PP.22.21: ONE YEAR CLINICAL OUTCOME OF TRANSCATHETER TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION USING INTERATRIAL IMPLANT TO LOWER LEFT ATRIAL PRESSURE. (June 2015)

• Record Type: Journal Article
• Authors: Málek, F.; Neuzil, P.; Gustafsson, F.; Walton, A.; Mates, M.; Sondergaard, L.; Ihlemann, N.; Kaye, D.
• Is Part Of: Journal of hypertension. Volume 33(2015)Supplement 1
• Publication Date: 2015-06
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000468410.48831.9f
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: Heart failure with preserved ejection fraction (HFpEF) is common and the therapeutic tools are limited. Treatment of the main comorbidities, e.g.: arterial hypertension, ischemic heart disease and atrial fibrillation and symptomatic therapy with diuretic are the only recommended treatment options in HFpEF patients. Increased left atrial pressure is a key contributor to the symptoms. A novel device intended to lower left atrial pressure by creating an 8 mm permanent shunt in the atrial septum (IASD®) has been evaluated in HFpEF patients. The study objective was to assess the one year clinical results of patients treated with IASD. Figure. No caption available. Design and method: Eleven patients were enrolled in the pilot study. Key inclusion criteria were: EF > 45%; baseline PCWP > 15 mmHg (rest), or > 25 mm Hg (exercise); > 1 hospitalization for heart failure within the past 12 months, or persistent NYHA Class III/IV for at least 3 months. Mean age, LVEF, and NYHA Class were 70 ± 12 years, 57 ± 9 %, and 3.2 ± 0.4, respectively. Prior year heart failure hospitalization rate was 1.36 per patient year. Significant proportion of patients had history of arterial hypertension (91 %) which was controlled by medical therapy. Results: The (IASD®) device was successfully implanted percutaneously in all patients, and filling pressures (pulmonary capillary wedge pressure) at 30–90 day follow-up were significantly reduced from 19.0 ± 5 to 14 ± 3 mm Hg (p = 0.005). At one year NYHA Class and quality of life were improved in 73% and 91% compared to baseline respectively. There were no deaths, cerebrovascular or systemic embolic events. The rate of HFH was reduced by 47% compared to the prior year. Survival free from HFH and worsening QOL was 73 % at one year. Conclusions: A device-based approach to reduce left atrial pressure may provide a new option to reduce heart failure hospitalization, improve symptoms and quality of life in HFpEF patients with advanced symptoms.