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J Cardiothorac Surg. 2017 Apr 4;12(1):23. doi: 10.1186/s13019-017-0587-3.

Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial.

Author information

1
German Heart Center, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, D-13353, Berlin, Germany. krabatsch@dhzb.de.
2
Institute for Clinical and Experimental Medicine, Vídenská 1958/9 Praha 4, Prague, Czech Republic.
3
Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
4
University of Vienna, Waehringer Guertel 18-20, A-1090, Vienna, Austria.
5
Heart Center Leipzig, Struempellstrasse 39, 04289, Leipzig, Germany.
6
Toronto General Hospital, 4N-464 200 Elizabeth St.,, Toronto, ON, M5G 2C4, Canada.
7
Herz- und Diabeteszentrum NRW, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
8
University Heart Center Freiburg-Bad Krozingen, Hugstetterstr 55, D-79106, Freiburg, Germany.
9
The Alfred Hospital, 55 Commercial Road, Prahran, VIC, 3181, Melbourne, Australia.
10
St. Jude Medical, 11 Da Vincilaan, Zaventem, 1935, Belgium.
11
National Research Cardiac Surgery Center, 010000, 38 Turan St., Astana, Kazakhstan.

Abstract

BACKGROUND:

The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein.

METHODS:

A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days.

RESULTS:

Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 + 0.5 L/min/m2 and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006).

CONCLUSIONS:

The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient's functional status and quality of life significantly improved over time.

TRIAL REGISTRATION:

Clinicaltrials.gov registration number: NCT02170363 . Registered June 19, 2014.

KEYWORDS:

Heart failure; HeartMate 3; LVAS; Magnetic levitation

PMID:
28376837
PMCID:
PMC5379553
DOI:
10.1186/s13019-017-0587-3
[Indexed for MEDLINE]
Free PMC Article

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