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Ann Thorac Surg 2002;73:1337-1340
© 2002 The Society of Thoracic Surgeons
a Oxford Heart Centre and The Heart Hospital, London, United Kingdom
b Texas Heart Institute, Houston, Texas, USA
c Jarvik Heart Inc, New York, New York, USA
Accepted for publication December 3, 2001.
* Address reprint requests to Dr Westaby, Oxford Heart Centre, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, United Kingdom
e-mail: swestaby{at}ahf.org.uk
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Abstract |
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Introduction |
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The Jarvik 2000 Heart is now undergoing clinical trials in end-stage heart failure patients both for bridge to transplantation and permanent mechanical circulatory support [3, 4]. Only the mode of power delivery differs between the two strategies.
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Technique |
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After induction of anesthesia, a left-sided double lumen endotracheal tube is deployed and a transesophageal echocardiography probe deployed. Detailed hemodynamic control is maintained with a combination of nitric oxide gas to reduce pulmonary arterial pressure together with glyceryl trinitrin, esmolol, adrenalin, and dopamine infusions as required. The patient is positioned in the lateral position providing access to the left chest and femoral vessels (Fig 1A). For permanent implants, the left shoulder, neck, and post-auricular scalp are prepared and included in the surgical field (Fig 1B).
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Left thoracotomy is performed through the sixth intercostal space to provide access to the apex of the left ventricle and the lower one-third of the descending thoracic aorta (Fig 1A). When feasible, the left lung is retracted gently rather than deflated. This reduces the propensity for a rise in pulmonary artery pressure and fall in cardiac output prior to heparinization. An appropriate site is identified for anastomosis of the distal part of the outflow graft. Reference to the thoracic CT scan helps determine the optimum position. We avoid atheromatous plaques or aneurysmal areas and have used the abdominal aorta. Ascending aortic anastomosis is feasible but reqires a longer graft. A side-biting clamp is applied and a 2-cm aortotomy made to accommodate the bevelled edge of a 16-mm Haemashield graft (Boston Scientific, Natick, MA). The oblique anastomosis is performed with continuous 4-0 polypropylene in such a way as to direct the graft in a gentle curve from the diaphragmatic sulcus to the anastomosis’ site. The graft is then clamped and the aortic side clamp removed, allowing the anastomosis to seal before heparinization.
The Jarvik 2000 Heart is brought into the operative field and the power cable tunnelled across the midline below the costal margin to exit through the right hypochondrium. The pump itself is placed in a bowl of saline, the power cable connected to the external controller and battery, and the system tested.
The pericardium is then widely opened anterior to the phrenic nerve. The apex of the left ventricle is inspected to determine the implant site in relation to the left anterior descending and diagonal vessels. The site is chosen to avoid the papillary muscles and allow the pump to lie parallel to the septum. At this point, heparin is administered, the intraaortic balloon pump is removed, and cannulation is undertaken for partial cardiopulmonary bypass. A long, thin-walled, venous cannula is advanced from the groin into the right atrium. Normothermic cardiopulmonary bypass is undertaken and the patient tipped into the head down position. The heart is fibrillated to prevent ejection during the coring procedure. Accurate suture placement is easier in the nonbeating heart. A cruciate incision is made through the left ventricular apex at the site for implantation (Fig 2A). The index finger is passed into the ventricle to determine proximity of the papillary muscles. A cylindrical coring knife is used to excise a ring of apical muscle to accommodate the Jarvik 2000 Heart. The ventriculotomy is inspected for muscle strands or thrombus which might impinge on the device. Eight to 10 Teflon (Impra Inc, subsidiary of L. R. Bard, Tempe, AZ) buttressed, mattress sutures of 2-0 Tycron are inserted circumferentially through the myocardium in order to anchor the cuff (Fig 2B). We aim to pass each through full-thickness myocardium and endocardium. Care is taken not to overtighten the knots (Fig 2C). Alternatively the cuff can be sewn on before coring and with the heart beating. With this method the pump has been implanted without CPB in a Jehovah’s Witness patient.
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With the circuit filled with blood, pump flow is established at 8,000 rpm and gradually increased to 10,000 rpm. If the left lung has been collapsed to facilitate the surgery, ventilation is restored with the addition of nitric oxide gas to reduce pulmonary vascular resistance. Continuous deairing of the graft is used while discontinuing bypass, and the operating table is returned to the horizontal position. Low-dose adrenalin infusion is used as an inotrope for the right ventricle, while preload is optimized to provide a cardiac output between 5 and 6 litres per minute. Protamine sulfate is administered followed by fresh frozen plasma and platelets.
During chest closure, cardiac output, radial arterial, pulmonary arterial, and right atrial pressures are monitored continuously. Two intercostal drains and a pacing wire are deployed.
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Results |
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The pedestal is attached to the parietal bone about 5 cm behind and slightly above the ear. A relatively flat area of skull is chosen taking care to avoid the mastoid air cells, the mastoid emissary vein, or the transverse venous sinus. The titanium base is 3 mm in depth, and 8 mm self-tapping screws are employed. A cork bore instrument, the same diameter as the percutaneous stem of the pedestal, is first used to punch out a skin defect through to the periostium at the site chosen. A C-shaped, widely based, full-thickness flap is raised down to the periostium around this defect. The periostium is then elevated and a template used to define the position of the bone screws (Fig 3A). A dental drill is used to penetrate the external table before inserting the self-tapping screws. Incisions are made on the shoulder and neck to convey the three-pin connector and power cable to the skull pedestal site. This process is achieved by inserting the three-pin connector within the end of an intercostal drain. This is withdrawn out through the second intercostal space then via the second neck incision to the prepared cranial site in a gentle curve. The three-pin connector is inserted into the titanium pedestal, which is screwed onto the flat part of the external table with six bone screws. Bone dust from the screw holes is used to promote osseo integration. The skin flap is repositioned with the pedestal stem passed through the punched out defect (Fig 3B). The scalp and skin incisions are then closed securely before heparinization. The external power cable is joined to the skull pedestal and the power switched on to test the circuit. This process takes between 45 and 60 minutes, during which it is necessary to avoid profound hemodynamic deterioration before heparinization.
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Comment |
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The critical design feature is the high rotational speed to promote blood that continuously washes the tiny bearing and prevents thrombus formation. At 8,000 rpm, the pump acts only as a valve preventing functional aortic regurgitation through the Dacron graft. At the maximum speed (12,000 rpm), the left ventricle is completely offloaded with an arterial pulse pressure less than 10 mm Hg. As the pump speed is turned down, the arterial pulse pressure increases progressively, though the aortic valve does not open synchronously until the lower speeds of 8,000 to 10,000 rpm. Mean systemic arterial pressure increases with loss of pulse pressure reflecting increased baro-receptor activity. We employ pump speeds compatible with normal end-organ function preferably with ejection through the aortic valve and a pulse pressure of 10 to 20 mm Hg in the systemic circulation. When the aortic valve remains permanently closed, the brachiocephalic and coronary arteries receive blood only by retrograde aortic flow. Performance of the dilated ventricle often improves early after mechanical offloading, and continued cardiac work may promote left ventricular recovery. In the event of myocardial recovery, the device can be removed by cutting the tapes, withdrawing the pump, and oversewing the apex.
The thoracotomy approach enters only one body cavity leaving the sternotomy route for cardiac transplantation or avoiding resternotomy in those who have undergone coronary bypass. Access to the descending aorta is usually easy and only the apex of the left ventricle must be mobilized at the time of transplantation. Surgical trauma is considerably less than experienced during implantation of larger LVADs, and with further experience it is possible that cardiopulmonary bypass may not be required. The smaller transabominal drive line already seems less prone to infection than the larger stiff percutaneous lines of the TCI and Novacor LVADs. Our initial experience with post-auricular power delivery is encouraging with no infection to date. For permanent implants where the patients are discharged into the community, it is an advantage to be able to exchange the external system in the event of damage.
Given the encouraging early experience, the Jarvik 2000 Heart may fulfill its promise as a realistic device for widespread use on an outpatient basis.
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Footnotes |
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References |
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