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Methods: Between 1997 and 2000, 5 men (age 59–73) with end-stage dilated cardiomyopathy refractory to maximal drug treatment and with documented hemodynamic improvement on IABP were enrolled in a feasibility study.
Results: Mean bypass time was 157 min (range 120–196 min); mean cross-clamp time was 101 min (range 69–144). Pt I died intraoperatively. Pt 2 died 5–1/2 months after surgery in a device related death. This technical anomaly has since been identified and corrected. Pt 3 survived 6 weeks and died for reasons unrelated to the device. Pts 4 and 5 have now survived 105 and 30 days, both are discharged from the hospital, both improved from NYHA class IV to II and III respectively. Pt 4 deactivates the KCV for 3 hours, twice a day. Cardiac output (CO) increased in the last 3 patients from a preop 2.9 L/min to a postop 5.4 L/min. Postoperatively, the mean increase in CO with the KCV OFF to ON was .97 L/min (range .57–1.31 L/min).
Conclusion: Our initial clinical experience demonstrates the feasibility of successful surgical implantation of the KCV in end-stage patients, the satisfactory performance of the PAD, the ability of the device to be used intermittently without anticoagulation, and the hemodynamic and functional improvement in the status of the patient.
