Early hemodynamic performance of the Trifecta™ surgical bioprosthesis aortic valve in Indian patient population: 12 month outcomes of the EVEREST post-market study

Abstract

BackgroundIndian patients undergoing surgical aortic valve replacement (SAVR) differ from western populations with respect to aortic annulus size and valve disease morphology. The purpose of this post-market, non-randomized observational study was to evaluate the early hemodynamic performance of the Trifecta™ bioprosthesis (Abbott, previously St. Jude Medical, Minneapolis, US) in an Indian patient population.MethodsFrom January 2014 to September 2015, 100 patients (mean age 64.4 ± 7.1 years, 62% male) undergoing SAVR for valve disease (68% stenosis, 7% insufficiency, 25% mixed pathology) were enrolled across 10 centers in India. Patients implanted with a 19–27 mm Trifecta™ valve were eligible to participate and were prospectively followed for 12-months post-implantation. Echocardiographic hemodynamic performance was evaluated at pre-implant, pre-discharge and at 12-months by an independent core laboratory. Adverse events were adjudicated by the study sponsor. Functional status at 12-months was assessed according to NYHA classification. Continuous data was summarized using descriptive statistics (mean &standard deviation,) and categorical data was summarized using frequencies and percentages.ResultNinety patients (mean age 64.5, 62.2% male) completed the 12-month follow up. Significant improvements in hemodynamic valve performance were reported in 81 patients with available echocardiographic data at 12 months. Compared to baseline at 12-month follow up visit, mean effective orifice area increased from 0.75cm2 to 1.61cm2 (p < 0.0001), mean pressure gradient reduced to 10.42 mmHg from 51.47 mmHg (p < 0.0001), cardiac output increased from 4.46 l/min to 4.85 l/min (P 0.9254). Compared to baseline, functional status improved by ≥1 NYHA class in 75% of patients at 12 months (95% Clopper-Pearson (Exact) confidence limit [64.6%, 83.6%]). No instances of early mortality (< 30 days from index procedure) or structural valve dysfunction were reported.ConclusionIn an Indian patient population, implantation of the Trifecta™ bioprosthesis is shown to be safe and associated with favorable early hemodynamic performance and improved functional status at 12 months.Trial registrationThe clinical study has been registered under Clinical Trial Registry-India (http://www.ctri.nic.in) and registration number is CTRI/2014/02/004434 registered on 25 February 2014 retrospectively registered.

Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial

“…In the present study, none of the patients having Dafodil pericardial bioprosthesis for AVR died at 12-month follow-up. The 30-day mortality of patients receiving Dafodil pericardial bioprosthesis for AVR is similar to that of reported by the studies of other valves [3,[14][15][16]. Reported 30-days mortality rate of Trifecta (St. Jude Medical Inc., MN, USA), and Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences, Irvine, CA) bioprostheses was 0 and 2%, respectively [15].…”

“…Hence, we evaluated the hemodynamic performance of Dafodil pericardial bioprosthesis in all the patients up to 12-month follow-up. Hemodynamic performance of the Dafodil pericardial bioprosthesis at aortic position favourably correlates with the hemodynamic performance of the other valves having mean pressure gradients ranging from 9.4 ± 4.3 mmHg to 12.9 ± 3.8 mmHg and EOA ranging from 1.4 ± 2.4 cm 2 to 1.7 ± 0.4 cm 2 at 12-month follow-up [3,[14][15][16]. The mean mitral gradients and EOA (mitral valve) reported in the present study are comparable with those achieved by other mitral bioprostheses [27][28][29].…”

“…(2) STS scores < 4% (Low Risk). (3) Patients diagnosed with aortic/mitral disease requiring valve replacement based on pre-operative evaluation (Medical history, PT/INR or PTT, physical examination, echocardiography, and CBC). (4) Patient who had significant aortic/mitral stenosis or aortic/ Authors' contributions CSH and ARJ contributed to conceptualization, data curation, execution, and validation of the study.…”

“…In the Western world, one in every 1000 individuals aged > 65 years undergo valve replacement. According to an estimate, in India, approximately one hundred fifty thousand patients undergo cardiac surgeries, of which 30% are the valve surgeries, including both aortic and mitral valve replacement [2,3].…”

An Algorithm for Automatic Generation and Evaluation of Leaflet Apparatus Models for Heart Valve Prostheses

“…The literature data were used as a material model for this case [ 26 ], since Trifecta bioprostheses are fabricated from the bovine xenopericardium stabilized with glutaraldehyde. The area of leaflet opening obtained during simulation by the proprietary algorithm was compared with the data from the experimental studies reported in the literature [ 27 - 29 ] and manufacturer’s documentation for this bioprosthesis [ 30 ].…”