CorMatrix Anterior Leaflet Augmentation of the Tricuspid Valve: Midterm Results
Keywords:tricuspid regurgitation, valve repair, extracellular matrix patch
Background: Tricuspid annuloplasty is the most common surgical approach to correct tricuspid regurgitation (TR). In some patients, however, anterior leaflet patch augmentation may be necessary to optimize tricuspid competence. We reviewed our center cohort over the midterm and long term.
Methods: From January 2013 to August 2018, 424 tricuspid valve procedures were performed, of which 420 were repairs and 4 were replacements. Indications were either isolated severe TR or moderate or greater TR, concomitant with other surgery. In the repair cohort, we identified those that had a patch augmentation, and the database was interrogated for preoperative characteristics. The resulting patients had outpatient assessment (clinical and echocardiography) at 6 weeks and at a later interval. Additionally, a comparison was made between those who had good and poor results (moderate or greater TR or cardiac death).
Results: In the repair cohort, 19 patients underwent complex tricuspid valve repair with CorMatrix anterior leaflet augmentation. Preoperative characteristics were as follows: age, 65.5 ± 13.5 years; New York Heart Association (NYHA) class, 3.5 ± 0.5; left ventricular ejection fraction, 48.3% ± 5.9%; tricuspid annular plane systolic excursion, 17.1 ± 3.7 mm; right ventricle (good, mild, moderate, poor), 10, 5, 4, 0; annulus size, 40.9 ± 6.9 mm; mean tethering distance, 1.00 ± 0.3 cm; and mean tethering area, 1.53 ± 1.16 cm2. Mean follow-up was 2.1 ± 1.9 years, and survival at 2 years was 73.8%. There were 2 in-hospital deaths. Mean NYHA class was 1.0 ± 0.5 (6 weeks) and 1.5 ± 0.6 (later follow-up); mean residual TR grade was 0.5 ± 0.6 (6 weeks) and 1.3 ± 1.4 (follow-up). Ten of 13 survivors had a good result at last follow-up (TR 0 to 1). We compared the preoperative and operative data of this group versus those with poor results (TR >1 or cardiac mortality). Significant univariate predictors of poor results were larger preoperative tethering area (1.18 ± 0.43 versus 2.4 ± 1.5 cm2; P = .02), longer tethering distance (0.87 ± 0.21 versus 1.2 ± 0.19 cm; P = .007), or the presence of mild or greater TR at 6 weeks (0.2 ± 0.4 vs 1.25 ± 0.5; P = .03).
Conclusions: CorMatrix anterior leaflet augmentation produces successful, stable repair in the majority of this complex population. The presence of even mild TR at 6 weeks’ follow-up predicts a poor result. When the tethering area or the tethering distance is significantly high, replacement is probably a better option.
Baumgartner H, Falk V, Bax JJ, et al 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739-2791.
Besler C, Seeburger J, Thiele H, Lurz P. Treatment options for severe functional tricuspid regurgitation: Indications, techniques, and current challenges. e-J Cardiol Pract 2018;16. Available at: https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-16/Treatment-options-for-severe-functional-tricuspid-regurgitation-indications-techniques-and-current-challenges.
Calafiore AM, Iacò AL, Bivona A, et al. Echocardiographically based treatment of chronic ischemic mitral regurgitation. J Thorac Cardiovasc Surg 2011;141:1150‐1156.
Dreyfus GD, Raja SG, John Chan KM. Tricuspid leaflet augmentation to address severe tethering in functional tricuspid regurgitation. Eur J Cardiothorac Surg 2008;34:908-910.
Kelley TM, Kashem M, Wang H, et al. Anterior leaflet augmentation with CorMatrix porcine extracellular matrix in twenty-five patients: Unexpected patch failures and histologic analysis. Ann Thorac Surg 2017;103:114-120.
Kumar SP, Prabhakar G, Kumar M, Kumar N, Shahid M, Ali ML. Comparison of fresh and glutaraldehyde-treated autologous stented pericardium as pulmonary valve replacement. J Card Surg 1995;10:545-551.
Lancellotti P, Tribouilloy C, Hagendorff A, et al. Recommendations for the echocardiographic assessment of native valvular regurgitation: An executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2013;14:611-644.
McCarthy PM, Bhudia SK, Rajeswaran J, et al. Tricuspid valve repair: Durability and risk factors for failure. J Thorac Cardiovasc Surg 2004;127:674-685.
Mosala Nezhad Z, Poncelet A, de Kerchove L, Gianello P, Fervaille C, El Khoury G. Small intestinal submucosa extracellular matrix (CorMatrix®) in cardiovascular surgery: A systematic review. Interact Cardiovasc Thorac Surg 2016;22:839-850.
Mosala Nezhad Z, Poncelet A, Fervaille C, Gianello P. Comparing the host reaction to CorMatrix and different cardiac patch materials implanted subcutaneously in growing pigs. Thorac Cardiovasc Surg 2019;67:44-49.
Nath J, Foster E, Heidenreich PA. Impact of tricuspid regurgitation on long-term survival. J Am Coll Cardiol 2004;43:405-409.
Rescigno G, Meraglia A, Uddin M, Billing JS. CorMatrix patch augmentation of the tricuspid valve anterior leaflet. October 2019. Available at: https://ctsnet.figshare.com/articles/media/Cormatrix_Patch_Augmentation_of_the_Tricuspid_Valve_Anterior_Leaflet/9983360.
Rivera R, Duran E, Ajuria M. Carpentier’s flexible ring versus De Vega’s annuloplasty. A prospective randomized study. J Thorac Cardiovasc Surg 1985;89:196-203.
Ropcke DM, Rasmussen J, Ilkjær C, Skov SN, Tjørnild MJ, Baandrup UT, et al. Mid-term function and remodeling potential of tissue engineered tricuspid valve: Histology and biomechanics. J Biomech 2018;71:52-58.
Roshanali F, Saidi B, Mandegar MH, Yousefnia MA, Alaeddini F. Echocardiographic approach to the decision-making process for tricuspid valve repair. J Thorac Cardiovasc Surg 2010;139:1483-1487.
Singh SK, Tang GH, Maganti MD, Armstrong S, Williams WG, David TE, Borger MA. Midterm outcomes of tricuspid valve repair versus replacement for organic tricuspid disease. Ann Thorac Surg 2006;82:1735-1741.
Tomdio AN, Moey MYY, Siddiqui I, Movahed A. Dehiscence and embolization of CorMatrix tricuspid valve replacement in the setting of infective endocarditis: a case report. Eur Heart J Case Rep 2018;2:yty086.
van Rijswijk JW, Talacua H, Mulder K, et al. Failure of decellularized porcine small intestinal submucosa as a heart valved conduit. J Thorac Cardiovasc Surg 2020;160:e201-e205.
Wallen J, Rao V. Extensive tricuspid valve repair after endocarditis using CorMatrix extracellular matrix. Ann Thorac Surg 2014;97:1048-1050.
Wong WK, Chen SW, Chou AH, et al. Late outcomes of valve repair versus replacement in isolated and concomitant tricuspid valve surgery: A nationwide cohort study. J Am Heart Assoc 2020;9:e015637.
Yang L, Chen H, Pan W, et al. Analyses for prevalence and outcome of tricuspid regurgitation in China: An echocardiography study of 134,874 patients. Cardiology 2019;142:40-46.
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