Publications by Year: 2020

OBJECTIVE: Acute type B aortic dissection can be treated with medical management alone, open surgical repair, or thoracic endovascular aortic repair (TEVAR). The nationwide burden of readmissions after acute type B aortic dissection has not been comprehensively assessed.

METHODS: We analyzed adults with a hospitalization due to acute type B aortic dissection between January 1, 2010, and December 31, 2014, in the Nationwide Readmissions Database. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify hospitalizations with a primary diagnosis code for thoracic or thoracoabdominal aortic dissection. The primary outcome was nonelective 90-day readmission. Predictors of readmission were determined using hierarchical logistic regression.

RESULTS: The study population consisted of 6937 patients with unplanned admissions for type B aortic dissections from 2010 through 2014. Medical management alone was the treatment for 62.6% of patients, 21.0% had open surgical repair, and 16.4% underwent TEVAR. Nonelective 90-day readmission rate was 25.1% (23.6% with medical management alone, 26.9% with open repair, and 28.7% with TEVAR; P < .001). An additional 4.7% of patients were electively readmitted. The most common cause for nonelective readmission was new or recurrent arterial aneurysm or dissection (24.8%). Of those with unplanned readmissions, 5.2% underwent an aortic procedure. The mortality rate during nonelective readmission was 5.0%, and the mean cost of the rehospitalization was $22,572 ± $41,598.

CONCLUSIONS: More than one in four patients have a nonelective readmission 90 days after hospitalization for acute type B aortic dissection. Absolute rates of readmission varied by initial treatment received but were high irrespective of the initial treatment. The most common cause of readmission was aortic disease, particularly among those treated with medication alone. Further research is required to determine potential interventions to decrease these costly and morbid readmissions, including the role of multidisciplinary aortic teams.

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.

BACKGROUND: Hispanics are among the fastest growing population in the United States and are predicted to account for one third of the nation by 2060. Although melanoma is more common among white patients, Hispanic individuals are at greater risk of late-stage diagnosis, increased tumor thickness, and poorer survival.

OBJECTIVE: To better understand public awareness of melanoma and evaluate change over the last 21 years, particularly among high-risk minority populations.

METHODS: A cross-sectional survey collecting information on knowledge and awareness of melanoma was conducted on 285 participants from May through November 2017.

RESULTS: Approximately 39% of participants were unaware of melanoma. Sixty-five percent successfully identified early signs of disease. Approximately 86% of Fitzpatrick skin types (FST) I and II identified melanoma as a cancer, compared to 46.3% of FST III and IV and 57.6% of FST V and VI. Hispanic particiapnts were less likely to know what melanoma was compared to white participants (odds ratio [OR], 0.27; 95% confidence interval [CI], 0.65-0.11; P = .0037). US natives (OR, 2.38; 95% CI, 5.56-1.04; P = .0403) and patients with any college education (OR, 2.86; 95% CI, 5.26-1.54; P = .0007) were more likely to know the meaning of melanoma.

CONCLUSION: White participants and those with any college education were more likely to know the meaning of melanoma. Individuals of racial and ethnic minorities would benefit from educational programs geared toward early detection.

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.

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.

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: 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.

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.