title: Clinical evaluation of the HeartPak. A new pneumatic portable driver for use with the HeartMate Implantable Pneumatic Left Ventricular Assist System.
abstract: The HeartPak Portable Pneumatic Driver was designed for use with the HeartMate Implantable Pneumatic Left Ventricular Assist Device (IP-LVAS) (Thermo Cardiosystems, Inc., Woburn, MA). The HeartPak measures 48 x 23 x 15 cm, weighs 9.3 kg with batteries, and can be carried by a handle, by a shoulder strap, or on a trolley. Four 12 V batteries provide power for as long as 8 hr. To test the HeartPak in the hospital environment, seven men were studied who were bridge-to-transplant patients (mean age, 59.8 +/- 8.87 years) undergoing HeartMate IP-LVAS therapy. They were supported by the HeartPak for 429 days with a cycle count of 57,826,560. To normalize the mean pump flow rate, we used the body surface area to obtain a pump flow index in each case. The mean flow rate was 2.65 +/- 0.57 L/min/m2 for the HeartPak vs. 2.64 +/- 0.45 L/min/m2 for the HeartMate 1000, the conventional driver previously used in these patients. The only potentially serious problem with the HeartPak was console failure in one case. The patient took appropriate backup measures, and the HeartPak was replaced. In no case did the device cause any adverse effects or interruption of LVAS support. Compared with HeartMate 1000, the HeartPak was more convenient, easier to operate, and allowed better patient mobility.
authors.affiliation: Cardiovascular Surgical Research Laboratories, Texas Heart Institute, Houston 77225-0345, USA.
authors.forename: D
authors.initials: D
authors.lastname: Tamez
authors.forename: T J
authors.initials: TJ
authors.lastname: Myers
authors.forename: R W
authors.initials: RW
authors.lastname: Inman
authors.forename: K A
authors.initials: KA
authors.lastname: Miller
authors.forename: O H
authors.initials: OH
authors.lastname: Frazier
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D001698:Biomedical Engineering; D011211:Electric Power Supplies; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy; D016027:Heart Transplantation; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D013997:Time Factors