Vivek Rajagopal

Impact of Blood Transfusion on Short- and Long-Term Mortality in Patients With ST-Segment Elevation Myocardial Infarction

OBJECTIVES We sought to examine the short- and long-term outcomes of blood transfusion in patients presenting with ST-segment elevation myocardial infarction (STEMI). BACKGROUND The short- and long-term consequences of blood transfusion in anemic patients with recent STEMI remain controversial. METHODS We evaluated 30-day, 6-month, and 1-year all-cause mortality among 4,131 STEMI patients enrolled in the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) IIb trial. Patients were categorized according to whether they received a blood transfusion during hospitalization. Cox proportional hazards survival models with transfusion as a time-dependent covariate were conducted for the whole and for the propensity-matched groups. Additionally, a series of sensitivity analyses assessed the magnitude of hidden bias that would need to be present to explain the associations actually observed. RESULTS Death at 30 days (13.7% vs. 5.5%), 6 months (19.7% vs. 6.9%), and 1 year (21.8% vs. 8.7%) was significantly higher for transfused patients than for nontransfused patients, respectively. After adjusting for over 25 baseline characteristics, nadir hemoglobin, and propensity score for transfusion, and using transfusion as a time-dependent covariate, transfusion remained significantly associated with increased risk of mortality at 30 days (hazard ratio [HR]: 3.89, 95% confidence interval [CI]: 2.66 to 5.68, p < 0.001), 6 months (HR: 3.63, 95% CI: 2.67 to 4.95, p < 0.001), and 1 year (HR: 3.03, 95% CI: 2.25 to 4.08, p < 0.001). Similar results were observed in the propensity-matched patients. CONCLUSIONS Blood transfusion is associated with increased short- and long-term mortality in the setting of STEMI.

Incidence of Atrial Fibrillation in Heart Transplant Patients: Long‐Term Follow‐Up

Background: The incidence of atrial fibrillation (AF) in heart transplant patients has not been well documented.

Factor Xa inhibitors in acute coronary syndromes: moving from mythology to reality

See also Alexander JH, Yang H, Becker RC, Kodama K, Goodman S, Dyke CK, Kleiman NS, Hochman JS, Berger PB, Cohen EA, Lincoff AM, Burton JR, Bovill EG, Kawai C, Armstrong PW, Harrington RA on behalf of the XaNADU-ACS Investigators. First experience with direct, selective factor Xa inhibition in patients with non-ST-elevation acute coronary syndromes: results of the XaNADU-ACS Trial. This issue, pp 439–47.

Effect of mechanically expanded vs self-expanding transcatheter aortic valve replacement on mortality and major adverse clinical events in high-risk patients with aortic stenosis: The REPRISE III randomized clinical trial

Importance Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and paravalvular leak occur. Objective To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR. Design, Setting, and Participants The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017. Interventions Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305). Main Outcomes and Measures The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set. Results Among 912 randomized patients (mean age, 82.8 [SD, 7.3] years; 463 [51%] women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, −∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, −10.1%; Farrington-Manning 97.5% CI, −∞ to −4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, −6.1%; 95% CI, −9.6% to −2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, −10.2%; 95% CI, −16.3% to −4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%). Conclusions and Relevance Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients. Trial Registration ClinicalTrials.gov Identifier: NCT02202434

The optimal treatment of carotid atherosclerosis: a 2008 update and literature review.

Abstract Carotid and cerebrovascular disease have major public health implications given the associated morbidity and mortality. However, the best treatment for this disease is uncertain. Carotid endarterectomy has proven useful in primary and secondary prevention of strokes for patients with significant internal carotid artery stenoses. Many patients are considered at high risk for such surgical procedures and therefore have relatively few treatment options. Carotid stenting is currently being investigated as an alternative therapeutic intervention for these patients. This article reviews the literature pertaining to carotid intervention and its current status in 2008.

Impact of diabetes mellitus on outcome of patients undergoing carotid artery stenting: Insights from a single center registry†

Objective: To evaluate the impact of diabetic status on outcome of patients undergoing carotid artery stenting (CAS). Background: Diabetes has been demonstrated to be a strong predictor of adverse outcome in patients undergoing coronary revascularization. Its significance in predicting outcome of patients undergoing carotid interventions has not been ascertained. Methods: We evaluated the short‐term outcomes of 833 patients who underwent CAS at our institution. The primary outcome of this analysis was 30 day incidence of stroke, myocardial infarction, and death. Results: Diabetes was present in 311 patients. Baseline characteristics were comparable between diabetics and nondiabetics except for the diabetics having a lower left ventricular ejection fraction, lower hemoglobin, and a higher body mass index at baseline. Further, they were more likely to have congestive heart failure and coronary artery disease. There was no difference in the incidence of stroke (1.9% versus 2.7%,), myocardial infarction (MI) (2.6% versus 1.9%), death (3.9% versus 2.5%), or the composite of death stroke or MI (6.8% versus 5.9%) at 30 days between diabetics and nondiabetics. Similar results were seen when the analysis was restricted to patients treated with an emboli protection device. Diabetes was not a risk factor for adverse outcome after CAS after multivariate adjustment. Conclusion: Diabetics undergoing CAS are more likely to have associated co‐morbidities. However despite this handicap, their short term outcome after CAS is similar to that of nondiabetics.

Transcatheter Mitral-Valve Repair in Patients with Heart Failure

BACKGROUND Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral‐valve repair may improve their clinical outcomes. METHODS At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate‐to‐severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline‐directed medical therapy. Patients were randomly assigned to transcatheter mitral‐valve repair plus medical therapy (device group) or medical therapy alone (control group). The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow‐up. The primary safety end point was freedom from device‐related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 88.0%. RESULTS Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient‐year in the device group as compared with 67.9% per patient‐year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001). The rate of freedom from device‐related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P<0.001 for comparison with the performance goal). Death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001). CONCLUSIONS Among patients with heart failure and moderate‐to‐severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline‐directed medical therapy, transcatheter mitral‐valve repair resulted in a lower rate of hospitalization for heart failure and lower all‐cause mortality within 24 months of follow‐up than medical therapy alone. The rate of freedom from device‐related complications exceeded a prespecified safety threshold. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079.)

3-D PRINTING OF BIOLOGICAL TISSUE-MIMICKING AORTIC ROOT USING A NOVEL META-MATERIAL TECHNIQUE: POTENTIAL CLINICAL APPLICATIONS

Mimicking the dynamic mechanical properties of the human aorta in 3D printed models is challenging because of the inherent difference between mechanical behaviors of polymeric materials and human tissues (Fig. A). We sought to print the aortic root using materials which achieved the strain-