Diagnostic Value of Aortic Valve Calcification Levels in the Assessment of Low-Gradient Aortic Stenosis.

BACKGROUND: In patients with low-gradient aortic stenosis (AS) and low transvalvular flow, dobutamine stress echocardiography (DSE) is recommended to determine AS severity, whereas the degree of aortic valve calcification (AVC) supposedly correlates with AS severity according to current European and American guidelines. OBJECTIVES: The purpose of this study was to assess the relationship between AVC and AS severity as determined using echocardiography and DSE in patients with aortic valve area <1 cm2 and peak aortic valve velocity <4.0 m/s. METHODS: All patients underwent DSE to determine AS severity and multislice computed tomography to quantify AVC. Receiver-operating characteristics curve analysis was used to assess the diagnostic value of AVC for AS severity grading as determined using echocardiography and DSE in men and women. RESULTS: A total of 214 patients were included. Median age was 78 years (25th-75th percentile: 71-84 years) and 25% were women. Left ventricular ejection fraction was reduced (<50%) in 197 (92.1%) patients. Severe AS was diagnosed in 106 patients (49.5%). Moderate AS was diagnosed in 108 patients (50.5%; in 77 based on resting transthoracic echocardiography, in 31 confirmed using DSE). AVC score was high (≥2,000 for men or ≥1,200 for women) in 47 (44.3%) patients with severe AS and in 47 (43.5%) patients with moderate AS. AVC sensitivity was 44.3%, specificity was 56.5%, and positive and negative predictive values for severe AS were 50.0% and 50.8%, respectively. Area under the receiver-operating characteristics curve was 0.508 for men and 0.524 for women. CONCLUSIONS: Multi-slice computed tomography-derived AVC scores showed poor discrimination between grades of AS severity using DSE and cannot replace DSE in the diagnostic work-up of low-gradient severe AS.

Burden of Valvular Heart Diseases in Hispanic/Latino Individuals in the United States: The Echocardiographic Study of Latinos.

OBJECTIVE: To explore the burden and clinical correlates of valvular heart disease in Hispanics/Latinos in the United States. PATIENTS AND METHODS: A total of 1818 individuals from the population-based study of Latinos/Hispanics from 4 US metropolitan areas (Bronx, New York; Chicago, Illinois; San Diego, California; and Miami, Florida) underwent a comprehensive clinical and echocardiographic examination from October 1, 2011, through June 24, 2014. Logistic regression analysis was used to examine the associations of clinical and sociodemographic variables with valvular lesions. RESULTS: The mean age was 55.2±0.2 years; 57.4% were female. The prevalence of any valvular heart disease (AVHD) was 3.1%, with no considerable differences across sex, and a higher prevalence with increasing age. The proportion of US-born vs foreign-born individuals was similar in those with vs without AVHD (P=.31). The weighted prevalence of AVHD was highest in Central Americans (8.4%) and lowest in Mexicans (1.2%). Regurgitant lesions of moderate or greater severity were present in 2.4% of the population and stenotic lesions of moderate or greater severity in 0.2%. Compared with those without AVHD, individuals with AVHD were more likely to have health insurance coverage (59.6% vs 79.2%; P=.007) but similar income (P=.06) and educational status (P=.46). Univariate regression models revealed that regurgitant lesions were associated with lower body mass index whereas stenotic lesions were associated with higher body mass index. CONCLUSION: Our data provide the first population-based estimates of the prevalence of valvular heart disease in Hispanic/Latinos. Valvular heart disease is fairly common in the Hispanic/Latino population and may constitute an important public health problem.

Comparison between Three-Dimensional Echocardiography and Computed Tomography for Comprehensive Tricuspid Annulus and Valve Assessment in Severe Tricuspid Regurgitation: Implications for Tricuspid Regurgitation Grading and Transcatheter Therapies.

BACKGROUND: Tricuspid valve imaging is frequently challenging and requires the use of multiple modalities. Knowledge of limitations and methodologic discrepancies among different imaging techniques is crucial for planning transcatheter valve interventions. METHODS: Thirty-eight patients with severe symptomatic tricuspid regurgitation were included in this retrospective analysis. Tricuspid annulus (TA) measurements were made during mid-diastole using three-dimensional (3D) transthoracic echocardiographic direct planimetry (TTE_direct) and transesophageal echocardiographic direct planimetry (TEE_direct). Moreover, a semiautomated software was used to generate two-dimensional (2D) and 3D perimeter and area on transesophageal echocardiography (TEE) images. Both methods were compared with direct computed tomographic planimetry (CT_direct) and cubic spline interpolation (CT_indirect). The different TA values were used to calculate the effective regurgitant orifice area and compared with 3D Doppler vena contracta area. For tricuspid valve area TEE_direct and CT_direct as well as CT_indirect were measured. RESULTS: Agreement between TEE and computed tomography (CT) for TA sizing was obtained using semiautomated methods (3D TEE_indirect and CT_indirect). TTE_direct was overall less reliable compared with CT. TA area quantified by TEE_direct was 25% (difference 305 ± 238 mm2, P < .001, R = 0.9) and 19% (166 ± 247 mm2, P < .001, R = 0.89) smaller compared with CT_direct and CT_indirect, respectively. TA perimeter measurements by TEE_direct differed by 11% compared with CT_direct (12 ± 11 mm, P < .001, R = 0.87) and 3D CT_indirect (12 ± 11 mm, P < .001, R = 0.88), and 9% compared with 2D CT_indirect (7 ± 11 mm, P = .002, R = 0.87). TEE_direct of the TA allows the most accurate calculation of effective regurgitant orifice area compared with 3D vena contracta area (-8 ± 62 mm2, P = .50, R = 0.85). Tricuspid valve area by CT_indirect best correlated with conventional TEE_direct (80 ± 250 mm2, P = .11, R = 0.80). CONCLUSIONS: In patients with severe tricuspid regurgitation, semiautomated indirect planimetry results in high agreement between TEE and CT for TA sizing and measurement of the tricuspid valve area. TEE_direct of the TA allows the most accurate measurement of diastolic stroke volume for the calculation of regurgitation severity compared with 3D vena contracta area.

Sex-Specific Outcomes of Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve: Insights From the PARTNER II S3 High-Risk and Intermediate-Risk Cohorts.

OBJECTIVES: The purpose of this study was to identify sex-specific outcomes of intermediate risk patients undergoing transcatheter aortic valve replacement with the SAPIEN 3 valve. BACKGROUND: A survival difference has been observed in women as compared with men in inoperable and high-risk patients receiving early-generation balloon-expandable valves for transcatheter aortic valve replacement (TAVR). Whether a sex-specific outcome difference persists with newer-generation valves and in lower-risk patients is unknown. METHODS: The PARTNER (Placement of Aortic Transcatheter Valves) II S3 trial included high-risk (HR) (Society of Thoracic Surgeons risk score >8% or heart team determination) and intermediate-risk (IR) (Society of Thoracic Surgeons risk score 4% to 8% or heart team determination) patients with severe symptomatic aortic stenosis who were treated with TAVR with the SAPIEN 3 valve. Patient characteristics and clinical outcomes at 30 days and 1 year were compared by sex. RESULTS: Between October 2013 and December 2014, 1,661 patients were enrolled: 583 were HR (338 men, 245 women) and 1,078 were IR (666 men, 412 women). In both cohorts, women were more likely than men to be frail (22% vs. 13%; p < 0.001), but less likely to have comorbid conditions of renal insufficiency, coronary artery disease, atrial fibrillation, or chronic obstructive pulmonary disease. Women were more likely to receive ≤23-mm valves (74.1% vs. 11.1%; p < 0.001) and were less likely to receive 29-mm valves (1.4% vs. 35.1%; p < 0.001). In the combined cohorts, there was no difference in mortality for women compared with men at 30 days (2.0% vs. 1.2%; p = 0.20) or 1 year (9.3% vs. 10.2%; p = 0.59). There were no differences in disabling stroke or any stroke at 30 days or 1 year; however, women had an increased rate of minor stroke at 30 days (2.1% vs. 0.7%; p = 0.01). Female sex was associated with increased major vascular complications (7.9% vs. 4.4%; p = 0.003), but not with moderate or severe paravalvular regurgitation. Notably, similar outcomes regarding sex-specific outcomes were obtained within stratified analyses of the HR and IR cohorts. CONCLUSIONS: The study found no apparent sex-specific differences in survival or stroke in this trial of TAVR. This may reflect the changing demographic of patients enrolled, use of newer-generation valves with more sizes available, and more accurate valve sizing techniques.

Very low intravenous contrast volume protocol for computed tomography angiography providing comprehensive cardiac and vascular assessment prior to transcatheter aortic valve replacement in patients with chronic kidney disease.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a lifesaving procedure for many patients high risk for surgical aortic valve replacement. The prevalence of chronic kidney disease (CKD) is high in this population, and thus a very low contrast volume (VLCV) computed tomography angiography (CTA) protocol providing comprehensive cardiac and vascular imaging would be valuable. METHODS: 52 patients with severe, symptomatic aortic valve disease, undergoing pre-TAVR CTA assessment from 2013-4 at Columbia University Medical Center were studied, including all 26 patients with CKD (eGFR<30 mL/min) who underwent a novel VLCV protocol (20 mL of iohexol at 2.5 mL/s), and 26 standard-contrast-volume (SCV) protocol patients. Using a 320-slice volumetric scanner, the protocol included ECG-gated volume scanning of the aortic root followed by medium-pitch helical vascular scanning through the femoral arteries. Two experienced cardiologists performed aortic annulus and root measurements. Vascular image quality was assessed by two radiologists using a 4-point scale. RESULTS: VLCV patients had mean (±SD) age 86 ± 6.5, BMI 23.9 ± 3.4 kg/m(2) with 54% men; SCV patients age 83 ± 8.8, BMI 28.7 ± 5.3 kg/m(2), 65% men. There was excellent intra- and inter-observer agreement for annular and root measurements, and excellent agreement with 3D-transesophageal echocardiographic measurements. Both radiologists found diagnostic-quality vascular imaging in 96% of VLCV and 100% of SCV cases, with excellent inter-observer agreement. CONCLUSIONS: This study is the first of its kind to report the feasibility and reproducibility of measurements for a VLCV protocol for comprehensive pre-TAVR CTA. There was excellent agreement of cardiac measurements and almost all studies were diagnostic quality for vascular access assessment.

Improving the accuracy of effective orifice area assessment after transcatheter aortic valve replacement: validation of left ventricular outflow tract diameter and pulsed-wave Doppler location and impact of three-dimensional measurements.

BACKGROUND: Echocardiographic calculation of effective orifice area (EOA) after transcatheter aortic valve replacement is integral to the assessment of transcatheter heart valve (THV) function. The aim of this study was to determine the most accurate method for calculating the EOA of the Edwards SAPIEN and SAPIEN XT THVs. METHODS: One hundred intraprocedural transesophageal echocardiograms were analyzed. To calculate the post-transcatheter aortic valve replacement left ventricular outflow tract (LVOT) stroke volume (SV), four diameters were measured using two-dimensional echocardiography: (1) baseline LVOT diameter (LVOTd_PRE), (2) postimplantation LVOT diameter, (3) native aortic annular diameter, and (4) THV in-stent diameter. Four corresponding areas were planimetered by three-dimensional echocardiography. Two LVOT velocity-time integrals (VTI) were measured with the pulsed-wave Doppler sample volume at (1) the proximal (apical) edge of the valve stent or (2) within the valve stent at the level of the THV cusps. LVOT velocity-time integral with the sample volume at the proximal edge of the valve stent was used with the LVOT and aortic annular measurements above, whereas in-stent VTI was paired with the in-stent THV diameter to yield eight different SVs. Right ventricular outflow tract (RVOT) SV was calculated using RVOT diameter and RVOT VTI and was used as the primary comparator. Transaortic VTI was obtained by continuous-wave Doppler, and EOA calculations using each SV measurement were compared with (1) EOA calculated using RVOTSV and (2) planimetered aortic valve area using three-dimensional echocardiography (AVAplanimetry3D). RESULTS: Post-transcatheter aortic valve replacement EOA calculated using LVOTd_PRE was not significantly different from EOA calculated using RVOTSV (1.88 ± 0.33 vs 1.86 ± 0.39 cm(2), P = .36) or from AVAplanimetry3D (1.85 ± 0.28, P = .38, n = 34). All other two-dimensional EOA calculations were statistically larger than EOA calculated using RVOTSV. All three-dimensional echocardiography-based EOA calculations were statistically different from AVAplanimetry3D. CONCLUSIONS: The most accurate EOA after implantation of a balloon-expandable THV is calculated using preimplantation LVOT diameter and VTI.

Transcatheter mitral valve replacement: design implications, potential pitfalls and outcomes assessment.

Transcatheter mitral valve replacement (TMVR) is an emerging new treatment option in patients with advanced mitral valve disease deemed a high or prohibitive risk for surgery. Designing an ideal TMVR device requires a detailed understanding of different mitral valve pathologies and the complex, dynamic anatomy and physiology of the mitral apparatus. This review aims to critically evaluate design implications in TMVR in the context of mitral valve disease, imaging prerequisites, procedural approaches, potential complications, and outcomes assessment.

Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial.

BACKGROUND: In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR. METHODS AND RESULTS: Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve (PARTNER) I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79 619±40 570 ($50 891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia, and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12 475 per patient in initial hospital costs and 2.4 days of hospitalization. CONCLUSIONS: In the PARTNER trial, periprocedural complications were frequent, costly, and accounted for ≈25% of non-implant-related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical implications.

Surgical aortic valve replacement (SAVR) is currently the standard of care to treat patients with severe symptomatic aortic stenosis (AS) and is generally accepted to alleviate symptoms and prolong survival. Based on the results of randomized trials, transcatheter aortic valve implantation (TAVI) is the new standard of care for patients with symptomatic AS who are deemed 'inoperable'. Debatably, TAVI is also an alternative to SAVR in selected patients who are at high risk but operable. As we approach 10 years of clinical experience with TAVI, with over 50 000 implantations in 40 countries, a review of the current literature and clinical outcomes with this rapidly evolving technology is appropriate.

Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).

BACKGROUND: In patients with severe aortic stenosis who cannot have surgery, transcatheter aortic valve replacement (TAVR) has been shown to improve survival and quality of life compared with standard therapy, but the costs and cost-effectiveness of this strategy are not yet known. METHODS AND RESULTS: The PARTNER trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgery to TAVR (n=179) or standard therapy (n=179). Empirical data regarding survival, quality of life, medical resource use, and hospital costs were collected during the trial and used to project life expectancy, quality-adjusted life expectancy, and lifetime medical care costs to estimate the incremental cost-effectiveness of TAVR from a US perspective. For patients treated with TAVR, mean costs for the initial procedure and hospitalization were $42 806 and $78 542, respectively. Follow-up costs through 12 months were lower with TAVR ($29 289 versus $53 621) because of reduced hospitalization rates, but cumulative 1-year costs remained higher ($106 076 versus $53 621). We projected that over a patient's lifetime, TAVR would increase discounted life expectancy by 1.6 years (1.3 quality-adjusted life-years) at an incremental cost of $79 837. The incremental cost-effectiveness ratio for TAVR was thus estimated at $50 200 per year of life gained or $61 889 per quality-adjusted life-year gained. These results were stable across a broad range of uncertainty and sensitivity analyses. CONCLUSIONS: For patients with severe aortic stenosis who are not candidates for surgery, TAVR increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.