4%). The most common clinical adverse outcome was perforation (33.0%, n = 181) with 23.7% resulting in cardiac tamponade. Most perforation cases were treated by covered stent (44.2%), surgery (30.5%), stent (98%), and balloon angioplasty (9%). There were 89 (16.3%) events of death with 67% due to perforation (p < 0.001). Our study provided a glimpse of real-world adverse outcomes and common modes of failure due to orbital atherectomy. The most common mode of failure was the break or separation of a device part and the most common complication was perforation according to the MAUDE database. It will help physicians toanticipatecomplications and escalate careappropriately.

The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device

The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN) is a peripheral arterial disease management system that was recalled in December 2021 secondary to repeated guidewire prolapse. We set forth to analyze the patient problems and device issues that caused the device to be recalled and determine if the recall had a significant impact on the device reports utilizing the US Food and Drug Administration (FDA) database Manufacturer and User Facility Device Experience (MAUDE). MAUDE was queried for all adverse report events for the HawkOne device six months prior to and after its recall date in December 2021. Data collected included patient-based issues, device-based issues, and if the device was evaluated by the manufacturer. Fisher's exact test was utilized. There were 72 unique events reported prior to the device recall and 35 events reported after the recall. The majority of adverse events resulted in no adverse clinical outcomes before (55.6%) and after (21.3%) the recall. The most common reported device issue was detachment both before (54.8%) and after (57.1%) the recall. There was no significant difference in the rate of any patient outcome or device problem after the recall. The number of devices evaluated by the manufacturer after the recall was significantly reduced (69.9% vs 11.4%; P ≤ .001). There was no significant change in the rate of specific patient outcomes or device issues after the HawkOne device recall. The rate at which the devices were evaluated by the manufacturer significantly reduced after the recall. These data indicate possible influences that an official device recall might have on reporting to the MAUDE and warrant further study to understand the complexity of user-based feedback of such endovascular devices.

Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group.

Since the publication of the 2015 EAPCI consensus on rotational atherectomy, the number of percutaneous coronary interventions (PCI) performed in patients with severely calcified coronary artery disease has grown substantially. This has been prompted on one side by the clinical demand for the continuous increase in life expectancy, the sustained expansion of the primary PCI networks worldwide and the routine performance of revascularization procedures in elderly patients; on the other side, the availability of new and dedicated technologies such as orbital atherectomy and intravascular lithotripsy, as well as the optimization of the rotational atherectomy system, have increased operators' confidence in attempting more challenging PCI. This current EAPCI clinical consensus statement prepared in collaboration with the EURO4C-PCR group describes the comprehensive management of patients with heavily calcified coronary stenoses, starting with how to use non-invasive and invasive imaging to assess calcium burden and inform procedural planning. Objective and practical guidance is provided on the selection of the optimal interventional tool and technique based on the specific calcium morphology and anatomic location. Finally, the specific clinical implications of treating these patients are considered, including the prevention and management of complications, and the importance of adequate training and education.

Effectiveness of using both rotational atherectomy with smallest burr and orbital atherectomy system for stentless treatment of calcified nodules.

Effectiveness of using both rotational atherectomy with smallest burr and orbital atherectomy system for stentless treatment of calcified nodules.

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

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. 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. 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). 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.

Safety and effectiveness of bycross rotational atherectomy and aspiration device: a prospective, multi-center pre-market approval study

PurposeTo demonstrate safety and effectiveness of the novel ByCross® atherectomy system for treatment of complex femorodistal > 80% arterial stenosis.Materials and MethodsFrom September 2018 until April 2019 39 patients with 41 femorodistal lesions including the femoropopliteal and distal popliteal segments were treated in a prospective, nonrandomized pre-market approval study with 6 months follow up using the ByCross® atherectomy device (ClinicalTrials.gov identifier NCT03724279). Adjunctive treatment with balloon dilatation or stenting was allowed by the protocol. Mean patient age was 72 years with 62% male. The average lesions length was 125 ± 118 mm (30 and 450 mm) with an average reference vessel diameter of 5.2 ± 0.85 mm and a mean stenosis of 96.4 ± 6.2% based on CT or MR angiography measurements. The primary performance endpoint was defined as acute procedural success with angiographically determined residual stenosis of ≤ 50% and of ≤ 30% after atherectomy or adjunctive treatment. The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Secondary endpoints were stenosis of the target lesions measured by duplex ultrasound (DUS) and the ankle-brachial pressure index (ABPI) at discharge, 30 and 180 days as well as any major adverse event (MAE) through 6 months.ResultsThe acute procedural success was achieved in 39/41 (95.12%) lesions, partially without wire guidance (11/41 (26.82%)). No embolic protection was used, and adjunctive angioplasty and stenting was performed in 40/41 (97.56%) and 12/41 (29.26%) lesions, respectively without device related MAE’s at 30 days. Mean level of stenosis was 5.7% at discharge and 21.7% at 6 months FU measured by DUS. Mean ABPI was 0.8, 1.0 and 0.8 at baseline, discharge, and 6 months FU respectively.ConclusionsBased on the high technical success rate and the low rates of MAE`s through six months, the BYCROSS® Atherectomy System has shown to be safe and effective for the crossing and atherectomy of complex lower-extremity arterial occlusions.Trial registrationOctober 17, 2018,retrospectively registered. ClinicalTrials.gov Identifier: NCT03724279; https://clinicaltrials.gov/ct2/show/record/NCT03724279

Novel Therapeutic Concepts for Complex Femoropopliteal Lesions Using the Jetstream Atherectomy System.

The presence of severe arterial calcification is associated with less favorable outcomes in terms of procedural and clinical success as well as higher rates of major adverse limb events. Recent studies incorporating rotational atherectomy for effective preparation of severely calcified lesions demonstrate beneficial procedural outcomes by obtaining maximal luminal gain and improved long-term outcomes. This prospective single-center, observational study includes patients with severely calcified femoropopliteal lesions with chronic limb ischemia Rutherford 1-5 between January 2017 and July 2019, who underwent atherectomy using the Jetstream Atherectomy system, followed by drug-coated balloon angioplasty. Lesion calcification was categorized by the Peripheral Arterial Calcium Scoring System (PACSS), whereas lesion complexity was classified by the Transatlantic Inter-Society Consensus (TASC). Safety and efficacy aspects in terms of vessel injury, thromboembolism, and clinical success were systematically analyzed up to 12 months of follow-up (FU). In 162 consecutive patients, 210 non-stented and 22 stented lesions were treated. Twelve (7.4%) patients received bail-out stenting. Mean lesion length was 24.2±4.8 cm; 51% were chronic total occlusions (mean occlusion length 18.2±5.1 cm). TASC C lesions were present in 38 patients (23.5%) and TASC D lesions in 124 patients (76.5%). The mean PACCS score was 3.3±0.9. Device success was achieved in 88%; procedural success was noted in 99% of the lesions. Embolic protection device was used in 11.7%. Perforation or dissection occurred in none of the cases. Asymptomatic peripheral embolization was noted in 10 patients (6.2%). Clinical FU at 12 months was available in 157 of 162 patients (96.9%). At 12 month FU, (1) mean Rutherford classification at baseline of 3.7±0.6 significantly dropped to 1.0±0.9 (p<0.05), (2) baseline mean anke-brachial index (ABI) of 0.4±0.1 significantly increased to 0.8±0.2 (p<0.05), (3) 92.6% were free from target lesion revascularization (TLR), (4) 95.1% were free from target vessel revascularization (TVR), and (5) binary restenosis measured by duplex occurred in 22 patients (13.6%). Multivariate analyses showed lesion length as predictive of stent placement (p=0.02), whereas both lesion length (p=0.006) and PACCS score (p=0.02) are predictive of clinical success. Rotational atherectomy in combination with drug-coated balloon (DCB) can be safely performed in long, calcified (non-) occlusive lesions with a relatively low rate of bail-out stenting and favorable clinical mid-term results. In this prospective, single arm study we demonstrated that combination treatment using rotational atherectomy and DCB is safe and effective in complex and calcified TASC C/D femoropopliteal lesions in patients with claudication or CLTI in a real-world clinical setting. Despite mean lesion length of >20cm and a relatively high rate of chronic total occlusions, the rate of bail-out stenting was surprisingly low (7.4%), whereas the rates of freedom from TLR and TVR were surprisingly high. Thus, our study may encourage vascular specialists to choose an endovascular -first approach even in such complex and calcified femoropopliteal lesions and occlusions in daily clinical practice.