norway, page-16

useful research I posted the results of a good study on here the other day which demonstrated the outcomes of patients with implants that VCR will be competing against. For some reason or other it seems to have disappeared.
Given all the bleatings about the competition by a very biased poster on here, I thought it was useful information. Obviously it was, or it would not have been removed.
Just trying to get some actual figures for comparison.
The main point to take from it is that the patients in this trial were extremely sick and beyond medical therapy. One would presume that they are a similar patient base to that of the Ventrassist pilot trial.
The key figure would be the survival of only 30% at 180 days post-implant.
As we've been reminded, 4 of 9 implantees in the pilot trial died, and that's a survival rate of 56%, with an average survival of 5 months after just over a year of the trial, and noting that implants were made throughout that year.



Here it is again.

Title
Permanent mechanical circulatory support in patients of advanced age.

Source
European Journal of Cardio-Thoracic Surgery. 25(4):610-8, 2004 Apr.

Abstract
OBJECTIVE: This study details our initial results of long-term left ventricular assist device (LVAD) support in patients suffering from catecholamine-dependent end-stage heart failure or cardiogenic shock with age above 65 years or age above 60 and contraindications to cardiac transplantation.
METHODS: Between September 2000 and July 2002, 27 patients received implantation of left ventricular assist devices (Micromed DeBakey (n=15), Berlin Heart Excor (n=6), Arrow Lion Heart (n=4) and Novacor N100 (n=2)). The mean age of this group was 66.2+/-4.1 (60-77) years. The patients presented with the following features by the time of LVAD implantation: failure of weaning from inotropic support (78%), either profound cardiogenic shock (37%) or instable hemodynamic status (22%), high-dose inotropic (52%) or intraaortic balloon pump support (11%), dialysis (15%), artificial ventilation (15%), and at least one previous cardiac procedure (44%).
RESULTS: The cumulative survival rate for the whole group was 63% at 30 days, 30% at 180 days, and 22% at 2 years. The presence of preoperative cardiogenic shock was associated with a higher perioperative mortality rate. Late complications (n=7) included replacement of two thrombosed DeBakey LVADs and five late deaths secondary to thrombembolism/intracranial hemorrhage (DeBakey LVAD, n=3) or septicemia (n=2). As of May 15, 2003, six patients remain on LVAD support for an average of 653 (339-953) days, three patients now for more than 2 years. Ten patients were discharged home to spend 73% of their life span on out-of-hospital long-term LVAD support.
CONCLUSION: This study reports the first single-center experience of permanent LVAD support in patients of advanced age. For this initial experience, many patients with critical circulatory status and previous cardiac operations were included and a high postoperative mortality rate was encountered among them. Older age and associated multimorbidity are the key determinants rendering the conditions of LVAD therapy for this patient cohort to be different from the bridge-to-transplant experience. The LVADs employed in this study showed different capabilities with regard to long-term support. Our experience shows that permanent mechanical circulatory support does have the potential to evolve as a treatment option in selected elderly patients with end-stage heart failure.