Aortic annulus rupture after transcatheter aortic valve replacement: successful management of a dangerous complication.

OBJECTIVE: Aortic annulus rupture remains one of the most fatal complications of TAVR. While attempts have been made to describe and predict this complication, the data remains insufficient without evidence-based guidelines for management of this rare complication. METHODS: Here we describe a series of 3 aortic annulus ruptures after TAVR which were managed successfully to hospital discharge. RESULTS: Patient 1 suffered annulus rupture during balloon valvuloplasty prior to TAVR. The patient became hypotensive, and echocardiogram showed pericardial effusion. The patient underwent pericardiocentesis which transiently improved the blood pressure, but bleeding continued. The patient was transitioned to an open surgical aortic valve replacement due to ongoing hemorrhage. The chest was left open with delayed closure on post-op day 2. The patient was discharged on post-op day 15. Patient 2 was undergoing TAVR valve expansion. The patient became hypotensive. An echocardiogram revealed pericardial effusion. Pericardiocentesis yielded 200 mL of blood. SURGIFLO (Johnson & Johnson Wound Management, Somerville, NJ) was injected into the pericardial space. Aortic root angiography confirmed no further contrast extravasation. A pericardial drain was left in place for 2 days, and the patient was discharged on post-op day 7. Patient 3 received a TAVR valve and post-placement dilation due to paravalvular leak. The echocardiogram showed a pericardial effusion. Pericardiocentesis was performed, yielding 500 cc of blood. The patient's healthcare proxy declined emergent surgery; thus, a pericardial drain was placed. No hemostatic agents were used, and drainage reduced over several hours. The drain was removed on post-op day 3, and the patient was discharged on post-op day 8. CONCLUSIONS: Based on the timelines in these three cases, and interventions used, the following steps may be employed in the event of annulus rupture: identification of hemodynamic instability, echocardiogram to confirm pericardial effusion, emergent pericardiocentesis, pericardial drain placement for evacuation of the pericardial space and use of hemostatic agents, repeat aortogram to rule out ongoing extravasation. If hemostasis is unable to be achieved and/or the patient becomes hemodynamically unstable at any point, rapid transition to emergent surgical management is necessary. This management strategy proved successful for this case series and warrants further investigation.

Transcatheter aortic valve replacement 23 years after heart transplant for aortic insufficiency.

BACKGROUND: Clinicians continue to expand the availability of transcatheter aortic valve replacement (TAVR) for patients who historically would have been ineligible for surgical aortic valve replacement. Historically, reoperative aortic valve surgery after transplant was immensely complicated and high risk due to the repeat sternotomy approach, and the immunosuppression in transplant patients. As heart transplant patients continue to live longer, patients are beginning to develop novo aortic pathology of the transplanted organ. In these patients, TAVR may be a valuable rescue therapy for those with de-novo aortic valve disease. CASE PRESENTATION: Here, we present a single case of a 70-year-old man with a history of heart transplant 23 years prior complicated by severe sternal infection and subsequent removal of his sternum. Additionally, this patient had a recent history of kidney transplant due to renal cell carcinoma necessitating nephrectomy. He subsequently developed progressive symptomatic aortic insufficiency and underwent a successful TAVR to treat his new aortic disease. CONCLUSIONS: To our knowledge, this represents only the second case report of TAVR for severe aortic insufficiency and one of the first reports of TAVR in a multiple organ recipient. TAVR may represent an important rescue therapy for post-transplant valve pathologies instead of high-risk reoperative surgical aortic valve replacement.

New York Risk Model and Simplified Risk Score for In-Hospital/30-Day Mortality for Percutaneous Coronary Intervention.

Risk models and risk scores derived from those models require periodic updating to account for changes in procedural performance, patient mix, and new risk factors added to existing systems. No risk model or risk score exists for predicting in-hospital/30-day mortality for percutaneous coronary interventions (PCIs) using contemporary data. This study develops an updated risk model and simplified risk score for in-hospital/30-day mortality following PCI. To accomplish this, New York's Percutaneous Coronary Intervention Reporting System was used to develop a logistic regression model and a simplified risk score model for predicting in-hospital/30-day mortality and to validate both models based on New York data from the previous year. A total of 54,770 PCI patients from 2019 were used to develop the models. Twelve different risk factors and 27 risk factor categories were used in the models. Both models displayed excellent discrimination for the development and validation samples (range from 0.894 to 0.896) and acceptable calibration, but the full logistic model had superior calibration, particularly among higher-risk patients. In conclusion, both the PCI risk model and its simplified risk score model provide excellent discrimination and although the full risk model requires the use of a hand-held device for estimating individual patient risk, it provides somewhat better calibration, especially among higher-risk patients.

Ad Hoc Percutaneous Coronary Intervention in Stable Patients With Multivessel or Unprotected Left Main Disease.

BACKGROUND: There is very little information about the use of ad hoc percutaneous coronary intervention (PCI) in stable patients with multivessel (MV) disease or unprotected left main (LM) disease patients for whom a heart team approach is recommended. OBJECTIVE: To identify the extent of ad hoc PCI utilization for patients with multivessel disease or left main disease, and to explore the inter-hospital variation in ad hoc PCI utilization for those patients. METHODS: New York State's cardiac registries were used to examine the use and variation in use of ad hoc PCI for MV/LM disease as a percentage of all MV/LM PCIs and revascularizations (PCIs plus coronary artery bypass graft procedures) during 2018 to 2019 in New York. RESULTS: After exclusions, 6,425 of the 8,196 stable PCI patients with MV/LM disease (78.4%) underwent ad hoc PCI, ranging from 58.7% for patients with unprotected LM disease to 85.4% for patients with 2-vessel proximal left anterior descending (PLAD) disease. Ad hoc PCIs comprised 35.1% of all revascularizations, ranging from 11.5% for patients with unprotected LM disease to 63.9% for patients with 2-vessel PLAD disease. The risk-adjusted utilization of ad hoc PCI as a percentage of all revascularizations varied widely among hospitals (eg, from 15% in the first quartile to 46% in the last quartile for 3-vessel disease). CONCLUSIONS: Ad hoc PCIs occur frequently even among patients with MV/LM disease. This is particularly true among patients with 2-vessel PLAD disease. The frequency of ad hoc PCIs is lower but still high among patients with diabetes and low ejection fraction and higher in hospitals without surgery on-site (SOS). Given the magnitude of hospital- and physician-level variation in the use of ad hoc PCIs for such patients, consideration should be given to a systems approach to achieving heart team consultation and shared decision making that is consistent for SOS and non-SOS hospitals.

Impact of COVID-19 on percutaneous coronary intervention utilization and mortality in New York.

BACKGROUND: COVID-19 has disrupted the care of all patients, and little is known about its impact on the utilization and short-term mortality of percutaneous coronary intervention (PCI) patients, particularly nonemergency patients. METHODS: New York State's PCI registry was used to study the utilization of PCI and the presence of COVID-19 in four patient subgroups ranging in severity from ST-elevation myocardial infarction (STEMI) to elective patients before (December 01, 2018-February 29, 2020) and during the COVID-19 era (March 01, 2020-May 31, 2021), as well as to examine the impact of different COVID severity levels on the mortality of different types of PCI patients. RESULTS: Decreases in the mean quarterly PCI volume from the prepandemic period to the first quarter of the pandemic ranged from 20% for STEMI patients to 61% for elective patients, with the other two subgroups having decreases in between these values. PCI quarterly volume rebounds from the prepandemic period to the second quarter of 2021 were in excess of 90% for all patient subgroups, and 99.7% for elective patients. Existing COVID-19 was rare among PCI patients, ranging from 1.74% for STEMI patients to 3.66% for elective patients. PCI patients with COVID-19 and acute respiratory distress syndrome (ARDS) who were not intubated, and PCI patients with COVID-19 and ARDS who were either intubated or were not intubated because of Do Not Resuscitate//Do Not Intubate status had higher risk-adjusted mortality ([adjusted ORs = 10.81 [4.39, 26.63] and 24.53 [12.06, 49.88], respectively]) than patients who never had COVID-19. CONCLUSIONS: There were large decreases in the utilization of PCI during COVID-19, with the percentage of decrease being highly sensitive to patient acuity. By the second quarter of 2021, prepandemic volumes were nearly restored for all patient subgroups. Very few PCI patients had current COVID-19 throughout the pandemic period, but the number of PCI patients with a COVID-19 history increased steadily during the pandemic. PCI patients with COVID-19 accompanied by ARDS were at much higher risk of short-term mortality than patients who never had COVID-19. COVID-19 without ARDS and history of COVID-19 were not associated with higher mortality for PCI patients as of the second quarter of 2021.

Standardized Criteria for Identification of Cardiac Tamponade on Non-Electrocardiogram-gated Computed Tomography: Correlation With Echocardiographic Findings.

PURPOSE: To identify imaging parameters that can help in the diagnosis of cardiac tamponade on non-electrocardiogram (ECG)-gated computed tomography (CT) of the chest. MATERIALS AND METHODS: Retrospective analysis of 64 patients who had undergone CT and echocardiography for evaluation of cardiac tamponade. Of 64 patients, 34 were diagnosed with tamponade and underwent pericardiocentesis for further diagnosis and treatment. CT measurements obtained were: pericardial effusion (PeEff) pocket size in 6 locations (anterior, posterior, superior, inferior, right, and left lateral), pericardial thickening, diameters of the coronary sinus, upper superior vena cava, lower superior vena cava, and inferior vena cava. In addition, cardiac chamber sizes were measured. Subjective assessment of coronary sinus compression, pericardial enhancement, and pericardial thickening were also recorded. RESULTS: Measurement of the sum of the right lateral and left lateral PeEff thickness resulted in 91.2% sensitivity and 86.7% specificity for cardiac tamponade with a threshold of 30 mm (receiver-operating characteristic area under the curve=0.94 [0.84 to 0.98], P <0.0001). Using the combination of inferior PeEff >16 mm, sum of right lateral and left lateral PeEff>30 mm, and presence of pericardial thickening resulted in 56% sensitivity and 100% specificity and positive predictive value for the determination of cardiac tamponade. CONCLUSIONS: Our study suggests that CT measurements related to PeEff size and thickness aid in the diagnosis of cardiac tamponade.

Triggering of ST-elevation myocardial infarction by ultrafine particles in New York: Changes following Tier 3 vehicle introduction.

BACKGROUND: Previously, we found increased rates of ST-elevation myocardial infarction (STEMI) associated with increased ultrafine particle (UFP; <100 nm) concentrations in the previous few hours in Rochester, New York. Relative rates were higher after air quality policies and a recession reduced pollutant concentrations (2014-2016 versus 2005-2013), suggesting PM composition had changed and the same PM mass concentration had become more toxic. Tier 3 light duty vehicles, which should produce less primary organic aerosols and oxidizable gaseous compounds, likely making PM less toxic, were introduced in 2017. Thus, we hypothesized we would observe a lower relative STEMI rate in 2017-2019 than 2014-2016. METHODS: Using STEMI events treated at the University of Rochester Medical Center (2014-2019), UFP and other pollutants measured in Rochester, a case-crossover design, and conditional logistic regression models, we estimated the rate of STEMI associated with increased UFP and other pollutants in the previous hours and days in the 2014-2016 and 2017-2019 periods. RESULTS: An increased rate of STEMI was associated with each 3111 particles/cm3 increase in UFP concentration in the previous hour in 2014-2016 (lag hour 0: OR = 1.22; 95% CI = 1.06, 1.39), but not in 2017-2019 (OR = 0.94; 95% CI = 0.80, 1.10). There were similar patterns for black carbon, UFP11-50nm, and UFP51-100nm. In contrast, increased rates of STEMI were associated with each 0.6 ppb increase in SO2 concentration in the previous 120 h in both periods (2014-2016: OR = 1.26, 95% CI = 1.03, 1.55; 2017-2019: OR = 1.21, 95% CI = 0.87, 1.68). CONCLUSIONS: Greater rates of STEMI were associated with short term increases in concentrations of UFP and other motor vehicle related pollutants before Tier 3 introduction (2014-2016), but not afterwards (2017-2019). This change may be due to changes in PM composition after Tier 3 introduction, as well as to increased exposure misclassification and greater underestimation of effects from 2017 to 2019.

Relation of Operator Volume and Access Site to Short-Term Mortality in Radial Versus Femoral Access for Primary Percutaneous Coronary Intervention.

The relation between operator volume and mortality of primary percutaneous coronary intervention (PPCI) procedures for ST-elevation myocardial infarction has not been studied comprehensively. This study included patients who underwent PPCI between 2010 and 2017 in all nonfederal hospitals approved to perform PCI in New York State. We compared risk-adjusted in-hospital/30-day mortality for radial access (RA) and femoral access (FA) and the relation between risk-adjusted mortality and procedure volume for each access site. In 44,540 patients in the study period, the use of RA rose from 8% in 2,010% to 43% in 2017 (p <0.0001). There was no significant change in PPCI risk-adjusted mortality during the period (p=0.27 for trend). RA was associated with lower mortality when imposing operator exclusion criteria used in recent trials. There was a significant operator inverse volume-mortality relation for FA procedures but not for RA procedures. FA procedures performed by lower volume FA operators (lowest quartile) were associated with higher risk-adjusted mortality compared with RA procedures (3.71% vs 3.06%, p = 0.01) or compared with FA procedures performed by higher volume FA operators (3.71% vs 3.16%, p = 0.01). In conclusion, in patients with ST-elevation myocardial infarction referred for primary PCI in New York State, there was a significant uptake in the use of RA along with relatively constant in-hospital/30-day mortality. There was a significant inverse operator volume-mortality relation for FA procedures accompanied by higher mortality for FA procedures performed by low volume FA operators than for all other primary PCI procedures. In conclusion, this information underscores the need for operators to remain vigilant in maintaining FA skills and monitoring FA outcomes.

Percutaneous Coronary Intervention With and Without Intravascular Ultrasound for Patients With Complex Lesions: Utilization, Mortality, and Target Vessel Revascularization.

BACKGROUND: Intravascular ultrasound (IVUS) has several benefits during percutaneous coronary interventions (PCIs), including more accurate vessel sizing, improved stent expansion, and better strut apposition. Prior clinical trials have demonstrated a reduction in cardiac events when IVUS is used. However, there is limited information about the utilization of IVUS and the outcomes of IVUS-guided versus angiography-guided PCI in patients with complex lesions in a contemporary population-based setting. METHODS: New York's PCI registry was used to identify 44 305 patients with complex lesions (lesions that complicate stenting or that require multiple stents) undergoing PCI with and without IVUS guidance and discharged between December 1, 2013 and November 30, 2018. Trends and inter-hospital variation in IVUS use were examined. Risk-adjusted mortality and target vessel revascularization were compared. RESULTS: A total of 6174 (13.9%) PCI patients underwent IVUS-guided PCI. The median follow-up period was 2.5 years. The percent of patients with complex lesions who underwent IVUS-guided PCI rose from 13.4% in 2014 to 16.5% in 2018 (P<0.0001 for trend), with the main increases occurring in the last 2 years of the period. Only 31 of 66 hospitals in the study used IVUS for >5% of their study patients. IVUS-guided PCI patients experienced significantly lower mortality (adjusted hazard ratio=0.89 [0.79-0.98] after adjustment using a Cox proportional hazards model, and HR=0.88 [0.78-0.99] for propensity-matched patients). We also found that IVUS-guided PCI patients had a lower rate of target vessel revascularization (adjusted hazard ratio=0.88 [0.80-0.97]) after adjusting using Cox proportional hazards with competing risk of mortality and after propensity matching (0.88 [0.79-0.99]). CONCLUSIONS: Utilization of IVUS for complex lesions has increased but contemporary rates remain low, and there are large inter-hospital variations. The use of IVUS for complex lesions was associated with lower risk of medium-term mortality and target vessel revascularization.

The Association of Socioeconomic Factors With Percutaneous Coronary Intervention Outcomes.

BACKGROUND: Numerous studies have identified the association of socioeconomic factors with outcomes of cardiac surgical procedures. Most have focused on easily measured demographic factors or on socioeconomic characteristics of patients' 5-digit zip codes. The impact of socioeconomic information that is derived from smaller geographic regions has rarely been studied. METHODS: The association of the Area Deprivation Index (ADI) with short-term mortality and readmissions was tested for patients undergoing percutaneous coronary intervention (PCI) in New York while adjusting for numerous patient risk factors, including race, ethnicity, and payer. Changes in hospitals' risk-adjusted outcomes and outlier status with the addition of socioeconomic factors were examined. RESULTS: After adjustment, patients in the 2 most deprived ADI quintiles were more likely to experience in-hospital and 30-day mortality after PCI (adjusted odds ratios [95% confidence intervals] 1.39 [1.18-1.65] and 1.24 [1.03-1.49], respectively), than patients in the first quintile (least deprived). Also, patients in the second and fifth ADI quintiles had higher 30-day readmissions rates than patients in the first quintile (1.12 [1.01-1.25] and 1.17 [1.04-1.32], respectively). Medicare patients had higher mortality and readmission rates, Hispanics had lower mortality, and Medicaid patients had higher readmission rates. CONCLUSIONS: Patients with the most deprived ADIs are more likely to experience short-term mortality and readmissions after PCI. Ethnicity and payer are significantly associated with adverse outcomes even after adjusting for ADI. This information should be considered when identifying patients who are at the highest risk for adverse events after PCI and when risk-adjusting hospital outcomes and assessing quality of care.

Hybrid coronary revascularization vs. percutaneous coronary interventions for multivessel coronary artery disease.

OBJECTIVE: Hybrid coronary revascularization (HCR) combines a minimally invasive surgical approach to the left anterior descending (LAD) artery with percutaneous coronary intervention (PCI) for non-LAD diseased coronary arteries. It is associated with shorter hospital lengths of stay and recovery times than conventional coronary artery bypass surgery, but there is little information comparing it to isolated PCI for multivessel disease. Our objective is to compare long-term outcomes of HCR and PCI for patients with multivessel disease. METHODS: This cohort study used data from New York's cardiac surgery and PCI registries in 2010-2016 to examine mortality and repeat revascularization rates for patients with multivessel coronary artery disease who underwent HCR and PCI. Cox proportional hazards methods were used to reduce selection bias. Patients were followed for a median of four years. RESULTS: There was a total of 335 HCR patients (1.2%) and 25,557 PCI patients (98.8%) after exclusions. There was no difference in 6-year risk adjusted survival between HCR and PCI patients (83.17% vs. 81.65%, adjusted hazard ratio (aHR) = 0.90 (95% CI: 0.67-1.20). However, HCR patients were more likely to be free from repeat revascularization in the LAD artery (91.13% vs. 83.59%, aHR = 0.51 (95% CI: 0.34-0.77)). CONCLUSIONS: For patients with multi-vessel coronary artery disease, HCR is rarely performed. There are no differences in mortality rates after four years, but HCR is associated with lower repeat revascularization rates in the LAD artery, presumably due to better longevity in left arterial mammary grafts.

Sex-Specific Platelet Activation Through Protease-Activated Receptors Reverses in Myocardial Infarction.

OBJECTIVE: The platelet phenotype in certain patients and clinical contexts may differ from healthy conditions. We evaluated platelet activation through specific receptors in healthy men and women, comparing this to patients presenting with ST-segment-elevation myocardial infarction and non-ST-segment-elevation myocardial infarction. Approach and Results: We identified independent predictors of platelet activation through certain receptors and a murine MI model further explored these findings. Platelets from healthy women and female mice are more reactive through PARs (protease-activated receptors) compared with platelets from men and male mice. Multivariate regression analyses revealed male sex and non-ST-segment-elevation myocardial infarction as independent predictors of enhanced PAR1 activation in human platelets. Platelet PAR1 signaling decreased in women and increased in men during MI which was the opposite of what was observed during healthy conditions. Similarly, in mice, thrombin-mediated platelet activation was greater in healthy females compared with males, and lesser in females compared with males at the time of MI. CONCLUSIONS: Sex-specific signaling in platelets seems to be a cross-species phenomenon. The divergent platelet phenotype in males and females at the time of MI suggests a sex-specific antiplatelet drug regimen should be prospectively evaluated.

Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction Before and During COVID in New York.

Little is known about regional differences in volume, treatment, and outcomes of STEMI patients undergoing PCI during the pandemic. The objectives of this study were to compare COVID-19 pandemic and prepandemic periods with respect to regional volumes, outcomes, and treatment of patients undergoing percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) between January 1, 2019 and March 14, 2020 (pre-COVID period) and between March 15, 2020 and April 4, 2020 (COVID period) in 51 New York State hospitals certified to perform PCI. The hospitals were classified as being in either high-density or low-density COVID-19 counties on the basis of deaths/10,000 population. There was a decrease of 43% in procedures/week in high-density COVID-19 counties (p <0.0001) and only 4% in low-density counties (p = 0.64). There was no difference in the change in risk-adjusted in-hospital mortality rates in either type of county, but STEMI PCI patients in high-density counties had longer times from symptom onset to hospital arrival and lower cardiac arrest rates in the pandemic period. In conclusion, the decrease in STEMI PCIs during the pandemic was mainly limited to counties with a high density of COVID-19 deaths. The decrease appears to be primarily related to patients not presenting to hospitals in high-density COVID regions, rather than PCI being avoided in STEMI patients or a reduction in the incidence of STEMI. Also, high-density COVID-19 counties experienced delayed admissions and less severely ill STEMI PCI patients during the pandemic. This information can serve to focus efforts on convincing STEMI patients to seek life-saving hospital care during the pandemic.

Transcatheter aortic valve replacement in left ventricular assist device patient-overcoming the complications with transapical approach and circulatory arrest.

We present the patient with severe aortic insufficiency (AI) 5 years post left ventricular assist device (LVAD) implantation. His management was complicated with unsuccessful percutaneous aortic valve closure attempt, transcatheter aortic valve replacement (TAVR) implantation with a severe paravalvular leak, eventual valve dislodgment into the left ventricle (LV), and LVAD inflow cannula occlusion. We utilized a mini-thoracotomy approach to successfully retrieve the dislodged valve through the LV apex while deploying a valve-in-valve TAVR under direct visualization and deep hypothermic cardiac arrest. This case can serve as an example of the serious pitfalls and potential resolution strategies when treating LVAD-associated AI.

Sex differences in the treatment and outcomes of patients hospitalized with ST-elevation myocardial infarction.

OBJECTIVES: To compare mortality for women and men hospitalized with ST-elevation myocardial infarction (STEMI) by age and revascularization status. BACKGROUND: There is little information on the mortality of men and women not undergoing revascularization, and the impact of age on relative male-female mortality needs to be revisited. METHODS AND RESULTS: An observational database of 23,809 patients with STEMI presenting at nonfederal New York State hospitals between 2013 and 2015 was used to compare risk-adjusted inhospital/30-day mortality for women and men and to explore the impact of age on those differences. Women had significantly higher mortality than men overall (adjusted odds ratio [AOR] = 1.15, 95% CI [1.04, 1.28]), and among patients aged 65 and older. Women had lower revascularization rates in general (AOR = 0.64 [0.59, 0.69]) and for all age groups. Among revascularized STEMI patients, women overall (AOR = 1.30 [1.10, 1.53]) and over 65 had higher mortality than men. Among patients not revascularized, women between the ages of 45 and 64 had lower mortality (AOR = 0.68 [0.48, 0.97]). CONCLUSIONS: Women with STEMI, and especially older women, had higher inhospital/30-day mortality rates than their male counterparts. Women had higher mortality among revascularized patients, but not among patients who were not revascularized.

Assessment of repeat target lesion percutaneous coronary intervention as a quality measure for public reporting and general quality assessment for PCIs.

BACKGROUND: Target lesion percutaneous coronary intervention (TLPCI) within 1 year of PCI has been proposed by critics of public reporting of short-term mortality as an alternative measure for PCI reporting. METHODS: New York's PCI registry was used to identify 1-year repeat TLPCI and 1-year repeat TLPCI/mortality for patients discharged between December 1, 2013 and November 30, 2014. Significant independent predictors of the outcomes were identified. Hospital and cardiologist risk-adjusted outcomes were calculated, and outlier status and correlations of risk-adjusted rates were examined for the three outcomes. RESULTS: The adverse outcome rates were 1.30, 4.21, and 8.97% for in-hospital/30-day mortality, 1-year repeat TLPCI, and 1-year repeat TLPCI/mortality. There were many commonalities but also many differences in significant predictors of the outcomes. Hospital and cardiologist risk-adjusted 1-year repeat TLPCI rates and repeat TLPCI/mortality rates were poorly correlated with risk-adjusted in-hospital/30-day mortality rates (eg, Spearman R = -.16 [p = .23] and .27 [p = .04], respectively, for hospital 1-year repeat TLPCI vs. in-hospital/30-day mortality). Many more providers were found to have significantly higher and lower rates for repeat TLPCI than for short-term mortality. CONCLUSIONS: Hospital and cardiologist quality assessments are very different for TLPCI and repeat TLPCI/mortality than they are for short-term mortality. Repeat TLPCI/mortality rates are highly correlated with repeat TLPCI rates, but outlier providers differ. More study of repeat TLPCI and all the patient, cardiologist, and hospital factors associated with it may be required before using it as a supplement to, or in lieu of, short-term mortality in public reporting of PCI outcomes.

Treatment of Coronary Artery Disease and Acute Myocardial Infarction in Hospitals With and Without On-Site Coronary Artery Bypass Graft Surgery.

BACKGROUND: Many studies have revealed no outcome differences among patients undergoing percutaneous coronary intervention (PCI) in hospitals with and without surgery on-site (SOS), but one earlier study found differences in target vessel PCI rates and in mortality for patients with acute myocardial infarction who did not undergo PCI. It is important to examine outcome differences between SOS and non-SOS hospitals with more contemporary data. METHODS AND RESULTS: A total of 21 924 propensity-matched patients who were discharged between January 1, 2013, and November 30, 2015, who were in the New York PCI registry and other hospital databases were used to compare outcomes in hospitals with and without SOS for all patients and for patients with and without ST-segment-elevation myocardial infarction (STEMI) undergoing PCI. Also, 30-day mortality was compared for patients with STEMI regardless of whether they underwent PCI. For all patients with PCI and patients without STEMI, there were no significant differences in in-hospital/30-day mortality, 2-year mortality, or 2-year repeat target lesion PCI. For patients with STEMI, there were no significant mortality differences between patients in SOS and non-SOS hospitals. Patients with STEMI in SOS hospitals had significantly lower 2-year repeat target lesion PCI rates (adjusted hazard ratio, 0.68 [0.49-0.94]). There was no difference in the percentage of patients undergoing PCI in the 2 types of hospitals (75.7% versus 74.6%; P=0.21) or in 30-day mortality of all patients with STEMI (patients who did and did not undergo PCI, 10.86% versus 11.32%; adjusted odds ratio, 1.06 [0.88-1.29]). CONCLUSIONS: Short-term and long-term outcomes were not different in SOS and non-SOS hospitals except that 2-year repeat target lesion PCI rates were lower in SOS hospitals for patients with STEMI.

Heart Failure After Ischemic Stroke or Transient Ischemic Attack in Insulin-Resistant Patients Without Diabetes Mellitus Treated With Pioglitazone.

BACKGROUND: The IRIS trial (Insulin Resistance Intervention After Stroke) demonstrated that pioglitazone reduced the risk for both cardiovascular events and diabetes mellitus in insulin-resistant patients. However, concern remains that pioglitazone may increase the risk for heart failure (HF) in susceptible individuals. METHODS: In IRIS, patients with insulin resistance but without diabetes mellitus were randomized to pioglitazone or placebo (1:1) within 180 days of an ischemic stroke or transient ischemic attack and followed for ≤5 years. To identify patients at higher HF risk with pioglitazone, we performed a secondary analysis of IRIS participants without HF history at entry. HF episodes were adjudicated by an external review, and treatment effects were analyzed using time-to-event methods. A baseline HF risk score was constructed from a Cox model estimated using stepwise selection. Baseline patient features (individually and summarized in risk score) and postrandomization events were examined as possible modifiers of the effect of pioglitazone. Net cardiovascular benefit was estimated for the composite of stroke, myocardial infarction, and hospitalized HF. RESULTS: Among 3851 patients, the mean age was 63 years, and 65% were male. The 5-year HF risk did not differ by treatment (4.1% pioglitazone, 4.2% placebo). Risk for hospitalized HF was low and not significantly greater in pioglitazone compared with placebo groups (2.9% versus 2.3%, P=0.36). Older age, atrial fibrillation, hypertension, obesity, edema, high C-reactive protein, and smoking were risk factors for HF. However, the effect of pioglitazone did not differ across levels of baseline HF risk (hazard ratio [95% CI] for pioglitazone versus placebo for patients at low, moderate, and high risk: 1.03 [0.61-1.73], 1.10 [0.56-2.15], and 1.08 [0.58-2.01]; interaction P value=0.98). HF risk was increased in patients with versus those without incident myocardial infarction in both groups (pioglitazone: 31.4% versus 2.7%; placebo: 25.7% versus 2.4%; P<0.0001). Edema, dyspnea, and weight gain in the trial did not predict HF hospitalization but led to more study drug dose reduction with a lower mean dose of pioglitazone versus placebo (29±17 mg versus 33±15 mg, P<0.0001). Pioglitazone reduced the composite outcome of stroke, myocardial infarction, or hospitalized HF (hazard ratio, 0.78; P=0.007). CONCLUSIONS: In IRIS, with surveillance and dose adjustments, pioglitazone did not increase the risk of HF and conferred net cardiovascular benefit in patients with insulin resistance and cerebrovascular disease. The risk of HF with pioglitazone was not modified by baseline HF risk. The IRIS experience may be instructive for maximizing the net benefit of this therapy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00091949.

2017 Versus 2012 Appropriate Use Criteria for Percutaneous Coronary Interventions: Impact on Appropriateness Ratings.

OBJECTIVES: The purpose of this study is to revisit cases rated as "inappropriate" in the 2012 appropriate use criteria (AUC) using the 2017 AUC. BACKGROUND: AUC for coronary revascularization in patients with stable ischemic heart disease (SIHD) were released in January 2017. Earlier 2012 AUC identified a relatively high percentage of New York State patients for whom percutaneous coronary intervention (PCI) was rated as "inappropriate" versus optimal medical therapy alone. METHODS: New York State's PCI registry was used to rate inappropriateness of patients undergoing PCI in 2014 using the 2012 and 2017 AUC, and to examine patient characteristics for patients rated differently. RESULTS: A total of 911 of 9,261 (9.8%) patients who underwent PCI in New York State in 2014 with SIHD without prior coronary artery bypass grafting were rated as "inappropriate" using the 2012 AUC, but only 171 (1.8%) patients were rated as "rarely appropriate" ("inappropriate" in 2012 AUC terminology) using the 2017 AUC. A total of 26% of all 8,407 patients undergoing PCI in New York State with 1- to 2-vessel SIHD were without high-risk findings on noninvasive testing and were either asymptomatic or without antianginal therapy. No current or past randomized controlled trials have focused on these patients. CONCLUSIONS: The percentage of 2014 New York State PCI patients with SIHD who are rated "rarely appropriate" has decreased substantially using 2017 AUC in comparison with the older 2012 AUC. However, for many low-risk patients undergoing the procedure, the relative benefits of optimal medical therapy with and without PCI are unknown. Randomized controlled trials are needed to study these groups.

Daily land use regression estimated woodsmoke and traffic pollution concentrations and the triggering of ST-elevation myocardial infarction: a case-crossover study.

Prior work has reported acute associations between ST-elevation myocardial infarction (STEMI) and short-term increases in airborne particulate matter. Subsequently, the association between STEMI and hourly measures of Delta-C (marker of woodsmoke) and black carbon (marker of traffic pollution) measured at a central site in Rochester, NY, were examined, but no association was found. Therefore, land use regression estimates of Delta-C and black carbon concentrations at each patient's residence were developed for 246 STEMI patients treated at the University of Rochester Medical Center during the winters of 2008-2012. Using case-crossover methods, the rate of STEMI associated with increased Delta-C and BC concentration on the same and previous 3 days was estimated after adjusting for 3-day mean temperature and relative humidity. Non-statistically significant increased rates of STEMI associated with interquartile range increases in concentrations of BC in the previous 2 days (1.10 µg/m3; OR = 1.12; 95% CI 0.93, 1.35) and Delta-C in the previous 3 days (0.43 µg/m3; OR = 1.16; 95% CI 0.96, 1.40) were found. Significantly increased rates of STEMI associated with interquartile range increases in concentrations of BC (1.23 µg/m3; OR = 1.04; 95% CI = 0.87, 1.24) or Delta-C (0.40 µg/m3; OR = 0.94; 95% CI = 0.85, 1.09) on the same day were not observed likely due, in part, to temporal misalignment. Therefore, sophisticated spatial-temporal models will be needed to minimize exposure error and bias by better predicting concentrations at individual locations for individual hours, especially for outcomes with short-term responses to air pollution (< 24 h).