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).

German Heart Center Berlin Germany

Hannover Medical School Hannover Germany

Heart Center Leipzig Leipzig Germany

Institute for Clinical and Experimental Medicine Prague Czech Republic

National Research Cardiac Surgery Center Astana Kazakhstan

St Jude Medical Inc St Paul MN USA

The Alfred Hospital Melbourne Australia

Thoracic and Cardiovascular Surgery Clinic Bad Oeynhausen Germany

Toronto General Hospital Toronto Canada

University Heart Center Freiburg Bad Krozingen Freiburg Germany

University of Vienna Vienna Austria

000      

00000naa a2200000 a 4500

001      

bmc17031570

003      

CZ-PrNML

005      

20171030125622.0

007      

ta

008      

171025s2016 gw f 000 0|eng||

009      

AR

024    7_

$a 10.1093/ejcts/ezw169 $2 doi

035    __

$a (PubMed)27436871

040    __

$a ABA008 $b cze $d ABA008 $e AACR2

041    0_

$a eng

044    __

$a gw

100    1_

$a Zimpfer, Daniel $u University of Vienna, Vienna, Austria daniel.zimpfer@meduniwien.ac.at.

245    10

$a Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes / $c D. Zimpfer, I. Netuka, JD. Schmitto, Y. Pya, J. Garbade, M. Morshuis, F. Beyersdorf, S. Marasco, V. Rao, L. Damme, P. Sood, T. Krabatsch,

520    9_

$a 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).

650    _2

$a design vybavení $7 D004867

650    _2

$a ženské pohlaví $7 D005260

650    _2

$a následné studie $7 D005500

650    _2

$a celosvětové zdraví $7 D014943

650    _2

$a srdeční selhání $x mortalita $x patofyziologie $x chirurgie $7 D006333

650    _2

$a srdeční komory $x patofyziologie $x chirurgie $7 D006352

650    12

$a podpůrné srdeční systémy $7 D006353

650    _2

$a lidé $7 D006801

650    _2

$a incidence $7 D015994

650    _2

$a délka pobytu $x trendy $7 D007902

650    _2

$a mužské pohlaví $7 D008297

650    _2

$a lidé středního věku $7 D008875

650    _2

$a pooperační komplikace $x epidemiologie $x chirurgie $7 D011183

650    _2

$a prospektivní studie $7 D011446

650    _2

$a kvalita života $7 D011788

650    _2

$a reoperace $7 D012086

650    _2

$a míra přežití $x trendy $7 D015996

650    _2

$a časové faktory $7 D013997

655    _2

$a klinické zkoušky $7 D016430

655    _2

$a časopisecké články $7 D016428

655    _2

$a multicentrická studie $7 D016448

700    1_

$a Netuka, Ivan $u Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

700    1_

$a Schmitto, Jan D $u Hannover Medical School, Hannover, Germany.

700    1_

$a Pya, Yuriy $u National Research Cardiac Surgery Center, Astana, Kazakhstan.

700    1_

$a Garbade, Jens $u Heart Center Leipzig, Leipzig, Germany.

700    1_

$a Morshuis, Michiel $u Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany.

700    1_

$a Beyersdorf, Friedhelm $u University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.

700    1_

$a Marasco, Silvana $u The Alfred Hospital, Melbourne, Australia.

700    1_

$a Rao, Vivek $u Toronto General Hospital, Toronto, Canada.

700    1_

$a Damme, Laura $u St. Jude Medical Inc., St. Paul, MN, USA.

700    1_

$a Sood, Poornima $u St. Jude Medical Inc., St. Paul, MN, USA.

700    1_

$a Krabatsch, Thomas $u German Heart Center, Berlin, Germany.

773    0_

$w MED00001607 $t European journal of cardio-thoracic surgery official journal of the European Association for Cardio-thoracic Surgery $x 1873-734X $g Roč. 50, č. 3 (2016), s. 548-54

856    41

$u https://pubmed.ncbi.nlm.nih.gov/27436871 $y Pubmed

910    __

$a ABA008 $b sig $c sign $y a $z 0

990    __

$a 20171025 $b ABA008

991    __

$a 20171030125711 $b ABA008

999    __

$a ok $b bmc $g 1255163 $s 992597

BAS    __

$a 3

BAS    __

$a PreBMC

BMC    __

$a 2016 $b 50 $c 3 $d 548-54 $e 20160719 $i 1873-734X $m European journal of cardio-thoracic surgery $n Eur J Cardiothorac Surg $x MED00001607

LZP    __

$a Pubmed-20171025