Clinical Equivalence of Trubond® and Ethibond® Braided Polyester Sutures for Valvular Prosthesis Fixation During Aortic or Mitral Valve Replacement: A Single-Blind Randomized Controlled Trial.

Background Paravalvular leak (PVL) following valve replacement is a serious cardiovascular complication that increases morbidity and mortality. Valve replacement with the interrupted suture technique using polyester suture provides adequate tensile strength and reduces the probability of tissue reaction. This study compared the clinical equivalence of Trubond®(Healthium) and Ethibond® (Ethicon, Johnson & Johnson) braided polyester sutures for valvular prosthesis fixation using interrupted suturing, with respect to the proportion of subjects having PVL after aortic valve (AV) or mitral valve (MV) replacement. Methodology Patients undergoing AV/MV replacement were enrolled and randomized in this study. The primary endpoint of this prospective, multicentric, two-arm, randomized (1:1), parallel-group, single-blind study (December 2020-October 2022) was the presence of PVL in Trubond® (n = 40) and Ethibond® (n = 42) groups within 26 weeks of surgery. The secondary endpoints included event rate of all-cause mortality, cardiac death, stroke, myocardial infarction, re-hospitalization, re-intervention, wound infection, operative time, intraoperative suture parameters, postoperative hospital stay, time to resume normal activities and work, quality of life, patient satisfaction, and adverse events in both groups. Results Patients who underwent AV/MV replacement and were followed up until 26 weeks had no incidence of PVL or other postoperative complications. No requirement for readmission or re-intervention was noted in both groups. Intraoperative suture handling characteristics, operative time, and hospital stay were also comparable between the groups. With each follow-up, subjects in both groups exhibited improved postoperative functional abilities, quality of life, and health status. Conclusions Trubond® braided polyester suture is clinically equivalent to Ethibond® braided polyester suture. Trubond® suture is safe and effective for valvular prosthesis fixation in patients undergoing AV or MV replacement.

Novel Methods to Understand the Temporal Nature and Accuracy of Delivery for Insulin Infusion Pumps.

BACKGROUND: A wide suite of methods are available to evaluate delivery accuracy of insulin pumps. However, these methods do not capture any temporal information, which may be critical for design of artificial pancreas (AP) systems. We propose a novel video microscopy method to understand the delivery accuracy and temporal nature for a new durable pump under development (IFP), and a commercially available pump (Medtronic 722G, M722G). METHODS: The cannula tip of an infusion set is inserted into a graduated pipette placed under a digital microscope. A video of the delivery is captured to track the fluid meniscus, to measure volumetric delivery rate and accuracy. This was done for a programmed value of 0.5 and 1 U. A similar procedure was adopted to track linear motion of the piston rod, which actuates the reservoir plunger, for a programmed value of 10 U. RESULTS: It was observed that the commercially available pump delivers insulin in pulses of 0.05 U every two seconds. The mean absolute volumetric delivery error (MAE) for both pumps was found to be within the values reported previously. More importantly, it was found that a significant fraction of the programmed value is delivered, after completion of the planned bolus duration (IFP: 14.31% vs M722G: 9.38% for 1 U delivery). CONCLUSIONS: The methods presented in this article help understand the delivery dynamics of liquid drug delivery devices. Our results indicate that a significant fraction of insulin delivery happens after the planned bolus duration, which might be important consideration for design of AP systems.