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Mitral valve transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis is to report contemporary real-world outcomes in SMR patients treated with 3EXPAND is a prospective, multi-center, international, single arm study with 1041 patients treated for MR with MitraClip NTR/XTR, with 30-day and 1-year follow-up (FU). All echocardiograms were analyzed by an independent echocardiographic core lab. Study outcomes included: procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and hospitalizations for heart failure (HFH). A subgroup of 413 symptomatic patients (age 74.7±10.1 years, 58% male) with severe SMR were included. MR reduction to MR≤1+ and MR≤2+ was achieved in 93.0% and 98.5% of patients, respectively, which was sustained at 1-year-FU. All-cause mortality was 17.7% at 1-year-FU, and the combined endpoint of all-cause mortality or 1Under real-world conditions, optimal sustained MR reduction to MR≤1+ was achieved in a high percentage of patients with 3

Patients with severe mitral regurgitation (MR) and acute heart failure (HF) have refractory symptoms without adequate response to medical therapy. The objective of this analysis was to assess the impact of the MitraClip device in acutely ill HF patients, characterized by NYHA Class IV at baseline, in a real-world, contemporary setting.EXPAND was a prospective, multicenter, international study enrolling patients with MR who consented to receive the MitraClip System at 57 sites globally. The study outcomes included acute procedural success (APS), quality of life, heart failure hospitalizations (HFH), and all-cause mortality. The study population comprised 1,041 patients, with 118 patients having baseline NYHA Class IV, and 922 having baseline NYHA Class I/II/III. NYHA Class IV patients had a significantly higher rate of baseline co-morbidities and secondary MR aetiology compared with NYHA Class I/II/III patients. APS was achieved in 92.4% of NYHA Class IV patients and significant improvement in MR grade to ≤Mild (1+) in 90.7% of subjects at 30 days and 92.9% at 1 year was observed. 1-year-mortality was higher in the NYHA Class IV subjects compared with the NYHA Class I/II/III subjects (29.2% vs. 17.7%, P 0.01). Significant improvement in functional capacity assessed by NYHA Functional Class and Quality of Life assessed through KCCQ score was observed. At 1 year, 72.6% of NYHA Class IV subjects improved to NYHA Class I/II and ΔKCCQ was 31.2 (24.1, 38.3) compared with baseline.In the prospective, real-world EXPAND study, MitraClip in patients with severe MR and NYHA Class IV was found to be safe and effective in treating MR, and significantly improving QoL and long-term clinical outcomes.

AIMS The Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) was conceived in order to assess the safety and efficacy of MitraClip therapy in Italy. The aim of this study was to assess procedural and mid-term outcomes, and clinical and echocardiographic predictors of mid-term mortality after MitraClip therapy, stratifying the results according to the diagnosis of functional and degenerative mitral regurgitation (FMR vs. DMR). METHODS AND RESULTS Between January 2016 and March 2020, 1659 patients were prospectively included in the GIOTTO registry (FMR 59.4% vs. DMR 40.6%). Acute Mitral Valve Academic Research Consortium (MVARC) technical success was achieved in 97.2% of patients, without differences between FMR and DMR and with sustained results at 30 days. In the study population, all-cause mortality was 4.0%, 17.5% and 34.6% at 30 days, 1 year and 2 years, respectively. Cardiovascular death was the most frequent cause of mortality. Overall hospitalization rates were 6.3%, 23.4% and 31.7% at 30 days, 1 year and 2 years, respectively. The most frequent cause of hospitalization was heart failure, particularly in the first 30 days. FMR and MVARC structural and functional failure were strongly associated with 1-year mortality. Residual mitral regurgitation 1+ (rMR) was independently related to a reduced risk of 1-year mortality (hazard ratio 0.62; P = 0.005). Coherently, at 2-year follow up, FMR was associated with worse outcomes than DMR, and Kaplan-Meier all-cause mortality was related to rMR. CONCLUSIONS Functional mitral regurgitation aetiology affects 1-year mortality after MitraClip implantation, and differences in mortality and hospitalization rates between FMR and DMR can be observed within 2 years. Optimal rMR 1+ was correlated to a more favourable mid-term outcome, particularly in FMR.

Objectives The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit. Background The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging. Methods This was an international registry of 23 TAVR centers. Results In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05). Conclusions For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274 )

The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise.We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included.According to mean CHADOur registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period.

BACKGROUND: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing. AIMS: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients 70). For patients 4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the 70 groups. In the

BACKGROUND: Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. METHODS: We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). RESULTS: Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan-Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. CONCLUSIONS: MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF. (C) 2020 International Society for Heart and Lung Transplantation. All rights reserved.

Up to half of real-world patients with secondary mitral regurgitation who underwent transcatheter edge-to-edge repair (TEER) do not meet the highly selective COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) criteria. No randomized trials or standardized and validated tools exist to evaluate the risk: benefit ratio of TEER in this specific population. We sought to derive and externally validate a clinical risk score to predict the risk of death or heart failure (HF) hospitalization for COAPT-ineligible patients who underwent TEER (CITE score). The study population consisted of patients with secondary mitral regurgitation having at least 1 exclusion criterion of the COAPT trial. The derivation cohort included 489 patients from the GIOTTO (GIse registry of Transcatheter treatment of Mitral Valve regurgitaTiOn) registry. Cox proportional hazards regression was used to identify predictors of 2-year death/HF hospitalization and develop a numerical risk score. The predictive performance was assessed in the derivation cohort and validated in 268 patients from the MiZüBr (Milan-Zürich-Brescia) registry. The CITE score (hemodynamic instability, left ventricular impairment, New York Heart Association class III/IV, peripheral artery disease, atrial fibrillation, brain natriuretic peptide, and hemoglobin) showed a c-index for 2-year death or HF hospitalization of 0.70 (95% confidence interval [CI] 0.67 to 0.73) in the derivation cohort, and 0.68 (95% CI 0.64 to 0.73) in the validation cohort. A cutoff of12 points was selected to identify patients at lower risk of adverse outcomes, hazard ratio of 0.35 (95% CI 0.26 to 0.46). In conclusion, the CITE score is a simple 7-item tool for the prediction of death or HF hospitalization at 2 years after TEER in COAPT-ineligible patients. The score may support clinical decision-making by identifying those patients who, even if excluded from clinical trials, can still benefit from TEER.

Procedural success after transcatheter edge-to-edge mitral valve repair (TEER) is defined as a reduction of mitral regurgitation (MR) degree tomoderate (2+). However, post-procedural MR 0/1+ was found to be associated with a better outcome and a lower rate of MR recurrence compared to post-procedural MR 2+.To evaluate predictors and prognostic impact of optimal procedural result (MR 0/1+) after TEER.The Italian Society of Interventional Cardiology (GIse) Registry of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is a large multicenter registry including patients undergoing TEER in 19 Italian centers between January 2016 and March 2020. For the purpose of this analysis, only patients with secondary MR and successful TEER were included.Among 950 patients enrolled, 637 (67%) had an optimal procedural result (MR 0/1+) and 313 (33%) had an acceptable procedural result (MR 2+) after TEER. Moderate-to-severe, rather than severe, MR, left ventricular end-systolic diameter70 mm at baseline, and treatment in centers performing ≥20 procedures/year were independent predictors of the optimal procedural result. Compared to patients with acceptable procedural result, those with optimal result had shorter device time and length of stay and better outcomes with lower rates of all-cause and cardiac deaths (25.7% vs. 40%, p 0.001 and 16.3% vs. 24.8%, p = 0.003, respectively) and HF hospitalizations (24% vs. 30%; p = 0.035) at 2-year follow-up.In patients with secondary MR undergoing TEER, an optimal procedural result is associated with favorable outcomes and can be achieved by selecting patients with moderate-to-severe MR, without severe left ventricular dilatation, and treated in high-volume centers.mitral regurgitation, mitral valve repair, chronic heart failure.

Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes.aim of this study was to assess the efficacy and clinical results of MV-TEER in patients with previous cardiac surgery enrolled in the "multicentre Italian Society of Interventional Cardiology registry of transcatheter treatment of mitral valve regurgitation" (GIOTTO).Patients with previous coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), or mitral valve repair (MVR) were included. Those with multiple or combined previous cardiac surgeries were excluded. Clinical follow-up was performed at 30 days, 1 year, and 2 years. The primary endpoint was a composite of death or rehospitalization at 1- and 2-year follow-ups.A total of 330 patients enrolled in the GIOTTO registry were considered (CABG 77.9%, AVR 14.2%, and MVR 7.9%). Most patients showed FMR (66.9%), moderate reduction of left ventricular (LV) ejection fraction, and signs of LV dilation. Procedural and device successes were 94.8% and 97%. At 1 and 2 years, the composite endpoint occurred are 29.1% and 52.4%, respectively. The composite outcome rates were similar across the three subgroups of previous cardiac surgery (p = 0.928) and between the FMR and DMR subgroups (p = 0.850) at 2 years. In a multivariate analysis, residual mitral regurgitation (rMR) ≥2+ was the main predictor of adverse events at 1 year (hazard ratio: 1.54 [95% confidence interval, CI: 1.00-2.38]; p = 0.050). This association was confirmed at 2 years of Kaplan-Meier analysis (p = 0.001).MV-TEER is effective in these patients, regardless of the subtype of previous cardiac surgery and the MR etiology. An rMR ≥2+ is independently associated with adverse outcomes at 1-year follow-up.

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

The use of "Kissing Watchman" technique has been reported for left atrial appendage closure in particular case (i.e. large ostia). This case highlighted the feasibility of adapting this technique as bailout strategy in case of migration of a first device inside the LAA, due to a partial recapture of device.

Aims MitraClip treatment has been recently proposed as a ‘bridge strategy’ solution for advanced heart failure (HF) patients with significant functional mitral regurgitation (MR), who are potential candidates or are waiting for cardiac replacement therapy (LVAD or heart transplantation, HTx). In this clinical scenario, left-ventricular-related right ventricular dysfunction (RVD) represents an important prognostic factor. Our study aimed to investigate the possible prognostic implication of RVD in advanced HF patients treated with MitraClip as a bridge to HTx strategy. Methods and results RVD was assessed using the relationship between tricuspid annular peak systolic excursion (TAPSE) and pulmonary artery systolic pressure (PASP). All patients from the MitraBridge registry for whom these two echocardiographic parameters were available, were included in the study. A cut-off value of TAPSE/PASP ratio < 0.36 was used to defined RVD, as previously reported. The primary outcome was a composite Endpoint of all-cause death or rehospitalization for HF at 2-year. For patients who underwent LVAD implantation or HTx, follow-up data were censored at the time of those events. A total of 80 patients were included in the study. The median TAPSE/PASP ratio was 0.35 (25th–75th: 0.27–0.46), with 43 (54%) patients having a TAPSE/PASP ratio < 0.36 (RVD group). The latter had a prevalent MR ischaemic etiology (49% vs. 38%), with a more frequent history of percutaneous coronary intervention (46.5% vs. 22%, P = 0.02). Except for TAPSE (15.7 ± 3.6 mm vs. 19.2 ± 3.7 mm, P = 0.001) and PASP (61 ± 14 mmHg vs. 39.5 ± 9.5 mmHg, P Conclusions In advanced HF patients with functional MR, MitraClip treatment could prevent or ameliorate left-ventricular-related RVD, allowing safe access to HTx or LVAD.

Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge-to-edge repair with MitraClip implantation could differ in patients with ischaemic (I-MR) and non-ischaemic mitral regurgitation (NI-MR).PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random-effects model. Primary endpoint was the composite of all-cause death and heart failure-related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re-intervention. Seven studies enrolling 2501 patients were included. Patients with I-MR compared with patients with NI-MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; IThe risk of mortality after MitraClip implantation is lower in patients with NI-MR than in those with I-MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups.

Background A-FMR is considered a specific sub-type of secondary MR in patients with atrial fibrillation (AF) and preserved left ventricle ejection fraction (LVEF). Aim of the study was to investigate the acute and mid-term outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) with the MitraClip in atrial functional mitral regurgitation (A-FMR). Methods The study included patients with A-FMR and concomitant AF who underwent to the MitraClip at 7 Italian Centers. Aim of the study was to assess the safety, efficacy and mid-term cardiovascular outcomes. Results After reviewing 1153 patients with FMR treated with TMVr from 2009 to 2021, 87 patients (median age 81 years, 61% female) with A-FMR were identified. Technical success was achieved in 97%, 30-day device success in 83% and 30-day procedural success in 80%. All-cause death at 30-day was 5%. Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%, respectively, whereas freedom from all-cause death/heart failure hospitalization was 55%. Residual MR ≤ 2+ was encountered in 89% (n = 47/53) and improvement in NYHA class I/II in 79% (n = 48/61). Post-procedural MR ≥ 2+ (HR 5.400, CI 1.371–21.268) and inter-commissural annular diameter ≥ 35 mm (HR 4.159, CI 1.057–16.363) were independent predictors of all-cause death/heart failure hospitalization during the follow-up. Positive reverse remodeling of left atrium and mitral annular dimensions occurred after TMVr during the follow-up. Conclusions MitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients.

Background MitraClip treatment has been recently proposed as a “bridge strategy” solution for advanced heart failure (HF) patients with significant functional mitral regurgitation (MR), who are potential candidates or are waiting for cardiac replacement therapy (LVAD or heart transplantation, HTx). In this clinical scenario, left-ventricular-related right ventricular dysfunction (RVD) represents an important prognostic factor. Purpose Our study aimed to investigate the possible prognostic implication of RVD in advanced HF patients treated with MitraClip as a bridge to HTx strategy. Methods RVD was assessed using the relationship between tricuspid annular peak systolic excursion (TAPSE) and pulmonary artery systolic pressure (PASP). All patients from the MitraBridge registry for whom these two echocardiographic parameters were available, were included in the study. A cut-off value of TAPSE/PASP ratio Results A total of 80 patients were included in the study. The median TAPSE/PASP ratio was 0.35 (25th-75th: 0.27–0.46), with 43 (54%) patients having a TAPSE/PASP ratio Conclusion In advanced HF patients with functional MR, MitraClip treatment could prevent or ameliorate left-ventricular-related RVD, allowing safe access to HTx or LVAD. Funding Acknowledgement Type of funding sources: None.

Publisher Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. Objectives: To investigate how the changes of left ventricle ejection fraction (LVEF) between admission and discharge affected the long-term outcome in patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Background: An acute impairment of LVEF after surgical repair of mitral regurgitation, known as afterload mismatch, has been associated with increased all-cause mortality. Afterload mismatch after percutaneous edge-to-edge mitral valve repair has been postulated to be a transient phenomenon. Methods: This study is based on a single-center, retrospective, observational registry of patients who underwent percutaneous edge-to-edge mitral valve repair with the MitraClip (Abbot Vascular) system for the treatment of symptomatic, moderate-to-severe mitral regurgitation. We included data on 399 patients who underwent percutaneous edge-to-edge mitral valve repair for secondary mitral regurgitation. Expert echocardiographers assessed LVEF before the procedure and at discharge. The patients were divided into three groups according to the difference of periprocedural LVEF measurements: unchanged (n = 318), improved (n = 40), and decreased (n = 41) LVEF. Results: The median follow-up time was 2.0 years. When adjusted for gender, NYHA class and estimated glomerular filtration rate, decreased postprocedural LVEF was associated with an increased risk of death (adjusted HR 2.05, 95% CI 1.26–3.34) and increased postprocedural LVEF with a reduced risk of death (adjusted HR 0.47, 95% CI 0.24–0.91) compared to unchanged LVEF. Conclusion: Among patients who underwent percutaneous edge-to-edge mitral valve repair, decreased postprocedural LVEF was associated with increased mortality, while improved LVEF was associated with lower mortality compared to unchanged LVEF.

Objectives: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). Background: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited. Methods: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared. Results: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score–matched cohort (91 patients’ pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097). Conclusions: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).

Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high‐volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre‐SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9–9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In‐hospital all‐cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.

Background: The benefit of percutaneous mitral valve repair (PMVR) in patients with secondary MR is still debated. We aimed to compare the outcome of PMVR with optimal medical therapy (OMT) versus OMT alone in patients with secondary mitral regurgitation (MR) and to assess the role of potential effect modifiers. Methods: We performed a systematic review and meta-analysis of 2 randomized clinical trials (RCT) and 7 non-randomized observational studies (nROS). Hazard ratios (HR) and 95% confidence intervals (CI) were pooled through inverse variance random-effects model to compute the summary effect size for all-cause death, cardiovascular death and cardiac-related hospitalization. Subgroup and meta-regression analysis were also performed. Results: An overall population of 3118 individuals (67% men; mean age, 73 years) was included: 1775 PMVR+OMT and 1343 OMT patients, with mean follow-up of 24 ± 15 months. PMVR+OMT was associated with a lower risk of all-cause death (HR: 0.77; 95% CI: 0.68–0.87), cardiovascular death (HR: 0.55; 95% CI: 0.34–0.89) and cardiac-related hospitalization (HR:0.77; 95% CI: 0.64–0.92). Meta-regression analysis showed that larger left ventricular end-diastolic volume index (LVEDVI) portends higher risk of all-cause death, cardiovascular death and cardiac-related hospitalization after PMVR (p < 0.001 for all). Conclusions: This study-level meta-analysis shows that PMVR+OMT is associated with reduced all-cause death, cardiovascular death and cardiac-related hospitalization when compared with OMT alone in secondary MR. LVEDVI is a predictive marker of efficacy, as patients with smaller LVEDVI have been shown to derive the largest benefit from PMVR. (Less)

Objectives This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk. Background The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy. Methods This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3. Results A total of 126 patients (mean age 75 ± 8 years; mean CHA2DS2-VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis. Conclusions In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device.

Background Available scientific evidence of transcatheter mitral valve repair with the MitraClip comes from randomized controlled trials, which showed controversial results that hardly translate into real-world practice, and from registries of relatively small sample size. Aim To collect real-world data in a multicenter, prospective, country-level registry. Methods and result The Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is an ongoing single-arm, multicenter, prospective registry that started enrollment in February 2016. Clinical end points were defined according to the Mitral Valve Academic Research Consortium (MVARC) criteria. From February 2016 to December 2018, 1189 patients (mean age 76 ± 9.1 years) were enrolled. The main MR etiology was functional (64.9%). MVARC technical success was 96.6%. At 30-day follow-up ( n = 1131), MVARC device and procedural success were 92.5% and 87% respectively, and all-cause death was 3%. The majority of patients who died at 30-day had functional MR (69.7%). Mixed etiology (OR 0.94, 95% CI 0.02–0.61) and prolonged length of stay in ICU (OR 0.97, 95% CI 0.95–0.99) were found to be negative independent predictors of device success at 30-day. The EuroSCORE II (OR 0.96, 95% CI 0.93–0.99), LVEDV-I (OR 0.99, 95% CI 0.98–0.99) and prolonged length of stay in ICU (OR 0.98, 95% CI 0.97–0.99) were negative independent factors of MVARC procedural success at 30-day. Conclusions The GIOTTO registry is one of the largest prospective registries available on MitraClip and shows favorable acute and 30-day safety and efficacy.

Nowadays, tricuspid regurgitation (TR) is a widespread condition and this has led to a not-unexpected interest in the "forgotten valve". Medical treatment and/or a surgical approach remain the gold standard for this valve disorder, although these approaches are often limited. In the era of transcatheter therapies, the primary interest for less invasive percutaneous approaches targeted to the treatment of TR can thus find a clear rationale for its evolution. The aim of this review is to explore the different transcatheter techniques for TR that are available or under study, and also to report on preliminary clinical results worldwide.

The pattern and reasons for re-hospitalization (RH) after MitraClip implantation are not well characterized. A total of 322 consecutive MitraClip patients were included, with data stratified by RH status. Multivariate analyses were conducted to identify predictors of early (30-day) and late (30-day to 12-month) RH. Eighty-nine patients (27.6%) were readmitted to hospital during the study period and early RH occurred in 27%. The median time from MitraClip to RH was 99 days. RH was mostly related to cardiovascular causes (66.3%). Anemia and gastrointestinal bleeding were the most frequent noncardiovascular causes. Independent predictors of early RH were length of stay ≥3 days during the index procedure (odds ratio [OR] 4.13, 95% confidence interval [CI] 1.32 to 12.91), reduction of left ventricular ejection fraction ≥5% after MitraClip implantation (OR 4.88, 95% CI 1.36 to 18.91), and severe systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 3.72, 95% CI 1.23 to 11.26). Conversely, the independent predictors of late RH were device failure (OR 4.02, 95% CI 1.22 to 13.25) and systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 2.34, 95% CI 1.01 to 5.44). In patients with early RHs, survival was significantly worse at 12 months compared with patients with late RH and no-RH (69.3% vs 82.6% vs 86%, p 0.001). In conclusion, RH is not uncommon after MitraClip implantation and cardiovascular causes represent its most frequent etiology. Clinical and echocardiographic predictors of early and late RH can be identified at discharge. Early RH carries a worse prognosis than late RH.

Objectives This study deals with clinical and echocardiographic outcomes in cardiac resynchronization therapy (CRT) nonresponders patients undergoing Mitraclip procedure. Background Functional mitral regurgitation (FMR) occurs in approximately one-third of heart failure (HF) patients. Resynchronization therapy may correct FMR in patients with HF; however, significant FMR persists in 20-25% of CRT patients. Methods All patients included were previously treated with CRT for at least 6 months and remained classified as New York Heart Association (NYHA) functional class III or IV despite optimal medical therapy; the echocardiographic assessment showed lack of decrease of the left ventricular end-systolic volume (LVESV) of at least 10% and residual moderate-to-severe or severe FMR. Clinical and echocardiographic follow-up was scheduled at 1, 3, 6, and 12 months after Mitraclip implantation, and every 6 months thereafter. Results Thirty patients fulfilled inclusion criteria. Before Mitraclip implantation NYHA class was III in 83% and IV in 17% of patients; after CRT no patient experienced an improvement in FMR. There was a significant improvement in NYHA class from baseline to 6 months, which remained sustained at 12 and 24 months. The degree of FMR significantly improved from baseline to 6 months and from 6 to 12 months. There was left ventricle remodeling with significant reduction of LVESV and an increase of left ventricle ejection fraction at 6 and 12 months, while the opposite trend was noted between 12 and 24 months CONCLUSION: Treatment of moderate to severe FMR in CRT nonresponder is feasible, safe, and reasonably effective in reducing cardiac symptoms.

Kommerrell's diverticulum of the right aberrant subclavian artery is a rare disease, its treatment is still controversial. We report the case of a patient with a six cm aneurysmal dilation successfully treated in a hybrid surgical/endovascular way.

Percutaneous edge-to-edge mitral valve repair (PMVR) recently emerged as an effective treatment modality for patients with severe mitral regurgitation (MR). Length of postprocedural hospital stay may represent a modifiable cost associated with percutaneous treatment. We looked at feasibility, predictors and safety of early discharge (ED), defined as hospital discharge within 72 hours, in patients undergoing PMVR.Consecutive patients treated with MitraClip from October 2008 to December 2015 were analysed. Primary outcomes of interest were cardiovascular and non-cardiovascular mortality, rehospitalisation for heart failure and major adverse events at 30 days and 90 days. A total of 269 patients were included. Of these, 115 patients were early discharged (ED group). Rates of ED increased from 25.9% for the biennium 2008-2009 to 59.1% in 2014-2015 (p0.001 for trend). In a penalised logistic regression model, male gender (OR=2.13, 95% CI 1.17 to 3.95) and procedural year (OR=2.13, 95% CI 1.51 to 3.11) were associated with higher probability of ED. Conversely, atrial fibrillation (OR=0.48, 95% CI 0.27 to 0.85), any Mitral Valve Academic Research Consortium bleeding (OR=0.07, 95% CI 0.01 to 0.60), log-transformed N-terminal pro-brain natriuretic peptide levels (OR=0.79, 95% CI 0.63 to 0.99) and postimplant MR grade (OR=0.60, 95% CI 0.37 to 0.94) conferred a lower likelihood of ED. In propensity score-weighted analyses, overall survival, freedom from heart failure and major adverse events at 30 days and 90 days were not different in ED and non-ED groups (all weighted log-rank p value0.05).In selected patients undergoing PMVR, ED may be feasible and safe.

Background The benefit of percutaneous mitral valve repair with mitraclip (PMVR) in patients with secondary mitral regurgitation (MR) is still debated. Methods In order to compare the outcome of PMVR with optimal medical therapy (OMT) versus OMT alone in patients with secondary MR, we performed a systematic review and meta-analysis of 2 randomized clinical trials (RCT) and 7 non-randomized observational studies (nROS). Hazard ratios (HR) and 95% confidence intervals (CI) were pooled through inverse variance random-effect model to compute the summary effect size for all-cause mortality, cardiovascular death and cardiac-related hospitalization. Subgroup and meta-regression analysis were also performed. Results An overall population of 3,118 individuals (67% men; mean age, 73 years) was included: 1,775 PMVR+OMT and 1,343 OMT patients, with mean follow-up of 24±15 months. PMVR+OMT was associated with a lower risk of all-cause death (HR: 0.77; 95% CI: 0.68–0.87), cardiovascular death (HR: 0.55; 95% CI: 0.34–0.89) and cardiac-related hospitalization (HR: 0.77; 95% CI: 0.64–0.92). Meta-regression analysis showed that larger left ventricular end-diastolic volume index (LVEDVI) portends higher mortality after PMVR (p Conclusions This study-level meta-analysis shows that PMVR+OMT is associated with reduced all-cause death, cardiovascular death and cardiac-related hospitalization when compared with OMT alone in secondary MR. LVEDVI is a predictive marker of efficacy, as patients with smaller LVEDVI derive the largest benefit from PMVR.

Limited evidence is available on 5-year clinical outcomes after percutaneous edge-to-edge mitral valve repair.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.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 fraction30% were associated with an increased risk of both primary and secondary end points. EuroSCORE II5% was associated with an increased risk of 5-year mortality. Ischemic etiology of MR, baseline serum creatinine1.5 mg/dL, chronic obstructive pulmonary disease, and previous HF hospitalizations were independent predictors of 5-year secondary end point.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 II5%, chronic obstructive pulmonary disease), and advanced cardiomyopathy (ie, left ventricular ejection fraction30%, prior HF admission, creatinine1.5 mg/dL) significantly increase the relative risk of 5-year clinical events.

Controlled hypotension is a well-known technique used by anesthesiologists to limit intraoperative bleeding in patients undergoing middle ear surgery and improve visibility of the surgical field. Nitroglycerin and remifentanil are among the drugs used to induce controlled hypotension.The aim of our study was to compare the hemodynamic effects of remifentanil and nitroglycerin in this patient population.All consecutive patients who underwent middle ear surgery between January and December 2016, at the University Hospital Vittorio Emanuele in Catania were included in a retrospective study. Patients who were given nitroglycerin to induce controlled hypotension were compared to those given remifentanil. The following parameters were measured systolic and diastolic blood pressure, heart rate, peripheral (capillary) oxygen saturation, and fraction of expired carbon dioxide. A mean arterial pressure of 50-70 mmHg was considered optimal.Thirty patients who underwent stapedioplasty and tympanoplasty, 25 men and 5 women,with a mean age of 43 years (range 32-58 years) were included in the study. Fifteen patients had received nitroglycerin (group A) and 15 patients remifentanil (group B). The target blood pressure was reached in all patients and no significant difference was found between the groups with regard to the level of systolic and diastolic blood pressure, heart rate, peripheral (capillary) oxygen saturation, and fraction of expired carbon dioxide. However the heart rate of 2 younger patients in group A rose to100 bpm after the administration of nitroglycerin.Both remifentanil and nitroglycerin are effective in inducing controlled hypotension. In younger patients administration of nitroglycerin is associated with an increase in heart rate.Controlled hypotension, Middle ear surgery, Nitroglycerin, Remifentanil.L’ipotensione controllata è una tecnica anestesiologica che permette nella chirurgia dell’orecchio medio una diminuzione del sanguinamento con una migliore visione del campo operatorio al chirurgo.È stata eseguita una revisione sistematica su 30 interventi di chirurgia dell’orecchio medio eseguiti presso l’Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele di Catania nel 2016. Il campione aveva età compresa tra i 32 ed i 58 anni trattati con nitroglicerina o con remifentanil al fine di indurre ipotensione, considerando come valori ottimali di pressione media 50/70 mm/Hg.Esaminando i valori di pressione arteriosa misurati nel campione studiato non sono emersi variazioni significative dovute all’uso dei due farmaci. Gli effetti emodinamici sono risultati simili ad eccezione della frequenza cardiaca, che tende ad aumentare nei pazienti di giovane età in seguito a somministrazione di nitroglicerina.Entrambi i farmaci utilizzati risultano efficaci nell’induzione dell’ipotensione controllata. La tachicardia indotta nei pazienti di giovane età rende più agevole l’utilizzo del remifentanil in questa categoria di pazienti.

Aims To appraise the early effect of percutaneous mitral valve repair with the MitraClip system on myocardial function using real-time three-dimensional speckle-tracking echocardiography (3D-STE). Methods Consecutive patients with moderate-to-severe or severe mitral regurgitation, undergoing mitral valve repair with the MitraClip system, were prospectively evaluated during the peri-procedural workout and follow-up. Left ventricular deformation was evaluated by a two-dimensional and 3D speckle-tracking analysis. 3D-STE acquisitions were elaborated obtaining real-time 3D global longitudinal strain evaluation, and by appraising both volumetric and hemodynamic parameters (i.e. left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular ejection fraction, cardiac output, and stroke volume). Results In all, 30 patients were included. At 1-month follow-up, 3D-STE analysis revealed no changes in left ventricular end-diastolic volume (162.6 ± 73.7 ml at baseline vs. 159.8 ± 64.5 ml at 1-month follow-up; P = 0.63) and a downward trend in left ventricular end-systolic volume (104.7 ± 52.0 vs. 100.1 ± 50.4 ml, respectively; P = 0.06). Left ventricular ejection fraction did not significantly increase (38.1 ± 11.3% at baseline vs. 39.4 ± 11.0% at 1-month follow-up; P = 0.20). No significant changes were reported in cardiac output (4.3 ± 2.0 l/min at baseline vs. 4.0 ± 1.5 l/min at follow-up; P = 0.377) and in stroke volume (59.5 ± 25.5 ml at baseline vs. 59.9 ± 20.7 ml at follow-up; P = 0.867). On the contrary, left ventricular deformation capability significantly improved, with the real-time 3D global longitudinal strain value changing from -9.8 ± 4.1% at baseline to -11.0 ± 4.4% at follow-up (P = 0.018). Conclusions Accurately assessing myocardial function by the use of 3D-STE, this study reported irrelevant early changes in left ventricular size, but a positive effect on left ventricular deformation capability following mitral valve repair with the MitraClip system. These preliminary results need to be confirmed in larger series and extended to long-term follow-up.

We present a case of a patient with severe mitral regurgitation referred to our Institution for an echocardiographic examination as part of the routine workup to assess the eligibility for mitral valve percutaneous repair with either the MitraClip or Cardioband systems. Echocardiography showed the presence of an unusual interatrial membrane in the left atrium that represented a contraindication for the puncture of the interatrial septum. The patient was finally deferred to percutaneous mitral valve replacement using transapical access.