2024 Statement from Asia expert operators on transcatheter pulmonary valve replacement.

Transcatheter pulmonary valve replacement (TPVR), also known as percutaneous pulmonary valve implantation, refers to a minimally invasive technique that replaces the pulmonary valve by delivering an artificial pulmonary prosthesis through a catheter into the diseased pulmonary valve under the guidance of X-ray and/or echocardiogram while the heart is still beating not arrested. In recent years, TPVR has achieved remarkable progress in device development, evidence-based medicine proof and clinical experience. To update the knowledge of TPVR in a timely fashion, and according to the latest research and further facilitate the standardized and healthy development of TPVR in Asia, we have updated this consensus statement. After systematical review of the relevant literature with an in-depth analysis of eight main issues, we finally established eight core viewpoints, including indication recommendation, device selection, perioperative evaluation, procedure precautions, and prevention and treatment of complications.

Outcomes of Venus P-valve for dysfunctional right ventricular outflow tracts from Indian Venus P-valve database.

BACKGROUND: Balloon-expandable pulmonary valves are usually not suitable for dilated native outflow tracts. METHODS: Indian Venus P-valve registry was retrospectively analyzed for efficacy, complications, and midterm outcomes. Straight valve was used in prestented conduits in patients with right ventricular pressure above two-thirds systemic pressure and/or right ventricular dysfunction. Flared valve 1-4 mm larger than balloon waist was used in native outflow in symptomatic patients, large ventricular volumes, and ventricular dysfunction. OBJECTIVES: A self-expanding porcine pericardial Venus P-valve is available in straight and flared designs.. RESULTS: Twenty-nine patients were included. Straight valve was successful in all seven conduits, reducing gradients significantly, including one patient with left pulmonary artery (LPA) stent. Flared valve was successfully implanted in 20 out of 22 native outflow tracts. Sharp edges of the older design contributed to two failures. Complications included two migrations with one needing surgery, endocarditis in one, insignificant wire-frame fractures in three, and groin vascular complication in one patient. There were no deaths or valve-related reinterventions at a mean follow-up of 47.8 ± 24.5 months (1-85 months). Modifications of technique succeeded in three patients with narrow LPA. There was significant improvement in symptoms, right ventricular volume, and pulmonary regurgitant fraction. CONCLUSION: Straight and flared Venus P-valves are safe and effective in appropriate outflow tracts. Straight valve is an alternative to balloon-expandable valves in stenosed conduits. Flared valve is suitable for large outflows up to 34 mm, including patients with LPA stenosis. Recent design modifications may correct previous technical failures. Studies should focus on durability and late complications.

Correlating computed tomographic angiography of pulmonary circulation with clinical course and disease burden in patients with tetralogy of Fallot and pulmonary atresia.

PURPOSE: To determine the type of pulmonary circulation (PC) in patients with tetralogy of Fallot (TOF) and pulmonary atresia (TOF-PA) with the use of computed tomographic angiography (CTA), and describe their clinical courses, corrective surgery and disease burden. METHODS: 145 patients (median age 4 years, interquartile range: IQR2-8 years) were analyzed for PC which divided into 5 CTA-types and 11 subtypes based on presence of main pulmonary trunk (MPA) and confluent pulmonary arteries (confluence-PAs), presence of ductus arteriosus or major aortopulmonary collateral arteries (MAPCAs), respectively. Pulmonary arteries (PAs) were assessed by McGoon ratio and arborization. Corrective surgery or palliative management was recorded by type of PC. Disease burden was calculated as the sum of CTA, diagnostic angiography, and palliative management. RESULTS: The most common (N = 77, 53 %) PC was the presence of MPA with confluent-PAs (type-1) which was encountered mostly in TOF patients, followed by the presence of confluent-PAs with atretic MPA (type-2) (N = 47, 32 %) which found mainly in TOF-PA. McGoon ratio in type-1 (2.44 ± 0.84) was significantly larger than type-2 (1.61 ± 0.61) (median difference 0.84, 95 %CI 0.56-1.11, p < 0.001). Almost 2/3 of patients in type-1 (71 %) and 1/3 of patients in type-2 (34 %) achieved corrective surgery. There was no significant difference in amount of disease burden among the different PC, with the median value of 3 (IQR1-4). CONCLUSIONS: Types of PC allow suggestions for size and arborization of PAs and successful surgical correction with an inverse relationship with the numbers of MAPCAs. There is no significant difference in amount of disease burden among the types of PC.

Coronary artery changes in congenital coronary-cameral fistulas evaluated by computed tomographic angiography.

PURPOSE: The study sought to determine coronary artery diameter in congenital coronary-cameral fistula (cCCF), factors associated with coronary artery aneurysm, coronary artery changes after fistula closure, and computed tomographic (CT) findings after treatment. MATERIALS AND METHODS: We retrospectively reviewed CT findings of the cCCF for origins, terminations, fistula length, complexities, and Sakakibara classification. Coronary artery diameter was expressed as coronary artery Z score. Fistula features associated with coronary artery aneurysm were analyzed. Post-fistula closures were analyzed for coronary artery dilatation, coronary thrombosis, complete fistula closure, and fistula thrombosis. RESULTS: Twenty-five patients (median age 33 months, interquartile range, IQR 25-48) were included. Coronary feeders and terminations were frequently right coronary artery (48%) and right ventricle (56%), respectively. Fistula aneurysm occurred in 52% of cases. Mean coronary artery Z score was 13.03 ± 6.36 with a high incidence of giant coronary artery aneurysm (68%). We found no statistically significant risk factors associated with coronary artery aneurysm (p value range 0.075-0.370). Median duration of the follow-up CT after closure of the fistulas was 6.4 months (IQR 5.0-8.7). Coronary artery Z score significantly decreased by 0.82 (IQR 0.28-1.35), p = 0.006 and coronary thrombosis occurred in 23% of cases during follow-up. CONCLUSIONS: Large coronary aneurysm is common in cCCF. No characteristic feature of the fistula influencing coronary artery aneurysm is identified. There is a diminution in coronary artery Z score after fistula closure. Coronary thrombosis is a major complication after treatment.

Late Explantation of Venus P-Valve After Implantation: Macroscopic and Histologic Findings.

Percutaneous pulmonary valve replacement with the self-expandable Venus P-valve (Venus Medtech, Hangzhou, China) has shown satisfactory feasibility and early and midterm outcomes. However, the long-term results are not well described. This is a report of the gross and microscopic findings of an explanted Venus P-valve 78 months after implantation.

Effect of transcatheter closure by AmplatzerTM Duct Occluder II in patients with small ventricular septal defect.

Transcatheter closure of ventricular septal defect (VSD) is an alternative treatment of surgery. However, because of the potential risk of the complete atrioventricular block (AVB) and the lack of available dedicated devices for VSD, this procedure rarely used most centers. Recently in Thailand, with distinct device design that may cause less clamp force and radial force, the AmplatzerTMDuct Occluder (ADO) II has become available for the closure of small VSDs. This is a retrospective review of 49 patients who underwent transcatheter VSD closure using ADO II at Songklanagarind hospital and Queen Sirikit National Institute of Child Health between January 2014 and December 2016 with an intention to report procedural success rate and 12-months-outcomes. Twenty-six cases were female. The median age and weight at treatment were 7.8 year (ranged from 1.9 to 25 year) and 25.1 kg (ranged from 11 and 57 kg). The majority (65.3%) of the VSD was a perimembranous defect. The mean diameter of LV entry was 5.2 ± 2.5 mm and the mean RV exit was 3.2 ± 0.8 mm. Four patients had more than 1 exit at RV orifice. The mean length of the VSD was 5.3 ± 1.8 mm. The mean aortic valve-VSD distance was 3.9 ± 2.0 mm. The mean tricuspid valve-VSD distance was 3.8 ± 2.5 mm. The procedural success achieved in all patients (100%), most of the implantations were performed in a retrograde approach (53.1%). The ADO II was successfully implanted in 2 cases (5%) who failed other devices in the first attempts. There were no major complications. There were no changes in the severity of tricuspid and aortic valve regurgitation immediate after implantation and at 12 months' follow-up. Three patients (6%) had tiny to small residual shunt at 12 months' follow-up. None of the patients had a complete heart block. However, new-onset of left bundle branch block and right bundle branch block occurred in 2 (5%) cases and 5 (10%) cases, respectively. With symmetrical double-disc design and softness of the device, the ADO II can be safely and effectively used for closure of the VSDs with the defect size less than 6 mm.

Feasibility and early outcomes of aortic coarctation treatments with BeGraft Aortic stent.

OBJECTIVES: To assess feasibility and early outcomes of using BeGraft Aortic stent in the treatment of aortic coarctation (CoA). BACKGROUND: BeGraft Aortic stent (Bentley InnoMed, Hechingen, Germany) allows large postdilation diameter up to 30 mm. With availability of lengths of 19-59 mm and lower stent profile, they can be used in native and recurrent CoA in adults and in pediatric patients. MATERIALS AND METHODS: This is a multicentre retrospective analysis of 12 implanted BeGraft Aortic stents in CoA between May 2017 and April 2019. RESULTS: Twelve patients aged 7.7-38 years (median 18.3 years) with body weight of 19.9-56 kg (median 45.5 kg). Eight patients (66%) had native juxtaductal CoA while four had recurrent CoA after previous surgical or transcatheter treatments. The stents were implanted successfully in all the patients with no serious adverse events. The length of the stents ranged from 27 to 59 mm and the implanted stent diameter varied from 12 to 18 mm. The median intraprocedural CoA pressure gradient decreased from 25 mmHg (range 16-66 mmHg) to 2 mmHg (range 0-13 mmHg). The mean follow-up duration was 10.2 months. Two patient (16.6%) had residual stent narrowing requiring staged redilation. One patient (8%) had pseudoaneurysm formation at 1 year cardiac CT follow-up. CONCLUSIONS: The BeGraft Aortic stent may be considered to be safe and effective in the short term in treatment of CoA from childhood to adulthood. Long-term follow-up is needed.

Early clinical experience with the straight design of Venus P-valve™ in dysfunctional right ventricular outflow tracts.

OBJECTIVES: To assess the initial procedural and short to medium-term experience with the straight design of the Venus P-valve™ (Venus MedTech, Hangzhou, China) in dysfunctional right ventricular outflow tracts (RVOT). BACKGROUND: The Melody™ valve (Medtronic, Minneapolis, Minnesota) has been the only percutaneous valve option for smaller RVOT conduits. The straight Venus P-valve™ may provide an alternative to the Melody™ valve. METHODS: Retrospective data collection of patient characteristics, procedural data, clinical and imaging follow-up of the straight Venus P-valve™. RESULTS: Nine patients (four female) with a mean age of 23.1 ± 7.5 years and a mean weight of 72.7 ± 29.4 kg underwent straight Venus P-valve™ implantation between 03/2014 and 06/2016. All patients had right ventricle-to-pulmonary artery conduits which were pre-stented before the valve implantation. All valves were deployed successfully without any significant procedural complications. During the mean follow-up of 24 ± 9.1 months, there were no valve related re-interventions or deterioration in valve performance. There was one case of insignificant, single wire frame fracture and no cases of endocarditis. The cohort demonstrated a reduction in pulmonary regurgitation and tricuspid regurgitation, which was sustained throughout the follow-up. Similarly the gradient across the RVOT tract did not significantly increase. CONCLUSIONS: Implantation of the straight Venus P-valve™ has provided satisfactory short to mid-term results with high success rates and no complications and may be considered as an alternative option in patients with RVOT dysfunction.

Feasibility and 1-year outcome of transcatheter closure of perimembranous ventricular septal defects with different devices.

OBJECTIVE: To analyze feasibility of closing perimembranous ventricular septal defect (pmVSD) with different devices by percutaneous approach and determining initial 1-year outcome of the procedure. BACKGROUND: Transcatheter closure of pmVSD remains controversial due to a previous higher incidence of complete heart block (CHB), especially with the Amplatzer pmVSD occluder. Recently, several devices have been used to minimize the procedure-related complications. METHODS AND MATERIALS: A retrospective longitudinal cohort study of 133 patients who underwent transcatheter closure of pmVSD from September 2009 to March 2015. The median age and weight at intervention were 7.1 years (ranging from 9 months to 28 years) and 21.2 kg (ranging from 6.4 to 93 kg). RESULTS: Transcatheter pmVSD closure was successfully performed in 129 cases (97%) using 13 different devices. There were two new onset severe aortic regurgitation (AR) (1.5%), one new onset severe tricuspid regurgitation (0.7%), and one CHB (0.7%). Immediately after procedure, 41 patients (30.8%) had mild to moderate residual shunt and 27 patients (20.8%) had trivial to mild AR. At 1 year, there was no CHB and 10 patients (9.6%) had tiny to mild residual shunt and 10 patients (9.6%) had trivial AR. CONCLUSION: With proper case selection, good expertise, and judicious use of various devices with respect to anatomic details of pmVSD, transcatheter closure is feasible with satisfactory early outcome.

Medium-term results of percutaneous pulmonary valve implantation using the Venus P-valve: international experience.

AIMS: The aim of this study was to assess the international procedural and short-term to midterm experience with the new percutaneous Venus P-valve. METHODS AND RESULTS: Retrospective data of patient characteristics, clinical and imaging follow-up of Venus P-valve implantation outside China were collected. Thirty-eight patients underwent attempted Venus P-valve implantation between October 2013 and April 2017. Thirty-seven valves were successfully implanted during 38 procedures. There was one unsuccessful attempt and there were two valve migrations, one of which required surgical repositioning. The mean follow-up was 25 months with no short-term or midterm valve failure or deterioration in performance. Frame fractures occurred in 27% of patients. The cohort demonstrated a statistically significant reduction in pulmonary regurgitation fraction and indexed right ventricular diastolic volumes at six and 12 months. CONCLUSIONS: Implantation of the Venus P-valve has provided satisfactory short-term to midterm results with high success and low complication rates in an inherently challenging patient substrate.

What Interventional Cardiologists Are Still Leaving to the Surgeons?

Nowadays, development of new technologies is still ongoing with the ultimate goal of maximizing treatment outcomes with less invasiveness and reduced procedural risk. This review is intended to update on when interventionalists need surgical support in common or emerging problems in congenital heart disease.

Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series.

BACKGROUND: The Occlutech Figulla ASD device series (OFSO) shows an improved device design for interventional ASD closure, larger follow-up series are missing. METHODS: We retrospectively reviewed the feasibility, safety, implantation properties, results, and follow-up of ASD closure using Occlutech devices over a 5 year period by establishing a multi-institutional collaborative result registry with 16 contributing centers from 11 countries (IRFACODE). RESULTS: In 1315 patients of all age groups (female 66.9%), successful (98%) ASD closure was performed (mean age 28.9 years, weight 52 kg, height 148.6 cm). Of the defects, 47.9% showed no or only a deficient aortic rim; in 11.9%, there was more than one defect; a septum aneurysm was present in 21.5%; and the mean implanted device size was 20.5 mm. Immediate closure was achieved in 78.6%, at discharge in 83.1%, and 96.4% and 97.3% at 6 and 12 months follow-up, respectively. During a mean follow-up of 2.7 years (in total 3597 patient years), significant complications were minimal (total = 8, <1%) with secondary device embolizations in five and AV-blocks in three patients. No erosion or death was reported. CONCLUSION: ASD closure using OFSO is feasible in a large variety of patients, safe with only a minimal risk of severe side effects and especially without any aortic erosions despite a large percentage of large and complicated defects. © 2016 Wiley Periodicals, Inc.

Percutaneous pulmonary valve implantation with the Venus P-valve: clinical experience and early results.

BACKGROUND: At present, the exclusion for percutaneous pulmonary valve implantation for free pulmonary regurgitation after tetralogy of Fallot repair includes an unfavourably large right ventricular outflow tract. OBJECTIVE: To report feasibility and early experience with a recently developed transcatheter heart valve, Venus P-valveTM, implanted in six patients with severe pulmonary regurgitation with large right ventricular outflow tracts. Patients There were two female patients and four male patients. The median age of the patients was 18.5 years, and the mean body weight was 53.8 kg. All the patients were in NYHA class II and had severe pulmonary regurgitation after previous transannular patch repair of tetralogy of Fallot. The median time after the last surgical operation was 13.5 years. RESULTS: The Venus P-valveTM was successfully implanted in all the patients with implanted valve diameters ranging from 24 to 32 mm. The mean fluoroscopy time was 29.8 minutes. None of the patients had significant outflow tract gradient or pulmonary regurgitation immediately after valve implantation. Only one patient had unexpected mild proximal valve migration to the right ventricular body during withdrawal of the delivery system. It caused mild paravalvar leak and significant tricuspid regurgitation. At 6 months follow-up, the median of right ventricular end-diastolic volume indices decreased from 146 to 108 ml/m2 (p-value=0.046). The Doppler systolic peak gradient across the valve ranged from 4 to 40 mmHg, and there was no evidence of stent fracture on fluoroscopy or structural valve failure. CONCLUSION: The Venus P-valveTM can be implanted successfully and effectively in patients with severe pulmonary regurgitation and a large right ventricular outflow tract. The early results with this valve are encouraging.

Comparison of the Occlutech ® Figulla ® septal occluder and Amplatzer ® septal occluder for atrial septal defect device closure.

The Occlutech(®) Figulla(®) septal occluder (OFSO) is a later-generation double-disk device with few reports of its success rates and complications compared with the Amplatzer(®) septal occluder (ASO), which is the worldwide standard device in percutaneous atrial septal defect (ASD) closure. We recruited and compared the results in 149 patients (76.5 % female) who underwent ASD device closure in our center between January 2003 and June 2012. The patients ranged in age from 2.3 to 77.2 years. There were no statistically significant differences between the two groups regarding patient baseline characteristics and procedure variables. The success rate using either device was excellent (ASO 94.4 % and OFSO 97.4 %; p = 0.43). Although the diameter of the ASD and the pulmonary arterial pressure in the OFSO group were slightly higher than in the ASO group, the median fluoroscopic time in the OFSO group was significantly shorter (ASO 13.7 min; OFSO 9.0 min; p < 0.001). The overall median follow-up time was 3.6 years (interquartile range 2.1-9.0 years). There were no significant differences between the major and minor complications when comparing the two devices. Both devices were safe and effective for percutaneous ASD closures. The OFSO had the benefit of a shorter fluoroscopic time.

Progressive aneurysmal dilation of coronary arterial fistula after transcatheter closure: successfully treated by a second occlusion device.

We report on a 6-year-old boy with a huge right coronary artery to the right ventricle fistula, who had previously been treated by device closure at the right ventricular exit point. However, 3 years later, the right coronary artery aneurysm showed progressively dilation and compressed the right ventricle. To prevent further complications related to the aneurysm, the proximal part of the aneurysm was successfully occluded by a vascular plug.

Percutaneous balloon aortic valvuloplasty at the Queen Sirikit National Institute of Child Health: 25 years' experience.

BACKGROUND: Percutaneous balloon aortic valvuloplasty (BAV) is the treatment of choice in moderate and severe valvular aortic stenosis. In Thailand, the first procedure was performed at the Queen Sirikit National Institute of Child Health (QSNICH) in 1988. No previous studies have been reported regarding the outcome of these procedures at QSNICH. OBJECTIVE: To study the efficacy and complications of percutaneous balloon aortic valvuloplasty in the treatment of severe aortic stenosis. MATERIAL AND METHOD: A retrospective study from the medical records was performed. All patients with a diagnosis of moderate or severe valvular aortic stenosis treated with BAV from January 1988-December 2012 were recruited. Before 2008, the procedures were performed under local anesthesia with light systemic sedation. After that, most of the cases were performed under general anesthesia. The response to treatment was classified as good response, partial response or failure. The short-term complications were classified as vascular complications, arrhythmias and others. RESULTS: Sixty-eight recorded attempts on 60 patients (47 males = 71.67%) were enlisted in the study. The ages at the time of procedures ranged from 1 day to 15 years (mean 65.25, SD 53.54, median 51 months). Fourteen cases were under one year of age (20.58%). Immediate success comprised 85.29% with 65.51% classified as good response. Ten failures in nine cases all occurred before 1997. One of the cases was an attempted balloon aortic valvuloplasty with repeated failure. Three of the cases underwent open aortic valvuloplasty where one case (33.33%) survived. The other six cases refused to continue treatment and were lost to follow-up. Four deaths were reported. Repeated balloon aortic valvuloplasties were performed in eight cases. During the early phases (1988-1996), failures and mortality rates were extremely high. Experience and improved technology improved outcomes. Excluding the four dead cases, the only significant major complication occurred in a three-year-old boy with severe aortic stenosis who tore the chordae tendinae, producing severe, acute mitral regurgitation, together with ventricular tachycardia, requiring direct current cardioversion during the procedure and double valvuloplasty five years later. Other minor complications included transient cardiac arrhythmia in 12 cases, partial occlusion of femoral artery in 11 cases and groin hematoma in 8 cases. CONCLUSION: Percutaneous balloon aortic valvuloplasty was effective and safe for the treatment of moderate and severe aortic valve stenosis in pediatric patients without significant complications.

Double-balloon aortic valvuloplasty at Queen Sirikit National Institute of Child Health.

BACKGROUND: Balloon aortic valvuloplasty is the treatment of choice in moderate and severe valvular aortic stenosis. In order to reduce the risk of vascular complications, a double-balloon technique has been used with good results. OBJECTIVE: To present the results od double-balloon aortic valvuloplasty at QSNICH. MATERIALS AND METHOD: Consecutive cases of severe valvular aortic stenosis treated with double-balloon aortic valvuloplasty at QSNICH were recruited in the study. Data were obtained from the medical records starting from the day of presentations to December 2011. RESULTS: There were six cases of severe valvular aortic stenosis treated with double-balloon aortic valvuloplasty at QSNICH from 2004 to 2011. The age and weight ranged from 7 months to 12 years and 6 to 53.8 kilograms, respectively. The presenting symptoms were dyspnea in 3 (50%) and asymptomatic heart murmur in 3 cases (50%). Peak-to-peak pressure gradient (PG) before the procedure ranged from 48-104 mmHg (mean 70.00, SD 18.92 mmHg). Immediately after the procedure, PG significantly decreased to 15-52 mmHg (mean 34.33, SD 14.98 mmHg, p < 0.01). On the following day after the procedure, peak instantaneous pressure gradient (PIPG) obtained from echocardiogram ranged from 17-47 mmHg (mean 36.50, SD 10.93 mmHg). PIPG were not significantly different from PG immediately after valvuloplasty. There were two cases with partial femoral occlusion. The duration of follow-up ranged from 6-54 months (median 24 months). In the follow-up period, all of the patients were asymptomatic with functional class I. Echocardiogram after the procedure revealed no significant aortic regurgitation in any of the cases. CONCLUSION: Double-balloon aortic valvuloplasty can be performed safely with very good intermediate term outcome in selected patients. Long-term outcome in Thai children should be further studied.

An unusual cause of progressive cyanosis post Fontan operation: congenital extra-hepatic porto-systemic shunt.

OBJECTIVE: To report an unusual case of progressive cyanosis post Fontan operation due to porto-systemic venous shunt and the result of its treatment. MATERIAL AND METHOD: A patient with diagnosis of progressive cyanosis post Fontan operation from porto-systemic venous shunt at QSNICH RESULTS: This is a case of twelve years old girl, who had diagnosis of situs solitus, levocardia, atrio-ventricular concordant, ventriculo-arterial concordant, hypoplastic right ventricle with large ventricular septal defect. She had pulmonary artery banding at 4 months of age followed by a non-fenestrated extra-cardiac conduit Fontan performed at 7 years and 7 months of age. During the first year of post operation, her systemic oxygen saturation (SpO2) was 93-94% after which it decreased to 87%, 84%, 75% at 1.5, 2.5 and 3 years after surgery, respectively. Clinically she also had progressive dyspnea on exertion. Diffuse pulmonary arterio-venous malformation was demonstrated by contrast echocardiogram during cardiac catheterization. Cardiac magnetic resonance angiography showed abnormal extra-hepatic portal vein to inferior vena cava shunt. After balloon test occlusion in the cath lab, which showed no change in the portal venous pressure, complete occlusion of this porto-systemic venous shunt was performed by using Amplatzer Vascular Plug II. Her systemic oxygen saturation increased to 83% with functional class I at one-year post occlusion. CONCLUSION: The present report an unusual case of progressive cyanosis post Fontan operation due to pulmonary arteriovenous malformation, which was secondary to congenital extra-hepatic porto-systemic shunt. The venous blood from the intestinal and splenic veins was partially bypassing the liver into inferior vena cava. The patient's clinical condition and SpO2 improved after transcatheter occlusion of the shunt with the device.