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

BACKGROUND

Indian 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.

METHODS

From 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.

RESULT

Ninety 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 0.75cm to 1.61cm (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.

CONCLUSION

In 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 REGISTRATION

The 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.