Transcatheter Pulmonary Valve Replacement In Patients Research Articles

Early Outcomes of Pulmonary Valve Replacement With the Edwards Inspiris Resilia Pericardial Bioprosthesis.

Controversy regarding the optimal pulmonary valve substitute remains, with no approved surgical valve for pulmonary valve replacement (PVR). Furthermore, unfavorable anatomy often precludes transcatheter PVR in patients with congenital heart disease. We therefore sought to evaluate the feasibility of the Edwards Inspiris pericardial aortic bioprosthesis in the pulmonary position in pediatric and adult patients requiring PVR. Data from consecutive patients who underwent PVR from February 2019 to February 2021 at our institution were retrospectively reviewed. Postoperative adverse events included paravalvular or transvalvular leak, endocarditis, explant, thromboembolism, valve thrombosis, valve-related bleeding, hemolysis, and structural valve degeneration. Progression of valve gradients was assessed from discharge to 30 days and one year. Of 24 patients with median age of 26 years (interquartile range [IQR]: 17-33; range: 4-60 years), 22 (91.7%) patients had previously undergone tetralogy of Fallot repair and 2 (8.3%) patients had undergone double-outlet right ventricle repair in the neonatal period or infancy. All patients had at least mild right ventricular (RV) dilatation (median RV end-diastolic volume index 161.4, IQR: 152.3-183.5 mL/m2) and at least moderate pulmonary insufficiency (95.8%) or stenosis (8.3%). Median cardiopulmonary bypass and cross-clamp times were 71 (IQR: 63-101) min and 66 (IQR: 60-114) min, respectively. At a median postoperative follow-up of 2.5 years (IQR: 1.4-2.6; range: 1.0-3.0 years), there were no mortalities, valve-related reoperations, or adverse events. Postoperative valve gradients and the severity of pulmonary regurgitation did not change significantly over time. At short-term follow-up, the bioprosthesis in this study demonstrated excellent safety and effectiveness for PVR. Further studies with longer follow-up are warranted.

Pulmonary Artery Pseudoaneurysm After Transcatheter Pulmonary Valve Replacement, a Novel Approach for Complication Management

Transcatheter pulmonary valve replacement (TPVR) using the SAPIEN 3 (Edwards Lifesciences) transcatheter heart valve is increasingly used to treat patients with right ventricular outflow tract (RVOT) dysfunction. Yet, TPVR in patients with calcified RVOT homografts remains challenging and carries a high risk of complications. We present a case of a dysfunctional 24-mm calcified RVOT homograft in a patient with a history of truncus arteriosus and hypoplastic branch pulmonary arteries.

Edwards SAPIEN XT Transcatheter Pulmonary Valve Implantation: 5-year follow-up in a French Registry

This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. The primary efficacy outcome was met for 87,1% patients after a mean follow-up of 55 ± 21 months, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8–95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular insufficiency was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01–2.00%). At 5 years freedom from infective endocarditis was 98.4% (95% CI 89.1–99.8%) ( Fig. 1 ). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. This study confirms the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

Edwards SAPIEN XT transcatheter pulmonary valve implantation: 5‐year follow‐up in a French Registry

This study sought to investigate patient intermediate-term outcomes after transcatheter pulmonary valve replacement (TPVR) with Edwards SAPIEN valve. The Edwards SAPIEN valve, initially designed for percutaneous aortic valve replacement, has been approved for TPVR in patients with dysfunctional right ventricular outflow tracts (RVOT), but only short-term follow-up has been reported. From 2011 to 2016, 62 patients undergoing successful TPVR using the SAPIEN XT valve were consecutively included into the study. Primary efficacy and safety endpoints were defined as freedom from valve-reintervention and freedom from infective endocarditis at last follow-up, respectively. The primary efficacy outcome was met for 87.1% patients after a mean follow-up of 4.6 ± 1.8 years, corresponding to a freedom of reintervention at 5 years of 89% (95% CI 74.8-95.6%). Reinterventions were exclusively due to recurrent obstruction, no significant valvular regurgitation was observed. One case of infective endocarditis was reported, corresponding to a rate of 0.35% per patient-year (95% CI 0.01-2.00%). At 5 years, freedom from infective endocarditis was 98.4% (95% CI 89.1-99.8%). Six patients died or were transplanted due to advanced cardiac failure, without relationship with TPVR. In univariate analysis, reintervention was associated with young age, a smaller tube-graft, a higher pulmonary valve gradient after the procedure and a ratio of largest implanted stent diameter to invasive balloon conduit diameter over 1.35. This study documents the mid-term safety and efficacy of the Edwards SAPIEN XT valve in patients with dysfunctional RVOT, and identifies a patient profile associated with an uncertain benefit-risk balance.

Initial results from the off-label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi-institutional experience.

To describe a multi-center experience of percutaneous transcatheter pulmonary valve replacement (TPVR) using the Edwards Sapien S3 Valve. Off-label use of the Sapien S3 valve can allow for TPVR in patients with congenital heart disease (CHD) and large diameter dysfunctional right ventricular outflow tract (RVOT). The initial experience at five centers with the SAPIEN S3 valve for TPVR is presented with a focus on procedural techniques, success, complications, and efficacy. A retrospective review was performed of all patients with CHD and dysfunctional RVOT who underwent TPVR using Sapien S3 valve. Imaging data, procedural elements, and clinical follow-up data were collected to evaluate acute and short-term results. A total of 50 patients underwent percutaneous placement of the Sapien S3 in the pulmonary position. Of these, 38 were placed into "native RVOTs", measuring 24-32 mm in diameter, as assessed by compliant balloon sizing. In all cases, the valve was implanted after introduction and there were no cases of valve embolization. On follow up (range 1-9 months, median 3 months), no patients had significant obstruction or regurgitation through or around the valve requiring intervention. There were no procedural deaths. Major complications included severe aortic compression (n = 1) and tricuspid valve (TV) injury related to valve placement (n = 2) and prestenting (n = 1). TPVR in patients with large diameter dysfunctional RVOTs can be effectively performed with the Sapien S3. All procedures were technically successful with no embolizations, no perivalvular leaks, and excellent short-term valve function. Tricuspid valve injury from implantation of an uncovered valve was a serious procedural complication.

Transcatheter Versus Surgical Pulmonary Valve Replacement in Repaired Tetralogy of Fallot

Transcatheter pulmonary valve replacement (TC-PVR) is an alternative to surgical PVR (S-PVR) in repaired Tetralogy of Fallot (TOF). The purpose of this study is to compare in-hospital outcomes, hospital costs, and projected 5-year total costs of S-PVR to TC-PVR in patients with repaired TOF. We performed a multicenter, retrospective cohort study of children and adults with TOF ≥ 8 years of age who underwent PVR from January 1, 2010 to December 31, 2016 at 46 centers contributing to the Pediatric Health Information Systems database. Baseline characteristics, in-hospital outcomes, and costs were compared between the two groups. Projected 5-year costs were calculated by combining cost data with published reintervention rates. A total of 194 TC-PVR and 1,072 S-PVR were performed. The baseline characteristics of the TC-PVR and S-PVR groups were not significantly different with the exception of greater age in the TC-PVR group (median age of 17 years vs 15 years, p value <0.001). Discharge mortality, hospital charges and estimated cost, surgical complication rates, and acute kidney failure were not significantly different between the groups. Intensive care unit use, intensive care unit length of stay (LOS), mechanical ventilation use, extracorporeal membrane oxygenation use, and total LOS were lower with TC-PVR than S-PVR. Projected 5-year costs were greater with TC-PVR compared with S-PVR ($64,762 vs $56,536) due to the cost of the transcatheter pulmonary valve and higher reintervention rates. In conclusion, despite longer LOS and greater in-hospital resource utilization for patients with TOF who underwent S-PVR compared with TC-PVR, mortality, and in-hospital costs are the same, and projected 5-year costs are less.

Acute and Midterm Outcomes of Transcatheter Pulmonary Valve Replacement for Treatment of Dysfunctional Left Ventricular Outflow Tract Conduits in Patients With Aortopulmonary Transposition and a Systemic Right Ventricle.

Transcatheter pulmonary valve replacement (TPVR) is an established therapy for dysfunctional right ventricular (RV) outflow tract conduits. TPVR in patients with congenitally corrected transposition of the great arteries, subpulmonary left ventricle, and left ventricular outflow tract (LVOT) conduit dysfunction has not been studied. Unique anatomic and physiological aspects of this population may contribute to distinct risks and outcomes. Across 10 US centers, 27 patients with a dysfunctional LVOT conduit were evaluated in the catheterization laboratory between December 2008 and August 2015 with the intent to perform TPVR. TPVR was successful in 23 patients (85%). Five serious adverse events occurred in 4 cases (15%), including pulmonary hemorrhage, hypotension requiring vasoactive support, conduit disruption requiring covered stent (n=2), and acute RV dysfunction with flash pulmonary edema. After TPVR, the LVOT peak systolic ejection gradient decreased from median of 35 to 17 mm Hg (P<0.001); pulmonary insufficiency was trivial/none in all but 1 patient, where it was mild. Worsening of systemic RV dysfunction or tricuspid regurgitation was seen in 12 patients (57%) and was associated with a significantly lower post-TPVR LVOT peak systolic ejection gradient (median 17 versus 21 mm Hg; P=0.02) and higher post-TPVR RV sphericity index (median 0.88 versus 0.52; P=0.004). Post-TPVR, there were 2 late deaths because of RV failure and 1 cardiac transplantation because of progressive RV dysfunction and tricuspid regurgitation. TPVR in dysfunctional LVOT conduits is feasible but associated with an important rate of TPV nonimplantation and procedural serious adverse events. Worsening systemic RV function and tricuspid regurgitation may develop after LVOT TPVR.

Aortic root compression during transcatheter pulmonary valve replacement.

To describe the incidence of aortic root compression (ARC) during transcatheter pulmonary valve replacement (TPVR). ARC can occur during balloon sizing of the right ventricular outflow tract (RVOT) or during coronary compression testing (BS/CCT) prior to TPVR, causing aortic valve dysfunction and/or root distortion with or without coronary compression. This has limited the use of TPVR in patients with native RVOTs, including those with a transannular patch (TAP). The characteristics of this patient cohort have not previously been described. A retrospective review was performed of all patients with congenital heart disease who presented for TPVR at UCLA from 2010 to 2015. ARC characteristics during BS/CCT were noted for all relevant cases. Inclusion criteria were met by 174 patients. ARC occurred in 16 patients (9%), of whom 14 had Tetralogy of Fallot with a native/TAP RVOT (14/42, 33%, of all native/TAP patients). Five ARC patients also had concomitant coronary artery compression. Isolated coronary compression occurred in six patients. Two patients underwent successful TPVR despite ARC by implanting the valves in the distal RVOT. One patient required surgical PVR and Sapien valve explantation after TPVR caused severe ARC. The majority of cases of ARC occur in patients with native/TAP RVOTs. ARC during BS/CCT may identify those at risk for ARC following TPVR. While ARC is a real phenomenon, it is unclear if it can be accurately predicted, what its clinical significance will be and how it is best avoided. Further studies are necessary to answer these questions. © 2016 Wiley Periodicals, Inc.