Mortality, Stroke, and Hospitalization Associated With Deferred vs Expedited Aortic Valve Replacement in Patients Referred for Symptomatic Severe Aortic Stenosis During the COVID-19 Pandemic.

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

Serum lipoprotein(a) and 3-year outcomes in patients undergoing percutaneous coronary intervention.

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

Safety and Efficiency of Rotational Atherectomy in Chronic Total Coronary Occlusion-One-Year Clinical Outcomes of an Observational Registry.

The study sought to assess the procedural success of rotational atherectomy (RA) in coronary chronic total occlusion (CTO) and to investigate the in-hospital and one-year outcomes following RA. From 2015 to 2019, patients undergoing percutaneous coronary intervention for CTO (CTO PCI) were retrospectively included into the hospital database. The primary endpoint was procedural success. Secondary endpoints were in-hospital and one-year major adverse cardiovascular and cerebral event (MACCE) rates. During the study period of 5 years, 2.789 patients underwent CTO PCI. Patients treated with RA (n = 193, 6.92%) had a significantly higher procedural success (93.26% vs. 85.10%, p = 0.0002) compared to those treated without RA (n = 2.596, 93.08%). Despite a significantly higher rate of pericardiocentesis (3.11% vs. 0.50%, p = 0.0013) in the RA group, the in-hospital and one-year MACCE rate was similar in both groups (4.15% vs. 2.77%, p = 0.2612; 18.65% vs. 16.72%, p = 0.485). In conclusion, RA is associated with higher procedural success for CTO PCI, but has higher risks for pericardial tamponade than CTO PCI without the need for RA. Nevertheless, in-hospital and one-year MACCE rates did not differ in-between both groups

Impact of On-Clopidogrel Platelet Reactivity on Incidence of Peri-Interventional Bleeding in Patients Undergoing Transcatheter Aortic Valve Implantation.

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

Vascular response to everolimus- and biolimus-eluting coronary stents versus everolimus-eluting bioresorbable scaffolds – an optical coherence tomography substudy of the EVERBIO II trial

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 <0.001), and thicker neointimal hyperplasia (BVS 102 ± 44 µm vs EES and BES 66 ± 36 µm, p <0.01). There was no significant difference with regard to malapposed struts (2.1 ± 2.7% in the BVS vs 4.4 ± 8.8% in the EES and BES group, p = 0.41). In a predefined signal intensity scale, quantitative analysis of the “key component” (black) revealed lower intensity in BVS than EES and BES (14 ± 23% vs 13 ± 12%, p = 0.007). Intensity was lower in polylactide-containing stents (BVS and BES) than in EES (15 ± 19% vs 10 ± 10%, p <0.001). CONCLUSIONS: BVS has fewer uncovered struts and presents with a thicker neointimal coverage compared with EES and BES. It is not known whether this improved capping correlates with superior vascular healing. Polylactide-containing stents (BVS and BES) demonstrate lower peristrut intensity compared with EES

Natural history and mid-term prognosis of severe tricuspid regurgitation: A cohort study.

OBJECTIVES The objective of this study was to characterize a population of patients with severe tricuspid regurgitation (TR) evaluated at a tertiary care center, assess mid-term clinical outcomes, and identify prognostic factors. BACKGROUND The impact of TR on morbidity and mortality is increasingly recognized. Clinical characteristics and long-term outcomes of patients suffering from TR remain unclear. METHODS This is a retrospective observational single-center study from a tertiary care hospital including patients with echocardiographic diagnosis of severe TR between January 2017 and December 2018. We used the Kaplan-Meier method to estimate survival for up to 4 years. After excluding patients with tricuspid valve (TV) intervention and surgery during follow-up, a multivariate analysis was performed to assess predictors of 2-year mortality using the Cox regression model. RESULTS A total of 278 patients (mean age 74.9 ± 13.7 years, 47.8% female) with severe TR were included in the study. The majority (83.1%; n = 231) had secondary TR. Comorbidities such as atrial fibrillation (AFib) (68.0%; n = 189), severe renal failure (44.2%; n = 123), pulmonary hypertension (PHT) (80.9%; n = 225), and right ventricular (RV) dysfunction (59.7%; n = 166) were highly prevalent. More than half of patients with a cardiac implantable electronic device (CIED) (54.3%; n = 44) showed echocardiographic signs of lead-leaflet interaction causing or contributing to TR. The estimated 2- and 4-year all-cause mortality was 50 and 69%, respectively. Using multivariate analysis, age, severe renal failure, heart failure with reduced ejection fraction (HFrEF), and vena contracta width ≥14 mm were identified as predictors of 2-year mortality. Nine percent (n = 25) of the study cohort underwent transcatheter or surgical treatment for TR during follow-up. CONCLUSION Our study shows the high burden of morbidity and the dismal survival of patients with severe TR. It also highlights the extent of the therapeutic need, since the vast majority of patients were left untreated. Additionally, CIED RV lead-associated TR was prevalent suggesting a need for more attention in clinical routine and research

Sex-Based Differences in Bleeding Risk After Percutaneous Coronary Intervention and Implications for the Academic Research Consortium High Bleeding Risk Criteria.

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

Safety and Feasibility of MitraClip Implantation in Patients with Acute Mitral Regurgitation after Recent Myocardial Infarction and Severe Left Ventricle Dysfunction

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 \u3c 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