ENHANCEMENT OF STERNAL CLOSURE WITH NOVEL HARDENING BONE PUTTY ACCELERATES POST-OPERATIVE RECOVERY

Abstract

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.