Publications

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

IMPORTANCE: Cardiogenic shock after acute myocardial infarction (AMI) is associated with high mortality, particularly among patients with multivessel coronary artery disease. Recent evidence suggests that use of multivessel percutaneous coronary intervention (PCI) may be associated with harm. However, little is known about recent patterns of care and outcomes for this patient population.

OBJECTIVE: To evaluate patterns in the use of multivessel PCI vs culprit-vessel PCI in AMI and cardiogenic shock and outcomes in the US from 2009 to 2018.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study identified all patients in the CathPCI Registry) with AMI and cardiogenic shock who had multivessel coronary artery disease and underwent PCI between July 1, 2009, and March 31, 2018.

EXPOSURES: Multivessel or culprit-vessel PCI for AMI and shock.

PRIMARY OUTCOMES AND MEASURES: The primary outcome was in-hospital mortality. Temporal trends and hospital variation in PCI strategies were evaluated, while accounting for differences in case mix using hierarchical models. As a secondary outcome, the association of PCI strategy with postdischarge outcomes was evaluated in the subset of patients who were Medicare beneficiaries.

RESULTS: Of 64 301 patients (mean [SD] age, 66.4 [12.5] years; 20 366 [31.7%] female; 54 538 [84.8%] White) with AMI and shock at 1649 US hospitals, 34.9% had primary multivessel PCI. In the subgroup of 48 943 patients with ST-segment elevation myocardial infarction (STEMI), 31.5% underwent multivessel PCI. Between 2009 and 2018, this percentage increased by 6.7% per year for AMI and 5.8% for STEMI. Overall, multivessel PCI was associated with a greater adjusted risk of in-hospital complications (odds ratio [OR], 1.18; 95% CI, 1.14-1.23) and with greater in-hospital mortality in patients with STEMI (OR, 1.11; 95% CI, 1.06-1.16). Among Medicare beneficiaries, multivessel PCI use was not associated with postdischarge 1-year mortality (51.5% vs 49.8%; risk-adjusted OR, 0.97; 95% CI, 0.90-1.04; P = .37). Significant hospital variation was found in the use of multivessel PCI, with a higher multivessel PCI rate for similar patients across hospitals (median OR, 1.37; 95% CI, 1.33-1.41). Patients at hospitals with high rates of PCI in STEMI use had higher risk-adjusted in-hospital mortality (highest vs lowest hospital multivessel PCI quartile: OR, 1.10; 95% CI, 1.02-1.19).

CONCLUSIONS AND RELEVANCE: This cohort study found that multivessel PCI was increasingly used as the revascularization strategy in AMI and shock and that hospitals that used multivessel PCI more, especially among patients with STEMI, had worse outcomes. With recent evidence suggesting harm with this strategy, there appears to be an urgent need to change practice and improve outcomes in this high-risk population.

The association between active smoking and wound healing in critical limb ischemia (CLI) is unknown. Our objective was to examine in a retrospective cohort study whether active smoking is associated with higher incomplete wound healing rates in patients with CLI undergoing endovascular interventions. Smoking status was assessed at the time of the intervention, comparing active to no active smoking, and also during follow-up visits at 6 and 9 months. Cox regression analysis was conducted to compare the incomplete wound healing rates of the two groups during follow-up. A total of 264 patients (active smokers: n = 41) were included. Active smoking was associated with higher rates of incomplete wound healing in the 6-month univariate Cox regression analysis (hazard ratio (HR) for incomplete wound healing: 4.54; 95% CI: 1.41-14.28; p = 0.012). The 6-month Kaplan-Meier (KM) estimates for incomplete wound healing were 91.1% for the active smoking group versus 66% for the non-current smoking group. Active smoking was also associated with higher rates of incomplete wound healing in the 9-month univariable (HR for incomplete wound healing: 2.32; 95% CI: 1.11-4.76; p = 0.026) and multivariable analysis (HR for incomplete wound healing: 9.09; 95% CI: 1.06-100.0; p = 0.044). The 9-month KM estimates for incomplete wound healing were 75% in the active smoking group versus 54% in the non-active smoking group. In conclusion, active smoking status at the time of intervention in patients with CLI is associated with higher rates of incomplete wound healing during both 6- and 9-month follow-up.

INTRODUCTION: Substantial heterogeneity exists in reperfusion strategies for patients with ST-segment myocardial infarction (STEMI) in low- and middle-income countries (LMICs). We sought to compare outcomes associated with primary percutaneous coronary intervention (PPCI) and non-primary percutaneous coronary intervention (nPPCI) reperfusion strategies in patients with STEMI in Kerala, India.

METHODS: We performed a retrospective analysis of patients with STEMI (n = 8665) from the Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) randomized trial receiving either PPCI (n = 6623) or nPPCI (n = 2042). nPPCI included all PCI strategies implemented when PPCI was not available including all post-fibrinolysis PCI strategies and PCI without fibrinolysis. Clinical outcomes among patients undergoing PPCI and nPPCI were compared after propensity-score matching. The main outcomes were the rates of in-hospital and 30-day major adverse cardiovascular events (MACE), defined as the composite of death, reinfarction, stroke, and major bleeding.

RESULTS: In the propensity-score matched cohort (n = 1266 in each group), nPPCI had longer symptom onset to hospital arrival time (347.5 vs. 195.0 minutes, p < 0.001), door to balloon time (108 minutes vs. 75 minutes, p < 0.001), and were less likely to receive a coronary stent (89.4% vs. 95%, p < 0.001), including drug-eluting stents (89.5% vs. 94.4%, p < 0.001). There were no clinically meaningful differences in discharge medical therapy. However, patients treated with nPPCI were less commonly referred for cardiac rehabilitation (20.2% vs. 24.2%; p = 0.019). In-hospital (3.6% vs. 3.3%, p = 0.74%) and 30-day (4.4% vs. 4.6%, p = 0.77) MACE did not differ between nPPCI and PPCI matched groups.

CONCLUSION: In a large, contemporary population of STEMI patients from a LMIC, patients treated with a nPPCI reperfusion strategy had comparable short- and intermediate-term outcomes compared to PPCI despite differences in hospital presentation time and coronary stent use. These findings are reassuring but highlight the need for continued quality improvement in the delivery of STEMI care in resource-limited settings.

BACKGROUND: Patients with chronic kidney disease (CKD) have worsened clinical outcomes following percutaneous coronary intervention; however, limited evidence exists in patients undergoing peripheral vascular intervention (PVI).

PURPOSE: We aimed to assess the effect of CKD on outcomes following PVI for symptomatic peripheral artery disease.

METHODS: Using patients from the LIBERTY 360 study, we compared the rates of 30 day and 1 year major adverse vascular events (MAVE), a composite of all-cause mortality, major amputation, and target vessel/lesion revascularization, between patients with and without CKD (estimated glomular filtration rate less than 60) following PVI. Multivariable adjustment was performed to assess for independent association between CKD and outcomes.

RESULTS: Among 1189 patients enrolled, 378 patients (31.8%) had CKD. At 1 year, patients with CKD had higher rates of MAVE (34.6% vs 25.6%), all-cause mortality (11.9% vs 5.5%), and major amputation (5.9% vs 2.6%) when compared with patients without CKD (all P < .05). After adjustment, patients with CKD had higher risks of 1-year MAVE (HR 1.30, 95% CI 1.04-1.64; P = .023) and all-cause mortality (HR 1.88, 95% CI 1.22-2.91; P = .005) when compared with patients without CKD. There was no statistically significant difference in risk of major amputations (HR 1.70, 95% CI 0.91-3.17; P = .094).

CONCLUSIONS: Despite high procedural success and low amputation rates, patients with CKD remain at greater risk for MAVE and all-cause mortality after PVI. Further research is needed to determine treatment strategies to mitigate substantial mortality risk in this vulnerable population.

BACKGROUND: Optimal management of acute pulmonary embolism requires expertise offered by multiple subspecialties. As such, pulmonary embolism response teams (PERTs) have increased in prevalence, but the institutional consequences of a PERT are unclear.

METHODS: We compared all patients that presented to our institution with an acute pulmonary embolism in the 3 years prior to and 3 years after the formation of our PERT. The primary outcome was in-hospital pulmonary embolism-related mortality before and after the formation of the PERT. Sub-analyses were performed among patients with elevated-risk pulmonary embolism.

RESULTS: Between August 2012 and August 2018, 2042 patients were hospitalized at our institution with acute pulmonary embolism, 884 (41.3%) pre-PERT implementation and 1158 (56.7%) post-PERT implementation, of which 165 (14.2%) were evaluated by the PERT. There was no difference in pulmonary embolism-related mortality between the two time periods (2.6% pre-PERT implementation vs 2.9% post-PERT implementation, P = .89). There was increased risk stratification assessment by measurement of cardiac biomarkers and echocardiograms post-PERT implementation. Overall utilization of advanced therapy was similar between groups (5.4% pre-PERT implementation vs 5.4% post-PERT implementation, P = 1.0), with decreased use of systemic thrombolysis (3.8% pre-PERT implementation vs 2.1% post-PERT implementation, P = 0.02) and increased catheter-directed therapy (1.3% pre-PERT implementation vs 3.3% post-PERT implementation, P = 0.05) post-PERT implementation. Inferior vena cava filter use decreased after PERT implementation (10.7% pre-PERT implementation vs 6.9% post-PERT implementation, P = 0.002). Findings were similar when analyzing elevated-risk patients.

CONCLUSION: Pulmonary embolism response teams may increase risk stratification assessment and alter application of advanced therapies, but a mortality benefit was not identified.

AIMS: Pregnancy is a known risk factor for arterial dissection, which can result in significant morbidity and mortality in the peripartum period. However, little is known about the risk factors, timing, distribution, and outcomes of arterial dissections associated with pregnancy.

METHODS AND RESULTS: We included all women ≥12 years of age with hospitalizations associated with pregnancy and/or delivery in the Nationwide Readmissions Database between 2010 and 2015. The primary outcome was any dissection during pregnancy, delivery, or the postpartum period (42-days post-delivery). Secondary outcomes included timing of dissection, location of dissection, and in-hospital mortality. Among 18 151  897 pregnant patients, 993 (0.005%) patients were diagnosed with a pregnancy-related dissection. Risk factors included older age (32.8 vs. 28.0 years), multiple gestation (3.6% vs. 1.9%), gestational diabetes (14.3% vs. 0.2%), gestational hypertension (6.0% vs. 0.6%), and pre-eclampsia/eclampsia (2.7% vs. 0.4%), in addition to traditional cardiovascular risk factors. Of the 993 patients with dissection, 150 (15.1%) dissections occurred in the antepartum period, 232 (23.4%) were diagnosed during the admission for delivery, and 611 (61.5%) were diagnosed in the postpartum period. The most common locations for dissections were coronary (38.2%), vertebral (22.9%), aortic (19.8%), and carotid (19.5%). In-hospital mortality was 3.7% among pregnant patients with a dissection vs. <0.001% in patients without a dissection. Deaths were isolated to patients with an aortic (8.6%), coronary (4.2%), or supra-aortic (<2.5%) dissection.

CONCLUSION: Arterial dissections occurred in 5.5/100 000 hospitalized pregnant or postpartum women, most frequently in the postpartum period, and were associated with high mortality risk. The coronary arteries were most commonly involved. Pregnancy-related dissections were associated with traditional risk factors, as well as pregnancy-specific conditions.

BACKGROUND: National trends and costs associated with remote and in-office interrogations of pacemakers and implantable cardioverter-defibrillators (ICDs) have not been previously described.

OBJECTIVE: The purpose of this study was to evaluate utilization and Medicare spending for remote monitoring and in-office interrogations for pacemakers and ICDs.

METHODS: We performed a retrospective cohort study of claims and spending for remote and in-office interrogations of pacemakers and ICDs for Medicare fee-for-service beneficiaries from 2012 to 2015. Aggregate and per-beneficiary claims and spending were calculated for each device type.

RESULTS: Among all patients, 41.9% were female and the mean age was 78.3 years. From 2012 to 2015, remote monitoring utilization increased sharply. Aggregate professional remote monitoring claims for pacemakers increased by 61.3% and for ICDs by 5.6%, with an increase in technical claims (combined for pacemakers and ICDs) of 32.8%. Spending on all remote and in-office interrogations for these devices totaled $160 million per year, with remote costs increasing nearly 25% from $45.4 million in 2012 to $56.7 million in 2015. At the beneficiary level, remote interrogations increased for pacemakers from 0.6 to 0.9 per year, and for ICDs from 1.3 to 1.4 per year, whereas in-office interrogations decreased from 2.8 to 2.7 per year and from 3.0 to 2.9 per year, respectively. Beneficiary-level analysis revealed increased expenditures on remote interrogation offset by decreases in in-office expenditures, with total annual spending decreasing by $2 and $5 per beneficiary, respectively.

CONCLUSION: Remote monitoring utilization increased substantially from 2012 to 2015, whereas annual costs per beneficiary decreased.

While the presence of gender disparities in cardiovascular disease have been described, there is a paucity of data regarding the impact of sex in acute pulmonary embolism (PE). We identified all patients admitted to a tertiary care hospital with acute PE between August 1, 2012 through July 1, 2018. We stratified the presenting characteristics, management, and outcomes between women and men. Of the 2031 patients admitted with acute PE, 1081 (53.2%) were women. Women were more likely to present with dyspnea (59.8% vs 52.0%, p < 0.001) and less likely to present with hemoptysis (1.9% vs 4.0%, p = 0.01). Women were older (63.8 ± 17.4 years vs 62.3 ± 15.0 years, p = 0.04), but had lower rates of myocardial infarction, liver disease, smoking history, and prior DVT. PE severity was similar between women and men (massive: 4.9% vs 3.6%; submassive: 43.9% vs 41.8%; p = 0.19), yet women were more likely to present with normal right ventricular size on a surface echocardiogram (63.2% vs 54.8%, p = 0.01). In unadjusted analyses, women were less likely to survive to discharge (92.4% vs 94.7%, p = 0.04), but after adjustment, there was no sex-based survival difference. There were no sex differences in the PE-related diagnostic studies performed, use of advanced therapies, or short-term outcomes, before and after adjustment (p > 0.05 for all). In this large PE cohort from a tertiary care institution, women had different comorbidity profiles and PE presentations compared with men. Despite these differences, there were no sex disparities in PE management or outcomes.