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.

Quantitative coronary computed tomography assessment for differentiating between total occlusions and severe stenoses.

BACKGROUNDS: The impact of quantitative assessment to differentiate total occlusions (TOs) from severe stenoses on coronary computed tomography angiography (CCTA) remains unknown. OBJECTIVE: This study investigated whether quantitative characteristics assessed on CCTA could help differentiate a TO from a severe stenosis on invasive coronary angiography (ICA). METHODS: This study is a sub-analysis of the FASTTRACK CABG (NCT04142021) in which both CCTA and ICA were routinely performed. Quantitative analysis was performed with semi-automated CCTA plaque-analysis software. Blinded analysts compared TOs on CCTA, defined as a complete lack of contrast opacification within the coronary occlusion, with corresponding ICA. RESULTS: Eighty-four TOs were seen on CCTA in 59 of the 114 patients enrolled in the trial. The concordance in diagnosing a TO between ICA and CCTA was 56.0% (n â€‹= â€‹47). Compared to severe stenoses, TOs had a significantly longer lesion length (25.1 â€‹± â€‹23.0 â€‹mm vs 9.4 â€‹± â€‹11.2 â€‹mm, P â€‹< â€‹0.001). The best cut-off value to differentiate a TO from severe stenosis was a lesion length of 5.5 â€‹mm (area under the curve 0.77, 95% CI: 0.66-0.87), with a 91.1% sensitivity and 61.1% specificity. Dense calcium percentage atheroma volume (PAV) was significantly higher in TOs compared to severe stenoses (18.7 â€‹± â€‹19.6% vs. 6.6 â€‹± â€‹13.0%, P â€‹< â€‹0.001), whilst the opposite was seen for fibro-fatty PAV (31.3 â€‹± â€‹14.2% vs. 19.5 â€‹± â€‹10.5%, P â€‹< â€‹0.001). On a multivariable logistic regression analysis, lesion length (>5.5 â€‹mm) was the only parameter associated with differentiating a TO from a severe stenosis. CONCLUSION: In quantitative CCTA analysis, a lesion length >5.5 â€‹mm was the only independent predictor differentiating a TO from a severe stenosis. NCT REGISTRATION NUMBER: NCT04142021.

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.

Predictors of adverse cardiac events of coronary myocardial bridging diagnosed with computed tomography angiography.

AIMS: Myocardial bridging (MB) is a frequent congenital anomaly of the epicardial coronary arteries commonly considered a benign condition. However, in some cases a complex interplay between anatomical, clinical and physiology factors may lead to adverse events, including sudden cardiac death. Coronary CT angiography (CCTA) emerged as the gold standard noninvasive imaging technique for the evaluation of MB. Aim of the study was to evaluate MB prevalence and anatomical features in a large population of patients who underwent CCTA for suspected CAD and to identify potential anatomical and clinical predictors of adverse cardiac events at long-term follow-up. METHODS AND RESULTS: Two-hundred and six patients (mean age 60.3 ± 11.8 years, 128 male) with MB diagnosed at CCTA were considered. A long MB was defined as ≥25 mm of overlying myocardium, whereas a deep MB as ≥2 mm of overlying myocardium. The study endpoint was the sum of the following adverse events: cardiac death, bridge-related acute coronary syndrome, hospitalization for angina or bridge-related ventricular arrhythmias and MB surgical treatment. Of the 206 patients enrolled in the study, 9 were lost to follow-up, whereas 197 (95.6%) had complete follow-up (mean 7.01 ± 3.0 years) and formed the analytic population. Nineteen bridge-related events occurred in 18 patients (acute coronary syndrome in 7, MB surgical treatment in 2 and hospitalization for bridge-related events in 10). Typical angina at the time of diagnosis and long MB resulted as significant independent predictors of adverse outcome. CONCLUSIONS: Typical angina and MB length ≥ 25 mm were independent predictors of cardiac events.

Prevalence and prognosis of structural heart disease among athletes with negative T waves and normal transthoracic echocardiography.

INTRODUCTION: The aim of the present study was to evaluate the prevalence and prognosis of structural heart disease (SHD) among competitive athletes with negative T waves without pathological findings at transthoracic echocardiogram. METHODS: From a prospective register of 450 athletes consecutively evaluated during a second-level cardiological examination, we retrospectively identified all subjects with the following inclusion criteria: (1) not previously known cardiovascular disease; (2) negative T waves in leads other than V1-V2; (3) normal transthoracic echocardiogram. Patients underwent cardiac MRI and CT. The primary endpoint was the diagnosis of definite SHD after multimodality imaging evaluation. A follow-up was collected for a combined end-point of sudden death, resuscitated sudden cardiac death and hospitalization for any cardiovascular causes. RESULTS: A total of 55 competitive athletes were finally enrolled (50 males, 90%) with a mean age of 27.5 ± 14.1 years. Among the population enrolled 16 (29.1%) athletes had a final diagnosis of SHD. At multivariate analysis, only deep negative T waves remained statistically significant [OR (95% CI) 7.81 (1.24-49.08), p = 0.0285]. Contemporary identification of deep negative T waves and complex arrhythmias in the same patients appeared to have an incremental diagnostic value. No events were collected at 49.3 ± 12.3 months of follow-up. CONCLUSIONS: In a cohort of athletes with negative T waves at ECG, cardiac MRI (and selected use of cardiac CT) enabled the identification of 16 (29.1%) subjects with SHD despite normal transthoracic echocardiography. Deep negative T waves and complex ventricular arrhythmias were the only clinical characteristic associated with SHD diagnosis.

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.

Outcomes of Transcatheter Aortic Valve Replacement Patients With Different Transvalvular Flow-Gradient Patterns.

Low-flow low-gradient (LF-LG) aortic stenosis (AS) may occur with preserved or depressed left ventricular ejection fraction (LVEF). Both situations represent the most challenging subset of patients to manage and generally have a poor prognosis. Few and controversial data exist on the outcomes of these patients compared with normal flow-high gradient (NF-HG) AS after transcatheter aortic valve replacement (TAVR). We sought to characterize different transvalvular flow-gradient patterns and to examine their prognostic value after TAVR. We enrolled 1,208 patients with severe AS and categorized as follow: 976 patients NF-HG (mean aortic pressure gradient [MPG] ≥40 mm Hg), 107 paradoxical LF-LG (pLF-LG, MPG <40 mm Hg, LVEF ≥50%, stroke volume index <35 ml/m2), and 125 classical LF-LG (cLF-LG) (MPG <40 mm Hg, LVEF <50%, stroke volume index <35 ml/m2). When compared with NF-HG and pLF-LG, cLF-LG had a worse symptomatic status (New York Heart Association III to IV 86% vs 62% and 67%, p <0.001), a higher prevalence of eccentric hypertrophy and a higher level of LV global afterload reflected by a higher valvuloarterial impedance. Valvular function after TAVR was excellent over time in all patients. While 30-day mortality (p = 0.911) did not differ significantly among groups, cLF-LG had a lower 5-year survival rate (LF-LG 50% vs pLF-LG 62% and NF-HG 68%, p <0.05). cLF-LG was associated with a hazard ratio for mortality of 2.41 (95% confidence interval 1.65 to 3.52, p <0.001). In conclusion, TAVR is an effective procedure regardless of transvalvular flow-gradient patterns. However, special care should be given to characterized hemodynamic of AS, as patients with pLF-LG had similar survival rates than patients with NF-HG, whereas cLF-LG is associated with a twofold increased risk of mortality at 5-year follow-up.

Preoperative angiography-derived fractional flow reserve may predict coronary artery bypass grafting occlusion and disease progression.

BACKGROUND: Graft occlusion after coronary artery bypass grafting (CABG) has been associated with competitive flow of native coronary arteries. OBJECTIVES: To assess with coronary computed tomography angiography (CCTA) graft occlusion and coronary artery disease (CAD) progression of native vessels after CABG and their relationship with angiography-derived vessel fractional flow reserve (vFFR) performed before surgery. METHODS: Between 2006 and 2018, serial vFFR analyses were obtained before CABG in each major native coronary vessel from two institutions. All patients underwent follow-up CCTA. RESULTS: In 171 consecutive patients, serial preoperative angiograms were suitable for vFFR analysis of 298 grafted and 59 nongrafted vessels. Median time between CABG and CCTA was 2.1 years. Preoperative vFFR was assessed in 131 left anterior descending artery (LAD), 132 left circumflex artery (LCX) and 94 right coronary aretry (RCA) and was less than 0.80 in 255 of 298 bypassed vessels. Graft occlusion was observed at CCTA in 28 of 298 grafts. The median preoperative vFFR value of native coronaries was higher in occluded compared with patent grafts (0.75 vs. 0.60, P < 0.001) and was associated with graft. The best vFFR cut-off to predict graft occlusion was 0.67. Progression of CAD was higher in grafted than in nongrafted vessels (89.6 vs. 47.5%, P < 0.001). Pre-CABG vFFR predicted disease progression of grafted native vessels (AUC = 0.83). CONCLUSION: Preoperative vFFR derived from invasive coronary angiography was able to predict graft occlusion and CAD progression of grafted coronary arteries.

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.

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.

Treatment recommendation based on SYNTAX score 2020 derived from coronary computed tomography angiography and invasive coronary angiography.

The diagnostic performance of the SYNTAX score 2020 (SS-2020) when calculated using CCTA remains unknown. This study aimed to compare treatment recommendations based on the SS-2020 derived from coronary computed tomography angiography (CCTA) versus invasive coronary angiography (ICA). This interim analysis included 57 of the planned 114 patients with de-novo three-vessel disease, with or without left main coronary artery disease, enrolled in the ongoing FASTTRACK CABG trial. The anatomical SYNTAX scores derived from ICA or CCTA were evaluated by two separate teams of blinded core-lab analysts. Treatment recommendations were based on a maximal individual absolute risk difference in all-cause mortality between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) of 4.5% ([predicted PCI mortality] - [predicted CABG mortality]). The level of agreement was evaluated with Bland-Altman plots and Cohen's Kappa. The mean age was 66.2 ± 9.2 years and 89.5% of patients were male. Mean anatomical SYNTAX scores derived from ICA and CCTA were 35.1 ± 11.5 and 35.6 ± 11.4 (p = 0.751), respectively. The Bland-Altman analysis showed mean differences of - 0.26 and - 0.93, with standard deviation of 3.69 and 5.23, for 5- and 10-year all-cause mortality, respectively. The concordance in recommended treatment for 5- and 10-year mortalities were 84.2% (48/57 patients) and 80.7% (46/57 patients), with Cohen's κ coefficients of 0.672 and 0.551. There was moderate to substantial agreement between treatment recommendations based on the SS-2020 derived using CCTA and ICA, suggesting that CCTA could be used as an alternative to ICA when making decisions regarding the modality of revascularization.

Diagnosis and treatment of a left atrial myxoma originating from an atrial septal defect closure device: a case report.

Background: Ostium secundum atrial septal defect (osASD) is a common congenital heart disease and transcatheter closure is the preferred treatment. Late device-related complications include thrombosis and infective endocarditis (IE). Cardiac tumours are exceedingly rare. The aetiology of a mass attached to an osASD closure device can be challenging to diagnose. Case summary: A 74-year-old man with atrial fibrillation was hospitalized for evaluating a left atrial mass discovered incidentally 4 months earlier. The mass was attached to the left disc of an osASD closure device implanted 3 years before. No shrinkage of the mass was observed despite optimal intensity of anticoagulation. We describe the diagnostic workup and management of the mass that at surgery turned out to be a myxoma. Discussion: A left atrial mass attached to an osASD closure device raises the suspect of device-related complications. Poor endothelialisation may promote device thrombosis or IE. Cardiac tumours (CT) are rare, and myxoma is the most common primary CT in adults. Although no clear relationship exists between the implantation of an osASD closure device and a myxoma, the development of this tumour is a possible occurrence. Echocardiography and cardiovascular magnetic resonance play a key role in the differential diagnosis between a thrombus and a myxoma, usually identifying distinctive mass features. Nevertheless, sometimes non-invasive imaging may be inconclusive, and surgery is necessary to make a definitive diagnosis.

Diagnostic accuracy of subendocardial vs. transmural myocardial perfusion defect for the detection of in-stent restenosis or progression of coronary artery disease after percutaneous coronary intervention.

BACKGROUND: The ADVANTAGE study demonstrated in a cohort of stented patients a diagnostic accuracy of stress myocardial CT perfusion (CTP) significantly higher than that of coronary CT angiography (CCTA) for the detection of in-stent restenosis (ISR) or CAD progression vs. quantitative coronary angiography (QCA). This is a pre-defined subanalysis of the ADVANTAGE aimed at assessing the difference in terms of diagnostic accuracy vs. QCA of a subendocardial vs. a transmural perfusion defect using static stress CTP. METHODS: We enrolled consecutive patients who previously underwent coronary stenting and were referred for QCA. All patients underwent stress CTP and rest CTP â€‹+ â€‹CCTA. The diagnostic accuracy of CCTA and CTP were evaluated in territory-based and patient-based analyses. We compared the diagnostic accuracy of "subendocardial" perfusion defect, defined as hypo-enhancement encompassing >25% but <50% of the transmural myocardial thickness within a specific coronary territory vs. "transmural" perfusion defect, defined as hypo-enhancement encompassing >50% of the transmural thickness. RESULTS: In 150 patients (132 men, mean age 65.1 â€‹± â€‹9.1 years), the diagnostic accuracy of subendocardial vs. transmural perfusion defect in a vessel-based analysis was 93.5% vs. 87.7%, respectively (p â€‹< â€‹0.0001). The sensitivity and specificity of subendocardial vs. transmural defect were 87.9% vs. 46.9% (p â€‹< â€‹0.001) and 94.9% vs. 97.9% (p â€‹= â€‹0.004), respectively. In a patient-based analysis, the diagnostic accuracy of the subendocardial vs. transmural approach was 86.6% vs. 68% (p â€‹< â€‹0.0001). CONCLUSIONS: This study shows that detection of a subendocardial perfusion defect as compared to a transmural defect is significantly more accurate to identify coronary territories with ISR or CAD progression.

Impact of Mitral Regurgitation Etiology on Mitral Surgery After Transcatheter Edge-to-Edge Repair: From the CUTTING-EDGE Registry.

BACKGROUND: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown. OBJECTIVES: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology. METHODS: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery. RESULTS: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years. CONCLUSIONS: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.

Noblestitch® system for PFO closure: A novel but judicious alternative to traditional devices-A case report.

Background: Percutaneous suture-mediated patent foramen ovale (PFO) closure has recently been used with the aim of avoiding double-disc nitinol device implantation. This novel technique has been carried out successfully in several centers offering PFO closure with an effective closure rate comparable to conventional double-disc devices. Case summary: A 50-year-old man, a pentathlon athlete, suffering from a previous left-sided ischemic stroke, underwent percutaneous closure of a permanent right-to-left shunt via PFO with a large fenestrated septum primum aneurysm at another institution. The NobleStitch® system was successfully implanted using local anesthesia and under angiographic-fluoroscopic monitoring. He was discharged home on aspirin 100 mg daily with a moderate residual shunt on contrast transthoracic echocardiography (cTTE) that persisted unaltered at subsequent controls. After 7 months, unable to resume sporting activity because of physical discomfort and dyspnea on exertion, the patient asked for a second opinion at our Heart and Brain clinic. Two-dimensional (2D) TTE showed septum primum laceration next to a radiopaque polypropylene knot with a moderate bidirectional shunt located at the fenestrated septum primum far from the PFO site. A catheter-based closure of the septal defect was therefore planned under local anesthesia and rotational intracardiac echo monitoring. An equally sized discs 28.5 mm × 28.5 mm Flex II UNI occluder (Occlutech GmbH, Jena, Germany) was successfully implanted across the atrial septal defect without complications. The patient was discharged in good clinical conditions; dual antiplatelet therapy (aspirin 100 mg/daily and clopidogrel 75 mg/daily) was recommended for 2 months and then single antiplatelet therapy (aspirin100 mg/daily) up to 6 months. Abolition of the residual shunt was confirmed at 1- and 6-month follow-up by contrast transcranial Doppler and 2D color Doppler cTTE. Discussion: Closing a PFO with a suture-base system, without leaving a device implant behind, may be a cutting-edge technology and potential alternative to traditional devices. Nevertheless, meticulous selection of the PFO anatomies by 2D TEE is key to a successful closure procedure in order to avoid complications that must be managed again with a second percutaneous procedure or by surgery.

One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.

BACKGROUND: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce. AIMS: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3). METHODS: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year. RESULTS: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups. CONCLUSIONS: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

The SALINE Technique for the Treatment of the No-Reflow Phenomenon during Percutaneous Coronary Intervention in STEMI.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) performed for STEMI may be complicated by the "no-reflow" phenomenon. AIMS: A super-selective intracoronary injection of saline solution through a thrombus aspiration catheter (SALINE technique), was investigated for the treatment of no-reflow as compared with the standard care of therapy (SCT). METHODS: Among the 1471 patients with STEMI undergoing pPCI between May 2015 and June 2020, 168 patients developed no-reflow. Primary endpoints were the incidence of ST-segment resolution (STR) ≥ 70% at 90 min after PCI and the rate of flow restoration (TIMI flow grade 3 with an MBG > 1). The secondary endpoint was the incidence of major adverse cardiac and cerebrovascular events at 3 years follow-up. RESULTS: After propensity score matching analysis, patients treated with SALINE showed STR ≥ 70% in twelve out of the sixteen patients (75.0%), compared to only three patients out of the sixteen in the SCT control group (19.0%), (p < 0.004). SALINE was associated with a higher probability of final TIMI flow grade 3 with an MBG > 1, as shown in fourteen out of sixteen patients (87.5%), as compared to only seven out of sixteen patients in the SCT group (43.8%), (p < 0.03). MACCE at 3 years follow-up occurred in only one patient (6.3%) in the SALINE group, as compared to eight patients (50%) in the SCT group (p = 0.047). CONCLUSIONS: The SALINE technique showed to be a safe and effective strategy to reduce "no-reflow" in STEMI patients as assessed by significant STR, improvement of TIMI flow grade, and better 3-year outcomes.

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.