Hospitalization of Symptomatic Patients With Heart Failure and Moderate to Severe Functional Mitral Regurgitation Treated With MitraClip: Insights From RESHAPE-HF2.

BACKGROUND: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results. OBJECTIVES: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER. METHODS: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm2; 14% >0.40 cm2, 23% <0.20 cm2) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization. RESULTS: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (Pinteraction = 0.03) and of recurrent HF hospitalizations within 24 months (Pinteraction = 0.06). CONCLUSIONS: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF.

Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation.

BACKGROUND: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain. METHODS: We conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status). RESULTS: A total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P = 0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P = 0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%). CONCLUSIONS: Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.).

Remote proctoring during structural heart procedures: Toward a widespread diffusion of knowledge using mixed reality.

BACKGROUND: Despite its wide diffusion in surgical procedures, very few experiences are reported so far about the possible applications of remote proctoring (RP) in structural heart interventions. AIMS: Our aim was to demonstrate the feasibility, safety, and efficacy of RP during transcatheter edge-to-edge repair using a mixed reality-based head-mounted display (HMD). METHODS: Two users (a doctor and a proctor), wearing HMDs, were connected through a 5G network, allowing them to share audio and video signals. During the procedure, the proctor was located in a contiguous room, without any direct connection with the operator. The primary endpoint was noninferiority of HMD-mediated interaction if compared with direct in-person interaction. It was assessed using an operator-proctor interaction test based on six questions asked by the doctor to the proctor on six key procedural steps. RESULTS: Between September 2021 and April 2022, nine patients were enrolled in the study (15 clips delivered). The primary endpoint was reached in 9/15 clips implanted (60%). The first three failures were due to a chat software problem, and the others were linked with a 5G network malfunction. However, the HMD and its mixed reality tools were well tolerated by the operators, and no interference with the procedure was registered in any of the cases. CONCLUSIONS: In our experience, RP during structural heart interventions is feasible and efficacious. Wearing the HMD is comfortable and does not affect safety and effectiveness of interventional procedures. However, especially if considering a wide geographic use of this tool, a stable internet connection is imperative.

When annuloplasty is not enough: a case report of ventricular arrhythmias stepwise abolition after mitral valve re-repair.

Background: Some patients affected by mitral valve (MV) prolapse (MVP) are at higher risk of ventricular arrhythmias (VAs), but the underlying pathogenesis, as well as the effects of surgery on VA, remain not fully understood. Mitral valve repair, however, represents a privileged point of view to deepen the understanding of arrhythmogenesis in this context. Hence, we report an interesting case of MV re-repair. Case summary: A 52-year-old man was referred to our institution for severe mitral regurgitation (MR) due to P2 prolapse in the context of myxomatous MV degeneration. Pre-operative imaging showed systolic mitral annular disjunction, left ventricular (LV) wall curling, Pickelhaube's sign, and a prolapsing tricuspid valve (TV) with only mild regurgitation. Twenty-four-hour electrocardiogram (ECG) Holter revealed a significant burden of premature ventricular contractions (PVCs), most of them originating from anterior papillary muscle (APM), posterior papillary muscle (PPM), and mitral annulus (MA). Quadrangular resection of P2 and mitral annuloplasty were performed. One year later, relapse of severe MR due to a residual P2M1 prolapse occurred. Twenty-four-hour ECG Holter showed no PVCs from PPM and MA, while those from APM persisted. A central edge-to-edge repair was effectively used to fix the residual prolapse. After 1 year from REDO surgery, a third ECG Holter confirmed the absence of any remaining LV PVCs, but still few ectopic beats originating from TV were recorded. Discussion: Here, we report a case of VA resolution after specific, anatomical triggers addressing surgical gestures. Our experience confirms that MV surgery may have a role in MVP patients' arrhythmias correction.

Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.

Eligibility to COAPT trial in the daily practice: A real-world experience.

BACKGROUND: The COAPT Trial was the first ever to demonstrate a survival benefit in treating functional mitral regurgitation (FMR). That was achieved through transcatheter mitral repair in selected patients. The exact proportion of patients fulfilling COAPT selection criteria in the real-world is unknown. AIMS: To assess the applicability of COAPT criteria in real world and its impact on patients' survival. METHODS: We assessed the clinical data and follow-up results of all consecutive patients admitted for FMR at our Department between January 2016 and May 2021 according to COAPT eligibility. COAPT eligibility was retrospectively assessed by a cardiac surgeon and a cardiologist. RESULTS: Among 394 patients, 56 (14%) were COAPT eligible. The most frequent reasons for exclusion were MR ≤ 2 (22%), LVEF < 20% or >50% (19%), and non-optimized GDMT (21.3%). Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% confidence interval [CI: 0.864, 0.96] vs. 71.8% [CI: 0.509, 0.926], respectively, p = 0.027). CONCLUSIONS: Only a minority (14%) of real-world patients with FMR referred to a tertiary hospital fulfilled the COAPT selection criteria. Among Non-COAPT patients, weighted 4-year survival was higher in patients who received MitraClip compared to those who were left in optimized medical therapy (91.5% [0.864, 0.96] vs. 71.8% [0.509, 0.926], respectively, p = 0.027).

Long-term Results of Clover and Edge-to-Edge Leaflet Repair for Complex Tricuspid Regurgitation.

BACKGROUND: The aim of this study was to report the long-term results of the clover and edge-to-edge repair techniques for complex tricuspid regurgitation (TR). METHODS: This was a single-center observational study. A competing risks proportional-hazards regression model, using the Fine and Gray model, was performed to analyze the time to TR ≥2+, considering death as a competing risk. RESULTS: A total of 145 consecutive patients (57% female) with severe or moderately severe TR secondary to leaflet prolapse or flail (115 patients), tethering (27 patients), or mixed (3 patients) lesions underwent clover (110 patients) or edge-to-edge repair(35 patients). The TR origin was degenerative in 75% of cases, posttraumatic in 8%, and secondary to dilated cardiomyopathy in 17%. Ring (64%) or suture (31%) annuloplasty was performed in 95% of patients. Concomitant procedures (mainly mitral surgery) were performed in 80% of cases. Hospital death was 5.5%. Follow-up was 98% complete, and median was 15 years (interquartile range, 14-17 years). The 16-year overall survival was 56% ± 5%. Previous cardiac surgery (hazard ratio [HR], 2.83; 95% CI, 1.15-6.93; P = .023) and right ventricular dysfunction (HR, 2.24; 95% CI, 1.01-4.95; P = .046) were identified as predictors of death. The 16-year cumulative incidence function (CIF) of cardiac death with noncardiac death as a competing risk was 19.6%, and previous cardiac surgery (HR, 3.44; 95% CI, 1.23-9.65; P = .019) was detected as the only predictor of the event. At 16 years, the CIF of TR ≥2+ with death as a competing risk was 23.8%. In particular, TR ≥3+ was detected in 4 patients (3%). CONCLUSIONS: When TR could not be treated by annuloplasty alone, concomitant leaflet repair with the clover or edge-to-edge technique effectively restored valve competence with very satisfactory long-term results and a low rate of moderate or greater TR recurrence.

Subacute postoperative atrial fibrillation after heart surgery: Incidence and predictive factors in cardiac rehabilitation.

Background: Postoperative atrial fibrillation (POAF) is the most common arrhythmia following cardiac surgery (CS). It may occur between the 1st and the 4th postoperative day as acute POAF or between the 5th and the 30th as subacute (sPOAF). sPOAF is associated with higher thromboembolic risk, which consistently increase patients' morbidity. Neutrophil-to-lymphocyte ratio (NLR) is a low-cost inflammatory index proposed as possible POAF predictor. Identification of patients' risk categories might lead to improved postoperative outcomes. Methods: The aim was to assess the incidence of sPOAF and to identify possible predictors in patients performing cardiovascular rehabilitation (CR) after CS. A single-center cohort study was performed on 737 post-surgical patients admitted to CR on sinus rhythm. Continuous monitoring with 12-lead ECG telemetry was performed. We evaluated the predictive role of anamnestic, clinical, and laboratory data, including baseline NLR. Results: Subacute POAF was documented in 170 cases (23.1%). At the multivariate analysis, age (OR 1.03; p = .001), mitral valve surgery (OR 1.77; p = .012), acute POAF (OR 2.97; p < .001), and NLR at baseline (OR 1.13; p = .042) were found to be independent predictive factors of sPOAF following heart surgery. Conclusions: sPOAF is common after CS. Age, mitral valve procedures, acute POAF, and preoperative NLR were proved to increase sPOAF occurrence in CR. NLR is an affordable and reliable parameter which might be used to qualify the risk of arrhythmias at CR admission. Identification of new predictors of postoperative atrial fibrillation may allow to improve patients' prognosis.

A Novel Transcatheter Device for the Edge-to-Edge Treatment of Tricuspid Regurgitation: A Preliminary Evaluation.

Tricuspid regurgitation (TR) is the most common pathology of the tricuspid valve (TV), with significant mortality in severe cases. A well-established strategy to treat TR is represented by the clover surgical technique, which consists of stitching together the free edges of TV leaflets, producing a clover-shaped valvular orifice. Transcatheter treatments for TR constitute a valuable alternative for high-risk patients. In this work we investigated haemodynamic performances and safety of a novel device (StarTric device (STD)) aiming to perform the clover technique via percutaneous access. To assess haemodynamic performances, STD and clover were applied on porcine pathological TVs and tested. Fluid dynamic indexes of both strategies were compared to the pathological model. To evaluate device safety, forces exchanged between device and leaflets were compared to the extraction force (EF) required to STD to completely pass through the leaflet. Clover technique and STD induced a comparable TV backflow reduction (48% and 47%, respectively), with associated increase of TV flow in all tested conditions. Diastolic transvalvular pressure similarly increased indicating a reduction, though not significant, of the valvular orifice. Forces ranged from 1N to 1.71N, compared to an EF of 22.16 ± 8.6N. Force varied significantly amongst different working conditions (normotensive, mild, and severe hypertensive) for each leaflet, whilst no significative variation was found on different leaflets in the same working condition. In the adopted experimental scenario, STD demonstrated comparable efficacy to the surgical strategy in restoring TV haemodynamic. The forces acting on the leaflets following STD implantation were far lower when compared to EFs.

A novel versatile concept of cardioplegia delivery in cardiac surgery: The ReverseTWO cardioplegia circuit system.

Nowadays, the necessity of having a cardioplegia circuit capable of being adapted in order to administer different types of cardioplegia is strategically fundamental, both for the perfusionist and for the cardiac surgeon. This allows to avoid cutting tubes, guarantees sterility and, most of all, limits the number of cardioplegia circuits for the different strategies of cardiac arrest. The novel "ReverseTWO cardioplegia circuit system" is the development of the precedent "Reverse system" where mainly the 4:1 and crystalloid cardioplegia were used, It has the advantage of allowing immediate change of cardioplegia set-up versus four types of cardioplegia technique, when the strategy is unexpectedly changed before the beginning of cardiopulmonary bypass (CPB), is safe and enables the perfusionist to use one single custom pack of cardioplegia. Two pediatric roller pumps are usually used in our centre for cardioplegia administration; they have a standardized calibration (the leading with » inch and the follower with 1/8 inch) and the circuit consequently has two different tube diameters for the two different pumps. The presence in the circuit of two different shunts coupled with two different coloured clamps allows the immediate set-up for different cardioplegia administration techniques utilizing a colour-coding mechanism The aim of this manuscript is to present the new ReverseTWO Circuit. This novel system allows to administer four different cardioplegic solutions (4:1, 1:4, crystalloid, ematic) based on multiple tubes, which can be selectively clamped, identified through a color-coding method. The specificity of this circuit is the great versatility, which leads to numerous advantages, such as reduced risk of perfusion accident and reduced costs related not only to the purchase of different cardioplegia kits but also to the storage. https://youtu.be/ovJBE4ok2Ds.

Neochordae implantation versus leaflet resection in mitral valve posterior leaflet prolapse and dilated left ventricle: a propensity score matching comparison with long-term follow-up.

OBJECTIVES: Uncorrected severe mitral regurgitation (MR) due to posterior prolapse leads to left ventricular dilatation. At this stage, mitral valve repair becomes mandatory to avoid permanent myocardial injury. However, which technique among neochoardae implantation and leaflet resection provides the best results in this scenario remains unknown. METHODS: We selected 332 patients with left ventricular dilatation and severe degenerative MR due to posterior leaflet (PL) prolapse who underwent neochoardae implantation (85 patients) or PL resection (247 patients) at our institution between 2008 and 2020. A propensity score matching analysis was carried on to decrease the differences at baseline. RESULTS: Matching yielded 85 neochordae implantations and 85 PL resections. At 10 years, freedom from cardiac death and freedom from mitral valve reoperation were 92.6 ± 6.1% vs 97.8 ± 2.1% and 97.7 ± 2.2% vs 95 ± 3% in the neochordae group and in the PL resection group, respectively. The MR ≥2+ recurrence rate was 23.9 ± 10% in the neochordae group and 20.8 ± 5.8% in the PL resection group (P = 0.834) at 10 years. At the last follow-up, the neochordae group showed a higher reduction of left ventricular end-diastolic diameter (44 vs 48 mm; P = 0.001) and a better ejection fraction (60% vs 55%; P < 0.001) compared to PL resection group. CONCLUSIONS: In this subgroup of patients, both neochordae implantation and leaflet resection provide excellent durability of the repair in the long term. Neochordae implantation might have a better effect on dilated left ventricle.

Three Logistic Predictive Models for the Prediction of Mortality and Major Pulmonary Complications after Cardiac Surgery.

Background and Objectives: Pulmonary complications are a leading cause of morbidity after cardiac surgery. The aim of this study was to develop models to predict postoperative lung dysfunction and mortality. Materials and Methods: This was a single-center, observational, retrospective study. We retrospectively analyzed the data of 11,285 adult patients who underwent all types of cardiac surgery from 2003 to 2015. We developed logistic predictive models for in-hospital mortality, postoperative pulmonary complications occurring in the intensive care unit, and postoperative non-invasive mechanical ventilation when clinically indicated. Results: In the "preoperative model" predictors for mortality were advanced age (p < 0.001), New York Heart Association (NYHA) class (p < 0.001) and emergent surgery (p = 0.036); predictors for non-invasive mechanical ventilation were advanced age (p < 0.001), low ejection fraction (p = 0.023), higher body mass index (p < 0.001) and preoperative renal failure (p = 0.043); predictors for postoperative pulmonary complications were preoperative chronic obstructive pulmonary disease (p = 0.007), preoperative kidney injury (p < 0.001) and NYHA class (p = 0.033). In the "surgery model" predictors for mortality were intraoperative inotropes (p = 0.003) and intraoperative intra-aortic balloon pump (p < 0.001), which also predicted the incidence of postoperative pulmonary complications. There were no specific variables in the surgery model predicting the use of non-invasive mechanical ventilation. In the "intensive care unit model", predictors for mortality were postoperative kidney injury (p < 0.001), tracheostomy (p < 0.001), inotropes (p = 0.029) and PaO2/FiO2 ratio at discharge (p = 0.028); predictors for non-invasive mechanical ventilation were kidney injury (p < 0.001), inotropes (p < 0.001), blood transfusions (p < 0.001) and PaO2/FiO2 ratio at the discharge (p < 0.001). Conclusions: In this retrospective study, we identified the preoperative, intraoperative and postoperative characteristics associated with mortality and complications following cardiac surgery.

Imaging of the Diaphragm Following Cardiac Surgery: Focus on Ultrasonographic Assessment.

Diaphragm dysfunction is a common complication following cardiac surgery. Its clinical impact is variable, ranging from the absence of symptoms to the acute respiratory failure. Post-operative diaphragm dysfunction may negatively affect patients' prognosis delaying the weaning from the mechanical ventilation (MV), extending the time of hospitalization and increasing mortality. Ultrasonography is a valid tool to evaluate diaphragmatic impairment in different settings, like the Intensive Care Unit, to predict successful weaning from the MV, and the Cardiovascular Rehabilitation Unit, to stratify patients in terms of risk of functional recovery failure. The aim of this review is to describe the pathophysiology of post-cardiac surgery diaphragm dysfunction, the techniques used for its diagnosis and the potential applications of diaphragm ultrasound.

Ratio between right ventricular longitudinal strain and pulmonary arterial systolic pressure: A novel prognostic parameter in patients with severe tricuspid regurgitation.

BACKGROUND: In terms of pathophysiology, tricuspid regurgitation (TR), right ventricular function and pulmonary artery pressure are linked to each other. Our aim was to analyze whether the echocardiography-derived right ventricular free wall longitudinal strain/pulmonary artery systolic pressures (RVFWLS/PASP) ratio can improve risk stratification in patients with severe tricuspid regurgitation (TR). METHODS: In this single-center retrospective study, 250 consecutive patients with severe TR were enrolled from December 2015 to December 2018. Baseline clinical and echocardiographic parameters were collected. Echocardiography-derived TAPSE/PASP and RVFWLS/PASP were evaluated. The primary endpoint was all-cause mortality. RESULTS: Out of 250 consecutive patients, 171 meet inclusion criteria. Patients were predominantly female, with several cardiovascular risk factors and comorbidities. RVFWLS/PASP ≤0.34%/mmHg (AUC 0.68, p < 0.001, sensitivity 70%, specificity 67%) was associated with baseline clinical RV heart failure (p = 0.03). After univariate and multivariate analyses, RVFWLS/PASP, but not TAPSE/PASP, independently correlated with all-cause mortality (HR 0.004, p = 0.02). Patients with RVFWLS/PASP >0.26%/mmHg (AUC 0.74, p < 0.001, sensitivity 77%, specificity 52%) showed higher survival rates (p = 0.02). In addition at 24 months follow-up, the Kaplan-Meyer curves showed patients with RVFWLS >14% & RVFWLS/PASP >0.26%/mmHg had the best survival rate compared to patients without. CONCLUSION: RVFWLS/PASP is independently associated with baseline RV heart failure and poor long-term prognosis in patients with severe TR.

TRI-SCORE: a single-centre validation study.

OBJECTIVES: The TRI-SCORE is a recently published risk score for predicting in-hospital mortality in patients undergoing isolated tricuspid valve surgery (ITVS). The aim of this study is to externally validate the ability of the TRI-SCORE in predicting in-hospital and long-term mortality following ITVS. METHODS: A retrospective review of our institutional database was carried out to identify all patients undergoing isolated tricuspid valve repair or replacement from March 1997 to March 2021. The TRI-SCORE was calculated for all patients. Discrimination of the TRI-SCORE was assessed using receiver operating characteristic curves. Accuracy of the models was tested calculating the Brier score. Finally, a COX regression was employed to evaluate the relationship between the TRI-SCORE value and long-term mortality. RESULTS: A total of 176 patients were identified and the median TRI-SCORE was 3 (1-5). The cut-off value identified for increased risk of isolated ITVS was 5. Regarding in-hospital outcomes, the TRI-SCORE showed high discrimination (area under the curve 0.82), and high accuracy (Brier score 0.054). This score showed also very good performance in predicting long-term mortality (at 10 years, hazard ratio: 1.47, 95% confidence interval [1.31-1.66], P < 0.001), with high discrimination (area under the curve >0.80 at 1-5 and 10 years) and high accuracy values (Brier score 0.179). CONCLUSIONS: This external validation confirms the good performance of the TRI-SCORE in predicting in-hospital mortality. Moreover, the score showed also very good performance in predicting the long-term mortality.

The impact of mitral valve surgery on ventricular arrhythmias in patients with Barlow's disease: preliminary results of a prospective study.

OBJECTIVES: Aim of this study was to evaluate arrhythmic burden of patients with Barlow's disease and significant mitral regurgitation (MR) and assess the impact of mitral repair on ventricular arrhythmias (VA) in this group of subjects. METHODS: We prospectively included 88 consecutive patients with Barlow's disease referred to our Institution from February 2021 to May 2022. All enrolled patients underwent 24-h Holter monitoring before surgery. Sixty-three of them completed 3 months echocardiographic and Holter follow-up. Significant arrhythmic burden was defined as ≥1% premature ventricular beats/24 h or at least one episode of non-sustained ventricular tachycardia (VT), VT or ventricular fibrillation. RESULTS: At baseline, 29 patients (33%) were arrhythmogenic (AR), while 59 (67%) were not [non-arrhythmogenic (NAR)]. AR subjects tended to be more often females with history of palpitations. Sixty-three patients completed 3-months follow-up. Twenty of them (31.7%) were AR at baseline and 43 (68.3%) were not. Among AR patients, 9 (45%) remained AR after mitral surgery, while 11 (55%) became NAR. Considering NAR subjects at baseline, after mitral valve repair 8 (18.6%) evolved into AR, while 35 (81.4%) remained NAR. A higher prevalence of pre-operative MAD was found among patients experiencing VA reduction if compared with patients who remained arrhythmogenic (63.6% vs 11.1%, P = 0.028). CONCLUSIONS: In our experience, one-third of Barlow's patients referred for mitral surgery showed a significant arrhythmic burden. Almost half of the subjects arrhythmogenic at baseline were free from significant VA after mitral repair. However, a minority (18.6%) of subjects without arrhythmic burden at baseline experienced significant VA at follow-up.

Secondary Lymphedema: Clinical Interdisciplinary Tricks to Overcome an Intriguing Disease.

Secondary lymphedema is a complex pathology which is very impairing to the patient, consisting of fluid accumulation in the tissue, accompanied by alteration of the interstitial fibrous tissue matrix, deposition of cellular debris and local inflammation. It develops mostly in limbs and/or external genitals because of demolishing oncological surgery with excision of local lymph nodes, or it may depend upon inflammatory or infective diseases, trauma, or congenital vascular malformation. Its treatment foresees various approaches, from simple postural attitude to physical therapy, to minimally invasive lymphatic microsurgery. This review focuses on the different types of evolving peripheral lymphedema and describes potential solutions to single objective symptoms. Particular attention is paid to the newest lymphatic microsurgical approaches, such as lymphatic grafting and lympho-venous shunt application, to successfully heal, in the long term, serious cases of secondary lymphedema of limbs or external genitals. The presented data also emphasize the potential role of minimally invasive microsurgery in enhancing the development of newly formed lymphatic meshes, focusing on the need for further accurate research in the development of microsurgical approaches to the lymphatic vascular system.

Safety and efficacy of direct oral anticoagulants (DOACs) in very elderly patients (≥85 years old) with non-valvular atrial fibrillation.

BACKGROUND: Limited real-world data are available regarding the comparison about safety and efficacy of DOACs prescription in very elderly patients (≥85 years) with non-valvular atrial fibrillation (NVAF). Concern about the risk of bleeding with anticoagulation in very older patients still represents an important challenge for clinicians. The aim of this study was to evaluate the different prevalence of major bleeding and thromboembolic events between very elderly NVAF patients (≥85 years) compared to those non very elderly (<85 years). METHODS: Single center multidisciplinary registry including NVAF patients treated with DOACs. Primary safety endpoint was 2-year rate of major bleeding. Primary efficacy endpoint was 2-year rate of thromboembolic events. Event-free survival curves among groups were compared using Cox-Mantel Test. RESULTS: 908 NVAF consecutive patients were included, of these, 805 patients were <85 years (89%) and 103 patients were very elderly patients with ≥85 years (11%). Compared to patients <85 years, those very elderly have higher CHA2DS2-VASc Score (P=0.001), higher rate of hypertension (P=0.001), diabetes mellitus (P=0.030), previous bleeding events (P<0.001), previous stroke/TIA/SE (P≤0.001), heart failure (P≤0.001), and lower creatinine clearance (P<0.001). In terms of safety endpoints (overall ISTH-major bleeding) no significative difference between two groups (P=0.952) were observed up to 2-year follow-up. Systemic thromboembolic event (primary efficacy endpoint) was significantly higher in patients with ≥85 years (P=0.027). The incidence of all-cause death was significantly higher in very elderly patients (P<0.001). CONCLUSIONS: This single center registry, showed that the use of DOACs in very elderly NVAF was safe and is a therapeutic option to be pursued for stroke prevention especially for those who are at high risk of ischemic events.