Predictors of optimal procedural result after transcatheter edge-to-edge mitral valve repair in secondary mitral regurgitation.

BACKGROUND: Procedural success after transcatheter edge-to-edge mitral valve repair (TEER) is defined as a reduction of mitral regurgitation (MR) degree to

Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis.

AIMS: In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). METHODS AND RESULTS: Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%). CONCLUSION: While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.

Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: Insights from the Italian Clinical Service Project.

AIMS: We aim at exploring whether severe chronic kidney disease (CKD) may modify the impact of acute kidney injury (AKI) post-transcatheter aortic valve implantation (TAVI) on early, mid, and long-term mortality. METHODS AND RESULTS: The analysis included 2,733 TAVI patients from the Italian Clinical Service Project. The population was stratified in four groups according to the presence of baseline severe CKD and postprocedural AKI. All-cause mortality was the primary end point. Postprocedural AKI is associated with an increased risk of early and mid-term mortality after TAVI regardless of baseline severe CKD. Preprocedural severe CKD is associated with an increased risk of long-term mortality after TAVI regardless of postprocedural AKI. No interaction between preprocedural severe CKD and postprocedural AKI was observed in predicting mortality at both 30-day (CKD: hazard ratio [HR] = 2.65, 95% confidence interval [CI] = 1.15-6.12; no-CKD: HR = 3.83, 95% CI = 2.23-6.58; Pint = .129) and 1-year (CKD: HR = 2.29, 95% CI = 1.37-3.82; no-CKD: HR = 2.47, 95% CI = 1.75-3.49; Pint = .386). Preprocedural severe CKD is an independent predictor of postprocedural AKI (HR = 2.17, 95% CI = 1.56-3.03; p < .001) as well as general anesthesia and access alternative to femoral. Among no-AKI patients, those with severe CKD at admission underwent kidney function recovery after TAVI (serum creatinine at baseline 2.24 ± 1.57 mg/dL and at 48-hr 1.80 ± 1.17 mg/dL; p = .003). CONCLUSIONS: Preprocedural severe CKD did not modify the impact of postprocedural AKI in predicting early and mid-term mortality after TAVI. Closely monitoring of serum creatinine and strategies to prevent AKI post-TAVI are needed also in patients without severe CKD at admission.

Five-year clinical outcomes after percutaneous edge-to-edge mitral valve repair: Insights from the multicenter GRASP-IT registry.

Limited evidence is available on 5-year clinical outcomes after percutaneous edge-to-edge mitral valve repair. METHODS: The Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation in ITaly (GRASP-IT) is a multicenter registry including 304 consecutive patients undergoing Mitraclip between October 2008 and October 2013 at 4 Italian centers. Primary end point (all-cause mortality) and secondary end point (all-cause mortality or heart failure [HF] hospitalization) were evaluated up to 5 years and between 1 and 5 years. RESULTS: Cumulative incidence of the primary and secondary end points at 1, 2, 3, 4, and 5 years were 15.1%, 26.4%, 35.5%, 42.1%, and 47.3% and 29.1%, 41.7%, 49.8%, 56%, and 62.3%, respectively. Landmark analysis between 1 and 5 years showed an incidence of primary and secondary end point of 37.9% and 46.8%, respectively. Five-year event rates were significantly higher in patients with functional ischemic mitral regurgitation (MR) compared to other etiologies. MR recurrence and left ventricular ejection fraction <30% were associated with an increased risk of both primary and secondary end points. EuroSCORE II >5% was associated with an increased risk of 5-year mortality. Ischemic etiology of MR, baseline serum creatinine >1.5 mg/dL, chronic obstructive pulmonary disease, and previous HF hospitalizations were independent predictors of 5-year secondary end point. CONCLUSIONS: At 5-year follow-up after Mitraclip, nearly half of patients died and almost two thirds died or were admitted for HF. MR recurrence, ischemic etiology, high comorbidity burden (ie, EuroSCORE II >5%, chronic obstructive pulmonary disease), and advanced cardiomyopathy (ie, left ventricular ejection fraction <30%, prior HF admission, creatinine >1.5 mg/dL) significantly increase the relative risk of 5-year clinical events.

Predictors of clinical outcomes after edge-to-edge percutaneous mitral valve repair.

BACKGROUND: There is limited information on the long-term outcomes and prognostic clinical predictors after edge-to-edge transcatheter mitral valve repair with the MitraClip system. METHODS: Consecutive patients with mitral regurgitation (MR) undergoing MitraClip therapy between October 2008 and November 2013 in 4 Italian centers were analyzed. The primary end point of interest was all-cause death. The secondary end point was the composite of all-cause death or rehospitalization for heart failure. RESULTS: A total of 304 patients were included, of which 79% had functional MR and 17% were in New York Heart Association functional class IV. Acute procedural success was obtained in 92% of cases, with no intraprocedural death. The cumulative incidences of all-cause death were 3.4%, 10.8%, and 18.6% at 30 days, 1 year, and 2 years, respectively. The corresponding incidences of the secondary end point were 4.4%, 22.0%, and 39.7%, respectively. In the Cox multivariate model, New York Heart Association functional class IV at baseline and ischemic MR etiology were found to significantly and independently predict both the primary and the secondary end point. A baseline, left ventricular end-systolic volume >110 mL was found to be an independent predictor of the secondary endpoint. Acute procedural success was independently associated with a lower risk of all-cause death and the combination of all-cause death or rehospitalization for heart failure at long-term follow-up. CONCLUSIONS: In a cohort of patients undergoing MitraClip therapy, those presenting at baseline with ischemic functional etiology, severely dilated ventricles, or advanced heart failure and those undergoing unsuccessful procedures carried the worst prognosis.

Effectiveness of MitraClip therapy in patients with refractory heart failure.

OBJECTIVES: To assess outcomes for MitraClip therapy in patients with refractory heart failure (HF) and mitral regurgitation (MR) ≥3+. BACKGROUND: The beneficial role of Mitraclip also in patients with severe HF has been reported. METHODS: Out of 45 patients undergoing MitraClip implantation at our institute, 16 were on refractory HF defined as diuretics and/or inotropics infusion and/or IABP dependence (group A) or labile haemodynamic balance (group B). RESULTS: Patients were aged 69 ± 13 years and 75% were males. Group A (8 patients) had a mean hospitalization length before MitraClip procedure of 5333 days. Group B (8 patients) had a mean rate of hospitalization, in the last 50 days before procedure, of 254 days. Acute procedural success was observed in 94% of patients. All but one patients of group A were quickly weaned from pharmacologic and/or mechanical supports within 5 ± 3 days from procedure and discharged at 20±10 days. All patients of group B were discharged after 10±8 days from MitraClip. At 1 year: a) cumulative survival rate was 78%; b) all patients were in NYHA functional class ≤ II; c) residual MR ≤ 2 was observed in 90%; d) systolic pulmonary arterial pressure was significantly reduced compared to the baseline (from 5410 to 398; p = 0,008); e) significant reduction of cumulative HF hospitalization days in the post-procedure year (10 days) compared to the pre-implantation year (280 days; p = 0.023) was observed. CONCLUSIONS: In patients with refractory HF and MR ≥3+, MitraClip implantation resulted in acute and persistent clinical benefit and net reduction of HF re-hospitalization.

Deep learning to predict long-term mortality from plain chest X-ray in patients referred for suspected coronary artery disease.

Background: The hypothesis that a deep learning (DL) model can produce long-term prognostic information from chest X-ray (CXR) has already been confirmed within cancer screening programs. We summarize our experience with DL prediction of long-term mortality, from plain CXR, in patients referred for angina and coronary angiography. Methods: Data of patients referred to an Italian academic hospital were analyzed retrospectively. We designed a deep convolutional neural network (DCNN) that, from CXR, could predict long-term mortality. External validation was performed on patients referred to a Dutch academic hospital. Results: A total of 6,031 were used for model training (71%; n=4,259) and fine-tuning/validation (10%; n=602). Internal validation was performed with the remaining patients (19%; n=1,170). Patients' stratification followed the DL-CXR risk score quartiles division. Median follow-up was 6.1 years [interquartile range (IQR), 3.3-8.7 years]. We observed an increment in estimated mortality with the increase of DL-CXR risk score (low-risk 5%, moderate 17%, high 29%, very high 46%; P<0.001). The DL-CXR risk score predicted median follow-up outcome with an area under the curve (AUC) of 0.793 [95% confidence interval (CI): 0.759-0.827, sensitivity 78%, specificity 68%]. Prediction was better than that achieved using coronary angiography findings (AUC: 0.569, 95% CI: 0.52-0.61, P<0.001) and age (AUC: 0.735, 95% CI: 0.69-0.77, P<0.004). At Cox regression, the DL-CXR risk score predicted follow-up mortality (P<0.005, hazard ratio: 3.30, 95% CI: 2.35-4.64). External validation confirmed the DL-CXR risk score performance (AUC: 0.71, 95% CI: 0.49-0.92; sensitivity 0.838; specificity 0.338). Conclusions: In patients referred for coronary angiogram because of angina, the DL-CXR risk score could be used to stratify mortality risk and predict long-term outcome better than age and coronary artery disease status.

Deep learning to detect significant coronary artery disease from plain chest radiographs AI4CAD.

BACKGROUND: The predictive role of chest radiographs in patients with suspected coronary artery disease (CAD) is underestimated and may benefit from artificial intelligence (AI) applications. OBJECTIVES: To train, test, and validate a deep learning (DL) solution for detecting significant CAD based on chest radiographs. METHODS: Data of patients referred for angina and undergoing chest radiography and coronary angiography were analysed retrospectively. A deep convolutional neural network (DCNN) was designed to detect significant CAD from posteroanterior/anteroposterior chest radiographs. The DCNN was trained for severe CAD binary classification (absence/presence). Coronary angiography reports were the ground truth. Stenosis severity of ≥70% for non-left main vessels and ≥ 50% for left main defined severe CAD. RESULTS: Information of 7728 patients was reviewed. Severe CAD was present in 4091 (53%). Patients were randomly divided for algorithm training (70%; n = 5454) and fine-tuning/model validation (10%; n = 773). Internal clinical validation (model testing) was performed with the remaining patients (20%; n = 1501). At binary logistic regression, DCNN prediction was the strongest severe CAD predictor (p < 0.0001; OR: 1.040; CI: 1.032-1.048). Using a high sensitivity operating cut-point, the DCNN had a sensitivity of 0.90 to detect significant CAD (specificity 0.31; AUC 0.73; 95% CI DeLong, 0.69-0.76). Adding to the AI chest radiograph interpretation angina status improved the prediction (AUC 0.77; 95% CI DeLong, 0.74-0.80). CONCLUSION: AI-read chest radiographs could be used to pre-test significant CAD probability in patients referred for suspected angina. Further studies are required to externally validate our algorithm, develop a clinically applicable tool, and support CAD screening in broader settings.

Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results.

BACKGROUND: Recent trials showed that TAVI is neither inferior nor superior to surgical aortic valve replacement. The aim of this study was to evaluate the outcomes of Sutureless and Rapid Deployment Valves (SuRD-AVR) when compared to TAVI in low surgical risk patients with isolated aortic stenosis. METHODS: Data from five European Centers were retrospectively collected. We included 1306 consecutive patients at low surgical risk (EUROSCORE II < 4) who underwent aortic valve replacement by means of SuRD-AVR (n = 636) or TAVI (n = 670) from 2014 to 2019. A 1:1 nearest-neighbor propensity-score was performed, and two balanced groups of 346 patients each were obtained. The primary endpoints of the study were: 30-day mortality and 5-year overall survival. The secondary endpoint was 5-year survival freedom from major adverse cardiovascular and cerebrovascular events (MACCEs). RESULTS: Thirty-day mortality was similar between the two groups (SuRD-AVR:1.7%, TAVI:2.0%, p = 0.779), while the TAVI group showed a significantly lower 5-year overall survival and survival freedom from MACCEs (5-year matched overall survival: SuRD-AVR: 78.5%, TAVI: 62.9%, p = 0.039; 5-year matched freedom from MACCEs: SuRD-AVR: 64.6%, TAVI: 48.7%, p = 0.004). The incidence of postoperative permanent pacemaker implantation (PPI) and paravalvular leak grade ≥ 2 (PVL) were higher in the TAVI group. Multivariate Cox Regression analysis identified PPI as an independent predictor for mortality. CONCLUSIONS: TAVI patients had a significantly lower five-year survival and survival freedom from MACCEs with a higher rate of PPI and PVL ≥ 2 when compared to SuRD-AVR.

Valve-in-Valve Implantation of Medtronic CoreValve Prosthesis in Patients With Failing Bioprosthetic Aortic Valves: Mid-term Outcomes From the Italian CoreValve Clinical Service Project.

OBJECTIVES: We evaluated the acute and two-year safety and efficacy of using the Corevalve, Evolut R, and Evolut PRO valves for treating failed surgical bioprosthesis from the Italian CoreValve Clinical Service Project. BACKGROUND: Valve-in-valve (ViV) TAVR is an emerging treatment option for failed surgical bioprosthesis. Choice of transcatheter valve is an important determinant of procedural and clinical outcomes, however, longer-term data are lacking. METHODS: The Clinical Service Project is a national clinical data repository evaluating the use of implantable devices across Italy. The present multi-center analysis includes consecutive patients who underwent ViV-TAVR with the Medtronic CoreValve series between October 2008 to June 2019. Evaluated endpoints included rates of overall mortality, cardiovascular mortality, myocardial infarction, and cerebrovascular accidents at 2-year follow-up. Procedural success, complications, and echocardiographic outcomes were reported according to VARC-2 criteria. RESULTS: A total of 139 patients (mean age, 80 ± 7 years; 47.5% male; mean STS score, 10.0 ± 9.7%) underwent ViV-TAVR with CoreValve (28.5%), Evolut R (68.6%), and Evolut Pro (2.9%) valves. Device success was achieved in 68% and acute coronary obstruction requiring PCI was observed in 4 patients (2.9%). Moderate PVL was observed in 3.7% and 2.8% of patients at 30-day and 2-year follow-up and moderate structural valve degeneration seen only 5 patients (3.6%). All-cause and cardiovascular mortality were 3.6% and 2.9% at 30 days, respectively, and 20.6% and 10.2% at 2-year follow-up. CONCLUSIONS: This real-world nationwide analysis demonstrates the acute and longer-term safety and efficacy of using the self-expanding Medtronic THV for ViV-TAVR.

Safety, Efficacy and Long-Term Outcomes of Patients Treated with the Occlutech Paravalvular Leak Device for Significant Paravalvular Regurgitation.

Between December 2014 and March 2021, 144 patients with aortic (Ao) or mitral (Mi) paravalvular leaks (PVLs) were enrolled at 21 sites in 10 countries. Safety data were available for 137 patients, who were included in the safety analysis fraction (SAF), 93 patients with Mi PVLs and 44 patients with Ao PVLs. The full analysis set (FAS) comprised 112 patients with available stratum (aortic/mitral leak) as well as baseline (BL), 180-day or later assessments (2 years). Procedural success (implantation of the device with a proper closure of the PVL, defined as reduction in paravalvular regurgitation of ≥one grade as assessed by echocardiography post implantation) was achieved in 91.3% of FAS patients with Mi PVLs and in 90.0% of those with Ao PVLs. The proportion of patients suffering from significant or severe heart failure (HF), classified as New York Heart Association (NYHA) class III/IV, decreased from 80% at baseline to 14.1% at 2-year follow-up (FAS). The proportion of FAS patients needing hemolysis-related blood transfusion decreased from 35.5% to 3.8% and from 8.1% to 0% in Mi patients and Ao patients, respectively. In total, 35 serious adverse events (SAEs) were reported in 27 patients (19.7%) of the SAF population. The SAEs considered possibly or probably related to the device included device embolization (three patients), residual leak (two patients) and vascular complication (one patient). During follow-up, 12/137 (8.8%) patients died, but none of the deaths was considered to be device-related. Patients implanted with the Occlutech Paravalvular Leak Device (PLD) showed long-lasting improvements in clinical parameters, including NYHA class and a reduced dependency on hemolysis-related blood transfusions.

Effect of Chronic Kidney Disease on 5-Year Outcome in Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Percutaneous MitraClip Insertion.

Chronic kidney disease (CKD) is strongly related to outcomes in cardiovascular diseases. Limited data are available regarding the independent prognostic role of CKD after transcatheter mitral valve repair with MitraClip. We sought to evaluate the real impact of CKD in a large series of patients with heart failure (HF) and secondary mitral regurgitation (SMR) who underwent MitraClip treatment. The study included 565 patients with severe SMR from a multicenter international registry. Patients were stratified into 3 groups according to estimated glomerular filtration rate (eGFR) assessment before MitraClip implantation: normal eGFR (≥60 ml/min/1.73 m2) (n = 196), mild-to-moderate CKD (30 to 59 ml/min/1.73 m2) (n = 267), and severe CKD (<30 ml/min/1.73 m2) (n = 102). The primary end point was a composite of overall death and the first rehospitalization for HF, the secondary end points were overall death, cardiac death, and first rehospitalization for HF. CKD was present in about 2/3 of patients. At 5-year Kaplan-Meier analysis, primary clinical end point occurred in 60% of patients with normal eGFR, compared with 73% cases in patients with mild-to-moderate CKD and 91% in patients with severe CKD (p <0.001). Long-term overall death rate significantly decreased with increasing eGFR, and cardiac death and rehospitalization for HF rates. Multivariate Cox regression analysis identified severe CKD as the strongest independent predictor of adverse outcome (hazard ratio 2.136, 95% confidence interval 1.164 to 3.918, p = 0.014). In conclusion, CKD affected about 2/3 of patients who underwent MitraClip treatment for severe SMR, and it was a strong and independent predictor of 5-year adverse outcomes.

Prognostic Impact of Nutritional Status After Transcatheter Edge-to-Edge Mitral Valve Repair: The MIVNUT Registry.

Background Malnutrition is associated with poor prognosis in several cardiovascular diseases. However, its prognostic impact in patients undergoing transcatheter edge-to-edge mitral valve repair (TEER) is not well known. This study sought to assess the prevalence, clinical associations, and prognostic consequences of malnutrition in patients undergoing TEER. Methods and Results A total of 892 patients undergoing TEER from the international MIVNUT (Mitral Valve Repair and Nutritional Status) registry were studied. Malnutrition status was assessed with the Controlling Nutritional Status score. The association of nutritional status with mortality was analyzed with multivariable Cox regression models, whereas the association with heart failure admission was assessed by Fine-Gray models, with death as a competing risk. According to the Controlling Nutritional Status score, 74.4% of patients with TEER had any degree of malnutrition at the time of TEER (75.1% in patients with body mass index <25 kg/m2, 72.1% in those with body mass index ≥25 kg/m2). However, only 20% had moderate-severe malnutrition. TEER was successful in most of patients (94.2%). During a median follow-up of 1.6 years (interquartile range, 0.6-3.0), 267 (29.9%) patients died and 256 patients (28.7%) were admitted for heart failure after TEER. Compared with normal nutritional status moderate-severe malnutrition resulted a strong predictor of mortality (adjusted hazard ratio [HR], 2.1 [95% CI, 1.1-2.4]; P<0.001) and heart failure admission (adjusted subdistribution HR, 1.6 [95% CI, 1.1-2.4]; P=0.015). Conclusions Malnutrition is common among patients submitted to TEER, and moderate-severe malnutrition is strongly associated with increased mortality and heart failure readmission. Assessment of nutritional status in these patients may help to improve risk stratification.

A Score to Assess Mortality After Percutaneous Mitral Valve Repair.

BACKGROUND: Risk stratification for transcatheter edge-to-edge mitral valve repair (TEER) is paramount in the decision-making process for treating severe mitral regurgitation (MR). OBJECTIVES: This study sought to create and validate a user-friendly score (MitraScore) to predict the risk of mortality in patients undergoing TEER. METHODS: The derivation cohort was based on a multicentric international registry that included 1,119 patients referred for TEER between 2012 and 2020. Score discrimination was assessed using Harrell's c-statistic, and the calibration was evaluated with the Gronnesby and Borgan goodness-of-fit test. An external validation was carried out in 725 patients from the GIOTTO registry. RESULTS: After multivariate analysis, we identified 8 independent predictors of mortality during the follow-up (2.1 ± 1.8 years): age ≥75 years, anemia, glomerular filtrate rate <60 mL/min/1.73 m2, left ventricular ejection fraction <40%, peripheral artery disease, chronic obstructive pulmonary disease, high diuretic dose, and no therapy with renin-angiotensin system inhibitors. The MitraScore was derived by assigning 1 point to each independent predictor. The c-statistic was 0.70. Per each point of the MitraScore, the relative risk of mortality increased by 55% (HR: 1.55; 95% CI: 1.44-1.67; P < 0.001). The discrimination and calibration for mortality prediction was better than those of EuroSCORE II (c-statistic 0.61) or Society of Thoracic Surgeons score (c-statistic 0.57). The MitraScore maintained adequate performance in the validation cohort (c-statistic 0.66). The score was also predictive for heart failure rehospitalization and was correlated with the probability of clinical improvement. CONCLUSIONS: The MitraScore is a simple prediction algorithm for the prediction of follow-up mortality in patients treated with TEER.

Percutaneous Edge-to-Edge Mitral Valve Repair: Beyond the Left Heart.

Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are known to be associated with adverse outcomes in patients undergoing percutaneous mitral valve repair (PMVR). Although the effect of PMVR on left ventricular function is well known, data on the response of the right ventricle to PMVR, and its impact on prognosis, are limited. In this review the authors summarize available data regarding the prognostic role of RV function and TR in PMVR recipients and the possible effects of PMVR on the right heart. Preprocedural tricuspid annular plane systolic excursion < 15 mm, tricuspid annular tissue Doppler S' velocity < 9.5 cm/sec, and moderate or severe TR are reported as predictors of adverse outcome after PMVR. Therefore, they should be carefully evaluated for patient selection. Moreover, emerging data show that the benefit of PMVR may go beyond the left heart, leading to an improvement in RV function and a reduction in TR severity. Among PMVR recipients, improvement in RV function and reduction of TR degree are observed mainly in patients with RV dysfunction at baseline. On the other hand, high postprocedural transmitral pressure gradients seem to be associated with lack of RV reverse remodeling. Timing of mitral intervention with respect to RV impairment and predictors of RV reverse remodeling after PMVR are unknown. Further studies are needed to fill these gaps in evidence.

The impact of COVID-19 pandemic on AMI and stroke mortality in Lombardy: Evidence from the epicenter of the pandemic.

BACKGROUND: The first Covid-19 epidemic outbreak has enormously impacted the delivery of clinical healthcare and hospital management practices in most of the hospitals around the world. In this context, it is important to assess whether the clinical management of non-Covid patients has not been compromised. Among non-Covid cases, patients with Acute Myocardial Infarction (AMI) and stroke need non-deferrable emergency care and are the natural candidates to be studied. Preliminary evidence suggests that the time from onset of symptoms to emergency department (ED) presentation has significantly increased in Covid-19 times as well as the 30-day mortality and in-hospital mortality. METHODS: We check, in a causal inference framework, the causal effect of the hospital's stress generated by Covid-19 pandemic on in-hospital mortality rates (primary end-point of the study) of AMI and stroke over several time-windows of 15-days around the implementation date of the State of Emergency restrictions for COVID-19 (March, 9th 2020) using two quasi-experimental approaches, regression-discontinuity design (RDD) and difference-in-regression-discontinuity (DRD) designs. Data are drawn from Spedali Civili of Brescia, one of the most hit provinces in Italy by Covid-19 during March and May 2020. FINDINGS: Despite the potential adverse effects on expected mortality due to a longer time to hospitalization and staff extra-burden generated by the first wave of Covid-19, the AMI and stroke mortality rates are overall not statistically different during the first wave of Covid-19 than before the first peak. The obtained results provided by RDD models are robust also when we account for seasonality and unobserved factors with DRD models. INTERPRETATION: The non-statistically significant impact on mortality rates for AMI and stroke patients provides evidence of the hospital ability to manage -with the implementation of a dual track organization- the simultaneous delivery of high-quality cares to both Covid and non-Covid patients.

COAPT-Like Profile Predicts Long-Term Outcomes in Patients With Secondary Mitral Regurgitation Undergoing MitraClip Implantation.

OBJECTIVES: The aim of this study was to evaluate whether fulfilling COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) criteria identifies patients with better outcomes after MitraClip treatment for secondary mitral regurgitation (SMR). BACKGROUND: To date, COAPT is the only trial showing a prognostic benefit of MitraClip implantation compared with conservative management. METHODS: Three hundred four patients with SMR undergoing MitraClip placement in addition to optimal medical therapy at 3 European centers were analyzed. A COAPT-like profile was defined as absence of all the following criteria: severe left ventricular impairment, moderate to severe right ventricular dysfunction, severe tricuspid regurgitation, severe pulmonary hypertension, and hemodynamic instability. Freedom from all-cause death and from a composite endpoint (cardiovascular death and heart failure hospitalization) were evaluated at 2- and 5-year follow-up. RESULTS: A COAPT-like profile was observed in 65% of the population. Compared with non-COAPT-like patients, those fulfilling COAPT criteria had greater survival free from all-cause death and from the composite endpoint at both 2 year (75% vs. 55% and 67% vs. 47%; p < 0.001 for both) and 5-year (49% vs. 25% and 40% vs. 19%; p < 0.001 for both) follow-up. Among the non-COAPT-like patients, similar outcomes were observed in those fulfilling 1 or ≥1 criterion. Left ventricular impairment had a late impact on outcomes, while right ventricular impairment, pulmonary hypertension, and hemodynamic instability had early effects. COAPT-like profile was an independent predictor of long-term outcomes, as well as administration of neurohormonal antagonists, European System for Cardiac Operative Risk Evaluation II score, and previous heart failure hospitalization. CONCLUSIONS: A COAPT-like profile, including specific echocardiographic and clinical criteria, identifies patients with SMR who have a better prognosis after MitraClip implantation.

Prognostic Value of Pre-operative Atrial Fibrillation in Patients With Secondary Mitral Regurgitation Undergoing MitraClip Implantation.

Limited data are available regarding the independent prognostic role of preoperative atrial fibrillation (AF) after transcatheter mitral valve repair with MitraClip. We sought to evaluate the impact of preoperative AF in patients with heart failure (HF) and concomitant secondary mitral regurgitation (MR) after MitraClip treatment. The study included 605 patients with significant secondary MR from a multicenter international registry. Patients were stratified into 2 groups according to the presence or absence of preoperative AF. Primary end point was 5-year overall death, secondary end points were 5-year cardiac death and first re-hospitalization for HF. To account for baseline differences, patients were propensity score matched 1:1. The overall prevalence of preoperative AF was 44%. At 5-year Kaplan-Meier analysis, compared with patients without AF, those with AF had significantly more adverse events in term of overall death (67% vs 43%; HR 1.84, log-rank p <0.001) and cardiac death (56% vs 29%; HR 2.11, log-rank p <0.001) and re-hospitalization for HF (63% vs 52%; HR 1.33, log-rank p = 0.048). Multivariate analysis identified AF as independent predictor of worse outcome in term of primary end point (HR 1.729, 95% C.I. 1.060 to 2.821; p = 0.028). After propensity score matching, patients with AF had higher rates of death and cardiac mortality but similar rates of re-hospitalization for HF. In conclusion, in patients with HF undergoing MitraClip treatment for secondary MR, preoperative AF is common and an unfavourable predictor of 5-year death and cardiac death. However, AF did not affect the frequency of re-hospitalization for HF.

Transcatheter therapies for tricuspid valve regurgitation.

: Tricuspid regurgitation, either isolated or associated with left-valve disease, has a strong impact on outcome. Surgical treatment of tricuspid regurgitation has increased in recent years, but in-hospital mortality remains high probably due to the risk profile of the recipients. As a consequence, most of the patients with severe tricuspid regurgitation, especially if isolated, remain untreated. Transcatheter tricuspid valve interventions are rapidly spreading as alternative options to open-heart procedures fulfilling this important unmet need. Although patient selection and timing of intervention are unclear, many devices have been developed in recent years for both repair and replacement of tricuspid valve. Repair tools can be targeted to leaflets or annulus. Replacement devices include heterotopic and orthotropic systems. The aim of this review is to report possible indications and summarize current data about the different devices available for transcatheter tricuspid valve interventions.