Omar K. Khalique

Aortic annular sizing using a novel 3-dimensional echocardiographic method: use and comparison with cardiac computed tomography.

Background—Previous studies have shown cross-sectional 3-dimensional (3D) transesophageal echocardiographic (TEE) measurements to severely underestimate multidetector row computed tomographic (MDCT) measurements for the assessment of aortic annulus before transcatheter aortic valve replacement. This study compares annulus measurements from 3D-TEE using off-label use of commercially available software with MDCT measurements and assesses their ability to predict paravalvular regurgitation. Methods and Results—One hundred patients with severe, symptomatic aortic stenosis who had both contrast MDCT and 3D-TEE for annulus assessment before balloon-expandable transcatheter aortic valve replacement were analyzed. Annulus area, perimeter, and orthogonal maximum and minimum diameters were measured. Receiver operating characteristic analysis was performed with mild or greater paravalvular regurgitation as the classification variable. Three-dimensional TEE and MDCT cross-sectional perimeter and area measurements were strongly correlated (r=0.93–0.94; P<0.0001); however, the small differences (⩽1%) were statistically significant (P=0.0002 and 0.0074, respectively). Discriminatory ability for ≥ mild paravalvular regurgitation was good for both MDCT (area under the curve for perimeter and area cover index=0.715 and 0.709, respectively) and 3D-TEE (area under the curve for perimeter and area cover index=0.709 and 0.694, respectively). Differences in receiver operating characteristic analysis between MDCT and 3D-TEE perimeter and area cover indexes were not statistically significant (P=0.15 and 0.35, respectively). Conclusions—Annulus measurements using a new method for analyzing 3D-TEE images closely approximate those of MDCT. Annulus measurements from both modalities predict mild or greater paravalvular regurgitation with equivalent accuracy.

Quantity and location of aortic valve complex calcification predicts severity and location of paravalvular regurgitation and frequency of post-dilation after balloon-expandable transcatheter aortic valve replacement.

OBJECTIVES This study sought to determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR). BACKGROUND The impact of AVC in different locations within the aortic valve complex is incompletely understood. METHODS This study analyzed 150 patients with severe, symptomatic aortic stenosis who underwent TAVR. Total AVC volume scores were calculated from contrast-enhanced multidetector row computed tomography imaging. AVC was divided by leaflet sector and region (Leaflet, Annulus, left ventricular outflow tract [LVOT]), and a combination of LVOT and Annulus (AnnulusLVOT). Asymmetry was assessed. Receiver-operating characteristic analysis was performed with greater than or equal to mild PVR and PD as classification variables. Logistic regression was performed. RESULTS Quantity of and asymmetry of AVC for all regions of the aortic valve complex predicted greater than or equal to mild PVR by receiver-operating characteristic analysis (area under the curve = 0.635 to 0.689), except Leaflet asymmetry. Receiver-operating characteristic analysis for PD was significant for quantity and asymmetry of AVC in all regions, with higher area under the curve values than for PVR (area under the curve = 0.648 to 0.741). On multivariable analysis, Leaflet and AnnulusLVOT calcification were independent predictors of both PVR and PD regardless of multidetector row computed tomography area cover index. CONCLUSIONS Quantity and asymmetry of AVC in all regions of the aortic valve complex predict greater than or equal to mild PVR and performance of PD, with the exception of Leaflet asymmetry. Quantity of AnnulusLVOT and Leaflet calcification independently predict PVR and PD when taking into account multidetector row computed tomography area cover index.

Predicting paravalvular regurgitation following transcatheter valve replacement: utility of a novel method for three-dimensional echocardiographic measurements of the aortic annulus.

BACKGROUND Studies evaluating three-dimensional echocardiographic (3DE) annular sizing for balloon-expandable transcatheter aortic valve replacement (TAVR) are limited. In this study, a retrospective analysis of transesophageal echocardiographic images was performed to assess the feasibility of multiplanar measurements of annular dimensions by the novel off-label use of commercially available 3DE software and correlate annular sizing with severity of paravalvular regurgitation (PVR). METHODS Intraprocedural transesophageal echocardiography was performed in 58 patients undergoing TAVR for severe, symptomatic aortic stenosis. Off-label use of commercially available software was used to measure transesophageal 3DE volumes. Pre-TAVR annular linear dimensions included two-dimensional echocardiographic sagittal diameter and 3DE measurements of minimal diameter, maximal diameter (MaxDiam), and the average or mean diameter. Three-dimensional echocardiographic average annular diameter derived from annular perimeter (AveAnnDiamP) and average annular diameter derived from annular area (AveAnnDiamA) were calculated. A cover index was calculated using each measurement. Short-axis PVR color jet areas were summed after deployment and at the end of study. RESULTS Two-dimensional echocardiographic sagittal diameter was significantly smaller than 3DE MaxDiam (P < .0001) and AveAnnDiamP (P = .017), significantly larger than 3DE minimal diameter (P < .0001), and not significantly different from 3DE mean diameter (P = .36) and AveAnnDiamA (P = .38). There was a linear relationship between all 3DE annular measurements and immediate post-TAVR PVR area (P ≤ .0001), with the largest R(2) value (0.48) for 3DE MaxDiam, 3DE AveAnnDiamP, and 3DE AveAnnDiamA. The largest areas under the curve to detect greater than mild PVR were for 3DE AveAnnDiamP cover index (0.772) and 3DE AveAnnDiamA cover index (0.769). Intraclass correlation coefficients for interobserver and intraobserver variability were high for 3DE AveAnnDiamP and 3DE AveAnnDiamA and lower for 3DE MaxDiam. CONCLUSIONS Using a novel approach to 3DE annular measurements, 3DE AveAnnDiamP and 3DE AveAnnDiamA can be reliably measured and correlate best with post-TAVR PVR area. New sizing algorithms with 3DE measurements should be developed.

Aortic stenosis and coronary artery disease: What do we know? What don't we know? A comprehensive review of the literature with proposed treatment algorithms

Aortic valve stenosis is the most common form of valvular heart disease in the elderly population and occurs frequently in conjunction with coronary artery disease. The standard treatment option for patients with these two conditions has been surgical aortic valve replacement and coronary artery bypass grafting. The arrival of transcatheter aortic valve replacement has considerably shifted the treatment paradigms. Nevertheless, a lot of questions remain unanswered regarding the management of coronary artery disease in the setting of the transcatheter options for severe aortic stenosis. This article includes a comprehensive review of the literature and seeks to describe the actual knowledge on the topic of aortic stenosis and concomitant coronary artery disease.

Transcatheter Valve Implantation in Failed Surgically Inserted Bioprosthesis: Review and Practical Guide to Echocardiographic Imaging in Valve-in-Valve Procedures.

An increased use of bioprosthetic heart valves has stimulated an interest in possible transcatheter options for bioprosthetic valve failure given the high operative risk. The encouraging results of transcatheter aortic valve implantation in high-risk surgical candidates with native disease have led to the development of the transcatheter valve-in-valve (VIV) procedures for failed bioprostheses. VIV procedures are unique in many ways, and there is an increased need for multimodality imaging in a team-based approach. The echocardiographic approach to VIV procedures has not previously been described. In this review, we summarize key echocardiographic requirements for optimal patient selection, procedural guidance, and immediate post-procedural assessment for VIV procedures.

Impact of Coronary Artery Disease Severity Assessed With the SYNTAX Score on Outcomes Following Transcatheter Aortic Valve Replacement

Background The influence of coronary artery disease (CAD) on clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) is still controversial. We sought to evaluate the impact of CAD severity as measured by the SYNTAX score (SS) on patients undergoing TAVR. Methods and Results A total of 377 patients who underwent TAVR in 2 high‐volume centers in North America were included in our retrospective analysis. A blinded angiographic core laboratory calculated the SS on all available coronary angiograms with the use of quantitative coronary analysis. Patients were stratified into 4 groups: (1) no CAD (SS=0); (2) low SS (SS between 1 and 22); (3) intermediate SS (SS between 23 and 32); and (4) high SS (SS ≥33). Patients who had undergone percutaneous coronary intervention within 6 months prior to TAVR were separated into 2 categories based on their residual SS (<8 and ≥8). Patients with previous coronary artery bypass grafting (CABG) were divided into 2 groups: (1) low CABG SS and (2) high CABG SS. The primary end point was a composite of all‐cause mortality, myocardial infarction, and stroke. At 30 days and 1 year, both the presence and the severity of CAD had no impact on the rate of the combined primary end point and on all‐cause mortality, cardiovascular mortality, and myocardial infarction. Patients with less complete revascularization (residual SS ≥8 versus residual SS <8 and low CABG SS versus high CABG SS, had similar rates of the combined primary end point, all‐cause mortality, cardiovascular mortality, MI, and stroke, at both 30 days and 1 year. Conclusions In our core laboratory–validated study, neither the severity of CAD nor completeness of revascularization after percutaneous coronary intervention or CABG were associated with clinical outcomes after TAVR, at both 30 days and 1 year.

Association of Paravalvular Regurgitation With 1-Year Outcomes After Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve

Importance Moderate/severe and even mild paravalvular regurgitation (PVR) are associated with increased mortality following transcatheter aortic valve replacement (TAVR) with first and second generations of transcatheter valves. Objective To examine the incidence, evolution, and effect on 1-year outcomes of PVR following TAVR with a third-generation balloon-expandable transcatheter heart valve. Design, Setting, and Participants Prespecified analysis of PVR in the Placement of Aortic Transcatheter Valves (PARTNER) II SAPIEN 3 trial, conducted between October 1, 2013, and September 3, 2014. Multicenter, nonrandomized registry of 1661 patients at intermediate or high surgical risk undergoing TAVR with the SAPIEN 3. Patients with severe, symptomatic aortic stenosis and high/intermediate surgical risk were enrolled in the registry at 51 sites in the United States and Canada. Interventions Transcatheter aortic valve replacement with the SAPIEN 3 valve. Main Outcomes and Measures Paravalvular regurgitation was assessed in a core laboratory at 30 days and 1 year according to a 5-class scheme: 0, none or trace; 1, mild; 2, mild to moderate; 3, moderate; 4, moderate to severe; and 5, severe. We assessed the effect of PVR on 1-year mortality and heart failure rehospitalization. Results Among the 1661 included in the registry, 1592 received a SAPIEN 3 valve and had assessment of PVR. Of these patients, 55.7% had none-trace PVR, 32.6% had mild, 8.2% had mild to moderate, and 3.5% had at least moderate PVR at 30 days. At 1 year, 9.3% of patients had died and 14.2% had been rehospitalized. Only patients with at least moderate PVR had higher 1-year mortality (hazard ratio [HR], 2.40; 95% CI, 1.30-4.43; P = .005) and composite of mortality/rehospitalization (HR, 2.35; 95% CI, 1.52-3.62; P < .001). In a paired comparison including 1213 patients, 73% of the patients with at least moderate PVR at 30 days showed a reduction in PVR severity of at least 1 PVR class at 1 year. Conclusions and Relevance In this series of patients undergoing TAVR with the SAPIEN 3 valve, at least moderate PVR was rare but associated with increased risk of death and heart failure rehospitalization at 1 year. Even the upper range of the mild class in the 3-class grading scheme (ie, mild to moderate in the 5-class scheme) had no significant effect on short-term mortality or rehospitalization. Most patients with at least moderate PVR at 30 days showed a decrease of PVR severity grade at 1 year. Trial Registration clinicaltrials.gov Identifier: NCT01314313.

Impact of Methodologic Differences in Three-Dimensional Echocardiographic Measurements of the Aortic Annulus Compared with Computed Tomographic Angiography Before Transcatheter Aortic Valve Replacement

Background: Three‐dimensional (3D) echocardiographic (3DE) imaging is an alternative to multi–detector row computed tomography (MDCT) for aortic annular measurement before transcatheter aortic valve replacement (TAVR). A commonly used direct planimetry from a reconstructed short‐axis view has not been compared with semiautomated 3DE methods. Typically accepted optimal cutoffs for percent prosthesis‐area oversizing of the balloon‐expandable SAPIEN or SAPIEN XT valve to native annular size are approximately 5% to 15%. The aim of this study was to compare semiautomated and direct planimetric 3DE methods for aortic annular sizing with a gold standard of MDCT to determine predictive value for paravalvular regurgitation (PVR) and balloon postdilatation. Methods: In this retrospective analysis, aortic annular cross‐sectional area was measured from pre‐TAVR imaging using (1) MDCT (CT_Area), (2) a 3D transesophageal echocardiographic (TEE) semiautomated method (3DE_Area_SA), and (3) a 3D TEE direct planimetric method (3DE_Area_Direct). Annular area percent oversizing was calculated. PVR after TAVR was assessed from intraoperative TEE imaging. Need for balloon postdilatation was recorded. Results: One hundred patients who underwent TAVR with either the SAPIEN or SAPIEN XT balloon‐expandable prosthesis were analyzed. Twenty‐three patients had mild or greater PVR after TAVR. CT_Area was 442 ± 79 mm2, 3DE_Area_SA was 435 ± 81 mm2, and 3DE_Area_Direct was 429 ± 82 mm2. Both 3DE_Area_SA and 3DE_Area_Direct underestimated MDCT (P < .05). All methods were highly correlative (R = 0.88–0.93, P < .0001). Percent oversizing obtained by the three methods significantly predicted mild or greater PVR and need for balloon postdilatation by receiver operating characteristic analysis, with optimal cutoffs for CT_Area (9%–10%) and 3DE_Area_SA (14%) within the recommended ranges for the studied transcatheter valves and for 3DE_Area_Direct higher than the recommended range (18%–19%). Inter‐ and intraobserver reproducibility were lowest for 3DE_Area_Direct. Conclusions: Caution must be used when using 3D TEE direct planimetry of the aortic annulus, as optimal percent oversizing ranges approach the level associated with root injury, and measurements are less reproducible. Therefore, semiautomated 3DE planimetry is preferred to 3DE direct planimetry for aortic annulus sizing.

Transatrial implantation of a transcatheter heart valve for severe mitral annular calcification

Objective: To assess the outcomes of transatrial implantation of a transcatheter heart valve (THV) for the treatment of mitral valve disease with severe mitral annular calcification (MAC). Methods: Implantation of a balloon‐expandable THV was performed on cardiopulmonary bypass via left atrial exposure in patients considered at risk for left ventricular outflow tract obstruction. The anterior mitral valve leaflet was systematically resected and pledgeted sutures were placed to enhance stability and reduce paravalvular leak. Results: Twenty‐six consecutive symptomatic patients with severe MAC (mean age, 78 ± 7 years; 92% female; mean Society of Thoracic Surgeons score, 9.4 ± 4.8) were included at 6 different centers. Two patients (8%) received an Edwards Sapien XT (Edwards Lifesciences, Irvine, Calif), and 24 (92%) an Edwards Sapien 3 bioprosthesis (Edwards Lifesciences). Concomitant aortic valve replacement was performed in 11 patients. Technical success according to the criteria of the Mitral Valve Academic Research Consortium was achieved in all patients. The mean transmitral gradient decreased from 10 ± 5 to 4 ± 2 mm Hg (P < .001) with trace or mild regurgitation in all patients. An elevated mean transaortic gradient (30 mm Hg) was observed in 1 patient (4%). Five patients died during hospital stay (19%) and 2 additional between discharge and 30 days (30‐day mortality: 27%). Sustained functional improvement was observed in the remaining patients. Conclusions: Transatrial implantation of a THV for the treatment of MAC is associated with high technical success despite unfavorable anatomy. In this early experience of very high surgical risk patients, 30‐day all‐cause mortality was high. Patients at particular risk appear to be those with chronic kidney disease requiring multiple valve surgery.

Practical considerations for optimizing cardiac computed tomography protocols for comprehensive acquisition prior to transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) is performed frequently in patients with severe, symptomatic aortic stenosis who are at high risk or inoperable for open surgical aortic valve replacement. Computed tomography angiography (CTA) has become the gold standard imaging modality for pre-TAVR cardiac anatomic and vascular access assessment. Traditionally, cardiac CTA has been most frequently used for assessment of coronary artery stenosis, and scanning protocols have generally been tailored for this purpose. Pre-TAVR CTA has different goals than coronary CTA and the high prevalence of chronic kidney disease in the TAVR patient population creates a particular need to optimize protocols for a reduction in iodinated contrast volume. This document reviews details which allow the physician to tailor CTA examinations to maximize image quality and minimize harm, while factoring in multiple patient and scanner variables which must be considered in customizing a pre-TAVR protocol.