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Aims Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy. Methods and results Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (, + ID der Publikation: unilu_64224 + Sprache: Englisch + Letzte Aktualisierung: 2023-03-24 11:14:57

Introduction It has been reported that excimer laser atherectomy combined with a drug-coated balloon (ELA+DCB) can achieve better results than simple balloon angioplasty, especially for the treatment of femoropopliteal in-stent restenosis. However, reports on the application of ELA+DCB in China for femoropopliteal arteriosclerosis obliterans are lacking. This study focuses on analysing the effectiveness and safety of ELA+DCB. Methods This was a single-centre retrospective study that enrolled patients from November 2016 to January 2019 who had femoropopliteal arteriosclerosis obliterans treated by ELA+DCB. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically. Results There were 43 patients with an average patient age of 68.0±8.6 years; 79.1% were male. In 30 cases, the lesions were de novo and the others were in-stent restenosis (ISR). During the procedure, flow-limiting dissection (48.8%) was the main adverse event and there were 17 bailout stent implantations due to dissection. Mean (±sd) ankle–brachial index (ABI) in the patients was 0.42±0.31 before the operation and 0.83±0.13 before discharge. The mean (±sd) follow-up time was 29.35±9.71 months. The primary patency rate was 66.8%, 64.3% and 60.9% at 12, 24 and 36 months. Freedom from target lesion revascularisation (TLR) was 85.7%, 80.7% and 75.3% at 12, 24 and 36 months. Rutherford categories also greatly improved during follow-up. Overall mortality was 6.9% (3/48), and no deaths were related to the intervention. Conclusion The use of ELA+DCB had good clinical benefit for femoropopliteal arteriosclerosis obliterans, which had good primary patency and freedom from TLR, although intraoperative complications still required attention. Multicentre randomised controlled trials with long-term follow-up are needed.

To evaluate the feasibility and early outcomes of below the ankle orbital atherectomy in chronic limb-threatening ischemia in patients with calcified foot arteries.12 patients (mean age 69.4 ± 14.7; range 57 to 85 years) who were affected by diabetes underwent orbital atherectomy below the knee and ankle arterial segments. Technical success was defined as orbital atherectomy passage and debulked the calcified lesion, delivery of adjunctive therapy, and30% residual stenosis at final angiogram. The procedural outcome included complications, amputation-free survival, and freedom from clinically-driven target lesion revascularization at 30-days and 6-months of follow-up.Orbital atherectomy was performed in 3 cases in Anterior tibial (AT) and dorsalis pedis (Ped) arteries + Posterior tibial (PT) and Lateral Plantar (Lat Plan), 5 cases in PT and Lat Plan arteries, 1 case of PT and Medial Plantar, 1 case of Peroneal and Plan Lat, and 2 cases of AT and Ped. After atherectomy, we used a drug-coated balloon (DCB) angioplasty. Technical success was achieved in 11 (91.6%) cases. No deaths were registered during the follow-up. The limb salvage rate was 100%, and no major amputations were registered. Amputation-free survival was 50%. Freedom from CD-TLR was 100% at 30 days and 91.7% at 6-months. One patient underwent a TLR at three months. No major cardiovascular events, limb events, or significant procedure-related complications were registered.CSI orbital atherectomy and DCB angioplasty appear a feasible and promissor treatment options in diabetic CLTI patients.

To evaluate the feasibility and safety of coronary orbital atherectomy (OA) for the treatment of calcified ostial lesions.Percutaneous coronary intervention (PCI) is increasingly being completed in complex patients and lesions. OA is effective for severely calcified coronary lesions; however, there is a dearth of evidence on the use of OA in ostial lesions, especially with long-term outcome data.Data were obtained from a retrospective analysis of patients who underwent OA of heavily calcified ostial lesions followed by stent implantation from December 2010 to June 2019 at two high-volume PCI centers. Kaplan-Meier analysis was utilized to assess the primary endpoints of 30-day, 1-year, and 2-year freedom-from (FF) major adverse cardiac events (MACE: death, myocardial infarction, or target vessel revascularization), stroke, and stent thrombosis (ST).A total of 56 patients underwent OA to treat heavily calcified ostial coronary lesions. The mean age was 72 years with a high prevalence of diabetes (55%) and heart failure (36%), requiring hemodynamic support (14%). There was high FF angiographic complications (93%), and at 30-day, 1-year, and 2-year, a high FF-MACE (96%, 91%, and 88%), stroke (98%, 96%, and 96%), and ST (100%), respectively.This study represents the largest real-world experience of coronary OA use in heavily calcified ostial lesions with long-term outcomes over 2 years. The main finding in this retrospective analysis is that, despite the complex patients and lesions included in this analysis, OA appears to be a feasible and safe treatment option for calcified coronary ostial lesions.

Rotational atherectomy (RA) in ST-segment elevation myocardial infarction (STEMI) is uncommon and its use in a thrombotic lesion is labelled a contraindication by its manufacturer due to the concern for further increase in platelet activation and aggregation by the spinning burr or distal embolization of the thrombotic material promoting no-reflow (NR). However, thrombus burden varies significantly in the STEMI setting and can be classified according to the thrombolysis in myocardial infarction (TIMI) thrombus grade (TG). This case demonstrates the successful off-label use of RA-assisted primary percutaneous coronary intervention to facilitate treatment of a heavily calcified ostial right coronary artery lesion with low thrombotic burden (TIMI TG 0) in an octogenarian STEMI patient. Atherectomy drug cocktails, intracoronary vasodilators, short burr runs and avoidance of rotating the burr at slower than minimum approved rotational speed contribute to atherectomy success and decrease the chances of NR.

Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions.ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years.ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions.

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.

Nicolas W Shammas The Midwest Cardiovascular Research Foundation, Davenport, IA, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 E 4th Street, Suite A, Davenport, IA, 52801, USA, Email shammas@mchsi.comAbstract: Atherectomy is an effective vessel prepping device but not all atherectomy devices are equal. The depth of vessel injury and residual narrowing vary considerably among atherectomy devices with significant implications on outcome. Precision imaging is critical to optimize outcome using atherectomy as a vessel prepping technique. Prospective trials need to test the hypothesis that precision imaging has a significant impact on how operators approach the treatment of infrainguinal arterial disease.Keywords: atherectomy, aggressive debulking, vessel prepping, dissections, residual narrowing, complications, adventitial injury

Developed in the late 1980s, rotational atherectomy has raised a lot of hope for its innovative principle of selective ablation, allowing volume reduction (instead of redistribution) of atherosclerotic plaque, while sparing healthy tissue. Long shunned for its disappointing results on restenosis, the Rotablator finally reasserted itself in the 2000s; era of drug eluting stents and coronary angioplasty boom, thus generating emergence of complex lesions. Indeed, the Rotablator has demonstrated an undeniable benefit in complex (type C) and calcified lesions preparation (before stenting), with a procedural success rate of 95%. Although these lesions only represent a small amount (2-3%) of percutaneous coronary interventions (PCI), they remain a technical impasse for plain-old balloon angioplasty strategy, making the Rotablator more suitable for these resistant lesions' treatment. Registry data attest the safety of this therapy, with a rate of peri-procedural complications and in-hospital mortality comparable to conventional angioplasty (France PCI register). However, certain specific, rare but serious complications (burr entrapment, broken Rotawire, coronary perforation) justify trained teams, perfect knowledge of the equipment, and strict compliance with good practice guidelines. In 2018, the rise of a new method of atherectomy by intra-vascular lithotripsy (Shockwave) has coincided with Rotablator decreasing activity (this finding being biased by a general decrease in PCI activity due to Covid pandemic). This therapeutic range's enhancement revolutionizes calcified lesions treatment, tending towards precise targeting of each indication, depending in particular on calcium distribution's anatomy in the plaque.

To evaluate the most effective endovascular treatment modalities for de novo femoropopliteal lesions in intermittent claudication (IC) in terms of technical success, primary patency, target lesion revascularization (TLR) and all-cause mortality through network meta-analysis of randomized controlled trials.Medical databases were searched on December 3, 2020. 16 studies (3265 patients) and 7 treatments were selected. Outcomes were technical success, primary patency, TLR and mortality at 6 and/or 12 months.Regarding 6-month primary patency, drug-eluting stents (DES) was better than balloon angioplasty (BA; odds ratio [OR], 23.27; 95% confidence interval [CI], 12.57-43.06), drug-coated balloons (DCB; OR, 5.63; 95% CI, 2.26-14.03) and directional atherectomy (DA; OR, 31.52; 95% CI, 7.81-127.28), and bare nitinol stents (BNS) was better than BA (OR, 17.91; 95% CI, 7.22-44.48), DCB (OR, 4.33; 95% CI, 1.40-13.45) and DA (OR, 24.27; 95% CI, 5.16-114.11). Regarding 12-month primary patency, DES was better than BA (OR, 10.05; 95% CI, 4.56-22.16), DCB (OR, 3.70; 95% CI, 1.54-8.89) and DA (OR, 29.54; 95% CI, 7.26-120.26). DCB and combination of balloon and atherectomy were the most effective treatment regarding 12-month TLR and technical success (residual stenosis30%), respectively. DES, BNS and DA with DCB (DA-DCB) were included in the best cluster in the clustered ranking plot combining 12-month primary patency and TLR.Balloon and atherectomy may confer advantages over other treatments for technical success; DCB may for TLR. Stent technologies confer substantial advantages regarding primary patency. Stent technologies and DA-DCB should be given priority in treating femoropopliteal lesions in IC.

With aging society, one of the more challenging obstacles in percutaneous coronary interventions are calcified coronary lesions. Calcified lesions may impede stent delivery, limit balloon and stent expansion, cause uneven drug distribution, and hinder wire advancement. Even in the setting of acceptable procedural success, vessel calcification is independently associated with increased target lesion revascularization rates at follow-up and lower survival rates. In order to effectively manage such lesions, dedicated technologies have been developed. Atherectomy aims at excising tissue and debulking plaques, as well as compressing and reshaping the atheroma, generally referred to as lesion preparation that enables further balloon and/or stent expansion in contemporary clinical practice. In the current review, we will discuss the available methods for atherectomy, including rotational, orbital, and excimer laser coronary atherectomy, as well as intravascular lithotripsy. In addition, we will review the role of imaging in calcified lesions.

There are few studies on excimer laser (308 nm) atherectomy in the treatment of infrapopliteal artery disease. The purpose of this retrospective clinical study was to assess the efficacy and safety of excimer laser atherectomy (ELA) in combination with adjuvant drug-coated balloon angioplasty (DCB) compared to DCB for infrapopliteal arterial revascularization in patients with ischemic diabetic foot. From September 2018 to February 2019, a total of 79 patients with diabetic foot were treated for infrapopliteal arterial revascularization at Tianjin First Central Hospital (Tianjin, China). In this project, 35 patients were treated with ELA combined with DCB angioplasty, and 44 patients were treated with DCB angioplasty. The patients' baseline characteristics were similar between the 2 groups. The primary efficacy endpoints through 24 months were clinically driven target lesion revascularization (CD-TLR), wound healing rate, major amputation rate, and target vessel patency rate. The primary safety endpoint through 24 months was all-cause mortality. The primary efficacy results at 24 months of ELA + DCB versus DCB were CD-TLR of 14.3% versus 34.1% (p = 0.044), wound healing rate of 88.6% versus 65.9% (p = 0.019), target vessel patency rate of 80.0% versus 52.3% (p = 0.010), and major amputations rate of 5.7% versus 22.7% (p = 0.036). The safety signal at 24 months of all-cause mortality rate was 2.9% for ELA + DCB group and 4.5% for DCB group (p = 0.957). ELA combined with DCB angioplasty is more effective than DCB in the treatment of infrapopliteal artery disease in patients with ischemic diabetic foot, which can improve the wound healing rate and target vessel patency rate. There was no statistical difference in the safety results between the two groups.

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.

Percutaneous ventricular assist devices (pVAD) are frequently utilized in high-risk percutaneous coronary intervention (HR-PCI) to provide hemodynamic support in patients with complex cardiovascular disease and/or multiple comorbidities who are poor candidates for surgical revascularization. Using the National Inpatient Sample we identified pVAD-assisted PCI (excluding intra-aortic balloon pump) in patients without cardiogenic shock from January 2008 to December 2018. We evaluated the trends in patient and procedural characteristics, and complication rates across the 11-year study period. A total of 26,661 pVAD-PCI was performed. From 2008 to 2018 there has was a 27-fold increase in the number of pVAD-PCIs performed annually. There has also been an increase in the proportion of procedures performed in small to medium sized hospitals. The use of atherectomy, image-guided PCI, FFR/iFR, drug-eluting stents, and multi-vessel intervention has significantly increased. Patients undergoing pVAD-PCI had a higher burden of comorbidities, without a significant difference in mortality over time. There were decreased rates of acute stroke and blood transfusions over time, while vascular complications and acute kidney injury (AKI) requiring dialysis remained mostly unchanged. In conclusion, the use of pVAD for HR-PCI has increased significantly, along with adjunctive PCI techniques such as atherectomy, intravascular imaging, and physiologic lesion assessment. With increasing use of this device, there appeared to be lower rates of peri-procedural stroke, and blood transfusions. Despite a higher burden of comorbidities, adjusted mortality remained stable over time.

Recently, the efficacy was demonstrated of 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 ± 11 years; 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.

Summary: Background: To evaluate the safety and effectiveness of preparing instent femoropopliteal lesion with photoablative laser atherectomy or plain balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Patients and methods: The prospective, multicenter, randomized study enrolled patients with Rutherford-Becker-class (RBC) 1 to 5 and instent lesions located in superficial femoral artery and/or popliteal artery above the knee joint. Primary endpoint was target lesion percent stenosis at 1 year as determined by the angiographic core-laboratory. Secondary endpoints included procedural success, major adverse event rate, clinical improvement and improvement in ankle-brachial index (ABI), clinically-driven target lesion revascularization (CD-TLR), and primary patency rate at until 2-year follow-up. Results: The study was terminated prior to the enrollment goal due to slow enrollment. Thirty patients were included in the laser plus DCB cohort and 31 patients in the control cohort. Primary endpoint was not significantly different (p=0.331). Procedural success was 83.3% and 87.1% for the laser plus DCB and the control cohort, respectively. Serious adverse events at 30 days and 1-year were not statistically different between the two cohorts. For the ABI, significant improvements were present at discharge as well as at the follow-up visits. This was also evident for the RBC at the follow-up visits. One- and two-year freedom from CD-TLR was 86.7% vs. 87.1%, and 63.6% vs. 72%, respectively. Duplex derived primary patency was 90% at 6-months, 65.5% at one year and 56.5% at two year for the laser cohort and 90.3%, 75.9% and 53.8% for the control cohort. Conclusions: Safety of instent photoablative laser atherectomy followed by DCB angioplasty is confirmed by this study. Due to the small sample size, no benefit over POBA as vessel preparation could be shown.

To determine whether differences exist in fluoroscopy time and radiation exposure during lower extremity endovascular procedures performed by fellowship trained vascular surgeons vs general surgeons, to minimize radiation exposure to operating room staff.A retrospective review of all lower extremity endovascular procedures was performed from August 1, 2014, to January 29, 2016. The procedures were performed by the surgical department's four surgeons with endovascular privileges: two vascular surgeons and two general surgeons. Only procedures involving lower extremity arterial angiograms with balloon angioplasty, stenting, or atherectomy were included. The operative records were reviewed for each case. The total fluoroscopy time and total radiation dose for each procedure were recorded. Procedures were grouped according to the number of endovascular interventions as one to two interventions, three to four interventions, and five or more interventions performed. Statistical analysis was performed with a P value of less than .05 considered significant.About 271 lower extremity endovascular procedures were performed during the study period by 4 surgeons. The average age of the patient population was 70 years. The total number of procedures performed over the study period were 112, 45, 91, and 25 for surgeons 1 through 4, respectively. On average, 3.24 interventions were performed during each procedure. Vascular surgeons were found to have shorter fluoroscopy time for procedures involving one to two (7.8 vs 30.1; P .01), three to four (9.3 vs 34.2; P .01), and five or more (11.5 vs 51.9; P .01) interventions. Vascular surgeons were also found to have less radiation exposure compared with general surgeons in procedures with one to two (1.69 vs 3.53; P = .001) and five or more (2.3 vs 5.4; P = .003) interventions. There was no significant difference in radiation exposure between vascular and general surgeons for procedures with three to four interventions (5.86 vs 5.59; P = .95).In this small series at our institution, lower extremity endovascular procedures performed by specialty trained vascular surgeons were associated with both decreased operative fluoroscopy time and decreased radiation exposure when compared with general surgeons.

The aim of this study was to compare the long-term outcomes of below the knee revascularization with percutaneous atherectomy followed by drug-coated balloon and revascularization with drug-coated balloon alone for symptomatic diabetic patients with peripheral arterial disease.Between April 2015 and January 2020, total of 128 patients and 228 below the knee procedures were enrolled into this retrospective study. Sixty-five patients were treated with atherectomy followed by drug-coated balloon and 63 patients were treated solely with drug-coated balloon.Technical success rates were similar in the AT+DCB group and DCB group. Target lesion revascularization (TLR) was found similar in both groups at 6-month follow-up. Clinically, driven repeat endovascular and surgical limb revascularization rates were also significantly lower at 12 and 24 months.Combined usage of rotational atherectomy and drug-coated balloons for the treatment of diabetic patients with below-the knee arterial lesions and critical limb ischemia is associated with reduced long-term TLR rates and improved the long-term outcomes.El objetivo de este estudio fue comparar los resultados a largo plazo de la revascularización por debajo de la rodilla con aterectomía percutánea seguida de balón recubierto de fármaco y revascularización con balón recubierto de fármaco solo en pacientes diabéticos sintomáticos con arteriopatía periférica.Entre abril de 2015 y enero de 2020, un total de 128 pacientes y 228 procedimientos por debajo de la rodilla se inscribieron en este estudio retrospectivo. Sesenta y cinco pacientes fueron tratados con aterectomía seguida de balón recubierto de fármaco y 63 pacientes fueron tratados únicamente con balón recubierto de fármaco.Las tasas de éxito técnico fueron similares en el grupo AT+DCB y DCB. La revascularización de la lesión diana fue similar en ambos grupos a los 6 meses de seguimiento. Las tasas de revascularización endovascular y quirúrgica de las extremidades también fueron significativamente más bajas a los 12 y 24 meses.El uso combinado de aterectomía rotacional y balones recubiertos de fármaco para el tratamiento de pacientes diabéticos con lesiones arteriales por debajo de la rodilla e isquemia crítica de las extremidades se asocia con tasas reducidas de revascularización de la lesión diana a largo plazo y mejores resultados a largo plazo.

Background Atherectomy has become the fastest growing catheter‐based peripheral vascular intervention performed in the United States, and overuse has been linked to increased reimbursement, but the patterns of use have not been well characterized. Methods and Results We used Blue Cross Blue Shield of Michigan Preferred Provider Organization and Medicare fee‐for‐service professional claims data from the Michigan Value Collaborative for patients undergoing office‐based laboratory atherectomy in 2019 to calculate provider‐specific rates of atherectomy use, reimbursement, number of vessels treated, and number of atherectomies per patient. We also calculated the rate that each provider converted a new patient visit to an endovascular procedure within 90 days. Correlations between parameters were assessed with simple linear regression. Providers completing ≥20 office‐based laboratory atherectomies and ≥20 new patient evaluations during the study period were included. A total of 59 providers performing 4060 office‐based laboratory atherectomies were included. Median professional reimbursement per procedure was $4671.56 (interquartile range [IQR], $2403.09–$7723.19) from Blue Cross Blue Shield of Michigan and $14 854.49 (IQR, $9414.80–$18 816.33) from Medicare, whereas total professional reimbursement from both payers ranged from $2452 to $6 880 402 per year. Median 90‐day conversion rate was 5.0% (IQR, 2.5%–10.0%), whereas the median provider‐level average number of vessels treated per patient was 1.20 (IQR, 1.13–1.31) and the median provider‐level average number of treatments per patient was 1.38 (IQR, 1.26–1.63). Total annual reimbursement for each provider was directly correlated with new patient‐procedure conversion rate ( R 2 =0.47; P R 2 =0.31; P R 2 =0.33; P Conclusions A minority of providers perform most procedures and are reimbursed substantially more per procedure compared with most providers. Procedural conversion rate, number of vessels, and number of treatments per patient represent potential policy levers to curb overuse.

Die Kooperation von Medizinern, Ingenieuren und anderen Naturwissenschaften bringt weiterhin effektive Produkte auf den Markt, die dazu geeignet sind, die Dominanz der endovaskulären Techniken im Bereich der peripheren arteriellen Verschlusskrankheit (pAVK) weiter auszubauen. Begleitend werden zunehmend bildgebende Verfahren weiterentwickelt oder neu entwickelt, die helfen können, die Strahlenbelastung für Patient und Anwender trotz wachsender Zahlen strahlenbasierter Therapieverfahren deutlich zu reduzieren. Mittlerweile haben wir ein Materialportfolio an der Hand, das es erlaubt, jede Gefäßregion endovaskulär zu behandeln. Auf der anderen Seite dürfte das endovaskuläre Leistungsgefüge nicht flächendeckend homogen gestaltet sein und die jeweilige Ergebnisqualität dann für die Chirurgie sprechen. In diesem Übersichtsartikel sollen neue Materialien und neuere Ergebnisse vorgestellt werden, die den Bereich der endovaskulären Behandlung der pAVK in allen Gefäßsegmenten mit beeinflussen dürften.

BACKGROUND: Tobacco smoking and its harmful health effects also increase economic burdens globally. Surprisingly, despite the detrimental health consequences of smoking, some studies have shown better survival among smokers compared with non-smokers, a phenomenon called “smoker's paradox”. However, the impact of smoking status on clinical outcomes in severe calcified coronary artery disease (CAD) patients has yet to be reported. OBJECTIVES: Investigate the impact of smoking on clinical outcomes in calcified CAD receiving rotational atherectomy (RA). DESIGN: Retrospective review of medical records. SETTING: Multicenter registry in South Korea. PATIENTS AND METHODS: This multicenter registry included consecutive patients with calcified CAD who underwent RA at nine tertiary centers in Korea between January 2010 and October 2019. MAIN OUTCOME MEASURES: Target-vessel failure (TVF) which included the composite of cardiac death, target-vessel myocardial infarction (TVMI), and target-vessel revascularization (TVR). SAMPLE SIZE: 583 lesions in 540 patients followed for a median of 16.1 months. RESULTS: Lesions were divided into two groups: non-smokers (n=472, 81.0%) and smokers (n=111, 19.0%). TVF in the smoker group was significantly more frequent than in non-smoker group (log rank P =.016). The inverse probability of treatment weighting analysis also showed that smoking was significantly associated with a higher incidence of the primary outcome (HR: 1.617; 95% CI: 1.127–2.320; P =.009), cardiac death (HR 1.912; 95% CI: 1.105-3.311; P =.021), myocardial infarction (HR: 3.914; 95% CI: 1.884-8.132; P P =.029), and TVR (HR: 1.661; 95% CI: 1.043-2.643; P =.032). However, any bleeding was significantly observed less in the smokers. CONCLUSION: Smoking is significantly associated with adverse clinical outcomes in CAD patients requiring RA. LIMITATIONS: Retrospective design. CONFLICTS OF INTEREST: None.

Retention and entrapment of angioplasty device fragments is a rare consequence of percutaneous coronary intervention (PCI). Due to advances in retrieval devices and introduction of new interventional techniques the need for emergency surgery has reduced significantly. There might also be clinical scenarios were remnants of retained fragments might have to be left within the coronary vessel and this might be the most appropriate option. Here we report a case of a ruptured non-compliant angioplasty balloon that was entrapped in the right coronary artery and retained in situ after multiple failed attempts at percutaneous retrieval. Medical therapy failed and hence rotation atherectomy had to be performed followed by stent implantation, there by jailing the retained fragments underneath the stent struts. To our knowledge this is the first description of rotational atherectomy of an entrapped balloon to allow for percutaneous revascularization .

Background : One in three patients undergoing percutaneous coronary intervention (PCI) exhibits moderate or severe coronary artery calcification. Coronary calcification remains a major independent predictor of PCI failure and adverse outcomes. PCI of calcified coronary lesions remains challenging, despite significant improvements in the available tools and techniques. Rotational Atherectomy (RA) is a critical component to improve PCI success in these situations by producing lumen enlargement by physical removal of plaque and reduction in plaque rigidity, thus facilitating dilation Case Illustration : A 73-year-old man with exertional angina was referred to our hospital, with a history of hypertension, diabetes mellitus, ex-smoker and dyslipidemia. Physical exam, electrocardiogram, chest x-rays, and laboratory findings were unremarkable, but transthoracic echocardiogram revealed anterior wall hypokinesis. History of cardiac catheterization outside of our center with angiographic result of left anterior descending (LAD) lesion, highly calcified, non-dilatable on first several POBA attempts. Coronary angiography at our center, revealed diffuse calcification from proximal to distal of the LAD artery with about 90% maximum stenosis in mid LAD. RA (Rotablator, Boston) was then performed with A 1.50 mm burr gradually advanced at 150,000 rpm to passed the lesion. After deployments of stents, final angiogram showed well positioned stents with good distal run-off flow. The patient was uneventful during the procedure and was discharged following day. Discussion: In experienced hands, RA is as safe as standard PCI. RA is as a tool to make PCI possible in complex lesions with moderate or severe calcification when clinical variables make PCI appropriate. Rotablator is a catheter-based interventional cardiology procedure using a high-speed rotational device designed to ablate atherosclerotic plaque and restore luminal patency. This help to facilitate stent delivery, avoiding the barotrauma caused by repeated high-pressure balloon inflations that can lead to vessel dissection or perforation. Atherectomy can be performed safely with optimal burr selection and proper ablation techniques, and as a result, complication rates have been significantly minimized, with few changes in the acute complications reported in contemporary studies. Keywords: percutaneous coronary intervention, calcified lesion, rotational atherectomy.

Severely calcified lesions are the leading cause of stent under-expansion in peripheral vascular interventions. Current approved treatment options are limited to high pressure balloon angioplasty and laser atherectomy, both of which often yield sub-optimal results. Intravascular Lithotripsy offers a promising new treatment option for calcium-mediated peripheral vascular stent under-expansion.

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%, 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.

Objectives In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Methods Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. Results The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20–360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1–18) months. Re-occlusion was seen in three patients (7.5%) ( n = 2 at 2 months and n = 1 at 4 months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan–Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients ( p < 0.001). The increase in the ankle–brachial index after the procedure was found to be statistically significant in 36 patients ( p < 0.001). Conclusions Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.

BACKGROUND: Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical endarterectomy is still the gold standard. AIMS: The aim of this study was to evaluate the safety and efficacy of directional atherectomy (DA) for the treatment of CFA lesions. METHODS: A retrospective analysis of patients who underwent DA of the CFA between March 2009 and June 2017 was performed. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularisation (cdTLR). Secondary endpoints included the overall procedural complication rate at 30 days, change in ankle-brachial index (ABI), and Rutherford-Becker class (RBC) during follow-up. RESULTS: This analysis included 250 patients. The mean follow-up period was 31.03±21.56 months (range 1-88, median follow-up period 25 months). The procedural complication rate including access-site complications, target lesion perforation, and outflow embolisation was 10.4% (n=26). All but one complication could be treated conservatively or endovascularly. One surgical revision was necessary. Freedom from major adverse events (death, cdTLR, myocardial infarction and major target limb amputation) at 30 days was 99.6%. The rate of cdTLR during follow-up was 13.6% (n=34). A significant improvement of the mean ABI and the RBC was observed. Multivariate logistic regression analysis revealed residual target lesion stenosis >30% (p=0.005), and heavy calcification of the target lesion (p=0.033) to be independent predictors for cdTLR. CONCLUSIONS: The use of DA for the treatment of CFA lesions leads to promising midterm results with an acceptable complication rate.

Severe coronary artery calcification, too often underestimated, increases the complexity of percutaneous coronary interventions. Atherectomy is one of preferred approach for the preparation of calcified lesions before stent placement. Orbital atherectomy (OA) is a new method that has proven to be safe and effective in the preparation of calcium plaques (ORBIT I and ORBIT II studies). The OA is made up of a crown mounted with diamonds that abrades the endoluminal calcium plaque by centrifugal force and creates pulsatile forces on the wall that fractures the deep calcified plaques in the media. The OA Diamondback 360 ™ consists of a tableside electric powered motor handle connected to a drive shaft mounted with an eccentric crown. The OA specific 0.012" coronary guidewire made of Nitinol (ViperWire ™) has 3 qualities; the torquability, the ease of navigation and the support. Compared to rotational atherectomy, AO is associated with a lower rate of MACE at 1 year, with less revascularization of the target vessel and reduced fluoroscopy time but at the cost of an increased rate of coronary dissection and perforation. AO is a new, quite attractive, safe and effective tool to consider in the preparation of calcified coronary lesions.

Objectives To investigate the outcomes of patients with calcific lesions in the common femoral artery undergoing endovascular procedures with atherectomy device and scoring balloon angioplasty combined with treatment of steno-occlusive disease of the remaining arterial districts of the lower limb. Methods Between January 2015 and December 2018, 11 diabetic patients at high risk for “major amputation”, with calcific lesions of the common femoral artery and ischemic ulcers requiring endovascular treatment were retrospectively evaluated. Technical success was defined as revascularization of the common femoral artery with a residual stenosis lower than 30%. Primary endpoints were an immediate increase of perilesional transcutaneous oxygen pressure (TCPO2) > 40 mmHg, ulcerative lesions improvement up to healing or skin flaps re-epithelialization after minor amputation, limb rescue with rejected major amputation, and resolution of rest pain if present. Results The success rate of the revascularization procedures was 100%. No patient underwent surgical conversion. One case of peri-operative bleeding at the brachial access site was observed. There were no cases of arterial dissection or undesired distal embolization. The average baseline value of perilesional TCPO2 was 21.8 ± 9.2 mmHg. The mean TCPO2 value was 57.4 ± 7.2 mmHg three days after the procedure ( P Conclusions Endovascular approach for severely calcified atherosclerotic lesions of the common femoral artery seems to represent a valid therapeutic option associated with promising results in terms of clinical outcome and low complication rates.

Background: Balloon dilation and atherectomy have limitations in the treatment of heavily calcific coronary lesions. Introduction: Intravascular lithotripsy (IVL) is a state-of-the-art system that modifies severe calcific coronary plaques efficiently. In this paper, we report our experience with IVL in the context of a calcific in-stent chronic total occlusion. Case summary: A 75-year-old gentleman whose status was post percutaneous coronary intervention, with the deployment of two overlapping bare-metal stents in the mid-left anterior descending artery (LAD) 20 years ago, was admitted to our cardiac center for the elective intervention of in-stent chronic total occlusion (CTO) of LAD, which was performed using an antegrade wire escalation (AWE) technique. After recanalization of the CTO body, optical coherence tomography pullback confirmed a very high calcium score. Balloon dilatation attempts failed, so we proceeded with shockwave lithotripsy with successful full expansion of the 3.5-mm IVL balloon followed by a straightforward stent delivery. The procedure was complicated by distal wire perforation, which was handled in a timely manner with coil embolization. The patient’s postoperative course was uneventful. Conclusion: This case illustrates the feasibility and effectiveness of IVL that powerfully cracks coronary calcium while minimizing vessel wall trauma in the context of heavily calcific in-stent CTO. In our case, coronary perforation occurred in a small-caliber side branch, which was identified in a timely manner before hemodynamic compromise and treated successfully straight away with coil embolization.

Coronary artery perforation (CAP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI), however if recognized and managed promptly, its adverse consequences can be minimized. Risk factors for CAP include the use of advanced PCI technique (such as atherectomy and chronic total occlusion interventions) and treatment of severely calcified lesions. There are 3 major types of CAP depending on location: (a) large vessel perforation, (b) distal vessel perforation, and (c) collateral perforation. Large vessel perforation is usually treated with implantation of a covered stent, whereas distal and collateral vessel perforations are usually treated with coil or fat embolization. In this article we provide a state-of-the-art overview of the contemporary management of CAP.

Excimer laser coronary atherectomy (ELCA) during percutaneous coronary intervention (PCI) has been in use for more than twenty years. While early experiences were not favorable over balloon angioplasty alone, with improvement in operator technique, patient selection and technology, ELCA has established its own niche in contemporary PCI as a safe and effective atherectomy strategy. With growing experience in complex coronary interventions worldwide, ELCA has become one of the essential atherectomy tools offering unique advantages over other atherectomy devices. In the modern era, ELCA is commonly used for patients with in-stent restenosis, stent under expansion, balloon uncrossable lesions and chronic total occlusions. Technical success rates are reported to be >80% in most situations while procedural complication rates such as vessel dissection and perforation among others are reported to average 9% over the past 25 years with improvement over time. In this review, we provide a comprehensive systematic review of the ELCA system, its practical use, indications, and procedural techniques in the contemporary PCI era.

Background Endovascular management of isolated profunda femoris artery occlusive disease has not been well studied. Our aim is to analyze the outcomes of endovascular management of profunda artery occlusive disease. Methods This is a retrospective analysis using data from the Vascular Quality Initiative. All patients from 2013 to 2018 treated percutaneously for isolated profunda artery occlusive disease were included. Endovascular treatment included plain balloon alone, stent, stent graft, atherectomy, and drug-coated balloon without any concomitant endovascular or surgical treatment. Demographic, procedural, and follow-up data were obtained. Primary end points were primary patency, improvement of symptoms, and need for reintervention. Univariate and multivariable analysis was used to assess for significant variables. Results Of the 105,568 lower extremity endovascular interventions performed during this time period, there were 361 procedures (0.3%) performed on 341 patients for isolated profunda artery occlusive disease. The average age of these patients was 67.8 years (+/− 11.8), with 59.8% being men. The most common indication for treatment of the profunda artery was claudication (44.8%), followed by tissue loss (28.5%) and rest pain (26.0%). The most common treatment modality was plain balloon (58.5%), followed by stent (18.6%), drug-coated balloon (10.0%), atherectomy (9.4%), and stent graft (3.6%). At a mean follow-up of 13 months (+/−4.6), data were available for 238 patients (69.7%). Overall primary patency at 13 months was 92.9%. There was no significant difference in terms of patency for each treatment modality (Table I). Preoperative ambulatory status, aspirin, and statin were significantly associated with patency. At most recent follow-up, 67% of patients had improvement of their symptoms, whereas 29% were unchanged. Reintervention data were available for 247 patients, with a reintervention rate of 15.8% (n = 39) and a mean reintervention time of 226 days (+/− 173), with the majority of reinterventions (62%) occurring in the plain balloon group. Reinterventions were primarily endovascular (64%) with 9 patients (23%) undergoing surgical reintervention. Conclusions Endovascular management of profunda femoris artery occlusive disease has acceptable one-year patency rates with low reintervention rates. Endovascular treatment may be an acceptable alternative to selected patients who are high-risk for surgery.

Calcific left main disease poses a tricky situation for various atherectomy devices including rota-ablation, orbital and directional atherectomy. However, with the advent of intravascular lithotripsy (IVL) in the armamentarium for complex percutaneous coronary intervention (PCI), left main calcium has been relatively easier to tackle. We encountered one of such situation wherein calcific left main disease along with ostial left anterior descending (LAD) artery involvement had to be dealt with in addition to the challenge faced in wiring LAD due to a peculiar anatomical hindrance. To the best of our knowledge, this wiring trick is not described in the literature yet.

Aim The aim was to assess the safety and efficacy of rotational atherectomy followed by drug-eluting balloon (DEB) in patients with a high risk of bleeding. Methods A retrospective review was carried out of hospital records of consecutive patients who underwent the hybrid procedure. Results The average age of the 23 patients was 74 years. Risk factors for bleeding included renal failure (35%), oral anticoagulation use (26%) and peptic ulcer disease (35%). All patients had procedural success. No bleeding was reported over the 24-month follow-up period. Dual antiplatelet therapy was stopped successfully in six patients (26%) at three months. Two patients had confirmed target-lesion failure (restenosis). Two patients died over the study period but the cause of death was not known to be cardiovascular disease related. Conclusions For patients at high risk of bleeding who require rotablation, the use of a drug-eluting balloon may be a safe, effective alternative.

The Registry Assessment of Peripheral Devices (RAPID) convened a multidisciplinary group of stakeholders including clinicians, academicians, regulators and industry representatives to conduct an in-depth review of limitations associated with the data available to assess the paclitaxel mortality signal. Available studies were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, such as the development and use of harmonized data points and outcomes in a consensus lean case report form. We advocate for reduction in missing data and efficient means for accrual of larger sample sizes in Peripheral arterial disease studies or use of supplemental datasets. Efforts to share lessons learned and working collaboratively to address such issues may improve future data in this device area and ultimately benefit patients. Condensed Abstract: Data sources evaluating paclitaxel-coated devices were evaluated to identify strengths and limitations in the study design and data quality, which were translated to lessons learned to help guide the design, execution, and analyses of future studies. We suggest numerous actionable responses, which we believe may improve future data in this device area and ultimately benefit patients.

Background/purpose Although the incidence of peripheral artery disease (PAD) and amputations is higher in Native Americans (NA) than Caucasians, the study of revascularization NA is limited, resulting in their under representation in clinical studies. Orbital atherectomy (OA) is widely utilized for endovascular revascularization of significantly calcified peripheral arteries and has been shown to improve limb salvage rates. Methods/materials A cohort of 74 consecutive PAD subjects undergoing OA treatment was retrospectively analyzed via Kaplan Meier (KM) and Propensity Score Matched (PSM) analysis. Results A significant proportion of the subjects were NA (16.2%). Compared to the non-NA, the NA had higher numerical baseline rates of wounds, dialysis, chronic kidney disease (CKD), and critical limb ischemia, but were numerically less likely to smoke and had similar rates of diabetes. There were very high rates of severe calcification (100% vs. 87%) and pre-procedure diameter stenosis (99% vs. 95%) in both groups. The NA and non-NA had good angiographic outcomes, resulting in low rates of post-procedure residual diameter stenosis (10% vs. 11%). Lastly, KM analysis indicated high freedom from amputation in both groups at 1 year (89% vs. 95%), as well as in the PSM subjects (89% vs. 100%). Conclusions Despite numerically higher rates of co-morbidities at baseline (e.g., CKD, dialysis, and presence of non-healing wounds), the NA underwent successful revascularization with OA, resulting in high freedom from amputation at 1-year. Given the small sample size of NA, these results may not be generalizable—thus, larger studies on NA are warranted.

Background Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center. Methods This is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR). Results A total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients. Conclusion The combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease.

Severe coronary artery calcification increases percutaneous treatment complexity and the risk of intraprocedural complications, affecting acute and long-term outcomes. Current use of specialty balloons and atherectomy technologies is limited due to the higher risk of complications, degree of technical difficulty and operator experience. Intravascular lithotripsy (IVL) is a novel technology for severe calcified coronary artery disease that facilitates vessel preparation, enhancing vessel compliance. IVL system emits sonic waves that penetrate through vascular layers and disrupt both superficial and deep calcium, leaving the soft tissue unharmed. The purpose of the present review is to provide a summary of the evidence currently available on this therapy, including a practical description of the components and function of the shockwave coronary IVL system.

Paclitaxel-coated devices have been shown to decrease restenosis when used in the femoropopliteal artery. Recent reports have suggested a possible risk of increased late mortality in patients treated with paclitaxel. It has been suggested that younger patients and those with limited comorbidities may be at higher risk. Our objective was to analyze long-term mortality based on patient age comparing treatment with paclitaxel to uncoated devices.We performed a retrospective review of 1,170 consecutive patients who underwent femoropopliteal percutaneous intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. Patients were grouped by age at the time of procedure:60 years old (n = 244, 20.9%), 60-80 years old (n = 635, 54.3%), and80 years old (n = 291, 24.9%). Within each group, patients were further divided by use of paclitaxel. The primary outcome measure was survival assessed by Kaplan-Meier analysis. Differences between the groups were analyzed with analysis of variance. Multivariable analysis was performed using Cox proportional hazard models.Of the 1,170 patients who underwent femoropopliteal percutaneous intervention, 654 (55.9%) received a paclitaxel-coated device during treatment and 516 (44.1%) did not. Mean age of the overall patient cohort was 70.4 ± 12.6 years and 663 (56.7%) were male. When comparing the groups by age we found an increase in age but a decrease in the proportion of patients who smoke. The use of paclitaxel-coated devices was similar across the groups (60 years old, 56.2%; 60-80 years old, 57.0%;80 years old, 52.6%; P = 0.45). Demographics and comorbidities were similar between the patients treated with and without paclitaxel within each age group except more males in the60-year-old group treated without paclitaxel and more patients with chronic limb threatening ischemia in the80-year-old group treated with paclitaxel. In patients60 and 60-80 years old paclitaxel use was associated with increased survival at 4 years:60 (80.7% vs. 64.4%; P = 0.04); 60-80 (63.2% vs. 55.1%; P = 0.04). Survival was similar in the80-year-old group (46.6% vs. 32.8%; P = 0.65).Our data suggest that the use of paclitaxel-coated arterial devices is not associated with increased mortality. On the contrary, our data show that younger patients treated with paclitaxel show improved survival compared with those treated without paclitaxel. Paclitaxel-coated devices may be used with continued caution especially in patients at high risk for restenosis.

Public focus on health care spending has increased attention on variation in practice patterns and overutilization of high-cost services. Mainstream news reports have revealed that a small number of providers account for a disproportionate amount of total Medicare payments. Here, we explore variation in Medicare payments among vascular surgeons and compare practice patterns of the most highly reimbursed surgeons to the rest of the workforce.2016 Medicare Provider Utilization Data were queried to identify procedure, charge, and payment data to vascular surgeons, identified by National Provider Identification taxonomy. Commonly performed services (10/year) were stratified into categories (endovascular, open surgery, varicose vein, evaluation and management, etc.). Practice patterns of vascular surgeons comprising the top 1% Medicare payments (n = 31) were compared with the remainder of the workforce (n = 3,104).In 2016, Medicare payments to vascular surgeons totaled $589 M. 31 vascular surgeons-1% of the workforce-received $91 million (15% of total payments). Practice patterns of the 1% differed significantly from the remainder of vascular surgeons (P 0.05), with endovascular procedures accounting for 85% of their reimbursement. Specifically, the 1% received 49% of total Medicare payments for atherectomy ($121 M), 98% of which were performed in the office setting.One percentage of vascular surgeons receive an inordinate amount of total Medicare payments to the specialty. This discrepancy is due to variations in volume, utilization, and site of service. Disproportionate use of outpatient atherectomy in a small number of providers, for example, raises concerns regarding appropriateness and overutilization. Given current scrutiny over health care spending, these findings should prompt serious discussion regarding the utility of personal and societal self-regulation.

Introduction: The optimal approach to deal with severe coronary artery calcification (CAC) during percutaneous coronary intervention (PCI) remains ill-defined. Methods: We conducted an electronic database search of all published studies comparing Orbital versus Rotational Atherectomy in patients undergoing PCI. Results: Eight observational studies were included in the analysis. Overall, there were no significant differences in Major-adverse-cardiac-events/MACE (OR: 0.81, CI: 0.63–1.05, p =.11), myocardial-infarction/MI (OR: 0.75, CI: 0.56–1.00, p =.05), all-cause mortality (OR: 0.82, CI: 0.25–2.64, p =.73) or Target-vessel-revascularization/TVR (OR: 0.72, CI: 0.38–1.36, p =.31). However, OA was associated with lower long-term MACE (1-year), (OR: 0.66, CI: 0.44–0.99, p =.04), long-term TVR (OR: 0.40, CI: 0.18–0.89, p =.03), and short-term MI (in-hospital and 30-day) (OR: 0.64, CI: 0.44–0.94, p =.02). OA was associated with more coronary artery dissections (OR: 2.61, CI: 1.38–4.92, p =.003) and device-related coronary perforations (OR: 2.79, CI: 1.08–7.19, p =.03). There were no differences in cardiac tamponade (OR: 1.78, CI: 0.37–8.69, p =.47). OA was noted to have significantly lower fluoroscopy time (MD: −3.96 min, CI: −7.67, −0.25; p =.04) compared to RA. No significant difference was noted in terms of contrast volume between the two groups (OR: −4.35 ml, CI: −14.52, 23.22; p =.65). Conclusion: Although there was no difference in overall MACE, MI, all-cause mortality and TVR, OA was associated with lower long-term MACE and short-term MI. OA is associated with lower fluoroscopy time but higher rates of coronary artery dissection and coronary perforation.

Objectives To evaluate the safety and efficacy of a filter embolic protection device (FEPD) in endovascular interventions of the femoropopliteal arteries. Methods Patients who underwent endovascular interventions of the femoropopliteal arteries between 2008 and 2016 and in whom the SpiderFXTM FEPD was applied were included in this retrospective study. Clinical and angiographic characteristics, filter macroembolization (FME), device-related complications, distal embolization, as well as the early clinical and hemodynamic outcome, were assessed. Potential risk factors for FME were evaluated by multivariate analysis. Results A total of 244 cases were identified (203 patients, claudication 60.4%, critical limb ischaemia 39.6%, mean lesion length 13.2 ± 12.9 cm, complete occlusions in 72.7%). Balloon angioplasty ± stenting (BAP), directional atherectomy ± balloon angioplasty ± stenting (DA) and rotational thrombectomy ± balloon angioplasty ± stenting (RT) were performed in 141, 61 and 42 cases, respectively. FEPD placement and retrieval were successful in all but one case each. Permanent filter-related vessel damage was not observed. The rate of FME was 37.3% (BAP 36.2%, DA 32.8%, RT 47.7%). Risk factors for FME in the BAP- and DA-group were total occlusion, lesion length > 19 cm, visible thrombus and diabetes mellitus. The distal embolization rate despite filter protection was 4.1 % (BAP 4.9%, DA 1.6%, RT 4.8%) and was higher in cases with FME compared with those without FME (8.7% vs. 1.5%, p = 0.02). Conclusion The Spider FXTM device is safe and effective in capturing embolic debris during femoropopliteal interventions. A residual risk of peripheral embolization remains. Level of Evidence III, Cohort study

The aim of this study was to compare the ability of two different atherectomy modalities, the directional atherectomy system (DAS) and the orbital atherectomy system (OAS), to modify plaque and augment luminal gain as evaluated by angiography and intravascular ultrasound (IVUS) in patients with symptomatic femoro-popliteal peripheral arterial disease (PAD).Atherectomy is frequently utilized in the treatment of complex PAD. To date, there are no head-to-head comparisons of existing devices and their selection is based mostly on operator preference rather than on supportive data.This was a single-center, prospective, randomized trial designed to assess the impact of DAS in comparison to OAS on atherosclerotic plaque. Pre- and postatherectomy lesion characterization was performed by angiography and IVUS. Drug-coated balloon (DCB) angioplasty was performed after atherectomy with similar analysis repeated.Sixty patients were randomized to undergo either DAS or OAS. Pretreatment angiographic and IVUS characteristics were similar in the DAS and OAS groups. DAS led to a greater reduction in plaque volume throughout the entire lesion (5.9% vs. 1.1%, p = 0.003). This corresponded to a greater increase in total vessel and lumen volume by IVUS (161.5 mmCompared to OAS, DAS demonstrated a greater plaque volume reduction and luminal gain with significantly fewer stents needed post-DCB.

Calcified atheroma is frequently encountered in peripheral vascular intervention. Standard treatment with balloon and/or stenting alone does poorly in these cases due to vessel recoil, suboptimal luminal gain, and inadequate stent expansion. In light of the above challenges with angioplasty and stenting for PAD, endovascular atherectomy has emerged as a novel technology for atheroma treatment and removal, offering the benefits of surgical endarterectomy in a minimally invasive percutaneous approach. This review outlines the endovascular atherectomy devices available in clinical practice to date, compares and contrasts their mode of action, summarizes the relevant published data on indication and role of atherectomy over other treatment modalities for PAD, and discusses the future prospective on this emerging technology.Currently, there are host of peripheral atherectomy devices available with unique mechanism of action and relative advantages and disadvantages. Despite these recent technological advancements, there remains a paucity of data from well-designed studies regarding the superiority of atherectomy as an adjunctive treatment versus standard treatment with balloon and stenting. Emerging data have supported its use to improve patency rates in conjunction with drug-coated balloons. Although associated risks, including distal embolization and perforation, are often marginal, the cost of these devices to the healthcare system necessitates further investment in to establishing level 1 data to support their use. Peripheral atherectomy has the potential to improve limb-related outcomes, potentially through reduced need for bail-out scaffolds and improved drug uptake. Nonetheless, further investment in the evidence foundation supporting these devices versus standard practices is required.

Endovascular atherectomy enables minimally invasive plaque removal in peripheral artery disease (PAD).We aimed to evaluate the safety and the long-term effectiveness of the Phoenix atherectomy for the treatment of complex and calcified lesions in PAD patients.Consecutive all-comer patients with PAD underwent the Phoenix atherectomy. Device safety in terms of perforation and distal embolisation were evaluated. Lesion calcifications were categorised by the Peripheral Arterial Calcium Scoring System (PACSS) and lesion complexity was assessed by the Transatlantic Inter-Society Consensus (TASC). Clinically driven target lesion revascularisation (TLR) was assessed.A total of 558 lesions were treated in 402 consecutive patients. Clinical follow-up was available at 15.7±10.2 months for 365 (91%) patients. Of 402 patients, 135 (33.6%) had claudication, 37 (9.2%) had ischaemic rest pain and 230 (57%) exhibited ischaemic ulcerations. Lesions were mostly identified in the femoropopliteal segments (55%), followed by below-the-knee (BTK) segments (32%). Complex TASC C/D lesions and moderate to severe calcifications (PACSS score ≥2) were present in 331 (82%) and 323 (80%) patients, respectively. The mean lesion length was 20.6±14.3 cm. Five (1%) perforations and 10 (2%) asymptomatic embolisations occurred. Bail-out stenting was performed in 4%, 16% and 3% of patients with common femoral artery, femoropopliteal and BTK lesions, respectively. During follow-up, 5 (3.9%) patients with claudication and 52 (21.9%) patients with critical limb-threatening ischaemia (CLTI) died (hazard ratio [HR] 3.7; p0.001). Freedom from TLR was 87.5% (112 of 128) in patients with claudication and 82.3% (195 of 237) in patients with CLTI, respectively (HR 1.8; p=0.03).The Phoenix atherectomy can be safely performed in patients with complex lesions with a relatively low rate of bail-out stenting and clinically acceptable TLR rates.DRKS00016708.