BACKGROUND Regaining and maintaining sternal stability is key to recovering from cardiac surgery and resuming normal life. MontageTM (ABYRX, Irvington, NY, USA) is a settable, resorbable putty that adheres to bleeding bone and achieves rigid sternal fixation following application (Image). We evaluated feasibility, safety, and efficacy of enhanced sternal closure (ESC) with a novel bone putty to accelerate post-operative functional recovery in patients receiving median sternotomy. METHODS AND RESULTS A single-center, single-blinded (participant only), randomized controlled trial was performed (NCT03365843). Consenting patients for elective cardiac surgery via sternotomy received sternal closure using either 8-10 cc of bone putty with wire cerclage (ESC) or wire cerclage alone (control). To date, 32 patients with ESC and 25 control patients reached 6 weeks with 100% follow-up. Student t-test and Fischer's exact test analyzed continuous (mean ± SEM) and categorical variables (Table). Both groups had similar BMI. There were no device-related safety concerns. The ESC group had a shorter time to discharge. Bedside spirometry was used when COVID-19 restrictions allowed. At 5 days or discharge, more patients with ESC recovered to 60% of their baseline FVC (22/28 patients vs 11/23 patients; p=0.04; ESC vs Control). A Likert-type 11-point scale quantified incisional, chest wall, and back pain/discomfort. The ESC group had less incisional pain while resting and at post-operative day 5 or discharge; while breathing at day 5 or discharge; while sleeping at day 5 or discharge and 2 weeks; and while walking at day 5 or discharge. The ESC group had less chest wall pain at day 3 and day 5 or discharge; and less back pain at day 3 and day 5 or discharge. Standardized patient-reported outcomes measures assessed health-related quality of life (EQ-5D index) and physical disability (Health Assessment Questionnaire). ESC improved physical functional recovery with a lower HAQ Index at day 5 or discharge, 2 weeks, and 4 weeks. More patients with ESC recovered to baseline HAQ at 2 weeks and 4 weeks. ESC increased EQ-5D Index scores for quality of life at day 5 or discharge, 2 weeks, and 4 weeks. More patients with ESC recovered to baseline EQ-5D Index by 5 days or discharge. CONCLUSION Enhanced sternal closure with a novel hardening bone putty for rigid fixation accelerates patient recovery. ESC improved ventilatory recovery, reduced pain, and accelerated recovery to baseline function and quality of life. Earlier hospital discharge with ESC may provide substantial cost benefits for the healthcare system. Regaining and maintaining sternal stability is key to recovering from cardiac surgery and resuming normal life. MontageTM (ABYRX, Irvington, NY, USA) is a settable, resorbable putty that adheres to bleeding bone and achieves rigid sternal fixation following application (Image). We evaluated feasibility, safety, and efficacy of enhanced sternal closure (ESC) with a novel bone putty to accelerate post-operative functional recovery in patients receiving median sternotomy. A single-center, single-blinded (participant only), randomized controlled trial was performed (NCT03365843). Consenting patients for elective cardiac surgery via sternotomy received sternal closure using either 8-10 cc of bone putty with wire cerclage (ESC) or wire cerclage alone (control). To date, 32 patients with ESC and 25 control patients reached 6 weeks with 100% follow-up. Student t-test and Fischer's exact test analyzed continuous (mean ± SEM) and categorical variables (Table). Both groups had similar BMI. There were no device-related safety concerns. The ESC group had a shorter time to discharge. Bedside spirometry was used when COVID-19 restrictions allowed. At 5 days or discharge, more patients with ESC recovered to 60% of their baseline FVC (22/28 patients vs 11/23 patients; p=0.04; ESC vs Control). A Likert-type 11-point scale quantified incisional, chest wall, and back pain/discomfort. The ESC group had less incisional pain while resting and at post-operative day 5 or discharge; while breathing at day 5 or discharge; while sleeping at day 5 or discharge and 2 weeks; and while walking at day 5 or discharge. The ESC group had less chest wall pain at day 3 and day 5 or discharge; and less back pain at day 3 and day 5 or discharge. Standardized patient-reported outcomes measures assessed health-related quality of life (EQ-5D index) and physical disability (Health Assessment Questionnaire). ESC improved physical functional recovery with a lower HAQ Index at day 5 or discharge, 2 weeks, and 4 weeks. More patients with ESC recovered to baseline HAQ at 2 weeks and 4 weeks. ESC increased EQ-5D Index scores for quality of life at day 5 or discharge, 2 weeks, and 4 weeks. More patients with ESC recovered to baseline EQ-5D Index by 5 days or discharge. Enhanced sternal closure with a novel hardening bone putty for rigid fixation accelerates patient recovery. ESC improved ventilatory recovery, reduced pain, and accelerated recovery to baseline function and quality of life. Earlier hospital discharge with ESC may provide substantial cost benefits for the healthcare system.

Heart failure (HF) with preserved ejection fraction (HFpEF) forms an increasingly recognized portion of patients with clinical HF. Of interest, is characterizing vascular endothelial function in HFpEF and defining its contribution to pathology, relative role in risk prediction and therapeutic potential. Thus far, limited, and sometimes conflicting, data exists. AB-Heart is a prospective observational cohort study of patients recruited within AB ≥18 years, either with, or at risk for, HF. The purpose of the study was to characterize endothelial function in subjects with HFpEF compared to patients with HF with reduced ejection fraction (HFrEF) and controls. 188 patients (HFpEF, N=78; HFrEF, N=76; Controls, N=34) underwent clinical assessment and vascular evaluation with measurement of conduit vessel function with brachial flow mediated dilation (FMD), microvascular function with hyperaemic velocity (RHVTI) and finger-tip pulse arterial tonometry (PAT). Clinical and vascular parmeters were compared across and between groups. Univariate and multivariate correlation between clinical factors and vascular parameters was examined. Patients with HFpEF and HFrEF differed in multiple clinical characteristics vs. controls. RHVTI differed significantly across the HFpEF (92±38 cm), HFrEF (102±35 cm) and control (117±36 cm) groups; p=0.004. PAT index also significantly differed across the HFpEF (1.9±0.7), HFrEF (1.8±0.9) and control (2.4 ± 0.9) groups; p=0.016. No significant difference in FMD occurred across groups. Vascular parameters did not differ significantly between HFpEF vs. HFrEF on post-hoc analysis, but RHVTI was significantly reduced in HFpEF vs. controls (p=0.003) and PAT was significantly reduced in HFrEF vs. controls (p=0.014). Significant differences in vascular parameters were not detected between HFpEF vs. HFrEF, but both HF groups demonstrated impaired microvascular function measures vs. controls. Microvascular dysfunction may play an important role in the pathophysiology of subjects with heart failure regardless of ventricular function.

The signal-averaged ECG (SA-ECG) has established value in identifying patients a risk for serious ventricular arrhythmias following myocardial infarction. The standard SA-ECG has high negative (90-100%), but low positive (10-35%) predictive value. This latter characteristic appears, in part, related to the method by which the SA-ECG is derived. Given that the onset & offser of the QRS complex and the presence or absence of late potentials are inherently related to the signal to noise ratio, it may not be appropriate to derive these parameters using a single set of ECG epochs. To further addrms this issue, 78 individual SA-ECG recordings were analyzed at a target noise level of 0.5 pV and at a fmed number of templates (300). Wsing our mod@ed approach, a significant percentage of patients were classified as "indeterminate" in that the confidence interval for QRS width crossed the threshold level.