TY - JOUR

T1 - Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure

AU - Søndergaard, Lars

AU - Reddy, Vivek

AU - Kaye, David

AU - Malek, Filip

AU - Walton, Antony

AU - Mates, Martin

AU - Franzen, Olaf

AU - Neuzil, Petr

AU - Ihlemann, Nikolaj

AU - Gustafsson, Finn

N1 - © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

PY - 2014/7

Y1 - 2014/7

N2 - BACKGROUND: Heart failure with preserved or mildly reduced ejection fraction (HFpEF) is common and, to date, therapeutic options are limited. Increased left atrial pressure is a key contributor to the symptoms associated with HFpEF, particularly during physical activity. We report the 30-day outcome of patients treated with a novel device intended to lower left atrial pressure by creating an 8 mm permanent shunt in the atrial septum.METHODS AND RESULTS: Eleven patients were enrolled in the pilot trial. Key inclusion criteria were: EF >45%; baseline PCWP ≥15 mmHg (rest), or ≥ 25 mmHg (exercise); and ≥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. Most patients had significant co-morbidities. The interatrial septal device (IASD) device was implanted using percutaneous trans-septal access via the femoral vein. The device was successfully implanted in all patients. At 30 days, LV filling pressures were significantly reduced by 5.5 mmHg (19.7 ± 3.4 vs. 14.2 ± 2.7; P = 0.005), and NYHA class was improved by two classes in two patients, one class in five patients, and worsened by one class in one patient. No patient developed pulmonary hypertension. Two serious adverse events occurred; heart failure re-hospitalization, and implant malposition successfully treated with a new device.CONCLUSION: Contemporary management of HFpEF patients is confounded by the lack of effective therapies. The use of a device-based approach to reduce left atrial pressure provides a novel means to improve haemodynamic and symptomatic status in HFpEF patients and warrants further investigation.

AB - BACKGROUND: Heart failure with preserved or mildly reduced ejection fraction (HFpEF) is common and, to date, therapeutic options are limited. Increased left atrial pressure is a key contributor to the symptoms associated with HFpEF, particularly during physical activity. We report the 30-day outcome of patients treated with a novel device intended to lower left atrial pressure by creating an 8 mm permanent shunt in the atrial septum.METHODS AND RESULTS: Eleven patients were enrolled in the pilot trial. Key inclusion criteria were: EF >45%; baseline PCWP ≥15 mmHg (rest), or ≥ 25 mmHg (exercise); and ≥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. Most patients had significant co-morbidities. The interatrial septal device (IASD) device was implanted using percutaneous trans-septal access via the femoral vein. The device was successfully implanted in all patients. At 30 days, LV filling pressures were significantly reduced by 5.5 mmHg (19.7 ± 3.4 vs. 14.2 ± 2.7; P = 0.005), and NYHA class was improved by two classes in two patients, one class in five patients, and worsened by one class in one patient. No patient developed pulmonary hypertension. Two serious adverse events occurred; heart failure re-hospitalization, and implant malposition successfully treated with a new device.CONCLUSION: Contemporary management of HFpEF patients is confounded by the lack of effective therapies. The use of a device-based approach to reduce left atrial pressure provides a novel means to improve haemodynamic and symptomatic status in HFpEF patients and warrants further investigation.

KW - Aged

KW - Aged, 80 and over

KW - Atrial Function, Left

KW - Atrial Pressure

KW - Atrial Septum

KW - Blood Pressure

KW - Cardiac Catheterization

KW - Female

KW - Heart Failure

KW - Humans

KW - Hypertension

KW - Male

KW - Middle Aged

KW - Pilot Projects

KW - Prostheses and Implants

KW - Prosthesis Implantation

KW - Stroke Volume

KW - Treatment Outcome

U2 - 10.1002/ejhf.111

DO - 10.1002/ejhf.111

M3 - Journal article

C2 - 24961390

VL - 16

SP - 796

EP - 801

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

SN - 1567-4215

IS - 7

ER -