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OBJECTIVE:
The use of continuous-flow ventricular assist devices (cfVAD) is an approved therapy for patients with advanced heart failure. However, there is rapidly ongoing process of pump optimization and miniaturization. The impact of clinical implementation of newer miniaturized cfVAD on outcome, complication rate and quality of life compared to routinely used devices is unknown. Here we report our preliminary single-center experience with the mini-cfVAD HVAD (HeartWare).
METHODS:
In 2010 we extend our assist device program with a new miniaturized continuous-flow pump (HVAD, HeartWare). So far, 25 HVAD cfVAD (HeartWare) were used in patients due to refractory severe heart failure. All patients were high risk patients (INTERMACS Level 1: n=7; Level 2: n=9, and Level 3: n=9). Additionally, 4 transplantable patients were listed in high urgent status. The study population included 21 man and 4 women with a mean age of 57 ± 8 (range 37-79 years). In-hospital (30-day) and long-term survival, freedom form re-operation, neurological complication, and the rate of drive-line infection were examined.
RESULTS:
For safety reasons the first implants were obtained in relatively stable patients (INTERMACS 3). Mean support time was 242 days (range 13-592 days). In-hospital (30-day) mortality was 4% (n=1) due to severe cardiogenic shock with multiple organ failure and sepsis. No patient died due to procedural or device related complications. The follow-up survival for all was 21 of 25 patients (84.0%, INTERMACS 1: death n=1 and INTERMACS 2: death n=3). Bleeding requiring reoperation occurred in 4 patients (n=16%). Neurological problems were identified in 4 patients. There were 3 drive-line infections. 70% of all patients were discharged at home. Within the entire patient population no device failure, no problems with the components, or daily use were observed.
CONCLUSIONS: The inauguration of a new approved assist device does not have any negative impact on survival and complication rate. Extended teaching and education was observed and the consecutive attention may have a influence on successful clinical implementation.