St. Jude Medical Trifecta aortic valve: results from a prospective regional multicentre registry

Abstract

BackgroundThe Trifecta aortic bioprosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) is a stented pericardial heart valve with excellent preliminary results. Aim of the study was to evaluate its early clinical and hemodynamic performances in a multicenter regional registry.MethodsBetween January 2011 and June 2012, 178 consecutive patients undergoing aortic valve replacement with the Trifecta bioprosthesis were prospectively enrolled at 9 Italian centers. Clinical and echocardiographic data were collectedat discharge, 6-months and at 1-year postoperatively.ResultsThe average age was 75.4 ± 7.7 years,and 95 (53 %) were men. Indication for valve replacement included stenosis in 123 patients (69 %), mixed lesions in 25 (14 %), and regurgitation in 30 (17 %). Ninety-three (52 %) patients were in NYHA functional class III/ IV. Hospital mortality accounted for 5 (2.8 %) patients. No valve-related perioperative complications were encountered. Median follow-up was 20.5 months (range: 1-34). Early (≤6 months) complications included one thromboembolic event, one major bleeding, and 3 endocarditis (2 explants). Two late (>6 months) thromboembolic events and two endocarditis (1 explant) were registered. No valve thrombosis or structural deterioration were observed after discharge. At 30-months, freedom from all-cause mortality was 87 %, freedom from valve-related mortality 99.4 %, freedom from endocarditis 97.5 %, and freedom from valve explants 98 %. At 1-year, mean gradients ranged from 8 to 16 mmHg, and effective orifice area indexes from 1.0 to 1.2 cm2/m2 for valve sizes from 19 to27 mm, respectively. No patients had severe prosthesis-patient mismatch.ConclusionsTrifecta bioprosthesis provided favourable clinical and hemodynamic results over time.

Early and mid-term haemodynamic performance and clinical outcomes of St. Jude Medical Trifecta™ valve

“…The easier implantation technique combined with optimal haemodynamic performance of the latest generation of stented bioprosthesis might have reduce the use of stentless valves (4,7,8), which require a technically more complex implantation and a longer learning curve (5,7,(15)(16)(17). Although this is not a comparative study, our results support this hypothesis.…”

“…However, one of our reoperations that required Trifecta prosthesis replacement 12 days after implantation was due to stent distortion that caused severe intraprosthetic regurgitation. This condition could be attributed to an inappropriate sizing or an incorrect annular decalcification that might reduce haemodynamic performance and potentially cause regurgitation of improperly approximating cusps (5,29). Same authors emphasize the importance of the implant technique to prevent stent distortion which can abolish the benefits of the cuff designed to conform to the native annulus after implantation (8,30,31).…”

“…The low thrombogenic risk improved haemodynamic performance and longer durability, of recent pericardial bioprosthesis models (that translated into promising clinical outcomes) have made them an appealing solution even for younger patients. Trifecta prosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) is an aortic pericardial bioprosthesis with a titanium stent, designed to have minimal haemodynamic impact [smaller transprosthetic gradients and increased effective orifice area (EOA)]; leaflets are mounted as a single pericardial patch in the outer aspect of the struts which allows for almost circular cross-section during systole (4,5). Trifecta bioprosthesis received European CE-mark approval in 2010 and Food and Drug Administration (FDA) approval in 2011 (4).…”

Limitations in the Assessment of Prosthesis-Patient Mismatch

“…Although the use of EOAi is believed to account for these differences in physical constitution, it relates a measure of flow velocity to individual parameters twice (i.e., LVOT area Fig. 3 Postoperative mean pressure gradients as a function of the effective orifice area (EOA) after bioprothetic aortic valve replacement taken from publications reporting both values for the same patients (Epic, 30 Epic Supra, 33,41 Mosaic, 24,27,28,31,38,39,44 Perimount, [19][20][21]23,25,28,30,35,39,42 Magna, 20,23,24,27,41 Sorin Mitroflow, 23,29,43,48,49 and Trifecta 22,26,27,32,34,37,40,43 ). The numbers represent the size label of the prosthesis and the size of the circle corresponds with the size of the sample.…”

Early Outcomes of Isolated Aortic Valve Replacement Through Right Anterior Minithoracotomy Using the Latest-Generation Biological Prosthesis

“…The latest-generation Trifecta valves, Trifecta GT (St Jude Medical, Inc., St Paul, MN, USA), utilize proprietary Glide Technology and are designed to have improved hemodynamics (smaller gradients and increased effective orifice area [EOA]) due to several design features, including a stent design, effective anticalcification technology, and supra-annular sewing cuff. 3,4 Multiple studies have reported excellent clinical results and hemodynamic performance of Trifecta valves, 4 -7 but longer follow-up studies are needed to assess long-term durability and outcomes.…”