Real-World Experience and Outcomes With Percutaneous Coronary Intervention for Protected Versus Unprotected Left Main Coronary Artery Disease: Insights from the Veteran Affairs Clinical Assessment Reporting and Tracking Program.

The practice patterns and outcomes of protected left main (PLM) and unprotected left main (ULM) percutaneous coronary intervention (PCI) are not well defined in contemporary US clinical practice. Data were collected from all Veteran Affairs catheterization laboratories participating in the Clinical Assessment Reporting and Tracking Program between 2009 and 2019. The analysis included 4,351 patients who underwent left main PCI, of whom 1,306 pairs of PLM and ULM PCI were included in a propensity-matched cohort. Selected temporal trends were also assessed. The primary outcome was major adverse cardiovascular event (MACE) outcomes at 1 year, which was defined as a composite of all-cause mortality, rehospitalization for myocardial infarction (MI), rehospitalization for stroke, or urgent revascularization. Patients who underwent ULM PCI compared with patients who underwent PLM PCI were older (age 71.5 vs 69.2 years, p <0.001), more clinically complex, and more likely to present with acute coronary syndrome. In the propensity-matched cohort, radial access was used more often for ULM PCI (21% [273] vs 14% [185], p <0.001) and ULM PCI was more likely to involve the left main bifurcation (22% vs 14%, p = 0.003) and require mechanical circulatory support (10% [134] vs 1% [17], p <0.001). The 1-year MACEs occurred more frequently with ULM PCI than PLM PCI (22% [289] vs 16% [215], p ≤0.001) and all-cause mortality was also higher (16% [213] vs 10% [125], p ≤0.001). In the matched cohort, there was a low incidence of rehospitalization for MI (4% [48] ULM vs 4% [48] PLM, p = 1.000) or revascularization (7% [94] ULM vs 6% [84] PLM, p = 0.485). In this real-world experience, patients who underwent PLM PCI had better 1-year outcomes than those who underwent ULM PCI; however, in both groups, there was a high rate of mortality and MACEs at 1 year despite a relatively low rate of MI or revascularization.

Assessment of Medication Adherence Using Pharmacy Data Before and After Percutaneous Coronary Intervention.

Objective: Adherence to anti-platelet medications is critical following coronary stenting, but prior studies indicate that clinician assessment and patient self-assessment of adherence are poorly correlated with future medication-taking behavior. We therefore sought to determine if integrated pharmacy data can be used to identify patients at high risk of non-adherence after percutaneous coronary interventions (PCI). Methods: Using Veteran Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) data linked with pharmacy records, we assessed adherence to cardiovascular medications from 2012 to 2018. Adherence was defined as the proportion of days covered (PDC) ≥ 0.80. We assessed the association of pre-PCI adherence with post-PCI adherence to P2Y12 inhibitors and clinical outcomes using logistic regression and Cox proportional hazard models, respectively. Results: Among 56,357 patients, 66.0% filled at least 1 cardiovascular medication within VA for the year prior to PCI and were evaluable for adherence. Pre-PCI non-adherence was 20.7%, and non-adherent patients were more likely to be younger and present non-electively. Non-adherent patients were less likely to adhere to P2Y12 inhibitor therapy after PCI (Adjusted OR 0.45 C.I. 0.41-0.46), compared with adherent patients, and had a higher adjusted risk of mortality (HR 1.17 C.I. 1.03-1.33). Conclusion: Adherence to cardiovascular medications prior to PCI can be assessed for most patients using pharmacy data, and past adherence is associated with future adherence and mortality after PCI. Use of integrated pharmacy data to identify high-risk patients could improve outcomes and cost-effectiveness of adherence interventions.

Clinical Characteristics and Outcomes Among People Living With HIV Undergoing Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background Clinical characteristics and outcomes in people living with HIV (PLWH) undergoing percutaneous coronary intervention (PCI) remain poorly described. We sought to compare real-world treatment of coronary artery disease, as well as patient and procedural factors and outcomes after PCI between PLWH and uninfected controls. Methods and Results We utilized procedural registry data from the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program between January 1, 2009 and December 31, 2019 to analyze patients with obstructive coronary artery disease on angiography. In the PCI subgroup, we used inverse probability of treatment weighting and applied Cox proportional hazards to evaluate the association of HIV serostatus with outcomes, including all-cause mortality at 5 years. Among 184 310 patients with obstructive coronary artery disease, treatment strategy was similar between PLWH and controls-35.7% versus 34.2% PCI, 13.6% versus 15% coronary artery bypass grafting, and 50.7% versus 50.8% medical therapy. The PCI cohort consisted of 546 (0.9%) PLWH and 56 811 (99.1%) controls. PLWH undergoing PCI had well-controlled HIV disease, and compared with controls, were younger, more likely to be Black, had fewer traditional risk factors, more acute coronary syndrome, less extensive coronary artery disease, and similar types of stents and P2Y12 therapy. However, PLWH experienced worse survival as early as 6 months post-PCI, which persisted over time and amounted to a 21% increased mortality risk by 5 years (hazard ratio, 1.21 [95% CI, 1.03-1.42; P=0.02]). Conclusions Despite well-controlled HIV disease, a more favorable overall cardiovascular risk profile, and similar PCI procedural metrics, PLWH still have significantly worse long-term survival following PCI than controls.

Contemporary Management Before Chronic Total Occlusion Percutaneous Coronary Interventions: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

BACKGROUND: Guidelines recommend maximal antianginal medical therapy before attempted coronary artery chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The degree to which this occurs in contemporary practice is unknown. We aimed to characterize the frequency and variability of preprocedural use of antianginal therapy and stress testing within 3 months before PCI of CTO (CTO PCI) across a nationally integrated health care system. METHODS: We identified patients who underwent attempted CTO PCI from January 2012 to September 2018 within the Veterans Affairs Healthcare System. Patients were categorized by management before CTO PCI: presence of ≥2 antianginals, stress testing, and ≥2 antianginals and stress testing within 3 months of PCI attempt. Multivariable logistic regression and inverse propensity weighting were used for adjustment before trimming, with median odds ratios calculated for variability estimates. RESULTS: Among 4250 patients undergoing attempted CTO PCI, 40% received ≥2 antianginal medications and 24% underwent preprocedural stress testing. The odds of antianginal therapy with more than one medication before CTO PCI did not change over the years of the study (odds ratio [OR], 1.0 [95% CI, 0.97-1.04]), whereas the odds of undergoing preprocedural stress testing decreased (OR, 0.97 [95% CI, 0.93-0.99]), and the odds of antianginal therapy with ≥2 antianginals and stress testing did not change (OR, 0.98 [95% CI, 0.93-1.04]). Median odds ratios (MOR) showed substantial variability in antianginal therapy across hospital sites (MOR, 1.3 [95% CI, 1.26-1.42]) and operators (MOR, 1.35 [95% CI, 1.26-1.63]). Similarly, preprocedural stress testing varied significantly by site (MOR, 1.68 [95% CI, 1.58-1.81]) and operator (MOR, 1.80 [95% CI, 1.56-2.38]). CONCLUSIONS: Just under half of patients received guideline-recommended management before CTO PCI, with significant site and operator variability. These findings suggest an opportunity to reduce variability in management before CTO PCI.

Potential Reduction in Adverse Events and Cost with Novel Anticoagulants among Patients with Acute Limb Ischemia.

Background: Acute limb ischemia (ALI) is associated with significant morbidity and mortality. Novel anticoagulants reduce adverse events among patients with peripheral artery disease, though the potential effect of these therapies is unclear in patients with ALI. The present study thus sought to evaluate the potential clinical benefit of universal application of novel anticoagulants to a high-risk population of patients with ALI. Methods: In this retrospective cohort study, we identified patients diagnosed with ALI in the Veterans Affairs Healthcare System between 2015 and 2016. We then calculated the incidence of adverse cardiovascular events (death/stroke/myocardial infarction/amputation/repeat intervention) as if they were treated with rivaroxaban using published data. Further, we calculated the cost to treat a Veteran diagnosed with one of these outcomes, and the potential savings had patients been universally treated with novel anticoagulants. Results: We identified 286 patients that presented with lower extremity ALI and were not treated with anticoagulation. Potential treatment of these patients with rivaroxaban resulted in significantly fewer adverse events, with an 11.9% reduction in cases at 21 months (95% CI: 5.5-17.8%) and a 13.4% reduction in cases at 47 months (95% CI: 5.6-20.5%). This corresponded to significant decreases in healthcare spending for patients with ALI who were treated with rivaroxaban. Conclusions: Among patients with ALI, treatment with rivaroxaban could result in a significant reduction in adverse cardiovascular events. The reduction in events would in turn lead to significant decreases in healthcare spending for this population.

Impact of severity of baseline thrombocytopenia on outcomes after percutaneous coronary interventions: Analysis from the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA CART) Program.

OBJECTIVES: The aim of this study was to evaluate the effect of the degree of severity of baseline thrombocytopenia (TCP) on outcomes after percutaneous coronary intervention (PCI) BACKGROUND: The association of TCP with clinical outcomes among patients undergoing coronary intervention has not been previously evaluated. METHODS: Using data from the US Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) Program, we identified patients undergoing PCI between October 1, 2007, to September 30, 2017. The cohort was then stratified by platelet count, as no TCP (platelet count >150,000/mcl), mild TCP (100-150,000/mcl), or moderate-severe TCP (<100,000/mcl) and this was associated with clinical outcomes. RESULTS: The cohort included 80,427 patients (98% male), of which 14.9% (13.2% mild, 1.7% moderate-severe) suffered from TCP at the time of PCI. Compared with mild or no TCP, moderate-severe TCP was associated with increased risk of post-PCI pericardiocentesis (0.6% vs. 0.2% vs. 0.2%, p = 0.018) and in-hospital mortality (1.5% vs. 0.7% vs. 0.7%) without a difference in postprocedure stroke (0.5% vs. 0.3% vs. 0.3%, p = 0.6). Over a median follow-up of 1729 days, time-to-repeat revascularization was significantly shorter in moderate-severe TCP (1080 vs. 1347 vs. 1467 days, p < 0.001) despite lower risk of revascularization. Both mild (adjusted HR: 1.11, 95% CI: 1.07-1.15, p < 0.001) and moderate-severe TCP (HR: 1.55, 95% CI: 1.43-1.69, p < 0.001) were associated with increased all-cause mortality compared with those without TCP. CONCLUSIONS: Thrombocytopenia was associated with increased short- and long-term adverse events among patients undergoing PCI. Any degree of TCP was associated with increased long-term all-cause mortality while moderate-severe TCP was also associated with increased risk of periprocedural adverse events.

Transitions of Care Among Patients Undergoing Percutaneous Coronary Intervention for Stable Angina: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking Program.

Background Effective transitions from the procedural to outpatient setting are essential to ensure high-quality cardiovascular care across health care systems, particularly among patients undergoing invasive cardiac procedures. We evaluated the association of postprocedural follow-up visits and antiplatelet prescriptions with clinical outcomes among patients undergoing percutaneous coronary intervention for stable angina at community or Veterans Affairs (VA) hospitals. Methods and Results Patients who actively received care within the VA Healthcare System and underwent percutaneous coronary intervention for stable angina at a community or VA hospital between October 1, 2015, and September 30, 2019, were identified. We compared mortality for patients receiving community or VA care, and among subgroups of community-treated patients by the presence of a postprocedural follow-up visit within 30 days or prescription for antiplatelet (P2Y12) medication within 120 days of the procedure. Among 12 837 patients who survived the first 30 days, 5133 were treated at community hospitals, and 7704 were treated in the VA. Prescriptions for antiplatelet therapy were less common for those treated in the community (85%) compared with the VA at 1 year (95%; hazard ratio [HR], 0.46; 95% CI, 0.44-47). Compared with VA-treated patients, the hazards for death were similar for patients treated in the community with a follow-up visit (HR, 1.17; 95% CI, 0.97-1.40) or with a fill for an antiplatelet therapy (HR, 1.08; 95% CI, 0.90-1.30). However, patients treated in the community without a follow-up visit had an 86% (HR, 1.86; 95% CI, 1.40-2.48) increased hazard of death, and those without antiplatelet prescription fill had a 144% increased hazard of death (HR, 2.44; 95% CI, 1.85-3.21) compared with all VA-treated patients. Conclusions Patients treated at community facilities have a decreased chance of receiving antiplatelet prescriptions after percutaneous coronary intervention with a concordant increased hazard of mortality, emphasizing the importance of transitions of care across health care systems when assessing cardiovascular quality.

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.

Clinical Characteristics and Outcomes Among Patients Undergoing High-Risk Percutaneous Coronary Interventions by Single or Multiple Operators: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background High-risk percutaneous coronary intervention (HR-PCI) is increasingly common among contemporary patients with coronary artery disease. Experts have advocated for a collaborative 2-operator approach to support intraprocedural decision-making for these complex interventions. The impact of a second operator on patient and procedural outcomes is unknown. Methods and Results Patients who underwent HR-PCI from 2015 to 2018 within the Veterans Affairs Healthcare System were identified. Propensity-matched cohorts were generated to compare the outcomes following HR-PCI performed by a single or multiple (≥2) operators. The primary end point was the 12-month rate of major adverse cardiovascular events. We identified 6672 patients who underwent HR-PCI during the study period; 6211 (93%) were treated by a single operator, and 461 (7%) were treated by multiple operators, with a nonsignificant trend toward increased multioperator procedures over time. A higher proportion of patients treated by multiple operators underwent left main (10% versus 7%, P=0.045) or chronic total occlusion intervention (11% versus 5%, P<0.001). Lead interventionalists participating in multioperator procedures practiced at centers with higher annual HR-PCI volumes (124±71.3 versus 111±69.2; standardized mean difference, 0.197; P<0.001) but otherwise performed a similar number of HR-PCI procedures per year (34.4±35.3 versus 34.7±30.7; standardized mean difference, 0.388; P=0.841) compared with their peers performing single-operator interventions. In a propensity-matched cohort, there was no significant difference in major adverse cardiovascular events (32% versus 30%, P=0.444) between patients who underwent single-operator versus multioperator HR-PCI. Adjusted analyses accounting for site-level variance showed no significant differences in outcomes. Conclusions Patients who underwent multioperator HR-PCI had similar outcomes compared with single-operator procedures. Further studies are needed to determine if the addition of a second operator offers clinical benefits to a subset of HR-PCI patients undergoing left main or chronic total occlusion intervention.

Comparison of Patients With Nonobstructive Coronary Artery Disease With Versus Without Myocardial Infarction (from the VA Clinical Assessment Reporting and Tracking [CART] Program).

Comparisons of the outcomes of patients with myocardial infarction with nonobstructive coronary artery disease (MINOCA) and patients with nonobstructive coronary artery disease (CAD) without myocardial infarction (MI) are limited. Here we compare the outcomes of patients with MINOCA and patients with nonobstructive CAD without MI and assess the influence of medical therapy on outcomes in these patients. Veterans who underwent coronary angiography between 2008 to 2017 with nonobstructive CAD were divided into those with or without pre-procedural troponin elevation. Patients with prior revascularization, heart failure, or who presented with cardiogenic shock, STEMI, or unstable angina were excluded. After propensity matching, outcomes were compared between groups. The primary outcome was major adverse cardiovascular events (MACE: mortality, myocardial infarction, and revascularization) within one year: 3,924 patients with nonobstructive CAD and a troponin obtained prior to angiography were identified (n=1,986 with elevated troponin) and restricted to 1,904 patients after propensity-matching. There was a significantly higher risk of MACE among troponin-positive patients compared with those with a negative troponin (HR 2.37; 95% CI, 1.67 to 3.34). Statin (HR 0.32; 95% CI, 0.22 to 0.49) and ACE inhibitor (HR 0.49; 95% CI, 0.32 to 0.75) therapy after angiography was associated with decreased MACE, while P2Y12 inhibitor, calcium-channel and beta-blocker therapy were not associated with outcomes. In conclusion, Veterans with MINOCA are at increased risk for MACE compared with those with nonobstructive CAD and negative troponin at the time of angiography. Specific medications were associated with a reduction in MACE, suggesting an opportunity to explore novel approaches for secondary prevention in this population.

Clinical and Anatomic Complexity of Patients Undergoing Coronary Intervention With and Without On-Site Surgical Capabilities: Insights From the Veterans Affairs Clinical Assessment, Reporting and Tracking (CART) Program.

BACKGROUND: Professional society consensus statements articulate the clinical and anatomic complexity of patients that may undergo percutaneous coronary intervention (PCI) without on-site cardiothoracic surgery, although compliance with these recommendations has not been assessed. We sought to evaluate the clinical and anatomic complexity of patients undergoing PCI with and without cardiothoracic surgery on-site. METHODS: We identified all patients undergoing PCI in the Veterans Affairs health care system between October 2009 and September 2017. The clinical and anatomic complexity of patients treated at sites with or without cardiothoracic surgery was evaluated with a comparative interrupted time series, and mortality was ascertained in a propensity-matched cohort. RESULTS: We identified 75 564 patients who underwent PCI, with the majority (53 708, 71%) treated at sites with cardiothoracic surgery. The overall clinical complexity was statistically greater for those treated at sites with cardiothoracic surgery (National Cardiovascular Data Registries CathPCI: 18.4) compared with those at sites without (17.8, P<0.001) throughout the study, with similar annual increases in complexity before (2% versus 3%; P=0.107) and after (3% versus 3%; P=0.704) January 2014. The anatomic complexity of patients treated was also statistically greater (Veterans Affairs SYNTAX: 11.0 versus 10.2; P<0.001) and increased at comparable rates (2% versus 1%, P=0.731) before 2014. After publication of the consensus statement, anatomic complexity declined at sites with cardiothoracic surgery (-2%) but increased at sites without on-site surgery (5%, P=0.025) such that it was similar at the end of the study (P=0.622). Referrals for emergent cardiothoracic surgery were rare regardless of treatment venue (61, 0.08%) and the hazard for mortality was similar (hazard ratio, 0.883 [95% CI, 0.662-1.176]) after propensity matching. CONCLUSIONS: There are minor differences in complexity of patients undergoing coronary intervention at sites with and without cardiothoracic surgery. Clinical outcomes are similar regardless of treatment venue, suggesting an opportunity to improve access to complex interventional care without sacrificing quality.

Comparison of rotational and orbital atherectomy for the treatment of calcific coronary lesions: Insights from the VA clinical assessment reporting and tracking (CART) program.

BACKGROUND: Previous studies suggested that pre-treatment of coronary artery calcification (CAC) with rotational atherectomy (RA) prior to stent deployment improved procedural success but was not associated with a concomitant improvement in clinical outcomes. Orbital atherectomy (OA) has demonstrated similar benefits, though there are few data comparing the safety and efficacy of the two modalities. METHODS: Patients who underwent PCI of a native coronary lesion with RA or OA from 2014 to 2018 within the Veterans Affairs Healthcare System were identified. Propensity matched cohorts were generated to compare the clinical and safety outcomes following either RA or OA. The primary endpoint was the rate of 30-day major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause mortality, repeat myocardial infarction, target vessel revascularization, and stroke. RESULTS: We identified 1,091 patients that underwent atherectomy during the study period, 640 (59%) treated with RA and 451 (41%) treated with OA. Among a propensity-matched cohort consisting of 950 patients, there was no significant difference in MACCE for patients who underwent RA or OA (7.1 vs. 8.2%, p = .36). Components of the primary outcome including 30-day mortality, myocardial infarction, target vessel revascularization, and stroke were also similar in the matched cohort. Additionally, procedural complications including perforation, no-reflow, dissection, and in-stent thrombosis were comparable across both treatment strategies. CONCLUSIONS: Both rotational and orbital atherectomy are safe and effective strategies for the treatment of calcified coronary plaque prior to stent deployment, with similarly low rates of peri-procedural adverse events.

Potential unrealized mortality benefit of glucagon-like peptide-1 receptor agonists and sodium-glucose co-transport-2 inhibitors: A report from the Veterans Health Administration Clinical Assessment, Reporting and Tracking program.

AIM: To assess the unrealized potential of glucagon-like peptide-1 receptor agonist (GLP-1RA) or sodium-glucose co-transport-2 inhibitor (SGLT2i) use to reduce mortality in veterans with type 2 diabetes (T2D), coronary artery disease (CAD), and other characteristics congruent with clinical trial cohorts that established the efficacy of these agents. METHODS: Veterans with T2D and CAD on angiography in 2014 who were untreated with either a GLP-1RA or a SGLT2i were assessed for key eligibility criteria of the LEADER (GLP-1RA) and EMPA-REG OUTCOME (SGLT2i) trials. Trial hazard ratios and 95% confidence intervals for all-cause death were applied to deaths observed in veterans through 2018 to estimate the potential benefit of GLP-1RA or SGLT2i use. RESULTS: Median observation was 4.3 years. Of 15 987 veterans with T2D and CAD, 1186 (7.4%) were excluded for GLP-1RA or SGLT2i treatment, and 1386 lacked glycated haemoglobin measurement. Of the remaining 13 415 patients, 4103 (30.1%) and 5313 (39.6%) fulfilled the key criteria for the LEADER and EMPA-REG OUTCOME trials, respectively. Death occurred in 1009 (24.6%) of LEADER-eligible patients and 1335 (25.1%) of EMPA-REG OUTCOME-eligible patients. Under treatment with liraglutide in LEADER-eligible veterans, a 3.5% (0.7%-6.2%) potential absolute mortality reduction, corresponding to 144 (28-253) fewer deaths (0.88 [0.17-1.56] per 100 person-years), might have been expected. Similarly, under treatment with empagliflozin in EMPA-REG OUTCOME-eligible veterans, a 7.9% (4.5%-10.8%) potential absolute mortality reduction, corresponding to 418 (230-573) fewer deaths (1.98 [1.14-2.72] per 100 person-years), might have been expected. CONCLUSIONS: This analysis indicates unrealized opportunities to reduce mortality in selected veterans with T2D and CAD via increased GLP-1RA and SGLT2i use.

Contemporary Use and Outcomes of Arterial Closure Devices After Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background Arterial closure devices reduce the length of bedrest after invasive cardiac procedures via the femoral approach, but there are conflicting data on their association with major bleeding and vascular complications. We thus sought to evaluate the contemporary use of femoral arterial closure devices and their association with major bleeding among patients undergoing percutaneous coronary intervention. Methods and Results We identified patients undergoing percutaneous intervention via the femoral approach within the Veterans Affairs Healthcare System from December 2004 through September 2018. The association between arterial closure device use and major bleeding was evaluated using both propensity matching and instrumental variable analyses, incorporating contrast-induced nephropathy as a falsification end point. We identified 132 373 percutaneous coronary interventions performed by 681 operators, with closure device use increasing 1.2% each year (linear trend P<0.001). In a propensity-matched cohort, closure devices were associated with a 1.1% reduction in periprocedural bleeding (95% CI, -1.5% to -0.6%). Closure devices were also associated with a numerical decrease in contrast-inducted nephropathy that did not reach statistical significance (-0.6%; 95% CI, -1.3% to 0.1%). In an instrumental variable analysis of closure device use, there was no difference in the bleeding rate between those who received a closure device and those who did not (0.2%; 95% CI, -0.9% to 1.2%). Conclusions Arterial closure devices are associated with a reduction in major bleeding within a propensity-matched cohort. This association dissipates in an instrumental variable analysis, highlighting some of the methodologic limitations of comparative effectiveness research in observational analyses.

Temporal Trends and Site Variation in High-Risk Coronary Intervention and the Use of Mechanical Circulatory Support: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking (CART) Program.

Background Patients undergoing percutaneous coronary intervention (PCI) are older with greater medical comorbidities and anatomical complexity than ever before, resulting in an increased frequency of nonemergent high-risk PCI (HR-PCI). We thus sought to evaluate the temporal trends in performance of HR-PCI and utilization of mechanical circulatory support in the largest integrated healthcare system in the United States. Methods and Results A cohort of high-risk adult patients that underwent nonemergent PCI in the Veterans Affairs Healthcare System between January 2008 and June 2018 were identified by objective clinical, hemodynamic, and anatomic criteria. Temporal trends in the performance of HR-PCI, utilization of mechanical circulatory support, and site-level variation were assessed. Of 111 548 patients assessed during the study period, 554 met 3 high-risk criteria whereas 4414 met at least 2 criteria for HR-PCI. There was a significant linear increase in the proportion of interventions that met 3 (P<0.001) or at least 2 (P<0.001) high-risk criteria over time, with rates approaching 1.9% and 11.2% in the last full calendar year analyzed. A minority of patients who met all high-risk criteria received PCI with mechanical support (15.7%) without a significant increase over time (P=0.193). However, there was significant site-level variation in the probability of performing HR-PCI (4.0-fold higher likelihood) and utilizing mechanical circulatory support (1.9-fold higher likelihood) between high and low utilization sites. Conclusions The proportion of cases categorized as HR-PCI has increased over time, with significant site-level variation in performance. The majority of HR-PCI cases did not utilize mechanical support, highlighting a discrepancy between current recommendations and clinical practice in an integrated healthcare system.

Perceptions of Public and Nonpublic Reporting of Interventional Cardiology Outcomes and Its Impact on Practice: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

Background Physicians have expressed significant mistrust with public reporting of interventional cardiology outcomes. Similar data are not available on alternative reporting structures, including nonpublic quality improvement programs with internally distributed measures of interventional quality. We thus sought to evaluate the perceptions of public and nonpublic reporting of interventional cardiology outcomes and its impact on clinical practice. Methods and Results A standardized survey was distributed to 218 interventional cardiologists in the Veterans Affairs Healthcare System, with responses received from 62 (28%). The majority of respondents (90%) expressed some or a great deal of trust in the analytic methods used to generate reports in a nonpublic quality improvement system within Veterans Affairs, while a minority (35%) expressed similar trust in the analytic methods in a public reporting system that operates outside Veterans Affairs (P<0.001). Similarly, a minority of respondents (44%) felt that in-hospital and 30-day mortality accurately reflected interventional quality in a nonpublic quality improvement system, though a smaller proportion of survey participants (15%) felt that the same outcome reflected procedural quality in public reporting systems (P<0.001). Despite these sentiments, the majority of operators did not feel pressured to avoid (82% and 75%; P=0.383) or perform (72% and 63%; P=0.096) high-risk procedures within or outside Veterans Affairs. Conclusions Interventional cardiologists express greater trust in analytic methods and clinical outcomes reported in a nonpublic quality improvement program than external public reporting environments. The majority of physicians did not feel pressured to avoid or perform high-risk procedures, which may improve access to interventional care among high-risk patients.

Same-day discharge among patients undergoing elective PCI: Insights from the VA CART Program.

BACKGROUND: Available data suggest that same-day discharge (SDD) after elective percutaneous coronary intervention (PCI) is safe in select patients. Yet, little is known about contemporary adoption rates, safety, and costs in a universal health care system like the Veterans Affairs Health System. METHODS: Using data from the Veterans Affairs Clinical Assessment Reporting and Tracking Program linked with Health Economics Resource Center data, patients undergoing elective PCI for stable angina between October 1, 2007 and Sepetember 30, 2016, were stratified by SDD versus overnight stay. We examined trends of SDD, and using 2:1 propensity matching, we assessed 30-day rates of readmission, mortality, and total costs at 30 days. RESULTS: Of 21,261 PCIs from 67 sites, 728 were SDDs (3.9% of overall cohort). The rate of SDD increased from 1.6% in 2008 to 9.7% in 2016 (P < .001). SDD patients had lower rates of atrial fibrillation, peripheral arterial disease, and prior coronary artery bypass grafting and were treated at higher-volume centers. Thirty-day readmission and mortality did not differ significantly between the groups (readmission: 6.7% SDD vs 5.6% for overnight stay, P = .24; mortality: 0% vs. 0.07%, P = .99). The mean (SD) 30-day cost accrued by patients undergoing SDD was $23,656 ($15,480) versus $25,878 ($17,480) for an overnight stay. The accumulated median cost savings for SDD was $1503 (95% CI $738-$2,250). CONCLUSIONS: Veterans Affairs Health System has increasingly adopted SDD for elective PCI procedures, and this is associated with cost savings without an increase in readmission or mortality. Greater adoption has the potential to reduce costs without increasing adverse outcomes.