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Circulation. Cardiovascular... Apr 2021The folded valve is a manual shortening of the Melody device, which has been validated as a valuable therapeutic option for the management of dysfunctional right...
BACKGROUND
The folded valve is a manual shortening of the Melody device, which has been validated as a valuable therapeutic option for the management of dysfunctional right ventricular outflow tracts needing a short valved stent. In this article, we aimed to evaluate, in a multicenter cohort, the mid-term outcomes of patients in whom a percutaneous pulmonary valve implantation was performed using the folded valve technique.
METHODS
A 2012 to 2018 retrospective multicenter study was performed in 7 European institutions. All patients who benefit from percutaneous pulmonary valve implantation with a folded Melody valve were included.
RESULTS
A total of 49 patients (median age, 19 years [range 4–56], 63% male) were included. The primary percutaneous pulmonary valve implantation indication was right ventricular outflow tract stenosis (n=19; 39%), patched native right ventricular outflow tracts were the most common substrate (n=15; 31%). The folded technique was mostly used in short right ventricular outflow tracts (n=28; 57%). Procedural success was 100%. After a median follow-up of 28 months (range, 4–80), folded Melody valve function was comparable to the immediate postimplantation period (mean transvalvular peak velocity=2.6±0.6 versus 2.4±0.6 m/s, P>0.1; only 2 patients had mild pulmonary regurgitation). Incidence rate of valve-related reinterventions was 2.1% per person per year (95% CI, 0.1%–3.9%). The probability of survival without valve-related reinterventions at 36 months was 90% (95% CI, 76%–100%).
CONCLUSIONS
The folded Melody valve is a safe technique with favorable mid-term outcomes up to 6.5 years after implantation, comparable with the usual Melody valve implantation procedure. Complications and reinterventions rates were low, making this technique relevant in selected patients.
Topics: Adolescent; Adult; Cardiac Catheterization; Child; Child, Preschool; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Prosthesis Design; Pulmonary Valve; Pulmonary Valve Insufficiency; Retrospective Studies; Treatment Outcome; Young Adult
PubMed: 33726503
DOI: 10.1161/CIRCINTERVENTIONS.120.009707 -
Open Heart Apr 2023Cardiac surgery may cause temporarily impaired ventricular performance and myocardial injury. We aim to characterise the response to perioperative injury for patients... (Observational Study)
Observational Study
OBJECTIVE
Cardiac surgery may cause temporarily impaired ventricular performance and myocardial injury. We aim to characterise the response to perioperative injury for patients undergoing repair or pulmonary valve replacement (PVR) for tetralogy of Fallot (ToF).
METHODS
We enrolled children undergoing ToF repair or PVR from four tertiary centres in a prospective observational study. Assessment-including blood sampling and speckle tracking echocardiography-occurred before surgery (T1), at the first follow-up (T2) and 1 year after the procedures (T3). Ninety-two serum biomarkers were expressed as principal components to reduce multiple statistical testing. RNA Sequencing was performed on right ventricular (RV) outflow tract samples.
RESULTS
We included 45 patients with ToF repair aged 4.3 (3.4 - 6.5) months and 16 patients with PVR aged 10.4 (7.8 - 12.7) years. Ventricular function following ToF repair showed a fall-and-rise pattern for left ventricular global longitudinal strain (GLS) (-18±4 to -13±4 to -20±2, p < 0.001 for each comparison) and RV GLS (-19±5 to -14±4 to 20±4, p < 0.002 for each comparison). This pattern was not seen for patients undergoing PVR. Serum biomarkers were expressed as three principal components. These phenotypes are related to: (1) surgery type, (2) uncorrected ToF and (3) early postoperative status. Principal component 3 scores were increased at T2. This increase was higher for ToF repair than PVR. The transcriptomes of RV outflow tract tissue are related to patients' sex, rather than ToF-related phenotypes in a subset of the study population.
CONCLUSIONS
The response to perioperative injury following ToF repair and PVR is characterised by specific functional and immunological responses. However, we did not identify factors relating to (dis)advantageous recovery from perioperative injury.
TRIAL REGISTRATION NUMBER
Netherlands Trial Register: NL5129.
Topics: Humans; Tetralogy of Fallot; Pulmonary Valve; Pulmonary Valve Insufficiency; Heart Valve Prosthesis Implantation; Ventricular Function, Right; Cardiac Surgical Procedures; Ventricular Function; Biomarkers
PubMed: 37024245
DOI: 10.1136/openhrt-2022-002238 -
Journal of the American College of... Feb 2020Transcatheter pulmonary valve replacement (TPVR) is associated with a risk of procedural serious adverse events (SAE) and exposure to ionizing radiation.
BACKGROUND
Transcatheter pulmonary valve replacement (TPVR) is associated with a risk of procedural serious adverse events (SAE) and exposure to ionizing radiation.
OBJECTIVES
The purpose of this study was to define the risk of, and associations with, SAE and high-dose radiation exposure using large-scale registry data.
METHODS
The analysis of the multicenter C3PO-QI registry was limited to patients who underwent TPVR from January 1, 2014, to December 31, 2016. SAE were defined as the occurrence of ≥1 moderate, major, or catastrophic events. Radiation dose was reported as dose area product adjusted for weight. Associations with outcome measures were explored in univariate and multivariable analyses.
RESULTS
A total of 530 patients (59% male) underwent TPVR at a median age of 18.3 years (interquartile range [IQR]: 12.9 to 27.3 years) and weight of 58 kg (IQR: 43 to 77 kg) at 14 centers. Implant substrate included homograft (41%), bioprosthesis (30%), native right ventricular outflow tract (RVOT) (27%) and other (2%). TPVR indications were pulmonary insufficiency (28%), stenosis (23%), and mixed (49%). AE and SAE occurred in 26% and 13% of cases, respectively, including 1 mortality. SAE were more frequent in homograft conduit than other RVOT substrates, although SAE type and severity differed between implant substrates. Median radiation dose was 198 μGy·m/kg (IQR: 94 to 350 μGy·m/kg). Higher radiation dose was associated with older age, greater RVOT obstruction, and concomitant interventions (p < 0.001). During a median follow-up duration of 1 year, 13.3% underwent catheterization, surgery, or both, unrelated to infection. Younger age, smaller size, and hemodynamic and anatomic factors indicative of greater RVOT obstruction were associated with TPV reintervention.
CONCLUSIONS
The incidence of SAE during TPVR in the C3PO-QI registry is high, but mortality is uncommon. Radiation dose is greater than for other congenital interventions and is associated with patient and procedural factors. Reintervention is common during early follow-up.
Topics: Adolescent; Adult; Cardiac Catheterization; Cardiac Surgical Procedures; Catheterization; Child; Endocarditis; Female; Heart Defects, Congenital; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Incidence; Male; Multivariate Analysis; Pulmonary Valve; Pulmonary Valve Insufficiency; Radiation Exposure; Radiation, Ionizing; Registries; Risk; Tetralogy of Fallot; Young Adult
PubMed: 32000947
DOI: 10.1016/j.jacc.2019.11.042 -
Circulation. Arrhythmia and... Jun 2023Ventricular arrhythmias and sudden death are recognized complications in tetralogy of Fallot. Electrophysiological studies (EPS) before pulmonary valve replacement...
BACKGROUND
Ventricular arrhythmias and sudden death are recognized complications in tetralogy of Fallot. Electrophysiological studies (EPS) before pulmonary valve replacement (PVR), the most common reintervention in tetralogy of Fallot, could potentially inform therapy to improve arrhythmic outcomes.
METHODS
A prospective multicenter study was conducted to systematically assess EPS with programmed ventricular stimulation in patients with tetralogy of Fallot referred for PVR from January 2020 to December 2021. A standardized stimulation protocol was used across all centers.
RESULTS
A total of 120 patients were enrolled, mean age 39.2±14.5 years, 53.3% males. Sustained ventricular tachycardia was induced in 27 (22.5%) patients. When identifiable, the critical isthmus most commonly implicated (ie, in 90.0%) was between the ventricular septal defect patch and pulmonary annulus. Factors independently associated with inducible ventricular tachycardia were history of atrial arrhythmia (odds ratio, 8.56 [95% CI, 2.43-34.73]) and pulmonary annulus diameter >26 mm (odds ratio, 5.05 [95% CI, 1.47-21.69]). The EPS led to a substantial change in management in 23 (19.2%) cases: 18 (15.0%) had catheter ablation, 3 (2.5%) surgical cryoablation during PVR, and 9 (7.5%) defibrillator implantation. Repeat EPS 5.1 (4.8-6.2) months after PVR was negative in 8 of 9 (88.9%) patients. No patient experienced a sustained ventricular arrhythmia during 13 (6.1-20.1) months of follow-up.
CONCLUSIONS
Systematically performing programmed ventricular stimulation in patients with tetralogy of Fallot referred for PVR yields a high rate of inducible ventricular tachycardia and carries the potential to alter management. It remains to be determined whether a standardized treatment approach based on the results of EPS will translate into improved outcomes.
REGISTRATION
URL: https://clinicaltrials.gov/ct2/show/NCT04205461; Unique identifier: NCT04205461.
Topics: Male; Humans; Young Adult; Adult; Middle Aged; Female; Pulmonary Valve; Tetralogy of Fallot; Heart Valve Prosthesis Implantation; Prospective Studies; Treatment Outcome; Tachycardia, Ventricular; Arrhythmias, Cardiac; Pulmonary Valve Insufficiency
PubMed: 37170812
DOI: 10.1161/CIRCEP.122.011745 -
The Journal of Thoracic and... Jan 2022In this study, we sought to identify independent risk factors for mortality and reintervention after early surgical correction of truncus arteriosus using a novel...
OBJECTIVE
In this study, we sought to identify independent risk factors for mortality and reintervention after early surgical correction of truncus arteriosus using a novel statistical method.
METHODS
Patients undergoing neonatal/infant truncus arteriosus repair between January 1984 and December 2018 were reviewed retrospectively. An innovative statistical strategy was applied integrating competing risks analysis with modulated renewal for time-to-event modeling.
RESULTS
A total of 204 patients were included in the study. Mortality occurred in 32 patients (15%). Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were significantly associated with overall mortality (right ventricle to pulmonary artery conduit size: hazard ratio, 1.34; 95% confidence interval, 1.08-1.66, P = .008; truncal valve insufficiency: hazard ratio, 2.5; 95% confidence interval, 1.13-5.53, P = .024). truncal valve insufficiency at birth, truncal valve intervention at index repair, and number of cusps (4 vs 3) were associated with truncal valve reoperations (truncal valve insufficiency: hazard ratio, 2.38; 95%, confidence interval, 1.13-5.01, P = .02; cusp number: hazard ratio, 6.62; 95% confidence interval, 2.54-17.3, P < .001). Right ventricle to pulmonary artery conduit size 11 mm or less was associated with a higher risk of early catheter-based reintervention (hazard ratio, 1.54; 95% confidence interval, 1.04-2.28, P = .03) and reoperation (hazard ratio, 1.96; 95% confidence interval, 1.33-2.89, P = .001) on the right ventricle to pulmonary artery conduit.
CONCLUSIONS
Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were associated with overall mortality after truncus arteriosus repair. Quadricuspid truncal valve, the presence of truncal valve insufficiency at the time of diagnosis, and truncal valve intervention at index repair were associated with an increased risk of reoperation. The size of the right ventricle to pulmonary artery conduit at index surgery is the single most important factor for early reoperation and catheter-based reintervention on the conduit.
Topics: Adult; Cardiovascular Surgical Procedures; Causality; Female; Heart Valves; Heart Ventricles; Humans; Infant; Long Term Adverse Effects; Male; Mortality; Postoperative Complications; Pulmonary Artery; Reoperation; Retrospective Studies; Risk Assessment; Truncus Arteriosus, Persistent; United States
PubMed: 33726908
DOI: 10.1016/j.jtcvs.2021.01.136 -
Interactive Cardiovascular and Thoracic... Feb 2022This new and easily reproducible pulmonary valve-sparing technique for the correction of Tetralogy of Fallot is based on a conservative management of the native...
This new and easily reproducible pulmonary valve-sparing technique for the correction of Tetralogy of Fallot is based on a conservative management of the native pulmonary valve to preserve its growth potential. From July 2015 to December 2019, 67 children presenting with a Tetralogy of Fallot were operated consecutively in a single centre using this technique in all cases. A T-shaped infundibulotomy is used to release the anterior pulmonary annulus from any muscular attachment. After myocardial resection and ventricular septal defect closure, an extensive commissurotomy is achieved. Finally, the right ventricular outflow tract remodelling is completed by a shield-shaped bovine patch with an oversized square superior edge, attached directly on the pulmonary valve annulus, with an effect of systolic traction. Sixty patients (89.5%) had a Tetralogy of Fallot repair with preservation of the pulmonary valve. To date, with a median follow-up of 38.2 [14-64] months, no patient has needed a surgical or interventional procedure for pulmonary valve stenosis or regurgitation, with low residual gradients. This procedure could provide a significant increase in native pulmonary valve preservation. Long-term studies are needed to assess pulmonary valve growth and the consequent reduction in surgical or interventional reoperations.
Topics: Animals; Cattle; Child; Humans; Infant; Pulmonary Valve; Pulmonary Valve Insufficiency; Retrospective Studies; Tetralogy of Fallot; Treatment Outcome
PubMed: 34606581
DOI: 10.1093/icvts/ivab275 -
Journal of the American College of... Jun 2018
Topics: Allografts; Female; Humans; Pregnancy; Pregnancy Outcome; Pulmonary Valve; Pulmonary Valve Insufficiency
PubMed: 29880127
DOI: 10.1016/j.jacc.2018.04.007 -
JACC. Cardiovascular Interventions Oct 2018
Topics: Heart Valve Prosthesis; Humans; Pulmonary Valve; Pulmonary Valve Insufficiency; Registries; Treatment Outcome
PubMed: 30219328
DOI: 10.1016/j.jcin.2018.06.029 -
Pediatric Cardiology Oct 2022Reports have suggested a transient increase in ventricular ectopy early after percutaneous pulmonary valve implantation (PPVI). Little is known about the potential for...
Reports have suggested a transient increase in ventricular ectopy early after percutaneous pulmonary valve implantation (PPVI). Little is known about the potential for more serious ventricular arrhythmias (VA) in children who undergo PPVI. We sought to evaluate the incidence of severe VA following PPVI in a pediatric population and to explore potential predictive factors. A retrospective cohort study was conducted of patients who underwent PPVI under 20 years of age in our institution from January 2007 to December 2019. The primary outcome of severe VA was defined as sustained and/or hemodynamically unstable ventricular tachycardia (VT), inducible sustained VT, or sudden death of presumed arrhythmic etiology. A total of 21 patients (mean age 16.2 ± 2.1 years; 66.7% male) underwent PPVI. The majority of patients (N = 15; 71.4%) had tetralogy of Fallot (TOF) or TOF-like physiology, with the most common indication being pulmonary insufficiency (N = 10; 47.6%). During a median follow-up of 29.6 months (IQR 10.9-44.0), severe VA occurred in 3 (14.3%) patients aged 15.6 (IQR 14.7-16.1) a median of 12.3 months (IQR 11.2-22.3) after PPVI. All events occurred in patients with TOF-like physiology following Melody valve implant. In conclusion, severe VA can occur long after PPVI in a pediatric population, particularly in those with TOF-like physiology. Further studies are required to elucidate underlying mechanisms and assess strategies to mitigate risks.
Topics: Adolescent; Adult; Cardiac Catheterization; Child; Death, Sudden; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Pulmonary Valve; Pulmonary Valve Insufficiency; Retrospective Studies; Tachycardia, Ventricular; Tetralogy of Fallot; Treatment Outcome; Ventricular Premature Complexes; Young Adult
PubMed: 35394148
DOI: 10.1007/s00246-022-02881-5 -
Journal of the American Heart... Apr 2022Background Right ventricular outflow tract (RVOT) stenosis after repair of tetralogy of Fallot has been linked with favorable right ventricular remodeling but adverse...
Background Right ventricular outflow tract (RVOT) stenosis after repair of tetralogy of Fallot has been linked with favorable right ventricular remodeling but adverse outcomes. The aim of our study was to assess the hemodynamic impact and prognostic relevance of right ventricular pressure load in this population. Methods and Results A total of 296 patients with repaired tetralogy of Fallot (mean age, 17.8±7.9 years) were included in a prospective cardiovascular magnetic resonance multicenter study. Myocardial strain was quantified by feature tracking technique at study entry. Follow-up, including the need for pulmonary valve replacement, was assessed. The combined end point consisted of ventricular tachycardia and cardiac death. A higher echocardiographic RVOT peak gradient was significantly associated with smaller right ventricular volumes and less pulmonary regurgitation, but lower biventricular longitudinal strain. During a follow-up of 10.1 (0.1-12.9) years, the primary end point was reached in 19 of 296 patients (cardiac death, n=6; sustained ventricular tachycardia, n=2; and nonsustained ventricular tachycardia, n=11). A higher RVOT gradient was associated with the combined outcome (hazard ratio [HR], 1.03; 95% CI, 1.00-1.06; =0.026), and a cutoff gradient of ≥25 mm Hg was predictive for cardiovascular events (HR, 3.69; 95% CI, 1.47-9.27; =0.005). In patients with pulmonary regurgitation ≥25%, a mild residual RVOT gradient (15-30 mm Hg) was not associated with a lower risk for pulmonary valve replacement. Conclusions Higher RVOT gradients were associated with less pulmonary regurgitation and smaller right ventricular dimensions but were related to reduced biventricular strain and emerged as univariate predictors of adverse events. Mild residual pressure gradients did not protect from pulmonary valve replacement. These results may have implications for the indication for RVOT reintervention in this population.
Topics: Adolescent; Adult; Cardiac Surgical Procedures; Child; Humans; Prospective Studies; Pulmonary Valve; Pulmonary Valve Insufficiency; Retrospective Studies; Tetralogy of Fallot; Treatment Outcome; Ventricular Pressure; Young Adult
PubMed: 35301850
DOI: 10.1161/JAHA.121.022694