Functional improvement following direct interventional leaflet repair of severe tricuspid regurgitation

Abstract

Aims: Several new percutaneous tricuspid repair systems have recently been introduced as new treatment options for severe tricuspid regurgitation (TR). Clinical improvement following percutaneous tricuspid valve leaflet repair has been demonstrated by recent studies. A possible impact on exercise capacity has not yet been reported.

Methods and results: Eleven patients with at least severe TR and successful tricuspid leaflet repair using the PASCAL Ace implant at our cardiology department were included in this analysis. All patients suffered from symptomatic right-sided heart failure with compromised exercise capacity. Cardiopulmonary exercise testing (CPET), clinical, laboratory, and echocardiographic parameters were assessed at baseline and 3 months follow-up. The primary endpoint was the change in maximal oxygen consumption [VO₂ max (mL/(min*kg))] at 3 months follow-up. Secondary endpoints included improvement in TR, cardiac biomarkers, and other clinical outcomes. TR severity at 3 months follow-up post-PASCAL Ace implantation was significantly lower than at baseline (P = 0.004). Cardiac biomarkers including high-sensitivity troponin T and N-terminal pro-brain natriuretic peptide as well as right ventricular diameter improved slightly without reaching statistical significance (P = 0.89, P = 0.32, and P = 0.06, respectively). PASCAL Ace implantation resulted in a significant improvement in cardiopulmonary exercise capacity at 3 months follow-up compared with baseline. Mean VO₂ max improved from 9.5 ± 2.8 to 11.4 ± 3.4 mL/(min*kg) (P = 0.006), VO₂ max per cent predicted from 42 ± 12% to 50 ± 15% (P = 0.004), peak oxygen uptake from 703 ± 175 to 826 ± 198 mL/min (P = 0.004), and O₂ pulse per cent predicted from 67 ± 21% to 81 ± 25% (P = 0.011). Other CPET-related outcomes did not show any significant change over time.

Conclusions: In this single-centre retrospective analysis, direct tricuspid valve leaflet repair using the transcatheter PASCAL Ace implant system was associated with a reduced TR severity and improved cardiopulmonary exercise capacity.

Keywords: Cardiopulmonary exercise testing; Heart failure; Percutaneous valve repair; Tricuspid valve repair.

Figure 1

Patient flow. CPET, cardiopulmonary exercise testing.

Figure 2

Tricuspid regurgitation grade at baseline and 3 months follow‐up. Tricuspid regurgitation is displayed according to the newly proposed five‐level grading system. TR, tricuspid regurgitation.

Figure 3

Changes in cardiopulmonary exercise testing. Displayed are the results of cardiopulmonary exercise testing for peak oxygen uptake‐related outcomes at baseline and 3 months follow‐up. Predicted values were estimated by a gender‐adjusted, age‐adjusted, and height‐adjusted and protocol‐specific formula. Peak oxygen pulse was calculated as peak oxygen consumption divided by peak heart rate and expressed as per cent of predicted value. P‐values are the result of a Wilcoxon signed rank test between baseline and 3 months follow‐up. O₂ pulse, peak oxygen pulse; VO₂ max, maximal oxygen consumption; VO₂ peak, peak oxygen consumption.