The Tandem Heart percutaneous left ventricular assist device (pVAD) (Cardiac Assist Technologies, Inc., Ithaca, New York) may reduce complications associated with high-risk percutaneous coronary intervention (PCI), physicians in The Netherlands report.
“The increase in safety provided by the circulatory bypass may potentially allow the treatment of patients at an extremely elevated risk, thereby eventually broadening the application of percutaneous intervention to patients currently refused to this modality,” Dr. Patrick W. Serruys and associates write in the American Journal of Cardiology for February 15.
The research team used the pVAD device at Erasmus Medical Center, Rotterdam, for five patients with decreased heart function who underwent elective angioplasty and two patients with acute coronary syndromes and cardiogenic shock who underwent nonelective PCI.
Dr. Serruys’ team notes that pVAD implantation required 31 to 69 minutes. Continuous perfusion of heparin was maintained at a side port. Mean systemic arterial pressure increased and pulmonary wedge pressure decreased once pumping was initiated.
Following the procedures, patients were weaned from circulatory assist when they could maintain sufficient native cardiac function without use of inotropic drugs and without large increases in filling pressures. For three of the electively treated patients, this was achieved within 6 hours after the procedure. The other two patients developed hypothermia and weaning was postponed until 27 and 50 hours, respectively.
One patient who underwent nonelective treatment was weaned off the pVAD after 22 hours. The other emergently treated patients died soon after the pump was removed after 269 hours of support. Otherwise, the only other adverse effect was groin bleeding in four patients. There was no incidence of lower limb ischemia, and 30-day follow-up was “uneventful.”
These findings “contrast with the high incidence of device-related complications observed with other VAD modalities, highlighting a possibly more liberal indication of the Tandem Heart system in complex interventions,” Dr. Serruys and his associates conclude.
Am J Cardiol 2003;91:479-482.
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