Merging machine learning and patient preference: a novel tool for risk prediction of percutaneous coronary interventions.

BACKGROUND AND AIMS: Predicting personalized risk for adverse events following percutaneous coronary intervention (PCI) remains critical in weighing treatment options, employing risk mitigation strategies, and enhancing shared decision-making. This study aimed to employ machine learning models using pre-procedural variables to accurately predict common post-PCI complications. METHODS: A group of 66 adults underwent a semiquantitative survey assessing a preferred list of outcomes and model display. The machine learning cohort included 107 793 patients undergoing PCI procedures performed at 48 hospitals in Michigan between 1 April 2018 and 31 December 2021 in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) registry separated into training and validation cohorts. External validation was conducted in the Cardiac Care Outcomes Assessment Program database of 56 583 procedures in 33 hospitals in Washington. RESULTS: Overall rate of in-hospital mortality was 1.85% (n = 1999), acute kidney injury 2.51% (n = 2519), new-onset dialysis 0.44% (n = 462), stroke 0.41% (n = 447), major bleeding 0.89% (n = 942), and transfusion 2.41% (n = 2592). The model demonstrated robust discrimination and calibration for mortality {area under the receiver-operating characteristic curve [AUC]: 0.930 [95% confidence interval (CI) 0.920-0.940]}, acute kidney injury [AUC: 0.893 (95% CI 0.883-0.903)], dialysis [AUC: 0.951 (95% CI 0.939-0.964)], stroke [AUC: 0.751 (95%CI 0.714-0.787)], transfusion [AUC: 0.917 (95% CI 0.907-0.925)], and major bleeding [AUC: 0.887 (95% CI 0.870-0.905)]. Similar discrimination was noted in the external validation population. Survey subjects preferred a comprehensive list of individually reported post-procedure outcomes. CONCLUSIONS: Using common pre-procedural risk factors, the BMC2 machine learning models accurately predict post-PCI outcomes. Utilizing patient feedback, the BMC2 models employ a patient-centred tool to clearly display risks to patients and providers (https://shiny.bmc2.org/pci-prediction/). Enhanced risk prediction prior to PCI could help inform treatment selection and shared decision-making discussions.

Race and outcomes after percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: Current studies show similar in-hospital outcomes following percutaneous coronary intervention (PCI) between Black and White patients. Long-term outcomes and the role of individual and community-level socioeconomic factors in differential risk are less understood. METHODS: We linked clinical registry data from PCIs performed between January, 2013 and March, 2018 at 48 Michigan hospitals to Medicare Fee-for-service claims. We analyzed patients of Black and White race. We used propensity score matching and logistic regression models to estimate the odds of 90-day readmission and Cox regression to evaluate the risk of postdischarge mortality. We used mediation analysis to evaluate the proportion of association mediated by socioeconomic factors. RESULTS: Of the 29,317 patients included in this study, 10.28% were Black and 89.72% were White. There were minimal differences between groups regarding post-PCI in-hospital outcomes. Compared with White patients, Black patients were more likely to be readmitted within 90-days of discharge (adjusted OR 1.62, 95% CI [1.32-2.00]) and had significantly higher risk of all-cause mortality (adjusted HR 1.45, 95% CI 1.30-1.61) when adjusting for age and gender. These associations were significantly mediated by dual eligibility (proportion mediated [PM] for readmission: 11.0%; mortality: 21.1%); dual eligibility and economic well-being of the patient's community (PM for readmission: 22.3%; mortality: 43.0%); and dual eligibility, economic well-being of the community, and baseline clinical characteristics (PM for readmission: 45.0%; mortality: 87.8%). CONCLUSIONS: Black patients had a higher risk of 90-day readmission and cumulative mortality following PCI compared with White patients. Associations were mediated by dual eligibility, community economic well-being, and traditional cardiovascular risk factors. Our study highlights the need for improved upstream care and streamlined postdischarge care pathways as potential strategies to improve health care disparities in cardiovascular disease.

Identifying potentially avoidable femoral to popliteal expanded polytetrafluoroethylene bypass for claudication using cross-site blinded peer review.

OBJECTIVE: The surgical treatment of claudication can be associated with significant morbidity and costs. There are growing concerns that some patients proceed to interventions without first attempting evidence-based nonoperative management. We used a direct, cross-site, blinded expert review to evaluate the appropriateness of the surgical treatment of claudication. METHODS: We enlisted practicing vascular surgeons to perform retrospective clinical assessments of lower extremity bypass procedures in a statewide clinical registry. Cases were limited to elective, open, infrainguinal bypasses performed for claudication using prosthetic grafts. Reviewing surgeons were randomly assigned 10 cases from a sample of 139 anonymized bypass operations and instructed to evaluate procedural appropriateness based on their expert opinion and evidence-based guidelines for preoperative treatment, namely, antiplatelet, statin, cilostazol, exercise, and smoking cessation therapy as documented in the medical record. Ninety-day episode payments were estimated from a distinct but similar cohort of patients undergoing lower extremity bypass for claudication. RESULTS: Of 325 total reviews, surgeons stated they would not have recommended bypass in 134 reviews (41%) and deemed bypass inappropriate in 122 reviews (38%). The most common reason for inappropriateness was lack of preoperative medical and lifestyle therapy, which was present in 63% of reviews where bypass was deemed appropriate and 39% of reviews where bypass was deemed inappropriate (P < .001). Surgeons stated they would have recommended additional preoperative therapy in 65% of reviews where bypass was deemed inappropriate and 35% of reviews where bypass was deemed appropriate (P < .001). The mean total episode payments in a similar cohort of 1458 patients undergoing elective open lower extremity bypass for claudication were $31,301 ± $21,219. Extrapolating to the 325 reviews, the 134 reviews in which surgeons would not have recommended bypass were associated with potentially avoidable estimated total payments of $4,194,334, and the 122 reviews in which bypass was deemed inappropriate were associated with potentially avoidable estimated total payments of $3,818,722. CONCLUSIONS: In this cross-site expert peer review study, 40% of lower extremity bypasses were deemed premature and, therefore, potentially avoidable, primarily owing to a lack of medical and lifestyle management before surgery. Reviews deemed inappropriate were associated with approximately $4 million in potentially avoidable costs. This approach could inform performance feedback among surgeons to help align clinical practice with evidence-based recommendations for the treatment of claudication.

Comparative analysis of percutaneous revascularization practice in the United States and the United Kingdom: Insights from the BMC2 and BCIS databases.

BACKGROUND: International registry comparisons provide insight into regional differences in clinical practice patterns, procedural outcomes, and general trends in population health and resource utilization in percutaneous coronary intervention (PCI). We sought to compare data from a state-wide PCI registry in the United States with a national registry from the United Kingdom (UK). METHODS: We analyzed all PCI cases from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and the British Cardiovascular Intervention Society registries from 2010 to 2017. Procedural characteristics and in-hospital outcomes were stratified by PCI indication. RESULTS: A total of 248,283 cases were performed in Michigan and 773,083 in the United Kingdom during the study period. The proportion of patients with a prior diagnosis of diabetes in Michigan was nearly double that in the United Kingdom (38.9% vs. 21.0%). PCI for ST-elevation myocardial infarction was more frequent in the UK (25% UK vs. 14.3% Michigan). Radial access increased in both registries, reaching 86.8% in the United Kingdom versus 45.1% in Michigan during the final study year. Mechanical support utilization was divergent, falling to 0.9% of cases in the United Kingdom and rising to 3.95% of cases in Michigan in 2017. Unadjusted crude mortality rates were similar in the two cohorts, with higher rates of post-PCI transfusion and other complications in the Michigan population. CONCLUSIONS: In a real-world comparison using PCI registries from the US and UK, notable findings include marked differences in the prevalence of diabetes and other comorbidities, a greater proportion of primary PCI with more robust adoption of transradial PCI in the United Kingdom, and divergent trends in mechanical support with increasing use in Michigan.

The DISCO study-Does Interventionalists' Sex impact Coronary Outcomes?

OBJECTIVES: To examine the association of operator sex with appropriateness and outcomes of percutaneous coronary intervention (PCI). BACKGROUND: Recent studies suggest that physician sex may impact outcomes for specific patient cohorts. There are no data evaluating the impact of operator sex on PCI outcomes. METHODS: We studied the impact of operator sex on PCI outcome and appropriateness among all patients undergoing PCI between January 2010 and December 2017 at 48 non-federal hospitals in Michigan. We used logistic regression models to adjust for baseline risk among patients treated by male versus female operators in the primary analysis. RESULTS: During this time, 18 female interventionalists and 385 male interventionalists had performed at least one PCI. Female interventionalists performed 6362 (2.7%) of 239,420 cases. There were no differences in the odds of mortality (1.48% vs. 1.56%, adjusted OR [aOR] 1.138, 95% CI: 0.891-1.452), acute kidney injury (3.42% vs. 3.28%, aOR 1.027, 95% CI: 0.819-1.288), transfusion (2.59% vs. 2.85%, aOR 1.168, 95% CI: 0.980-1.390) or major bleeding (0.95% vs. 1.07%, aOR 1.083, 95% CI: 0.825-1.420) between patients treated by female versus male interventionalist. While the absolute differences were small, PCIs performed by female interventional cardiologists were more frequently rated as appropriate (86.64% vs. 84.45%, p-value <0.0001). Female interventional cardiologists more frequently prescribed guideline-directed medical therapy. CONCLUSIONS: We found no significant differences in risk-adjusted in-hospital outcomes between PCIs performed by female versus male interventional cardiologists in Michigan. Female interventional cardiologists more frequently performed PCI rated as appropriate and had a higher likelihood of prescribing guideline-directed medical therapy.

Contemporary use of and outcomes associated with ultra-low contrast volume in patients undergoing percutaneous coronary interventions.

BACKGROUND: The risk of contrast-induced acute kidney injury (CI-AKI) increases in a nonlinear fashion with increasing volume of contrast media. Prior studies recommend limiting contrast volume to less than three times the estimated creatinine clearance (CC). Recently, a number of operators have reported successful percutaneous coronary intervention (PCI) using even lower volumes of contrast. OBJECTIVES: To evaluate the prevalence and outcomes associated with ultra-low contrast volume among patients undergoing PCI. METHODS: We assessed the prevalence and outcomes associated with use of ultra-low contrast volume among 75 393 patients undergoing PCI in Michigan between July 2014 and June 2017 in the BMC2 (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) registry. Ultra-low contrast volume was defined as contrast volume less than or equal to the patient's estimated CC. Patients receiving dialysis at the time of the procedure were excluded. RESULTS: Ultra-low contrast volume was used in 13% of procedures with the majority of these patients being at low risk of renal complications. Compared with patients who received a contrast volume between one and three times the CC, use of ultra-low volume of contrast was associated with a significantly lower incidence of AKI (aOR 0.682, 95% CI 0.566-0.821, P < 0.001) and a lower incidence of need for dialysis (aOR = 0.341, 95% CI 0.165-0.704, P = 0.003). These benefits were most evident in the patients with a high baseline predicted risk of AKI. CONCLUSIONS: A small but clinically significant number of patients are treated with ultra-low contrast volume. Ultra-low contrast volume use is associated with a significant reduction in the incidence of AKI or need for dialysis. It may be prudent to consider this new threshold when performing PCI on patients who are at an increased risk of AKI.

Primary percutaneous coronary intervention at centers with and without on-site surgical support: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

BACKGROUND: Primary percutaneous coronary intervention (PPCI) is being increasingly performed nationally at sites without on-site cardiac surgery; however, recent guidelines only provide a Class IIa recommendation for this practice. The state of Michigan has permitted PPCI without on-site surgery under a closely monitored system that mandates auditing of all procedures and quarterly feedback on quality and outcomes. This study sought to compare outcomes of patients undergoing PPCI at centers with and without on-site surgery in the state of Michigan. METHODS: Consecutive patients who underwent PPCI at 47 hospitals in Michigan from January 2010 to December 2015 were included. From this cohort, 4,091 patients from sites with and without on-site cardiac surgery were propensity matched in a 1:1 fashion to compare baseline characteristics, procedural details, and in-hospital outcomes. RESULTS: Of the 25,886 PPCIs performed at 47 hospitals in Michigan from 2010 to 2015, 21,610 (83.5%) were performed at sites with on-site surgery and 4,276 (16.5%) at sites without on-site surgery. Using propensity score matched cohorts (4,091 patients for each site type), we found no significant differences in baseline characteristics. Overall mortality (5.4% vs 5.8%; P=.442); composite outcome of in-hospital mortality, contrast-induced nephropathy, bleeding, and stroke (13.8% vs 12.8%; P=.152); and individual outcomes within the composite group showed no significant differences. Additionally, there were no clinically meaningful differences in rates of urgent/emergent coronary artery bypass graft or length of stay. Significant differences, however, were found in procedural access site, antiplatelet therapy, contrast volume, and anticoagulant strategy. CONCLUSIONS: Primary PCI performed at centers with and without cardiac surgery have comparable outcomes and complication rates when performed with close monitoring of quality and outcomes.

Clinical outcomes of percutaneous coronary intervention in patients turned down for surgical revascularization.

OBJECTIVES: We examined clinical outcomes following percutaneous coronary intervention (PCI) in patients turned down for surgical revascularization across a broad population. BACKGROUND: Prior studies suggest that surgical ineligibility is associated with increased mortality in patients with unprotected left main or multivessel coronary artery disease undergoing PCI. METHODS: This study included consecutive patients who underwent PCI in a multicenter registry in Michigan from January 2010 to December 2014. Surgical ineligibility required documentation indicating that a cardiac surgeon deemed the patient ineligible for surgery. In-hospital outcomes included mortality (primary outcome), cardiogenic shock, cerebrovascular accident, contrast-induced nephropathy (CIN), and a new requirement for dialysis (NRD). RESULTS: Of 99,370 patients at 33 hospitals with on-site surgical backup, 1,922 (1.9%) were surgically ineligible. The rate of ineligibility did not vary by hospital (range: 1.5-2.5%; P = 0.79). Overall, there were no major differences in baseline characteristics or outcomes between surgically ineligible patients and the rest (i.e., nonineligible patients): mortality (0.52% vs. 0.52%; P > 0.5), cardiogenic shock (0.68% vs. 0.73%; P > 0.5), cerebrovascular accident (0.05% vs. 0.19%; P = 0.28), NRD (0.16% vs. 0.19%; P > 0.5), CIN (2.7% vs. 2.3%; P = 0.27). Among 1,074 patients who underwent unprotected left main PCI, 20 (1.9%) were surgically ineligible and experienced increased rates of mortality (20.0% vs. 5.3%; P = 0.022; adjusted OR = 7.38; P < 0.001) and other complications as compared to the remainder. CONCLUSIONS: PCI in a broad population of surgically ineligible patients is generally safe. However, among patients who underwent unprotected left main PCI, those deemed surgically ineligible experienced significantly worse outcomes as compared to the rest. © 2016 Wiley Periodicals, Inc.

The comparative safety and effectiveness of bivalirudin versus heparin monotherapy in patients on dialysis undergoing percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan cardiovascular consortium.

BACKGROUND: Dialysis patients are at a higher risk of bleeding after percutaneous coronary intervention (PCI); however, due to their exclusion from randomized clinical trials, the optimal antithrombotic regimen for this population remains unknown. We sought to evaluate the comparative safety and effectiveness of bivalirudin monotherapy versus unfractionated heparin (UFH) monotherapy in dialysis patients undergoing PCI. METHODS: We included dialysis patients who underwent PCI in a multicenter registry between January 2010 and September 2015 at 47 Michigan hospitals. We compared in-hospital outcomes between bivalirudin versus UFH; excluding those treated with glycoprotein IIb/IIIa inhibitors. Optimal full matching was used to account for the nonrandom use of these drugs. RESULTS: Of 177,963 patients who underwent PCI, 4,303 (2.4%) were on dialysis. Among those, 1,257 (29.2%) received bivalirudin monotherapy and 2,112 (49.1%) received UFH monotherapy. Patients treated with bivalirudin had fewer comorbidities. After matching, there were no significant differences in outcomes between those who received bivalirudin versus UFH: bleeding (adjusted odds ratio: 0.67; 95% confidence interval: 0.41-1.07; P = 0.093); major bleeding (0.81; 0.19-3.50; P = 0.77); transfusion (1.01; 0.77-1.33; P = 0.96); repeat PCI (0.57; 0.14-2.24; P = 0.42); stent thrombosis (0.56; 0.05-5.83; P = 0.63); and death (0.84; 0.46-1.51; P = 0.55). CONCLUSIONS: We found no significant differences in in-hospital outcomes between bivalirudin and UFH monotherapy among dialysis patients undergoing PCI. Randomized clinical trials are needed to determine the optimal anticoagulant regimen for this population. © 2017 Wiley Periodicals, Inc.

Coronary artery perforations after contemporary percutaneous coronary interventions: Evaluation of incidence, risk factors, outcomes, and predictors of mortality.

OBJECTIVES: We sought to evaluate the incidence, risk factors, in-hospital, and long-term outcomes and predictors of mortality of coronary artery perforations (CAP) in the contemporary percutaneous coronary intervention (PCI) era. BACKGROUND: CAP is a rare but serious complication of PCI associated with increased risk of morbidity and mortality. METHODS: We included 181,590 procedures performed across 47 hospitals in Michigan from January 1, 2010 to December 31, 2015. Endpoints evaluated included the incidence of CAP and its association with in-hospital outcomes. Logistic regression analysis was utilized to determine independent risk factors for CAP and to examine whether the effect of CAP on mortality varied by gender. RESULTS: CAP occurred in 625 (0.34%) patients. Independent predictors for CAP included older age, peripheral arterial disease, presence of left ventricular dysfunction or cardiomyopathy, lower body mass index, pre-PCI insertion of a mechanical ventricular support device, treatment of complex lesions (Type C), and treatment of chronic total occlusions, the latter of which was the strongest predictor of perforation (adjusted odds ratio (OR) 7.01, P < 0.001). After adjusting for baseline risk, the incidence of adverse outcomes remained substantially greater in patients with a perforation, with an adjusted OR estimate of 5.00 for mortality (95% CI 3.42-7.31), 3.25 for acute kidney injury (95% CI 2.30-4.58), and 5.26 for transfusion (95% CI 4.03-6.87) (all P < 0.001). Perforation was associated with a higher mortality in women than men (interaction P value = 0.01). CONCLUSIONS: CAP is a rare complication but is associated with high morbidity and mortality especially in women. Further investigation is warranted to determine why women fare worse after CAP. © 2017 Wiley Periodicals, Inc.

The comparative safety of abciximab versus eptifibatide in patients on dialysis undergoing percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

OBJECTIVES: We sought to evaluate the patterns of use and outcomes associated with eptifibatide and abciximab administration among dialysis patients who underwent percutaneous coronary intervention (PCI). BACKGROUND: Contraindicated medications are frequently administered to dialysis patients undergoing PCI often resulting in adverse outcomes. Eptifibatide is a glycoprotein IIb/IIIa inhibitor that is often used during PCI and is contraindicated in dialysis. METHODS: We included dialysis patients who underwent PCI from January 2010 to September 2015 at 47 hospitals in Michigan. We compared outcomes between patients who received eptifibatide compared with abciximab. Both groups required concurrent treatment with unfractionated heparin only. In-hospital outcomes included repeat PCI, bleeding, major bleeding, need for transfusion, and death. Optimal full matching was used to adjust for non-random drug administration. RESULTS: Of 177 963 patients who underwent PCI, 4303 (2.4%) were on dialysis. Among those, 384 (8.9%) received eptifibatide and 100 (2.3%) received abciximab. Prior to matching, patients who received eptifibatide had higher pre-procedural hemoglobin levels (11.3 g/dL vs. 10.7 g/dL; P < 0.001) and less frequently had a history of myocardial infarction (36.5% vs. 52.0%; P = 0.005). After matching, there were no significant differences in in-hospital outcomes between eptifibatide and abciximab including transfusion (aOR: 1.15; 95%CI: 0.55-2.40; P = 0.70), bleeding (1.47; 0.64-3.40; P = 0.36), major bleeding (4.68; 0.42-52.3; P = 0.21), repeat PCI (0.38; 0.03-4.23; P = 0.43), and death (1.53; 0.2-9.05; P = 0.64). CONCLUSIONS: Despite being contraindicated in dialysis, eptifibatide was used approximately 3.5 times more frequently than abciximab among dialysis patients undergoing PCI but was associated with similar in-hospital outcomes.

The comparative efficacy of bivalirudin is markedly attenuated by use of radial access: insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

AIM: The purpose of our study was to evaluate the relative impact of bivalirudin on bleeding outcomes associated with trans-radial interventions (TRI) in real world practice. METHODS AND RESULTS: Data for patients undergoing percutaneous coronary intervention (PCI) between January 2010 and March 2014 at the 47 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) were utilized. Propensity matching was used within cohorts defined by access site. The impact of bivalirudin use on in-hospital outcomes was evaluated with Fisher's exact tests. Among patients undergoing trans-femoral interventions (TFI), use of bivalirudin was associated with a reduction in bleeding compared with both glycoprotein IIb/IIIa inhibitors (GPI; 1.67 vs. 3.46%, absolute risk reduction (ARR) 1.79%, odds ratio, OR, 0.47, confidence interval, CI, 0.41-0.54, number needed to treat, NNT 56, P < 0.001) and heparin (1.26 vs. 1.76%, ARR 0.5%, OR 0.71, CI 0.61-0.82, NNT 197, P < 0.001). Among patients undergoing TRI, there was a more modest absolute reduction in bleeding with bivalirudin compared with GPI (0.79 vs. 1.41%, ARR 0.62%, OR 0.56, CI 0.34-0.90, NNT 161, P = 0.016) and no difference in bleeding compared with heparin (0.46 vs. 0.46%, OR 1, CI 0.54-1.84, P = 1). CONCLUSION: Bivalirudin is markedly efficacious in reducing bleeding in patients undergoing TFI. The reduction in bleeding associated with bivalirudin use is minimal to absent in patients undergoing TRI. Given its lower cost and comparable outcomes, heparin should be the preferred anticoagulation strategy in those undergoing radial PCI.

The optimal definition of contrast-induced acute kidney injury for prediction of inpatient mortality in patients undergoing percutaneous coronary interventions.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Using simulation for teaching femoral arterial access: A multicentric collaboration.

OBJECTIVE: To assess the impact of simulation training on complications associated with femoral arterial access obtained by first year cardiology fellows. BACKGROUND: Prior studies demonstrate a higher incidence of arterial access related complications among patients undergoing invasive cardiac procedures. METHODS: First year cardiology fellows at four teaching hospitals in Michigan tracked their femoral access experience and any associated complications between July 2011 and June 2013. Fellows starting their academic training in July 2012 were first trained on a specially developed simulator before starting their rotation in the catheterization laboratory. The primary outcome was access proficiency, defined as five successful femoral access attempts without any complication or need to seek help from a more experienced team member. RESULTS: A total of 1,278 femoral access attempts were made by 21 fellows in 2011-2012 compared with 869 femoral access attempts made by 21 fellows in 2012-2013. There was a lower rate of access related complications in patients undergoing access attempts by first year fellows in year 2 compared with year 1 (2.1% versus 4.5%, P = 0.003). The number of procedures to achieve procedural proficiency was significantly higher in year 1 compared with year 2 (median 20 versus 10, P = 0.007). CONCLUSIONS: Incorporation of simulation in the training of first year fellows was associated with an improvement in proficiency and a clinically meaningful reduction in vascular complications.

Radial PCI and the obesity paradox: Insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

OBJECTIVE: To examine if transradial approach (TRA) negates the increased risk associated with femoral access in lean and morbidly obese patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Patients at extremes of body mass are at increased risk of bleeding after PCI. TRA has been associated with lower overall rates of bleeding compared to femoral approach. METHODS AND RESULTS: We studied patients undergoing emergent and elective PCI from 2010 to 2012 across 47 hospitals in Michigan who participate in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. The primary outcomes were the incidences of bleeding and postprocedure transfusion. Propensity matching (PM) was used to adjust for nonrandomized use of TRA. TRA was used in 10,235 procedures. In PM analyses, use of TRA was associated with a reduction in bleeding (0.80 vs. 1.9%, odds ratio [OR] = 0.41, 95% confidence interval [CI] = 0.32-0.54, P < 0.001) and need for transfusion (1.4 vs. 2.5%, OR = 0.56, 95% CI = 0.45-0.69, P < 0.001) compared with femoral access. The absolute difference in bleeding and transfusion associated with TRA was largest in patients with lean body mass (BMI < 25 kg/m(2)) and morbid obesity (BMI ≥ 40 kg/m(2)): Lean patients undergoing TRA had a rate of bleeding of 1.2 versus 2.8% for femoral access (OR = 0.43, 95% CI = 0.24-0.77, P = 0.002); and rate of transfusion of 2.4 versus 3.9% (OR = 0.61, 95% CI = 0.40-0.94, P = 0.019). The morbidly obese had a rate of bleeding of 0.8% for TRA versus 2.4% for femoral access (OR = 0.33, 95% CI = 0.44-0.72, P = 0.004); and rate of transfusion of 1.7 versus 3.0%, (OR = 0.55, 95% CI = 0.30-1.0, P = 0.051). CONCLUSIONS: Compared with the femoral approach, TRA is associated with a reduction in bleeding across all patients undergoing PCI and the absolute benefit was greatest in those with extremely low or high BMI.

If not now, when? Prescription of evidence-based medical therapy prior to hospital discharge increases utilization at 6 months in patients with symptomatic peripheral artery disease.

We evaluated the impact of the prescription of evidence-based medical therapy (EBMT) including aspirin (ASA), beta-blockers (BB), ACE-inhibitors or angiotensin receptor blockade (ACE/ARB), and statins prior to discharge after peripheral vascular intervention (PVI) on long-term medication utilization in a large multi-specialty, multicenter quality improvement collaborative. Among patients undergoing coronary revascularization, use of the component medications of EBMT at hospital discharge is a major predictor of long-term utilization. Predictors of EBMT use after PVI are largely unknown. A total of 10,169 patients undergoing PVI between 1 January 2008 and 31 December 2011 were included. Post-PVI discharge and 6-month medication utilization in patients without contra-indications to ASA, BB, ACE/ARB, and statins were compared. ASA was prescribed at discharge to 9345 (92%) patients, BB to 7012 (69%), ACE/ARB to 6424 (63%), and statins to 8342 (82%), and all four component drugs of EBMT in 3953 (39%). Compared with patients not discharged on the appropriate medications, post-procedural use was associated (all p<0.001) with reported 6-month use: ASA (84.5% vs 39.2%), BB (82.5% vs 11.1%), ACE/ARB (78.2% vs 11.8%), statins (84.6% vs 21.8%). Multivariable analysis revealed that prescription of EBMT at the time of discharge remained strongly associated with use at 6 months for each of the individual component drugs as well as for the combination of all four EBMT medications. In conclusion, prescription of the component medications of EBMT at the time of PVI is associated with excellent utilization at 6 months, while failure to prescribe EBMT at discharge is associated with low use of these medications 6 months later. These data suggest that the time of a PVI is a therapeutic window in which to prescribe EBMT in this high-risk cohort and represents an opportunity for quality improvement.

Differences in sex-related bleeding and outcomes after percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) registry.

BACKGROUND: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.

Preprocedural statin use in patients undergoing percutaneous coronary intervention.

BACKGROUND: Earlier studies suggest that administering statins prior to percutaneous coronary interventions (PCIs) is associated with lower risk of periprocedural myocardial infarction and contrast-induced nephropathy. Current American College of Cardiology/American Heart Association guidelines recommend routine use of statins prior to PCI. It is unclear how commonly this recommendation is followed in clinical practice and what its effect on outcomes is. METHODS: We evaluated the incidence and in-hospital outcomes associated with statin pretreatment among patients undergoing PCI and enrolled in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry at 44 hospitals in Michigan between January 2010 and December 2012. Propensity and exact matching were used to adjust for the nonrandom use of statins prior to PCI. Long-term mortality was assessed in a subset of patients who were linked to Medicare data. RESULTS: Our study population was comprised of 80,493 patients of whom 26,547 (33 %) did not receive statins prior to undergoing PCI. When compared to statin receivers, nonreceivers had lower rates of prior cardiovascular disease. In the matched analysis, absence of statin use prior to PCI was associated with a similar rate of in-hospital mortality (0.43% vs 0.42%, odds ratio 1.00, 95% CI 0.70-1.42, P = .98) and periprocedural myocardial infarction (2.34% vs 2.10%, odds ratio 1.13, 95% CI 0.97-1.32, P = .11) compared to statin receivers. Likewise, no difference in the rate of coronary artery bypass grafting, cerebrovascular accident (CVA), or contrast-induced nephropathy was observed. There was no association between pre-PCI use of statins and long-term survival among the subset of included Medicare patients (hazard ratio = 1.0, P = .96). CONCLUSIONS: A significant number of patients undergo PCI without statin pretreatment, but this is not associated with in-hospital major complications or long-term mortality.

Does change in device detected frequency of non-sustained or diverted episodes serve as a marker for inappropriate shock therapy? Analyses from the INTRINSIC RV and ALTITUDE-REDUCES Trials.

AIMS: Implantable cardioverter-defibrillators (ICDs) treat ventricular tachycardia or fibrillation but may also deliver unnecessary shocks. We sought to determine if the frequency of ICD-detected non-sustained or diverted (NSD) episodes increases before appropriate or inappropriate ICD shocks. METHODS AND RESULTS: We evaluated NSD episodes in the INTRINSIC RV Trial and their relationship to ICD shocks (appropriate and inappropriate). Time from NSD to shock was analysed. Results were validated by utilizing 1495 adjudicated ICD and cardiac resynchronization therapy-defibrillator shocks following NSD episodes collected through the LATITUDE remote monitoring system as part of the ALTITUDE-REDUCES Study. In INTRINSIC RV, 185 participants received 373 shocks; 148 had at least 1 NSD episode. Non-sustained or diverted frequency increased 24 h before the first shock for those receiving an inappropriate (P < 0.01) but not an appropriate shock (P = 0.17). Patients with NSD episodes within 24 h of a shock were significantly more likely to receive inappropriate therapy [odds ratio (OR) = 3.12, P < 0.01]. At the receiver operator curve determined optimal cutoff, an NSD episode within 14 min before shock strongly predicted inappropriate therapy (sensitivity 48%, specificity 91%; OR = 8.8, and P < 0.001). The 14 min cut-off evaluated on an independent dataset of 1495 shock episodes preceded by an NSD in the ALTITUDE-REDUCES Study confirmed these results (sensitivity = 47%, specificity = 85%, OR = 5.0, and P < 0.001). CONCLUSION: Device-detected NSD episodes increase before inappropriate but not appropriate shocks. Novel alerts or automated algorithms based on NSD episodes may reduce inappropriate shocks.

Performance of an automatic arrhythmia classification algorithm: comparison to the ALTITUDE electrophysiologist panel adjudications.

INTRODUCTION: Adjudication of thousands of implantable cardioverter defibrillator (ICD)-treated arrhythmia episodes is labor intensive and, as a result, is most often left undone. The objective of this study was to evaluate an automatic classification algorithm for adjudication of ICD-treated arrhythmia episodes. METHODS: The algorithm uses a machine learning algorithm and was developed using 776 arrhythmia episodes. The algorithm was validated on 131 dual-chamber ICD shock episodes from 127 patients adjudicated by seven electrophysiologists (EPs). Episodes were classified by panel consensus as ventricular tachycardia/ventricular fibrillation (VT/VF) or non-VT/VF, with the resulting classifications used as the reference. Subsequently, each episode electrogram (EGM) data was randomly assigned to three EPs without the atrial lead information, and to three EPs with the atrial lead information. Those episodes were also classified by the automatic algorithm with and without atrial information. Agreement with the reference was compared between the three EPs consensus group and the algorithm. RESULTS: The overall agreement with the reference was similar between three-EP consensus and the algorithm for both with atrial EGM (94% vs 95%, P = 0.87) and without atrial EGM (90% vs 91%, P = 0.91). The odds of accurate adjudication, after adjusting for covariates, did not significantly differ between the algorithm and EP consensus (odds ratio 1.02, 95% confidence interval: 0.97-1.06). CONCLUSIONS: This algorithm performs at a level comparable to an EP panel in the adjudication of arrhythmia episodes treated by both dual- and single-chamber ICDs. This type of algorithm has the potential for automated analysis of clinical ICD episodes, and adjudication of EGMs for research studies and quality analyses.