Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study

I. Netuka, P. Sood, Y. Pya, D. Zimpfer, T. Krabatsch, J. Garbade, V. Rao, M. Morshuis, S. Marasco, F. Beyersdorf, L. Damme, JD. Schmitto,

. 2015 ; 66 (23) : 2579-89.

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc16020089

BACKGROUND: The HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse. OBJECTIVES: The aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS. METHODS: The primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction ≤ 25%, cardiac index ≤ 2.2 l/min/m(2) without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant. RESULTS: Fifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model-predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score > 3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement. CONCLUSIONS: The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363).

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc16020089
003      
CZ-PrNML
005      
20160801110839.0
007      
ta
008      
160722s2015 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.jacc.2015.09.083 $2 doi
024    7_
$a 10.1016/j.jacc.2015.09.083 $2 doi
035    __
$a (PubMed)26670056
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Netuka, Ivan $u Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Second Department of Surgery, Department of Cardiovascular Surgery, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic. Electronic address: ivan.netuka@ikem.cz.
245    10
$a Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study / $c I. Netuka, P. Sood, Y. Pya, D. Zimpfer, T. Krabatsch, J. Garbade, V. Rao, M. Morshuis, S. Marasco, F. Beyersdorf, L. Damme, JD. Schmitto,
520    9_
$a BACKGROUND: The HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse. OBJECTIVES: The aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS. METHODS: The primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction ≤ 25%, cardiac index ≤ 2.2 l/min/m(2) without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant. RESULTS: Fifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model-predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score > 3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement. CONCLUSIONS: The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363).
650    _2
$a senioři $7 D000368
650    _2
$a kardiotonika $x terapeutické užití $7 D002316
650    12
$a design vybavení $7 D004867
650    _2
$a ženské pohlaví $7 D005260
650    12
$a srdeční selhání $x diagnóza $x mortalita $x patofyziologie $x chirurgie $7 D006333
650    _2
$a transplantace srdce $x statistika a číselné údaje $7 D016027
650    _2
$a srdeční komory $x patofyziologie $7 D006352
650    12
$a podpůrné srdeční systémy $7 D006353
650    12
$a hemodynamika $7 D006439
650    _2
$a lidé $7 D006801
650    _2
$a dlouhodobá péče $x metody $7 D008134
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a prospektivní studie $7 D011446
650    _2
$a stupeň závažnosti nemoci $7 D012720
650    _2
$a tepový objem $7 D013318
650    _2
$a analýza přežití $7 D016019
650    _2
$a výsledek terapie $7 D016896
655    _2
$a klinické zkoušky $7 D016430
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Sood, Poornima $u Clinical Affairs, St. Jude Medical, Burlington, Massachusetts.
700    1_
$a Pya, Yuriy $u National Research Cardiac Surgery Center, Astana, Kazakhstan.
700    1_
$a Zimpfer, Daniel $u Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
700    1_
$a Krabatsch, Thomas $u Department of Cardiothoracic and Vascular Surgery, German Heart Center, Berlin, Germany.
700    1_
$a Garbade, Jens $u Heart Center Leipzig, Department of Cardiac Surgery, University of Leipzig, Leipzig, Germany.
700    1_
$a Rao, Vivek $u Toronto General Hospital, Toronto, Canada.
700    1_
$a Morshuis, Michiel $u Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany.
700    1_
$a Marasco, Silvana $u Cardiothoracic Surgical Unit, The Alfred Hospital, Melbourne, Australia.
700    1_
$a Beyersdorf, Friedhelm $u Department of Cardiovascular Surgery Freiburg, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.
700    1_
$a Damme, Laura $u Clinical Affairs, St. Jude Medical, Burlington, Massachusetts.
700    1_
$a Schmitto, Jan D $u Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
773    0_
$w MED00002964 $t Journal of the American College of Cardiology $x 1558-3597 $g Roč. 66, č. 23 (2015), s. 2579-89
856    41
$u https://pubmed.ncbi.nlm.nih.gov/26670056 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20160722 $b ABA008
991    __
$a 20160801111106 $b ABA008
999    __
$a ok $b bmc $g 1154759 $s 944617
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2015 $b 66 $c 23 $d 2579-89 $i 1558-3597 $m Journal of the American College of Cardiology $n J. Am. Coll. Cardiol. $x MED00002964
LZP    __
$a Pubmed-20160722

Najít záznam

Citační ukazatele

Možnosti archivace