Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

Frailty and cardiovascular outcomes in the National Health and Aging Trends Study.

AIMS: Physical frailty is a commonly encountered geriatric syndrome among older adults without coronary heart disease (CHD). The impact of frailty on the incidence of long-term cardiovascular outcomes is not known.We aimed to evaluate the long-term association of frailty, measured by the Fried frailty phenotype, with all-cause-mortality and MACE among older adults without a history of CHD at baseline in the National Health and Aging Trends Study. METHODS AND RESULTS: We used the National Health and Aging Trends Study, a prospective cohort study linked to a Medicare sample. Participants with a prior history of CHD were excluded. Frailty was measured during the baseline visit using the Fried physical frailty phenotype. Cardiovascular outcomes were assessed during a 6-year follow-up.Of the 4656 study participants, 3259 (70%) had no history of CHD 1 year prior to their baseline visit. Compared to those without frailty, subjects with frailty were older (mean age 82.1 vs. 75.1 years, P < 0.001), more likely to be female (68.3% vs. 54.9%, P < 0.001), and belong to an ethnic minority. The prevalence of hypertension, falls, disability, anxiety/depression, and multimorbidity was much higher in the frail and pre-frail than the non-frail participants. In a Cox time-to-event multivariable model and during 6-year follow-up, the incidences of death and of each individual cardiovascular outcomes were all significantly higher in the frail than in the non-frail patients including major adverse cardiovascular event (MACE) [hazard ratio (HR) 1.77, 95% confidence interval (CI) 1.53, 2.06], death (HR 2.70, 95% CI 2.16, 3.38), acute myocardial infarction (HR 1.95, 95% CI 1.31, 2.90), stroke (HR 1.71, 95% CI 1.34, 2.17), peripheral vascular disease (HR 1.80, 95% CI 1.44, 2.27), and coronary artery disease (HR 1.35, 95% CI 1.11, 1.65). CONCLUSION: In patients without CHD, frailty is a risk factor for the development of MACEs. Efforts to identify frailty in patients without CHD and interventions to limit or reverse frailty status are needed and, if successful, may limit subsequent adverse cardiovascular events.

Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States.

BACKGROUND: We examined the outcomes of older adults undergoing nontrans-femoral (non-TF) transcatheter aortic valve replacement (TAVR) procedures including trans-apical (TA), trans-aortic (TAo), trans-subclavian (TSub), and trans-carotid (TCa) techniques. METHODS AND RESULTS: This is an observational study of all consecutive older patients who underwent non-TF TAVR for symptomatic severe AS with Edwards Sapien (ES), Medtronic CoreValve, ES3 or Lotus Valve at three centers in France and the United States from 04/2008 to 02/2017. Baseline characteristics and clinical outcomes were defined according to VARC-2 criteria. Of 857 patients who received TAVR, 172 (20%) had an alternative access procedure. Of these, 45 (26%) were TA, 67 (39%) TAo, 17 (10%) TSub, and 43 (25%) TCa procedures. The preference for non-TF access site was different between the two countries (US: TA 39%, TAo 52%, TSub 9%; TCa 0% vs. France: TA 9%, TAo 23%, TSub 11%, and TCa 57%, P-value < .001). Most patients who underwent TAo TAVR were older women (median age: TA 82, TAo 84, TSub 81, TCa 81, P-value = 0.043; female gender: TA 32 (27%), TAo 30 (55%), TSub 10 (41%), TCa 27 (37%), P-value = .021). The predicted Society of Thoracic Surgery risk of mortality was similar among groups (TA 7%, TAo 7%, TSub 6%, TCa 7%, P-value= .738). No differences were observed in the frequency of para-valvular leak, intra-procedural bleeding, vascular complications, conversion to open-heart surgery, or development of acute kidney injury. The highest in-hospital mortality was observed in the TAo group (TA 2%, TAo 15%, TSub 0%, TCa 2%, P-value = .014). However, hospital length of stay, one-month, and one-year mortality were similar among non-TF techniques. CONCLUSION: Although regional differences exist in the choice of alternative access techniques, centers with high technical expertise can provide a safe alternative to traditional TF TAVR. TAo TAVR was associated with higher in-hospital mortality than other non-TF approaches, and this may have reflected patient rather than procedural factors. All alternative access techniques had similar mortality rates and clinical outcomes at one-year follow-up. Trans-carotid access is safe and feasible compared to other non-TF access techniques.

Contemporary risk model for inhospital major bleeding for patients with acute myocardial infarction: The acute coronary treatment and intervention outcomes network (ACTION) registry®-Get With The Guidelines (GWTG)®.

BACKGROUND: Major bleeding is a frequent complication for patients with acute myocardial infarction (AMI) and is associated with significant morbidity and mortality. OBJECTIVE: To develop a contemporary model for inhospital major bleeding that can both support clinical decision-making and serve as a foundation for assessing hospital quality. METHODS: An inhospital major bleeding model was developed using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database. Patients hospitalized with AMI between January 1, 2012 and December 31, 2013 across 657 hospitals were used to create a derivation cohort (n=144,800) and a validation cohort (n=96,684). Multivariable hierarchal logistic regression was used to identify significant predictors of major bleeding. A simplified risk score was created to enable prospective risk stratification for clinical care. RESULTS: The rate of major bleeding in the overall population was 7.53%. There were 8 significant, independent factors associated with major bleeding: presentation after cardiac arrest (OR 2.99 [2.77-3.22]); presentation in cardiogenic shock (OR 2.22 [2.05-2.40]); STEMI (OR 1.72 [1.65-1.80]); presentation in heart failure (OR 1.55 [1.47-1.63]); baseline hemoglobin less than 12 g/dL (1.55 [1.48-1.63]); heart rate (per 10 beat per minute increase) (OR 1.13 [1.12-1.14]); weight (per 10 kilogram decrease) (OR 1.12 [1.11-1.14]); creatinine clearance (per 5-mL decrease) (OR 1.07 [1.07-1.08]). The model discriminated well in the derivation (C-statistic = 0.74) and validation (C-statistic = 0.74) cohorts. In the validation cohort, a risk score for major bleeding corresponded well with observed bleeding: very low risk (2.2%), low risk (5.1%), moderate risk (10.1%), high risk (16.3%), and very high risk (25.2%). CONCLUSION: The new ACTION Registry-GWTG inhospital major bleeding risk model and risk score offer a robust, parsimonious, and contemporary risk-adjustment method to support clinical decision-making and enable hospital quality assessment. Strategies to mitigate risk should be developed and tested as a means to lower costs and improve outcomes in an era of alternative payment models.

New-onset versus prior history of atrial fibrillation: Outcomes from the AFFIRM trial.

BACKGROUND: There are limited data on prognosis and outcomes of patients with new-onset atrial fibrillation (AF) compared with those with a prior history of AF. METHODS AND RESULTS: We conducted a comparison of these 2 groups in the AFFIRM trial. New-onset AF was the qualifying arrhythmia in 1,391 patients (34%). Compared with patients with prior history of AF, patients with new-onset AF were more likely to have a history of heart failure. There was no mortality difference between rate control (RaC) and rhythm control (RhC) among patients with new-onset AF (17% vs 20%, P = .152). In the univariate model, new-onset AF was associated with increased risk of mortality compared with history of prior AF (RaC unadjusted hazard ratio [HR] 1.36 [P = .010], RhC unadjusted HR 1.39 [P = .003]). However, after multivariate adjustments, new-onset AF did not carry an increased risk of mortality (RaC adjusted HR 1.14 [P = .370], RhC adjusted HR 1.16 [P = .248]). Subjects with new-onset AF randomized to the RhC arm were more likely to remain in normal sinus rhythm at follow-up (adjusted HR 0.79, P = .012) compared with patients with prior history of AF. CONCLUSIONS: In a multivariable analysis adjusting for confounders, new-onset AF was not associated with increased mortality compared with prior history of AF regardless of the treatment strategy. Patients with new-onset AF treated with the rhythm control strategy were more likely to remain in normal sinus rhythm on follow-up.

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.

Safety of transradial cardiac catheterization in patients with end-stage liver disease.

BACKGROUND: Transradial access may be advantageous for patients with end-stage liver disease (ESLD) who need to undergo left heart catheterization (LHC). We aimed to assess the safety of transradial cardiac catheterization in patients listed for orthotopic liver transplantation. METHODS: This is a retrospective analysis of consecutive adult patients with the diagnosis of ESLD, who underwent LHC via transradial access as part of a pre-operative liver transplantation evaluation. All the patients also underwent right heart catheterization (RHC) via brachial or femoral vein. The primary outcome measure was procedure-related major bleeding. Secondary outcomes included access site minor bleeding, in-hospital mortality, radial access failure, and acute kidney injury. RESULTS: A total of 82 consecutive patients with ESLD, who underwent LHC via transradial access, were enrolled in the study. All patients also underwent RHC (n = 45 via brachial and n = 37 via femoral vein). The median age was 59 (54, 67) years old, and 58% were male. History of coronary artery disease or heart failure was present in 17% of patients. The median MELD score was 19 (13, 24.5), baseline hemoglobin was 10.5 mg/dL (9.4, 11.8), INR was 1.4 (1.2, 1.8) and platelets were 74,000 (53,000, 117,000)/mm(3) . The most common etiology of liver failure was viral hepatitis (51%), followed by alcoholic cirrhosis (24%) and non-alcoholic steatohepatitis (21%). Angiographically significant coronary artery disease was present in 17 (21%) patients. Major bleeding and acute kidney injury each occurred in two patients (2.4%). There were no instances of vascular complications. There were no deaths attributable to complications from cardiac catheterization. CONCLUSION: Upper extremity right and left heart catheterization appears to be a safe method to evaluate coronary anatomy and hemodynamics in a severely ill population of patients with ESLD awaiting transplant.

Impact of CMS coverage decision on access to transcatheter aortic valve replacement.

OBJECTIVES: To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. BACKGROUND: TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. MATERIALS AND METHODS: A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. RESULTS: Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. CONCLUSIONS: After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women. © 2014 Wiley Periodicals, Inc.

Comparative safety of vascular closure devices and manual closure among patients having percutaneous coronary intervention.

BACKGROUND: The role of vascular closure devices (VCDs) in patients having percutaneous coronary intervention (PCI) is controversial, and recommendations for use vary. OBJECTIVE: To examine the use of and outcomes associated with VCDs in real-world practice. DESIGN: Observational cohort study. SETTING: 32 hospitals in Michigan that participate in a large multicenter quality improvement collaborative. PATIENTS: Consecutive patients having emergent and nonemergent PCI from 2007 to 2009. MEASUREMENTS: Vascular complications and the need for transfusion. RESULTS: Of the 85 048 PCIs performed during the study that met the inclusion criteria, 28 528 (37%) procedures used VCDs. In propensity score-matched analysis, VCDs were associated with reductions in vascular complications (odds ratio [OR], 0.78 [95% CI, 0.67 to 0.90]; P = 0.001) and postprocedure transfusions (OR, 0.85 [CI, 0.74 to 0.96]; P = 0.011). These findings were consistent across many prespecified subgroups except for patients with a body mass index (BMI) less than 25 kg/m2 and those treated with platelet glycoprotein (GP) IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated. When the specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR, 0.69 [CI, 0.58 to 0.83]; P < 0.001) or pseudoaneurysms (OR, 0.54 [CI, 0.38 to 0.76]; P < 0.001) but an increase in the odds of retroperitoneal bleeding (OR, 1.57 [CI, 1.12 to 2.20]; P = 0.009). LIMITATION: Unmeasured confounding cannot be excluded despite the study having measured and balanced many confounders. CONCLUSION: Vascular closure devices were associated with a significant reduction in vascular complications and need for transfusion in this large cohort of patients having transfemoral PCI. This benefit was lost in patients receiving GP IIb/IIIa inhibitors and those with normal or lean BMI and was counterbalanced by a small increase in the more serious risk for retroperitoneal bleeding.

Current medical management of stable coronary artery disease before and after elective percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD) is not superior to optimal medical therapy. It remains unclear if patients who receive PCI for stable CAD are receiving appropriate medical therapy. METHODS: We evaluated the medical management of 60,386 patients who underwent PCI for stable CAD between 2004 and 2009. We excluded patients with contraindications to aspirin, clopidogrel, statins, or ß-blockers (BBs). We defined essential medical therapy of stable CAD as treatment with aspirin, statin, and BB before PCI and treatment with aspirin, clopidogrel, and statin after PCI. RESULTS: Essential medical therapy was used in 53.0% of patients before PCI and 82.1% at discharge. Aspirin was used in 94.8% patients before PCI and 98.3% of after PCI. Statins were used in 69.5% of patients before PCI and 84.5% after PCI. ß-Blockers were used in 72.8% of patients before PCI. Clopidogrel was used in 97.3% of patients after PCI. Patients with a history of myocardial infarction or revascularization before PCI had better medical therapy compared with patients without such a history (62.8% vs 34.3% [P < .001] before PCI and 83.6% vs 79.1% [P < .001] after PCI). After adjusting for confounders and clustering, women (odds ratio 0.74, 95% CI 0.71-0.78) and patients on dialysis (odds ratio 0.68, 95% CI 0.57-0.80) were less likely to receive a statin at discharge. CONCLUSIONS: Medical therapy remains underused before and after PCI for stable CAD. Women are less likely to receive statin therapy. There are significant opportunities to optimize medical therapy in patients with stable CAD.

Differences in the outcome of patients undergoing percutaneous coronary interventions at teaching versus non-teaching hospitals.

BACKGROUND: Teaching hospitals have superior outcomes for major medical conditions including cardiovascular disease compared to non-teaching hospitals. This may not be applicable to invasive cardiac procedures given a potential increase in complications due to trainee participation. METHODS: We assessed the impact of hospital teaching status on the outcome of 89,048 patients who underwent percutaneous coronary intervention (PCI). Teaching hospitals were defined as trainee involvement in greater than 50% of PCIs conducted at that hospital and corresponded to teaching status granted by national accreditation agencies. Unadjusted and risk adjusted analyses were used to determine differences in process of care, morbidity and mortality. RESULTS: Of 89,048 patients studied, 30,870 received their PCI at teaching hospitals and 58,178 at non-teaching hospitals. Risk-adjusted analysis showed no significant difference in death, in-hospital myocardial infarction, contrast induced nephropathy or gastrointestinal bleeding between teaching and non-teaching hospitals. PCI at teaching hospitals was associated with a lower rate of emergency coronary artery bypass grafting (OR, 0.63; 95% CI, 0.49-0.83; P = .0009) and an increased rate of vascular complications (OR, 1.33; 95% CI, 1.21-1.46; P < .0001). CONCLUSIONS: General outcomes of patients undergoing PCI are similar across hospital types. However, PCI at teaching hospitals is associated with increased risk of vascular complications and reduced risk of emergency coronary artery bypass grafting compared to non-teaching hospitals.

The association between patient race, treatment, and outcomes of patients undergoing contemporary percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

BACKGROUND: The aim of this study was to examine if racial disparities exist in the treatment and outcomes of patients undergoing contemporary percutaneous coronary intervention (PCI). METHODS: We examined the association between race, process of care, and outcomes of patients undergoing PCI between January 1, 2010, and December 31, 2011, and enrolled in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. We used propensity matching to compare the outcome of black and white patients. RESULTS: The study cohort comprised 65,175 patients, of whom 6,873 (10.5%) were black and 55,789 (85.6%) were white. Black patients were more likely to be younger, be female, have more comorbidities, and be uninsured. Overall, black patients were less likely to receive prasugrel (10.0% vs 14.5%, P < .001) and drug-eluting stents (62.5% vs 67.7%, P < .001), largely related to lower use of these therapies in hospitals treating a higher proportion of black patients. No differences were seen between white and black patients with regard to inhospital mortality (odds ratio 1.34, 95% CI 0.82-2.2, P = .24), contrast-induced nephropathy (OR 1.06, 95% CI 0.81-1.40, P = .67), and need for transfusion (OR 1.27, 95% CI 0.98-1.64, P = .06). White race was associated with increased odds of heart failure (OR 1.48, 95% CI 1.05-2.08, P = .024) and vascular complications (OR 1.40, 95% CI 1.03-1.90, P = .032). CONCLUSIONS: Compared with white patients, black patients undergoing PCI have a greater burden of comorbidities but, after adjusting for these differences, have similar inhospital survival and lower odds of vascular complications and heart failure after PCI.

The changing definition of contrast-induced nephropathy and its clinical implications: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

BACKGROUND: The traditional definition of contrast-induced nephropathy (CIN) has been an absolute rise of serum creatinine (Cr) of ≥0.5 mg/dL, although most recent clinical trials have included a ≥25% increase from baseline Cr. The clinical implication of this definition change remains unknown. METHODS AND RESULTS: We compared the association of the two definitions with risk of death or need for dialysis among 58,957 patients undergoing percutaneous coronary intervention in 2007 to 2008 in a large collaborative registry. Patients with a preexisting history of renal failure requiring dialysis were excluded. Contrast-induced nephropathy as defined by a rise in Cr ≥0.5 mg/dL (CIN(Traditional)) developed in 1,601, whereas CIN defined either as Cr ≥0.5 mg/dL or ≥25% increase in baseline Cr (CIN(New)) developed in 4,308 patients. Patients meeting the definition of CIN(New) but not CIN(Traditional) were classified as CIN(Incremental) (n = 2,707). Compared with CIN(New), CIN(Traditional) was more commonly seen in patients with abnormal renal function, which was more likely to develop in patients with normal renal function at baseline. Compared with CIN(Incremental), patients meeting the definition of CIN(Traditional) were more likely to die (16.7% vs 1.7%) and require in-hospital dialysis (9.8% vs 0%). CONCLUSIONS: Our data suggest that the traditional definition of CIN (a rise in Cr of ≥0.5 mg/dL) in patients undergoing PCI is superior to ≥25% increase in Cr at identifying patients at greater risk for adverse renal and cardiac events.

Racial and ethnic differences in the treatment of acute myocardial infarction: findings from the Get With the Guidelines-Coronary Artery Disease program.

BACKGROUND: Racial/ethnic differences in cardiovascular care have been well documented. We sought to determine whether racial/ethnic differences in evidence-based acute myocardial infarction care persist among hospitals participating in a national quality improvement program. METHODS AND RESULTS: We analyzed 142 593 acute myocardial infarction patients (121 528 whites, 10 882 blacks, and 10 183 Hispanics) at 443 hospitals participating in the Get With the Guidelines-Coronary Artery Disease (GWTG-CAD) program between January 2002 and June 2007. We examined individual and overall composite rates of defect-free care, defined as the proportion of patients receiving all eligible performance measures. In addition, we examined temporal trends in use of performance measures according to race/ethnicity by calendar quarter. Overall, individual performance measure use was high, ranging from 78% for use of angiotensin-converting enzyme inhibitors to 96% for use of aspirin at discharge. Use of each of these improved significantly over the 5 years of study. Overall, defect-free care was 80.9% for whites, 79.5% for Hispanics (adjusted odds ratio versus whites 1.00, 95% confidence interval 0.94 to 1.06, P=0.94), and 77.7% for blacks (adjusted odds ratio versus whites 0.93, 95% confidence interval 0.87 to 0.98, P=0.01). A significant gap in defect-free care was observed for blacks mostly during the first half of the study, which was no longer present during the remainder of the study. Overall, progressive improvements in defect-free care were observed regardless of race/ethnic groups. CONCLUSIONS: Among hospitals engaged in a national quality monitoring and improvement program, evidence-based care for acute myocardial infarction appeared to improve over time for patients irrespective of race/ethnicity, and differences in care by race/ethnicity care were reduced or eliminated.

Trends and disparities in referral to cardiac rehabilitation after percutaneous coronary intervention.

BACKGROUND: Despite the known benefits of cardiac rehabilitation in patients with coronary artery disease, referral rates to rehabilitation programs remain low. We determined the incidence and determinants of cardiac rehabilitation referral rates for patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: The incidence and predictors of referral to cardiac rehabilitation were assessed among 145,661 consecutive patients undergoing PCI and surviving to hospital discharge across 31 hospitals in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium between 2003 and 2008. The 6-year cardiac rehabilitation referral rate was 60.2%. Younger age, male gender, white race, and presentation with acute or severe disease (ie, acute myocardial infarction [AMI] in the previous 24 hours and ST-elevation myocardial infarction) were associated with increased referral to rehabilitation (all P < .0001). Most medical comorbidities were associated with decreased referral. Referral rates for cardiac rehabilitation were below the rates of other AMI quality-of-care indicators and more variable across hospital sites. Race-specific referral rates differed significantly in the lowest referring hospitals (P < .0001) but not in the highest referring hospitals (P = .16). Women had a 0.7% relative decrease in referral as compared to men (P = .0188) in the highest referring hospitals but a 26.7% relative decrease in referral in the lowest referring hospitals (P = .02). CONCLUSIONS: Over one third of patients undergoing PCI are not referred for cardiac rehabilitation. Referral rates are below the rates of other AMI quality-of-care performance measures and more variable across sites. Racial and gender disparities in referral to rehabilitation exist but are concentrated at the lowest referring hospitals.

The association of sex with outcomes among patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction in the contemporary era: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

BACKGROUND: historically, women with ST elevation myocardial infarction (STEMI) have had a higher mortality compared with men. It is unclear if these differences persist among patients undergoing contemporary primary percutaneous coronary intervention (PCI) with focus on early reperfusion. METHODS: we assessed the impact of sex on the outcome of 8,771 patients with acute STEMI who underwent primary PCI from 2003 to 2008 at 32 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. A propensity-matched analysis was performed to adjust for differences in baseline characteristics and comorbidities between men and women. RESULTS: twenty-nine percent of the cohort was female. Compared with men, women were older and had more comorbidity. Female sex was associated with a higher unadjusted in-hospital mortality (6.02% vs 3.45%, odds ratio [OR] 1.79, 95% CI 1.45-2.22, P < .0001) and higher risk of contrast-induced nephropathy (OR 1.75, P < .0001), vascular complications (OR 2.13, P < .0001), and postprocedure transfusion (OR 2.84, P < .0001). The gap in sex-specific mortality narrowed over time. In a propensity-matched analysis, female sex was associated with a higher rate of transfusion (OR 1.88, 95% CI 1.57-2.24, P < .0001) and vascular complications (OR 1.65, 95% CI 1.26-2.14, P < .0002); but there was no difference in mortality (OR 1.30, 95% CI 0.98-1.72, P = .07). CONCLUSIONS: women make up approximately one third of patients undergoing primary PCI for STEMI. Female sex is associated with an apparent hazard of increased mortality among patients undergoing primary PCI for STEMI, but this difference is likely explained by older age and worse baseline comorbidities among women.

Effect of performing real time three-dimensional transesophageal echocardiography in addition to two-dimensional transesophageal echocardiography on operator diagnostic confidence.

BACKGROUND: This study evaluates the effects of performing real time three-dimensional transesophageal echocardiography in addition to conventional two-dimensional transesophageal echocardiography on diagnostic confidence. METHODS: Operator diagnostic confidence in addressing clinical questions posed by the referral was scored using a five-point scale for two-dimensional transesophageal echocardiography alone and the combination of two-dimensional and real time three-dimensional transesophageal echocardiography in 136 consecutive patients undergoing examination in an academic hospital. RESULTS: Mean diagnostic confidence score was higher for the combined studies compared to two-dimensional transesophageal echocardiography alone (4.5 vs. 4.1, P < 0.001)). The addition of real time three-dimensional transesophageal echocardiography increased diagnostic confidence score in 45 (33.1%) patients, and the percentage of studies with total diagnostic confidence rose from 40.4% with two-dimensional transesophageal echocardiography alone to 65.4% after performing real time three-dimensional transesophageal echocardiography. Type of clinical indication was associated with improved score by the combined exams (P < 0.004). The addition of real time three-dimensional transesophageal echocardiography was most likely to improve diagnostic confidence score in studies performed to assess valve disease (56.1%) and least likely in examinations performed for intracardiac infection (14.9%). The location (anterior or posterior) of the primary cardiac pathology was not associated with improved score by the combined studies (P = 0.498). CONCLUSIONS: The addition of real time three-dimensional transesophageal echocardiography to two-dimensional transesophageal echocardiography increases diagnostic confidence in examinations routinely performed in an academic practice. Further studies of the impact of real time three-dimensional transesophageal echocardiography on patient management, outcomes and displacement of or need for downstream testing are warranted.

Physical Frailty Phenotype and the Development of Geriatric Syndromes in Older Adults with Coronary Heart Disease.

BACKGROUND: Frailty, a clinical state of vulnerability, is associated with subsequent adverse geriatric syndromes in the general population. We examined the long-term impact of frailty on geriatric outcomes among older patients with coronary heart disease. METHODS: We used the National Health and Aging Trends Study, a prospective cohort study linked to a Medicare sample. Coronary heart disease was identified by self-report or International Classification of Diseases (ICD) codes 1-year prior to the baseline visit. Frailty was measured using the Fried physical frailty phenotype. Geriatric outcomes were assessed annually during a 6-year follow-up. RESULTS: Of the 4656 participants, 1213 (26%) had a history of coronary heart disease 1-year prior to their baseline visit. Compared to those without frailty, subjects with frailty were older (ages ≥75: 80.9% vs 68.9%, P < 0.001), more likely to be female, and belong to an ethnic minority. The prevalence of hypertension, stroke, falls, disability, anxiety/depression, and multimorbidity were much higher in the frail, than nonfrail, participants. In a discrete time survival model, the incidence of geriatric syndromes during 6-year follow-up including 1) dementia, 2) loss of independence, 3) activities of daily living disability, 4) instrumental activities of daily living disability, and 5) mobility disability were significantly higher in the frail than in the nonfrail older patients with coronary heart disease. CONCLUSION: In patients with coronary heart disease, frailty is a risk factor for the accelerated development of geriatric outcomes. Efforts to identify frailty in the context of coronary heart disease are needed, as well as interventions to limit or reverse frailty status for older patients with coronary heart disease.

Gender differences in adverse outcomes after contemporary percutaneous coronary intervention: an analysis from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) percutaneous coronary intervention registry.

BACKGROUND: Prior studies have shown a relationship between female gender and adverse outcomes after percutaneous coronary interventions (PCIs). Whether this relationship still exists with contemporary PCI remains to be determined. METHODS: We evaluated gender differences in clinical outcomes in a large registry of contemporary PCI. Data were prospectively collected from 22,725 consecutive PCIs in a multicenter regional consortium (Blue Cross Blue Shield of Michigan Cardiovascular Consortium) between January 2002 and December 2003. The primary end point was in-hospital all-cause mortality; other clinical outcomes evaluated included in-hospital death, vascular complications, transfusion, postprocedure myocardial infarction, stroke, and a combined major cardiovascular adverse event (MACE) end point including myocardial infarction, death, stroke, emergency coronary artery bypass grafting, and repeated PCI at the same site. Independent predictors of adverse outcomes were identified using multivariate logistic regression analysis. RESULTS: Compared with men, women were older, had a higher prevalence of comorbidities, and had a significantly higher frequency of adverse outcomes after PCI. After adjustment for baseline demographics, comorbidities, clinical presentation, and lesion characteristics, female gender was associated with an increased risk of in-hospital death, vascular complication, blood transfusion, stroke, and MACE. The relationship between female gender and increased risk of death and MACE was no longer present after further adjustment for kidney function and low body surface area. CONCLUSIONS: Differences in mortality rates between men and women no longer exist after PCI. However, our data suggest that technological advancements have not completely offset the relationship between gender and adverse outcomes after PCI.

Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for acute ST elevation MI: a meta-analysis of randomized controlled trials.

BACKGROUND: Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI. METHODS: Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models. RESULTS: There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07). CONCLUSIONS: Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.