Background The interrelationships between left atrial appendage (LAA) dimensions and device following implantation are unknown. We aimed to analyze the impact of Watchman device implantation on LAA ...dimensions following its percutaneous closure and potential predictors of remodeling. Methods and Results All consecutive LAA closure procedures performed at 2 centers between November 2017 and December 2020 were included in the WATCH‐DUAL (Watchman 2.5 Versus Watchman FLX in a Dual‐Center Left Atrial Appendage Closure Cohort) registry. This study included patients who had pre‐ and postintervention computed tomography scan analysis. The LAA and device dimensions were measured in a centralized core lab by 3‐dimensional computed tomography scan reconstruction methods, focusing on the device landing zone. This analysis included 104 patients (age, 76.0 range, 72.0–83.0 years; 72% men; 53% Watchman FLX; 47% Watchman 2.5). The baseline characteristics were comparable between Watchman 2.5 and Watchman FLX groups, except for the higher use of oversizing in the latter group. The median delay for computed tomography control was 49 (range, 43–64) days. The landing zone area (median, 446 range, 363–523 versus 290 222–366 mm 2 ; P <0.001) and minimal diameter (median, 23.0 range, 20.7–24.8 versus 16.7 14.7–19.4 mm; P <0.001) significantly increased after implantation. The absolute (median, 157 range, 98–220 versus 85 18–148 mm 2 , P <0.001) and relative (median, 50% range, 32%–79% versus 26% 4%–50%; P <0.001) increases in landing zone area were more pronounced in patients with oversized device. Baseline LAA dimensions were smaller, landing zone eccentricity larger, and oversized device more frequent in patients with significant overexpansion compared with the others. Conclusions LAA dimensions increased at the site of the Watchman prosthesis after implantation, suggesting a local positive remodeling after the procedure. This phenomenon was more pronounced in the case of oversized devices.
Background
Early withdrawal of recommended antiplatelet treatment with clopidogrel adversely affects prognosis following percutaneous coronary interventions. Optimal antiplatelet treatment is ...essential following ST‐segment elevation myocardial infarction (STEMI) given the increased risk of thrombotic complications. This study assessed the frequency, predictors, and clinical impact of early prasugrel cessation in patients with STEMI undergoing primary percutaneous coronary interventions.
Methods and Results
We pooled patients with STEMI discharged on prasugrel in 2 prospective registries (Bern PCI Registry NCT02241291 and SPUM‐ACS (Inflammation and Acute Coronary Syndromes) NCT01000701) and 1 STEMI trial (COMFORTABLE‐AMI (Comparison of Biomatrix Versus Gazelle in ST‐Elevation Myocardial Infarction) NCT00962416). Prasugrel treatment status at 1 year was categorized as no cessation; crossover to another P2Y12‐inhibitor; physician‐recommended discontinuation; and disruption because of bleeding, side effects, or patient noncompliance. In time‐dependent analyses, we assessed the impact of prasugrel cessation on the primary end point, a composite of cardiac death, myocardial infarction, and stroke. Of all 1830 included patients (17% women, mean age 59 years), 83% were treated with new‐generation drug‐eluting stents. At 1 year, any prasugrel cessation had occurred in 13.8% of patients including crossover (7.2%), discontinuation (3.7%), and disruption (2.9%). Independent predictors of any prasugrel cessation included female sex, age, and history of cerebrovascular event. The primary end point occurred in 5.2% of patients and was more frequent following disruption (hazard ratio 3.04, 95% confidence interval,1.34–6.91; P=0.008), without significant impact of crossover or discontinuation. Consistent findings were observed for all‐cause death, myocardial infarction, and stent thrombosis following prasugrel disruption.
Conclusions
In this contemporary study of patients with STEMI, early prasugrel cessation was not uncommon and primarily involved change to another P2Y12‐inhibitor. Disruption was the only type of early prasugrel cessation associated with statistically significant excess in ischemic risk within 1 year following primary percutaneous coronary interventions.
According to current guidelines, hemodynamic status should guide the decision between immediate and delayed coronary angiography (CAG) in out-of-hospital cardiac arrest (OHCA) patients without ...ST-segment elevation. A delayed strategy is advised in hemodynamically stable patients, and an immediate approach is recommended in unstable patients.
This study sought to assess the frequency, predictors, and clinical impact of acute coronary occlusion in hemodynamically stable and unstable OHCA patients without ST-segment elevation.
Consecutive unconscious OHCA patients without ST-segment elevation who were undergoing CAG at Bern University Hospital (Bern, Switzerland) between 2011 and 2019 were included. Frequency and predictors of acute coronary artery occlusions and their impact on all-cause and cardiovascular mortality at 1 year were assessed.
Among the 386 patients, 169 (43.8%) were hemodynamically stable. Acute coronary occlusions were found in 19.5% of stable and 24.0% of unstable OHCA patients (P = 0.407), and the presence of these occlusions was predicted by initial chest pain and shockable rhythm, but not by hemodynamic status. Acute coronary occlusion was associated with an increased risk of cardiovascular death (adjusted HR: 2.74; 95% CI: 1.22-6.15) but not of all-cause death (adjusted HR: 0.72; 95% CI: 0.44-1.18). Hemodynamic instability was not predictive of fatal outcomes.
Acute coronary artery occlusions were found in 1 in 5 OHCA patients without ST-segment elevation. The frequency of these occlusions did not differ between stable and unstable patients, and the occlusions were associated with a higher risk of cardiovascular death. In OHCA patients without ST-segment elevation, chest pain or shockable rhythm rather than hemodynamic status identifies patients with acute coronary occlusion.
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Healthcare systems adopted various strategies to minimize the impact of the COVID-19 pandemic on clinical outcomes of patients with symptomatic severe aortic stenosis referred for transcatheter ...aortic valve implantation (TAVI). We aimed to compare baseline characteristics and procedural and clinical outcomes of patients who underwent TAVI during COVID-19 surge periods with those of patients who underwent TAVI during the nonsurge and prepandemic periods. In the prospective Bern TAVI registry, the pandemic period was divided into surge and nonsurge periods on the basis of the mean number of occupied beds in the intensive care unit in each month and matched with 11 months immediately preceding the pandemic. A total of 1,069 patients underwent TAVI between April 1, 2019 and December 31, 2021. Patients who underwent TAVI during surge periods had a higher surgical risk (Society of Thoracic Surgeons predicted risk of mortality) than that of patients who underwent TAVI during nonsurge and prepandemic periods. Diagnosis-to-procedure time (in days) was longer for patients who underwent TAVI during the surge period than during the nonsurge and prepandemic periods (95.20 ± 121.07 vs 70.99 ± 72.25 and 60.46 ± 75.43, both p <0.001). At 30 days, all-cause mortality was higher in the surge than in the nonsurge group (4.9 vs 1.1%, hazard ratio 4.68, 95% confidence interval 1.55 to 14.10, p = 0.006), and in the surge than in the prepandemic group (4.9 vs 1.3%, hazard ratio 3.67, 95% confidence interval 1.34 to 10.11, p = 0.012). In conclusion, TAVI during COVID-19 surge periods was associated with higher Society of Thoracic Surgeons predicted risk of mortality score, delayed procedure scheduling, and increased 30-day mortality than that of TAVI during nonsurge and prepandemic periods.
Pericardial effusion (PE) is the most common serious left atrial appendage closure (LAAC) complication, but its mechanisms, time course, and prognostic impact are poorly understood.
This study sought ...to assess the frequency, timing, predictors and clinical impact of PE after LAAC.
Data on consecutive patients undergoing percutaneous LAAC between 2009 and 2022 were prospectively collected including the 1-year follow-up. Both single (Watchman 2.5/FLX, Boston Scientific) and double (Amplatzer Cardiac Plug or Amulet, St. Jude Medical/Abbott) LAAC devices were used. An imaging core laboratory adjudicated the PEs and categorized them as early (≤7 days) and late (8-365 days). Logistic regression analysis was used to identify predictors of early and overall PE.
Of 1,023 attempted LAAC procedures, PE was observed in 44 (4.3%) patients; PE was categorized as early in 34 (3.3%) and late in 10 (0.9%) patients. The majority of PEs occurred within 6 hours after LAAC (n = 25, 56.8%) and were clinically relevant (n = 28, 63.6%). Independent predictors of early PE were double-closure left atrial appendage devices (adjusted OR: 8.20; 95% CI: 1.09-61.69), female sex (adjusted OR: 3.41; 95% CI: 1.50-7.73), the use of oral anticoagulation (OAC) at baseline (adjusted OR: 2.60; 95% CI: 1.11-6.09), and advanced age (adjusted OR: 1.07; 95% CI: 1.01-1.23), whereas female sex and OAC at baseline remained independent predictors of overall PE.
In this large LAAC registry, PE was observed in <1 in 20 patients and usually occurred within 6 hours after procedure. The majority of early PEs were clinically relevant and occurred in the Amplatzer Cardiac Plug/Amulet procedures. Independent predictors included the use of double-closure devices, female sex, OAC at baseline, and advanced age. (LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure; NCT04628078)
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The effect of the PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor alirocumab on platelet aggregation among patients with acute myocardial infarction (AMI) remains unknown. We aimed to ...explore the effect of alirocumab added to high-intensity statin therapy on P2Y12 reaction unit (PRU) among AMI patients receiving dual antiplatelet therapy (DAPT) with a potent P2Y12 inhibitor (ticagrelor or prasugrel). In addition, we assessed circulating platelet-derived noncoding RNAs (microRNAs and YRNAs).
This was a prespecified, powered, pharmacodynamic substudy of the PACMAN trial, a randomized, double-blind trial comparing biweekly alirocumab (150 mg) versus placebo in AMI patients undergoing percutaneous coronary intervention. Patients recruited at Bern University Hospital, receiving DAPT with a potent P2Y12 inhibitor, and adherent to the study drug (alirocumab or placebo) were analyzed for the current study. The primary endpoint was PRU at 4 weeks after study drug initiation as assessed by VerifyNow P2Y12 point-of-care assays.
Among 139 randomized patients, the majority of patients received ticagrelor DAPT at 4 weeks (57 86.4% in the alirocumab group vs. 69 94.5% in the placebo group,
= 0.14). There were no significant differences in the primary endpoint PRU at 4 weeks between groups (12.5 interquartile range, IQR: 27.0 vs. 19.0 IQR: 30.0,
= 0.26). Consistent results were observed in 126 patients treated with ticagrelor (13.0 IQR: 20.0 vs. 18.0 IQR: 27.0,
= 0.28). Similarly, platelet-derived noncoding RNAs did not significantly differ between groups.
Among AMI patients receiving DAPT with a potent P2Y12 inhibitor, alirocumab had no significant effect on platelet reactivity as assessed by PRU and platelet-derived noncoding RNAs.
BACKGROUNDUp to 70% of out-of-hospital cardiac arrest (OHCA) patients have a relevant coronary stenosis which may need revascularization. The short- and long-term ischemic and bleeding risk of ...unconscious and conscious OHCA patients undergoing percutaneous coronary intervention (PCI) is largely unknown. OBJECTIVESThis study sought to compare the occurrence of 1-year outcomes after PCI between OHCA patients, stratified on the basis of state of consciousness, with patients with acute coronary syndrome (ACS) not preceded by OHCA. METHODSThe study assessed the unadjusted and adjusted risk of cardiovascular events in a prospective single-center cohort of 9,303 consecutive PCI patients. RESULTSAt 1 year, all-cause mortality was higher in unconscious (49.5%) but not in conscious OHCA (8.9%) patients than in ACS patients (8.0%), and both unconscious and conscious OHCA patients were more likely than ACS patients to experience definite stent thrombosis (4.4% and 3.5% vs 1.3%) and Bleeding Academic Research Consortium 3 or 5 bleeding (17.8% and 9.0% vs 5.1%). The higher hazards were largely determined by events occurring in the first 30 days. After multivariable adjustment, only unconscious OHCA patients remained at increased risk of death (adjusted HR: 3.27; 95% CI: 2.65-4.05), definite stent thrombosis (adjusted HR: 2.40; 95% CI: 1.30-4.43), and Bleeding Academic Research Consortium 3 or 5 bleeding (adjusted HR: 2.51; 95% CI: 1.82-3.47) at 1 year. CONCLUSIONSAt 1 year after PCI, unconscious OHCA patients were at higher risk of death, definite stent thrombosis, and bleeding, while conscious OHCA patients had similar hazards compared with an all-comer ACS population without OHCA. Dedicated PCI strategies for OHCA patients taking into account their state of consciousness after resuscitation are warranted.
BACKGROUNDEvidence to support immediate P2Y12 inhibitor loading in ST-segment elevation myocardial infarction (STEMI) is limited.OBJECTIVESThis study sought to compare outcomes of STEMI patients ...receiving immediate or delayed P2Y12 inhibitor treatment.METHODSUsing data from the prospective Bern-PCI registry between 2016 and 2020, we stratified STEMI patients undergoing percutaneous coronary intervention according to time periods with different institutional recommendations regarding P2Y12 inhibitor pretreatment. In cohort 1 (October 2016-September 2018), immediate P2Y12 inhibitor treatment was recommended. In cohort 2 (October 2018-September 2020), P2Y12 inhibitor treatment was recommended after coronary anatomy was confirmed. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events (MACCEs) defined as all-cause death, recurrent myocardial infarction, stroke, or definite stent thrombosis at 30 days. Sensitivity analysis included only patients in whom these recommendations were followed.RESULTSCohort 1 included 1,116 patients; pretreatment was actually given in 708 (63.4%). Cohort 2 included 847 patients; pretreatment was withheld in 798 (94.2%). The mean age was 65 ± 13 years, and 24% were female. Baseline characteristics were well-balanced between groups. The median difference for P2Y12 loading to angiography was 52 minutes between cohort 1 and 2 and 100 minutes between patients receiving vs not receiving pretreatment. Rates of MACCEs were similar between cohort 1 and cohort 2 (10.1% vs 8.1%; adjusted HR: 0.91; 95% CI: 0.65-1.28; P = 0.59) and between patients receiving vs not receiving pretreatment (7.1% vs 8.4%; adjusted HR: 1.17; 95% CI: 0.78-1.74; P = 0.45).CONCLUSIONSIn this cohort study of patients with STEMI undergoing primary percutaneous coronary intervention, P2Y12 inhibitor pretreatment was not associated with improved MACCEs.
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