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.

Severe aortic stenosis echocardiographic thresholds revisited.

BACKGROUND: In view of inconsistencies in threshold values of severe aortic stenosis (AS) hemodynamic indices, it is unclear what is the relative contribution of each variable in a binary classification of AS based on aortic valve replacement (AVR) indication. We aimed to assess relative discriminative value and optimal threshold of each constituent hemodynamic parameter for this classification and confirm additional prognostic value. METHODS: Echocardiography studies of 168 patients with ≥ moderate AS were included. AS types were dichotomized into Group-A, comprising moderate and Normal-Flow Low-Gradient (NFLG), and Group-B, comprising High-Gradient(HG), Low Ejection Fraction Low-Flow Low-Gradient(Low EF-LFLG), and Paradoxical Low-Flow Low-Gradient(PLFLG) AS. Aortic valve area (AVA), Doppler velocity index (DVI), peak aortic velocity, mean gradient, stroke volume index and transaortic flow rate(TFR) were assessed for A/B Group discrimination value and optimal thresholds were determined. Dichotomized values were assessed for predictive value for AVR or death. RESULTS: C-statistic values for binary AS classification was .74-.9 for the tested variables. AVA and DVI featured the highest score, and SVI the lowest one. AVA≤.81 cm2 and DVI≤.249 had 87.6% and 86% respective sensitivity for Group B patients, and a similar specificity of 80.9%. During a mean follow-up of 9.1±10.1 months, each of the tested dichotomized variables except for SVI predicted AVR or death on multivariate analysis. CONCLUSION: An AVA value ≤.81 cm2 or a DVI ≤ .249 threshold carry the highest discriminative value for severe AS in patients with aortic stenosis, translating into an independent prognostic value, and can be helpful in making clinical decisions.

Interaction between anemia and renal dysfunction in relation to long-term survival following acute myocardial infarction.

BACKGROUND: Anemia and chronic kidney disease (CKD) adversely affect prognosis following acute myocardial infarction (AMI). We aimed to assess their interaction regarding long-term survival post-AMI. METHODS: This is a single-center, retrospective analysis of consecutive AMI survivors. Stratified by admission-time anemia status and CKD grade, as determined by hemoglobin and creatinine levels, the cohort was evaluated for all-cause mortality at 10 years after hospital discharge. RESULTS: A total of 11,395 patients (69.1% males, mean age 65.8 ± 13.9 years, 49.6% with ST elevation MI) were included, of whom 29.9% had anemia and 15.9% - grade 3b or higher CKD. CKD was more advanced among anemic patients and the prevalence of anemia rose as CKD grade increased (p for trend < 0.001). At 10 years, 47.8% of patients died. Notwithstanding differences in baseline characteristics, presentation, and treatment between those with various anemia status and CKD grades, anemia presence (HR 1.40, 95% CI 1.32-1.49, p < 0.001) and increasing CKD grade (HR 1.10, 95% CI 1.02-1.20, p for trend < 0.001) were independently associated with a higher mortality risk. The incremental hazard imposed by either anemia or more advanced CKD was limited to patients with normal renal function and up to grade 3a (in the total cohort and the conservative treatment subgroup) or 4 (in the invasive revascularization subgroup) CKD. The added risk associated with increasing CKD grade also affected non-anemic individuals irrespective of the specific CKD grade. CONCLUSION: Anemia and more advanced CKD are associated with reduced long-term survival post-AMI, inflicting higher risk when conjoined in lower-grade CKD.

Two-Year Clinical Outcomes of Staged Transcatheter Mitral Edge-to-Edge Repair After Transcatheter Aortic Valve Replacement.

Residual significant mitral regurgitation (MR) can increase the risk of adverse events after transcatheter aortic valve replacement (TAVR). The clinical benefits of staged transcatheter edge-to-edge repair (TEER) after TAVR remain underexplored. This study aimed to investigate the clinical outcomes of staged TEER for residual significant MR after TAVR. This observational study included 314 consecutive patients with chronic residual grade 3+ or 4+ MR at the 30-day follow-up after TAVR, with 104 patients (33.1%) treated with staged TEER (TEER group) and 210 (66.9%) with medical therapy alone. The primary composite outcomes were all-cause mortality and heart failure hospitalization at 2 years. Additional analysis, including changes in MR grade and the New York Association functional classification, and subgroup outcome comparisons based on MR etiology were also conducted. In our study, the rate of primary composite outcome was lower in the TEER group than in the medical therapy alone group (33.7% vs 48.1%, p = 0.015). Significant improvement in MR grade and New York Association class was observed in the TEER group after 2 years. The subgroup analysis demonstrated that in patients with degenerative MR, a lower incidence of composite outcome and heart failure hospitalization was observed in the TEER group (hazard ratio 0.35, 95% confidence interval 0.23 to 0.53, p <0.001). In conclusion, staged TEER after TAVR was associated with reduced MR and improved clinical outcomes. The clinical significance of MR after TAVR should be carefully evaluated, and TEER should be considered for patients with significant residual MR, particularly, those with degenerative MR.

TAVR-in-TAVR with a balloon-expandable valve for paravalvular leak.

Introduction: Paravalvular leak (PVL) is a severe complication of transcatheter aortic valve replacement (TAVR) that can lead to poor outcomes. TAVR-in-TAVR is a promising treatment for PVL; however, reports on its safety or efficacy are limited. In this study, we aimed to investigate the clinical outcomes of TAVR-in-TAVR using balloon-expandable prostheses for PVLs after TAVR. Methods: We retrospectively analyzed data from patients who underwent TAVR-in-TAVR using balloon-expandable Sapien prostheses for PVL after an initial TAVR at our institution. The procedural success, in-hospital complications, all-cause mortality, and echocardiographic data for up to 2 years post-surgery were evaluated. Results: In total, 31 patients with a mean age of 81.1 ± 7.9 years and mean Society of Thoracic Surgeons score of 8.8 ± 5.4% were identified. The procedural success rate of TAVR-in-TAVR was 96.8% (30/31). No in-hospital deaths, cardiac tamponade, or conversion to sternotomy occurred. Re-intervention was performed in only one patient (3.2%) during hospitalization. The all-cause mortality rates at 30 days and 2 years were 0% and 16.1%, respectively. A significant reduction in the PVL rate was observed at 30 days compared with that at baseline (p < 0.01). Discussion: Our findings suggest that TAVR-in-TAVR using balloon-expandable prostheses is safe and effective for PVL after TAVR with low complication rates and acceptable long-term outcomes. Further studies with larger sample sizes are needed to confirm our findings.

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.

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.

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.

The Prognostic Value of Pulmonary Venous Flow Reversal in Patients with Significant Degenerative Mitral Regurgitation.

Background: The prognostic significance of pulmonary venous (PV) flow reversal in degenerative mitral regurgitation (dMR) is not well-established. Objective: We aimed to assess whether reversed PV flow is associated with adverse outcomes in patients with significant dMR. Methods: We retrospectively analyzed consecutive patients referred to a tertiary center for evaluation of dMR of greater than moderate degree, who had normal sinus rhythm, had a left ventricular ejection fraction of above 60%, and did not suffer from any other major valvular disorders. The primary outcome was the combined rate of all-cause mortality, mitral intervention, or new-onset atrial fibrillation (AF) at 5 years following index echocardiogram. Secondary outcomes included individual components of the primary outcome. Results: Overall, 135 patients (median age 68 (IQR, 58-74) years; 93 (68.9%) males; 89 (65.9%) with severe MR) met the inclusion criteria and were followed for 115.2 (IQR, 60.0-155.0) months. Patients with a reversed PV flow pattern (PVFP) (n = 34) more often presented with severe MR compared to those with a normal (n = 49) and non-reversed PVFP (n = 101) (RR = 2.03 and 1.59, respectively, all p < 0.001). At 5 years, they experienced the highest cumulative incidence of the primary outcome (80.2% vs. 59.2% and 67.3%, p = 0.008 and 0.018, respectively). Furthermore, a reversed PVFP was independently associated with a higher risk of the primary outcome compared to normal PVFP (HR 2.53, 95% CI 1.21-5.31, p = 0.011) and non-reversed PVFP (HR 2.14, 95% CI 1.12-4.10, p = 0.022). Conclusion: PV flow reversal is associated with a worse 5-year composite of mortality, mitral intervention, or AF in patients with significant dMR.

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.

Progression of Non-Significant Mitral and Tricuspid Regurgitation after Surgical Aortic Valve Replacement for Aortic Regurgitation.

Little is known about the natural history of non-significant mitral and tricuspid regurgitation (MR and TR) following surgical aortic valve replacement (SAVR) for aortic regurgitation (AR). We retrospectively analyzed 184 patients (median age 64 (IQR, 55-74) years, 76.6% males) who underwent SAVR for AR. Subjects with significant non-aortic valvulopathies, prior/concomitant valvular interventions, or congenital heart disease were excluded. The cohort was evaluated for MR/TR progression and, based on the latter's occurrence, for echocardiographic and clinical indices of heart failure and mortality. By 5.8 (IQR, 2.8-11.0) years post-intervention, moderate or severe MR occurred in 20 (10.9%) patients, moderate or severe TR in 25 (13.5%), and either of the two in 36 (19.6%). Patients who developed moderate or severe MR/TR displayed greater biventricular disfunction and functional limitation and were less likely to be alive at 7.0 (IQR, 3.4-12.1) years compared to those who did not (47.2 vs. 79.7%, p < 0.001). The emergence of significant MR/TR was associated with preoperative atrial fibrillation/flutter, symptomatic heart failure, and above-mild MR/TR as well as concomitant composite graft use, but not with baseline echocardiographic measures of biventricular function and dimensions, aortic valve morphology, or procedural aspects. In conclusion, among patients undergoing SAVR for AR, significant MR/TR developed in one fifth by six years, correlated with more adverse course, and was anticipated by baseline clinical and echocardiographic variables.

Left ventricular morphologic progression in apical hypertrophic cardiomyopathy.

BACKGROUND: Left ventricular (LV) morphologic progression in apical hypertrophic cardiomyopathy (AHC) has not been well studied. We evaluated serial echocardiographic changes in LV morphology. METHODS: Serial echocardiograms in AHC patients were assessed. LV morphology was categorized according to the presence of an apical pouch or aneurysm, and LV hypertrophic severity and extent; relative, pure, and apical-mid type defined as mild (<15 mm thickness) apical hypertrophy, significant (≥15 mm) apical hypertrophy, and both apical and midventricular hypertrophy, respectively. Adverse clinical events and late gadolinium enhancement (LGE) extent on cardiac magnetic resonance were evaluated for each morphologic type. RESULTS: In 41 patients, 165 echocardiograms (maximal interval: 4.2 [IQR, 2.3-11.8] years) were evaluated. Morphologic changes were observed in 19 (46%) patients. Eleven (27%) patients displayed the progression of LV hypertrophy toward pure or apical-mid type. Five (12%) and 6 (15%) patients developed new pouches and aneurysms. Patients with progression tended to be younger (50 ± 15.6 vs 59 ± 14.4 years, P = 0.058) and had a longer period of follow-up (12 [5-14] vs 3 [2-4] years, P < 0.001). During a follow-up of 7.6 (IQR 3.0-12.1) years, 21 (51%) experienced clinical events. The relative, pure, and apical-mid types showed different LGE extents (2%, 6%, and 19%, P = 0.004). Patients with severe hypertrophic and apical involvement showed higher clinical event rates. CONCLUSIONS: About half of AHC patients had a progression of LV morphology to more hypertrophic involvement and/or an apical pouch or aneurysm formation. Advanced AHC morphologic types were associated with higher event rates and scar burdens.

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.