Echocardiographic and clinical features of patients developing prosthesis-patient mismatch after TAVR: insights from the Recovery TAVR registry.

BACKGROUND: The impact of prosthesis-patient mismatch (PPM) on major endpoints after transcatheter aortic valve replacement (TAVR) is controversial and the effects on progression of heart damage are poorly investigated. Therefore, our study aims to evaluate the prevalence and predictors of PPM in a "real world" cohort of patients at intermediate and low surgical risk, its impact on mortality and the clinical-echocardiographic progression of heart damage. METHODS: 963 patients who underwent TAVR procedure between 2017 and 2021, from the RECOVERY-TAVR international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data of these patients were analyzed at 1-year follow-up (FU). Clinical and echocardiographic features were stratified by presence of PPM and PPM severity, as per the most current international recommendations, using VARC-3 criteria. RESULTS: 18% of patients developed post-TAVR. PPM, and 7.7% of the whole cohort had severe PPM. At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, p=0.33), aged 82 (IQR 79-85y) years vs 82 (IQR 78-86 p=0.46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, p=0.04); they had smaller left ventricular outflow tract (LVOT) diameter (20 mm, IQR 19-21 vs 20 mm, IQR 20-22, p=0.02), reduced SVi (34.2 vs 38 ml/m2, p<0.01) and transaortic flow rate (190.6 vs 211 ml/s, p<0.01). At pre-discharge FU patients with PPM had more paravalvular aortic regurgitation (moderate-severe AR 15.8% vs 9.2%, p<0.01). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in end-systolic diameter (33 mm vs 28 mm, p=0.03) and a significant increase in left ventricle end systolic indexed volume in those with moderate and severe PPM (52 IQR 42-64 and 52, IQR 41-64 vs.44 IQR 35-59 in those without, p=0.02)). No evidence of a significant impact of PPM on overall (p=0.71) and CV (p=0.70) mortality was observed. Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, p=0.03). Prosthesis size≤23 mm (OR 11.6, 1.68-80.1) was an independent predictor of PPM, while SVi (OR 0.87, 0.83-0.91, p<0.001) and LVOT diameter (OR 0.79, 0.65-0.95, p=0.01) had protective effect. CONCLUSIONS: PPM was observed in 18% of patients undergoing TAVR. Echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations, possibly precursor to a reduction in cardiac function, associated with a significant deterioration in NYHA class at 1 year. These findings emphasize the importance of prevention of PPM of any grade in patients undergoing TAVR procedure, especially in populations at risk.

Transcatheter edge-to-edge repair in papillary muscle injury complicating acute myocardial infarction.

AIMS: Acute mitral regurgitation (MR) in the setting of myocardial infarction (MI) may be the result of papillary muscle rupture (PMR). This condition is associated with high morbidity and mortality. We aim to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (TEER) in this acute setting. METHODS AND RESULTS: We analysed data from the International Registry of MitraClip in Acute Mitral Regurgitation following acute Myocardial Infarction (IREMMI) of 30 centres in Europe, North America, and the middle east. We included patients with post-MI PMR treated with TEER as a salvage procedure, and we evaluated immediate and 30-day outcomes. Twenty-three patients were included in this analysis (9 patients suffered complete papillary muscle rupture, 9 partial and 5 chordal rupture). The patients' mean age was 68 ± 14 years. Patients were at high surgical risk with median EuroSCORE II 27% (IQR 16, 28) and 20 out of 23 (87% were in cardiogenic shock). All patients were treated with vasopressors, and 17 out of 23 patients required mechanical support. TEER procedure was performed on the median 6 days after the index MI date IQR (3, 11). Procedural success was achieved in 87% of patients. The grade of MR was significantly decreased after the procedure. MR reduction to 0 or 1 + was achieved in 13 patients (57%), to 2 + in 7 patients (30%), P < 0.01. V-Wave was reduced from 49 ± 8 mmHg to 26 ± 10 mmHg post-procedure, P < 0.01. Sixteen out of 23 patients (70%) were discharged from hospital and 5 of them required reintervention with surgical mitral valve replacement. No additional death at 1 year was documented. CONCLUSIONS: TEER is a feasible therapy in critically ill patients with PMR due to a recent MI. TEER may have a role as salvage treatment or bridge to surgery in this population.

Is Moderate/Large Residual Shunt After PFO Closure Justifiable for a Patient with a Prior History of Cryptogenic Stroke and Transient Ischemic Attack?

A 36-year-old woman suffered from an embolic stroke of an undetermined source documented by magnetic resonance imaging with residual right arm weakness. She underwent percutaneous patent foramen ovale (PFO) closure with an 18/25 mm device in another center. One year later, the patient suffered from a transient ischemic attack with dysarthria. She asked for a second opinion at our institution and a contrast-transthoracic (cTTE) /transesophageal echocardiography showed a large residual right-to-left shunt (RLS) through a still patent tunnel after PFO closure. Written informed consent for a redo procedure was obtained from the patient. A catheter-based closure of the residual shunt was therefore planned under local anesthesia and rotational intracardiac echo monitoring. A second equally sized disc (18/18 mm) device was successfully implanted without complications. The patient was discharged home the following day in good clinical condition. Dual antiplatelet therapy was recommended for the first 2 months and then single antiplatelet therapy up to 6 months. At the 6-month follow-up, the cTTE color Doppler showed the stable position of the two nitinol double-disc devices and the c-transcranial Doppler confirmed the abolition of the residual RLS.

Baseline Characteristics and 3-Year Outcome of Nonvalvular Atrial Fibrillation Patients Treated with the Four Direct Oral Anticoagulants (DOACs).

Direct oral anticoagulants (DOACs) represent the cornerstone therapy for cardioembolic events prevention in patients with nonvalvular atrial fibrillation (NVAF). In practice, the choice of one DOAC over another is guided by the decision-making process of the physician, which considers specific patient and drug characteristics. This study aimed to evaluate the clinical features and long-term outcomes of a real-world population treated with DOACs, where the use of the 4 different DOACs is quite equal. We conducted a retrospective observational, single-center, multidisciplinary study enrolling consecutive NVAF patients treated with one of the 4 DOACs. From an initial number of 753 patients, we excluded 72 patients because of loss to follow-up, at the end we enrolled 681:174 (23%) treated with dabigatran, 175 (23%) with apixaban, 190 (25%) with rivaroxaban, and 214 (29%) with edoxaban. Patients treated with apixaban were significantly older, more women represented (p <0.001), and with a higher cardioembolic and bleeding risk (p <0.001). Dabigatran was preferred in patients with liver failure (p = 0.008), whereas Apixaban and Edoxaban were chosen in chronic kidney disease (p = 0.002). At 3-year follow-up, 20 patients (2.7%) experienced a systemic thromboembolic event without significant differences in the 4 DOACs. In the same period, an International Society of Thrombosis and Hemostasis classification major bleeding event occurred in 26 patients (3.6%), more statistically correlated to edoxaban (6.1%) (p = 0.038). Thromboembolic events or major bleeding were higher in the edoxaban group (10%) compared with the others (p = 0.014). In our single-center real-world experience, the choice of the DOAC for a patient with NVAF was tailored to specific clinical features and drug pharmacokinetics of the patient. As a result, a small number of adverse events were observed.

Direct oral anticoagulants versus percutaneous left atrial appendage occlusion in atrial fibrillation: 5-year outcomes.

BACKGROUND: LAAO is an emerging option for thromboembolic event prevention in patients with NVAF. We previously reported data on comparison between LAAO and DOAC at two-year follow-up in NVAF patients at HBR (HAS-BLED ≥3). AIMS: Limited data are available on long term follow-up. We aimed to evaluate the efficacy and safety of DOACs versus LAAO indication after 5 years. METHODS: We enrolled 193 HBR treated with LAAO and 189 HBR patients with DOACs. At baseline, LAAO group had higher HAS-BLED (4.2 vs 3.3, p < 0.001) and lower CHADS-VASc (4.3 vs. 4.7, p = 0.005). After 1:1 PSM, 192 patients were included (LAAO n = 96; DOACs n = 96). RESULTS: At 5-year follow-up the rate of the combined safety and effectiveness endpoint (ISTH major bleeding and thromboembolic events) was significantly higher in LAAO group (p = 0.042), driven by a higher number of thromboembolic events (p = 0.047). The rate of ISTH-major bleeding events was similar (p = 0.221). After PSM no significant difference in the primary effectiveness (LAAO 13.3% vs DOACs 9.5%, p = 0.357) and safety endpoint (LAAO 7.5% vs DOACs 7.5%; p = 0.918) were evident. Overall bleeding rate was significantly higher in DOACs group (25.0% vs 13.7%, p = 0.048), while a non-significant higher number of TIA was reported in LAAO group (5.4% vs 1.1%, p = 0.098). All-cause and cardiovascular mortality were higher in LAAO group at both unmatched and matched analysis. CONCLUSION: We confirmed safety and effectiveness of both DOAC and LAAO in NVAF patients at HBR, with no significant differences in thromboembolic events or major bleeding were at 5-year follow-up. The observed increased mortality after LAAO warrants further investigations in RCTs.

Acute Reduction in Left Ventricular Function Following Transcatheter Mitral Edge-to-Edge Repair.

Background Little is known about the impact of transcatheter mitral valve edge-to-edge repair on changes in left ventricular ejection fraction (LVEF) and the effect of an acute reduction in LVEF on prognosis. We aimed to assess changes in LVEF after transcatheter mitral valve edge-to-edge repair for both primary and secondary mitral regurgitation (PMR and SMR, respectively), identify rates and predictors of LVEF reduction, and estimate its impact on prognosis. Methods and Results In this international multicenter registry, patients with both PMR and SMR undergoing transcatheter mitral valve edge-to-edge repair were included. We assessed rates of acute LVEF reduction (LVEFR), defined as an acute relative decrease of >15% in LVEF, its impact on all-cause mortality, major adverse cardiac event (composite end point of all-cause death, mitral valve surgery, and residual mitral regurgitation grade ≥2), and LVEF at 12 months, as well as predictors for LVEFR. Of 2534 patients included (727 with PMR, and 1807 with SMR), 469 (18.5%) developed LVEFR. Patients with PMR were older (79.0±9.2 versus 71.8±8.9 years; P<0.001) and had higher mean LVEF (54.8±14.0% versus 32.7±10.4%; P<0.001) at baseline. After 6 to 12 months (median, 9.9 months; interquartile range, 7.8-11.9 months), LVEF was significantly lower in patients with PMR (53.0% versus 56.0%; P<0.001) but not in patients with SMR. The 1-year mortality was higher in patients with PMR with LVEFR (16.9% versus 9.7%; P<0.001) but not in those with SMR (P=0.236). LVEF at baseline (odds ratio, 1.03 [95% CI, 1.01-1.05]; P=0.002) was predictive of LVEFR for patients with PMR, but not those with SMR (P=0.092). Conclusions Reduction in LVEF is not uncommon after transcatheter mitral valve edge-to-edge repair and is correlated with worsened prognosis in patients with PMR but not patients with SMR. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT05311163.

The long-term clinical course of moderate tricuspid regurgitation.

BACKGROUND: To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology. METHODS: Clinical and echocardiographic follow-up were assessed in 250 patients diagnosed with moderate TR between January 2016 and July 2020. TR progression at follow-up was defined as TR grade increase to at least severe. The primary endpoint was all-cause death; secondary endpoints were cardiovascular (CV) death and the composite of heart failure (HF) hospitalization plus tricuspid valve (TV) intervention. RESULTS: After a median follow-up of 3.6 years, TR progression occurred in 84 patients (34%). At multivariate analyses, atrial fibrillation (AF, OR 1.81, CI 1.01-3.29, p = 0.045) and right ventricular end-diastolic diameter (RVEDD, OR 2.19, CI 1.26-3.78, p = 0.005) were independent predictors of TR progression. The primary endpoint occurred in 59 patients (24%) and was significantly more frequent in the group with TR progression (p = 0.009). At multivariate analyses, chronic kideney disease (OR 2.80, CI 1.30-6.03, p = 0.009), left ventricular ejection fraction (OR 0.97, CI 0.94-0.99, p = 0.041) and TR progression (OR 2.32, CI 1.31-4.12, p = 0.004) were independent predictors of the primary outcome. Moreover, both the secondary endpoints of CV death and HF hospitalization plus TV intervention were more frequent in the TR progression group (p = 0.001 and p < 0.001, respectively). CONCLUSIONS: Moderate TR progresses in a significant proportion of patients over a long-term follow-up, leading to a worse prognosis. TR progression is an independent determinant of hard clinical events and AF and RVEDD are associated with TR progression.

Accuracy and Reliability of Left Atrial Appendage Morphology Assessment by Three-Dimensional Transesophageal Echocardiographic Glass Rendering Modality: A Comparative Study With Computed Tomography.

BACKGROUND: Contrast-enhanced computed tomography is the reference-standard imaging technique to assess left atrial appendage (LAA) morphology. The aim of this study was to evaluate the accuracy and reliability of two-dimensional and new three-dimensional (3D) transesophageal echocardiographic rendering modalities in assessing LAA morphology. METHODS: Seventy consecutive patients who underwent both computed tomography and transesophageal echocardiography (TEE) were retrospectively enrolled. The traditional LAA morphology classification system (LAAcs; chicken wing, cauliflower, cactus, and windsock) and a new simplified LAAcs based on the LAA bend angle were used for the analysis. LAA morphology was independently assessed by two trained readers using three different modalities: two-dimensional TEE, 3D TEE with multiplanar reconstruction, and a new 3D transesophageal echocardiographic rendering modality with improved transparency (Glass). The new LAAcs and traditional LAAcs were compared in terms of intra- and interrater reliability. RESULTS: With the new LAAcs, two-dimensional TEE was fairly accurate in identifying LAA morphology (κ = 0.43, P < .05), with moderate interrater (κ = 0.50, P < .05) and substantial intrarater (κ = 0.65, P < .005) agreement. Three-dimensional TEE showed higher accuracy and reliability: 3D TEE with multiplanar reconstruction had almost perfect accuracy (κ = 0.85, P < .001) and substantial (κ = 0.79, P < .001) interrater reliability, while 3D TEE with Glass had substantial accuracy (κ = 0.70, P < .001) and almost perfect (κ = 0.84, P < .001) interrater reliability. Intrarater agreement was almost perfect for both 3D transesophageal echocardiographic modalities (κ = 0.85, P < .001). Accuracy was considerably lower when the traditional LAAcs was used, with 3D TEE with Glass being the most reliable technique (κ = 0.75, P < .05). The new LAAcs showed higher inter- and intrarater reliability compared with the traditional LAAcs (interrater, κ = 0.85 vs κ = 0.49; intrarater, κ = 0.94 vs κ = 0.68; P < .05). CONCLUSIONS: Three-dimensional TEE is an accurate, reliable, and feasible alternative to computed tomography in assessing LAA morphology with the new LAAcs. The new LAAcs shows higher reliability rates than the traditional one.

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.

Feasibility and reliability of comprehensive three-dimensional transoesophageal echocardiography screening process for transcatheter mitral valve replacement.

AIMS: The procedural planning of transcatheter mitral valve replacement (TMVR) requires a specific imaging assessment to establish patient eligibility. Computed tomography (CT) is considered the reference method. In this setting, data regarding the role of transoesophageal echocardiography (TOE) are lacking. We evaluated the feasibility and reliability of a comprehensive 3D-TOE screening in TMVR candidates. METHODS AND RESULTS: We performed a retrospective observational study including 72 consecutive patients who underwent a pre-procedural CT and 3D-TOE for TMVR evaluation. The measurements of mitral annulus (MA), length of anterior mitral leaflet (AML), native left ventricular outflow tract (LVOT), and predicted neo-LVOT acquired with CT and 3D-TOE were compared using a novel semi-automated software for post processing analysis (3 mensio Structural Heart 10.1-3mSH, Pie Medical Imaging, Bilthoven, Netherlands). The final suitability decision was given by the valve manufacturer based on CT measurements and clinical conditions. Among 72 patients screened, all patients had adequate image quality for 3D-TOE analysis. 3D-TOE and CT measurements for AML length (r = 0.97), MA area (r = 0.90), perimeter (r = 0.68), anteroposterior (r = 0.88), and posteromedial-anterolateral (r = 0.74) diameters were found highly correlated, as well as for native LVOT (r = 0.86) and predicted neo-LVOT areas (r = 0.96) (all P-values <0.0001). An almost perfect agreement between CT and 3DTOE was found in assessing the eligibility for TMVR implantation (Cohen kappa 0.83, P < 0.001). CONCLUSION: 3D-TOE appraisements showed good correlations with CT measurements and high accuracy to predict TMVR screening success.

Stroke volume index and transvalvular flow rate trajectories in severe aortic stenosis treated with TAVR.

AIMS: The prognostic impact of flow trajectories according to stroke volume index (SVi) and transvalvular flow rate (FR) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) remains poorly assessed. We evaluated and compared SVi and FR prior and after TAVR for severe AS. METHODS AND RESULTS: Patients were categorized according to SVi (<35 mL/m2) and FR (<200 mL/s). The association of pre- and post-TAVR SVi and FR with all-cause mortality up to 3 years was assessed with multivariable Cox regression models. Among 980 patients with pre-TAVR flow assessment, SVi was reduced in 41.3% and FR in 48.1%. Baseline flow status was not an independent mortality predictor [SVi: hazard ratio (HR) 1.22, 95% confidence interval (CI) 0.85-1.82, FR: HR 0.78, 95% CI 0.48-1.27]. Among 731 patients undergoing early (5 days, interquartile range 2-29) post-TAVR flow assessment, SVi recovered in 40.1% and FR in 49.0% patients with baseline low flow. Reduced FR following TAVR was an independent predictor of mortality (HR 1.67, 95% CI 1.02-2.74), whereas SVi was not (HR 0.97, 95% CI 0.53-1.78). Three-year estimated mortality in patients with recovered FR was lower than that in patients with reduced FR (13.3 vs. 37.7% vs, P = 0.003) and similar to that in patients with normal baseline FR (P = 0.317). CONCLUSION: Baseline flow status was not an independent predictor of mid-term mortality among all-comers with severe AS undergoing TAVR. Flow recovery early after TAVR was frequent. Post-TAVR FR, but not SVi, was independently associated with mid-term all-cause mortality. By impacting flow status, AV replacement modifies the association of flow status with outcomes.

Left atrial appendage closure: a new strategy for cardioembolic events despite oral anticoagulation.

BACKGROUND: Patients with non-valvular atrial fibrillation (nvAF) who experienced a cardioembolic (CE) event despite adequate oral anticoagulation (OAC) are at high risk of recurrence, and further prevention strategies are deemed necessary. The present study aimed to evaluate the safety and efficacy of off-label use of left atrial appendage closure (LAAC) in this subset of patients. METHODS: Seventy-five consecutive patients with nvAF who experienced a CE event despite adequate OAC therapy were retrospectively enrolled from two Italian centers. Patients were divided according to the treatment strategy following the index event: DOAC group (49 patients who continued OAC therapy with DOACs) and LAAC group (26 patients who underwent LAAC procedure). 1:1 propensity-score matching between the two groups was performed. LAAC group was made up of two subgroups according to the post-procedural pharmacological regimen: 1) dual antiplatelet therapy (DAPT) for 3 months followed by indefinite single antiplatelet therapy (LAAC+SAPT); or 2) aspirin plus DOAC for 3 months followed by indefinite DOAC therapy (LAAC+DOAC). The primary endpoint was a composite of CE event, major bleeding, or procedure-related major complication. RESULTS: During a median follow-up of 3.4 years (IQR: 2.0-5.3), LAAC was a predictor of primary endpoint-free survival (HR=0.28, 95% CI: 0.08-0.97; P=0.044); within LAAC group, no procedure-related major complication occurred. Moreover, a trend toward a lower rate of both CE events and major bleedings was observed in LAAC group, particularly in the subgroup LAAC+DOAC. CONCLUSIONS: LAAC is a reasonable therapeutic option in nvAF patients who suffered a CE event despite adequate OAC therapy.

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.

Duration and kind of dual antiplatelet therapy for acute coronary syndrome patients: a network meta-analysis.

INTRODUCTION: For acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI), the choice of the duration and kind of dual antiplatelet therapy (DAPT) offering the most accurate balance between ischemic and bleeding risk remains unknown. EVIDENCE ACQUISITION: A network meta-analysis was performed including all Randomized Controlled Trials (RCTs) comparing different DAPT regimens and duration in ACS patients undergoing PCI. Trial-defined MACE and major bleedings were the primary endpoints. Stroke, stent thrombosis (ST), all-cause and cardiovascular death, myocardial infarction (MI) represented secondary endpoints. EVIDENCE SYNTHESIS: 13 RCTs encompassing 46145 patients were included. Mean age was 62 (61-64) years old, 42% being admitted with STEMI, 33% with NSTEMI and 25% with UA. The competitive arms were: clopidogrel and aspirin for 12 months (6 arms/18183 patients), clopidogrel and aspirin for 6 months (4/3329), clopidogrel and aspirin >12 months (3/2238), ticagrelor and aspirin for 12 months (6/12942) and prasugrel and aspirin for 12 months (3/9453). Trial-defined MACE and major bleedings, stroke and death were similar among the different arms. DAPT with prasugrel and aspirin for 12 months reduced MI compared to aspirin and clopidogrel for 12 months (OR 0.71, 95% CI: 0.54.0.94) and reduced the risk of ST compared to ticagrelor (OR 0.66, 95% CI: 0.49-0.90). Both prasugrel and ticagrelor reduced ST as compared to clopidogrel and aspirin for 12 months. CONCLUSIONS: Different DAPT strategies yield similar risk of MACE, major bleeding, death and stroke in ACS patients. Prasugrel and aspirin for 12 months proved to be the most effective strategy regarding ST and MI.

Anesthesia-Induced Intraprocedural Downgrading of Mitral Regurgitation During Transcatheter Edge-to-Edge Repair.

During transcatheter edge-to-edge repair (TEER), the reduction of functional mitral regurgitation (FMR) severity, compared with baseline evaluation, is not uncommon. Because the procedural strategies are mainly guided by the location and severity of the regurgitant jets, intraprocedural downgrading (ID) of regurgitation severity could affect the procedural strategy and the results. The aim of this study was to evaluate the prevalence of ID during TEER and to compare early and midterm outcomes in patients with and without ID. All patients with moderate-to-severe or severe FMR who underwent TEER in San Raffaele Hospital between 2018 and 2020 were evaluated in this single-center, retrospective study. ID was defined as mild (1+) or moderate (2+) regurgitation degree during intraprocedural evaluation. The outcomes, assessed at discharge and at 2 years of follow-up, were all-cause mortality, heart failure hospitalization, and recurrence of mitral regurgitation >2+. The final study cohort included 55 patients: 42% presented with ID. At discharge, 85.5% of patients achieved regurgitation reduction to 2+ or less: 100% in patients with ID versus 75% in patients without ID, p <0.009. At 2 years, no significant difference in the incidence of all-cause mortality, heart failure hospitalization, and the recurrence of mitral regurgitation >2+ between patients with ID or without ID was found. In conclusion, ID is frequent during TEER in FMR. No baseline characteristics were found to identify this group of patients. In patients with ID, the combination of live intraprocedural imaging and baseline ambulatory assessment of regurgitant jets seems effective in the procedural guiding to achieve a successful and durable mitral repair.

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.

Working on the dirty side-the ipsilateral subclavian access for temporary pacing after lead extraction.

Background: Temporary pacing is necessary in pacemaker-dependent patients after transvenous lead extraction (TLE) for cardiac implantable electronic device infection. In case of unavailability of other accesses, we propose to use the ipsilateral subclavian access (ISA) combined with a standard permanent active fixation lead for the temporary pacemaker and present preliminary data. Methods: We consecutively enrolled patients undergoing TLE who received a temporary pacemaker using the ISA between August 2016 and April 2020 at our centre. Results: During the observation period, 36 patients undergoing TLE for pocket infection (72.2%), endocarditis (25.0%) or other causes received a temporary pacemaker over the ISA. Their mean age was 77.0 ± 10.7 years, and 13.9% were female. Complete TLE was achieved in 94.4%. There were no major periprocedural complications. Intra-hospital mortality was 11.1%. Pocket revision was performed in 19.4%. During long-term follow-up (23 ± 13 months), 8.3% had a relapse of local pocket infection and 2.8% needed rehospitalization for reintervention. Conclusions: Temporary pacing using a standard permanent active fixation lead using the ISA is a convenient alternative to conventional venous accesses. However, risks of implanting a lead into a previously infected area have to be taken into account.

Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions.

BACKGROUND: With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce. OBJECTIVE: We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units. METHOD: Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005 and 2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality. RESULTS: CS performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs. 62 [31-102 IQR] months, CS vs. cardiologists, p < .001) and with pre-dominantly non-infectious indications (57.4% vs. 50.2%, CS vs. cardiologists, p < .001). CS achieved a higher complete success per lead than the cardiologists (98.1% vs. 95.7%, respectively, p < .01), with a higher number of minor complications (5.51% vs. 2.1%, p < .01) and similar number of major complications (0.47% vs. 1.3%, p = .12). Thirty-day mortality was similarly low in the CS and cardiologist groups (1.76% vs. 0.94%, p = .21). Unmatched data multivariate analysis revealed infection indication (OR 6.12 [1.9-20.3], p < .01), procedure duration (OR 1.01 [1.01-1.02], p < .01) and CS operator (OR 2.67, [1.12-6.37], p = .027) were associated with 30-day mortality. CONCLUSION: TLE by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centers.

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

OBJECTIVES: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. BACKGROUND: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. METHODS: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. RESULTS: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. CONCLUSIONS: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.