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

Lars Søndergaard; Vivek Reddy; David Kaye; Filip Malek; Antony Walton; Martin Mates; Olaf Franzen; Petr Neuzil; Nikolaj Ihlemann; Finn Gustafsson

doi:10.1002/ejhf.111

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

Lars Søndergaard, Vivek Reddy, David Kaye, Filip Malek, Antony Walton, Martin Mates, Olaf Franzen, Petr Neuzil, Nikolaj Ihlemann, Finn Gustafsson

Department of Drug Design and Pharmacology

62 Citations (Scopus)

Abstract

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.

Original language	English
Journal	European Journal of Heart Failure
Volume	16
Issue number	7
Pages (from-to)	796-801
Number of pages	6
ISSN	1388-9842
DOIs	https://doi.org/10.1002/ejhf.111
Publication status	Published - Jul 2014

Keywords

Aged
Aged, 80 and over
Atrial Function, Left
Atrial Pressure
Atrial Septum
Blood Pressure
Cardiac Catheterization
Female
Heart Failure
Humans
Hypertension
Male
Middle Aged
Pilot Projects
Prostheses and Implants
Prosthesis Implantation
Stroke Volume
Treatment Outcome

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Søndergaard, L., Reddy, V., Kaye, D., Malek, F., Walton, A., Mates, M., Franzen, O., Neuzil, P., Ihlemann, N., & Gustafsson, F. (2014). Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. European Journal of Heart Failure, 16(7), 796-801. https://doi.org/10.1002/ejhf.111

Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. / Søndergaard, Lars; Reddy, Vivek; Kaye, David et al.
In: European Journal of Heart Failure, Vol. 16, No. 7, 07.2014, p. 796-801.

Research output: Contribution to journal › Journal article › Research › peer-review

Søndergaard, L, Reddy, V, Kaye, D, Malek, F, Walton, A, Mates, M, Franzen, O, Neuzil, P, Ihlemann, N & Gustafsson, F 2014, 'Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure', European Journal of Heart Failure, vol. 16, no. 7, pp. 796-801. https://doi.org/10.1002/ejhf.111

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title = "Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure",

abstract = "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.",

keywords = "Aged, Aged, 80 and over, Atrial Function, Left, Atrial Pressure, Atrial Septum, Blood Pressure, Cardiac Catheterization, Female, Heart Failure, Humans, Hypertension, Male, Middle Aged, Pilot Projects, Prostheses and Implants, Prosthesis Implantation, Stroke Volume, Treatment Outcome",

author = "Lars S{\o}ndergaard and Vivek Reddy and David Kaye and Filip Malek and Antony Walton and Martin Mates and Olaf Franzen and Petr Neuzil and Nikolaj Ihlemann and Finn Gustafsson",

note = "{\textcopyright} 2014 The Authors. European Journal of Heart Failure {\textcopyright} 2014 European Society of Cardiology.",

year = "2014",

month = jul,

doi = "10.1002/ejhf.111",

language = "English",

volume = "16",

pages = "796--801",

journal = "European Journal of Heart Failure",

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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

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.

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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

SN - 1388-9842

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SP - 796

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JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

IS - 7

ER -

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

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