Beating Versus Arrested Heart for Mitral Valve Replacement
NCT ID: NCT01641614
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
34 participants
INTERVENTIONAL
2010-04-30
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Beating heart surgery
Group A (Beating heart) surgery was performed under normal temperature (36⁰ C) ,once CPB was established, the patient was placed in Trendelenburg position and a retrograde perfusion catheter was inserted into the coronary sinus and ligated by a simple suture line. Aorta cross clamping was immediately established and blood was oxygenated and delivered continuously through a catheter Mitral valve was exposed using the left atrial retractor. Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture De Vegas' technique.
Mitral valve replacement
Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups
heart surgery Group B
Group B (arrested heart) surgery was performed under moderate hypothermia (32⁰C) as technique requirement (3). After cardiac arrest, during the period of cross clamping, the aortic root was perfused through the cardioplegias's cannula with oxygenated blood at a rate between 200 mL/min to 300 mL/min for 2 minutes with 15 minutes intervals.Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture De Vegas' technique.
mitral valve replacement
Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups
Interventions
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Mitral valve replacement
Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups
mitral valve replacement
Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups
Eligibility Criteria
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Inclusion Criteria
* with an echocardiography diagnosis of mitral and/or tricuspid valve disease due to inflammatory acquired diseases,
* no previous history of cardiac surgery and d) elective indication for valve replacement.
Exclusion Criteria
* with coronary artery diseases,
* dilated myocardiopathy,
* with severe chronic pulmonary obstructive diseases,
* with present or past history of malignant diseases,
* acute endocarditis
* with severe pre-operatory laboratory parameters such as creatinine levels \> 3mg/dL, Hemoglobin ≤ 7.0 g/dL, Prothrombin time/activity ≤ 70% and clotting time ≥ 10 minutes.
18 Years
60 Years
ALL
No
Sponsors
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Federal University of Bahia
OTHER
Responsible Party
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Clotario Neptali Carrasco Cueva
Medical Doctor , Profesor of Cardiac Surgery
Locations
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Hospital Ana Neri
Salvador, Estado de Bahia, Brazil
Countries
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References
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Schaper J, Schwarz F, Kittstein H, Stammler G, Winkler B, Scheld H, Hehrlein F. The effects of global ischemia and reperfusion on human myocardium: quantitative evaluation by electron microscopic morphometry. Ann Thorac Surg. 1982 Feb;33(2):116-22. doi: 10.1016/s0003-4975(10)61895-4.
Babaroglu S, Yay K, Parlar AI, Ates C, Mungan U, Cicekcioglu F, Tutun U, Katircioglu SF. Beating heart versus conventional mitral valve surgery. Interact Cardiovasc Thorac Surg. 2011 Mar;12(3):441-7. doi: 10.1510/icvts.2010.255240. Epub 2010 Dec 21.
Kaplon RJ, Pham SM, Salerno TA. Beating-heart valvular surgery: a possible alternative for patients with severely compromised ventricular function. J Card Surg. 2002 Mar-Apr;17(2):170-2. doi: 10.1111/j.1540-8191.2002.tb01194.x.
Matsumoto Y, Watanabe G, Endo M, Sasaki H, Kasashima F, Kosugi I. Efficacy and safety of on-pump beating heart surgery for valvular disease. Ann Thorac Surg. 2002 Sep;74(3):678-83. doi: 10.1016/s0003-4975(02)03753-0.
Salhiyyah K, Taggart D. Beating-heart valve surgery: A systematic review. Asian Cardiovasc Thorac Ann. 2009 Dec;17(6):650-8. doi: 10.1177/0218492309348942.
Ghosh S, Jutley RS, Wraighte P, Shajar M, Naik SK. Beating-heart mitral valve surgery in patients with poor left ventricular function. J Heart Valve Dis. 2004 Jul;13(4):622-7; discussion 627-9.
Mizuno T, Arai H. On-pump beating-heart mitral valve plasty without aortic cross-clamping. Jpn J Thorac Cardiovasc Surg. 2006 Oct;54(10):454-7. doi: 10.1007/s11748-006-0031-4.
Bara C, Zhang R, Haverich A. De Vega annuloplasty for tricuspid valve repair in posttraumatic tricuspid insufficiency--16 years experience. Int J Cardiol. 2008 Jun 6;126(3):e61-2. doi: 10.1016/j.ijcard.2007.01.027. Epub 2007 Mar 29.
Hassan HT, Veit A, Maurer HR. Synergistic interactions between differentiation-inducing agents in inhibiting the proliferation of HL-60 human myeloid leukaemia cells in clonogenic micro assays. J Cancer Res Clin Oncol. 1991;117(3):227-31. doi: 10.1007/BF01625429.
Herrera JM, Cuenca J, Campos V, Rodriguez F, Vicente Valle J, Juffe A. [Coronary surgery without extracorporeal circulation: 5-year experience]. Rev Esp Cardiol. 1998 Feb;51(2):136-40. Spanish.
Karolak W, Hirsch G, Buth K, Legare JF. Medium-term outcomes of coronary artery bypass graft surgery on pump versus off pump: results from a randomized controlled trial. Am Heart J. 2007 Apr;153(4):689-95. doi: 10.1016/j.ahj.2007.01.033.
Karadeniz U, Erdemli O, Yamak B, Genel N, Tutun U, Aksoyek A, Cicekcioglu F, Parlar AI, Katircioglu SF. On-pump beating heart versus hypothermic arrested heart valve replacement surgery. J Card Surg. 2008 Mar-Apr;23(2):107-13. doi: 10.1111/j.1540-8191.2007.00536.x.
Lichtenstein SV, Ashe KA, el Dalati H, Cusimano RJ, Panos A, Slutsky AS. Warm heart surgery. J Thorac Cardiovasc Surg. 1991 Feb;101(2):269-74.
Kamlot A, Bellows SD, Simkhovich BZ, Hale SL, Aoki A, Kloner RA, Kay GL. Is warm retrograde blood cardioplegia better than cold for myocardial protection? Ann Thorac Surg. 1997 Jan;63(1):98-104. doi: 10.1016/s0003-4975(96)01074-0.
Eke CC, Gundry SR, Fukushima N, Bailey LL. Is there a safe limit to coronary sinus pressure during retrograde cardioplegia? Am Surg. 1997 May;63(5):417-20.
Gundry SR, Wang N, Sciolaro CM, Van Arsdell GS, Razzouk AJ, Hill AC, Bailey LL. Uniformity of perfusion in all regions of the human heart by warm continuous retrograde cardioplegia. Ann Thorac Surg. 1996 Jan;61(1):33-5. doi: 10.1016/0003-4975(95)00880-2.
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Other Identifiers
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REQ:690
Identifier Type: -
Identifier Source: org_study_id