Improvement In Functional Class Research Articles

Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial (final results)

Abstract Background In heart failure (HF), implantable hemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left-sided hemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure (PAP) monitoring systems. Aims We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients (V-LAP). Methods and Results The VECTOR-HF study was a first-in-human, prospective, multicenter, single-arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After three months, a right heart catheterization (RHC) was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute Major Adverse Cardiac and Neurological Events (MACNE). At 3 months, freedom from short-term MACNE was 97%. Agreement between sensor-calculated LAP and PCWP was consistent, with a mean difference of -0.22±4.92mmHg, the correlation coefficient and the Lin’s Concordance Correlation Coefficient values were equal to 0.79 (P<0.0001) and 0.776 (95%CI=0.582-0.886), respectively. Preliminary experience with VLAP-based HF management was associated with significant improvements in NYHA functional class (32% of patients reached NYHA II class at 6 months, P<0.005; 60% of patients at 12 months, P<0.005) and 6-minute walk-test distance (from 244.59±119.59m at baseline to 311.78±129.88m after 6 months, P<0.05, and 343.95±146.15m after 12 months, P<0.05). Conclusion The V-LAP™ monitoring system proved to be safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms that could be associated to a better outcome. Further studies are needed to test the efficacy of the device in heart failure patients.

Impact of transcatheter edge-to-edge repair (TEER) of mitral valve on the clinical outcomes in the management of atrial functional mitral regurgitation

Abstract Background Atrial functional mitral regurgitation (aFMR) has become a novel topic of interest. Data on the safety and efficacy of transcatheter edge-to-edge repair (TEER) of mitral valve among patients with aFMR and ventricular functional mitral regurgitation (vFMR) is scarce and limited to single center studies. Purpose We conducted a systematic review and meta-analysis to assess the safety and efficacy of TEER in the management of aFMR vs vFMR and its impact on clinical outcomes. Methods PubMed/MEDLINE, Cochrane Library and EMBASE databases were queried to identify studies comparing the efficacy of TEER between aFMR and vFMR. The primary outcome of interest was mortality at 1 year and composite of all-cause mortality and heart failure (HF) hospitalizations. Secondary outcomes included mitral regurgitation (MR) reduction, presence of residual MR, improvement in NYHA functional class, postoperatively and at 1-year. Risk ratios (RR’s) and their corresponding 95% confidence intervals (CIs) were calculated using random-effects model. Results We included a total of 3,314 patients from 6 observational studies which met the inclusion criteria (mean age 63.8 ± 3.8 years, 43% male). There were 443 aFMR patients and 2871 vFMR patients with an average follow-up of 12 months. Mortality at 1-year and the composite outcome of all-cause mortality and heart failure hospitalizations were comparable between aFMR and vFMR groups (RR 1.06; 95% CI 0.64 - 1.75; p = 0.81 and RR 0.92; 95% CI 0.75 - 1.14; p = 0.47, respectively). There were no significant differences between aFMR and vFMR groups in terms of MR reduction postoperatively (RR 0.99; 95% CI 0.96 - 1.02; p = 0.53) or at 1-year (RR 1.15; 95% CI 0.96 - 1.38; p = 0.14). Moreover, the presence of residual MR grade ≥ 3+ postoperatively (RR 1.31; 95% CI 0.83 - 2.08; p = 0.25) and at 1-year (RR 0.96; 95% CI 0.44 - 2.11; p = 0.92) was similar between aFMR and vFMR cohorts. Overall, although there was a clinical improvement in symptoms in terms of NYHA functional class at 1 year (grade ≤ 2), there was no statistical significance between the two groups (RR 1.02; 95% CI 0.93 - 1.11; p = 0.74). Conclusion This meta-analysis suggests that transcatheter edge-to-edge repair is likely to be an efficacious and safe option in patients with aFMR and vFMR. Future randomized control trials are needed to fully assess the clinical impact of this procedure in the two MR etiologies.Figure 1Figure 2

Sex differences and survival after TAVI for severe aortic stenosis

Abstract Background There is still controversy about survival rates and clinical response of women versus men who undergo transcatheter aortic valve implantation (TAVI) for the treatment of severe aortic stenosis (SAS). Purpose Assess mortality and heart failure (HF) symptoms following TAVI for SAS, according to sex. Methods A retrospective analysis of a single-center database including all TAVI performed in 2011-2019 was performed. Clinical, echocardiographic, and blood-analysis data were determined, and all-cause mortality over the five years after the procedure was compared based on sex. A reduction of at least one New York Heart Association (NYHA) class after TAVI was the secondary endpoint. Results Of the 488 cases analyzed, 252 (51.6%) were women. They were older (84 vs. 80 years-old, p<0.001), had a lower body surface area, and had a higher estimated surgical risk, as determined by EuroSCORE II (4.5 vs. 3.8, p=0.011) and STS-mortality (4.46 vs. 3.44, p<0.001). However, they had a lower prevalence of diabetes mellitus, coronary artery disease, and peripheral artery disease, a lower estimated creatinine clearance, and a lower frequency of previous pacemaker implantation. Women had more frequently a phenotype of high gradient severe aortic stenosis, with lower functional aortic valve areas. While there was no difference in TAVI design, smaller valves were implanted in women. Median follow-up was 46 months and there was a 40% mortality rate over the five years after treatment, with no statistically significant differences according to sex in both univariate and multivariate analysis, after adjusting for estimated surgical risk. EuroSCORE II had a statistically significant association with the primary endpoint (hazard ratio 1.03 (1.01-1.05), p=0.004). Despite having a similar NYHA class before TAVI, women experienced a lower frequency of functional class improvement (61% vs. 72%, p=0.034). Conclusions Although women had a higher estimated surgical risk, no differences were found regarding survival after TAVI for SAS. However, improvement in HF symptoms was less frequent in this subset.Table 1Figure 1

Bilateral Cardiac Sympathetic Denervation for Refractory Multifocal Premature Ventricular Contractions in Patients With Nonischemic Cardiomyopathy

BackgroundBilateral cardiac sympathetic denervation (BCSD) for refractory life-threatening ventricular arrhythmias is a neuromodulatory intervention targeting sympathetically driven focal or re-entrant ventricular arrhythmias. ObjectivesThis study sought to provide a more complete and successful option for intervention in patients in whom premature ventricular contraction (PVC) ablation is not feasible or has been unsuccessful. MethodsA total of 43 patients with >5% PVC burden and concomitant nonischemic cardiomyopathy (NICM) who previously failed medical and ablation therapies were referred for BCSD. All patients underwent bilateral video-assisted thoracoscopic surgical approach with T1-T4 sympathectomy. Primary effectiveness endpoints were postprocedural PVC burden resolution, improvement in left ventricular ejection fraction (LVEF), and cessation of antiarrhythmic drugs (AADs). Safety endpoints included peri- and postprocedural complications. Outcomes were assessed over a 1-year follow-up period. ResultsAmong the 43 patients who underwent BCSD, the mean age was 52.3 ± 14.7 years, 69.8% of whom were male patients. Presenting mean LVEF was 38.7% ± 7.8%, and PVC burden was 23.7% ± 9.9%. There were significant reductions in PVC burden postprocedurally (1.3% ± 1.1% post-BCSD, compared with 23.7% ± 9.9% pre-BCSD, P < 0.001) and improvements in LVEF (46.3% ± 9.5% post-BCSD, compared with 38.7% ± 7.8% pre-BCSD, P < 0.001). The rate of ICD therapies decreased from 81.4% (n = 35) to 11.6% (n = 5) (P < 0.001), leading to a significant reduction in use of AADs (100.0% to 11.6%, P < 0.001) and improvement in mean NYHA functional class (2.5 ± 0.5 to 1.4 ± 0.2, P < 0.001). Major intraoperative complications were seen in 4.7% of patients (hemothorax and chylothorax). Of the patients, 81.4% (n = 35) experienced no mortality or major complications over a 1-year follow-up period, with the remaining still within their first year postprocedure. ConclusionsBCSD is effective for the management of refractory PVCs and ventricular tachycardia who have failed previous ablation therapy.

Navigating the Sotatercept landscape: A meta-analysis of clinical outcomes.

Pulmonary arterial hypertension (PAH) is a widespread condition that affects around 1% of the global population, with a higher prevalence among older individuals. The approach to managing PAH has undergone significant changes, requiring extensive treatment strategies. Sotatercept, an FDA-approved medication, has recently attracted attention for its potential role in PAH therapy. However, information on its safety and effectiveness is scarce. In this study, we performed a meta-analysis of existing randomized clinical trials to assess the impact of Sotatercept on PAH patients. Our findings revealed that those treated with Sotatercept showed greater improvement in pulmonary vascular resistance and World Health Organization functional class compared with placebo recipients. The occurrence of adverse events was similar between both groups. Importantly, the Sotatercept group displayed a considerably higher number of cases with an increase in hemoglobin levels. Considering that about 33% of PAH patients experience anemia and both anemia and polycythemia can adversely affect disease prognosis, additional research is necessary to establish the potential advantages and disadvantages of Sotatercept as a treatment choice, specifically regarding its erythropoietic properties.

Echocardiographic and Clinical Outcomes in Symptomatic Patients With Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement

Optimal timing for aortic valve replacement in symptomatic patients with less than severe aortic stenosis (AS) is not well defined. There is limited information on the benefit of valve replacement in these patients. Symptomatic patients with less than severe AS, defined as a mean aortic gradient ≥20 and <40mm Hg, peak aortic velocity >3 and <4m/s, and aortic valve area >1.0 and <1.5cm2, enrolled in the Society for Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry and who underwent attempted supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) were reviewed. Site-reported valve hemodynamics, clinical events, and quality of life metrics were analyzed at 30days and 1year after the procedure. A total of 1,067 patients with attempted TAVR (mean age 78.4 ± 8.4years; Society for Thoracic Surgery score 4.7 ± 3.4%) were found to have symptoms but less than severe AS. From baseline to postprocedure, mean gradient decreased (29.9 ± 4.9 vs 8.4 ± 4.8mm Hg, p <0.001), and aortic valve area increased (1.2 ± 0.1 vs 2.2 ± 0.7cm2, p <0.001). Clinical events included 30-day and 1-year all-cause mortality (1.5% and 9.6%), stroke (2.2% and 3.3%), and new pacemaker implantation (18.1% and 20.9%). There were statistically significant improvements in the New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire at 30days and 1year. In conclusion, patients with symptomatic but less than severe AS who underwent supra-annular, self-expanding TAVR experienced improved valve hemodynamics and quality of life measures 1year after the procedure. Randomized studies of TAVR versus a control arm in symptomatic patients with less than severe AS are ongoing.

Effects of sacubitril/valsartan in patients with cancer therapy-related heart failure

To evaluate the effect of Sacubitril/Valsartan (S/V) on the functional status, systolic and diastolic function of the left ventricle (LV), tolerability of therapy and to determine predictors of its effectiveness in patients with cancer therapy-related heart failure (СTRHF). Forty patients 58 [46; 65.5] years of age with HF associated with anthracycline-containing cancer therapy were enrolled. Clinical examination, echocardiography, and assessment of potassium and creatinine levels were performed at baseline and after 6 months of S/V therapy. NYHA functional class (FC) improvement was observed in 22 (64.7%) patients. Radiation therapy (RT) decreased (OR 0.091; 95% CI 0.01-0.83; p=0.03) while baseline low LV EF increased (OR 9.0; 95% CI 1.78-45.33; p=0.008) the odds of FC improvement. LV EF increased from 37.3 [30; 42.5] % to 45 [38; 48] % (p<0.0001) and exceeded 50% in 7 (20.6%) patients. The odds of LV EF recovery increased when S/V therapy was initiated ≤1 year after anthracycline therapy (OR 10.67; 95% CI 1.57-72.67; p=0.0016) and decreased in patients with the history of RT (OR 0.14; 95% CI 0.02-0.89; p=0.0037) and in patients over 58 years (OR 0.07; 95% CI 0.01-0.68; p=0.022). LV diastolic function improvement included E/e' descent from 13.6 [10; 18.3] to 8.9 [6.9; 13.7] (p=0.0005), and decrease in diastolic dysfunction grade in 18 (45%) patients (p=0.0001). No significant change in serum potassium (4.45 [4.2; 4.8] versus 4.5 [4.3; 4.8]; p=0.5) and creatinine (75.4 [67.6; 85.1] versus 75.5 [68.2; 98.3]; p=0.08) levels were observed. S/V therapy is associated with improvement of EF, systolic and diastolic LV function, demonstrates a favorable tolerability profile in patients with СTRHF. Lack of RT and low baseline LV EF increased the odds of LV EF improvement; lack of RT, early (≤1 year) start of treatment after discontinuation of anthracycline therapy, and age <58 years increased the odds of LV EF recovery.

Abstract P121: Medical Treatment And Outcomes In Adults With Co-occurring Hypertrophic Cardiomyopathy And Hypertension: A Scoping Review

Background: Over 50% of adults with hypertrophic cardiomyopathy (HCM) have co-occurring hypertension (HTN). Therapeutic management poses a clinical challenge as first and second-line antihypertensive medications (AHM) can worsen obstructive HCM (OHCM), which comprises ~70% of all HCM. Treatment and clinical course in adults with HCM+HTN are underexplored. With this scoping review, we sought to 1) characterize the literature on the management and outcomes of HCM+HTN, and 2) identify knowledge gaps to inform future research directions. Methods: We searched 5 databases (PubMed, CINAHL, Scopus, Embase, Web of Science) to identify and review eligible articles: 1) peer-reviewed; 2) English-language; 3) cohorts with an established HCM diagnosis; 4) data on management, and/or outcomes related to co-occurring HTN; 5) published 2011 - 2023. We reviewed reference lists of eligible articles to find other relevant studies. The review was conducted according to PRISMA ScR guidelines, with 2 independent reviewers at each stage of review. Results: We extracted data from 12 articles (of 966 results); all were retrospective observational. Five defined HTN (JNC7 criteria and/or AHM). One study examined HTN in adults with apical HCM, 2 in adults with OHCM, and 9 did not differentiate HCM phenotype. Only 1 study described a medication strategy for treating HCM+HTN, showing that prioritizing β1 selective blockers and verapamil over direct vasodilators led to improvement in functional (NYHA) class and lower blood pressure. There was notable heterogeneity in definitions and analytic methods related to outcomes. Four studies showed worse renal function in those with HCM+HTN versus HCM alone, but results were equivocal in other outcomes, including stroke, cardiovascular disease, atrial fibrillation, surgical interventions for HCM, and sudden death. All-cause mortality was similar between those with HCM+HTN and HCM alone. Conclusions: To our knowledge, this is the first scoping review to examine the literature on the clinical course and outcomes of patients with HCM+HTN. Our results highlight the critical need for further research to improve understanding of co-occurring HCM and HTN, with particular focus on medical management to optimize clinical course and outcomes.

Efficacy and Safety of Mavacamten in the Treatment of Hypertrophic Cardiomyopathy: A Systematic Review.

Current pharmacological options for hypertrophic cardiomyopathy (HCM) are not disease-specific; while it treats symptoms, mavacamten targets the underlying pathology. We aim to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive HCM. This systematic review of the literature followed the PRISMA guidelines. Title/abstract and topics were searched using the following term: "mavacamten". The electronic research literature databases included the Cochrane Library, MedLine, and clinicaltrials.gov from July to August 2022. Primary efficacy endpoint was to assess clinical response at the end of treatment compared with baseline, defined as, at least one New York Heart Association (NYHA) class reduction. Two secondary endpoints from baseline were determined. The first was defined as improvement in mixed venous oxygen pressure (pVO2). The second was defined as reduction of the post-exercise left ventricular outflow tract (LVOT) gradient. We included in our analyses data from four studies that met our review eligibility criteria. There were three randomised placebo-controlled clinical trials and one non-randomised open-label clinical trial. All four studies showed a reduction in NYHA class from mavacamten use. Three out of four studies demonstrated >1 NYHA functional class improvement ranging from 34% to 80%, while only one study showed a smaller percentage of patients remaining at class 3. Three out of four studies measured pVO2 as an outcome, and all three studies noticed an increase in peak oxygen consumption after mavacamten treatment. Additionally, three out of four studies measured post-exercise LVOT gradient reduction as an outcome and all three found significant reduction in the post-exercise LVOT gradient after treatment. The most commonly observed adverse side effects were atrial fibrillation and decreased left ventricular ejection fraction, but all participants recovered without long-term sequelae and only one patient dropped out of the trial. Mavacamten has a greater efficacy than placebo in the treatment of HCM. It also showed promising tolerability and efficacy profiles in the treatment of HCM in adults. The three endpoints used in the evaluation of studies were reduction in NYHA class, increase in pVO2, and post-exercise LVOT gradient reduction. Mavacamten showed greater reduction in NYHA, larger effects on increase of pVO2, and significant reduction of the LVOT gradient. Mavacamten was also found to be well tolerated, like the placebo. The side effect profile was limited for the majority of individuals taking mavacamten. In the future, authors recommended dose-optimisation studies, and studies that evaluate mavacamten both in comparison to, and in conjunction with other current treatments.

Management of Moderate Ischemic Mitral Regurgitation in Patients Undergoing Surgical Revascularization

Abstract Background Chronic ischemic mitral regurgitation (IMR) is not uncommonly seen in association with patients diagnosed with coronary artery disease and represents a late sequel of chronic myocardial ischemia and infarction. It adversely affects cardiovascular mortality and morbidity especially in patients undergoing coronary artery bypass grafting (CABG) surgery. We aim to identify the optimal management of moderate IMR in patients undergoing coronary artery bypass grafts surgery (CABG), whether to address this pathology during revascularization surgery or not. Methods 100 patients diagnosed with Ischemic Heart Disease (IHD) associated with moderate IMR undergoing Coronary Artery Bypass Grafting (CABG). Patients were divided into two equal groups according to their Mitral valve intervention: Group A; 50 Patients with IMR planned for complete revascularization only and Group B; 50 patients planed for revascularization combined with mitral valve surgery. The two groups were compared demographically, for intraoperative and post-operative events. The primary end point was hospital mortality, secondary end points included post-operative improvement in the NYHA functional class, improvement of EF % and reduction of LV dimensions in post-operative echocardiography and finally, the incidence of neurological dysfunction in both groups. Results All the patients in both groups underwent CABG surgery using cardiopulmonary bypass machine. Patients in group B underwent combined Mitral valve surgery in the form of; Mitral valve replacement using a mechanical valve in 7 patients, Mitral valve repair with downsizing annuloplasty surgery using complete semi-rigid ring in 43 patients, of which 13 patients required additional chordal repair with artificial chordea. Group (A) patients were found to have statistically significant shorter total bypass time 72.2± 17.6 vs 113.5± 14.3 (p &amp;lt; 0.001), ischemic time 47.4 min ± 12.1 vs 79.7 min ± 12.3 (p &amp;lt; 0.001), mechanical ventilation duration 10.9 hours ±14.9 vs 14.9 hours ±12.1 (p &amp;lt; 0.001), total period of ICU stay was 46.1 hours ±21.2 vs 63.7 hours ±22.2 and ward stay 5.7 days ±2.3 vs 6.8 days ±2.9 vs (p &amp;lt; 0.001) in group A vs group B respectively. Hospital mortality was insignificant between the 2 groups [(5 patients in group A (10%) vs 4 patients in group B (8%) P = 0.84)]. One month post-surgery, all survivors showed improvement of their ejection fraction and reduction in left ventricular and left atrial dimensions in Transthoracic echo however, there were no statistical significant improvement when comparing patients in both groups. Both groups showed similar improvement in Dyspnea score at one month follow up. Neurological insults were comparable in both groups (none vs one patient in group A vs B simultaneously. Conclusion Addition of mitral-valve surgery to CABG in patients with moderate degree of Ischemic Mitral regurgitation did not show significant benefit on survival, post-operative NYHA class of the patients, the echocardiographic findings or stroke incidence during the short term follow up. On the contrary, it resulted in longer durations of cardiopulmonary bypass, aortic cross-clamp time and longer ICU stay. Longer term follow-up is required to identify its potential benefit.

Abstract P2138: Long-Term Clinical Value And Impact Of Mavacamten In Symptomatic Obstructive Hypertrophic Cardiomyopathy: A Systematic Review And Meta-Analysis

Introduction: Hypertrophic cardiomyopathy (HCM) is a common genetic cardiac disorder involving the cardiac sarcomere. Mavacamten is the first-in-class oral cardiac myosin inhibitor approved for treating HCM in adults targeting sarcomere hypercontractility. We aimed to evaluate the efficacy and safety of mavacamten in symptomatic obstructive HCM. Methods: We conducted a systematic literature search in Embase, PubMed, Scopus, and Web of Science databases from inception until March 05, 2023. Results: After screening 349 studies, our final analysis included 5 studies with 843 obstructive HCM patients and an average follow-up of 27.2 weeks. A fixed effects model was used to calculate risk ratios (RRs). Our meta-analysis revealed a significant improvement in NYHA functional class from baseline in patients on mavacamten compared to placebo [RR, 4.59 (95% CI: 2.94-7.16), p&lt;0.00001]. Mavacamten use in obstructive HCM patients also resulted in significantly lower rates of septal reduction therapy (SRT) or patients who were guideline-eligible for SRT versus placebo [RR, 0.29 (95% CI: 0.22-0.39), p&lt;0.00001]. There was no significant effect of mavacamten use on the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (p = 0.22). Also, no significant difference was observed in the occurrence of ≥1 serious adverse event (p = 0.77), atrial fibrillation (p = 0.98), and non-sustained ventricular tachycardia (p = 0.44) between mavacamten and placebo group. Conclusions: A substantial improvement in NYHA functional class without any serious adverse events, and a significant reduction in the number of patients requiring SRT, makes mavacamten a promising drug for obstructive HCM.

Ferric carboxymaltose for patients with heart failure in all-range ejection fraction

Introduction and objectivesIron deficiency (ID) is common in heart failure (HF) patients and is linked to exercise impairment, worse quality of life, and HF hospitalisation. Clinical practice guidelines recommend checking and correcting ID with ferric carboxymaltose (FCM). However, there is a lack of evidence in patients with left ventricular ejection fraction (LVEF) >40%. MethodsWe included all HF outpatients treated with FCM after ID diagnosis (ferritin <100ng/mL or ferritin 100–299ng/mL and transferrin saturation <20%). We analysed clinical and analytical parameters before FCM administration and at 3 months according to LVEF: preserved (>50%), mildly reduced (41–49%), and reduced (<40%). ResultsWe included 235 patients (51.5% female) aged 73.5±10.7 years. Ninety-six patients have reduced LVEF (40.8%), 41 mildly reduced (17.4%), and 98 preserved (41.7%). Patients with preserved LVEF have more anaemia (42.6% vs 26.8% vs 52.6%; P=.02). Less than 50% of patients received the correct dose of FCM, especially patients with preserved LVEF (P=.004). One patient (0.4%) presented a local exanthema with no other adverse effects. At 3 months, all analytical parameters significantly improved, except haemoglobin (12.9 vs 13.0mg/dL; P=.95) and natriuretic peptides (3261 vs 3471pg/mL; P=.56) in mildly reduced LVEF patients. The functional class did not improve in preserved LVEF patients, but it did in the rest. ConclusionsFCM is safe and effective in correcting ID in HF patients regardless of LVEF. Natriuretic peptides are reduced in all patients except those with mildly reduced LVEF. Functional class improvement is less likely in patients with preserved LVEF.

Clinical outcomes following tricuspid transcatheter edge-to-edge repair with PASCAL: A meta-analysis

BackgroundPatients with severe tricuspid regurgitation (TR) exhibit high morbidity and mortality. Tricuspid transcatheter edge-to-edge repair (T-TEER) is a rapidly evolving strategy to address the unmet clinical need of severe TR therapies. ObjectiveOrganize the current body of evidence on outcomes following use of the PASCAL (Edwards Lifesciences) system for T-TEER. MethodsFor this meta-analysis, we searched the MEDLINE/PubMed, Embase, and Cochrane databases for keywords [“tricuspid”] and [“transcatheter” or “edge-to-edge”] and [“PASCAL” or “leaflet repair” or “valve repair”] from the database inception until January 11, 2023. Primary outcomes of interest were procedural success, mortality, New York Heart Association (NYHA) functional class, 6-min walking distance (6MWD), and TR severity. ResultsA total of 549 patients undergoing PASCAL or PASCAL Ace T-TEER were included. The mean age ranged from 71.0 to 80.3 years, with 25.0 to 63.6% females. The follow-up duration ranged from 30 days to 1 year. The success rate was 83.5% (409/490). There was improvement in symptoms based on NYHA classification (at 1- to 6-months; NYHA ≥3 RR 0.27 [95% CI 0.19–0.39]; p < 0.001) and 6MWD (at 1-month; 50.96 [95% CI 32.34–69.59]; p < 0.001) post-procedure. On imaging, there was improvement in TR severity post-procedure (at 1- to 12-months; ≥ severe TR 0.21 [95% CI 0.14–0.31]; p < 0.001), which remained significant with each study removed. ConclusionPASCAL for T-TEER is associated with high procedural success rates along with improvements in NYHA functional class, TR severity, 6MWD, and patient-reported outcomes.

The risk profile change in patients with severe chronic thromboembolic pulmonary hypertension treated with subcutaneous treprostinil.

Chronic thromboembolic pulmonary hypertension (CTEPH) is successfully treatable with pulmonary endarterectomy (PEA), balloon pulmonary angioplasty, and medical therapy. Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management risk score (RRS) is able to predict long-term outcome in inoperable patients or in patients with residual PH after surgery. We performed a post hoc analysis of RRS in patients who were enrolled in the CTREPH study (NCT01416636), a randomized, double-blind clinical trial comparing high-dose and low-dose subcutaneous (SC) treprostinil in patients with severe CTEPH that was classified by an interdisciplinary CTEPH team as nonoperable, or as persistent or recurrent pulmonary hypertension after PEA. Baseline mean RRS was similar in both treatment groups (8.7 in high-dose arm vs. 8.6 in low-dose arm), but mean RRS change from baseline to Week 24 was greater in the high-dose treprostinil group than in the low-dose treprostinil group (-0.88 vs. -0.17). The difference in RRS change from baseline to Week 24 between high dose versus low dose was statistically significant with mean difference of -0.70 (95% confidence interval: -1.36 to -0.05, p = 0.0352), and was driven mainly by improvement of World Health Organization functional class and N-terminal pro-brain natriuretic peptide concentration. SC treprostinil therapy administered in standard dose had positive effect on the risk profile measured by RRS in patients with inoperable or persistent/recurrent severe CTEPH. Although our study was limited by the small sample size and post hoc nature, assessment of risk profile is of great importance to this particular patient population with very poor prognosis.

Outcomes of transcatheter aortic valve replacement in patients with cardiogenic shock.

The safety and efficacy of transcatheter aortic valve replacement (TAVR) with contemporary balloon expandable transcatheter valves in patients with cardiogenic shock (CS) remain largely unknown. In this study, the TAVRs performed for CS between June 2015 and September 2022 using SAPIEN 3 and SAPIEN 3 Ultra bioprosthesis from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were analysed. CS was defined as: (i) coding of CS within 24 h on Transcatheter Valve Therapy Registry form; and/or (ii) pre-procedural use of inotropes or mechanical circulatory support devices and/or (iii) cardiac arrest within 24 h prior to TAVR. The control group was comprised of all the other patients undergoing TAVR. Baseline characteristics, all-cause mortality, and major complications at 30-day and 1-year outcomes were reported. Landmark analysis was performed at 30 days post-TAVR. Cox-proportional multivariable analysis was performed to determine the predictors of all-cause mortality at 1 year. A total of 309 505 patients underwent TAVR with balloon-expandable valves during the study period. Of these, 5006 patients presented with CS prior to TAVR (1.6%). The mean Society of Thoracic Surgeons score was 10.76 ± 10.4. The valve was successfully implanted in 97.9% of patients. Technical success according to Valve Academic Research Consortium-3 criteria was 94.5%. In a propensity-matched analysis, CS was associated with higher in-hospital (9.9% vs. 2.7%), 30-day (12.9% vs. 4.9%), and 1-year (29.7% vs. 22.6%) mortality compared to the patients undergoing TAVR without CS. In the landmark analysis after 30 days, the risk of 1-year mortality was similar between the two groups [hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.95-1.21]. Patients who were alive at 1 year noted significant improvements in functional class (Class I/II 89%) and quality of life (ΔKCCQ score +50). In the multivariable analysis, older age (HR 1.02, 95% CI 1.02-1.03), peripheral artery disease (HR 1.25, 95% CI 1.06-1.47), prior implantation of an implantable cardioverter-defibrillator (HR 1.37, 95% CI 1.07-1.77), patients on dialysis (HR 2.07, 95% CI 1.69-2.53), immunocompromised status (HR 1.33, 95% CI 1.05-1.69), New York Heart Association class III/IV symptoms (HR 1.50, 95% CI 1.06-2.12), lower aortic valve mean gradient, lower albumin levels, lower haemoglobin levels, and lower Kansas City Cardiomyopathy Questionnaire scores were independently associated with 1-year mortality. This large observational real-world study demonstrates that the TAVR is a safe and effective treatment for aortic stenosis patients presenting with CS. Patients who survived the first 30 days after TAVR had similar mortality rates to those who were not in CS.

Association between early changes of left atrial volume and right ventricular function after transcatheter edge-to-edge repair for mitral regurgitation

Abstract Funding Acknowledgements Type of funding sources: None. Background Transcatheter edge-to-edge repair (TEER) has recently become a therapeutic option for patients with severe mitral regurgitation (MR) who are unsuitable for surgery, in order to improve clinical outcomes. MR is a determinant of structural and functional changes of all cardiac chambers. The left atrium (LA) and the right ventricle (RV) play an important role in the pathogenesis of symptoms in patients affected by severe MR. Recent data suggests that reverse changes of left ventricle (LV), as well as LA and RV, are associated to reduced morbidity and mortality. Purpose The aim of the study is to test the association between changes of LAV and RV function early after TEER. Methods This is a retrospective study that enrolled patients with chronic functional severe MR, at high surgical risk, who underwent TEER between February 2015 and July 2022. We evaluated the changes of LA and RV function between baseline and before discharge and their relation with symptoms. Results A total of 52 patients were included (mean age 65.2 ± 10.2 years; 69% males, mean left ventricular ejection fraction [LVEF] 28.8 ± 5.7%). No differences of baseline clinical and echocardiographic characteristics were detected between the groups of patients who had LA volume (LAV) reduction (n = 31) and those who did not (n = 21), including symptoms assessed with New York Heart Association (NYHA) classification. However, the former group had a significant higher LA size (LAVI 76.6 ± 18.2 vs. 61.2 ± 17.6 mL/m2, p = 0.004). In the overall population, we observed a significant increase in tricuspid annular plane systolic excursion (TAPSE), S’ wave at Tissue Doppler and ratio between TAPSE and pulmonary artery systolic pressure (TAPSE/PASP), as well as a decrease of PASP (respectively, p = 0.034, p = 0.003, p &amp;lt; 0.001 and p &amp;lt; 0.001). Compared to patients who did not have LAV reduction, those who had showed a significant increase of TAPSE/PASP (from 0.40 ± 0.17 to 0.52 ± 0.21 mm/mmHg, p = 0.002), S’ wave (from 8.7 ± 1.6 to 9.4 ± 1.7 cm/s, p = 0.005) and a decrease of PASP (from 50.3 ± 14.3 to 38.9 ± 11.5 mmHg, p &amp;lt; 0.001). The absolute change of LAV from baseline to discharge was associated with the change of PASP (b coefficient 0.55, 95% confidence interval 0.09, 1.02, p = 0.022) and TAPSE/PASP (b coefficient −4.06, 95% confidence interval −7.78, −0.33, p = 0.033), even after adjustment for covariates (respectively, b coefficient 0.61, 95% confidence interval 0.07, 1.14, p = 0.027 and b coefficient −4.82, 95% confidence interval −9.43, −0.23, p = 0.040). Finally, NYHA class significantly improved in the group of patients whose LAV reduced (p = 0.011). Conclusion In this retrospective study, an association between early changes of LA structure and RV functional parameters has been described. After TEER, RV function improved, especially in patients who had LAV reduction. In the latter, we observed an improvement of NYHA functional class.

Study design and rationale of EXPLORER-CN: a phase III, randomised, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of mavacamten in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy

IntroductionHypertrophic cardiomyopathy (HCM) is a primary myocardial disease commonly caused by pathogenic genetic variants encoding sarcomere proteins. Mavacamten, a first-in-class allosteric inhibitor of cardiac-specific myosin, has demonstrated efficacy and safety...

Left ventricular global strain and duration of QRS complex as predictors of prognosis after cardiac resynchronization therapy

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): National heart institute and Menoufia university, Egypt. Background cardiac resynchronization therapy is effective for patients with chronic heart failure with reduced left ventricular ejection fraction and wide QRS (≥120 ms). We aimed to verify that a baseline left ventricular global longitudinal strain(LVGLS) and qrs duration may be beneficial as predictors of prognosis of CRT response. purpose We aimed to evaluate if LVGLS &amp; QRS duration may be of additive prognostic value in CRT response. Methods Transthoracic echocardiography was performed prior to and 6 months after CRT implantation. Echocardiography was performed to assess left ventricular function as LVGLS. The response to CRT was defined as improvement in NYHA functional class (at least one class) and ≥ 15% reduction in the left ventricular end-systolic volume or improvement in left ventricular ejection fraction &amp;gt; 10. Comparison between responders and not responders was done using the appropriate test, and ROC analyses were done for QRS duration and LVGLS to predict CRT response. Results fifty-five HF patients (age 58 ±8 years, LVEF 23 ±5%, QRS duration 159 ±8ms, 30.9% ischemic aetiology of HF) underwent CRT implantation. The percentage of responders was 72.72% (Table). Baseline LVGLS differed significantly according to CRT response (P &amp;lt; 0.019). The best cutoff for LVGLS to predict response was 6.2, at which sensitivity and specificity were 70% and 73.3%, respectively with AUC of 0.793, with a 95% confidence interval (CI) of 0.651 - 0.936 (P = 0.001). Also, there was a statistically significant difference of the baseline QRS duration between the patients who had and hadn’t CRT response (P &amp;lt;0.001). The best cutoff was &amp;gt;154 ms,at which sensitivity and specificity were 87.5% and 86.7%, respectively. (AUC was of 0.793, with a 95% CI ranging from 0.651 - 0.936 (P = 0.001). Conclusion Baseline LVGLS and QRS duration may have a prognostic value in prediction CRT response. Baseline LVGLS (&amp;gt;6.2) and QRS duration (&amp;gt;154ms) may help to select CRT responders.

Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice

BackgroundSevere tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality. ObjectivesThe authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting. MethodsThe bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory. ResultsEnrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days. ConclusionsTranscatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089)

Long-Term Survival of Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension: A Single-Center Cohort.

Pulmonary arterial hypertension (PAH) is a rare but severe complication of connective tissue disease (CTD). CTD-associated PAH (CTD-PAH) is the most common subgroup of PAH in East Asia. We prospectively collected 41 patients with CTD-PAH and followed them for a mean period of 43 ± 36 months. The long-term survival rates of the CTD-PAH patients at 1, 2, 3 and 5 years were 90%, 80%, 77%, and 60%, respectively. The non-survivors had more dilated main pulmonary arteries, higher pulmonary artery pressure and pulmonary vascular resistance (PVR). PAH-specific therapy resulted in improvements in functional class, 6-minute walk distance, serum uric acid, right ventricular function and PVR. Increased C-reactive protein during follow-up, indicating inflammatory processes, was also crucial for the management of CTD-PAH. Therefore targeting both PAH and inflammation is important in this specific subgroup of PAH. The results of this study may help develop treatment strategies for CTD-PAH patients.