Beating Versus Arrested Heart for Mitral Valve Replacement

Mitral Insufficiency Clinical Trial

— BAHMVR  

Official title:

Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641614
• Other study ID #: REQ:690
• Status: Completed
• Phase: Phase 4
• First received: July 10, 2012
• Last updated: July 17, 2012
• Start date: April 2010
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immediately clinic and ultramicroscopic myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested heart versus on-pump empty beating heart surgical techniques.

Description:

During open-heart surgery prevention of ischemia and reperfusion following cardioplegic arrest are essential for myocardial protection. Beating heart surgery on normothermic bypass simulates physiologic cardiac status and is good method for myocardial protection. A comparison of both available techniques for valve replacement arrested heart versus on-pump empty beating heart of the clinical and ultramicroscopic myocardial alterations will allowed to better understand myocardial protection because eliminated the use of cardioplegia and the corollary risk of ischemic reperfusion injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• all patient included into the study were adults 18-60 years old,

• 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 metabolic diseases such as diabetes mellitus and uremia,

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Insufficiency
• Mitral Stenosis
• Mitral Valve Insufficiency
• Mitral Valve Stenosis

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Brazil	Hospital Ana Neri	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

References & Publications (17)

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. — View Citation

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. Epub 2007 Mar 29. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Herrera JM, Cuenca J, Campos V, Rodríguez F, Vicente Valle J, Juffé A. [Coronary surgery without extracorporeal circulation: 5-year experience]. Rev Esp Cardiol. 1998 Feb;51(2):136-40. Spanish. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Karolak W, Hirsch G, Buth K, Légaré 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Peña E, Solano L, Portillo Z, Meertens de Rodríguez L. [Nutritional status of institutionalized elderly. Valencia, State of Carabobo, Venezuela]. Arch Latinoam Nutr. 1998 Jun;48(2):104-11. Spanish. — View Citation

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. Review. — View Citation

Schaper J, Schwarz F, Kittstein H, Stämmler 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 with the beating heart also in the group B.	1hour , 3 hours and 1 hour after surgery procedure	No
Secondary	Ultramicroscopic evidences of ischemia	During the surgery myocardial biopsies were performed as full thickness transmural specimen of three small fragments for electromicrospic analysis	1hour, 3 hours and 1 hour after aortic clamping	No