Abstract Background In EVEREST II (Endovascular Valve Edge-to-Edge Repair Study), treatment of mitral regurgitation (MR) with a novel percutaneous device showed superior safety compared with surgery, ...but less effective reduction in MR at 1 year. Objectives This study sought to evaluate the final 5-year clinical outcomes and durability of percutaneous mitral valve (MV) repair with the MitraClip device compared with conventional MV surgery. Methods Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the device or conventional MV surgery in a 2:1 ratio (178:80). Patients prospectively consented to 5 years of follow-up. Results At 5 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the as-treated population was 44.2% versus 64.3% in the percutaneous repair and surgical groups, respectively (p = 0.01). The difference was driven by increased rates of 3+ to 4+ MR (12.3% vs. 1.8%; p = 0.02) and surgery (27.9% vs. 8.9%; p = 0.003) with percutaneous repair. After percutaneous repair, 78% of surgeries occurred within the first 6 months. Beyond 6 months, rates of surgery and moderate-to-severe MR were comparable between groups. Five-year mortality rates were 20.8% and 26.8% (p = 0.4) for percutaneous repair and surgery, respectively. In multivariable analysis, treatment strategy was not associated with survival. Conclusions Patients treated with percutaneous repair more commonly required surgery for residual MR during the first year after treatment, but between 1- and 5-year follow-up, comparably low rates of surgery for MV dysfunction with either percutaneous or surgical therapy endorse the durability of MR reduction with both repair techniques. (EVEREST II Pivotal Study High Risk Registry; NCT00209274 )
Clinical guidelines recommend patients with aortic stenosis (AS) being considered for transcatheter aortic valve implantation or surgical aortic valve replacement to participate in shared ...decision-making (SDM) with a heart valve team (HVT). Data supporting these recommendations are limited. This project gathered data on feasibility and preliminary efficacy of a decision aid (DA) in decision-making for patients with severe AS deciding between transcatheter aortic valve implantation and surgical aortic valve replacement.
This institutional review board-approved randomized pilot trial assigned eligible patients to receive either the American College of Cardiology's DA for patients with AS or usual care. Patients were surveyed after their visit regarding knowledge, treatment-preference concordance, SDM (SDM process and CollaboRATE Scales), and decisional conflict. Patients were followed for 3 months to collect data on treatment received.
Of 62 patients approached, 59 (95%) consented and participated. The average age of participants was 72 years, they were 100% white, and 32% of them were female. Intervention patients had higher knowledge scores (75.6 vs 65.5) and more frequently reported CollaboRATE top scores (67% vs 33%) than usual care patients. No other group comparisons reached significance. Patients who saw both members of the HVT before survey completion reported higher SDM process scores than those who saw only 1 specialist (3.1 vs 2.4).
The study exceeded enrollment targets, indicating feasibility. Results suggest the American College of Cardiology's DA improved patient knowledge and communication scores. Patients who met with both members of the HVT reported higher SDM. These observations highlight the importance of SDM and multidisciplinary HVT assessment in the management of severe AS.
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•Use of a decision aid increased patient knowledge and improved communication.•Exposure to both heart valve team members led to greater shared decision-making.•Decision aids may be a way to support shared decision making for aortic valve replacement.
Abstract Background Paravalvular regurgitation (PVR) is an important predictor of mortality after transcatheter aortic valve replacement (TAVR). Aortic valve (AV) calcification is strongly associated ...with PVR. Objectives This study proposes a new metric to quantify AV total calcium burden and its composition in large calcium nodules (CNs) and explores its relation with PVR after TAVR. Methods In 133 patients that underwent TAVR, calcium burden of the AV was quantified with multidetector row CT as calcium mass. Each CN was characterized. The AV CN score (AVCNS) was defined as AV calcium mass × mass of the largest CN. PVR was assessed with echocardiography at 1 month. Logistic regression analysis was conducted to identify predictors of PVR. Results Mean age was 84.1 ± 7.6 years (56% women). TAVR access was transapical in 56%. Procedural success was achieved in 92%. In-hospital mortality was 5%. At follow-up, the prevalence of absent/trace, mild, moderate, and severe PVR was 58%, 31%, 11%, and 0%, respectively. The only independent predictors of at least mild PVR were AVCNS (odds ratio OR, 2.269; 95% CI, 1.433–3.593; P < .001), number of CNs on aortic annulus (OR, 1.822; 95% CI, 1.137–2.921; P = .013), and aortic annulus area (OR, 1.112; 95% CI, 1.010–1.223; P = .030). This model showed an area under the curve of 0.895 (95% CI, 0.830–0.960) for PVR prediction. Conclusions AVCNS, a variable that comprises the total burden of AV calcification as well as calcification agglomeration in form of large nodules, is a novel and powerful independent predictor of PVR after TAVR.
Objectives The aim of this study was to determine whether nitrogen-containing bisphosphonate (NCBP) therapy is associated with the prevalence of cardiovascular calcification. Background ...Cardiovascular calcification correlates with atherosclerotic disease burden. Experimental data suggest that NCBP might limit cardiovascular calcification, which has implications for disease prevention. Methods The relationship of NCBP use to the prevalence of aortic valve, aortic valve ring, mitral annulus, thoracic aorta, and coronary artery calcification (AVC, AVRC, MAC, TAC, and CAC, respectively) detected by computed tomography was assessed in 3,710 women within the MESA (Multi-Ethnic Study of Atherosclerosis) with regression modeling. Results Analyses were age-stratified, because of a significant interaction between age and NCBP use (interaction p values: AVC p < 0.0001; AVRC p < 0.0001; MAC p = 0.002; TAC p < 0.0001; CAC p = 0.046). After adjusting for age; body mass index; demographic data; diabetes; smoking; blood pressure; cholesterol levels; and statin, hormone replacement, and renin-angiotensin inhibitor therapy, NCBP use was associated with a lower prevalence of cardiovascular calcification in women ≥65 years of age (prevalence ratio: AVC 0.68 95% confidence interval (CI): 0.41 to 1.13; AVRC 0.65 95% CI: 0.51 to 0.84; MAC 0.54 95% CI: 0.33 to 0.93; TAC 0.69 95% CI: 0.54 to 0.88; CAC 0.89 95% CI: 0.78 to 1.02), whereas calcification was more prevalent in NCBP users among the 2,181 women <65 years of age (AVC 4.00 95% CI: 2.33 to 6.89; AVRC 1.92 95% CI: 1.42 to 2.61; MAC 2.35 95% CI: 1.12 to 4.84; TAC 2.17 95% CI: 1.49 to 3.15; CAC 1.23 95% CI: 0.97 to 1.57). Conclusions Among women in the diverse MESA cohort, NCBPs were associated with decreased prevalence of cardiovascular calcification in older subjects but more prevalent cardiovascular calcification in younger ones. Further study is warranted to clarify these age-dependent NCBP effects.
Objectives The aim of this study was to evaluate the relationship between percentage of predicted left ventricular mass (%PredLVM) and valve calcification in the MESA (Multi-Ethnic Study of ...Atherosclerosis) study. Background Cardiac valve calcification has been associated with left ventricular hypertrophy (LVH), which portends cardiovascular events. However, this relationship and its mediators are poorly understood. Methods The MESA study is a longitudinal cohort study of men and women 45 to 84 years of age without clinical cardiovascular disease in whom serial cardiac magnetic resonance and computed tomography imaging were performed. The relationships between baseline %PredLVM and the prevalence, severity, and incidence of aortic valve (AVC) and mitral annulus calcification (MAC) were determined by regression modeling. Results Prevalent AVC was observed in 630, and MAC was observed in 442 of 5,042 subjects (median 55.9 and 71.1 Agatston units, respectively). After adjustment for age, sex, body mass index (BMI), ethnicity, socioeconomic status, physical activity, diabetes, cholesterol levels, blood pressure, smoking, kidney function, serum lipids, and antihypertensive and statin medications, %PredLVM was associated with prevalent AVC (odds ratio OR: 1.18/SD increase in %PredLVM 95% confidence interval (CI): 1.08 to 1.30; p = 0.0004) and MAC (OR: 1.18 95% CI: 1.06 to 1.32; p = 0.002). Similarly, %PredLVM was associated with increased severity of prevalent AVC (risk difference = 0.26 95% CI: 0.15 to 0.38; p < 0.0001) and MAC (risk difference = 0.20 95% CI: 0.03 to 0.37; p = 0.02). During follow-up (mean 2.4 ± 0.9 years), 153 subjects (4%) developed AVC, and 198 (5%) developed MAC. The %PredLVM was associated with incident AVC (OR: 1.24 95% CI: 1.04 to 1.47; p = 0.02) and MAC (OR: 1.18 95% CI: 1.01 to 1.40; p = 0.04). Further adjustment for inflammatory markers and coronary artery calcification did not attenuate these associations. Specifically, concentric LVH most strongly predicted incident valve calcification. Conclusions Within the MESA cohort, LVH was associated with prevalence, severity, and incidence of valve calcification independent of hypertension and other identified confounders.
Abstract Background The C-arm used for fluoroscopy during transcatheter aortic valve replacement (TAVR) may also be used to acquire 3-dimensional data sets similar to multidetector row CT (MDCT). ...Objective The aim of this study was to evaluate the feasibility of C-arm CT (CACT) for aortic annulus and root (AoA/R) measurements in TAVR planning compared with MDCT. Methods Twenty patients who were studied for TAVR underwent MDCT and CACT. Two independent observers measured predicted perpendicular projection to annular plane, diameters of the aortic annulus, sinus of Valsalva, sinotubular junction and ascending aorta, distance of coronary ostia to annular plane, sinus of Valsalva height, and leaflet length. Correlation between MDCT and CACT and interobserver variability were analyzed. Results MDCT and CACT showed strong correlation for all the measurements of the AoA/R ( r ranging from 0.62 to 0.94; P between <.001 and .042) and also for the predicted perpendicular projection (left/right anterior oblique: r = 0.96, P = .002; cranial/caudal: r = 0.83, P = .043). Interobserver variability analysis showed disagreement for the measurements of the aortic annulus structures with CACT (intraclass correlation coefficient ICC, <0.25) but not for the rest of the variables (ICC between 0.47 and 0.97). MDCT showed no interobserver variability for all the measurements (ICC between 0.45 and 0.93). Conclusions CACT showed strong correlation with MDCT for the measurement of all AoA/R structures. However, CACT showed also important interobserver variability for the assessment of the aortic annulus. Therefore, valve sizing may not be reliably performed on the basis of CACT measurements alone.
Abstract Background The relationship of peak exercise oxygen consumption (VO2 ) to survival in black heart failure (HF) patients is not well established. We examined the effects of race on peak VO2 ...values and survival in HF patients with systolic dysfunction. Methods and Results This study evaluated consecutive ambulatory HF patients who underwent symptom-limited stress tests with breath-by-breath expired gas analyses using ramped treadmill protocols. The relationship between cardiopulmonary exercise parameters and patient transplant-free survival was assessed by race. This study included 580 HF patients (mean age 52 ± 12 years; 28% females; 22% blacks; mean left ventricular ejection fraction 26 ± 12%; mean body mass index 28.7 ± 5.4; 73% on β-blocker). Black patients had a significantly lower peak VO2 than white patients (14.2 ± 5.2 versus 16.4 ± 7.0; P < .0001), despite adjusting for identified covariates. However, there was no significant difference in the 1-year transplant-free survival between black and white HF patients (87% versus 85%; P = NS). Peak VO2 was significantly associated with survival in both racial groups. Conclusions Black HF patients had significantly lower peak VO2 , but yet had equivalent survival rates at 1 year. Further study is warranted to clarify the impact of these racial differences on the timing of cardiac transplantation black HF patients.
Reply Elmariah, Sammy, MD; Goldberg, Lee R., MD, MPH, FACC; Allen, Michael T., EMT-P ...
Journal of the American College of Cardiology,
2007, Letnik:
49, Številka:
3
Journal Article
PDF
