Sistema di assistenza ventricolare CircuLite Synergy: un nuovo approccio all'insufficienza cardiaca terminale

Translated title of the contribution: CircuLite Synergy ventricular assist device: A new approach to end-stage congestive heart failure

Alessandro Barbone, Daniela Pini, Diego Ornaghi, Maria Maddalena Visigalli, Laura Ardino, Renato Bragato, Mirko Curzi, Sara Anna Cioccarelli, Lara Di Diodoro, Alessio Basciu, Antioco Cappai, Fabrizio Settepani, Enrico Citterio, Alessio Cappelleri, Margherita Calcagnino, Maurizio Mangiavacchi, Giuseppe Tarelli, Maddalena Lettino, Ettore Vitali

Research output: Contribution to journalArticle

Abstract

Background. The Synergy system, a miniature partial circulatory support device, is implanted by an off-pump, minimally invasive surgical approach. The system has been optimized to improve performance in an EU clinical trial for chronic ambulatory heart failure. This therefore offers the possibility of treating elderly chronic heart failure patients who might not usually be considered for long-term circulatory support. Methods. From June 2007 to December 2012, 63 patients were implanted with the Synergy system (12 patients ≥70 years) using four different releases of the device. Briefly, the system draws blood through the inflow cannula from the left atrium into the micro-pump (placed in a right subclavicular pocket) and pumps it through an outflow graft to the right subclavian artery. In this paper, we present an intermediate analysis of the clinical trial as performed on April 30, 2013, leading to the placing of the CE mark. Results. Mean duration of support is ongoing at 230 days (range 23-1387). Follow-up showed improved hemodynamic response, with additional improvements in 6-min walk distance (299 ± 144 to 420 ± 119 m) and Minnesota Living with Heart Failure Questionnaire (69.5 ± 20.4 to 49.2 ± 24.3). Older patients had longer mean durations of support (337 vs 188 days). On average, elderly and younger patients showed similar improvements in hemodynamics and 6-min walk distance (107 ± 120 vs 130 ± 121 m). Major adverse cardiac events included bleeding (n=4) with one bleeding related to renal failure resulting in death. Conclusions. Clinical use of the Synergy device was associated with a significant functional improvement. Very low adverse event rates were reported with the latest device release. Older patients had smaller body sizes and worse renal function than younger patients. Both groups experienced similar hemodynamic benefits and functional improvements. The risk of bleeding and renal dysfunction appears to be increased in the elderly, though still within acceptable ranges compared to other full support devices. Minimally invasive long-term circulatory support devices, like Synergy, offer a new treatment option that might be available even for the elderly chronic heart failure population.

Original languageItalian
Pages (from-to)116-122
Number of pages7
JournalGiornale Italiano di Cardiologia
Volume15
Issue number2
Publication statusPublished - 2014

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Heart-Assist Devices
Heart Failure
Equipment and Supplies
Hemodynamics
Hemorrhage
Clinical Trials
Kidney
Subclavian Artery
Body Size
Heart Atria
Renal Insufficiency
Transplants
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Sistema di assistenza ventricolare CircuLite Synergy : un nuovo approccio all'insufficienza cardiaca terminale. / Barbone, Alessandro; Pini, Daniela; Ornaghi, Diego; Visigalli, Maria Maddalena; Ardino, Laura; Bragato, Renato; Curzi, Mirko; Cioccarelli, Sara Anna; Di Diodoro, Lara; Basciu, Alessio; Cappai, Antioco; Settepani, Fabrizio; Citterio, Enrico; Cappelleri, Alessio; Calcagnino, Margherita; Mangiavacchi, Maurizio; Tarelli, Giuseppe; Lettino, Maddalena; Vitali, Ettore.

In: Giornale Italiano di Cardiologia, Vol. 15, No. 2, 2014, p. 116-122.

Research output: Contribution to journalArticle

Barbone, A, Pini, D, Ornaghi, D, Visigalli, MM, Ardino, L, Bragato, R, Curzi, M, Cioccarelli, SA, Di Diodoro, L, Basciu, A, Cappai, A, Settepani, F, Citterio, E, Cappelleri, A, Calcagnino, M, Mangiavacchi, M, Tarelli, G, Lettino, M & Vitali, E 2014, 'Sistema di assistenza ventricolare CircuLite Synergy: un nuovo approccio all'insufficienza cardiaca terminale', Giornale Italiano di Cardiologia, vol. 15, no. 2, pp. 116-122.
Barbone, Alessandro ; Pini, Daniela ; Ornaghi, Diego ; Visigalli, Maria Maddalena ; Ardino, Laura ; Bragato, Renato ; Curzi, Mirko ; Cioccarelli, Sara Anna ; Di Diodoro, Lara ; Basciu, Alessio ; Cappai, Antioco ; Settepani, Fabrizio ; Citterio, Enrico ; Cappelleri, Alessio ; Calcagnino, Margherita ; Mangiavacchi, Maurizio ; Tarelli, Giuseppe ; Lettino, Maddalena ; Vitali, Ettore. / Sistema di assistenza ventricolare CircuLite Synergy : un nuovo approccio all'insufficienza cardiaca terminale. In: Giornale Italiano di Cardiologia. 2014 ; Vol. 15, No. 2. pp. 116-122.
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T2 - un nuovo approccio all'insufficienza cardiaca terminale

AU - Barbone, Alessandro

AU - Pini, Daniela

AU - Ornaghi, Diego

AU - Visigalli, Maria Maddalena

AU - Ardino, Laura

AU - Bragato, Renato

AU - Curzi, Mirko

AU - Cioccarelli, Sara Anna

AU - Di Diodoro, Lara

AU - Basciu, Alessio

AU - Cappai, Antioco

AU - Settepani, Fabrizio

AU - Citterio, Enrico

AU - Cappelleri, Alessio

AU - Calcagnino, Margherita

AU - Mangiavacchi, Maurizio

AU - Tarelli, Giuseppe

AU - Lettino, Maddalena

AU - Vitali, Ettore

PY - 2014

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N2 - Background. The Synergy system, a miniature partial circulatory support device, is implanted by an off-pump, minimally invasive surgical approach. The system has been optimized to improve performance in an EU clinical trial for chronic ambulatory heart failure. This therefore offers the possibility of treating elderly chronic heart failure patients who might not usually be considered for long-term circulatory support. Methods. From June 2007 to December 2012, 63 patients were implanted with the Synergy system (12 patients ≥70 years) using four different releases of the device. Briefly, the system draws blood through the inflow cannula from the left atrium into the micro-pump (placed in a right subclavicular pocket) and pumps it through an outflow graft to the right subclavian artery. In this paper, we present an intermediate analysis of the clinical trial as performed on April 30, 2013, leading to the placing of the CE mark. Results. Mean duration of support is ongoing at 230 days (range 23-1387). Follow-up showed improved hemodynamic response, with additional improvements in 6-min walk distance (299 ± 144 to 420 ± 119 m) and Minnesota Living with Heart Failure Questionnaire (69.5 ± 20.4 to 49.2 ± 24.3). Older patients had longer mean durations of support (337 vs 188 days). On average, elderly and younger patients showed similar improvements in hemodynamics and 6-min walk distance (107 ± 120 vs 130 ± 121 m). Major adverse cardiac events included bleeding (n=4) with one bleeding related to renal failure resulting in death. Conclusions. Clinical use of the Synergy device was associated with a significant functional improvement. Very low adverse event rates were reported with the latest device release. Older patients had smaller body sizes and worse renal function than younger patients. Both groups experienced similar hemodynamic benefits and functional improvements. The risk of bleeding and renal dysfunction appears to be increased in the elderly, though still within acceptable ranges compared to other full support devices. Minimally invasive long-term circulatory support devices, like Synergy, offer a new treatment option that might be available even for the elderly chronic heart failure population.

AB - Background. The Synergy system, a miniature partial circulatory support device, is implanted by an off-pump, minimally invasive surgical approach. The system has been optimized to improve performance in an EU clinical trial for chronic ambulatory heart failure. This therefore offers the possibility of treating elderly chronic heart failure patients who might not usually be considered for long-term circulatory support. Methods. From June 2007 to December 2012, 63 patients were implanted with the Synergy system (12 patients ≥70 years) using four different releases of the device. Briefly, the system draws blood through the inflow cannula from the left atrium into the micro-pump (placed in a right subclavicular pocket) and pumps it through an outflow graft to the right subclavian artery. In this paper, we present an intermediate analysis of the clinical trial as performed on April 30, 2013, leading to the placing of the CE mark. Results. Mean duration of support is ongoing at 230 days (range 23-1387). Follow-up showed improved hemodynamic response, with additional improvements in 6-min walk distance (299 ± 144 to 420 ± 119 m) and Minnesota Living with Heart Failure Questionnaire (69.5 ± 20.4 to 49.2 ± 24.3). Older patients had longer mean durations of support (337 vs 188 days). On average, elderly and younger patients showed similar improvements in hemodynamics and 6-min walk distance (107 ± 120 vs 130 ± 121 m). Major adverse cardiac events included bleeding (n=4) with one bleeding related to renal failure resulting in death. Conclusions. Clinical use of the Synergy device was associated with a significant functional improvement. Very low adverse event rates were reported with the latest device release. Older patients had smaller body sizes and worse renal function than younger patients. Both groups experienced similar hemodynamic benefits and functional improvements. The risk of bleeding and renal dysfunction appears to be increased in the elderly, though still within acceptable ranges compared to other full support devices. Minimally invasive long-term circulatory support devices, like Synergy, offer a new treatment option that might be available even for the elderly chronic heart failure population.

KW - Elderly

KW - Heart failure

KW - Hemodynamics

KW - Left ventricular assist device

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