Modification of a hybrid technique for closure of muscular ventricular septal defects in a pig model.

OBJECTIVE: Closure of muscular ventricular septal defects (mVSDs) beyond the moderator band is still a challenge for both surgeons and interventional cardiologists. We evaluated a new technique in a pig model for hybrid patch closure of mVSDs via 2 stab wound incisions in the left ventricle (LV) without cardiopulmonary bypass. METHODS: Ten pigs underwent left anterolateral thoracotomy to expose the LV. mVSDs were created via a stab wound incision of the lateral wall of the LV under epicardial echocardiographic control. The patch system was forwarded through a second puncture of the LV apex and positioned in front of the mVSD. The stapler for fixation of the patch was introduced through the same incision as used for VSD creation. Finally, the patch was attached to the septum with nitinol anchors under epicardial echocardiographic and fluoroscopic guidance. Finally, detailed echocardiographic evaluation was done. All hearts were explanted, and macroscopic evaluation was done, either immediately after patch implantation (n = 4) or after 90 days (n = 6). RESULTS: mVSD creation was successful in all pigs. Closure of mVSDs was successful in 8 of 10 pigs, as confirmed by echocardiography, hemodynamic measurements, and macroscopic examination. One patch embolized through the mVSD into the pulmonary artery because of insecure fixation, and 1 animal died during the procedure because of ventricular fibrillation. The final echocardiographic evaluation revealed good LV function and no damage to the valves. CONCLUSIONS: Closure of mVSDs can be successfully performed in a hybrid technique on the beating heart with 2 stab wound incisions; however, further modifications need to be developed before clinical application.

Evaluation of a new hybrid technique for closure of muscular ventricular septal defects in a long-term setting.

OBJECTIVE: Therapy for muscular ventricular septal defects beyond the moderator band, especially in neonates and infants, has always been challenging for both surgeons and cardiologists. Recently, we established a patch closure hybrid therapy for muscular ventricular septal defects. In this study, we evaluated it in a long-term porcine model. METHODS: Thirteen minipigs underwent anterolateral thoracotomy to expose the left ventricle. Muscular ventricular septal defects were created under 2- and 3-dimensional echocardiographic guidance with a 7.5-mm sharp punch instrument. Closure of the defects was undertaken with our new patch system in hybrid technique. Animals were observed for 3 months. Echocardiographic evaluation and pathologic examination, including immunohistochemical staining, were undertaken. RESULTS: Defects were successfully created in 12 pigs and closed in 10 pigs. Seven survived for 3 months. Residual shunting was noticed in 1 animal. Neither left ventricular dysfunction nor relevant damage to the valves could be detected. Pathologic examination showed complete endothelialization of the patch and the nitinol anchors without protruding parts of the system. Cellular organization was proceeding. Immunohistochemical staining demonstrated endothelial cells on the surface of the patch and fibromuscular cells around the patch. CONCLUSION: Our hybrid therapy was efficacious in closing muscular ventricular septal defects without impairment of cardiac function. The patch system and nitinol anchors demonstrated good integration into the septum. Further development of the system for human application is already being undertaken.