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EuroIntervention : Journal of EuroPCR... Dec 2023There is a paucity of real-world data on the in-hospital (IH) and post-discharge outcomes in patients undergoing lower extremity peripheral vascular intervention (PVI)...
BACKGROUND
There is a paucity of real-world data on the in-hospital (IH) and post-discharge outcomes in patients undergoing lower extremity peripheral vascular intervention (PVI) with adjunctive atherectomy.
AIMS
In this retrospective, registry-based study, we evaluated IH and post-discharge outcomes among patients undergoing PVI, treated with or without atherectomy, in the National Cardiovascular Data Registry PVI Registry.
METHODS
The IH composite endpoint included procedural complications, bleeding or thrombosis. The primary out-of-hospital endpoint was major amputation at 1 year. Secondary endpoints included repeat endovascular or surgical revascularisation and death. Multivariable regression was used to identify predictors of atherectomy use and its association with clinical endpoints.
RESULTS
A total of 30,847 patients underwent PVI from 2014 to 2019, including 10,971 (35.6%) treated with atherectomy. The unadjusted rate of the IH endpoint occurred in 524 (4.8%) of the procedures involving atherectomy and 1,041 (5.3%) of non-atherectomy procedures (p=0.07). After adjustment, the use of atherectomy was not associated with an increased risk of the combined IH endpoint (p=0.68). In the 6,889 (22.4%) patients with out-of-hospital data, atherectomy was associated with a reduced risk of amputation (adjusted hazard ratio [aHR] 0.67, 95% confidence interval [CI]: 0.51-0.85; p<0.01) and surgical revascularisation (aHR 0.63, 95% CI: 0.44-0.89; p=0.017), no difference in death rates (p=0.10), but an increased risk of endovascular revascularisation (aHR 1.21, 95% CI: 1.06-1.39; p<0.01) at 1 year.
CONCLUSIONS
The use of atherectomy during PVI is common and is not associated with an increase in IH adverse events. Longitudinally, patients treated with atherectomy undergo repeat endovascular reintervention more frequently but experience a reduced risk of amputation and surgical revascularisation.
Topics: Humans; Retrospective Studies; Peripheral Arterial Disease; Aftercare; Endovascular Procedures; Risk Factors; Treatment Outcome; Patient Discharge; Atherectomy; Lower Extremity
PubMed: 37750241
DOI: 10.4244/EIJ-D-23-00432 -
JACC. Cardiovascular Interventions Sep 2023There are several retrospective studies comparing rotational atherectomy (RA) and orbital atherectomy (OA), but all percutaneous coronary interventions (PCIs) in those... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
There are several retrospective studies comparing rotational atherectomy (RA) and orbital atherectomy (OA), but all percutaneous coronary interventions (PCIs) in those studies were not performed under intracoronary imaging guidance.
OBJECTIVES
This study sought to compare the efficacy and safety of optical coherence tomography (OCT)-guided PCI with RA vs OA.
METHODS
The DIRO (To directly compare RA and OA for calcified lesions, a prospective randomized trial) trial was conducted. We enrolled patients with de novo calcified lesions (arc >180°) assessed by OCT or angiographically moderate or severe calcifications if the OCT catheter could not cross the lesion before any intervention. Eligible patients were randomly 1:1 allocated to lesion preparation with RA vs OA. Stent expansion was defined as the minimum stent area divided by the distal reference area multiplied by 100. Tissue modification was assessed using preatherectomy and postatherectomy OCT images. Procedural outcomes including periprocedural myocardial infarctions were evaluated. Furthermore, clinical events and vascular healing evaluated by OCT at 8 months postprocedure were assessed.
RESULTS
The stent expansion was significantly greater in the RA group vs the OA group (99.5% vs 90.6%; P = 0.02). The maximum atherectomy area was significantly larger in the RA group than in the OA group (1.34 [IQR: 1.02-1.89] mm vs 0.83 [IQR: 0.59-1.11] mm; P = 0.004). The procedural outcomes and clinical events at 8 months did not differ between the groups. The vascular healing was sufficient in both groups.
CONCLUSIONS
The prospective randomized DIRO trial revealed that RA could produce a more favorable tissue modification, which may lead to a larger stent expansion than OA in heavily calcified lesions.
Topics: Humans; Tomography, Optical Coherence; Percutaneous Coronary Intervention; Prospective Studies; Retrospective Studies; Treatment Outcome; Atherectomy
PubMed: 37704299
DOI: 10.1016/j.jcin.2023.06.016 -
The Journal of Cardiovascular Surgery Oct 2014A systematic review was performed to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing debulking... (Meta-Analysis)
Meta-Analysis Review
A systematic review was performed to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing debulking atherectomy versus balloon angioplasty for treatment of femoropopliteal artery occlusive disease. PubMed (MEDLINE), EMBASE, AMED, Scopus, online content and meeting abstracts were searched in May 2014 for eligible RCTs following the PRISMA selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Pooled risks were calculated with a random effects model to account for clinical and conceptual heterogeneity. Sensitivity analysis was employed to test the robustness of the results. Six RCTs comprising 287 patients (328 lesions) treated with either debulking atherectomy or balloon angioplasty for femoropopliteal artery disease were analyzed and synthesized. Technical success was similar between the atherectomy and the angioplasty group (93.6% vs. 96.2%, RR: 0.99. 95%CI: 0.95-1.03, P=0.57, I(2)=0%). Need for bail-out stenting and distal arterial embolization were largely similar between atherectomy and balloon angioplasty alone. After a median follow-up of 9 months the 2 groups showed similar primary patency (RR: 0.90, 95%CI: 0.56-1.46, P=0.68, I(2)=69%). Only 2 low-quality studies reported amputation and mortality rates, both of which were found significantly less in the atherectomy arms. Analysis of a limited body of low quality evidence with high risk of bias showed that debulking atherectomy of the femoropopliteal artery does not seem to confer any procedural advantage or improvement of clinical outcomes over balloon angioplasty alone.
Topics: Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chi-Square Distribution; Embolization, Therapeutic; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 25008063
DOI: No ID Found -
Therapeutic Advances in Cardiovascular... 2021Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia. (Review)
Review
BACKGROUND
Our aim was to review the current literature of the use of directional atherectomy (DA) in the treatment of lower extremity critical-limb ischemia.
METHODS
A search for relevant literature was performed in PubMed and PubMed Central on 16 April 2020, sorted by best match. Three searches across two databases were performed. Articles were included that contained clinical and procedural data of DA interventions in lower extremity critical-limb ischemia patients. All studies that were systematic reviews were excluded.
RESULTS
Eleven papers were included in this review. Papers were examined under several parameters: primary patency and secondary patency, limb salvage/amputation, technical/procedural success, complications/periprocedural events, and mean lesion length. Primary and secondary patency rates ranged from 56.3% to 95.0% and 76.4% to 100%, respectively. Limb salvage rates ranged from 69% to 100%. Lesion lengths were highly varied, representing a broad population, ranging from 30 ± 33 mm to 142.4 ± 107.9 mm.
CONCLUSIONS
DA may be a useful tool in the treatment of lower extremity critical-limb ischemia.
Topics: Atherectomy; Humans; Ischemia; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; Treatment Outcome; Vascular Patency
PubMed: 34796770
DOI: 10.1177/17539447211046953 -
The Cochrane Database of Systematic... Sep 2020Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014.
OBJECTIVES
To evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019.
SELECTION CRITERIA
We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease.
DATA COLLECTION AND ANALYSIS
Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications.
MAIN RESULTS
We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events. There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively).
AUTHORS' CONCLUSIONS
This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.
Topics: Acute Coronary Syndrome; Angioplasty, Balloon; Atherectomy; Cause of Death; Heart Failure; Humans; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Stents
PubMed: 32990327
DOI: 10.1002/14651858.CD006680.pub3 -
Cardiovascular Revascularization... Jan 2024
Topics: Humans; Atherectomy, Coronary; Atherectomy
PubMed: 37537102
DOI: 10.1016/j.carrev.2023.07.021 -
EuroIntervention : Journal of EuroPCR... Jul 2020
Topics: Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Humans
PubMed: 32686649
DOI: 10.4244/EIJV16I4A45 -
Journal of Vascular Surgery Apr 2024We evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of...
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.
Topics: Humans; Femoral Artery; Atherectomy, Coronary; Retrospective Studies; Treatment Outcome; Angioplasty, Balloon; Peripheral Arterial Disease; Popliteal Artery; Atherectomy; Vascular Patency
PubMed: 38128846
DOI: 10.1016/j.jvs.2023.12.030 -
Expert Review of Cardiovascular Therapy Jun 2016Heavily calcified coronary plaques represent a complex lesion subset and a challenge to the interventional cardiologist, as they are often resistant to simple plaque... (Review)
Review
Heavily calcified coronary plaques represent a complex lesion subset and a challenge to the interventional cardiologist, as they are often resistant to simple plaque modification with conventional balloon angioplasty. Inadequate plaque modification can lead to stent underdeployment, which itself predisposes to in-stent restenosis and stent thrombosis. Over the years, a number of mechanical devices ranging from modified angioplasty balloons to atherectomy devices have become available in order to tackle such lesions. Here we review these devices concentrating on the evidence behind their use.
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Calcinosis; Coronary Angiography; Coronary Artery Disease; Humans; Plaque, Atherosclerotic; Stents; Treatment Outcome
PubMed: 26924773
DOI: 10.1586/14779072.2016.1159513 -
EuroIntervention : Journal of EuroPCR... Oct 2019Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher... (Review)
Review
Heavily calcified lesions may be difficult to dilate adequately with conventional balloons and stents, which causes frequent periprocedural complications and higher rates of target lesion revascularisation (TLR). High-pressure non-compliant balloon angioplasty may be of insufficient force to modify calcium and, even when successful, may be limited in its ability to modify the entire calcified lesion. Scoring and cutting balloons hold theoretical value but data to support their efficacy are lacking and, because of their high lesion crossing profile, they often fail to reach the target lesion. Rotational and orbital atherectomy target superficial calcium; however, deep calcium, which may still impact on vessel expansion and luminal gain, is not affected. Intravascular lithotripsy (IVL), based on lithotripsy for renal calculi, is a new technology which uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue. Energy is delivered via a balloon catheter, analogous to contemporary balloon catheters, with transmission through diluted ionic contrast in a semi-compliant balloon inflated at low pressure with sufficient diameter to achieve contact with the vessel wall. With coronary and peripheral balloons approved in Europe, peripheral balloons approved in the USA and multiple new trials beginning, we review the indications for these recently introduced devices, summarise the clinical outcomes of the available trials and describe the design of ongoing studies.
Topics: Arteries; Atherectomy, Coronary; Calcinosis; Constriction, Pathologic; Europe; Humans; Lithotripsy; Tomography, Optical Coherence; Ultrasonography, Interventional; Vascular Calcification
PubMed: 31062700
DOI: 10.4244/EIJ-D-18-01056