Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: A prospective study using the INTERMACS registry (interagency registry for mechanically assisted circulatory support)

Ulrich P. Jorde, Sudhir S. Kushwaha, Antone J. Tatooles, Yoshifumi Naka, Geetha Bhat, James W. Long, Douglas A. Horstmanshof, Robert L. Kormos, Jeffrey J. Teuteberg, Mark S. Slaughter, Emma J. Birks, David J. Farrar, Soon J. Park

Research output: Contribution to journalArticle

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Abstract

Objectives A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. Background New device technology developed in the clinical research setting requires validation in a real-world setting. Methods The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Results Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Conclusions Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).

Original languageEnglish (US)
Pages (from-to)1751-1757
Number of pages7
JournalJournal of the American College of Cardiology
Volume63
Issue number17
DOIs
StatePublished - May 6 2014

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Drug Approval
Heart-Assist Devices
United States Food and Drug Administration
Registries
Prospective Studies
Therapeutics
Survival
Clinical Trials
Equipment and Supplies
Length of Stay
Patient Care
Survival Rate
Hemorrhage
Technology
Infection
Research

Keywords

  • assist device
  • destination therapy
  • heart failure

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device : A prospective study using the INTERMACS registry (interagency registry for mechanically assisted circulatory support). / Jorde, Ulrich P.; Kushwaha, Sudhir S.; Tatooles, Antone J.; Naka, Yoshifumi; Bhat, Geetha; Long, James W.; Horstmanshof, Douglas A.; Kormos, Robert L.; Teuteberg, Jeffrey J.; Slaughter, Mark S.; Birks, Emma J.; Farrar, David J.; Park, Soon J.

In: Journal of the American College of Cardiology, Vol. 63, No. 17, 06.05.2014, p. 1751-1757.

Research output: Contribution to journalArticle

Jorde, Ulrich P. ; Kushwaha, Sudhir S. ; Tatooles, Antone J. ; Naka, Yoshifumi ; Bhat, Geetha ; Long, James W. ; Horstmanshof, Douglas A. ; Kormos, Robert L. ; Teuteberg, Jeffrey J. ; Slaughter, Mark S. ; Birks, Emma J. ; Farrar, David J. ; Park, Soon J. / Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device : A prospective study using the INTERMACS registry (interagency registry for mechanically assisted circulatory support). In: Journal of the American College of Cardiology. 2014 ; Vol. 63, No. 17. pp. 1751-1757.
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abstract = "Objectives A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. Background New device technology developed in the clinical research setting requires validation in a real-world setting. Methods The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Results Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28{\%} were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62{\%} (PA group) versus 58{\%} (TR group). PA group survival at 1 and 2 years was 82 ± 5{\%} and 69 ± 6{\%} for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3{\%} and 60 ± 4{\%} for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Conclusions Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).",
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author = "Jorde, {Ulrich P.} and Kushwaha, {Sudhir S.} and Tatooles, {Antone J.} and Yoshifumi Naka and Geetha Bhat and Long, {James W.} and Horstmanshof, {Douglas A.} and Kormos, {Robert L.} and Teuteberg, {Jeffrey J.} and Slaughter, {Mark S.} and Birks, {Emma J.} and Farrar, {David J.} and Park, {Soon J.}",
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T1 - Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device

T2 - A prospective study using the INTERMACS registry (interagency registry for mechanically assisted circulatory support)

AU - Jorde, Ulrich P.

AU - Kushwaha, Sudhir S.

AU - Tatooles, Antone J.

AU - Naka, Yoshifumi

AU - Bhat, Geetha

AU - Long, James W.

AU - Horstmanshof, Douglas A.

AU - Kormos, Robert L.

AU - Teuteberg, Jeffrey J.

AU - Slaughter, Mark S.

AU - Birks, Emma J.

AU - Farrar, David J.

AU - Park, Soon J.

PY - 2014/5/6

Y1 - 2014/5/6

N2 - Objectives A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. Background New device technology developed in the clinical research setting requires validation in a real-world setting. Methods The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Results Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Conclusions Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).

AB - Objectives A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. Background New device technology developed in the clinical research setting requires validation in a real-world setting. Methods The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Results Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Conclusions Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).

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