scholarly journals 637 Real-world experience with the new watchman FLX device: data from two high volume sicilian centres. The FLX-iest registry

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Giampiero Vizzari ◽  
Paolo Mazzone ◽  
Andrea Sardone ◽  
Giulia Laterra ◽  
Marco Frazzetto ◽  
...  
Keyword(s):  
Real World ◽  
Bleeding Complications ◽  
Hospital Death ◽  
Intestinal Bleeding ◽  
High Risk Population ◽  
Bleeding Events ◽  
Size Change ◽  
Procedural Volume ◽  
First Choice ◽  
Procedural Success

Abstract Aims Left Atrial Appendage closure (LAAC) represents a standard therapy for patients with Atrial Fibrillation and contraindication to oral anticoagulation (OAC). The ‘Watchman FLX’ presented innovative features: higher conformability to LAA shapes, reduced length of the device, closed ‘atraumatic’ distal end with ‘flex-ball’ shape during deployment, flattened covered external surface. We report the early ‘real-world’ experience with the innovative Watchman-FLX device, in two centres at high-procedural volume with consolidated LAAC experience. Methods and results From May 2019 to January 2021, we enrolled 200 consecutive patients treated with Watchman FLX in a non-randomized double-centre registry. We collected procedural data and followed up the patients for mid-term clinical outcomes. Mean age was 77 ± 7.18 years (67.5% male). Patients presented hypertension in 93% of cases, CKD in 57.5% (mean creatinine level 2 ± 1.1), Diabetes mellitus in 41.5%, Coronary artery disease and Heart failure in 55%. 29% had previous stroke and 56.5 bleeding events. Mean CHA2DS2-VASc was 5 ± 1.40 and HAS-BLED 4 ± 1.01. LAAC indication was: 39.5% of cases symptomatic Haemorrhage, 39% need for Triple antithrombotic therapy, 32% gastro-intestinal bleeding; 18% of patients presented OAC intolerance. TEE guidance was feasible in 186 cases (93%), of which 96 (48%) in general anesthesia and 90 (45%) in conscious sedation (MID-DEX) protocol. 14 ICE cases (7%) were performed in local anesthesia. FLX device repositioning after first attempt was required in 40 cases (20%) without any complication. Device size change, after first choice was needed in eight cases (4%). In one exceptional case simultaneous implant of two Watchman FLX devices was performed in a bi-lobed LAA. Peri-device leak was found in two cases (1%), one solved by changing FLX size (31 to 35 mm). Final procedural success was 99.5%; one unsuccessful case due to LAA reverse chicken-wing with very short depth; no device embolization. Six complications were related to access-site (3%), two cases of combined LAAC-Mitraclip procedure; two major bleedings occurred and one in-hospital death due to hemorrhagic shock (HAS-BLED = 6). At mean follow-up of 272 ± 172.76 days, only 2% of (non-device-related) stroke and 0.6% fatal bleeding resulted. Conclusions Our registry in a high-risk population treated with the innovative Watchman FLX device, showed high technical procedural success with easy implant and repositioning, no embolization, good LAA sealing and low rate of ischaemic/bleeding complications. 637 Figure

scholarly journals Risk definition and outcomes with the application of the PEGASUS-TIMI 54 trial inclusion criteria to a “real world” STEMI population: results from the Italian “CARDIO-STEMI SANREMO” registry

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Sanchez ◽  
Valentina Boasi ◽  
Matteo Vercellino ◽  
Chiara Tacchi ◽  
Pierpaolo Cannarile ◽  
...  
Keyword(s):  
Real World ◽  
Risk Scores ◽  
Hospital Death ◽  
Cumulative Number ◽  
Inclusion Criteria ◽  
Bleeding Events ◽  
Hemorrhagic Risk ◽  
The Impact

Abstract Background The PEGASUS-TIMI 54 trial inclusion criteria effectively identified high-risk patients with recent myocardial infarction (MI) who would benefit from continuing dual antiplatelet therapy (DAPT) with ticagrelor for more than 12 months. It is unknown how many real-world patients meet these criteria during the acute phase of ST-elevation MI (STEMI), or the extent to which these criteria predict a patient's risk and prognosis. Study objectives were: (1) determine the proportion of PEGASUS-TIMI 54-like patients (PG-l) in a real-world cohort of patients hospitalized with STEMI and to assess their ischemic and hemorrhagic risk; (2) examine their ischemic and hemorrhagic in-hospital events (major adverse cardiovascular and cerebrovascular events [MACCE] and clinically relevant bleeding); (3) evaluate their long-term outcomes and the impact on the long-term prognosis of the type of DAPT prescribed at discharge. Methods This observational study was conducted in 1086 patients admitted to hospital with a diagnosis of STEMI between February 2011 and March 2018 and enrolled in the CARDIO-STEMI Sanremo registry. Patients’ demographic and clinical characteristics, procedural variables, and individual ischemic and hemorrhagic risk scores were assessed in-hospital. Four-year survival was also analyzed. Results The proportion of PG-I patients was 69.2%. Compared with non-PG-l patients, PG-l patients were older, had more multivessel disease and comorbidities, and experienced more frequent MACCE (8.3% vs. 3.6%, p = 0.005) and clinically significant bleeding events (6.7% vs. 2.7%, p = 0.008), a higher rate of in-hospital death (6.5% vs. 1.5%, p < 0.001), and higher follow-up mortality rate (14.8% vs. 7.7%; p = 0.002). Four-year survival was significantly lower in the PG-l group (83.9% vs. 91.8%; Log-rank = 0.001) and was related to the cumulative number of concurrent risk factors. In the unadjusted analysis, survival was greater in patients discharged on ticagrelor than on another P2Y12 inhibitor (90.2% vs. 76.7%, Log-rank = 0.001), and the difference was particularly evident in PG-l patients. Conclusions The risk of MACCE for PG-l patients increased with the number of concurrent PEGASUS-TIMI 54 risk features. Treatment with ticagrelor on discharge was associated with improved survival rates during 4 years of follow-up.

Abstract 211: A Comparison of Bleeding in Patients Treated with Clopidogrel or Prasugrel in a US Hospital Database

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Frank Ernst ◽  
Jay Bae ◽  
Craig Lipkin ◽  
Douglas Faries ◽  
Zhenxiang Zhao ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Real World ◽  
Patient Characteristics ◽  
Coronary Intervention ◽  
Observational Research ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Real World Data ◽  
Coronary Syndrome ◽  
Cohort Differences

Background: Newer, more potent antiplatelet therapy is commonly perceived as being associated with a higher incidence of bleeding complications. There are limited real-world data on bleeding among patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) with new antiplatelet therapy. The objective of this study was to compare “real-world” incidence of bleeding among patients on clopidogrel vs. prasugrel therapy in a large database from diverse US hospitals. Methods: We analyzed patient characteristics and the incidence of bleeding complications during the index (first) hospitalization among ACS-PCI patients treated with clopidogrel or prasugrel between July 2009 and June 2011. Bleeding was defined as the presence of bleeding ICD-9 codes and transfusion. Cohort differences in outcomes were assessed with unadjusted chi-square tests and adjusted for demographics and baseline clinical differences using logistic regression. Results: 105,490 patients received clopidogrel and 10,544 received prasugrel. Among clopidogrel and prasugrel patients, respectively, 66% and 75% were men, 37% and 46% presented with STEMI, with median age of 64 and 57. During the index hospitalization, the unadjusted incidence of bleeding events was 7% in clopidogrel-treated patients and 4% in prasugrel-treated patients (P<0.0001). Similar patterns were reported in key subgroups (e.g. ACS types, heart failure, anemia, diabetes, renal insufficiency), as well as after a multivariate adjustment. Conclusion: It appears that observed bleeding complications among patients treated with prasugrel is not higher than those treated with clopidogrel, even after multivariate adjustments. However, the potential for unobserved confounders remains a limitation for such observational research. It is conceivable that appropriate patient selection helps to control bleeding complications, as shown here in this large, “real-world” database.

Transfusion with Cryoprecipitate for Very Low Fibrinogen Levels Does Not Affect Bleeding or Survival in Critically Ill Cirrhosis Patients

2021 ◽  
Author(s):  
Isadore Budnick ◽  
Jessica Davis ◽  
Anirudh Sundararaghavan ◽  
Samuel Konkol ◽  
Chelsea Lau ◽  
...  
Keyword(s):  
Disease Severity ◽  
Critically Ill ◽  
Tertiary Care ◽  
Severity Of Illness ◽  
Meld Score ◽  
Independent Effect ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Acute Bleeding ◽  
Transplant Center

Background: Fibrinogen (FIB) levels less than 150 mg/dL have been associated with increased rates of bleeding and lower survival in critically ill cirrhosis patients. Objective: We aimed to determine if treatment with cryoprecipitate (CRYO) for low FIB levels were associated with bleeding complications or survival. Patients / Methods: 237 cirrhosis patients admitted to an intensive care unit at a tertiary care liver transplant center with initial FIB levels less than 150 mg/dL were retrospectively assessed for CRYO transfusion, bleeding events, and survival outcomes. Results: The mean MELD score was 27.2 (95% CI 26.0 - 28.3) and CLIF-C Acute on Chronic Liver Failure (ACLF) score was 53.4 (51.9 - 54.8). Ninety-nine (41.8%) were admitted for acute bleeding and the remainder were admitted for non-bleeding illnesses. FIB level on admission correlated strongly with disease severity. After adjusting for disease severity, FIB on admission was not an independent predictor of 30-day survival (HR 0.99, 95% CI 0.99 - 1.01, p = 0.68). CRYO transfusion increased FIB levels but had no independent effect on mortality or bleeding complications (HR 1.10, 95% CI 0.72 - 1.70, p = 0.65). Conclusions: In cirrhosis patients with critical illness, low FIB levels on presentation reflect severity of illness but are not independently associated with 30-day mortality. Treatment of low FIB with CRYO also does not affect survival or bleeding complications suggesting FIB is an additional marker of severity of illness but is not itself a direct factor in the pathophysiology of bleeding in critically ill cirrhosis patients.

Aspirin I.V. Loading during Elective Percutaneous Coronary Intervention

Pharmacology ◽  
2021 ◽  
pp. 1-5
Author(s):  
David Naguib ◽  
Carolin Helten ◽  
Saif Zako ◽  
Philipp Mourikis ◽  
René M’Pembele ◽  
...  
Keyword(s):  
Pilot Study ◽  
Light Transmission ◽  
Platelet Reactivity ◽  
Coronary Intervention ◽  
Bleeding Complications ◽  
Loading Dose ◽  
Bleeding Events ◽  
Elective Percutaneous Coronary Intervention ◽  
Percutaneous Coronary ◽  
The Impact

Additional loading dose of acetylsalicylic acid (ASA) during percutaneous coronary interventions (PCIs) despite permanent oral ASA medication is frequently applicated. The impact on platelet reactivity and clinical events is not known. In this pilot study, we aimed to analyze high on-treatment platelet reactivity (HTPR) to aspirin in patients undergoing elective PCI. Platelet reactivity was measured using light-transmission aggregometry in 100 patients on permanent low-dose ASA medication undergoing elective PCI. Platelet reactivity measured by arachidonic acid-induced maximum of aggregation (MoA) in patients with versus without additional peri-procedural ASA loading (500 mg i.v.) was compared. HTPR was defined as MoA &#x3e;20% for ASA. Major adverse cerebro- and cardiovascular events (MACCEs) and bleeding events were evaluated during hospital course. HTPR rate was similar in both groups (HTPR to ASA: loading vs. control 6% vs. 16%, odds ratio [OR] = 0.33, 95% confidence interval [CI] 0.08–1.35, <i>p</i> = 0.12). In-hospital MACCEs were not different between groups (MACCE: loading vs. control: 0 vs. 0 patient, OR = 1.32, 95% CI 0.03–67.95, <i>p</i> = 0.89). Thrombolysis in myocardial infarction minimal bleedings were numerically higher in patients without ASA loading dose. In this pharmacodynamic pilot study, additional ASA loading did not reduce HTPR to ASA. Furthermore, ASA loading did not increase in-hospital MACCE and bleeding complications.

scholarly journals Age independently predicts hemodynamic, but not arrhythmic STEMI-related complications. Data from a cohort study on 848 STEMI patients

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
RC Serban ◽  
L Hadadi ◽  
I Sus ◽  
EK Lakatos ◽  
Z Demjen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Coronary Intervention ◽  
Hospital Death ◽  
High Risk Population ◽  
Time Interval ◽  
Killip Class ◽  
St Segment Elevation ◽  
Catheterization Laboratory ◽  
Cardiac Stimulation ◽  
Cardiac Catheterization Laboratory

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Romanian Ministry of Education and Research, CNCS-UEFISCDI BACKGROUND Age is one of the most relevant prognostic factors in patients presenting with ST-segment elevation myocardial infarction (STEMI). However, it remains unknown whether this impaired prognosis is due to the occurrence of hemodynamic and/or arrhythmic STEMI-related complications. Understanding the mechanisms involved in STEMI-related complications with advancing age could significantly improve outcomes in this high-risk population. PURPOSE We aimed to investigate the contribution of advanced age to the occurrence of hemodynamic and arrhythmic complications in STEMI patients. METHODS A total of 848 consecutive patients treated by primary percutaneous coronary intervention for STEMI were evaluated. Heart failure, cardiogenic shock, asystole, inotropic and diuretic use, and kidney dysfunction were used as in-hospital markers of hemodynamic complications. Ventricular fibrillation, conduction disorders, cardiac stimulation, and antiarrhythmic drugs use were used as markers of arrhythmic complications. The relationship between age and the occurrence of hemodynamic and arrhythmic complications was evaluated. The contribution of age to in-hospital death was also assessed. RESULTS In-hospital death occurred in 50 (5.8%) patients; patients who deceased were significantly older than their non-deceased counterparts (70.9 ± 10.9 vs. 61.2 ± 11.8 years; p&lt; 0.0001). There was no association between age and the occurrence of any of the evaluated arrhythmic complications (all p &gt;0.05). However, patients who presented hemodynamic complications were significantly older than those who did not (all p&lt; 0.05). Age &gt;60 years was a significant predictor of hemodynamic complications (p&lt; 0.0001) with 61.7% sensitivity and 60.4% specificity. The association between age and hemodynamic complications remained significant after correction for additional risk factors (i.e., hypertension, diabetes mellitus, pre-existing heart failure, Killip class on admission, symptom onset-to-cardiac catheterization laboratory time interval). CONCLUSIONS In the present study, age was identified as an independent predictor of STEMI-related hemodynamic, but not arrhythmic complications. These data indicate that whereas age does not seem to affect the occurrence of STEMI-related rhythm disorders, patients above the age of 60 should particularly benefit from closer follow-up and more intensive strategies to prevent life-threating hemodynamic complications.

Abstract 14873: Is There Difference in Clinical Outcomes Following Percutaneous Coronary Intervention (PCI) for Acute Coronary Syndrome (ACS) between Hospitals With and Without Onsite Cardiac Surgery Backup?

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Tomonori Akasaka ◽  
Seiji Hokimoto ◽  
Noriaki Tabata ◽  
Kenji Sakamoto ◽  
Kenichi Tsujita ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards Model ◽  
Bleeding Complications ◽  
Hospital Death ◽  
Coronary Syndrome ◽  
Significant Difference ◽  
The Impact

Background: Based on 2011 ACCF/AHA/SCAI PCI guideline, it is recommended that PCI should be performed at hospital with onsite cardiac surgery. But, recent data suggests that there is no significant difference in clinical outcomes following primary or elective PCI between hospitals with and without onsite cardiac surgery. The proportion of PCI centers without onsite cardiac surgery comprises approximately more than half of all PCI centers in Japan. We examined the impact of with or without onsite cardiac surgery on clinical outcomes following PCI to ACS. Methods: From Aug 2008 to March 2011, subjects (n=2288) were enrolled from the Kumamoto Intervention Conference Study (KICS), which is a multicenter registry, and enrolling consecutive patients undergoing PCI in 15 centers in Japan. Patients were assigned to two groups treated in hospitals with (n=1954) or without (n=334) onsite cardiac surgery. Clinical events were followed up for 12 months. Primary endpoint was in-hospital death, cardiovascular death, myocardial infarction, and stroke. And we monitored other events those were non-cardiovascular deaths, bleeding complications, revascularizations, and emergent CABG. Results: There was no overall significant difference in primary endpoint between hospitals with and without onsite cardiac surgery (9.6%vs9.5%; P=0.737). There was also no significant difference when events in primary endpoint were considered separately. In other events, only revascularization was more frequently seen in hospitals with onsite cardiac surgery (22.1%vs12.9%; P<0.001). Kaplan-Meier analysis for primary endpoint showed that there was no significant difference between two groups (Log Rank P=0.943). By cox proportional hazards model analysis for primary endpoint, without onsite cardiac surgery was not a predictive factor for primary endpoint (HR 0.969, 95%CI 0.704-1.333; P=0.845). We performed propensity score matching analysis to correct for the disparate patient numbers between two groups, and there was also no significant difference for primary endpoint (6.9% vs 8.0%; P=0.544). Conclusions: There is no significant difference in clinical outcomes following PCI for ACS between hospitals with and without onsite cardiac surgery backup in Japan.

scholarly journals Clinical Outcomes of Multiple Myeloma Patients Treated with Direct Oral Anticoagulants for Immunomodulatory Drug Associated Venous Thromboembolism

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4964-4964 ◽  
Author(s):  
Zachary Crowther ◽  
Jamie Doyle ◽  
Stanford Taylor ◽  
Nadia Ali
Keyword(s):  
Multiple Myeloma ◽  
Venous Thromboembolism ◽  
Clinical Outcomes ◽  
Chart Review ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Direct Result ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Growing Body

Introduction: Venous thromboembolism (VTE) is a common complication in multiple myeloma (MM) patients for several reasons; hematologic malignancy itself is a VTE risk factor and standard of care immunomodulatory drugs (IMiDs) in combination with dexamethasone (Dex) increase the risk further. This combination therapy has a mean VTE incidence of 21.5% in studies that did not use thromboprophylaxis and is recommended for all patients on IMiDs, although the optimal thromboprophylactic regimen remains uncertain. In clinical practice, aspirin (ASA) is commonly prescribed for VTE prophylaxis due to the ease of use. Despite this, the incidence of VTE remains between 7-14%. There is a growing body of literature supporting the efficacy and safety of direct oral anticoagulants (DOACs) for the treatment of VTE in cancer populations. We wanted to assess the incidence of VTE despite ASA prophylaxis at our institution and to further characterize the role of DOACs in the MM population. To do this, we performed a chart review of all MM patients who had been treated with lenalidomide and a DOAC, assessing for VTE development and patient outcomes. Methods: We conducted a retrospective chart review of patients with the diagnosis of MM treated with lenalidomide therapy at Fox Chase Cancer Center at Temple University Hospital or Cottman Avenue after Jan 1st, 2015 to July 2019. Eligible patients were identified through electronic medical record data mining for patients that had been diagnosed with MM, had been prescribed lenalidomide, had been taking ASA while on lenalidomide, and switched to rivaroxaban, edoxaban or apixaban. For comparison, the number of patients treated with lenalidomide and ASA who did not switch to a DOAC were also identified. Patient charts were reviewed for VTE development and bleeding complications after DOAC administration. Results: 132 patients were identified who had a diagnosis of MM and had been prescribed lenalidomide between Jan 1, 2015 and July 31, 2019. These patients were also prescribed aspirin except for three who were already on a DOAC prior to starting lenalidomide. Of the total 132 patients, only 17 were prescribed a DOAC. Six of the patients were on DOACs for reasons other than VTE (atrial fibrillation N=4, atrial flutter N=1, marantic endocarditis N=1). Eleven patients were started on DOACs for VTE; incidence of 8.3% in our myeloma population. However three of these VTEs occurred within one month of high dose melphalan chemotherapy and autologous stem cell rescue. These three patients had been off lenalidomide for over one month prior to VTE. Eight of the 17 patients with VTE developed clots in the setting of active MM and concurrent therapy with IMiD/Dex, independent of hospitalizations or other provoking factors. This is an incidence of 6.0% for VTE directly attributed to therapy. Six patients were on lenalidomide and Dex, while two patients developed VTE while on pomalidomide and Dex. No patients on lenalidomide experienced recurrent VTEs after being switched to therapeutic dose DOAC. One patient on pomalidomide/Dex did experience recurrent VTE. We examined all 17 patients who were on DOACs, 16 of which had been on IMiD and DOACs concurrently. Three had minor bleeding events which all resolved spontaneously. One patient had a major bleeding event, which was a fatal ruptured cerebral aneurysm while on a DOAC and ASA concurrently. Conclusion: The incidence of VTE in our patient population receiving IMiD/Dex while on ASA prophylaxis therapy was similar to what has been previously reported in the literature. We examined the clinical outcomes of 16 patients treated with IMiDs and DOACs concurrently and found few bleeding events. The one major bleed was likely precipitated by malignant hypertension and not a direct result of being on a DOAC. Taken together these results further support the growing body of evidence that DOACs are effective and safe treatments for VTE in cancer patients, including MM. Moving forward, our clinical experience with treatment dose DOACs supports the use of prophylactic dose DOACs to potentially further reduce the incidence of VTE in this high-risk population. Disclosures No relevant conflicts of interest to declare.

Abstract 15073: Best Anticoagulation Strategy for Stroke Prophylaxis in Atrial Fibrillation Patients With Amyloidosis

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sanghamitra Mohanty ◽  
CHINTAN G TRIVEDI ◽  
Joseph Gallinghouse ◽  
Domenico G Della Rocca ◽  
Carola Gianni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Bleeding Complications ◽  
Considerable Proportion ◽  
Medical Procedure ◽  
Bleeding Events ◽  
Full Dose ◽  
Half Dose ◽  
Group 2 ◽  
Group 1

Background: A considerable proportion of elderly patients are known to have coexistent atrial fibrillation (AF) and amyloidosis. Both conditions increase stroke risk. Objective: We evaluated the best anticoagulation strategy in a series of AF patients with amyloidosis. Methods: Consecutive AF patients with coexistent amyloidosis undergoing catheter ablation at our center were included in the analysis. Based on the stroke-prophylaxis approach they were divided into 2 groups; group 1: left atrial appendage occlusion (LAAO) with Watchman and group 2: oral anticoagulation. Following LAAO, all patients remained on full dose non-vitamin K oral anticoagulants (NOAC) for 45 days. Transesophageal echocardiogram (TEE) was performed at 45 days to assess completeness of closure. If the occlusion was complete, patients were kept on aspirin, 81 mg/day for long-term. In case of leak or dense ‘smoke’ in the left atrium (LA) or enlarged LA, they were prescribed half-dose NOAC. NOACs included dabigatran, apixaban, endoxaban and rivaroxaban. Group 2 patients remained on full-dose NOAC during the whole study period (1 year). All patients were prospectively followed up for 1 year. Results: A total of 87 patients were included in the analysis; group 1: 56 and group 2: 31 . CHA 2 DS 2 -VASc score was comparable between the groups (gr. 1: 3.7±1.6 and gr. 2: 3.2±1.7, p=0.18). The most commonly used NOACs were apixaban (45, 51.7%) and rivaroxaban (34, 39%). After the 45-day TEE, 34 patients from group 1 remained on baby-aspirin and 22 on half-dose NOAC. Of the 22, 12 patients had leaks <5 mm, 6 had large LA (mean diameter 5.2±1.4 cm) and 4 patients had dense LA smoke. At 1-year follow-up, 3 stroke and 1 transient ischemic attack were reported in group 1 on baby-aspirin (4/34, 11.8%). No stroke or bleeding complications occurred in the 22 patients on half-dose NOAC. In group 2 patients on full-dose OAC, a total of 5 (5/31, 16.1%) bleeding events (1 subdural hematoma and 4 GI bleedings) were recorded. Additionally, a stroke was reported that happened during brief discontinuation of OAC for another medical procedure. Conclusion: In our series of patients with coexistent AF and amyloidosis, half-dose NOAC following LAA occlusion procedure was observed to be the safest stroke-prophylaxis strategy.

Abstract 15440: Bleeding Complications May Outweigh the Risk of Thrombosis in Patients With End-stage Liver Disease Taking Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sami J Natour ◽  
May Myint Thanda Kyaw ◽  
Ronald W Busuttil ◽  
Jonathan M Tobis ◽  
Henry M Honda
Keyword(s):  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Coronary Intervention ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Stent Restenosis ◽  
Percutaneous Coronary ◽  
Ischemic Complications ◽  
End Stage

Introduction: Randomized trials have demonstrated the safety and efficacy of one month of dual antiplatelet therapy (DAPT) after placement of drug-eluting stents in patients with high bleeding risk. Patients with end-stage liver disease (ESLD) are underrepresented in these trials. Patients who undergo percutaneous coronary intervention (PCI) in preparation for orthotopic liver transplantation (OLT) exhibit a high incidence of bleeding complications on DAPT. The rates of bleeding versus thrombotic complications in ESLD patients placed on DAPT following PCI are poorly described. Methods: We retrospectively collected data from 61 patients who were evaluated for OLT between 2016 and 2019 and underwent PCI prior to listing. Bleeding events were classified using the Bleeding Academic Research Consortium (BARC) definitions and included if the following criteria were met: events occurred in the setting of DAPT, were non-procedural in etiology, and occurred during the time following PCI and prior to OLT. Ischemic complications were evaluated by the incidence of myocardial infarction (MI), stent thrombosis, in-stent restenosis (>50%) and all-cause mortality at 1 year follow-up. Results: A total of 55/61 patients (90%) were placed on DAPT following PCI. Among them, 21/55 patients (38%) bled while taking DAPT, including 15 patients (27%) with BARC types 3-5 first-time bleeding events and 10 patients (18%) requiring early discontinuation of therapy. The median time to first bleeding event was 8 days (range 1 to 477 days, 85 th percentile 17 days). Among ischemic complications, MI occurred in 11/55 patients (20%) however only one patient had a type 1 MI with the remaining being type 2 in etiology. There were no episodes of stent thrombosis and 2 episodes of in-stent restenosis during the 1 year follow-up. A total of 12/55 patients (22%) went on to receive OLT and 18/55 (33%) passed away by 1 year post-PCI. Conclusions: Patients with ESLD exhibit a high rate of clinically significant bleeding on DAPT when compared to overall thrombotic events. The majority of bleeds occurred within the first month after PCI. These findings illustrate the need for larger studies to assess the safety of single instead of dual antiplatelet therapy in patients with ESLD who receive PCI.

scholarly journals Vascular Complications in Patients with Hepatocellular Carcinoma Treated with Sorafenib

Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2961 ◽  
Author(s):  
Katharina Pomej ◽  
Bernhard Scheiner ◽  
Dabin Park ◽  
David Bauer ◽  
Lorenz Balcar ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Cardiovascular Risk ◽  
Treatment Option ◽  
Multivariable Analysis ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Increased Risk ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic

VEGF(R)-targeted therapies are associated with an increased risk of thromboembolism and bleeding, which might be pronounced in patients with increased cardiovascular risk. Nevertheless, sorafenib represents an important treatment option in patients with hepatocellular carcinoma (HCC). We retrospectively investigated the risk of arterial/venous thromboembolic and bleeding events in 252 patients treated with sorafenib for HCC between 05/2006 and 03/2020 at the Medical University of Vienna. Cardiovascular risk was assessed using Framingham score. Eight patients (3.2%) experienced 11 arterial/venous thromboembolic events. Only two patients (0.8%) developed arterial thromboembolism even though cardiovascular risk was low, intermediate, and high in 15 (8.7%), 104 (60%), and 54 (31.2%) of 173 assessable patients. Median overall survival (OS) was shorter in the high risk vs. low/intermediate risk group 7.4 (95% CI: 3.4–11.3) vs. 10.0 (95% CI: 6.8–13.2 months) and independently associated with OS in multivariable analysis HR: 1.53 (95% CI: 1.07–2.19; p = 0.019). Forty-eight (19%) patients experienced a bleeding, most commonly gastrointestinal bleeding (14%) followed by epistaxis (4.7%). Advanced liver dysfunction was not associated with an increased incidence of bleeding/venous thromboembolism. Sorafenib represents a safe treatment option even in patients with increased cardiovascular risk. Bleeding complications were comparable with previous reports, even though patients with more advanced liver disease were included.

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