Novel hardening bone putty enhances sternal closure and accelerates postoperative recovery.

OBJECTIVES: Regaining and maintaining sternal stability are key to recovery after cardiac surgery and resuming baseline quality of life. Montage (ABYRX) is a moldable, calcium phosphate-based putty that adheres to bleeding bone, hardens after application, and is resorbed and replaced with bone during the remodeling process. We evaluate the feasibility, safety, and efficacy of enhanced sternal closure with this novel putty to accelerate recovery in patients after sternotomy. METHODS: A single-center, single-blinded, randomized controlled trial was performed (NCT03365843). Patients undergoing elective cardiac surgery via sternotomy received sternal closure with either Montage bone putty and wire cerclage (enhanced sternal closure; n = 33) or wire cerclage alone (control; n = 27). Standardized patient-reported outcomes assessed health-related quality of life (EQ-5D Index) and physical disability (Health Assessment Questionnaire). A Likert-type 11-point scale quantified pain. Spirometry assessed respiratory function. Patients reached 6-week follow-up, with 1-year follow-up for safety end points. RESULTS: There were no device-related adverse events. Enhanced sternal closure improved physical functional recovery (reduced Healthcare Index and Quality) and quality of life (increased EQ-5D Index) at day 5/discharge, week 2, and week 4. Enhanced sternal closure reduced incisional pain while resting, breathing, sleeping, and walking at day 5/discharge. Enhanced sternal closure reduced chest wall and back pain at day 3 and day 5 discharge. A higher proportion of patients with enhanced sternal closure recovered to 60% of their baseline forced vital capacity by day 5/discharge. Enhanced sternal closure shortened hospital stay. CONCLUSIONS: Enhanced sternal closure improves and accelerates postoperative recovery compared with conventional wire closure. Earlier discharge may provide substantial cost benefits for the healthcare system.

Post-exercise assessment of cardiac repolarization alternans in patients with coronary artery disease using the modified moving average method.

OBJECTIVES: We sought to evaluate the utility of T-wave alternans (TWA) assessment in the immediate post-exercise period to identify and validate cutpoints for the modified moving average (MMA) assessment method. BACKGROUND: The presence of TWA is associated with an increased risk of cardiovascular death (CVD). The immediate post-exercise period, where increased physiologic stress and minimal surface artifact coexist, appears ideal to implement the MMA method. METHODS: A test (n = 322) and validation cohort (n = 681) provided 1,003 patients with coronary artery disease (CAD). We assessed TWA immediately after exercise. The outcomes, CVD and mortality, were adjudicated independent of the TWA results. RESULTS: During 48 months of follow-up 85 deaths, 54 categorized as CVD (64%), were observed. A linear relationship between the magnitude of TWA and the risk of CVD was identified. As a continuous measure TWA voltage was equivalent to ejection fraction in predicting the risk of CVD. To facilitate clinical application, a sensitive, modest predictive accuracy (20 microV) and a specific, greater predictive accuracy MMA cutpoint (60 microV) were identified and validated. Each cutpoint was associated with a 2.5-fold greater risk of CVD, independent of other important variables, including ejection fraction. CONCLUSIONS: Post-exercise assessment of TWA using the MMA method is a strong, independent predictor of risk in patients with CAD. The 20-microV cutpoint (87% sensitivity) appears to be most suitable in higher-risk patients, whereas the 60-microV cutpoint (95% specificity) appears more appropriate when TWA is used as a single screening test in those at lower risk. (Assessment of Noninvasive Methods to Identify Patients at Risk of Serious Arrhythmias After a Heart Attack; NCT00399503).

Predictive value of repeated versus single N-terminal pro B-type natriuretic peptide measurements early after-myocardial infarction.

BACKGROUND: A single, markedly elevated B-type natriuretic peptide (BNP) serum concentration predicts an increased risk of death after myocardial infarction (MI), though its sensitivity and predictive accuracy are low. We compared the predictive value of a modestly and persistently elevated, versus a single, markedly elevated measurement of N terminal pro-BNP (NT-BNP) early after MI. METHODS AND RESULTS: NT-BNP was measured 2-4, 6-10, and 14-18 weeks after MI. The median age of the 100 patients was 61 years, median left ventricular ejection fraction (LVEF) was 0.40, and 88% were males. Over a median follow-up of 39 months, 10 patients died. The initial median NT-BNP was 802 pg/mL and declined over time (P = 0.002). An initial NT-BNP > or =2,300 pg/mL (upper quintile) was observed in 19 patients and predicted a 3.4-fold higher independent risk of death (P = 0.05), with modest sensitivity (30%) and positive predictive accuracy (16%). A NT-BNP consistently > or =1,200 pg/mL (upper tertile) was observed in 19 patients, and was associated with a 5.7-fold higher independent risk of death (P = 0.01), with a higher sensitivity (50%) and positive predictive accuracy (26%) than a single, markedly elevated NT-BNP measurement. CONCLUSIONS: A moderately and persistently elevated NT-BNP in the early post-MI period was associated with a 5.7-fold higher risk of death, independent of age, LVEF, and functional class. Compared with a single measurement, serial NT-BNP measurements early after MI were more accurate predictors of risk of death.

Noninvasive risk assessment early after a myocardial infarction the REFINE study.

OBJECTIVES: This study sought to determine whether combined assessment of autonomic tone plus cardiac electrical substrate identifies most patients at risk of serious events after myocardial infarction (MI) and to compare assessment at 2 to 4 weeks versus 10 to 14 weeks after MI. BACKGROUND: Methods to identify most patients at risk of serious events after MI are required. METHODS: Patients (n = 322) with an ejection fraction (EF) <0.50 in the initial week after MI were followed up for a median of 47 months. Serial assessment of autonomic tone, including heart rate turbulence (HRT), electrical substrate, including T-wave alternans (TWA), and EF was performed, interpreted blinded, and categorized using pre-specified cut-points where available. The primary outcome was cardiac death or resuscitated cardiac arrest. All-cause mortality and fatal or nonfatal cardiac arrest were secondary outcomes. RESULTS: Mean EF significantly increased over the initial 8 weeks after MI. Testing 2 to 4 weeks after MI did not reliably identify patients at risk, whereas testing at 10 to 14 weeks did. The 20% of patients with impaired HRT, abnormal exercise TWA, and an EF <0.50 beyond 8 weeks post-MI had a 5.2 (95% confidence interval [CI] 2.4 to 11.3, p < 0.001) higher adjusted risk of the primary outcome. This combination identified 52% of those at risk, with good positive (23%; 95% CI 17% to 26%) and negative (95%; 95% CI 93% to 97%) accuracy. Similar results were observed for the secondary outcomes. CONCLUSIONS: Impaired HRT, abnormal TWA, and an EF <0.50 beyond 8 weeks after MI reliably identify patients at risk of serious events. (Assessment of Noninvasive Methods to Identify Patients at Risk of Serious Arrhythmias After a Heart Attack; http://www.clinicaltrials.gov/ct/show/NCT00399503?order=1; NCT00399503).