Impact of Operator Volumes and Experience on Outcomes After Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

BACKGROUND: Recent analyses of the volume-outcome relationship for percutaneous coronary intervention (PCI) have suggested a less robust association than previously reported. It is unknown if novel factors such as lifetime operator experience influence this relationship. OBJECTIVES: To assess the relationship between annual volumes and outcomes for PCI and determine whether lifetime operator experience modulates the association. METHODS: Annual PCI volumes for facilities and operators within the Veterans Affairs Healthcare System and their relationship with 30-day mortality following PCI were described. The influence of operator lifetime experience on the volume-outcome relationship was assessed. Hierarchical logistic regression was used to adjust for patient and procedural factors. RESULTS: 57,608 PCIs performed from 2013 to 2018 by 382 operators and 63 institutions were analyzed. Operator annualized PCI volume averaged 47.6 (standard deviation [SD] 49.1) and site annualized volume averaged 189.2 (SD 105.2). Median operator experience was 9.0 years (interquartile range [IQR] 4.0-15.0). There was no independent relationship between operator annual volume, institutional volume, or operator lifetime experience with 30-day mortality (p > 0.10). However, the interaction between operator volume and lifetime experience was associated with a marginal decrease in mortality (odds ratio [OR] 0.9998, 95% CI 0.9996-0.9999). CONCLUSIONS: There were no significant associations between facility or operator-level procedural volume and 30-day mortality following PCI in a nationally integrated healthcare system. There was a marginal association between the interaction of operator lifetime experience, operator annual volume, and 30-day mortality that is unlikely to be clinically relevant, though does suggest an opportunity to explore novel factors that may influence the volume-outcome relationship.

The Vitamins in Psychosis Study: A Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Vitamins B12, B6, and Folic Acid on Symptoms and Neurocognition in First-Episode Psychosis.

BACKGROUND: Elevated homocysteine is observed in schizophrenia and associated with illness severity. The aim of this study was to determine whether vitamins B12, B6, and folic acid lower homocysteine and improve symptomatology and neurocognition in first-episode psychosis. Whether baseline homocysteine, genetic variation, sex, and diagnosis interact with B-vitamin treatment on outcomes was also examined. METHODS: A randomized, double-blind, placebo-controlled trial was used. A total of 120 patients with first-episode psychosis were randomized to an adjunctive B-vitamin supplement (containing folic acid [5 mg], B12 [0.4 mg], and B6 [50 mg]) or placebo, taken once daily for 12 weeks. Coprimary outcomes were change in total symptomatology (Positive and Negative Syndrome Scale) and composite neurocognition. Secondary outcomes included additional measures of symptoms, neurocognition, functioning, tolerability, and safety. RESULTS: B-vitamin supplementation reduced homocysteine levels (p = .003, effect size = -0.65). B-vitamin supplementation had no significant effects on Positive and Negative Syndrome Scale total (p = .749) or composite neurocognition (p = .785). There were no significant group differences in secondary symptom domains. A significant group difference in the attention/vigilance domain (p = .024, effect size = 0.49) showed that the B-vitamin group remained stable and the placebo group declined in performance. In addition, 14% of the sample had elevated baseline homocysteine levels, which was associated with greater improvements in one measure of attention/vigilance following B-vitamin supplementation. Being female and having affective psychosis was associated with improved neurocognition in select domains following B-vitamin supplementation. Genetic variation did not influence B-vitamin treatment response. CONCLUSIONS: While 12-week B-vitamin supplementation might not improve overall psychopathology and global neurocognition, it may have specific neuroprotective properties in attention/vigilance, particularly in patients with elevated homocysteine levels, patients with affective psychosis, and female patients. Results support a personalized medicine approach to vitamin supplementation in first-episode psychosis.

Temporal Trends in Coronary Angiography and Percutaneous Coronary Intervention: Insights From the VA Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: The aim of this study was to evaluate temporal trends in characteristics and outcomes among patients referred for invasive coronary procedures within a national health care system for veterans. BACKGROUND: Coronary angiography and percutaneous coronary intervention remain instrumental diagnostic and therapeutic interventions for coronary artery disease. METHODS: All coronary angiographic studies and interventions performed in U.S. Department of Veterans Affairs cardiac catheterization laboratories for fiscal years 2009 through 2015 were identified. The demographic characteristics and management of these patients were stratified by time. Clinical outcomes including readmission (30-day) and mortality were assessed across years. RESULTS: From 2009 to 2015, 194,476 coronary angiographic examinations and 85,024 interventions were performed at Veterans Affairs facilities. The median numbers of angiographic studies (p = 0.81) and interventions (p = 0.22) remained constant over time. Patients undergoing these procedures were progressively older, with more comorbidities, as the proportion classified as having high Framingham risk significantly increased among those undergoing angiography (from 20% to 25%; p < 0.001) and intervention (from 24% to 32%; p < 0.001). Similarly, the median National Cardiovascular Data Registry CathPCI risk score increased for diagnostic (from 14 to 15; p = 0.005) and interventional (from 14 to 18; p = 0.002) procedures. Post-procedural medical management was unchanged over time, although there was increasing adoption of transradial access for diagnostic (from 6% to 36%; p < 0.001) and interventional (from 5% to 32%; p < 0.001) procedures. Complications and clinical outcomes also remained constant, with a trend toward a reduction in the adjusted hazard ratio for percutaneous coronary intervention mortality (hazard ratio: 0.983; 95% confidence interval: 0.967 to 1.000). CONCLUSIONS: Veterans undergoing invasive coronary procedures have had increasing medical complexity over time, without attendant increases in mortality among those receiving interventions. As the Department of Veterans Affairs moves toward a mix of integrated and community-based care, it will be important to account for these demographic shifts so that quality can be maintained.

Hospital Variation in Premature Clopidogrel Discontinuation After Drug-Eluting Stent Placement in the Veterans Affairs (VA) Healthcare System.

BACKGROUND: Premature clopidogrel discontinuation after drug-eluting stent placement is associated with adverse outcomes. Little is known about patient and hospital factors associated with premature discontinuation or whether less variation in premature discontinuation exists in integrated health care systems such as the Veterans Affairs (VA). METHODS AND RESULTS: We evaluated the frequency of premature clopidogrel discontinuation, defined as a gap between clopidogrel refills of ≥90 days during the first 6 months of treatment, among 12 707 patients who received drug-eluting stents in VA hospitals between 2008 and 2010. We evaluated the association between premature discontinuation and all-cause mortality and/or acute myocardial infarction, variation in the proportion of premature discontinuation among hospitals, the patient and hospital characteristics associated with premature discontinuation, and the extent to which unexplained hospital characteristics contribute to premature discontinuation. Of the patients, 963 (7.6%) discontinued clopidogrel prematurely. Premature discontinuation was associated with acute myocardial infarction and all-cause mortality (hazard ratio 1.65, 95% CI 1.37-1.99, P<0.001). The proportion of patients with premature discontinuation varied across hospitals from 0% to 16.5% (P<0.001). We found a median of 24% greater odds of patients with identical covariates with premature discontinuation at one randomly selected hospital compared with another (median odds ratio 1.24, 95% CI 1.17-1.44). Patient factors associated with premature discontinuation included lack of cardiology follow-up within 30 days of discharge and smaller initial clopidogrel fill. CONCLUSION: One in 13 patients prematurely discontinued clopidogrel, and variation in discontinuation across hospitals was observed. Patient factors were associated with premature discontinuation that may represent targets for quality improvement.

Percutaneous Coronary Intervention in Native Coronary Arteries Versus Bypass Grafts in Patients With Prior Coronary Artery Bypass Graft Surgery: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: The aim of this study was to examine the frequency, associations, and outcomes of native coronary artery versus bypass graft percutaneous coronary intervention (PCI) in patients with prior coronary artery bypass grafting (CABG) in the Veterans Affairs (VA) integrated health care system. BACKGROUND: Patients with prior CABG surgery often undergo PCI, but the association between PCI target vessel and short- and long-term outcomes has received limited study. METHODS: A national cohort of 11,118 veterans with prior CABG who underwent PCI between October 2005 and September 2013 at 67 VA hospitals was examined, and the outcomes of patients who underwent native coronary versus bypass graft PCI were compared. Logistic regression with generalized estimating equations was used to adjust for correlation between patients within hospitals. Cox regressions were modeled for each outcome to determine the variables with significant hazard ratios (HRs). RESULTS: During the study period, patients with prior CABG represented 18.5% of all patients undergoing PCI (11,118 of 60,171). The PCI target vessel was a native coronary artery in 73.4% and a bypass graft in 26.6%: 25.0% in a saphenous vein graft and 1.5% in an arterial graft. Compared with patients undergoing native coronary artery PCI, those undergoing bypass graft PCI had higher risk characteristics and more procedure-related complications. During a median follow-up period of 3.11 years, bypass graft PCI was associated with significantly higher mortality (adjusted HR: 1.30; 95% confidence interval: 1.18 to 1.42), myocardial infarction (adjusted HR: 1.61; 95% confidence interval: 1.43 to 1.82), and repeat revascularization (adjusted HR: 1.60; 95% confidence interval: 1.50 to 1.71). CONCLUSIONS: In a national cohort of veterans, almost three-quarters of PCIs performed in patients with prior CABG involved native coronary artery lesions. Compared with native coronary PCI, bypass graft PCI was significantly associated with higher incidence of short- and long-term major adverse events, including more than double the rate of in-hospital mortality.

Patient access and 1-year outcomes of percutaneous coronary intervention facilities with and without on-site cardiothoracic surgery: insights from the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program.

BACKGROUND: The safety of percutaneous coronary intervention (PCI) at medical facilities without on-site cardiothoracic (CT) surgery has been established in clinical trials. However, the comparative effectiveness of this strategy in real-world practice, including impact on patient access and outcomes, is uncertain. The Veterans Affairs (VA) health care system has used this strategy, with strict quality oversight, since 2005, and can provide insight into this question. METHODS AND RESULTS: Among 24,387 patients receiving PCI at VA facilities between October 2007 and September 2010, 6616 (27.1%) patients underwent PCI at facilities (n=18) without on-site CT surgery. Patient drive time (as a proxy for access), procedural complications, 1-year mortality, myocardial infarction, and rates of subsequent revascularization procedures were compared by facility. Results were stratified by procedural indication (ST-segment-elevation myocardial infarction versus non-ST-segment-elevation myocardial infarction/unstable angina versus elective) and PCI volume. With the inclusion of PCI facilities without on-site CT surgery, median drive time for patients treated at those facilities decreased by 90.8 minutes (P<0.001). Procedural need for emergent coronary artery bypass graft and mortality rates were low and similar between facilities. Adjusted 1-year mortality and myocardial infarction rates were similar between facilities (hazard ratio in PCI facilities without relative to those with on-site CT surgery, 1.02; 95% confidence interval, 0.87-1.2), and not modified by either PCI indication or PCI volume. Subsequent revascularization rates were higher at sites without on-site CT surgery facilities (hazard ratio, 1.21; 95% confidence interval, 1.03-1.42). CONCLUSIONS: This study suggests that providing PCI facilities without on-site CT surgery in an integrated health care system with quality oversight improves patient access without compromising procedural or 1-year outcomes.

Normal coronary rates for elective angiography in the Veterans Affairs Healthcare System: insights from the VA CART program (veterans affairs clinical assessment reporting and tracking).

OBJECTIVES: This study sought to determine if an integrated healthcare system is selective and consistent in the use of angiography, as reflected by normal coronary rates. BACKGROUND: Rates of normal coronary arteries with elective coronary angiography vary considerably among U.S. community hospitals. This variation may in part reflect incentives in fee-for-service care. METHODS: Using national data from the Veterans Affairs (VA) Clinical Assessment Reporting and Tracking (CART) program representing all 76 VA cardiac catheterization laboratories, we evaluated all patients who underwent elective coronary angiography from October 2007 to September 2010. Normal coronary angiography was defined as <20% stenosis in all vessels. To assess hospital-level variation in normal coronary rates, we categorized hospitals by quartiles as defined by their proportion of normal coronaries. RESULTS: Overall, 4,829 of 22,538 patients (21.4%) had normal coronary angiography. Hospital proportions of normal coronaries varied markedly (median hospital proportion 20.5%; interquartile range: 15.1% to 25.3%; range: 5.5% to 48.5%). Categorized as hospital quartiles, the median proportion of normal coronaries in the lowest quartile was 10.8%, as compared with a median proportion of 19.1% in the second lowest quartile, 23.1% in the second highest quartile, and 30.3% in the highest quartile. Hospitals with lower rates of normal coronaries had higher rates of obstructive coronary disease (59.2% vs. 51.3% vs. 52.6% vs. 44.3%; p < 0.001) and subsequent revascularization (38.1% vs. 33.9% vs. 31.5% vs. 29.3%; p < 0.001). CONCLUSIONS: Approximately 1 in 5 patients undergoing elective coronary angiography in the VA had normal coronaries. This rate is lower than prior published studies in other systems. However, the observed hospital-level variation in normal coronary rates suggests opportunities to improve patient selection for diagnostic coronary angiography.

Effectiveness of complementary and self-help treatments for anxiety in children and adolescents.

OBJECTIVE: To review the evidence for the effectiveness of complementary and self-help treatments for anxiety disorders and situational anxiety in children and adolescents. DATA SOURCES: Systematic literature search using PubMed, PsycINFO and the Cochrane Library for 111 treatments up to February 2006. STUDY SELECTION: There were 11 treatments for which intervention studies had been undertaken and reported. DATA EXTRACTION: Studies on each treatment were reviewed by one author and checked by a second. A consensus was reached for level of evidence. DATA SYNTHESIS: Relevant evidence was available for bibliotherapy, dance and movement therapy, distraction techniques, humour, massage, melatonin, relaxation training, autogenic training, avoiding marijuana, a mineral-vitamin supplement (EMPower +) and music therapy. Findings from case-control studies, individual cohort studies or low quality randomised controlled trials indicated that several treatments may have potential to reduce anxiety, including bibliotherapy, massage, melatonin, and relaxation training. CONCLUSIONS: Although some complementary and self-help treatments might be useful for children and adolescents with anxiety, they need to be tested adequately through randomised controlled trials before they could be recommended.

Effectiveness of complementary and self-help treatments for depression in children and adolescents.

OBJECTIVE: To review the evidence for the effectiveness of complementary and self-help treatments for depression in children and adolescents. DATA SOURCES: Systematic literature search using PubMed, PsycINFO and the Cochrane Library for 131 treatments up to February 2006. STUDY SELECTION: There were 13 treatments that had been evaluated in intervention studies. DATA EXTRACTION: Studies on each treatment were reviewed by one author and checked by a second. A consensus was reached for level of evidence. DATA SYNTHESIS: Relevant evidence was available for glutamine, S-adenosylmethionine, St John's wort, vitamin C, omega-3 fatty acids, light therapy, massage, art therapy, bibliotherapy, distraction techniques, exercise, relaxation therapy and sleep deprivation. However, the evidence was limited and generally of poor quality. The only treatment with reasonable supporting evidence was light therapy for winter depression. CONCLUSIONS: Given that antidepressant medication is not recommended as a first line treatment for children and adolescents with mild to moderate depression, and that the effects of psychological treatments are modest, there is a pressing need to extend the range of treatments available for this age group.

Herbal and vitamin supplement use in a prostate cancer screening population.

OBJECTIVES: To report the observed usage trend of herbal and vitamin supplements in a population of men visiting a prostate cancer screening clinic and its relation to the Sexual Health Inventory for Men score and the American Urological Association Symptom Score (AUA-SS). METHODS: Men participating in the 2001 and 2002 Prostate Cancer Awareness Week screening for prostate cancer were given a self-administered questionnaire. The questions were designed to gather background health information and to determine the use of prescription medications for lower urinary tract symptoms (LUTS), as well as the use of herbal and vitamin supplements. In addition, the AUA-SS and Sexual Health Inventory for Men score were calculated for each participant in the study. RESULTS: The number of questionnaires completed was 12,457. Of the completed questionnaires, 70% of the participants reported the use of multivitamins, and 21% reported the use of herbal supplements. Ten percent of all men reported the use of prescription medications for LUTS (AUA-SS greater than 15). Of the men reporting the use of prescription medications, 19% were taking finasteride, 17% doxazosin, 20% terazosin, 23% tamsulosin, and 22% other prescription medications. Moreover, the average AUA-SS was greater for the men taking herbs or supplements than for those who did not take herbs or supplements (P <0.001). Nonetheless, the Sexual Health Inventory for Men score did not show a positive correlation between the intake of alternative medications and the severity of erectile dysfunction. CONCLUSIONS: We observed that a substantial proportion of men with LUTS participating in a national prostate cancer screening program were not taking prescription medications for these symptoms. Furthermore, we observed that men taking herbs or vitamin supplements tended to have higher AUA scores. Additional investigation is warranted into the reason some men are not receiving standard prescription medications for LUTS and whether reliance on alternative treatments is playing a role in this phenomenon.