1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study.

BACKGROUND: A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy. OBJECTIVES: The aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk. METHODS: This prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory. RESULTS: A total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg). CONCLUSIONS: The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363).

Interchangeability of transthoracic and transesophageal echocardiographic right heart measurements in the perioperative setting and correlation with hemodynamic parameters.

Reduction of right ventricular (RV) function after cardiac surgery has been shown to impact outcomes. Conventional indices for right ventricular dysfunction are validated using transthoracic echocardiogram (TTE) which has limited use compared to transesophageal echocardiogram (TEE) in the perioperative settings. The aim of this study was to assess the agreement of RV systolic function assessment with TEE compared to TTE and assess the association of echocardiographic parameter with hemodynamic indices of RV dysfunction. This was a single center prospective observational study in an academic institution. Fifty adult patients undergoing elective cardiac surgery were included. TTE, TEE and stroke volume measurements pre-cardiopulmonary bypass (CPB) and post-CPB were performed. The variables of interest were anatomical M-mode tricuspid annular plane systolic excursion (AMM-TAPSE), fractional area change (FAC), tricuspid annular velocity (S') and myocardial performance index (MPI). FAC and AMM-TAPSE measured at the mid-esophageal 4 chamber view had substantial agreement with the TTE acquired parameters (Lin's concordance correlation coefficient (CCC) = 0.76, 95%CI 0.59-0.86 and CCC = 0.85, 95%CI 0.76-0.91). S' was significantly underestimated by TEE (CCC = 0.07, 95%CI 0.04-0.19) and MPI showed moderate agreement (CCC = 0.45 95%CI 0.19-0.65). Despite the significant changes in echocardiographic parameters, there were no corresponding changes in stroke volume (SV) or pulmonary artery pulsatility index at the post-CPB period. TEE acquired FAC and AMM-TAPSE had substantial agreement with pre-operative TTE values and no significant differences between the pre-CPB and post-CPB period. Systolic RV echocardiographic parameters decreased post-CPB but this was not accompanied by significant hemodynamic changes.

The multidisciplinary management of a mechanical mitral valve thrombosis in pregnancy: a case report and review of the literature.

Background: The management of anticoagulation for mechanical heart valves during pregnancy poses a unique challenge. Mechanical valve thrombosis is a devastating complication for which surgery is often the treatment of choice. However, cardiac surgery for prosthetic valve dysfunction in pregnant patients confers a high risk of maternofetal morbidity and mortality. Case summary: A 39-year-old woman in her first pregnancy at 30 weeks gestation presented to hospital with a mechanical mitral valve thrombosis despite therapeutic anticoagulation with low-molecular-weight heparin. She underwent an emergent caesarean section followed immediately by a bioprosthetic mitral valve replacement. This occurred after careful planning and organization on the part of a large multidisciplinary team. Discussion: A proactive, rather than reactive, approach to the surgical management of a mechanical valve thrombosis in pregnancy will maximize the chances of successful maternal and fetal outcomes.

Optimal Fluoroscopic Projections of Coronary Ostia and Bifurcations Defined by Computed Tomographic Coronary Angiography.

OBJECTIVES: The aim of this study was to define the optimal fluoroscopic viewing angles of both coronary ostia and important coronary bifurcations by using 3-dimensional multislice computed tomographic data. BACKGROUND: Optimal fluoroscopic projections are crucial for coronary imaging and interventions. Historically, coronary fluoroscopic viewing angles were derived empirically from experienced operators. METHODS: In this analysis, 100 consecutive patients who underwent computed tomographic coronary angiography (CTCA) for suspected coronary artery disease were studied. A CTCA-based method is described to define optimal viewing angles of both coronary ostia and important coronary bifurcations to guide percutaneous coronary interventions. RESULTS: The average optimal viewing angle for ostial left main stenting was left anterior oblique (LAO) 37°, cranial (CRA) 22° (95% confidence interval [CI]: LAO 33° to 40°, CRA 19° to 25°) and for ostial right coronary stenting was LAO 79°, CRA 41° (95% CI: LAO 74° to 84°, CRA 37° to 45°). Estimated mean optimal viewing angles for bifurcation stenting were as follows: left main: LAO 0°, caudal (CAU) 49° (95% CI: right anterior oblique [RAO] 8° to LAO 8°, CAU 43° to 54°); left anterior descending with first diagonal branch: LAO 11°, CRA 71° (95% CI: RAO 6° to LAO 27°, CRA 66° to 77°); left circumflex bifurcation with first marginal branch: LAO 24°, CAU 33° (95% CI: LAO 15° to 33°, CAU 25° to 41°); and posterior descending artery and posterolateral branch: LAO 44°, CRA 34° (95% CI: LAO 35° to 52°, CRA 27° to 41°). CONCLUSIONS: CTCA can suggest optimal fluoroscopic viewing angles of coronary artery ostia and bifurcations. As the frequency of use of diagnostic CTCA increases in the future, it has the potential to provide additional information for planning and guiding percutaneous coronary intervention procedures.

Predictors of Outcomes Following Transcatheter Edge-to-Edge Mitral Valve Repair.

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice.

A Case of TAVR Complicated by Severe Functional Mitral Regurgitation.

Mitral regurgitation (MR) is a known complication of transcatheter aortic valve replacement (TAVR). We report a case of a 90-year-old man with severe symptomatic aortic stenosis who underwent elective TAVR. The procedure was complicated by severe functional MR from left ventricular stunning and dilatation caused by hypotension throughout the procedure. An Impella CP (Abiomed, Inc, Danvers, MA) was inserted to unload the left ventricle and decrease its size with subsequent improvement in MR severity, which was sustained after Impella CP removal. In conclusion, we present the first case of successful management of post-TAVR severe functional MR with an Impella CP.

Recursive multiresolution convolutional neural networks for 3D aortic valve annulus planimetry.

PURPOSE: Transcatheter aortic valve replacement (TAVR) is the standard of care in a large population of patients with severe symptomatic aortic valve stenosis. The sizing of TAVR devices is done from ECG-gated CT angiographic image volumes. The most crucial step of the analysis is the determination of the aortic valve annular plane. In this paper, we present a fully tridimensional recursive multiresolution convolutional neural network (CNN) to infer the location and orientation of the aortic valve annular plane. METHODS: We manually labeled 1007 ECG-gated CT volumes from 94 patients with severe degenerative aortic valve stenosis. The algorithm was implemented and trained using the TensorFlow framework (Google LLC, USA). We performed K-fold cross-validation with K = 9 groups such that CT volumes from a given patient are assigned to only one group. RESULTS: We achieved an average out-of-plane localization error of (0.7 ± 0.6) mm for the training dataset and of (0.9 ± 0.8) mm for the evaluation dataset, which is on par with other published methods and clinically insignificant. The angular orientation error was (3.9 ± 2.3)° for the training dataset and (6.4 ± 4.0)° for the evaluation dataset. For the evaluation dataset, 84.6% of evaluation image volumes had a better than 10° angular error, which is similar to expert-level accuracy. When measured in the inferred annular plane, the relative measurement error was (4.73 ± 5.32)% for the annular area and (2.46 ± 2.94)% for the annular perimeter. CONCLUSIONS: The proposed algorithm is the first application of CNN to aortic valve planimetry and achieves an accuracy on par with proposed automated methods for localization and approaches an expert-level accuracy for orientation. The method relies on no heuristic specific to the aortic valve and may be generalizable to other anatomical features.

Optimal fluoroscopic viewing angles of right-sided heart structures in patients with tricuspid regurgitation based on multislice computed tomography.

AIMS: This study sought to analyse multislice computed tomography (MSCT) data of patients with tricuspid regurgitation and to report the variability of fluoroscopic viewing angles for several right-sided heart structures, as well as chamber views of the right heart in order to determine the optimal fluoroscopic viewing angles of six right-sided heart structures and right-heart chamber views. METHODS AND RESULTS: The MSCT data of 44 patients with mild to severe tricuspid regurgitation (TR) were retrospectively analysed. For each patient, we determined the optimal fluoroscopic viewing angles of the annulus/orifice en face view of the tricuspid valve, atrial septum, superior vena cava (SVC), inferior vena cava (IVC), coronary sinus (CS) and pulmonary valve. In this TR patient cohort, the average fluoroscopic viewing angle for the en face view of the tricuspid valve annulus was LAO 54-CAUD 15; RAO 10-CAUD 66 for the SVC orifice; LAO 27-CRA 59 for the IVC orifice; RAO 28-CRA 19 for the CS orifice; RAO 33-CAUD 33 for the atrial septum and LAO 13-CAUD 52 for the pulmonary valve annulus. The average viewing angle for right-heart chamber views was LAO 55-CAUD 15 for the one-chamber view; RAO 59-CAUD 54 for the two-chamber view; RAO 27-CRA 19 for the three-chamber view and LAO 5-CRA 60 for the four-chamber view. CONCLUSIONS: MSCT can provide patient-specific fluoroscopic viewing angles of right-sided heart structures. This information may facilitate transcatheter right-heart interventions.

Fluoroscopic Anatomy of Right-Sided Heart Structures for Transcatheter Interventions.

Performing transcatheter tricuspid valve interventions requires a thorough knowledge of right-heart imaging. Integration of chamber views across the spectrum of imaging modalities (i.e., multislice computed tomography, fluoroscopy, and echocardiography) can facilitate transcatheter interventions on the right heart. Optimal fluoroscopic viewing angles for guiding interventional procedures can be obtained using pre-procedural multislice computed tomography scans. The present paper describes fluoroscopic viewing angles necessary to appreciate right-heart chamber anatomy and their relationship to echocardiography using multislice computed tomography.

Transcatheter Mitral Valve Implantation Using the HighLife System.

OBJECTIVES: This study is the first report of 2 cases of HighLife (HighLife, Paris, France) implantation in humans. BACKGROUND: Transcatheter mitral valve implantation represents a promising approach to treating mitral regurgitation in patients at increased risk of perioperative mortality. The HighLife transcatheter mitral valve is a 2-component system. The valve is implanted in the mitral position and is anchored by interacting and then reaching an equilibrium position with a previously positioned subannular implant. METHODS: The procedures were successfully performed in a 69-year-old man and a 65-year-old woman with severe functional mitral regurgitation. Both patients were in New York Heart Association functional class IV heart failure with depressed left ventricular ejection fraction and additional comorbidities. RESULTS: The valve was implanted uneventfully in both patients. General anesthesia was used. The subannular implant was deployed through the transfemoral access, whereas the transcatheter mitral valve was released using the transapical access. Patients maintained hemodynamically stable. There were no intraoperative complications. Acutely, post-procedural echocardiograms demonstrated excellent prosthetic valve function with a low transvalvular gradient and no paravalvular leak and left ventricular outflow tract obstruction. Both patients had mild intraprosthetic regurgitation. Patient #1 survived at 5-months follow-up in New York Heart Association functional class II with excellent prosthesis performance. Patient #2 expired 4 days after a technically successful procedure, because the left ventricle did not tolerate the reduction of mitral regurgitation and despite a high dose of inotropic agents the left ventricular function rapidly deteriorated. CONCLUSIONS: Transcatheter mitral valve implantation using the 2-component HighLife system is technically feasible and can be performed safely. Early hemodynamic performance of the prosthesis was excellent.

Optimal fluoroscopic viewing angles of left-sided heart structures in patients with aortic stenosis and mitral regurgitation based on multislice computed tomography.

BACKGROUND: Transcatheter interventions are currently undertaken using "generic" fluoroscopic viewing angles. However, the position and orientation of heart structures may vary across patients and disease-specific remodeling processes. OBJECTIVE: This study uses multislice computed tomography to determine optimal fluoroscopic viewing angles of the aortic and mitral annuli, the left atrial appendage and the atrial septum. We explored differences between patients with severe aortic stenosis (AS) and severe mitral regurgitation (MR). METHODS AND RESULTS: The multislice computed tomographies of 28 patients with severe aortic stenosis (AS) and 32 patients with severe functional mitral regurgitation (MR) were analyzed. For each patient, we evaluated the optimal fluoroscopic viewing angles of the aortic and mitral annuli (en face, maximal and minimal diameters, aortic root with right, left and non coronary sinus in center), left atrial appendage orifice (en face, maximal and minimal diameters), and atrial septum (fossa ovalis) en face. The TAVR implantation view with right coronary sinus in center was LAO 9 - CRA 0 in the AS group and LAO 6 - CAU 5 in the MR group (p = NS). AS and MR patients differed significantly with respect to the fluoroscopic angulation of the aortic annulus en face (8.3°), the aortic annulus maximal (17.7°) and minimal (18.5°) diameters, the mitral annulus aorto-mural diameter (11.3°), and the left atrial appendage orifice en face (11.1°) (all p-values<0.05). CONCLUSION: Optimal fluoroscopic viewing angles of left-sided structures vary considerably between patients. Multislice computed tomography is a valuable tool to determine the most procedurally relevant angulations, with the potential to optimize procedural safety, efficacy and duration.

Three-dimensional echocardiography vs. computed tomography for transcatheter aortic valve replacement sizing.

AIMS: The accuracy of transcatheter aortic valve replacement (TAVR) sizing using three-dimensional transoesophageal echocardiography (3D-TEE) compared with the gold-standard multi-slice computed tomography (MSCT) remains unclear. We compare aortic annulus measurements assessed using these two imaging modalities. METHODS AND RESULTS: We performed a single-centre prospective cohort study, including 53 consecutive patients undergoing TAVR, who had both MSCT and 3D-TEE for aortic annulus sizing. Aortic annular dimensions, expected transcatheter heart valve (THV) oversizing, and hypothetical valve size selection based on CT and TEE were compared. 3D-TEE and CT cross-sectional mean diameter (r = 0.69), perimeter (r = 0.70), and area (r = 0.67) were moderately to highly correlated (all P-values <0.0001). 3D-TEE-derived measurements were significantly smaller compared with MSCT: perimeter (68.6 ± 5.9 vs. 75.1 ± 5.7 mm, respectively; P < 0.0001); area (345.6 ± 64.5 vs. 426.9 ± 68.9 mm(2), respectively; P < 0.0001). The percentage difference between 3D-TEE and MSCT measurements was around 9%. Agreement between MSCT- and 3D-TEE-based THV sizing (perimeter) occurred in 44% of patients. Using the 3D-TEE perimeter annular measurements, up to 50% of patients would have received an inappropriate valve size according to manufacturer-recommended, area-derived sizing algorithms. CONCLUSION: Aortic annulus measurements for pre-procedural TAVR assessment by 3D-TEE are significantly smaller than MSCT. In this study, such discrepancy would have resulted in up to 50% of all patients receiving the wrong THV size. 3D-TEE should be used for TAVR sizing, only when MSCT is not available or contraindicated. The clinical impact of this information requires further study.

North American single-center experience with a sutureless aortic bioprosthesis.

OBJECTIVE: Surgical sutureless aortic valves have the potential for shorter procedural times and could benefit patients with increased risk. The Enable (Medtronic Inc, Minneapolis, Minn) valve is a bioprosthesis housed in a Nitinol cage allowing folding and deployment once implanted. We aimed to evaluate the early clinical and echocardiographic results with the Enable valve. METHODS: Patients with aortic stenosis, Society of Thoracic Surgeons score greater than 5.0%, the need for combined procedures, and frailty were considered for Enable implantation. RESULTS: Between August 2012 and October 2014, 63 patients underwent implantation of the Enable valve (Medtronic Inc, Minneapolis, Minn). Thirty patients underwent isolated aortic valve replacement. Combined procedures were aortic valve replacement/coronary artery bypass grafting (26), aortic valve replacement/mitral valve repair (2), aortic valve replacement/mitral valve repair/coronary artery bypass grafting (2), and aortic valve replacement/ascending aortic graft (3). Predicted Society of Thoracic Surgeons score was 8.06 ± 7.73 (0.94-41.30). Implant success was 100%. Mean crossclamp time for isolated aortic valve replacement was 44 ± 14 minutes (30-91). Thirty-day mortality was 1.6% (1/63), and late mortality was 3.2% (2/62). No mortality was valve related. Intraoperative need for revision was 6.3% (4/63). Early migration requiring reoperation occurred in 1.6% of patients (1/63). Postoperative indexed aortic valve area was 1.08 ± 0.22 cm(2)/m(2), and peak and mean gradients were 17 ± 7 mm Hg and 9 ± 4 mm Hg, respectively. The rate of complications was as follows: pacemaker 3.1% (2/63), transient ischemic attack 1.6% (1/63), other thromboembolic events 0%, bleeding 0%, and endocarditis 0%. Mean follow-up was 10 ± 8 months. At latest follow-up, 61 patients were in New York Heart Association class I. Moderate or severe aortic regurgitation did not develop in any patients in the follow-up period. CONCLUSIONS: The Enable bioprosthesis is an acceptable alternative to conventional aortic valve replacement in higher-risk patients. The early hemodynamic performance seems favorable.

Quantitative multi-slice computed tomography assessment of the mitral valvular complex for transcatheter mitral valve interventions part 1: systematic measurement methodology and inter-observer variability.

AIMS: Transcatheter mitral valve replacement (TMVR) is an emerging technology with the potential to treat patients with severe mitral regurgitation at excessive risk for surgical mitral valve surgery. Multimodality imaging of the mitral valvular complex and surrounding structures will be an important component for patient selection for TMVR. Our aim was to describe and evaluate a systematic multi-slice computed tomography (MSCT) image analysis methodology that provides measurements relevant for transcatheter mitral valve replacement. METHODS AND RESULTS: A systematic step-by-step measurement methodology is described for structures of the mitral valvular complex including: the mitral valve annulus, left ventricle, left atrium, papillary muscles and left ventricular outflow tract. To evaluate reproducibility, two observers applied this methodology to a retrospective series of 49 cardiac MSCT scans in patients with heart failure and significant mitral regurgitation. For each of 25 geometrical metrics, we evaluated inter-observer difference and intra-class correlation. The inter-observer difference was below 10% and the intra-class correlation was above 0.81 for measurements of critical importance in the sizing of TMVR devices: the mitral valve annulus diameters, area, perimeter, the inter-trigone distance, and the aorto-mitral angle. CONCLUSIONS: MSCT can provide measurements that are important for patient selection and sizing of TMVR devices. These measurements have excellent inter-observer reproducibility in patients with functional mitral regurgitation.

A Systematic Review and Meta-Analysis of Outcomes Following Mitral Valve Surgery in Patients with Significant Functional Mitral Regurgitation and Left Ventricular Dysfunction.

BACKGROUND AND AIM OF THE STUDY: The surgical correction of functional mitral regurgitation (MR) remains challenging and controversial. The study aim was to systematically review the outcomes of surgical mitral valve repair (MVRpr) and mitral valve replacement (MVR) in patients with significant functional MR and left ventricular (LV) dysfunction. METHODS: A meta-analysis was performed of published data acquired from patients with moderate to severe functional MR and LV ejection fraction (LVEF) <40% who underwent surgical MVRpr or MVR. The data were meta-analyzed across studies using Bayesian hierarchical models when feasible. RESULTS: The search yielded 36 observational studies. The pooled proportion of operative mortality following MVRpr was 5% (33 studies; 2,231 patients; 95% credible interval (CrI) 4-7%), while that following MVR was 10% (10 studies; 389 patients; 95% CrI 5-18%). For patients undergoing MVRpr, pooled proportions of postoperative cerebrovascular accidents and renal failure were 2% (11 studies; 750 patients; 95% CrI 1-3%) and 9% (11 studies; 756 patients; 95% CrI 5-16%), respectively. The five-year actuarial survival rates following MVRpr across 12 studies ranged from 47% to 78% (median 66%). CONCLUSIONS: In selected patients with significant functional MR and LV dysfunction, surgical MVRpr and MVR can be performed with acceptable intermediate operative mortality risks.

Computed Tomography for Structural Heart Disease and Interventions.

Transcatheter cardiac interventions are a fast evolving field. The past decade has seen the development of transcatheter aortic valve replacement, transcatheter mitral valve repair and replacement, septal defect closure devices and left atrial appendage closure devices for thromboprophylaxis. More than ever, medical imaging is taking a central role in the care of patients with structural heart disease. In this review article we outline the use of MSCT as a tool for diagnosis of structural heart interventions, as well as patient selection, pre-procedural planning, device sizing and post-procedural assessment. We focus on procedures targeting the aortic valve, the mitral valve, the inter-atrial septum and the left atrial appendage.

Transcatheter heart valve failure: a systematic review.

AIMS: A comprehensive description of transcatheter heart valve (THV) failure has not been performed. We undertook a systematic review to investigate the aetiology, diagnosis, management, and outcomes of THV failure. METHODS AND RESULTS: The systematic review was performed in accordance with the PRISMA guidelines using EMBASE, MEDLINE, and Scopus. Between December 2002 and March 2014, 70 publications reported 87 individual cases of transcatheter aortic valve implantation (TAVI) failure. Similar to surgical bioprosthetic heart valve failure, we observed cases of prosthetic valve endocarditis (PVE) (n = 34), structural valve failure (n = 13), and THV thrombosis (n = 15). The microbiological profile of THV PVE was similar to surgical PVE, though one-quarter had satellite mitral valve endocarditis, and surgical intervention was required in 40% (75% survival). Structural valve failure occurred most frequently due to leaflet calcification and was predominantly treated by redo-THV (60%). Transcatheter heart valve thrombosis occurred at a mean 9 ± 7 months post-implantation and was successfully treated by prolonged anticoagulation in three-quarters of cases. Two novel causes of THV failure were identified: late THV embolization (n = 18); and THV compression (n = 7) following cardiopulmonary resuscitation (CPR). These failure modes have not been reported in the surgical literature. Potential risk factors for late THV embolization include low prosthesis implantation, THV undersizing/underexpansion, bicuspid, and non-calcified anatomy. Transcatheter heart valve embolization mandated surgery in 80% of patients. Transcatheter heart valve compression was noted at post-mortem in most cases. CONCLUSION: Transcatheter heart valves are susceptible to failure modes typical to those of surgical bioprostheses and unique to their specific design. Transcatheter heart valve compression and late embolization represent complications previously unreported in the surgical literature.

Transcatheter aortic valve replacement in bicuspid aortic valve disease.

BACKGROUND: Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). OBJECTIVES: This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. METHODS: We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. RESULTS: A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥ 2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). CONCLUSIONS: TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.

Fluoroscopic anatomy of left-sided heart structures for transcatheter interventions: insight from multislice computed tomography.

With the introduction of transcatheter structural heart therapies, cardiologists are increasingly aware of the importance of understanding anatomical details of left-sided heart structures. Understanding fluoroscopic cardiac anatomy can facilitate optimal positioning and deployment of prostheses during transcatheter valve repair/replacement, left atrial appendage occlusion, septal defect closure, and paravalvular leak closure. It is possible to use multislice computed tomography to determine optimal fluoroscopic viewing angles for such transcatheter therapies. The purpose of this paper is to describe how optimal fluoroscopic viewing angles of left-sided heart structures can be obtained using computed tomography. Two- and 3-chamber views are described and may become standard in the context of transcatheter structural heart interventions.