Author Device ICU stay Hospital Implant Complications All-cause mortality (mean/ stay successa median (mean/ days) median days) Kocher et al Intuity (n = NR NR 96% 2% 8% (other TE 4%) 1% major 2.1% 7.5% (2013)() 152) bleedb (30-day) (mean 10mo) Martens et al 3f Enable (n = NR NR 100% 3% NR 1% NR 3.6% 12.9% (2011)() 140) (major) (30-day) (≈1y) Eichstaedt et 3f Enable (n = NR 9 100% 2% 7% 1% 3% major 6.7% 9% al.() 120) bleedb (major; (other TE 1%) (30-day) (mean 9mo) ≥grade 2) a Study valve successfully implanted and functioning. b Reoperation required due to significant bleeding. c 4% during implantation and affecting successful valve implantation; 4% necessitating reoperation. d Necessitating reoperation. e An update including 175 patients was later presented at a conference.() Outcomes were very similar. At a median follow-up of 10 months the noncardiac mortality rate was 1.7%. ICU = intensive care unit; GI = gastrointestinal; TE = thromboembolism; tx = blood transfusion.
Author Device ICU stay (mean/ median days) Hospital stay (mean/ median days) Implant successa Complications All-cause mortality Kocher et al (2013)() Intuity (n = 152) NR NR 96% 2% 8% (other TE 4%) 1% major bleedb 2.1% (30-day) 7.5% (mean 10mo) Martens et al (2011)() 3f Enable (n = 140) NR NR 100% 3% (major) NR 1% NR 3.6% (30-day) 12.9% (≈1y) Eichstaedt et al.() 3f Enable (n = 120) NR 9 100% 2% (major; ≥grade 2) 7% 1% (other TE 1%) 3% major bleedb 6.7% (30-day) 9% (mean 9mo) a Study valve successfully implanted and functioning. b Reoperation required due to significant bleeding. c 4% during implantation and affecting successful valve implantation; 4% necessitating reoperation. d Necessitating reoperation. e An update including 175 patients was later presented at a conference.() Outcomes were very similar. At a median follow-up of 10 months the noncardiac mortality rate was 1.7%. ICU = intensive care unit; GI = gastrointestinal; TE = thromboembolism; tx = blood transfusion.