AimsWe aimed to determine whether treatment with sildenafil improves outcomes of patients with persistent pulmonary hypertension (PH) after correction of valvular heart disease (VHD).Methods and resultsThe sildenafil for improving outcomes after valvular correction (SIOVAC) study was a multricentric, randomized, parallel, and placebo-controlled trial that enrolled stable adults with mean pulmonary artery pressure ≥ 30 mmHg who had undergone a successful valve replacement or repair procedure at least 1 year before inclusion. We assigned 200 patients to receive sildenafil (40 mg three times daily, n = 104) or placebo (n = 96) for 6 months. The primary endpoint was the composite clinical score combining death, hospital admission for heart failure (HF), change in functional class, and patient global self-assessment. Only 27 patients receiving sildenafil improved their composite clinical score, as compared with 44 patients receiving placebo; in contrast 33 patients in the sildenafil group worsened their composite score, as compared with 14 in the placebo group [odds ratio 0.39; 95% confidence interval (CI) 0.22–0.67; P < 0.001]. The Kaplan–Meier estimates for survival without admission due to HF were 0.76 and 0.86 in the sildenafil and placebo groups, respectively (hazard ratio 2.0, 95% CI = 1.0–4.0; log-rank P = 0.044). Changes in 6-min walk test distance, natriuretic peptides, and Doppler-derived systolic pulmonary pressure were similar in both groups.ConclusionTreatment with sildenafil in patients with persistent PH after successfully corrected VHD is associated to worse clinical outcomes than placebo. Off-label usage of sildenafil for treating this source of left heart disease PH should be avoided.The trial is registered with ClinicalTrials.gov, number NCT00862043.

This study compares the implantation characteristics and the hemodynamic performance of the new Carpentier-Edwards Perimount Magna (CEPM) xenograft with those of the standard Perimount (CEPS) valve in the aortic position. Eighty consecutive patients surviving an aortic valve replacement with either the CEPS valve (n=40) or the CEPM prosthesis (n=40) in the supra-annular position were retrospectively reviewed. One year follow-up was complete and hemodynamic performance assessed by Doppler echocardiography. The mean valve size implanted was 21.3+/-1.7 mm (CEPS) vs. 22.2+/-1.8 mm (CEPM). The average mean pressure gradient was 13.6+/-5.1 mmHg in the CEPS group and 9.6+/-3.3 mmHg in the CEPM group (P<0.0001). Mean and peak gradients were slightly lower and the effective orifice areas (EOA) were larger for the Magna prosthesis than for the comparable standard valves: 19 mm (1.58+/-0.2 vs. 1.28+/-0.1 cm(2)), 21 mm (1.90+/-0.4 vs. 1.69+/-0.4 cm(2)), 23 mm (2.07+/-0.3 vs. 1.86+/-0.3 cm(2)), 25 mm (2.30+/-0.1 vs. 1.89+/-0.5 cm(2)). The average indexed EOA was statistically different between groups (CEPS 0.98+/-0.21 cm(2)/m(2) vs. CEPM 1.20+/-0.25 cm(2)/m(2)). Patient-prosthesis mismatch (indexed EOA

We compared the hemodynamic performance of the Edwards Perimount Magna (EPM) and the Medtronic Mosaic (MM) bioprostheses according to the patient aortic annulus diameter (AAD). Eighty-six patients undergoing aortic valve replacement were prospectively assigned to receive either an EPM-valve (n=43) or an MM-bioprosthesis (n=43). Randomization was performed after measuring the AAD and patients were grouped according to their AAD: <22 mm (n=12), 22-23 mm (n=31) and >23 mm (n=43). Echocardiographic assessment was performed one year postoperatively. The mean AAD (EPM 23.9+/-2.1 mm vs. MM 23.6+/-2.3 mm) and mean valve size implanted (EPM 22.6+/-2.1 mm vs. MM 23.3+/-2.1 mm) were comparable in both groups. The EPM-group showed significantly lower mean gradient (EPM 10.2+/-3.2 mmHg vs. MM 17.1+/-8.2 mmHg) and larger effective orifice area (EOA) (EPM 1.99+/-0.4 cm(2) vs. MM 1.69+/-0.4 cm(2), P<0.0001). The EPM-valve was superior with respect to mean pressure gradient and EOA in all AAD. This difference was statistically significant in AAD of 22-23 mm (EPM 9.6+/-3.0 mmHg vs. MM 18.2+/-8.6 mmHg; EPM 1.82+/-0.3 cm (2) vs. MM 1.51+/-0.2 cm (2)) and >23 mm (EPM 9.9+/-3.1 mmHg vs. MM 14.2+/-5.6 mmHg; EPM 2.18+/-0.4 cm(2) vs. MM 1.94+/-0.5 cm(2)). Patient-prosthesis mismatch was present in 26.8% (MM) vs. 6.9% (EPM) of the patients (P=0.01). When the same AAD is taken as a reference, the EPM-valve was hemodynamically superior to the MM-bioprosthesis. The EPM-prosthesis significantly reduced the incidence of PPM.

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Background The determinants and consequences of pulmonary hypertension after successfully corrected valvular heart disease remain poorly understood. We aim to clarify the hemodynamic bases and risk factors for mortality in patients with this condition. Methods and Results We analyzed long‐term follow‐up data of 222 patients with pulmonary hypertension and valvular heart disease successfully corrected at least 1 year before enrollment who had undergone comprehensive hemodynamic and imaging characterization as per the SIOVAC (Sildenafil for Improving Outcomes After Valvular Correction) clinical trial. Median (interquartile range) mean pulmonary pressure was 37 mm Hg (32–44 mm Hg) and pulmonary artery wedge pressure was 23 mm Hg (18–26 mm Hg). Most patients were classified either as having combined precapillary and postcapillary or isolated postcapillary pulmonary hypertension. After a median follow‐up of 4.5 years, 91 deaths accounted for 4.21 higher‐than‐expected mortality in the age‐matched population. Risk factors for mortality were male sex, older age, diabetes mellitus, World Health Organization functional class III and higher pulmonary vascular resistance—either measured by catheterization or approximated from ultrasound data. Higher pulmonary vascular resistance was related to diabetes mellitus and smaller residual aortic and mitral valve areas. In turn, the latter correlated with prosthetic nominal size. Six‐month changes in the composite clinical score and in the 6‐minute walk test distance were related to survival. Conclusions Persistent valvular heart disease–pulmonary hypertension is an ominous disease that is almost universally associated with elevated pulmonary artery wedge pressure. Pulmonary vascular resistance is a major determinant of mortality in this condition and is related to diabetes mellitus and the residual effective area of the corrected valve. These findings have important implications for individualizing valve correction procedures. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00862043.