Cardiac-resynchronization therapy is recommended for patients with advanced, symptomatic heart failure. This clinical trial found benefit in asymptomatic patients, but since the rate of death was not ...affected, it remains to be seen whether clinical guidelines will be modified to include asymptomatic patients.
This clinical trial found benefit with cardiac-resynchronization therapy in asymptomatic patients, but since the rate of death was not affected, it remains to be seen whether clinical guidelines will be modified to include asymptomatic patients.
Patients with cardiac disease and reduced left ventricular function are at increased risk for arrhythmia-related sudden death and heart failure. The placement of an implantable cardioverter–defibrillator (ICD) improves survival and reduces the risk of sudden death in appropriately selected patients with cardiac disease.
1
–
3
However, life-prolonging defibrillator therapy is associated with an increased risk of first and recurrent heart-failure events.
4
Cardiac-resynchronization therapy (CRT) with biventricular pacing is an effective adjunctive therapy to pharmacologic management in reducing the rate of hospitalization in symptomatic patients with advanced heart-failure symptoms (New York Heart Association NYHA class III or IV), an ejection fraction of . . .
Background:The MitraClip®system is a transcatheter-based therapeutic option for patients with chronic mitral regurgitation (MR) who are at high risk for surgery. A prospective, multicenter, ...single-arm study was initiated to confirm the transferability of this system to Japan.Methods and Results:Patients with symptomatic chronic moderate-to-severe (3+) or severe (4+) functional or degenerative MR with a Society of Thoracic Surgery (STS) score ≥8%, or the presence of 1 predefined risk factor were enrolled. Patients with left ventricular (LV) ejection fraction (EF) <30% were excluded. MR severity and LV function were assessed by an independent echocardiography core lab. Primary outcome included major adverse events (MAE) at 30 days and acute procedural success (APS). A total of 30 patients (age: 80±7 years; STS score: 10.3%±6.6%) were treated with the MitraClip®. At baseline, all patients had MR 3+/4+ with 53%/47% patients with degenerative/functional etiology with mean LVEF of 50.2±12.8%, and 37% of patients were NYHA class III/IV. APS was achieved in 86.7% with no occurrence of MAE. At 30 days, 86.7% of patients had MR ≤2+ and 96.7% were NYHA class I/II.Conclusions:The MitraClip®procedure resulted in clinically meaningful improvements in MR severity, function and quality of life measures, and low MAE rates. These early results suggest the transferability of this therapy to appropriately selected Japanese patients. (Trial Registration: clinicaltrials.gov Identifier NCT02520310.)
Background Significant advances over the last 5 decades have allowed most patients with congenital heart disease to survive well past childhood and into adulthood. Population-based data from the ...United States are limited regarding mortality in adult survivors. Methods We used the Center for Disease Control Multiple Cause-of-Death registry to determine trends in mortality from 1979 to 2005 among individuals with congenital heart disease in the United States. Results There were significant reductions in death rates for adults with a number of congenital defects including ventricular septal defect, patent ductus arteriosus, coarctation of the aorta, and Ebstein anomaly. Notably, when all ages were analyzed, there was a 71% decline in deaths associated with transposition of the great arteries ( P = .001) and a 40% reduction in deaths associated with tetralogy of Fallot ( P < .001). Mortality related to other lesions declined as well. Among adults with cyanotic lesions, the primary contributing cause of death was arrhythmia followed by heart failure. For adults with noncyanotic lesions, the major contributing cause before 1990 was arrhythmia; after 1990, myocardial infarction became the leading contributing cause of death. There was an overall decrease in the incidence of arrhythmia as the cause of death in all ages, particularly among children. Conclusions Patients with congenital heart disease are living longer. Arrhythmia remains the primary contributing cause of death for those with cyanotic lesions. Myocardial infarction is now the leading contributing cause for adults with noncyanotic congenital heart disease consistent with late survival and an increasing impact of acquired heart disease.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objective The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral ...valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Methods Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. Results The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients ( P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37patients ( P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology ( P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. Conclusions These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Mitral valve surgery is the standard of care for patients with symptomatic mitral regurgitation (MR) or asymptomatic MR with evidence of left ventricular dysfunction or dilation. Whether ...an endovascular approach to repair can offer comparable effectiveness with improved safety remains to be determined in randomized trials. Study Design The EVEREST II Trial is a multicenter, randomized controlled trial to evaluate the benefits and risks of endovascular mitral valve repair using the MitraClip device compared with open mitral valve surgery (control) in patients with moderate or severe MR. Using a 2:1 randomization ratio, the trial is enrolling up to 186 MitraClip-treated subjects and 93 control subjects. Trial end points include a primary efficacy end point: the proportion of patients free from death, surgery for valve dysfunction, and with moderate-severe (3+) or severe (4+) MR at 12 months; the primary safety end point includes the proportion of patients with death, myocardial infarction, reoperation, nonelective cardiovascular surgery, stroke, renal failure, deep would infection, ventilation >48 hours, gastrointestinal complication, new permanent atrial fibrillation, septicemia, or transfusion of ≥2 U at 30 days or hospital discharge, whichever is longer. Conclusions This randomized controlled trial is designed to evaluate the performance of endovascular mitral repair in comparison to open mitral valve surgery in patients with significant MR.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
The aims of the echocardiographic substudy of this multicenter trial were to evaluate the use of quantitative assessment of mitral regurgitation (MR) severity using serial echocardiography and to ...assess the efficacy of percutaneous mitral valve repair. Previous surgical repair studies did not use quantitative echocardiographic methods. Results of a percutaneous mitral valve repair clip device in a core echocardiographic laboratory were evaluated. Published parameters for quantifying MR were used in a systematic protocol to qualify patients for study entry and evaluate treatment efficacy at discharge and 6 months after clip repair. Baseline results were presented for 55 patients, and follow-up results, for 49. Ninety-eight percent of required echocardiographic studies were submitted to the core laboratory, and >85% of required measurements were possible. At baseline, mean regurgitant volume was 54.8 ± 24 ml, regurgitant fraction was 46.9 ±16.2%, effective regurgitant orifice area was 0.71 ± 0.40 cm2 , and vena contracta width was 0.66 ± 0.20 cm. Based on a severity scale of 1 to 4, mean color flow grade was 3.4 ± 0.7, and mean pulmonary vein flow was 2.8 ± 1.2. In patients with a clip at 6 months, all measurements of MR severity were significantly decreased versus baseline, with mean regurgitant volume decreased from 50.3 to 27.5 ml (change −22.8 ml; p <0.0001), regurgitant fraction from 44.6% to 28.9% (change −15.7%; p <0.0001), color flow grade from an average of 3.4 to 1.8 (change −1.6; p <0.0001), and pulmonary vein flow from 2.8 to 1.8 (change −1.0; p <0.0018). In conclusion, quantitative assessment of MR is feasible in a multicenter trial, and percutaneous mitral repair with the MitraClip produces a sustained decrease in MR severity to moderate or less for ≥6 months.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abnormal cardiac structure and function are common in chronic kidney disease (CKD) and end-stage renal disease (ESRD) and linked with mortality and heart failure. We examined changes in ...echocardiographic measures during the transition from CKD to ESRD and their associations with post-ESRD mortality.
Prospective study.
We studied 417 participants with CKD in the Chronic Renal Insufficiency Cohort (CRIC) who had research echocardiograms during CKD and ESRD.
We measured change in left ventricular mass index, left ventricular ejection fraction (LVEF), diastolic relaxation (normal, mildly abnormal, and moderately/severely abnormal), left ventricular end-systolic (LVESV), end-diastolic (LVEDV) volume, and left atrial volume from CKD to ESRD.
All-cause mortality after dialysis therapy initiation.
Cox proportional hazard models were used to test the association of change in each echocardiographic measure with postdialysis mortality.
Over a mean of 2.9 years between pre- and postdialysis echocardiograms, there was worsening of mean LVEF (52.5% to 48.6%; P<0.001) and LVESV (18.6 to 20.2mL/m2.7; P<0.001). During this time, there was improvement in left ventricular mass index (60.4 to 58.4g/m2.7; P=0.005) and diastolic relaxation (11.11% to 4.94% with moderately/severely abnormal; P=0.02). Changes in left atrial volume (4.09 to 4.15mL/m2; P=0.08) or LVEDV (38.6 to 38.4mL/m2.7; P=0.8) were not significant. Worsening from CKD to ESRD of LVEF (adjusted HR for every 1% decline in LVEF, 1.03; 95% CI, 1.00-1.06) and LVESV (adjusted HR for every 1mL/m2.7 increase, 1.04; 95% CI, 1.02-1.07) were independently associated with greater risk for postdialysis mortality.
Some missing or technically inadequate echocardiograms.
In a longitudinal study of patients with CKD who subsequently initiated dialysis therapy, LVEF and LVESV worsened and were significantly associated with greater risk for postdialysis mortality. There may be opportunities for intervention during this transition period to improve outcomes.
Background As patients with congenital heart disease (CHD) are living longer, understanding the comorbidities they develop as they age is increasingly important. However, there are no published ...population-based estimates of the comorbidity burden among the US adult patients with CHD. Methods and Results Using the IBM MarketScan commercial claims database from 2010 to 2016, we identified adults aged ≥18 years with CHD and 2 full years of continuous enrollment. These were frequency matched with adults without CHD within categories jointly defined by age, sex, and dates of enrollment in the database. A total of 40 127 patients with CHD met the inclusion criteria (mean SD age, 36.8 14.6 years; and 48.2% were women). Adults with CHD were nearly twice as likely to have any comorbidity than those without CHD (
<0.001). After adjusting for covariates, patients with CHD had a higher prevalence risk ratio for "previously recognized to be common in CHD" (risk ratio, 9.41; 95% CI, 7.99-11.1), "other cardiovascular" (risk ratio, 1.73; 95% CI, 1.66-1.80), and "noncardiovascular" (risk ratio, 1.47; 95% CI, 1.41-1.52) comorbidities. After adjusting for covariates and considering interaction with age, patients with severe CHD had higher risks of previously recognized to be common in CHD and lower risks of other cardiovascular comorbidities than age-stratified patients with nonsevere CHD. For noncardiovascular comorbidities, the risk was higher among patients with severe than nonsevere CHD before, but not after, the age of 40 years. Conclusions Our data underscore the unique clinical needs of adults with CHD compared with their peers. Clinicians caring for CHD may want to use a multidisciplinary approach, including building close collaborations with internists and specialists, to help provide appropriate care for the highly prevalent noncardiovascular comorbidities.
Abnormal left ventricular structure and function are associated with increased risk of adverse outcomes among patients with CKD and ESRD. A better understanding of changes in left ventricular mass ...and ejection fraction during the transition from CKD to ESRD may provide important insights to opportunities to improve cardiac outcomes.
This was a longitudinal study of a subset of participants of the Chronic Renal Insufficiency Cohort who were enrolled from 2003 to 2007 and followed through January of 2011. Participants were included if they had serial echocardiograms performed at advanced CKD (defined as estimated GFR<20 ml/min per 1.73 m(2)) and again after ESRD (defined as need for hemodialysis or peritoneal dialysis).
A total of 190 participants (44% female, 66% black) had echocardiograms during advanced CKD and after ESRD. Mean (SD) estimated GFR at advanced CKD was 16.9 (3.5) ml/min per 1.73 m(2). Mean (SD) time between the advanced CKD echocardiogram and ESRD echocardiogram was 2.0 (1.0) years. There was no significant change in left ventricular mass index (62.3-59.5 g/m(2.7), P=0.10) between advanced CKD and ESRD; however, ejection fraction significantly decreased (53%-50%, P=0.002). Interactions for age, race, dialysis modality, and diabetes status were not significant (P>0.05).
Mean left ventricular mass index did not change significantly from advanced CKD to ESRD; however, ejection fraction declined during this transition period. Although left ventricular mass index is fixed by advanced stages of CKD, ejection fraction decline during more advanced stages of CKD may be an important contributor to cardiovascular disease and mortality after dialysis.
PDF
