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Institutional Variation in Patient Radiation Doses During Transcatheter Valve Interventions: A Statewide Experience
No full textBACKGROUND: Little is known about institutional radiation doses during transcatheter valve interventions.
OBJECTIVES: The authors sought to evaluate institutional variability in radiation doses during transcatheter valve interventions.
METHODS: Using a large statewide registry, transcatheter edge-to-edge mitral valve repair, transcatheter mitral valve replacement, and transcatheter aortic valve replacement procedures between January 1, 2020, and December 31, 2022, with an air kerma (AK) recorded were analyzed. Patient and procedural characteristics were compared between cases with AK ≥ 2 and ≥ 2 Gy were investigated using Bayesian random effects modeling and median ORs for the performing hospital.
RESULTS: Among 9,446 procedures across 30 hospitals, median (Q1-Q3) procedural AK was 0.592 Gy (0.348-0.989 Gy) with AK ≥ 2 Gy in 533 cases (5.6%). Wide variation in procedural AK was observed, with an institutional frequency of AK ≥ 2 Gy ranging from 0.0% to 29.5%. Bayesian modeling identified the performing hospital as more strongly associated with the odds of a procedural AK ≥ 2 Gy than any patient or procedural factors (hospital median OR: 3.54 [95% credible interval: 2.52-16.66]).
CONCLUSIONS: In a large, multicenter state-wide registry, there is wide institutional variability in patient-level radiation doses during transcatheter valve interventions, with the performing hospital having a higher odds of an AK ≥ 2 Gy than any patient or procedural factors. Future interventions are warranted to reduce procedural-related variation in radiation exposure
National Trends and Outcomes of Pedal Bypass Surgery
No full textOBJECTIVE: The technical demands associated with pedal bypass (PB) surgery place it at risk of underutilization and may be limiting its widespread adoption as a valuable revascularization modality. This study aims to evaluate trends in PB performance, assess its outcomes, and compare its results between high- and low-volume centers.
METHODS: All patients receiving a PB between 2003 and 2023 were identified in the Vascular Quality Initiative (VQI) infrainguinal bypass (IIB) module. The ratio of PB to total IIB performed was calculated for each year and trended over the study period. Centers performing PB were categorized according to their annual PB volume into tertiles of low-volume centers (LVC, \u3c2 PB/year), medium-volume centers (MVC, 2-4 PB/year), and high-volume centers (HVC, \u3e4 PB/year) for comparison. Patient characteristics and outcomes were compared using the χ(2) or Fisher exact test as appropriate for categorical variables and the analysis of variance test or Kruskal-Wallis test as appropriate for continuous variables. Cox regression analysis was used to study the association between center volume and the primary outcomes of primary patency, primary-assisted patency, secondary patency, reintervention, amputation, and major adverse limb events (MALE), defined as the composite outcome of amputation and/or reintervention.
RESULTS: A total of 3466 patients received a PB during the study period. The ratio of PB to IIB dropped from 14% to 4% between 2003 and 2023. Primary, primary-assisted, and secondary patency rates were 65%, 76%, and 80%, respectively, and limb salvage rate was 83% at 1 year. Nineteen percent of centers performing IIBs in the VQI did not perform any PBs during the study period. Of the 246 centers performing PBs, 78% were LVC, 15% were MVC, and only 7% were HVC. On Cox regression analysis, HVCs were associated with a lower risk of primary patency loss (hazard ratio [HR], 0.79; 95% confidence interval [CI], 0.66-0.95; P = .010), reintervention (HR, 0.75; 95% CI, 0.60-0.95; P = .016), amputation (HR, 0.77; 95% CI, 0.61-0.98; P = .034), and MALE (HR, 0.78; 95% CI, 0.66-0.93; P = .005) compared with LVCs. No difference in secondary patency between high- and low-volume centers was observed (P = .680).
CONCLUSIONS: The utilization of PB operations experienced a four-fold decrease over the past 20 years, despite favorable patency and limb salvage outcomes. Centers with a higher operative volume in PB achieve better outcomes than LVCs, and accordingly, patients with extensive tibioperoneal disease may benefit from evaluation at centers with documented expertise in PB before resorting to an alternative revascularization modality or a major limb amputation
The Burden Of Substance Abuse And Mental Health Disorders In Patients Admitted With Stress Cardiomyopathy
No full textIntroduction: Several studies have linked mental health disorders and substance abuse as risk factors for stress cardiomyopathy (SC). However, the true burden of these disorders amongst patients with stress cardiomyopathy remains unknown. Methods: We used the 2016-2020 National Inpatient Sample database to identify hospitalizations for SC who underwent diagnostic catheterization. We assessed the proportion of patients diagnosed with a substance abuse or mental health disorder. Subsequently, the association of these disorders in SC compared to patients admitted for myocardial infarction (MI) was assessed using the chi-square test. Results: From 2016 to 2020, there were 33,075 hospitalizations for stress cardiomyopathy who were diagnosed by cardiac catheterization. Of these patients, 5,920 (17.9 %) had depression, 8,500 (25.7 %) had anxiety, 1058 (3.2 %) had severe stress reactions, and 16,372 (49.5 %) were diagnosed with a mental health disorder. 9,955 (30.1 %) were smokers, 5,358 (16.2%) abused hallucinogens, 5,457 (16.5 %) abused cocaine, 5,457 (16.5%) abused sedatives, 6,019 (18.2 %) abused cannabis, 5,920 (17.9%) abused opioids, 6,416 (19.4 %) abused alcohol. Subsequently, the association of stress cardiomyopathy with mental and substance abuse disorder was compared with patients admitted with myocardial infarction See Table 1. Conclusion: Mental health and substance abuse disorders are common in patients diagnosed with SC. These disorders are more commonly present in SC compared to MI. Further research is needed to assess the significance of these findings
Comparison of 30-Day Outcomes of TAVR vs. SAVR in Patients with Prior CABG: A Meta-Analysis
No full textIntroduction: Managing severe aortic stenosis in patients with a history of coronary artery bypass grafting (CABG) is challenging. Traditionally, surgical aortic valve replacement (SAVR) was the standard treatment, but transcatheter aortic valve replacement (TAVR) offers a less invasive alternative. This meta-analysis compares the 30-day outcomes of TAVR versus SAVR in patients with prior CABG. Methods: A systematic review and meta-analysis were conducted according to PRISMA guidelines. Studies comparing TAVR and SAVR in patients with prior CABG were included. The primary outcomes were 30-day (cardiovascular) CV mortality, allcause mortality, stroke, and myocardial infarction. Heterogeneity was assessed using the Chi-squared test and I-squared statistic. P value \u3c0.05 was considered statistically significant. Results: Nine studies with a total of 8,487 patients were included for the 30-day outcomes. The pooled odds ratio (OR) for 30-day CV mortality was 1.00 (95% CI: 0.48-2.06), with no significant difference between TAVR and SAVR (p=0.99). For 30- day all-cause mortality, the pooled OR was 0.75 (95% CI: 0.51-1.10), also showing no significant difference between TAVR and SAVR (p=0.14). The pooled OR for 30-day myocardial infarction was 0.34 (95% CI: 0.09-1.27), indicating no significant difference between TAVR and SAVR (p=0.11). However, the pooled OR for 30-day stroke was 0.67 (95% CI: 0.50-0.90), showing a significantly lower incidence with TAVR compared to SAVR (p=0.007). Detailed results in Figure 1. Conclusion: In patients with a history of CABG, TAVR appears to have comparable 30-day outcomes to SAVR in terms of CV mortality, all-cause mortality, and myocardial infarction. However, TAVR is associated with a significantly lower incidence of 30-day stroke. These findings suggest that TAVR may be a safer option in the short term for this high-risk patient population. Further research is needed to confirm these results in larger, randomized controlled trials. (Figure Presented)
Efficacy and safety of seladelpar in patients with primary biliary cholangitis and compensated liver cirrhosis in the open-label long-term ASSURE safety study: interim results
No full textBackground and aims: Seladelpar, a potent and selective PPAR-delta agonist (ie, a delpar), has anti-cholestatic and anti-pruritic activity in patients with primary biliary cholangitis (PBC). The ongoing international, phase 3 ASSURE study (NCT03301506) is an openlabel long-term study of seladelpar in patients with PBC who participated in a prior seladelpar study. Here we report interim efficacy and safety results on a subset of patients with compensated liver cirrhosis. Method: Patients with PBC and cirrhosis were eligible for ASSURE if they had an inadequate response or intolerance to ursodeoxycholic acid (UDCA), previously participated in a seladelpar study, and had no history of hepatic decompensation. All patients received open-label seladelpar 10 mg oral daily. As of the data cutoff (29 June 2023), 174 patients from previous seladelpar studies (CB8025–21629 NCT02955602; CB8025-31731, NCT03301506; ENHANCE NCT03602560; CB8025-21838, NCT04950764) had enrolled, of whom 33 had compensated liver cirrhosis at study entry. Biochemical efficacy end points included the composite response of alkaline phosphatase (ALP) \u3c1.67x upper limit of normal (ULN), ALP decrease ≥15%, and total bilirubin ≤ULN; ALP normalization; and change from baseline in ALP, total bilirubin, gamma-glutamyl transferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) all at Month 12. Results: Of the 33 patients with cirrhosis, most were female (91%) with a mean age of 60.4 years. Eight patients (24.2%) had portal hypertension, 93.9% were Child-Pugh (CP) class A, and 6.1% were CPB. Mean baseline liver stiffness by FibroScan was 19.3 kPa. At baseline mean ALP was 241.9 U L, and total bilirubin was 0.92 mg dL (27.3% \u3eULN). As of the data cutoff date, 23 patients with compensated cirrhosis had completed 12 months of treatment. Twelve out of 23 (52.2%) patients met the composite biochemical end point at Month 12. ALP normalization occurred in 39.1% (9 23 patients) at Month 12 and the mean percent change from baseline in ALP was −38.1% (absolute change: −99.5 U L). Reductions were also observed in GGT and ALT (percent changes from baseline: −35.1% and −19.6% respectively) at Month 12; no change was observed in AST or total bilirubin. There were no serious adverse events that were liverrelated or related to study drug and no discontinuations due to adverse events. Conclusion: In this interim analysis of the ongoing ASSURE study PBC patients with compensated cirrhosis treated with seladelpar 10 mg for 12 months achieved clinically meaningful improvements in markers of cholestasis and liver injury. Seladelpar appeared overall safe andwell tolerated. These findings suggest that seladelpar has the potential to offer a safe and effective therapy for PBC patients with compensated cirrhosis
Hyperarousal/Sleep Disturbance and Inability to Discontinue Chronic Hypnotic Use
No full textSelect Drug Category Sedative/Hypnotics Topic Behavior Abstract Detail Clinical – Experimental Abstract Category Original Research Aim: Inability to discontinue hypnotics remains a concern among clinicians. In a controlled prospective study using self-administration choice procedures we tested whether baseline sleep disturbance (SE\u3c85%) and hyperarousal (MSLT\u3e12 min), alone or in combination, would predict discontinuation difficulty after 6 months of nightly hypnotic use. Methods: DSM-V diagnosed insomnia subjects, aged 23-61 yrs., (n=41, 36 females), with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the trial. Following a screening polysomnogram and MSLT, participants were randomized to zolpidem XR 12.5 mg (n=16), eszopiclone 3 mg (n=11), or placebo (n=14) nightly for 6 months. After 6 months, nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned “blinded” medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Results: Over the 14 nights 21 subjects took zero (51%) capsules; among the 20 taking capsules the median total number chosen over the two weeks was 3. The three treatment groups did not differ in baseline SE and MSLT. Across the three groups, the number of capsules taken declined from week 1 to 2 (p\u3c.001). Those with both MSLT \u3e12 min and SE\u3c85% (n=14) did not reduce capsule choice (i.e., continued capsule use at the same rate) from week 1 to 2 (p\u3c.04) relative to the rest of the subjects. Neither MSLT nor SE alone predicted discontinuation difficulty. Conclusions: The majority (51%) of the participants discontinued 6-month nightly hypnotic use and among those taking capsules the rate declined from week 1 to 2. Hyperarousal and sleep disturbance may help identify those with difficulty discontinuing chronic hypnotic use. Financial Support: The majority (51%) of the participants discontinued 6-month nightly hypnotic use and among those taking capsules the rate declined from week 1 to 2. The non-hypnotic receptor specific eszopiclone group took a greater number of capsules than the placebo group. This is the first demonstration of differential abuse liability among BzRA hypnotics
Airway and Systemic Dysregulation of Interferon Responses Promote Asthma Exacerbations in Urban Children
No full textRationale: To understand the molecular pathways that differ during colds that progress to asthma exacerbation versus resolve without intervention, we compared differential gene expression in peripheral blood and airway samples during illnesses. Methods: 208 urban children (6-17 years) with exacerbation-prone asthma and blood eosinophils ≥150/microliter were prospectively monitored for cold symptoms. Exacerbation illnesses (Ex+), defined as colds leading to an asthma exacerbation requiring systemic corticosteroid use within 10 days, were compared to colds that resolved without exacerbation (Ex-). Participants had blood and nasal lavage samples collected after cold symptom onset. RNA sequencing of blood and nasal airway samples and differential gene expression analysis were performed comparing Ex+ versus Ex- illnesses using mixed effects modeling. Results: 106 participants were evaluated during 153 colds [46 Ex+ (33 virus-positive) and 107 Ex- (69 virus-positive)]. Significant differentially expressed genes comparing Ex+ to Ex- illnesses included: blood (502 total: 433 up-regulated, 69 down-regulated), airway (3144 total: 1712 up-regulated, 1432 down-regulated) [FDR\u3c0.05]. Blood and airway samples had 252 overlapping significant differentially expressed genes. Gene set enrichment analysis identified interferon pathways (including CXCL10, IRF7, IFIT2, STAT1) as the most significantly up-regulated pathways in both blood and airway samples during illnesses resulting in exacerbation [FDR\u3c0.05] (Hallmark/C2 Pathways). Conclusions: While viral infections exist in both Ex+ and Ex- illnesses, illnesses that resulted in asthma exacerbations exhibited significantly greater up-regulation of interferon pathways in both peripheral blood and airway samples. These results suggest that both local and systemic dysregulation of interferon responses play an important role in asthma exacerbations in urban children
100.17 Liberal Versus Conservative Transfusion Strategy for Patients With Acute Myocardial Infarction and Anemia: A Systematic Review and Meta-Analysis
No full textBackground: A goal hemoglobin (Hb) level of 7 or 8 d/dL has been standard of care across the medical field, below which blood transfusion is necessitated. The question of whether patients presenting with acute myocardial infarction (MI) may benefit from a more liberal transfusion strategy has been a topic of debate. We performed a meta-analysis of all trials that have aimed to answer this clinical question. Methods: We conducted a systematic review and meta-analysis including all available RCTs that compared a liberal versus a restrictive transfusion strategy for patient with acute MI presenting with anemia. The primary outcomes were recurrent MI and death or MI. Secondary outcomes included risk of stroke, revascularization, heart failure, and death from any cause. Given the small number of trials, we ran the analysis using the Paul-Mendele method with Hartung Knapp adjustment. Results: Four RCTs were included comprising a total of 2155 patients treated with a liberal transfusion strategy vs 2170 patients treated with a conservative transfusion strategy. Compared with a conservative transfusion strategy, liberal transfusion was not significantly associated with a reduction in MI (relative risk [RR] 0.85; 95% CI 0.72 - 1.02, p = 0.07) or death or MI (relative risk [RR] 0.88; 95% CI 0.45 - 1.71, p = 0.57). It also showed no difference in death from any cause (relative risk [RR] 0.82; 95% CI 0.25 - 2.68, p = 0.63), stroke (relative risk [RR] 0.89; 95% CI 0.48 - 1.64, p = 0.50), revascularization (relative risk [RR] 0.0.93; 95% CI 0.48 - 1.80, p = 0.68), or heart failure (relative risk [RR] 0.1.14; 95% CI 0.04 - 28.84, p = 0.88). Conclusion: Our meta-analysis further solidifies current medical practices of restricting transfusion of patients with acute MI to those with a Hb level of 7 or 8 g/dL, as more liberal transfusion strategies did not translate into improved clinical outcomes. [Formula presented
ALL ABOUT THE FLOW - INSIGHTS INTO HIGH OUTPUT HEART FAILURE
No full textBackground High output heart failure (HF) is an uncommon etiology for HF, but an essential one to investigate given its high morbidity. Case A 74-year-old man with ESRD status post renal transplant, allograft nephropathy, HF presented with leg swelling, dyspnea, and respiratory failure. Patient has had multiple similar presentations previously. Physical exam was notable for respiratory distress, soft systolic murmur in the left upper sternal border, pitting lower extremity edema, and warm extremities. Blood work showed known renal dysfunction, minimal BNP and troponin elevations. ECG showed sinus rhythm, and CXR pulmonary congestion. Echocardiogram showed hyperdynamic LV ejection fraction, normal LV cavity size, wall thickness, indeterminate diastology, pulmonary artery pressure (PAP) 63 mmHg, and normal right ventricle (RV) size and function. Transaortic maximum velocity was 3.74 m/s, but valve area suggested mild stenosis. Cardiac output was 11.97 L/min, cardiac index 4.69 L/min/m2. Invasive hemodynamics showed mildly elevated right atrial pressure at 7 mmHg, mean PAP 22 mmHg, capillary wedge pressure 12. Cardiac output and index were 12.49 L/min, and 4.77 L/min/m2, systemic vascular resistance (SVR) 627 dynes/sec/cm2. Decision-making Given elevated cardiac output, patient\u27s HF was thought to be secondary to a high flow state. He had an arteriovenous fistula (AVF) from prior dialysis. Interrogation of the AVF shows elevated flow at 1335 mL/sec. Patient underwent fistula revision with reduction in cephalic vein lumen size. Repeat echocardiogram showed normalized cardiac output and index, measuring 5.4 L/min and 2.24 L/min/m2. Patient has dramatic improvement in symptomatically. HF has numerous etiologies, and high disease burden. High output HF is relatively uncommon and is defined by increased cardiac output (greater than 8 L/min) and reduced SVR. It is secondary to other pathologies, such as obesity, shunts, liver, and lung disease. Persistence of AVF is an uncommon cause of high flow state but needs to be factored in. Conclusion AVF in rare instances contribute to high output heart failure and systemic workup could lead to correct diagnosis and management
Intermacs Analysis of Impact of Significant Post-LVAD Mitral Regurgitation on Outcomes
No full textPurpose: Impact of significant post-implant mitral regurgitation (PI-MR) on left ventricular assist device (LVAD) outcomes remains controversial. We investigated the effect of PI-MR from a real-world experience. Methods: Intermacs Database was queried to identify 7,385 patients receiving primary HeartMate 3 implant from 2014-2021. Patients undergoing concomitant mitral valve procedures were excluded. Significant PI-MR following LVAD implant was defined as moderate/severe MR post-implant on 1 or 3-month echocardiogram. Those not surviving 3 months (n=682) and/or without echocardiogram results available (n=781) were excluded. Survival and readmission analysis using log-rank statistics were conditional on 3 month survival. Results: The study cohort consisted of 363 patients with significant PI-MR and 2,744 patients without significant PI-MR. Those with significant PI-MR were younger (53 vs 57 years, P\u3c0.001), more likely to be African American (39% vs 31%, P\u3c0.01), have a higher pre-implant total bilirubin (1.5 vs 1.2 mg/dL) and more likely to have an intra-aortic balloon pump at the time of LVAD implant (35% vs 28%, P\u3c0.01) compared to patients with no PI-MR. Of those with preop significant MR, 17% (n=292) had persistent significant PI-MR. For those with mild or less pre-implant MR, 5% (n=71) developed new significant PI-MR. Patients with significant PI-MR had worse survival at 2 years, conditional upon surviving 3 months (80% vs 87%, P=0.024) and freedom from all-cause readmissions (27% vs 36%, P=0.03). Significant PI-MR also predicted worse conditional mortality based on log-rank statistics (P=0.012, Figure A) and increased readmissions (P=0.004, Figure B). Those patients with significant PI-MR were more likely to have received concomitant tricuspid valve surgery (17% vs 10%, P\u3c0.001). Conclusion: Significant residual MR following LVAD adversely impacts 2-year survival and all-cause readmissions. These data suggest that strategies to reduce the occurrence of PI-MR may improve durable LVAD outcomes. [Formula presented