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• W2059059600 abstract "In the United States, children with end-stage heart failure listed for heart transplant face the highest waiting list mortality in transplant medicine.1Almond C.S. Thiagarajan R.R. Piercey G.E. et al.Waiting list mortality among children listed for heart transplantation in the United States.Circulation. 2009; 119: 717-727Crossref PubMed Scopus (293) Google Scholar Mechanical circulatory support (MCS) devices have revolutionized advanced heart failure management by creating a durable bridge to transplant.2Dembitsky W.P. Tector A.J. Park S. et al.Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial.Ann Thorac Surg. 2004; 78 ([discussion 2129–30]): 2123-2129Abstract Full Text Full Text PDF PubMed Scopus (131) Google Scholar A shift has occurred in the adult MCS population to intracorporeal MCS devices that allow for ambulatory care while awaiting transplantation.3Emin A. Rogers C.A. Parameshwar J. et al.Trends in long-term mechanical circulatory support for advanced heart failure in the UK.Eur J Heart Fail. 2013; 15: 1185-1193Crossref PubMed Scopus (27) Google Scholar The future of pediatric MCS is the expansion of long-term ambulatory devices; however, the pediatric and small adult populations do not typically meet conservative intracorporeal device fit criteria, and poor post-operative outcomes related to device mismatch have been reported.4Copeland J.G. Smith R.G. Arabia F.A. et al.Total artificial heart bridge to transplantation: a 9-year experience with 62 patients.J Heart Lung Transplant. 2004; 23: 823-831Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar The CardioWest temporary Total Artificial Heart (TAH-t; SynCardia Systems Inc, Tucson, AZ) is well suited for certain pediatric and young adult heart failure patients with previously limited MCS options. The standard fit criteria includes a body surface area (BSA) of 1.7 m2 and an anteroposterior distance greater than 10 cm from the sternum to the 10th thoracic vertebra (T10).4Copeland J.G. Smith R.G. Arabia F.A. et al.Total artificial heart bridge to transplantation: a 9-year experience with 62 patients.J Heart Lung Transplant. 2004; 23: 823-831Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar On the basis of these criteria, most pediatric and small adult patients are excluded from TAH-t placement. Innovative imaging techniques are necessary to improve eligibility for TAH-t placement in smaller patients; therefore, we developed a novel technique using virtual TAH-t implantation in pediatric and small adult patients to compare with standard fit criteria. Five patients (aged 12–34 years; BSA, 1.31–1.98 m2) identified as potential candidates for TAH-t as a bridge to cardiac transplantation underwent virtual implantation (Table 1). Detailed methods are available on the jhltonline.org Web site. Briefly, an accurately scaled 3-dimensional (3D) surface rendering of the TAH-t was placed within a 3D reconstruction of the chest to assess for proper fit. Device compression of pertinent intrathoracic structures, including systemic veins, pulmonary veins, aorta, lungs, and diaphragm, was assessed.Table 1SynCardia Total Artificial HeartaSynCardia Systems, Tucson, Arizona. Virtual Implantation Compatibility Compared with Standard Fit CriteriaPtAge (years)Height (cm)Weight (kg)BSA (m2)T10–sternum distance (cm)Meets standard fit criteria3D virtual implant successfulTAH-t device placed11916062.31.648.9NoYesYes23416393.51.9810.2YesYesYes32016862.91.7112.1YesNoNo41214144.61.3111.1NoNoNo52915456.41.549.5NoYesNo3D, 3-dimensional; BSA, body surface area; TAH-t, CardioWest temporary Total Artificial Heart.aSynCardia Systems, Tucson, Arizona.a SynCardia Systems, Tucson, Arizona. Open table in a new tab 3D, 3-dimensional; BSA, body surface area; TAH-t, CardioWest temporary Total Artificial Heart.aSynCardia Systems, Tucson, Arizona. Two patients underwent actual TAH-t placement, with 1 of those patients not meeting standard fit criteria. Both patients had successful virtual implantation, and post-device chest imaging showed no compression of pertinent intrathoracic structures, as predicted by the pre-device simulation. The first patient was a 19-year-old woman with a history of renal cell carcinoma who developed anthracycline-induced cardiomyopathy and required heart transplantation. Multiple episodes of rejection after transplant led to restrictive cardiomyopathy. She required a biventricular MCS device as a bridge to heart retransplantation; however, she did not meet the TAH-t standard fit criteria. Her BSA was 1.64 m2, and the T10–sternum distance was 8.9 cm. Virtual TAH-t implantation was performed, and the device compatibility within the constraints of the chest wall was assessed (Figure 1A; Video 1, available on the jhltonline.org Web site). Proximity measures noted minimal concern for compression of pertinent structures. She underwent successful TAH-t placement and had no compression-related post-operative complications. Post-device computed tomography (CT) reconstruction confirmed accurate pre-operative virtual implantation (Figure 2). The patient was transitioned to the Freedom Driver (SynCardia Systems), discharged from the hospital, and underwent successful transplantation after 14 months of support. The second patient was a 34-year-old woman with complex congenital heart disease who required multiple surgical palliations. Over time, biventricular heart failure developed, and she required biventricular mechanical support. She met the standard criteria for TAH-t (BSA, 1.98 m2; T10–sternum distance, 10.2 cm); however, there were concerns of device compatibility given her history of multiple sternotomies and intrathoracic adhesions. Virtual TAH-t implantation showed no concerns for compression of pertinent structures, and she underwent successful TAH-t placement. Post-device CT reconstruction confirmed accurate preoperative virtual implantation. The patient initially did well; however, overwhelming viremia developed, and she died several months after implantation. The third patient was a 20-year-old man with ectodermal dysplasia, severe scoliosis, and complex congenital heart disease that failed surgical palliation. He was undergoing evaluation for long-term bridge-to-transplant device placement. He met the standard fit criteria for TAH-t placement (BSA, 1.71 m2; T10–sternum distance, 12.1 cm); however, virtual implantation was unsuccessful due to severe scoliosis and significant overlap of the right TAH-t device with the anterior chest wall (Figure 1B; Video 2, available on the jhltonline.org Web site). Given the concerns of device mismatch and severe scoliosis, the patient did not undergo TAH-t placement. The fourth patient was a 12-year-old girl with complex congenital heart disease who had undergone multiple failed palliations and was being considered for device placement as a bridge to heart transplantation. She did not meet standard criteria (BSA, 1.31 m2; T10–sternum distance, 11.1 cm), and virtual implantation was unsuccessful, with the right TAH-t overlapping the anterior chest wall. After extensive discussion, the family decided to postpone TAH-t placement, and she died several weeks later while listed as status 1a for heart transplantation. The fifth patient was a 29-year-old woman with restrictive cardiomyopathy listed for heart transplantation but not in need of a MCS device. She was pre-screened for device placement in the event that acute decompensation would occur. Virtual implantation was successful despite not meeting standard criteria (BSA, 1.54 m2; T10–sternum distance, 9.5 cm). The patient did not require TAH-t placement and underwent a successful transplant several months later. The SynCardia TAH-t is well suited for certain pediatric and young adult heart failure populations requiring biventricular MCS secondary to chronic transplant rejection, complex congenital heart disease, and restrictive cardiomyopathy. However, the use of TAH-t in these patients carries a risk of device incompatibility. A patient whose chest cannot be closed post-operatively is at increased risk for device malfunction, bleeding, infection, and death.4Copeland J.G. Smith R.G. Arabia F.A. et al.Total artificial heart bridge to transplantation: a 9-year experience with 62 patients.J Heart Lung Transplant. 2004; 23: 823-831Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar, 5Leprince P. Bonnet N. Varnous S. et al.Patients with a body surface area less than 1.7 m2 have a good outcome with the CardioWest Total Artificial Heart.J Heart Lung Transplant. 2005; 24: 1501-1505Abstract Full Text Full Text PDF PubMed Scopus (25) Google Scholar After the TAH-t is placed and the chest is closed, device compression of pertinent intrathoracic structures remains of high concern. Our cohort demonstrates the use of novel 3D imaging techniques to improve patient eligibility for TAH-t placement. With increasing use of MCS devices in adolescent and young adult patients, virtual compatibility testing allows for improved eligibility despite failing standard fit criteria. The introduction of new devices, such as the smaller SynCardia 50 cc/50 cc TAH-t, will benefit from similar rigorous virtual implantation techniques to help establish safer compatibility criteria. In addition, applying this method to other ventricular assist devices that have suggested body size limitations, such as the HeartWare Ventricular Assist Device (HeartWare International, Inc, Framingham, MA), may expand its utility as a screening tool. Future prospective studies and multi-site collaborations are required to adequately test virtual implantation and measure the following outcomes: device incompatibility resulting in an open chest post-operatively, device compression of pertinent structures requiring reoperation, death secondary to device failure, and successful bridge to cardiac transplantation. The authors acknowledge Todd Pietila, BS, from Materialise Inc (Plymouth, MI), for assistance in the development of this technique, creation of images and videos, and enhancement of quantitative applications. None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose. eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiI2ZGZjYTI2NDlkM2UxY2IxMGYzMzVlOGM0NmY1ZDQ3NSIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4OTgyNDAyfQ.IXTCBcki8mJzoAH3Ia1qgsPiwrvAW7FbXlfftdbQjuClXpRDEKkMLlaTLlq81qeiVro54YQh6g4ZeCYZ-HCihrJWtfwz-V13PP52zc0JGK02ssRXxLO0oBRV7vNW7xOkgoHueQotNKIV4bmpEjPg1hVB8Mi0tqdxDFW8nAO4kfhWp9Dl2T9W800y_afn5JD8IVovnzpamsiGTtus1cvJjC2uZbrK1bwYm0oXZzx5dhSQX4ctDF0mUyUUR6z5icEb4enU4z1NCxctml6bAKuInKb8lKaDJC3Sfv5NiW9sjAqck_6IuYOq0SGC0SOtD_D4EDyN9O_V1yaMkKoXJbU6Kg Download .mp4 (11.87 MB) Help with .mp4 files Video 1 eyJraWQiOiI4ZjUxYWNhY2IzYjhiNjNlNzFlYmIzYWFmYTU5NmZmYyIsImFsZyI6IlJTMjU2In0.eyJzdWIiOiJkODBjZGNiZDM0YmNiOGMzMTg0YWVmMTQwZmVmYTVmYyIsImtpZCI6IjhmNTFhY2FjYjNiOGI2M2U3MWViYjNhYWZhNTk2ZmZjIiwiZXhwIjoxNjc4OTgyNDAyfQ.KeRDdhUyZtozQF5Blkyp-A160EE7JQh7A52mnPUh_Ijbtm1BBhXBgWJowCcqUnE0oJFeM81jFEywJE8STqBNjiVhmTDzFNy2756RtTuBDuYJw4X45rBZAmubuEdySh02_AMtHxFTCYf_aF4yV_Uff1WbqO6kpSRPH4C9gGEsKPzyn1-i9n9Ln-Ih9nrpxShPmgpiXyX2qy9XotJsqNRm2zYDUYtYbeZCN-pG7hnfyGqIy28b83RuoImlwwkCGHya0Gog1rsg10f0P8yGz-RLURwFGcdSVlntVPckxwT2GExsVTTF9sucbM8-hxz7ATM4vz8Px1AszVscqbgXvXc4yA Download .mp4 (12.4 MB) Help with .mp4 files Video 2" @default.
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• W2059059600 title "Virtual implantation evaluation of the total artificial heart and compatibility: Beyond standard fit criteria" @default.
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