Right Ventricular Outflow Tract Reintervention Research Articles

Long-term results after the réparation à l'étage ventriculaire procedure for transposition of the great arteries and double-outlet right ventricle with pulmonary stenosis.

The purpose of this study is to describe the long-term results of the 'réparation à l'étage ventriculaire' (REV) technique for double-outlet right ventricle and transposition of the great arteries (TGA) with pulmonary stenosis (PS). Between 1980 and 2021, 157 patients underwent a REV procedure (median age and weight: 20.8 months and 7.7 kg). The most frequent anatomical presentation was the association between TGA, ventricular septal defect and PS (n = 116, 73.9%). Sixty-seven patients (42.7%) underwent a Rashkind procedure, and 67 patients (42.7%) a prior surgical palliation (including 62 systemic-to-pulmonary artery shunts). Resection of the conal septum and/or ventricular septal defect enlargement was performed in 109 patients (69.4%). Thirteen patients (8.3%) died, including 4 during the first postoperative month and 2 after heart transplant. Overall survival at 40 years was 89.3%. Thirty-seven patients (23.6%) required 68 reinterventions on the right ventricular outflow tract (RVOT), including 49 reoperations, with a median delay of 9 years after the REV (8 months to 27 years). Twenty patients (12.7%) underwent RVOT valvulation (16 surgical and 4 interventional). Freedom from RVOT reintervention and reoperation at 40 years were 60.3% and 62.6%, respectively. Four patients (2.5%) required reoperation for left ventricular outflow tract obstruction, with a median delay of 4.8 years. The REV procedure is a good alternative for TGA and double-outlet right ventricle with PS patients. Only a quarter of the patients required redo surgery on the RVOT. Reoperations for left ventricular outflow tract obstruction are scarce.

Decreased clinical performance in TGA-ASO patients after RVOT re-interventions; multicenter European collaboration

Abstract Background In patients with transposition of the great arteries and an arterial switch operation (TGA-ASO) right ventricular outflow tract (RVOT) obstruction is a common complication requiring one or more RVOT reinterventions. However, data on the impact of reinterventions on clinical performance is scarce. Therefore, we aimed to assess in TGA-ASO patients the cardiopulmonary exercise capacity (CPET) and right ventricular function stratified for the number of RVOT reinterventions. Method This multicenter observational study was performed in adult (≥16 years) TGA-ASO patients from the EPOCH (European Collaboration for Prospective Outcome Research in Congenital Heart disease). All patients underwent a comprehensive clinical workup including CPET and echocardiography, including right ventriculo-arterial (VA) coupling (defined as tricuspid annular plane systolic excursion (TAPSE) / right ventricular systolic pressure (RVSP) ratio). Patients were stratified for the number of reinterventions at the RVOT, including re-interventions at the pulmonary valve, main pulmonary artery and pulmonary branches. Association between RVOT re-intervention(s) and functional parameters, including predicted (%) peak oxygen uptake (peak VO2), TAPSE, right ventricle (RV) S’ and VA coupling of the RV were analyzed with linear regression. Results A total of 449 TGA patients were included in this study, with a mean age of 25.4 ± 5.6 years and median time until ASO was 8 days [IQR 6-15]. Eleven (2.5%) patients with previous re-interventions at the left ventricular outflow tract (LVOT) or aortic arch were excluded from the analysis. Twenty-six percent of the included patients had a ventricular septal defect (VSD) and 1.6% were diagnosed with double outlet right ventricle (DORV). In the total cohort, 13% of the patients had 1 previous RVOT re-intervention, 8% had 2 RVOT re-interventions and 5% had 3 RVOT re-interventions. Patients had echocardiographic examination and 55% underwent CPET. Predicted VO2peak was significantly reduced in patients with 1 RVOT re-intervention (72%), 2 RVOT re-interventions (69%) and 3 RVOT re-interventions (71%) compared to patients without any-reintervention (77%) (p=0.0268). Right VA coupling was a significant predictor (p=0.017) for reduced hemodynamic performance in patients with 1 RVOT re-intervention (0,50), 2 RVOT re-interventions (0,51) and 3 RVOT re-interventions (0,26). Conclusion In TGA-ASO patients, RVOT reinterventions were associated with a reduced clinical performance. VA coupling of the right ventricle was the most sensitive marker for hemodynamic performance in TGA-ASO patients.

Systematic review and meta-analysis of time-to-event long-term outcomes following the Ross procedure.

The optimal aortic valve substitute for non-elderly adults remains controversial. Recently, considerable data on the Ross procedure have accumulated. This study aimed to analyze long-term outcomes following the Ross procedure from the current literature using a meta-analysis of time-to-event outcomes. A literature search was performed with MEDLINE, EMBASE, Cochrane Library, Web of Science, and Google Scholar through June 2022; studies reporting clinical outcomes of the Ross procedure beyond 20 years were included for analysis. The outcomes of interest were late survival and freedom from surgical or percutaneous reintervention of the autograft or right ventricular outflow tract (RVOT). Six studies, including 4,910 patients (3,601 males), were identified and analyzed. Survival rate at 5, 10, 15, and 20 years was 99.9%±0.1%, 97.6%±0.5%, 94.3%±0.9%, and 87.4%±1.9%. Freedom from autograft reintervention at 5, 10, 15, and 20 years was 97.7%±0.5%, 95.3%±0.7%, 91.4%±1.2%, 84.8%±2.5%. Freedom from RVOT reintervention was 99.0%±0.3%, 99.0%±0.3%, 97.5%±0.7%, 93.3%±1.8%. Freedom from any valve reintervention (either autograft or RVOT) at 5, 10, 15, and 20 years was 95.8%±0.6%, 92.6%±0.9%, 88.5%±1.2%, 80.8%±2.5%. This meta-analysis demonstrated that the Ross procedure was confirmed to provide excellent survival despite the need for reintervention of autograft or RVOT in approximately 20% of patients at 20 years.

Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial)

Significant pulmonary regurgitation (PR) and pulmonary stenosis are common after surgical repair of some congenital heart defects. This prospective, single-arm, multicenter trial enrolled patients who underwent transcatheter heart valve (THV) implantation with a SAPIEN 3 valve to treat dysfunctional right ventricular outflow tract (RVOT) conduits or pulmonic surgical valves (≥ moderate PR and/or mean RVOT gradient ≥35mm Hg). The primary end point was a nonhierarchical composite of THV dysfunction at 1year comprising RVOT reintervention, ≥ moderate total PR, and mean RVOT gradient >40mm Hg. A performance goal of <25% of upper confidence interval (CI) was prespecified for the primary end point, using a 95% exact binomial CI. Patients (n=58) were enrolled between July 5, 2016 and July 17, 2018, with mean age of 32years. Prestenting was performed in 53.4%. At discharge, the device success was 98.1% (single valve without explant, < moderate PR, gradient <35mm Hg). At 30days, there were no major adjudicated adverse clinical events. At 1year, the primary end point composite was 4.3% (95% CI 0.5 to 14.5). The composite components were 0% (0 of 56) RVOT reintervention, 2.1% (1 of 47) ≥ moderatePR, and 2.1% (1 of 48) mean RVOT gradient >40mm Hg. No mortality, endocarditis, thrombosis, or stent fracture were reported at 1year. In conclusion, the SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year. Clinical trial registration: NCT02744677; https://clinicaltrials.gov/ct2/show/NCT02744677.

Decellularized bovine jugular vein and hand-sewn ePTFE valved conduit for right ventricular outflow tract reconstruction in children undergoing Ross procedure.

BackgroundThe Ross procedure is recommended as an optimal aortic valve replacement (AVR) in children and young adults due to several advantages. Nevertheless, multiple reconstructions of the right ventricular outflow tract (RVOT) with new valve conduits have caused some concern regarding the durability of the Ross AVR. Decellularized bovine jugular vein conduit (BJVC) (DP-BJVC) and hand-sewn expanded polytetrafluoroethylene valved conduits (ePTFE VC) are widely employed to reconstruct the RVOT with satisfactory long-term outcomes. However, few studies have compared the safety and efficacy between the two valve conduits. We aimed to evaluate the early outcomes and report our single center experience in the application of these conduits.MethodsTwenty-two pediatric patients (aged < 18 years) who underwent Ross procedures with DP-BJVC and ePTFE VC in our center between 1 June, 2017 and 31 January, 2022 were enrolled. The Kaplan–Meier method was used to evaluate survival, freedom from RVOT reintervention, and freedom from RVOT graft dysfunction. Mixed-effects analysis with the Geisser–Greenhouse correction and Sidak's multiple comparisons test for post-hoc analysis was employed to compare the peak gradient across the conduit at varying follow-ups.ResultsAll patients were followed up in full. The total early survival rate was 90.9%; two patients in the DP-BJVC group died. There was no significant difference in early mortality, cross-clamp time (p = 0.212), in-hospital stay (p = 0.469), and RVOT graft thrombosis or endocarditis between the two groups. There was similarly no significant difference between Kaplan–Meier freedom from RVOT graft dysfunction curve (P = 0.131). The transprosthetic gradient gradually increased over time in both groups and was significantly higher in the DP-BJVC group at follow-up (P < 0.05).ConclusionsBoth conduits show excellent early and midterm outcomes for RVOT reconstruction in the Ross procedure. We suggest that DP-BJVC is more suitable for infants, and ePTFE conduit is more suitable for older children who require larger conduits.

Long-term results after the REV (réparation à l’étage ventriculaire) procedure for malposition of the great arteries

Several surgical techniques can be used to repair anomalies of the ventriculoarterial connection with sub-pulmonary stenosis. Although there is no equivocal evidence that one technique is superior to another, the arterial switch operation (ASO) and Rastelli procedure are the preferred options to correct transposition of the great arteries (TGA) with ventricular septal defect (VSD) and left ventricular outflow tract obstruction (LVOTO). Despite innovative features and satisfactory short- and long-term results, the “réparation à l’étage ventriculaire” (REV) procedure has not gained large popularity and still struggles to establish itself as a legitimate alternative to the Rastelli operation. By describing our long-term results, we wish to address the misconceptions about the technical aspects and the long-term results of this technique that have been suggested to explain the reluctance towards it. Between 1980 and 2022, 157 patients underwent a REV procedure (median age and weight: 20.8 months and 7.7 kg). The most frequent anatomical presentation was the association between TGA, VSD and LVOTO ( n = 113, 72.0%). Sixty-seven patients (42.7%) underwent a Rashkind procedure, and 67 patients (42.7%) had a prior surgical palliation (including 62 systemic-to-pulmonary artery shunts). Resection of the conal septum and/or ventricular septal defect enlargement was performed in 65 patients (41.4%). Thirteen patients (8.3%) died, including 4 during the first postoperative month and 2 after heart transplant. Overall survival at 40 years was 89%. Thirty-seven patients (23.6%) required 67 reinterventions on the right ventricular outflow tract (RVOT), including 49 reoperations, with a median delay of 9 years after the REV (8 months – 27 years). Twenty patients (12.7%) underwent RVOT valvulation (16 surgical and 4 interventional). Freedom from RVOT reintervention and reoperation at 40 years were 60.3% and 62.6% respectively. Four patients (2.5%) required reoperation for left ventricular outflow tract obstruction, with a median delay of 4.8 years ( Fig. 1 ). The REV procedure is a good alternative to the Rastelli intervention when an arterial switch operation is not feasible. A quarter of the patients required redo surgery on the right ventricular outflow tract. Reoperations for left ventricular outflow tract obstruction are scarce.

Comparison of staged repair versus single-stage complete repair for pulmonary atresia with ventricular septal defect: A systematic review and meta-analysis.

To evaluate comparative outcomes of the repair of pulmonary atresia with ventricular septal defect (PAVSD), done as staged repair (SR) or single-stage complete repair (CR). A systematic online search was conducted using the following databases: PubMed, Scopus, Cochrane database, The Virtual Health Library, Clinical trials.gov, and ScienceDirect for studies comparing SR versus CR for treatment of PAVSD. Total mortality rate, operative and early post-operative mortality rate, post-operative ventilation duration, duration of post-operative intensive care unit (ICU) stay, need for post-operative extra-corporeal membrane oxygenation (ECMO) support rate, transcatheter re-intervention rate, unplanned re-operation rate, freedom from right ventricular outflow tract (RVOT) re-intervention, and length of hospital stay (LOS) were the evaluated outcome parameters. Four comparative studies reporting a total of 264 patients who underwent SR (167 patients) or CR (97 patients) were included. Total mortality was higher in the SR group compared to the CR group (odds ratio (OR) 2.58, P = 0.03). Two groups were comparable regarding operative and early post-operative mortality (OR 1.37, P = 0.62), post-operative ventilation duration (mean difference (MD) - 1.58, P = 0.43), need for post-operative ECMO support rate (OR 4.72, P = 0.16), transcatheter re-intervention rate (OR 0.60, P = 0.53), unplanned re-operation rate (OR 0.73, P = 0.57), and LOS (MD - 3.39, P = 0.45). Higher rate of freedom from RVOT re-intervention was observed in the SR group (OR 4.16, P = 0.00001). Single-staged early CR of PAVSD significantly reduced total mortality rate as compared with SR. However, there is life-long risk of frequent need for RVOT re-interventions. Future high-quality randomised studies with robust methodological qualities are encouraged to evaluate the optimal timing and technique for repair of PAVSD, by analysing more outcomes in large patient groups and multi-centre studies.

Long-Term Outcomes of Patients Undergoing the Ross Procedure

BackgroundTreatment of aortic-valve disease in young patients still poses challenges. The Ross procedure offers several potential advantages that may translate to improved long-term outcomes. ObjectivesThis study reports long-term outcomes after the Ross procedure. MethodsAdult patients who were included in the Ross Registry between 1988 and 2018 were analyzed. Endpoints were overall survival, reintervention, and major adverse events at maximum follow-up. Multivariable regression analyses were performed to identify risk factors for survival and the need of Ross-related reintervention. ResultsThere were 2,444 adult patients with a mean age of 44.1 ± 11.7 years identified. Early mortality was 1.0%. Estimated survival after 25 years was 75.8% and did not statistically differ from the general population (p = 0.189). The risk for autograft reintervention was 0.69% per patient-year and 0.62% per patient-year for right-ventricular outflow tract (RVOT) reintervention. Larger aortic annulus diameter (hazard ratio [HR]: 1.12/mm; 95% confidence interval [CI]: 1.05 to 1.19/mm; p < 0.001) and pre-operative presence of pure aortic insufficiency (HR: 1.74; 95% CI: 1.13 to 2.68; p = 0.01) were independent predictors for autograft reintervention, whereas the use of a biological valve (HR: 8.09; 95% CI: 5.01 to 13.08; p < 0.001) and patient age (HR: 0.97 per year; 95% CI: 0.96 to 0.99; p = 0.001) were independent predictors for RVOT reintervention. Major bleeding, valve thrombosis, permanent stroke, and endocarditis occurred with an incidence of 0.15% per patient-year, 0.07% per patient-year, 0.13%, and 0.36% per patient-year, respectively. ConclusionsThe Ross procedure provides excellent survival over a follow-up period of up to 25 years. The rates of reintervention, anticoagulation-related morbidity, and endocarditis were very low. This procedure should therefore be considered as a very suitable treatment option in young patients suffering from aortic-valve disease. (Long-Term Follow-up After the Autograft Aortic Valve Procedure [Ross Operation]; NCT00708409)

Allografts and xenografts for right ventricular outflow tract reconstruction in Ross patients

Pulmonary allografts (AG) are the gold standard for right ventricular outflow tract (RVOT) reconstruction during the Ross procedure. However, there is limited availability of AG in some countries, and the use of alternative grafts for RVOT reconstruction remains controversial. This study aimed to compare the rates of freedom from RVOT graft dysfunction for AG and diepoxide-treated pericardial xenografts (DPXG). Between 1998 and 2015, 793 adult patients underwent the Ross procedure in our centre. Using propensity score matching, the clinical outcomes and echocardiographic results of AG and DPXG were compared. Propensity score matching resulted in 2 groups (AG and DPXG) of 122 patients each. No difference was found in early mortality (2.5%) in both groups. The freedom from RVOT graft dysfunction curves were comparable between the AG and DPXG groups (P = 0.186) and the 8-year rates of freedom from graft dysfunction were 91.8% and 82.2%, respectively. The survival rates at 8 years were 90.5% and 90.1%, and the rates of freedom from RVOT reintervention at 8 years were 100% and 96.8% for the AG and DPXG groups, respectively. At discharge and follow-up, transprosthetic gradients were significantly higher in the DPXG group. The rate of the RVOT gradient progression was also higher in the DPXG group than in the AG group (1.80 ± 0.06 vs 1.39 ± 0.04 mmHg/year, P < 0.001). There was no difference in freedom from RVOT graft dysfunction by 8 years when using AG and DPXG in adult Ross patients, nor in survival and freedom from RVOT conduit reintervention. Long-term results need further evaluation.

Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve

ObjectivesThe aim of this analysis was to evaluate outcomes following transcatheter reintervention for degenerated transcatheter pulmonary valves (TPVs). BackgroundTPV replacement (TPVR) with the Melody valve demonstrated sustained relief of right ventricular outflow tract (RVOT) obstruction and pulmonary regurgitation. MethodsAll 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. ResultsA 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). ConclusionsTPV-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.

Percutaneous Pulmonary Valve Implantation.

Percutaneous pulmonary valve implantation (PPVI) is recognized as a feasible and low risk alternative to surgery to treat dysfunctional right ventricular outflow tract (RVOT) in usually pluri-operated patients. Evolving technology allowed to develop different kind of prosthesis and to go from an initial treatment exclusively of stenotic conduit to an actual approach extended also to wide native RVOT. The Melody transcatheter pulmonary valve (TPV) and the Edwards Sapien valve are nowadays the most commonly implanted prostheses. However, other devices have been developed to treat large RVOT (i.e., the Venus p-valve, the Medtronic Harmony TPV, the Alterra Adaptive Prestent, and the Pulsta valve). Indications for PPVI are the same as for surgical interventions on pulmonary valve, with limits related to the maximum diameter of the available percutaneous prosthesis. Therefore, an accurate preoperative evaluation is of paramount importance to select patients who could benefit from this procedure. The overall periprocedural mortality incidence is around 1.4%, while freedom from RVOT reintervention ranges from 100% at 4 months to 70% at 70 months, according to the different published studies.

Incidence and Risk Factors for Right Ventricular Outflow Tract Obstruction after the Arterial Switch Operation.

The aim of this study was to evaluate the incidence and risk factors for the development of right ventricular outflow tract obstruction (RVOTO) after the arterial switch operation (ASO). Between 1983 and 2014, a total of 688 patients underwent ASO. RVOTO was defined as any obstruction of the right ventricular outflow tract (RVOT) requiring reintervention. RVOTO developed in 79 patients (11%) at a median time of 3.8 years (range, 1 day-23.6 years) after ASO. Freedom from RVOT reintervention was 96 ± 1, 89 ± 1, and 83 ± 2% at 1, 10, and 25 years, respectively. Independent risk factors for the development of RVOTO in a Cox's regression model were side-by-side great arteries (p < 0.001), aortic arch anomalies (p < 0.001), use of a pericardial patch for augmentation of the coronary buttons (p < 0.001), and a peak gradient more than 20 mm Hg over the RVOT at discharge (p < 0.001). The incidence of RVOTO after ASO is not negligible. Complex morphology, such as side-by-side great arteries and aortic arch anomalies influences the development of RVOTO.

Transcatheter Pulmonary Valve Replacement With the Melody Valve in Small Diameter Expandable Right Ventricular Outflow Tract Conduits

ObjectivesThis study sought to evaluate the safety, feasibility, and outcomes of transcatheter pulmonary valve replacement (TPVR) in conduits ≤16 mm in diameter. BackgroundThe Melody valve (Medtronic, Minneapolis, Minnesota) is approved for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits ≥16 mm in diameter at the time of implant. Limited data are available regarding the use of this device in smaller conduits. MethodsThe study retrospectively evaluated patients from 9 centers who underwent percutaneous TPVR into a conduit that was ≤16 mm in diameter at the time of implant, and reported procedural characteristics and outcomes. ResultsA total of 140 patients were included and 117 patients (78%; median age and weight 11 years of age and 35 kg, respectively) underwent successful TPVR. The median original conduit diameter was 15 (range: 9 to 16) mm, and the median narrowest conduit diameter was 11 (range: 4 to 23) mm. Conduits were enlarged to a median diameter of 19 mm (29% larger than the implanted diameter), with no difference between conduits. There was significant hemodynamic improvement post-implant, with a residual peak RVOT pressure gradient of 7 mm Hg (p < 0.001) and no significant pulmonary regurgitation. During a median follow-up of 2.0 years, freedom from RVOT reintervention was 97% and 89% at 2 and 4 years, respectively, and there were no deaths and 5 cases of endocarditis (incidence rate 2.0% per patient-year). ConclusionsIn this preliminary experience, TPVR with the Melody valve into expandable small diameter conduits was feasible and safe, with favorable early and long-term procedural and hemodynamic outcomes.

Right ventricular outflow tract reintervention after primary tetralogy of Fallot repair in neonates and young infants

ObjectiveTo assess the outcomes following primary tetralogy of Fallot (TOF) repair in neonates and young infants with pulmonary stenosis (PS) and pulmonary atresia and compare differences in reintervention on the right ventricular outflow tract (RVOT) among those undergoing valve sparing repair (VSR), transannular RVOT patch (TAP), and right ventricle–to–pulmonary artery (RV-PA) conduit surgeries. MethodsData were collected retrospectively in 101 patients who underwent TOF repair over a 10-year period between January 2005 and September 2015. The primary endpoint was reintervention on the RVOT, defined as a surgical procedure or cardiac catheterization–based RVOT reintervention. ResultsForty-three patients had TOF/PS, of whom 24 (56%) underwent TAP and 19 (44%) underwent VSR. Fifty-eight patients had TOF/PA, 14 (24%) underwent TAP and 44 (76%) underwent RV-PA conduit repair. Overall patient mortality was 2.9% (3 of 101). Thirty-three patients underwent surgical reintervention, and 52 underwent catheterization-based reintervention. Patients with TOF/PA who underwent RV-PA conduit repair had a higher surgical reintervention rate than those who underwent TAP (45% vs 21%). Patients with TOF/PSs undergoing VSR with a lower median birth weight (2.5 kg vs 3.7 kg) required more surgical reintervention. ConclusionsNeonatal TOF repair can be performed with low mortality but frequent RVOT reinterventions. Surgical reintervention is earlier and the rate is higher among patients with TOF/PA undergoing RV-PA conduit repair compared with those undergoing TAP. Although there were no overall differences in RVOT reintervention rate between patients with TOF/PS undergoing VSR and those undergoing TAP, a lower birth weight in the patients undergoing VSR is associated with a higher surgical reintervention rate.

Relationships Among Conduit Type, Pre-Stenting, and Outcomes in Patients Undergoing Transcatheter Pulmonary Valve Replacement in the Prospective North American and European Melody Valve Trials

ObjectivesThis study sought to evaluate the incidence of and risk factors for conduit and stent-related outcomes following transcatheter pulmonary valve replacement (TPVR). BackgroundStent 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. MethodsData 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. ResultsOf 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. ConclusionsRisks 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.

Transcatheter Pulmonary Valve Replacement Reduces Tricuspid Regurgitation in Patients With Right Ventricular Volume/Pressure Overload

BackgroundTricuspid regurgitation (TR) is a common and important comorbidity in patients with postoperative right ventricular outflow tract (RVOT) obstruction or pulmonary regurgitation (PR). Transcatheter pulmonary valve replacement (TPVR) has become a useful tool in the management of postoperative RVOT obstruction and PR, but it is unknown whether relief of the right ventricular volume and/or pressure overload by TPVR will have a beneficial effect on TR, as is often seen with surgical pulmonary valve replacement. ObjectivesThis study sought to assess the prevalence of and factors associated with significant TR in patients undergoing TPVR for RVOT obstruction or PR. MethodsData were combined from 3 prospective multicenter trials of patients referred for TPVR. Follow-up data through 5 years post-implantation were analyzed. ResultsOf 300 patients studied, 77 (25.6%) had moderate or severe TR at baseline. After TPVR, TR severity was improved in 65% of those patients, and more than one-half had mild TR or less TR at discharge. Of 13 patients with severe TR pre-implantation, only 1 had severe TR at 1-year follow-up and beyond. Moderate or severe baseline TR was associated with shorter freedom from RVOT reintervention after TPVR. ConclusionsIn this prospective multicenter study of post-operative patients with RVOT obstruction and/or PR, TR was common. In patients with significant baseline TR, TPVR resulted in clinically relevant acute reductions in TR that persisted over at least 5 years of follow-up. These observations support the application of TPVR therapy in patients with RVOT obstruction or PR who are anatomically suitable, even in the setting of significant concomitant TR.

Tetralogy of Fallot With Atrioventricular Septal Defect: Surgical Strategies for Repair and Midterm Outcome of Pulmonary Valve-Sparing Approach

Repair for tetralogy of Fallot (TOF) with complete atrioventricular septal defect (CAVSD) has been reported with good early and intermediate outcomes. Morbidity, however, remains significantly high. To date, repair of CAVSD/TOF using a pulmonary valve-sparing technique (PVS) and freedom from valve reoperation are not well defined. A study was undertaken to investigate outcomes. This study was conducted in as a retrospective investigation. Between January 1988 and December 2008, 13 consecutive patients with CAVSD/TOF were identified, and their records were reviewed retrospectively. Of these 13 patients, 9 had Rastelli type C CAVSD. Trisomy 21 was present in 9 cases (69 %; 7 with type C). Five patients had received a systemic-to-pulmonary shunt (SPS) before complete repair at a mean age 1.7 ± 0.6 months. All the patients survived until complete repair. At complete CAVSD/TOF repair, AVSD was corrected with a two-patch technique in all patients. For eight patients (61.5 %), PVS was used. The remaining five patients had transannular patch (TAP) repair. The mean age at complete repair was 6.3 ± 2.4 months. At complete repair, the mean cardiopulmonary bypass time was 173.5 ± 30.6 min, and the cross-clamp time was 134.7 ± 28.8 min. There was one hospitalization and no late deaths. The median follow-up period was 9.2 years [interquartile range (IQR), 4.7-13.3 years]. The actuarial survival was 90.0 ± 9.5 % at 1 year, 90 ± 9.5 % at 5 years, and 90 ± 9.5 % at 8 years. Of the 12 survivors, 6 had some reintervention during the follow-up period. Within the first 11 years after complete repair, two patients underwent left atrioventricular (AV) valve repair, and one patient had right AV valve repair. Two patients had residual VSD closure. Four patients underwent the first right ventricular outflow tract (RVOT) reintervention for critical insufficiency or stenosis at a mean interval of 6 ± 21) months. One patient had a second RVOT reoperation. Findings showed that CAVSD/TOF with PVS was related to significantly higher freedom from RVOT reintervention (100 % at 1, 5, and 8 years compared with 80 ± 17.9 % at 1 year, 60 ± 21.9 % at 5 years, and 40 ± 21.9 % at 8 years for CAVSD/TOF using TAP; P < 0.05). No patient who underwent PVS had left ventricular outflow tract obstruction requiring reoperation. Overall freedom from any reintervention was 90.9 ± 8.6 % at 1 year, 71.6 ± 14.0 % at 5 years, and 53.7 ± 8.7 % at 8 years in this group of patients. Correction of TOF with CAVSD can be performed at low risk with favorable intermediate-term survival and satisfactory freedom from reoperation. Use of TAP can be avoided in almost two thirds of patients and may influence freedom from early RVOT reintervention.

Stent Fracture, Valve Dysfunction, and Right Ventricular Outflow Tract Reintervention After Transcatheter Pulmonary Valve Implantation

Among patients undergoing transcatheter pulmonary valve (TPV) replacement with the Melody valve, risk factors for Melody stent fracture (MSF) and right ventricular outflow tract (RVOT) reintervention have not been well defined. From January 2007 to January 2010, 150 patients (median age, 19 years) underwent TPV implantation in the Melody valve Investigational Device Exemption trial. Existing conduit stents from a prior catheterization were present in 37 patients (25%, fractured in 12); 1 or more new prestents were placed at the TPV implant catheterization in 51 patients. During follow-up (median, 30 months), MSF was diagnosed in 39 patients. Freedom from a diagnosis of MSF was 77±4% at 14 months (after the 1-year evaluation window) and 60±9% at 39 months (3-year window). On multivariable analysis, implant within an existing stent, new prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001), whereas TPV compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF. Freedom from RVOT reintervention was 86±4% at 27 months. Among patients with a MSF, freedom from RVOT reintervention after MSF diagnosis was 49±10% at 2 years. Factors associated with reintervention were similar to those for MSF. MSF was common after TPV implant in this multicenter experience and was more likely in patients with severely obstructed RVOT conduits and when the TPV was directly behind the anterior chest wall and/or clearly compressed. A TPV implant site protected by a prestent or bioprosthetic valve was associated with lower risk of MSF and reintervention.

Early Reintervention on the Pulmonary Arteries and Right Ventricular Outflow Tract After Neonatal or Early Infant Repair of Truncus Arteriosus Using Homograft Conduits

Patients with truncus arteriosus often require pulmonary arterial (PA) and/or right ventricular outflow tract (RVOT) reintervention within the first year of repair. However, little is known about the risk factors for early reintervention on the PAs or RVOT in this population. The objective of the present retrospective cohort study was to determine the risk factors for early PA or RVOT reintervention after repair of truncus arteriosus in neonates and young infants. Of 156 patients ascertained (median age at repair 14 days; 143 early survivors), reinterventions on the RVOT and/or PAs were performed in 109. The first reintervention was catheter therapy in 73 patients (conduit dilation/stenting in 29, PA dilation/stenting in 31, both in 13) and conduit reoperation in 36 patients. The freedom from any RVOT or PA reintervention was 68 ± 4% at 1 year and 48 ± 5% at 2 years. The factors associated with early reintervention (shorter 1-year freedom from reintervention) on univariate analysis were repair quartile, neonatal repair, smaller weight at repair, and smaller implanted conduit size. On multivariable analysis, only smaller conduit size remained significant (multivariable hazard ratio 0.66/mm, range 0.53 to 0.83; p <0.001). The freedom from conduit reoperation was 92 ± 3% at 1 year and 76 ± 4% at 2 years. Overall, the left and right PA sizes were modestly larger than normal by the 1-sample t test, and PA Z scores and the PA area index were not associated with the risk of reintervention. Early reintervention for PA and/or RVOT conduit obstruction is common after neonatal and early infant repair of truncus arteriosus using homograft conduits. A smaller conduit size was associated with early RVOT/PA reintervention. The branch PA size was normal before surgery, suggesting that the PA stenosis in these patients resulted from factors other than intrinsic stenosis or hypoplasia.

Abstract 4784: The Ross Operation: Lessons From Long Term Follow-up

Background: The Ross operation is considered the procedure of choice for aortic valve replacement in children and represents an attractive alternative in selected young adults. However, long term follow-up has demonstrated high rates of pulmonary autograft failure raising concern regarding its clinical utility. We analyze long term outcomes of our Ross series, focusing on predictors of autograft failure. Methods: Between 1991 and 2006, 260 consecutive patients underwent Ross operation. Mean age was 35±15 years (range: 1 day to 64 years) and 75% were male. The technique for autograft implantation was a full root replacement in 70% (n=183), inclusion cylinder in 28% (n=73) and subcoronary in 2% (n=4). Right ventricular outflow tract (RVOT) was reconstructed with a pulmonary homograft in 94% (n=245) and with a xenograft in 6% (n=15). Mean clinical follow-up (97% complete) was 97±46 months (13 to 196 months). Echocardiographic follow-up was available in 234 survivors (94%). Results: Hospital mortality was 1.9% (n=5) and 7 patients died during follow-up (3 non cardiac). Twelve year overall survival was 93±4% and freedom from autograft reoperation and from autograft valve replacement was 83±7% and 94±5% respectively. Twenty-five patients (9.6%) underwent autograft reoperation either for insufficiency (n=8), autograft or ascending aorta dilatation (n=6), or both (n=11) with no mortality. In 76% (n=19) of these patients, the autograft valve was preserved. Predictors for autograft dilatation (≥45 mm) were preoperative aortic insufficiency and full root technique. RVOT reintervention was required in 10 (4%) patients (reoperations n=7, balloon dilatation n=3). Twelve year freedom from RVOT reintervention was 95±4. Twelve year freedom from thrombo-embolic and bleeding events was 99±1% (1 stroke, 1 TIA, 1 bleeding event). Conclusions: This long terms study confirms the excellent survival after Ross operation with an extremely low rate of thrombo-embolic and bleeding events. Autograft reoperation rate remains acceptable. Full root technique is associated with increased risk of autograft dilatation, and should be avoided especially in adults with preoperative aortic insufficiency. Autograft valve preservation is feasible in autograft reoperation.