E. Scott Monrad

Outcome and profile of ventricular septal rupture with cardiogenic shock after myocardial infarction: a report from the SHOCK Trial Registry☆

OBJECTIVES We wished to assess the profile and outcomes of patients with ventricular septal rupture (VSR) in the setting of cardiogenic shock (CS) complicating acute myocardial infarction (MI). BACKGROUND Cardiogenic shock is often seen with VSR complicating acute MI. Despite surgical therapy, mortality in such patients is high. METHODS We analyzed 939 patients enrolled in the SHOCK Trial Registry of CS in acute infarction, comparing 55 patients whose shock was associated with VSR with 884 patients who had predominant left ventricular failure. RESULTS Rupture occurred a median 16 h after infarction. Patients with VSR tended to be older (p = 0.053), were more often female (p = 0.002) and less often had previous infarction (p < 0.001), diabetes mellitus (p = 0.015) or smoking history (p = 0.033). They also underwent right-heart catheterization, intra-aortic balloon pumping and bypass surgery significantly more often. Although patients with rupture had less severe coronary disease, their in-hospital mortality was higher (87% vs. 61%, p < 0.001). Surgical repair was performed in 31 patients with rupture (21 had concomitant bypass surgery); 6 (19%) survived. Of the 24 patients managed medically, only 1 survived. CONCLUSIONS There is a high in-hospital mortality rate when CS develops as a result of VSR. Ventricular septal rupture may occur early after infarction, and women and the elderly may be more susceptible. Although the prognosis is poor, surgery remains the best therapeutic option in this setting.

Effect of Physician Volume on the Relationship Between Hospital Volume and Mortality During Primary Angioplasty

OBJECTIVES We sought to examine the combined effect of hospital and physician volume of primary percutaneous coronary intervention (PCI) on in-hospital mortality. BACKGROUND An inverse relationship between volume and outcome has been observed for both hospitals and physicians after primary PCI for acute myocardial infarction. METHODS Using the New York State PCI registry, we examined yearly hospital volume, physician volume, and risk-adjusted mortality in 7,321 patients undergoing primary PCI for acute myocardial infarction. Risk-adjusted mortality rates for high-volume hospitals (>50 cases/year) and high-volume physicians (>10 cases/year) were compared with their respective low-volume counterparts. RESULTS Primary PCI by high-volume hospitals (odds ratio [OR]: 0.58; 95% confidence interval [CI]: 0.38 to 0.88) and high-volume physicians (OR: 0.66; 95% CI: 0.48 to 0.92) was associated with lower odds of mortality. Furthermore, there was a significant interaction between hospital and physician volume on adjusted mortality (p = 0.02). Although unadjusted mortality was lower when primary PCI was performed by high-volume physicians in high-volume hospitals compared with low-volume physicians in low-volume hospitals (3.2% vs. 6.7%, p = 0.03), the risk-adjusted mortality rate was not statistically significant (3.8% vs. 8.4%, p = 0.09). In low-volume hospitals, the average risk-adjusted mortality rate for low-volume physicians was 8.4% versus 4.8% for high-volume physicians (OR: 1.44; 95% CI: 0.68 to 3.03). However, in high-volume hospitals, the risk-adjusted mortality rate for high-volume physicians was 3.8% versus 6.5% for low-volume physicians (OR: 0.58; 95% CI: 0.39 to 0.86). CONCLUSIONS During primary PCI, physician experience significantly modifies the hospital volume-outcome relationship. Therefore, policymakers need to consider physician experience when developing strategies to improve access to primary PCI.

Absence of Gender Differences in Clinical Outcomes in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction A Report From the SHOCK Trial Registry

OBJECTIVES The aim of this study was to assess the impact of gender on clinical course and in-hospital mortality in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). BACKGROUND Previous studies have demonstrated higher mortality for women compared with men with ST elevation myocardial infarctions and higher rates of CS after AMI. The influence of gender and its interaction with various treatment strategies on clinical outcomes once CS develops is unclear. METHODS Using the SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? (SHOCK) Registry database of 1,190 patients with suspected CS in the setting of AMI, we examined shock etiologies by gender. Among the 884 patients with predominant left ventricular (LV) failure, we compared the patient demographics, angiographic and hemodynamic findings, treatment approaches as well as the clinical outcomes of women versus men. This study had a 97% power to detect a 10% absolute difference in mortality by gender. RESULTS Left ventricular failure was the most frequent cause of CS for both gender groups. Women in the SHOCK Registry had a significantly higher incidence of mechanical complications including ventricular septal rupture and acute severe mitral regurgitation. Among patients with predominant LV failure, women were, on average, 4.6 years older, had a higher incidence of hypertension, diabetes and a lower cardiac index. The overall mortality rate for the entire cohort was high (61%). After adjustment for differences in patient demographics and treatment approaches, there was no significant difference in in-hospital mortality between the two gender groups (odds ratio = 1.03, 95% confidence interval of 0.73 to 1.43, p = 0.88). Mortality was also similar for women and men who were selected for revascularization (44% vs. 38%, p = 0.244). CONCLUSIONS Women with CS complicating AMI had more frequent adverse clinical characteristics and mechanical complications. Women derived the same benefit as men from revascularization, and gender was not independently associated with in-hospital mortality in the SHOCK Registry.

Rosiglitazone and Outcomes for Patients With Diabetes Mellitus and Coronary Artery Disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial

Background— Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease remain unknown. Methods and Results— To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes mellitus and coronary artery disease, we analyzed events among 2368 patients with type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction, and stroke, and the individual incidence of death, myocardial infarction, stroke, congestive heart failure, and fractures, were compared during 4.5 years of follow-up among patients treated with rosiglitazone versus patients not receiving a thiazolidinedione by use of Cox proportional hazards and Kaplan–Meier analyses that included propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.58–1.18), whereas there was a lower incidence of composite death, myocardial infarction, and stroke (HR, 0.72; 95% CI, 0.55–0.93) and stroke (HR, 0.36; 95% CI, 0.16–0.86) and a higher incidence of fractures (HR, 1.62; 95% CI, 1.05–2.51); the incidence of myocardial infarction (HR, 0.77; 95% CI, 0.54–1.10) and congestive heart failure (HR, 1.22; 95% CI, 0.84–1.82) did not differ significantly. Among propensity-matched patients, rates of major ischemic cardiovascular events and congestive heart failure were not significantly different. Conclusions— Among patients with type 2 diabetes mellitus and coronary artery disease in the BARI 2D trial, neither on-treatment nor propensity-matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Prediction of Length of Stay Following Elective Percutaneous Coronary Intervention

There have been published risk stratification approaches to predict complications following percutaneous coronary interventions (PCI). However, a formal assessment of such approaches with respect to predicting length of stay (LOS) is lacking. Therefore, we sought to assess the performance of, an easy-to-use, tree-structured prognostic classification model in predicting LOS among patients with elective PCI. The study is based on the New York State PCI database. The model was developed on data for 1999-2000, consisting of 67,766 procedures. Validation was carried out, with respect to LOS, using data for 2001-2002, consisting of 79,545 procedures. The risk groups identified by the model exhibited a strong progressively increasing relative risk pattern of longer LOS. The predicted average LOS ranged from 3 to 9 days. The performance of this model was comparable to other published risk scores. In conclusion, the tree-structured prognostic classification is a model which can be easily applied to aid practitioners early on in their decision process regarding the need for extra resources required for the management of more complicated patients following PCI, or to justify to payors the extra costs required for the management of patients who have required extended observation and care after PCI.

Severe Multivessel Coronary Vasospasm Presenting as Acute ST-Segment Elevation Myocardial Infarction

![Figure][1] A 60-year-old woman was brought to the emergency room after acute onset chest pain and shortness of breath developed while she was shopping. Her medical history was significant for migraine headaches. Her home medications were sumatriptan and ibuprofen. A 12-lead

Response to Letter Regarding Article, “Rosiglitazone and Outcomes for Patients With Diabetes Mellitus and Coronary Artery Disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial”

They point out that, in contrast to our results, previous pooled analyses of randomized trials of rosiglitazone showed a higher incidence of myocardial infarction, and that our observed differences (or rather lack of differences) in cardiovascular outcomes associated with rosiglitazone were potentially attributable to residual confounding. They also raise the point that we did not report a falsification end point that could have assessed the likelihood that observed results were more likely attributable to confounding than true effects. Our study reported prospectively collected longitudinal results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial cohort based on the diabetes mellitus treatment received, and was not a cross-sectional analysis. We agree that there is no substitute for randomization and no observational study, ours included, can fully exclude residual confounding. We should then also note the potential weaknesses of the meta-analysis that first implicated rosiglitazone as a cause of myocardial infarction, and reemphasize the unique aspects of the BARI 2D design and analysis that would be expected to minimize the impact of confounding. Even a well-conducted meta-analysis of limited studies will remain limited, because it is unable to compensate for the weaknesses of the original studies and may even unintentionally conceal those weaknesses. A carefully performed, independent examination of the meta-analysis regarding cardiovascular hazard from rosiglitazone concluded that the risk for myocardial infarction and death for diabetic patients taking rosiglitazone remained uncertain. 2 It is within this context that the BARI 2D design and results merit further consideration. In the BARI 2D trial, 3 patients were randomly assigned to a glycemic strategy of insulin sensitization or insulin provision. Therefore, initiation of rosiglitazone was generally determined by treatment assignment rather than patient indication, and the biases seen when the initiation of drug treatment is influenced by severity of illness were minimized. We used propensity-matching to further reduce any baseline differences when comparing treatment groups. Despite this, we did not detect a signal of ischemic cardiovascular harm from rosiglitazone. Similar conclusions were recently confirmed by a thorough FDA review of the independent readjudication of the 1 completed randomized trial designed to test the cardiovascular safety of rosiglitazone. 4