Midterm outcomes of rotational atherectomy-assisted endovascular treatment of severe peripheral arterial disease.

OBJECTIVE: We evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of patients with superior outcomes. METHODS: We conducted a single-center, physician-initiated, nonindustry-sponsored retrospective analysis of patients with Rutherford category ranging from II to V and de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries treated with atherectomy-assisted angioplasty (Jetstream rotational atherectomy + drug-eluting ballooning). In cases of subintimal recanalization or patients without an SFA stamp, with previous ipsilateral bypass surgery, systemic coagulopathy, end-stage renal disease requiring hemodialysis, life expectancy of <12 months, and intolerance to aspirin, clopidogrel, and/or heparin were excluded. RESULTS: In a total of 103 enrolled patients, the median SFA and/or popliteal lesion length was 80 mm (interquartile range, 61.2 mm) with 73 lesions being occlusive (70.9%) and 84 (81.5%) classified as Fanelli calcification score 3 and 4. Technical success was met in 96.1% of cases (n = 99) at a median operative time of 108 minutes. Adjunctive stenting was needed in 10 patients (9.8%). At a median follow-up of 18.0 ± 10.8 months, Rutherford class clinical improvement was present in 77 patients (74.8%), and 7 patients (6.79%) presented target lesion occlusion needing reintervention in 6 cases (5.82%). The primary patency rates were 97% at 12 months and 83% at 24 months with secondary patency rates of 99% at 12 months and 91% at 24 months of follow-up. There were no significant differences when treating differently located lesions, diabetic vs nondiabetic patients, or comparing experienced vs nonexperienced operators. CONCLUSIONS: The use of rotational atherectomy and drug-eluting balloons for the treatment of severe femoropopliteal disease showed relatively low need for bailout stenting and good midterm primary patency rates. The influence of lesion location, diabetes mellitus, or operator experience did not show statistically different results in terms of patency. Longer term outcomes and comparative analysis are needed to consolidate further clinical evidence.

Practices and outcomes of rotational atherectomy in China: The Rota China registry.

BACKGROUND: Rotational atherectomy (RA) remains an integral tool for the treatment of severe coronary calcified lesions despite emergence of newer techniques. We aimed to evaluate the contemporary clinical practices and outcomes of RA in China. METHODS: The Rota China Registry (NCT03806621) was an investigator-initiated, prospective, multicenter registry based on China Rota Elite Group. Consecutive patients treated with RA were recruited. A pre-designed, standardized protocol was recommended for the RA procedure. The primary safety endpoint was major adverse cardiovascular events (MACE: composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) at 30 days. The primary efficacy endpoint was procedural success. RESULTS: Between July 2018 and December 2020, 980 patients were enrolled at 19 sites in China. Mean patient age was 68.4 years, and 61.4% were men. Radial access was used in 79.1% patients, and 32.7% procedures were guided by intravascular imaging. A total of 22.6% procedures used more than 1 burr, and the maximal burr size was ≥1.75 mm in 24.4% cases, with burr upsizing in 19.3% cases, achieving a final burr-to-artery ratio of 0.52. Procedural success was achieved in 91.1% of patients, and the rate of 30-day and 1-year MACE was 4.9% and 8.2%, respectively. Multivariable analysis identified the total lesion length (HR 1.014, 95% CI: 1.002-1.027; p = 0.021) as predictor of 30-day MACE, and renal insufficiency (HR 1.916, 95% CI: 1.073-3.420; p = 0.028) as predictor of 1-year MACE. CONCLUSIONS: In this contemporary prospective registry in China, the use of RA was effective in achieving high procedural success rate with good short- and long-term outcomes in patients with severely calcified lesions.

Current applications, procedural and 1-year outcomes of Rotatripsy for the treatment of calcified coronary lesions.

BACKGROUND: Intravascular lithotripsy (IVL) combined with rotational atherectomy (RA), known as Rotatripsy, is used to treat severe coronary artery calcification (CAC), though data on efficacy, midterm safety and use sequence is limited. We aimed to identify indicators for Rotatripsy use and to assess its safety and success rates, both acutely and at 1-year follow-up. METHODS: Patients undergoing Rotatripsy for severe CAC across six centers from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success [composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised Rotatripsy-related complications and MACE at 1-year follow-up. RESULTS: A total of 114 patients (75 ± 9 years, 78% male) underwent Rotatripsy for 120 lesions. In the majority of procedures RA was followed by IVL, mostly electively (n = 68, 57%) but also for balloon underexpansion (n = 37, 31%) and stent crossing failure (n = 1, 1%). Diverse and complex target lesions were addressed with an average SYNTAX score of 24.6 ± 13.0. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications included two (2%) coronary perforations, one (1%) coronary dissection and one (1%) burr entrapment. At 1-year follow-up(present in 77(67%) patients), MACE occurred in 7(9%) cases. CONCLUSIONS: Over a 1-year follow-up period, Rotatripsy was safe and effective, predominantly using RA electively before IVL.

Methods for treating coronary eruptive calcified nodules.

Eruptive calcified nodules (CNs) are a manifestation of severely calcified plaques, which exist in acute coronary syndrome (ACS), non-ACS lesions. Optical coherence tomography is crucial for diagnosing and treating eruptive CNs in clinical practice. Management of eruptive CNs is still a challenge for interventional cardiologists. There have been significant advances in the treatment of eruptive CNs such as intravascular lithotripsy, excimer laser coronary atherectomy, rotational atherectomy, and orbital atherectomy. We find a range of treatment modalities to be effective under different conditions. The selection of these devices should be considered based on guidewire position, lesion characteristics, clinical manifestations, and operator's experiences.

Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Comparison of intravascular lithotripsy versus rotational atherectomy for the treatment of severe coronary artery calcification.

BACKGROUND: Calcified lesions are one of the most challenging cases for PCI, where optimal angiographic results and satisfying outcomes are hard to achieve. METHODS: We evaluated the baseline clinical, procedures characteristics and outcomes of patients with severe coronary artery calcification (CAC) who underwent coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA). RESULTS: Respectively 152 and 238 patients who underwent IVL and RA are enrolled from January 2023 to November 2023. Regarding demographic characteristics, the gender proportion, medical history of PCI and smoke history among groups reach statistical significance. Left anterior descending and right coronary artery were the main vessels treated in both groups. The 2.5 and 3.0 mm IVL balloons and 1.5 mm burr were the most commonly used. 99.3% cases were successfully implanted drug-eluting stents after IVL balloon pre-treatment, which was higher than in the group treated with RA. During hospitalization, there were no serious adverse events in the IVL group, but there were two adverse events in the RA group. Procedural complications were higher in the RA group than the IVL group (5.5% vs. 0.7%, P = 0.027). CONCLUSIONS: IVL appears to be safe and effective for the treatment of severe CAC lesions compared to RA.

Injury of the superficial femoral artery and posterior tibial artery associated with an atherectomy device.

OBJECTIVES: Rotational 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). METHODS: A 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). RESULTS: The 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. CONCLUSION: While 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.

Long-term comparison of rotational and directional atherectomy outcomes in patients with femoropopliteal lesions.

Objective: This study aims to elucidate the differences in vessel patency rates, procedural complications, and the need for repeat interventions between these two techniques, thereby providing insights into the optimal atherectomy strategy for managing peripheral arterial disease in the femoropopliteal segment. Material and Methods: This retrospective study investigated the long-term effectiveness of two atherectomy techniques, rotational atherectomy (RA) and directional atherectomy (DA), in treating lower extremity peripheral artery disease (LE-PAD) affecting the superficial femoral artery (SFA) and popliteal arteries. A total of 134 patients with symptomatic LE-PAD and significant stenosis (70%-99%) were included and divided into two groups based on the atherectomy method used. Both groups underwent similar pre- and post-atherectomy procedures, including drug-coated balloon angioplasty. The primary outcome measure was clinical success, defined as procedural success and an improvement in Rutherford classification at 1 year. Results: Baseline characteristics were similar between the two groups, with no significant differences in demographics or lesion characteristics, except for a higher proportion of right-sided lesions in the DA group. While both RA and DA effectively improved ankle-brachial index (ABI) and Rutherford classification at 12 months, RA demonstrated superior long-term benefits, with significantly higher ABI at 24 months and a greater proportion of asymptomatic patients. Although RA had a longer procedural duration and a higher incidence of dissection, it resulted in lower residual stenosis and fewer cases of treated segment thrombosis than DA. Both RA and DA are effective treatment options for femoropopliteal lesions, but RA may offer advantages in long-term symptom management and vessel patency. Conclusion: Both rotational and directional atherectomy effectively treat femoropopliteal lesions, with rotational atherectomy demonstrating superior long-term outcomes in terms of symptom management and vessel patency. Despite longer procedural times and a slightly higher risk of dissection, rotational atherectomy resulted in lower residual stenosis and fewer cases of treated segment thrombosis than directional atherectomy.

Rotational Atherectomy in Coronary Heart Disease Patients with Different Rotational Speed: In Hospital and Six-Month Outcomes.

Background: Rotational atherectomy (RA) is an important technique for the management of severe coronary calcification. However, optimal rotational speed is yet to be defined. Methods: A total of 372 coronary heart disease (CHD) patients were retrospectively analyzed between February 2017 and January 2022. The patients were divided into four groups based on the maximum RA speed: group 1 ( < 150,000 rpm, 76 cases), group 2 (150,000 rpm, 156 cases), group 3 (160,000 rpm, 90 cases) and group 4 ( ≥ 170,000 rpm, 50 cases). The outcomes analyzed were procedural complications, six-months major cardiovascular and cerebrovascular events (MACCE) and chronic heart failure. Results: Patients in group 4 had a higher incidence of slow flow during the RA operation (p = 0.025). There was no significant difference in other complications among the four groups, as well as six-month MACCE. After adjusting for confounding factors, increase in rotational speed led to a higher probability of slow flow (p for non-linearity = 0.131; adjusted model) and MACCE (p for non-linearity = 0.183; adjusted model). Logistic regression analysis showed that rotational speed was a predictor of slow flow during RA operation (OR = 1.25, 95% CI: 1.05~1.49, p = 0.01). Moreover, the analysis demonstrated that individuals with lower rotational speed ( < 150,000 rpm) were at 230% higher risk of vasospasm compared with a higher rotational speed (160,000 rpm) (OR = 3.3, 95% CI: 1.08~10.09, p = 0.036). Conclusions: CHD patients treated with a rotational speed of ≥ 170,000 rpm had a higher risk of slow flow after RA. Rotational speed is an independent risk factor for slow flow in CHD patients. Moreover, a rotational speed of < 150,000 rpm was associated with a higher risk of vasospasm compared with rotational speed of 160,000 rpm. There was no significant difference in six-month outcomes in comparison to elective CHD patients with different rotational speeds, and the probability of MACCE was intensified with increase in rotational speed.

Outcomes of Patients Undergoing Rotational Atherectomy with Intra-Aortic Balloon Pump Support in Patients with Multivessel Disease and Low Left Ventricular Ejection Fraction.

Background: The aim of the present study was to investigate whether intra-aortic balloon pump (IABP) support was associated with better outcomes after rotational atherectomy (RA) in patients with multivessel disease and low left ventricular ejection fraction (LVEF). Methods: Between January 2015 and December 2021, 596 consecutive patients with severely calcified coronary lesions who underwent elective RA were retrospectively enrolled. Of these, a total of 156 patients were included in this study based on the propensity score matching and divided into two groups according to elective IABP insertion (IABP group, n = 80) or no insertion (non-IABP group, n = 76) before the RA procedure. The primary endpoints were procedural success and major adverse cardiovascular events (MACE) before discharge. The secondary endpoints were mortality and readmission due to heart failure (HF) during 90-day and 180-day follow-up. Results: 77 of patients (96.3%) in the IABP group and 72 of patients (94.7%) in the non-IABP group got procedural success (p = 0.714), separately. We had not observed significant differences in periprocedural complications except for less frequent hypotension in the IABP group (p < 0.001). In-hospital MACE occurred in 7.5% of patients who received IABP support, which was significantly lower compared to the non-IABP group (p = 0.002). In addition, the cumulative incidence of readmission due to HF was also significantly lower in the IABP group during the 90-day (p < 0.001) and 180-day (p = 0.004) follow-up. However, there were no significant differences between groups regarding the incidence of all-cause mortality. Conclusions: The present study suggests the important role of IABP support in improving the outcomes of patients after RA if multivessel disease and low LVEF are anticipated. Prophylactic IABP implantation was related to a lower incidence of in-hospital MACE, and readmission due to HF within 90-day and 180-day follow-up without significant impact on the procedural success and all-cause mortality.

Prognostic Impact of Periprocedural Myocardial Infarction in Patients with Heavily Calcified Coronary Artery Disease Receiving Rotational Atherectomy.

Background: Periprocedural myocardial infarction (PMI) occurs more frequently in patients with heavily calcified lesion and undergoing rotational atherectomy (RA). However, there are limited studies addressing prognostic impact of PMI in patients requiring RA due to severe coronary artery calcification (CAC). Therefore, the objective of this study was to determine the prognostic impact of PMI in patients who underwent percutaneous coronary intervention (PCI) using RA. Methods: A total of 540 patients (583 lesions) who received PCI using RA were enrolled between January 2010 and October 2019. PMI was defined as elevations of creatine kinase-myocardial band (CK-MB) > 10 times the upper limited normal. Patients were divided into a PMI group and a non-PMI group. Primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), a composite of cardiac death, target-vessel myocardial infarction, target-vessel revascularization, and cerebrovascular accident. Results: Although in-hospital events occurred more frequently in the PMI group than in the non-PMI group (15 [3.0%] vs. 6 [13.3%], p = 0.005), the incidence of MACCEs at 1 month, 1-12 months, or 12 months failed to show a significant difference between the two groups (1 month, 10 [2.0%] vs. 1 [2.2%], p > 0.999; 1-12 months, 39 [7.9%] vs. 7 [15.6%], p = 0.091; 12 months, 49 [9.9%] vs. 8 [17.8%], p = 0.123). Conclusions: This study shows that PMI after RA in patients with severe CAC was associated with more frequent in-hospital events and a nonsignificant trend for more events during 1 year follow-up.

Prognostic Value of Angiography-Derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease Undergoing Rotational Atherectomy.

Background: Rotational atherectomy (RA) is the major tool used to treat severely calcified lesions in patients with coronary artery disease (CAD). The relationship between coronary microvascular dysfunction and RA remains unknown. Therefore, we attempted to explore the predictive implications of the coronary angiography-derived index of microcirculatory resistance (angio-IMR) in CAD patients undergoing RA. Methods: This retrospective study included 118 patients with severe coronary calcification who underwent a successful RA from January 2018 to June 2021. The angio-IMR was calculated based on computed flow and pressure dynamic principles to assess coronary microcirculatory function. Follow-up was performed on all patients for major adverse cardiovascular events (MACEs), including all-cause death, non-fatal myocardial infarction, target vessel revascularization (TVR), and stroke. Results: The mean angio-IMR for all patients was 25.58 ± 7.93. Patients were stratified the groups based on a mean angio-IMR of 25, fifty-four (45.8%) patients had angio-IMR ≥ 25. The logistic regression analysis showed that angiography-derived fractional flow reserve was significantly associated with coronary microvascular dysfunction. After median follow-up of 21.7 (15.1-24.0) months, MACEs occurred in 30.6%, including 12.5% all-cause deaths, 6.4% non-fatal myocardial infarction, 14.5% TVR, and 0.9% stroke. Kaplan-Meier analysis demonstrated that patients with angio-IMR ≥ 25 had greater cumulative MACEs (41.6%) and TVR (20.7%) than patients with preserved angio-IMR. COX regression analysis indicated that angio-IMR ≥ 25 and reduced left ventricular ejection fraction were independent predictors of MACEs. In addition, angio-IMR ≥ 25 and lowered minimum luminal area independently predicted TVR occurrence. Conclusions: In CAD patients undergoing RA, angio-IMR ≥ 25 was an independent and significant predictor of MACEs and TVR. Clinical Trial Registration: NCT05435898.

Contribution of the Optical Coherence Tomography in Calcified Lesions.

Coronary artery calcification is a complex process found predominantly in the elderly population. Coronary angiography frequently lacks sensitivity to detect, evaluate and quantify these lesions. Yet calcified lesions are considered stable, it remains associated with a higher rate of peri procedural complications during percutaneous coronary intervention (PCI) including an increased risk of stent under expansion and struts mal apposition leading to poor clinical outcome. Intracoronary imaging (Intravascular Ultra Sound (IVUS) and Optical Coherence Tomography (OCT)) allows better calcified lesions identification, localization within the coronary artery wall (superficial or deep calcifications), quantification. This lesions characterization allows a better choice of dedicated plaque-preparation tools (modified balloons, rotational or orbital atherectomy, intravascular lithotripsy) that are crucial to achieve optimal PCI results. OCT could also assess the impact of these tools on the calcified plaque morphology (plaque fracture, burring effects…). An OCT-guided tailored PCI strategy for calcified lesions still requires validation by clinical studies which are currently underway.

Coronary intravascular lithotripsy and rotational atherectomy for severely calcified stenosis: Results from the ROTA.shock trial.

BACKGROUND: Severely calcified coronary lesions present a particular challenge for percutaneous coronary intervention. AIMS: The aim of this randomized study was to determine whether coronary intravascular lithotripsy (IVL) is non-inferior to rotational atherectomy (RA) regarding minimal stent area (MSA). METHODS: The randomized, prospective non-inferiority ROTA.shock trial enrolled 70 patients between July 2019 and November 2021. Patients were randomly (1:1) assigned to undergo either IVL or RA before percutaneous coronary intervention of severely calcified coronary lesions. Optical coherence tomography was performed at the end of the procedure for primary endpoint analysis. RESULTS: The primary endpoint MSA was lower but non-inferior after IVL (mean: 6.10 mm2 , 95% confidence interval [95% CI]: 5.32-6.87 mm2 ) versus RA (6.60 mm2 , 95% CI: 5.66-7.54 mm2 ; difference in MSA: -0.50 mm2 , 95% CI: -1.52-0.52 mm2 ; non-inferiority margin: -1.60 mm2 ). Stent expansion was similar (RA: 0.83 ± 0.10 vs. IVL: 0.82 ± 0.11; p = 0.79). There were no significant differences regarding contrast media consumption (RA: 183.1 ± 68.8 vs. IVL: 163.3 ± 55.0 mL; p = 0.47), radiation dose (RA: 7269 ± 11288 vs. IVL: 5010 ± 4140 cGy cm2 ; p = 0.68), and procedure time (RA: 79.5 ± 34.5 vs. IVL: 66.0 ± 19.4 min; p = 0.18). CONCLUSION: IVL is non-inferior regarding MSA and results in a similar stent expansion in a random comparison with RA. Procedure time, contrast volume, and dose-area product do not differ significantly.

Intravascular lithotripsy compared to rotational atherectomy for the treatment of calcified distal left main coronary artery disease: A single center experience.

BACKGROUND: The safety and efficacy of intravascular lithotripsy (IVL) for the treatment of calcified distal left main (LM) disease remains unclear, especially compared to rotational atherectomy (RA). METHODS: We retrospectively analyzed the baseline clinical, angiographic, intravascular ultrasound (IVUS) characteristics and procedural outcomes of 107 patients who underwent distal LM percutaneous coronary intervention (PCI) with IVL (with or without adjunct atherectomy) versus RA alone for plaque modification before stenting at a single center between 2020 and 2022. RESULTS: A total of 50 patients underwent calcium modification with IVL with or without adjunct atherectomy and 57 with RA only. The mean age was 73 years and with a high prevalence of diabetes (58.9%), chronic kidney disease (42.1%), prior revascularization (coronary artery bypass graft surgery [36.4%] or prior PCI [32.7%]). Acute coronary syndrome was the primary indication for PCI in over 50% of the patients in both groups. Medina 1-1-1 LM bifurcation disease was identified in 64% and 60% of the IVL and RA groups (p = 0.64) respectively. Final minimum stent area in distal LM (>8.2 mm2 ), ostial LAD (>6.3 mm2 ) and ostial LCX (>5.0 mm2 ) were achieved in 96%, 85% and 89% of cases treated with IVL respectively and 93%, 93% and 100% of cases treated with RA respectively (LM p = 1.00; LAD p = 0.62; LCX; p = 1.00 for difference between the two groups). Procedural success (technical success without in-hospital major adverse events) was achieved in 98% of the IVL group and 86% of the RA-only group (p = 0.04). There were eight procedural complications (flow-limiting dissection, perforation, or slow/no-reflow) in the RA group compared to four in the IVL group (NS), and one patient in the RA required salvaged mechanical support compared to none in the IVL group. CONCLUSION: Plaque modification with coronary IVL appears to be efficacious and safe for the treatment of severely calcified distal LM lesions compared to RA only. Larger randomized studies are needed to confirm these findings.

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

INTRODUCTION: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

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

INTRODUCTION: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

Stand-Alone Rotational Atherectomy Versus Combination With Drug-Coated Balloon Angioplasty for the Endovascular Treatment of Heavily-Calcified Femoropopliteal and Popliteal Lesions.

BACKGROUND: Despite major technical advances in the endovascular treatment for peripheral artery disease (PAD), heavy calcification still represents a major obstacle to overcome both due to the high number of periprocedural complications (dissections, embolization, etc) and the limited long-term durability. A promising tool to overcome these obstacles is debulking calcified lesions with atherectomy. Since vessel preparation with atherectomy might even improve the diffusion of antiproliferative substances, we wanted to evaluate the impact of atherectomy±DCB in lower extremity PAD. OBJECTIVES: To explore the safety, efficacy, and long-term durability on treatment of rotational atherectomy in heavily-calcified complex femoropopliteal and isolated popliteal lesions. In addition, we wanted to investigate whether advanced debulking strategies where atherectomy is followed by a drug-coated angioplasty bear an additional advantage over atherectomy and standard percutaneous angioplasty alone in terms of clinical success and freedom from target lesion revascularization. RESULTS: In total, 218 femoropopliteal and 46 popliteal predominantly heavily-calcified lesions have been investigated. Of 264 cases, in a total of 53 cases, atherectomy treatment was followed by a drug-eluting balloon (DEB) angioplasty (43 in the femoropopliteal and 10 in the popliteal lesions). The lesions were characterized by a significant length (17.3±12.1 cm) and complexity (TASC C in 48.4% and TASC D in 19.7%). During a mean follow-up of 19 (±11) months, a total of 12 patients (4.5%) died. Clinically-driven target lesion revascularization (CD-TLR) was performed in 32 (14.7%) femoropopliteal and 11 isolated popliteal (23.9%) lesions and did not differ significantly between stand-alone atherectomy and atherectomy followed by a DEB. Mean ABI was improved from 0.57±0.22 immediately before intervention to 0.86±0.23 on intervention and remained stable: 0.83±0.16 at follow-up. During follow-up, a mean Rutherford category was reduced from 3.64±1.0 to 2.38±0.98. CONCLUSIONS: Our real-life study provides evidence that atherectomy in combination with DEB is safe and effective but did not have a significant impact on the freedom from target lesion revascularization in our population. Additional large-scale randomized trials are needed to verify these findings. CLINICAL IMPACT: This study investigates the efficacy and safety of combining rotational atherectomy with drug-coated balloon (DCB) angioplasty for treating heavily calcified femoropopliteal and isolated popliteal lesions in peripheral artery disease (PAD). The retrospective analysis of 264 patients highlights the potential of this combination in improving procedural success and reducing periinterventional complications. While demonstrating an excellent procedural and clinical success rate over an average 19-month follow-up, the study finds no significant long-term benefit in freedom from target lesion revascularization (TLR) compared to atherectomy alone. These findings suggest the need for further research to optimize treatment strategies for complex PAD cases, particularly in evaluating the long-term clinical benefits of such combined interventions.

Effectiveness of the Rotarex Excisional Atherectomy System in Both Subacute and Chronic Aortoiliac Endograft Thrombosis: An Innovative Option for the Modern Endovascular Surgeon Toolkit.

PURPOSE: To report a successful revascularization case using the Rotarex™S atherothrombectomy system in a recent iliac limb thrombosis, and chronic hypogastric stent obstruction after previous aortoiliac aneurysm endovascular repair (EVAR). CASE REPORT: A 72-year-old patient was treated for recent right iliac limb thrombosis and left iliac branch chronic hypogastric stent occlusion, 5 years after EVAR. A total endovascular approach, using both upper extremity and femoral vascular access, was settled with 2 Rotarex™S (6Fr and 10Fr) devices. The Rotarex™S catheters removed most of the intraluminal material, allowing additional endografts and bare metal stents to be deployed to support a new healthy lumen surface. CONCLUSION: The total endovascular approach provided by the Rotarex™S device appears to be safe and effective in treating aortoiliac endografts occlusions, both in subacute and chronic phases. Larger studies could highlight differences and eventual advantages compared with more traditional solutions.

Clinical research of drug-coated balloon after rotational atherectomy for severe coronary artery calcification.

BACKGROUND: Current research results show that drug-coated balloons (DCB) have unique advantages in the treatment of in-stent restenosis, small vessel disease, bifurcation lesions, and de novo lesions, but the data regarding rotational atherectomy (RA) followed by DCB treatment in calcified lesions, especially severe coronary artery calcification (CAC), are limited. METHODS: A retrospective study was conducted on 318 individuals with severe CAC who underwent RA-assisted PCI at the First Affiliated Hospital of Zhengzhou University from May 2018 to July 2021. Among them, 57 patients (RA/DCB group) were treated with DCB, and 261 patients (RA/DES group) were treated with drug-eluting stents (DES). The two groups' clinical baseline data, lesion characteristics, intraoperative complications, in-hospital adverse events, and major adverse cardiovascular and cerebrovascular events (MACCE) were compared throughout the follow-up period. RESULTS: The baseline clinical data, intraoperative complications, and in-hospital adverse events were not significantly different between the two groups. The anatomical categories in the RA/DES group were more complex and included left main coronary disease, bifurcation disease, and multivessel disease. Although target lesion revascularization (13.79% vs. 7.02%) and MACCE (18.77% vs. 12.28%) occurred more frequently in the RA/DES group than in the RA/DCB group, there was no statistically significant difference (p > 0.05). Multivariate Cox regression analysis showed that bifurcation lesions (HR 2.284, 95% CI 1.063-4.908, p = 0.034), total length of DCB/DES (HR 1.023, 95% CI 1.005-1.047, p = 0.014) and SYNTAX score (HR 1.047, 95% CI 1.013-1.082, p = 0.006) were independent risk factors for MACCE during the follow-up period. CONCLUSION: Drug-coated balloon treatment after rotational atherectomy appears safe and effective in selected severe coronary artery calcification.