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Mortality is the most devastating complication of percutaneous coronary interventions (PCI). Identifying the most common causes and mechanisms of death after PCI in contemporary practice is an important step in further reducing periprocedural mortality. To systematically analyze the cause and circumstances of in-hospital mortality in a large, multi-center, statewide cohort. In-hospital deaths after PCI occurring at 39 hospitals included in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) between 2012 and 2014 were retrospectively reviewed using validated methods. A priori PCI-related mortality risk was estimated using the validated BMC2 model. A total of 1,163 deaths after PCI were included in the study. Mean age was 71±13 years, and 507 (44%) were women. Left ventricular failure was the most common cause of death (52% of cases). The circumstance of death was most commonly related to prior acute cardiovascular condition (61% of cases). Procedural complications were considered contributing to mortality in 235 (20%) cases. Death was rated as not preventable or slightly preventable in 1,045 (89.9%) cases. The majority of the deaths occurred in intermediate or high-risk patients, but 328 (28.2%) deaths occurred in low-risk patients (<5% predicted risk of mortality). PCI was considered rarely appropriate in 30% of preventable deaths. In-hospital mortality after PCI is rare, and primarily related to pre-existing critical acute cardiovascular condition. However, approximately 10% of deaths were preventable. Further research is needed to characterize preventable deaths, in order to develop strategies to improve procedural safety.

The COVID-19 pandemic has severely impacted healthcare delivery and patient outcomes globally. We aimed to evaluate the influence of the COVID-19 pandemic on the temporal trends and outcomes of patients undergoing percutaneous coronary intervention (PCI) in Michigan. We compared all patients undergoing PCI in the BMC2 Registry between March and December 2020 (\"pandemic cohort\") with those undergoing PCI between March and December 2019 (\"pre-pandemic cohort\"). A risk-adjusted analysis of in-hospital outcomes was performed between the pre-pandemic and pandemic cohort. A subgroup analysis was performed comparing COVID-19 positive vs. negative patients during the pandemic. There was a 15.2% reduction in overall PCI volume from the pre-pandemic (n = 25,737) to the pandemic cohort (n = 21,822), which was more pronounced for stable angina and non-ST-elevation acute coronary syndromes (ACS) presentations, and between February and May 2020. Patients in the two cohorts had similar clinical and procedural characteristics. Monthly mortality rates for primary PCI were generally higher in the pandemic period. There were no significant system delays in care between the cohorts. Risk-adjusted mortality was higher in the pandemic cohort (aOR 1.26, 95% CI 1.07-1.47, p = 0.005), a finding that was only partially explained by worse outcomes in COVID-19 patients and was more pronounced in subjects with ACS. During the pandemic, COVID-19 positive patients suffered higher risk-adjusted mortality (aOR 5.69, 95% CI 2.54-12.74, p<0.001) compared with COVID negative patients. During the COVID-19 pandemic, we observed a reduction in PCI volumes and higher risk-adjusted mortality. COVID-19 positive patients experienced significantly worse outcomes.

Background The COVID-19 pandemic has severely impacted healthcare delivery and patient outcomes globally. Aims We aimed to evaluate the influence of the COVID-19 pandemic on the temporal trends and outcomes of patients undergoing percutaneous coronary intervention (PCI) in Michigan. Methods We compared all patients undergoing PCI in the BMC2 Registry between March and December 2020 (“pandemic cohort”) with those undergoing PCI between March and December 2019 (“pre-pandemic cohort”). A risk-adjusted analysis of in-hospital outcomes was performed between the pre-pandemic and pandemic cohort. A subgroup analysis was performed comparing COVID-19 positive vs. negative patients during the pandemic. Results There was a 15.2% reduction in overall PCI volume from the pre-pandemic (n = 25,737) to the pandemic cohort (n = 21,822), which was more pronounced for stable angina and non-ST-elevation acute coronary syndromes (ACS) presentations, and between February and May 2020. Patients in the two cohorts had similar clinical and procedural characteristics. Monthly mortality rates for primary PCI were generally higher in the pandemic period. There were no significant system delays in care between the cohorts. Risk-adjusted mortality was higher in the pandemic cohort (aOR 1.26, 95% CI 1.07–1.47, p = 0.005), a finding that was only partially explained by worse outcomes in COVID-19 patients and was more pronounced in subjects with ACS. During the pandemic, COVID-19 positive patients suffered higher risk-adjusted mortality (aOR 5.69, 95% CI 2.54–12.74, p<0.001) compared with COVID negative patients. Conclusions During the COVID-19 pandemic, we observed a reduction in PCI volumes and higher risk-adjusted mortality. COVID-19 positive patients experienced significantly worse outcomes.

Prior studies have proposed to restrict the contrast volume (CV) to <3x calculated creatinine clearance (CCC), to prevent contrast induced nephropathy (CIN) post percutaneous coronary interventions (PCI). The predictive value of this algorithm for CIN and therefore the benefit of this approach in high risk patients has been questioned. The aim of our study was to assess the association between contrast dose and the occurrence of CIN in patients at varying predicted risks of CIN and baseline CCC following contemporary PCI. Consecutive patients undergoing PCI between 2010-2012 were included. Baseline risk of CIN was calculated using a previously validated risk tool. High contrast dose was defined as CV/CCC >3. Likelihood ratio tests were used to evaluate whether the effect of a high contrast dose on the risk of CIN and nephropathy requiring dialysis (NRD) varied across the spectrum of baseline predicted risk. Of the 82,120 PCI included in our analysis, 25% were performed using a high contrast dose. Patients treated with a high compared with a low contrast dose were at increased risks of CIN and NRD, throughout the entire range of baseline predicted risk and CCC in our population. The effect size of a high contrast dose on risks of both outcomes varied significantly with baseline predicted CIN risk and CCC (CIN p = 0.004, NRD p<0.001 for adding interactions), and was largest for patients with predicted CIN risk <10% and pre-existing chronic kidney disease. The use of a high contrast dose is associated with increased risks of CIN and NRD across the continuum of baseline predicted risk and CCC. Efforts to reduce contrast dose may therefore be effective in preventing renal complications in all patients undergoing PCI.

Cigarette smoking, hypertension, dyslipidemia, diabetes, and obesity are conventional risk factors (RFs) for coronary artery disease (CAD). Population trends for these RFs have varied in recent decades. Consequently, the risk factor profile for patients presenting with a new diagnosis of CAD in contemporary practice remains unknown. To examine the prevalence of RFs and their temporal trends among patients without a history of myocardial infarction or revascularization who underwent their first percutaneous coronary intervention (PCI). We examined the prevalence and temporal trends of RFs among patients without a history of prior myocardial infarction, PCI, or coronary artery bypass graft surgery who underwent PCI at 47 non-federal hospitals in Michigan between 1/1/2010 and 3/31/2018. Of 69,571 men and 38,930 women in the study cohort, 95.5% of patients had 1 or more RFs and nearly half (55.2% of women and 48.7% of men) had [greater than or equal to]3 RFs. The gap in the mean age at the time of presentation between men and women narrowed as the number of RFs increased with a gap of 6 years among those with 2 RFs to <1 year among those with 5 RFs. Compared with patients without a current/recent history of smoking, those with a current/recent history of smoking presented a decade earlier (age 56.8 versus 66.9 years; p <0.0001). Compared with patients without obesity, patients with obesity presented 4.0 years earlier (age 61.4 years versus 65.4 years; p <0.0001). Modifiable RFs are widely prevalent among patients undergoing their first PCI. Smoking and obesity are associated with an earlier age of presentation. Population-level interventions aimed at preventing obesity and smoking could significantly delay the onset of CAD and the need for PCI.

Ticagrelor has greater antiplatelet activity than clopidogrel and is approved for use in patients with acute coronary syndrome (ACS). There are limited data on use of ticagrelor in real-world practice. We assessed ticagrelor use in 64,600 patients who underwent percutaneous coronary intervention from January 2012 to March 2014 at 47 Michigan hospitals in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Preprocedural risk of major adverse events was estimated with Blue Cross Blue Shield of Michigan Cardiovascular Consortium risk prediction models. The proportion of patients receiving clopidogrel, prasugrel, and ticagrelor was 72% (n = 46,864), 20% (n = 12,596), and 8% (n = 5,140), respectively, using ticagrelor increasing over time. Ticagrelor was used at 45 hospitals, ranging from 0.5% to 64.9% of discharges. Patients receiving ticagrelor were older (63.6 vs 59.4), more often women (32.9% vs 26.7%), and were more likely to present with ST-segment elevation myocardial infarction (24.4% vs 18.8%), cardiogenic shock within 24 hours (1.3% vs 0.9%), and anginal class IV (47.8% vs 43.0%) (p <0.05). Compared with prasugrel, ticagrelor was prescribed in patients with a higher predicted risk of percutaneous coronary intervention complications: contrast nephropathy (2.5% vs 1.6%), transfusion (2.2% vs 1.4%), and death (1.2% vs 0.7%) (p <0.001); >10% of patients were given prasugrel or ticagrelor for a non-ACS indication. Ticagrelor is prescribed to a higher risk population, and 1 in 10 patients prescribed ticagrelor or prasugrel did not have ACS.

Bleeding after percutaneous coronary intervention (PCI) is more common in women than in men. However, the relationship of sex and bleeding with outcomes is less well studied. We examined the sex-related differences in the incidence of bleeding and its association with in-hospital outcomes among 96,637 patients undergoing PCI enrolled in the BMC2 registry (2010-2012). Women had higher bleeding rate than did men (3.9% vs 1.8%) and thus received more blood transfusions (59% vs 41%). Both men (odds ratio [OR] 2.25, 95% CI 1.70-2.97) and women (OR 3.13, 95% CI 2.42-4.07) who bled had higher risk-adjusted death compared with their counterparts without bleeding. Although there was no difference in adjusted mortality between women and men without bleeding (OR 1.14, 95% CI 0.99-1.32), among patients who bled, adjusted death was higher in women (OR 1.28, 95% CI 1.11-1.47). Among patients with bleeding, transfusion was associated with similar increased risk of death in both men (OR 2.00, 95% CI 1.23-3.25) and women (OR 2.18, 95% CI 1.31-3.63) compared with their counterparts without transfusion(s). Post-PCI bleeding was more common and associated with higher-than-expected in-hospital death in women compared with men with bleeding. This trend for higher death in women with bleeding was independent of transfusion. Quality efforts geared toward reducing bleeding in general, with a special focus on women, need to be explored to help reduce post PCI-bleeding and mortality and decrease sex-related disparity in adverse events.

Transfusion is a common complication of Percutaneous Coronary Intervention (PCI) and is associated with adverse short and long term outcomes. There is no risk model for identifying patients most likely to receive transfusion after PCI. The objective of our study was to develop and validate a tool for predicting receipt of blood transfusion in patients undergoing contemporary PCI. Random forest models were developed utilizing 45 pre-procedural clinical and laboratory variables to estimate the receipt of transfusion in patients undergoing PCI. The most influential variables were selected for inclusion in an abbreviated model. Model performance estimating transfusion was evaluated in an independent validation dataset using area under the ROC curve (AUC), with net reclassification improvement (NRI) used to compare full and reduced model prediction after grouping in low, intermediate, and high risk categories. The impact of procedural anticoagulation on observed versus predicted transfusion rates were assessed for the different risk categories. Our study cohort was comprised of 103,294 PCI procedures performed at 46 hospitals between July 2009 through December 2012 in Michigan of which 72,328 (70%) were randomly selected for training the models, and 30,966 (30%) for validation. The models demonstrated excellent calibration and discrimination (AUC: full model  = 0.888 (95% CI 0.877-0.899), reduced model AUC = 0.880 (95% CI, 0.868-0.892), p for difference 0.003, NRI = 2.77%, p = 0.007). Procedural anticoagulation and radial access significantly influenced transfusion rates in the intermediate and high risk patients but no clinically relevant impact was noted in low risk patients, who made up 70% of the total cohort. The risk of transfusion among patients undergoing PCI can be reliably calculated using a novel easy to use computational tool (https://bmc2.org/calculators/transfusion). This risk prediction algorithm may prove useful for both bed side clinical decision making and risk adjustment for assessment of quality.

Non-primary percutaneous coronary intervention (non-PPCI) recently received certificate of need approval in the state of Michigan at sites without cardiac surgery on-site (cSoS). This requires quality oversight through participation in the BMC2 registry. While previous studies have indicated the safety of this practice, real-world comprehensive outcomes, case volume changes, economic impacts, and readmission rates at diverse healthcare centers with and without cSoS remain poorly understood. Consecutive patients undergoing non-PPCI at 47 hospitals (33 cSoS and 14 non-cSoS) in Michigan from April 2016 to March 2018 were included. Using propensity-matching, patients were analyzed to assess outcomes and trends in non-PPCI performance at sites with and without cSOS. Of 61,864 PCI's performed, 50,817 were non-PPCI, with 46,096 (90.7%) performed at sites with cSoS and 4,721 (9.3%) at sites without cSoS. From this cohort, 4,643 propensity-matched patients were analyzed. Rates of major adverse cardiac events (2.6% vs. 2.8%; p = 0.443), in-hospital mortality (0.6% vs. 0.5%; p = 0.465), and several secondary clinical and quality outcomes showed no clinically significant differences. Among a small subset with available post-discharge data, there were no differences in 90-day readmission rates, standardized episode costs, or post-discharge mortality. Overall PCI volume remained stable, with a near three-fold rise in non-PPCI at sites without cSoS. Non-PPCI at centers without cardiac SoS was associated with similar comprehensive outcomes, quality of care, 90-day episode costs, and post-discharge mortality compared with surgical sites. Mandatory quality oversight serves to maintain appropriate equivalent outcomes and may be considered for other programs, including the performance of non-PPCI at ambulatory surgical centers in the near future.

It is unknown which definition of contrast-induced acute kidney injury (CI-AKI) in the setting of percutaneous coronary interventions is best associated with inpatient mortality and whether this association is stable across patients with various preprocedural serum creatinine (SCr) values. We applied logistic regression models to multiple CI-AKI definitions used by the Kidney Disease Improving Global Outcomes guidelines and previously published studies to examine the impact of preprocedural SCr on a candidate definition's correlation with the adverse outcome of inpatient mortality. We used likelihood ratio tests to examine candidate definitions and identify those where association with inpatient mortality remained constant regardless of preprocedural SCr. These definitions were assessed for specificity, sensitivity, and positive and negative predictive values to identify an optimal definition. Our study cohort included 119,554 patients who underwent percutaneous coronary intervention in Michigan between 2010 and 2014. Most commonly used definitions were not associated with inpatient mortality in a constant fashion across various preprocedural SCr values. Of the 266 candidate definitions examined, 16 definition's association with inpatient mortality was not significantly altered by preprocedural SCr. Contrast-induced acute kidney injury defined as an absolute increase of SCr ≥0.3 mg/dL and a relative SCr increase ≥50% was selected as the optimal candidate using Perkins and Shisterman decision theoretic optimality criteria and was highly predictive of and specific for inpatient mortality. We identified the optimal definition for CI-AKI to be an absolute increase in SCr ≥0.3 mg/dL and a relative SCr increase ≥50%. Further work is needed to validate this definition in independent studies and to establish its utility for clinical trials and quality improvement efforts.