Transcatheter Treatment Research Articles

Transcatheter or surgical treatment of paravalvular leaks: A meta-analysis of 13 studies and 2003 patients

Transcatheter or surgical treatment of paravalvular leaks: A meta-analysis of 13 studies and 2003 patients

A miniaturized cooling system for trans-esophageal echocardiographic probes may improve patients safety in minimally invasive cardiac surgery or trans-catheter percutaneous interventions

Abstract Introduction The recent development of real-time three-dimensional trans-esophageal echocardiography (RT-3D TEE) has favoured a wider transition from open-heart to minimally invasive surgery (MIS) or various trans-catheter percutaneous interventions, minimizing surgical risks and allowing faster post-operative and procedural discharge [1]. However, recent studies have highlighted the potential risk of oesophageal lesions partly related to thermal injury caused by the heat of the TEE probe during cardiac interventions [2]. Purpose This work aims to design a cooling system for trans-esophageal echocardiographic probes to be used during MIS or trans-catheter procedures. Currently during those interventions, fluoroscopic and RT-3D TEE images are simultaneously used, since commercial TEE probes automatically switch off at a temperature threshold of approximately 42.5°C [3], to avoid potential thermal oesophageal lesions. Additionally, ultrasound (US) image quality tends to decrease as temperature increases. The creation of a cooling device for TEE probes would therefore increase the reliability of US images in the intraoperative context, also considering their complete harmlessness to the patient. Methods The proposed cooling system design is a silicone cap – thus potentially sterilisable and reusable - into which the probe is inserted. The cap has an inner tube in which water flows at 25°C, constituting the cooling fluid. Heat exchange was studied through thermo-fluid dynamic simulations to analyse the cooling phenomenon. The hydraulic flow is controlled by a pumping device that activates when the probe temperature reaches a specific threshold deemed to be critical, also for image quality. Temperature trends are constantly monitored by means of two thermistors. Results The cooling system was extensively tested (5 repetitions for each experimental condition: Probe alone, Passive silicone and Active cooling system) on a probe produced by GE Healthcare, setting 38°C as the activation temperature threshold for the pump. Considering the duration of MIS or transcatheter interventions (about two hours) [2], it was experimentally observed that by using the cooling system the probe never exceeded the temperature of 39°C. From experimental tests, it is possible to state that the insulating properties of silicone result in a dual effect: a) silicone passively hinders heat dispersion produced by the probe due to the Joule effect - Passive silicone condition ; b) once the system is activated the cooling effect is maintained by the precence of water inside the cap - Active cooling system condition. Conclusions In conclusion, based on numerical simulations and experimental results, this novel tool seems promising, increasing the safety and potentially also the reliability of US images in the intraoperative and intraprocedural scenario. Cooling system design Experimental results

Transcatheter treatment of severe mitral regurgitation in high surgical risk patients: analysis of clinical and echocardiographic data from a referral center

Abstract Introduction Mitral regurgitation (MR) is the most common valvular heart disease, affecting 2-3% of the population, with a prevalence of around 10% in individuals over 75 years old. It is a frequent cause of decompensation in patients with heart failure (HF), associated with unfavorable clinical outcomes, including increased morbidity and mortality. Transcatheter mitral valve repair using an edge-to-edge mitral valve leaflet repair technique has become a therapeutic option for patients with severe MR who are considered high surgical risk. Transesophageal echocardiography (TEE) is crucial for determining eligibility, guiding the procedure, monitoring potential complications, and assessing the final result. Objectives To analyze data related to etiology (primary, secondary, and mixed), number of clips used, average age, severity of MR, and the final procedure outcome. Methods We conducted a descriptive analysis of a series of 43 cases of high surgical risk severe mitral regurgitation from 2019 to 2024 at a referral hospital in São Paulo, indicated for transcatheter treatment by a "heart team". We described the prevalence of etiologies, average age, pre-procedure MR severity, and final echocardiographic outcome. Continuous variables were described as mean and standard deviation. Results We analyzed 43 cases of transcatheter mitral valve implantation from 2019 to 2024. One patient died on the first day post-procedure. Of the total cases, 42% had primary MR, 38% secondary MR, and 20% mixed etiology. The average age of the patients was 79.8 years and the number of implanted clips was 1.62 ± 0.72, considering all the cases. A decrease in the average number of clips implanted is observed When analyzed separately by year: in 2019, na average of 2.3±1, and in 2023/2024, 1.8±0.7. All procedures were performed in a catheterization or hybrid room, guided by TEE with the addition of three-dimensional technology. Using a grading scale for MR from mild (1+) to severe (4+), evaluated by TEE, the average after clip implantation was 1.27 ± 0.59. Regarding the mean gradient, the average post-procedure was 3 ± 1.2 mmHg. Conclusion The use of the transcatheter mitral valve implantation, following anatomical criteria for mitral valve selection, proved to be an effective and safe therapeutic option for reducing MR in high-risk patients. TEE is an essential tool in patient eligibility, guiding the procedure, evaluating the final result, and identifying potential complications.

Pressure-strain-volume analysis-derived wasted work predicts clinical outcomes after transcatheter tricuspid valve intervention

Abstract Background The pressure-strain loop is a non-invasive alternative to the traditional pressure-volume analysis for calculating myocardial work. Incorporating volume into work calculations may be particularly beneficial in evaluating patients with tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI), who often present with highly varied load conditions. Purpose The study aimed to test the hypothesis that pressure-strain-volume analysis-derived right ventricular (RV) work will predict the composite clinical outcome of heart failure hospitalization (HFH) and death within 12 months after the TTVI. Methods Patients undergoing TTVI at two tertiary centers were included between June 2021 and November 2023. The pre-procedural three-dimensional echocardiographic acquisitions of the RV (to obtain RV volumes and global longitudinal strain) and RV pressures obtained from same day, pre-procedural right heart catheterization or calculated from TR maximal velocity and right atrial pressure were integrated into pressure-strain-volume loops using dedicated software (ReVISION, Argus Cognitive, USA). The pressure-strain-volume derived myocardial work was quantified as the volume under the three-dimensional curve and characterized by the following metrics: global work index (GWIV), global constructive work (GCWV), global wasted work (GWWV), and global work efficiency (GWEV). Conventional pressure-strain analysis-derived metrics were also calculated as previously described (1). The composite outcome was HFH or death within 12 months after TTVI. Cox regression analysis was performed to investigate the possible associations with the composite outcome and included all baseline clinical, echocardiographic, hemodynamic and RV work parameters. Variables were considered for multivariate analysis when they were related to composite endpoint on univariate analysis with a p value <0.05. Results Of 76 patients included, 52.6% were female. The mean age was 79.3 ± 7.5 years and median TRI-Score 5 [4-7] points. Transcatheter interventions included transcatheter tricuspid valve repair (61.8%) and tricuspid valve replacement (38.2%). TR at discharge was trace/mild, moderate, severe or massive in 60.6%, 26.3%, 13.2% and 0% cases respectively. At 12-month follow-up, 26 (34.2%) patients met the composite endpoint. After adjustment for number of HFH 12 months prior to TTVI, atrial fibrillation, glomerular filtration rate and NT-proBNP, GWWV remained the only baseline parameter significantly associated with increased risk of HFH and death at 12-month follow-up in the multivariate analysis with an adjusted OR of 1.079 (95% confidence interval 1.020 - 1.143; p = 0.009). Conclusion Results of this analysis show that baseline pressure-strain-volume analysis-derived wasted work identifies patients at higher risk for HFH or death following TTVI. Thus, the GWWV calculation may help identify individuals who are more likely to benefit from TTVI.

Percutaneous self-expandable valve implantation in patients with stented pulmonary arteries: case examples.

CHDs affecting the right ventricular outflow tract often require repeated surgical or transcatheter interventions due to pulmonary insufficiency or stenosis. This study presents percutaneous implantation of large self-expanding valves in patients with complex right ventricular outflow tract anatomy after prior pulmonary branch stenting.

Embracing a new era of echocardiography-guided percutaneous and non-fluoroscopical procedure for structure heart disease

Abstract The advancement of catheter-based interventional techniques represents a significant evolution in cardiovascular medicine. However, traditional methods that rely on fluoroscopic guidance present considerable limitations including radiation exposure and contrast agent-related risks and the heavy load-caused lead suits. In response, zero or low X-ray emerge, including percutaneous and non-fluoroscopical (PAN) procedure coming as a transformative solution, particularly in treating congenital heart disease, valvular disease, and arrhythmias. These methods minimize the risk of iatrogenic injuries associated with radiative procedures. Innovative PAN procedures and methodologies have been developed to enhance imaging, transcatheter interventions, safety, and accuracy, overcoming previous limitations. By eliminating radiation and expanding accessibility, PAN procedures offer a safe, effective, and economically viable alternative to traditional methods, ushering in a new era of minimally invasive cardiovascular treatment.

Current Status of CT Imaging Before Common Transcatheter Interventions for Structural Heart Disease.

Background: Over the past decade, several trials and observational studies have validated the use of minimally invasive cardiac interventions as viable treatment options for various cardiac diseases. Transcatheter techniques for severe aortic valve stenosis have rapidly emerged as alternatives to surgical aortic valve replacement in certain patient populations. Additionally, non-surgical treatment options have expanded for conditions affecting other cardiac valves, such as the mitral valve. These emerging minimally invasive interventions complement already well-established endovascular techniques for, among others, atrial septal defect closure, left atrial appendage occlusion and pulmonary vein isolation in patients with atrial fibrillation. Given their non-surgical nature and lack of direct visualisation of the targeted anatomy, these procedures heavily rely on precise pre-procedural radiological imaging for optimal patient selection and procedural success. Method: This paper is based on the expert opinion of the authors and an exhaustive literature research. Results: This manuscript reviews the most commonly employed minimally invasive cardiac interventions, highlighting the essential pre-procedural imaging information and key aspects that must be included in radiological reports to mitigate potential complications. Conclusion: Accurate pre-procedural imaging is crucial for ensuring safe and effective minimally invasive cardiac interventions, underscoring the importance of the radiologist in the pre-procedural work-up of these patients.

Discussion to: Surgery and transcatheter intervention for degenerative mitral regurgitation in the United States

Discussion to: Surgery and transcatheter intervention for degenerative mitral regurgitation in the United States

Comparative Transcatheter Intervention for Pulmonary Valve Stenosis: Multicenter Collaborative Study Across Pediatric and Veterinary Cardiology Centers

Comparative Transcatheter Intervention for Pulmonary Valve Stenosis: Multicenter Collaborative Study Across Pediatric and Veterinary Cardiology Centers

Advanced Management of Patients Undergoing Transcatheter Treatment for Pulmonary Embolism: Evidence-Based Strategies for Optimized Patient Care.

Pulmonary embolism (PE) is a life-threatening medical condition caused by the thrombotic occlusion of one or more branches of the lung vasculature, which represents the third most common cause of cardiovascular mortality after myocardial infarction and stroke. PE treatment requires a tailored approach based on accurate risk stratification and personalized treatment decision-making. Anticoagulation is the cornerstone of PE management, yet patients at higher clinical risk may require more rapid reperfusion therapies. In recent years, transcatheter treatment has emerged as a valuable option for patients with intermediate-high or high-risk PE who have contraindications to systemic thrombolysis. Recent advancements in catheter-directed therapies, such as catheter-directed thrombolysis (CDT) and catheter-directed mechanical thrombectomy (CDMT), provide minimally invasive options for swift symptom relief and hemodynamic stabilization. This review aims to provide a practical approach for optimal patient selection and management for PE percutaneous therapies, supported by a thorough evaluation of the current evidence base supporting these procedures. A focus on post-procedural management, the prevention of recurrence, and monitoring for long-term complications such as chronic pulmonary hypertension and post-PE syndrome is also specifically tackled.

Incidence and Prognosis of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement for Bicuspid Aortic Stenosis.

Evidence regarding the incidence of prosthesis-patient mismatch (PPM) and long-term mortality after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS) is scarce. This study sought to assess the incidence and prognostic impact of PPM after TAVR for bicuspid AS compared with that for tricuspid AS. In total, 7,393 patients who underwent TAVR were prospectively enrolled in the OCEAN-TAVI (Optimized Catheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry, an ongoing Japanese, multicenter registry. We analyzed 7,051 patients (median age=85 years, 68.4% women) and identified 503 (7.1%) with bicuspid AS. We compared the incidence of PPM and long-term mortality in 497 patients with and 497 without bicuspid AS after one-to-one propensity score matching analysis. Among the 7,051 patients, moderate and severe PPM were observed in 756 (10.7%) and 92 (1.3%) patients, respectively. Upon Kaplan-Meier curve analysis of the overall cohort, severe PPM appeared to be associated with long-term mortality (log-rank test, P=0.065). After propensity score matching analysis, moderate and severe PPM were more frequently observed among patients with tricuspid AS than patients with bicuspid AS (moderate PPM, 11.7% vs 4.4%; severe PPM, 1.4% vs 1.0%; P=0.0001). Severe PPM appeared to be associated with all-cause mortality. Moderate and severe PPM were more frequently observed in patients with tricuspid AS than patients with bicuspid AS.

A Protocol Investigation Comparing Transcatheter Repair with the Standard Surgical Procedure for Secondary Mitral Regurgitation.

Background: Secondary mitral regurgitation (SMR) is characterized by a pathological process impacting the left ventricle (LV) as opposed to the mitral valve (MV). In the absence of structural alterations to the MV, the expansion of the LV or impairment of the papillary muscles (PMs) may ensue. A number of technical procedures are accessible for the purpose of determining the optimal resolution for MR. Nevertheless, there is a dearth of rigorous data to facilitate a comparative analysis of MV replacement, MV repair (including subvalvular repair), and transcatheter mitral valve interventions (TMV-Is). The objective of this investigation is to evaluate and compare the efficacy and clinical outcomes of transcatheter mitral valve repair (TMV-r) utilizing the edge-to-edge mitral valve repair (TEER) procedure in comparison to conventional surgical mitral valve interventions (S-SMVis) in patients with secondary mitral regurgitation. Methods and analysis: A consortium of five cardiac surgery institutions from four European states and Japan have joined forces to establish a multicenter observational registry, designated TEERMISO. Patients who underwent technical procedures for SMR between January 2007 and December 2023 will be enrolled consecutively into the TEERMISO registry. The investigation team evaluated the comparative efficacy of replacement and repair techniques, utilizing both the standard surgical methodology and the transcatheter intervention. The primary clinical outcome will be the degree of left ventricular remodeling, as assessed by the left ventricular end-diastolic volume index, at 10 years. The forthcoming research will assess a variety of secondary endpoints, among which all-cause mortality will be the primary endpoint. Subsequent assessments will be made in the following order: functional status, hospitalization, neurocognition, physiological measures (echocardiographic assessment), occurrence of adverse clinical incidents, and reoperation. Ethics and dissemination: The multicenter design of the database is anticipated to reduce the potential for bias associated with institutional caseload and surgical experience. All participating centers possess an established mitral valve protocol that facilitates comprehensive follow-up and management of any delayed mitral complications following replacement surgery or surgical repair of the secondary mitral regurgitation. The data collected will provide insights into the impact of diverse surgical approaches on standard mitral valve surgery and TEER. This will facilitate the evaluation of LV remodeling over the course of long-term post-procedural follow-up. Trial Registration: ClinicalTrials.gov ID: NCT05090540; IRB ID: 202201143.

Impact of Right Ventricular to Pulmonary Artery Coupling on Survival Following Indirect Mitral Annuloplasty.

Right ventricular-to-pulmonary artery (RV-PA) coupling is an important predictor of long-term survival following transcatheter edge-to-edge repair. However, its impact on survival in patients undergoing indirect mitral annuloplasty is unknown. The study aimed to assess the impact of baseline RV-PA coupling on survival following indirect mitral annuloplasty in heart failure patients. Patients were classified according to baseline RV-PA coupling: TAPSE (tricuspid annular plane systolic excursion)/PASP (pulmonary artery systolic pressure) > 0.55 (group 1), ≤ 0.55 ≥ 0.32 (group 2) and ≤ 0.32 (group 3). Clinical follow-up and RV function were assessed 3 and 12 months following indirect annuloplasty. A TAPSE/PASP > 0.55 was found in 19 patients, while 47 patients showed a TAPSE/PASP ≤ 0.55 > 0.32 and 26 a TAPSE/PASP ≤ 0.32. A significant reduction in vena contracta and regurgitant volume compared to baseline was found in all groups at 3-months and 12-months follow-up. One-year mortality was significantly increased in group 3 compared to the other groups (group 1: 0.95, group 2: 0.91, group 3: 0.77; Log-Rank test p = 0.018). In groups 2 and 3 the TAPSE/PASP significantly improved during the 12-months follow-up, while it remained unchanged in group 1 (group 1: baseline = 0.71 ± 0.03, 12-months = 0.67 ± 0.01; group 2: baseline = 0.43 ± 0.06, 12-months: 0.56 ± 0.04; group 3: baseline = 0.25 ± 0.06, 12-months: 0.4 ± 0.03; p < 0.001). RV-PA uncoupling before indirect mitral annuloplasty is associated with poor survival. However, Carillon device implantation improved right heart function and RV-PA coupling in patients with severe RV dysfunction at baseline. Therefore, Carillon device implantation can be a valuable option for transcatheter treatment of patients with FMR and right heart failure.

Case Report: Concurrent transcatheter aortic and mitral valve replacement for symptomatic concomitant aortic and mitral valve stenoses

In patients undergoing transcatheter aortic valve implantation (TAVI), multi-valve disease is common and associated with worse outcomes. Despite multiple emerging transcatheter valve treatment options, no guidelines exist for the transcatheter treatment of multi-valve disease. We present a case of a 76-year-old patient with concomitant severe aortic valve stenosis and severe mitral valve stenosis who underwent concurrent TAVI and transcatheter mitral valve replacement. In this case report, we demonstrate the feasibility of concurrent double-valve transcatheter intervention to treat patients with multi-valve disease. We also highlight the role of the heart valve team to guide individual patient treatment strategies in the absence of clinical guidelines and the importance of multi-modality imaging to plan and execute the procedure.

Long-term outcomes with medical therapy, transcatheter repair, or surgery for isolated tricuspid regurgitation: a systematic review and network meta-analysis.

Several transcatheter tricuspid valve (TV) repair devices for tricuspid regurgitation (TR) have emerged. However, few studies have compared transcatheter TV repair with medical therapy (MT) alone or isolated TV surgery. PubMed and EMBASE were searched in February 2024. Studies comparing at least any of the following 2 were included: MT, surgical TV repair, surgical TV replacement, or transcatheter TV repair. The primary outcome was long-term mortality (≧ 1year). The secondary outcomes were short-term mortality (30-day or in-hospital mortality) and periprocedural complications. We performed a network meta-analysis using a random effects model. A total of 25,831 patients from 22 studies (one randomized trial and 21 observational studies) were included. MT alone was associated with higher long-term mortality compared to surgical TV repair (HR [95% CI] 1.72 [1.34-2.23]), surgical TV replacement (HR [95% CI] 1.49 [1.14-1.96]), and transcatheter TV repair (HR [95% CI] 1.52 [1.30-1.78]). Long-term mortality was comparable between transcatheter and surgical interventions. Transcatheter TV repair had a lower risk of short-term mortality (versus surgical TV repair; RR [95% CI] 0.40 [0.22-0.72], versus surgical TV replacement; RR [95% CI] 0.35 [0.19-0.66]) and lower rates of periprocedural complications, including new pacemaker implantation, renal complications, cardiogenic shock than surgical interventions. MT alone for TR was associated with higher long-term mortality compared to surgical or transcatheter TV interventions. Transcatheter TV repair had better periprocedural outcomes compared to surgical interventions with similar long-term mortality. Despite the possibility of selection bias, transcatheter TV repair appears to be an attractive option for TR treatment.

Arrhythmias Following Patent Foramen Ovale Closure: An Unsolved Enigma.

Patent foramen ovale (PFO) closure has proven to be an effective method of reducing the risk of recurrent stroke in patients with embolic stroke of unknown origin (ESUS). One of the most recognized post-procedural complications is the de novo occurrence of supraventricular arrhythmias, mainly atrial fibrillation, in the first three months following PFO closure. Earlier studies reported the incidence to be around 3.4-7%; however, this percentage has risen in recent studies up to 21%. The pathogenesis behind this type of arrhythmia is complex and not clearly understood, although it seems that direct effects of the device on the atria, as well as an inflammatory response, are the two most prevalent mechanisms. Management of this complication might be challenging given the heterogenicity of patient characteristics, so an individualized approach is most wisely followed. This review aims to present the current data on the incidence, pathogenesis and therapeutic strategies behind this rather common concern in an era of increasing transcatheter interventions for PFO.

Transcatheter Interventions in Adults With Fontan Palliation.

The Fontan circuit is associated with chronically elevated systemic venous pressures and decreased cardiac output, often leading to circuit failure. Managing Fontan circuit failure is complex and requires multiple therapeutic options. Transcatheter interventions have emerged as a reliable approach. They can alleviate obstructions and improve cyanosis by enhancing pulmonary blood flow and oxygen saturation. These procedures can also increase cardiac output and reduce systemic venous pressure, contributing to patient stabilization. In addition, they help mitigate volume overload and decrease the risk of bleeding during heart or combined heart and liver transplants. In recent years, percutaneous interventions have rapidly evolved and become a key therapeutic option for addressing various aspects of Fontan circuit failure. These interventions should be considered integral to the management strategy for this specific patient population.

Beyond Prostaglandin E1: Management of Infants With Critical Congenital Heart Defects

Critical congenital heart defects (CHDs) are life-threatening cardiac lesions requiring cardiac surgery or transcatheter intervention or result in death within 28 days after birth. In infants with critical CHDs, delayed diagnosis and inappropriate management are associated with higher mortality and comorbidities. Antenatal anomaly screening and fetal echocardiography has improved the detection of fetal CHDs, which helps in perinatal management planning with multidisciplinary teams. Even with precision delivery planning, postnatal transition may affect each infant with CHDs differently depending on the variants and severity of the defect. Therefore, it is important to have a thorough understanding of the hemodynamic physiology in infants with a critical CHD during the transition from intrauterine to extrauterine life and alter management accordingly. This review summarizes the care of infants with critical CHDs in the immediate transition period with a focus on cases with distinctive physiology.

Outcomes of Following Transcatheter and Surgical Interventions in Patients with Acute Valvular Dysfunction with Cardiogenic Shock

Outcomes of Following Transcatheter and Surgical Interventions in Patients with Acute Valvular Dysfunction with Cardiogenic Shock

Morphological Characteristics of Interatrial Septum and Its Clinical Relevance

ABSTRACTBackgroundThe development of new trans‐septal transcatheter interventions for patients with structural heart disease necessitates a precise and comprehensive understanding of the anatomy of the interatrial septum (IAS). The scarcity of gross anatomical studies has triggered our interest in exploring the morphometry and morphology of IAS.AimsTo study the morphology, morphometry and variations of the interatrial septum in autopsied human hearts.MethodsThe study was conducted on 97 autopsied fresh human hearts, in which we observed the position and shape of fossa ovalis (FOv), along with prominence of the limbus and its location. The diameter of FOv, thickness of its floor, redundancy and any variation in the IAS were noted.ResultsIn most cases (72.9%), the FOv was situated toward the inferior vena cava and was oval shaped (69.8%), with mean horizontal and vertical diameters of 17.21 ± 4.11 mm and 12.74 ± 3.78 mm, respectively. The limbus was prominent in 72.2% specimens, most commonly prominent all around (36.6%), followed by antero‐superior (28.2%), antero‐inferior (16.9%) and anterior (8.5%) prominence. The mean thickness of the floor of FOv was 0.71 ± 0.98 mm, and redundancy was observed in 47% of samples. Probe patency was seen only in 10.3% specimens. The right surface of the IAS showed more variations (71.1%) compared to the left (44.3%), in form of recesses, atrial septal pouches, fibrous strands, retinacular‐type fibrous networks and combination of more than one type.ConclusionVariations in the location of FOv, the prominence of limbus and the common occurrence of anatomical variants of the IAS mandate the preprocedural imaging of the region to reduce the failure rate and complications.