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Nihon Rinsho. Japanese Journal of... May 2003
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Cardiovascular Revascularization... Jan 2024
Topics: Humans; Atherectomy, Coronary; Atherectomy
PubMed: 37537102
DOI: 10.1016/j.carrev.2023.07.021 -
Annals of the Royal College of Surgeons... Sep 2023This study is an analysis of the therapeutic effects of directional atherectomy combined with drug-coated balloon angioplasty (DA+DCB) in treating superficial femoral...
INTRODUCTION
This study is an analysis of the therapeutic effects of directional atherectomy combined with drug-coated balloon angioplasty (DA+DCB) in treating superficial femoral arteriosclerosis obliterans.
METHODS
Patients in our hospital with superficial femoral arteriosclerosis obliterans who received DA+DCB during the period June 2016 to February 2019 were identified retrospectively. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically.
RESULTS
Between June 2016 and February 2019, 48 patients were enrolled in this retrospective study. The average age of the patients was 66.85 ± 11.28 years; 83.3% of the patients were male. During the procedure, flow-limiting dissection occurred frequently (9/48 patients) and there were six bailout stent implantations owing to flow-limiting dissections. The incidence rate of target artery thrombosis was 4.2% (2/48). There was no vessel perforation, embolism or operation-related death. The technical success rate was estimated at 100%. The mean ankle-brachial index of the patients was 0.54 ± 0.28 before the operation and 0.93 ± 0.13 before discharge ( < 0.0001). The mean follow-up time was 19.6 ± 9.0 months. The primary patency rate was 89.4%, 82.4% and 76.5% at 12, 24 and 36 months. The freedom from target lesion revascularisation (TLR) was 97.9%, 93.8% and 84.4% at 12, 24 and 36 months.
CONCLUSION
The use of DA+DCB showed good clinical benefit for superficial femoral arteriosclerosis obliterans, which had good primary patency and freedom from TLR. Multicentre randomised controlled trials with long-term follow-up are needed.
Topics: Humans; Male; Middle Aged; Aged; Female; Femoral Artery; Popliteal Artery; Retrospective Studies; Peripheral Arterial Disease; Arteriosclerosis Obliterans; Treatment Outcome; Risk Factors; Time Factors; Coated Materials, Biocompatible; Vascular Patency; Vascular Access Devices; Angioplasty, Balloon; Atherectomy
PubMed: 36927132
DOI: 10.1308/rcsann.2022.0164 -
The Journal of Invasive Cardiology Apr 2023Peripheral artery disease (PAD) is associated with high morbidity and mortality, particularly once patients develop critical limb threatening ischemia (CLTI). Minorities... (Observational Study)
Observational Study
BACKGROUND
Peripheral artery disease (PAD) is associated with high morbidity and mortality, particularly once patients develop critical limb threatening ischemia (CLTI). Minorities and vulnerable populations often present with CLTI and experience worse outcomes. The use of directional atherectomy (DA) and drug-coated balloon (DCB) during lower-extremity revascularization (LER) has not been previously described in a safety-net population.
OBJECTIVE
To review demographic and clinical characteristics, and short- intermediate term outcomes of patients presenting to a safety-net hospital with PAD treated with DA and DCB during LER.
METHODS
In this retrospective, observational cohort study, chart review was performed of all patients who underwent DA and DCB during LER for PAD from April 2016 to January 2020 in a safety-net hospital.
RESULTS
The analysis included 58 patients, with 41% female, 24% Black/African American, and 31% Hispanic. From this group, 17% spoke a non-English primary language and 10% reported current or previous housing insecurity. Most (65%) presented with CLTI and had undergone a previous index leg LER (58%). The combination of DA and DCB was efficacious, resulting in low rates of bail-out stenting (16%) and target-vessel revascularization (26%) at 2 years. Low complication rates (tibial embolism in 12% and vessel perforation in 2% of cases) were also observed. Most patients (67%) with Rutherford category 5 experienced wound healing by 2 years.
CONCLUSION
In this safety-net population, the majority presented with CLTI and a previous LER of the index leg. The combination of DA and DCB resulted in low complication rates, and good short-intermediate outcomes in this frequently undertreated population.
Topics: Humans; Female; Male; Retrospective Studies; Femoral Artery; Popliteal Artery; Angioplasty, Balloon; Treatment Outcome; Risk Factors; Peripheral Arterial Disease; Atherectomy; Vascular Patency; Coated Materials, Biocompatible
PubMed: 37029994
DOI: 10.25270/jic/22.00382 -
Annals of Vascular Surgery Jul 2020The use of directional atherectomy (DA) with or without drug-coated balloon (DCB) may be considered for the management of common femoral artery (CFA) occlusive disease...
BACKGROUND
The use of directional atherectomy (DA) with or without drug-coated balloon (DCB) may be considered for the management of common femoral artery (CFA) occlusive disease because of its minimally invasive nature with early mobilization, reduced incision complications, and infection rates. However, it has recognized complications, which may be related to the learning curve. We present our initial experience using DA and suggest changes that may, based on our practice, improve outcomes.
METHODS
Retrospective analysis with a prospective data collection from 2 centers to analyze outcomes in all consecutive patients treated during 1 year (n = 25). Patients who underwent CFA DA with/without DCB for CFA >70% stenosis. Primary end points include technical success, primary patency of the CFA, morbidity, and mortality. Secondary end points include change in Rutherford-Becker class, length of stay, and target lesion revascularization rate.
RESULTS
Between July 2017 and December 2018, 25 patients underwent CFA DA. Two had an occluded CFA, and 23 had >70% CFA stenosis as determined by ultrasound scan (USS) and/or computed tomography angiogram (CTA) preoperatively. There were no deaths within 30 days. Procedure-related complications included 2 cases of CFA pseudoaneurysm (one of them repaired by open surgery) and 1 CFA perforation (repaired with covered stent). No distal embolization or limb loss occurred. Mean length of stay was 1.9 days. Primary and secondary patency at 3 and 6 months was 100%. At 12 months, it was 96%.
CONCLUSIONS
Early results suggest that CFA DA with/without DCB is safe and effective. Previous CTA, focused USS, and/or intravascular USS may be useful to minimize the risk of pseudoaneurysm or perforation by excessive thinning of the media. Experience is required to prevent localized dilatation over time.
Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Atherectomy; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency; Western Australia
PubMed: 32035268
DOI: 10.1016/j.avsg.2020.01.094 -
Catheterization and Cardiovascular... Mar 2022
Topics: Angioplasty, Balloon; Atherectomy; Atherectomy, Coronary; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Treatment Outcome; Vascular Patency
PubMed: 35441823
DOI: 10.1002/ccd.30169 -
Minerva Cardioangiologica Oct 2002Restenosis after coronary stent implantation remains the major limitation of this treatment modality. At present, re-dilatation is considered the therapeutic option of... (Comparative Study)
Comparative Study Review
Restenosis after coronary stent implantation remains the major limitation of this treatment modality. At present, re-dilatation is considered the therapeutic option of choice for focal lesions, however, long restenotic lesions (>10 mm) do not respond favourably. Despite the emerging concept of intracoronary radiation, encouraging acute procedural results are also reported for different debulking techniques (Excimer laser angioplasty, directional coronary atherectomy, and rotational atherectomy, or rotablation). Rotablation has been studied most extensively with acute and long- term results published in a total of more than 850 patients. Experimental and first clinical data indicate favourable results for the rotablator as compared to balloon angioplasty alone for the treatment of in-stent restenosis. Data from the first 2 randomized clinical trials (ROSTER-, and ARTIST-trial) have now been published with conflicting results: The european multicenter ARTIST-trial including 300 patients could not prove a benefit for the rotablator as compared to re-dilatation in patients with diffuse stent restenosis. On the contrary, the monocenter ROSTER-trial, which has been presented as an abstract until today, suggests a clinical benefit of patients treated by the rotablator if they were studied with intracoronary ultrasound prior to randomization. Currently, rotablation for the treatment of restenosis cannot be considered as the first line treatment modality in patients with in-stent restenosis. As a result of unsatisfying angiographic and clinical long-term results by the use of a variety of treatment modalities in diffuse stent restenosis, prevention of this iatrogenic entity has become mandatory.
Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy; Coronary Angiography; Coronary Restenosis; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Stents; Ultrasonography, Interventional
PubMed: 12384637
DOI: No ID Found -
Journal of Endovascular Therapy : An... Dec 2022Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
Optimal balloon angioplasty for infrapopliteal lesions is often limited by severe calcification, which has been associated with decreased procedural success and lower long-term patency.
MATERIALS AND METHODS
This was a prospective, randomized, multicenter pilot trial that included adult subjects with calcified lesions located from the popliteal segment below the knee (BTK) joint to within 5 cm above the ankle with ≥70% diameter stenosis by angiography. Patients were randomized 1:1 to undergo orbital atherectomy (OA) with adjunctive drug-coated balloon (DCB) angioplasty versus plain balloon angioplasty (BA) and DCB angioplasty (control). The periprocedural and 12 month outcomes of both procedures were compared.
RESULTS
Overall, 66 subjects (OA + DCB = 32 vs control = 34) were included in an intention to treat analysis. Baseline demographics and lesion characteristics were well-balanced. The mean lesion length was 101.3 mm (SD = 72.8 mm) and 78.8 (SD = 61.0 mm) in the OA + DCB and control groups, respectively, with almost all lesions having severe calcification per the Peripheral Academic Research Consortium (PARC) criteria. Chronic total occlusions (CTOs) were present in 43.8% and 35.3% of the patients in the OA + DCB and control groups, respectively. The technical success of OA + DCB versus DCB was 81.8% and 89.2%, respectively, with 3 slow flow/no reflow, 1 perforation, 1 severe dissection occurred in OA + DCB group, and one distal embolization occurred in the control group. The target lesion primary patency rate was numerically higher in the OA + DCB versus control group at 6 (88.2% vs 50.0%, p=0.065) and 12 month follow-up (88.2% vs 54.5%, p=0.076). The 12 month freedom from major adverse events, clinically-driven target lesion revascularization, major amputation, and all-cause mortality rates were similar between both groups.
CONCLUSION
The results of the Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified BTK (OPTIMIZE BTK) pilot study indicated that utilization of OA + DCB is safe for infrapopliteal disease. Further prospective adequately powered studies should investigate the potential benefit of combined OA + DCB for BTK lesions.
Topics: Adult; Humans; Pilot Projects; Popliteal Artery; Peripheral Arterial Disease; Vascular Patency; Coated Materials, Biocompatible; Treatment Outcome; Time Factors; Atherectomy; Angioplasty, Balloon; Femoral Artery
PubMed: 35086385
DOI: 10.1177/15266028211070968 -
World Journal of Surgery 1996Atherectomy physically removes plaque by cutting, pulverizing, or shaving it in atherosclerotic arteries using a mechanical, catheter-deliverable endarterectomy device.... (Comparative Study)
Comparative Study Review
Atherectomy physically removes plaque by cutting, pulverizing, or shaving it in atherosclerotic arteries using a mechanical, catheter-deliverable endarterectomy device. Theoretically, atherectomy offers the following advantages over percutaneous transluminal angioplasty (PTA): It shows a greater immediate success rate with less dissection and acute occlusion, treats complex lesions, and reduces the restenosis rate. This article presents the unique features of four atherectomy devices designed to meet the above challenges: Simpson AtheroCath, Transluminal Extraction Catheter (TEC), Trac-Wright Catheter, and Auth Rotablator. The results, complications, and limitations reported by clinical investigators are discussed critically and realistically. A new device, the OmniCath, under investigative trial, is presented briefly. Clinical studies evaluating the Simpson AtheroCath have reported impressively high initial success rates (ranging from 82% to 100%) but disparate intermediate patency results (ranging from 35% to 84%). Complications associated with the device include hematoma, pseudoaneurysm, and distal embolization. Clinical studies show that the device is relatively ineffective for treating diffusely diseased and long-occluded lesions. Restenosis has also been a primary constraint of the Simpson device, with reported restenosis rates ranging from 11% to 55% at 6 months. The initial technical and clinical success rates reported with the TEC atherectomy device have been promising at 79% to 92%; however, short- and mid-term follow-up results have been either lacking or disappointing, with a reported patency of 67% at 6 months and 51% at 12 months. Furthermore, the problems of restenosis and reocclusion have limited its short-term benefits. The Trac-Wright catheter has demonstrated widely disparate technical success rates (from 58% to 100%) and clinical success rates (from 33% to 80%). Patency rates reported have been suboptimal, ranging from 25% to 68% at 6 months and 25% to 45% at 12 months. Furthermore, severe complications associated with the device include perforation, dissection, and embolization. Reocclusion also limits the applicability of the device. The reported immediate success rates of 72% to 94% using the Auth Rotablator are similar to those reported for other atherectomy devices. Patencies reported at 1 and 2 years are dismal, ranging from 31% to 61% and from 12% to 18%, respectively. Significant complications are associated with the device, including thrombosis, arterial spasm, hemoglobinuria, hematoma, and embolization. Contrary to previous studies and expectations, perforations and dissections have been encountered by some investigators. Late restenosis and reocclusion are also significant limiting factors of the Auth Rotablator. Atherectomy currently has limited applications for treatment of peripheral arterial occlusive disease. The intermediate- and long-term results obtained with the atherectomy devices are worse than those reported for PTA. Furthermore, all of the atherectomy devices have failed to reduce the restenosis and reocclusion rates from those reported for PTA. The problem of restenosis, reocclusion, and other complications must be solved before atherectomy can be used generally as an alternative to vascular reconstruction procedures such as PTA.
Topics: Arterial Occlusive Diseases; Arteriosclerosis; Atherectomy; Endarterectomy; Equipment Design; Equipment Failure; Follow-Up Studies; Humans; Postoperative Complications; Recurrence
PubMed: 8662146
DOI: 10.1007/s002689900097 -
EuroIntervention : Journal of EuroPCR... Jun 2021Endovascular therapy is the first-line strategy for femoropopliteal obstructive disease. However, for lesions involving the common femoral artery (CFA) surgical...
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.
Topics: Angioplasty, Balloon; Atherectomy; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 32176618
DOI: 10.4244/EIJ-D-19-00693