Transcatheter Balloon Dilation Research Articles

In Vitro Proof of Concept of a First-Generation Growth-Accommodating Heart Valved Conduit for Pediatric Use.

Currently available heart valve prostheses have no growth potential, requiring children with heart valve diseases to endure multiple valve replacement surgeries with compounding risks. This study demonstrates the in vitro proof of concept of a biostable polymeric trileaflet valved conduit designed for surgical implantation and subsequent expansion via transcatheter balloon dilation to accommodate the growth of pediatric patients and delay or avoid repeated open-heart surgeries. The valved conduit is formed via dip molding using a polydimethylsiloxane-based polyurethane, a biocompatible material shown here to be capable of permanent stretching under mechanical loading. The valve leaflets are designed with an increased coaptation area to preserve valve competence at expanded diameters. Four 22mm diameter valved conduits are tested in vitro for hydrodynamics, balloon dilated to new permanent diameters of 23.26±0.38mm, and then tested again. Upon further dilation, two valved conduits sustain leaflet tears, while the two surviving devices reach final diameters of 24.38±0.19mm. After each successful dilation, the valved conduits show increased effective orifice areas and decreased transvalvular pressure differentials while maintaining low regurgitation. These results demonstrate concept feasibility and motivate further development of a polymeric balloon-expandable device to replace valves in children and avoid reoperations.

2019 American College of Cardiology best conference

<p>As every year, the 68<sup>th</sup> American College of Cardiology (ACC) conference was held in New Orleans, Louisiana, from March 16 to 18. With carnival and jazzas the background, he convened the world cardiology again to promote knowledge by displaying a variety of scientific activities. More than 16000 participants attended and 2300 articles were received, many of which will undoubtedly change current clinical practice. It is also worth noting that the introduction of the guidelines for primary pretreatment of cardiovascular diseases emphasizes that acetylsalicylic acid is almost completely abandoned in primary pretreatment due to the lack of net profit.</p><p>We will briefly summarize some of the major scientific papers submitted:</p><p>1. Antithrombotic therapy after PCI for acute coronary syndrome or atrial fibrillation—Augustus test</p><p>2. Transcatheter aortic valve replacement and balloon dilatation in low-risk patients-partner 3 trial</p><p>3. Safety and effectiveness of STEMI femoral artery access: Safari STEMI trial</p><p>4. One month after drug-eluting stent implantation, clopidogrel monotherapy was compared with clopidogrel standard 12-month dual antiplatelet therapy. Stop dapt 2 test</p><p>5. Results of a large-scale application based study using Smartwatch to identify atrial fibrillation: Apple heart research</p>

B-32 | Adjustable Pulmonary Artery Banding Palliation in Patients with Anomalous Left Coronary Artery from Pulmonary Artery (ALCAPA)

ALCAPA is a rare congenital anomaly resulting in severe left ventricular (LV) dysfunction. Surgical placement of a pulmonary artery band(PAB) during ALCAPA repair may assist with recovery of patients with severe left ventricular function (ejection fraction EF<25%). The aim of this study is to describe our experience creating a dilatable PAB via transcatheter balloon dilation (TCBD) in ALCAPA patients.

Design optimization of a cardiovascular stent with application to a balloon expandable prosthetic heart valve

A cardiovascular stent design optimization method is proposed with application to a pediatric balloon-expandable prosthetic heart valve. The prosthetic valved conduit may be expanded to a larger permanent diameter in vivo via subsequent transcatheter balloon dilation procedures. While multiple expandable prosthetic heart valves are currently at different stages of development, this work is focused on one particular design in which a stent is situated inside of an expandable polymeric valved conduit. Since the valve and conduit must be joined with a robust manufacturing technique, a polymeric glue layer is inserted between the two, which results in radial retraction of the valved region after expansion. Design of an appropriate stent is proposed to counteract this phenomenon and maintain the desired permanent diameter throughout the device after a single non-compliant balloon dilation procedure. The finite element method is used to compute performance metrics related to the permanent expansion diameter and required radial force. Additionally, failure due not only to high cycle fatigue but also due to ductile fracture is incorporated into the design study through the use of an existing ductile fracture criterion for metals. Surrogate models are constructed with the results of the high fidelity simulations and are subsequently used to numerically obtain a set of Pareto-optimal stent designs. Finally, a single design is identified by optimizing a normalized aggregate objective function with equal weighting of all design objectives.

Dilatable Pulmonary Artery Banding Palliation in Congenital Heart Disease

Surgical pulmonary artery banding (PAB) has been limited in practice because of later requirement for surgical removal or adjustment. The aim of this study is to describe our experience creating a dilatable PAB via transcatheter balloon dilation (TCBD) in congenital heart disease (CHD) patients. Retrospective chart review of adjustable PAB-outline anatomical variants palliated and patient outcomes. Sixteen patients underwent dilatable PAB-median age 52 days (range 4-215) and weight 3.12 kg (1.65-5.8). Seven (44%) of the patients were premature, 11 (69%) had ventricular septal defect(s) with pulmonary over-circulation, four (25%) atrioventricular septal defects, and four (25%) single ventricle physiology. Subsequent to the index procedure: five patients have undergone intracardiac complete repair, six patients remain well palliated with no additional intervention, and four single ventricles await their next palliation. One patient died from necrotizing enterocolitis (unrelated to PAB) and one patient required a pericardiocentesis postoperatively. Five patients underwent TCBD of the PAB without complication-Two had one TCBD, two had two TCBD, and another had three TCBD. The median change in saturation was 14% (complete range 6-22) and PAB diameter 1.7 mm (complete range 1.1-5.2). Median time from PAB to most recent outpatient follow-up was 868 days (interquartile range 190-1,079). Our institution has standardized a PAB technique that allows for transcatheter incremental increases in pulmonary blood flow over time. This methodology has proven safe and effective enough to supplant other institutional techniques of limiting pulmonary blood flow in most patients-allowing for interval growth or even serving as the definitive palliation.

Balloon angioplasty of bidirectional Glenn anastomosis.

We aim to assess the safety and efficacy of the transcatheter balloon dilation of superior cavopulmonary anastomosis (SCPA). SCPA stenosis can lead to impaired pulmonary blood flow, hypoxemia and development of veno-venous collaterals with right-to-left shunt. Balloon dilation of SCPA has been rarely reported and follow-up information is lacking. We performed a retrospective review of patients who underwent cardiac catheterisation and angioplasty of SCPA and reviewed patient's demographics, diagnosis, SCPA surgery and post-operative course, catheterisation haemodynamics, procedural technique, angiography, and the findings of follow-up catheterisation. Between 2008 and 2017, seven patients showed significant narrowing of SCPA and underwent balloon angioplasty, all of whom had undergone bidirectional Glenn (BDG). Indications for cardiac catheterisation included persistent pleural effusion, hypoxemia, and echocardiographic evidence of BDG stenosis or routine pre-Fontan assessment. Five patients had bilateral SCPA. The procedure was successful in all cases with increase in the stenosis diameter from a median of 3.3 mm (range 1.2-4.7 mm) to a median of 4.7 mm (range 2.6-7.8 mm). All patients had at least one follow-up cardiac catheterisation. Only one patient required repeat angioplasty at the 2.3-month follow-up with no further recurrence. Sustained results and interval growth were noted in all other cases during up to 29 months of follow-up. No adverse events were encountered. Based on our small series, balloon angioplasty of BDG stenosis is feasible and safe and appears to provide sustained improvement with interval growth and only the rare recurrence of stenosis.

Prosthetics provide room to grow

Cardiology Children with congenital heart disease who require heart valve replacement often must undergo multiple high-risk surgeries because the replacement valve cannot grow as their heart grows. Inspired by this problem, Hofferberth et al. developed a prosthetic valve that mimics the geometry of the human venous valve, which maintains function despite large fluctuations in blood volume. The prosthesis, composed of polymeric leaflets attached to a stainless-steel stent, can be mechanically expanded using transcatheter balloon dilation to adapt to larger fluid volumes. Size-adaptable valves maintained function when implanted into growing lambs and could be mechanically expanded over 10 weeks. Sci. Transl. Med. 12 , eaay4006 (2020).

Modified technique for Melody valve implantation in the mitral position

Modified technique for Melody valve implantation in the mitral position

Evaluation of Congenital Valvular Heart Diseases by the Pediatrician: When to Follow, When to Refer for Intervention?

Isolated congenital valvular heart disease in children constitutes a small fraction of congenital heart diseases. Valve involvement is seen more along with other congenital diseases. The most commonly involved valve is the pulmonary valve followed by the aortic valve. Stenotic lesions of the pulmonary and aortic valves are more frequently encountered than mitral and tricuspid valvular lesions. The presentation depends on the severity of the lesion and the age of the patient. Symptoms range from asymptomatic status to florid symptoms of valve obstruction and/or leak. Detailed clinical assessment and various imaging techniques confirm the diagnosis and help in management planning. Transcatheter balloon dilatation for obstructive pulmonary valve has very good long-term outcomes. The results of balloon dilation of aortic valve are also good enough for it to be the treatment of choice. Significant lesions of the mitral and tricuspid valve, regurgitant lesions, sub and supra valvular obstructions require surgical correction. Most valvar lesions mandate regular follow up. Communication and coordination between the pediatric cardiologist and the pediatrician helps in the optimal management.

Make use of time, let not advantage slip – How this William Shakespeare (1564–1616) quote lead us to optimize occlusion time for balloon dilatations –

Neuro-developmental impairment which follows management of complex congenital heart disease is a major issue. Balloon dilation is a frequent procedure, which can lead to brain injury. Whereas the pressure and diameter of balloon for inflation are quite normalized, there are no written guidelines for time of inflation. Our aim was to study the brain perfusion with the NIRS (Near Infra Red Spectroscopy) during catheter procedure. We prospectively enrolled 20 consecutive children (mean ± SD: age = 2.8 ± 3.4 y.o.; weight = 15.6 ± 13.6 kg) who underwent transcatheter balloon dilation of pulmonary valve, trunk or conduit stenosis. Procedure was done under general anesthesia with regular monitoring. SpO2 was used by physician for patient safety. Cerebral oxygen saturation (Rso2) was monitored by NIRS. Each brain desaturation events were collected. 40% of rSO2 was considered as the cut-off limit below which brain injury may occurs. Time to reach this limit (TTR40), time to recover (TTR95), area under curve and deepness of the events were extracted ( Appendix 1 ). The total number of inflation was 56, with a mean of 2,8 inflations per patient (min = 2; max = 10). The NIRS curve had two parts: it decreased during balloon inflation due to CO interruption and then increased during the reperfusion. Both were easily detected (Se = 100%) whereas the SpO2 remained wrongfully high. Near 36% of desaturation were under the cut-off (NIRS < 40%). TTR40 was 56.76 s and TTR95 was 34.85 s for the whole group. The linear regression based on NIRS shows two significant ( P < 0.0001) slopes: −0.68 rSO2%/s for TTR40 and +0.70 rSO2%/s for TTR95. Our results suggest that a cumulative time over 44 s (95% CI) of multiples occlusions without recovery may cause brain injury. A recovery delay of 40 s (95% CI) after each set of balloon inflation is therefore mandatory. Pulmonary valve, trunk or conduit dilatation requires short occlusion and total recovery before any new inflation.

Transcatheter therapy for aortic coarctation with severe systemic hypertension during pregnancy

Aortic coarctation is an unusual cause of hypertension during pregnancy and its management is not clarified. We report transcatheter balloon dilatation and stenting for native aortic coarctation in a 22-year-old pregnant woman with severe and uncontrolled systemic hypertension. Arterial blood pressure could be successfully controlled with medical treatment during the rest of the pregnancy and the patient underwent uneventful delivery. No adverse events or recoarctation was observed during 24 months clinical follow-up. In conclusion, native aortic coarctation can be successfully treated during pregnancy with transcatheter therapy. More experience is needed to confirm the safety and efficacy of such management.

318 Williams’ syndrome: an unusual cause of neonatal coarctation

To determine the frequency, clinical profile and outcome of patients with Williams syndrome and neonatal coarctation. Among 135 reviewed patients less than 3months of age who underwent aortic coarctation repair in our institution between January 1996 and June 2007, Williams syndrome was found in 3 cases (2,2%). They presented with congestive heart failure and absent femoral pulses, the diagnostic being confirmed by echocardiography. One case had an associated small ventricular septal defect. The 3 patients were operated at a mean age and weight of 51.6±32.7days and 3.5±0.6kg, respectively. All had resection of the coarctation segment with end-to-end anastomosis, through left thoracotomy in 2 cases, and sternotomy under cardiopulmonary bypass with large patch enlargement of the aortic arch and ventricular septal defect closure in one. The diagnosis of Williams syndrome was confirmed postoperatively by FISH analysis. All patients remained hypertensive and presented with recoarctation 2, 2.3, and 14.3months after initial repair. Transcatheter balloon dilation was attempted with failure to proceed in one and partial success in 2 cases. All had redo surgery at 0.6, 1.2 and 10.9 years after initial repair with patch enlargement of the aorta in two cases and an extra-anatomic bypass in the third, with good results and discontinuation of antihypertensive treatment. Williams syndrome may present as neonatal coarctation and is characterized by more complex repair and recurrent aortic obstruction. Balloon dilation seems disappointing to treat successfully these recoarctations. Reoperations are often necessary with patch enlargement and/or exclusion of the stenotic aortic segment.

Percutaneous implantation of pulmonary valves for treatment of right ventricular outflow tract dysfunction: a single-centre experience

Stenosis and/or regurgitation of the right-ventricle-to-pulmonary-artery conduit are common conditions in patients after corrective surgery for congenital heart defects. Percutaneous pulmonary valve implantation was introduced to reduce the number of operations needed during the total lifetime of patients with right-ventricle-to-pulmonary-artery conduits. Between April 2007 and April 2008, six patients with severe stenosis and/or regurgitation of the conduit underwent percutaneous pulmonary valve implantation. Cardiac diagnoses were tetralogy of Fallot (three patients), truncus arteriosus (two patients) and post Ross operation (one patient). The median age was 13 (range 7–21) years. Deployment of percutaneous pulmonary valve implantation was achieved without major complications. Right ventricular systolic pressure and right ventricular outflow tract gradient decreased respectively from 61 to 40 mmHg and 37 to 20 mmHg. Follow-up ranged from–to 16 (mean 11) months. All patients are free from reoperation, and valvular competence has been well maintained. One patient experienced recurrence of the obstruction, which was successfully treated with transcatheter balloon dilatation 9 months after the implant. This small study confirms Professor Bonhoeffer's findings that percutaneous pulmonary valve implantation is a safe and feasible treatment that allows the avoidance of surgery in postoperative congenital heart disease patients with a dysfunctioning right-ventricle-to-pulmonary-artery conduits.

Transcatheter intravascular stent placement to relieve supravalvular pulmonic stenosis

Valvular pulmonic stenosis has been successfully treated in dogs via minimally invasive transcatheter balloon dilation procedures for almost 20 years. Supravalvular pulmonic stenosis however is not amenable to balloon dilation procedures. Although several surgical procedures are described for treatment of pulmonic stenosis, the morbidity and mortality of these procedures are significantly higher than for transcatheter approaches. Two cases of supravalvular pulmonic stenosis are presented, one acquired and one congenital, which were successfully treated with transcatheter intravascular stent placement. The procedure alleviated the stenotic lesion and resolved clinical signs.

Surgical management of aortopulmonary window and associated lesions

Background Aortopulmonary window is a rare congenital heart defect commonly associated with other cardiac anomalies. Although single institutional experience is low, several surgical techniques have been reported. The purpose of this study is to describe our approach to the management of aortopulmonary window and its associated lesions. Methods Between February 1996 and November 2002, 13 patients underwent repair of aortopulmonary window. The age range went from 4 days to 5.5 months (mean 42 ± 52 days), with 9 patients younger than 1 month old. The weight range was from 1.9 to 6.7 kg (mean 3.5 ± 1.2 kg). Concomitant cardiac anomalies were present in 11 patients. The major additional anomalies were interruption of aortic arch in 4 patients and tracheal stenosis in 1 patient. Initial diagnoses were made using two-dimensional echocardiography only. Results There was one postoperative death. In general, patients with aortopulmonary window and additional major defects had a prolonged intensive care unit and hospital stay when compared with the other patients. Follow-up time ranged from 2 months to 6.8 years (mean of 2.5 ± 2.2 years). There were no reoperations and no late deaths. Transcatheter balloon dilatation of the repaired aortic arch was required in 1 patient and of the right pulmonary artery in another. All other patients had good flow to both pulmonary arteries. No residual shunts were detected at the aortopulmonary window site, and pulmonary pressures were normal. Conclusions Aortopulmonary window may be effectively diagnosed with echocardiography. Early surgical treatment (neonatal period, if possible) is safe and associated with the best long-term results, even in the presence of other cardiac anomalies. Complete separation and reconstruction of both aorta and pulmonary arteries under direct vision may prevent recurrence and distortion of adjacent structures.

Aortic Coarctation Presenting As Acute Abdominal Pain In A Child

Coarctation of aorta is the most common correctable cardiovascular cause of hypertension and early diagnosis is often not made. We report a 9-year-old child who was admitted with severe intractable abdominal pain as the presenting symptom of post-subclavian aortic coarctatation with hypertension. His pain resolved after control of the hypertension with parenteral antihypertensives and narcotic analgesics in the pediatric intensive care unit. He subsequently underwent transcatheter balloon dilatation of the aortic coarctation and remains well with normal blood pressure on follow up.

Are Outcomes of Surgical Versus Transcatheter Balloon Valvotomy Equivalent in Neonatal Critical Aortic Stenosis?

Background For neonates with critical aortic valve stenosis who are selected for biventricular repair, valvotomy can be achieved surgically (SAV) or by transcatheter balloon dilation (BAV). Methods and Results Data regarding 110 neonates with critical aortic valve stenosis were evaluated in a study by the Congenital Heart Surgeons Society from 1994 to 1999. Reduced left ventricular function was present in 46% of neonates. The initial procedure was SAV in 28 patients and BAV in 82 patients. Mean percent reduction in systolic gradient was significantly greater with BAV (65±17%) than SAV (41±32%; P &lt;0.001). Higher residual median gradients were present in the SAV versus BAV group (36 mm Hg [range, 10 to 85 mm Hg] versus 20 mm Hg [0 to 85 mm Hg], P &lt;0.001). Important aortic regurgitation was more often present after BAV (18%) than SAV (3%; P =0.07). Time-related survival after valvotomy was 82% at 1 month and 72% at 5 years, with no significant difference for SAV versus BAV, even after adjustment for differences in patient and disease characteristics. Independent risk factors for mortality were mechanical ventilation before valvotomy, smaller aortic valve annulus ( z score), smaller aortic diameter at the sinotubular junction ( z score), and a smaller subaortic region. A second procedure was performed in 46 survivors. Estimates for freedom from reintervention were 91% at 1 month and 48% at 5 years after the initial valvotomy and did not differ significantly between groups. Conclusions SAV and BAV for neonatal critical aortic stenosis have similar outcomes. There is a greater likelihood of important aortic regurgitation with BAV and of residual stenosis with SAV.

Coarctation of the aorta.

Coarctation of the aorta may seem to be a relatively simple lesion, but controversy persists about the optimal management strategy for this condition. A plethora of options are available, and strong evidence to guide clinical decision making is lacking. The age of the patient at presentation and anatomic variations have a significant effect on the type of therapy chosen and the outcome of intervention, which can include death, recurrence of obstruction, and persistent or late hypertension. The current trend in practice is to favor surgical repair in neonates and infants and transcatheter balloon dilation in older children and adults.

Anomalous origin of one pulmonary artery from the ascending aorta: 36 years' experience from one centre.

Anomalous origin of one pulmonary artery from the ascending aorta is an uncommon lesion with an uncertain outcome. We reviewed 16 consecutive children (9 males) presenting with this lesion over a 36 year period at a single institution. Median age at presentation was 2 days (range, birth to 3.2 years). The anomalous pulmonary was the right in 12 and the left in 4, all originating from the proximal ascending aorta, with no patient having stenosis at the origin of the anomalous pulmonary artery. Associated cardiac anomalies were noted in 9 patients. No intervention was attempted in 2 patients: one was deemed inoperable due to complex associated lesions and pulmonary vascular obstructive disease, while the other one died before repair. Surgical intervention was attempted in 14 patients, with 3 intraoperative deaths (21%). Of 11 operative survivors, 8 developed pulmonary arterial stenosis graded severe in 2, moderate in 1 and mild in 5. Patients with severe stenosis required surgical angioplasty, 1 after unsuccessful dilation combined with placement of an endovascular stent. One patient with moderate, and one with mild, stenosis underwent successful transcatheter balloon dilation. The remaining 4 patients with mild stenosis remain unchanged during follow-up. One patient had biopsy evidence of pulmonary vascular obstructive disease at 3.3 years of age. There were no late deaths, giving a total mortality of 25% (4/16). While early diagnosis and repair of anomalous origin of one pulmonary artery from the ascending aorta is necessary, restenosis of the site of repair is common.

Transcatheter balloon dilation versus surgery for native aortic coarctation in children — a clinical decisionanalysis

Transcatheter balloon dilation versus surgery for native aortic coarctation in children — a clinical decisionanalysis