Trial Outcomes & Findings for Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea (NCT NCT04915924)

Last Updated: 2026-08-11

Results Overview

Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (60 days post-stroke Modified Rankin Score \>3) or reoperation for pump replacement. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will not be considered to have experienced a primary endpoint event.

Recruitment status

COMPLETED

Study phase

Target enrollment

358 participants

Primary outcome timeframe

From enrollment to 36 months

Results posted on

2026-08-11

Participant Flow

The Korea HM3 Post Market Surveillance enrolled patients implanted from October 30, 2020 - 02 June 2024. The study enrolled 358 subjects at 18 investigational sites in Korea.

Participant milestones

Participant milestones
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) Patients implanted with the HeartMate 3 left ventricular assist device
Overall Study STARTED	358
Overall Study COMPLETED	358
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

INTERMACS Profile was recorded for 321 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
Age, Continuous	58.3 Years STANDARD_DEVIATION 14.3 • n=327 Participants
Sex: Female, Male Female	67 Participants n=327 Participants
Sex: Female, Male Male	260 Participants n=327 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=327 Participants
Race (NIH/OMB) Asian	327 Participants n=327 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=327 Participants
Race (NIH/OMB) Black or African American	0 Participants n=327 Participants
Race (NIH/OMB) White	0 Participants n=327 Participants
Race (NIH/OMB) More than one race	0 Participants n=327 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=327 Participants
Region of Enrollment South Korea	327 Participants n=327 Participants
Body Mass Index	23.9 kg/m^2 STANDARD_DEVIATION 11.5 • n=327 Participants
Intended Use Bridge to Transplant (BTT)	263 Participants n=327 Participants
Intended Use Possibly BTT: Likely to be Eligible	10 Participants n=327 Participants
Intended Use Possibly BTT: Moderate Likelihood	1 Participants n=327 Participants
Intended Use Possibly BTT: Unlikely to Become Eligible	1 Participants n=327 Participants
Intended Use Destination Therapy	52 Participants n=327 Participants
Intended Use Bridge to Recovery	0 Participants n=327 Participants
Intended Use Rescue Therapy	0 Participants n=327 Participants
INTERMACS Profile 1	25 Participants n=321 Participants • INTERMACS Profile was recorded for 321 participants
INTERMACS Profile 2	51 Participants n=321 Participants • INTERMACS Profile was recorded for 321 participants
INTERMACS Profile 3	217 Participants n=321 Participants • INTERMACS Profile was recorded for 321 participants
INTERMACS Profile 4	22 Participants n=321 Participants • INTERMACS Profile was recorded for 321 participants
INTERMACS Profile 5	2 Participants n=321 Participants • INTERMACS Profile was recorded for 321 participants
INTERMACS Profile 6 or 7	4 Participants n=321 Participants • INTERMACS Profile was recorded for 321 participants
New York Heart Association (NYHA) Class Class I	0 Participants n=326 Participants • NYHA Class was recorded for 326 participants.
New York Heart Association (NYHA) Class Class II	25 Participants n=326 Participants • NYHA Class was recorded for 326 participants.
New York Heart Association (NYHA) Class Class IIIA	55 Participants n=326 Participants • NYHA Class was recorded for 326 participants.
New York Heart Association (NYHA) Class Class IIIB	49 Participants n=326 Participants • NYHA Class was recorded for 326 participants.
New York Heart Association (NYHA) Class Class IV	197 Participants n=326 Participants • NYHA Class was recorded for 326 participants.

PRIMARY outcome

Timeframe: From enrollment to 36 months

Population: The study enrolled 358 patients, of whom 327 provided informed consent. The remaining 31 patients experienced a terminal outcome (transplanted, explanted, or expired) before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome with all other identifiers removed. These patients were included for completeness of mortality reporting but were excluded from other outcomes, as the requisite input data were not collected for this cohort.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
Primary Efficacy Endpoint: Kaplan-Meier Success Rate of Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (60 Days Post-stroke Modified Rankin Score >3) or Reoperation for Pump Replacement	80.6 Percentage of Participants Interval 69.4 to 88.1

PRIMARY outcome

Timeframe: From enrollment until the study conclusion date (up to 43 months, 3 days)

Cumulative occurrence of adverse events will be presented as percent of patients with adverse events.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Right Heart Failure Requiring RVAD	7 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Venous Thromboembolism	1 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Wound Dehiscence	2 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Suspected Device Thrombosis	1 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Hemolysis	0 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Other Adverse Event	84 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Stroke -- Hemorrhagic Stroke	6 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Stroke -- Ischemic Stroke	7 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Other Neurological Event	4 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Other Neurological Event -- Encephalopathy	1 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Other Neurological Event -- Seizure	2 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Other Neurological Event -- Transient Ischemic Attack	1 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Other Neurological Event -- Other	0 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Pericardial Fluid Collection	1 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Psychiatric Episode	3 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Renal Dysfunction	14 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Respiratory Dysfunction	7 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Right Heart Failure	10 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Major Infection -- Other	22 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Myocardial Infarction	0 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Stroke	12 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Arterial Non-CNS Thromboembolism	6 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Bleeding	40 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Bleeding Requiring Surgery	16 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events GI Bleeding	15 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Cardiac Arrhythmia	14 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Ventricular Arrhythmia	12 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Supra-ventricular Arrhythmia	2 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Ventricular and Supra-ventricular Arrhythmia	0 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Hepatic Dysfunction	2 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Hypertension	1 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Major Infection	60 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Major Infection -- Localized	28 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Major Infection -- Sepsis	8 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Major Infection -- Driveline	19 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Major Infection -- Pump Pocket or Pseudo Pocket	0 Participants
Primary Safety Endpoint: Number of Cumulative Occurrences of Adverse Events Major Infection -- Pump or Pump Components	1 Participants

SECONDARY outcome

Timeframe: Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant

Population: The number of participants in each row is reflective of the number for whom Six Minute Walk Test data are available. The median follow-up duration in this study was approximately one year, and many participants did not complete scheduled follow-up visits through 36 months.

The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
Six-minute Walk Test Distance Baseline	131.3 Meters Standard Deviation 168.3
Six-minute Walk Test Distance Month 1	94.4 Meters Standard Deviation 144.4
Six-minute Walk Test Distance Month 6	225.8 Meters Standard Deviation 208.2
Six-minute Walk Test Distance Month 12	220.9 Meters Standard Deviation 204.7
Six-minute Walk Test Distance Month 24	202.7 Meters Standard Deviation 201
Six-minute Walk Test Distance Month 36	227.7 Meters Standard Deviation 165.6

SECONDARY outcome

Timeframe: Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months post-implant

Population: The number of participants in each row is reflective of the number for whom NYHA data are available. The median follow-up duration in this study was approximately one year, and many participants did not complete scheduled follow-up visits through 36 months.

Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
New York Heart Association (NYHA) Functional Status Baseline · Class I	0 Participants
New York Heart Association (NYHA) Functional Status Baseline · Class II	25 Participants
New York Heart Association (NYHA) Functional Status Baseline · Class III	104 Participants
New York Heart Association (NYHA) Functional Status Baseline · Class IV	197 Participants
New York Heart Association (NYHA) Functional Status Month 1 · Class I	14 Participants
New York Heart Association (NYHA) Functional Status Month 1 · Class II	189 Participants
New York Heart Association (NYHA) Functional Status Month 1 · Class III	66 Participants
New York Heart Association (NYHA) Functional Status Month 1 · Class IV	19 Participants
New York Heart Association (NYHA) Functional Status Month 6 · Class I	22 Participants
New York Heart Association (NYHA) Functional Status Month 6 · Class II	182 Participants
New York Heart Association (NYHA) Functional Status Month 6 · Class III	24 Participants
New York Heart Association (NYHA) Functional Status Month 6 · Class IV	4 Participants
New York Heart Association (NYHA) Functional Status Month 12 · Class I	28 Participants
New York Heart Association (NYHA) Functional Status Month 12 · Class II	112 Participants
New York Heart Association (NYHA) Functional Status Month 12 · Class III	16 Participants
New York Heart Association (NYHA) Functional Status Month 12 · Class IV	2 Participants
New York Heart Association (NYHA) Functional Status Month 24 · Class I	5 Participants
New York Heart Association (NYHA) Functional Status Month 24 · Class II	26 Participants
New York Heart Association (NYHA) Functional Status Month 24 · Class III	10 Participants
New York Heart Association (NYHA) Functional Status Month 24 · Class IV	1 Participants
New York Heart Association (NYHA) Functional Status Month 36 · Class I	1 Participants
New York Heart Association (NYHA) Functional Status Month 36 · Class II	5 Participants
New York Heart Association (NYHA) Functional Status Month 36 · Class III	2 Participants
New York Heart Association (NYHA) Functional Status Month 36 · Class IV	0 Participants

SECONDARY outcome

Timeframe: Baseline, 1 Month, 6 Months, 12 Months, 24 Months, 36 Months Post-Implant

Population: The number of participants in each row is reflective of the number for whom EQ-5D-5L data are available. The median follow-up duration in this study was approximately one year, and many participants did not complete scheduled follow-up visits through 36 months.

Subject's quality-of-life (QoL) will be measured by the EQ-5D-5L QoL questionnaire at baseline and all visits after HM3 implant until the end of surveillance period. The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life. The overall mean and standard deviation of the Visual Analog Scale (VAS) will be presented for all follow-up visits. The VAS is not available for all participants at all follow up timepoints.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
EQ-5D-5L Quality-of-Life Visual Analog Scale Baseline	58.3 Scores on a Scale Standard Deviation 23.3
EQ-5D-5L Quality-of-Life Visual Analog Scale Month 1	61.4 Scores on a Scale Standard Deviation 20.8
EQ-5D-5L Quality-of-Life Visual Analog Scale Month 6	71.8 Scores on a Scale Standard Deviation 16.3
EQ-5D-5L Quality-of-Life Visual Analog Scale Month 12	71.7 Scores on a Scale Standard Deviation 18.2
EQ-5D-5L Quality-of-Life Visual Analog Scale Month 24	61.9 Scores on a Scale Standard Deviation 21.4
EQ-5D-5L Quality-of-Life Visual Analog Scale Month 36	73.3 Scores on a Scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: From enrollment until the study conclusion date (up to 43 months, 3 days)

Frequency of rehospitalization events inclusive of rehospitalization for heart transplantation.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
Frequency of Rehospitalization	268 Rehospitalizations

SECONDARY outcome

Timeframe: From enrollment until the study conclusion date (up to 43 months, 3 days)

Number of reoperation events inclusive of heart transplantations.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
Frequency of Reoperation	152 Reoperations

SECONDARY outcome

Timeframe: From enrollment until the study conclusion date (up to 43 months, 3 days)

Population: The Korea HM3 study included 358 subjects, including 327 implanted patients who provided informed consent (196 prior to implant, and 131 after implant) and 31 implanted patients who experienced an outcome prior to having the opportunity to provide consent. The latter 31 patients were anonymized, and data collection was limited to days of HM3 support and patient outcome. Device deficiency data were only available for the 327 patients who provided informed consent.

All suspected HM3 device malfunctions will be reported. Device malfunctions will be collected under the general category of Device Deficiencies. Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance, such as malfunction, misuse or use error and inadequate labeling. This includes the failure of the device to meet its performance specifications or otherwise perform as intended.

Outcome measures

Outcome measures
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 Participants Patients implanted with the HM3 LVAS
Device Malfunctions	2 Device Malfunctions

Adverse Events

HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)

Serious events: 154 serious events

Other events: 8 other events

Deaths: 51 deaths

Serious adverse events

Serious adverse events
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 participants at risk Patients will be implanted with the HM3 LVAS
Vascular disorders Arterial Non-CNS Thromboembolism	1.8% 6/327 • Number of events 6 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Vascular disorders Bleeding	11.9% 39/327 • Number of events 51 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Cardiac Arrhythmia	4.0% 13/327 • Number of events 15 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Hepatobiliary disorders Hepatic Dysfunction	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Infections and infestations Major Infection	16.8% 55/327 • Number of events 83 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Nervous system disorders Hemorrhagic Stroke	1.8% 6/327 • Number of events 6 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Nervous system disorders Ischemic Stroke	1.8% 6/327 • Number of events 8 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Nervous system disorders Seizure	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Pericardial Fluid Collection	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Renal and urinary disorders Renal Dysfunction	4.3% 14/327 • Number of events 14 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Arrhythmia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Respiratory, thoracic and mediastinal disorders Respiratory Dysfunction	2.1% 7/327 • Number of events 7 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Right Heart Failure	3.1% 10/327 • Number of events 10 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Vascular disorders Venous Thromboembolism	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Injury, poisoning and procedural complications Wound Dehiscence	0.61% 2/327 • Number of events 4 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Product Issues Suspected Device Thrombosis	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Abdominal Pain	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Renal and urinary disorders Acute Kidney Injury	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Respiratory, thoracic and mediastinal disorders Airway Obstruction	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Chronic Gastritis	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Musculoskeletal and connective tissue disorders Back Pain	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	1.2% 4/327 • Number of events 4 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Cardiac arrest	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Cardiomegaly	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Chest pain	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Hepatobiliary disorders Cholelithiasis	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Hepatobiliary disorders Bile duct stone	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Infections and infestations Covid-19	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Investigations Blood creatinine increased	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Metabolism and nutrition disorders Dehydration	0.31% 1/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Dental caries	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Diarrhoea	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Nervous system disorders Syncope	1.2% 4/327 • Number of events 4 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Medical device site discharge	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 5/327 • Number of events 6 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Enterocolitis	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Abdominal pain upper	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Pyrexia	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Musculoskeletal and connective tissue disorders Flank pain	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Injury, poisoning and procedural complications Fracture	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Metabolism and nutrition disorders Hypervolaemia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Asthenia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Nervous system disorders Headache	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Cardiac failure	2.4% 8/327 • Number of events 9 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Skin and subcutaneous tissue disorders Henoch-schonlein purpura	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Hepatobiliary disorders Hepatic function abnormal	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Metabolism and nutrition disorders Hyperkalaemia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Vascular disorders Hypertension	0.92% 3/327 • Number of events 3 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Vascular disorders Hypotension	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Colitis ischaemic	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Product Issues Device alarm issue	1.5% 5/327 • Number of events 6 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Multiple organ dysfunction syndrome	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Musculoskeletal and connective tissue disorders Muscle hypertrophy	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Nausea	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Ventricular tachycardia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Infections and infestations Periodontitis	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Nervous system disorders Neuralgia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.4% 11/327 • Number of events 11 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Pulseless electrical activity	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Cardiac disorders Right ventricular failure	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Vascular disorders Haematoma	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Gastrointestinal disorders Dysphagia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Investigations Anticoagulation drug level below therapeutic	0.61% 2/327 • Number of events 2 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Sudden cardiac death	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Sudden death	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Musculoskeletal and connective tissue disorders Pain in extremity	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
Blood and lymphatic system disorders Thrombocytopenia	0.31% 1/327 • Number of events 1 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.
General disorders Death	0.92% 3/327 • Number of events 3 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.

Other adverse events

Other adverse events
Measure	HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) n=327 participants at risk Patients will be implanted with the HM3 LVAS
Infections and infestations Major Infection	2.4% 8/327 • Number of events 9 • Adverse events were collected from enrollment until the study conclusion date (up to 43 months, 3 days, median of approximately 1 year) The study enrolled 358 patients, but 31 experienced a terminal outcome before informed consent could be obtained, and data collection was limited to duration of HM3 support and terminal outcome. Mortality data are therefore available for 358, but adverse event data are available for 327. Key adverse events were pre-defined in the study protocol. Adverse events meeting these criteria area are described as protocol defined. Other adverse events are categorized according to MedDRA preferred terms.

Additional Information

Morgan Collins, PhD

Abbott

Phone: 6176316505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place