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Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock
Published on: August 16, 2021
Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes
Daniel Zimpfer1, Ivan Netuka2, Jan D Schmitto3
1University of Vienna, Vienna, Austria daniel.zimpfer@meduniwien.ac.at.
Insights
The HeartMate 3 Left Ventricular Assist System (LVAS) showed excellent 30-day survival (98%) in advanced heart failure patients. This investigational study reported low adverse events and no device failures, demonstrating effective LVAS performance.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Outcomes
Background:
- The HeartMate 3 Left Ventricular Assist System (LVAS) is a device for advanced heart failure.
- The Conformité Européenne (CE) Mark clinical trial evaluated its initial performance.
- ClinicalTrials.gov Identifier: NCT02170363.
Purpose of the Study:
- To assess the operative experience and 30-day outcomes of HeartMate 3 LVAS implantation.
- To evaluate patient safety and device performance in a clinical trial setting.
Main Methods:
- Adult patients with advanced heart failure were enrolled.
- Implantation of the HeartMate 3 LVAS was performed for bridge to transplant or destination therapy.
- Operative parameters, adverse events, and clinical outcomes were monitored for 30 days post-implantation.
Main Results:
- A total of 50 patients were implanted across 10 centers in 6 countries.
- The 30-day survival rate was 98%, with a median operative time of 200 minutes.
- Common adverse events included bleeding (30%), arrhythmia (28%), and infection (20%); 4% experienced strokes.
Conclusions:
- The HeartMate 3 LVAS demonstrated excellent 30-day survival rates in this CE Mark trial.
- The device performed as intended, with no instances of hemolyis or device failure reported.
- Low rates of adverse events suggest a favorable safety profile for the HeartMate 3 LVAS.
Objectives:
The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformité Européenne (CE) Mark clinical trial.
Methods:
Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant.
Results:
Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 ± 2.3 units), fresh frozen plasma (6.5 ± 5 units) and platelets (2 ± 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes.
Conclusions:
The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure.
Clinicaltrialsgov Identifier:
NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark).
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