•Transcatheter mital valve (MV) replacement for failed bioprosthetic MV is well established and reasonable treatment option.•Patient selection for transcatheter replacement of native MV remains ...challenging due to anatomical complexity of MV and peri-MV structure.•Early feasibility studies of transcatheter devices for native MV replacement demonstrate the safety and are under transition to pivotal trials.
Transcatheter mitral valve (MV) repair, specifically the edge-to-edge leaflet repair, is a less invasive treatment of symptomatic mitral regurgitation (MR) in patients with high or prohibitive surgical risk. In cases with severe leaflet calcification, small mitral orifice area, and/or extremely wide regurgitation across the entire MV commissure, transcatheter MV repair may rather cause suboptimal or potentially hazardous outcomes. In these cases, MV replacement can be a more suitable option. Recently, percutaneous transcatheter MV replacement has emerged as an acceptable therapeutic option for the treatment of degenerated surgical bioprosthetic disease. Moreover, several transcatheter devices for native MV replacement are under evaluation with a hope to provide more complete and reproducible restoration of MV function. In this article, we will review current status, applications, clinical outcomes, and limitations that need to be overcome for transcatheter MV replacement for both degenerated surgical bioprosthetic disease and native MV disorders.
Abstract Objectives This study sought to develop a robust and definitive risk model for new permanent pacemaker implantation (PPMI) after SAPIEN 3 (third generation balloon expandable valve) (Edwards ...Lifesciences, Irvine, California) transcatheter aortic valve replacement (third generation balloon expandable valve TAVR), including calcification in the aortic-valvular complex (AVC). Background The association between calcium in the AVC and need for PPMI is poorly delineated after third generation balloon expandable valve TAVR. Methods At Cedars-Sinai Heart Institute in Los Angeles, California, a total of 240 patients with severe aortic stenosis underwent third generation balloon expandable valve TAVR and had contrast computed tomography. AVC was characterized precisely by leaflet sector and region. Results The total new PPMI rate was 14.6%. On multivariate analysis for predictors of PPMI, pre-procedure third generation balloon expandable valve TAVR, right bundle branch block (RBBB), shorter membranous septum (MS) length, and noncoronary cusp device-landing zone calcium volume (NCC-DLZ CA) were included. Predictive probabilities were generated using this logistic regression model. If 3 pre-procedural risk factors were present, the c-statistic of the model for PPMI was area under the curve of 0.88, sensitivity of 77.1%, and specificity of 87.1%; this risk model had high negative predictive value (95.7%). The addition of the procedural factor of device depth to the model, with the parameter of difference between implantation depth and MS length, combined with RBBB and NCC-DLZ CA increased the c-statistic to 0.92, sensitivity to 94.3%, specificity to 83.8%, and negative predictive value to 98.8% Conclusions By using a precise characterization of distribution of calcification in the AVC in a single-center, retrospective study, NCC-DLZ CA was found to be an independent predictor of new PPMI post–third generation balloon expandable valve TAVR. The findings also reinforce the importance of short MS length, pre-existing RBBB, and ventricular implantation depth as important synergistic PPMI risk factors. This risk model will need validation by future prospective multicenter studies.
Atrial fibrillation (AF) is the most common cardiac arrhythmia and the cause of thromboembolic events in elderly patients worldwide. AF is associated with a significantly increased risk of morbidity ...and mortality due to cardiac emboli, primarily from left atrial appendage (LAA) thrombus. Oral anticoagulation therapy is the standard treatment to effectively reduce the risk of thromboembolic events in patients with AF. However, anticoagulation treatment increases bleeding risk. LAA closure (LAAC) has recently been introduced as a feasible mechanical preventive intervention for thromboembolic events while minimizing the risk of bleeding. Transcatheter LAAC devices have evolved in the past decade, and several ongoing trials have demonstrated the improvements of safety and outcomes in newer generation devices. This review summarizes the current perspectives and outcomes regarding LAAC as an alternative to pharmacologic therapy.
The aim of this study was to evaluate the risk of coronary obstruction due to sinus sequestration in redo transcatheter aortic valve replacement (TAVR) using post-TAVR computed tomography (CT).
...Little information is available regarding the risk of coronary obstruction due to sinus sequestration in redo TAVR inside a previously implanted TAV.
Post-TAVR CT of 66 patients who received an Evolut R or Evolut PRO and 345 patients who received a SAPIEN 3 were analyzed. Redo TAVR was considered at risk of coronary obstruction due to sinus sequestration if: 1) the prior TAV commissure level was above sinotubular junction (STJ); and 2) the distance between TAV and STJ was <2.0 mm in each coronary sinus.
In total, 45.5% in the Evolut R/Evolut PRO group and 2.0% in the SAPIEN 3 group had CT-identified risk of sinus sequestration at 1 or both coronary arteries (p < 0.001). CT-identified risk of sinus sequestration was observed in 39.4% for the left coronary artery and 24.2% for the right coronary artery in the Evolut R/Evolut PRO group, while those percentages were 2.0% for the left coronary artery and 0.6% for the right coronary artery in the SAPIEN 3 group. In a coronary-level analysis, overlaps between the first TAV commissural posts and coronary ostium were observed in 45.2% in the Evolut R/Evolut PRO group and 11.1% in in the SAPIEN 3 group among coronary arteries at CT-identified risk of sinus sequestration.
The risk of sinus sequestration in redo TAVR should be carefully screened by CT, especially in patients with low STJ height. TAV with low commissure height that was designed to achieve commissure-to-commissure alignment with the native aortic valves may be preferable to avoid the risk of coronary obstruction due to sinus sequestration and allow for a preventive leaflet laceration procedure in future redo TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation RESOLVE; NCT02318342)
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Objectives This study compared cross-sectional three-dimensional (3D) transesophageal echocardiography (TEE) to two-dimensional (2D) TEE as methods for predicting aortic regurgitation after ...transcatheter aortic valve replacement (TAVR). Background Data have shown that TAVR sizing using cross-sectional contrast computed tomography (CT) parameters is superior to 2D-TEE for the prediction of paravalvular aortic regurgitation (AR). Three-dimensional TEE can offer cross-sectional assessment of the aortic annulus but its role for TAVR sizing has been poorly elucidated. Methods All patients had severe symptomatic aortic stenosis and were treated with balloon-expandable TAVR in a single center. Patients studied had both 2D-TEE and 3D imaging (contrast CT and/or 3D-TEE) of the aortic annulus at baseline. Receiver-operating characteristic curves were generated for each measurement parameter using post-TAVR paravalvular AR moderate or greater as the state variable. Results For the 256 patients studied, paravalvular AR moderate or greater occurred in 26 of 256 (10.2%) of patients. Prospectively recorded 2D-TEE measurements had a low discriminatory value (area under the curve = 0.52, 95% confidence interval: 0.40 to 0.63, p = 0.75). Average cross-sectional diameter by CT offered a high degree of discrimination (area under the curve = 0.82, 95% confidence interval: 0.73 to 0.90, p < 0.0001) and mean cross-sectional diameter by 3D-TEE was of intermediate value (area under the curve = 0.68, 95% confidence interval: 0.54 to 0.81, p = 0.036). Conclusions Cross-sectional 3D echocardiographic sizing of the aortic annulus dimension offers discrimination of post-TAVR paravalvular AR that is significantly superior to that of 2D-TEE. Cross-sectional data should be sought from 3D-TEE if good CT data are unavailable for TAVR sizing.
Background: Transcatheter aortic valve-in-valve (VIV) replacement within failed bioprosthetic surgical aortic valves is a feasible therapeutic option. However, data comparing the hemodynamic and ...clinical outcomes of VIV replacement with supra-annular self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. Methods and Results: Outcomes of 40 and 95 patients treated with supra-annular self-expanding and balloon-expandable THV, respectively, were compared after propensity score matching, which yielded 37 pairs of patients with similar baseline characteristics. Hemodynamic and clinical outcomes were analyzed. Postprocedural mean gradient was significantly lower in the self-expanding THV group than in the balloon-expandable THV group (12.1±6.1 mmHg vs. 19.0±7.3 mmHg, P<0.001). The incidence of at least mild postprocedural aortic regurgitation (AR) was comparable between the self-expanding and balloon-expandable THV groups (21.6% vs. 10.8%, P=0.39). In the self-expanding THV group, the new-generation THV showed a trend towards a lower incidence of at least mild AR compared with the early-generation THV (12.5% vs. 38.5%, P=0.07). A similar trend was observed in the balloon-expandable THV group (4.2% vs. 23.1%, P=0.08). There was no significant difference between the self-expanding and balloon-expandable THV groups in the cumulative 2-year all-cause mortality rates (22.4% vs. 43.4%, log-rank P=0.26). Conclusions: The supra-annular self-expanding THV was associated with a lower postprocedural mean gradient compared with balloon-expandable THV in patients undergoing aortic VIV replacement.
Multidetector computed tomography (MDCT) can provide valuable information for mitral assessment, but its role in transcatheter mitral edge-to-edge repair (TEER) planning has been poorly elucidated. ...We aimed to compare MDCT with 3-dimensional transesophageal echocardiography (3D-TEE) for TEER preprocedural evaluation. We analyzed the preprocedural MDCT and 3D-TEE of 108 consecutive patients with mitral regurgitation (MR) who underwent MitraClip implantation. The levels of agreement for the etiology and mechanism of MR, mitral calcification, mitral annulus, and mitral valve orifice area (MVOA) measurements were compared between MDCT and 3D-TEE data. Receiver-operating-characteristic curves were generated for mitral annulus area and MVOA using a low mean transmitral pressure gradient at discharge (<5 mm Hg) as the state variable, and the primary outcome of all-cause mortality or rehospitalization for heart failure at 1 year was compared between MDCT's and 3D-TEE's MVOA <4-cm2 cutoff. Good levels of agreement between MDCT and 3D-TEE were observed for determining the etiology (κ = 0.81) and mechanism (κ = 0.62) of MR but not for grading mitral calcification (κ = 0.31 to 0.35). The correlations between MDCT and 3D-TEE measurements were strong for mitral annulus area (r = 0.90) and good for MVOA (r = 0.73). Furthermore, no significant differences in the area under the receiver-operating-characteristic curve to predict low transmitral pressure gradient at discharge or the primary outcome at 1 year were detected between MDCT- and 3D-TEE-derived parameters (all p >0.05). In conclusion, in patients who underwent TEER with MitraClip, a high degree of agreement for comprehensive evaluation of MR and prediction of clinical outcomes between MDCT and 3D-TEE was observed.
Background. Limited data exist regarding the association between the quality of life (QoL) and clinical outcomes following transcatheter mitral valve repair (TMVr). We aimed to evaluate the ...prognostic significance of QoL assessment following TMVr and to characterize those who had procedural success, yet reported a low Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score. Methods. We reported the experience of Cedars-Sinai Medical Center patients between 2013 and 2020. Patients were allocated into four groups according to the 30-day KCCQ: <25, 25–49, 50–74, and ≥75. Primary outcome included 1-year all-cause death or heart failure (HF) hospitalizations. We also examined the association between QoL and the primary outcome in those with procedural success. Results. A total of 555 patients were included in our analysis, median follow-up of 650 days (IQR 243–1113). The lower KCCQ groups had a higher prevalence of functional mitral regurgitation (65%, 60%, 56%, and 43%, p=0.001), as well as a higher Society of Thoracic Surgeon (STS) score. These groups had a significantly higher occurrence of 1-year all-cause death or HF hospitalizations in a stepwise fashion (40%, 22%, 16%, and 10%, p<0.001). Multivariable Cox regression analysis revealed 30-day KCCQ as the strongest predictor of the 1-year primary outcome (HR 0.98, 95%CI (0.97–0.99), p=0.006). Approximately a quarter of patients with procedural success had a low KCCQ score. These patients had a higher rate of the combined 1-year outcome regardless of procedural success or failure. Conclusion. QoL following TMVr is a powerful prognostic factor. KCCQ assessment is an important indicator for identifying patients prone to adverse outcomes even after procedural success.
BACKGROUNDTranscatheter edge-to-edge repair (TEER) has been increasingly used for selected patients with mitral regurgitation (MR), but limited data are available regarding clinical outcomes in ...patients with varied etiology and mechanism of MR. OBJECTIVESThe aim of this study was to evaluate the outcomes of TEER according to etiology and left ventricular (LV) and left atrial remodeling. METHODSConsecutive patients who underwent TEER between 2007 and 2020 were included in the analysis. Among patients with functional MR (FMR), those with predominant LV remodeling were classified as having ventricular FMR (v-FMR), whereas those without LV remodeling but predominant left atrial remodeling were classified as having atrial FMR (a-FMR). The primary outcome was a composite of all-cause mortality and heart failure hospitalization at 2 years and was compared among patients with degenerative MR (DMR), a-FMR, and v-FMR. RESULTSA total of 1,044 patients (11% with a-FMR, 48% with v-FMR, and 41% with DMR) with a mean Society of Thoracic Surgeons score of 8.6 ± 7.8 underwent TEER. Patients with a-FMR had higher rates of atrial fibrillation and severe tricuspid regurgitation with larger left and right atria, whereas patients with v-FMR had lower LV ejection fractions with larger LV dimensions. Residual MR more than moderate at discharge was not significantly different among the 3 groups (5.2% vs 3.2% vs 2.6%; P = 0.37). Compared with patients with DMR, 2-year event rates of the primary outcome were significantly higher in patients with a-FMR and v-FMR (21.6% vs 31.5% vs 42.3%; log-rank P < 0.001). CONCLUSIONSDespite excellent procedural outcomes, patients with a-FMR and v-FMR had worse clinical outcomes compared with those with DMR.
Background: Patients with severe aortic stenosis (AS) and an extra-large annulus (ELA) area (>683 mm2) can rarely be treated by transcatheter aortic valve replacement (TAVR) because of the size ...limitation of the transcatheter heart valves. This study aimed to evaluate the feasibility of TAVR using a 29-mm SAPIEN3 (S3) valve in patients with ELA and S3-dimensions by post-procedural computed tomography (post-CT). Methods and Results: We included 261 patients undergoing TAVR using a 29-mm S3: 30 patients with ELA and 231 with non-ELA were identified. S3-dimensions were evaluated at the S3 inflow and annulus level by post-CT in 129 patients. The ELA group had a greater aortic annulus area measured by pre-procedural CT (737.3±54.7 vs. 578.4±41.9 mm2, P<0.0001), higher balloon inflation volume (36 vs. 33 mL, P<0.0001), a larger S3 area at inflow by post-CT (729.6±42.2 vs. 682.2±35.0 mm2, P<0.001), and a correlation between the inflation volume and S3 area (r=0.71, P=0.0005). No differences were observed between groups in paravalvular aortic regurgitation (PAR) ≥mild (43.3% vs. 27.6%, P=0.09), PAR ≥moderate (3.3% vs. 1.3%, P=0.39) or 1-year mortality (10.0% vs. 9.1%, P=0.87). Conclusions: TAVR using a 29-mm S3 with extra inflation of the delivery balloon can be considered as a treatment option for patients with severe AS and ELA.
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