Recent improvements in outcome with the Novacor left ventricular assist device.
BACKGROUND
The Novacor implantable, electrically powered, wearable, left ventricular assist device (LVAD) has been used as a bridge to transplantation at our institution since 1994. Recent changes in protocol have resulted in a decreased incidence of infections, thromboembolism, and mortality.


METHODS
We reviewed the medical records of all 43 patients who received implantable LVADs at the Mount Sinai Medical Center. After 1998, a number of protocol modifications were instituted. Vascular grafts were changed from a low-porosity, woven polyester (Cooley) to a gelatin-sealed, knitted polyester graft (Vascutek), the devices were implanted pre-peritoneally rather than in the posterior rectus sheath, and extensive drainage of the chest and pre-peritoneal pocket was used. The following anti-coagulation regimen was used: low-molecular-weight Dextran for 1 day, initiated after chest tube drainage <50 cc/hour; then IV heparin for 10 to 14 days, beginning at 500 U/hour, slowly increasing partial thromboplastin time to 1.5 to 2 x control; and finally Coumadin, maintaining the international normalized ratio at 2.5 to 3.5. Daily aspirin, 325 mg, was begun on post-operative Day 7. We compared 22 patients who electively underwent surgery before the changes, Group I, with 18 patients treated thereafter, Group II.


RESULTS
Groups I and II were well matched with regard to age (47 vs 44 years); cause of heart failure (idiopathic, 50% vs 44%; ischemic, 50% vs 56%), and duration of support (79 vs 76 days). The incidence of thromboembolic cerebrovascular events was significantly less in Group II (6%) than in Group I (23%), p = 0.025. The incidence of bleeding increased mildly in Group I. Pocket infections occurred in 27% of Group I patients vs 11% of Group II patients, p = 0.018. Only 2 patients (11%) in Group II died while receiving device support, vs 7 (32%) in Group I, p = 0.019.


CONCLUSIONS
Our results indicate that pre-peritoneal implantation, use of a new generation of vascular grafts, extensive drainage, and a more restricted anti-coagulation regimen improve outcome after Novacor LVAD implantation for advanced heart failure.
Strauch
Justus T
JT
Department of Cardiothoracic Surgery, Mount Sinai School of Medicine/New York University, New York, New York 10029, USA. ju.strauch@gmx.de
Spielvogel
David
D
Haldenwang
Peter L
PL
Correa
Rhodora K
RK
deAsla
Richard A
RA
Seissler
Peter E
PE
Baran
David A
DA
Gass
Alan L
AL
Lansman
Steven L
SL
D000293:Adolescent; D000328:Adult; D000368:Aged; D001243:Assisted Circulation / Q000295:instrumentation; D002423:Cause of Death; D004867:Equipment Design; D005260:Female; D006331:Heart Diseases / Q000401:mortality / Q000601:surgery; D016027:Heart Transplantation / Q000295:instrumentation; D006353:Heart-Assist Devices; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009518:New York / Q000453:epidemiology; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality; D012086:Reoperation; D013223:Statistics as Topic; D016019:Survival Analysis; D016896:Treatment Outcome