Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Early experience with a novel pericardial aortic prosthesis designed to provide improved durability and facilitate future valve-in-valve treatment
O. Bhadra1, A. Schäfer1, Y. Schneeberger1, S. Blankenberg2, D. Westermann2, H. Reichenspurner1, L. Conradi1
1Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 2Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Hamburg;

Objectives

The expanded use of bioprosthetic aortic valve replacement (AVR) results in a decreasing mean age of patients at the time of implantation. Therefore, surgeons will increasingly be confronted with deteriorated valves requiring subsequent treatment strategies including valve-in-valve (ViV) therapy. The novel Edwards Inspiris bovine pericardial valve (Edwards Lifesciences, Irvine, CA, USA) offers a stent frame expansion zone intended to facilitate possible future ViV. This can lead to a larger EOA due to the implantation of a larger transcatheter valve resulting in better hemodynamic performance. This single centre report evaluates early clinical outcomes and hemodynamic performance of this novel bioprosthesis.

Methods

From October 2017 – June 2021, 81 patients (age 50±9.5 years, 62% male, logEuroSCORE II 1.6±1.5%, STS Score 0.93±0.53%) underwent elective AVR. Isolated AVR were performed via partial upper sternotomy. Acute clinical and hemodynamic results are presented.

Results

Indications for AVR were severe aortic regurgitation, severe aortic stenosis and mixed lesions in 48% (39/81), 27% (22/81) and 25% (20/81). 60% (49/81) of the patients had a bicuspid aortic valve. Isolated AVR was performed in 56% (45/81), combined procedures in 44% (36/81) including replacement of the ascending aorta 26% (21/81), CABG 16% (13/81), mitral valve repair/replacement 9% (7/81), Bentall procedure 7% (6/81), tricuspid valve replacement 1% (1/81). 27% (22/81) of patients underwent redo surgery. Valve sizes used were 21/23/25/27/29mm in 2%/17%/36%/38%/7% of cases. Mean procedure / cardiopulmonary bypass / aortic cross-clamp times for isolated vs. combined procedures were 214±85 / 116±46 / 80±29 and 268±103 / 159±70 / 101±45 minutes.  Duration of intensive care and overall hospital stay were 2.7±3.1 and 8.3±2.6 days. Echocardiography at discharge demonstrated peak/mean transvalvular gradients of 18.9±6.9/10.3±4.8 mmHg and no paravalvular leakage >mild in any patient. In-hospital and 30-day mortality were 0%. There was a significant difference in permanent pacemaker implantation rate between first and redo surgery cohorts (3% vs. 18%, p=0.04, overall: 7% (6/81)).

Conclusion

Early experience with this novel type of pericardial valve was favourable in a mixed patient population resulting in early mortality of 0% despite a high rate of redo-surgery (27%). Durability as well as feasibility and hemodynamic advantages of ViV procedure in this new modified surgical valve must be proven in the future.


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