Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea

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 will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. 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 be censored at that time in the analysis.

Cumulative occurrence of adverse events will be presented as percent of patients with adverse events and events per patient year of support.

The 6-minute Walk test will be conducted at all follow-up visits until the end of the surveillance period. Distance walked at each visit will be compared to baseline using Wilcoxon signed-rank test. To assess the overall changes, repeated measure analysis will be performed using all data collected from baseline to the end of the surveillance period. The overall mean, median, standard deviation, minimum, and maximum will be presented for all follow-up visits. Differences in walking distance between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in walking distance over time.

Percent of subjects in each NYHA class will be presented for all follow-up visits. For comparison, patients will be grouped into NYHA Class I/II (No limitation and Slight limitation of physical activity) vs. NYHA Class III/IV (Marked limitation and Inability to carry out physical activities). McNemar's test will be used to assess if there is an increase in proportion of Class I and II subjects at each visit comparing to the baseline.

Subject's quality of life 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 overall mean, median, standard deviation, minimum and maximum will be presented for all follow-up visits. Differences in QoL Score between each visit and baseline will be calculated and assessed for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show changes in QoL over time.

Frequency and reason will be reported for rehospitalization and reoperation. Freedom from rehospitalization and reoperation will be assessed using the Kaplan-Meier product-limit method.

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. Data on device malfunctions will be analyzed for the following:

• The component of the device involved
• Days to the malfunction
• Action taken in response to the malfunction
• Reoperations due to malfunction
• Death due to malfunction

Incidence of adverse events will be assessed including, but not limited to, neurological dysfunction, bleeding, infections and device thrombosis.