TRI-SCORE and benefit of intervention in patients with severe tricuspid regurgitation.

BACKGROUND AND AIMS: Benefit of tricuspid regurgitation (TR) correction and timing of intervention are unclear. This study aimed to compare survival rates after surgical or transcatheter intervention to conservative management according to a TR clinical stage as assessed using the TRI-SCORE. METHODS: A total of 2,413 patients with severe isolated functional TR were enrolled in TRIGISTRY (1217 conservatively managed, 551 isolated tricuspid valve surgery, and 645 transcatheter valve repair). The primary endpoint was survival at 2 years. RESULTS: The TRI-SCORE was low (≤3) in 32%, intermediate (4-5) in 33%, and high (≥6) in 35%. A successful correction was achieved in 97% and 65% of patients in the surgical and transcatheter groups, respectively. Survival rates decreased with the TRI-SCORE in the three treatment groups (all P < .0001). In the low TRI-SCORE category, survival rates were higher in the surgical and transcatheter groups than in the conservative management group (93%, 87%, and 79%, respectively, P = .0002). In the intermediate category, no significant difference between groups was observed overall (80%, 71%, and 71%, respectively, P = .13) but benefit of the intervention became significant when the analysis was restricted to patients with successful correction (80%, 81%, and 71%, respectively, P = .009). In the high TRI-SCORE category, survival was not different to conservative management in the surgical and successful repair group (61% and 68% vs 58%, P = .26 and P = .18 respectively). CONCLUSIONS: Survival progressively decreased with the TRI-SCORE irrespective of treatment modality. Compared to conservative management, an early and successful surgical or transcatheter intervention improved 2-year survival in patients at low and, to a lower extent, intermediate TRI-SCORE, while no benefit was observed in the high TRI-SCORE category.

Transcatheter Ventricular Septal Defect Closure with Lifetech™ Konar-MF Occluder in Infants Under 10 kg with Only Using Venous Access.

Transcatheter closure of VSD remains a complex procedure in infants with technical challenges and carries the risk of significant complications, due to its complex anatomical morphology and closed proximity to the atrioventricular valves and the conduction system. In this article, we presented transcatheter VSD closure in infants under 10 kg using the Lifetech Konar-MF device via only venous route without TEE guidance and arterial access. Between January 2021 and May 2023, a total of 34 patients weighing less than 10 kg who underwent transcatheter VSD closure antegradely with Lifetech™ Konar-Multifunctional (MF) occluder were included in the study. The mean age of the patients was 8.1 (3.5-35) months. Average weight was 6.5 kg (range 4.5-10 kg). VSD was perimembranous in 27 patients (79.4%). Successful device placement was achieved in all 34 patients. However, device embolization occurred in three patients. One of the patients was successfully implanted with a one size larger device, the surgical closure was performed other two cases. TR occurred in seven patients (20.6%) after releasing devices. None of the patients developed complete heart block. Right bundle branch block developed in two patients. Residual shunt was observed in 9 patients (six small, two moderate, and one large). During follow-up, residual shunt disappeared in six of these patients and only mild residual shunt remained in the other four patients which have not required any further intervention. Transcatheter closure of VSD with Lifetech Konar-MF device is safe and effective in infants less than 10 kg via only venous access with a high success rate and low complication rate. In these patients, transcatheter VSD closure can be performed by excluding the risk of complications that may occur due to AV loop formation, arterial intervention, endotracheal intubation and TEE use.

Penumbra Indigo® system to safely remove intracardiac thrombus in a 7-month-old infant with severe immunodeficiency disorder.

We report on a 7-month-old boy (4.2 kg/60 cm) with severe immunodeficiency disorder and bacterial septicaemia who was referred for an infected atrial thrombus secondary to a jugular central line. The echocardiogram showed a teardrop-shaped thrombus with a wide base adherent to the interatrial wall and a flimsy tail moving freely in the right atrium. Chest CT scan showed multiple lesions in both lungs consistent with infected micro-thrombi. The thrombus increased in size despite 2 weeks of antibiotics and anticoagulation. We applied the Indigo® Lightning® 7 aspiration system from Penumbra® (Alameda, USA) and removed percutaneously the thrombus under transoesophageal ultrasound and biplane fluoroscopic guidance. At 6 weeks of follow-up, the patient is alive, under enoxaparin with no procedure-related complication.

A focus on the percutaneous therapy of mitral and tricuspid regurgitation.

While mitral stenosis of rheumatic origin has been effectively treated percutaneously for more than 20 years, transcatheter treatment of mitral (MR) and tricuspid (TR) regurgitation appears as a contemporary unmet clinical need. The advent of new transcatheter therapies offers several treatment options for elderly and frail patients at high surgical risk. MitraClip is now consolidated as a therapy for functional MR in selected patients. Transcatheter mitral valve replacement is a promising alternative to transcatheter repair, for both functional and degenerative forms. However, further developments and new evidence are needed. Transcatheter treatment of the tricuspid valve has arrived late compared to similar technologies that have been developed for the aortic and mitral valve, and is currently in its infancy. This is likely due, in part, to the previously underreported impact of TR on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on annuloplasty and tricuspid valve replacement are limited and more evidence is needed. The future looks promising for transcatheter mitral and tricuspid valve therapies, although their place in clinical practice has yet to be clearly defined.

Update on Transcatheter Device Closure of Congenital Septal Defects.

PURPOSE OF REVIEW: The goal of this paper is to review currently available devices for closure of atrial septal defects (ASDs) and ventricular septal defects (VSDs). RECENT FINDINGS: Favorable results from the ASSURED trial resulted in FDA approval for the most recently developed device for transcatheter ASD closure in the United States. Further studies are required to assist in the development or approval of safe devices for transcatheter perimembranous VSD closure in pediatric patients. Device closure is the less invasive and preferred management option for many ASDs, with multiple studies demonstrating lower complication rates, shorter hospital stays, and lower mortality than surgical repair. Complex ASDs that make device closure more difficult include large defects, rim deficiencies, fenestrated defects, multiple defects, and the presence of pulmonary arterial hypertension. Device closure has also become an accepted alternative to surgery for some types of ventricular septal defects VSDs, though challenges and limitations remain. Future innovations including novel devices and techniques are needed to further expand on the types of defects that can be safely closed via transcatheter approach.

Transcatheter Fontan Fenestration Closure: Sustained Improvements in Oxygen Saturation with Minimal Morbidity and Mortality.

Fontan fenestration decreases central venous pressure and preserves cardiac output while decreasing systemic oxygen saturation. Transcatheter fenestration closure increases oxygen saturation, though the persistence of this increase and the long-term incidence of adverse outcomes such as death and heart transplant remain unknown. We describe immediate and long-term clinical and adverse outcomes following fenestration closure. Catheterization, echocardiogram, and clinic reports were reviewed following transcatheter Fontan fenestration closure. Data were reported as n (%) and median (IQR). Continuous variables were compared using Wilcoxon ranked sum test. 51 patients had fenestration closure 0.9 (0.7-1.5) years following extracardiac Fontan operation. Most (84%) were closed with Amplatzer Septal Occluders. Systemic O2 saturation immediately increased from 87 (83-89) to 95 (94-97)%, P < 0.05. Cardiac index decreased from 4 (3-5) to 2.9 (2.6-3.5) L/min/m2. Fontan pressure and pulmonary vascular resistance were not significantly changed. Clinical follow-up duration for all patients was 7.3 (range 1.3-16) years. Oxygen saturation at last follow-up was 94.5 (92-97)% and did not decrease over time (P < 0.05). One patient (2%) developed protein losing enteropathy, 1 (2%) had heart transplant, and 1 (2%) patient died 9.4 years following fenestration closure. No patient required fenestration re-creation following closure. Transcatheter Fontan fenestration closure leads to sustained increases in systemic oxygen saturation and a low incidence of adverse outcomes such as death and transplant. Further study comparing fenestration closure to non-closure and longer follow-up duration are required to determine if there is a survival benefit to fenestration closure.

Improvised bespoke technique for atrial septostomy in the shortage of atrioseptostomy balloon catheters.

Atrioseptostomy balloon catheter is an essential item to have on our shelves. However, the recall and shortage in production of the commonly used balloon atrioseptostomy catheters posed an imminent threat to our patients. Herein, we present the case of a newborn with a post-natal diagnosis of simple transposition of great arteries and restrictive atrial communication where repeated static balloon atrial septostomy using a 9 mm x 20 mm Sterling balloon failed to improve his status. We had to improvise per-operatively a new bespoke technique to perform a vital pull-through balloon atrial septostomy. The distal third of a 10 mm x 20 mm semi-compliant Cristal balloon was exteriorised out the tip of a 6-Fr 55 cm Cook Flexor sheath in the left atrium, and both were simultaneously pulled back to the right atrium to create an 8 mm septal defect. The procedure was successful without any complications. The baby was weaned off prostaglandin on day 3 and surgically repaired on day 5 with excellent results.

Percutaneous atrial shunt closure and the risk of recurrent ischemic stroke: A register-based, nationwide cohort study.

OBJECTIVES: We aimed to investigate the risk of recurrent stroke in patients with transcatheter closure of an atrial shunt (ASCIos), compared to patients with an atrial shunt and cerebrovascular event (CVE) but only medical treated (ASMed), and to age- and sex-matched control individuals without a previous CVE. METHODS: In total, 663 ASCIos patients were identified in the Swedish National Patient Register from 1997 to 2016 and matched by using propensity score with 663 ASMed patients. Nine age- and sex-matched controls to ASCIos patients (n = 6,302) without a diagnosis of atrial shunt or history of CVE were randomly selected from the general population. RESULTS: At a mean follow-up of 6.5 years, the incidence rate of recurrent stroke in the ASCIos group vs ASMed group was 0.9 vs 0.7 per 100 patient-years. The hazard ratio of recurrent stroke in the ASCIos group compared with index stroke in the control group was 9.9 (95% confidence interval, 5.5-17.9). The incidence of atrial fibrillation was similar in the ASCIos and the ASMed group, however four times higher in the ASCIos than in the control group. CONCLUSIONS: Our large nationwide, register-based cohort study showed that, unexpectedly, the risk of recurrent stroke in the ASCos group was as high as in the ASMed group and almost ten times higher than the risk of an index stroke in matched controls without previous stroke.

Transcatheter implantation of covered stents serving as extravascular conduits-Proof of a CT-based approach in three cases.

BACKGROUND: Covered stents perform similar to surgically implanted conduits, although the stents work inside of vessels. We present a computed tomography (CT)-based workflow for the implantation of covered stents as extravascular conduits. METHODS: We selected three different use cases: 1. Connecting a left-sided partially anomalous drainage of a pulmonary vein to the left atrium. 2. Bypassing an outgrown Dacron conduit in aortic recoarctation. 3. Re-directing hepatic venous blood to the left lung in a Fontan patient with heterotaxy, connecting the innominate vein to the right pulmonary artery like a right-sided cavopulmonary connection. By postprocessing and analyzing CT scans for planning and by the use of long needles under biplane fluoroscopy for the realization of the procedure, we projected and performed the exit of a long needle out of a vessel, the re-entering of a target vessel, and the bridging of the extravascular distance by implantation of covered stents. RESULTS: In all three cases, the covered stents were placed successfully, connecting vessels of 15-50 mm distance from each other with very good hemodynamic results. In one case, two stents were placed consecutively, overlapping each other to accomplish an exact fitting at the connection sites to the native vessels.

Transcatheter pulmonary valve-in-valve implantation within the expandable Inspiris Resilia® bioprosthetic valve.

Transcatheter pulmonary valve implantation (TPVI) is a common intervention for patients with repaired congenital heart disease. A key issue relates to the presence of an appropriately sized implantation zone for the transcatheter valve. We report the first case, to our knowledge, of TPVI within the newly engineered Inspiris Resilia® bioprosthetic valve, intentionally designed with a balloon-expandable valve ring (a.k.a. VFit zone) for prospective valve implantation.

Transcatheter closure of an acquired post-operative aorta to right ventricle shunt in a child with complex univentricular heart.

KONAR-MultifunctionalTM VSD Occluder (Lifetech, Shenzhen, China) is one of the most recent additions to the armamentarium of device closure interventions offering special features to tackle complex cardiac anatomies. Herein, we report the first use of the KONAR-MFO in an 8.5-year-old female patient (27 kg/129 cm) with stage III palliated univentricular heart to close an acquired post-operative tunnel-like communication (5 mm long × 2.6 mm large) between the right anterior non-coronary aortic sinus and the rudimentary right ventricular cavity. The shunt was diagnosed two and a half years after bulboventricular foramen surgical enlargement. The 5× 3 mm KONAR-MFO was retrogradely implanted under ultrasound and biplane fluoroscopic guidance. Immediate and 12-month follow-up confirmed successful outcomes with complete shunt closure and preserved aortic valve competence.

Super telescopic catheter system parallel to a contralateral stiff guide wire to cross extremely complex pulmonary arteries.

Access to complex stenotic pulmonary arteries can be challenging due to their anatomy or secondary to prior multiple surgeries and interventions. Two techniques have been previously described to address this issue: the telescopic catheter-in-long sheath parallel to a stiff guidewire technique and the use of a microcatheter in a telescopic scope. We integrated and modified these techniques creating a super telescopic system with a SuperCross® microcatheter-in-catheter-in-long sheath, parallel to a contralateral stiff guidewire to access a previously repaired and stented left pulmonary artery. The stiff wire support and the 90° flexiblity of the Supercross® microcatheter assembled coaxial to the diagnostic catheter and the long sheath contributed to the successful ballooning and stenting-in-stent of the pulmonary artery.

Transcatheter valve-in-valve implantation versus surgical redo aortic root replacement in patients with degenerated freestyle aortic bioprosthesis.

BACKGROUND: Transcatheter aortic valve-in-valve implantation (ViV TAVI) represents a new treatment option for patients with degenerated aortic bioprosthesis. Comparative data to redo surgical aortic valve replacement (redo SAVR) are limited. OBJECTIVE: We investigated feasibility and outcome of ViV TAVI versus redo SAVR in patients with symptomatic degenerated Medtronic Freestyle aortic bioprosthesis (FSB). METHODS: Between January 2002 and February 2020, 25 patients with failed FSB underwent ViV TAVI and 10 patients with failed FSB underwent redo SAVR. Endpoints were defined according to the Valve Academic Research Consortium-2 (VARC-2) criteria. RESULTS: Age and logistic EuroSCORE II were higher in patients with ViV TAVI (75.4 ± 1.7 vs. 62.9 ± 5.1 years, p = .019; 11.5 ± 1.6 vs. 5.6 ± 5.6%, p = .007). Valve implantation was successful in all cases. Mean transvalvular pressure gradients were significantly lower in patients with redo SAVR than ViV TAVI (7.6 ± 1.0 vs. 10.3 ± 0.8 mmHg, p = .037). Aortic valve regurgitation was absent in 91% and 100% of patients with ViV TAVI and redo SAVR, respectively. Thirty-day mortality rates were 12% in the ViV TAVI cohort versus 0% in the redo SAVR cohort (p = .542). Within the first year after hospital discharge, one patient after ViV TAVI had redo surgical intervention. CONCLUSIONS: ViV TAVI and redo SAVR lead to excellent functional results in patients with degenerated FSB. Post-procedural early complications must be considered particularly in patients with ViV TAVI because of higher clinical risk profiles.

The Use of Chronic Total Occlusion (CTO) Wires for Perforation of Atretic Pulmonary Valve; Two Centers Experience.

Pulmonary valve atresia with intact ventricular septum (PA-IVS) can be treated either surgically or transcatheterly for eligible patients. Perforation of pulmonary valves using chronic total occlusion (CTO) guidewires has been reported as an alternative to radiofrequency (RF) perforation. We sought to report our experience with CTO guidewires for perforation of atretic pulmonary valves and subsequent balloon dilatation (with or without patent ductus arteriosus stenting) in patients with PA-IVS from two centers. A retrospective study was carried out on PA-IVS patients who underwent intervention between March 2014 and September 2019, in which CTO guidewire was employed for pulmonary valve perforation. A total of 26 patients were identified. The median age and weight of the patients were 5.2 days (range 1-21 days) and 3.1 kg (range 2.2-3.8 kg), respectively. All patients were situs solitus, except one patient with left atrial isomerism. The right ventricle (RV) morphology was bipartite in 22/26 patients and tripartite in 4/26 patients. Before the procedure, the mean saturation was 76% (range 70-86%) while the patients were under prostaglandin infusion. The pulmonary valve perforation attempt was performed with the Asahi Conquest Pro 9 CTO wire (n = 6) or Asahi Pro 12 CTO wire (n = 18) and/or Asahi Miracle CTO wire (n = 2). The procedure was successful in 20/26 (77%) patients using CTO wires. We analyzed the efficiency of CTO wire based on the subtypes: Conquest Pro 9 in 6/6 (100%) patients, Conquest Pro 12 in 12/18 (67%) patients, and Miracle in 2/2 (100%) patients. Before CTO wire usage in 3 patients, radiofrequency (RF) perforation was unsuccessful. Among these 3 patients, pulmonary valve perforation was successful in 2 patients with CTO wire; hence, in the remaining patient, perforation was also unsuccessful with CTO wire. After CTO wire perforation was unsuccessful in 6 patients, RF perforation was attempted in 3 patients (2 successful attempts and 1 unsuccessful attempts), and one patient as referred to surgery. Desaturation was persistent in 19 cases, which necessitated ductus arteriosus stenting. Early procedural complication was observed in 3/26 (11%) patients. Two of these patients had vascular complications due to the sheath, which was treated with heparin infusion and streptokinase, and the remaining patient had sudden bradycardia and cardiac arrest during the procedure and did not respond to cardiac resuscitation. CTO wires should be keep in mind for atretic pulmonary valve perforation as a first choice or when RF perforation is unsuccessful.

Transcatheter closure of extracardiac Fontan conduit fenestration using new promising materials.

Fenestration transcatheter closure is widely considered to eliminate persistent right-to-left shunt after Fontan surgeries. Three consecutive children with stage III-palliated univentricular hearts recently underwent successful endovascular fenestration closure using 43 mm/Large Optimus-CVS™ that were implanted using the new Altosa-XL™ PTA balloon catheters (AndraTec GmbH). The procedure was fast with no complication and patients were discharged the following day with complete shunt closure. One-month follow-up confirmed excellent outcomes. This report aims to highlight and discuss the competitive advantages of these promising new materials in this particular intervention.

Timing of intervention in asymptomatic patients with valvular heart disease.

Current management of valvular heart disease (VHD) seeks to optimize long-term outcome by timely intervention. Recommendations for treatment of patients with symptoms due to severe valvular disease are based on a foundation of solid evidence. However, when to intervene in asymptomatic patients remains controversial and decision requires careful individual weighing of the potential benefits against the risk of intervention and its long-term consequences. The primary rationale for earlier intervention is prevention of irreversible left ventricular (LV) myocardial changes that might result in later clinical symptoms and adverse cardiac events. A number of outcome predictors have been identified that facilitate decision-making. This review summarizes current recommendations and discusses recently published data that challenge them suggesting even earlier intervention. In adults with asymptomatic aortic stenosis (AS), emerging risk markers include very severe valve obstruction, elevated serum natriuretic peptide levels, and imaging evidence of myocardial fibrosis or increased extracellular myocardial volume. Currently, transcatheter aortic valve implantation (TAVI) is not recommended for treatment of asymptomatic severe AS although this may change in the future. In patients with aortic regurgitation (AR), the potential benefit of early intervention in preventing LV dilation and dysfunction must be balanced against the long-term risk of a prosthetic valve, a particular concern because severe AR often occurs in younger patients with a congenital bicuspid valve. In patients with mitral stenosis, the option of transcatheter mitral balloon valvotomy tilts the balance towards earlier intervention to prevent atrial fibrillation, embolic events, and pulmonary hypertension. When chronic severe mitral regurgitation is due to mitral valve prolapse, anatomic features consistent with a high likelihood of a successful and durable valve repair favour early intervention. The optimal timing of intervention in adults with VHD is a constantly changing threshold that depends not only on the severity of valve disease but also on the safety, efficacy, and long-term durability of our treatment options.

Transcatheter stent implantation in a child with severe stenosis of the inferior caval vein secondary to injury.

Stenosis of the Inferior Caval Vein is rarely encountered in the paediatric setting. A 5-year-old male sustained severe injuries secondary to a fall from a three story balcony and was subsequently found to have severe stenosis of the inferior caval vein resulting in extensive lymphatic drainage with chylothorax, chyloperitoneum, and severe abdominal ascites. This was successfully treated with transcatheter stent placement resulting in complete resolution of the stenosis and significant clinical improvement allowing for transfer to a rehabilitation centre and eventual discharge home.

Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder.

OBJECTIVE: To assess the outcomes and potential predictors of residual leak after implantation of the GORE CARDIOFORM Septal Occluder (GSO) in secundum atrial septal defects (ASDs). BACKGROUND: The non-self-centering design of the GSO could lead to residual leak at the edge of the device. Outcomes of residual leak are poorly understood. METHODS: Retrospective, multicenter review of patients treated with the GSO for the pivotal and continued access study. Procedural, echocardiographic, and follow up data were reviewed. Multivariate analysis was performed to determine predictors of leak at implant and outcomes of these leaks. RESULTS: There were 370 total ASD device closures with the GSO, 65 (17.56%) of which were found to have residual leak at implantation. Patients with residual leak had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006) and smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), as compared to those without leak. Larger devices were implanted (p = .008) and more devices per case (p = .007) were utilized in the residual leak cohort as compared to those without leak. Overall, among patients with residual leak, there was a significant decrease in leak size over 1 year, from 1.55 ± 0.75 mm to 0.25 ± 0.74 mm (p < .001), with the majority (87.6%) disappearing by 12-month follow-up. CONCLUSIONS: Residual leak at implantation can be seen after ASD device closure with the GSO, more commonly in larger defects with smaller retroaortic rims. The vast majority of these leaks completely resolve by 1 year follow up.

Why Follow-up Examinations After Left Atrial Appendage Closure Are Important: Detection of Complications During Follow-up and How to Deal with Them.

PURPOSE OF REVIEW: Device-related thrombus (DRT) formation and incomplete left atrial appendage closure (LAAC) are the two major complications that can occur after LAAC and can potentially limit the success of such a procedure. This review discusses the incidence, clinical and/or prognostic significance, detection methods, treatment options, and potential strategies to prevent these complications. RECENT FINDINGS: It has recently been proven that the presence of a DRT represents an independent predictor for ischemic stroke after LAAC. Continued need for anticoagulation due to incomplete LAAC is clinically relevant to the patient. The appearances of a DRT or an incompletely closed LAA after a LAAC procedure are not rare complications. Due to the clinical and/or prognostic significance of these complications, it is important to detect them in a timely manner during follow-up by using the appropriate diagnostic imaging techniques. Since a DRT is associated with an increased risk of stroke, the therapy should be aggressive. In the case of incomplete LAA closure, an additional closure device may be used to complete occlusion and avoid lifelong anticoagulation therapy.

3D Printing Applications for Transcatheter Aortic Valve Replacement.

PURPOSE OF REVIEW: A combination of evolving 3D printing technologies, new 3D printable materials, and multi-disciplinary collaborations have made 3D printing applications for transcatheter aortic valve replacement (TAVR) a promising tool to promote innovation, increase procedural success, and provide a compelling educational tool. This review synthesizes the knowledge via publications and our group's experience in this area that exemplify uses of 3D printing for TAVR. RECENT FINDINGS: Patient-specific 3D-printed models have been used for TAVR pre-procedural device sizing, benchtop prediction of procedural complications, planning for valve-in-valve and bicuspid aortic valve procedures, and more. Recent publications also demonstrate how 3D printing can be used to test assumptions about why certain complications occur during THV implantation. Finally, new materials and combinations of existing materials are starting to bridge the large divide between current 3D material and cardiac tissue properties. Several studies have demonstrated the utility of 3D printing in understanding challenges of TAVR. Innovative approaches to benchtop testing and multi-material printing have brought us closer to being able to predict how a THV will interact with a specific patient's aortic anatomy. This work to date is likely to open the door for advancements in other areas of structural heart disease, such as interventions involving the mitral valve, tricuspid valve, and left atrial appendage.