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Tricuspid regurgitation is a prevalent disease associated with high morbidity and mortality, with few treatment options. The aim of the TRILUMINATE trial is to evaluate the safety and effectiveness of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation. The TRILUMINATE trial is a prospective, multicentre, single-arm study in 21 sites in Europe and the USA. Patients with moderate or greater triscuspid regurgitation, New York Heart Association class II or higher, and who were adequately treated per applicable standards were eligible for enrolment. Patients were excluded if they had systolic pulmonary artery pressure of more than 60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. Tricuspid regurgitation was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was a reduction in tricuspid regurgitation severity by at least one grade at 30 days post procedure, with a performance goal of 35%, analysed in all patients who had an attempted tricuspid valve repair procedure upon femoral vein puncture. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups. The trial has completed enrolment and follow-up is ongoing; it is registered with ClinicalTrials.gov, number NCT03227757. Between Aug 1, 2017, and Nov 29, 2018, 85 patients (mean age 77·8 years [SD 7·9]; 56 [66%] women) were enrolled and underwent successful TriClip implantation. Tricuspid regurgitation severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97·5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p<0·0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, five (6%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p<0·0001). Single leaflet attachment occurred in five (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolisations, or strokes occurred. At 6 months, all-cause mortality had occurred in four (5%) of 84 patients. The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure. Abbott.

ObjectiveTo determine the implications of applying guideline-recommended definitions of aortic stenosis to echocardiographic data captured in routine clinical care.MethodsRetrospective observational study of 213 174 patients who underwent transthoracic echocardiographic imaging within Allina Health between January 2013 and October 2017. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of echocardiographic measures for severe aortic stenosis were determined relative to the documented interpretation of severe aortic stenosis.ResultsAmong 77 067 patients with complete assessment of the aortic valve, 1219 (1.6%) patients were categorised as having severe aortic stenosis by the echocardiographic reader. Relative to the documented interpretation, aortic valve area (AVA) as a measure of severe aortic stenosis had the high sensitivity (94.1%) but a low positive predictive value (37.5%). Aortic valve peak velocity and mean gradient were specific (>99%), but less sensitive (<70%). A measure incorporating peak velocity, mean gradient and dimensionless index (either by velocity time integral or peak velocity ratio) achieved a balance of sensitivity (92%) and specificity (99%) with little detriment in accuracy relative to peak velocity and mean gradient alone (98.9% vs 99.3%). Using all available data, the proportion of patients whose echocardiogram could be assessed for aortic stenosis was 79.8% as compared with 52.7% by documented interpretation alone.ConclusionA measure that used dimensionless index in place of AVA addressed discrepancies between quantitative echocardiographic data and the documented interpretation of severe aortic stenosis. These findings highlight the importance of understanding the limitations of clinical data as it relates to quality improvement efforts and pragmatic research design.

Transfemoral transcatheter aortic valve replacement (TF-TAVR) is mostly performed under general anesthesia (GA) in most US centers. We examined in-hospital and 30-day outcomes in patients who underwent TF-TAVR with a self-expanding bioprosthesis using local anesthesia (LA) or GA. Patients from the Transcatheter Valve Therapeutics Registry who underwent TF-TAVR from January 2014 to June 2016 with LA or GA were evaluated. Propensity matching was performed and procedural and clinical outcomes compared up to 30 days. A total of 11,006 patients were included (GA: 8,239 [74.9%] and LA: 2,767 [25.1%]). After propensity matching (n = 1,988 matched sets), device success was similar (94.5% vs 94.6%, p = 0.905). No differences in in-hospital stroke (2.7% vs 2.3%, p = 0.413) or paravalvular regurgitation grade (p = 0.113) were noted. Fewer LA patients were converted to open heart surgery (0.2% vs 0.6%, p = 0.076) or experienced an in-hospital major vascular complication (0.7% vs 1.4%, p = 0.026). Intensive care unit time (40.1 ± 58.4 vs 50.9 ± 72.1 hours, p < 0.001) and postprocedure length of stay (4.1 ± 3.6 vs 5.0 ± 4.5 days, p < 0.001) were significantly shorter with LA. In-hospital and 30-day all-cause mortality were lower in the LA cohort compared to the GA cohort ([1.1% vs 2.7%, p < 0.001] and [2.1% vs 3.9%, p = 0.001]). In conclusion, in the largest series of self-expanding bioprostheses for TF-TAVR, these propensity-matched cohorts demonstrate that LA is an acceptable alternative to GA with comparable success, lower safety outcomes, complications rates, and in-hospital and 30-day all-cause mortality.

Background The natural history of patients with moderate aortic stenosis (AS) is poorly understood. We aimed to determine the long-term outcomes of patients with moderate AS. Methods We examined patients with moderate AS defined by echocardiography in our healthcare system, and performed survival analyses for occurrence of death, heart failure (HF) hospitalization, and progression of AS, with accounting for symptoms, left ventricular dysfunction, and comorbidities. Results We examined 729 patients with moderate AS (median age, 76 years; 59.9 % men) with a median follow-up of 5.0 years (interquartile range: 2.0 to 8.1 years). The 5-year overall survival was 52.3 % (95 % confidence interval [CI]: 48.6 % to 56.0 %) and survival free of death or HF hospitalization was 43.2 % (95 % CI: 39.5 % to 46.9 %). Worse New York Heart Association (NYHA) functional class was associated with poor long-term survival, with mortality rates ranging from 7.9 % (95 % CI: 6.6–9.2 %) to 25.2 % (95 % CI: 20.2–30.3 %) per year. Among patients with minimal or no symptoms, no futility markers, and preserved left ventricular function, 5-year overall survival was 71.9 % (95 % CI: 66.4–77.4 %) and survival free of death or HF hospitalization was 61.4 % (95 % CI: 55.5–67.3 %). Risk factors associated with adverse events were age, NYHA class, low ejection fraction and high aortic valve velocity (all p  < 0.05). Conclusions Patients with moderate AS are at significant risk of death. Our findings highlight the need for more study into appropriate therapeutic interventions to improve the prognosis of these patients.

As a measure of the global left ventricular afterload, valvuloarterial impedance (ZVA) can be estimated using transthoracic echocardiography (TTE) and invasive measuring methods. The objective of this study was to compare the performance of TTE in measuring ZVA with invasive haemodynamics, direct Fick and thermodilution (TD), in patients with severe aortic stenosis (AS). This is a retrospective cohort study of 66 patients with severe AS who underwent TTE and bilateral heart catheterisation preaortic valve replacement. ZVA was calculated non-invasively from TTE and invasively using TD and Fick. The differences in measurements were estimated using a generalised estimating equation approach. The exchangeability of the measurements from different methods was evaluated under binary risk stratification rules. The mean±SD ZVA by TTE was 4.6±1.4 vs 4.9±1.6 by TD vs 4.3±1.2 mm Hg m /mL by Fick. From multivariate analyses, ZVA by TTE was 5.9% (95% CI -15.0 to 2.5) lower than by TD and 5.9% (95% CI -1.5 to 12.8) higher than by Fick. At the same time, ZVA by TD was 12.5% (3.0 to 22.9) higher than with Fick. Risk classifications for ZVA-based binary decision rules showed poor agreement between TTE and invasive methods (kappa ≤0.3). The differences in ZVA estimates between TTE and invasive standards do not appear to exceed those between the standards. As such TTE-based estimates may be deemed acceptable as a clinical measure of global haemodynamic load. However, TTE-based and invasive measurements may not be interchangeable to identify patients at risk using binary classification rules based on ZVA.

In a randomized trial, patients with tricuspid regurgitation who were treated with transcatheter edge-to-edge repair had more favorable clinical outcomes at 1 year than did patients who received medical therapy.

In a randomized trial, 1468 patients with severe aortic stenosis who were at low risk for death with surgery were assigned to either transcatheter aortic-valve replacement with a self-expanding valve or surgical aortic-valve replacement. At 2 years, TAVR was noninferior to surgery with respect to death or disabling stroke.

To investigate the effect of left ventricular diastolic dysfunction on outcome in patients with mitral stenosis undergoing percutaneous mitral balloon valvotomy (PMBV). We evaluated consecutive patients with mitral stenosis who underwent PMBV from November 1, 2002, through October 30, 2011, at our institution. Of 107 total patients, 35 (32.7%) had diastolic dysfunction, defined as a preprocedural elevation in left ventricular end-diastolic pressure (LVEDP) (>15 mm Hg). The LVEDP was normal in the remaining 72 patients (≤15 mm Hg). Clinical factors associated with diastolic dysfunction were body mass index (32±7 vs 28±5; P=.004) and diabetes mellitus (29% vs 6%; P=.002), but no differences were found in severity of pulmonary hypertension or degree of improvement in mitral valve hemodynamics after PMBV between the 2 groups. Survival free of recurrent severe symptoms, repeated PMBV, or mitral valve replacement was worse in patients with elevated LVEDP vs normal LVEDP (1-year estimate, 42% vs 81%; hazard ratio, 2.83; 95% CI, 1.62-4.96). In patients referred for treatment of symptomatic mitral stenosis, left ventricular diastolic dysfunction may contribute to elevated left atrial pressure, and its presence is associated with a greater risk of failure of PMBV to improve symptoms. These data have implications for counseling and patient selection for PMBV.