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BACKGROUND In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. METHODS By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. RESULTS Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9-52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. CONCLUSIONS After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases.

BACKGROUND Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown. AIMS The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function. METHODS We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE

Objectives We investigated the durability of tricuspid regurgitation (TR) reduction and the clinical outcomes through 12 months after transcatheter tricuspid valve repair (TTVr) with the PASCAL Transcatheter Valve Repair System. Background TTVr has rapidly developed and demonstrated favorable acute outcomes, but longer follow-up data are needed. Methods Overall, 30 patients (age 77 ± 6 years; 57% female) received PASCAL implantation from September 2017 to May 2019 and completed a clinical follow-up at 12 months. Results The TR etiology was functional in 25 patients (83%), degenerative in three (10%), and mixed in two (7%). All patients had TR severe or greater (massive or torrential in 80%) and heart failure symptoms (90% in NYHA III or IV) under optimal medical treatment. Single-leaflet device attachment occurred in two patients. Moderate or less TR was achieved in 23/28 patients (82%) at 30 days, which was sustained at 12 months (86%). Two patients underwent repeat TTVr due to residual torrential TR (day 173) and recurrence of severe TR (day 280), respectively. One-year survival rate was 93%; 6 patients required rehospitalization due to acute heart failure. NYHA functional class I or II was achieved in 90% and 6-minute walk distance improved from 275 ± 122 m at baseline to 347 ± 112 m at 12-month (+72 ± 82 m, p

Despite the technological advances and increasing operator experience, the rate of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) has not decreased over time. With a continuous downward trend in post-TAVR length of stay, prolonged home-monitoring may have a key role in detecting potentially serious conduction abnormalities after TAVR discharge.In this study, the ZioPatch-AT monitor was used to detect conduction abnormalities after TAVR discharge. The cardiac monitoring device was systematically provided to all patients having pre-existing right bundle branch block or developing intra-/peri-procedural conduction disturbances, in the absence of guideline indication for PPI at discharge.From a total of 75 patients at high-risk of conduction disturbances, 8 (11%) of them underwent PPI and most of them (6/8) were detected before symptoms' occurrence. Paired analysis between baseline and discharge electrocardiograms detected a significant widening of the QRS in all patients; on the contrary, PR length was significantly increased only in the group experiencing HAVB after discharge (p 0.01).In an early post-TAVR discharge era, 30-day outpatient cardiac rhythm monitoring is potentially a safe solution to allow timely recognition of new conduction disturbances requiring PPI.

Objectives The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. Background Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. Methods The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. Results Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). Conclusions TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

BACKGROUND: Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. METHODS: We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). RESULTS: Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. CONCLUSIONS: MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF. (C) 2020 International Society for Heart and Lung Transplantation. All rights reserved.

AimsThe impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone.Methods and resultsThe Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015–18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23–0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18–0.89, P = 0.03).ConclusionAfter TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

Transcatheter aortic valve implantation (TAVI) has risen over the past 20 years as a safe and effective alternative to surgical aortic valve replacement for treatment of severe aortic stenosis, and is now a well-established and recommended treatment option in suitable patients irrespective of predicted risk of mortality after surgery. Studies of numerous devices, either newly developed or reiterations of previous prostheses, have been accruing. We hereby review TAVI devices, with a focus on commercially available options, and aim to present a guide for prosthesis tailoring according to patient-related anatomical and clinical factors that may favor particular designs.

The right ventricular (RV)-pulmonary arterial (PA) coupling ratio relates the efficiency with which RV stroke work is transferred into the PA. Lower ratios indicate an inadequate RV contractile response to increased afterload.This study sought to evaluate the prognostic significance of RV-PA coupling in patients with tricuspid regurgitation (TR) who were undergoing transcatheter tricuspid valve repair or replacement (TTVR).The study investigators calculated RV-PA coupling ratios for patients enrolled in the global TriValve registry by dividing the tricuspid annular plane systolic excursion (TAPSE) by the PA systolic pressure (PASP) from transthoracic echocardiograms performed before the procedure and 30 days after the procedure. The primary endpoint was all-cause mortality at 1-year follow-up.Among 444 patients analyzed, their mean age was 76.9 ± 9.1 years, and 53.8% of the patients were female. The median TAPSE/PASP ratio was 0.406 mm/mm Hg (interquartile range: 0.308-0.567 mm/mm Hg). Sixty-three patients died within 1 year of TTVR, 21 with a TAPSE/PASP ratio0.406 and 42 with a TAPSE/PASP ratio ≤0.406. In multivariable Cox regression analysis, a TAPSE/PASP ratio0.406 vs ≤0.406 was associated with a decreased risk of all-cause mortality (HR: 0.57; 95% CI: 0.35-0.93; P = 0.023). In 234 (52.7%) patients with echocardiograms 30 days after TTVR, a decline in RV-PA coupling was independently associated with reduced odds of all-cause mortality (odds ratio [OR]: 0.42; 95% CI: 0.19-0.93; P = 0.032). The magnitude of TR reduction after TTVR (≥1+ vs 1+; OR: 2.53; 95% CI: 1.06-6.03; P = 0.037) was independently associated with a reduction in post-TTVR RV-PA coupling.RV-PA coupling is a powerful, independent predictor of all-cause mortality in patients with TR undergoing TTVR. These data suggest that the TAPSE/PASP ratio can inform patient selection and prognostication following TTVR.

Objectives The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the PASCAL transcatheter valve repair system and its impact on short-term clinical outcomes in patients with severe tricuspid regurgitation (TR). Background Transcatheter repair of severe TR is a promising treatment option for patients at prohibitive surgical risk. Large leaflet coaptation gaps and tethering represent common features that challenge the application of transcatheter repair techniques. Methods Twenty-eight patients with severe TR were treated with the PASCAL system in a compassionate use experience at 6 sites. All patients had heart failure due to severe TR and were deemed at high surgical risk by institutional heart teams. The primary outcome was procedural success, defined as the implantation of at least 1 device with post-procedural TR grade ≤2+, without mortality or conversion to surgery. Results All patients (mean age 78 ± 6 years, 54% women) were at high surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 6.2 ± 5.2%). TR etiology was functional in 92%, with mean tricuspid annular diameter of 49.5 ± 6 mm and mean coaptation gap of 6.9 ± 3 mm. Procedural success was 86%, with 1.4 ± 0.6 devices implanted per patient. There were no intraprocedural complications. At 30-day follow-up, mortality was 7.1%, 88% of patients were in New York Heart Association functional class I or II, with TR grade ≤2+ in 85%. There were 2 single-leaflet device attachments, which were managed conservatively. Six-min walk distance improved from 240 m (interquartile range: 172 to 337 m) to 335 m (interquartile range: 251 to 385 m) (p Conclusions This first-in-human experience evaluating transcatheter tricuspid repair with the PASCAL system demonstrated high procedural success, acceptable safety, and significant clinical improvement. Larger prospective studies with long-term follow-up are needed to confirm these initial promising results and further define the impact of PASCAL tricuspid repair on clinical outcomes.

Despite the increasing knowledge of the long-term adverse consequence of severe tricuspid regurgitation (TR), most patients with moderate- to-severe TR are still treated conservatively because of the high risk of surgery. Percutaneous procedures have emerged as an attractive alternative treatment. Transcatheter edge-to-edge repair is a validated technique to treat mitral regurgitation. In recent years, the same concept has been applied to patients with TR and prohibitive operative risk. Early trials have shown feasibility and safety. More clinical experiences and long-term results are still being gathered. In this article, we provide an overview of transcatheter edge-to-edge repair and look at the current evidence and clinical results regarding procedure.

Objectives The aim of this study was to assess the additional utility of measuring left atrial (LA) pressure as a complement to transesophageal echocardiography (TEE) and Doppler imaging. Background The efficacy of the MitraClip (MC) is assessed intraoperatively by TEE. However, TEE measures are operator dependent and can be influenced by left ventricular (LV) function and changes in LA compliance. Methods Fifty patients undergoing MC therapy with continuous left-sided heart pressure measurements were analyzed. LA V-wave pressure (LAvP), LA mean pressure (LAmP), LV systolic pressure, and LV end-diastolic pressure were measured continuously. LA pressures were indexed to LV pressures to account for changes in afterload during the procedure. Results Most patients (70%) had degenerative mitral regurgitation (MR). TEE MR grade decreased from 3+ to 0+. LAvP (p Conclusions This study demonstrates the value of real-time monitoring of LA pressure during MC therapy to predict clinical outcomes. An increase in LAmP was a predictive of worse clinical outcomes at short-term follow-up, independent from echocardiographic findings.

Objectives A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. Background TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). Methods The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4tech, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (Caval Implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. Results A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm2). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. Conclusions TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.

We aimed to identify the clinical characteristics and examine outcomes in patients with significant tricuspid regurgitation (TR) who received transcatheter tricuspid valve intervention (TTVI) compared with guideline directed medical therapy (GDMT).Between 2015 and 2019, 124 patients with symptomatic severe TR were assessed at St. Michael's Hospital. Seventy-one patients were ineligible and received GDMT only while 53 patients received TTVI and GDMT. During follow-up, TTVI was associated with significant improvements in NYHA functional class and 6-min walk distance (p .001). GDMT patients had lower survival (46.9% vs 75.1%, p = .047) and lower freedom from heart failure hospitalization (HHF) and mortality (33.2% vs 62.7%, p = .027), higher incidences per 100 person-year of gastrointestinal bleeding [15.58 (95% CI 8.90-25.31) vs 4.24 (95% CI 0.85-12.37), p = .04] and acute kidney injury [36.98 (95% CI 26.17-50.76) vs 14.12 (95% CI 6.76-25.96), p = .001] compared with TTVI patients.TTVI in addition to GDMT was effective at improving TR symptoms, functional status, and was associated with lower rates of all-cause mortality, the combined endpoint of HHF and mortality, AKI and GI bleeding. Future randomized controlled trials on TTVI are needed.

Objectives The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI). Background The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR. Methods The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year. Results Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048). Conclusions Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166)

This chapter is dedicated to the preoperative multimodality imaging necessary for a thorough surgical or interventional aortic planning.

This chapter covers the fundamental aspects of intraprocedural imaging, related to the surgical replacement or repair of the aortic valve and its corresponding transcatheter, the TAVI.

What is known about The Cardioband in the clinical area? Severe secondary mitral valve insufficiency frequently affects high-risk surgical patients. Cardioband system is a novel percutaneous surgical-like device for direct annuloplasty. It is totally implanted in the beating heart, by transvenous femoral access with minimal impact on hemodynamic and cardiac function during the implantation. It has been demonstrated to be safe and feasible in high-risk patients with functional mitral regurgitation, with high rates of implant success, significant annular reduction and regurgitation improvements. That positively impacts directly on ventricular function, functional status and quality of life. Recently, Cardioband has been used also in tricuspid position, with initial promising results. Bibliographic review.

Background Clinical practice guidelines recommend implantable cardioverter defibrillators (ICDs) for the secondary prevention of sudden death after a cardiac arrest not from a reversible cause, but "real world" implantation rates are not well described. Methods Adults with out of hospital cardiac arrest attended by Emergency Medical Services are captured in the Toronto Regional RescuNET database. We analyzed those who survived to hospital discharge and collected data on age, sex, initial rhythm, ST-elevation myocardial infarction (STEMI) on presenting electrocardiogram (ECG), in-hospital revascularization, neurologic status (Modified Rankin Scale [MRS]) at discharge, and admission hospital type. To estimate ‘indicated' ICD implantation rates, "likely ICD-eligible" patients were defined as having an initial shockable rhythm, no STEMI on presenting ECG, no revascularization, and good neurologic status (MRS 0-3). "Not likely ICD-eligible" patients were defined as having a STEMI on presenting ECG, revascularization, or poor neurologic status (MRS 4-5). Results In the 1238 adults (2011-2014) analyzed, the overall ICD implantation rate was 23.9%. Two hundred fifty-six patients were "likely ICD-eligible," of whom 146 (57.0%) received an ICD. The implantation rate for "not likely ICD-eligible" patients was 16.7% (112 of 670). ICD eligibility could not be determined for 312 patients, of whom 38 (12.2%) received an ICD. Admission to a hospital with ICD implantation facilities was associated with a higher probability of ICD implantation (odds ratio, 2.85; 95% confidence interval, 1.40-5.82). Conclusions Postcardiac arrest ICD implantation rates in eligible patients are lower than expected. Implementation strategies to monitor guideline adherence after out of hospital cardiac arrest are warranted.

Background The EMPA-HEART trial showed a reduction in left ventricular (LV) mass index by cardiac MRI at 6 months in patients treated with Empagliflozin vs placebo. A secondary analysis of key echocardiographic parameters was performed to provide further insight into the mechanism of LV remodeling. Methods All patients enrolled prospectively underwent transthoracic echocardiography (TTE) at baseline and at 6 months. Measurements were performed according to the American Society of Echocardiography guidelines. Key outcomes of interest included changes in diastolic function and right ventricle parameters at 6 months in patients treated with Empagliflozin vs placebo. Results A total of 97 patients were enrolled (49 treated with Empagliflozin and 48 in the placebo group). There was no significant difference in the change in average E/E' at 6-months in the Empagliflozin group vs placebo (−0.4 vs +0.2, adjusted difference −0.2, 95% CI [−1.3 to 0.82], p=0.7) Similarly, there was no difference between the groups in secondary TTE parameters (Table 1). Subgroup analyses showed no benefit among patients with baseline LVEF >50% vs. ≤50%, and baseline LV mass index ≥60 g/m2 vs Echocardiographic Parameter Placebo (n=48) Empagliflozin (n=49) Adjusted Difference Between Groups 95% CI P-Value Baseline 6 months Change Baseline 6 months Change LVEF (%)* 55.5 (8.7) 54.3 (8.9) −1.0 (6.5) 58.0 (7.5) 59.1 (8.57) 0.72 (5.1) 2.2 (−0.2, 4.7) 0.1 Diastolic Parameters: Average E/e' 10.1 (3.1) 10.3 (2.5) 0.2 (3.0) 10.6 (3.0) 10.5 (3.6) −0.4 (2.5) −0.2 (−1.3, 0.8) 0.7 Medial E/e' 12.3 (3.9) 12.5 (3.6) 0.1 (3.7) 12.6 (4.2) 12.6 (5.2) −0.3 (3.3) −0.3 (−1.7, 1.1) 0.7 Lateral E/e' 8.0 (2.8) 8.2 (2.2) 0.2 (2.7) 8.7 (2.6) 8.4 (2.5) −0.4 (2.7) −0.1 (−1.0, 0.8) 0.8 E velocity (cm/sec) 68.6 (15.2) 70.6 (14.7) 1.8 (15.4) 74.4 (18.2) 71.2 (16.8) −3.2 (15.1) −2.3 (−7.9, 3.3) 0.4 A velocity (cm/sec) 74.7 (17.9) 77.9 (18.8) 2.9 (15.9) 76.2 (16.5) 75.8 (14.5) −1.4 (11.7) −3.5 (−8.9, 1.6) 0.2 LA volume index (mL/m2) 32.7 (7.9) 30.8 (8.1) −2.0 (6.7) 30.2 (6.7) 28.7 (5.5) −1.6 (6.5) −0.9 (−3.4, 1.6) 0.5 RV Parameters: TAPSE (cm) 1.8 (0.5) 1.8 (0.4) 0.1 (0.4) 2.0 (1.2) 1.8 (0.4) −0.3 (1.4) −0.1 (−0.3, 0.1) 0.3 RV S' TDI (cm/sec) 10.9 (2.9) 10.6 (2.5) −0.1 (2.2) 10.4 (2.7) 10.2 (2.6) −0.4 (2.0) −0.3 (−1.2, 0.5) 0.4 *Measured by cardiac MRI. LA, left atrium; LVEF, left ventricular ejection fraction; RV, right ventricle; TAPSE, tricuspid annular plane systolic excursion; TDI, tissue Doppler imaging. Data expressed as mean (standard deviation). Conclusion This study showed no significant change in key echocardiographic parameters in patients treated with Empagliflozin, suggesting that changes in loading conditions induced by empagliflozin (i.e. preload) do not mediate the reduction in LV mass.

Introduction Intraprocedural guidance and monitoring with transesophageal echocardiography (TEE) and invasive hemodynamic assessment are currently the best available options for evaluating procedural success of percutaneous mitral valve (MV) repair with Mitraclip System (Abbott Vascular, Santa Clara, CA, USA). However, despite its crucial importance, echocardiography has some limitations in immediate evaluation of residual jets after clip implantation, so that, in absence of validated method for double orifice effective regurgitant orifice (ERO) assessment, the most reliable parameter that is currently used is the mean trans-valvular gradient. Purpose This prospective study aimed to assess the role of a new echocardiographic parameter obtained from 3D-Color-Full volume imaging of MR for evaluation of outcomes of mitraclip procedures, comparing it with invasive LAP measurements. Material and methods We prospectively performed the computation of a new parameter in patients with symptomatic moderate-severe to severe primary or secondary mitral regurgitation (MR) underwent MitraClip procedure. This parameter is easy and fast to be obtained out of 3D dataset and represents the 2D area of the proximal isovelocity surface zone visualized from the ventricular view, without any imaging processing (“3D dual volume PISA area”) (figure). It was obtained as following: i) acquisition of 3D-zoomed-color image of MR jet with adequate frame rates; ii)displaying of the volume sampling in “dual volume layout” so one can see the “ventricular aspect” of the jet area corresponding to proximal isovelocity surface “zone”; iii) awareness of correct alignment to the direction of the flow in proximal zone; iiii) freezing and direct measurement of this area (summarize if more than 1 orifice) (1 attached). We compared the variation of this parameter from the beginning to end of procedure with the variation of LAP measurements, that is currently the most important parameter for assessing outcome of procedures. Results The study includes dataset of 11 patients. The baseline value of 3D dual volume PISA area was 1,191±0,40 cm2 and the mean change we obtained was 0,65±0,30 cm2 (mean of 77% of reduction until the end of procedure). Mean values of LAP were slightly decreased in all cases: basal m-LAP was 12±3,3 mmHg and decreased by 15%. Despite the small number of patients, we observed a significant correlation between the changes of LAP and the change of 3D dual volume PISA area (R: 0.6, p: 0,048). Conclusions This is the first demonstration of the usefulness of echocardiographic parameter obtained by 3Ddual volume layout imaging for rapid intraprocedural guidance in Mitraclip procedure. This parameter is related to hemodynamic variations that it currently considerable surrogate of outcomes. These data need to be confirmed by a larger study.

The goal of this study was to evaluate the effect of transcatheter edge-to-edge tricuspid valve repair (TTVR) for severe tricuspid regurgitation (TR) on hospitalization for heart failure (HHF) and HF-related endpoints.Patients with severe TR need effective therapies beyond conservative treatment. The impact of TTVR on HHF and HF-related endpoints is unknown.Isolated TTVR was performed in 119 patients. Assessments were conducted of New York Heart Association functional class, 6-min walk distance, Minnesota Living with Heart Failure Questionnaire scores, N-terminal pro-B-type natriuretic peptide level, and medication. HHFs were analyzed in the preceding 12 months before and until the longest available follow-up after TTVR. Results were compared with those of 114 patients who underwent combined mitral and tricuspid valve repair.Procedural success with a reduction to moderate or less TR and no in-hospital death was achieved in 82% of patients. With a median follow-up of 360 days (interquartile range: 187 to 408 days), a durable TR reduction to moderate or less was achieved in 72% of patients (p 0.001). TTVR reduced the annual rate of HHF by 22% (1.21 to 0.95 HHF/patient-year; p = 0.02), with concomitant clinical improvement in New York Heart Association functional class (patients in class II or lower: 9% to 67%; p 0.001), 6-min walk distance (+39 m; p = 0.001), and Minnesota Living with Heart Failure Questionnaire score (-6 points; p = 0.02). N-terminal pro-B-type natriuretic peptide level decreased numerically by 783 pg/ml. Diuretic dose before TTVR was increased, but HF medication did not change after TTVR. Procedural success was associated with improved 1-year survival (79% vs. 60%; p = 0.04) and event-free-survival (death + first HHF: 67% vs. 40%; p = 0.001). Transcatheter mitral and tricuspid valve repair-treated patients had comparable outcomes.TTVR for severe TR is associated with a reduction of HHF and improved clinical outcomes.

Until recently, tricuspid valve (TV) disease has been relatively neglected for a long time, but recently tricuspid regurgitation (TR) has attracted attention. Although the prognosis of patients with these disorders is poor, the high mortality and morbidity associated with TV surgery have resulted in many patients not receiving surgical therapy. Current guidelines recommend that TV surgery should be considered in patients with severe TR who are symptomatic or have progressive right ventricle (RV) dilatation or dysfunction. In the absence of severe RV or left ventricle dysfunction, surgery should be considered in cases of severe pulmonary vascular disease or hypertension; however, it is difficult to assess RV dysfunction. Symptoms of right heart failure are more nonspecific and difficult to diagnose than those of left heart failure. Furthermore, the severity of TR is easily influenced by the use of diuretics. These factors lead to difficulties in patient selection and in determination of optimal timing for surgery. Transcatheter therapies for TR have begun to emerge as an alternative for patients with severe symptomatic TR who are at high-risk for standard surgery. Although initial results from a recent international multicenter registry have demonstrated that transcatheter TV therapy is feasible and safe, its clinical experience is still under development. In the present review, we describe the currently available techniques of transcatheter TV intervention and preliminary clinical results.

PURPOSE OF REVIEW Worldwide experience in transcatheter tricuspid valve intervention is increasing as more options become available for the treatment of severe tricuspid regurgitation. These devices can be categorized by their primary mechanism of action, including edge-to-edge leaflet devices, space occupying devices, annuloplasty devices, complete valve replacement and caval valve implantation. This review summarizes the current technologies in use, early clinical results and factors that may affect procedural success. RECENT FINDINGS Almost all transcatheter devices for tricuspid regurgitation are investigational with very limited evidence. The most commonly used device is the MitraClip (Abbott, Santa Clara, CA, USA) edge-to-edge leaflet device, which is often more effective when the leaflet coaptation gap is not too large (ideally under 7 mm). The Tricuspid Cardioband (Edwards Lifesciences, Irvine, CA, USA) annuloplasty device has CE mark approval with promising short-term procedural results. Guideline-based assessment of disease severity and medication optimization is crucial during heart team evaluation of eligibility for intervention. SUMMARY Although important lessons have been learned thus far regarding patient and device selection for transcatheter tricuspid regurgitation interventions, the field remains young and further research is needed to optimize treatment in terms of who, when and with what device. Our proposed algorithm for patient selection based on current knowledge incorporates both clinical and anatomic factors.

BACKGROUND Tricuspid regurgitation is associated with increased rates of heart failure (HF) and mortality. Transcatheter tricuspid valve interventions (TTVI) are promising, but the clinical benefit is unknown. OBJECTIVES The purpose of this study was to investigate the potential benefit of TTVI over medical therapy in a propensity score matched population. METHODS The TriValve (Transcatheter Tricuspid Valve Therapies) registry collected 472 patients from 22 European and North American centers who underwent TTVI from 2016 to 2018. A control cohort formed by 2 large retrospective registries enrolling medically managed patients with >= moderate tricuspid regurgitation in Europe and North America (n = 1,179) were propensity score 1:1 matched (distance +/- 0.2 SD) using age, EuroSCORE II, and systolic pulmonary artery pressure. Survival was tested with Cox regression analysis. Primary endpoint was 1-year mortality or HF rehospitalization or the composite. RESULTS After matching, 268 adequately matched pairs of patients were identified. Compared with control subjects, TTVI patients had lower 1-year mortality (23 +/- 3% vs. 36 +/- 3%; p = 0.001), rehospitalization (26 +/- 3% vs. 47 +/- 3%; p < 0.0001), and composite endpoint (32 +/- 4% vs. 49 +/- 3%; p = 0.0003). TTVI was associated with greater survival and freedom from HF rehospitalization (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.79; p = 0.003 unadjusted), which remained significant after adjusting for sex, New York Heart Association functional class, right ventricular dysfunction, and atrial fibrillation (HR: 0.39; 95% CI: 0.26 to 0.59; p < 0.0001) and after further adjustment for mitral regurgitation and pacemaker/defibrillator (HR: 0.35; 95% CI: 0.23 to 0.54; p < 0.0001). CONCLUSIONS In this propensity-matched case-control study, TTVI is associated with greater survival and reduced HF rehospitalization compared with medical therapy alone. Randomized trials should be performed to confirm these results. (C) 2019 by the American College of Cardiology Foundation.

OBJECTIVES A large, prospective international registry was developed to evaluate the initial clinical applications of transcatheter tricuspid valve intervention (TTVI) with different devices. BACKGROUND TTVI for native tricuspid valve dysfunction has been emerging during the last few years as an alternative therapeutic option to serve a large high-risk population of patients with severe symptomatic tricuspid regurgitation (TR). METHODS The TriValve Registry included 312 high-risk patients with severe TR (76.4 ± 8.5 years of age; 57% female; EuroSCORE II 9 ± 8%) at 18 centers. Interventions included repair at the level of the leaflets (MitraClip, Abbott Vascular, Santa Clara, California; PASCAL Edwards Lifesciences, Irvine, California), annulus (Cardioband, Edwards Lifesciences; TriCinch, 4TECH, Galway, Ireland; Trialign, Mitraling, Tewksbury, Massachusetts), or coaptation (FORMA, Edwards Lifesciences) and replacement (caval implants, NaviGate, NaviGate Cardiac Structures, Lake Forest, California). Clinical outcomes were prospectively determined during mid-term follow-up. RESULTS A total of 108 patients (34.6%) had prior left heart valve intervention (84 surgical and 24 transcatheter, respectively). TR etiology was functional in 93%, and mean annular diameter was 46.9 ± 9 mm. In 75% of patients the regurgitant jet was central (vena contracta 1.1 ± 0.5; effective regurgitant orifice area 0.78 ± 0.6 cm). Pre-procedural systolic pulmonary artery pressure was 41 ± 14.8 mm Hg. Implanted devices included: MitraClip in 210 cases, Trialign in 18 cases, TriCinch first generation in 14 cases, caval valve implantation in 30 cases, FORMA in 24 cases, Cardioband in 13 cases, NaviGate in 6 cases, and PASCAL in 1. In 64% of the cases, TTVI was performed as a stand-alone procedure. Procedural success (defined as the device successfully implanted and residual TR ≤2+) was 72.8%. Greater coaptation depth (odds ratio: 24.1; p = 0.002) was an independent predictor of reduced device success. Thirty-day mortality was 3.6% and was significantly lower among patients with procedural success (1.9% vs. 6.9%; p = 0.04); Actuarial survival at 1.5 years was 82.8 ± 4% and was significantly higher among patients who had procedural success achieved. CONCLUSIONS TTVI is feasible with different technologies, has a reasonable overall procedural success rate, and is associated with low mortality and significant clinical improvement. Mid-term survival is favorable in this high-risk population. Greater coaptation depth is associated with reduced procedural success, which is an independent predictor of mortality.

Recurrent mitral regurgitation (MR) due to mitral annuloplasty ring dehiscence is an uncommon late complication of surgery, and is associated with an increased risk of heart failure and mortality. We report the first application of MitraClip for recurrent primary MR and annuloplasty ring dehiscence in a patient with prohibitive surgical risk.

Transesophageal echocardiography (TEE) remains the preferred test to rule out infective endocarditis (IE) but is resource intensive and carries risk. Multiple studies report low sensitivity of transthoracic echocardiography (TTE) for detection of IE; however, these studies did not account for TTE quality. We test the validity of a simple valve visualization grading tool to stratify TTEs by quality and determine whether a high-quality TTE may be used to exclude valvular vegetation and forgo the need for TEE.The Valve Visualization on Echocardiography Grade (VEG) tool scores the TTE from 0 to 10 based on leaflet visualization and valve leaflet clarity. The tool was retrospectively applied to 309 sequential patients who underwent both TTE and TEE at an academic teaching hospital between 2011 and 2015. The TEE report was the gold standard for presence or absence of vegetation. Patients with prosthetic valves and pacemaker wires were excluded. Sensitivity of TTE for detecting vegetation was calculated at each VEG score, and the optimal cutoff was identified.A total of 309 patients were included in the analysis. Among the 216 negative TTEs, 19 (9%) had a positive TEE. The median VEG score was 4. A VEG score cutoff6 provided optimal sensitivity and was used as the cutoff. Overall, 75 (25%) patients had a VEG score6, and 234 (75%) had a score ≤6. Sensitivity and negative predictive value for IE were higher in the VEG6 versus VEG ≤6 group (sensitivity 96% vs 66%, negative predictive value 97.5% vs 90%; P .05). The false-negative rate was lower (2.5% vs 10%; P = .04) in VEG 6 versus VEG ≤ 6 groups, respectively.Leaflet visualization and valve leaflet clarity are important components in the TTE evaluation of patients with suspected IE. This study demonstrates that the better the valve leaflets are visualized on TTE (as represented in this population by a score6), the higher the confidence one can have that the TTE will not be falsely negative for vegetation(s) when vegetation(s) are not noted on these TTEs. If validated in future prospective studies, this may reduce the need to perform an invasive TEE in selected patients undergoing evaluation for native valve IE.

Introduction Are the current data on the Cardioband in the clinical area enough to consider it a tool for mitral regurgitation treatment? Severe secondary mitral valve insufficiency frequently affects high-risk surgical patients. The Cardioband system is a novel percutaneous surgical-like device for direct annuloplasty. It is implanted into the beating heart by transvenous femoral access, with minimal impact on hemodynamic and cardiac function during implantation. So far, it has demonstrated safety and feasibility in high-risk patients with functional mitral regurgitation; it has imparted significant annular reduction and regurgitation improvements. In well-selected patients, it could be an option for mitral valve repair. Areas covered This is a bibliographic review based on scientific publications and medical congress reports. It includes the most current information related to Cardioband in mitral regurgitation. Expert commentary This novel, less-invasive and effective tool is an option for the open repair or replacement of the mitral valve in high-risk surgical patients. Although the current results of Cardioband are promising, more data and longer follow-up times are necessary to confirm its safety and efficacy and to evaluate the durability of the results.

Advancements in transcatheter technology has increased the number of therapeutic options for patients with tricuspid regurgitation. One category of repair devices attempts to augment leaflet coaptation by either leaflet plication or by functioning as a space occupying device. These include the MitraClip (Abbott, Santa Clara, CA, USA), PASCAL (Edwards Lifesciences, Irvine, CA, USA) and FORMA (Edwards Lifesciences, Irvine, CA, USA) devices. All three have been successfully implanted with promising short-term echocardiographic and clinical outcomes. Improvements in patient selection, device design and procedural technique will lead to more effective tricuspid regurgitation reduction. Further research to assess efficacy, safety and durability of these devices is needed, along with determination of long-term clinical outcomes.

In the field of transcatheter tricuspid valve (TV) therapy [(1,2)][1] the only device designed to treat TR by completely replacing the valve is the NaviGate self-expandable tricuspid valved stent (NaviGate Cardiac Structures Inc., Laguna Hills, California) [(3,4)][2]. We present clinical

An 82-year-old woman presented with advanced right heart failure, recurrent hospitalizations, and secondary tricuspid regurgitation (TR). She had persistent New York Heart Association functional class IV dyspnea, severe fatigue, ascites, and peripheral edema. Past history included coronary artery

PURPOSE OF REVIEW Mitral regurgitation remains a common problem, and when severe, is associated with significant morbidity and mortality. At present, echocardiography remains the primary modality for assessing both mechanism and severity of mitral regurgitation. However, recent studies demonstrate that the echocardiographic assessment of mitral regurgitation severity may be subject to variability as a result of semiquantitative parameters, dependence upon loading conditions and significant interobserver variability. RECENT FINDINGS Cardiac magnetic resonance (CMR) imaging is the gold standard in the assessment of cardiac function and structure, and offers an alternative method to estimate mitral regurgitation severity. Herein, we discuss the pitfalls of echocardiography in the assessment of mitral regurgitation and describe recent data demonstrating improved accuracy of CMR in the assessment of mitral regurgitation severity. Further, CMR derived regurgitant volume of ≤55 ml is associated with freedom from surgical intervention, in contrast to traditional volumetric measures, which fail to predict the need for surgical intervention. SUMMARY The CMR assessment of mitral regurgitation severity is easily performed and appears to be more accurate and predictive of the need for surgery than traditional echocardiography. These promising findings require further confirmation in larger outcome trials.

Acute decompensated heart failure is a common reason for presentation to the emergency department and is associated with high rates of admission to hospital. Distinguishing between higher-risk patients needing hospitalization and lower-risk patients suitable for discharge home is important to optimize both cost-effectiveness and clinical outcomes. However, this can be challenging and few validated risk stratification tools currently exist to help clinicians. Some prognostic variables predict risks broadly in those who are admitted or discharged from the emergency department. Risk stratification methods such as the Emergency Heart Failure Mortality Risk Grade and Acute Heart Failure Index clinical decision support tools, which utilize many of these predictors, have been found to be accurate in identifying low-risk patients. The use of observation units may also be a cost-effective adjunctive strategy that can assist in determining disposition from the emergency department.