Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure

Christopher Hayward; William Peters; Alan Merry; Peter Ruygrok; Paul Jansz; Gerry O'Driscoll; Robert Larbalestier; Julian Smith; Betty Ho; Malcolm Legget; F Paget Milsom

doi:10.1016/j.healun.2010.06.014

Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure

Christopher Hayward, William Peters, Alan Merry, Peter Ruygrok, Paul Jansz, Gerry O'Driscoll, Robert Larbalestier, Julian Smith, Betty Ho, Malcolm Legget, F Paget Milsom

Surgery Monash Health

Research output: Contribution to journal › Article › Research › peer-review

25 Citations (Scopus)

Abstract

BACKGROUND: Some patients continue to have significant heart failure symptoms despite optimal medical therapy. METHODS: We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years. RESULTS: All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60 ) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway.

Original language	English
Pages (from-to)	1427 - 1432
Number of pages	6
Journal	The Journal of Heart and Lung Transplantation
Volume	29
Issue number	12
DOIs	https://doi.org/10.1016/j.healun.2010.06.014
Publication status	Published - 2010

Access to Document

10.1016/j.healun.2010.06.014

Cite this

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title = "Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure",

abstract = "BACKGROUND: Some patients continue to have significant heart failure symptoms despite optimal medical therapy. METHODS: We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years. RESULTS: All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60 ) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway.",

author = "Christopher Hayward and William Peters and Alan Merry and Peter Ruygrok and Paul Jansz and Gerry O'Driscoll and Robert Larbalestier and Julian Smith and Betty Ho and Malcolm Legget and Milsom, {F Paget}",

year = "2010",

doi = "10.1016/j.healun.2010.06.014",

language = "English",

volume = "29",

pages = "1427 -- 1432",

journal = "The Journal of Heart and Lung Transplantation",

issn = "1053-2498",

publisher = "Elsevier",

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TY - JOUR

T1 - Chronic extra-aortic balloon counterpulsation: First-in-human pilot study in end-stage heart failure

AU - Hayward, Christopher

AU - Peters, William

AU - Merry, Alan

AU - Ruygrok, Peter

AU - Jansz, Paul

AU - O'Driscoll, Gerry

AU - Larbalestier, Robert

AU - Smith, Julian

AU - Ho, Betty

AU - Legget, Malcolm

AU - Milsom, F Paget

PY - 2010

Y1 - 2010

N2 - BACKGROUND: Some patients continue to have significant heart failure symptoms despite optimal medical therapy. METHODS: We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years. RESULTS: All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60 ) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway.

AB - BACKGROUND: Some patients continue to have significant heart failure symptoms despite optimal medical therapy. METHODS: We describe a first-in-human experience with an implantable non-blood-contacting extra-ascending aortic counterpulsation heart assist system (C-Pulse) in 5 end-stage heart failure patients, aged 54 to 73 years. RESULTS: All patients improved by 1 NYHA class and improvements in invasive hemodynamics were documented in 3 patients. Three of 5 patients (60 ) had infectious complications. Two patients were explanted at 5 and 7 weeks, respectively, as a result of mediastinal infection related to the implant procedure. One patient was successfully transplanted at 1 month and 1 remained hemodynamically improved on the device at 6 months but suffered infective complications. The device and protocol have been modified as a result of this pilot study with a further multicenter safety study underway.

U2 - 10.1016/j.healun.2010.06.014

DO - 10.1016/j.healun.2010.06.014

M3 - Article

SN - 1053-2498

VL - 29

SP - 1427

EP - 1432

JO - The Journal of Heart and Lung Transplantation

JF - The Journal of Heart and Lung Transplantation

IS - 12

ER -