Guideline-Directed Medical Therapy in Patients with Chronic Kidney Disease Undergoing Peripheral Vascular Intervention.

INTRODUCTION: Guideline-directed medical therapy (GDMT) is imperative to improve cardiovascular and limb outcomes for patients with critical limb ischemia (CLI), especially amongst those at highest risk for poor outcomes, including those with comorbid chronic kidney disease (CKD). Our objective was to examine GDMT prescription rates and their variation across individual sites for patients with CLI undergoing peripheral vascular interventions (PVIs), by their comorbid CKD status. METHODS: Patients with CLI who underwent PVI (October 2016-April 2019) were included from the Vascular Quality Initiative (VQI) database. CKD was defined as GFR <60 mL/min/1.73 m2. GDMT included the composite use of antiplatelet therapy and a statin, as well as an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker if hypertension was present. The use of GDMT before and after the index procedure was summarized in those with and without CKD. Adjusted median odds ratios (MORs) for site variability were calculated. RESULTS: The study included 28,652 patients, with a mean age of 69.4 ± 11.7 years, and 40.8% were females. A total of 47.5% had CKD. Patients with CKD versus those without CKD had lower prescription rates both before (31.7% vs. 38.9%) and after (36.5% vs. 48.8%) PVI (p < 0.0001). Significant site variability was observed in the delivery of GDMT in both the non-CKD and CKD groups before and after PVI (adjusted MORs: 1.31-1.41). DISCUSSION/CONCLUSION: In patients with CLI undergoing PVI, patients with comorbid CKD were less likely to receive GDMT. Significant variability of GDMT was observed across sites. These findings indicate that significant improvements must be made in the medical management of patients with CLI, particularly in patients at high risk for poor clinical outcomes.

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

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 International Classification of Diseases, Ninth and Tenth Edition, Clinical Modification 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% Ptrend<0.0001 as well as overall peripheral artery disease admissions (4.5%-8.9%, Ptrend<0.0001). In-hospital mortality for the entire CLI cohort decreased from 3.3% to 2.7%, Ptrend<0.0001, and major amputations decreased from 10.9% to 7%, Ptrend<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 (Ptrend<0.0001), whereas admission costs increased from USD $11 791 ($6676-$21 712) to $12 597 ($7248-$22 748; Ptrend<0.0001). Endovascular interventions increased (Ptrend<0.0001) against a decline in surgical interventions (Ptrend<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.

Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions.

OBJECTIVE: Our aim was to evaluate the efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, Calif) and report the in-hospital and 30-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored the factors associated with procedural success. METHODS: We conducted a retrospective review of 135 consecutive procedures in 116 patients from July 2011 to September 2018 performed by eight operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was used for lower extremity CTO. The patient demographics, preprocedural symptoms, preprocedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, 30-day major adverse cardiovascular events, and 30-day major adverse limb events. We conducted univariate comparisons of the provider, patient, and procedural characteristics stratified by procedural success. RESULTS: Procedural success was observed in 118 procedures overall (87.4%), and success rates ≤95.8% were observed for operators with an experience level of >25 devices deployed. No device-related complications, such as pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation, were observed. The Pioneer Plus catheter was mostly often used for CTO in the superficial femoral and popliteal arteries. Overall, the procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). The 30-day major adverse limb events included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%) and occurred in 5.9% of the procedures. The only factor associated with procedural success was operator experience (P < .0001). CONCLUSIONS: The results from the present study have shown that Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTO. However, further investigation is needed to identify patient- and provider-level factors to optimize patient outcomes.

Systematic review and meta-analysis of outcomes of lower extremity peripheral arterial interventions in patients with and without chronic kidney disease or end-stage renal disease.

OBJECTIVE: Patients with chronic kidney disease (CKD) have a greater risk of peripheral arterial disease (PAD). Although individual studies have documented an association between CKD and/or end-stage renal disease (ESRD) and adverse outcomes in patients undergoing PAD interventions in an era of technological advances in peripheral revascularization, the magnitude of the effect size is unknown. Therefore, we performed a meta-analysis to compare the outcomes of PAD interventions for patients with CKD/ESRD with those patients with normal renal function, stratified by intervention type (endovascular vs surgical), reflecting contemporary practice. METHODS: Five databases were analyzed from January 2000 to June 2019 for studies that had compared the outcomes of lower extremity PAD interventions for patients with CKD/ESRD vs normal renal function. We included both endovascular and open interventions, with an indication of either claudication or critical limb ischemia. We analyzed the pooled odds ratios (ORs) across studies with 95% confidence intervals (CIs) using a random effects model. Funnel plot and exclusion sensitivity analyses were used for bias assessment. RESULTS: Seventeen observational studies with 13,140 patients were included. All included studies, except for two, had accounted for unmeasured confounding using either multivariable regression analysis or case-control matching. The maximum follow-up period was 114 months (range, 0.5-114 months). The incidence of target lesion revascularization (TLR) was greater in those with CKD/ESRD than in those with normal renal function (OR, 1.68; 95% CI, 1.25-2.27; P = .001). The incidence of major amputations (OR, 1.97; 95% CI, 1.37-2.83; P < .001) and long-term mortality (OR, 2.28; 95% CI, 1.45-3.58; P < .001) was greater in those with CKD/ESRD. The greater TLR rates with CKD/ESRD vs normal renal function were only seen with endovascular interventions, with no differences for surgical interventions. The differences in rates of major amputations and long-term mortality between the CKD/ESRD and normal renal function groups were statistically significant, regardless of the intervention type. CONCLUSIONS: Patients with CKD/ESRD who have undergone lower extremity PAD interventions had worse outcomes than those of patients with normal renal function. When stratifying our results by intervention (endovascular vs open surgery), greater rates of TLR for CKD/ESRD were only seen with endovascular and not with open surgical approaches. Major amputations and all-cause mortality were greater in the CKD/ESRD group, irrespective of the indication. Evidence-based strategies to manage this at-risk population who require PAD interventions are essential.

Impact of Kidney Disease on Peripheral Arterial Interventions: A Systematic Review and Meta-Analysis.

BACKGROUND: There are limited data on outcomes of patients undergoing peripheral arterial disease (PAD) interventions who have comorbid CKD/ESRD versus those who do not have such comorbid condition. We performed a systematic review and meta-analysis to analyze outcomes in this patient population. METHODS: Five databases were searched for studies comparing outcomes of lower extremity PAD interventions for claudication and critical limb ischemia (CLI) in patients with CKD/ESRD versus non-CKD/non-ESRD from January 2000 to June 2019. RESULTS: Our study included 16 observational studies with 44,138 patients. Mean follow-up was 48.9 ± 27.4 months. Major amputation was higher with CKD/ESRD compared with non-CKD/non-ESRD (odds ratio [OR 1.97] [95% confidence interval [CI] 1.39-2.80], p = 0.001). Higher major amputations with CKD/ESRD versus non-CKD/non-ESRD were only observed when indication for procedure was CLI (OR 2.27 [95% CI 1.53-3.36], p < 0.0001) but were similar for claudication (OR 1.15 [95% CI 0.53-2.49], p = 0.72). The risk of early mortality was high with CKD/ESRD patients undergoing PAD interventions compared with non-CKD/non-ESRD (OR 2.55 [95% CI 1.65-3.96], p < 0.0001), which when stratified based on indication, remained higher with CLI (OR 3.14 [95% CI 1.80-5.48], p < 0.0001) but was similar with claudication (OR 1.83 [95% CI 0.90-3.72], p = 0.1). Funnel plot of included studies showed moderate bias. CONCLUSIONS: Patients undergoing lower extremity PAD interventions for CLI who also have comorbid CKD/ESRD have an increased risk of experiencing major amputations and early mortality. Randomized trials to understand outcomes of PAD interventions in this at-risk population are essential.

Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis.

INTRODUCTION: The femoropopliteal (FP) segment is a common site of involvement in peripheral arterial disease (PAD) and endovascular therapy has been shown to be safe and effective in the treatment of FP disease. Self-expanding nitinol stents are now frequently used for the treatment of FP disease but in-stent restenosis (ISR) remains a major issue that can lead to recurrence of symptoms requiring repeated revascularizations. Compared to plain old balloon angioplasty (POBA), drug-coated balloons (DCBs) have shown promising results with reduction of ISR rates and target lesion revascularization (TLR). AREAS COVERED: The aim of this review is to describe the mechanisms and classification of ISR and to summarize the available data on outcomes of all DCBs, especially in the treatment of FP ISR. EXPERT OPINION: Currently available data supports the use of DCBs as a first-line therapy in patients with FP ISR, with lower rates of TLR and higher patency rates at 1-year follow-up, when compared to POBA. Further randomized studies are essential to evaluate longer term safety and efficacy of DCBs.

Utility of Intravascular Ultrasound in Peripheral Vascular Interventions: Systematic Review and Meta-Analysis.

OBJECTIVES: We sought to compare outcomes between intravascular ultrasound- (IVUS) versus angiography (AO)-guided peripheral vascular interventions (PVIs). Introduction: Intravascular ultrasound facilitates plaque visualization and angioplasty during PVIs for peripheral arterial disease. It is unclear whether IVUS may improve the durability of PVIs and lead to improved clinical outcomes. METHODS: This is a study-level meta-analysis of observational studies. The primary end points of this study were rates of primary patency and reintervention. Secondary end points included rates of vascular complications, periprocedural adverse events, amputations, technical success, all-cause mortality, and myocardial infarction. RESULTS: Eight observational studies were included in this analysis with 93 551 patients. Mean follow-up was 24.2 ± 15 months. Intravascular ultrasound-guided PVIs had similar patency rates when compared with AO-guided PVIs (relative risk [RR]: 1.30, 95% confidence interval [CI]: 0.99-1.71, P = .062). There was no difference in rates of reintervention in IVUS-guided PVIs when compared to non-IVUS-guided PVIs (RR: 0.41, 95% CI: 0.15-1.13, P = .085). There is a lower risk of periprocedural adverse events (RR: 0.81, 95% CI: 0.70-0.94, P = .006) and vascular complications (RR: 0.81, 95% CI: 0.68-0.96, P = .013) in the IVUS group. All-cause mortality (RR: 0.76, 95% CI: 0.56-1.04, P = .084), amputation rates (RR 0.83, 95% CI: 0.32-2.15, P = .705), myocardial infarctions (RR: 1.19, 95% CI: 0.58-2.41, P = .637), and technical success (RR: 1.01, 95% CI: 0.86-1.19, P = .886) were similar between the groups. Conclusions: Intravascular ultrasound-guided PVIs had similar primary patency and reintervention when compared with AO-guided PVIs with significantly lower rates of periprocedural adverse events and vascular complications in the IVUS-guided group.

Evaluating the benefits of home-based management of atrial fibrillation: current perspectives.

Atrial fibrillation (AF) is the most common arrhythmia worldwide, leading to an extensive public health and economic burden. The increasing incidence and prevalence of AF is due to the advancing age of the population, structural heart disease, hypertension, diabetes, and thyroid disease. The majority of costs associated with AF have been attributed to the cost of hospitalization. In order to minimize costs and decrease hospitalizations, counseling on modifiable risk factors contributing to AF has been strongly emphasized. With the release of novel oral anticoagulants bypassing the need for anticoagulant bridging or laboratory monitoring, post-discharge nurse-led home intervention, and novel methods of heart rate monitoring, home-based AF management has reached a new level of ease and sophistication. In this review, we aimed to review modifiable risk factors for AF and various methods of home-based management of AF, along with their benefits.

Temporal Trends, Predictors, and Outcomes of In-Hospital Gastrointestinal Bleeding Associated With Percutaneous Coronary Intervention.

Since the introduction of new antiplatelet and anticoagulant agents in the last decade, large-scale data studying gastrointestinal bleeding (GIB) in patients undergoing percutaneous coronary intervention (PCI) are lacking. Using the Nationwide Inpatient Sample, we identified all hospitalizations from 2006 to 2012 that required PCI. Temporal trends in the incidence and multivariate predictors of GIB associated with PCI were analyzed. A total of 4,376,950 patients underwent PCI in the United States during the study period. The incidence of GIB was 1.1%. Mortality rate in the GIB group was significantly higher (9.71% vs 1.1%, p <0.0001). Although the incidence of GIB remained stable during the study period (0.97% in 2006 to 1.19% in 2012), in-hospital mortality rate increased significantly from 7.9% in 2006 to 10.78% in 2012, with a peak of 12% in 2010. The GIB group had a longer median length of stay (5.80 vs 1.57 days) and an increased median cost of hospitalization ($26,564 vs $16,879). The predictors of GIB included cardiovascular co-morbidities such as acute myocardial infarction, cardiogenic shock, atrial fibrillation, congestive heart failure, valvular heart diseases, and a history of transient ischemic attack/stroke. Gastrointestinal co-morbidities including diverticulosis, esophageal cancer, stomach cancer, small intestine cancer, large intestine cancer, rectosigmoid cancer, gastrointestinal ulcer, and liver disease were predictors of GIB. Interestingly, a lower risk of GIB was associated with obese patients and patients with private insurance. A higher risk of GIB was noted in urgent versus elective admissions and weekend versus weekday admissions. In conclusion, the incidence of GIB in patients who underwent PCI remained stable from 2006 to 2012; however, the in-hospital mortality increased significantly. Identifying patients at higher risk for GIB is critically important to develop preventive strategies to reduce morbidity and mortality.

Anti-arrhythmic medications increase non-cardiac mortality - A meta-analysis of randomized control trials.

INTRODUCTION: Anti-arrhythmic medications (AAMs) are known to increase cardiac mortality significantly due to their pro-arrhythmic effects. However, the effect of AAMs on non-cardiac mortality has not been evaluated. METHODS: Trials published in English language journals from 1990 to 2015 were thoroughly retrieved by searching websites such as PubMed, Medline, Cochrane Library, and Google Scholar. Randomized controlled trials reporting non-cardiac deaths as primary or secondary outcomes were used to compare AAMs to non-arrhythmic therapy (AV nodal blocking agents, implantable cardiovascular defibrillation (ICD), or placebo). Information regarding the sample size, treatment type, baseline characteristics, and outcomes was obtained by using a standardized protocol. The fixed effect model was used to perform meta-analysis, and results were expressed in terms of odds ratio (OR) with confidence interval (CI) of 95%, inter study heterogeneity was assessed using I (2). Intention to treat principle was applied to extract data. RESULTS: Total of 18,728 patients were enrolled in 15 trials; 9359 patients received AAMs and 9369 received non-arrhythmic therapy. AAMs were associated with an increased risk of non-cardiac mortality (OR=1.30, [95% CI: 1.12, 1.50], p=0.0005, I (2) index=24%) and all-cause mortality (OR=1.09, [95% CI: 1.01, 1.18], p=0.04, I (2)=54%) as compared to non-arrhythmic therapy. There was no difference in the cardiac mortality (OR=1.01, [95% CI: 0.92, 1.11], p=0.82, I (2)=53%) or arrhythmic mortality (OR=1.00, [95% CI: 0.89, 1.13], p=0.94, I (2)=64%) between the two groups. CONCLUSION: AAMs are associated with an increased risk of non-cardiac and all-cause mortality. The effect of AAMs, especially amiodarone, on non-cardiac mortality requires further evaluation.

Safety and efficacy of second-generation versus first-generation cryoballoons for treatment of atrial fibrillation: a meta-analysis of current evidence.

BACKGROUND: The newer second-generation cryoballoons (CB-2 or Arc-Adv-CB) have been shown to achieve significantly lower temperature and faster pulmonary vein isolation (PVI) time in comparison with first-generation cryoballoons (CB-1 or Arc-CB). To test the premise that second-generation cryoballoons can improve clinical outcomes in comparison to first-generation cryoballoons in terms of safety and efficacy, we pooled data for systemic review and meta-analyses from all available literature comparing their clinical performance. METHODS: The Cochrane Library, PubMed, Google Scholar, and studies presented at various meetings were searched for any published literature comparing safety and efficacy of the second-generation cryoballoons (Arctic Front Advance cryoballoons) with first-generation cryoballoons (Arctic Front Cryoballoons). A total of ten published studies, with 2310 patients, were included in this meta-analysis with 957 patients in second-generation cryoballoon group and 1237 patients in first-generation cryoballoon group. RESULTS: The pooled analysis showed significant superiority of second-generation cryoballoons in terms of less procedure time, less fluoroscopic time, and fewer incidences of arrhythmia recurrences compared to first-generation cryoballoons at the cost of higher incidence of persistent and transient phrenic nerve palsy. The differences in the rate of pericardial effusion and incidence of access site complications were not statistically significant. CONCLUSIONS: Second-generation cryoballoons are associated with a shorter procedure time and fluoroscopy time, along with lower arrhythmia recurrence rates, reflecting higher procedure efficacy when compared to first-generation cryoballoons. However, they are also associated with a higher incidence of transient and persistent phrenic nerve palsies with a non-significant difference in rates of access site complications and pericardial effusion.

Prognostic impact of atrial fibrillation on clinical outcomes of acute coronary syndromes, heart failure and chronic kidney disease.

Atrial fibrillation (AF) is the most common type of sustained arrhythmia, which is now on course to reach epidemic proportions in the elderly population. AF is a commonly encountered comorbidity in patients with cardiac and major non-cardiac diseases. Morbidity and mortality associated with AF makes it a major healthcare burden. The objective of our article is to determine the prognostic impact of AF on acute coronary syndromes, heart failure and chronic kidney disease. Multiple studies have been conducted to determine if AF has an independent role in the overall mortality of such patients. Our review suggests that AF has an independent adverse prognostic impact on the clinical outcomes of acute coronary syndromes, heart failure and chronic kidney disease.

Trends in hospitalization for atrial fibrillation: epidemiology, cost, and implications for the future.

Atrial fibrillation (AF) is the most prevalent arrhythmia worldwide and the most common arrhythmia leading to hospitalization. Due to a substantial increase in incidence and prevalence of AF over the past few decades, it attributes to an extensive economic and public health burden. The increasing number of hospitalizations, aging population, anticoagulation management, and increasing trend for disposition to a skilled facility are drivers of the increasing cost associated with AF. There has been significant progress in AF management with the release of new oral anticoagulants, use of left atrial catheter ablation, and novel techniques for left atrial appendage closure. In this article, we aim to review the trends in epidemiology, hospitalization, and cost of AF along with its future implications on public health.