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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 -
Catheterization and Cardiovascular... Nov 2021The optimal approach to deal with severe coronary artery calcification (CAC) during percutaneous coronary intervention (PCI) remains ill-defined. (Meta-Analysis)
Meta-Analysis
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.
Topics: Atherectomy; Atherectomy, Coronary; Coronary Artery Disease; Coronary Stenosis; Humans; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Treatment Outcome; Vascular Calcification
PubMed: 33325587
DOI: 10.1002/ccd.29430 -
Cardiovascular Revascularization... Apr 2020Percutaneous coronary intervention (PCI) outcomes for patients with significant calcification have been consistently inferior compared to patients without significant... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Percutaneous coronary intervention (PCI) outcomes for patients with significant calcification have been consistently inferior compared to patients without significant calcification. Procedural success and long-term outcomes after PCI have been worse in patients with severe coronary calcium.
OBJECTIVE
A Bayesian meta-analysis of outcomes comparing rotational atherectomy (RA) with orbital atherectomy (OA) was performed.
METHODS
PubMed, Embase, and Cochrane Library databases were searched through 30th November 2018 and identified 4 observational studies.
RESULTS
The primary end-point, Major Adverse Cardiac Event (MACE) composing of death, MI and stroke at 1 year was more likely with RA (OR = 1.61; 95% CI: 1.11-2.33; p = 0.01) as compared to OA. The driver of the difference in MACE between the two groups was a statistically significant difference in mortality favoring OA (OR = 4.65; 95% CI: 1.36-15.87; p = 0.01). Peri-procedural MI, the other component of the primary end-point was 1.3 times more likely in the RA arm (OR = 1.35; 95% CI 0.95-1.92; p-0.09) and was not statistically different between the groups. The odds of a vascular complication were not different in the two groups (OR = 1.26; 95% CI: 0.73-2.17; p = 0.41). In an adjusted Bayesian analysis, mortality (OR = 3.69; 95% CI: 0.30-38.51), MACE (OR = 1.68; 95% CI: 0.55-5.49), MI (OR = 1.42; 95% CI: 0.50-4.29) and dissections/perforations (OR = 0.38; 95% CI: 0.10-1.38) were not different in RA and OA groups.
CONCLUSION
Our study is the first published Bayesian meta-analysis comparing MACE and peri-procedural outcomes in RA compared to OA. These findings lay the foundation for a randomized comparison between the two competing technologies.
Topics: Atherectomy, Coronary; Bayes Theorem; Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Risk Factors; Severity of Illness Index; Treatment Outcome; Vascular Calcification
PubMed: 31377129
DOI: 10.1016/j.carrev.2019.07.019 -
Journal of Vascular Surgery Feb 2022Atherectomy has become increasingly used as an endovascular treatment of lower extremity atherosclerotic disease in the United States. However, concerns and...
OBJECTIVE
Atherectomy has become increasingly used as an endovascular treatment of lower extremity atherosclerotic disease in the United States. However, concerns and controversies about its indications and outcomes exist. The goal of the present systematic review and meta-analysis was to investigate the outcomes and complications related to atherectomy to treat femoropopliteal atherosclerotic disease.
METHODS
A systematic review in accordance with the recommendations from the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement was performed. Four major scientific repositories (MEDLINE, Embase, the Cochrane Library, and Thompson Web of Sciences) were queried from their inception to April 5, 2020. We reviewed and entered the data in a dedicated dataset. The outcomes included the patency rates, clinical and hemodynamic improvement, and morbidity and mortality associated with atherectomy interventions.
RESULTS
Twenty-four studies encompassing 1900 patients met the inclusion criteria for the present study. Of the 1900 patients, 74.3% had presented with Rutherford class 1 to 3 and 25.7% presented with Rutherford class 4 to 6; 1445 patients had undergone atherectomy, and 455 patients had been treated without atherectomy. The atherectomy group had undergone directional atherectomy (n = 851), rotational atherectomy (n = 851), laser atherectomy (n = 201), and orbital atherectomy (n = 78). Most of these patients had also received adjunct treatments, which varied across the studies and included a combination of stenting, balloon angioplasty, or drug-coated balloon angioplasty. Technical success was achieved in 92.3% of the cases. Distal embolization, vessel perforation, and dissection occurred in 3.4%, 1.9%, and 4% of the cases, respectively. The initial patency was 95.4%. At the 12-month median follow-up, the primary patency was 72.6%. The ankle brachial index had improved from a preoperative mean of 0.6 to a postoperative mean of 0.84. The incidence of major amputation and mortality during the follow-up period was 2.2% and 3.4%, respectively.
CONCLUSIONS
The results from our review of the reported data suggest that femoropopliteal atherectomy can be completed safely, modestly improving the ankle brachial index and maintaining the 1-year patency in nearly three of four patients. However, these findings were based on heterogeneous studies that skewed the generalizable conclusions about atherectomy's efficacy. Atherectomy places a high cost burden on the healthcare system and is used in the United States at a higher rate than in other countries. Our review of the literature did not demonstrate clear atherectomy superiority to alternatives that would warrant the pervasive and increasing use of this costly technology. Future work should focus on developing high-quality randomized controlled trials to determine the specific patient and lesion characteristics for which atherectomy can add value.
Topics: Angioplasty, Balloon; Atherectomy; Atherosclerosis; Coated Materials, Biocompatible; Femoral Artery; Humans; Intermittent Claudication; Popliteal Artery; Stents; Vascular Patency
PubMed: 34303802
DOI: 10.1016/j.jvs.2021.07.106 -
Journal of Endovascular Therapy : An... Aug 2020Endovascular revascularization has been increasingly utilized to treat patients with chronic limb-threatening ischemia (CLTI), particularly atherosclerotic disease in...
Endovascular revascularization has been increasingly utilized to treat patients with chronic limb-threatening ischemia (CLTI), particularly atherosclerotic disease in the infrapopliteal arteries. Lesions of the infrapopliteal arteries are the result of 2 different etiologies: medial calcification and intimal atheromatous plaque. Although several devices are available for endovascular treatment of infrapopliteal lesions, balloon angioplasty still comprises the mainstay of therapy due to a lack of purpose-built devices. The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. In many cases, the diffuse nature of infrapopliteal disease and plaque complexity may lead to dissection, recoil, and early restenosis. Optimal balloon angioplasty requires careful attention to assessment of vessel calcification, appropriate vessel sizing, and the use of long balloons with prolonged inflation times, as outlined in a treatment algorithm based on this systematic review. Further development of specific devices for this arterial segment are warranted, including devices for preventing recoil (eg, dedicated atherectomy devices), treating dissections (eg, tacks, stents), and preventing neointimal hyperplasia (eg, novel drug delivery techniques and drug-eluting stents). Further understanding of infrapopliteal disease, along with the development of new technologies, will help optimize the durability of endovascular interventions and ultimately improve the limb-related outcomes of patients with CLTI.
Topics: Algorithms; Amputation, Surgical; Angioplasty, Balloon; Chronic Disease; Clinical Decision-Making; Decision Support Techniques; Humans; Ischemia; Limb Salvage; Patient Selection; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Risk Factors; Treatment Outcome; Vascular Patency
PubMed: 32571125
DOI: 10.1177/1526602820931488 -
Catheterization and Cardiovascular... Feb 2019Orbital atherectomy (OA) is routinely being used for plaque modification to facilitate percutaneous revascularization in patients with peripheral arterial disease (PAD)...
BACKGROUND/OBJECTIVES
Orbital atherectomy (OA) is routinely being used for plaque modification to facilitate percutaneous revascularization in patients with peripheral arterial disease (PAD) and arterial calcification. Guidewire fracture (GWF) during OA, though anecdotally described, has not been studied in a systematic manner. We conducted a review of the Manufacturer and User Facility Device Experience (MAUDE) database to study the reports of wire fracture and its management and consequences.
METHODS
We queried the MAUDE database for all events involving the current generation of the OA device: "Diamondback 360 Peripheral Orbital Atherectomy System", and "Stealth 360° Orbital PAD System".
RESULTS
We identified 62 reports of GWF during OA for PAD. The superficial femoral artery was the most commonly involved atherectomy site. The wire fractured at the soft tip in a majority of cases (68%). Embolized wire fragments were left in the patient in 36 cases (58%), retrieved percutaneously in 10 cases (16%), and trapped by a stent against the arterial wall in eight cases (13%). Lastly, eight patients (13%) underwent surgery for removal of the wire fragment.
CONCLUSIONS
This is the first published report to study the complication of GWF during peripheral OA. GWF is an uncommon but has significant procedural and clinical consequences. It results in a high rate of ancillary rescue procedures (including surgery) and is associated with a higher risk of arterial thrombosis and complications from wire retrieval attempts. The risk of wire fracture may be avoided with carefully adherence to the IFU.
Topics: Atherectomy; Catheterization, Peripheral; Databases, Factual; Device Removal; Equipment Failure; Foreign-Body Migration; Health Care Sector; Humans; Peripheral Arterial Disease; Risk Factors; Treatment Outcome; Vascular Access Devices
PubMed: 30387234
DOI: 10.1002/ccd.27933 -
Journal of Community Hospital Internal... Mar 2021: Coronary artery calcification (CAC) is a pathological deposition of calcium in the intimal and medial layer of the arterial wall. A plethora of therapeutic calcium... (Review)
Review
: Coronary artery calcification (CAC) is a pathological deposition of calcium in the intimal and medial layer of the arterial wall. A plethora of therapeutic calcium debulking techniques is available for the treatment of CAC, including orbital or rotational atherectomy, excimer lasers, cutting, and scoring balloons, which are associated with a soaring rate of complication and low efficacy. To this end, in 2016, the Food and Drug Administration (FDA) posited that shockwave intravascular lithotripsy (S-IVL) technique can be employed with minimal complication. : A retrospective review of cases received lithotripsy for calcified coronary artery disease was performed by using online data from PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The available search results were downloaded into an Endnote library and analyzed into two phases. : Out of 24 participants from case reports and series, Majority were found to be Male. There was no significant difference found in the mortality of patients undergoing IVL for the stenosis of the left main stem, left anterior descending, left circumflex artery, or diagonal branch. The mortality was found to be high among 6 patients with prior comorbidities and underwent more than 3 cycles of IVL (OR 37,95% Cl 1.54-886.04, P 0.02). Out of 24 patients, 2 (8.33%) patients developed complications such as vessel dissection (OR 3.4, 95% Cl 17.87-64.68, P 0.4). : Shockwave intravascular lithotripsy (S-IVL) may be used in cases of the calcified disease to gain vessel lumen in order to deploy drug-eluting stents with PCI. The success of the DES implantation of IVL can be 100% with a minimal complication rate.
PubMed: 33889320
DOI: 10.1080/20009666.2021.1883219 -
International Angiology : a Journal of... Dec 2017The aim of this review is to explore the safety and effectiveness of intravascular ultrasound (IVUS) during lower limb endovascular interventions in patients with... (Review)
Review
INTRODUCTION
The aim of this review is to explore the safety and effectiveness of intravascular ultrasound (IVUS) during lower limb endovascular interventions in patients with peripheral arterial disease (PAD).
EVIDENCE ACQUISITION
A systematic review of the PubMed and Scopus databases was performed according to PRISMA guidelines. Clinical studies evaluating IVUS as an adjunct to angiography during revascularization procedures in patients with PAD were included.
EVIDENCE SYNTHESIS
Thirteen studies were identified, with a total number of 2258 patients having had IVUS for PAD intervention. Seven investigated the role of IVUS for angioplasty and stenting, with the majority being retrospective cohorts. Technical success and patency rates ranged from 90-100% and 45-100%, respectively, with a follow-up that ranged from 4.3-63 months. Three of these studies compared IVUS and non-IVUS guided angioplasty and demonstrated a significant difference in the events of amputations or re-interventions in favor of the IVUS group. Furthermore, five studies evaluated IVUS use in true-lumen re-entry, with the technical success ranging between 97-100%. In one study, where IVUS was used for atherectomy, the technical success was 100% and the long-term patency was 90% during a 12-month follow-up. Overall, no significant peri/postoperative IVUS related complications were reported, whereas, 2 studies suggested an IVUS-associated increase in procedure costs that ranged from $1080-$1333.
CONCLUSIONS
There is limited and heterogeneous evidence regarding the use of IVUS for the management of PAD. Further research is required to elucidate the optimal role of IVUS in PAD as well as the cost effectiveness of this approach for routine use in the management of PAD.
Topics: Amputation, Surgical; Angioplasty; Disease Management; Humans; Lower Extremity; Peripheral Arterial Disease; Stents; Ultrasonography, Interventional
PubMed: 28895369
DOI: 10.23736/S0392-9590.17.03866-4 -
Journal of Endovascular Therapy : An... Feb 2020To report the results of a network meta-analysis of randomized controlled trials (RCTs) comparing multiple endovascular treatments for de novo femoropopliteal lesions.... (Meta-Analysis)
Meta-Analysis
To report the results of a network meta-analysis of randomized controlled trials (RCTs) comparing multiple endovascular treatments for de novo femoropopliteal lesions. The MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were systematically searched on June 1, 2019, for prospective RCTs comparing 14 treatments [ie, atherectomy, brachytherapy, cryoplasty, cutting balloons, drug-coated balloons, bare nitinol stents, drug-eluting stents (DES), covered stents (CS), and combinations] in the treatment of de novo femoropopliteal lesions. Outcomes were technical success; binary restenosis and target lesion revascularization (TLR) at 6, 12, and/or 24 months; and all-cause mortality at 12 months. Ultimately, 53 articles reporting on 45 studies (91 study arms; 5565 patients) were selected. For the technical success outcome, all types of stents, all balloons, and all atherectomy devices were aggregated in stent, balloon, and atherectomy technology groups, respectively. In terms of technical success for aggregated treatment types, stent technology was the most effective treatment and was better than balloon and atherectomy technologies. In terms of binary restenosis, DES was the most effective single treatment at the 6- and 12-month follow-up and CS at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments, including balloon angioplasty, cutting balloon, cryoplasty, directional atherectomy, and bare nitinol stent during all follow-up periods. In terms of TLR, DES was the second most effective single treatment and the most effective single treatment at the 6- and 12-month follow-up intervals; CS was the most effective single treatment at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments. The 12-month all-cause mortality of both DES and CS were similar to other treatments, whereas cryoplasty seemed to be the least effective treatment with regard to binary restenosis and TLR. Both DES and CS had substantial advantages in terms of restenosis and TLR in femoropopliteal lesions and were similar to aggregate stent technology in terms of technical success. DES performed better within 12 months after operation and CS at ~24 months, but neither had much advantage in terms of mortality. In contrast, cryoplasty seemed to be a less effective treatment.
Topics: Aged; Comparative Effectiveness Research; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Network Meta-Analysis; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 31948375
DOI: 10.1177/1526602819895996