Transcatheter edge-to-edge repair for chronic functional mitral regurgitation in patients with very severe left ventricular dysfunction.

BACKGROUND: There is scarce data on transcatheter edge-to-edge repair (TEER) for chronic functional mitral regurgitation (FMR) in the setting of very severe left ventricular dysfunction (LVD), defined by a left ventricular ejection fraction (LVEF) of <20%. METHODS: We retrospectively explored periprocedural characteristics and one-year clinical and echocardiographic outcomes of consecutive patients with chronic FMR and very severe LVD who underwent an isolated, first-time TEER. The composite of all-cause mortality or heart failure hospitalizations constituted the primary outcome. RESULTS: Ninety-six patients (median age 69 [IQR, 55-76] years, 64 (66.7%) males, median LVEF 15 [IQR, 12-17] %) were included. In 47 (49.0%), TEER was performed urgently or in the setting of hemodynamic instability. Almost all procedures (98.0%) were technically successful, leading to ≤moderate MR in 94.7% and 90.7% of cases by 1-month and 1-year, respectively. New York Heart Association class ≤II was maintained in 60.0% of patients. One-year survival and freedom from the primary outcome were 74.0% and 50.0%, respectively. Functional and echocardiographic improvement compared to baseline was independent of procedural urgency, hemodynamic stability, and downstream left ventricular assist device implantation / heart transplantation (n = 12). Mortality was not predicted by COAPT exclusion criteria, nor was the primary outcome discriminated by published risk models. CONCLUSION: TEER for chronic FMR is feasible, safe, and efficacious in selected patients with very severe LVD. Preprocedural risk stratification in this population may be optimized.

Society of thoracic surgeons risk score and left atrial pressure for predicting clinical outcomes among transcatheter mitral edge-to-edge repair patients.

BACKGROUND: Limited data exist regarding the performance of the Society of Thoracic Surgeons (STS) risk score among transcatheter mitral edge-to-edge repair (TEER) patients. OBJECTIVE: Evaluate STS score accuracy, and the incremental value of post-procedural left atrial pressure (LAP). METHODS: A retrospective analysis of TEER patients between 2013 and 2020. Patients were allocated into 3 groups: high (≥8% [n = 298, 31%]), intermediate (4%-8% [n = 318, 33%]), and low (<4% [n = 344, 36%]). Primary outcomes included 1-year mortality or cardiovascular hospitalizations. Cox proportional hazards regression modeling was used to determine the hazard ratio of the primary outcome, and STS score accuracy was assessed by receiver operating characteristic. A spline curve was used to display the relationship between LAP and the primary endpoint. Continuous net reclassification improvement (NRI) was used to determine the incremental value of LAP. RESULTS: We included 960 patients, primarily elderly (79 [70-85]), with a median STS risk of 5.6 (3-9). High-risk patients were older (83 [75-89], 81 [74-87], 72 [64-79], p < 0.001), and had more comorbidities compared to intermediate and low-risk groups. Upon Cox regression, STS score (high vs. low: HR 2.5 [1.7-3.8]; Intermediate vs. low: HR 1.8 [1.2-2.7] and LAP HR 1.03 [1.01-1.06], p = 0.007) were associated with the outcome. C statistics analysis revealed low accuracy of the STS score (AUC-0.61 [0.58-0.65, p < 0.001]). Continuous NRI analysis indicated an improvement in risk prediction of 17% (6.9-26.2), p < 0.001. CONCLUSION: STS risk score has low accuracy in predicting clinical outcomes after TEER. Adding LAP measurements can improve reclassification and identify those prone to adverse outcomes.

Quality of Life, Procedural Success, and Clinical Outcomes following Transcatheter Mitral Valve Repair.

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.

Clinical predictive factors of coronary stenosis in patients with high­risk valvular heart disease who received diagnostic coronary angiography prior to cardiac valve surgery.

Valvular heart disease (VHD) may lead to morbidities and mortality due to heart failure or sudden death. Concomitant coronary artery disease (CAD) is a crucial condition that needs to be explored in patients with VHD prior to cardiac valve surgery as it may increase morbidity and mortality. Patient age >40 years and mitral regurgitation are key risk factors for CAD in patients with VHD. The present study aimed to identify clinical risk factors for coronary stenosis in patients with high-risk VHD. The retrospective cohort study recruited patients aged >40 years who received cardiac valve surgery and coronary angiogram prior to cardiac valve surgery. Clinical factors predictive of coronary stenosis were computed by logistic regression analysis. There were 533 patients; 114 patients (21.38%) had coronary stenosis. Four factors were positively associated with coronary stenosis including age, male sex, mitral regurgitation and hypertension, while two factors were negatively associated with coronary stenosis, namely estimated glomerular filtration rate and rheumatic heart disease. Hypertension had the highest adjusted odds ratio at 2.596, while rheumatic heart disease had the lowest adjusted odds ratio at 0.428. Patient age >55 years showed a sensitivity and specificity of coronary stenosis of 80.70 and 37.47%, respectively. Clinical factors predictive of coronary stenosis in patients with high-risk VHD were age >55 years, male sex, mitral regurgitation and hypertension, while a high estimated glomerular filtration rate and presence of rheumatic heart disease were protective factors.

Prognostic Value of Left Ventricular Global Longitudinal Strain in Transcatheter Edge-to-Edge Repair for Chronic Primary Mitral Regurgitation.

AIMS: Left ventricular global longitudinal strain (LVGLS) is a known outcome predictor in transcatheter edge-to-edge repair (TEER) for functional mitral regurgitation (MR). We aimed to assess its prognostic yield in the setting of TEER for chronic primary MR. METHODS AND RESULTS: We conducted a single-center, retrospective analysis of 323 consecutive patients undergoing isolated, first-time procedures. Stratified by baseline LVGLS quartiles (≤-19%, -18.9-(-16)%, -15.9-(-12)%, > -12%), the cohort was evaluated for the primary composite outcome of all-cause mortality or heart failure hospitalizations, as well as secondary endpoints consisting of mitral reinterventions and the persistence of significant residual MR and/or functional disability - all along the first year after intervention. Subjects with worse (i.e., less negative) LVGLS exhibited higher comorbidity, more advanced HF, and elevated procedural risk. Post-TEER, those belonging to the worst LVGLS quartile group sustained increased mortality (16.9 vs 6.3%, Log-Rank p = 0.005, HR 1.75, 95% CI 1.08-4.74, p = 0.041) and, when affected by LV dysfunction/dilatation, more primary outcome events (21.1 vs 11.5%, Log-Rank p = 0.037, HR 1.68, 95% CI 1.02-5.46, p = 0.047). No association was demonstrated with other endpoints. Upon exploratory analysis, 1-month postprocedural LVGLS directly correlated with and was worse than its baseline counterpart by 1.6%, and a more impaired 1-month value - but not the presence/extent of deterioration - conferred heightened risk for the primary outcome. CONCLUSION: TEER for chronic primary MR is feasible, safe, and efficacious irrespective of baseline LVGLS. Yet, worse baseline LVGLS forecasts a less favorable postprocedural course, presumably reflecting a higher-risk patient profile.

Implications of Mitral Annular Calcification on Outcomes Following Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: Limited data exist regarding the impact of mitral annular calcification (MAC) on outcomes of transcatheter edge-to-edge repair for mitral regurgitation (MR). METHODS: We retrospectively analyzed 968 individuals (median age, 79 [interquartile range, 70-86] years; 60.0% males; 51.8% with functional MR) who underwent an isolated, first-time intervention. Stratified by MAC extent per baseline transthoracic echocardiogram, the cohort was assessed for residual MR, functional status, all-cause mortality, heart failure hospitalizations, and mitral reinterventions post-procedure. RESULTS: Patients with above-mild MAC (n=101; 10.4%) were older and more likely to be female, exhibited a greater burden of comorbidities, and presented more often with severe, primary MR. Procedural aspects and technical success rate were unaffected by MAC magnitude, as was the significant improvement from baseline in MR severity and functional status along the first postprocedural year. However, the persistence of above-moderate MR or functional classes III and IV at 1 year and the cumulative incidence of reinterventions at 2 years were overall more pronounced within the above-mild MAC group (significant MR or functional impairment, 44.7% versus 29.9%, P=0.060; reinterventions, 11.9% versus 6.2%, P=0.033; log-rank P=0.035). No link was demonstrated between MAC degree and the cumulative incidence or risk of mortality and mortality or heart failure hospitalizations. Differences in outcomes frequencies were mostly confined to the primary MR subgroup, in which patients with above-mild MAC also experienced earlier, more frequent 2-year heart failure hospitalizations (20.8% versus 9.6%; P=0.016; log-rank P=0.020). CONCLUSIONS: Mitral transcatheter edge-to-edge repair in patients with and without above-mild MAC is equally feasible and safe; however, its postprocedural course is less favorable among those with primary MR.

Mitral Transcatheter Edge-to-Edge Repair in Nonagenarians.

BACKGROUND: There are scarce data regarding mitral transcatheter edge-to-edge repair (TEER) in individuals aged 90 years and above. We aimed to evaluate patient characteristics, procedural aspects, and outcomes in this rapidly growing group. METHODS: We retrospectively studied a single-centre database of 967 isolated, first-time interventions, 103 (10.7%) of which were performed in nonagenarians. Outcomes included all-cause mortality, heart failure (HF) hospitalizations, and the persistence of significant mitral regurgitation (MR) or New York Heart Association functional class III/IV during the first postprocedural year. Analyses were repeated on a 204-patient, propensity score-matched subcohort, controlling for MitraScore elements, sex, race, MR etiology, functional status, atrial fibrillation/flutter, and procedural urgency. RESULTS: Compared with subjects below 90 years of age, nonagenarians were more likely to be white women of higher socioeconomic status; had a higher interventional risk, driven mainly by age and chronic kidney disease; presented more often with primary MR (71.8 vs 39.1%, P < 0.001); and exhibited less advanced biochemical/echocardiographic indices of cardiac remodelling. Further, their procedures were more commonly nonurgent and used fewer devices. A similarly high (> 97%) technical success rate was achieved in the 2 study groups. Likewise, no intergroup differences were observed in the rates or cumulative incidences of any of the explored endpoints, and neither of the outcomes' risks was associated with age 90 and above. Comparable outcomes were also noted in the propensity score-matched subgroups. CONCLUSIONS: In our experience, mitral TEER was equally feasible, safe, and efficacious in patients below and above 90 years of age.

Repeat Mitral Transcatheter Edge-to-Edge Repair for Recurrent Significant Mitral Regurgitation.

Background There are limited data on repeat mitral transcatheter edge-to-edge repair for recurrent significant mitral regurgitation (MR). Methods and Results We conducted a single-center, retrospective analysis of consecutive patients referred to a second mitral transcatheter edge-to-edge repair after a technically successful first procedure. Clinical, laboratory, and echocardiographic measures were assessed up to 1 year after the intervention. The composite of all-cause death or heart failure (HF) hospitalizations constituted the primary outcome. A total of 52 patients (median age, 81 [interquartile range, 76-87] years, 29 [55.8%] men, 26 [50.0%] with functional MR) met the inclusion criteria. MR recurrences were mostly related to progression of the underlying cardiac pathology. All procedures were technically successful. At 1 year, most patients with available records (n=24; 96.0%) experienced improvement in MR severity or New York Heart Association functional class that was statistically significant but numerically modest. Fourteen (26.9%) patients died or were hospitalized due to HF. These were higher-risk cases with predominantly functional MR who mostly underwent an urgent procedure and exhibited more severe HF indices before the intervention, as well as an attenuated 1-month clinical and echocardiographic response. Overall, 1-year course was comparable to that experienced by patients who underwent only a first transcatheter edge-to-edge repair at our institution (n=902). Tricuspid regurgitation of greater than moderate grade was the only baseline parameter to independently predict the primary outcome. Conclusions Repeat mitral transcatheter edge-to-edge repair is feasible, safe, and clinically effective, especially in non-functional MR patients without concomitant significant tricuspid regurgitation.

Prognostic value of mitral valve haemodynamic parameters obtained by intraprocedural echocardiography in transcatheter edge-to-edge repair.

AIMS: To assess whether intraprocedural transesophageal echocardiographic (TEE)-derived haemodynamic parameters predict outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR). METHODS AND RESULTS: This is a single-centre, retrospective analysis encompassing 458 (IQR, 104-1035) days of follow-up after 926 consecutive patients [481 (52%) with functional MR] referred to an isolated mitral TEER between 2013 and 2020. Cases without actual clip deployment, or in whom prior mitral procedures had taken place, were excluded. The primary outcome was the combined rate of all-cause mortality or heart failure (HF) hospitalizations. Secondary endpoints included single components of the primary outcome, as well as MR severity at one month and one year following the procedure. A multivariable analysis identified two intraprocedural echocardiographic observations made after clip deployment as independent predictors of the primary outcome: an above mild MR (HR for whole study period 1.49, 95% CI 1.05-2.13, P = 0.026) and a 100% or more increase from baseline in the transmitral mean pressure gradient (TMPG) (HR for whole study period 1.32, 95% CI 1.01-1.72, P = 0.039). Also, MR grade of above mild and the absence of a normal pulmonary venous flow pattern (PVFP) bilaterally were associated with an increased risk for HF hospitalizations and greater-than-mild 1-month MR. No prognostic role was demonstrated for the change in MR severity, the absolute TMPG, or the mere improvement in PVFP. CONCLUSION: Immediate post-TEER MR severity and the relative change in TMPG are predictive of clinical and echocardiographic outcomes following the procedure.

Predicting the risk of iliofemoral vascular complication in complex transfemoral-TAVR using new generation transcatheter devices.

Objective: Design a predictive risk model for minimizing iliofemoral vascular complications (IVC) in a contemporary era of transfemoral-transcatheter aortic valve replacement (TF-TAVR). Background: IVC remains a common complication of TF-TAVR despite the technological improvement in the new-generation transcatheter systems (NGTS) and enclosed poor outcomes and quality of life. Currently, there is no accepted tool to assess the IVC risk for calcified and tortuous vessels. Methods: We reconstructed CT images of 516 propensity-matched TF-TAVR patients using the NGTS to design a predictive anatomical model for IVC and validated it on a new cohort of 609 patients. Age, sex, peripheral artery disease, valve size, and type were used to balance the matched cohort. Results: IVC occurred in 214 (7.2%) patients. Sheath size (p = 0.02), the sum of angles (SOA) (p < .0001), number of curves (NOC) (p < .0001), minimal lumen diameter (MLD) (p < .001), and sheath-to-femoral artery diameter ratio (SFAR) (p = 0.012) were significant predictors for IVC. An indexed risk score (CSI) consisting of multiplying the SOA and NOC divided by the MLD showed 84.3% sensitivity and 96.8% specificity, when set to >100, in predicting IVC (C-stat 0.936, 95% CI 0.911-0.959, p < 0.001). Adding SFAR > 1.00 in a tree model increased the overall accuracy to 97.7%. In the validation cohort, the model predicted 89.5% of the IVC cases with an overall 89.5% sensitivity, 98.9% specificity, and 94.2% accuracy (C-stat 0.842, 95% CI 0.904-0.980, p < .0001). Conclusion: Our CT-based validated-model is the most accurate and easy-to-use tool assessing IVC risk and should be used for calcified and tortuous vessels in preprocedural planning.

Outcomes of Transcatheter Edge-to-Edge Repair for Functional Mitral Regurgitation According to Cardiac Resynchronization Therapy Status.

Current guidelines, supported by limited data, prioritize the use of cardiac resynchronization therapy (CRT) over mitral transcatheter edge-to-edge repair (TEER) in eligible patients. To examine TEER results and outcomes in CRT-eligible patients with functional mitral regurgitation (MR) according to CRT status, we conducted a single-center, retrospective analysis of 126 consecutive patients who underwent TEER while fulfilling guideline criteria for CRT before the procedure. The primary outcome was the composite of all-cause mortality or heart failure hospitalizations at 1 year. The secondary outcomes included individual components of the primary outcome, as well as 1-year all-cause hospitalizations and 1-month MR severity, indexed left atrial volume, and indexed left ventricular mass by echocardiography. A total of 70 patients (56%) did not undergo CRT at the time of TEER. The baseline characteristics and procedural results were mostly comparable between those with and without CRT. The no-CRT group experienced higher rates of the primary outcome (43% vs 25%, p = 0.041), which were accounted for by increased mortality (26% vs 11%, p = 0.033). After multivariable analysis, the absence of CRT was associated with more than twice the risk for the primary outcome (hazard ratio 2.36, 95% confidence interval 1.1 to 4.98, p = 0.0.017), a finding which was confined to patients with a class I indication for the device. Rates of secondary endpoints did not differ between the groups. In conclusion, in CRT-eligible patients who underwent TEER for functional MR, the 1-year clinical outcome was more favorable when the procedure was preceded by CRT.

Correlates and prognostic implications of LVEF reduction after transcatheter edge-to-edge repair for primary mitral regurgitation.

AIMS: To explore the characteristics and outcomes of patients undergoing transcatheter edge-to-edge repair (TEER) for primary mitral regurgitation (MR) according to the presence of left ventricular ejection fraction (LVEF) reduction post-procedure. METHODS AND RESULTS: We retrospectively analysed 317 individuals [median age 83 (interquartile range, 75-88) years, 197 (62.1%) males] treated with an isolated, first-time TEER that was concluded by a successful clip deployment. Stratified by LVEF change at 1-month compared with baseline, the cohort was evaluated for residual MR and heart failure (HF) indices up to 1-year, as well as all-cause mortality and HF hospitalizations at 2-years. Overall, 212 (66.9%) patients displayed LVEF reduction, which was mainly driven by lowered total stroke volume and diffuse hypocontractility. While post-procedural MR, transmitral mean pressure gradient, and functional status were comparable in the two study groups, patients with LVEF reduction exhibited a greater decline in filling pressures intra-procedurally; left ventricular mass index, pulmonary arterial systolic pressure, and serum natriuretic peptide level at 1-month; and walking limitation at 1-year. Also, by 2 years, they were less likely to die (13.3% vs. 5.7%, P = 0.019), be readmitted for HF (17.1% vs. 9.0%, P = 0.033), and experience either of the two (23.8% vs. 12.7%, P = 0.012). Lastly, LVEF reduction was the only 1-month echocardiographic parameter to independently confer an attenuated risk for the composite of deaths or HF hospitalizations (HR 0.28, 95% CI 0.10-0.78, P = 0.016). CONCLUSION: LVEF reduction at 1-month post-TEER for primary MR is associated with better clinical outcomes, possibly reflecting a more pronounced unloading effect of the procedure.

Outcome Prediction score for mitral transcatheter edge-to-edge repair in patients with concomitant significant tricuspid regurgitation.

BACKGROUND: Tricuspid regurgitation (TR) adversely affects prognosis following mitral transcatheter edge-to-edge repair (TEER). We aimed to derive a risk stratification tool for patients undergoing TEER for mitral regurgitation while exhibiting significant TR. METHODS: This is a single-center, retrospective analysis of 217 consecutive individuals referred to an isolated mitral TEER who had moderate-to-severe or greater TR at baseline. The primary outcome was the 1-year composite of all-cause mortality or heart failure hospitalizations. The cohort was randomly split in a 75%-to-25% ratio, creating train (n = 163) and test (n = 54) datasets. Model development, discrimination, and calibration were based on the train dataset. Internal validation was applied to the test dataset. RESULTS: Overall, 81 (37.3%) patients experienced the primary outcome. After multivariable analysis, a score for predicting the primary outcome was constructed that utilized a 0-to-3 scale, in which each point represented one of three baseline variables independently associated with this combined endpoint: serum B-natriuretic peptide (BNP) level >1,000 pg/mL, qualitative right ventricular (RV) dysfunction on transthoracic echocardiogram, and cardiac implantable electronic device (CIED). C-statistic of the model was 0.66 (95% CI, 0.57-0.75, p = 0.002) and 0.75 (95% CI, 0.61-0.89, p = 0.004) in the train and test datasets, respectively-representing comparable performance to current, more complex tools. Neither this BNP-RV-CIED (BRC) score nor other models were prognostically meaningful in 32 patients excluded from the main analysis who underwent a combined mitral-tricuspid TEER. CONCLUSION: The BRC score is a simple clinical prediction tool that may aid in the triage of isolated mitral TEER candidates with significant pre-existing TR.

Racial disparities in characteristics and outcomes of patients undergoing mitral transcatheter edge-to-edge repair.

Background: There are scarce data regarding the post-mitral transcatheter edge-to-edger repair (TEER) course in different racial groups. Objective: To assess the impact of race on outcomes following TEER for mitral regurgitation (MR). Methods: This is a single-center, retrospective analysis of consecutive TEER procedures performed during 2013-2020. The primary outcome was the composite of all-cause mortality or heart failure (HF) hospitalizations along the first postprocedural year. Secondary outcomes included individual components of the primary outcome, New York Heart Association (NYHA) class, MR grade, and left ventricular mass index (LVMi). Results: Out of 964 cases, 751 (77.9%), 88 (9.1%), 68 (7.1%), and 57 (5.9%) were whites, blacks, Asians, and Hispanics, respectively. At baseline, non-whites and blacks were younger and more likely be female, based in lower socioeconomic areas, not fully insured, diagnosed with functional MR, and affected by biventricular dysfunction. Intra-procedurally, more devices were implanted in blacks. At 1-year, non-whites (vs. whites) and blacks (vs. non-blacks or whites) experienced higher cumulative incidence of the primary outcome (32.9% vs. 22.5%, p = 0.002 and 38.6% vs. 23.4% or 22.5%, p = 0.002 or p = 0.001, respectively), which were accounted for by hospitalizations in the functional MR sub-cohort (n = 494). NYHA class improved less among blacks with functional MR. MR severity and LVMi equally regressed in all groups. White race (HR 0.62, 95% CI 0.39-0.99, p = 0.047) and black race (HR 2.07, 95% CI 1.28-3.35, p = 0.003) were independently associated with the primary outcome in functional MR patients only. Conclusion: Mitral TEER patients of different racial backgrounds exhibit major differences in baseline characteristics. Among those with functional MR, non-whites and blacks also experience a less favorable 1-year clinical outcome.

Prognostic Value of Baseline Tricuspid Annular Plane Systolic Excursion to Pulmonary Artery Systolic Pressure Ratio in Mitral Transcatheter Edge-to-Edge Repair.

BACKGROUND: A surrogate of right ventricular-pulmonary arterial coupling, the ratio of tricuspid annular plane systolic excursion (TAPSE) to pulmonary artery systolic pressure (PASP) has been associated with outcomes across a wide range of cardiac pathologies and interventions. The aim of this study was to assess the prognostic significance of baseline TAPSE/PASP ratio in patients undergoing mitral transcatheter edge-to-edge repair. METHODS: This was a single-center, retrospective analysis encompassing 448 days (interquartile range, 86-958 days) of follow-up after 707 consecutive isolated, first-time mitral transcatheter edge-to-edge repair procedures. Stratified by the cohort's median TAPSE/PASP ratio of 0.37 mm/mm Hg, eligible cases were examined for the occurrence of all-cause mortality and heart failure hospitalization. RESULTS: Patients with low TAPSE/PASP ratios exhibited a greater prevalence of functional mitral regurgitation, a higher burden of comorbidities, and worse clinical and echocardiographic indices of cardiac function, as well as an attenuated rate of technical success. After the procedure, they experienced similar 1-month and 1-year improvement in mitral regurgitation grade and functional status but higher rates of death, heart failure hospitalizations, and the composite of both at all time points explored (1 year, 15.3% vs 7.6%, 20.7% vs 10.2%, and 32.3% vs 16.1%, respectively; P < .001 for all). Lower TAPSE/PASP ratio was independently associated with a higher risk for the 1-year combined end point of death or heart failure hospitalizations (hazard ratio, 2.84; 95% CI, 1.09-7.43; P = .033). A novel TAPSE/PASP-MitraScore risk model showed a better discriminative property than currently validated scores. Subgroup analysis produced similarly significant observations solely in patients with functional mitral regurgitation (n = 383 [54.2%]), which remained when using subgroup-specific medians of the baseline TAPSE/PASP ratio. CONCLUSIONS: A low TAPSE/PASP ratio before mitral transcatheter edge-to-edge repair identifies higher risk patients and predicts a less favorable outcome after the procedure.

Implications of Mitral Annular Disjunction in Patients Undergoing Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation.

BACKGROUND: Little is known about mitral transcatheter edge-to-edge repair (TEER) in patients with mitral annular disjunction (MAD). OBJECTIVES: The authors sought to explore TEER for degenerative mitral regurgitation (MR) according to MAD status. METHODS: We retrospectively analyzed 271 consecutive patients (median age 82 [Q1-Q3: 75-88] years, 60.9% men) undergoing an isolated, first-ever TEER for whom there were viewable preprocedural echocardiograms. Stratified by MAD status at baseline, the cohort was evaluated for all-cause mortality, heart failure hospitalizations, and mitral reinterventions-the composite of which constituted the primary outcome-as well as functional capacity and residual MR, all along the first postprocedural year. RESULTS: Individuals with (n = 62, 22.9%) vs without MAD had more extensive prolapse and larger valve dimensions. Although the former's procedures were longer, utilizing more devices per case, technical success rate and residual MR were comparable. MAD presence was associated with higher mortality risk (HR: 2.64; 95% CI: 1.82-5.52; P = 0.014), and increased MAD length-with lower odds of functional class ≤II (OR: 0.65; 95% CI: 0.47-0.88; P = 0.006). Among 47 MAD patients with retrievable 1-month data, MAD regressed in 91.5% and by an overall 50% (Q1-Q3: 22%-100%) compared with baseline (P < 0.001). A greater MAD shortening conferred attenuated risk for the primary outcome. CONCLUSIONS: In our experience, TEER for degenerative MR accompanied by MAD was feasible and safe; however, its postprocedural course was somewhat less favorable. MAD shortening following TEER was observed in most patients and proved prognostically beneficial.

Multidetector Computed Tomography in Patients Who Underwent Transcatheter Mitral Edge-to-Edge Repair.

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.

Preprocedural transthoracic echocardiography for predicting outcomes of transcatheter edge-to-edge repair for chronic primary mitral regurgitation.

INTRODUCTION AND OBJECTIVES: Limited data exist on the prognostic usefulness of transthoracic echocardiography preceding MitraClip for chronic primary mitral regurgitation (MR). We evaluated the predictive ability of transthoracic echocardiography in this setting. METHODS: A total of 410 patients (median age, 83 years, 60.7% males) were included in the study. The primary outcome was the 1-year composite of all-cause mortality or heart failure hospitalization. Secondary endpoints encompassed individual elements of the primary outcome, the persistence of significant functional impairment or above-moderate MR at 1 year, and above-mild MR at 1-month. RESULTS: Left ventricular end-systolic diameter index of ≥ 2.1cm/m2, corresponding to the cohort's 4th quartile (HR, 2.44; 95%CI, 1.09-4.68; P=.022). Concurrently, higher left atrial volume index (LAVi) and a mid-diastolic medial-lateral mitral annular diameter (MAD) equal to or above the cohort's median of 32.2mm were linked to a higher probability of death and heart failure hospitalization, respectively. LAVi of ≥ 60mL/m2, above-mild mitral annular calcification, and above-moderate tricuspid regurgitation conferred higher odds of functional class III-IV or above-moderate MR persistence. All variables except LAVi and MAD, as well as indexed mid-diastolic medial-lateral MAD of ≥ 20.2mm/m2 and mitral effective regurgitant orifice area of ≥ 0.40 cm2, were associated with greater-than-mild MR at 1 month. CONCLUSIONS: Preprocedural increased indexed left heart dimensions, mainly left ventricular end-systolic diameter index, MAD, mitral annular calcification, mitral effective regurgitant orifice area, and tricuspid regurgitation mark a less favorable course post-MitraClip for chronic primary MR.

Commissural Alignment After Balloon-Expandable Transcatheter Aortic Valve Replacement Is Associated With Improved Hemodynamic Outcomes.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is generally performed without control over the alignment of the bioprosthesis to the native aortic valve (AV) commissures. Data on the impact of commissural misalignment (CMA) on the clinical and hemodynamic outcome after TAVR are scarce. OBJECTIVES: The aim of this study was to investigate the impact of commissural misalignment (CMA) on the clinical and hemodynamic outcome in patients with severe tricuspid aortic stenosis undergoing TAVR using the balloon-expandable (BE) SAPIEN 3 valve (Edwards LifeSciences). METHODS: Clinical data of consecutive patients who underwent BE TAVR at Cedars-Sinai Medical Center (Los Angeles, California, USA) enrolled in the RESOLVE (Assessment of TRanscathetER and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation) registry were retrospectively analyzed to evaluate CMA, which was defined as a neocommissure position >30° compared with native commissures on computed tomography. RESULTS: A total of 324 patients (36.6% female, median Society of Thoracic Surgeons score of 3.9%) were included in the analysis. CMA was present in 171 individuals (52.8%). At 30 days, rates of aortic regurgitation greater than mild (5.6%) and a residual AV gradient ≥20 mm Hg (7.4%) were not different between CMA and non-CMA patients. Commissural orientation was independently associated with a relative AV mean gradient increase >50% from discharge to 30 days (per increase of 10° misalignment; OR: 1.3; 95% CI: 1.0-1.4; P = 0.01). The long-term composite outcome of death or stroke was not different between groups (log-rank P = 0.29). CONCLUSIONS: In patients with severe tricuspid aortic stenosis who undergo SAPIEN 3 TAVR, the neocommissures align randomly. Our data demonstrate that commissural alignment may impact device performance and clinical outcomes in patients undergoing BE TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic VaLVve Dysfunction with Multimodality Imaging and Its TrEatment with Anticoagulation [RESOLVE]; NCT02318342).

Usefulness of computed tomography to predict residual mitral regurgitation after transcatheter mitral valve edge-to-edge repair.

BACKGROUND: Multidetector computed tomography (MDCT) can provide valuable information for preprocedural planning of transcatheter mitral valve interventions. However, no data exist on MDCT parameters predicting residual mitral regurgitation (MR) post-MitraClip (Abbott Laboratories, Abbott Park, IL, USA). METHODS: We analyzed preprocedural MDCTs of 78 consecutive patients with secondary MR undergoing MitraClip implantation at our institution. Moderate-or-severe mitral leaflet calcification (MLC) was defined as calcification, with-or-without mitral annular calcification, extending beyond the mitral leaflet base. Residual MR was assessed by postprocedural transesophageal echocardiography, and clinical outcomes were assessed at 1-year. RESULTS: Fifteen patients (19 %) had residual MR ≥2+. Compared to patients with none-or-mild residual MR, MDCT-derived mitral valve orifice area (MVOA) to mitral annulus area (MAA) ratio was significantly lower (0.32 ±â€¯0.06 vs. 0.39 ±â€¯0.09; p = 0.003), and the prevalence of MLC was higher (40 % vs. 18 %; p = 0.057) in those with residual MR ≥2+. Furthermore, the MVOA/MAA ratio and MLC were independent predictors of residual MR ≥2+ post-MitraClip [adjusted odds ratio (ORadj): 0.88 (0.80-0.97) and 5.50 (1.16-26.23), respectively]. On receiver-operating-characteristic-curve analysis, MVOA/MAA ratio <0.31 had a sensitivity of 87 % and a specificity of 60 % for residual MR ≥2+. When patients were classified according to the presence of MLC and an MVOA/MAA ratio <0.31, those with both parameters had significantly higher rates of postprocedural residual MR ≥2+ and mitral reintervention at 1-year than those with only one, and those without both parameters. CONCLUSIONS: In patients with secondary MR undergoing the MitraClip procedure, preprocedural MDCT parameters, specifically MVOA/MAA ratio and MLC, are useful to predict postprocedural residual MR.