Author + information
- Finn Gustafsson1,
- Filip Malek2,
- Petr Neuzil3,
- Vivek Reddy4,
- Lars Sondergaard1,
- Tony Walton5 and
- David Kaye6
Diastolic dysfunction develops in most cardiac conditions, and leads to elevation of left ventricular filling pressures and heart failure. We report the initial experience with a novel device intended to lower left atrial pressure by creating a small permanent atrial septal shunt. The objective of the study was to evaluate safety and potential benefits of the Intra Atrial Shunt Device (IASD(tm)) System in patients with symptomatic heart failure with preserved or mildly reduced ejection fraction, despite appropriate medical management.
The first 6 patients in a prospective multicenter feasibility study were enrolled under an approved protocol. Key inclusion criteria were: EF > 45%; PCWP at rest ≥ 15 or exercise ≥ 25mm Hg; or ≥ 1 hospitalization for heart failure within prior 12 months; or persistent NYHA Class III/IV for at least 3 months.
Mean age, EF, and NYHA Class were 75 Y, 57 %, and III, respectively. Most patients had multiple comorbidities. The IASD Device was successfully implanted in each patient using standard interventional techniques and guidance. One SAE (complete heart block) occurred within 30 days, and resolved (pacemaker). The SAE was not related to the procedure or device. At 30 days, PCWP was reduced, and at 30 days clinical symptoms had improved in 5 of 6 patients. Additional follow-up data will be presented.
|m PCWP (mmHg)||18.8||14.3 (30)|
|m RAP (mmHg)||11.5||12 (30)|
|RVSP (mmHg)||49.5||52.5 (30)|
|6 MWD (m)||318.5||343.3 (90)|
|NT-Pro-BNP (pmol/L)||294.4||237 (90)|
|MLWHF score||41.8||32.3 (90)|
This initial data demonstrates that the shunt device can be safely implanted and early clinical improvement can be obtained in patients with heart failure and preserved or mildly reduced ejection fraction. Longer term follow-up is warranted.