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Ann Thorac Surg 1999;68:698-704
© 1999 The Society of Thoracic Surgeons

Description Of Devices And Surgical Techniques

Implantation technique for the CardioWest total artificial heart

Francisco A. Arabia, MDa, Jack G. Copeland, MDa, Alan Pavie, MDb, Richard G. Smith, MSEEa

a University of Arizona Health Sciences Center, Tucson, Arizona, USA
b Groupe Hospitalier Pitie-Salpêtriere, Paris, France

Address reprint requests to Dr Arabia, University of Arizona Health Sciences Center, PO Box 245071, Tucson, AZ 85724-5071
e-mail: arabia{at}u.arizona.edu

Presented at the Fourth International Conference on Circulatory Support Devices for Severe Cardiac Failure, Houston, TX, Oct 3–5, 1997.

Abstract

The CardioWest total artificial heart is a pneumatically driven device that totally replaces the failing ventricles. It is currently undergoing clinical investigation as a bridge to heart transplantation in several centers throughout the world. A bilateral ventriculectomy is performed and the device is implanted. Blood flows are usually maintained at 6–8 L/min. Approximately 130 patients have undergone bridge to transplant with this device. Patient selection and excellent surgical technique are required for a successful outcome. A detailed description of the implantation technique is presented to facilitate the use of this technology.

The CardioWest C-70 total artificial heart (TAH; CardioWest Technologies, Inc, Tucson, AZ) is the only circulatory device available at the present time that is used as a bridge to heart transplantation and totally replaces the failing heart. It is a direct descendent of the Jarvik 7-70 TAH (Symbion, Tempe, AZ) that was commonly used during the 1980s as a permanent device or a successful bridge to heart transplant [1, 2]. CardioWest Technologies, Inc acquired the device in 1992, and the first implant was performed in January 1993. The CardioWest TAH is available in selected transplant centers in France and Canada. It is also available in the US in five centers under investigational device exemption (IDE) from the Food and Drug Administration (FDA) (Table 1).


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  		Table 1. Centers Utilizing the CardioWest TAH as a Bridge to Heart Transplantation

 
The CardioWest TAH is one of five devices that are available with the intention of bridge to heart transplantation. The Novacor (Division of Baxter Health Care Co, Oakland, NJ) and the HeartMate (Thermo Cardiosystem, Inc, Woburn, MA) represent prototypes of implantable univentricular assist devices that provide pulsatile assistance to the failing left ventricle. Paracorporeal pumps provide univentricular or biventricular pulsatile flow. A system of two or four cannulae provide inflow and outflow to the blood pumps. The most commonly used devices have been Thoratec (Berkeley, CA) and Abiomed (Danvers, MA), [3]. The primary role of the Abiomed system is for cardiac failure in the postcardiotomy period. Selection criteria have been established in the US for use of the TAH. These criteria are described in Table 2 [4].


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  		Table 2. Patient Selection Criteria

 
Description

DeVries [5] and Levinson and Copeland [6] described techniques for implanting this type of device. Surgical experience obtained during the last few years has made implantation of the TAH easier. This description of this technique follows.

The CardioWest C-70 is a pneumatically driven TAH (Fig 1). The prosthetic ventricles are made of polyurethane, and Medtronic-Hall mechanical valves provide unidirectional flow. Blood and air are separated by a four-layer, segmented polyurethane diaphragm that retracts during diastole and is displaced forward by compressed air during systole to propel blood out of the prosthetic ventricle. The TAH can provide flows up to 10 L/min. However, it is usually used to provide flows at 6–8 L/min. Once the prosthetic ventricles have been implanted, the drive lines exit the patient through the skin under the left costal margin. The drivelines then connect to a console.



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  		Fig 1. CardioWest TAH.

 
The device console (Fig 2) provides adjustment of the heart rate, systolic duration, and drive line pressures for each of the ventricles. The TAH is operated so that there is incomplete filling but complete emptying with each stroke. The atrial pressure on each side determines ventricular filling; as atrial pressure increases, a higher stroke volume and cardiac output are obtained.



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  		Fig 2. Console for the CardioWest TAH.

 
Surgical technique

Three steps are taken in preparation for implantation before giving heparin: the arterial grafts are prepared, the atrial cuffs are trimmed to appropriate size, and the drive lines are tunneled through the skin.

The grafts are first preclotted three times with the patient’s blood before giving the heparin. After exposure to the blood, approximately 30 cc for each graft each time, they are stretched and left to dry for about 5 minutes and then preclotted again. The grafts are coated on the outside with biologic glue (cryoprecipitate with calcium and topical thrombin). They are once more placed in a stretched position and allowed to dry. This is done early in the operation before cannulation so there is plenty of time to obtain excellent preclotting of the grafts. If the patient has been heparinized before making the decision to implant the TAH, the arterial conduits are preclotted with a combination of heparinized blood, protamine, and thrombin.

The quick connects of the atrial cuffs are trimmed. The edges of the atrial quick connects for the atrial anastomoses are cut to a radius extending out from the quick connect for 5–7 mm, as shown in Figure 3. They are cut in a completely circular fashion. They are then stretched and inverted.



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  		Fig 3. Atrial cuffs before and after being trimmed to 5–7 mm.

 
The drive lines for the ventricles are passed through their subcutaneous pathways before heparinization of the patient. The left-sided ventricle drive line is positioned in the epigastrium at about the level of the midclavicular line and approximately 2 inch below the costal margin. A semicircular skin flap incision is made on the left midclavicular line approximately 5 to 10 cm below the costal margin. A long clamp is placed through the subcutaneous tissue, rectus fascia, rectus muscle, and into the chest much as a chest tube would be placed. A similar approach is used to place the drive line for the prosthetic right ventricle approximately 4 to 5 cm medial to the left ventricle drive line so that no necrosis between the two exit sites will result. The pathway is enlarged somewhat by opening the clamp and a 1-inch Penrose drain through the pathway. The end of the drive line is then placed in the Penrose drain and advanced approximately 8–10 cm. The Penrose drains are pulled through the pathway that delivers the drive line through the skin. The ventricles are then positioned lateral to the wound and covered with a towel while the rest of the procedure takes place. This provides ample opportunity for small bleeders in the drive line pathway to clot.

Removal of the recipient’s heart
Cannulation of the aorta and both superior and inferior vena cavae are done in a standard fashion. Umbilical tape chokers are used on the cavae. Dissection around the aorta and pulmonary artery is limited to the proximal portion of the aorta in anticipation of later transplantation, thus leaving some untouched areas that will not be very fibrotic. Cardiopulmonary bypass is instituted and the heart is fibrillated. Total bypass is instituted by pulling on the choker tapes. The heart is fibrillated and the excision of the heart begun. The excision is significantly different from that used for transplantation. It seeks to preserve the annulus of both the tricuspid and mitral valves. Thus, an incision is made on the ventricular side of the AV groove of the right ventricle (Figs 4A, 4B). This can be done with a knife and extended with either a knife or scissors. It is extended anteriorly across the right ventricular outflow tract and just proximal to the pulmonary valve. Posteriorly, it is extended to the interventricular septum and across the septum, again staying on the left ventricular side of the arterioventricular (AV) groove and preserving the entirety of the mitral annulus. The anterior and posterior lines of incision are dissected apart from each other out to the level of the pulmonary bifurcation. Finally, the excess muscle, on the right and left sides, is trimmed down to near the AV valves. Chordae are trimmed away, and a 2-mm edge of valve tissue along with the annulus is left intact. The atrial cuff generally extends 1 cm beyond the AV valve and consists of residual ventricular muscle and fat in the AV groove. All chordae are trimmed away. The portion of the cuff in the left ventricular outflow tract consists of the residual anterior leaflet of the mitral valve and some aortic tissue. Most of the aortic tissue is trimmed away, however, some is left intact because it is felt to present strong tissue for the sewing of the quick connect cuff (Fig 5). The great vessels are then separated from the remaining ventricular myocardium just above the valvular level. The great vessels are separated from each other.



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  		Fig 4. (A) A ventriclectomy of 1 cm below the level of the AV groove is necessary for adequate placement of the CardioWest TAH. (B) The great vessels.

 


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  		Fig 5. Diagram of the ventricular rim with the AV valves removed. The aorta and pulmonary artery have been prepared for placement of the outflow conduits.

 
Next, the coronary sinus entrance into the right atrium is over-sewn. This prevents backflow of blood through the coronary sinus and out to the cut vessels on the AV groove.

The outer walls of the entire right and left atrial cuff complex are encircled with Teflon felt buttresses (Fig 6). These are placed in such a way that they can be used for strengthening the anastomosis to the quick connect and also to tamponade and control all possible bleeding from the AV groove portion of the cuff. These are cut to approximately 10–12 mm in width and are generally 10 cm in length. It most often takes at least two of these to extend around the entire cuff. They are placed on the outer edge of the cuff and sewn in place with a running 3-0 polypropylene. A long needle is used to accomplish this (MH needle) and, after completing this, the left and right atrial cuffs are surrounded by Teflon felt buttresses.



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  		Fig 6. Felt strips sutured around ventricular cuffs. Atrial quick connects are being sutured in place.

 
Attachment of the grafts and atrial quick connects and testing for hemostasis
The atrial quick connect is seen first, which is inverted, placed inside the left atrial cuff on the lateral wall. A 3-0 polypropylene is used with an MH needle with a running stitch, taking care to tailor the atrial cuff and the quick connect into a single hemostatic suture line. The suture line includes both the free walls of the atrium, which is buttressed with a Teflon felt in the atrial septum, which has no buttressing material. After completing this entire suture line, a similar procedure is done with the right quick connect. Again, the quick connector is inverted and placed within the atrium, the suture line is run, and after completing both suture lines, ie, for the left and right atrial cuffs, the quick connects are everted so that they will be in the normal position.

At this time, checking for hemostasis is done with the plastic tester made to fit within the quick connect. A syringe (60–100 cc in volume) is used to inject into a three-way stopcock connected with the tester to test the left atrial suture line, the surgeon places his hand posterior to the left atrium, and compresses the right and left pulmonary veins, while the surgical assistant injects saline mixed with a small amount of blood into the left atrium (Fig 7). Observation for leaks is then made. If there are any leaks present, sutures are placed at this time. On the right side, the cavae are already obstructed by the caval tapes, thus fluid is simply injected into the right atrium under pressure. Again, closure of leaks with a 3-0 MH polypropylene suture is done at this time.



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  		Fig 7. Left atrial cuff being tested for anastomotic leaks. Arterial conduits are already in place. It is easier to check the atrial conduits before anastomosing the arterial conduits.

 
Next, the anastomosis of the great vessels are made. The pulmonary artery anastomosis is made first. The length of the main pulmonary artery present is the entire main pulmonary artery from just above the commissures of the valve. The length of the great vessel conduits is determined by placing the prosthetic ventricles in their position within the pericardial cavity and interposing the conduit between the aortic or pulmonic valve and its respective great vessel. The conduit is then cut to the appropriate length, usually 3 to 5 cm. An anastomosis is made with running 4-0 polypropylene in an end-to-end fashion, beginning with the lateral wall and running the back wall of the anastomosis from the inside. A similar anastomosis is made with the aortic suture line (Fig 8). Following this, we use the aortic tester, which is inserted into the aortic quick connect. Saline is injected under pressure, observed for leaks, and then any leaks are closed with 4-0 polypropylene. The pulmonary artery needs to be cross-clamped in order to test the integrity of the pulmonary artery to conduit anastomosis. The pulmonary artery and aortic tester is the same, but smaller, than the one utilized for the atrial quick connect.



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  		Fig 8. Aortic conduit is anastomosed to the aorta with a running suture of 4-0 polypropylene.

 
Implantation of the ventricles and deairing
Once adequate hemostasis of all suture lines has been established, placement of the ventricles is begun. First, the left ventricle is connected. This is done by grasping the left atrial quick connector with two large Mayo clamps placed side by side, with a good hold of the connector (Figs 9A, 9B). The opposite side of the plastic fitting for the connector of the device is placed within the connector, and the operator pulls with the Mayo clamps and pushes the device into quick connect. This takes a bit of practice and should be done a number times in mock settings before it is actually attempted in the operating room. The position in which the heart sits for the duration of the support of the patient is determined by the orientation of the ventricle as it is placed into the atrial quick connect. Therefore, a careful assessment of exactly where the aortic graft will connect to the left ventricle, and the anticipated position of the left ventricle should be made before the atrial quick connect is completed. It is then an easy matter to snap on the aortic connector, taking care not to twist the graft or aorta. While this is being done, the ventricle should be filled with saline through the aortic valve as well as the graft. Once the connection is made, the patient is placed in steep Trendelenburg position and large vent sites are placed in the highest point of the aortic graft and the aorta for removal of air. The right ventricle is then connected. The atrial connection is made first, again taking care with the orientation of the ventricle so that the direction of flow from the outlet valve is appropriate for the anatomy of the patient. After the atrial connection is made, the pulmonary graft connection is made again, taking care not to twist. Before connecting the pulmonary graft, the chokers on the superior and inferior vena cava should be removed. This allows a flow of blood into the right atrium and the right ventricle, and flushes air out as the connection to the pulmonic graft is made (Fig 10).



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  		Fig 9. (A) Two Mayo clamps are used to grasp the side of the atrial quick connect as the inflow aspect of the prosthetic ventricle is brought near. (B) The inflow connect is pushed into the atrial quick connect with steady pressure. The same maneuver is performed for the right prosthetic ventricle.

 


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  		Fig 10. The CardioWest TAH connected to the respective atria and great vessels.

 
Then, with the patient in extremely steep Trendelenburg position and with the lungs being slowly ventilated, pumping is begun at a very slow rate. Agitation of the ventricles, as well as the atria, is done at this time. If available, monitoring for air bubbles in the atria and aorta with transesophageal echo can help greatly in deciding when the device has been completely deaired. As air is slowly removed from the device, the pumping rate and pressure are increased. Generally, this process takes about 10 minutes and should be done with patience and attention to complete removal of air before the artificial heart takes over from the heart-lung machine. During this time, decreasing flow on the heart-lung machine temporarily may help move air through the lungs and into the device. Once satisfied that all air is out of the device, the vent sites may be closed and full pumping with the device begun as the heart-lung machine is weaned off. The patient should be kept in steep Trendelenburg for an additional 15–20 minutes.

After this, as the bed is flattened out, the initial tries at positioning the ventricles within the mediastinum can be made. Optimally, the pleura on both sides should not be opened and the pericardium should be left intact for closure if possible or for closure with an interposed polytetrafluoroethylene (PTFE) membrane if primary closure is not possible. In smaller patients, there may be a need to force the right ventricle under the left edge of the sternum. When this is done, care should be taken to examine the left pulmonary veins and the inferior vena cava for evidence of compression. This is facilitated with transesophageal echo.

Great attention to hemostasis is necessary at this time. Optimally, these patients should be treated with aprotinin 60,000 U/kg total given as follows: one-third given as a bolus in the pump, one-third given as a bolus by anesthesia, and one-third given over a 4-hour period by continuous infusion. A test dose of aprotinin should be given before these boluses are delivered. Aprotinin has helped tremendously in obtaining hemostasis. It is an absolute requirement that complete hemostasis must be obtained before closing the chest. Bleeding cannot be permitted in these patients because transfusion results in significant hemolysis and sensitization of patients who may, therefore, be disqualified for transplantation. Once absolute hemostasis is obtained, chest tubes are placed in the mediastinum. We usually use a right-angle tube on the diaphragmatic surface and a straight tube that lies next to the right ventricle. The pericardium is closed or a PTFE graft is used to close the pericardium. This is not tight, and it is placed to facilitate opening the sternum at time of transplant. Irrigation with copious amounts of antibiotic solution is undertaken before closure. The sternum and remaining incision are closed in a routine fashion. Attention is placed to the device output, central venous pressure, and device filling when the chest is closed because chest closure may alter the anatomy, specifically causing pressure on the left-sided pulmonary veins, inferior vena cava, and occasionally the right-sided pulmonary veins. If decreased flow is noted, then the chest must be reopened and changes made in the position of the device. The most helpful change has often been to mobilize the diaphragmatic attachment of the pericardium, allowing the device to sit more leftward in the chest. This requires opening the left pleura and allowing the TAH to slightly migrate into the left pleural space. The lung should be protected from becoming adherent to the device using pericardium or PTFE membrane because adhesions to the device at the time of transplant may be extremely dense and difficult to deal with and, if involving the lung, cause significant lung tears and bleeding.

Postoperative management
If the TAH has been implanted before end-organ damage has occurred, postoperative management tends to be fairly simple. Postoperative bleeding should be at a minimum. In most cases, the only intravenous pharmacologic agents in the immediate postoperative period include nitroprusside for blood pressure management and aprotinin. If end-organ damage has occurred, then each organ dysfunction should be treated appropriately. Once the patient is stable, mechanical ventilation should be discontinued. In most institutions where the TAH is used, the patient is transferred out of the intensive care unit as soon as possible and intensive physical and emotional rehabilitation is begun. The patient should be allowed to recover completely before considering exploit and heart transplantation. Success rates of bridge to transplant in the 90% range [7] have been shown when the transplant is performed at a time when the patient is in an optimal normal physiologic state.

Anticoagulation protocols tend to vary with institutions. Usually, intravenous heparin is started shortly after implantation when mediastinal bleeding has ceased. Dipyridamole and aspirin are started soon after via a nasogastic tube or when the patient is tolerating oral intake. Warfarin is started at this time to maintain an international normalized ratio (INR) between 2.5 and 3.5. Heparin is then discontinued. Anticoagulation is usually maintained with these three pharmacologic agents until the time of explant. If a bleeding complication occurs before explantation, clinical judgment is required to determine the appropriate management of anticoagulation.

Explantation
Explantation of the device should be handled like any other redo cardiac procedure. Great care should be taken in the separation of the sternum from the device, the great vessel conduits, and the drive lines. If the device was covered with a PTFE membrane, explantation might be easier. Cardiopulmonary bypass is initiated with dual caval cannulation with tourniquets, the aorta is cross-clamped, and the TAH is turned off. The prosthetic ventricles are separated from the atrial quick connects. The great vessel conduits still attached to the ventricles are amputated at the levels of the conduit-great vessel anastomosis. The drive lines are transected, and the TAH is removed from the operating field. The drive lines are pulled through the skin. The remaining atrial quick connects are still in the remaining portion of ventricular muscle that they were initially sutured to. They are removed by transecting the AV groove throughout. The remaining atria and great vessels can now be trimmed to accept the donor heart.

Comment

The CardioWest TAH is a reliable and efficacious device that can be utilized as a bridge to heart transplantation. From experience, it appears that the implantation of this device is easier than that of other currently available devices. The postoperative management is also easier, as there is no need to continue inotropes or antiarrythmics. A portable driver is now being developed to allow patients greater mobility.

References

  1. DeVries W.L., Anderson J.L., Joyce L.D., et al. Initial human application of the Utah total artificial heart. N Engl J Med 1984;310:273-278.[Abstract]
  2. Copeland J.G., Smith R.G., Icenogle T.B., et al. Orthotopic total artificial heart bridge to transplantation. J Heart Transplant 1989;8:124-138.[Medline]
  3. Arabia F.A., Copeland J.G., Larson D.F., Smith R.G., Cleavinger M.R. Circulatory assist devices. In: Gravlee G.P., Davis R.F., Utley J.R., eds. Cardiopulmonary bypass. Baltimore: Williams & Wilkins, 1993:693-712.
  4. Copeland J.G., Pavie A., Duveau D., et al. Bridge to transplantation with the CardioWest total artificial heart. J Heart Lung Transplant 1996;15:94-99.[Medline]
  5. DeVries W.C. Surgical technique for implantation of the Jarvik-7-100 total artificial heart. J Am Med Assoc 1988;259:875-880.[Abstract/Free Full Text]
  6. Levinson M.M., Copeland J.C. Technical aspects of total artificial heart implantation for temporary applications. J Cardiac Surg 1987;2:3-19.[Medline]
  7. Arabia F.A., Smith R.G., Rose D.S., Arzouman D.A., Sethi G.K., Copeland J.G. Success rates of long term circulatory assist devices currently used for bridge to heart transplant. ASAIO J 1996;42:M542-M546.[Medline]



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