scholarly journals Major cardiovascular and bleeding events with long-term use of aspirin in patients with prior cardiovascular diseases: 1-year follow-up results from the Management of Aspirin-induced Gastrointestinal Complications (MAGIC) study

2019 ◽  
Vol 35 (2) ◽  
pp. 170-176
Author(s):  
Shinichiro Uchiyama ◽  
◽  
Shinya Goto ◽  
Hideki Origasa ◽  
Naomi Uemura ◽  
...  
Keyword(s):  
Cardiovascular Diseases ◽  
Bleeding Events ◽  
Gastrointestinal Complications

Abstract 4784: The Ross Operation: Lessons From Long Term Follow-up

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Laurent de Kerchove ◽  
Jean Rubay ◽  
Agnès Pasquet ◽  
Alain Poncelet ◽  
Munir Boodhwani ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Bleeding Event ◽  
Right Ventricular Outflow Tract ◽  
Aortic Insufficiency ◽  
Bleeding Events ◽  
Ross Operation ◽  
Increased Risk ◽  
Long Term Follow Up

Background: The Ross operation is considered the procedure of choice for aortic valve replacement in children and represents an attractive alternative in selected young adults. However, long term follow-up has demonstrated high rates of pulmonary autograft failure raising concern regarding its clinical utility. We analyze long term outcomes of our Ross series, focusing on predictors of autograft failure. Methods: Between 1991 and 2006, 260 consecutive patients underwent Ross operation. Mean age was 35±15 years (range: 1 day to 64 years) and 75% were male. The technique for autograft implantation was a full root replacement in 70% (n=183), inclusion cylinder in 28% (n=73) and subcoronary in 2% (n=4). Right ventricular outflow tract (RVOT) was reconstructed with a pulmonary homograft in 94% (n=245) and with a xenograft in 6% (n=15). Mean clinical follow-up (97% complete) was 97±46 months (13 to 196 months). Echocardiographic follow-up was available in 234 survivors (94%). Results: Hospital mortality was 1.9% (n=5) and 7 patients died during follow-up (3 non cardiac). Twelve year overall survival was 93±4% and freedom from autograft reoperation and from autograft valve replacement was 83±7% and 94±5% respectively. Twenty-five patients (9.6%) underwent autograft reoperation either for insufficiency (n=8), autograft or ascending aorta dilatation (n=6), or both (n=11) with no mortality. In 76% (n=19) of these patients, the autograft valve was preserved. Predictors for autograft dilatation (≥45 mm) were preoperative aortic insufficiency and full root technique. RVOT reintervention was required in 10 (4%) patients (reoperations n=7, balloon dilatation n=3). Twelve year freedom from RVOT reintervention was 95±4. Twelve year freedom from thrombo-embolic and bleeding events was 99±1% (1 stroke, 1 TIA, 1 bleeding event). Conclusions: This long terms study confirms the excellent survival after Ross operation with an extremely low rate of thrombo-embolic and bleeding events. Autograft reoperation rate remains acceptable. Full root technique is associated with increased risk of autograft dilatation, and should be avoided especially in adults with preoperative aortic insufficiency. Autograft valve preservation is feasible in autograft reoperation.

scholarly journals Long‐Term Imaging Evolution and Clinical Prognosis Among Patients With Acute Penetrating Aortic Ulcers: A Retrospective Observational Study

2020 ◽  
Vol 9 (18) ◽  
Author(s):  
Lin Yang ◽  
Quan‐Yu Zhang ◽  
Xiao‐Zeng Wang ◽  
Xin Zhao ◽  
Xuan‐Ze Liu ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Aortic Rupture ◽  
Cerebral Stroke ◽  
Bleeding Events ◽  
Clinical Prognosis ◽  
All Cause Mortality ◽  
Related Mortality

Background Acute penetrating aortic ulcers (PAUs) are reported to dynamically evolve into different clinical outcomes ranging from regression to aortic rupture, but no practice guidelines are available in China. Methods and Results All 109 patients with acute PAUs were monitored clinically. At 30 days follow‐up, 31 patients (28.44%) suffered from aortic‐related adverse events, a composite of aortic‐related mortality, aortic dissection, or an enlarged ulcer. In addition, 7 (6.42%) patients had clinically related adverse events, including all‐cause mortality, cerebral stroke, nonfatal myocardial infarction, acute heart failure alone or acute exacerbation of chronic heart failure, acute renal failure, arrhythmia, and bleeding events. In the present study, the intervention criteria for the Chinese PAU population included a PAU diameter of 12.5 mm and depth of 9.5 mm. The multivariate analysis showed that an ulcer diameter >12.5 mm (hazard ratio [HR], 3.846; 95% CI, 1.561–9.476; P =0.003) and an ulcer depth >9.5 mm (HR, 3.359; 95% CI, 1.505–7.494; P =0.003) were each independent predictors of aortic‐related events. Conclusions Patients with acute PAUs were at high risk for aortic‐related adverse events and clinically related adverse events within 30 days after onset. Patients with an ulcer diameter >12.5 mm or an ulcer depth >9.5 mm have a higher risk for disease progression, and early intervention may be recommended.

Mitral Regurgitation: Comparison between Edge-to-Edge Repair and Valve Replacement

2003 ◽  
Vol 11 (2) ◽  
pp. 131-134 ◽  
Author(s):  
Jai Raman ◽  
Pallav Shah ◽  
Siven Seevanayagam ◽  
John Cheung ◽  
Brian Buxton
Keyword(s):  
Mitral Regurgitation ◽  
Valve Replacement ◽  
Prosthetic Valve Endocarditis ◽  
Early Death ◽  
Bleeding Events ◽  
Long Term Follow Up ◽  
Group 2 ◽  
Group 1

Mitral regurgitation due to bileaflet prolapse and ischemic causes can be difficult to repair. Midterm experience of the Alfieri edge-to-edge repair as an alternative to valve replacement is reported. Twenty-six patients with severe mitral regurgitation underwent the Alfieri repair between January 1998 and December 2000 (group 1); 15 cases were due to bileaflet prolapse and 7 were of ischemic origin. During the same period, valve replacement was performed in 36 patients (group 2), 20 of whom had similar indications. Follow-up was complete to a mean of 15 months (range, 1–28 months). There was no early death in either group. During follow-up, there was no reoperation in group 1, while 2 patients in group 2 required reoperations due to prosthetic valve endocarditis. There were 4 major thromboembolic or bleeding events in group 2, and none in group 1. All patients in group 1 had trivial to mild mitral regurgitation on follow-up echocardiography. The mean mitral valve gradient was significantly higher in group 2 compared to group 1 (7.2 versus 3.2 mm Hg, p = 0.001). The edge-to-edge repair is associated with good early and midterm results. Long-term follow-up is required to evaluate the durability of this technique.

Antithrombotic Treatment and Outcomes of Splanchnic Vein Thrombosis in an International Prospective Registry: Results of 2-Year Follow-up

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 592-592
Author(s):  
Walter Ageno ◽  
Nicoletta Riva ◽  
Sam Schulman ◽  
Jan Beyer-Westendorf ◽  
Soo-Mee Bang ◽  
...  
Keyword(s):  
Risk Factors ◽  
Major Bleeding ◽  
Research Funding ◽  
Bleeding Events ◽  
Primary Analysis ◽  
Vascular Events ◽  
Vein Thrombosis ◽  
Cirrhotic Patients

Abstract Background: Little information is available on the long-term clinical outcome of patients with splanchnic vein thrombosis (SVT). We aimed to assess incidence rates of bleeding, recurrence, and mortality in a large prospective cohort of SVT patients after a 2-year follow-up. Methods: Consecutive SVT patients were enrolled in a multicenter international registry, from 2008 to 2012. Information was gathered on baseline characteristics, risk factors and therapeutic strategies. Clinical outcomes (major bleeding; vascular events, defined as venous or arterial thrombosis, and mortality) during follow-up were collected and reviewed by a Central Adjudication Committee. Major bleeding was defined using the ISTH definition plus the need for hospitalization. The primary analysis was performed up to the first adjudicated major bleeding or thrombotic event. Results: 604 patients from 31 centers were enrolled in this study, 21 (3.5%) were lost to follow-up. Median follow-up duration was 2 years (IQR 1-2). Median age was 54 years (range 16-85); 62.6% were males. Most common risk factors were liver cirrhosis in 27.8% of patients and solid cancer in 22.3%. Portal vein was the most common site of thrombosis. 139 patients were not anticoagulated; 175 received parenteral anticoagulants only (median duration 5.8 months, IQR 3-12) and 290 were started on vitamin K antagonists (median duration 24 months, IQR 7-24). According to the primary analysis, 103 events occurred during follow-up: 35 major bleeding events (3.8/100 patient-years [pt-y]; 95%CI, 2.7-5.2), 2 of which were fatal bleeding, and 68 thrombotic events (7.3/100 pt-y; 95%CI 5.8-9.3), 9 of which were vascular deaths. All-cause mortality occurred in 106 patients (10.3/100 pt-y; 95% CI 8.5-12.5). The incidence of major bleeding events was 4.0/100 pt-y in patients on anticoagulant drugs and 3.4/100 pt-y in patients not receiving anticoagulants. The incidence of vascular events was 5.6/100 pt-y and 9.7/100 pt-y, respectively. Major bleeding and vascular event rates were highest in cirrhotic patients (10.0/100 pt-y and 11.3/100 pt-y, respectively), and lowest in the subgroup of non-malignant non-cirrhotic patients (1.8/100 pt-y and 5.6/100 pt-y, respectively). Conclusions: SVT patients have a non-negligible long-term risk of both bleeding and thrombotic events, but this risk varies according to the pathogenesis of SVT. Anticoagulant treatment is associated with a reduced incidence of thrombotic events without apparently resulting in an increased risk of bleeding. Funding: The study was funded by a grant from Pfizer Canada to ISTH Disclosures Ageno: Bayer Healthcare: Research Funding. Schulman:Bayer HealthCare: Consultancy, Honoraria, Research Funding; Boehringer Ingelheim: Consultancy, Honoraria, Research Funding. Beyer-Westendorf:Bayer: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Boehringer: Honoraria, Research Funding.

scholarly journals The long-term efficacy and safety of combining ablation and left atrial appendage closure: A systematic review and meta-analysis

2021 ◽  
Author(s):  
Feng Li ◽  
Jin-Yu Sun ◽  
Li-Da Wu ◽  
Jian-feng Hao ◽  
Ru-Xing Wang
Keyword(s):  
Pericardial Effusion ◽  
Adverse Events ◽  
Meta Analysis ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Combined Procedure ◽  
Term Efficacy ◽  
Device Embolization

Backgroud The long-term outcomes of this combined procedure remain elusive. This meta-analysis aimed to assess the long-term efficacy and safety of combined procedure. Methods PubMed, Embase, Cochrane Library, and Web of Science were systematically searched from the establishment of databases to 1 January 2021. Studies on the long-term (defined as a mean follow-up of approximately 12 months or longer) efficacy and safety outcomes of combined ablation and LAAC were included for meta-analysis. Results A total of 16 studies comprising 1,428 patients were included in the meta-analysis. The pooled long term freedom rate from atrial arrhythmia was 0.66 (95% confidence interval [CI], 0.59-0.71), long-term successful rate sealing of LAAC was 1.00 (95% CI, 1.00-1.00), and ischemic stroke/transient ischemic attack/systemic embolism during follow-up was 0.01 (95% CI, 0.00-0.02). Meanwhile, the rates of peri-procedural adverse events included phrenic nerve palsy, intracoronary air embolus, device embolization, peri-procedural death of 0.00 (95% CI, 0.00-0.00), procedure-related bleeding events of 0.03 (95% CI, 0.02-0.04), and pericardial effusion requiring or not requiring intervention of 0.00 (95% CI, 0.00-0.01). Moreover, the rates of long-term adverse events rate included device dislocation, intracranial bleeding, and pericardial effusion requiring or not requiring intervention, and all-cause mortality of 0.00 (95% CI, 0.00-0.00), device embolization of 0.01 (95% CI, 0.00-0.01), and other bleeding events of 0.01 (95% CI, 0.00-0.03). Conclusion This meta-analysis suggests that the strategy of combined atrial ablation and LAAC is effective and safe during long-term follow-up

Sulfasalazine Decreases Acute Gastrointestinal Complications Due to Pelvic Radiotherapy

2001 ◽  
Vol 35 (7-8) ◽  
pp. 806-810 ◽  
Author(s):  
Diclehan Kilic ◽  
Seren Ozenirler ◽  
Ibrahim Egehan ◽  
Ayse Dursun
Keyword(s):  
Gastrointestinal Toxicity ◽  
Double Blind Study ◽  
Pelvic Radiotherapy ◽  
Double Blind ◽  
Gastrointestinal Complications ◽  
Pelvic Malignancies ◽  
Long Term Follow Up ◽  
Radiation Induced

BACKGROUND: Radiation-induced gastrointestinal toxicity is a significant concern for patients who are treated with this modality for pelvic malignancies. Eicosanoids and free radicals are thought to be among the reasons for this effect. Sulfasalazine is an inhibitor of their synthesis in the mucosa. OBJECTIVE: To determine whether sulfasalazine can reduce the radiation-induced acute gastrointestinal complications. METHODS: In this prospective, double-blind study, 31 patients receiving pelvic radiotherapy were randomized to receive two sulfasalazine 500-mg tablets twice daily or placebo, administered orally from the first day of irradiation. Patients were evaluated weekly, and gastrointestinal toxicities were graded according to the Late Effect of Normal Tissue — Subjective Objective Management Analytic (LENT-SOMA) toxicity table during pelvic radiotherapy. On the last day of week 5, the subjects were graded endoscopically, and biopsies taken from the rectum were classified histopathologically. RESULTS: Groups did not differ in age, gender, tumor site, or irradiation procedure. During radiotherapy, grade 2 or higher gastrointestinal toxicity occurred in 20% (3/15) and 63% (10/16) of the sulfasalazine and placebo groups, respectively. This difference was significant (p = 0.017). No statistically significant differences were found in endoscopic and histopathologic evaluations. CONCLUSIONS: Sulfasalazine is effective in decreasing clinically acute gastrointestinal toxicities. Long-term follow-up with the subjects will help to determine the net effect of sulfasalazine on the radiation-induced gastrointestinal injuries.

Long-term risk of major bleeding after discontinuing anticoagulation for unprovoked venous thromboembolism: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Faizan Khan ◽  
Alvi Rahman ◽  
Tobias Tritschler ◽  
Marc Carrier ◽  
Clive Kearon ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Case Fatality ◽  
Incidence Rates ◽  
Bleeding Events ◽  
Randomized Controlled ◽  
Fatal Bleeding

Background: The long-term risk of major bleeding after discontinuing anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain. Objectives: To determine the incidence of major bleeding up to 5 years after discontinuing anticoagulation for a first unprovoked VTE. Methods: We searched MEDLINE, EMBASE, and Cochrane CENTRAL (from inception to January 2021) to identify relevant randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding after discontinuing anticoagulation in patients with a first unprovoked VTE who had completed ≥3 months of initial treatment. Unpublished data on major bleeding events and person-years were obtained from authors of included studies to calculate study-level incidence rates. Random-effects meta-analysis was used to pool results across studies. Results: Of 1123 records identified by the search, 20 studies (17 RCTs) and 8740 patients were included in the analysis. During 13 011 person-years of follow-up after discontinuing anticoagulation, the pooled incidence of major bleeding (n=41) and fatal bleeding (n=7) per 100 person-years was 0.35 (95% confidence interval [CI], 0.20-0.54) and 0.09 (95% CI, 0.05-0.15). The 5-year cumulative incidence of major bleeding was of 1.0% (95% CI, 0.4%-2.4%). The case-fatality rate of major bleeding after discontinuing anticoagulation was 19.9% (95% CI, 10.6%-31.1%). Conclusions: Patients with a first unprovoked VTE have a non-trivial risk of major bleeding once anticoagulants are discontinued. Estimates from this study can help clinicians counsel patients about the incremental risk of major bleeding with extended anticoagulation to guide decision making about treatment duration for unprovoked VTE.

Fondakids II: Long-Term Follow-up Data of Children Receiving Fondaparinux for Treatment of Venous Thrombotic Events

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3415-3415 ◽  
Author(s):  
Richard Har Ko ◽  
Carlo Michieli ◽  
Laura Bernardini ◽  
Guy Young
Keyword(s):  
Allergic Reaction ◽  
Complete Resolution ◽  
Research Funding ◽  
Bleeding Events ◽  
Partial Resolution ◽  
Venous Thromboembolic Events ◽  
Long Term Follow Up ◽  
The Mean

Abstract Abstract 3415 Background: The incidence of venous thrombotic events (VTE) in children has risen substantially over the past decade, resulting in increasing use of anticoagulants and making it imperative that pharmacokinetic (PK) and pharmacodynamic studies be performed in children. Fondaparinux has several advantages over low molecular weight heparins including once-daily dosing, no risk for heparin-induced thrombocytopenia, and possibly reduced effects on bone mineral metabolism. A PK, dose-finding, and safety study of fondaparinux was published; however it only studied relatively short-term outcomes and adverse effects. The purpose of this study was to investigate the long-term safety, dosing, and efficacy of fondaparinux in children. Methods: The study included all children 1–18 years (yrs) old treated consecutively with fondaparinux in a single institution between September 1, 2007 and June 20, 2011. The following data were abstracted from the medical records: demographics, location of initial VTE, fondaparinux dosing and levels, bleeding events, other adverse events, status of VTE at each subsequent imaging study (complete resolution, partial resolution, no change, or progression), and VTE recurrence. Descriptive statistics are used to describe the patients and the outcomes. Results: Data from 22 patients were collected and all were available for the safety analysis while 19 were analyzed for dosing (1 excluded due to only receiving 2 doses secondary to an allergic reaction and 2 excluded for ineligible diagnoses) and 16 for efficacy (1 excluded due to allergic reaction, 1 because fondaparinux was given as prophylaxis, and 4 due to ineligible diagnoses/insufficient data). There were 11 females (F) and 11 males (M) (10 F and 9 M analyzed for dosing; 9 F and 7 M for efficacy). The mean age of the patients was 9 yrs (median: 10 yrs; range: 1–17 yrs). The mean duration of treatment with fondaparinux was 377 days (d) (median: 171 d; range: 6–1566 d). The mean dose of fondaparinux was 0.1 mg/kg/dose (median: 0.1 mg/kg/dose; range: 0.07–1.4 mg/kg/dose). Nine of 16 evaluable patients (56.3%) had complete resolution of their thrombus while 6/16 (37.5%) had partial resolution, and 1/16 (6.3%) had no change in their thrombus. Thus, 15/16 (93.8%) patients had either a complete or partial response and 0/16 had progression. The mean time to best outcome from initiation of fondaparinux was 110.5 d (median: 63 d; range: 4–487 d). Seven patients needed a total of 12 dose adjustments (one subject with 3 adjustments and one with 4) to achieve therapeutic levels. Three patients (18.8%) (2 had prior complete resolution of the initial VTE) had a recurrent VTE. Two patients were on fondaparinux at the time of recurrence and 1 was on warfarin. There were 2 major (intracranial hemorrhage- occurred prior to initiation of fondaparinux and subretinal hemorrhage) and 3 minor (all with blood in stool) bleeding events. One patient had an allergic reaction after starting fondaparinux. Conclusions: In this long-term follow-up study on children treated with fondaparinux for VTE, 95% of patients had either complete or partial resolution while the recurrence rate was in line with previous studies. There were 5 bleeding events (2 major and 3 minor), though only 1 event required the discontinuation of fondaparinux. Given the advantages of fondaparinux over other anticoagulants, this study suggests that fondaparinux could be considered a safe and effective alternative for the management of VTE in children. Disclosures: Off Label Use: fondaparinux: anti-coagulation for the treatment of venous thromboembolic events in children. Young:Biogen Idec: Research Funding; Baxter: Consultancy, Honoraria; Novo Nordisk: Consultancy, Honoraria, Research Funding.

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