An Absorbable Hydrogel Spray Reduces Postoperative Mediastinal Adhesions After Congenital Heart Surgery

Hasaniya, Nahidh; Razzouk, Anees J.; Newcombe, Jennifer; Hassneiah, Dana; Heimes, Jessica; Gysbers, Joshua; Martens, Timothy P.; Bailey, Leonard L.

doi:10.1016/j.athoracsur.2017.07.015

Cited by 8 publications

(8 citation statements)

References 25 publications

(27 reference statements)

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“…One may claim that the adhesion prevention effects of BAX602 will be more clearly proven by performing the second surgery at a longer time period than 2 weeks, such as several months or years after the first surgery. In fact, a previous randomized controlled study showed that BAX602 achieved significant adhesion prevention effects at 2–8 months after the first pediatric cardiac surgery [ 10 ]. In contrast, the present study will have a 2–12-week interval between the first and second cardiac surgeries, as the included patients are undergoing extracorporeal VAD implantation by the median sternotomy approach, and will need VAD explant surgery within 2–3 months [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

“…Several adhesion prevention reagents have been proposed. The application of Coseal spray (Baxter Healthcare Corporations, Deerfield IL, USA), hereafter referred to as BAX602, over the epicardium and the great vessels reportedly contributes to adhesion prevention after surgical procedures, including cardiac surgery [ 10 , 11 ] and even VAD implantation surgery [ 12 , 13 ]. BAX602 is composed of two synthetic polyethylene glycols (PEGs): a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution.…”

Section: Introductionmentioning

confidence: 99%

“…Spraying the heart and the great vessels with BAX602 causes this hydrogel to coat the surface of the heart and the great vessels; this hydrogel coating is sustained for 7 days before being hydrolyzed, consequently preventing adhesion formation over the surface of the heart and the great vessels [ 11 ]. Although there are positive reports of the use of BAX602 in pediatric cardiac surgery in observational [ 11 ] and prospective randomized [ 10 ] studies, the safety and efficacy of BAX602 for adhesion prevention have not been fully established in adult patients with an implanted VAD.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

“BAX602” in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial

Fukushima

Asakura

Hamasaki

et al. 2020

Cardiovasc Drugs Ther

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Background The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure. Methods and Design This investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2–12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5). Ethics and Dissemination The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals. Trial Registration The trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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“BAX602” in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial

Fukushima

Asakura

Hamasaki

et al. 2020

Cardiovasc Drugs Ther

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“…The absorbable hydrogel spray reported by Hasaniya et al (16) was proposed on the market about 10 years ago (Coseal Surgical Sealant, Baxter Healthcare, Deerfield, IL, USA). It is a hydrogel initially designed to act as a sealant around a sutured site.…”

mentioning

confidence: 99%

“…Thirty-six of these patients underwent chest reopening at a mean interval of 8 months. Adhesions were classified according to site and grade, in a manner very similar to that described in Hasaniya et al (16). In particular, around 85% of adhesions were allocated the least severe classification of filmy and avascular.…”

mentioning

confidence: 99%

An investment for the future

Napoleone

2018

Transl Pediatr

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Injectable Polyzwitterionic Lubricant for Complete Prevention of Cardiac Adhesion

Wang

Zhai

Zhang

et al. 2023

Macromolecular Bioscience

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After cardiac surgery, tissue damage to the heart may cause adhesion between heart and its surrounding tissues. Post‐operative cardiac adhesion may lead to limited normal cardiac function, decreased quality of cardiac surgery, and increased risk of major bleeding during reoperation. Therefore, it is necessary to develop an effective anti‐adhesion therapy to overcome cardiac adhesion. An injectable polyzwitterionic lubricant is developed to prevent adhesion between the heart and surrounding tissues and to maintain normal pumping function of the heart. This lubricant is evaluated in a rat heart adhesion model. Poly (2‐methacryloyloxyethyl phosphorylcholine) (i.e., PMPC) polymers are successfully prepared via free radical polymerization of monomer MPC, and the optimal lubricating performance, biocompatibility both in vitro and in vivo is demonstrated. Besides, a rat heart adhesion model is conducted to evaluate the bio‐functionality of lubricated PMPC. The results prove that PMPC is a promising lubricant for complete adhesion‐prevention. The injectable polyzwitterionic lubricant shows excellent lubricating properties and biocompatibility and can effectively prevent cardiac adhesion.

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An Absorbable Hydrogel Spray Reduces Postoperative Mediastinal Adhesions After Congenital Heart Surgery

Cited by 8 publications

References 25 publications

“BAX602” in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial

“BAX602” in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial

An investment for the future

Injectable Polyzwitterionic Lubricant for Complete Prevention of Cardiac Adhesion

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