Clinical introduction of the Tandemheart, a percutaneous left ventricular assist device, for circulatory support during high-risk percutaneous coronary intervention.

Abstract

Background: In patients with poor left ventricular function and high-risk coronary lesions, prolonged ischemia during percutaneous coronary intervention (PCI) may have major hemodynamic consequences. The Tandemheart is a percutaneous left ventricular assist device intended for short-term circulatory support.

Methods and results: The Tandem-heart incorporates 9-17 F. arterial cannulae and a unique 21 F. transseptal cannula and centrifugal bloodpump. Operating at 7500 rpm, the pump withdraws oxygenated blood from the left atrium and delivers up to 4 liters/min to the arterial circulation. As of May 2001, the Tandem-heart was electively employed in three male patients (ages 52, 54 and 56) scheduled for high-risk PCI. The mean time to initial circulatory support was less than 30 minutes. Systemic hemodynamics significantly improved prior to PCI in two patients. Pump flow after one hour ranged from 2.43 to 3.8 liters/min (mean 3.17 liters/min) and duration of support from 23 to 49 hours (mean 33 hours). Procedural success was 100%, with no significant hemolysis or bleeding. Successful weaning was completed in all patients, who have remained free of major cardiac events up to seven months post-PCI.

Conclusions: In this first clinical experience of elective use of Tandem-heart for circulatory support during high-risk PCI, the device was easily inserted and preserved hemodynamic stability, regardless of the intrinsic cardiac function, creating optimism for more widespread use for this and other indications.