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1.
Ann Thorac Surg ; 2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38936588
2.
Ann Thorac Surg ; 117(4): 789-795, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38216078

ABSTRACT

BACKGROUND: Trileaflet aortic valve neocuspidization (AVN) using autologous pericardium (Ozaki procedure) is an emerging surgical treatment option for aortic valve diseases. Although excellent results have been reported from Japan, data pertaining to its use in the United States are sparse. METHODS: All adult patients who underwent AVN (AVN group) or surgical aortic valve replacement (SAVR) with a bioprosthetic valve (SAVR group) between 2015 and 2022 were identified. Propensity score matching was used to adjust the baseline characteristics between the 2 groups. RESULTS: A total of 101 patients underwent AVN, and 1816 patients underwent SAVR with a bioprosthetic valve. None in the AVN group required conversion to SAVR. Before matching, mean age in the AVN group was 68.5 ± 8.8 years, and 56 patients (55.4%) underwent concomitant procedures. Preoperatively, 3 (3%) had endocarditis. Bicuspid valve was observed in 38 (38.4%). None died at 30 days in the AVN group. The median follow-up duration was 3.2 years. After propensity score matching, the expected survival and freedom from at least moderate aortic regurgitation at 5 years was 91.7% ± 3.1% and 97.6% ± 1.7%, respectively. Propensity score matching yielded 77 patients in each group. The Kaplan-Meier curve demonstrated equivalent survival at 5 years between the 2 groups (P = .95). Additionally, freedom from at least moderate aortic regurgitation was comparable at 5 years (P = .23). CONCLUSIONS: AVN can be safely performed for a variety of aortic valve diseases, with or without concomitant operations. AVN demonstrated similar midterm outcomes compared with SAVR with a bioprosthetic valve in the United States adult population.


Subject(s)
Aortic Valve Disease , Aortic Valve Insufficiency , Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Adult , Humans , United States , Middle Aged , Aged , Aortic Valve/surgery , Transcatheter Aortic Valve Replacement/methods , Heart Valve Prosthesis Implantation/methods , Aortic Valve Stenosis/surgery , Aortic Valve Insufficiency/surgery , Treatment Outcome , Aortic Valve Disease/surgery , Risk Factors
3.
Ann Thorac Surg ; 117(2): 370-377, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37774760

ABSTRACT

BACKGROUND: Studies that have assessed the Rastelli and Nikaidoh operations for transposition of the great arteries (TGA) with obstructed left ventricular outflow tract obstruction (LVOTO) have not fully evaluated the anatomic drivers that may contribute to surgical selection. We present our procedural selection process for optimizing outcomes of complex TGA in the modern era. METHODS: This is a single-center, retrospective study that included pediatric patients who underwent either a Nikaidoh or Rastelli operation for the treatment of TGA-LVOTO, congenitally corrected TGA-LVOTO, or double-outlet right ventricle TGA type-LVOTO from June 2004 to June 2021. RESULTS: There were 34 patients stratified by Nikaidoh (n = 16) or Rastelli (n = 18) operation. The incidence of all postoperative complications and mortality was low, and the incidence of complications between the groups was similar. Patients were more likely to have undergone a Nikaidoh than a Rastelli if they had a pulmonary annulus >5 mm (87.5% vs 11.1%), anteriorly/posteriorly oriented great vessels (88% vs 8%), remote (80% vs 11%) or restrictive (75% vs 6%) ventricular septal defect, and right ventricular hypoplasia (50% vs 0%; all, P < .05). The resulting rates of reoperation were similar between the groups (44.0% vs 37.5%; P = .24) and largely composed of conduit replacements in the Rastelli patients and valvular repairs or replacements in the Nikaidoh group. Rates of catheter-based interventions were also similar. CONCLUSIONS: These findings suggest that for the optimal treatment of conotruncal anomalies with discordant ventriculoarterial connections, procedural selection should be based on pathoanatomic criteria that can ensure patients undergo the operation most suited to their anatomy.


Subject(s)
Transposition of Great Vessels , Ventricular Outflow Obstruction, Left , Ventricular Outflow Obstruction , Child , Humans , Infant , Transposition of Great Vessels/complications , Transposition of Great Vessels/surgery , Retrospective Studies , Treatment Outcome , Ventricular Outflow Obstruction/complications
5.
Ann Thorac Surg ; 116(5): 980-986, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37429515

ABSTRACT

BACKGROUND: This study aimed to longitudinally compare expanded polytetrafluoroethylene (ePTFE)-valved conduits vs pulmonary homograft (PH) conduits after right ventricular outflow tract reconstruction in the Ross procedure. METHODS: Patients undergoing a Ross procedure from June 2004 to December 2021 were identified. Echocardiographic data, catheter-based interventions, or conduit replacements, as well as time to first reintervention or replacement, were comparatively assessed between handmade ePTFE-valved conduits and PH conduits. RESULTS: A total of 90 patients were identified. The median age and weight were 13.8 years (interquartile range [IQR], 8.08-17.80 years) and 48.3 kg (IQR, 26.8-68.7 kg), respectively. There were 66% (n = 60) ePTFE-valved conduits and 33% (n = 30) PHs. The median size was 22 mm (IQR, 18-24 mm) for ePTFE-valved conduits and 25 mm (IQR, 23-26 mm) for PH conduits (P < .001). Conduit type had no differential effect in the gradient evolution or the odds of presenting with severe regurgitation in the last follow-up echocardiogram. Of the 26 first reinterventions, 81% were catheter-based interventions, without statistically significant differences between the groups (69% PH vs 83% ePTFE). The overall surgical conduit replacement rate was 15% (n = 14), and it was higher in the homograft group (30% vs 8%; P = .008). However, conduit type was not associated with an increased hazard for reintervention or reoperation after adjusting for covariates. CONCLUSIONS: Right ventricular outflow tract reconstruction using handmade ePTFE-valved conduits after a Ross procedure provides encouraging midterm results, without a differential effect in hemodynamic performance or valve function compared with PH conduits. These results are reassuring about the use of handmade valved conduits in pediatric and young adult patients. Longer follow-up of tricuspid conduits will complement valve competency assessment.

6.
Article in English | MEDLINE | ID: mdl-36606517

ABSTRACT

Achieving a safe and accurate coronary transfer in the context of the precise geometry of the realigned great arterial connections is the essence of the arterial switch operation for transposition. Because the incidence of variant coronary patterns is not low, one needs to be familiar with techniques to transfer all types of coronary patterns when performing the arterial switch operation. Both closed and open techniques for coronary transfer have been widely adopted for the arterial switch operation. We routinely use the open technique for coronary transfer combined with a liberal use of trapdoor incisions. We demonstrate that this technique, with appropriate technical modifications, serves as a template for achieving accurate coronary transfer even in the context of complex looping and intramural variants.


Subject(s)
Arterial Switch Operation , Coronary Vessel Anomalies , Transposition of Great Vessels , Humans , Arterial Switch Operation/methods , Transposition of Great Vessels/surgery , Coronary Vessels/surgery , Coronary Vessel Anomalies/surgery
7.
Semin Thorac Cardiovasc Surg ; 35(1): 148-155, 2023.
Article in English | MEDLINE | ID: mdl-35278667

ABSTRACT

Interest and core training in congenital heart surgery (CHS) has not been characterized among current cardiothoracic surgical trainees. This study aimed to evaluate perceptions, interest, exposure, and experience among current trainees. A 22 question survey was distributed to all cardiothoracic surgical trainees in ACGME-accredited thoracic surgery residencies. Questions included demographics, exposure to CHS during, perceptions of, participation in and quality assessment of CHS training. There were 106 responses (20.1% response rate) of which 31 (29.0%) were female and 87 (81.3%) were cardiothoracic track. While 69 (64.5%) reported having an interest in CHS at some point during training, only 24 (22.4%) were actively pursuing CHS. All but 7 (6.5%) residents reported having easy access to congenital mentorship, with 35 (32.7%) actively participating in CHS research. Three months was the median duration of congenital rotations. Residents reported less operative participation on CHS compared to adult cardiac surgery. Several residents noted the need for earlier exposure and increased technical/operative experience as areas in need of improvement. The most cited primary influences to pursue CHS included: mentorship, breadth of pathology, and technical nature of the specialty. Lack of consistent job availability and length of additional training were reported as negative influences. Cardiothoracic residents report adequate exposure to obtain case requirements and knowledge for board examinations in CHS but highly variable operative involvement. Mentorship and early exposure remain important for those interested in CHS, while additional training time and limited job availability remain hurdles to CHS.


Subject(s)
Cardiac Surgical Procedures , Heart Defects, Congenital , Internship and Residency , Thoracic Surgery , Adult , Humans , Female , Male , Treatment Outcome , Thoracic Surgery/education , Cardiac Surgical Procedures/education , Education, Medical, Graduate , Surveys and Questionnaires
8.
ASAIO J ; 69(6): 610-617, 2023 06 01.
Article in English | MEDLINE | ID: mdl-36562607

ABSTRACT

Cardiac surgical patients requiring extracorporeal membrane oxygenation (ECMO) are at increased risk for hemorrhage due to necessary anticoagulation, in-situ cannulas, and disturbed hemostasis. We performed a retrospective, cross-sectional study of patients 0-18 years old in our cardiac intensive care unit (CICU) cannulated to ECMO within 48 h of cardiopulmonary bypass. The 69 patients included in the study were divided into three analysis groups based on serial chest tube output per hour: no bleeding (NB) on admission to the CICU (21/69, 30%), bleeding stopped (BS) with medical management (26/69, 38%), bleeding requiring emergent mediastinal exploration (BME) (22/69, 32%). The NB group had a more favorable coagulation profile upon admission to the CICU (PTT 53 s NB, 105 s BS, 83 s BME p < 0.001, ACT 169 s NB, 225 s BS, 211 s BME, p =0.013). Only chest tube output during the first three postcannulation hours remained associated with the need for mediastinal exploration by multivariable analysis. An average chest-tube output of 11.6 mL/kg/h during the first three hours had the highest percentage of patients classified correctly (84%) for requiring mediastinal exploration during their ECMO run (sensitivity 91%, specificity 81%).


Subject(s)
Cardiac Surgical Procedures , Extracorporeal Membrane Oxygenation , Child , Humans , Infant, Newborn , Infant , Child, Preschool , Adolescent , Extracorporeal Membrane Oxygenation/adverse effects , Retrospective Studies , Cross-Sectional Studies , Heart , Cardiac Surgical Procedures/adverse effects , Hemorrhage/etiology
9.
Pediatr Cardiol ; 44(1): 15-23, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36151322

ABSTRACT

Ebstein anomaly is the most common form of tricuspid valve congenital anomalies. The tricuspid valve is abnormal with different degrees of displacement of the septal leaflet and abnormal rotation of the valve towards the right ventricular outflow tract. In severe forms, it results in significant tricuspid regurgitation and requires surgical repair. There is an increased interest in understanding the anatomy of the tricuspid valve in this lesion as the surgical repair has evolved with the invention and wide adoption of the cone operation. Multimodality imaging plays an important role in diagnosis, follow-up, surgical planning and post-operative care. This review provides anatomical tips for the cardiac imagers caring for patients with Ebstein anomaly and will help provide image-based personalized medicine.


Subject(s)
Cardiac Surgical Procedures , Ebstein Anomaly , Tricuspid Valve Insufficiency , Humans , Ebstein Anomaly/diagnostic imaging , Ebstein Anomaly/surgery , Treatment Outcome , Tricuspid Valve/diagnostic imaging , Cardiac Surgical Procedures/methods
10.
Ann Thorac Surg ; 115(4): 983-989, 2023 04.
Article in English | MEDLINE | ID: mdl-35988739

ABSTRACT

BACKGROUND: Conduit longevity after right ventricular outflow tract (RVOT) reconstruction is determined by the interaction of different factors. We evaluated the relationship between conduit anatomic position and long-term durability among ≥18 mm polytetrafluoroethylene (PTFE) conduits. METHODS: A single-institution RVOT reconstructions using a PTFE conduit ≥18 mm were identified. Catheter-based interventions or the need for conduit replacement were comparatively assessed between orthotopic vs heterotopic conduit position. Time to the first reintervention, censored by death, was compared between the groups. RESULTS: A total of 102 conduits were implanted in 99 patients, with a median age of 13.2 years (interquartile range [IQR] 8.9-17.8 years), median weight of 47 kg (IQR, 29-67 kg), and body surface area of 1.4 m2 (IQR, 1-1.7 m2). Overall, 50.9% (n = 52) of conduits were placed in an orthotopic position after the Ross procedure in congenital aortic valve abnormalities (80% [n = 36]). Tetrology of Fallot in 39% (n = 18), followed by truncus arteriosus with 33% (n = 15), were the most common in the heterotopic position. Trileaflet configuration was similar (67% vs 69%; P = .32) between the groups. Survival free from reintervention was 91% (95% CI, 79-97) and 88% (95% CI, 71-95) in the orthotopic and the heterotopic group, respectively, at 5 years, without differences in the Kaplan Meier curves (log-rank >.05). CONCLUSIONS: RVOT reconstruction with PTFE conduits ≥ 8 mm showed >90% conduit survival free from replacement in our cohort at 5 years. The anatomic position of the PTFE conduit does not seem to impact intermediate durability.


Subject(s)
Heart Defects, Congenital , Heart Valve Prosthesis , Truncus Arteriosus, Persistent , Ventricular Outflow Obstruction , Humans , Infant , Child , Adolescent , Polytetrafluoroethylene , Treatment Outcome , Heart Defects, Congenital/surgery , Truncus Arteriosus, Persistent/surgery , Blood Vessel Prosthesis , Retrospective Studies , Ventricular Outflow Obstruction/surgery , Reoperation
11.
J Thorac Cardiovasc Surg ; 164(5): 1261-1262, 2022 11.
Article in English | MEDLINE | ID: mdl-35987865
12.
JTCVS Open ; 10: 282-289, 2022 Jun.
Article in English | MEDLINE | ID: mdl-36004250

ABSTRACT

Objective: This study's objective was to evaluate the scholastic and career effects of receiving either the American Association for Thoracic Surgery (AATS) Foundation research scholarship or surgical investigator program. Methods: AATS annual reports and recipient listings were used to generate the awardees. MEDLINE and SCOPUS were used to assess publications, citations, and H-Index for awardees. The National Institutes of Health (NIH) RePorter was used to collate NIH grant awarding to awardees. Publicly available institutional profiles were used to assess promotion status and leadership positions. Results: Awardees of the research scholarship had a median of 4733 citations and a median H-Index of 33. The surgical investigator program recipients had a median of 1346 citations with a median H-Index of 17. Across both funding mechanisms, 45% secured subsequent NIH funding. Most awardees received an academic promotion, with 62% of the research scholarship awardees promoted to full professor and 37% of the surgical investigator program to associate professor. Approximately half (48%) of all awardees hold leadership positions, with most being a clinical director or division chief. Conclusions: Receiving the AATS Foundation research scholarship or surgical investigator program positions early-career cardiothoracic surgeons for a promising future in academic surgery.

13.
J Thorac Cardiovasc Surg ; 164(5): 1259-1260, 2022 11.
Article in English | MEDLINE | ID: mdl-36028366
14.
Ann Thorac Surg ; 114(4): 1108-1117, 2022 10.
Article in English | MEDLINE | ID: mdl-35439450

ABSTRACT

BACKGROUND: Aortic valve replacement is the traditional surgical treatment for aortic valve diseases, yet standardized aortic valve neocuspidization (AVNeo) is a promising alternative that is gaining popularity. The purpose of this article is to review the available published literature of AVNeo using glutaraldehyde-treated autologous pericardium, also known as the Ozaki procedure, including indications, outcomes, potential benefits, and modes of failure for the reconstructed valve. METHODS: A comprehensive literature search was performed using keywords related to aortic valve repair, AVNeo, or Ozaki procedure. All articles describing performance of AVNeo were reviewed. RESULTS: Reported early mortality after AVNeo varies from 0% to 5.88%. The largest cohort of patients in the literature includes 850 patients with an inhospital mortality rate of 1.88%. Cumulative incidence of aortic valve reoperation was 4.2% in the largest series. Reoperation was uncommon and mainly due to infective endocarditis or degeneration of the reconstructed valve (most commonly due to aortic valve regurgitation, rather than stenosis). CONCLUSIONS: Aortic valve neocuspidization is a versatile and standardized alternative to aortic valve replacement with a biological prosthesis. Early to midterm outcomes from a number of centers are excellent and demonstrate the safety and durability of the procedure. Long-term outcomes and clinical trial data are necessary to determine which patients benefit the most from this procedure.


Subject(s)
Aortic Valve Insufficiency , Aortic Valve Stenosis , Heart Valve Prosthesis , Aortic Valve/surgery , Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/surgery , Glutaral , Humans , Pericardium/transplantation , Reoperation , Treatment Outcome
16.
Ann Thorac Surg ; 113(3): e227-e229, 2022 03.
Article in English | MEDLINE | ID: mdl-33971175

ABSTRACT

Available aortic prosthesis replacement options present a challenge to achieving low perioperative morbidity, low pressure gradients, and prolonged durability. Trileaflet aortic valve reconstruction using autologous pericardium offers an alternative treatment option with excellent postoperative gradients, large effective orifice areas, and the avoidance of long-term anticoagulation. The modified Bentall procedure with either tissue xenograft valved conduit or mechanical valved conduit is considered the gold standard for patients with aortic root pathology requiring surgical replacement. We report a novel adaptation of the modified Bentall procedure with a self-fabricated valved conduit with trileaflet aortic valve neocuspidization using autologous pericardium.


Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Aorta/surgery , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Humans , Pericardium/transplantation
17.
Ann Thorac Surg ; 114(4): 1427-1433, 2022 10.
Article in English | MEDLINE | ID: mdl-34363794

ABSTRACT

BACKGROUND: High risk (HR) factors have been shown to have increased rates of mortality after stage 1 palliation (S1P) for single ventricle physiology. It remains unclear how initial HR status affects longitudinal outcomes after subsequent stage 2 palliation (S2P) and stage 3 palliation (S3P). METHODS: Single ventricle patients undergoing S1P between July 2004 and October 2018 at a single institution were included. Patients having one or more HR factors were considered to have HR status, with all others classified as low risk (LR). Longitudinal survival stratified by risk status was compared after each palliative stage, in addition to readmission and length of stay. Proportional hazards modeling was used to determine risk factors for longitudinal mortality. RESULTS: Of 132 patients presenting during the study for S1P, 57 (43.2%) were classified as HR. Overall 10-year survival was decreased in the HR cohort (P = .001). The HR patients were at significantly increased risk of death during interstage I (P = .01) and interstage II (P = .01), but survival was similar to that of LR patients after S3P (P = .31). Readmission rates after S2P were higher among HR patients (41.9% vs 22.5%, P = .029), but were similar after S3P. Length of stay was increased in the HR cohort after S2P (median 11 vs 9 days, P = .024) but similar to the LR group after S3P. Prematurity was the risk factor most consistently associated with increased mortality after all stages. CONCLUSIONS: A high risk status of patients undergoing S1P portends a higher risk of mortality, length of stay, and readmission after S2P. High-risk patients have survival similar to that of low-risk patients after S3P.


Subject(s)
Hypoplastic Left Heart Syndrome , Univentricular Heart , Cohort Studies , Heart Ventricles , Humans , Palliative Care , Retrospective Studies , Risk Factors , Treatment Outcome
18.
Ann Thorac Surg ; 114(3): 800-808, 2022 09.
Article in English | MEDLINE | ID: mdl-34237293

ABSTRACT

BACKGROUND: Aortic root translocation (Nikaidoh), Rastelli, and réparation à l'etage ventriculaire (REV) are repair options for transposition of the great arteries (TGA) with ventricular septal defects and left ventricular outflow tract obstruction (VSD-LVOTO) or double outlet right ventricle TGA type (DORV-TGA). METHODS: This retrospective study using The Society of Thoracic Surgeons Congenital Heart Surgery Database evaluates surgical procedure utilization and outcomes of patients undergoing repair of TGA-VSD-LVOTO and DORV-TGA with a Nikaidoh, Rastelli, or REV procedure. RESULTS: A total of 293 patients underwent repair at 82 centers (January 2010 to June 2019). Most patients underwent a Rastelli (n = 165, 56.3%) or a Nikaidoh (n = 119, 40.6%) operation; only 3.1% (n = 9) underwent a REV. High-volume centers performed the majority of the repairs. Fewer Nikaidoh than Rastelli patients had prior cardiac operations (n = 57 [48.7%] vs n = 102 [63.0%]; P = .004). Nikaidohs had longer median cardiopulmonary bypass time (227 [interquartile range (IQR), 167-299] minutes vs 175 [IQR, 133-225] minutes; P < .001) and median aortic cross-clamp times (131 [IQR, 91-175] minutes vs 105 [IQR, 82-141] minutes; P = .0015). Operative mortality was 3.1% (95% confidence interval [CI], 1.0%-7.0%; n = 5) for Rastelli, 4.4% (95% CI, 1.4%-9.9%; n = 5) for Nikaidoh, and 11.1% (95% CI, 0.3%-48.3%, n = 1) for REV. The rates of cardiac arrest, unplanned reoperation, mechanical circulatory support, prolonged ventilation, and permanent pacemaker placement were higher in the Nikaidoh population but with 95% CIs overlapping those of the other procedures. CONCLUSIONS: Rastelli and Nikaidoh procedures are the prevalent repair strategies for patients with DORV-TGA and TGA-VSD-LVOTO. Most are performed at high-volume institutions, and early outcomes are similar.


Subject(s)
Double Outlet Right Ventricle , Heart Defects, Congenital , Heart Septal Defects, Ventricular , Surgeons , Transposition of Great Vessels , Ventricular Outflow Obstruction , Heart Defects, Congenital/surgery , Heart Septal Defects, Ventricular/surgery , Humans , Infant , Retrospective Studies , Transposition of Great Vessels/surgery , Treatment Outcome , Ventricular Outflow Obstruction/surgery
19.
J Extra Corpor Technol ; 53(3): 208-213, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34658414

ABSTRACT

Medical simulation provides a realistic environment for practitioners to experience a planned clinical event in a controlled educational setting. We established a simulation model composed of synthetic ballistic gelatin that provided an inexpensive high-fidelity model for our extracorporeal membrane oxygenation (ECMO) team members to develop, master, and maintain clinical skills necessary for percutaneous cervical or femoral cannulation. The simulation component includes a cervical torso or femoral percutaneous synthetic gelatin model that is attached to either a static fluid model or to the high-fidelity perfusion simulator. Either model can be accessed with ultrasound guidance, cannulated with appropriately sized cannula, and connected to an in situ ECMO circuit. This article explains how the model is made and connected to the simulator with the purpose of re-creating this high-fidelity experience at any institution.


Subject(s)
Extracorporeal Membrane Oxygenation , Cannula , Catheterization , Clinical Competence , Humans , Perfusion
20.
Int J Cardiol ; 339: 36-42, 2021 09 15.
Article in English | MEDLINE | ID: mdl-34265312

ABSTRACT

BACKGROUND: Patients with Tetralogy of Fallot with pulmonary stenosis (ToF/PS), the most common form of cyanotic congenital heart disease (CHD), develop adverse right ventricular (RV) remodeling, leading to late heart failure and arrhythmia. We recently demonstrated that overactive ß-adrenergic receptor signaling inhibits cardiomyocyte division in ToF/PS infants, providing a conceptual basis for the hypothesis that treatment with the ß-adrenergic receptor blocker, propranolol, early in life would increase cardiomyocyte division. No data are available in ToF/PS infants on the efficacy of propranolol as a possible novel therapeutic option to increase cardiomyocyte division and potentially reduce adverse RV remodeling. METHODS: Using a randomized, double-blind, placebo-controlled trial, we will evaluate the effect of propranolol administration on reactivating cardiomyocyte proliferation to prevent adverse RV remodeling in 40 infants with ToF/PS. Propranolol administration (1 mg/kg po QID) will begin at 1 month of age and last until surgical repair. The primary endpoint is cardiomyocyte division, quantified after 15N-thymidine administration with Multi-isotope Imaging Mass Spectrometry (MIMS) analysis of resected myocardial specimens. The secondary endpoints are changes in RV myocardial and cardiomyocyte hypertrophy. CONCLUSION: This trial will be the first study in humans to assess whether cardiomyocyte proliferation can be pharmacologically increased. If successful, the results could introduce a paradigm shift in the management of patients with ToF/PS from a purely surgical approach, to synergistic medical and surgical management. It will provide the basis for future multi-center randomized controlled trials of propranolol administration in infants with ToF/PS and other types of CHD with RV hypertension. CLINICAL TRIAL REGISTRATION: The trial protocol was registered at clinicaltrials.gov (NCT04713657).


Subject(s)
Pulmonary Valve Stenosis , Tetralogy of Fallot , Humans , Infant , Myocytes, Cardiac , Randomized Controlled Trials as Topic , Receptors, Adrenergic, beta-2 , Tetralogy of Fallot/diagnostic imaging , Tetralogy of Fallot/surgery , Ventricular Remodeling
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