Treatment of late paravalvular regurgitation after transcatheter aortic valve implantation: prognostic implications.

AIMS: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated. METHODS AND RESULTS: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]. CONCLUSION: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation.

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.

The impact of anxiety level on decision to seek medical care of non-COVID cardiac patients during the pandemic outbreak-single-center experience in Israel.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has significantly the delivery of healthcare all around the world. In part, an abnormal and unexplained high non-COVID-related cardiovascular mortality rate was reported during the outbreak. We assess the correlation between anxiety level and decision to seek medical care (DSMC) during the COVID-19 pandemic. MATERIALS AND METHODS: We recruited patients with cardiovascular complaints admitted to the emergency department in a single institute in Israel between February and September 2020. Anxiety level was measured using available questionnaires. DSMC was assessed with a newly designed questionnaire (DM-19). RESULTS: Two-hundreds seventy patients were included in the study. The mean age was 52.6 ± 14.9 (females represent 36.2%). 23.6% of the patients had at least moderate cardiovascular risk. High anxiety levels were (HAL) reported in nearly half of the patients (57.1% and 49.8% for General Anxiety Disorder Assessment [GAD-7] and Beck Anxiety Inventory [BAI], respectively). It was more prevalent in old, married, and unemployed patients (significant p-value for all in both questionnaires). Age was an independent factor (χ2 = 6.33, p < 0.001, odds-ratio: 4.8) and had a positive correlation on anxiety level (r = 0.81, p < 0.001 and r = 0.62, p < 0.001, for GAD-7 and BAI, respectively). The DM-19 revealed a strong and positive correlation of seeking medical care with anxiety level (R2 linear = 0.44, r = 0.70, p < 0.001 and R2 linear = 0.30, r = 0.58, p < 0.001 for GAD-7 and BAI, respectively) and results in deferring medical care for several days than patient with low anxiety level (p = 0.02). CONCLUSIONS: We observed an abnormal prevalence of a high level of anxiety among non-COVID patients with cardiovascular complaints, which affected the patient's likelihood to seek medical care and resulted in an unreasonable postponement of medical treatment. Our results may explain cardiovascular mortality trends during the outbreak and should be considered in health crisis management. Future studies will involve multi-institutional efforts to address reproducibility of our findings across geographic regions in the state of the global impact. Additionally, it is imperative to understand the effects of the coronavirus vaccine on patient consideration to seek medical care.

Sinus Node Dysfunction due to Occlusion of the Sinus Node Artery during Percutaneous Coronary Intervention.

BACKGROUND: Sinus node artery occlusion (SNO) is a rare complication of percutaneous coronary intervention (PCI). We analyze both the short- and long-term consequences of SNO. METHODS: We retrospectively reviewed 1379 consecutive PCI's involving RCA and Cx arteries performed in our heart institute from 2016 to 2019. Median follow-up was 44 ± 5 months. RESULTS: Among the 4844 PCIs performed during the study period, 284 involved the RCA and the circumflex's proximal segment. Periprocedural SNO was estimated by angiography observed in 15 patients (5.3%), all originated from RCA. The majority of SNO occurred during urgent and primary PCIs following acute coronary syndrome (ACS). Sinus node dysfunction (SND) appeared in 12 (80%) of patients. Four (26.6%) patients had sinus bradycardia, which resolved spontaneously, and 8 (53.3%) patients had sinus arrest with an escaped nodal rhythm, which mostly responded to medical treatment during the first 24 hours. There was no association between PCI technique and outcome. Three patients (20%) required urgent temporary ventricular pacing. One patient had permanent pacemaker implantation. Pacemaker interrogation during follow-up revealed a recovery of the sinus node function after one month. CONCLUSION: SNO is rare and seen mostly during angioplasty to the proximal segment of the RCA during ACS. The risk of developing sinus node dysfunction following SNO is high. SND usually appears during the first 24 h of PCI. The majority of SND patients responded to medical treatment, and only in rare cases were permanent pacemakers required.

Tricuspid regurgitation in ischemic mitral regurgitation patients: prevalence, predictors for outcome and long-term follow-up.

BACKGROUND: Functional tricuspid regurgitation (FTR) is common in left-sided heart pathology involving the mitral valve. The incidence, clinical impact, risk factors, and natural history of FTR in the setting of ischemic mitral regurgitation (IMR) are less known. METHOD: We conducted a cohort study based on data collected from January 2012 to December 2014. Patients diagnosed with IMR were eligible for the study. The median follow-up was 5 years. The primary outcome is defined as FTR developing at any stage. RESULTS: Among the 134 IMR patients eligible for the study, FTR was detected in 29.9% (N = 40, 20.0% mild, 62.5% moderate, and 17.5% severe). In the FTR group, the average age was 60.7 ± 9.2 years (25% females), the mean LV ejection fraction (LVEF) was 37.3 ± 6.45 [%], LA area 46.4 ± 8.06 (mm2), LV internal diastolic diameter (LVIDD) 59.6 ± 3.94 (mm), RV fractional area change 22.3 ± 4.36 (%), systolic pulmonary artery pressure (SPAP) 48.4 ± 9.45 (mmHg). Independent variables associated with FTR development were age ≥ 65y [OR 1.2], failed revascularization, LA area ≥ 42.5 (mm2) [OR 17.1], LVEF ≤ 24% [OR 32.5], MR of moderate and severe grade [OR 419.4], moderate RV dysfunction [OR 91.6] and pulmonary artery pressure of a moderate or severe grade [OR 33.6]. During follow-up, FTR progressed in 39 (97.5%) patients. Covariates independently associated with FTR progression were lower LVEF, RV dysfunction, and PHT of moderate severity. LA area and LVIDD were at the margin of statistical significance (p = 0.06 and p = 0.05, respectively). CONCLUSION: In our cohort study, FTR development and progression due to IMR was a common finding. Elderly patients with ischemic MR following unsuccessful PCI are at higher risk. FTR development and severity are directly proportional to LV ejection fraction, to the extent of mitral regurgitation, and SPAP. FTR tends to deteriorate in the majority of patients over a mean of 5-y follow-up.

Outcomes and safety of concurrent coronary and peripheral catheterization (REVascularization in concomitant PERIpheral artery disease and coronary artery disease REV-PERICAD Study).

BACKGROUND: Atherosclerosis affects various vascular beds, such as the coronary and carotid arteries and peripheral vessels, of the lower limbs. Current recommendations for treating multiple vascular beds include targeted catheterization at different intervals and are mainly intended to avoid kidney injury. We examined the efficacy and safety of simultaneous coronary and lower limb catheterization. METHODS: This retrospective cohort study included 121 patients who underwent catheterization between January 2008 and December 2016. Patients were divided into four groups: 20 (16.5%) simultaneously underwent coronary and peripheral vascular bed catheterization; 32 (26%) underwent separate procedures (time interval between procedures >2 months); 50 (41%) underwent staged procedure (time interval ≤2 months); and 19 (16%) underwent only peripheral catheterization (single procedure). RESULTS: No significant between-group differences were observed regarding demographic variables except for sex and diabetes and congestive heart failure incidences. Almost half of all the patients who underwent a single procedure were symptomatic. The successful peripheral catheterization rate was significantly higher in the single procedure group, with no significant difference among the other groups. There were no significant between-group differences with respect to major cardiovascular events, 30-day mortality, mortality within 1 year, and 24-hr vascular complication rate/acute renal failure incidences. CONCLUSION: Our study demonstrates the efficacy and safety of concurrent catheterization of coronary arteries and lower limb arteries, regardless of the time interval between these two procedures. Simultaneous catheterization of different vascular beds is an effective, timesaving, and safe option. Our findings should be verified in a large-scale prospective study involving additional vascular beds.

Epinephrine soaked tampons induced transient acute dilated cardiomyopathy during FESS procedure.

BACKGROUND: Epinephrine, in all modes of use, may pose a wide range of cardiotoxic events, ranging from sinus tachycardia to heart failure, life threatening arrhythmias, and even death. Because of daily and extensive use of epinephrine, these unusual and rare events tend to be forgotten by physicians. We present a case of dilated cardiomyopathy that developed following routine use of epinephrine-impregnated tampons during function endoscopic sinus (FESS) surgery. CASE PRESENTATION: A healthy, 24-year-old man with no family history of heart disease has undergone elective surgery under general anesthesia to repair the paranasal sinuses using endoscopic approach. During surgery, soon after being treated with 1: 1000 diluted epinephrine-soaked tampons, an hypertensive crisis was noticed followed by pulseless electrical activity. An extensive examination led to the diagnosis of non-ischemic dilated cardiomyopathy. After several days of heart failure medical therapy, complete resolution of all structural and functional changes was achieved. CONCLUSION: In our case, we present an unusual and rare event of acute dilated cardiomyopathy following the use of epinephrine-soaked tampons during elective FESS surgery. A prompt response was observed after several days of heart failure treatment. Awareness of the epinephrine cardiotoxic potential even in the form of soaked tampons is essential for proper diagnosis and prompt treatment.

Role of thrombin generation assays in the diagnosis of acute myocarditis and non-ST myocardial infarction.

Myocarditis and myocardial infarction share a common clinical characteristics despite significant differences in etiology and pathogenesis. Current guidelines recommend using cardiac magnetic resonance imaging (MRI) or endocardial biopsy for a definite diagnosis; however, these guidelines are not fully implemented due to the high cost and low availability. We used a thrombin generation assay and simple blood test to characterize both diseases. We conducted a cross-sectional study from April to December 2018. Patients with initial clinical suspicions of non-ST elevation myocardial infarction (NSTEMI) or myocarditis were eligible. All patients were recruited prior to anticoagulant treatment. Patients in both groups underwent acceptable standard clinical evaluation. Twenty-eight patients were enrolled; 12 patients in the NSTEMI group and 16 in the myocarditis group. Patients in the NSTEMI group were significantly older than those in the myocarditis group (64.25 ± 9.67 vs. 37.94 ± 19.66 years, p < 0.01, respectively) with a higher prevalence of hyperlipidemia, diabetes mellitus, and ischemic heart disease (p < 0.01 for all). There was no difference between the groups regarding INR, PT, aPTT, and serum levels of creatinine, urea, CPK, troponin, and fibrinogen. Endogenous thrombin potential (ETP), which represents the total thrombin concentration in the plasma, was significantly higher in the myocarditis group than in the NSTEMI group (2091.88 ± 336.41 vs. 1860.75 ± 438.02 nM × min, p < 0.03). Myocarditis and myocardial infarction have a different pattern of thrombin generation Thrombogram. The myocarditis group had significantly higher plasma ETP than the NSTEMI group. This finding requires further evaluation to define a numerical threshold, thus avoiding invasive or expensive assessment of myocarditis.

Long-Term Survival of Discharged Patients Admitted to Intensive Coronary Care Unit after Out-of-Hospital Cardiac Arrest.

BACKGROUND: Survival of patients who were discharged from the hospital following out-of-hospital cardiac arrest (OHCA) has not been well defined. OBJECTIVES: To verify predictor variables for prognosis of patients following OHCA who survived hospitalization. METHODS: We retrospectively reviewed clinical, demographic, and outcome data of consecutive patients who were hospitalized from January 1, 2009, through December 31, 2014, into the intensive coronary care unit (ICCU) after aborted OHCA and discharged alive. The patients were followed until December 31, 2015. RESULTS: Of the 180 patients who were admitted into ICCU after OHCA, 64 were discharged alive (59.3%): 55 were male (85.9%), 14 died 16.5 ± 18 months after their discharge. During 1 year follow-up, nine patients (14.1%) died after a median period of 5.5 months and 55 patients (85.9 %) survived. Diabetes mellitus and chronic renal failure (CRF) were more frequent in patients who died within 1 year after their hospital discharge than those who survived. Ventricular fibrillation, such as initial arrhythmia, and opening of occluded infarct related artery were more frequent in survivors. CONCLUSIONS: Most of the patients who were discharged after OHCA were alive at the 1 year follow-up. The risk of death of cardiac arrest survivors is greatest during the first year after discharge. CRF remains a poor long-term prognostic factor beyond the patients' discharge. Ventricular fibrillation, as initial arrhythmia, and opening of occluded infarct related artery have a positive impact on long-term survival.

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.

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.

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation after TAVR in Sievers Type-1 Bicuspid Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: To identify the incidence, predictors, and clinical outcomes of PVR following TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with severe Sievers type 1 BAV stenosis undergoing TAVR with current generation transcatheter heart valves (THVs) in 24 international centres were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAE), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%): mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were larger virtual raphe ring (VRR) perimeter (ORadj 1.07, 95% CI 1.02-1.13), severe annular or left ventricular outflow tract (LVOT) calcification (ORadj 5.21, 95% CI 1.45-18.77), self-expanding valve (ORadj 9.01, 95% CI 2.09-38.86), and intentional supra-annular THV positioning (ORadj 3.31, 95% CI 1.04-10.54). At a median follow-up of 1.3 [IQR 0.5-2.4] years, moderate or severe PVR was associated with an increased risk of MAE (HRadj 2.52, 95% CI 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAE during follow-up.

Leaflet thrombosis in transcatheter aortic valve intervention: mechanisms, prevention, and treatment options.

Introduction: Transcatheter aortic valve intervention (TAVR) has emerged as a promising alternative to surgical aortic valve replacement for patients with severe aortic stenosis. However, leaflet thrombosis has raised concerns about the long-term durability and outcomes of TAVR. This study aims to provide an overview of the mechanisms, prevention strategies, and treatment options for leaflet thrombosis in TAVR. Clinical evidence: Leaflet thrombosis refers to the formation of blood clots on bioprosthetic valve leaflets, leading to impaired leaflet mobility, early valve degeneration and dysfunction, and potential clinical implications. While the mechanisms underlying thrombus formation on valve leaflets are not fully understood, several factors, such as altered blood flow patterns within valve neosinuses, prothrombotic surfaces, and patient-related causes, have been implicated. Two distinct entities have been identified, namely, hypoattenuated leaflet thickening and restricted leaflet motion. Their occurrence appears dynamic over time and is related to the valve type. Imaging, including transesophageal echocardiography and multidetector computed tomography, plays a crucial role in the diagnosis and follow-up of leaflet thrombosis. Prevention and treatment options: Preventing leaflet thrombosis requires a comprehensive and tailored approach involving identifying high-risk patients, close monitoring, and antithrombotic therapy. Antithrombotic therapy with dual antiplatelet agents or anticoagulation is commonly employed in TAVR patients, although the optimal regimen is yet to be defined. Novel antithrombotic agents, such as direct oral anticoagulants, are being investigated for their efficacy and safety in preventing leaflet thrombosis. When leaflet thrombosis is detected, treatment options include intensified antithrombotic therapy, valve-in-valve intervention, or balloon valvuloplasty. The long-term outcomes and impact of leaflet thrombosis on valve durability and patient prognosis are areas of ongoing research. Summary: Leaflet thrombosis in TAVR is a considerable complication affecting valve function and patient outcomes. Understanding the mechanisms underlying thrombus formation and implementing appropriate prevention strategies are essential for mitigating this risk. Treatment options aim to restore leaflet mobility and optimize valve performance. Further research is needed to establish standardized protocols for antithrombotic therapy, identify high-risk patient populations, and determine the long-term consequences of leaflet thrombosis on TAVR outcomes.

Hemodynamic and Mid-Term Outcomes for Transcatheter Aortic Valve Replacement in Degenerated Internally Stented Valves.

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement is indicated in patients undergoing repeat intervention for degenerative aortic valve bioprostheses. Patients with internally stented valves (ie, Mitroflow and Trifecta) are at high risk for coronary artery obstruction during ViV procedures because of valve design, as the leaflets are mounted outside the valve stent. OBJECTIVES: The aim of this study was to compare the hemodynamic and clinical outcomes of transcatheter aortic valve replacement within internally stented valves (ViV-IS) vs other surgical valves (ViV-OS). METHODS: Baseline characteristics, hemodynamic parameters, and clinical outcomes of patients who underwent ViV-IS were retrospectively collected and compared with those of patients who underwent ViV-OS. RESULTS: A total of 250 patients (65% men, median Society of Thoracic Surgeons score 4.4% [IQR: 2.2%-8.4%]) were included. Seventy-one patients (28%) underwent ViV-IS, and 179 (72%) patients underwent ViV-OS. Patients who underwent ViV-OS had better periprocedural hemodynamic status compared with those who underwent ViV-IS (median mean gradient 6 [IQR: 2-13] vs 12 [IQR: 6-16]; P < 0.001). This was not significantly different when both groups were matched on the basis of age, sex, and valve internal diameter size (median mean gradient: 18 [IQR: 13-25] for ViV-OS vs 18 [IQR: 11-24] for ViV-IS; P = 0.36). Coronary protection for potential occlusion was performed more in ViV-IS vs ViV-OS pr (79% vs 6%, respectively; P < 0.001). Patients who underwent ViV-IS had a higher risk for coronary occlusion, requiring stent deployment, compared with those who underwent ViV-OS (54% vs 3%, respectively; P < 0.001. There was no difference in mortality at 3 years between the 2 groups (P = 0.59). CONCLUSIONS: Patients who underwent ViV-IS had a very high incidence of coronary compromise that can be safely and effectively treated. In the setting of a systematic coronary protection strategy, ViV-OS and ViV-IS provide similar mid-term outcome, and periprocedural hemodynamic status (following adjustment for age, sex, and true internal diameter).

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.