PMID- 26299240 OWN - NLM STAT- MEDLINE DCOM- 20151112 LR - 20161125 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 170 IP - 2 DP - 2015 Aug TI - Ultraslow thrombolytic therapy: A novel strategy in the management of PROsthetic MEchanical valve Thrombosis and the prEdictors of outcomE: The Ultra-slow PROMETEE trial. PG - 409-18 LID - S0002-8703(15)00301-4 [pii] LID - 10.1016/j.ahj.2015.04.025 [doi] AB - BACKGROUND: Low-dose (25mg), slow infusion (6hours) of tissue-type plasminogen activator (t-PA) with repetition as needed has been shown to provide effective and safer thrombolysis in patients with prosthetic valve thrombosis (PVT). Further prolonging the infusion time may be rational with regard to reducing complication rates without reducing success rates. We aimed to investigate the efficacy and safety of ultraslow (25hours) infusion of low-dose (25mg) alteplase (t-PA) for PVT. METHODS AND RESULTS: Transesophageal echocardiography-guided thrombolytic therapy (TT) was administered to 114 patients with PVT in 120 different episodes between 2009 and 2013 in a single center. Prosthetic valve thrombosis was obstructive in 77 (64.2%) and nonobstructive in 43 (35.8%) episodes. Ultraslow infusion (25hours) of low-dose (25mg) t-PA, as the TT regimen, was used in all patients admitted with PVT. The end points were thrombolytic success, mortality, and complication rates. The overall success rate of TT was 90% (95% CI 0.85-0.95). The univariate predictors of an unsuccessful result were higher New York Heart Association (NYHA) class, thrombus cross-sectional area, duration of suboptimal anticoagulation, lower baseline valve area, and presence of atrial fibrillation. The NYHA class was the only independent predictor of TT failure by multiple variable analysis. The overall complication rate was 6.7% (3.3% nonfatal major, 2.5% minor, and 0.8% death). The predictors of complications were presence of atrial fibrillation, higher NYHA class, and thrombus area. CONCLUSION: Ultraslow (25hours) infusion of low-dose (25mg) t-PA without bolus appears to be associated with quite low nonfatal complications and mortality for PVT patients without loss of effectiveness, except for those with NYHA class IV. CI - Copyright (c) 2015 Elsevier Inc. All rights reserved. FAU - Ozkan, Mehmet AU - Ozkan M AD - Department of Cardiology, Faculty of Medicine, Kars Kafkas University, Kars, Turkey; Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Gunduz, Sabahattin AU - Gunduz S AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. Electronic address: sabahattingunduz@yahoo.com. FAU - Gursoy, Ozan Mustafa AU - Gursoy OM AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Karakoyun, Suleyman AU - Karakoyun S AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Astarcioglu, Mehmet Ali AU - Astarcioglu MA AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Kalcik, Macit AU - Kalcik M AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Aykan, Ahmet Cagri AU - Aykan AC AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Cakal, Beytullah AU - Cakal B AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Bayram, Zubeyde AU - Bayram Z AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Oguz, Ali Emrah AU - Oguz AE AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Erturk, Emre AU - Erturk E AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Yesin, Mahmut AU - Yesin M AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Gokdeniz, Tayyar AU - Gokdeniz T AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Duran, Nilufer Eksi AU - Duran NE AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Yildiz, Mustafa AU - Yildiz M AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. FAU - Esen, Ali Metin AU - Esen AM AD - Department of Cardiology, Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey. LA - eng PT - Clinical Trial PT - Journal Article DEP - 20150502 PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 RN - 0 (Fibrinolytic Agents) SB - IM CIN - Am Heart J. 2016 Apr;174:e1-2. PMID: 26995386 MH - Adult MH - Aged MH - Aged, 80 and over MH - Dose-Response Relationship, Drug MH - Echocardiography, Transesophageal MH - Female MH - Fibrinolytic Agents/*administration & dosage MH - Follow-Up Studies MH - Heart Diseases/diagnosis/*drug therapy/etiology MH - Heart Valve Diseases/complications/surgery MH - Heart Valve Prosthesis/*adverse effects MH - *Heart Ventricles MH - Humans MH - Infusions, Intravenous MH - Male MH - Middle Aged MH - Postoperative Complications MH - *Practice Guidelines as Topic MH - Prosthesis Failure MH - Retrospective Studies MH - Thrombolytic Therapy/*methods MH - Thrombosis/diagnostic imaging/*drug therapy/etiology MH - Time Factors MH - Treatment Outcome MH - Young Adult EDAT- 2015/08/25 06:00 MHDA- 2015/11/13 06:00 CRDT- 2015/08/25 06:00 PHST- 2014/11/21 00:00 [received] PHST- 2015/04/16 00:00 [accepted] PHST- 2015/08/25 06:00 [entrez] PHST- 2015/08/25 06:00 [pubmed] PHST- 2015/11/13 06:00 [medline] AID - S0002-8703(15)00301-4 [pii] AID - 10.1016/j.ahj.2015.04.025 [doi] PST - ppublish SO - Am Heart J. 2015 Aug;170(2):409-18. doi: 10.1016/j.ahj.2015.04.025. Epub 2015 May 2.