BACKGROUND:Severe tricuspid regurgitation (TR) causes high morbidity and recurrent heart failure hospitalization (HFH). Transcatheter tricuspid valve replacement (TTVR) consistently eliminates TR, but real-world data on HFH reduction are limited. We therefore evaluated the effect of TTVR on HFH and clinical outcomes in a diverse cohort of compassionate-use and trial patients. METHODS:This prospective, multicentre Canadian registry included 75 high-risk patients (Society of Thoracic Surgeons [STS] score 8.2% ± 5.9%) who underwent TTVR with the EVOQUE system (Edwards Lifesciences, Irvine, CA). The primary end point was a composite of all-cause death or HFH within 1 year after TTVR. Secondary end points included the annualized HFH rate 12 months before vs after TTVR, symptoms, quality of life (using the Kansas City Cardiomyopathy Questionnaire [KCCQ]), and functional capacity. RESULTS:Procedural success was high (technical: 97.3%; device: 93.3%), with sustained TR reduction to ≤ mild (94.3%), and a 6.7% 1-year mortality. TTVR resulted in a 76.1% relative reduction in HFH (P < 0.001). New York Heart Association class III-IV decreased from 76% to 10% (P < 0.001). Significant improvements were observed in 6-minute walk distance (260.8 ± 104.7 to 334.5 ± 103.5 m; P < 0.001) and KCCQ score (56.2 ± 15.2 to 73.5 ± 19.2 points; P = 0.001). Multivariable analysis identified baseline New York Heart Association class IV (odds ratio, 3.96; P = 0.003) and previous HFH (odds ratio, 2.31; P = 0.033) as independent predictors of the composite end point (HFH and/or death). Comparative analysis showed that although compassionate-use patients (n = 24) had a higher-risk profile than trial patients (n = 51), both cohorts achieved comparable and significant clinical improvements. CONCLUSIONS:In a diverse, high-risk cohort, TTVR dramatically reduced HFH and significantly improved quality of life. These results reinforce the therapeutic benefits of TTVR in high-risk patients with severe TR.

Background Despite the high prevalence and significant mortality associated with aortic stenosis (AS), data demonstrate low rates of referral to specialized heart valve teams. The objectives of this study were therefore to highlight contemporary referral patterns in patients with significant AS and identify potential barriers to referral. Methods Patients undergoing transthoracic echocardiography (TTE) in a large public health catchment had automatically generated text inserted into their TTE report and electronic medical record if the TTE met the American Society of Echocardiography criteria for moderate or severe AS. Text recommended referral to a heart valve team for further assessment or treatment. Patients were prospectively identified and followed. Structured telehealth was performed to clarify symptom status and perceived barriers to referral. Results Over 6 months, 343 patients with severe (n = 142) or moderate (n = 201) AS were identified. Despite significant AS alongside a referral prompt, only 86 (61%) patients with severe and 44 (22%) with moderate AS were referred for assessment. Patient and echocardiographic characteristics were similar between referred and nonreferred. Mortality was significantly higher in nonreferred patients with severe AS (19.6 vs. 2.3% referred, p < 0.001). Of the nonreferred patients who died, 5/11 (45%) had no compelling reason for lack of referral. Most nonreferred patients with severe AS reported progressive symptoms (75% New York Heart Association class II/III). Over half (51.2%) reported being managed with a “watchful waiting” strategy despite meeting a class I indication for aortic valve replacement, and nearly one-third (27.5%) were unaware of their diagnosis. Conclusions Despite automatically generated referral prompts in patients with severe AS, many patients without a compelling reason for lack of referral were not appropriately assessed and died.

AIMS:The mitral valve-in-valve (MVIV) procedure has emerged as an important therapy in failing surgical bioprosthetic valves. We aimed to evaluate factors associated with outcome following MVIV intervention, specifically the impact of 30-day MVIV gradient. We also explored the value of intraprocedural MVIV three-dimensional anatomic orifice area (3D-AOA) by transoesophageal echocardiography in a subset of patients (n = 68). METHODS AND RESULTS:Consecutive MVIV patients from a single institution with 30-day transthoracic echocardiography (TTE) were included (N = 100). Clinical and echocardiographic variables were evaluated. The primary outcome was one-year composite of all-cause mortality, heart failure hospitalization or re-intervention. Multivariable analysis was performed to determine predictors of primary outcome. Mean age was 77.3 ± 10.6 years and pre-intervention mean mitral gradient was 11.5 ± 4.0 mmHg. Thirty-day MVIV mean gradient was 7.4 ± 2.6 mmHg with ≤1+ residual regurgitation in 99.0% of patients. Multivariable analysis identified MVIV mean gradient as the only independent determinant of the primary outcome (HR 1.31, CI: 1.07-1.61, P = 0.009). MVIV 3D-AOA was associated with a 30-day MVIV mean gradient of >7 mmHg by TTE (ROC-AUC 0.8, P < 0.001), and patients with 3D-AOA > 2 cm2 had significantly lower 1-year all-cause mortality (2.5% vs. 18.7%, Kaplan-Meier log-rank P = 0.03). CONCLUSION:Elevated 30-day mean gradient is associated with worse outcomes after MVIV, and smaller intraprocedural MVIV 3D-AOA is associated with a higher 30-day mean gradient and worse mortality. Optimizing MVIV orifice area at the time of procedure may improve valve haemodynamics and patient outcomes.

Aims:Tricuspid regurgitation (TR) is associated with increased morbidity and mortality. The optimal timing for referral and intervention remains uncertain. To evaluate outcomes in patients with TR referred for tricuspid valve intervention. Methods and results:Fifty-eight consecutive patients were referred from May 2018 to April 2023. Patients were stratified into two groups: Group 1 who underwent either tricuspid valve transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR); Group 2 who died without intervention due to: awaiting candidacy assessment; awaiting intervention; deemed unsuitable for intervention. Key endpoints: in-patient, 30-day, 12- and 18-month mortality; new pacemaker implantation; echocardiographic TR grading; improvement in NYHA functional class; and heart failure-related readmissions at 30 days and 12 months. Among 58 patients, 43 underwent intervention (TTVR, n = 29; T-TEER, n = 14), 15 died without intervention (awaiting assessment n = 11; awaiting procedure n = 1, unsuitable n = 3). At the time of referral, the mean age was 77.0 ± 9.8 years, and 52 patients (90%) were diagnosed with functional TR; 30-day mortality in Group 1 was 12%, and 12-month mortality reached 33%, with heart failure readmission (37%); 12-month mortality in Group 2 was 73%. At 18 months, mortality reached 37% in Group 1 and 100% in Group 2. Baseline characteristics differed significantly between the groups for body mass index, severity of TR (massive or torrential), NYHA III-IV symptoms, and validated mortality scores. Conclusion:Referrals for TR often occur after substantial comorbidities have developed resulting in high mortality but should be considered for a referral and intervention at an earlier stage.

Background:Transcatheter tricuspid valve replacement (TTVR) is typically reserved for patients in whom tricuspid valve transcatheter edge-to-edge repair (T-TEER) is deemed unsuitable or unlikely to provide effective treatment. Comparative data evaluating patient profiles, disease stage, and outcomes between T-TEER and TTVR are limited. We aimed to analyze and compare patient profiles, selection, and outcomes with either T-TEER or TTVR. Methods:A total of 43 consecutive patients from May 2018 to April 2023 were retrospectively divided into 2 groups: Group-1 underwent T-TEER; and Group-2 underwent TTVR. Primary endpoints are as follows: inpatient mortality; and 30-day and 12-month mortality. Secondary endpoints are as follows: echocardiographic tricuspid regurgitationgrading; new pacemaker implantation; and heart failure-related readmissions at 30 days and 12 months. Results:A total of 43 patients underwent intervention (T-TEER, n = 14; TTVR, n = 29;). The mean age was 77.6 ± 10.3 years, and 38 patients (88%) were diagnosed with functional tricuspid regurgitation. The in-hospital mortality rate was 7%; the 30-day mortality rate was 12% with heart failure readmission for 14%.The 12-month mortality rate was 33%, with heart failure readmission for 37%. No in-hospital or 30-day mortality occurred in the T-TEER group. The 12-month mortality rate was 29% in the T-TEER group vs 34% in the TTVR group. The TTVR cohort showed numerically younger patients (76.2 ± 10.6 vs 80.4 ± 9.6 years, P = 0.24) and numerically higher TRI-scores (for tricuspid; 6.0, interquartile range [IQR], 4.0-7.0 vs 4.5, 1.5-5.75, P = 0.09). The calculated GLIDE-score (gap, location, image quality, density, en-face TR morphology) was significantly lower in the T-TEER cohort (P < 0.01). The length of hospitalization was significantly longer in the TTVR group (1, interquartile range, 1-4 vs 1, 1-1; P = 0.02). Conclusions:Our findings suggest that patients undergoing T-TEER vs TTVR may represent different disease stages. Further data are required to determine the best patient selection for T-TEER vs TTVR to optimize patient outcomes.

With the recent approval of the transcatheter EVOQUE tricuspid valve replacement system to treat severe, symptomatic tricuspid regurgitation, there is a need to define the appropriate patient population and anatomical considerations for this device. In this consensus document, the authors review these considerations, describe the procedural steps and imaging requirements to ensure technical success, and discuss management of complex intraprocedural circumstances.

Background:Novel pathways are needed to accommodate the increasing demand for transcatheter aortic valve implantation (TAVI) and ensure equitable access. A single Vancouver Facilitated TAVI program (VFTP) based at St. Paul's and Vancouver General Hospitals was established to streamline the assessment of remote patients with severe aortic stenosis using virtual technologies. Methods:Remote patients with severe aortic stenosis who expressed difficulties traveling to complete their pre-TAVI workup were included and received prospective follow-up. Clinical and echocardiographic parameters were reported per the Valve Academic Research Consortium 3. Results:Between December 2020 and March 2023, a total of 56 remote patients were included in the VFTP. The mean patient age was 79.7 ± 9.1 years. A total of 55 patients (98%) passed the screening for candidacy; 45 patients (80%) were found suitable for transfemoral TAVI, 5 patients (9%) were directed toward surgical aortic valve replacement; 3 (5%) underwent alternative-access TAVI; and 2 patients (4%) were assigned to a watchful waiting strategy. No inpatient mortality, stroke, or major bleeding occurred in the transfemoral TAVI group, and the median hospital stay was 1 day (interquartile range, 1-2 days; range, 1-24 days). Two patients had an access-closure failure requiring surgical intervention; 1 patient had tamponade; and 4 patients had complete heart block requiring permanent pacemaker implantation. No hospital readmission had occurred at 30 days. Conclusions:A simplified assessment pathway to assess TAVI candidacy using virtual technologies is safe and feasible. The VFTP potentially can increase access to TAVI and reduce inequity in TAVI care.

BACKGROUND AND AIMS:For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. METHODS:The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. RESULTS:Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. CONCLUSIONS:In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

AIMS:Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease. Insertable cardiac monitors (ICMs) are increasingly used in this population to provide closer monitoring, with the potential for notification systems. However, little is known regarding the psychological impact this information may have on patients. The Abbott Confirm Rx™ ICM has the capability of connecting to the patient's smartphone to enable active participation in their care, as well as two-way communication between the patient and their care providers. This study aimed to explore individuals' experiences of having a smartphone-enabled ICM to monitor for arrhythmias in HCM. METHODS AND RESULTS:Semi-structured interviews were conducted with 10 participants. Utilizing a grounded theory approach, the interview guide was modified based on emerging themes throughout the study. Reflexive thematic analysis was applied to categorize interview data into codes and overacting themes, with each interview independently coded by two study members. Analysis revealed three key themes: (i) psychological impact, (ii) educational needs, and (iii) technology expectations. Participants reported that receiving feedback from ICM transmissions resulted in improved symptom clarity, providing reassurance, and aiding implantable cardioverter defibrillator decision-making. Some participants reported uncertainty regarding when to send manual transmissions. Lastly, participants reported the app interface did not meet expectations with regard to the amount of data available for patients. CONCLUSION:Overall, utilizing a smartphone app to facilitate two-way communication of ICM transmissions was well accepted. Future directions include addressing gaps in educational needs and improvements in the patient interface with increased access to data.

OBJECTIVES The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR). BACKGROUND Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population. METHODS Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events. RESULTS At baseline, all patients (age: 77 +/- 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% +/- 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade <= 2+ and <= 1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation. CONCLUSIONS In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy. (C) 2022 by the American College of Cardiology Foundation.

A 77-year-old female with symptomatic severe mitral bioprosthetic valve regurgitation was referred for transseptal mitral valve-in-valve implantation. She had no other major comorbidity and no previous psychiatric condition. The mitral valve-in-valve procedure was successfully performed under general anesthesia (fentanyl, propofol and rocuronium) with a 29mm Sapien 3 transcatheter heart valve (Edwards Lifesciences LLC, Irvine, CA, USA) implanted within a 33mm Epic St. Jude surgical valve (Figure 1A and video 1).

Background:Sudden cardiac death (SCD) risk stratification in hypertrophic cardiomyopathy (HCM) currently relies on arrhythmic burden quantification by 24 or 48-hour Holter monitoring. Whether this approach adequately captures arrhythmic burden, compared with longer-term continuous monitoring, is unclear. We sought to assess the long-term incidence of nonsustained ventricular tachycardia (NSVT) in HCM patients at low or moderate SCD risk, using implantable cardiac monitors (ICMs) paired with a novel Bluetooth-enabled 2-way communication platform.Methods:This prospective, single-arm, observational study enrolled 33 HCM patients. Patients were implanted with an Abbott (Chicago, IL) Confirm Rx ICM and monitored using a protocolized care pathway.Results:A total of 20 patients (60.6%) had ≥ 1 episode of NSVT recorded on the ICM, the majority of whom had previous Holter monitors that did not identify NSVT (60%, n = 12). A total of 71 episodes of NSVT were detected. Median time to first NSVT detection was 76.5 days (range: 0-553 days). A total of 19 patients underwent primary prevention implantable cardioverter defibrillator implantation during an average follow-up of 544 days (range: 42-925 days). A total of 172,112 automatic transmissions were received, and 65 (0.04%) required clinical follow-up. A total of 325 manual transmissions were received and managed. A total of 14 manual transmissions (4.3%) required follow-up, whereas 311 (95.7%) were managed solely with a text message.Conclusions:Surveillance and reporting systems utilizing 2-way communication enabled by novel ICMs are feasible and allow remote management of patients with HCM. Prolonged monitoring with ICMs identified more patients with nonsustained arrythmias than did standard Holter monitoring. In many cases, this information impacted both SCD risk stratification and patient management.