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Objectives The aim of this analysis was to evaluate outcomes following transcatheter reintervention for degenerated transcatheter pulmonary valves (TPVs). Background TPV replacement (TPVR) with the Melody valve demonstrated sustained relief of right ventricular outflow tract (RVOT) obstruction and pulmonary regurgitation. Methods All patients who underwent TPVR with a Melody valve as part of 3 Medtronic-sponsored prospective multicenter studies were included. Transcatheter reinterventions included balloon dilation of the previously implanted Melody valve, placement of a bare-metal stent within the implanted TPV, or placement of a new TPV in the RVOT (TPV-in-TPV). Indications for reintervention, decisions to reintervene, and the method of reintervention were at physician discretion. All patients provided written informed consent to participate in the trials, and each trial was approved by local or central Institutional Review Boards or ethics committees at participating sites. Results A total of 309 patients who underwent TPVR were discharged from the implantation hospitalization with Melody valves in place. Transcatheter reintervention on the TPV was performed in 46 patients. The first transcatheter reintervention consisted of TPV-in-TPV in 28 patients (median 6.9 years [quartile 1 to quartile 3: 5.2 to 7.8 years] after TPVR), simple balloon dilation of the implanted Melody valve in 17 (median 4.9 years [quartile 1 to quartile 3: 4.0 to 6.0 years] after TPVR), and bare-metal stent placement alone in 1 (4.4 years after TPVR). There were no major procedural complications. Overall, 4-year freedom from explant and from any later RVOT reintervention after the first reintervention were 83% and 60%, respectively. Freedom from repeat RVOT reintervention was longer in patients undergoing TPV-in-TPV than balloon dilation (71% vs. 46% at 4 years; p = 0.027). Conclusions TPV-in-TPV can be an effective and durable treatment for Melody valve dysfunction. Although balloon dilation of the Melody valve was also acutely effective at reducing RVOT obstruction, the durability of this therapy was limited in this cohort compared with TPV-in-TPV.

A 13-year-old girl with repaired truncus arteriosus and single right coronary artery presented with progressive exertional dyspnea for 1 year. She underwent initial cardiac repair at 6 weeks of age, followed by 2 subsequent right ventricle to pulmonary artery (RV-PA) conduit replacement surgeries

Objectives This study compares 30-day, 1-year, and 3-year echocardiographic findings and clinical outcomes of transcatheter pulmonary valve-in-valve replacement (TPVR) and repeat surgical pulmonary valve replacement (SPVR). Background In patients with adult congenital heart disease and previous pulmonary valve replacement (PVR) who require redo PVR, it is unclear whether TPVR or repeat SPVR is the preferred strategy. Methods We retrospectively identified 66 patients (TPVR, n = 36; SPVR, n = 30) with bioprosthetic pulmonary valves (PVs) who underwent either TPVR or repeat SPVR at Emory Healthcare from January 2007 to August 2017. Results The TPVR cohort had fewer men and more patients with baseline New York Heart Association (NYHA) functional class III or IV. There was no difference in mortality, cardiovascular readmission, or post-procedural PV reintervention at 30 days, 1 year, or 3 years. Post-procedural echocardiographic findings showed no difference in mean PV gradients between the TPVR and SPVR groups at 30 days, 1 year, or 3 years. In the TPVR cohort, there was less right ventricular dysfunction at 30 days (2.9% vs. 46.7%; p Conclusions In patients with bioprosthetic PV dysfunction who underwent either TPVR or SPVR, there was no difference in mortality, cardiovascular readmission, or repeat PV intervention at 30 days, 1 year, or 3 years. Additionally, TPVR and SPVR had similar intermediate-term PV longevity, with no difference in PV gradients or PVR. The TPVR cohort also had less right ventricular dysfunction at 30 days despite a higher baseline NYHA functional classification. These intermediate-term results suggest that TPVR may be an attractive alternative to SPVR in patients with previous bioprosthetic surgical PVs.

Objectives: This study sought to determine the safety and feasibility of transcatheter pulmonary valve replacement (TPVR) using the Melody valve in native (nonconduit) right ventricular out...

Objectives This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance. Background The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement. Methods Three sites participated in this first Food and Drug Administration–approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported. Results Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg). Conclusions In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.

Objectives This study sought to evaluate the incidence of and risk factors for conduit and stent-related outcomes following transcatheter pulmonary valve replacement (TPVR). Background Stent fracture (SF) and right ventricular outflow tract (RVOT) reintervention are among the most important adverse outcomes after TPVR using the Melody valve (Medtronic, Minneapolis, Minnesota). The conduit environment and conduit preparation practices vary among patients who undergo TPVR. Methods Data from 3 prospective Melody valve multicenter studies were pooled and analyzed. All patients who had successful implant of a Melody valve that was present at hospital discharge comprised the study cohort; patients who had TPVR into a stentless conduit comprised the analysis cohort. SF was diagnosed using protocol-specified or clinical fluoroscopy or radiography, and classified as major or minor. Results Of 358 patients who underwent catheterization with intent to perform TPVR, 309 were discharged with the Melody valve in place (study cohort) of which 251 patients had TPVR into a stentless conduit (analysis cohort). Median follow-up was 5 years. New pre-stents were placed in 68% of patients with a stentless conduit, and 22% received multiple pre-stents. At 3 years, freedom from any SF and major SF was 74 ± 3% and 85 ± 2%, respectively, and freedom from RVOT reintervention was 85 ± 2%. New pre-stents were associated with longer freedom from SF and RVOT reintervention than was no pre-stent. Conclusions Risks of SF and reintervention after TPVR with a Melody valve were reduced by implantation of pre-stents, which has become standard practice. This study supports pre-stenting as an important component of TPVR therapy.

Objectives This study sought to investigate the impact of tricuspid regurgitation (TR) on right ventricular function after percutaneous pulmonary valve implantation (PPVI). Background PPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Recovery of the right ventricle has been described after PPVI for patients with pulmonary stenosis and for those with pulmonary regurgitation. Additional TR enforces RV dysfunction by supplemental volume overload. Limited data are available on the potential of the right ventricle to recover in such a specific hemodynamic situation. Methods In a matched cohort study, we compared patients who underwent PPVI with additional TR with those without TR. Results The degree of TR improved in 83% of the patients. In our patients (n = 36) exercise capacity and right ventricular volume index improved similarly 6 months after PPVI in patients with and without important TR. None of them had significant TR in the long-term follow-up of median 78 months. Conclusions PPVI improves not only RV-PA-conduit dysfunction, but also concomitant TR. In patients with a dysfunctional RV-PA conduit and TR, the decision whether to fix TR should be postponed after PPVI.

Transcatheter electrosurgery is used for planned caval-aortic access and to facilitate transcatheter mitral and aortic valve implantation [(1,2)][1]. It has been used for percutaneous cavopulmonary shunt [(3)][2]. This technique can also be used for unplanned clinical rescue; we describe re

Georgiev et al. ([1][1]) reported that long-term follow-up in 226 patients who underwent transcatheter pulmonary valve replacement (TPVR) showed excellent outcomes. However, of the 17 patients (7.2%) requiring valve replacement during the study, 10 had known infectious endocarditis (IE), and

We would like to thank Dr. Jian-Fang Ren and colleagues for their interest in our recently published work on the long-term outcomes after percutaneous pulmonary valve implantation (PPVI) ([1][1]). We fully agree that great suspicion for infective endocarditis (IE) is needed in patients after PPVI

Objectives This study sought to review the outcomes for the Sapien and Sapien XT valves (Edwards Lifesciences, Irvine, California) for percutaneous pulmonary valve implantation (PPVI). Background PPVI has emerged as a viable alternative to surgery in patients with right ventricular (RV) outflow tract dysfunction. Limited data are available for the Sapien and Sapien XT valves in this setting. Methods Retrospective analysis was performed for all patients to have undergone PPVI using the Edwards Sapien system at a large quaternary center. Results Twenty-five patients (70% male, mean age 34 ± 8.9 years) were identified. Primary underlying diagnosis was tetralogy of Fallot (n = 15), Ross procedure (n = 5), and other (n = 5). RV outflow tract characteristics included: biological valve (n = 16) and homograft (n = 9). Technical success was 96%. One patient required elective surgical pulmonary valve replacement for a high residual gradient. Pre-stenting was performed in all cases (52% covered stents). Valve sizes were 23 mm (n = 8), 26 mm (n = 15), and 29 mm (n = 2). Procedural hemodynamics revealed a decrease in the mean RV-to-systemic pressure ratio from 0.64 to 0.36 (p Conclusions The Edwards Sapien system is a viable and durable option for PPVI in this single-center study.

[Figure][1] Since its inception nearly 2 decades ago, transcatheter pulmonary valve replacement (TPVR) has brought on a paradigm shift in the approach to patients with significant right ventricle–to–pulmonary artery (RV-PA) conduit dysfunction [(1)][2]. Excellent immediate-, short

Objectives The aim of this review is to describe the incidence, features, predisposing factors, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter valve replacement (TVR). Background Very few data exist on PVE after TVR. Methods Studies published between 2000 and 2013 regarding PVE in patients with transcatheter aortic valve replacement (TAVR) or transcatheter pulmonary valve replacement (TPVR) were identified through a systematic electronic search. Results A total of 28 publications describing 60 patients (32 TAVRs, 28 TPVRs) were identified. Most TAVR patients (66% male, 80 ± 7 years of age) had a very high-risk profile (mean logistic EuroSCORE: 30.4 ± 14.0%). In TPVR patients (90% male, 19 ± 6 years of age), PVE was more frequent in the stenotic conduit/valve (61%). The median time between TVR and infective endocarditis was 5 months (interquartile range: 2 to 9 months). Typical microorganisms were mostly found with a higher incidence of enterococci after TAVR (34.4%), and Staphylococcus aureus after TPVR (29.4%). As many as 60% of the TAVR-PVE patients were managed medically despite related complications such as local extension, embolism, and heart failure in more than 50% of patients. The valve explantation rate was 57% and 23% in balloon- and self-expandable valves, respectively. In-hospital mortality for TAVR-PVE was 34.4%. Most TPVR-PVE patients (75%) were managed surgically, and in-hospital mortality was 7.1%. Conclusions Most cases of PVE post-TVR involved male patients, with a very high-risk profile (TAVR) or underlying stenotic conduit/valve (TPVR). Typical, but different, microorganisms of PVE were involved in one-half of the TAVR and TPVR cases. Most TPVR-PVE patients were managed surgically as opposed to TAVR patients, and the mortality rate was high, especially in the TAVR cohort.

For patients with significant congenital heart disease, the right ventricular outflow tract (RVOT) represents one of the most frequent areas prone to surgical and transcatheter modification. Surgical reconstruction (transannular patches, right ventricle to pulmonary artery conduits, bioprosthetic

This study sought to investigate the effects of exercise on the right ventricle in patients with an obstructed right ventricular outflow tract (RVOT) conduit before and after transcatheter pulmonary valve replacement (TPVR).Conventionally, assessment of the right ventricle in congenital heart disease patients with dysfunctional RVOT conduits is performed at rest. However, this does not reflect dynamic exercise changes.Exercise stress echocardiography (ESE) before and 6 months after TPVR was performed. ESE protocol included measurement of rest and immediate post-exercise RVOT maximal instantaneous gradients (MIGs), right ventricular (RV) systolic pressure, 2-dimensional fractional area change, and global longitudinal strain (GLS).Twenty patients with RVOT conduit obstruction (median age, 18 years), the majority (n = 14) with tetralogy of Fallot, completed the study. Pre-TPVR, the median resting MIG across the RVOT was 53 mm Hg (23 to 95 mm Hg) and increased to 93 mm Hg (49 to 156 mm Hg; p0.001) with exercise. After TPVR, the median MIG at rest was 26 mm Hg (6 to 41 mm Hg, and after exercise, it was 45 mm Hg (9 to 102 mm Hg), both significantly lower than before TPVR (p ≤ 0.001), but there was still a substantial increase in gradient with exercise in many patients. The RV fractional area change, RV GLS, and left ventricular GLS, both at rest and after exercise, were significantly greater after TPVR than before. A greater pre-TPVR exercise-related increase in RV function was associated with improvement in peak Vo2 after TPVR (p = 0.01).In patients with obstructed RVOT conduits, TPVR resulted in significant improvement in conduit stenosis and RV function at both rest and at peak exercise and in exercise cardiopulmonary function. The ability to augment RV function at peak exercise before TPVR was associated with improved exercise capacity 6 months after TPVR.

Trans-catheter pulmonary valve implantation (TPVI) has become a less-invasive alternative to those at higher risk for surgical pulmonary valve replacement. Recent publications have raised concern with increased incidence of infective endocarditis (IE) following TPVI. We evaluated our cohort of