Daniel Zimpfer1, Ivan Netuka2, Jan D Schmitto3, Yuriy Pya4, Jens Garbade5, Michiel Morshuis6, Friedhelm Beyersdorf7, Silvana Marasco8, Vivek Rao9, Laura Damme10, Poornima Sood10, Thomas Krabatsch11. 1. University of Vienna, Vienna, Austria daniel.zimpfer@meduniwien.ac.at. 2. Institute for Clinical and Experimental Medicine, Prague, Czech Republic. 3. Hannover Medical School, Hannover, Germany. 4. National Research Cardiac Surgery Center, Astana, Kazakhstan. 5. Heart Center Leipzig, Leipzig, Germany. 6. Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany. 7. University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany. 8. The Alfred Hospital, Melbourne, Australia. 9. Toronto General Hospital, Toronto, Canada. 10. St. Jude Medical Inc., St. Paul, MN, USA. 11. German Heart Center, Berlin, Germany.
Abstract
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).
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).
Authors: Christina Feldmann; Anamika Chatterjee; Jasmin S Hanke; Guenes Dogan; Axel Haverich; Jan D Schmitto Journal: J Thorac Dis Date: 2017-06 Impact factor: 2.895
Authors: Dominik Wiedemann; Thomas Haberl; Philipp Angleitner; Kamen Dimitrov; Günther Laufer; Daniel Zimpfer Journal: Indian J Thorac Cardiovasc Surg Date: 2018-02-24
Authors: Ulrich Geisen; Kerstin Brehm; Georg Trummer; Michael Berchtold-Herz; Claudia Heilmann; Friedhelm Beyersdorf; Johannes Schelling; Axel Schlagenhauf; Barbara Zieger Journal: J Am Heart Assoc Date: 2018-01-13 Impact factor: 5.501