Percutaneous pulmonary valve implantation in patients with right ventricular outflow tract dysfunction: a systematic review and meta-analysis

Abstract

Background: Pulmonary valve replacement is required for patients with right ventricular outflow tract (RVOT) dysfunction. Surgical and percutaneous pulmonary valve replacement are the treatment options. Percutaneous pulmonary valve implantation (PPVI) provides a less-invasive therapy for patients. The aim of this study was to evaluate the effectiveness and safety of PPVI and the optimal time for implantation. Methods: We searched PubMed, EMBASE, Clinical Trial , and Google Scholar databases covering the period until May 2018. The primary effectiveness endpoint was the mean RVOT gradient; the secondary endpoints were the pulmonary regurgitation fraction, left and right ventricular end-diastolic and systolic volume indexes, and left ventricular ejection fraction. The safety endpoints were the complication rates. Results: A total of 20 studies with 1246 participants enrolled were conducted. The RVOT gradient decreased significantly [weighted mean difference (WMD) = −19.63 mmHg; 95% confidence interval (CI): −21.15, −18.11; p < 0.001]. The right ventricular end-diastolic volume index (RVEDVi) was improved (WMD = −17.59 ml/m²; 95% CI: −20.93, −14.24; p < 0.001), but patients with a preoperative RVEDVi >140 ml/m² did not reach the normal size. Pulmonary regurgitation fraction (PRF) was notably decreased (WMD = −26.27%, 95% CI: −34.29, −18.25; p < 0.001). The procedure success rate was 99% (95% CI: 98–99), with a stent fracture rate of 5% (95% CI: 4–6), the pooled infective endocarditis rate was 2% (95% CI: 1–4), and the incidence of reintervention was 5% (95% CI: 4–6). Conclusions: In patients with RVOT dysfunction, PPVI can relieve right ventricular remodeling, improving hemodynamic and clinical outcomes.

Outcomes of Venus P-valve for dysfunctional right ventricular outflow tracts from Indian Venus P-valve database

“…Early endocarditis after Venus P-valve recorded in 7% of patients in the Chinese study was comparable to an annual risk of 2% in the pooled analysis after Melody valve implantation. [ 12 29 ] In the Chinese study, one mortality and another patient needing surgery among four patients with infective endocarditis is of concern and needs meticulous patient education about dental hygiene and antibiotic prophylaxis. [ 14 30 ] Early withdrawal of aspirin after 6 months in the Chinese study was associated with pulmonary thromboembolism needing urokinase.…”

Early Outcomes of Percutaneous Pulmonary Valve Implantation with Pulsta and Melody Valves: The First Report from Korea

“…As a result, only one case of type 1 fracture was observed. The efforts made to prevent and reduce the occurrence of fractures of hemodynamically important valves are likely to yield even better long-term outcomes than those documented in previous studies [ 5 , 6 , 7 , 32 ].…”

“…Since its first implementation in 2000 by Bonhoeffer et al [ 3 ] and subsequent approval by the Food and Drug Administration in 2010, PPVI using the Melody and Edwards SAPIEN valves has been performed in more than 13,000 patients with postoperative RVOT dysfunction worldwide. Indeed, surgically implanted RV-to-PA valves and conduits are being replaced by balloon-expandable PPVIs, which showed excellent long-term outcome by several reports [ 5 , 6 , 7 , 8 , 9 , 10 ]. However, recent advances such as valve-in-valve replacement within dysfunctional bioprosthetic valves (BPVs) and smaller conduits in smaller patients (<30 kg), or recognized factors for a better outcome such as the routine use of pre-stenting and the avoidance of high post-interventional gradients across RVOT, are not uniformly applied to existing studies.…”

Patient Screening for Self-Expanding Percutaneous Pulmonary Valves using Virtual Reality

“…The current practice for selection of suitable patients for these devices include the clinical criteria for pulmonary valve replacement iii and additional screening for “anatomic fit” . ECG gated cardiac computed tomography (CT) is performed, with the cardiac phase used for self-expanding TPVR evaluation depending on the valve type, as determined during the respective clinical trials (70% diastole for Harmony TPV and 30% systole for Alterra Adaptive PreStent™) iv .…”