Background
Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. ...Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue.
Aim
To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real‐world patient with persistent LAA thrombus.
Methods and results
The study retrospectively enrolled consecutive patients with non‐valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high‐volume centres. Twenty‐seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2DS2‐VASc and HAS‐BLEED scores 3 2–5 and 3 2.75–4, respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra‐aortic trunks dissection was recorded.
Conclusions
In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.
The differential impact on ischaemic and bleeding events of the type of drug-eluting stent durable polymer stents DES vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS) and length of ...dual antiplatelet therapy (DAPT) remains to be defined.
Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) a composite of death, myocardial infarction (MI), and target vessel revascularization. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent everolimus-eluting (EES), zotarolimus-eluting (ZES) with 12mDAPT, EES/ZES with <12 months of DAPT, and EES/ZES with >12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT.
Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length.
Abstract
Background
the coronavirus disease 2019 (COVID-19) is characterized by poor outcomes and mortality, particularly in older patients.
Methods
post hoc analysis of the international, ...multicentre, ‘real-world’ HOPE COVID-19 registry. All patients aged ≥65 years hospitalised for COVID-19 were selected. Epidemiological, clinical, analytical and outcome data were obtained. A comparative study between two age subgroups, 65–74 and ≥75 years, was performed. The primary endpoint was all cause in-hospital mortality.
Results
about, 1,520 patients aged ≥65 years (60.3% male, median age of 76 IQR 71–83 years) were included. Comorbidities such as hypertension (69.2%), dyslipidaemia (48.6%), cardiovascular diseases (any chronic heart disease in 38.4% and cerebrovascular disease in 12.5%), and chronic lung disease (25.3%) were prevalent, and 49.6% were on ACEI/ARBs. Patients aged 75 years and older suffered more in-hospital complications (respiratory failure, heart failure, renal failure, sepsis) and a significantly higher mortality (18.4 vs. 48.2%, P < 0.001), but fewer admissions to intensive care units (11.2 vs. 4.8%). In the overall cohort, multivariable analysis demonstrated age ≥75 (OR 3.54), chronic kidney disease (OR 3.36), dementia (OR 8.06), peripheral oxygen saturation at admission <92% (OR 5.85), severe lymphopenia (<500/mm3) (OR 3.36) and qSOFA (Quick Sequential Organ Failure Assessment Score) >1 (OR 8.31) to be independent predictors of mortality.
Conclusion
patients aged ≥65 years hospitalised for COVID-19 had high rates of in-hospital complications and mortality, especially among patients 75 years or older. Age ≥75 years, dementia, peripheral oxygen saturation <92%, severe lymphopenia and qSOFA scale >1 were independent predictors of mortality in this population.
To investigate the impact of pulmonary artery catheter (PAC) monitoring on survival of cardiogenic shock(CS), in the light of the controversies in available evidence.
MEDLINE, EMBASE, Cochrane ...library and Web of Science were systematically screened to identify most relevant studies on patients with CS comparing PAC use to non-use during hospital stay. Short-term mortality was the primary endpoint and the use of Mechanical Circulatory Support (MCS) devices was the secondary one.
Six observational studies including 1,166,762 patients were selected. The most frequent etiology of CS was post-myocardial infarction (75% 95% CI 55–89% in PAC-group and 81%95% CI 47–95% in non-PAC group). Overall, PAC was used in 33%(95% CI 24–44%) of cases. Pooling data adjusted for confounders, a significant association between the PAC-group and a reduction in short-term mortality emerged when compared to the non-PAC group (36%95% CI 27–45% vs 47%95% CI 35–59%;AdjustedOR 0.71, 95% CI 0.59–0.87, p < 0.01). MCS use was significantly higher in PAC vs non-PAC group (59% 95% CI 54–65%) vs 48% 95% CI 43–53%);OR 1.60 95% CI 1.27–2.02, p < 0.01).
PAC was associated with lower incidence of short-term mortality in CS pooling adjusted observational studies. Prospective studies are needed to confirm our hypothesis and better clarify the mechanisms of this potential prognostic benefit.
•Short-term mortality in patients admitted for cardiogenic shock (CS) remains high•Six observational studies comparing pulmonary artery catheter (PAC) use versus conventional care in CS were identified.•Pooling results adjusted for confounders, PAC-group was associated with a lower short-term mortality than the non-PAC one.•The percentage of mechanical cardiac support device use was significantly higher among PAC-group.•Further studies are needed to confirm and clarify the mechanism of the present findings.
Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular ...lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9%). The primary safety end point occurred in 145 cases (90.6%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9%), and perforation in 4 patients (2.5%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy.
The present study aimed to identify patients at a higher risk of hospitalization for heart failure (HF) in a population of patients with acute coronary syndrome (ACS) treated with percutaneous ...coronary revascularization without a history of HF or reduced left ventricular (LV) ejection fraction before the index admission. We performed a Cox regression multivariable analysis with competitive risk and machine learning models on the incideNce and predictOrs of heaRt fAiLure After Acute coronarY Syndrome (CORALYS) registry (NCT 04895176), an international and multicenter study including consecutive patients admitted for ACS in 16 European Centers from 2015 to 2020. Of 14,699 patients, 593 (4.0%) were admitted for the development of HF up to 1 year after the index ACS presentation. A total of 2 different data sets were randomly created, 1 for the derivative cohort including 11,626 patients (80%) and 1 for the validation cohort including 3,073 patients (20%). On the Cox regression multivariable analysis, several variables were associated with the risk of HF hospitalization, with reduced renal function, complete revascularization, and LV ejection fraction as the most relevant ones. The area under the curve at 1 year was 0.75 (0.72 to 0.78) in the derivative cohort, whereas on validation, it was 0.72 (0.67 to 0.77). The machine learning analysis showed a slightly inferior performance. In conclusion, in a large cohort of patients with ACS without a history of HF or LV dysfunction before the index event, the CORALYS HF score identified patients at a higher risk of hospitalization for HF using variables easily accessible at discharge. Further approaches to tackle HF development in this high-risk subset of patients are needed.
Aortic dissection type A is a disease with high mortality. Iatrogenic aortic dissection after interventional procedures is infrequent, and prognostic data are scarce. Our objective was to analyze its ...incidence, patient profile, and long-term prognosis.
Between 2000 and 2014, we retrospectively analyzed 74 patients with dissection of the ascending aorta. Clinical and procedural data were reviewed, and later, we performed a prospective clinical follow-up by telephone or in the office. The incidence of aortic dissection was 0.06%. Our patients, predominantly male (67.6%), had a mean age of 66.9±10.8 years. With multiple cardiovascular risk factors, the main reason for cardiac catheterization was an acute coronary syndrome (n=54). The complication was detected acutely in all, trying to engage the right coronary artery in 47 and the left main artery in 30 and after other maneuvers in 2, mostly complex therapeutic procedures (78.4%). A coronary artery was involved in 45 patients (60.8%). Thirty-five patients underwent an angioplasty and stent implantation; 3 had cardiac surgery; and 36 were managed conservatively. Two patients died of cardiogenic shock after the dissection. After a median follow-up of 51.2 months (range, 16.4-104.8 months), none of the remaining patients developed complications as a result of the dissection, progression, ischemia, pain, or dissection recurrence.
Iatrogenic catheter dissection of the aorta is a rare complication that carries an excellent short- and long-term prognosis with the adoption of a conservative approach. When a coronary artery is involved as an entry point, it usually can be safely sealed with a stent with good long-term outcomes.
Abstract Incidence, predictors and impact on prognosis of target lesion revascularization (TLR) for patients treated with second generation drug eluting stents (DESs) on unprotected left main (ULM) ...remain to be defined. The present is a multicenter study including patients treated with a second generation DES on ULM from June 2007 to January 2015. Rate of target lesion revascularization was the primary end point. All cause death, myocardial infarction, target vessel revascularization and stent thrombosis were the secondary end points. 1270 patients were enrolled: after a follow up of 650 days (230-1170) 47 (3.7%) of them underwent a re-PCI TLR on the left main, 22 during a planned angiographic follow up. Extent of CAD was similar among groups (median value of Syntax of 27±10 vs. 26±9, p 0.45), as localization of the lesion in the ULM. Of patients reporting with TLR on ULM; 56% presented with a focal re-stenosis, 33% diffuse and 10% proliferative. At multivariate analysis), insulin dependent diabetes mellitus increased risk of TLR (HR 2.0: 1.1-3.6, p 0.04), while use of IVUS resulted protective (HR 0.5: 0.3-0.9, p 0.02) At follow up, rates of cardiovascular death did not differ among the two groups (4% vs.4%, p 0.95). At multivariate analysis, TLR on LM did not increase risk of all cause death (HR 0.4: 0.1-1.6, p 0.22), while cardiogenic shock and III tertile of Syntax portended a worse prognosis (respectively HR 4.5: 2.1-10.2 p 0.01 and HR 1.4:1.1-1.6 p 0.03).. In conclusion, repeated revascularization after implantation of second generation DES on ULM represents an unfrequent event, being increased in insulin dependent patients and reduced by IVUS. Impact on prognosis remains neutral, being related to clinical presentation and extent of CAD.
Abstract Trans-radial access (TRA) is often avoided in favour of the trans-femoral access (TFA) during percutaneous coronary interventions (PCI) of the unprotected left main coronary artery (ULM), ...due to technical and safety concerns. Aim of this study was to compare the performance of TRA and TFA in the treatment of ULM with second-generation drug-eluting stents (DES-II). Consecutive patients undergoing PCI on ULM with DES-II were retrospectively enrolled in the multicenter FAILS 2 registry. Patients were stratified according to the arterial access. Choice between TRA and TFA was left to each operator’s preferences. Bleedings during index hospitalization were the primary end-point. Secondary end-points were major adverse cardiovascular events (MACE, a composite of death, reinfarction, target lesion revascularization TLR), the single components of MACE at follow-up and stent thrombosis. Propensity score matching was executed to account for possible confounding. Overall, 1247 patients were enrolled (289, 23.2%, of female sex, mean age 70.2±10.2 years). Diagnosis at presentation was stable angina in 603(48.7%) cases, NSTE-ACS in 465(37.3%), STEMI in 117(9.5%). Mean follow-up was 726±654 days. After propensity score with matching, 354 patients were included. The primary end-point was significantly reduced in patients treated with TRA (2.0% vs. 4.0%, p 0.042), while no differences emerged pertaining the secondary end-points, including TLR and reinfarction. In conclusion, TRA may reduce in-hospital bleedings in patients undergoing percutaneous treatment of the ULM, without increasing the rate of adverse cardiovascular events at follow-up, and may therefore be safely used in the treatment of the ULM.
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