Aims: To assess short-term safety defined as the successful delivery and deployment of the ventricular partitioning device (VPD) implant, as well as 12-month functional, clinical, and haemodynamic effectiveness.
Methods and results: Ventricular partitioning device implantation was successful in 15/18 (83%) patients with anteroapical regional wall motion abnormalities following myocardial infarction. In one patient, the VPD was removed 3 days post implantation and the patient subsequently died due to extra-cardiac sepsis. When compared with baseline, there was significant improvement at 6 and 12 months following VPD implantation in NYHA class (2.21 +/- 0.57 vs. 1.28 +/- 0.46 vs. 1.23 +/- 0.4.3, respectively, P < 0.001 for both), left ventricular (LV) end-systolic volume (189 +/- 45 vs. 142 +/- 29 vs. 151 +/- 48 mL/m(2), respectively, P < 0.001 for both), and LV end-diastolic volume (260 +/- 47 vs. 208 +/- 33 vs. 222 +/- 58 mL/m(2), respectively, P < 0.001 for both). After 12 months, an improvement in LV ejection fraction was noted (28 +/- 7 vs. 32 +/- 7 vs. 33 +/- 9%, respectively, P = 0.02) as well as improvement in 6 min walk distance (382 +/- 123 vs. 409 +/- 7 vs. 425 +/- 140 m) when compared with pre-procedural values.
Conclusion: Our data indicate that VPD implantation is safe and feasible, and that VPD implantation improves LV haemodynamics and functional capacity in the 12 months following the procedure.