Seventy-six studies across 84 publications were included in the review (n=2,375 apparently unique patients; range one to 646); 50 publications were case reports (n=67 patients) and 34 were case series (n=2,311 patients).
Overall, percutaneous heart valve replacement was successful for 1,843 out of 1,967 (94%) patients. The 30-day survival across all studies was 89%; the overall 30-day mortality rate was 11%. For the femoral artery approach, implantation success was 93% and 30-day survival was 90%. For the transapical approach, implantation success was 94% and 30-day survival was 88%.
Serious adverse events associated with percutaneous heart valve replacement included: major access site complication, life-threatening arrhythmias, need for haemodynamic support, need for a second valve, and ventricular perforation. Large case-series reported approximately 8% of patients experiencing a major adverse cardiovascular or cerebrovascular event.