CharActeristics, sizing anD outcomes of stenotic, tapered, rapHe-type bicuspid aOrtic valves treated with trans-catheter device implantation: Insights the AD HOC registry.

BACKGROUND: Raphe-type bicuspid aortic valve (BAV) is a potential hostile scenario in trans-catheter aortic valve replacement (TAVR) due to pronounced calcium burden, possibly associated with tapered valve configuration. Trans-Catheter heart valve (THV) sizing strategy (annular vs. supra-annular) is controversial in this valve subtype. OBJECTIVES: To describe the phenotypical characteristics of severe, tapered, raphe-type, BAV stenosis undergoing TAVR and to explore safety and efficacy of modern-generation THVs, analysing the impact of annular and supra-annular sizing strategies on short- and mid-terms outcomes. METHODS: This is a retrospective, multicenter registry enrolling consecutive stenotic Sievers type 1 BAV treated with TAVR. Study population was divided into tapered and non-tapered configuration according to MSCT analysis. Matched comparison between annular and supra-annular sizing groups was performed in tapered population. RESULTS: From January 2016 to June 2023, 897 patients were enrolled. Of them, 696 patients displayed a tapered configuration. Of those, 510 received a THV according to annular sizing. After propensity score matching 186 matched pairs were selected. Technical success (96.2 % vs 94.1 %, OR 1.61 [0.61-4.24], p = 0.34), 30-day device success (83.6 % in both groups, OR 1.42 [0.78-2.57], p = 0.25) and 30-day early safety (71.8 % vs 70.5 %, OR 1.07 [0.68-1.68], p = 0.78) were similar between the annular and supra-annular sizing groups; a higher post-TAVR gradient was observed in supra-annular group, although it was only 2 mmHg mean. At mid-term follow-up, the rate of clinical efficacy was 84.7 %. CONCLUSIONS: TAVR with modern-generation devices is safe and effective for tapered raphe-type BAV, showing comparable results for annular and supra-annular sizing strategies.

Incidence and Predictors of Cerebrovascular Accidents in Patients Who Underwent Transcatheter Mitral Valve Repair With MitraClip.

Transcatheter mitral edge-to-edge repair (TEER) with transcatheter devices has become a mainstay in the minimally invasive treatment of patients with severe mitral regurgitation at increased surgical risk. Despite its apparently favorable risk profile, there is uncertainty on the risk and features of cerebrovascular accidents (CVAs) early and long after transcatheter mitral valve repair. We aimed to appraise the incidence and predictors of CVA in patients who underwent TEER. We explicitly queried the data set of an ongoing multicenter prospective observational study dedicated to TEER with MitraClip (Abbott Vascular, Santa Clara, California). The incidence of CVAs after TEER was formally appraised, and we explored potential predictors of such events. Descriptive, bivariate, and diagnostic accuracy analyses were performed. Of 2,238 patients who underwent TEER, CVAs occurred in 33 patients (1.47% [95% confidence interval 1.02% to 2.06%]), including 6 (0.27% [0.10% to 0.58%]) in-hospital strokes and 27 events after discharge (0.99% [0.66% to 1.44%]), over a median follow-up of 14 months. Most CVAs were major ischemic strokes during and after the in-hospital phase. Overall, CVAs were more common in patients with atrial fibrillation (p = 0.018), renal dysfunction (p = 0.032), higher EuroSCORE II (p = 0.033), and, as expected, higher CHA2DS2-VASc score (p = 0.033), despite the limited prognostic accuracy of the score. Notably, the occurrence of CVA did not confer a significantly increased risk of long-term (p = 0.136) or cardiac death (p = 0.397). The incidence of CVA in patients who underwent TEER is low, with most events occurring after discharge and being associated with preexisting risk features. These findings, although reassuring on the safety of TEER, call for proactive antithrombotic therapy whenever CVA risk is increased before and after TEER.

Prevalence and outcome of elderly and low-risk patients with degenerative mitral regurgitation undergoing transcatheter edge-to-edge repair.

AIM: The aims of this study were: i) to report the prevalence of low-risk patients with degenerative mitral regurgitation (DMR) undergoing mitral transcatheter edge-to-edge repair (M-TEER) in a real-world setting; ii) to evaluate the prognostic significance of EuroSCORE II; iii) to determine whether an optimal M-TEER provides a mortality benefit regardless of EuroSCORE-II. METHODS: We analyzed data from the GIOTTO registry that enrolled patients undergoing M-TEER in Italy. We included only patients with DMR. Two groups were defined: patients with EuroSCORE<4% and with EuroSCORE≥4%. A further stratification according to variables included in the EuroSCORE-II was made. Interaction between EuroSCORE-II and optimal procedural success was evaluated. Outcome of interest was all-cause death at 2-year. RESULTS: Among 1659 patients prospectively enrolled in the GIOTTO registry, 657 had DMR, 364 with an EuroSCORE<4% (53%) and 311 with an EuroSCORE≥4% (47%). Patients with lower EuroSCORE were older with less comorbidities. All-cause mortality was higher in patients with EuroSCORE≥ vs <4%. EuroSCORE II ≥ 4% was independently associated with an increased risk of mortality (HR 2.36, 95%CI 1.28-4.38, p = 0.007). Among variables included in the EuroSCORE-II, Left Ventricular Ejection Fraction<35% and systolic Pulmonary Artery Pressure ≥ 50mmhg were independent predictors of clinical outcome. Two-year all-cause death was higher in patients without optimal MR reduction regardless of the calculated surgical risk (p for interaction 0.3). CONCLUSION: More than half of patients with DMR undergoing M-TEER had a Euroscore<4% with a median age of 81. An optimally successful M-TEER was associated with a lower mortality regardless of EuroSCORE.

Impact of heart failure severity on the mortality benefit of mitral transcatheter edge-to-edge valve repair.

BACKGROUND: To assess the interaction between heart failure (HF) severity and optimal reduction of secondary mitral regurgitation (SMR) on mortality in patients undergoing transcatheter edge-to-edge repair (M-TEER). METHODS AND RESULTS: Among 1656 patients included in the Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) 984 had SMR and complete data on advanced HF. Advanced HF was defined as NYHA class III or IV, left ventricular ejection fraction ≤ 30%, and > 1 HF hospitalization during the last 12 months. Optimal M-TEER was defined as residual SMR ≤ 1 + at discharge. One hundred sixteen patients (11.8%) had advanced HF. Achievement of an optimal SMR reduction was similar in patients with and without advanced HF (65% and 60% respectively). Advanced HF was an independent predictor of 2-year all-cause death (adjusted HR 1.52, 95% CI 1.09-2.10). Optimal M-TEER, as compared to a no-optimal M-TEER, was associated with a reduced risk of death both in patients with advanced (HR 0.55, 95% CI 0.32-0.97; p = 0.039) and no-advanced HF (HR 0.59, 95% CI 0.46-0.78; p < 0.001; p = 0.778 for interaction). CONCLUSIONS: Advanced HF is associated with poor outcome in patients undergoing M-TEER. However, an optimal SMR reduction reduces the risk of 2-year mortality regardless of HF severity.

Transcatheter Mitral Valve Repair With the MitraClip Device for Prior Mitral Valve Repair Failure: Insights From the GIOTTO-FAILS Study.

BACKGROUND: Minimally invasive mitral valve repair has a favorable risk-benefit profile in patients with significant de novo mitral regurgitation. Its role in patients with prior mitral valve repair is uncertain. We aimed to appraise the outcome of patients undergoing transcatheter edge-to-edge repair (TEER) with prior transcatheter or surgical mitral valve repair (SMVR). METHODS AND RESULTS: We queried the Italian multicenter registry on TEER with MitraClip, distinguishing naïve patients from those with prior TEER or (SMVR). Inhospital and long-term clinical/echocardiographic outcomes were appraised. The primary outcome was the occurrence of death or rehospitalization for heart failure. A total of 2238 patients were included, with 2169 (96.9%) who were naïve to any mitral intervention, 29 (1.3%) with prior TEER, and 40 (1.8%) with prior SMVR. Several significant differences were found in baseline clinical and imaging features. Respectively, device success was obtained in 2120 (97.7%), 28 (96.6%), and 38 (95.0%, P=0.261) patients; procedural success in 2080 (95.9%), 25 (86.2%), and 38 (95.0%; P=0.047); and inhospital death in 61 (2.8%), 1 (3.5%), and no (P=0.558) patients. Clinical follow-up after a mean of 14 months showed similar rates of death, cardiac death, rehospitalization, rehospitalization for heart failure, and their composite (all P>0.05). Propensity score-adjusted analysis confirmed unadjusted analysis, with lower procedural success for the prior TEER group (odds ratio, 0.28 [95% CI, 0.09-0.81]; P=0.019) but similar odds ratios and hazard ratios for all other outcomes in the naïve, TEER, and SMVR groups (all P>0.05). CONCLUSIONS: In carefully selected patients, TEER can be performed using the MitraClip device even after prior TEER or SMVR.

Progression of the ascending aorta diameter after surgical or transcatheter bicuspid aortic valve replacement.

OBJECTIVES: Ascending aorta (AA) dilatation in patients with bicuspid aortic valve (AV) is related both to genetic and haemodynamic factors. The aim of this study is to compare late progression of AA dilatation in bicuspid AV patients undergoing surgical aortic valve replacement (SAVR) versus transcatheter aortic valve implantation (TAVI). METHODS: Data of 189 consecutive patients who underwent AV replacement for severe bicuspid AV stenosis were prospectively collected. Patients who underwent SAVR were compared to patients who underwent TAVI. Indication to the procedure was validated by the institutional Heart Team. Aortic diameters were evaluated by transthoracic echocardiogram. Differences between preoperative and long-term follow-up AA diameters were compared in the 2 groups. RESULTS: Between January 2015 and December 2021, 143 (76%) patients underwent SAVR and 46 (24%) patients underwent TAVI. At 4.6 (standard deviation 1.7) years follow-up, patients in the TAVI group showed significantly lower survival (P = 0.00013) and event-free survival (P < 0.0001). AA diameter progression was lower in surgical compared to transcatheter patients, 0.95 (0.60, 1.30) vs 1.65 (0.67, 2.63) mm, P = 0.02. AA diameter progression indexed for body surface area and height was lower in the surgical group: 0.72 (0.38, 1.05) vs 1.05 (0.39, 1.71) mm/m2, P = 0.02, and 0.59 (0.36, 0.81) vs 1.11 (0.44, 1.78) mm/m, P = 0.001, respectively. At multivariable linear regression analysis transcatheter procedure, baseline aortic diameter and paravalvular leak were significantly associated with increased postoperative AA dilatation. CONCLUSIONS: Bicuspid AV patients who underwent SAVR, showed significantly less long-term AA diameter progression than patients who underwent transcatheter procedure.

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

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.

Transcatheter mitral valve repair with MitraClip: comparison of NT, NTr, and XTr Devices.

OBJECTIVES: Transcatheter edge-to-edge repair (TEER) has become an established minimally invasive treatment for significant mitral regurgitation. Ongoing refinements and the availability of different clipping devices have expanded the indications for and effectiveness of TEER, but comprehensive comparative data on this issue are lacking. In this study, we compared NT, NTr, and XTr MitraClip devices (Abbot) for TEER. METHODS: Details on patient, imaging, and procedural details, as well as short- and long-term outcomes, were sought from a national prospective clinical registry on TEER with MitraClip. The primary outcome of interest was discharge after procedural success without major clinical complications. RESULTS: A total of 2236 patients were included, 1228 (54.9%) in whom NT implantation only was attempted, 233 (10.4%) in whom NTr but not XTr implantation was attempted, and 775 (34.7%) in whom XTr implantation was attempted. Clinical and imaging features differed substantially across the groups, reflecting expanding indications with NTr and XTr devices. In-hospital outcomes were largely similar among the 3 groups, including death. Long-term unadjusted estimates of effect showed significant differences in several outcomes, including death, rehospitalization, and their composite, which demonstrated that NT was associated with more unfavorable outcomes compared with the other devices (all P less than .05). However, most differences depended on baseline features, as adjusted analysis showed no significant differences for early as well as long-term outcomes, including long-term death, rehospitalization, and their composite (all P greater than .05). CONCLUSIONS: New-generation MitraClip devices are associated with favorable procedural and clinical outcomes, despite being used in patients with more adverse features, when compared with patients treated with previous devices.

Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Atrial Functional Mitral Regurgitation from the GIOTTO Registry.

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478 days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes.

Comparison of ultrasound- versus fluoroscopy-guidEd femorAl access In tranS-catheter aortic valve replacement In the Era of contempoRary devices: The EASIER registry.

BACKGROUND: Vascular complications (VCs) still represent one of the principal concerns of trans-femoral trans-catheter aortic valve replacement (TF-TAVR). New-generation devices can minimize such complications but the arterial access management is left to the operator's choice. This study aims to describe the rate of VCs in a contemporary cohort of patients undergoing TAVR with new-generation devices and to determine whether an ultrasound-guided (USG) vs. a fluoroscopy-guided (FG) femoral access management has an impact on their prevention. METHODS: This is a prospective, observational, multicenter study. Consecutive patients undergoing TAVR with new-generation devices were analyzed from January 2022 to October 2022 in five tertiary care centers. Femoral accesses were managed according to the operator's preferences. All the patients underwent a pre-discharge peripheral ultrasound control. VCs and bleedings were the main endpoints of interest. RESULTS: A total of 458 consecutive patients were enrolled (274 in the USG group and 184 in the FG group). VCs occurred in 6.5 % of the patients (5.2 % minor and 1.3 % major). There was no difference between the USG and the FG groups in terms of any VCs (7.3 % vs. 5.4 %; p = 0.4), or any VARC-3 bleedings (6.9 % vs 6 %, p = 0.9). At logistic regression analysis, the two guidance strategies did not result as predictors of VCs (odds Ratio 0.8, 95 % Confidence Interval 0.46-1.4; P = 0.4). CONCLUSIONS: In a contemporary cohort of patients undergoing TAVR with new-generation devices, the occurrence of VCs is low and mostly represented by minor VCs. USG and FG modalities did not affect the rate of VCs.

Impact of extra-mitral valve cardiac involvement in patients with primary mitral regurgitation undergoing transcatheter edge-to-edge repair.

BACKGROUND: In the context of primary mitral regurgitation (PMR), the selection of patients for transcatheter edge-to-edge repair (TEER) does not include a systematic assessment of PMR-associated cardiac remodelling. AIMS: We aimed to investigate the epidemiology and prognostic significance of different phenotypes of extra-mitral valve (MV) cardiac involvement in a large series of patients with PMR referred for TEER. METHODS: The study included 654 patients from the multicentre Italian GIOTTO registry, stratified into groups according to extra-mitral valve (MV) cardiac involvement. The primary endpoint was all-cause death at 2-year follow-up. RESULTS: Patients with no cardiac involvement (NI; n=58), left heart involvement (LHI; n=343) and right heart involvement (RHI; n=253) were analysed. Acute technical success was achieved in 98% of patients. Kaplan-Meier curve analysis revealed significantly worse survival in patients with LHI and RHI (p=0.041). On multivariate Cox regression analysis, extra-MV cardiac involvement, haemoglobin level and technical success were independent predictors of the primary endpoint occurrence. CONCLUSIONS: Grading cardiac involvement may help refine risk stratification, since at least 1 group of extra-MV cardiac involvement represents in itself a negative predictor of midterm outcome.

Prognostic Significance of Flail Mitral Leaflet in Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation.

Despite the growing experience with MitraClip in the broad spectrum of mitral regurgitation (MR), limited data are available regarding the independent prognostic role on survival of different mitral regurgitation etiology subtypes. We sought to evaluate the impact of flail leaflet etiology in a large series of patients with primary MR (PMR) who underwent MitraClip treatment. The study included 588 patients with significant PMR from the multicenter GIOTTO (Italian Society of Interventional Cardiology [GIse] registry Of Transcatheter treatment of mitral valve regurgitaTiOn), stratified into 2 groups according to MR etiology: flail+ (n = 300) and flail- (n = 288). The primary end point was a composite of cardiac death and first rehospitalization for heart failure (HF). To account for the baseline differences, patients were propensity score-matched 1:1. Flail leaflet etiology was present in about a half of the patients. Acute technical success was achieved in 98% of the overall cohort, with no significant differences between the study groups (p = 0.789). At the 2-year Kaplan-Meier analysis, the primary end point occurred in 13% of flail+ patients compared with 23% in flail- (p = 0.009). The flail+ group presented lower rates of both cardiac death and rehospitalization for HF, whereas a similar overall death rate was observed between the groups. A multivariate Cox regression analysis identified flail leaflet etiology as an independent predictor of favorable outcome in terms of the primary end point (hazard ratio 0.141, 95% confidence interval 0.049 to 0.401, p <0.001). After propensity score matching, flail+ patients had confirmed lower rates of cardiac mortality and rehospitalization for HF but similar rates of overall death. In conclusion, flail leaflet-related etiology was common in patients with PMR who underwent MitraClip treatment and was an independent predictor of midterm favorable clinical outcomes.

Impact of coronary artery disease on outcome after transcatheter edge-to-edge mitral valve repair with the MitraClip system.

BACKGROUND: The clinical impact of coronary artery disease (CAD) on the prognosis of patients undergoing MitraClip implantation is still unclear. METHODS: One thousand nine hundred fifty-three patients undergoing MitraClip implantation included in the multicenter GIOTTO Registry were stratified according to CAD. Endpoints were all-cause death, cardiac death, and re-hospitalization for heart failure at follow-up (median 15.8 months). RESULTS: Although younger, CAD patients were more symptomatic, had worse cardiovascular risk profile, higher burden of comorbidities, more frequently affected by functional MR, with higher left ventricle (LV) diameters and lower ejection fraction (EF). At follow-up, CAD patients showed higher rates of all-cause death (25.4% vs. 19.6%; P=0.002), cardiovascular death (14.0% vs. 10.1%; P=0.007) and re-hospitalization for heart failure (13.9% vs. 10.2%; P=0.011). Dividing the population according to mitral regurgitation (MR) etiology (functional vs. non-functional MR), no differences were observed between CAD and no-CAD patients. At multivariate logistic regression, NYHA III/IV class, prior heart failure hospitalization, severe chronic kidney disease, atrial fibrillation, LV end-diastolic diameter and LVEF<30% but not CAD resulted independent predictors of all-cause death. The same finding was confirmed even after propensity score adjustment. CONCLUSIONS: CAD did not show a relevant impact on mid-term prognosis per se, but seemed to identify a more complex and diseased cohort of patients with worse clinical and functional status.

Two innovative aortic bioprostheses evaluated in the real-world setting. First results from a two-center study.

BACKGROUND: The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability. METHODS: In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance. RESULTS: From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm2 vs. 1.4 cm2 (P=0.4) and 0.8 vs. 0.7 cm2/m2 (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m2 for the Inspiris and AVALUS groups, respectively, (R2-adjusted =0.14; P<0.01). CONCLUSIONS: INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.

Extracorporeal life support in mitral papillary muscle rupture: Outcome of multicenter study.

BACKGROUND: Post-acute myocardial infarction papillary muscle rupture (post-AMI PMR) may present variable clinical scenarios and degree of emergency due to result of cardiogenic shock. Veno-arterial extracorporeal life support (V-A ECLS) has been proposed to improve extremely poor pre- or postoperative conditions. Information in this respect is scarce. METHODS: From the CAUTION (meChanical complicAtion of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study) database (16 different Centers, data from 2001 to 2018), we extracted adult patients who were surgically treated for post-AMI PMR and underwent pre- or/and postoperative V-A ECLS support. The end-points of this study were in-hospital survival and ECLS complications. RESULTS: From a total of 214 post-AMI PMR patients submitted to surgery, V-A ECLS was instituted in 23 (11%) patients. The median age was 61.7 years (range 46-81 years). Preoperatively, ECLS was commenced in 10 patients (43.5%), whereas intra/postoperative in the remaining 13. The most common V-A ECLS indication was post-cardiotomy shock, followed by preoperative cardiogenic shock and cardiac arrest. The median duration of V-A ECLS was 4 days. V-A ECLS complications occurred in more than half of the patients. Overall, in-hospital mortality was 39.2% (9/23), compared to 22% (42/219) for the non-ECLS group. CONCLUSIONS: In post-AMI PMR patients, V-A ECLS was used in almost 10% of the patients either to promote bridge to surgery or as postoperative support. Further investigations are required to better evaluate a potential for increased use and its effects of V-A ECLS in such a context based on the still high perioperative mortality.

Prediction of mortality and heart failure hospitalisations in patients undergoing M-TEER: external validation of the COAPT risk score.

BACKGROUND: A risk score was recently derived from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial. However, external validation of this score is still lacking. AIMS: We aimed to validate the COAPT risk score in a large multicentre population undergoing mitral transcatheter edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). METHODS: The Italian Society of Interventional Cardiology (GIse) Registry of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) population was stratified according to COAPT score quartiles. The performance of the COAPT score for 2-year all-cause death or heart failure (HF) hospitalisation was evaluated in the overall population and in patients with or without a COAPT-like profile. RESULTS: Among the 1,659 patients included in the GIOTTO registry, 934 had SMR and complete data for a COAPT risk score calculation. The incidence of 2-year all-cause death or HF hospitalisation progressively increased through the COAPT score quartiles in the overall population (26.4% vs 44.5% vs 49.4% vs 59.7%; log-rank p<0.001) and COAPT-like patients (24.7% vs 32.4% vs 52.3% vs. 53.4%; log-rank p=0.004), but not in those with a non-COAPT-like profile. The COAPT risk score had poor discrimination and good calibration in the overall population, moderate discrimination and good calibration in COAPT-like patients and very poor discrimination and poor calibration in non-COAPT-like patients. CONCLUSIONS: The COAPT risk score has a poor performance in the prognostic stratification of real-world patients undergoing M-TEER. However, after application to patients with a COAPT-like profile, moderate discrimination and good calibration were observed.

Derivation and Validation of a Clinical Risk Score for COAPT-Ineligible Patients Who Underwent Transcatheter Edge-to-Edge Repair.

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 of <12 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.

Pacemaker after Sutureless and Rapid-Deployment Prostheses: A Progress Report from the SURD-IR.

OBJECTIVES: The aim of this study was to investigate the need for postoperative permanent pacemaker implantation (PPI) following sutureless and rapid-deployment aortic valve replacement (SuRD-AVR) in the context of a progress report from a large multicenter international registry (SURD-IR). METHODS: We retrospectively analyzed 4,166 patients who underwent SuRD-AVR between 2008 and 2019. The primary outcome was the need for PPI before discharge. The study population was analyzed separately according to the implanted prostheses (Su cohort and RD cohort). Each cohort was divided into two groups based on the operation date: an early group ("EG" = 2008-2016) and a late group ("LG" = 2017-2019). RESULTS: The rate of PPI decreased significantly in the Su cohort over time (EG = 10.8% vs LG = 6.3%, p < 0.001). In the Su cohort, a decrease in age, risk profile, and incidence of bicuspid aortic valve, increased use of anterior right thoracotomy, reduction of cardiopulmonary bypass time and of associated procedures, and more frequent use of smaller prostheses were observed over time. In the RD cohort, the rate of PPI was stable over time (EG = 8.8% vs LG = 9.3%, p = 0.8). In this cohort, a younger age, lower risk profile, and higher incidence of concomitant septal myectomy were observed over time. CONCLUSION: Our analysis showed a significant decrease in the PPI rate in patients who underwent Su-AVR over time. Patient selection as well as surgical improvements and a more accurate sizing could be correlated with this phenomenon. The RD cohort revealed no significant differences either in patient's characteristics or in PPI rate between the two time periods.