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Eur J Cardiothorac Surg 2005;28:337-339
© 2005 Elsevier Science NL


How-to-do-it

Implantation of the Jarvik 2000 left-ventricular-assist-device: role of the maxillofacial surgeon

Bettina Hohlweg-Majert * , Ralf Gutwald, Michael P. Siegenthaler, Rainer Schmelzeisen

Department of Oral and Maxillofacial Surgery, University Hospital Freiburg, Freiburg, Germany

Received 22 November 2004; received in revised form 25 April 2005; accepted 25 April 2005.

* Corresponding author. Address: Department of Oral and Maxillofacial Surgery, Albert-Ludwigs-University, Hugstetterstrasse 55, D-79106 Freiburg, Black Forest, Germany. Tel.: +49 761 270 4701; fax: +49 761 270 4877. (Email: hohlweg{at}zmk2.ukl.uni-freiburg.de).


    Abstract
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
The Jarvik 2000 system of axial-flow LVAD—is implanted for permanent mechanical circularly support in patients with end-stage heart failure waiting to undergo heart transplantation. The battery is connected with a power plug to the percutaneous skull-mounted footplate, which is monocortically fixated to the retro auricular bone. Patient selection should be highly specific, including careful preoperative evaluation. No device failures have been published so far, but complications can occur due to heparinisation. We describe the procedure from the perspective of the maxillofacial surgeon and give suggestions to prevent surgical complications.

Key Words: Jarvik 2000 • Surgery • Maxillo-facial surgeon • Complications


    1. Introduction
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
The Jarvik 2000 is an axial-flow pump that provides continuous flow from the left ventricle to the aorta which is implanted for permanent mechanical circularly support. The system works with a percutaneous electric power supply (Fig. 1 ). The pump is powered by a portable internal and external polymer lithium-ion battery. The first implantation was described in 2000 [1].



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Fig. 1. The percutaneous power supply of the Jarvik 2000.

 
The most frequently reported complications of conventional LVADs are bleeding, infection, device-failure and thrombo-embolism [2]. The Jarvik 2000 offers advantages to reduce potential complications, such as left thoracotomy, absence of an inflow-cannula, no fixation of the cardiac apex, minimal alloplastic material and anastomosis to the descending aorta.

Fixation of the footplate is a high risk surgical intervention. Several centres have published their clinical experience with skin-exit sites from cochlear implants [3]. In our centre, the footplate is fixated to the retro auricular bone by a cranio-maxillofacial surgeon.


    2. Pre-operative evaluation
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
Heart failure patients in need of mechanical left-ventricular support with a Columbia-University risk-score index ≤5 are considered for implantation. The Jarvik system promotes 5–6l/min and the body surface should not be higher than 2.1m2 [4]. Patients with fixed pulmonary-vascular-resistance >7 Wood Units are considered for a conventional LVAD with access to the right-ventricle. The thickness of the parietal bone (≥4mm) is determined with a CT. In high risk situations, computer-assisted surgery is used.


    3. Pedestal implantation for power supply
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
The pedestal implantation is performed by the maxillofacial surgeon. A round skin excision in the retro auricular region is performed and punched out. A semi-lunar incision runs parallel to the ear curvature and a broad-based flap is prepared. The periosteum is slit cruciform-shaped. Holes are drilled with a 6mm long drill with a stop. Via two incisions the power-cable is guided through a tunnel from the chest to the retro auricular region and connected to the pedestal (Fig. 2 a). The cable must allow free mobility of the neck without straining. Self-tapping screws allow a 1.5mm safety-margin to prevent skull penetration and are used to fix the pedestal after cable connection (Fig. 2b). After repositioning the periosteum, the flap is readapted. The battery cable is connected to test the system and the skin is closed.



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Fig. 2. (a) The guided cable connected to the pedestal. (b) The cruciform periosteal-flap and the elevated broad-based flap and fixation of the plug on the retroauricular bone with 6mm self-tapping screws.

 

    4. Implantation of the Jarvik 2000
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
The Jarvik 2000 system was implanted by the cardiovascular surgeon [5]. An intravenous antibiotic is prescribed for the first 48h. Healing of the pedestal wound is checked every 2 days and the suture is removed 10 days after implantation. Follow up is done after 2 and 6 months.


    5. Clinical results
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
Between May 2001 and October 2003, nine skull pedestals with the Jarvik devices have been implanted. One patient died on day 8 postoperatively.

Two patients suffered from a pedestal infection, but were treated successfully with a continued intravenous antibiotic. Two patients developed haematoma in the retro auricular area several days postoperatively, but after surgical treatment no more complications occurred. In one case cerebrospinal fluid (CSF) appeared. The defect was closed with fibrin glue and by inserting the screw. No other complications occurred during further follow up (up to January 2005).

None of these patients required a second surgical intervention. No complications were observed during the permanence of the assist device.

Follow up until January 2005 revealed no more complications. In two patients, the pedestal was removed without problems and both successfully received a heart transplantation.


    6. Suggestions to prevent surgical complications
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
Intracranial bleeding can be prevented by determining the correct pedestal position using a preoperative CT. After tunnelling to place the interne cable, the system should be checked.

To avoid intracranial bleeding and liquorrhea, the thickness of the parietal bone has to measured on CT. If the thickness of the parietal bone is <4mm, a computer-assisted system should be used. Self-tapping screws are utilised to allow a 1.5mm safety-margin to prevent skull penetration. If perforation and leakage occurs, a glucose check should be done to assess the presence of CSF. In case of loss of CSF, fibrin glue, bone chips or bone wax can be used to close the defect and the screw can be inserted, which additionally stops the loss. Postoperative antibiotic therapy is indicated to prevent an infection.

Haemorrhage in the retro auricular region with existing coagulopathy can be avoided with electro cauterisation. If haematoma occurs, an incision should be performed, in combination with preventive antibiotic therapy.

Drill holes and pedestal coverage with cruciform-sliced periosteum promotes bony apposition.


    7. Discussion and conclusions
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 
The retro auricular region is chosen because of best bone quality and thickness. In this region, the skin is not movable, which reduces the risk of infections. The pedestal is better protected by ear mussel than in other regions and the scar is less visible. The plug does not have to be fixated in the hairy region. It can also be fixated in the frontal or fronto-parietal bone, but this has not been reported in literature.

The use of this minimally invasive approach has been described by the ENT surgeon for implantation of the cochlear implant [3]. Pau et al. [6] reported no local circulation disorders of this flap. We also could not find any problems in our patients. Wound-related complications were rarely observed in our study.

The Jarvik 2000 is an adequate alternative for other LVADs for patients awaiting heart transplantation. Until now no failure of this device has been published. The device can easily be implanted and is a good and safe choice [7,8]. We provided suggestions for the maxillofacial surgeon to prevent surgical complications based on our own experience. Of course, the procedure has to be performed precisely, in order to reduce or prevent surgical complications.


    References
 Top
 Abstract
 1. Introduction
 2. Pre-operative evaluation
 3. Pedestal implantation for...
 4. Implantation of the...
 5. Clinical results
 6. Suggestions to prevent...
 7. Discussion and conclusions
 References
 

  1. Westaby S, Banning AP, Jarvik R, Frazier OH, Pigott DW, Jin XY, Catarino PA, Saito S, Robson D, Freeland A, Myers TJ, Poole-Wilson PA. First permanent implant of the Jarvik 2000 Heart. Lancet 2000;365:900-990.
  2. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembinsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MZ, Poirier VL, Meier P, The randomized Evaluation of mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435-1443.[Abstract/Free Full Text]
  3. Parkin JL. Percutaneous pedestal in cochlear implantation. Ann Oto Rhinol Laryngol 1990;99:796-800.[Medline]
  4. Oz MC, Goldstein DJ, Pepino P, Weinberg AD, Thompson SM, Catanese KA, Vargo RL, McCarthy PM, Rose EA, Levin HR. Screening scale predicts patients successfully receiving long-term implantable left ventricular assist devices. Circulation 1995;92:II169-II173.[Medline]
  5. Siegenthaler MP, Martin J, Frazier OH, Beyersdorf F. Implantation of the permanent Jarvik-2000 left-ventricular-assist-device: surgical technique. Eur J Cardiothorac Surg 2002;21:546-548.[Abstract/Free Full Text]
  6. Pau HW, Sievert U, Graumuller S, Wild E. Incisions for chochlear implant and superficial skin temperature. Skin temperature/blood circulation in CI flaps. Otolaryng Pol 2004;58:713-719.
  7. Frazier OH, Myers TJ, Jarvik RK, Westaby S, Pigott DW, Gregoric ID, Khan T, Tamez DW, Conger JL, Marcris MP. Research and development of an implantable, axial flow left ventricular assist device: the Jarvik 2000 Heart. Ann Thorac Surg 2001;71:125-131.
  8. Banbury MK. Stapled explant of the Javik 2000 left ventricular assist device. Ann Thorac Surg 2003;75:297.[Abstract/Free Full Text]




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Michael P. Siegenthaler
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Right arrow Articles by Hohlweg-Majert, B.
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