Transcatheter Valve Research Articles

Abstract 4120270: Risk Factors for Catastrophic Complications Requiring Emergent Extracorporeal Life Support in Patients Undergoing Transcatheter Aortic Valve Replacement

Background: Transcatheter Aortic Valve Replacement (TAVR) is often performed in the cardiology catheterization suite. Although rare, instances of annular rupture, cardiac arrest, and coronary occlusion may occur requiring institution of emergent extracorporeal life support (ECLS). This study aims to examine the risk factors for complications requiring ECLS during TAVR procedures to identify patients who may benefit from having procedures performed in hybrid operating rooms. Methods: Data from the Transcatheter Valve Therapy registry for our institution was obtained on patients (n=4908) who underwent TAVR between November 2012 and July 2023. Univariable logistic regression was performed to compare relevant covariates in those requiring intraoperative ECLS (n=23) to the rest of the patient cohort (n=4885). All-cause mortality during the follow-up period was compared to assess the impact of emergent intraoperative ECLS. Results: The patients requiring ECLS experienced significantly higher all-cause mortality (69.6% versus 28.8%, p<0.001) with median follow up of 2 years (Table 1) . Female sex (p=0.013) and smaller annulus size (p=0.007) were significant independent risk factors for complications requiring emergent intraoperative ECLS based on univariable logistic regression (Table 2). Patients requiring ECLS had significantly smaller annulus sizes (21.0-23.2 mm) compared to the uncomplicated cohort (22.0-25.8 mm). Of the patients requiring ECLS, 11 cases (47.8%) were due to annular/ventricular rupture while 4 cases (17.4%) resulted from valve embolization. Of note, valve type (self-expanding versus balloon expandable), annular calcification, and porcelain aorta were not found to be significant risk factors. Conclusions: In this large volume single-center retrospective cohort study, female sex and smaller aortic annular size significantly increased the risk of complications necessitating ECLS support during TAVR procedures. Our study represents the first to identify independent risk factors for catastrophic complications during TAVR procedures. Patients with these high-risk profiles should have their TAVR procedures performed in the hybrid operating room with cardiopulmonary bypass on immediate standby.

Clip It or Let It: The Efficacy of Mitral Valve Transcatheter Edge-to-Edge Repair Versus Conservative Treatment in Reducing Mortality Among Patients With Ischemic Mitral Regurgitation

BACKGROUND: Despite revascularization and optimal medial therapy (OMT) residual ischemic mitral regurgitation (IMR) continues in a self-aggravating vicious cycle to affect prognosis and survival adversely. Mitral valve surgery in combination with coronary artery bypass graft remains a subject of debate due to the absence of a net overall benefit. Mitral valve transcatheter edge-to-edge repair (M-TEER) has been gaining grounds as a viable option from observational studies, but results from randomized controlled trials (RCTs) have yielded mixed results. Thus, this study was conducted to determine whether the current collective data support the efficacy of M-TEER with OMT versus OMT alone in patients with clinically significant IMR. METHODS: A literature search from PubMed/MEDLINE, Cochrane Review Central, Clinical Trials Registry, ResearchGate, Mendeley, and Google Scholar for relevant RCTs and observational studies was conducted and reviewed independently by three reviewers. Published and unpublished studies indexed from inception until 2023 were included. The pooled estimates for the primary outcome of all-cause mortality and secondary outcomes of cardiac mortality and heart failure hospitalizations were measured using R Studio statistical software (R Foundation forStatistical Computing, Vienna, Austria). RESULTS: Seven eligible studies (five observational and two RCTs) allocated 1610 IMR patients to M-TEER + OMT (n = 942) or OMT alone (n = 668). The effect estimate using random-effects model demonstrated M-TEER with OMT to significantly reduce 1-year (odds ratio [OR], 0.67; 95% confidence interval [CI], 0.52–0.86; P = 0.002) and 2-year (OR, 0.50; 95% CI, 0.38–0.67; P < 0.00001) all-cause mortality. Cardiac mortality (OR, 0.58; 95% CI, 0.27–1.23; P = 0.15) and heart failure hospitalization (OR, 0.45; 95% CI, 0.18–1.13; P = 0.09) did not reach statistical significance between the treatment arms. CONCLUSION: In patients with IMR, M-TEER on top of OMT was able to afford a 2-year allcause mortality advantage. KEYWORDS: ischemic mitral regurgitation, mitral valve transcatheter edge-to-edge repair, optimal medical therapy

Body mass index and prognostic outcomes after transcatheter aortic valve replacement: Insights from the Chinese Cardiovascular Association Database-National Transcatheter Valve Therapeutics Registry.

Body mass index and prognostic outcomes after transcatheter aortic valve replacement: Insights from the Chinese Cardiovascular Association Database-National Transcatheter Valve Therapeutics Registry.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in Chinese patients with intermediate and high surgical risk for aortic stenosis: a decision analysis on effect, affordability and cost-effectiveness

ObjectiveExamine the cost-effectiveness of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) for Chinese patients with severe aortic stenosis (AS) at intermediate and high surgical risk.DesignA two-phase model, comprising a 1-month decision tree to simulate perioperative outcomes and a 5-year Markov model with monthly cycles to simulate long-term outcomes, has been developed to evaluate the cost-effectiveness of TAVI compared with SAVR for Chinese patients with AS at intermediate and high risk. The event rates for both phases are sourced from the Placement of Aortic Transcatheter Valves IA and IIA trials, while the cost inputs and utility values are sourced from local sources or published literature. Adjustments for inflation were made using consumer price indexes for healthcare to enhance precision. To ensure the reliability and robustness of the model, sensitivity analyses were conducted to assess their impact on outcomes.SettingChina healthcare system perspective.ParticipantsA hypothetical cohort of Chinese patients with AS in intermediate and high surgical risk.InterventionsTAVI versus SAVR.Outcome measuresCost, quality-adjusted life-years (QALYs), life-years gained and incremental cost-effectiveness Ratio (ICER).ResultFor both intermediate- and high-risk AS patients, offering TAVR resulted in high healthcare costs but moderate benefits compared with SAVR. Specifically, in the intermediate-risk population, TAVR led to a 0.34 QALY increase over SAVR, with an incremental cost of $16 707.58, resulting in an ICER of $49 176.60/QALY. Similarly, in the high-risk population, TAVR showed a 0.15 QALY increase over SAVR, with an incremental cost of $18 093.52, leading to an ICER of $122 696.37/QALY. However, both ICERs exceeded the willingness-to-pay threshold of $37 654.50/QALY. Sensitivity analyses confirmed the model’s stability under parameter uncertainty.ConclusionTAVI was deemed not cost-effective compared with SAVR for patients with AS at intermediate or high surgical risk in the Chinese healthcare system. Lowering valve costs was considered an effective approach to improve the cost-effectiveness of TAVI.

Outcomes of Balloon-Expandable Transcatheter Aortic Valve Replacement in Younger Patients in the Low-Risk Era

Guidelines advise heart team assessment for all patients with aortic stenosis, with surgical aortic valve replacement recommended for patients younger than 65 years or with a life expectancy greater than 20 years. If bioprosthetic valves are selected, repeat procedures may be needed given limited durability of tissue valves; however, younger patients with aortic stenosis may have major comorbidities that can limit life expectancy, impacting decision-making. To characterize patients younger than 65 years who received transcatheter aortic valve replacement (TAVR) and compare their outcomes with patients aged 65 to 80 years. This retrospective registry-based analysis used data on 139 695 patients from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, inclusive of patients 80 years and younger undergoing TAVR from August 2019 to September 2023. Balloon-expandable valve (BEV) TAVR with the SAPIEN family of devices. Comorbidities (heart failure, coronary artery disease, dialysis, and others) and outcomes (death, stroke, and hospital readmission) of patients younger than 65 years compared to patients aged 65 to 80 years. In the years surveyed, 13 849 registry patients (5.7%) were younger than 65 years, 125 846 (52.1%) were aged 65 to 80 years, and 101 725 (42.1%) were 80 years and older. Among those younger than 65, the mean (SD) age was 59.7 (4.8) years, and 9068 of 13 849 patients (65.5%) were male. Among those aged 65 to 80 years, the mean (SD) age was 74.1 (4.2) years, and 77 817 of 125 843 patients (61.8%) were male. Those younger than 65 years were more likely to have a bicuspid aortic valve than those aged 65 to 80 years (3472/13 755 [25.2%] vs 9552/125 001 [7.6%], respectively; P < .001). They were more likely to have congestive heart failure, chronic lung disease, diabetes, immunocompromise, and end stage kidney disease receiving dialysis. Patients younger than 65 years had worse baseline quality of life (mean [SD] Kansas City Cardiomyopathy Questionnaire score, 47.7 [26.3] vs 52.9 [25.8], respectively; P < .001) and mean (SD) gait speed (5-meter walk test, 6.6 [5.8] seconds vs 7.0 [4.9] seconds, respectively; P < .001) than those aged 65 to 80 years. At 1 year, patients younger than 65 years had significantly higher readmission rates (2740 [28.2%] vs 23 178 [26.1%]; P < .001) and all-cause mortality (908 [9.9%] vs 6877 [8.2%]; P < .001) than older patients. When propensity matched, younger patients still had higher 1-year readmission rates (2732 [28.2%] vs 2589 [26.8%]; P < .03) with similar mortality to their older counterparts (905 [9.9%] vs 827 [10.1%]; P = .55). Among US patients receiving BEV TAVR for severe aortic stenosis in the low-surgical risk era, those younger than 65 years represent a small subset. Patients younger than 65 years had a high burden of comorbidities and incurred higher rates of death and readmission at 1 year compared to their older counterparts. These observations suggest that heart team decision-making regarding TAVR for most patients in this age group is clinically valid.

Polyphenol-treatment without preceding glutaraldehyde fixation: a potential paradigm change for bioprosthetic heart valves

Abstract Background Glutaraldehyde (GA) is the common fixative agent for bioprosthetic heart valves (BHVs). However, its chemical instability can expose calcium binding sites and, at commercially used concentrations, GA does not ensure effective immunological tolerance, triggering an immune response correlated to degeneration. Recently, polyphenols (PPs) achieved an almost complete xenoantigens inactivation in GA-fixed BHVs ensuring chemical stability of the treated tissue while improving mechanical characteristics and adding anti-infective and anti-thrombotic properties [1-4]. Purpose A new PP-based treatment has been introduced as a potential GA substitute in BHV manufacturing. The unique chemical properties of PPs permit them to interact with the tissue through stable chemical bonds without depolymerization over time, achieving several improvements that promise to extend the long-term durability of BHVs (Fig.1). Methods The study compared the effects of two cross-linking methods on bovine pericardial tissue: (1) traditional fixation in GA, and (2) treatment with PPs without GA. The type of chemical interaction between PPs and tissue was evaluated through nuclear magnetic resonance. The xenoantigens inactivation was quantified in-vitro by ELISA test and in-vivo in a humanized mouse animal model. Biomechanical properties were assessed through uniaxial stress-strain tests and cross-link density through the shrinkage temperature test. The protective effect against bacterial adhesion was evaluated against a strain of S aureus, while the inhibition of thrombosis was evaluated in-vivo in a pig animal model and in-vitro in a blood-loop using bovine blood with radio-labeled platelets. Results PPs effectuated multiple chemical bonds with and within the pericardium including cross-links based on covalent and hydrogen bonds, stacking, and electrostatic interactions. The inactivation of over 90% of surface-xenoantigens of the treated tissue allowed for superior biocompatibility (compared to &amp;lt;50% by commercial GA concentrations). The increase in elongation exhibited by PP-treated tissue confirmed excellent biomechanical features (Fig.2) while a sufficient degree of cross-linking was demonstrated through an adequate shrinkage temperature. Furthermore, a significant degree of bacterial adhesion (86% inhibition evaluated with S. aureus) and thrombus formation (Fig.2, up to 90% inhibition) were observed. Conclusion There is a real clinical need for improved chemical stability, calcification resistance, and immunological tolerance of current BHVs (surgical and transcatheter). PP technology may substitute the use of GA extending their performance and durability, thereby opening trans-catheter heart valves to younger patients. Reducing the need for mechanical heart valves would also address the associated risks of lifelong anticoagulation therapy.Figure 1Figure 2

Prognostic impact of mitral valve geometry in patients with secondary mitral regurgitation: a secondary analysis of the MITRA-FR trial

Abstract Background Mitral valve (MV) transcatheter edge-to-edge repair (TEER) has emerged as a second line therapy on top of guidelines-directed medical treatment (GDMT) in heart failure (HF) patients with severe secondary mitral regurgitation (SMR). Following the disparate results of the COAPT and MITRA-FR pivotal trials, echocardiographic markers of LV remodeling and MR severity have been proposed to select patients most likely to benefit from MV-TEER. The characterization of MV geometry arises as a potential tool to stratify risk of outcomes in SMR patients, who underwent classical surgery or MV-TEER intervention. However, it remains unknown whether MV geometry parameters were associated with prognosis in MITRA-FR patients and whether MV-TEER could modulate their impact on outcomes. Purpose To evaluate the association between MV geometry and outcomes of HF patients with SMR in the MITRA-FR trial, as well as the impact of SMR treatment modality. Methods Thirteen MV geometry parameters were assessed from baseline transthoracic echocardiograms in patients from the MITRA-FR trial. The prognostic impact of MV geometry parameters was studied on top of the baseline clinical variables used in the primary analysis of MITRA-FR (i.e. age, atrial fibrillation [AF], ischemic cardiomyopathy, myocardial infarction, left ventricular ejection fraction [LVEF] and effective regurgitant orifice area [EROA]). The primary endpoint was the composite of all-cause mortality or HF hospitalization (HFH) within 2 years. The effect of treatment arms (MV-TEER plus GDMT vs. GDMT alone) on this association was also evaluated. Results Among the 307 patients included in the pivotal trial, 272 were analyzed in the present study (i.e. 135 from the GDMT group and 137 from the GDMT + MV-TEER group). Mean age was 70±10, 74% male. 50% had ischemic cardiomyopathy and 34% AF. LVEF was 33±7% and EROA was 31±11 mm². MV geometry parameters were presented for the whole population and according to the randomization group in the Table. Among these parameters, only MV tenting area remained independently associated with the primary endpoint (Hazard Ratio (HR) = 1.22 per 1 cm², Confidence Interval (CI) = 1.01-1.47; p=0.041) after multivariate analysis (Figure). Tenting height was independently associated with the risk of HFH (HR=1.07 per 1 mm, CI=1.00-1.14, p=0.037), but no MV geometry variable was associated with all-cause death. These findings remained consistent in both treatment arms (p&amp;gt;0.20 for interaction). Conclusion In HF patients with SMR included in the MITRA-FR trial, MV tenting area and MV tenting height were independently associated with the risk of HFH or all-cause mortality and HFH respectively, without any difference according to treatment arms. These data suggest that MV tethering provides an incremental prognostic value beyond classical echocardiographic variables, including EROA, and then should be considered in the risk stratification of patients with HF and SMR.Table of MV geometry parameters featuresMultivariate analysis (Forrest-plots)

The Key Role of 3D TEE in Assessing the Morphology of Degenerative Mitral Valve Regurgitation

Two-dimensional transthoracic echocardiography (2D TTE) and two-dimensional transesophageal echocardiography (2D TEE) are regarded as the main imaging techniques for the assessment of degenerative mitral valve regurgitation (DMVR). However, describing the complex morphology of DMVR with 2D TTE and 2D TEE remains at the very least challenging. Three-dimensional (3D) TEE is an ideal technique for illustrating the extremely variable morphology of DMVR, providing images of unparalleled quality in terms of anatomical detail. In this review, we describe the key role of 3D TEE in various morphological scenarios that reflect everyday experiences in an echocardiographic laboratory. We also discuss the growing role of 3D TEE in mitral valve (MV) transcatheter edge-to-edge repair (TEER) and new modalities such as photorealistic and transparent displays, surface rendering parametric color maps, new algorithms for MVR quantification, and the potential role of new mini-TEE probes in adult patients with DMVR.

Transcatheter valve replacement as rescue treatment for heart failure in infective endocarditis. A multinational series.

Abstract Background Transcatheter valve replacement (TVR) could be a therapeutic alternative for refractory heart failure in patients with infective endocarditis (IE) unsuitable for open surgery. However, evidence of tis use in this scenario is limited to isolated case reports. Purpose We aimed to describe the clinical characteristics and outcome of IE patients in whom a TVR was performed during the active phase of infection in a multinational case series. Methods This retrospective study was conducted in 23 referral hospitals for IE and TVR procedure in 8 countries. All consecutive adult patients (≥18 y) with definite IE in whom a TVR was performed during antimicrobial treatment of within the 3 three months after its withdrawal were included. The inclusion period was between July 2011 and July 2023. Baseline, IE-related, TVR-related, outcome and follow-up (min. 3 months) variables were collected. Results Forty-five patients [median age 74 years (IQR 64 – 82), 35 males (78%), median Charlson comorbidity index 6 (4 – 7) points] were included in the study: 42 aortic TVR, 2 mitral TVR and 1 tricuspid TVR. In 20 patients (44%) TVR was performed on a native valve and in 25 on a prosthetic valve. The most frequent microorganisms causing IE were streptococci (n=16, 36%), staphylococci (n=13, 29%) and enterococci (n=5, 11%). Acute heart failure was present in 41 (91%). Of them, 23 (51%) developed acute pulmonary oedema or cardiogenic shock. The main reasons for excluding open surgery were: high surgical risk [n=39, 87%; median EuroSCORE 17 (9 – 28)] and technical impossibility (n=3, 7%). TVR was performed during antimicrobial treatment in 27 cases (60%) [median 25 (13 – 54) days after initiation] and within the first three months after its completion in 18 (40%) [median 25 (17 – 68) days after discontinuation]. Four patients (9%) died during admission. Over a median follow-up of 10 (6 -30) months, 7/41 patients (17%) died and there were 2/41 (5%) relapses, one of which required open valve replacement surgery 17 days after TVR procedure. Two other patients underwent open surgery due to paravalvular leaks (11 and 44 days after TVR). All cases of relapse and open surgery occurred when TVR was performed during antibiotic treatment. Conclusion TVR could be an option as rescue treatment for heart failure in selected IE patients unsuitable for open surgery. This represents a paradigm shift in the management of IE and may change the natural history of the disease in patients who would otherwise die.

Prevalence of amyloidosis among patients with mild to severe aortic stenosis. Validation of screening parameters

Abstract Background Cardiac amyloidosis (CA) is an increasingly recognized cause of human heart failure. Up to 16% of patients with severe aortic stenosis (AS) undergoing transcatheter valve replacement have been reported to suffer concomitant transthyretin CA (ATTR). Since the diagnosis of CA implies distinct therapies with prognostic relevance, early diagnosis of CA is crucial. Different parameters have been described to improve screening accuracy for detection of CA, but it is unknown whether these parameters are valid, and the prevalence of CA is stable throughout the spectrum of AS. Purpose To validate screening parameters for the detection of CA in mild, moderate and severe AS. Methods Patient 65 years and above undergoing echocardiography with mild to severe AS, defined as calculated valve orifice area &amp;lt;2 cm2 by velocity-time-integral, and an intraventricular septum thickness &amp;gt; 11mm, fulfilling at least one of two additional criteria (Sokolow-Lyon-Index to left ventricular mass index ratio &amp;lt; 1.5 or stroke volume index &amp;lt; 35 ml/m2) were prospectively included and screened for CA using bone scintigraphy and immunofixation in blood and urine. Results 57 patients were included and completed the diagnostic work-up. Mean age was 83 ± 0.7 years and 71% were male. Overall, 15 (26%) of patients were diagnosed with CA (12 with ATTR and 3 with light-chain CA, Figure1A). 17 patients had mild, 21 had moderate and 19 patients were diagnosed with severe AS. Among patients with mild AS 41% were diagnosed with CA, whereas only 24% of patients with moderate and 16% of patients with severe AS suffered CA (Figure 1B), these results did not show statistically significant differences (p= 0.2, by Chi-Square Quadrat test). Patients with CA were less likely to have NYHA classes I or II (20 vs. 57%, p= 0.03), had higher values of NT-proBNP (4572 [2323; 6044] vs. 817 [589; 2571], p&amp;lt; 0.001) and high-sensitive troponin (66 [47; 103.5] vs. 22.5 [17; 33.6], p&amp;lt; 0.001) and were more likely to have an atrioventricular block of any degree (60 vs. 26%, p=0.04). Conclusion Prevalence of CA among patients fulfilling the criteria of this screening algorithm seems to be high independent of AS severity. Clinicians should not only focus on patients with severe AS to detect CA early. Further research is needed to estimate the prevalence of CA among all patients with AS. Figure 1 A: Among patients with an age &amp;gt;65 years, IVS &amp;gt;11mm, AS and SLI/LVMMI &amp;gt;1.5 or SVI &amp;lt;35 ml/m2 26% (red area) of patients were diagnosed with CA (n= 57). B: In patients with mild AS 41% were diagnosed with CA, whereas in patients with moderate AS only 24% and in patients with severe AS 16% had CA. These differences did not show statistical significance (p= 0.2). IVS: intraventricular septum, AS: aortic stenosis, SLI: Skolow-Lyon-Index, LVMM= left ventricular myocardial mass index, SVI: stroke volume index, CA: cardiac-amyloidosis. (Statistics performed by chi-square test using GraphPad Prism 9.0).

Comparison of mortality scores performance in transcatheter aortic valve replacement: suiting up to percutaneous intervention

Abstract Introduction As transcatheter aortic valve replacement (TAVR) is increasingly relevant for patients with severe symptomatic aortic stenosis, having a reliable procedure specific risk-prediction tool is paramount to provide high-quality care. Surgical scores as the EuroScore II and the Society of Thoracic Surgeons (STS) score II have been widely used to identify patients with high surgical risk in whom percutaneous treatment might be more favorable. However, current literature lacks a consensual specific predictive model for short-term and mid-term prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). Purpose We aimed to access short and midterm (30 days and one year) mortality and to access the ability of a directly adapted score in estimating mortality in a real-world population. Methods We conducted a retrospective observational study in patients who implanted TAVR in a single center. Surgical mortality scores – EUROSCORE II and STS score II – and adapted score Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) transcatheter valve therapy (TVT) score were used to estimate mortality. Predictive abilities of these three scores were compared using area under the receiver operating characteristics (ROC) curve for 30-day and one year mortality. Results From January 2018 to December 2021, 416 patients were submitted to TAVR procedure in our center. The mean age was 83+-6 years old and 229 (55%) were female. 94% had hypertension, 80% dyslipidemia, 40% diabetes mellitus, 35% coronary artery disease, 32% chronic kidney disease. Mean ejection fraction was 56%. During a mean follow-up (FUP) of 816 ± 492 days, 30-day mortality was 1,7% and after 1 year mortality rate was 12,2% (higher than reported in PARTNER 3 trial, 8,5%). The Mean EuroSCORE was 3,4±3,2, mean STS-II 3,9±1,8 and mean value for STS/ACC-TVT score was 3,55±1,34. ROC curve analysis showed a significantly higher discriminative power of STS/ACC-TVT (AUC 0,749, 95% CI 0,681-0,818) compared with surgical scores (p=0,001) – figure 1. We also divided population into quartiles and compared the mortality rate at 30 days and 1 year in each quartile using either STSII or STS/ACC-TVT; As can be seen in figure 2, mortality rates correlated better with the STS/ACC-TVT score than with the STS score. Conclusion A score adapted to a TAVI population showed better predictive capacity than traditional surgical scores. Less preponderance of previous surgical status, relevance of access site and more adapted weight of age might explain the best performance of STS/ACC-TVT score. Surgical scores are helpful in choosing treatment option, but adapted scores are better to predict pos-TAVR mortality.

Edge-to-edge repair for tricuspid valve regurgitation: 1-year follow up and clinical implications from the TR- Interventional Study (TRIS)

Abstract Background Tricuspid regurgitation (TR) affects 7% of the population, contributing significantly to heart failure-related hospitalizations. Traditional treatments have several limitations, prompting the exploration of innovative interventions. Purpose The present study aims to investigate the efficacy of tricuspid valve transcatheter edge-to-edge repair (T-TEER) in real-world patients with severe and symptomatic TR deemed at high surgical risk. Primary objectives focus on assessing T-TEER-induced TR reduction and reverse structural remodeling of the RV. Secondary objectives include assessment of functional status, quality of life, and residual regurgitation during the 12-month follow-up period. Methods The TR-Interventional study (TRIS) is a prospective, single-arm study. From January 2021 to December 2023, we enrolled 44 symptomatic patients with at least severe TR referred for TEER. Outcomes included safety and effectiveness along with assessment of clinical status. Results The study cohort had a mean age of 78.3±7 years, with 77.3% women and a mean TRISCORE of 5.1±1.9. Seventeen patients (38.6%) had massive, 7 (15.9%) had torrential, and 20 (45.5%) patients had severe TR. Etiologies included functional (40.9%), degenerative (13.64%), lead-induced (15.9%), and mixed (29.54%) origin. The primary efficacy endpoint, which assesses the successful implantation and performance of the device at the 30-day mark, was attained in 82.9% of patients. The secondary efficacy endpoint, assessing the stability of TR reduction at the 12-month, was achieved in 82,3% of patients. Post-procedural TR reduction of at least 2 degrees was achieved in 84% of patients. Echocardiographic assessments indicate ongoing beneficial remodeling over the one-year follow-up (Figure 1). Effects on RV remodeling also became apparent at the one-year follow-up, including reductions in the RV end-diastolic basal (p&amp;lt;0.01) and medium (p= 0.04) diameters of the TA septal-lateral diameter (p&amp;lt; 0.01). Significant reduction in vena contracta width (9 mm to 3 mm; p=&amp;lt;0.01), regurgitant volume (58 ml to 30 ml; p&amp;lt;0.01), and effective regurgitant orifice area (EROA) (0.6 cm2 to 0.3 cm2; p&amp;lt;0.01), occurred between baseline and one-year follow-up (Figure 2). The NYHA Functional Class and KCCQ scores were improved from 30 days to 1 year (Figure 2). Conclusion TRIS suggests that T-TEER is a durable, effective, and safe therapeutic option for high-risk patients with severe TR. The enduring nature of TR reduction at one year correlates with sustained clinical benefits and reverse structural remodeling of the right ventricle.TR reductionNYHA and functional status

Trans catheter edge to edge repair for mitral regurgitation and left ventricular outflow obstruction in hypertrophic cardiomyopathy

Abstract Background Based on previous reports, mitral valve transcatheter edge to edge repair (TEER) may be considered in patients with severe mitral regurgitation (MR) and left ventricular obstruction in patients with hypertrophic obstructive cardiomyopathy (HOCM) that are high risk for surgery. Objective We aimed to evaluate the feasibility, and immediate and short-term outcomes of mitral TEER in symptomatic patients with severe MR and HOCM. Methods Five patients (age 75±6, 3 men) with severe MR and HOCM with high surgical risk, and anatomy not suitable for septal ethanol ablation, who remained symptomatic despite maximally tolerated drug therapy were selected for TEER using the MitrClip system. Result The procedure was performed successfully on all 5 patients. Devices were deployed at the A2-P2 scallops of the mitral valve. MR severity declined from severe to mild in all patients, left ventricular outflow (LVOT) maximal gradient decreased from 140±46 to 8±5 mmHg after TEER, and was 41±32 mmHg at 4±2 month follow- up, Clinically, all patients reported improvement of their symptoms to Class I-II NYHA functional Class. Conclusion TEER may be a beneficial procedure for severely symptomatic patients with severe MR and obstructive HOCM on maximal tolerated medical therapy, who are not amenable to surgery because of excessive risk, old age, and frailty.Pre and Post procedure EchoPre and Post Cath

Transcatheter Valve Repair for TricuspidRegurgitation: 1-Year Results from a Large European Real-World Registry.

Tricuspid valve transcatheter edge-to-edge repair has emerged as a valuable treatment option for patients with severe tricuspid regurgitation (TR). This study aims to investigate the safety and effectiveness of the PASCAL transcatheter valve repair system in treating severe TR in a real-world patient population. The PASTE (PASCAL for Tricuspid Regurgitation-a European registry) study is an investigator-initiated, multicenter, retrospective, and prospective observational cohort analysis conducted across 16 European heart valve centers including consecutive patients treated with the PASCAL transcatheter valve repair system from February 2019 to November 2023. Echocardiographic assessments were performed at baseline, discharge, and follow-up, and were subjected to centralized analysis. The study included 1,059 high-risk patients (mean age 79 ± 9 years; 53% female; TRI-SCORE risk 23% ± 18%; 87% NYHA functional class III/IV) with multiple comorbidities. Severe or higher graded TR was observed in 96% of patients. Intraprocedural success according to Tricuspid Valve Academic Research Consortium criteria was achieved in 85%, and TR reduced to ≤moderate in 87%. Independent predictors for a postprocedure residual TR of >moderate were coaptation gaps≥8mm (OR: 1.67; 95%CI: 1.03-2.72; P=0.038), tenting height≥10mm (OR: 2.18; CI: 1.30-3.65; P=0.003), the presence of a transvalvular lead (OR: 1.91; 95% CI: 1.19-3.05; P=0.007), right ventricular dilatation >42mm (OR: 3.35; 95% CI: 1.37-9.1; P=0.009) and massive/torrential TR at baseline (OR: 4.59; 95% CI:2.35-8.96; P< 0.001). At 1 year, 83% of patients showed ≤moderate TR. Significant clinical improvements included enhanced NYHA functional class (66% class I/II vs 17% at baseline; P< 0.001). Patients treated with the first-generation PASCAL system (n = 570) and with the new PASCAL Precision system (n = 489) had similar clinical profiles and TR severity at baseline. However, the Precision cohort showed greater TR reduction to trace/mild (63% vs 49%; P< 0.001), shorter procedure times (median 93minutes [Q1-Q3: 69-130 minutes] vs 120minutes [Q1-Q3: 82-165 minutes]; P< 0.001), and higher clinical success rates according to the Tricuspid Valve Academic Research Consortium at 30days and 1 year (87% vs 81% [P=0.021] and 56% vs 50% [P=0.044], respectively). Higher center experience (≥21 patients/year) resulted in higher intraprocedural and clinical success. The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up. (PASCAL for Tricuspid Regurgitation-a European registry [PASTE]; NCT05328284).

Adaptation of Aortic Bioprosthetic Valves for Pulmonary Position: Comparative Analysis of Transcatheter and Surgical Valves.

Pulmonary valve dysfunction is common in congenital heart disease, often leading to interventions like right ventricular outflow tract reconstruction. Transcatheter pulmonary valve replacement (TPVR) has emerged as a successful alternative to surgery, showcasing promising outcomes for managing postoperative RVOT complications. The study aimed to compare two bioprosthetic valves-Carpentier Edwards Perimount Magna Ease surgical valve and Edwards SAPIEN 3 transcatheter valve-originally designed for aortic use but adapted for pulmonary applications. The hemodynamic characteristics of a 26-mm SAPIEN 3 and a 25-mm Magna Ease were assessed in a pulse duplicator under both pulmonary and aortic conditions. Furthermore, detailed structural analyses of the leaflets were conducted using computational simulations under these conditions. The results highlighted significant differences in the hydrodynamic and structural characteristics of these two bioprosthetic valves when exposed to pulmonary versus aortic conditions. The study enhances our understanding of the biomechanics involved in surgical and transcatheter pulmonary valve replacement.

Heart failure with reduced ejection fraction and chronic kidney disease: a focus on therapies and interventions.

In heart failure with reduced ejection fraction (HFrEF), the presence of concomitant chronic kidney disease (CKD) predicts poorer cardiovascular outcomes, more aggravated heart failure (HF) status, and higher mortality. Physicians might be reluctant to initiate life-saving anti-HF medications out of fear of worsening renal function and a higher incidence of adverse events. Moreover, international guidelines do not give clear recommendations on managing this subgroup of patients as well as advanced CKD was always an exclusion criterion in most major HF trials. Nevertheless, in this review, we will highlight several recent clinical trials and post-hoc analyses of major trials that showed the safety and efficacy of the different therapies in HFrEF patients with CKD, besides several small-scale cohorts that tested guideline-directed medical therapies in End Stage Kidney Disease (ESKD). Regarding interventions in this subgroup of patients, we will provide up-to-date data on implantable cardioverter defibrillators, cardiac resynchronization therapy, and coronary revascularization, in addition to mitral valve transcatheter edge-to-edge repair and implantable pulmonary artery pressure sensors.

Long-Term Efficacy of Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER) for Exercise-Induced Mitral Regurgitation in a Cardiac Resynchronization Therapy (CRT) Non-responder: A Three-Year Follow-Up

Long-Term Efficacy of Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER) for Exercise-Induced Mitral Regurgitation in a Cardiac Resynchronization Therapy (CRT) Non-responder: A Three-Year Follow-Up

Trends in Transcatheter Aortic Valve Replacement Outcomes

Although transcatheter aortic valve replacement (TAVR) outcomes in the US have improved substantially since 2011, it is unknown whether these trends have continued since 2019. To examine changes in risk-adjusted TAVR outcomes from 2019 to 2022 and to examine any noteworthy trends over time. This cohort study examined data from patients with severe aortic stenosis treated with TAVR at 786 US hospitals between January 1, 2019, and March 31, 2022, included in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry. Patients who underwent TAVR. The primary outcome was 30-day mortality, and the secondary outcomes were in-hospital mortality and 30-day composite adverse events. To understand factors explaining these trends, a series of logistic regression models was constructed for each outcome, with time as the primary explanatory variable. After adjusting for changing patent characteristics and procedural factors, a series of exploratory analyses was performed to examine the extent to which these findings could be explained by several plausible hypotheses. This study's analytic cohort included a total of 210 495 patients. Median (IQR) patient age was 79 (73-85) years, and 91 313 patients (43.4%) were female. Median (IQR) STS predicted risk of mortality (PROM) was 3.3% (2.0%-5.3%). There were no significant changes in unadjusted 30-day mortality from quarter 1 of 2019 (2.4%) to the end of quarter 1 of 2022 (2.2%) (P for trend = .10), with an unadjusted odds ratio (OR) for time of 0.98 per year (95% CI, 0.94-1.01). After adjusting for patient characteristics, the OR increased to 1.05 per year (95% CI, 1.02-1.08), which increased further after adjusting for procedural characteristics to 1.09 per year (95% CI, 1.05-1.13). In exploratory analyses, there were no meaningful changes in the adjusted odds of death after excluding sites that entered the STS/ACC TVT Registry in 2019 or later (OR, 1.09; 95% CI, 1.05-1.13), low-volume sites (OR, 1.09; 95% CI, 1.06-1.13), low-risk patients (OR, 1.11; 95% CI, 1.07-1.15), patients with a bicuspid aortic valve (OR, 1.09; 95% CI, 1.05-1.13), in-hospital deaths (OR, 1.08; 95% CI, 1.03-1.14), or patients who experienced a major vascular complication (OR, 1.09; 95% CI, 1.05-1.12). In this observational cohort study performing a national analysis of outcomes after TAVR, it was found that risk-adjusted 30-day mortality increased modestly from January 2019 to March 2022. However, no site-level, patient-related, or process-related factors were identified that could explain these findings. Although the absolute increase in risk-adjusted mortality during the study period was relatively small, these findings warrant continued surveillance.

TCT-119 Long-Term Incidence and Predictors of Transcatheter vs Surgical Bioprosthetic Pulmonary Valve Failure

TCT-119 Long-Term Incidence and Predictors of Transcatheter vs Surgical Bioprosthetic Pulmonary Valve Failure

TCT-826 A Validated Risk Model for Acute Kidney Injury Prediction in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the STS/ACC National Cardiovascular Data Registry–Transcatheter Valve Therapy Registry

TCT-826 A Validated Risk Model for Acute Kidney Injury Prediction in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights From the STS/ACC National Cardiovascular Data Registry–Transcatheter Valve Therapy Registry