Burden of Hypertensive Crisis in Patients With End-Stage Kidney Disease on Maintenance Dialysis: Insights From United States Renal Data System Database.

BACKGROUND: There is paucity of information on the incidence, clinical characteristics, admission trends, and outcomes of hypertensive crisis (HTN-C) in patients with end-stage kidney disease (ESKD) who are on maintenance dialysis. METHODS: We conducted a retrospective observational study of HTN-C admissions in patients with end-stage kidney disease using the United States Renal Data System. We identified patients with end-stage kidney disease aged ≥18 years on dialysis and were hospitalized for HTN-C from January 2006 to August 2015. RESULTS: A total of 54 483 patients with end-stage kidney disease were hospitalized for HTN-C during the study period. After study exclusions, 37 214 patients were included in the analysis. A majority of patients were Black, there were more women than men and the South region of the country accounted for a great majority of patients. During the study period, hospitalization rates increased from 1060 per 100 000 beneficiary years to 1821 (Ptrend<0.0001). Overall, in-hospital mortality, 30-day, and 1-year mortality were 0.6%, 2.3%, and 21.8%, respectively, and 30-day readmission rate was 31.1%. During the study period, most study outcomes showed a significant decreasing trend (in-hospital mortality 0.6%-0.5%, 30-day mortality 2.4%-1.9%, 1-year mortality 23.9%-19.7%, Ptrend<0.0001 for all). CONCLUSIONS: Hospitalizations for HTN-C have increased consistently during the decade studied. Although temporal trends showed improving mortality and readmission rates, the absolute rates were still high with 1 in 3 patients readmitted within 30 days and 1 in 5 patients dying within 1 year of index hospitalization.

Outcomes in patients with history of cocaine use presenting with chest pain to the emergency department: Insights from the Nationwide Emergency Department Sample 2016-2018.

OBJECTIVES: Cocaine use (CU) related chest pain (CP) is a common cause of emergency department (ED) visits in the United States. However, information on disposition and outcomes in these patients is scarce. We conducted a nationwide study to assess disposition from ED, hospitalization rates, in-hospital outcomes, and health care costs in patients with history of CU who presented to the ED with CP. METHODS: We queried the Nationwide Emergency Department Sample database from 2016-2018 for adult patients with CU presenting to the ED with CP. International Classification of Diseases, Tenth Revision codes were used to identify study patients. RESULTS: We identified 149,372 patients. The majority were male (76%), presented to metropolitan centers (91.3%), and had a high prevalence of cardiovascular risk factors (48.1% with hypertension, 24.4% with coronary artery disease, 18.2% with diabetes) and psychiatric illnesses (21%). Overall, 21.4% of patients were hospitalized, 68.6% were discharged from ED and 6.6% left against medical advice. Patients requiring admission were older (51.8 vs 45.0; P < 0.0001) and had a higher prevalence of coronary artery disease, peripheral arterial disease, hypertension, diabetes, and chronic kidney disease. Of those admitted, 45.7% were diagnosed with myocardial infarction (MI), constituting 9.7% of the total study population. Over 80% of these patients underwent coronary angiography and 38.6% had coronary intervention. Mortality was 1.2%. CONCLUSION: CU patients who present to ED are predominantly male, are from lower economic strata, and have significant comorbidity burden. One in 5 patients requires hospitalization and has more prevalent cardiovascular risk factors and comorbidities. In-hospital mortality is low, but incidence of MI and subsequent invasive procedures is high. CU may be considered a cardiac risk factor as it is associated with high rates of in-hospital MI.

Impact of Annular Size on Outcomes After Surgical or Transcatheter Aortic Valve Replacement.

BACKGROUND: This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients. METHODS: The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to <26 mm), and small (<23 mm). Hemodynamics, PPM, and clinical outcomes were assessed. RESULTS: At all postprocedure visits, mean gradients were significantly lower for TAVR compared with SAVR in small and medium size annuli (p < 0.001). Annular size was significantly associated with mean gradient after SAVR, with small annuli having the highest gradients (p < 0.05 at all timepoints); gradients were similar across all annular sizes after TAVR. In subjects receiving SAVR, the frequency of PPM was significantly associated with annular size, with small annuli having the greatest incidence. No difference in PPM incidence by annular sizing was observed with TAVR. In addition, TAVR subjects had significantly less PPM than SAVR subjects in small and medium annuli (p < 0.001), with no difference in the incidence of PPM between TAVR and SAVR in large annuli (p = 0.10). CONCLUSIONS: Annular size has a significant effect on hemodynamics and the incidence of PPM in SAVR subjects, not observed in TAVR subjects. With respect to annular size, TAVR results in better hemodynamics and less PPM for annuli less than 26 mm and should be strongly considered when choosing a tissue valve for small and medium size annuli.

Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial.

OBJECTIVES: This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). BACKGROUND: In patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment. METHODS: Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time. RESULTS: Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire's physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points. CONCLUSIONS: Health status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Defining patients at high risk for gastrointestinal hemorrhage after drug-eluting stent placement: a cost utility analysis.

INTRODUCTION: The study goal was to evaluate the cost-effectiveness of drug-eluting stent (DES) placement with consideration of gastrointestinal (GI) bleeding risk. DES reduce the need for future coronary revascularization, but require prolonged dual anti-platelet (DAT) therapy, which may increase the risk for GI bleeding. While DES have been found to be cost-effective in patients at average risk for GI bleeding, they may not be the most cost-effective strategy in higher risk patients. METHODS: A Markov model was created to compare DES with bare metal stents (BMS). Patients were a hypothetical cohort of 60-year-old individuals with coronary artery stenosis that required nonemergent percutaneous coronary revascularization (PCI). The primary outcomes were the threshold incremental risks of GI bleeding from DAT based on willingness to pay (WTP) of $50,000, $100,000, and $150,000 per quality adjusted life year (QALY) gained. RESULTS: For a WTP of $100,000, the relative risk of GI bleeding from DAT could be as high as 10.8 (when compared to aspirin alone) before DES would no longer be cost-effective. In patients with two risk factors for GI bleeding, the threshold relative risk could be as low as 1.6. CONCLUSION: In average-risk patients, the risk of GI bleeding from DAT can be substantial without affecting the cost-effectiveness of DES. However, DES are unlikely to be cost-effective in patients with two or more risk factors for GI bleeding.

Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme.

AIMS: We report 2-year outcomes in a large unselected drug-eluting stent population (N=7,492) in the TAXUS Express2 ARRIVE post-market surveillance programme (101 U.S. sites). METHODS AND RESULTS: No specific inclusion/exclusion criteria were mandated; patients enrolled at procedure initiation. Two-year follow-up was 94%, with independent adjudication of major cardiac events, monitoring of patients with cardiac events and an additional 10-20% sample by site. Most ARRIVE cases (64%, n=4,794) typified expanded use based on patient/lesion characteristics outside the simple use (single vessel/stent) pivotal trial populations. These expanded use patients had higher 2-year rates than simple use patients for mortality (7.8% vs. 4.2%, P<0.001), myocardial infarction (MI, 3.9% vs. 2.2%, P<0.001), target lesion revascularisation (TLR, 9.2% vs. 5.4%, P<0.001), and stent thrombosis (3.3% vs. 1.4%, P<0.001). Among subgroups with renal disease, chronic total occlusion (CTO), lesion >28 mm, reference vessel diameter (RVD) <2.5 mm, multivessel stenting, acute MI, bifurcation, vein graft, or in-stent restenosis, TLR ranged from 3.8% to 8.9% in year one, and from 1.3% to 6.0% during year two. CONCLUSIONS: Mortality and stent-related events were higher in expanded use than simple use patients in the pivotal trials. ARRIVE provides a detailed estimate of procedural and 2-year outcomes in such real-world patients.

Iatrogenic deep musculocutaneous radiation injury following percutaneous coronary intervention.

Radiation-induced skin injury has been reported for multiple fluoroscopic procedures. Previous studies have indicated that prolonged fluoroscopic exposure during even a single percutaneous coronary intervention (PCI) may lead to cutaneous radiation injury. We document a novel case of deep muscle damage requiring wide local debridement and muscle flap reconstruction in a 59-year-old man with a large radiation-induced wound to the lower thoracic region following 1 prolonged PCI procedure. The deep muscular iatrogenic injury described in this report may be the source of significant morbidity. Recommendations to reduce radiation-induced damage include careful examination of the skin site before each procedure, minimized fluoroscopy time, utilization of pulse fluoroscopy, employment of radiation filters, and collimator s and rotation of the location of the image intensifier.