NEW ORLEANS — A transcatheter interatrial shunt device improved quality of life, improved exercise capacity and showed acceptable MACCE rates at 1 year in patients with HF with preserved ejection fraction, according to a presentation at the American Heart Association Scientific Sessions.
Data from the REDUCE LAP-HF study also showed patency of the shunt device (IASD System, Corvia Medical) as well as clinical and hemodynamic benefit at 6 months and 1 year.
“It is now widely accepted that the left ventricular ejection fraction is preserved or near normal in at least half of all patients presenting with symptoms of HF,” David M. Kaye, MD, PhD, from Baker IDI Heart and Diabetes Institute in Melbourne, Australia, said at a press conference. “The pathophysiology of HFpEF is complex, and elevated left atrial pressure particularly during physical activity is a key feature.”
The researchers evaluated 64 patients with LVEF > 40% (mean age, 69 years; 66% women; mean LVEF, 47%; mean BMI, 33 kg/m2; 81% with hypertension), the majority of whom were NYHA Class II to IV with elevated pulmonary capillary wedge pressure at rest (≥ 15 mm Hg) or during exercise (≥ 25 mm Hg).
Outcomes of interest were safety as determined by major adverse cardiovascular, cerebrovascular and embolic adverse events; device performance as determined by shunting on echocardiography; and persistence of clinical benefit as measured by NYHA class, Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score, 6-minute walk test, and cardiac structure and function based on echocardiography. The findings were simultaneously published in Circulation: Heart Failure.
Although there was one instance of stroke in a patient with a CHA2DS2-Vasc score of 6, the implantation procedure was safe and the 1-year survival rate was 95%, Kaye said.
Device patency was confirmed by echocardiography or oximetry in 54 patients; image quality was inadequate in the other patients. A stable Qp:Qs of approximately 1.28:1 at 1 year was observed.
Among patients with data at baseline, 6 months and 1 year, at 1 year, NYHA class improved (P < .001), MLWHFQ score dropped by 15 (P < .001) and 6-minute walk distance increased by 33 m (P < .01), Kaye said.
The researchers also observed a significant increase in right ventricular EF (P < .01), which was accompanied by a stable modest fall in LV end diastolic volume (P < .001) and a minimal rise in RV end diastolic volume (P < .001). There were no changes in atrial volume.
At 1 year, the researchers preformed invasive hemodynamic studies and found a stable increase in thermodilution cardiac output reflecting an increase in right sided cardiac output (baseline, 5.2; 1 year, 6.7; P < .01). Hemodynamic exercise evaluation showed 1-year increases in exercise time (P < .05), work capacity (P < .01) and exercise cardiac output (P < .01).
Kaye said perhaps the most significant finding from the exercise hemodynamic study was that implantation the shunt device allowed for an increased workload to be carried out at unchanged left atrial pressure, which resulted in significantly lower work-corrected pulmonary capillary wedge pressure at 1 year (P < .01).
“The twelve-month REDUCE LAP-HF results are very reassuring in regard to mid-term safety and therapy while the efficacy remains undetermined, but is potentially promising,” Nancy K. Sweitzer, MD, PhD, professor of medicine, chief of cardiology and director of Sarver Heart Center at the University of Arizona, said during a discussant presentation. “Device therapy would have an enormous impact in this disease and it challenges those of us in the field to identify these patients earlier in the disease process if this therapy is in fact effective.” – by Dave Quaile
Kaye DM, et al. LBCT.04 – Guiding the Momentum to Effect HF Outcomes – Ironing Out the Wrinkles. Presented at: American Heart Association Scientific Sessions; Nov. 12-16, 2016; New Orleans.
Kaye DM, et al. Circ Heart Fail. 2016;doi:10.1161/CIRCHEARTFAILURE.116.003662.
Disclosure: The study was funded by Corvia Medical. Kaye reports being an unpaid member of the scientific advisory group for Corvia Medical. Sweitzer reports being an investigator for the REDUCE LAP-HF randomized U.S. trial.