Undergoing Transcatheter Pulmonary Valve Replacement Research Articles

Transcatheter Pulmonary Valve Replacement With the Harmony Valve in Patients Who Do Not Meet Recommended Oversizing Criteria on the Screening Perimeter Plot.

Anatomic selection for Harmony valve implant is determined with the aid of a screening report and perimeter plot (PP) that depicts the perimeter-derived radius along the right ventricular outflow tract (RVOT) and projects device oversizing. The PP provides an estimation of suitability for implant, but its sensitivity as a screening method is unknown. This study was performed to describe anatomic features and outcomes in patients who underwent Harmony TPV25 implant despite a PP that predicted inadequate oversizing. We reviewed RVOT anatomic features and measurements in patients who underwent transcatheter pulmonary valve replacement with the Harmony TPV25 device despite a PP that predicted inadequate oversizing. This study included 22 patients. There were no unsuccessful implants or adverse valve-related events. Anatomic features varied, but all patients fit into 1 of 3 anatomic types characterized by differences in RVOT dimensions. Type 1 patients (n=9) had a long RVOT with a choke point and a wide main pulmonary artery. Type 2 patients (n=6) had a short RVOT that was pyramidal in shape, with no choke point, and extensive main pulmonary artery lengthening/expansion during systole. Type 3 patients (n=7) had a short, bulbous main pulmonary artery with a choke point and an open pulmonary artery bifurcation. Transcatheter pulmonary valve replacement with the Harmony valve is feasible in some patients whose PP fit analysis predicts inadequate oversizing. All cases in this series fit into 1 of 3 anatomic patterns, which are not identified in the screening report. Implanters must review cases individually to assess the feasibility of the implant.

4D flow magnetic resonance imaging to assess right ventricular outflow tract in patients undergoing transcatheter pulmonary valve replacement

Introduction and objectivesMagnetic resonance imaging (MRI) including 4D flow is used before percutaneous pulmonary valve implantation (PPVI). As PPVI is limited by the size of the right ventricular outflow tract (RVOT), accurate sizing is needed to plan the intervention. The aim of this study was to compare different MRI modalities and invasive angiography to balloon sizing of RVOT. MethodsSingle-center prospective study of patients who underwent PPVI for isolated pulmonary regurgitation assessed by 4D flow MRI, 3D steady-state free precession/gradient echo (3D SSFP/GRE) and contrast magnetic resonance angiography. Balloon sizing was considered as the reference. ResultsA total of 23 adults were included (mean age, 38.4±12.5 years). Eighteen patients underwent successful primary PPVI. The average of the narrowest RVOT diameter was 25.4±4.3 mm by balloon sizing. Compared to balloon sizing, RVOT diameters were better correlated when estimated by systolic 4D flow MRI (r=0.89, P<.001) than by diastolic 4D flow MRI (r=0.71, P <.001), 3D contrast magnetic resonance angiography (r=0.73; P <.001) and 3D SSFP/GRE (r=0.50; P=.04) and was not significantly correlated when estimated by 2D in diastole and systole. The mean difference between systolic 4D flow MRI and balloon sizing was 0.2 mm (95%CI, –3.5 to 3.9 mm), whereas it was wider with other techniques. ConclusionsBeyond the quantification of pulmonary valve regurgitation, 4D flow allows accurate estimation of RVOT diameters, especially in systole, which is fundamental before planning PPVI.

Ventricular Arrhythmic Events After Transcatheter Pulmonary Valve Replacement in Adults with Repaired Tetralogy of Fallot.

Arrhythmias are a major cause of morbidity and mortality in repaired Tetralogy of Fallot (rTOF). However, predicting those at risk for life-threatening ventricular arrhythmias (VA) remains difficult. Many centers approach risk assessment at the time of surgical pulmonary valve intervention. Increasing numbers of patients have undergone transcatheter pulmonary valve replacement (TPVR), yet there are no studies evaluating VA in rTOF undergoing TPVR and the approach to risk assessment for these patients. A single center retrospective study was performed. The institutional interventional database was queried to identify all adults ≥ 18years of age with rTOF status who underwent TPVR from 2010 to 2019. A total of 81 patients with rTOF underwent TPVR from 2010 to 2019. Mean age at time of TPVR was 27 ± 13years; follow up after TPVR was 6.4 ± 3.1years. VA events occurred in 4 patients (5%). There was no significant difference in current era VA risk factors in rTOF patients between the VA event group and the non-VA event group. VA risk in this cohort of rTOF with TPVR was 5%, comparable to that reported in current era surgical cohort with similar follow up. Multi-center agreement on risk assessment protocol is needed for future studies.

Ventricular arrhythmias following balloon-expandable transcatheter pulmonary valve replacement in the native right ventricular outflow tract.

Ventricular arrhythmia incidence in children and adolescents undergoing transcatheter pulmonary valve replacement (TPVR) within the native right ventricular outflow tract (nRVOT) is unknown. We sought to describe the incidence, severity, and duration of ventricular arrhythmias and identify associated risk factors in this population. This was a retrospective cohort study of 78 patients <21 years of age who underwent TPVR within the nRVOT. Patients were excluded for pre-existing ventricular arrhythmia or antiarrhythmic use. Study variables includedsurgical history, valve replacement indication, valve type/size, and ventricular arrhythmia. Univariable logistic regression models were used to evaluate factors associated with ventricular arrhythmias, followed by subset analyses. Nonsustained ventricular arrhythmia occurred in 26/78 patients (33.3%). The median age at the procedure was 10.3 years (interquartle range [IQR]: 6.5, 12.8). Compared with other nRVOT types, surgical repair with transannular patch was protective against ventricular arrhythmia incidence: odds ratio (OR): 0.35 (95% confidence interval [CI], 0.13-0.95). Patient weight, valve type/size, number of prestents, and degree of stent extension into the RVOT were not associated with ventricular arrhythmia occurrence. Beta blocker was started in 16/26 (61.5%) patients with ventricular arrhythmia. One additional patient was lost to follow-up. The median beta blocker duration was 46 days (IQR 42, 102). Beta blocker was discontinued in 10 patients by 8-week follow-up and in the remaining four by 9 months. Though common after balloon-expandable TPVR within the nRVOT, ventricular arrhythmias were benign and transient. Antiarrhythmic medications were successfully discontinued in the majority at 6- to 8-week follow-up, and in all patients by 20 months.

Piggyback mounting for stent and valve deployment during percutaneous pulmonary valve implantation

We report our experience in simultaneously implanting multiple stents and valves mounted on a single balloon before and during transcatheter pulmonary valve placement. Heterogeneity and complexity of the right ventricular outflow tract(RVOT) may complicate stent deployment when preparing a landing zone for transcatheter pulmonary valve implantation. Retrospective analysis of patients from Children's Hospital of Colorado, USA; and Oslo University Hospital, Norway, undergoing transcatheter pulmonary valve replacement that had at least twostents mounted on a single balloon, deployed in the RVOT. Over a 42-month period, a total of 50 subjects from the two centers met inclusion criteria for the study. Subjects were predominantly male (58%), and the median age was 17 years (4-78 years). In six subjects (12%), there was need for prestenting with use of the double or triple stent piggyback technique. Forty subjects (80%) had a Melody ™ TPV implanted. In 45 cases (90%),one or more stents were mounted over the pulmonary valve using its delivery system, either the Ensemble for the Melody™ TPV or the Edwards Commander for the SAPIEN 3 THV. Thirty-sevensubjects (74%) had one stent mounted and eight subjects (16%) had two stents mounted over the pulmonary valve for simultaneous deployment. No complications related to this technique were reported. The piggyback technique aims to simplify and facilitate adequate conduit preparation and valve insertion by minimizing manipulation across the outflow tract and decreasing the risk of stent distortion, misalignment, and embolization.

Abstract 11700: Hemodynamic Impact of Severe Pulmonary Regurgitation in Patients With Right Ventricular Hypertension Secondary to Peripheral Pulmonary Arterial Stenosis

Introduction: Severe pulmonary regurgitation (PR) is a common sequela of surgery for dysfunctional right ventricular outflow tract (RVOT). Peripheral pulmonary arterial stenosis (PPS) is frequently associated with conotruncal anomalies like Tetralogy of Fallot. Whether severe PR, which increases the right ventricular stroke volume, worsens right ventricular hypertension (RVHTN) in patients with PPS has not been previously investigated. Hypothesis: In patients with RVH secondary to PPS, the abolishment of severe PR ameliorates the degree of RVH. Methods: Retrospective longitudinal study of patients with PPS and severe PR, who underwent transcatheter pulmonary valve replacement (TPVR) at Boston Children’s Hospital between 01/2016 and 12/2019. Patients were included if they met all 3 of the following criteria: (1) PPS, (2) RVHTN immediately before TPVR (defined as an RV to Ao systolic pressure ratio [RV/AO] of at least 0.5 after interventions on the RVOT/PPS and before TPVR), and (3) severe PR. Patients with missing data were excluded. Hemodynamic data were collected at baseline, before TPVR (following the interventions for PPS and on the RVOT), and after TPVR. Variables were analyzed using a repeated-measure non-parametric ANOVA (Friedman test). A post-hoc analysis with Dunn-Bonferroni adjustment was performed. Results: In the study period, 17 patients (median age 14.6 years, IQR 10.1-19.7) met the inclusion criteria and had available hemodynamic data. Right ventricle systolic pressure, RVOT gradient, and RV/AO changed significantly overtime (all p&lt;0.001). While there was no significant difference in RVOT gradient before and after TPVR, re-establishment of valve competence did result in a further significant drop in RV pressure (Table 1). Conclusion: In patients with RVHTN secondary to PPS and severe PR, reestablishment of pulmonary valve competence significantly decreases the degree of RV hypertension compared to RVOT/PPS interventions alone.

Utility of CT Angiography for the Prediction of Coronary Artery Compression in Patients Undergoing Transcatheter Pulmonary Valve Replacement.

We aimed to evaluate the utility of computed tomography angiography (CTA) for coronary compression (CC) prediction in patients with congenital heart disease undergoing balloon-expandable transcatheter pulmonary valve replacement (TPVR). Coronary compression is a serious complication of TPVR, but the value of preprocedural CTAs to assess CC risk is largely unexplored. In all, 586 patients underwent TPVR between January 2009 and July 2018. Adults with a pre-TPVR CTA and children with a CTA performed less than one year prior to TPVR were included. Patients with poor CTA image quality or with aborted cases due to reasons other than CC were excluded. Sixty-six patients were finally included. Cardiac anatomy was assessed via multiplanar reconstruction of CTAs. Coronary compression occurred in 9 (14%) of the 66 patients who underwent TPVR. Most CC cases (seven of nine) occurred in patients with conduits. Proximity of the right ventricular outflow tract (RVOT) landing zone to the coronary arteries and to the chest wall was a significant risk factor for compression (P < .001 and P = .019, respectively). Compression risk increased significantly if patients had an RVOT to coronary artery distance of ≤3 mm (P < .001) and an RVOT to chest wall distance of ≤8 mm (P = .026). Anomalous course of coronary arteries was another significant univariate risk factor (P = .003). Right ventricular outflow tract landing zone distance of ≤3 mm to a coronary artery, landing zone distance of ≤8 mm to the chest wall, and anomalous coronary arteries are associated with increased CC risk. Electrocardiogram gating may not be necessary if coronary arteries are opacified on CTAs. Larger studies are needed to explore and confirm these coronary artery compression risk factors.

Risk factors for infective endocarditis following transcatheter pulmonary valve replacement in patients with congenital heart disease.

We sought to delineate the risk factors for infective endocarditis (IE) in patients undergoing transcatheter pulmonary valve replacement (TCPVR). Despite the therapeutic benefits of TCPVR for treatment of dysfunctional right ventricular outflow tracts, IE is a major complication of the approach. Specific hemodynamic gradients and patient immune status as predisposing factors for IE are largely unexplored. We performed a retrospective review of patients who had undergone TCPVR at UCLA between October 2010 and October 2017. Cases of IE were diagnosed based on the modified Duke criteria. Two hundred and thirty-five cases of TCPVR were performed with a mean follow-up of 2.6 years (range 0.0-8.0 years). Sixteen distinct IE events developed in 13 patients (Melody™ n = 12, SAPIEN n = 1), with a median time from implant to IE of 3.3 years (range 2.0-7.2 years). Univariate Cox regression showed that immunocompromised status was significantly associated with the development of IE hazard ratios (HR 5.43 [1.80-16.4], p = .003). Kaplan-Meier curves show that the 5-year freedom from IE among immunocompetent patients was 87% (95% CI 78-96%) versus 64% (95% CI 39-89%) among immunocompromised patients (log-rank p = .02). Postimplant right ventricular systolic pressure was higher among immunocompromised patients (p = .03). The risk of IE post-TCPVR in immunocompromised patients with residual pulmonary stenosis was 43%. Among the risk factors examined in this study, immunocompromised status was the most significant predictor of IE development post-TCPVR. Patients with the lowest risk of IE are those with competent immune systems, without a history of IE, and with minimal residual pulmonary valve gradients post-TCPVR.

4D flow MRI to assess right ventricular outflow tract in patients undergoing transcatheter pulmonary valve replacement for severe pulmonary regurgitation

Magnetic resonance imaging (MRI) is essential to assess right ventricular enlargement and function as well as the severity of pulmonary regurgitation before pulmonary valve replacement. Transcatheter pulmonary valve replacement (TPVR) has emerged as an alternative to surgical replacement but limited by the size of the right ventricular outflow tract (RVOT). The aim of the study was to compare the measurements of native RVOT between different MRI imaging sequences and catheterization findings. Single-center retrospective study of patients who underwent TPVI for severe pulmonary regurgitation assessed by 4D flow MRI, without significant residual RVOT obstruction. Balloon calibration was used as the reference. Nine adult with repaired tetralogy of Fallot and one patient with Ross procedure were included (mean age: 43.9 ± 12.9). One patient had a too large RVOT to achieve a TPVR, 1 patient had TPVR with Edwards XT 29 mm valve, 7 patients had Melody valve implantation procedure. Mean RVOT measured 25.1 ± 3.0 mm by balloon calibration, 25.0 ± 3.2 mm and 22.5 ± 3.0 mm 4D flow MRI, in respectively in systole and diastole, 22.7 ± 2.4 mm in 2D SSFP MRI. Interventional angiograms dimensions were 26.7 ± 3.3 mm and 24.4 ± 1.3 mm respectively in systole and diastole. No statistical differences were found comparing different measurements dimensions. Good correlation was found between balloon calibration and MRI 4D flow in systole ( r = 0.794, P = 0.01), while no correlation existed between balloon calibration, 2D MRI and 4D flow MRI in diastole. Balloon calibration was also well correlated to angiograms measurements ( r = 0.881; P = 0.0002 and r = 0.775; P = 0.024, respectively). 4D flow MRI sequence allowing 3D measurement through the cardiac cycle, appears as an interesting technique to measure RVOT in daily practice and therefore to plan TPVI.

Endocarditis After Transcatheter Pulmonary Valve Replacement

BackgroundEndocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves. ObjectivesThe aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials. MethodsAll patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator. ResultsA total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008). ConclusionsEndocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy. (Melody Transcatheter Pulmonary Valve [TPV] Study: Post Approval Study of the Original Investigational Device Exemption [IDE] Cohort; NCT00740870; Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692; and Melody Transcatheter Pulmonary Valve [TPV] Post-Market Surveillance Study; NCT00688571)

Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: A multicenter study

BackgroundStented bioprosthetic valves (BPVs) are commonly used for surgical pulmonary valve (PV) replacement in postoperative congenital heart disease, but develop structural failure in a time-related fashion. The Melody transcatheter PV (TPV) (Medtronic, Minneapolis, Minn) has been used to treat BPV dysfunction, but there have been few studies in this population. MethodsWe performed a retrospective, multicenter study to evaluate Melody valve function in patients who underwent TPV replacement (TPVR) into a dysfunctional pulmonary BPV. ResultsOne hundred patients who underwent TPVR at 10 centers between January 2010 and June 2015 were enrolled. The median patient age was 22 years (range, 5-79 years), and 32 patients were age <18 years. The underlying diagnosis was tetralogy of Fallot in 80 patients, and moderate or severe pulmonary regurgitation (PR) was present in 84%. The TPV was implanted into various types of BPVs, with a median size of 23 mm (range, 19-33 mm). At hospital discharge, PR was mild or less in all but 1 patient, and the mean Doppler right ventricular outflow tract (RVOT) gradient was reduced from a mean of 29.3 ± 12.0 mm Hg to 16.2 ± 6.9 mm Hg (median, 29 mm Hg to 16 mm Hg; P < .001). During follow-up (median, 12.4 months), no patients underwent reintervention on the TPV. Endocarditis was diagnosed in 1 patient who was managed medically without intervention. The mean RVOT gradient at the most recent follow-up was ≤35 mm Hg in all patients, and was similar to that at early postimplantation. PR was more than mild in only 1 patient. Hemodynamic outcomes did not differ between patients with small BPVs (≤23 mm) and those with large BPVs (≥25 mm). ConclusionsTPVR restores competence and relieves the obstruction of dysfunctional surgical BPVs, with excellent early results in both small and large BPVs, highlighting the potential for TPVR to extend the life of existing BPVs in adults and children. Collaboration between surgeons and cardiologists is important to determine the optimal lifetime management, combining surgical PV replacement and TPVR in this population.

Transcatheter pulmonary valve replacement: State of the art.

The number of patients undergoing transcatheter pulmonary valve replacement has been steadily increasing, resulting in many research projects focusing on this patient population. This has highlighted the need to summarize the currently available data. A review of the literature was conducted and the results summarized. At present, the two commercially available valves approved for transcatheter pulmonary valve replacement include the Edwards Sapien valve and the Medtronic Melody valve. More data has been published relating to the Melody valve; this included the incidence of coronary anatomy prohibiting valve implantation of 5%, an incidence of conduit disruption of 6%, and freedom from stent fracture of the Melody valve stent of 60% at 30 months. Short and medium term outcomes seem to be comparable if not superior to surgical valve replacement, but long-term data is still lacking. There may also be a cost benefit with transcatheter valve implantation when compared to surgical pulmonary valve replacement. Transcatheter pulmonary valve replacement is here to stay. The main challenge of treating patients with a native right ventricular outflow tract still needs to be addressed and device development efforts centered in this area. © 2015 Wiley Periodicals, Inc.

Medium‐term CT evaluation of stent geometry, integrity, and valve function of the Edwards SAPIEN transcatheter heart valve in the pulmonary position

Distortion of transcatheter heart valve (THV) stent shape and morphology has been shown to impact on THV function. This study sought to evaluate the relationship between geometrical CT follow-up data and consequent valve function in patients undergoing transcatheter pulmonary valve replacement with the Edwards SAPIEN THV. All patients were enrolled in the COMPASSION trial. Multidetector computed tomography (MDCT) was performed as part of the study protocol at 6 months and yearly thereafter following valve implantation. Prosthesis eccentricity indices, circularity ratios, and expansion ratios (ER) were calculated. Valve function and reintervention rates were correlated with MDCT findings. Twenty consecutive patients undergoing 58 CT scans were included. Maximum Doppler gradients across the right ventricular outflow tract (RVOT) were significantly reduced following valve implantation (P < 0.001). Geometrical indices and maximum RVOT gradients were compared between the reintervention group (n = 4) and the nonreintervention group (n = 16). Although there was no difference in eccentricity index between the groups, ER [6 months: 90 +/- 12% vs. 69 ± 9%; P = 0.014; at 12 months: 89 ± 14 vs. 69 ± 10%; P = 0.018; at 24 months: 87 ± 14% vs. 70 ± 11%; P = 0.056] and valve area [6 months: 3.98 ± 0.54 vs. 2.86 ± 0.38 P = 0.005; at 12 months: 3.93 ± 0.56 vs. 2.86 ± 0.39 P = 0.006; 24 months: 3.78 ± 0.50 vs. 2.90 ± 0.45 P = 0.019] were lower in the reintervention group compared with the nonreintervention group at all time periods. Geometrical THV measurements as assessed by CT may predict the need for reintervention in patients undergoing transcatheter pulmonary valve replacement with the SAPIEN valve. Valve symmetry is maintained, however under-expansion and smaller valve area are strongly associated with the need for reintervention.