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Clinical research

The TandemHeart®, percutaneous transseptal left ventricular assist device: a safeguard in high-risk percutaneous coronary interventions. The six-year Rotterdam experience

1. Department of Cardiac Intensive Care & Interventional Cardiology, Virga Jesseziekenhuis, Hasselt, Belgium; 2. Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Centre, Rotterdam, The Netherlands; 3. Cardialysis B.V., Clinical Research Organisation & Core Laboratories, Rotterdam, The Netherlands; 4. Department of Interventional Cardiology, S. Giovanni Battista Hospital, University of Turin, Turin, Italy

Aims: Percutaneous coronary interventions (PCI) in high-risk cardiac patients are preferentially referred to specialised myocardial intervention centres (MIC). Included in this group are patients with a haemodynamic collapse or high likelihood of haemodynamic collapse, either during balloon inflation or with acute vessel closure. The TandemHeart®, a percutaneous transseptal left ventricular assist (PTVA®) that can be introduced using standard catheterisation laboratory techniques, offers interesting perspectives to reduce procedural risks.

Methods and results: Between September 2000 to July 2006, The TandemHeart®, supported the circulation of 23 patients (age: range 46-74, mean 59) admitted to our centre for high risk, either emergency or elective, PCI. Successful implantation was achieved in 100% of patients. The mean time for implementation of circulatory support was 35 minutes (range 16-62). The index PCI was successful in all patients except two. A pump flow up to 4L/min was achieved with significant reduction of left ventricular filling pressures, pulmonary capillary wedge pressure and with significant increase of systemic arterial pressures. Duration of support ranged from 1-222 hours (mean 31±49.8 hours). Five patients died with the TandemHeart® in place, four of whom were in irreversible cardiogenic shock at admission. Mild to moderate access site bleeding was seen in 27% of patients. One patient experienced a loge syndrome of the leg. Core temperature (Ct) decreased to <36.5°C in six patients, profound hypothermia (Ct < 35°C) was observed in two patients. There was no technical device failure.

Conclusions: The TandemHeart® - PTVA® provides effective, total left ventricular support in very high risk PCI settings. The rate of device related cardiac and vascular complications was acceptable.

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