Publications by authors named "Mehdi H Shishehbor"

189 Publications

PROMISE I early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia 12-month results.

J Vasc Surg 2021 May 18. Epub 2021 May 18.

Chesapeake Vascular PC.

Objective: We report the 6 and 12-month outcomes of the PROMISE I early feasibility study (EFS) after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System.

Methods: Thirty-two no-option CLTI patients, previously offered major amputation, were enrolled in this single-arm EFS of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months.

Results: Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and 2 (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. Wound healing status of fully healed or healing was 67% at 6-months, and 75% at 12-months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first three months. The majority of reinterventions, 12 (75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention.

Conclusions: The LimFlow pDVA System was utilized in treating no-option patients with CLTI. High technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System which supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population.
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http://dx.doi.org/10.1016/j.jvs.2021.04.057DOI Listing
May 2021

Establishing Thresholds for Minimal Clinically Important Differences for the Peripheral Artery Disease Questionnaire.

Circ Cardiovasc Qual Outcomes 2021 May 5;14(5):e007232. Epub 2021 May 5.

Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, Yale University, New Haven, CT (C.M.-H., Q.-U.-A.J., K.G.S.).

Background: Understanding minimum clinically important differences (MCID) in patient-reported outcomes is essential in interpreting the magnitude of changes in these measures. No MCID from patients' perspectives has ever been published for peripheral artery disease-specific health status assessment tools. The Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral artery disease-specific health status instrument for which we sought to prospectively establish its MCID from patients' perspectives.

Methods And Results: Patients presenting to vascular clinics with new or worsened claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry who completed baseline and follow-up PAQ assessments along with the Global Assessment of Functioning scale were included. Mean change in PAQ summary scores from 3- to 6-month follow-up was calculated according to Global Assessment of Functioning category. MCID was defined as the mean difference in scores between those with small improvement or deterioration and those with no change. Multivariable linear regression was used to provide an MCID estimate after adjusting for patients' 3-month PAQ score. Of the 483 patients who completed the Global Assessment of Functioning score at 6 months and who had available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were female, and 71% were White. The MCIDs for PAQ summary scale improvement and worsening were 8.7 (2.9-14.5) and -11.0 (-18.6 to -3.3), respectively. After multivariable adjustment, these were 8.9 (3.0-14.8) and -11.2 (-18.2 to -4.2), respectively. There was no significant interaction between treatment (invasive versus noninvasive) and Global Assessment of Functioning response (=0.75).

Conclusions: In patients with new or worsened claudication, a 10-point change in PAQ summary score represents an MCID. This estimate needs external validation and may inform the interpretation of PAQ scores when used as outcomes in clinical trials or in routine clinical care. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007232DOI Listing
May 2021

Predictors and potential advantages of PERT and advanced therapy use in acute pulmonary embolism.

Catheter Cardiovasc Interv 2021 Jun 12;97(7):1430-1437. Epub 2021 Apr 12.

Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.

Objectives: We sought to examine predictors of pulmonary embolism response team (PERT) utilization and identify those who could benefit from advanced therapy.

Background: PERT and advanced therapy use remain low. Current risk stratification tools heavily weight age and comorbidities, which may not always correlate with presentation's severity.

Methods: We prospectively studied patients with CT-confirmed PE between January 2019 and December 2019 at our hospital. PERT activation was left to the treating physician. Multivariable analyses were utilized to identify predictors of PERT activation and advanced therapy. Using the log odd ratio of each significant predictor of advanced therapy, we created a scoring system and a score of 2 was associated with the highest use. Primary outcomes were 30- and 90-day all-cause mortality, readmission, and major bleed.

Results: Of the 307 patients, PERT was activated in 22.5%. While abnormal vital signs and right ventricular (RV) strain were associated with PERT activation, pulmonary embolism severity index (PESI) was not. Advanced therapy use was significantly higher in the PERT cohort (35% vs 2%). Predictors of advanced therapy use were composite variable (heart rate > 110 or systolic blood pressure < 100 or respiratory rate > 30 or oxygen saturation < 90%) and right-to-left ventricular ratio > 0.9. PERT patients with advanced therapy use, when compared to the no-PERT patients who could have qualified (score of 2), had significantly lower 30- and 90-day mortality and 30-day readmission without difference in major bleed.

Conclusion: PERT has important therapeutic impact, yet no guidelines to direct activation. We recommend a multidisciplinary approach for higher acuity pulmonary embolism cases and physician education regarding PERT and the scope of advanced therapy use.
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http://dx.doi.org/10.1002/ccd.29697DOI Listing
June 2021

Advances in chronic limb-threatening ischemia.

Vasc Med 2021 Apr;26(2):126-130

Harrington Heart & Vascular Institute, University Hospitals and Case Western Reserve University School of Medicine, Cleveland, OH, USA.

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http://dx.doi.org/10.1177/1358863X21998436DOI Listing
April 2021

Invasive Approaches in the Management of Cocaine-Associated Non-ST-Segment Elevation Myocardial Infarction.

JACC Cardiovasc Interv 2021 Mar;14(6):623-636

Harrington Heart and Vascular Institute, Case Western Reserve University, Cleveland, Ohio, USA. Electronic address:

Objectives: The aim of this study was to determine the impact of invasive approaches and revascularization in patients with cocaine-associated non-ST-segment elevation myocardial infarction (NSTEMI).

Background: The role of invasive approaches in cocaine-associated NSTEMI is uncertain.

Methods: This retrospective cohort study identified 3,735 patients with NSTEMI and history of cocaine use from the Nationwide Readmissions Database from 2016 to 2017. Invasive approaches were defined as coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). Revascularization was defined as PCI and CABG. The primary efficacy outcome was major adverse cardiac events (MACE), and the primary safety outcome was emergent revascularization. Nonadherence was identified using appropriate International Classification of Diseases-Tenth Revision codes. Two propensity-matched cohorts were generated (noninvasive vs. invasive and noninvasive vs. revascularization) through multivariate logistic regression.

Results: In the propensity score-matched cohorts, an invasive approach (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.56 to 0.92; p = 0.008) and revascularization (HR: 0.54; 95% CI: 0.40 to 0.73; p < 0.001) (compared with a noninvasive approach) were associated with a lower rate of MACE, without an increase in emergent revascularization. On stratification, PCI and CABG individually were associated with a lower rate of MACE. Emergent revascularization was increased with PCI (HR: 1.78; 95% CI: 1.12 to 2.81; p = 0.014) but not with CABG. Nonadherent patients after PCI and CABG did not have significant difference in rate of MACE. PCI in nonadherent patients was associated with an increase in emergent revascularization (HR: 4.45; 95% CI: 2.07 to 9.57; p < 0.001).

Conclusions: Invasive approaches and revascularization for cocaine-associated NSTEMI are associated with lower morbidity. A history of medical nonadherence was not associated with a difference in morbidity but was associated with an increased risk for emergent revascularization with PCI.
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http://dx.doi.org/10.1016/j.jcin.2021.01.005DOI Listing
March 2021

Prospective Experience of Pulmonary Embolism Management and Outcomes.

J Invasive Cardiol 2021 03 11;33(3):E173-E180. Epub 2021 Feb 11.

Professor of Medicine, Case Western Reserve University School of Medicine, University Hospitals, 11100 Euclid Avenue, Lakeside 3rd floor, Cleveland, OH 44106 USA.

Objective: We sought to evaluate the impact of pulmonary embolism (PE) response teams (PERTs) on all consecutive patients with PE.

Background: Multidisciplinary PERTs have been promoted for the management and treatment of (PE); however, the impact of PERTs on clinical outcomes has not been prospectively evaluated.

Methods: We prospectively studied 220 patients with computed tomography (CT)-confirmed PE between January, 2019 and August, 2019. Baseline characteristics, as well as medical, interventional, and operational care, were captured. The total population was divided into 2 groups, ie, those with PERT activation and those without PERT activation. PERT activation was left at the discretion of the primary team. Our primary outcome was 90-day composite endpoint (rate of readmission, major bleeds, and mortality). Using 2:1 propensity-matched and multivariable-adjusted Cox proportional hazard analyses, we examined the impact of PERT activation on primary outcome, treatment approach, and length of stay.

Results: Of the total 220 patients, PERT was activated in 47 (21.4%). The PERT cohort, as compared with the non-PERT cohort, was more likely to present with dyspnea, syncope, lower systolic blood pressure, higher heart rate, higher respiratory rate, lower oxygen saturation, higher troponin levels, and higher right ventricular to left ventricular ratio. PERT activation was associated with increased use of advanced therapies (36.2% vs 1.2%; P<.001) and catheter-directed inventions (25.5% vs 0.6%; P<.001). In multivariable-adjusted analysis of propensity-matched cohorts, PERT activation was associated with lower 90-day outcomes (hazard ratio, 0.40; 95% confidence interval, 0.21-0.75; P<.01).

Conclusion: At our institution, PERT had a clinically significant impact on therapeutic strategies and 90-day outcomes in patients with PE.
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March 2021

Contemporary Trends in Hospital Admissions and Outcomes in Patients With Critical Limb Ischemia: An Analysis From the National Inpatient Sample Database.

Circ Cardiovasc Qual Outcomes 2021 Feb 5;14(2):e007539. Epub 2021 Feb 5.

Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, Yale University, New Haven, CT (M.A.-N., A.B.S., F.L.-C., C.M.-H., K.G.S.).

Background: Critical limb ischemia (CLI) morbidity and mortality rates have historically been disproportionately higher than for other atherosclerotic diseases, however, recent trends have not been reported. In patients admitted with CLI, we aimed to examine trends in in-hospital mortality, major amputations, length of stay, and cost of hospitalizations overall and stratified by type of revascularization procedures.

Methods: Using 2011 to 2017 National Inpatient Sample data, we identified CLI-related admissions based on codes. Primary outcomes of interest were in-hospital mortality and major amputations. Secondary outcomes were the length of stay and cost of hospitalization. We stratified outcomes based on endovascular or open surgical interventions. We also performed hierarchical multivariable regression analyses of outcomes based on age, sex, race, hospital size, type, and location.

Results: We identified 2 643 087 CLI-related admissions between 2011 and 2017. CLI admissions increased from 0.9% to 1.4% <0.0001 as well as overall peripheral artery disease admissions (4.5%-8.9%, <0.0001). In-hospital mortality for the entire CLI cohort decreased from 3.3% to 2.7%, <0.0001, and major amputations decreased from 10.9% to 7%, <0.0001. A decline was also noted for the length of stay from 5.7 (3.1-10.1) to 5.4 (3.0-9.2) days (<0.0001), whereas admission costs increased from USD $11 791 ($6676-$21 712) to $12 597 ($7248-$22 748; <0.0001). Endovascular interventions increased (<0.0001) against a decline in surgical interventions (<0.0001). Black race, female sex, and age ≥60 years were associated with higher in-hospital mortality, whereas Black race, male sex, and age<60 years were associated with higher major amputations.

Conclusions: A relatively small decrease in absolute numbers for mortality and major amputations were observed against a backdrop of increasing CLI admissions over recent years. Patients with CLI received more endovascular interventions than surgical interventions over time. However, admissions for endovascular interventions were characterized by higher risk patient profiles and a higher risk of major amputations as compared with surgical interventions.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007539DOI Listing
February 2021

The Relationship Between Carotid Revascularization Procedural Volume and Perioperative Outcomes in Australia and New Zealand.

Angiology 2021 Feb 4:3319721991717. Epub 2021 Feb 4.

Department of Surgery, Prince of Wales Hospital, Sydney, Australia.

Carotid endarterectomy (CEA) and carotid artery stenting (CAS) prevent stroke in selected patients. However, each intervention carries a risk of perioperative complications including stroke or death (S/D). We aimed to determine the relationship between operator volume, hospital volume, and the perioperative risk of S/D in carotid revascularization in Australia and New Zealand. Retrospective analysis was performed on prospectively collected data extracted from the Australasian Vascular Audit between 2010 and 2017. Annual caseload volume was analyzed in quintiles (Q) using multivariate regression to assess its impact on perioperative S/D. Carotid endarterectomy procedures (n = 16 765) demonstrated higher S/D rates for lower-volume operators (2.21% for Q1-Q3 [1-17 annual cases] vs 1.76% for Q4-Q5 [18-61 annual cases]; odds ratio [OR]: 1.28; 95% CI: 1.001-1.64; = .049). Carotid artery stenting procedures (n = 1350) also demonstrated higher S/D rates for lower-volume operators (2.63% for Q1-Q3 [1-11 annual cases] vs 0.37% for Q4-Q5 [12-31 annual cases]; OR: 6.11; 95% CI: 1.27-29.33; = .024). No significant hospital volume-outcome effect was observed for either procedure. An inverse relationship was demonstrated between operator volume and perioperative S/D rates following CEA and CAS. Consideration of minimum operator thresholds, restructuring of services and networked referral pathways of care in Australia and New Zealand, would likely result in improved patient outcomes.
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http://dx.doi.org/10.1177/0003319721991717DOI Listing
February 2021

Clinical outcomes of patients with and without chronic kidney disease undergoing endovascular revascularization of infrainguinal peripheral artery disease: Insights from the XLPAD registry.

Catheter Cardiovasc Interv 2021 Feb 1. Epub 2021 Feb 1.

Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

Objectives: The purpose of the present study was to define clinical outcomes of chronic kidney disease (CKD) patients undergoing endovascular revascularization of infrainguinal peripheral artery disease (PAD).

Background: CKD is an established predictor of advanced PAD. However, clinical outcomes for these patients following endovascular revascularization remain inadequately defined.

Methods: Using the ongoing multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851), we analyzed all-cause death, target limb amputation, and need for repeat revascularization for patients with and without CKD undergoing infrainguinal endovascular revascularization between the years 2005 and 2018.

Results: Of 3,699 patients, 15.1% (n = 559) had baseline CKD. CKD patients had significantly higher incidence of heavily calcified lesions (48.4% vs. 38.1%, p < .001) and diffuse disease (66.9% vs. 61.5%, p = .007). Kaplan-Meier analysis showed significant differences between CKD and non-CKD patient outcomes at 12 months for freedom from target limb amputation (79.9% vs. 92.7%, p < .001) and all-cause death (90.1% vs. 97.6%, p < .001). However, freedom from target vessel revascularization was similar between the groups. After adjusting for baseline comorbidities in the CKD and non-CKD groups, the hazard ratios for target limb amputation and death at 12 months were 2.28 (95% confidence interval or CI 1.25-4.17, p < .001) and 4.38 (95% CI 2.58-7.45, p < .001), respectively.

Conclusions: Following endovascular revascularization for infrainguinal PAD, CKD was an independent predictor of all-cause death and target limb amputation at 12 months.
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http://dx.doi.org/10.1002/ccd.29491DOI Listing
February 2021

In-Hospital Outcomes and Trends of Endovascular Intervention vs Surgical Revascularization in Octogenarians With Peripheral Artery Disease.

Am J Cardiol 2021 04 15;145:143-150. Epub 2021 Jan 15.

Wayne State University, Detroit Medical Center, Detroit Heart Hospital, Detroit, Michigan. Electronic address:

It is unknown whether endovascular intervention (EVI) is associated with superior outcomes when compared with surgical revascularization in octogenarian. National Inpatient Sample (NIS) database was used to compare the outcomes of limb revascularization in octogenarians who had surgical revascularization versus EVI. The NIS database's information on PAD patients ≥80-year-old who underwent limb revascularization between 2002 and 2014 included 394,504 octogenarian patients, of which 184,926 underwent surgical revascularization (46.9%) and 209,578 underwent EVI (53.1%). Multivariate analysis was performed to examine in-hospital outcomes. Trend over time in limb revascularization utilization was examined using Cochrane-Armitage test. EVI group had lower odds of in-hospital mortality (adjusted odds ratio [aOR]: 0.61 [95% CI: 0.58 to 0.63], myocardial infarction (aOR: 0.84 [95% CI: 0.81 to 0.87]), stroke (aOR: 0.93 [95% CI: 0.89 to 0.96]), acute kidney injury (aOR: 0.79 [95% CI: 0.77 to 0.81]), and limb amputation (aOR: 0.77 [95% CI: 0.74 to 0.79]) compared with surgical group (p < 0.001 for all). EVI group had higher risk of bleeding (aOR: 1.20 [95% CI: 1.18 to 1.23]) and vascular complications (3.2% vs 2.7%, aOR: 1.25 [95% CI: 1.19 to 1.30]) compared with surgical group (p < 0.001 for all). Within study period, EVI utilization increased in octogenarian patients from 2.6% to 8.9% (ptrend < 0.001); whereas use of surgical revascularization decreased from 11.6% to 5.2% (ptrend < 0.001). In conclusion, the utilization of EVI in octogenarians is increasing, and associated with lower risk of in-hospital mortality and adverse cardiovascular and limb outcomes as compared with surgical revascularization.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.091DOI Listing
April 2021

Paclitaxel-coated devices in the treatment of femoropopliteal stenosis among patients ≥65 years old: An ACC PVI Registry Analysis.

Am Heart J 2021 03 13;233:59-67. Epub 2020 Dec 13.

Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Duke University Health System, Durham, NC. Electronic address:

Background: The connection between paclitaxel-coated devices (PCD) use during peripheral vascular interventions (PVI) and mortality is debated. We aimed to analyze patterns of PCD use and the safety and effectiveness of PCD use in the superficial femoral and/or popliteal arteries.

Methods: Patients undergoing PVI of femoropopliteal lesions with and without PCD between January 1, 2015 and June 30, 2017 were compared using the American College of Cardiology's National Cardiovascular Data Registry PVI Registry. Outcomes were derived from Centers for Medicare & Medicaid claims data. The primary outcome was all-cause mortality at 6-, 12-, and 24-months following PVI. Inverse probability weighting and frailty models were used to assess the differences between groups. The analysis was IRB-approved.

Results: In the overall cohort consisting of 6,302 femoropopliteal PVIs, PCD-PVI patients were more likely to be treated for claudication (63.5% vs 51.3%, P< .001), less likely to have a chronic total occlusion (24.6% vs 34.7%, P < .001), and more likely to be treated in certain geographic and practice settings. In the analytic cohort consisting of 1,666 femoropopliteal PVIs with linked claims outcomes (888 PCD-PVI, 53.3%), unadjusted rates of all outcomes were lower in PCD-PVI patients. After adjustment, there were no significant differences in mortality following PCD-PVI versus non-PCD PVI at 1 year (adjusted RR 0.78, 95% CI 0.60-1.01, P= .055) or 2 years (aRR 0.98, 95% CI 0.77-1.24, P= .844).

Conclusion: There were significant differences between the patients in whom and settings in which PCD-PVI was versus was not used. PCD-PVI was not associated with an increased risk of 2-year mortality in real-world use.
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http://dx.doi.org/10.1016/j.ahj.2020.12.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078180PMC
March 2021

Association of Diabetes Mellitus With Health Status Outcomes in Patients With Peripheral Artery Disease: Insights From the PORTRAIT Registry.

J Am Heart Assoc 2020 11 6;9(22):e017103. Epub 2020 Nov 6.

University of Missouri-Kansas City Kansas City MO.

Background Patients with peripheral artery disease (PAD) and coexisting diabetes mellitus (DM) have greater PAD progression and adverse limb events. Our aim was to study whether PAD-specific health status differs by DM. Methods and Results The PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) trial is a 16-center international registry that includes patients with recent exacerbations or new-onset symptomatic PAD presenting to specialty clinics. We assessed PAD-specific health status initially and at 3, 6, and 12 months (Peripheral Artery Questionnaire [PAQ]). We used hierarchical, multivariable, linear regression, and repeated measures analyses to study the association between DM and baseline health status initially and over 3 to 12 months. Models were adjusted for demographics, socioeconomic factors, PAD severity, comorbidities, and psychosocial characteristics. The interaction of DM with PAD revascularization on 3- to 12-month health status was also tested. Of 1204 patients, 398 (33%) had DM (94% type 2). Patients with versus those without DM had lower unadjusted PAQ summary scores at baseline and 3, 6, and 12 months (46.1 versus 50.8, 63.6 versus 68.2, 65.7 versus 71.7, and 65.4 versus 72.6; ≤0.01). In fully adjusted models, the effect of DM on baseline (mean difference, -0.65; 95% CI, -2.86 to 1.56 [=0.56]) and over 3- to 12-month PAQ summary scores (mean difference, -1.59; 95% CI, -4.06 to 0.88 [=0.21]) was no longer significant. Twelve-month health status gains following revascularization were similar in both groups (=0.69). Conclusions Patients with PAD with coexisting DM have poorer health status, mostly explained by the differences in their psychosocial and other comorbidity burden. Patients with PAD and DM versus those without DM experience similar health status benefits following PAD revascularization.
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http://dx.doi.org/10.1161/JAHA.120.017103DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763706PMC
November 2020

Physical Activity After Treatment for Symptomatic Peripheral Artery Disease.

Am J Cardiol 2021 01 13;138:107-113. Epub 2020 Oct 13.

Yale University School of Medicine, Vascular Medicine Outcomes lab, New Haven, Connecticut.

The association of invasive versus noninvasive treatment and physical activity level in patients with claudication remains unclear. Participants with claudication were enrolled from US vascular clinics. Treatment was categorized as invasive (surgical or endovascular treatment <3 months of initial visit) versus noninvasive. Self-reported leisure time (LTPA) and work related physical activity (WRPA) (sedentary, mild, moderate/strenuous), and health status (peripheral artery questionnaire summary score [PAQ SS]) was measured at baseline and 12 months. Change in PA was also categorized as increased, decreased, persistent sedentary [reference] and persistent active based on activity status at baseline and 12 months. Multivariable logistic regression assessed the association of treatment with 12-month LTPA and WRPA. Multivariable linear regression examined the association between 12-month change in PA with a 12-month change in PAQ. A total of 196of 656 patients (29.9%) underwent invasive treatment. There was no association between treatment and 12-month LTPA (p = 0.77) or WRPA (p = 0.26). Compared with being persistently sedentary, increased LTPA was associated with increased PAQ SS (OR 11.1 95% CI [4.4 to 17.7], p <0.01). In conclusion, there was no association between invasive treatment and physical activity at follow up despite a greater health status change in the invasive group. As increased physical activity was associated with more health status gains than remaining sedentary, additional ways to improve physical activity levels could potentially improve PAD outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2020.10.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736254PMC
January 2021

Temporal trends and outcomes of critical limb ischemia among patients with chronic kidney disease.

Vasc Med 2021 Apr 1;26(2):155-163. Epub 2020 Oct 1.

Harrington Heart & Vascular Institute, University Hospitals, Cleveland, OH, USA.

There is a paucity of data on the outcomes and revascularization strategies for critical limb ischemia (CLI) among patients with chronic kidney disease (CKD). Hence, we conducted a nationwide analysis to evaluate the trends and outcomes of hospitalizations for CLI with CKD. The National Inpatient Sample database (2002-2015) was queried for hospitalizations for CLI. The trends of hospitalizations for CLI with CKD were reported, and endovascular versus surgical revascularization strategies for CLI with CKD were compared. The main study outcome was in-hospital mortality. The analysis included 2,139,640 hospitalizations for CLI, of which 484,224 (22.6%) had CKD. There was an increase in hospitalizations for CLI with CKD (P = 0.01), but a reduction in hospitalizations for CLI without CKD (P = 0.01). Patients with CLI and CKD were less likely to undergo revascularization compared with patients without CKD. CLI with CKD had higher rates of in-hospital mortality (4.8% vs 2.5%, adjusted odds ratio (OR) 2.01; 95% CI 1.93-2.11) and major amputation compared with no CKD. Revascularization for CLI with CKD was associated with lower rates of mortality (3.7% vs 5.3%, adjusted-OR 0.78; 95% CI 0.72-0.84) and major amputation compared with no revascularization. Compared with endovascular revascularization, surgical revascularization for CLI with CKD was associated with higher rates of in-hospital mortality (4.7% vs 2.7%, adjusted-OR 1.67; 95% CI 1.43-1.94). In conclusion, this contemporary observational analysis showed an increase in hospitalizations for CLI among patients with CKD. CLI with CKD was associated with higher in-hospital mortality compared with no CKD. Compared with endovascular therapy, surgical revascularization for CLI with CKD was associated with higher in-hospital mortality.
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http://dx.doi.org/10.1177/1358863X20951270DOI Listing
April 2021

Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials.

Catheter Cardiovasc Interv 2020 11 24;96(5):1087-1099. Epub 2020 Aug 24.

Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.

Background: Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality.

Objectives: To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials.

Methods: The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise.

Results: The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p = .286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p = .381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p < .001). Causes of death did not differ by treatment arm.

Conclusions: In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.
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http://dx.doi.org/10.1002/ccd.29152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7693077PMC
November 2020

Total IN.PACT All-Subjects One-Year Analysis and Standard vs Broader Implications.

J Invasive Cardiol 2020 Jul;32(7):243-248

Case Western Reserve University School of Medicine, University Hospitals, 11100 Euclid Avenue, Lakeside 3rd Floor, Cleveland, OH 44106 USA.

Drug-coated balloons (DCBs) have been shown to be superior to percutaneous transluminal angioplasty (PTA) for symptomatic femoropopliteal disease in randomized clinical trials; however, their clinical effectiveness and safety in more complex disease is less defined. The study sought to conduct a patient-level pooled analysis of all prospective randomized and single-arm studies evaluating the safety and efficacy of IN.PACT Admiral DCB (Medtronic) worldwide and in patients with complex disease. Subjects were treated with either IN.PACT Admiral DCB (n = 1837) or PTA (n = 143). The primary endpoint was freedom from clinically driven target-lesion revascularization (CD-TLR) within 12 months. The primary safety composite endpoint was freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months. Subsequently, we examined "real-life" complex lesions in a subgroup analysis, with standard use defined as simple, single de novo lesions (n = 712) and broader use defined as bilateral or multiple lesions (n = 1125). DCB when compared with PTA had significantly higher rates of freedom from CD-TLR through 12 months (93.8% vs 80.2%, respectively; P<.001). The DCB group did note higher rates of mortality at 1 year (3.1% DCB vs 0.0% PTA; P=.03). Notably, the broader use group showed superiority over the PTA group for freedom from CD-TLR (91.7% vs 80.2%; P<.001). IN.PACT Admiral DCB showed clinical superiority to PTA in the largest patient-level pooled analysis. Additionally, despite more complex and challenging lesions, DCB was superior to PTA. However, further adequately powered randomized studies are needed to confirm these results.
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July 2020

Coronavirus Disease 2019 Catheterization Laboratory Survey.

J Am Heart Assoc 2020 08 9;9(15):e017175. Epub 2020 Jun 9.

Minneapolis Heart Institute Foundation Minneapolis MN.

Background The coronavirus disease 2019 pandemic is expected to affect operations and lifestyles of interventional cardiologists around the world in unprecedented ways. Timely gathering of information on this topic can provide valuable insight and improve the handling of the ongoing and future pandemic outbreaks. Methods and Results A survey instrument developed by the authors was disseminated via e-mail, text messaging, WhatsApp, and social media to interventional cardiologists between April 6, 2020, and April 11, 2020. A total of 509 responses were collected from 18 countries, mainly from the United States (51%) and Italy (36%). Operators reported significant decline in coronary, structural heart, and endovascular procedure volumes. Personal protective equipment was available to 95% of respondents; however FIT-tested N95 or equivalent masks were available to only 70%, and 74% indicated absence of coronavirus disease 2019 pretesting. Most (83%) operators expressed concern when asked to perform cardiac catheterization on a suspected or confirmed coronavirus disease 2019 patient, primarily because of fear of viral transmission (88%). Although the survey demonstrated significant compliance with social distancing, high use of telemedicine (69%), and online education platforms (80%), there was concern over impending financial loss. Conclusions Our survey indicates significant reduction in invasive procedure volumes and concern for viral transmission. There is near universal adoption of personal protective equipment; however, coronavirus disease 2019 pretesting and access to FIT-tested N95 masks is suboptimal. Although there is concern over impending financial loss, substantial engagement in telemedicine and online education is reported.
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http://dx.doi.org/10.1161/JAHA.120.017175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792243PMC
August 2020

Impact of COVID-19 pandemic on ST-elevation myocardial infarction in a non-COVID-19 epicenter.

Catheter Cardiovasc Interv 2021 02 1;97(2):208-214. Epub 2020 Jun 1.

Cardiovascular Interventional Center, Harrington Heart and Vascular Institute, University Hospitals and Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

Objectives: We sought to study the impact of COVID-19 pandemic on the presentation delay, severity, patterns of care, and reasons for delay among patients with ST-elevation myocardial infarction (STEMI) in a non-hot-spot region.

Background: COVID-19 pandemic has significantly reduced the activations for STEMI in epicenters like Spain.

Methods: From January 1, 2020, to April 15, 2020, 143 STEMIs were identified across our integrated 18-hospital system. Pre- and post-COVID-19 cohorts were based on March 23rd, 2020, whenstay-at-home orders were initiated in Ohio. We used presenting heart rate, blood pressure, troponin, new Q-wave, and left ventricle ejection fraction (LVEF) to assess severity. Duration of intensive care unit stay, total length of stay, door-to-balloon (D2B) time, and radial versus femoral access were used to assess patterns of care.

Results: Post-COVID-19 presentation was associated with a lower admission LVEF (45 vs. 50%, p = .015), new Q-wave, and higher initial troponin; however, these did not reach statistical significance. Among post-COVID-19 patients, those with >12-hr delay in presentation 31(%) had a longer average D2B time (88 vs. 53 min, p = .033) and higher peak troponin (58 vs. 8.5 ng/ml, p = .03). Of these, 27% avoided the hospital due to fear of COVID-19, 18% believed symptoms were COVID-19 related, and 9% did not want to burden the hospital during the pandemic.

Conclusions: COVID-19 has remarkably affected STEMI presentation and care. Patients' fear and confusion about symptoms are integral parts of this emerging public health crisis.
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http://dx.doi.org/10.1002/ccd.28997DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7300525PMC
February 2021

Cilostazol and peripheral artery disease-specific health status in ambulatory patients with symptomatic PAD.

Int J Cardiol 2020 10 25;316:222-228. Epub 2020 May 25.

Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA. Electronic address:

Background: Improvement of symptoms and functional status is one of the main peripheral artery disease (PAD) treatment goals but pharmacological options are limited. The objective of this study was to assess the use of cilostazol and its association with patient-reported health status quantified by the Peripheral Artery Questionnaire (PAQ).

Methods: Initiation of cilostazol therapy was assessed in 567 patients in the US cohort of PORTRAIT between June 2011 and December 2015. Patients with heart failure history, on cilostazol prior to enrollment, with no baseline or follow-up PAQ scores were excluded. Health status over time was quantified using linear mixed models adjusting for baseline PAQ scores and patient characteristics.

Results: Of the 567 cilostazol-naïve patients, 65 (11%) were started on cilostazol. Mean age was 68.5 ± 9.6 years, 43% were female and 71.1% white. There was no significant difference in the mean PAQ score changes from baseline to 12 months between the cilostazol and non-cilostazol group, with difference of 3.8 [CI (-2.6, 10.1), p = .24] for summary scores, 1.6 [CI (-5.5, 8.6), p = .66] for quality of life, 3.6 [CI (-4.3, 11.6), p = .37] for symptoms, 6.2 [CI (-3.1, 15.5), p = .19] for physical limitation and 3.2 [CI (-3.9, 10.2), p = .38] for social limitation scores.

Conclusions: We found a low rate of cilostazol use and while there was no significant association between cilostazol initiation and subsequent health status, the ability to define small differences in health status was limited due to the small sample size.
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http://dx.doi.org/10.1016/j.ijcard.2020.05.042DOI Listing
October 2020

Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results.

J Endovasc Ther 2020 08 18;27(4):669-675. Epub 2020 May 18.

Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.

To present the 6-month results of the tromal Cell-Derived Factor-1 Plasmid reatment fr atients with eripheral rtery isease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee. The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months. Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major]. Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.
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http://dx.doi.org/10.1177/1526602820919951DOI Listing
August 2020

Effect of drug-coated balloons versus bare-metal stents on endothelial function in patients with severe lower limb peripheral artery disease.

Vascular 2020 Oct 26;28(5):548-556. Epub 2020 Apr 26.

Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.

Background: Research shows impaired endothelial function in patients with vascular diseases and improved endothelial function following revascularization and medical treatment. There is, however, a dearth of data on the effects of different endovascular therapeutic strategies on endothelial function. We sought to compare the effects of two endovascular strategies of drug-coated balloons versus stenting on endothelial function.

Methods: The reactive hyperemia index, the ankle-brachial index, and the toe-brachial index were measured in patients undergoing endovascular revascularization preprocedurally and on the 90th postprocedural day. After adjusting for baseline line characteristics, reactive hyperemia index were compared between the two groups at baseline and at 90 days.

Results: Between January 2018 and March 2019, 86 patients were prospectively included in a non-randomized manner. Drug-coated ballooning alone was carried out on 46 patients, and bailout stenting after plain balloon angioplasty was performed on the remaining 40 patients The post-revascularization reactive hyperemia index exhibited a significant rise in both groups (1.58 ± 0.21 vs. 1.43 ± 0.20; =0.0001). There was no difference in the postprocedural reactive hyperemia index between the two treatment groups. Additionally, the follow-up reactive hyperemia index showed no significant change compared with the postprocedural reactive hyperemia index (1.58 ± 0.23 vs. 1.57 ± 0.22). The results of subgroup analysis between a group of clinically high-risk patients and a group of patients with complex lesions were similar to the aforementioned results.

Conclusions: The reactive hyperemia index was significantly improved by endovascular therapy in our study population. However, no difference was observed between drug-coated ballooning and bare-metal stenting, which highlights the effects of vessel patency on endothelial function.
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http://dx.doi.org/10.1177/1708538120921316DOI Listing
October 2020

From the Coronary to the Peripheral Microcirculation: Using a Validated Concept to Develop a Novel Index.

JACC Cardiovasc Interv 2020 04 26;13(8):986-988. Epub 2020 Feb 26.

Harrington Heart and Vascular Institute, University Hospitals of Cleveland, Case Western Reserve University School of Medicine, Cleveland, Ohio.

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http://dx.doi.org/10.1016/j.jcin.2019.12.024DOI Listing
April 2020

The IN.PACT DEEP Clinical Drug-Coated Balloon Trial: 5-Year Outcomes.

JACC Cardiovasc Interv 2020 02;13(4):431-443

Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria.

Objectives: The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial.

Background: Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population.

Methods: IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile.

Results: Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile.

Conclusions: Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).
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http://dx.doi.org/10.1016/j.jcin.2019.10.059DOI Listing
February 2020

Endovascular Versus Surgical Revascularization for Acute Limb Ischemia: A Propensity-Score Matched Analysis.

Circ Cardiovasc Interv 2020 01 17;13(1):e008150. Epub 2020 Jan 17.

Division of Cardiology, Lifespan Cardiovascular Institute, Warren Alpert Medical School of Brown University, Providence, RI (S.T.M., O.N.H., P.S., H.D.A.).

Background: The optimal revascularization strategy for acute limb ischemia (ALI) remains unclear, and contemporary comparative effectiveness data on endovascular versus surgical revascularization are lacking.

Methods: We used the 2010 to 2014 National Inpatient Sample databases to identify hospitalizations with a primary diagnosis of ALI. Patients were propensity-score matched on the likelihood of undergoing endovascular versus surgical revascularization using a logistic regression model. The primary outcome was in-hospital mortality. Secondary outcomes included myocardial infarction, stroke, composite of death/myocardial infarction/stroke, any amputation, fasciotomy, acute kidney injury, major bleeding, transfusion, vascular complications, length of stay, and hospital costs.

Results: Of 10 484 (weighted national estimate=51 914) hospitalizations for ALI, endovascular revascularization was performed in 5008 (47.8%) and surgical revascularization in 5476 (52.2%). In the propensity-score matched cohort (n=7746; 3873 per group), patients who underwent endovascular revascularization had significantly lower in-hospital mortality (2.8% versus 4.0%; =0.002), myocardial infarction (1.9% versus 2.7%; =0.022), composite of death/myocardial infarction/stroke (5.2% versus 7.5%; <0.001), acute kidney injury (10.5% versus 11.9%; =0.043), fasciotomy (1.9% versus 8.9%; <0.001), major bleeding (16.7% versus 21.0%; <0.001), and transfusion (10.3% versus 18.5%; <0.001), but higher vascular complications (1.4% versus 0.7%; =0.002), compared with those undergoing surgical revascularization. Rates of any amputation were similar between the 2 groups (4.7% versus 5.1%; =0.43). Median length of stay was shorter and hospital costs higher with endovascular versus surgical revascularization.

Conclusions: In patients with ALI, endovascular revascularization was associated with better in-hospital clinical outcomes compared with surgical revascularization. Contemporary randomized controlled trials are needed to determine the optimal revascularization strategy for ALI.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008150DOI Listing
January 2020

Paclitaxel-coated peripheral artery devices are not associated with increased mortality.

J Vasc Surg 2020 09 6;72(3):968-976. Epub 2020 Jan 6.

Harrington Heart and Vascular Institute, University Hospitals, Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio.

Objective: Long-term safety concerns have been raised that the use of paclitaxel-coated balloons and stents is linked to excess mortality. Our objective was to compare outcomes in patients treated with paclitaxel vs uncoated devices and to analyze long-term mortality.

Methods: We conducted a retrospective single-institution review of 1170 consecutive patients who underwent femoropopliteal percutaneous revascularization by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. The primary outcome measure was all-cause mortality. Groups were divided into patients who received paclitaxel (n = 652) and those who did not (n = 518). Categorical variables were assessed using χ analysis and continuous variables with the Wilcoxon signed rank test. A multivariable analysis was performed using multivariable logistic regression models. Mortality was compared using Kaplan-Meier survival analysis.

Results: Demographics, risk factors, and Rutherford class were similar between the groups, except that the paclitaxel group was more likely to have diabetes (60.9% vs 55.0%; P = .04), was less likely to be on dialysis (10.7% vs 14.9%; P = .04), and had lower average creatinine concentration (1.6 ± 1.8 mg/dL vs 2.0 ± 2.3 mg/dL; P = .003). There were no differences in all-cause mortality through 2 years between paclitaxel and no-paclitaxel cohorts (25.5% vs 30.3%; log-rank, P = .098). At 3 years and 3.5 years, mortality was significantly lower in the paclitaxel group: year 3, 32.1% vs 39.4% (log-rank, P = .041); year 3.5, 35.2% vs 43.9% (log-rank, P = .027). Survival rates were not significantly different in examining subgroups by diabetes, chronic kidney disease, presence of chronic limb-threatening ischemia, or paclitaxel-coated balloon manufacturer. Multivariable analysis demonstrated that age, dialysis, chronic limb-threatening ischemia, chronic kidney disease, and congestive heart failure were independent risk factors for mortality, whereas paclitaxel use was associated with lower mortality.

Conclusions: The use of paclitaxel-coated balloons and stents does not increase mortality compared with uncoated devices out to 3.5 years. Paclitaxel-coated devices can be used with continued caution, especially in patients at increased risk of restenosis. Further long-term studies are needed to determine the risk of late mortality.
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http://dx.doi.org/10.1016/j.jvs.2019.10.100DOI Listing
September 2020

Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts.

J Vasc Surg 2019 10;70(4):1177-1191.e9

Harvard Medical School, Boston, Mass.

Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA.

Methods: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders.

Results: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA.

Conclusions: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA.
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http://dx.doi.org/10.1016/j.jvs.2019.02.030DOI Listing
October 2019

Sometimes less is more: The role of carotid revascularization prior to open heart surgery.

Vasc Med 2019 10 23;24(5):439-441. Epub 2019 Sep 23.

Cardiovascular Interventional Center, Division of Cardiovascular Medicine, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.

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http://dx.doi.org/10.1177/1358863X19874376DOI Listing
October 2019