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The Journal of Invasive Cardiology Feb 2022In this study, we aimed to describe the immediate and long-term vascular effects of OAS in patients with peripheral arterial disease (PAD) and moderate to severely...
OBJECTIVE
In this study, we aimed to describe the immediate and long-term vascular effects of OAS in patients with peripheral arterial disease (PAD) and moderate to severely calcified lesions.
BACKGROUND
Debulking the calcified atherosclerotic plaque with the orbital atherectomy system (OAS) can potentially enhance vessel compliance and increase the chance of reaching a desirable angioplasty result.
METHODS
A total of 7 patients were evaluated both at baseline and at 6-month follow-up. Following a diagnostic peripheral angiogram, patients with significant SFA disease had a baseline intravascular optical coherence tomography (IV-OCT) and the lesion was treated with OAS. Repeat IV-OCT was performed after atherectomy and after drug-coated balloon, if used. Patients were also evaluated with angiography and IV-OCT imaging at their 6-month follow-up.
RESULTS
The majority of tissue removed was fibrous tissue. During follow-up, luminal volume increased for 4 of the 7 patients from baseline to 6-month follow-up and decreased in 3 patients. On average there was a 6% increase of luminal volume (P<.01 compared with baseline). A recent virtual histology algorithm was used for automatic classification of IV-OCT images unaided by any reader. The algorithm used convolutional neural networks to identify regions as either calcium, fibrous, or lipid plaque, and it agreed with an expert reader 82% of the time.
CONCLUSION
To the best of our knowledge, the current report is the first to describe vascular effects of OAS in medial calcified lesions immediately after and at follow-up using IV-OCT in patients with severe PAD.
Topics: Atherectomy; Atherectomy, Coronary; Coronary Artery Disease; Humans; Peripheral Arterial Disease; Plaque, Atherosclerotic; Time Factors; Treatment Outcome; Vascular Calcification
PubMed: 35058375
DOI: No ID Found -
The American Journal of Cardiology Oct 2023Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose... (Meta-Analysis)
Meta-Analysis
Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose to stent thrombosis and in-stent restenosis. To date, SU with heavily CCP can be addressed using very high-/high-pressure noncompliant balloons, off-label rotational atherectomy/orbital atherectomy, excimer laser atherectomy, and intravascular lithotripsy (IVL). In this meta-analysis, we investigated the success rate of IVL for the treatment of SU because of CCP. Studies and case-based experiences reporting on the use of IVL strategy for treatment of SU were included. The primary end point was IVL strategy success, defined as the adequate expansion of the underexpanded stent. A metanalysis was performed for the main focuses to calculate the proportions of procedural success rates with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. This meta-analysis included 13 studies with 354 patients. The mean age was 71.3 years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2% to 82.4%) were male. The mean follow-up time was 2.6 months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4 mm (95% CI 3 to 3.8), and the post-IVL value was 6.9 mm (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in 7 studies, the pre-IVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). In conclusion, the "stent-through" IVL plaque modification technique is a safe tool to treat SU caused by CCP, with a high success rate and a very low incidence of complications.
Topics: Humans; Male; Aged; Female; Lithotripsy; Stents; Endovascular Procedures; Atherectomy; Atherectomy, Coronary; Constriction, Pathologic
PubMed: 37611414
DOI: 10.1016/j.amjcard.2023.07.144 -
VASA. Zeitschrift Fur Gefasskrankheiten Sep 2022The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare...
The present study evaluated the prognosis of directional atherectomy (DA)+drug-coated balloon (DCB) angioplasty for femoropopliteal artery lesions compared with bare nitinol stent (BNS). This retrospective cohort study included patients with femoropopliteal artery lesions who underwent percutaneous endovascular surgery between January 2016 and June 2019. The primary outcome was the primary patency rate after 12, 24, and 36 months; the secondary outcomes comprised incidence of flow-limiting dissections, technical success, limb salvage, and all-cause death. During the study period, 110 (44%) patients underwent DA+DCB, and 140 (56%) patients underwent bare nitinol stent (BNS). There were no differences in the 12- and 24-month patency rates of the two groups (98.2% vs. 93.6% and 68.2% vs. 60.0%, both >.05). The 36-month primary patency rate in the DA+DCB group was significantly higher than that of the BNS group (27.3% vs. 15.7%, =.003). The technical success rate and all-cause death were similar between groups (>.05). Flow-limiting dissections occurred more frequently in the BNS group than in the DA+DCB group (27.9% vs. 10.9%, =.033). After adjustment for potential confounders, such as sex, smoking, hypertension, hyperlipidemia, ABI after surgery, TASC II B, lesion length ≥15 cm, two-vessel runoff, and three-vessel runoff, the HR for primary patency rate comparing BNS to DA+DCB was 2.61 (95%CI: 1.61-4.25). In this retrospective cohort study, DA+DCB was associated with a higher 30-month primary patency rate and a lower flow-limiting dissection incidence than BNS.
Topics: Alloys; Angioplasty, Balloon; Atherectomy; Coated Materials, Biocompatible; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency
PubMed: 35801303
DOI: 10.1024/0301-1526/a001010 -
The Journal of Invasive Cardiology Mar 2022Severely calcified coronary stenoses remain a significant challenge during contemporary percutaneous coronary intervention (PCI), often requiring advanced therapies to...
OBJECTIVE
Severely calcified coronary stenoses remain a significant challenge during contemporary percutaneous coronary intervention (PCI), often requiring advanced therapies to circumvent suboptimal lesion preparation and major adverse cardiac events (MACEs). Recent reports suggest combined coronary atherectomy and intravascular lithotripsy (IVL) may achieve superior preparation of severely calcified coronary stenoses during PCI. We sought to evaluate the safety and utility of combined orbital atherectomy (OA) and IVL for the modification of coronary artery calcification (CAC) prior to drug-eluting stent (DES) implantation in PCI.
METHODS
We performed a retrospective review of all patients who underwent coronary OA and IVL within a single PCI procedure at our institution. The primary outcome was procedural success, defined as successful DES implantation with a residual percent diameter stenosis of <30% and Thrombolysis in Myocardial Infarction (TIMI) 3 flow following PCI without occurrence of in-hospital MACE (cardiac death, myocardial infarction, or target-vessel revascularization). MACE was additionally assessed at 30 days post intervention.
RESULTS
Eight patients underwent combined coronary OA and IVL within a single PCI procedure. The mean percent diameter stenosis prior to intervention was 80.5 ± 8.3%, with a mean calcific arc of 338 ± 42°. Procedural success was achieved in 7 of 8 cases (87.5%). Both in-hospital and 30-day MACE rates were 0%.
CONCLUSION
We report the safe and effective use of combined coronary OA and IVL for the preparation of severely calcified coronary stenoses during PCI. Through their distinct yet complementary mechanisms of action, the combined use of these therapies may achieve superior preparation of severely calcified coronary stenoses during PCI.
Topics: Atherectomy; Atherectomy, Coronary; Constriction, Pathologic; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Humans; Lithotripsy; Myocardial Infarction; Percutaneous Coronary Intervention; Treatment Outcome; Vascular Calcification
PubMed: 35192504
DOI: No ID Found -
Journal of Vascular Surgery Feb 2017The purpose of this study was to evaluate the trends in procedure volume, clinical sites of care, and Medicare expenditure for peripheral vascular interventions (PVIs)...
OBJECTIVE
The purpose of this study was to evaluate the trends in procedure volume, clinical sites of care, and Medicare expenditure for peripheral vascular interventions (PVIs) for lower extremity occlusive disease since the Centers for Medicare and Medicaid Services instituted reimbursement policy changes that broadened payment for procedures performed in physician-owned office-based laboratories (OBLs).
METHODS
We analyzed fee-for-service Medicare claims data from 2011 to 2014 to obtain the frequency of use of PVI by type, care setting, and physician specialty. We also assessed changes in the total Medicare cost for PVI by setting.
RESULTS
There was a 60% increase in atherectomy cases among Medicare beneficiaries between 2011 and 2014. During the same period, OBLs experienced a 298% increase in atherectomy volume vs a 27% increase in hospital outpatient settings and an 11% decrease for inpatient hospital settings. In 2014, OBLs were the most common setting for atherectomy. Nonatherectomy PVIs grew more modestly at just 3% but also experienced site of care shifts. Vascular surgeons and cardiologists accounted for the majority of office-based PVIs in 2014. Total Medicare costs for PVIs increased 18% from 2011 to 2014. Hospital inpatient costs declined 1%, whereas costs for hospital outpatient PVIs increased by 41% and physician office costs increased by 258%.
CONCLUSIONS
The migration of revascularization procedures for lower extremity peripheral arterial occlusive disease continues from the inpatient to the outpatient setting and especially to OBLs. Increased use of atherectomy in all segments of the lower extremity arterial system has been observed, particularly in OBLs, without substantial evidence in the literature of increased efficacy compared with standard angioplasty with or without stenting. Generous Medicare reimbursement for in-office atherectomy procedures is likely contributing to the volume shifts observed.
Topics: Ambulatory Care; Ambulatory Surgical Procedures; Atherectomy; Databases, Factual; Health Care Costs; Health Expenditures; Health Services Needs and Demand; Humans; Lower Extremity; Medicare; Office Visits; Peripheral Arterial Disease; Practice Patterns, Physicians'; Process Assessment, Health Care; Time Factors; United States; Workload
PubMed: 27986487
DOI: 10.1016/j.jvs.2016.08.112 -
JACC. Cardiovascular Interventions Mar 2021
Topics: Atherectomy; Humans; Peripheral Arterial Disease; Treatment Outcome
PubMed: 33736775
DOI: 10.1016/j.jcin.2021.01.041 -
Journal of Vascular Surgery Jul 2017Distal embolization (DE) during peripheral arterial endovascular interventions is a well-known complication that is poorly studied. The goal of this study was to...
OBJECTIVE
Distal embolization (DE) during peripheral arterial endovascular interventions is a well-known complication that is poorly studied. The goal of this study was to determine the incidence, risk factors, and effect of DE on the outcomes of lower extremity endovascular interventions (LEIs).
METHODS
All LEIs between 2010 and 2014 in the Vascular Study Group of New England (VSGNE) database were reviewed. Patient characteristics were analyzed to determine predictors of DE. LEIs involving the superficial femoral artery (SFA) were reviewed to assess the effect of type of treatment on DE. The outcomes examined were loss of patency, limb loss, and mortality after LEI involving the SFA. A multivariable regression was used to determine predictors of DE.
RESULTS
There were 10,875 procedures. The incidence of DE was 17.3 per 1000 procedures, and 68% required treatment (57% endovascular, 11% open surgery). DE was more common in patients treated for critical limb ischemia compared with claudication (relative risk [RR], 2.06; 95% confidence interval [CI], 1.24-3.45; P = .006) and for emergency interventions compared with elective (RR, 2.98; 95% CI, 1.22-7.30; P = .017). DE increased with the number of arteries treated (P < .0001) and with the length of occlusion (P < .0001). The SFA was the most commonly treated artery (4751 [43.7%]). In comparison with atherectomy and balloon angioplasty, stenting alone (RR, 0.36; 95% CI, 0.17-0.73; P = .005), balloon angioplasty alone (RR, 0.23; 95% CI, 0.13-0.41; P < .0001), and combined stenting and balloon angioplasty (RR, 0.29; 95% CI, 0.17-0.49; P < .0001) were associated with a significantly lower risk of DE. DE was not significantly associated with loss of patency, major amputation, or mortality.
CONCLUSIONS
The incidence of DE during LEIs is 1% to 2% in the VSGNE database, and most patients are treated with additional endovascular interventions. The incidence increases in patients with critical limb ischemia and with the use of atherectomy.
Topics: Aged; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chi-Square Distribution; Critical Illness; Databases, Factual; Disease-Free Survival; Embolism; Female; Femoral Artery; Humans; Incidence; Intermittent Claudication; Ischemia; Limb Salvage; Lower Extremity; Male; Middle Aged; Multivariate Analysis; New England; Odds Ratio; Peripheral Arterial Disease; Proportional Hazards Models; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency
PubMed: 28366300
DOI: 10.1016/j.jvs.2017.01.032 -
Journal of Vascular Surgery Aug 2016This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease. (Comparative Study)
Comparative Study
BACKGROUND
This study evaluated the feasibility, safety, and effectiveness of endovascular interventions for common femoral artery (CFA) occlusive disease.
METHODS
Using a prospectively maintained multicenter database, we analyzed outcomes in 167 consecutive patients who underwent percutaneous CFA interventions for Rutherford class 3 to class 6 (R3-R6) disease. The standardized treatment approach included primary percutaneous transluminal angioplasty (PTA) only, atherectomy + PTA, and provisional stenting. Outcomes included technical failure rate, recurrence, complications, and major or minor amputation rate. Data were analyzed using multivariate regression analysis.
RESULTS
During a 7-year period, 167 patients with R3 (n = 91 [54.5%]) and R4 to R6 (n = 76 [45.5%]) disease underwent CFA interventions that included PTA only (n = 114 [68.2%]), atherectomy ± PTA (n = 38 [22.8%]), and provisional stenting (n = 15 [9.0%]) for failed atherectomy ± PTA. Procedure-related complications included pseudoaneurysm (n = 1 [0.6%]), thrombosis (n = 1 [0.6%]), distal embolization (n = 1 [0.6%]), and death (R6, n = 1 [0.06%]). CFA restenosis was observed in 34 (20.4%) patents; these underwent further percutaneous (n = 18 [10.8%]) or surgical (n = 17 [10.2%]) revascularization that included CFA endarterectomy ± femoral distal bypass. Major or minor amputations were observed in none of the R3 patients and in only three (3.9%) and five (6.5%) of the R4 to R6 patients, respectively. Compared with the atherectomy + PTA group, patients in the PTA-only group had a significantly lower patency. Furthermore, during long-term mean follow-up of 42.5 months, the CFA provisional stent group had a 100% primary patency, which was significantly better than the primary patency in the CFA nonstent groups combined (77.0%; P = .0424).
CONCLUSIONS
Data from this study to date would suggest that percutaneous CFA interventions in select patients are relatively safe and effective. In the long term, CFA stenting has significantly better primary patency than CFA atherectomy and PTA combined. CFA atherectomy + PTA has significantly better primary patency than CFA PTA-only at midterm, especially in patients with claudication. Future randomized controlled trials are warranted.
Topics: Aged; Aged, 80 and over; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Databases, Factual; Feasibility Studies; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Patient Selection; Peripheral Arterial Disease; Recurrence; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Failure; Vascular Patency
PubMed: 27763265
DOI: 10.1016/j.jvs.2016.03.418 -
The American Journal of Cardiology Oct 2023We aimed to describe the clinical characteristics and outcomes of patients who underwent atherectomy at the time of percutaneous coronary intervention in centers with...
We aimed to describe the clinical characteristics and outcomes of patients who underwent atherectomy at the time of percutaneous coronary intervention in centers with on-site surgical centers (SCs) versus nonsurgical centers (NSCs). Patients treated with coronary atherectomy between January 1, 2006, to December 31, 2019, from the British Cardiovascular Society Intervention (BCIS) registry were included. Primary outcomes were in-hospital all-cause mortality and major adverse cardiovascular and cerebrovascular events. A total of 20,833 patients were treated with coronary atherectomy, of which 7,983 (38%) were performed at NSC. The proportion of coronary atherectomies performed in NSC increased from 12.5% in 2006 to 42% in 2019. Compared with patients treated at SC, patients treated in NSC were older (mean age 75.1 ± SD years vs 74.2 ± SD, p <0.001), but had comparable prevalence of hypertension (NSC 73.9% vs SC 72.8%, p = 0.085), diabetes mellitus (NSC 32.2% vs SC 31.6%, p = 0.43) and renal disease (NSC 6.0% vs SC 6.0%, p = 0.99). Intracoronary imaging was used more often in NSC than SC (22.3% vs 19.4%, p <0.001). After adjustment, the odds of in-hospital mortality (odds ratios [OR] 0.76, 95% confidence intervals [CI] 0.50 to 1.16), major adverse cardiovascular and cerebrovascular events (OR 0.80, 95% CI 0.53 to 1.21), emergency coronary artery bypass graft (OR 0.49, 95% CI 0.15 to 1.57), major bleeding (OR 0.67, 95% CI 0.36 to 1.24) and coronary perforation (OR 1.07, 95% CI 0.97 to 1.43) in NSC were comparable with SC. In conclusion, coronary atherectomy in hospitals with off-site surgical cover has become more frequent, with no association with poorer outcomes, compared with hospitals with on-site surgical cover.
Topics: Humans; Aged; Atherectomy, Coronary; Coronary Artery Disease; Treatment Outcome; Percutaneous Coronary Intervention; Coronary Artery Bypass; Retrospective Studies
PubMed: 37556893
DOI: 10.1016/j.amjcard.2023.07.073 -
Journal of the American Heart... Jun 2019Background The long-term effectiveness of atherectomy treatment for peripheral arterial disease is unknown. We studied 5-year clinical outcomes by endovascular treatment...
Background The long-term effectiveness of atherectomy treatment for peripheral arterial disease is unknown. We studied 5-year clinical outcomes by endovascular treatment type among patients with peripheral arterial disease. Methods and Results We queried the Medicare-linked VQI (Vascular Quality Initiative) registry for endovascular interventions from 2010 to 2015. The exposure was treatment type: atherectomy (with or without percutaneous transluminal angioplasty [ PTA] ), stent (with or without PTA ), or PTA alone. The outcomes were major amputation, any amputation, and major adverse limb event (major amputation or any reintervention). We used the center-specific proportions of atherectomy procedures performed in the 12 months before a patient's procedure as the instruments to perform an instrumental-variable Cox model analysis. Among 16 838 eligible patients (median follow-up: 1.3-1.5 years), 11% underwent atherectomy, 40% received PTA alone, and 49% underwent stenting. Patients receiving atherectomy commonly underwent femoropopliteal artery treatment (atherectomy: 65%; PTA : 49%; stenting: 43%; P<0.001) and had worse disease severity (Trans-Atlantic Inter-Society Consensus score [TASC] B and greater; atherectomy: 77%; PTA : 68%; stenting: 67%; P<0.001). The 5-year rate of major adverse limb events was 38% in patients receiving atherectomy versus 33% for PTA and 32% for stenting (log rank P<0.001). Controlling for unmeasured confounding using instrumental-variable analysis, patients treated with atherectomy experienced outcomes similar to those of patients treated with PTA , except for a higher risk of any amputation (hazard ratio: 1.51; 95% CI , 1.08-2.13). However, compared with stenting, atherectomy patients had a higher risk of major amputation (hazard ratio: 3.66; 95% CI , 1.72-7.81), any amputation (hazard ratio: 2.73; 95% CI , 1.60-4.76), and major adverse limb event (hazard ratio: 1.61; 95% CI , 1.10-2.38). Conclusions Atherectomy is used to treat severe femoropopliteal and tibial peripheral arterial disease even though long-term adverse outcomes occur more frequently after this treatment modality.
Topics: Aged; Aged, 80 and over; Amputation, Surgical; Atherectomy; Cohort Studies; Endovascular Procedures; Female; Femoral Artery; Humans; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Postoperative Complications; Time Factors; Treatment Outcome
PubMed: 31165658
DOI: 10.1161/JAHA.119.012081