Trial Outcomes & Findings for Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation (NCT NCT00121472)

Last Updated: 2022-06-27

Results Overview

Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).

Recruitment status

COMPLETED

Study phase

Target enrollment

194 participants

Primary outcome timeframe

180 days

Results posted on

2022-06-27

Participant Flow

486 patients were recruited at 36 cardiac transplantation hospitals between 8 Mar 2005 and 21 Apr 2008. After enrolling the initial 133 patients prespecified by the study protocol, an additional 353 patients were enrolled under a Continued Access Protocol(CAP) and in a concurrent Canadian study.

194 patients were followed to at least 1 year after implantation of the device, all 133 of the Pivotal Study Cohort patients and 61 of the US CAP patients, results of which are summarized below and in the final FDA-approved labeling for the HeartMate II LVAS. The remaining 292 patients followed for less than 1 year are not included.

Participant milestones

Participant milestones
Measure	HeartMate II (HMII) HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).
Overall Study STARTED	194
Overall Study COMPLETED	194
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HM II n=194 Participants HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
Age, Continuous	50.6 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants
Body Surface Area	1.99 sq. meter STANDARD_DEVIATION 0.29 • n=5 Participants
Cardiac Index	2.0 L/min/m^2 STANDARD_DEVIATION 0.5 • n=5 Participants
PCWP	26.0 mmHg STANDARD_DEVIATION 7.7 • n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: The first consecutive 194 patients enrolled under the Pivotal Study Protocol (n=133) and the Continued Access Protocol (CAP, n=61) were analyzed when the last subject reached the 1 year followup point on September 14, 2007. Analysis was Intent To Treat (ITT).

Outcome measures

Outcome measures
Measure	HM II n=194 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Survival Transplanted	112 participants
Survival Myocardial recovery, device removed	6 participants
Survival Alive on device at 180 days & UNOS Status 1A or 1B	18 participants
Survival Alive on device at 180 days, not Status 1A or 1B	19 participants
Survival Received other ventricular assist device	3 participants
Survival Expired prior to 180 days while on VAD support	36 participants

SECONDARY outcome

Timeframe: continuous

Confirmed malfunctions/Serious Adverse Events

Outcome measures

Outcome measures
Measure	HM II n=194 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Clinical Reliability (Malfunctions/Failures) Power Base Unit Cable	1 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Batteries	1 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Battery Clips	0 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Shower Kit	0 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Surgical Accessories	0 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Pump	7 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Inflow Cannula	2 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Outflow Cannula	2 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) System Controller	10 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) System Monitor	0 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Display Module	0 Number of Serious Events
Clinical Reliability (Malfunctions/Failures) Power Base Unit	0 Number of Serious Events

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Patients alive and capable of performing the test at 6 months

KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.

Outcome measures

Outcome measures
Measure	HM II n=53 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Kansas City Cardiomyopathy Questionaire (KCCQ) KCCQ Overall Summary Score (OSS)	29.5 Units on a KCCQ Score scale Standard Error 2.7
Kansas City Cardiomyopathy Questionaire (KCCQ) KCCQ Clinical Summary Score (CSS)	28.8 Units on a KCCQ Score scale Standard Error 2.4

SECONDARY outcome

Timeframe: baseline, 1 month, 3 months, 6 months

Population: All patients who survived to interval are included.

NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort

Outcome measures

Outcome measures
Measure	HM II n=194 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
New York Heart Association (NYHA) Classification Baseline NYHA Class	4.0 units on NYHA scale Full Range 0.1 • Interval 3.0 to 4.0
New York Heart Association (NYHA) Classification Month 1 NYHA Class	2.2 units on NYHA scale Full Range 0.8 • Interval 1.0 to 4.0
New York Heart Association (NYHA) Classification Month 3 NYHA Class	1.8 units on NYHA scale Full Range 0.7 • Interval 1.0 to 4.0
New York Heart Association (NYHA) Classification Month 6 NYHA Class	1.7 units on NYHA scale Full Range 0.7 • Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Patients alive and capable of performing the test at 6 months

MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.

Outcome measures

Outcome measures
Measure	HM II n=52 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Minnesota Living With Heart Failure Questionnaire (MLWHF)	-32.3 units on a MLWHF Score scale Standard Error 2.9

SECONDARY outcome

Timeframe: baseline to 6 months

Population: Mean change from baseline in 6MWT distance at Month 1, 3, and 6. Only patients alive, capable and willing to perform test are included.

The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.

Outcome measures

Outcome measures
Measure	HM II n=194 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Six Minute Walk Test (6MWT) Month 1 (N = 151)	149.2 meters Standard Error 14.5
Six Minute Walk Test (6MWT) Month 3 (N = 101)	235.4 meters Standard Error 22.0
Six Minute Walk Test (6MWT) Month 6 (N = 64)	296.8 meters Standard Error 27.8

SECONDARY outcome

Timeframe: continuous

Additional surgery after the initial implant operation

Outcome measures

Outcome measures
Measure	HM II n=194 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Reoperations HMII Replacement	8 Number of Events
Reoperations Bleeding	104 Number of Events
Reoperations Mediastinal exploration, evacuation and chest clos	7 Number of Events
Reoperations Chest closure or reinforcement of closure	32 Number of Events
Reoperations ICD placement or exchange	8 Number of Events
Reoperations Evacuation of pericardial effusion	1 Number of Events
Reoperations RVAD placemant or removal	9 Number of Events
Reoperations Tracheostomy	9 Number of Events
Reoperations Cholecystectomy, feeding tube placement, tracheost	1 Number of Events
Reoperations Evacuation of pleural effusion, dialysis catheter	1 Number of Events
Reoperations Feeding tube placement, chest tube placement	1 Number of Events
Reoperations Left lower lobe wedge resection	1 Number of Events
Reoperations LVAD evaluation and repair	2 Number of Events
Reoperations Mediastinal exploration and evacuation	1 Number of Events
Reoperations Mediastinal exploration , wound debridement, ICD r	1 Number of Events
Reoperations Placement of chest tubes	1 Number of Events
Reoperations Removal of foreign body	1 Number of Events
Reoperations Total abdominal cholectomy with end-ileostomy	1 Number of Events
Reoperations Device explant	1 Number of Events
Reoperations Feeding tube placement	1 Number of Events
Reoperations Mediastinal exploration, chest closure, gortex gra	2 Number of Events
Reoperations Mediastinal exploration , evacuation, pacemaker re	1 Number of Events
Reoperations Pericardial window	1 Number of Events

SECONDARY outcome

Timeframe: 30 days, 1 year

Population: Patients (n=112) who recieved a cardiac transplant were followed at 30 day and 1 year post-transplant to determine if the device influenced post-transplant survival.

30 day and 1 year post transplant survival

Outcome measures

Outcome measures
Measure	HM II n=112 Participants HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
Post-transplant Survival Survival at 30 days (%)	96 percentage of participants
Post-transplant Survival Survival at 1 year (%)	87 percentage of participants

Adverse Events

HMII

Serious events: 194 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HMII n=194 participants at risk HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
General disorders Bleeding	60.3% 117/194 • Number of events 225 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Blood and lymphatic system disorders Bleeding requiring surgery	28.9% 56/194 • Number of events 64 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Nervous system disorders Stroke	8.8% 17/194 • Number of events 19 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Infections and infestations Driveline infection	8.2% 16/194 • Number of events 20 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Infections and infestations Pocket infection	2.1% 4/194 • Number of events 4 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Infections and infestations Sepsis	18.0% 35/194 • Number of events 47 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Cardiac disorders Right heart failure	18.6% 36/194 • Number of events 37 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Blood and lymphatic system disorders Device thrombosis	1.5% 3/194 • Number of events 3 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Blood and lymphatic system disorders Hemolysis	3.1% 6/194 • Number of events 6 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Nervous system disorders Other neurological	7.7% 15/194 • Number of events 18 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Infections and infestations Local infection	23.2% 45/194 • Number of events 74 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Blood and lymphatic system disorders Peripheral Thromboembolism	5.2% 10/194 • Number of events 11 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Respiratory, thoracic and mediastinal disorders Respiratory failure	27.3% 53/194 • Number of events 66 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Cardiac disorders Cardiac arrhythmias	42.3% 82/194 • Number of events 135 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Renal and urinary disorders Renal failure	12.9% 25/194 • Number of events 26 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Hepatobiliary disorders Hepatic dysfunction	1.5% 3/194 • Number of events 3 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Psychiatric disorders Psychological	1.5% 3/194 • Number of events 5 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
Cardiac disorders Myocardial infarction	1.0% 2/194 • Number of events 2 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).

Other adverse events

Other adverse events
Measure	HMII n=194 participants at risk HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
General disorders Bleeding	8.2% 16/194 • Number of events 50 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
General disorders Localized Infection	7.7% 15/194 • Number of events 44 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
General disorders Driveline Infection	5.2% 10/194 • Number of events 16 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
General disorders Cardiac Arrhythmias	14.9% 29/194 • Number of events 69 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
General disorders Psychological	5.2% 10/194 • Number of events 10 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).
General disorders Device Malfunctions	18.6% 36/194 • Number of events 61 • From time of device implant to time of cardiac transplantation, permanent device removal, or death. Adverse events were documented by study site staff as they occured per protocol definitions. Adverse events were adjudicated by an independent Clinical Events Committee (CEC).

Additional Information

Poornima Sood, MD, MBA, Sr. Director, Clinical Affairs

Thoratec Corporation

Phone: (781) 852-8334

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place