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Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction
Abstract
Valved conduits from the right ventricle to the pulmonary artery are frequently used in paediatric cardiac surgery. However, stenosis and insufficiency of the conduit usually occur in the follow-up and lead to reoperations. Conduit stenting can delay surgical replacement, but it aggravates pulmonary insufficiency. We developed an innovative system for percutaneous stent implantation combined with valve replacement.
A 12-year-old boy with stenosis and insufficiency of a prosthetic conduit from the right ventricle to the pulmonary artery underwent percutaneous implantation of a bovine jugular valve in the conduit.
Angiography, haemodynamic assessment, and echocardiography after the procedure showed no insufficiency of the implanted valve, and partial relief of the conduit stenosis. There were no complications after 1 month of follow-up, and the patient is presently in good physical condition.
We have shown that percutaneous valve replacement in the pulmonary position is possible. With further technical improvements, this new technique might also be used for valve replacement in other cardiac and non-cardiac positions.
... The postoperative RVOT dysfunction, in terms of pulmonary obstruction or regurgitation, requires further intervention with either surgical or transcatheter procedures. In 2000, Phillip Bonhoeffer and colleagues reported the first successful transcatheter pulmonary valve replacement (TPVR) using a bovine jugular venous valve in a platinum iridium stent frame [3][4][5], representing a significant milestone for RVOT transcatheter intervention. The successor to that valve was the Melody transcatheter pulmonary valve (Medtronic, Inc., Minneapolis, MN, USA), and a series of studies have since described the clinical improvements and good hemodynamic outcomes associated with the valve [4,[6][7][8][9][10][11][12][13][14]. ...
... Initial regulatory trials for TPVR excluded smaller patients (< 30 kg) [3,4,15,[23][24][25], but improvements in TPVR technique and gains in technical experience have allowed TPVR to be extended to smaller (< 20 kg) and younger patients [23]. In our cohort, the smallest patient was an 8-year-old male weighing 18 kg, and he successfully underwent TPVR via the femoral vessels without vascular complication. ...
Background
Studies of transcatheter pulmonary valve replacement (TPVR) with the Melody valve have demonstrated good clinical and hemodynamic outcomes. Our study analyzes the midterm clinical and hemodynamic outcomes for patients who underwent Melody valve implantation in Southeast Asia.
Methods
Patients with circumferential conduits or bioprosthetic valves and experiencing post-operative right ventricular outflow tract (RVOT) dysfunction were recruited for Melody TPVR.
Results
Our cohort (n = 14) was evenly divided between pediatric and adult patients. The median age was 19 years (8–38 years), a male-to-female ratio of 6:1 with a median follow-up period of 48 months (16–79 months), and the smallest patient was an 8-year-old boy weighing 18 kg. All TPVR procedures were uneventful and successful with no immediate mortality or conduit rupture. The primary implant indication was combined stenosis and regurgitation. The average conduit diameter was 21 ± 2.3 mm. Concomitant pre-stenting was done in 71.4% of the patients without Melody valve stent fractures (MSFs). Implanted valve size included 22-mm (64.3%), 20-mm (14.3%), and 18-mm (21.4%). After TPVR, the mean gradient across the RVOT was significantly reduced from 41 mmHg (10–48 mmHg) to 16 mmHg (6–35 mmHg) at discharge, p < 0.01. Late follow-up infective endocarditis (IE) was diagnosed in 2 patients (14.3%). Overall freedom from IE was 86% at 79 months follow-up. Three patients (21.4%) developed progressive RVOT gradients.
Conclusion
For patients in Southeast Asia with RVOT dysfunction, Melody TPVR outcomes are similar to those reported for patients in the US in terms of hemodynamic and clinical improvements. A pre-stenting strategy was adopted and no MSFs were observed. Post-implantation residual stenosis and progressive stenosis of the RVOT require long term monitoring and reintervention. Lastly, IE remained a concern despite vigorous prevention and peri-procedural bacterial endocarditis prophylaxis.
... Ana M. Aristizabal 1,2 *, Sandra Galvis 1,2 , Jaiber Gutiérrez ,1 y Walter Mosquera 1,2 Introducción En los últimos años, la colocación de válvulas por vía percutánea ha avanzado de forma permanente, hasta lograr, en la actualidad, realizar intervenciones menos invasivas y menos mórbidas en comparación con los procedimientos quirúrgicos 1 . En pacientes con cardiopatía congénita, el implante percutáneo de válvula pulmonar es el tratamiento de elección en casos de un tracto de salida del ventrículo derecho (TSVD) disfuncional 2 . ...
... Ana M. Aristizabal 1,2 *, Sandra Galvis 1,2 , Jaiber Gutiérrez ,1 y Walter Mosquera 1,2 Introducción En los últimos años, la colocación de válvulas por vía percutánea ha avanzado de forma permanente, hasta lograr, en la actualidad, realizar intervenciones menos invasivas y menos mórbidas en comparación con los procedimientos quirúrgicos 1 . En pacientes con cardiopatía congénita, el implante percutáneo de válvula pulmonar es el tratamiento de elección en casos de un tracto de salida del ventrículo derecho (TSVD) disfuncional 2 . ...
... Specifically, pulmonary valve stenosis has been used to be treated for many years with invasive procedures and bioprosthesis insertion, which over time became dysfunctional or restenose due to fibrous tissue accumulation and valve calcification 6,7 . Due to the complications resulting from surgical injury, less invasive measures have been described for the management of residual stenosis. ...
... Due to the complications resulting from surgical injury, less invasive measures have been described for the management of residual stenosis. The first of these was the development of percutaneous stent implantation (Cheatham platinum stent) through balloon-in-balloon catheterization, which was first documented by Bonhoeffer et al., 6 with a successful case in 2000. Afterwards, the era of a new generation of percutaneous stents with the Melody valve extracted from the bovine jugular vein, mounted on a platinum-iridium stent, and percutaneously implanted using an Ensemble system 8 , and the SAPIEN valve began 9 . ...
... Transcatheter pulmonary valve implantation (TPVI) or percutaneous pulmonary valve implantation (PPVI), originally reported in the late 1990s, is a major advancement in the percutaneous management of congenital heart disease (CHD) [1]. Due to the poor longterm performance of the biological valve systems, most individuals with right ventricular outflow tract disease require numerous treatments or operations throughout their lives, which makes TPVI an attractive and less invasive substitute for reoperation of right ventricular outflow tract (RVOT) dysfunction in patients with CHD [2]. ...
... Transcatheter pulmonary valve implantation (TPVI) or percutaneous pulmon valve implantation (PPVI), originally reported in the late 1990s, is a major advancem in the percutaneous management of congenital heart disease (CHD) [1]. Due to the p long-term performance of the biological valve systems, most individuals with right tricular outflow tract disease require numerous treatments or operations throughout t lives, which makes TPVI an attractive and less invasive substitute for reoperation of r ventricular outflow tract (RVOT) dysfunction in patients with CHD [2]. ...
Background:
Transcatheter pulmonary valve implantation (TPVI) is an effective non-surgical treatment method for patients with right ventricle outflow tract dysfunction. The Medtronic Melody and the Edwards Sapien are the two valves approved for use in TPVI. Since TPVI patients are typically younger, even a modest annual incidence of infective endocarditis (IE) is significant. Several previous studies have shown a growing risk of IE after TPVI. There is uncertainty regarding the overall incidence of IE and differences in the risk of IE between the valves.
Methods:
A systematic search was conducted in the MEDLINE, EMBASE, PubMed, and Cochrane databases from inception to 1 January 2023 using the search terms 'pulmonary valve implantation', 'TPVI', or 'PPVI'. The primary outcome was the pooled incidence of IE following TPVI in Melody and Sapien valves and the difference in incidence between Sapien and Melody valves. Fixed effect and random effect models were used depending on the valve. Meta-regression with random effects was conducted to test the difference in the incidence of IE between the two valves.
Results:
A total of 22 studies (including 10 Melody valve studies, 8 Sapien valve studies, and 4 studies that included both valves (572 patients that used the Sapien valve and 1395 patients that used the Melody valve)) were used for the final analysis. Zero IE incidence following TPVI was reported by eight studies (66.7%) that utilized Sapien valves compared to two studies (14.3%) that utilized Melody valves. The pooled incidence of IE following TPVI with Sapien valves was 2.1% (95% CI: 0.9% to 5.13%) compared to 8.5% (95% CI: 4.8% to 15.2%) following TPVI with Melody valves. Results of meta-regression indicated that the Sapien valve had a 79.6% (95% CI: 24.2% to 94.4%, p = 0.019; R2 = 34.4) lower risk of IE incidence compared to the Melody valve.
Conclusions:
The risk of IE following TPVI differs significantly. A prudent valve choice in favor of Sapien valves to lower the risk of post-TPVI endocarditis may be beneficial.
... This has since transformed the timeline for dysfunctional RVOT management, heralding a new era of TCPVR, which has become one of the most common procedures for patients with ACHD [51]. Bonhoeffer's initial valve, a valved bovine internal jugular vein sewn inside a platinum stent [50], was eventually developed into the Melody valve (Medtronic, Minneapolis, MN, USA) and became commercially available in 2006, earning FDA approval in 2010 [48]. The Edwards SAPIEN/SAPIEN XT valve (Edwards Lifesciences, Irvine, CA, USA), initially designed for the aortic position, also became widely adopted for pulmonic use after favorable results from the COMPASSION trial [52], and has had specific FDA indications since 2016 [51]. ...
The field of adult congenital interventions is unique in the world of cardiac catheterization, combining the structural concepts commonly employed in pediatric heart disease and applying them to adult patients, who are more amenable to device intervention as they no longer experience somatic growth. Rapid advances in the field have been made to match the growing population of adult patients with congenital heart disease, which currently surpasses the number of pediatric patients born with congenital heart disease. Many congenital defects, which once required surgical intervention or reoperation, can now be addressed via the transcatheter approach, minimizing the morbidity and mortality often encountered within adult congenital surgeries. In this paper, we aim to provide a focused review of the more common procedures that are utilized for the treatment of adult congenital heart disease patients in the catheterization laboratory, as examples of current practices in the United States, as well as emerging concepts and devices awaiting approval in the future.
... In recent years, percutaneous valve implantation has consistently progressed, achieving today's interventions that are less invasive and have lower morbidity, compared to surgical procedures 1 . For patients with congenital heart disease, percutaneous pulmonary valve implantation is the treatment of choice for dysfunctional right ventricular outflow tracts (RVOTs) 2 . ...
... In patients with pulmonary valve dysfunction, valve replacement can be performed either surgically (SPVR) or through a transcatheter implantation (TPVI) approach. Since its introduction in 2000 [1], various analyses have shown an excellent long-term outcome for TPVI compared to SPVR [2][3][4]. Specifically in patients with congenital heart disease (CHD), a cohort of patients that faces repeated surgical interventions throughout their lifetime, TPVI appears to be an attractive minimally invasive alternative to repeated surgery. ...
Background: Conflicting data exist on the occurrence and outcome of infective endocarditis (IE) after pulmonary valve implantation. Objectives: This study sought to assess the differences between transcatheter pulmonary valve implantation (TPVI) and surgical pulmonary valve replacement (SPVR). Methods: All patients ≥ 4 years who underwent isolated pulmonary valve replacement between 2005 and 2018 were analyzed based on the data of a major German health insurer (≈9.2 million insured subjects representative of the German population). The primary endpoint was a composite of IE occurrence and all-cause death. Results: Of 461 interventions (cases) in 413 patients (58.4% male, median age 18.9 years [IQR 12.3–33.4]), 34.4% underwent TPVI and 65.5% SPVR. IE was diagnosed in 8.0% of cases during a median follow-up of 3.5 years. Risk for IE and all-cause death was increased in patients with prior IE (p < 0.001), but not associated with age (p = 0.50), sex (p = 0.67) or complexity of disease (p = 0.59). While there was no difference in events over the entire observational time period (p = 0.22), the time dynamics varied between TPVI and SPVR: Within the first year, the risk for IE and all-cause death was lower after TPVI (Hazard Ratio (HR) 95% CI 0.19 (0.06–0.63; p = 0.006) but increased over time and exceeded that of SPVR in the long term (HR 10.07 (95% CI 3.41–29.76; p < 0.001). Conclusions: Patients with TPVI appear to be at lower risk for early but higher risk for late IE, resulting in no significant difference in the overall event rate compared to SPVR. The results highlight the importance of long-term specialized care and preventive measures after both interventions.
... If left untreated, significant complications including heart failure will occur. Although the first transcatheter pulmonary valve was successfully implanted in a patient two decades ago (1,2), these early-generation balloon-expandable valves can only be used in a failed conduit or bioprosthetic valve (3)(4)(5). However, PS and PR patients with native anatomy account for over 80% of the total cases (3). ...
This study aims to evaluate the fluid dynamic characteristics of the VenusP Valve System™ under varying cardiac outputs in vitro . A thorough hemodynamic study of the valve under physiological cardiac conditions was conducted and served as an independent assessment of the performance of the valve. Flow fields downstream of the valve near the pulmonary bifurcation were quantitatively studied by two-dimensional Particle Image Velocimetry (PIV). The obtained flow field was analyzed for potential regions of flow stasis and recirculation, and elevated shear stress and turbulence. High-speed en face imaging capturing the leaflet motion provided data for leaflet kinematic modeling. The experimental conditions for PIV studies were in accordance with ISO 5840-1:2021 standard, and two valves with different lengths and different orientations were studied. Results show good hemodynamics performance for the tested valves according to ISO 5840 standard without significant regions of flow stasis. Observed shear stress values are all well below established hemolysis limits.
... The lifespan of a prosthetic pulmonary valve that has been surgically replaced, however, is constrained, and patients frequently require several PVR procedures over their lives, which increases complications and decreases survival rates [9,10]. The first successful transcatheter pulmonary valve replacement (TPVR) was reported by Bonhoeffer et al. in 2000 [11]. The Melody (Medtronic, Minneapolis, MN, USA) and the SAPIEN platforms (Edwards Lifesciences, Irvine, CA, USA) are the currently widely used balloon-expandable Table 1. ...
Pulmonary regurgitation usually leads to right heart dilatation and eventually right heart dysfunction, which is associated with a poor prognosis. Transcatheter pulmonary valve replacement is a developing treatment for pulmonary valve dysfunction that can take the place of traditional surgery and make up for the shortcomings of a large injury. Echocardiography plays a significant role in assessing ventricular function; however, conventional echocardiographic parameters have several limitations. Speckle tracking echocardiography has been regarded as a more accurate tool for quantifying cardiac function than conventional echocardiography. Therefore, the aim of this review was to summarize the application of speckle tracking echocardiography for evaluating right and left ventricular functions in patients after transcatheter pulmonary valve replacement.
... Percutaneous pulmonary valve implantation (PPVI) is effective in treating right ventricle outflow (RVOT) dysfunction. Jugular-vein-based valves mounted on a chromium platinum stent were used first in the conduit or native right ventricular outflow tract, ranging between 16 to 24 mm [1]. Prestenting was recommended in order to increase radial strength and the risk of valvular stent fracture during follow-up [2]. ...
Introduction:
Percutaneous pulmonary valve implantation (PPVI) with a SAPIEN 3 valve is effective for treating treat right ventricle outflow (RVOT) dysfunction. A modified technique was developed without prestenting using a protective valve delivery method. We aimed to compare the procedural results of the modified technique group (MTG) to those of patients in a conventional technique group (CTG).
Methods:
We designed a matched before-after study. All consecutive PPVI with SAPIEN 3 performed in the MTG over 9 months were matched, based on the RVOT type and size, to consecutive procedures performed previously with SAPIEN 3.
Results:
A total of 54 patients were included, equally distributed in the two groups. The sizes of the SAPIEN 3 valves were 23 mm (n = 9), 26 mm (n = 9), 29 mm (n = 36). The two groups were similar regarding demographic data, RVOT type, and pre-procedure hemodynamics. PPVI was performed in a single procedure in all patients of the MTG, whereas six (22.2%) patients of the CTG group underwent prestenting as a first step and valve implantation later (p = 0.02). The procedures were successful in all cases. Stent embolization was reported in two patients (7.4%) in the CTG, which were impacted in pulmonary arteries. In one case (3.7%), in the MTG, an unstable 29 mm SAPIEN 3 valve was stabilized with two stents and additional valve-in-valve implantation. The hemodynamics results were good in all cases, without significant differences between the two groups. The procedures' durations and fluoroscopy times were significantly reduced in the MTG (48.1 versus 82.6 min, p < 0.0001; 15.2 versus 29.8 min, p = 0.0002). During follow-up, neither stent fracture nor valve dysfunction was noticed in either group.
Conclusion:
PPVI without prestenting and with a protective delivery method of the SAPIEN 3 valve significantly reduces the procedure's complexity, the duration, and the irradiation while maintaining excellent hemodynamics results in selected cases.
... Percutaneous pulmonary valve implantation (PPVI) has emerged as a minimally invasive, transcatheter-based approach aimed at prolonging the lifespan of conduits/homografts by addressing stenosis and regurgitation without the need for open-heart surgery. 1 The pioneering work of Bonhoeffer et al. in 2000 marked the first successful human PPVI, subsequently demonstrating its safety and efficacy in selected patients with right ventricular outflow tract (RVOT) dysfunction. [2][3][4] Balloon-expandable PPVI using Melody and Edwards SAPIEN valves has been most common method so far. However, balloon-expandable PPVI has certain limitations when dealing with native RVOT lesions characterized by varying geometries and significant pulmonary regurgitation. ...
Background
Pulsta valve is increasingly used for percutaneous pulmonary valve implantation (PPVI) in patients with large native right ventricular outflow tract (RVOT). The aim of this study is to reveal Pulsta valve implantation outcomes within the native RVOT and to evaluate the adaptability of Pulsta valve to diverse native main pulmonary artery (PA).
Methods
A multicenter retrospective study encompassing 183 patients with moderate to severe pulmonary regurgitation (PR) in the native RVOT who underwent PPVI with Pulsta valves® between February 2016 and August 2023 at the five Korean and Taiwanese tertiary referral centers.
Results
Successful implantation of the Pulsta valves was achieved in 180 out of 183 patients (98.4 %) with an average age of 26.6 ± 11.0 years. Mean follow-up duration was 29 months. Baseline assessments revealed enlarged right ventricle (RV) volume (mean indexed RV end-diastolic volume: 163.1(Interquartile range, IQR, 152.2-179.9) mL/m2), which significantly decreased to 123.0(IQR: 106.9-137.2) mL/m2 after one year. In this study, the main PA types were classified as follows: pyramidal (3.8%), straight (38.3%), reverse pyramidal (13.7%), convex (26.2%), and concave (18.0%) shapes. Pulsta valve placement was adapted, with distal main PA for pyramidal shapes and proximal or mid-PA for reverse pyramidal shapes. The remaining patients underwent Pulsta valve implantation in the proximal or mid part of the main PA, depending on the anatomical features and size of the main PA. Two patients experienced Pulsta valve embolization to RV, necessitating surgical removal, and one patient encountered valve migration to the distal main PA, necessitating surgical fixation.
Conclusions
Customized valve insertion sites are pivotal in self-expandable PPVI considering diverse native RVOT shape. Rather soft and compact structure of Pulsta valve has characteristics to be adaptable to diverse native RVOT geometries.
Key words
percutaneous pulmonary valve implantation; native right ventricular outflow tract type; congenital heart disease; pulmonary regurgitation
... In the SAPIEN 3 THV, the next iteration after the SAPIEN XT, an outer skirt was incorporated to reduce the incidence of paravalvular leak (Fig. 6B). It comes with 4 different valve sizes (20,23,26, and 29 mm) to treat a larger range of anatomies. Of note, the 29 mm valve can be expanded up to 31 mm without compromise in valve function. ...
Surgical treatment of tetralogy of Fallot (TOF) involves surgical relief of right ventricular outflow tract (RVOT) obstruction and closure of ventricular septal defect. However, some patients may require staged palliation before surgical repair. This traditionally was achieved only with surgery but recently evolved to include catheter-based techniques. RVOT dysfunction occurs inevitably after the surgical repair of TOF and, depending on the surgical approach, manifests as either progressive stenosis, regurgitation, or a combination of both. This predisposes the individual to repeated RVOT interventions with the attendant risks of multiple open-heart surgeries. The advent of transcatheter pulmonary valve replacement has reduced the operative burden, and the expansion of transcatheter pulmonary valve replacement device platforms has widened the type and size of RVOT anatomies that can be treated. This review will discuss the transcatheter therapies available throughout the lifespan of the patient with TOF.
... 9 The first successful transcatheter valve was placed in the dysfunctional pulmonary conduit of a 12-year-old boy in 2000. 10 Transcatheter PVR (TPVR) is now performed in previously placed conduits and bioprosthetic valves of appropriate size. [11][12][13] More recently, TPVR is used for the treatment of the native or patched right ventricular outflow tract (RVOT) as devices that accommodate a larger dimension have become available. ...
This consensus document for the performance of cardiovascular computed tomography (CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with congenital heart disease (CHD) was developed collaboratively by pediatric and adult interventionalists, surgeons, and cardiac imagers with expertise specific to this patient subset. The document summarizes definitions of RVOT dysfunction as assessed by multimodality imaging techniques and reviews existing consensus statements and guideline documents pertaining to indications for intervention. In the context of this background information, recommendations for CCT scan acquisition and a standardized approach for reporting prior to surgical or transcatheter pulmonary valve replacement are proposed and presented. It is the first Imaging for Intervention collaboration for CHD patients and encompasses imaging and reporting recommendations prior to both surgical and percutaneous pulmonary valve replacement.
... Recent advances in surgical techniques and perioperative care have dramatically improved the long-term outcome of CHD. Prior to the ground-breaking contribution of Dr. Bonhoeffer in the year 2000, open-heart surgery was the only modality to address RVOT dysfunction (5). The technical challenges of repeat redo cardiac surgery and the risk of myocardial injury related to repeated cardiopulmonary bypass adds to the complexity of the underlying CHD, which necessitated the search for an alternative approach. ...
Objective
Bovine pericardium is common biological material for bioprosthetic heart valve. There remains a significant need, however, to improve bioprosthetic valves for longer-term outcomes. This study aims to evaluate the chronic performance of bovine pulmonary visceral pleura (PVP) as bioprosthetic valve cusps.
Methods
The PVP was extracted from the bovine lung and fixed in 0.625% glutaraldehyde overnight at room temperature. The PVP valve cusps for the bioprosthetic valve were tailored using a laser cutter. Three leaflets were sewn onto a nitinol stent. Six PVP bioprosthetic valves were loaded into the test chamber of the heart valve tester to complete 100 million cycles. Six other PVP bioprosthetic valves were transcardially implanted to replace pulmonary artery valve of six pigs. Fluoroscopy and intracardiac echocardiography were used for in vivo assessments. Thrombosis, calcification, inflammation, and fibrosis were evaluated in the terminal study. Histologic analyses were used for evaluations of any degradation or calcification.
Results
All PVP bioprosthetic valves completed 100 million cycles without significant damage or tears. In vivo assessments showed bioprosthetic valve cusps open and coaptation at four months post-implant. No calcification and thrombotic deposits, inflammation, and fibrosis were observed in the heart or pulmonary artery. The histologic analyses showed complete and compact elastin and collagen fibers in the PVP valve cusps. Calcification-specific stains showed no calcific deposit in the PVP valve cusps.
Conclusions
The accelerated wear test demonstrates suitable mechanical strength of PVP cusps for heart valve. The swine model demonstrates that the PVP valve cusps are promising for valve replacement.
... Depending on the severity of the condition, patients may require multiple surgeries in the future [63]. To avoid or reduce multiple reinterventions, Phillip Bonhoeffer initially described the Medtronic Melody valve implantation procedure on humans in 2000 [64]. The most crucial disadvantage of this procedure is the increased risk of infective endocarditis compared to surgery (almost three times higher for the Melody valve-1.6%), ...
Infective endocarditis (IE) is a disease of the endocardium, which leads to the appearance of vegetation on the valves, cardiac structures, or, potentially, vascular endothelium of the heart. The risk of IE can be increased more than 140 times by congenital heart disease (50–59% of all IE), particularly if cyanotic. An increase in mortality may result from IE in patients with a complex cardiac pathology or patients with an implanted prosthetic material, most frequently conduits in a pulmonary position. Cardiac implantable electronic devices (CIED) infective endocarditis is a life-threatening complication representing 10% of all cases of endocarditis. Common signs of presentation are often fever and chills; redness and swelling at the pocket of the pacemaker, including the erosion and exteriorization of the device; and life-threatening sepsis. The use of intracardiac echocardiography for the diagnosis of IE is an innovative method. This may be needed, especially in older children undergoing complex cardiac surgery, when transthoracic echocardiography (TTE) and transesophageal echocardiography (TOE) failed to provide a reliable diagnosis. The 2018 European Heart Rhythm Association (EHRA) experts’ consensus statement on transvenous lead extraction recommends complete device removal and antimicrobial therapy for any device-related infection, including CIED-IE. The most detected microorganism was Staphylococcus Aureus. In addition, cardiac surgery and interventional cardiology associated with the placement of prostheses or conduits may increase the risk of IE up to 1.6% for Melody valve implantation. Our manuscript presents a comprehensive review of infective endocarditis associated with cardiac devices and prostheses in the pediatric population, including recent advances in diagnosis and management.
Background. Preliminary results with the recently certified self-expandable Venus P-Valve™ designed for percutaneous pulmonary valve implantation in patients with dilated right ventricular outflow tracts are encouraging, but experience is limited. We therefore assessed our early and midterm outcomes with the Venus P-Valve™. Methods. Twenty patients who underwent Venus P-Valve™ implantation in our institution were included in this retrospective study. Procedural data and clinical, imaging, and hemodynamic data at baseline and last follow-up were recorded and analyzed. Results. Mean patient age was 35.0 ± 16.8 years, and five patients were <18 years of age. Procedural success was 100%, and there was no major valve-related procedural complication. At last follow-up (median 0.5 (range 0.1–6.6) years), valve function was excellent in all patients. Two patients had mild regurgitation after 6.2 and 6.6 years, respectively, while all other patients had no or only trace regurgitation. Flow was unobstructed with a mean gradient estimated by echocardiography of 12 ± 4 mmHg. NYHA functional class improved significantly (p=0.009), and right ventricular dimensions significantly decreased (right ventricular end-diastolic diameter 56±9 mm vs. 44±8 mm) (p<0.001). Transient benign ventricular arrhythmias were frequent. One patient experienced a severe arrhythmia with sustained ventricular tachycardia during follow-up. Conclusions. Early and midterm results with the Venus P-Valve™ are excellent. It considerably extends the interventional options and offers a safe and effective alternative to surgery in patients with large right ventricular outflow tracts. Larger multi-institutional studies with longer follow-up duration are required to reliably assess the long-term performance and possible long-term complications of the Venus P-Valve™.
After the first transcatheter aortic valve replacement became a reality in humans in 2002, there has been an explosion in the development of transcatheter devices for the treatment of various heart valve diseases. A variety of different design concepts have collided with each other, and various devices are increasingly being used in clinical care. Specifically, transcatheter treatment of aortic stenosis with transcatheter aortic valve replacement as the primary approach is relatively mature and has gained more clinical evidence, and although this technique still has more complications, corresponding ideas for improvement have been generated. Other valvular diseases with a higher incidence, such as aortic regurgitation, mitral regurgitation, pulmonary stenosis, and tricuspid regurgitation, are still in the process of continuous experimentation. In this chapter, we provide an overview of transcatheter devices for the abovementioned high-incidence heart valve diseases.
Polymeric heart valves (PHVs) present a promising alternative for treating valvular heart diseases with satisfactory hydrodynamics and durability against structural degeneration. However, the cascaded coagulation, inflammatory responses, and calcification in...
Background: Right ventricular outflow tract (RVOT) dysfunction in adult congenital heart disease patients frequently requires repeated interventions. Percutaneous pulmonary valve implantation (PPVI) is being used increasingly to treat pulmonary stenosis (PS) and regurgitation (PR), improving symptoms, right ventricular haemodynamics and function and, indirectly, left ventricular filling and function. This article explores the authors’ early local experience with PPVI. Methods: Between 2017 and 2022, PPVI was attempted in 10 patients at a single tertiary centre, including six with PS and four with PR. Patients underwent multimodality imaging and dental clearance. PPVI was then performed. Patients were continued on lifelong single antiplatelet therapy and dental hygiene was reinforced. Results: Overall, there was an 80% success rate of Melody PPVI in the 10 adult congenital heart disease (ACHD) patients (mean age 35.8 ± 13.7 years; 60% male), with significant improvements in RVOT pathology, right ventricle function and pulmonary pressures. Melody PPVI was cancelled in one patient due to risk of coronary compression, and an Edwards S3 PPVI was implanted in another patient instead due to a large RVOT size causing stent embolisation. Two patients experienced complications of bleeding and stent fracture, both of which were conservatively managed and had good long-term outcomes. Conclusion: The authors present their early local experience with PPVI in ACHD patients at a single tertiary centre. PPVI has proven to be safe and efficacious, improving PS and PR, right and left ventricle function and pulmonary pressures. Nonetheless, precautions must be taken to minimise complications such as coronary compression, access site bleeding, device embolisation and stent fracture.
OBJECTIVES
Surgical management of mitral valve disease is challenging in infants <1 year-old. We aimed at reviewing the French experience with Melody mitral valve replacement in critically ill infants
METHODS
A retrospective cohort study reporting the French experience with Melody mitral valve replacement.
RESULTS
Seven symptomatic infants (complete atrioventricular septal defect [N = 4, Down syndrome: N = 3], hammock valve [N = 3]) underwent Melody mitral valve replacement (age: 3 mo [28 days-8mo], weight: 4.3 kg [3.2–6.4 kg]) because of severe mitral valve regurgitation (6) or mixed valve disease (1) and 14 mm (11-16mm) mitral valve annulus. In 2 patients whose valve was felt irreparable, Melody mitral valve replacement was performed straightaway. The others underwent 2 (1–3) previous attempts of valve repair; 3 were on extracorporeal membrane oxygenation. Melody mitral valve replacement led to competent valve and low gradient (3 mmHg, [1-4mmHg]). One patient died 3 days post-implant from extracorporeal membrane oxygenation-related stroke. Of the 6 discharged home patients, 3 (50%) were readmitted for a definite diagnosis (1) or high suspicion (2) of infective endocarditis, of which 2 died. Over the follow-up, one underwent balloon expansions of the valve at 9- and 16-months post-implant, and mechanical mitral valve replacement at 2 years; another is currently planned for transcatheter Melody valve dilation.
CONCLUSIONS
Melody mitral valve replacement may be considered in selected infants with small mitral valve annulus as an alternative to mechanical mitral valve replacement. Our experience highlights a high-risk of late IE that deserves further consideration.
Pre-stenting of the right ventricular outflow tract (RVOT) is commonly performed before percutaneous pulmonary valve implantation (PPVI), to relieve obstruction, prevent valved stent fractures, and provide a landing zone. This study aimed to evaluate the biomechanical characteristics of the stents currently used to perform pre-stenting of the RVOT.
We assessed five commercially available stents: Cheatham-Platinum Stent (“CP Stent”), AndraStent XL, AndraStent XXL, Optimus XL, and Optimus XXL. Following stent deployment at nominal pressure, radial and longitudinal elastic recoils and radial resistance were measured. The bending stiffness of the stents crimped onto the balloons was also evaluated.
Three samples were tested for each stent. Our study showed no significant difference between the stent platforms in terms of radial elastic recoil, which was relatively low (< 10%). The longitudinal elastic recoil was also low for all the devices (< 5%). Significant differences were observed in radial resistance (P < 0.001). CP Stent and AndraStent XL exhibited the highest radial resistances. The bending stiffnesses of the stents crimped on their balloons were significantly different (P < 0.00001). Optimus XL and XXL were more flexible than the other stents.
This study highlights the significant differences between the stents currently used in RVOT pre-stenting. Stents with good radial resistance are preferred, especially for calcified vessels, and flexibility is crucial for tortuous vessels. We proposed an algorithm for selecting the most suitable stent according to the need for radial force and flexibility, which will help inform clinicians considering RVOT revalvulation.
Infective endocarditis (IE) remains a serious disease that is associated with significant morbidity and mortality, and despite the significant advances that have been made in understanding the disease process in past decades, its incidence appears to be on the rise recently. Endocarditis in children is no longer a rare occurrence. This appeared to be related to a combination of the improved survival of children with congenital heart diseases (CHDs), increase use of intracardiac protheses, and catheter-related interventions. The American Heart Association (AHA) 2007 guidelines reduced the recommendations for use of prophylactic antibiotics in those with CHDs which occurred despite the noticeable increase in endocarditis incidence around that time. In general, the recommendations for managing children with IE are derived from the adults’ guidelines, and the evidence-base is lacking in many clinical scenarios. Understanding the epidemiology, clinical presentations, microbiology, and outcomes of different management strategies for endocarditis is needed to have a clear and optimal plan for these children. In the current narrative review, we discuss IE in the pediatric population in terms of etiology, predisposing factors, and different treatment strategies for this unique population.
Pulmonary homograft dysfunction is challenging to treat in patients with a previous Ross procedure, and results in significant morbidity and mortality in case of reoperation. We report the case of a patient with early severe pulmonary homograft stenosis 18 months after a Ross procedure and successful management using transcatheter pulmonary valve replacement.
Background
Pulsta valve is increasingly used for percutaneous pulmonary valve implantation (PPVI) in patients with a large native right ventricular outflow tract (RVOT). This study aims to elucidate the outcomes of Pulsta valve implantation within the native RVOT and assess its adaptability to various native main pulmonary artery (PA) anatomies.
Methods
A multicenter retrospective study included 182 patients with moderate to severe pulmonary regurgitation in the native RVOT who underwent PPVI with Pulsta valves® between February 2016 and August 2023 at five Korean and Taiwanese tertiary referral centers.
Results
Pulsta valve implantation was successful in 179 out of 182 patients (98.4%) with an average age of 26.7 ± 11.0 years. The median follow‐up duration was 29 months. Baseline assessments revealed enlarged right ventricle (RV) volume (mean indexed RV end‐diastolic volume: 163.1 (interquartile range, IQR: 152.0–180.3 mL/m²), which significantly decreased to 123.6(IQR: 106.6–137.5 mL/m ² after 1 year. The main PA types were classified as pyramidal (3.8%), straight (38.5%), reverse pyramidal (13.2%), convex (26.4%), and concave (18.1%) shapes. Pulsta valve placement was adapted, with distal main PA for pyramidal shapes and proximal or mid‐PA for reverse pyramidal shapes. Two patients experienced Pulsta valve embolization to RV, requiring surgical removal, and one patient encountered valve migration to the distal main PA, necessitating surgical fixation.
Conclusions
Customized valve insertion sites are pivotal in self‐expandable PPVI considering diverse native RVOT shape. The rather soft and compact structure of the Pulsta valve has characteristics to are adaptable to diverse native RVOT geometries.
Various transcatheter interventions for the right ventricular outflow tract (RVOT) have been introduced and developed in recent decades. Transcatheter pulmonary valve perforation was first introduced in the 1990s. Radiofrequency wire perforation has been the approach of choice for membranous pulmonary atresia in newborns, with high success rates, although complication rates remain relatively common. Stenting of the RVOT is a novel palliative treatment that may improve hemodynamics in neonatal patients with reduced pulmonary blood flow and RVOT obstruction. Whether this option is superior to other surgical palliative strategies or early primary repair of tetralogy of Fallot remains unclear. Transcatheter pulmonary valve replacement has been one of the biggest innovations in the last two decades. With the success of the Melody and SAPIEN valves, this technique has evolved into the gold standard therapy for RVOT abnormalities with excellent procedural safety and efficacy. Challenges remain in managing the wide heterogeneity of postoperative lesions seen in RVOT, and various technical modifications, such as pre-stenting, valve ring modification, or development of self-expanding systems, have been made. Recent large studies have revealed outcomes comparable to those of surgery, with less morbidity. Further experience and multicenter studies and registries to compare the outcomes of various strategies are necessary, with the ultimate goal of a single-step, minimally invasive approach offering the best longer-term anatomical and physiological results.
Tetralogy of Fallot (TOF) is the most common form of cyanotic congenital heart disease, occurring in 1 in 3600 live births. Complete repair of TOF was devised over 50 years ago (first reported by Lillehei in 1954) and can result in complete intracardiac repair in early infancy. There are excellent short- and medium-term survival rates, and 25-year actuarial survival for patients repaired before their fifth birthday is now greater than 90% of the expected survival rate, though the annualized risk of death triples in the third postoperative decade. Late morbidity and mortality related to pulmonary incompetence have been observed in many patients long after total repair. Cardiovascular magnetic response imaging forms an essential part of the long-term follow-up of repaired TOF, guiding when to perform pulmonary valve replacement (PVR), selecting which patients should undergo surgical or percutaneous PVR, and helping to risk assess patients for adverse events.
A common feature of congenital heart disease is the presence of right ventricular outflow tract (RVOT) obstruction that can range from mild to severe and can lead to atresia of the pulmonary valve, in extreme conditions. RVOT abnormalities can frequently be corrected surgically or via interventional means. However, most of these patients will ultimately develop pulmonary valve insufficiency and eventual right ventricular dilation, which will require a pulmonary valve replacement at some point in their life to mitigate the detrimental effects of pulmonary valve regurgitation (PVR) on the right ventricle (RV). The evolution from the studies done by Philip Bonhoeffer to implant a pulmonary valve via transcatheter means, have provided a bedrock for transcatheter pulmonary valve replacement (TPVR). Yet, several areas of unmet need for a demographic of patients still exist. Here, we discuss the clinical unmet needs in children under 20 Kg and expand the use of hybrid and other TPVR approaches along with the current indications and contraindications for pulmonary valve replacement. The constraints and limitations from commercially available pulmonary valves will be discussed from a clinical standpoint. Finally, we explore the use of hybrid and periventricular delivery of transcatheter pulmonary valves in younger patients.
Patients with surgically repaired congenital right ventricular (RV) outflow anomalies face reintervention due to RV to pulmonary artery (PA) conduit dysfunction in adulthood. Conduit regurgitation, valvular stenosis, and conduit stenosis with calcification are all mechanisms of failure that if untreated lead to deterioration in RV function. Re-operation is associated with high risks and subsequently percutaneous pulmonary valve implantation (PPVI) has been developed as a less invasive alternative. PPVI is established as a safe and effective option for patients with dysfunctional surgical RV-PA conduits. This chapter demonstrates real-life examples of PPVI in clinical practice and reviews the current landscape in RV-PA conduit intervention.KeywordsPulmonary valveConduitCongenital heart diseaseTranscatheterRight ventricular outflow tractPercutaneous valve replacement
This consensus document for the performance of Cardiovascular Computed Tomography (CCT) to guide intervention in the right ventricular outflow tract (RVOT) in patients with congenital disease (CHD) was developed collaboratively by pediatric and adult interventionalists, surgeons and cardiac imagers with expertise specific to this patient subset. The document summarizes definitions of RVOT dysfunction as assessed by multi-modality imaging techniques and reviews existing consensus statements and guideline documents pertaining to indications for intervention. In the context of this background information, recommendations for CCT scan acquisition and a standardized approach for reporting prior to surgical or transcatheter pulmonary valve replacement are proposed and presented. It is the first Imaging for Intervention collaboration for CHD patients and encompasses imaging and reporting recommendations prior to both surgical and percutaneous pulmonary valve replacement.
It has been over 20 years since the first-in-human PPVI procedure by Phillip Bonhoeffer et al., the possibilities for transcatheter heart valve replacement have boomed and many lives have been saved or enhanced. The transcatheter valve market has opened to dozens of solutions which are collectively able to treat any of the four human heart valves, using different materials, designs and deployment methods to innovate around well-recognised limitations in all applications. This chapter discusses this rich history of transcatheter technologies and describes many of the novel innovative solutions.
Between 1971 and 1982, 249 patients received right heart extracardiac conduits. The 173 patients who survived 30 days were reviewed retrospectively; 72 had antibiotic-sterilized aortic homografts, 97 had xenografts of various types, and four had valveless tubes. Reoperation for conduit obstruction was required as early as 13 months after the original operation, but actuarial analysis showed no differences in overall performance of homograft and heterograft conduit groups with respect to late death or survival free of conduit obstruction. More important risk factors for late death or the need for reoperation were the severity of the underlying cardiac lesions and the influence of early postoperative complications. When analyzed statistically, the performance of conduits bearing homografts was disappointing, influenced sometimes by complications in the Dacron extension tubes. Repairs dispensing with conduits entirely should be evaluated.
Six to thirty percent of right ventricular-to-pulmonary arterial (RV-PA) valved conduits in children fail within 5 years. Experience with correction of tetralogy of Fallot has shown that a competent pulmonary valve is not essential for excellent late results in most patients. Between March 1980 and November 1984, 26 patients who were 12.5 +/- 3.3 years old underwent conduit replacement 6.7 +/- 2.4 years after definitive repair of congenital heart defects in which a xenograft RV-PA valved conduit had been used. A new Dacron tube graft (n = 15) or pericardial (n = 8), dura mater (n = 2), or Dacron patch (n = 1) over the previous conduit bed was used as replacement. Preoperative mean right ventricular systolic pressure was 90.5 +/- 20 mm Hg and mean gradient across the conduit was 67.9 +/- 24.5 mm Hg. After replacement with a nonvalved conduit, right ventricular systolic pressure was reduced to 45.2 +/- 10.8 mm Hg (p less than .001), with a gradient of 8.9 +/- 7.6 mm Hg (p less than .001). There were no operative deaths. Follow-up at 19.5 +/- 14.9 months (range = 0 to 53) showed that all patients were in New York Heart Association class I (n = 21) or class II (n = 5). In the absence of pulmonary hypertension, hypoplastic pulmonary arteries, significant right ventricular dysfunction, or unrepaired tricuspid regurgitation, replacement of an obstructed conduit with a nonvalved conduit gives excellent early results and may diminish the need for late reoperation.
Long-standing pulmonary insufficiency after repair of tetralogy of Fallot may adversely affect ventricular function. We evaluated 20 patients at a mean of 9 years after repair by radionuclide ventriculography, 24 hour Holter monitoring, and M-mode echocardiography. The mean age at complete repair was 7.1 ± 2.6 years. Patients were divided into groups as follows: Group I (eight patients), no clinical pulmonary insufficiency; Group II (12 patients), moderate to severe pulmonary insufficiency. Group II was further divided: Group IIa, transannular patch (six patients): Group IIb, no transannular patch (six patients). There was no difference between groups for age at operation, duration of follow-up, right ventricular pressure, or right ventricular-pulmonary arterial gradient. No patient had a residual shunt and all were in New York Heart Association Class I. Serious ventricular dysrhythmias occurred in 38% of Group I patients and 50% of Group II (p = NS). The echocardiographic ratio of right to left ventricular end-diastolic dimension was greater in patients with pulmonary insufficiency than in those without pulmonary insufficiency: 0.83 ± 0.17 versus 0.55 ± 0.15, p < 0.01. Right ventricular ejection fraction was 0.39 ± 0.08 in Group I and 0.27 ± 0.07 in Group II, p < 0.01. Left ventricular ejection fraction was 0.64 ± 0.12 in Group I and 0.53 ± 0.07 in Group II, p < 0.02. Radionuclide angiography is a useful means of identifying right ventricular dysfunction following repair of tetralogy of Fallot. The dysfunction appears significantly worse in patients with pulmonary insufficiency.
In January 1997, experts from the United States, Europe, and Japan gathered at Stanford University to review their collective experience with intracoronary and noncoronary stenting and to identify and prioritize issues requiring further clinical investigation. This report summarizes the discussions that took place during this stent summit. Knowledge of stent-tissue interaction from animal and human pathologic specimens was reviewed in the context of evolving stent designs. The relative merits of coil and slotted tubular stent designs were discussed. Stent deployment routines, including self-expansion, balloon expansion, and high-pressure delivery were debated. The potential for covered stents and coated stents was explored. Problems surrounding the routine deployment of stents were identified: small vessel disease, long lesions, bifurcation stenoses, vein graft disease, ostial disease, left main stenoses, and intrastent restenosis. The value of intravascular ultrasound, as an adjunct to stenting, was explored and debated. An algorithm for “provisional stenting” based on ultrasound criteria was developed. Noncoronary stenting of the aorta, iliacs, and carotids were discussed. Clinical applications that may lead to randomized clinical trials were identified. (Am Heart J 1998;136:578-99.)
Objectives:
This study was designed to assess the impact of implantation of balloon-expandable stents on right ventricular outflow obstruction in children with congenital heart disease.
Background:
Intravascular stenting has been established as a useful treatment in adults with coronary and peripheral vascular disease. Its application in the treatment of infants and children with pulmonary, systemic and right ventricular conduit obstruction resistant to balloon angioplasty is limited.
Methods:
A total of 24 stainless steel stents were implanted in 17 patients. Five stents were placed within right ventricular to pulmonary artery conduits, 17 in branch pulmonary arteries and 1 in an aortopulmonary collateral vessel. Follow-up time has ranged from 1 to 14 months, with 6 patients having hemodynamic and angiographic studies greater than 1 year after stent placement. The mean age at implantation was 7.4 +/- 5.6 years and the mean weight 33 +/- 16 kg.
Results:
Optimal stent position was obtained in 22 of 24 implantations. In one patient the stent slipped from the delivery balloon and was left positioned in the inferior vena cava. No embolization or thrombotic event has been documented. Among patients with right ventricular to pulmonary artery conduit obstruction, the gradient was immediately reduced from 85 +/- 30 mm Hg to 35 +/- 20 mm Hg after stent implantation; however, three patients required conduit replacement because of persistent obstruction with elevated right ventricular pressures (82 +/- 16 mm Hg). In 10 of 11 patients with pulmonary artery stenosis, clinical improvement was noted in association with enlargement of vessel diameter by 92% +/- 90% (range 17% to 355%) and the gradient reduction of 22 +/- 24 mm Hg to 3 +/- 4 mm Hg.
Conclusions:
These data support the view that intravascular stenting will become an important adjunct in the management of children with congenital heart disease.
Between 1971 and 1993, 656 conduits were placed in the subpulmonary position. Patients receiving heterografts or valveless conduits and patients dying within 90 days of insertion were excluded; thus 405 homograft conduits were studied. There were 293 aortic homografts, 94 pulmonary, and 18 of unknown type. The end point of conduit failure was defined by conduit replacement for whatever reason, balloon dilation of the conduit, or death of the patient with the conduit in place. The following factors were analyzed: aortic versus pulmonary homograft, antibiotic preservation versus cryopreservation, ABO and Rh compatibility, type of material used for conduit extension, age at operation, size of the conduit, diagnosis, and reoperations. Conduit number (1 to 405) in the series was included in the multivariable model.
First conduits and conduits inserted earlier in the series appeared to last longer than second and subsequent conduits and those inserted later in the series (p = 0.001 and 0.003, respectively). Overall survival of conduits at 5, 10, and 15 years was 84% (95% CL, 80% to 88%), 58% (95% CL, 50% to 66%), and 31% (95% CL, 19% to 43%). Corresponding figures for the first conduits were 88% (95% CL, 84% to 92%), 65% (95% CL, 56% to 73%), and 34% (95% CL, 20% to 47%). The longest surviving homograft conduit in our series lasted 22.7 years. Regarded univariately, reoperation (redo worse), order number (recent worse), type of conduit (pulmonary worse than aortic), preservation (cryopreserved worse than antibiotic preserved), and age at operation (older patients worse) were statistically significant. However, in multivariable analysis, including all the above in the model, only reoperation and order number had significant predictive power. When patient survival was considered, patients operated on more recently survived longer despite the fact that their conduits were being replaced earlier. Overall, survival of patients at 5 and 15 years was 95% (95% CL, 93% to 98%) and 85% (95% CL, 77% to 92%), respectively.
Pulmonary and aortic homografts, both cryopreserved and preserved in nutrient antibiotic solution, give similar results. All conduits will probably have to be replaced during the lifetime of the patient. In view of the worse performance of replacement conduits, techniques of repair that avoid the use of conduits should be further explored. Despite gradual deterioration of homograft conduits, they remain an important tool in the correction of many complex lesions with excellent 15-year patient survival.
Four types of valved conduits used to correct venous ventricle to pulmonary artery (V-PA) discontinuity were compared.
Four hundred fifty-seven patients with congenital heart defects requiring a V-PA connection during the past 25 years were reviewed. Age at implant varied from 1 day to 64 years (mean, 9.1 years). Four types of valved prostheses were used: 1) homograft conduit (HC, n = 178), 2) valved Dacron conduit (VDC, n = 126), 3) polystan conduit (PC, n = 47), and 4) orthotopic pulmonary valve implant (PVI, n = 106). There were 83 early deaths (18.2%) and 34 late deaths (8.5%). Follow-up ranged from 1 month to 22 years (mean, 3.5 years). One hundred eight conduit replacements were performed in 93 patients (21%). The overall patient survival was 73 +/- 2.3%, 67 +/- 3.2%, and 56 +/- 6.8% at 5, 10, and 15 years, respectively. Factors predictive of patient survival were diagnosis (p < 0.001) and valve size (p < 0.001). Age at operation (p < 0.001) and type of valve (p < 0.001) were the only risk factors for valve survival. At 5 years, survival of PVI (89 +/- 5%) and VDC (89 +/- 4%) was significantly better than survival of HC (46 +/- 13%) or PC (57 +/- 9%).
Patients who survived the initial construction of a V-PA conduit had a reasonable long-term survival. A PVI was the most durable prosthesis. A Dacron porcine-valved conduit had significantly better durability than either a cryopreserved homograft or a PC.
This study evaluates our experience with the cryopreserved homograft valved conduit used for reconstruction of the pulmonary circulation in patients with congenital heart disease.
Between July 1, 1985, and December 31, 1990, 219 patients had cryopreserved homograft extracardiac valved conduits placed in the pulmonary circuit. Average age at operation was 7.2 years. Of these, 132 patients had a pulmonary homograft, and 87 had an aortic homograft. Twenty-four patients (11%) died in hospital. Hospital survivors (n = 195) have been followed an average of 29.8 months (SD, +/- 18.4 months). Fourteen patients died during follow-up, almost all related to the complexity of their original cardiac malformation. Thirty-two patients (15%) have required reoperation for conduit-related problems. Actuarial freedom from conduit reoperation is 55 +/- 12% at 5 years. The most common indication for reoperation was calcific stenosis (n = 27). Other indications for reoperation were pseudoaneurysm (n = 2), conduit infection (n = 2), and pulmonary insufficiency (n = 1). Reoperation rate for patients with aortic homografts (16 of 87) compared with that for pulmonary homografts (16 of 132) was not significantly different by the actuarial method.
Long-term function of cryopreserved homograft valved conduits in the pulmonary circulation is disappointing.
Between 1971 and 1983, 201 patients received synthetic right heart conduits, predominantly porcine-valved Dacron conduits, at The Children's Hospital, Boston. There were 45 hospital deaths (22%). Follow-up has been achieved in 148 of 156 survivors (95%). Thirty-four conduits have been replaced, all because of conduit obstruction. The actuarial freedom from conduit replacement was 81% at 5 years, 61% at 7 years, and 0% at 10 years for valved conduits. There was no significant difference to 5 years in reoperation rate between patients with Carpentier-Edwards and those with Hancock conduits. Patients older than 18 years at the time of conduit insertion were 92% free of conduit replacement at 5 years. Those with nonvalved conduits were 100% reoperation free at 4 years. The actuarial survival of patients with valved conduits was 91% at 5 years and 83% at 10 years. The poor performance of porcine-valved tightly woven Dacron conduits warrants a change to use of an alternative conduit, particularly in smaller children. Possible alternatives include antibiotic-sterilized homografts and valved or nonvalved high-porosity knitted Dacron conduits appropriately pretreated with collagen impregnation or fibrin glue.
Actuarial freedom from reoperation for obstruction in 147 patients receiving cryopreserved or fresh allograft valved conduits between a ventricle and the pulmonary arteries was 94% at 3.5 years. The 2 patients undergoing reoperation were 6 and 36 months of age at the time of insertion of the allograft. Among 24 patients in whom cardiac catheterization was performed on indication late postoperatively, 5 had gradients of more than 40 mm Hg across the conduit. For comparison, among 78 patients receiving xenograft or irradiated allograft valved conduits, the percentages of freedom from conduit reoperation at 3.5, 5, 10, and 15 years were 99%, 95%, 59%, and 11%, respectively. The diameters of the allograft and xenograft valves inserted varied directly with the age and size of the patients, but in patients 3 to 5 years of age, allografts with a diameter of at least 21 mm could usually be used.
Long-standing pulmonary insufficiency after repair of tetralogy of Fallot may adversely affect ventricular function. We evaluated 20 patients at a mean of 9 years after repair by radionuclide ventriculography, 24 hour Holter monitoring, and M-mode echocardiography. The mean age at complete repair was 7.1 +/- 2.6 years. Patients were divided into groups as follows: Group I (eight patients), no clinical pulmonary insufficiency; Group II (12 patients), moderate to severe pulmonary insufficiency. Group II was further divided: Group IIa, transannular patch (six patients); Group IIb, no transannular patch (six patients). There was no difference between groups for age at operation, duration of follow-up, right ventricular pressure, or right ventricular-pulmonary arterial gradient. No patient had a residual shunt and all were in New York Heart Association Class I. Serious ventricular dysrhythmias occurred in 38% of Group I patients and 50% of Group II (p = NS). The echocardiographic ratio of right to left ventricular end-diastolic dimension was greater in patients with pulmonary insufficiency than in those without pulmonary insufficiency: 0.83 +/- 0.17 versus 0.55 +/- 0.15, p less than 0.01. Right ventricular ejection fraction was 0.39 +/- 0.08 in Group I and 0.27 +/- 0.07 in Group II, p less than 0.01. Left ventricular ejection fraction was 0.64 +/- 0.12 in Group I and 0.53 +/- 0.07 in Group II, p less than 0.02. Radionuclide angiography is a useful means of identifying right ventricular dysfunction following repair of tetralogy of Fallot. The dysfunction appears significantly worse in patients with pulmonary insufficiency.
Analysis of the late results in 352 patients surviving insertion of an extracardiac conduit before mid 1977 has provided a mean follow-up interval of 65 months. Three fourths of the patients remain in improved condition after operation. Serial measurements of transconduit gradient are available in 90. The median change was +7 mm Hg and the mean +21 mm Hg. Reoperation was required in 16 percent of patients (mortality rate 9 percent), most commonly (77 percent) because of progressive conduit stenosis, more commonly for transposition of the great arteries than for other types of anomalies, and more commonly after use of a homograft aortic conduit than a Hancock conduit. The side of the aorta on which the conduit was placed exerted no significant influence. The postrepair transconduit gradient did not affect the need for reoperation. Late survival was 95 percent at 1 year, 85 percent at 5 years, and 73 percent at 10 years and was significantly better (probability [p] less than 0.006) for patients with pulmonary atresia than for the others. The hospital mortality rate was highest, and the late mortality rate lowest, for children less than 5 years of age; the overall survival rate in this age group was lower. The postrepair right ventricular to left ventricular pressure ratio, together with age, was a principal prognostic indicator of late survival, being less good when more than 0.73. THe most frequent causes of late death were progressive congestive heart failure and sudden death.
Right ventricle-to-pulmonary artery (RV-PA) homografts and bioprosthetic conduits are commonly used to palliate various types of complex congenital heart disease. These conduits frequently develop progressive obstruction and require surgical replacement. This report reviews our experience implanting balloon-expandable stents to relieve conduit obstruction and delay reoperation.
A retrospective review identified 44 patients who underwent placement of 48 stents in obstructed RV-PA conduits. Median patient age was 6.9 years (range, 7 months to 30 years), and median follow-up time was 14.2 months (range, 0 to 48 months). Stent implantation initially decreased the RV-PA pressure gradient from 61.0 +/- 16.9 to 29.7 +/- 11.9 mm Hg (P < or = .001) and the right ventricular-to-systemic arterial pressure ratio from 0.92 +/- 0.17 to 0.63 +/- 0.20 (P < or = .001). The diameter of the stenotic region expanded from 9.3 +/- 3.5 to 12.3 +/- 3.3 mm in the anteroposterior view (P < or = .001) and from 6.6 +/- 2.9 to 10.9 +/- 2.5 mm in the lateral view (P < or = .001). During the follow-up period, 2 patients had their stents redilated, 7 had additional conduit stents deployed, and 14 underwent surgical replacement of their conduits. Actuarial freedom from conduit reoperation was 65% at 30 months postprocedure. Seven patients were found to have fractured stents on follow-up, suggesting an important role for external compressive forces in conduit failure. Recatheterization in 16 patients a median of 11.8 months (3 to 48 months) postprocedure demonstrated hemodynamic evidence of recurrent obstruction despite sustained enlargement at the previously stented sites. Complications included stent displacement (n = 1), bacterial endocarditis (n = 1), and false aneurysm formation (n = 1). One patient died awaiting conduit replacement surgery.
Stent implantation in obstructed RV-PA conduits results in significant immediate hemodynamic and angiographic improvement. In a subgroup of patients, the procedure prolongs conduit life span by several years and increases the interval between conduit reoperations. Recurrent obstruction is caused by external compression and progressive stenosis outside the stented region.
To determine late patient outcome and homograft durability, we reviewed 326 patients who received aortic (n = 230) or pulmonary (n = 118) cryopreserved homografts for right ventricular outflow reconstruction between January 1985 and October 1993. Patient survival, including operative mortality, 5 years after the operation was similar between the two groups (pulmonary homograft 86%, aortic homograft 80%; p = not significant by log-rank test). However, 5-year freedom from homograft failure was significantly better for pulmonary homografts (94% versus 70%, p < 0.01 by log-rank test). Late calcification was evaluated by chest roentgenography and echocardiography. Overall, 20% of aortic homografts became moderately or severely calcified compared with 4% of pulmonary homografts (p < 0.01). Twenty-six percent of aortic homografts in children 4 years old or younger had moderate or severe obstruction associated with calcification, whereas only 11% of aortic homografts in patients over 4 years of age had calcific obstruction (p < 0.01). No late deaths among patients receiving pulmonary homografts were related to graft failure; two late deaths in the aortic homograft group were homograft related. Risk factors for patient mortality and homograft failure (defined as either need for homograft replacement because of homograft failure or as homograft-related death) were identified by the Cox multivariate analysis. Aortic type of homograft was a significant risk factor for homograft failure (p < 0.0001), but type of homograft was not correlated with patient mortality. Age 4 years or younger was a significant risk factor for both mortality (p < 0.01) and homograft failure (p = 0.03) in aortic homograft recipients but not in pulmonary homograft recipients. These results indicate that both aortic and pulmonary homografts provided excellent intermediate-term patient survival after right ventricular outflow tract reconstruction, but pulmonary homografts are more durable than aortic homografts with less calcification and obstruction, especially among children 4 years old or younger.
Balloon-expandable stents (Johnson and Johnson Interventional Systems) have been in use for congenital heart disease since late 1989. They have made possible treatment in previously untreatable branch pulmonary artery stenoses and systemic venous stenosis. The purpose of this report is to detail the results and intermediate-term follow-up of stents used for treatment of congenital heart disease.
Eighty-five patients underwent placement of 121 stents in Houston and Boston. Fifty-eight patients had stents put in pulmonary arteries, nine had stents in conduits or outflow tracts, and 21 had stents in venous stenoses or narrowed Fontan anastomoses. (Three patients had stents in two locations.) These stent procedures resulted in gradient reduction from 55.2 +/- 33.3 to 14.2 +/- 13.5 mm Hg in pulmonary arteries, from 41.4 +/- 26.0 to 20.7 +/- 17.0 mm Hg in conduits or outflow tracts, and from 9.8 +/- 6.9 to 2.4 +/- 3.1 mm Hg in venous stenoses or Fontan anastomoses. Diameter of narrowings increased from 4.6 +/- 2.3 to 11.3 +/- 3.2 mm in the pulmonary artery, from 8.8 +/- 3.6 to 12.7 +/- 2.6 in conduits, and from 3.8 +/- 2.9 to 11.3 +/- 2.8 in venous stenoses. Follow-up has shown stent fracture in one patient, restenosis in one, and sudden death in one. Recatheterization has been done in 38 patients an average of 8.6 months after stent installation. Compared with immediately postimplant data, there was no significant change in luminal diameter or pressure gradient. Redilation was performed in 14 patients (17 stents) 1 week to 24 months after implantation (mean, 10.2 months), with a small but significant increase in stenosis diameter.
We conclude that stent treatment of vascular stenoses in congenital heart disease retains efficacy at medium-term follow-up and offers a much-improved outlook for patients with these lesions.
The aim of this study was to evaluate the long-term results of the use of an autologous pericardial valved conduit in the outflow tract of the venous ventricle in congenital heart malformations.
Fifty-one patients were followed up for a period of 12 to 120 months; 30 for more than 36 months and 13 for more than 72 months. All were evaluated clinically and by two-dimensional and Doppler echocardiography. Eight patients were recatheterized. Postoperative evaluation included serial measurement of pressure gradients and the conduit's diameter at the proximal, valvular, and distal levels. Reoperation because of stenosis was indicated when the gradient across the right ventricular outflow was greater than 50 mm Hg. The reoperation rate in relation with postoperative time, diameter of the autologous pericardial valved conduit at the time of implantation, and malformation was statistically analyzed.
In 27 patients the conduit increased its diameter 1 to 7 mm. In 20 patients the diameter remained unchanged, whereas a reduction was noted in 4. Conduit survival free of reoperation for the whole group was 89.9% at 5 years. Conduit survival free of reoperation was 100% at 5 and 7 years for conduits larger than 16 mm at the time of implantation. It was 95% (standard deviation = 4.8%) at 5 years and 72.3% at 7 years for those 16 mm or less. For patients operated after January 1, 1986 (technical modification), conduit survival free of reoperation was 95.4% at 7 years postoperatively.
These results compare favorably with those of other available conduits.
In January 1997, experts from the United States, Europe, and Japan gathered at Stanford University to review their collective experience with intracoronary and noncoronary stenting and to identify and prioritize issues requiring further clinical investigation. This report summarizes the discussions that took place during this stent summit. Knowledge of stent-tissue interaction from animal and human pathologic specimens was reviewed in the context of evolving stent designs. The relative merits of coil and slotted tubular stent designs were discussed. Stent deployment routines, including self-expansion, balloon expansion, and high-pressure delivery were debated. The potential for covered stents and coated stents was explored. Problems surrounding the routine deployment of stents were identified: small vessel disease, long lesions, bifurcation stenoses, vein graft disease, ostial disease, left main stenoses, and intrastent restenosis. The value of intravascular ultrasound, as an adjunct to stenting, was explored and debated. An algorithm for "provisional stenting" based on ultrasound criteria was developed. Noncoronary stenting of the aorta, iliacs, and carotids were discussed. Clinical applications that may lead to randomized clinical trials were identified.
This retrospective study was initiated to evaluate the long-term results of valved prosthetic conduits implanted in the right ventricular outflow tract in patients with complex ventricular-pulmonary discontinuity.
A cohort of 103 patients out of 127 (24 early deaths, 19%) operated on between 1973 and 1996 with porcine valved conduits was available for evaluation, with a follow-up ranging from 1 to 21.6 years (mean follow-up 8.4 +/- 6 years). A total of 74 hemodynamic studies were performed after the operation, 50 patients having undergone at least 1 cardiac catheterization during the follow-up period.
There were 16 late deaths, and the actuarial survivals, including early mortality, were 72.9% +/- 4% at 5 years, 63.1% +/- 5% at 10 years, and 58.2% +/- 5% at 15 years, at which time 20 patients were still available for review and exposed to the risk of dying. The mean peak systolic gradient across the right ventricular outflow tract was plotted as a function of time, showing a gradual increase and a significant step-up after the eighth year, from 43 +/- 36 to 69 +/- 19 mm Hg (P < .005). Reoperation was required for progressive conduit obstruction between 1.1 and 17.7 years after implantation (mean 7.4 +/- 4.8 years) in 25 patients (24%, 70% CL 15%-33%), with generally very few symptoms, or for residual ventricular septal defect in 3 patients. Freedom from reoperation was 79.5% +/- 5% at 10 years and 65.8% +/- 7% at 15 years.
Porcine conduits may represent a valuable alternative to biologic substitutes with similar long-term results. Given the few symptoms, progressive conduit stenosis after the eighth postoperative year imposes a yearly noninvasive patient evaluation during the follow-up.
Prosthetic conduits, with or without biological valves, are often inserted in surgical procedures to correct or palliate cardiac malformations. The principal problem is degeneration which causes variable degrees of obstruction requiring reoperation for their replacement. The aims of this study were to assess the feasibility, safety and efficacy of a non-surgical method of treating these obstructive prostheses by dilatation-implantation of a metallic vascular endoprosthesis (stenting). Thirteen patients were treated (age range 7.7 to 36 years; mean: 15 years). Eight had pulmonary atresia with a ventricular septal defect corrected by a valved conduit from the right ventricle to the pulmonary artery which became obstructive nearly 10 years later: the implantation of the stent reduced the transconduit pressure gradient in all cases except one who had not undergone closure of the septal defect in which the cyanosis was improved. There are two cases of obstruction of a modified Blalock anastomosis in which the stent revascularised the shunt with improvement in cyanosis. In the final 3 cases, the whole Fontan procedure was compromised by obstruction of a conduit incorporated in the system, and which dilatation with stenting considerably improved. The efficacy of the procedure was constant with no complications other than rupture of the balloon in 3 cases. The good results were maintained for an average of 7.3 months (range 1 to 25 months), but it was necessary to redilate one restenosed stent after 8 months. Dilatation followed by stenting in obstructive cardiovascular prostheses is a simple, safe and effective alternative to surgical reoperation.
Extracardiac conduits between the right ventricle and pulmonary arteries commit patients to multiple reoperations. We reviewed our experience with stent implantation in obstructed conduits.
Between 1990 and 1997, stents were implanted across 43 conduits. The median age at procedure was 6 years (0.5-17 years), and the median interval between conduit insertion and stent implantation was 2.4 years (0.3-14 years).
Mean systolic right ventricular pressures and gradients, respectively, decreased from 71 +/- 18 mm Hg and 48 +/- 19 mm Hg before to 48 +/- 15 mm Hg and 19 +/- 13 mm Hg after stent placement. Mean percentage of predicted valve area for body surface area increased from 26% +/- 12% to 48% +/- 17% after stent placement. Fifteen patients underwent a second transcatheter intervention (dilation or additional stent), and 2 patients, a third, allowing further postponement of surgery in 8 patients. One sudden death occurred 2.8 years after stent placement. Surgical conduit replacement has occurred in 20 patients. Body growth was maintained during follow-up. Freedom from surgical reintervention was 86% at 1 year, 72% at 2 years, and 47% at 4 years. Higher right ventricular pressure and gradient before and after stent placement and lower percentage of predicted valve area for body surface area after stent placement were associated with shorter palliation.
Endovascular stent placement across obstructed conduits is a safe and effective palliation that allows for normal body growth.
Evaluate long-term results of autologous pericardial valved conduits in the pulmonary outflow.
Between June 1983 and October 1993, 82 conduits were placed in the outflow of the venous ventricle. Patients who received homografts (n = 2 patients), heterografts (n = 3 patients), and valveless conduits (n = 19 patients) and those patients who died within 90 days after the operation were excluded. Fifty-four survivors of pulmonary outflow reconstruction with fresh autologous pericardial valved conduits were followed up from 5 to 15 years (mean, 7.47 +/- 2.8 years). Diagnosis include d -transposition of great arteries (n = 16 patients), L -transposition of great arteries (n = 14 patients), tetralogy of Fallot, pulmonary atresia with ventricular septal defect (n = 11 patients), truncus arteriosus (n = 10 patients), and double-outlet ventricle (n = 3 patients). Implantation age ranged from 0.25 to 24 years (mean, 5.2 +/- 4.2 years). Median conduit diameter was 16 mm. Two-dimensional echocardiographic Doppler evaluations were made yearly; 9 patients underwent cardiac catheterization. Reintervention for stenosis was indicated when the pressure gradient exceeded 50 mm Hg.
Three late deaths were unrelated to the conduit. Thirty-five autologous pericardial valved conduits increased in diameter (1-7 mm), remained unchanged in 15 patients, and reduced 1 to 2 mm in 4 patients. The median diameter was 18 mm at the last evaluation (P =.0001). Eight patients required conduit-related reoperation 3 to 8 years after the implantation. Two patients underwent balloon dilation of the autologous pericardial valved conduit. No conduit had to be replaced. Freedom from reintervention at 5 and 10 years was 92% and 76%, being 100% at 10 years for conduits larger than 16 mm at time of implantation.
Autologous pericardial valved conduits show excellent long-term results and compare favorably with other conduits.
Pulmonary regurgitation can lead to severe right ventricular dysfunction, which is a delicate postoperative problem in the long-term follow-up of patients who had surgery for congenital heart diseases. Clinical conditions of patients suffering from pulmonary valve incompetence are improved by valve replacement with a prosthetic valve. To date, the surgical approach is the only option to replace a pulmonary valve. We report the first experience of percutaneous pulmonary valve implantation.
A fresh bovine jugular vein containing a native valve was sutured into a vascular stent and then cross-linked with a 0.6% glutaraldehyde solution for 36 hours. After being hand-crimped onto a balloon catheter, the device was inserted percutaneously according to standard stent-placing techniques. The valved stent was finally deployed in the position of the native pulmonary valve of the lamb. Hemodynamic evaluation was carried out before and 2 months after implantation. Anatomic evaluation was finally performed. Percutaneous pulmonary valve replacement was successful in 5 lambs. No complications were noted. Early and late angiographic and hemodynamic studies confirmed a good position of the stents with a competent valve at the end of the protocol. One stent was slightly stenotic, with macroscopically visible calcifications.
Nonsurgical implantation of pulmonary valves is possible in the lamb. This new technique is similar to standard stent implantation. Thus, it should be feasible in humans, in whom it will lead to a significant reduction of reoperations in patients in need of pulmonary valve replacement.
Outcome of pulmonary and aortic homografts for rightventricular outflow tract reconstruction.
- Bando K
- Danielson GK
- Schaff HV
- Mair DD
- Julsrud PR
- Puga FJ
Traitement des obstructions des prothèses tubulaires par implantation percutanée de stents.
- Saliba Z
- Bonhoeffer P
- Aggoun Y
Traitement des obstructions des prothèses tubulaires par implantation percutanée de stents
- Saliba
Outcome of pulmonary and aortic homografts for rightventricular outflow tract reconstruction
- Bando