Trial Outcomes & Findings for The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial (NCT NCT01166347)

Results Overview

The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale \>=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percent of 100) are used.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

451 participants

Primary outcome timeframe

Implant to 2 years

Results posted on

2018-09-06

Participant Flow

Five enrolled subjects were not randomized to a group due to lack of written insurance approval to receive the study device, death prior to randomization, prior screen failure (later improved), or withdrawal of consent.

Participant milestones

Participant milestones
Measure	HeartWare® Ventricular Assist System (VAS) HeartWare® Ventricular Assist System(VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control Left Ventricular Assist Device (LVAD) Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.
Overall Study STARTED	297	149
Overall Study COMPLETED	295	148
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HeartWare® VAS n=297 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=148 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.	Total n=445 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 11.60 • n=5 Participants	66.2 years STANDARD_DEVIATION 10.23 • n=7 Participants	64.7 years STANDARD_DEVIATION 11.20 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	26 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	227 Participants n=5 Participants	122 Participants n=7 Participants	349 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	288 Participants n=5 Participants	142 Participants n=7 Participants	430 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	66 Participants n=5 Participants	32 Participants n=7 Participants	98 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	228 Participants n=5 Participants	115 Participants n=7 Participants	343 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Implant to 2 years

Population: Only randomized subjects who successfully received an implant are included.

The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale \>=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percent of 100) are used.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=297 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=148 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Stroke-Free Survival Probability for 2 Years Post Implant	55.4 Probabillity	59.1 Probabillity

SECONDARY outcome

Timeframe: Implant to two years

Population: Only randomized subjects who successfully received an implant are included.

Number of participants with bleeding, per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. The event of bleeding is defined as: An episode of suspected internal or external bleeding that results in one or more of the following: 1. Death, 2. Re-operation, 3. Hospitalization, 4. Transfusion of red blood cells as follows: During first 7 days post implant * Adults (≥ 50 kg): ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant. After 7 days post implant * Any transfusion of packed red blood cells (PRBC) after 7 days following implant.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=297 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=148 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Number of Participants With Bleeding	180 Participants	88 Participants

SECONDARY outcome

Timeframe: Implant to two years

Population: Only randomized subjects who successfully received an implant are included.

Number of participants with major infections, per INTERMACS definition. A major infection is defined as: A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). A positive culture from the infected site or organ should be present unless strong clinical evidence indicates the need for treatment despite negative cultures. The general categories of infection include Localized non-device infection Percutaneous site and/or pocket infection Internal pump component, inflow or outflow tract infection Sepsis

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=297 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=148 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Number of Participants With Major Infections	206 Participants	92 Participants

SECONDARY outcome

Timeframe: Implant to two years

Population: Only randomized subjects who successfully received an implant are included.

Overall survival is the probability (expressed as a percent of 100) did not died within 2 years post implant via the Kaplan-Meier method. Participants that did not died were censored at the time of last follow-up or 2 years post implant, whichever occurred first.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=297 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=148 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Overall Survival at 2 Years	60.7 Probability	67.6 Probability

SECONDARY outcome

Timeframe: Implant to two years

Population: Only randomized subjects who successfully received an implant are included.

Number of Participants with device malfunctions per INTERMACS definition. Device malfunction denotes a failure of one or more of the components of the Mechanical Circulatory Support Device (MCSD) system which either directly causes or could potentially induce a state of inadequate circulatory support (low cardiac output state) or death. The manufacturer must confirm device failure. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure. Device failure should be classified according to which components fails as follows: 1. Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components). 2. Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber)

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=297 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=148 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Number of Participants With Device Malfunctions	93 Participants	38 Participants

SECONDARY outcome

Timeframe: Change from baseline to 2 years

Population: Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.

Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=138 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=76 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	30.2 Units on a scale Standard Deviation 24.12	30.8 Units on a scale Standard Deviation 28.81

SECONDARY outcome

Timeframe: Change from baseline to 2 years

Population: Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.

The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). An adjustment was done on the response where the scores were normalized based on this paper: Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=139 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=77 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Health Status Change Measured by EuroQol EQ-5D (Version 3L)	1.7 units on a scale Standard Deviation 1.98	1.8 units on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: Change from baseline to 2 years

Population: Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.

Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA: I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea. II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=152 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=84 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Change in Functional Status Measured by New York Heart Association (NYHA) Class Worsened 1 NYHA Class	2 Participants	0 Participants
Change in Functional Status Measured by New York Heart Association (NYHA) Class No Change in NYHA Class	15 Participants	6 Participants
Change in Functional Status Measured by New York Heart Association (NYHA) Class Improved 1 NYHA Class	39 Participants	19 Participants
Change in Functional Status Measured by New York Heart Association (NYHA) Class Improved 2 NYHA Classes	63 Participants	40 Participants
Change in Functional Status Measured by New York Heart Association (NYHA) Class Improved 3 NYHA Classes	33 Participants	19 Participants

SECONDARY outcome

Timeframe: Change from baseline to 2 years

Population: Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete the assessment or indicate Not Completed to be analyzed at both the baseline and Month 24 visits. If the subject did not complete the assessment, a value of 0 was imputed.

Change in functional status, as measured by 6-minute walk test.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=160 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=89 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Change in Functional Status as Measured by 6-minute Walk	95.6 Meters Standard Deviation 177.09	109.8 Meters Standard Deviation 181.34

SECONDARY outcome

Timeframe: Implant to the end of the initial hospitalization

Population: Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. Subjects who died while in the hospital or have a missing discharge date were not included.

Length of Initial Hospitalization post implant

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=265 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=132 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Length of Initial Hospitalization	26.0 Days Standard Deviation 20.52	25.0 Days Standard Deviation 15.58

SECONDARY outcome

Timeframe: Implant to two years

Population: Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received.

Number of participants who had a re-hospitalization while on the device

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=296 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=149 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Number of Participants Who Had a Re-hospitalization	249 Participants	118 Participants

SECONDARY outcome

Timeframe: Implant to two years

Population: Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. Subjects who died while in the hospital or have a missing discharge date were not included.

Duration of Re-hospitalization while on device

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=241 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=118 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Duration of Re-hospitalization	44.1 Days Standard Deviation 37.01	39.3 Days Standard Deviation 33.77

SECONDARY outcome

Timeframe: Implant to two years

Population: Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received.

Cause of Re-hospitalization while on device. The reason a participant may have been re-hospitalized was due to an adverse event, the need for an explant, or for various "Other" reasons.

Outcome measures

Outcome measures
Measure	HeartWare® VAS n=296 Participants HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=149 Participants Control LVAD: Any FDA-approved LVAD for destination therapy.
Cause of Re-hospitalization Other	53 Participants	32 Participants
Cause of Re-hospitalization Adverse Event	241 Participants	107 Participants
Cause of Re-hospitalization Explant	33 Participants	28 Participants

Adverse Events

HeartWare® VAS

Serious events: 284 serious events

Other events: 112 other events

Deaths: 116 deaths

Control LVAD

Serious events: 141 serious events

Other events: 50 other events

Deaths: 48 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	HeartWare® VAS n=296 participants at risk HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=149 participants at risk Control LVAD: Any FDA-approved LVAD for destination therapy.
Blood and lymphatic system disorders Major Bleeding	8.8% 26/296 • Number of events 33 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	6.0% 9/149 • Number of events 10 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Cardiac Arrhythmia	7.4% 22/296 • Number of events 25 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	6.0% 9/149 • Number of events 9 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Product Issues Device Malfunction/Failure	9.5% 28/296 • Number of events 42 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	3.4% 5/149 • Number of events 6 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Hypertension	6.1% 18/296 • Number of events 23 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	5.4% 8/149 • Number of events 8 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Infections and infestations Major Infection	18.2% 54/296 • Number of events 76 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	17.4% 26/149 • Number of events 40 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Psychiatric disorders Psychiatric Episode	5.7% 17/296 • Number of events 19 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	4.7% 7/149 • Number of events 7 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Right Heart Failure	6.4% 19/296 • Number of events 19 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	4.0% 6/149 • Number of events 6 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.

Additional Information

Thomas Vassiliades

Medtronic

Phone: +15085321942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In most cases, the contract allows the principal investigator to publish their data after the release of the multi-center publication (or one year after the conclusion of the study if no multi-center publication is submitted) following the sponsor review for (a) disclosure of confidential information, and (b) information that would impair the sponsor's ability to obtain patent protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	HeartWare® VAS n=296 participants at risk HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.	Control LVAD n=149 participants at risk Control LVAD: Any FDA-approved LVAD for destination therapy.
Blood and lymphatic system disorders Major Bleeding	57.4% 170/296 • Number of events 377 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	58.4% 87/149 • Number of events 189 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Cardiac Arrhythmia	33.1% 98/296 • Number of events 153 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	36.9% 55/149 • Number of events 74 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Product Issues Device Malfunction	24.0% 71/296 • Number of events 82 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	22.8% 34/149 • Number of events 37 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Blood and lymphatic system disorders Hemolysis	8.4% 25/296 • Number of events 33 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	9.4% 14/149 • Number of events 15 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Hepatobiliary disorders Hepatic Dysfunction	4.7% 14/296 • Number of events 14 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	7.4% 11/149 • Number of events 11 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Hypertension	10.8% 32/296 • Number of events 39 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	12.1% 18/149 • Number of events 21 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Infections and infestations Major Infection	62.5% 185/296 • Number of events 389 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	53.0% 79/149 • Number of events 145 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Myocardial Infarction	1.4% 4/296 • Number of events 4 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	0.00% 0/149 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Nervous system disorders Neurological Dysfunction	32.8% 97/296 • Number of events 140 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	16.8% 25/149 • Number of events 26 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Pericardial Fluid Collection	2.7% 8/296 • Number of events 8 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	6.0% 9/149 • Number of events 9 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Psychiatric disorders Psychiatric Episode	11.5% 34/296 • Number of events 36 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	6.7% 10/149 • Number of events 11 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Renal and urinary disorders Renal Dysfunction	14.5% 43/296 • Number of events 52 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	11.4% 17/149 • Number of events 18 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	27.4% 81/296 • Number of events 109 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	24.2% 36/149 • Number of events 46 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Cardiac disorders Right Heart Failure	33.4% 99/296 • Number of events 114 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	23.5% 35/149 • Number of events 40 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Vascular disorders Arterial Non-CNS Thromboembolism	1.7% 5/296 • Number of events 6 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	2.0% 3/149 • Number of events 9 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Vascular disorders Venous Thromboembolism	2.7% 8/296 • Number of events 11 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	3.4% 5/149 • Number of events 5 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
Skin and subcutaneous tissue disorders Wound Dehiscence	0.00% 0/296 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	0.00% 0/149 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.
General disorders Other Intermacs	76.4% 226/296 • Number of events 724 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.	71.8% 107/149 • Number of events 301 • The adverse events are summarized from the date of implant through 2 years while on the originally implanted device. Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) adverse event definitions are geared towards subjects who have a mechanical circulatory support device.