Operative Techniques for Implantation of the AbioCor Total Artificial Heart  Robert D. Dowling, Steven W. Etoch, Laman A. Gray  Operative Techniques in Thoracic and Cardiovascular Surgery  Volume 7, Issue 3, Pages 139-151 (August 2002) DOI: 10.1053/otct.2002.36316 Copyright © 2002 Elsevier Inc. Terms and Conditions

1A An infraclavicular incision is made approximately 8.0 to 9.0 cm in length and placed approximately 2.0 cm cephalad to the nipple. This can be performed on either the left or right side. The position is often dictated by the handedness of the patient or the presence of a previously placed pacemaker or internal cardiac difibrillator. A pocket for the internal TET coil is made directly over the pectoral fascia. This position of the internal TET coil will allow for the external and internal TET coils to be close enough to allow energy transfer. Median sternotomy incision is then performed. The internal TET coil is placed in the pocket and the TET cable is tunneled over the ribs and brought out through the lower portion of the sternotomy incision. The incision over the internal TET coil is closed in 2 layers before heparinization in an attempt to decrease the likelihood of hematoma formation. Any fluid or hematoma around the internal TET coil could interfere with energy transfer. 1B The 4 internal components of the AbioCor implantable replacement heart. The AbioCor thoracic unit is positioned in an orthotopic position after excision of the native ventricles. The internal TET coil is placed in the infraclavicular space directly over the pectoral fascia. The internal battery and internal controller are placed in the abdominal wall. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

2 Sternal retractor is placed in the chest, and a pericardial cradle is created. Dissection is made in the preperitoneal space for placement of the internal controller and an internal battery. In severely cachectic patients, the battery and controller may be placed anterior to the posterior sheath of the rectus fascia to avoid entry into the peritoneal cavity. Intravenous heparin is administered. Depending on the length of the aorta, the distal ascending aorta or the femoral artery may be cannulated for arterial inflow. A right angle cannula is placed in the superior vena cava, and a long femoral vein cannula is placed through the femoral vein and positioned just below the right atrium using manual palpation to verify appropriate position. No cannulas are placed in the right atrium in an attempt to avoid any sites that would allow for air to be entrained into the right atrium during normal function of the AbioCor thoracic unit. Caval tapes are placed around the SVC and inferior vena cava. The cable from the internal controller is passed off the operative field to the external controller. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

3 Cardiopulmonary bypass is initiated. The caval tapes are snared down. The aorta is cross-clamped. Lidocaine is injected directly into the proximal aorta to provide rapid diastolic arrest of the heart (not shown). Beginning on the right side of the heart, the ventricles are excised on the ventricular side of the atrioventricular groove, leaving the mitral and tricuspid annula intact. The great vessels are transected at the origin. The ventricles are further trimmed to leave a small rim of ventricular muscle in place. The mitral and tricuspid valve leaflets are excised. Inspection is then made for a patent foramen ovale, and if that is present, it should be closed at this time. The left atrial appendage is ligated. The coronary sinus is oversewn to prevent any venous bleeding from cut branches of draining veins. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

4 A left atrial Milar catheter is placed through the right superior pulmonary vein. The left atrial cuff is trimmed to appropriate size and sewn to the native left annulus using a running 4-0 Prolene suture. A second layer of 4-0 Prolene is used with the suture being placed over a second layer of felt strip that is placed directly on top of the anastomosis to reinforce the anastomosis. The 2 reinforced suture layers are designed to prevent both bleeding and entrainment of air. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

5 The left atrial anastomosis is checked for leaks using an inflated Foley catheter to occlude the pulmonary veins while injecting saline into the left atrium. A similar procedure is then used to anastomose the right atrial cuff to the native right atrial remnant. This is usually done at the level of the annulus but may be performed directly to the right atrium if the right atrium is excessively large. Alternatively, the right atrium may be plicated to decrease its size and allow for the atrial cuff to be anastomosed at the level of the annulus. The right atrial anastomosis is also tested for leaks by forcefully injecting saline into the right atrium as was performed on the left. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

6 The AbioCor dummy heart is passed up to the operative field and attached to the left and right atrial cuffs. This allows for determination of the length and orientation of the right and left outflow grafts. The pulmonary artery outflow graft is then trimmed to an appropriate length and sewn end-to-end to the pulmonary artery using running 4-0 Prolene. This graft will likely be quite short. The anastomosis is tested for hemostasis. Similarly, the outflow graft to the aorta is trimmed to appropriate length and sewn end-to-end to the aorta. This is also tested for hemostasis by putting a plug on the proximal end and temporarily removing the aortic cross-clamp. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

7A The AbioCor thoracic unit is brought up to the operative field. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

7B The cables from the TET coil and thoracic unit are connected to the internal controller. The AbioCor is placed into the pericardial space. 7C The left atrial quick connect is performed first followed by the aortic quick connect and the pulmonary artery quick connect. Initially, the right atrial quick connect is not attached. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

8 A bulb syringe is used to inject saline into the right ventricle of the AbioCor to facilitate de-airing. When the air in the right ventricle is minimized, the caval tapes are released with partial occlusion of the venous return to facilitate filling of the right atrium, and the right atrial quick connect is performed. One or two single injections of the AbioCor are then performed to ensure that the connections are adequate. The SVC tubing is clamped, and the SVC cannula is removed. This site is oversewn to allow for hemostasis and aerostasis. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

9 While the cross-clamp remains on the aorta, de-airing is performed by allowing the AbioCor to beat at an increasing rate and progressively higher stroke volumes. The blood is ejected through side ports on both the pulmonary artery and aortic outflow conduits. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

10 When the right ventricle is completely de-aired, the side port of the pulmonary artery outflow conduit is clamped, and complete de-airing of the left side of the AbioCor is performed while allowing the entire stroke volume to be ejected out the aortic side port. One can very easily manipulate the AbioCor to assist in complete de-airing, and one can visualize the entire ventricles to ensure that there is no residual air in the device. Typically, we allow the AbioCor to beat at a rate of 60 to 80 beats per minute with a full stroke volume. Once we are convinced, based on echocardiography of the atria and inspection of the AbioCor, that de-airing is complete, we allow for 1 or 2 more minutes of this de-airing procedure. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

11 After complete de-airing, the aortic cross-clamp is released, and simultaneously the outflow side port of the aortic outflow graft is clamped. The patient is rapidly weaned from cardiopulmonary bypass onto full AbioCor support over a 1- or 2-minute time period. The patient is on full AbioCor support with continuous monitoring of left and right atrial pressures. Manual palpation of the right atrium is continuously performed to help determine appropriate fluid administration and AbioCor beat rate. An imbalance between the left and right-sided filling pressures is corrected by making appropriate adjustments to the atrial balance chamber. If left and right filling pressures are both low, this is treated by volume administration. If they are both high, the beat rate of the AbioCor device is increased. After surgical hemostasis is obtained, protamine is administered and decannulation is performed. A sterile bag is placed over the external TET coil, which is placed over the internal TET coil. The internal battery is passed up to the operative field, connected to the controller, and placed in the right preperitoneal space. At this point, the patient is relying entirely on the internal components with transcutaneous energy transfer. Echocardiography is crucial at this point to determine whether there are normal velocities in the pulmonary veins, particularly the left-sided pulmonary veins. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions

12 The sternum is approximated using 2 or 3 towel clips, and pulmonary flow velocities are re-assessed. If there is any increase of flow in the pulmonary veins, the AbioCor can be tacked caudad by placing a stitch around either the right ventricular outflow tract or through one of the islets. The suture is then placed around the lowest rib, and the suture is tied. The sternum is again approximated to demonstrate normal pulmonary vein flow velocities. Appropriate chest tubes are placed. Operative Techniques in Thoracic and Cardiovascular Surgery 2002 7, 139-151DOI: (10.1053/otct.2002.36316) Copyright © 2002 Elsevier Inc. Terms and Conditions