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Introduction: Secondary mitral regurgitation (SMR) is one of the most common valvulopathies and is associated with poor prognosis. Over the past years, medical management and mitral valve repair op...

Dual anti-platelet therapy (DAPT) with clopidogrel and acetylsalicylic acid (ASA) has previously been recommended after transcatheter aortic valve implantation (TAVI) and is still the standard of care in patients who underwent coronary stent placement within 3 months prior to TAVI. This study sought to evaluate whether on-treatment platelet reactivity is a predictor for the occurrence of bleeding events after TAVI. This study enrolled 484 patients undergoing TAVI from November 2013 until April 2018. Patients were either on long-term DAPT with clopidogrel and ASA or received loading doses of both drugs before TAVI, reflecting the standard of care at the time of the patient’s enrollment. Platelet reactivity was determined by multi-electrode impedance aggregometry before TAVI, at days 1 and 5 thereafter. Peri-interventional bleeding was assessed up to 5 days following TAVI and coded according to BARC-classification. Bleeding events were seen in 199 (41.1%) patients. The most frequent were BARC 2 bleeding cases (24.2%), followed by BARC 1 (6.0%), BARC 3b (5.2%), and BARC 3a (4.5%) cases. Low on-clopidogrel platelet reactivity before TAVI was present in 243 patients, of which 44.4% had a bleeding event. In contrast, the incidence of bleeding was 30.5% in the 95 patients with high on-clopidogrel platelet reactivity. Multivariate logistic regression analysis identified low/normal/high on-clopidogrel platelet reactivity (OR: 0.533; CI: 0.309–0.917; p = 0.023) and use of oral anticoagulation (OR: 1.766; CI: 1.209–2.581; p = 0.003) as strongest predictors for peri-interventional bleeding events. These findings support current recommendations advocating against the routine use of dual antiplatelet therapy following TAVI.

BACKGROUND AND AIMS We aimed at addressing the association between serum lipoprotein (a) levels and clinical outcomes of consecutive patients undergoing PCI. METHODS We used consecutive patients undergoing PCI at the Heart Center University of Freiburg, Bad Krozingen in Germany between January 2005 and November 2013. A total of 6679 patients [men (n = 5391) and women (n = 1288)] mean aged 67.5 (± 11.1) years were assessed at baseline and prospectively followed for 3 years. Lp(a) measurement were performed at hospital admission as a routine laboratory parameter. RESULTS Approximately 30% of PCI patients show an elevated Lp(a) value of more than 50mg/dL. In total, 736 Patients died during the follow-up, thereof 189 (11.3%) in the first quartile, 186 (10.7%) in the second quartile, 183 (11.5%) in the third quartile and 178 (10.7%) in the last quartile (p value 0.843 from LogRank test). The MACE rate showed consistent results with 409 (24.4%), 385 (22.1%), 395 (24.7%) and 419 (25.3%) in the different respective quartiles (p value 0.125 from LogRank test). CONCLUSION In this large non-selected cohort of patients undergoing PCI followed by moderate intensity statin therapy, higher Lp(a) levels were not associated with worse clinical outcomes during a follow-up of 3 years.

Aims Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. Methods and results Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18–0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5–19) vs. 19 days (10–40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55–9.07, P < 0.01). Conclusions Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.

OBJECTIVES To investigate whether the integrative echocardiographic criteria used in the cardiovascular outcomes assessment of the mitraclip percutaneous therapy (COAPT) for heart failure patients with functional mitral regurgitation study predict outcomes after edge-to-edge trancatheter mitral valve repair (TMVr) for the treatment of secondary mitral regurgitation (SMR). BACKGROUND Two randomized controlled trials comparing TMVr to medical treatment reported conflicting findings. Differences in patient selection criteria may have contributed to these diverging results. METHODS Patients undergoing TMVr were stratified following the integrative COAPT echocardiographic criteria in noneligible and eligible patients who were further classified into three tiers according to effective regurgitant orifice (EROA) (Tier 1: EROA ≥ 0.3cm2 ; Tier 2: EROA 0.2cm2 and 0.29cm2 ; Tier 3: EROA

Background Female sex was not included among the high bleeding risk (HBR) criteria by the Academic Research Consortium (ARC) as it remains unclear whether it constitutes an HBR condition after percutaneous coronary intervention. We investigated whether female sex associates with HBR and assessed the performance of ARC HBR criteria separately in women and men. Methods and Results Among all consecutive patients undergoing percutaneous coronary intervention between 2009 and 2018, bleeding occurrences up to 1 year were prospectively collected and centrally adjudicated. All but one of the originally defined ARC HBR criteria were assessed, and the ARC HBR score generated accordingly. Among 16 821 patients, 25.6% were women. Compared with men, women were older and had lower creatinine clearance and hemoglobin values. After adjustment, female sex was independently associated with access‐site (adjusted hazard ratio, 2.14; 95% CI, 1.22–3.74; P =0.008) but not with overall or non–access‐site 1‐year Bleeding Academic Research Consortium 3 or 5 bleeding. This association remained consistent when the femoral but not the radial approach was chosen. The ARC HBR score discrimination, using the original criteria, was lower among women than men (c‐index 0.644 versus 0.688; P =0.048), whereas a revised ARC HBR score, in which age, creatinine clearance, and hemoglobin were modeled as continuous rather than dichotomized variables, performed similarly in both sexes. Conclusions Female sex is an independent predictor for access‐site bleeding but not for overall bleeding events at 1 year after percutaneous coronary intervention. The ARC HBR framework shows an overall good performance in both sexes, yet is lower in women than men, attributable to dichotomization of age, creatinine clearance, and hemoglobin values, which are differently distributed between sexes. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02241291.

Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The "Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)—35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF &lt, 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

BACKGROUND The identification of bleeding risk factors in patients undergoing percutaneous coronary intervention (PCI) is essential to inform subsequent management. Whether clinical presentation per se affects bleeding risk after PCI remains unclear. AIMS We aimed to assess whether clinical presentation per se predisposes to bleeding in patients undergoing PCI and if the Academic Research Consortium (ARC) High Bleeding Risk (HBR) criteria perform consistently in acute (ACS) and chronic (CCS) coronary syndrome patients. METHODS Consecutive patients undergoing PCI from the Bern PCI Registry were stratified by clinical presentation. Bleeding events at one year were compared in ACS versus CCS patients, and the originally defined ARC-HBR criteria were assessed. RESULTS Among 16,821 patients, 9,503 (56.5%) presented with ACS. At one year, BARC 3 or 5 bleeding occurred in 4.97% and 3.60% of patients with ACS and CCS, respectively. After adjustment, ACS remained associated with higher BARC 3 or 5 bleeding risk (adjusted HR 1.21, 95% CI: 1.01-1.43; p=0.034), owing to non-access site-related occurrences, which accrued mainly within the first 30 days after PCI. The ARC-HBR score had lower discrimination among ACS compared with CCS patients, and its performance slightly improved when ACS was computed as a minor criterion. CONCLUSIONS ACS presentation per se predicts one-year major bleeding risk after PCI. The ARC-HBR score discrimination appeared lower in ACS than CCS, and its overall performance improved numerically when ACS was computed as an additional minor risk criterion.

Aims The ESC/EACTS guidelines propose criteria that determine the likelihood of true-severe aortic stenosis (AS). We aimed to investigate the impact of the guideline-based criteria of the likelihood of true-severe AS in patients with low-flow low-gradient (LFLG) AS with preserved ejection fraction (pEF) on outcomes following transcatheter aortic valve replacement (TAVR). Methods and results In a prospective TAVR registry, LFLG-AS patients with pEF were retrospectively categorized into high (criteria ≥6) and intermediate (criteria 70% of LFLG-AS patients had functional improvement, impaired functional status [New York Heart Association (NYHA III/IV)] persisted more frequently at 1 year in LFLG-AS than in high-gradient AS patients (7.8%), irrespective of the likelihood (high: 17.4%, P = 0.006; intermediate: 21.1%, P Conclusion Patients with LFLG-AS with pEF had comparable survival but worse functional status at 1 year than high-gradient AS with pEF, irrespective of the likelihood of true-severe AS. Clinical Trial Registration https://www.clinicaltrials.gov. NCT01368250.

PURPOSE OF REVIEW This review article describes the technical features of the novel Edwards PASCAL transcatheter valve repair system as well as the evidence accumulated so far. RECENT FINDINGS Transcatheter mitral and tricuspid valve leaflet approximation enable treatment of patients with mitral and tricuspid regurgitation who are not eligible for surgery. The PASCAL device offers an alternative that may allow to overcome some of the limitations of previous systems and open the path for an approach adapted to individual patient's anatomy. Early data show similar safety and efficacy compared with the Abbott MitraClip system. The PASCAL system is a valuable addition to the armamentarium of transcatheter mitral and tricuspid valve repair devices. Randomized head-to-head comparisons and long-term data are needed to confirm the promising results observed so far.

Aims To validate the set of clinical and biochemical criteria proposed by consensus by the Academic Research Consortium (ARC) for High Bleeding Risk (HBR) for the identification of HBR patients. These criteria were categorized into major and minor, if expected to carry in isolation, respectively, ≥4% and Methods and results All patients undergoing PCI at Bern University Hospital, between February 2009 and September 2018 were prospectively entered into the Bern PCI Registry (NCT02241291). Age, haemoglobin, platelet count, creatinine, and use of oral anticoagulation were prospectively collected, while the remaining HBR criteria except for planned surgery were retrospectively adjudicated. A total of 16 580 participants with complete ARC-HBR criteria were included. After assigning 1 point to each major and 0.5 point to each minor criterion, we observed for every 0.5 score increase a step-wise augmentation of BARC 3 or 5 bleeding rates at 1 year ranging from 1.90% among patients fulfilling no criterion, through 4.01%, 5.98%, 7.42%, 8.60%, 12.21%, 12.29%, and 17.64%. All major and five out of six minor criteria, conferred in isolation a risk for BARC 3 or 5 bleeding at 1 year exceeding 4% at the upper limit of the 95% confidence intervals. Conclusion All major and the majority of minor ARC-HBR criteria identify in isolation patients at HBR.

Reticulated platelets (RPs) are young thrombocytes, newly released from the bone marrow. The identification and quantification of these cells remained difficult for decades due to a lack of standardized preanalytical and analytical methods. With the introduction of automated hematology analyzers in clinical routine, the determination of RPs, either as a total count or as a fraction, became more reliable, faster and more affordable. Currently, RPs are the focus of research in multiple clinical settings. In cardiovascular medicine, recent studies have focused on the relationship between RPs, coronary artery disease (CAD) and clinical outcomes, as well as the impact of RPs on the effects of antiplatelet therapy. Cohort studies showed increased levels of RPs in patients with acute coronary syndrome (ACS) or cardioembolic stroke. In patients with ACS, increased levels of RPs were also associated with an increased incidence of major ischemic cardiovascular events during follow-up. Further studies showed an association of levels of RPs with the antiplatelet response to less-potent P2Y12 inhibitors. In patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation, levels of RPs differed significantly depending on the achieved rhythm (sinus rhythm vs. recurrent atrial fibrillation). Levels of RPs appear to also be predictive for bleeding events in patients with various hematological diagnoses. Although no causal relationship has so far been proven, RP values have been associated with a large number of pathologies and clinical scenarios. This review summarizes the current evidence with regard to RPs and their potential diagnostic and prognostic value for noncardiovascular patients and for cardiovascular patients in particular. It describes further perspectives on how the testing of these cells might improve the treatment of cardiovascular patients.

This cohort study evaluates the outcomes associated with deferred vs expedited aortic valve replacement in patients with severe aortic stenosis during the COVID-19 pandemic.

BackgroundThe first CE-approved bioresorbable vascular scaffold (BVS) is effective at treating simple lesions and stable coronary artery disease, but it has yet to be assessed versus the best-in-class drug-eluting stents (DES).ObjectivesThis study sought to compare the performance of a BVS with that of everolimus-eluting stents (EES) and biolimus-eluting stents (BES) in all-comer patients.MethodsThe EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) trial was a single-center, assessor-blinded study of 240 patients randomly assigned in a 1:1:1 ratio to EES, BES, or BVS. The only exclusion criterion was a reference vessel diameter >4.0 mm, which precluded treatment with BVS. The primary endpoint was angiographic late lumen loss (LLL) at 9 months. Secondary endpoints included patient-oriented major acute coronary events (MACE) (death, myocardial infarction [MI], and any revascularization), device-oriented MACE (cardiac death, MI, and target lesion revascularization), and stent thrombosis at the 9-month clinical follow-up.ResultsFollow-up angiography was performed in 216 patients (90.7%) at 9 months. In-stent LLL was similar between patients treated with BVS (0.28 ± 0.39 mm) and those treated with EES/BES (0.25 ± 0.36 mm; p = 0.30). Clinical outcomes were similar at 9 months: the patient-oriented MACE rate was 27% in BVS and 26% in the EES/BES group (p = 0.83) and the device-oriented MACE rate was 12% in BVS and 9% in the EES/BES group (p = 0.6).ConclusionsNew-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931)

QUESTIONS UNDER STUDY: Head-to-head optical coherence tomography (OCT) data comparing metallic stents with bioresorbable vascular scaffolds (BVS) are lacking. This study assessed vascular healing at 9-month follow-up after implantation of everolimus- and biolimus-eluting stents (EES BES) and everolimus-eluting BVS.METHODS: OCT was performed in 74 patients enrolled in the EVERBIO II (NCT01711931) trial (23 with EES: 26 lesions, 7 625 struts; 23 with BES: 26 lesions, 6 140 struts; 28 with BVS: 33 lesions, 10 891 struts). OCT images were acquired using the pullback and nonocclusive flushing technique and analysed offline.RESULTS: BVS demonstrated fewer uncovered struts per patient (12 ± 27 [3.8 ± 8.4%] vs 59 ± 55 [21.8 ± 13.7%] in the EES and BES group, p

BACKGROUND: Second-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion. METHODS/DESIGN: The EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter>4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography. DISCUSSION: EVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients. TRIAL REGISTRATION: The trial listed in clinicaltrials.gov as NCT01711931.