scholarly journals Novel Oral Anticoagulant Use in Adults With Congenital Heart Disease: a Single-center Experience

Author(s):  
Daniel Samarai ◽  
Nazim Isma ◽  
Sandra Lindstedt ◽  
Joanna Hlebowicz

Abstract IntroductionAdults with congenital heart disease (ACHD) are a group with an increased risk of thromboembolic complications and arrhythmias. Vitamin K antagonists (VKA) are the most commonly used thromboprophylaxis therapy in this population. Studies on the efficacy and safety of novel oral anticoagulants (NOAC) are scare, but emerging together with their increasing use.MethodsACHD patients taking NOAC treatment were identified in AuriculA, a Swedish national quality register for atrial fibrillation and anticoagulation. Data on duration of treatment and patient characteristics were provided by the Register. CHA2DS2-VASc and HAS-BLED scores for atrial fibrillation were calculated. CHD severity was determined according to guidelines. Thromboembolic and major bleeding events were provided by AuriculA. Results30 patients who had been taking NOAC treatment for a minimum of 3 months were included. Their median age was 55 years (SD 17 years) and 57% were male. Median follow-up was 17 months (IQR: 10-41). Apixaban was the most commonly used NOAC (47%). Median CHA2DS2-VASc score was 2 (IQR: 0-3) and HAS-BLED was 1 (IQR: 0-2). Complex CHD was prevalent in 27% of the patients. No thromboembolic events were recorded; however, one major bleeding, unspecified, was reported during the total cumulative patient follow-up time of 64 years. ConclusionThe results of our study, although limited in size, suggest NOAC to be a non-inferior alternative to VKA in a heterogenic study group with a balanced inclusion of CHD severity defects. Further and larger studies on VKA and NOAC in ACHD patients are warranted.

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Norihisa Toh ◽  
Ines Uribe Morales ◽  
Zakariya Albinmousa ◽  
Tariq Saifullah ◽  
Rachael Hatton ◽  
...  

Background: Obesity can adversely affect most organ systems and increases the risk of comorbidities likely to be of consequence for patients with complex adult congenital heart disease (ACHD). Conversely, several studies have demonstrated that low body mass index (BMI) is a risk factor for heart failure and adverse outcomes after cardiac surgery. However, there are currently no data regarding the impact of BMI in ACHD. Methods: We examined the charts of 87 randomly selected, complex ACHD patients whose first visit to our institution was at 18-22 years old. Patients were categorized according to BMI at initial visit: underweight (BMI < 18.5 kg/m 2 ), normal (BMI 18.5 - 24.9 kg/m 2 ), overweight/obese (BMI ≥ 25 kg/m 2 ). Events occurring during follow-up were recorded. Data was censured on 1/1/2014. Cardiac events were defined as a composite of cardiac death, heart transplantation or admission for heart failure. Results: The cohort included patients with the following diagnoses: tetralogy of Fallot n=31, Mustard n=28, Fontan n=17, ccTGA n=9 and aortic coarctation n=2. The median (IQR) duration of follow-up was 8.7 (4.2 - 1.8) years. See table for distribution and outcomes by BMI category. Cardiac events occurred in 17/87 patients. After adjustment for age, sex, and underlying disease, the underweight group had increased risk of cardiac events (HR=12.9, 95% CI: 2.8-61.5, p < 0.05). Kaplan-Meier curves demonstrate the poorer prognosis of underweight patients (Figure). Conclusions: Underweight was associated with increased risk of late cardiac events in ACHD patients. We were unable to demonstrate significant overweight/obesity impact.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Z Mandalenakis ◽  
C K Karazisi ◽  
K S Skoglund ◽  
A R Rosengren ◽  
G L Lappas ◽  
...  

Abstract Background Adult patients with congenital heart disease (CHD) have an increased incidence of cancer presumably due to repeated radiation exposure, genetic predisposition or a continued stress factor during heart interventions. Purpose We aimed to investigate the risk to be diagnosed with cancer from birth up to the age of 42 years in patients with CHD and compared to matched controls. Methods Using data from the Patient and Cause of Death Registers in Sweden, we identified successive cohorts of patients with CHD born 1970–79, 1980–89 and 1990–93. Each CHD patient was matched for birth year, sex and county with 10 controls without CHD from the general population with follow-up data and comorbidities collected from birth until 2011. Results We identified 21,982 patients with CHD and 219,816 matched controls of whom 428 (1.95%) and 2,072 (0.94%), respectively, were diagnosed with cancer over a mean follow-up of 26.2 and 27.5 years. The overall hazard ratio (HR) for cancer was 2.24 times (95% confidence interval [CI], 2.01–2.48) in children and young adults with CHD compared to controls; higher in men (HR 2.41 (95% CI, 2.08–2.79)) and among patients with isolated atrial or ventricular defects, as well as in the large group of miscellaneous anomalies. The cumulative incidence of cancer in patients with CHD increased by birth cohort with almost 2% among those born 1990–93 been diagnosed with cancer on reaching adulthood. Conclusions Young patients with CHD had more than 2 timmes increased risk to develop cancer compared to matched controls. At the age of 42, 1 out of 50 patients with CHD developed cancer and the risk was significantly higher in men with CHD. The patient groups with atrial and ventricular septal defects had a significantly increased risk of cancer and a systematic screening for cancer could be considered to this vulnerable group of patients. Acknowledgement/Funding By grants from the Swedish state under the agreement concerning research and education of doctors, the Swedish Research Council.


Author(s):  
Kok Wai Giang ◽  
Maria Fedchenko ◽  
Mikael Dellborg ◽  
Peter Eriksson ◽  
Zacharias Mandalenakis

Background Patients with congenital heart disease (CHD) are at increased risk of developing ischemic stroke (IS) compared with controls without CHD. However, the long‐term outcomes after IS, including IS recurrence and mortality risk, remain unclear. Methods and Results We identified all patients with CHD in Sweden who were born between 1930 and 2017 using the Swedish National Patient Register and the Cause of Death Register. Ten controls without CHD were randomly selected from the general population and matched for birth year and sex for each patient with CHD. The follow‐up of the study population was performed between January 1970 and December 2017. In total, 88 700 patients with CHD (50.6% men) and 890 450 matched controls (51.0%) were included in this study. During a mean follow‐up of 25.1±22.0 years, patients with CHD had a 5‐fold higher risk of developing an index IS (hazard ratio [HR], 5.01; 95% CI, 4.81–5.22) compared with controls. However, the risk of developing a recurrent IS was lower in patients with CHD compared with controls (HR, 0.66; 95% CI, 0.56–0.78), an observation that persisted after adjustment for cardiovascular risk factors and comorbidities. Patients with CHD were also at a significantly lower risk of all‐cause mortality after index IS than controls (HR, 0.53; 95% CI, 0.49–0.58). Conclusions Patients with CHD had a 5‐fold higher risk of developing index IS compared with matched controls. However, the risk of recurrent IS stroke and all‐cause mortality were 34% and 47% lower, respectively, in patients with CHD compared with controls.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.W Giang ◽  
M Fedchenko ◽  
M Dellborg ◽  
P Eriksson ◽  
A Rosengren ◽  
...  

Abstract Introduction With an increasing proportion of adults with congenital heart disease (CHD) surviving into middle age and beyond, CHD patients will be at increased risk of acquired cardiovascular conditions, such as ischemic stroke. Compared to controls, patients with CHD have a higher prevalence of arrhythmias, persistent shunts enabling paradoxical embolization, heart failure, mechanical valves as well as potentially hypercoagulable states, all of which can further increase the risk of stroke. Purpose The aim of our study was to investigate the risk of developing ischemic stroke in adults with CHD in Sweden compared to controls from the general population. Methods We used data from the Swedish National Patient and Cause of Death registries to identify all CHD patients ≥18 years of age, born during the period 1930–1998, with a first time diagnosis of ischemic stroke. Follow-up started in January 1970 and went on until December 2017. Approximately ten controls matched for age and sex were randomly selected from the general population for each patient with CHD. CHD diagnoses were classified into six lesion groups according to a previously published hierarchical classification system. Results In total, 43,110 patients with CHD and 474,267 controls were included in the study (51.4% men) and mean follow up time was 25.4±18.4 years. Patients with CHD had a 6 times higher risk of developing an ischemic stroke compared with controls (hazard ratio 6.0, 95% confidence interval 5.8–6.2, p≤0.001), with altogether 8.8% (n=3785) of CHD patients developing ischemic stroke compared with 1.6% (n=7516) of controls. Ischemic stroke was more common in all CHD lesion groups; however, patients with atrial septal defects/patent foramen ovale had the highest incidence rate of ischemic stroke with an incidence rate of 76.1 events/10,000 patient years compared with 8.7 in controls. Patients with CHD and ischemic stroke had markedly less hypertension, diabetes mellitus and hypercholesterolemia, compared with controls (7.1%, 2.0%, 2.9% respectively in CHD patients, compared with 19.6%, 6.6%, 5.3%, in controls, p≤0.001 for all). In addition, atrial fibrillation and heart failure were only slightly more common in CHD patients with ischemic stroke compared to controls (atrial fibrillation: 12.0% in CHD vs 10.4% in controls, p=0.01; heart failure: 8.7% in CHD vs 7.3% in controls, p=0.009). Conclusion In this large nationwide study, we found that the risk of ischemic stroke in adult patients with CHD was six times higher than in controls, despite a lower prevalence of common risk factors for stroke such as hypertension, diabetes mellitus and hypercholesterolemia. In addition, atrial fibrillation and heart failure were only slightly more common in CHD patients compared with controls. This implies that the etiology of ischemic stroke might be different in CHD patients compared with controls. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): This work was funded by the Swedish state under an agreement between the Swedish government and county councils, the ALF agreement (Grant number: 236611) and the Swedish Heart-Lung Foundation (Grant Number: 20090724).


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Freisinger ◽  
J Koeppe ◽  
L Bronstein ◽  
L Makowski ◽  
H Reinecke ◽  
...  

Abstract Background The life-span of patients with congenital heart disease strongly increased during the last decades due to advances in diagnostic and therapeutic approaches. Some cardiac malformations may involve an increased risk of thrombo-embolic complications. Further, adult patients with congenital heart disease (ACHD) are at increased risk to develop cardiac arrhythmia, such as atrial flutter or fibrillation. Therefore, various constellations may indicate anti-thrombotic and/ or anti-coagulative preventive or therapeutic regimen. Concomitantly, progress was made in the development of anticoagulative pharmacotherapy in the last decade with the development of the novel oral anticoagulants (NOACs). Purpose Aim of the study is to assess the use of oral anticoagulants, particularly of the NOACs dabigatran, rivaroxaban, apixaban, and edoxaban in ACHD in an unselected real-world scenario. Methods Data are derived from the German BARMER health insurance comprising approx. 9 million insurants. Within the years 2005 - 2017, we identified all adult patients that were hospitalized with a main or secondary diagnosis of a congenital heart disease by ICD-10 (Q20–28). Patients were categorized into simple, moderate, and high complexity cardiac lesions of heart disease. Oral anticoagulants were identified by ATC codes and assigned to the patient if prescribed at least twice. Results Overall, we included 13,344 ACHD patients (137,079 patient years). The use of oral anticoagulants increased from 8.3% in 2005, to 13.1% in 2010, 19.8% in 2015 and up to 22.5% of patients in 2017. Correspondingly, the use of vitamin K antagonists increased, reaching a plateau at approx. 14% since 2012. More interestingly, however, the prescription of NOACs constantly increased from 1.6% in 2012 to 8.4% in 2017. Therefore, NOACs were used for anticoagulation in 37% (n=802) of ACHD patients in 2017. Among those treated with NOACs, apixaban was used in 44.1% of patients, compared to rivaroxaban in 38.5%, edoxaban in 10.5% and dabigatran in 6.9%. With regard to heart disease complexity, oral anticoagulation was used in 21% ACHD with simple defects (1,065 of 5,080 patients), 19% of ACHD with moderate complexity disease (430 of 2,296), and 30% in complex ACHD patients (644 of 2,138). NOACs were applied to 6.2% of simple ACHD patients, 7.7% of ACHD patients with moderate complexity disease and 14.6% of complex ACHD patients. In 2017, 22.5% of ACHD (2,139) were anticoagulated. Thereof, Vit K ant. were used in 62.5%, apixaban in 16.5% and rivaroxaban in 14.4% (see figure). 2017: Use of oral anticoagulants in ACHD Conclusion Over 20% of ACHD patients require anticoagulation in the current era. Interestingly, despite the lack of prospective studies increasingly NOACs are replacing vitamin K antagonists in the ACHD population. In 2017 NOACs accounted for 37% of all anticoagulated patients in our study. The use of NOACs was not restricted to simple lesions but up to 30% of complex ACHD patients received NOACs in the current era.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Stephanie Jou ◽  
Isaac L Goldenthal ◽  
Angelo B Biviano ◽  
Elaine Wan ◽  
Amardeep S Saluja ◽  
...  

Introduction: Both typical cavo-tricuspid isthmus (CTI) dependent (or its equivalent) and atypical atrial flutter (AFL) are common in adults with congenital heart disease (CHD) either due to its inherent cardiac anatomy or as a result of prior surgical procedures. Radiofrequency catheter ablation is routinely used as a therapeutic option. Hypothesis: Patients with CHD will have an improvement in systemic ventricular ejection fraction and a decreased incidence of atrial arrhythmias after ablation. Methods: A retrospective study was conducted on 99 patients with CHD who underwent ablation for clinical AFL at a single institution between 2010 and 2019. Of these patients, 62 had CTI-AFL. The 2 patients with unspecified CHD were excluded. CHD was divided into 3 categories according to the American College of Cardiology Task Force 1 of the 32nd Bethesda Conference - simple, moderate severity, and great complexity lesions. Outcomes of ablation at 1 year follow up were assessed. Results: Typical counterclockwise CTI-AFL was seen in 50 patients. The mean age was 49.1±13.6 years old with 29 (48.3%) females. Of the 60 patients, 35% (n=21) had simple lesions, 51.7% (n=31) had moderate lesions, and 13.3% (n=8) had great complexity lesions. The mean left or systemic ventricular ejection fraction (EF) significantly improved on follow-up echo among patients with simple CHD (49.1±13.1 to 56.5±4.7%, p=0.018) and moderate CHD (49.5±14.9 to 54±8.5%, p=0.02), but did not change among patients with great complexity CHD (52.5±6 to 52.5±9.25%, p=0.9). There was a significantly increased incidence of atrial fibrillation (9.5% vs. 16.1% vs. 50%, p=0.04) post ablation among simple, moderate, and great complexity lesions, respectively, but no significant difference in the recurrence rate of atrial flutter (p=0.3). Conclusions: Patients who underwent CTI-AFL ablation showed an improvement in EF in patients with simple and moderate CHD. There was also a significantly increased incidence in the development of atrial fibrillation post ablation in CHD with great complexity compared to simple or moderate CHD.


2021 ◽  
pp. ASN.2020111566
Author(s):  
An S. De Vriese ◽  
Rogier Caluwé ◽  
Hans Van Der Meersch ◽  
Koen De Boeck ◽  
Dirk De Bacquer

BackgroundIn patients with normal renal function or early stage CKD, the risk-benefit profile of direct oral anticoagulants (DOACs) is superior to that of vitamin K antagonists (VKAs). In patients on hemodialysis, the comparative efficacy and safety of DOACs versus VKAs are unknown.MethodsIn the Valkyrie study, 132 patients on hemodialysis with atrial fibrillation were randomized to a VKA with a target INR of 2–3, 10 mg rivaroxaban daily, or rivaroxaban and vitamin K2 for 18 months. Patients continued the originally assigned treatment and follow-up was extended for at least an additional 18 months. The primary efficacy end point was a composite of fatal and nonfatal cardiovascular events. Secondary efficacy end points were individual components of the composite outcome and all-cause death. Safety end points were life-threatening, major, and minor bleeding.ResultsMedian (IQR) follow-up was 1.88 (1.01–3.38) years. Premature, permanent discontinuation of anticoagulation occurred in 25% of patients. The primary end point occurred at a rate of 63.8 per 100 person-years in the VKA group, 26.2 per 100 person-years in the rivaroxaban group, and 21.4 per 100 person-years in the rivaroxaban and vitamin K2 group. The estimated competing risk–adjusted hazard ratio for the primary end point was 0.41 (95% CI, 0.25 to 0.68; P=0.0006) in the rivaroxaban group and 0.34 (95% CI, 0.19 to 0.61; P=0.0003) in the rivaroxaban and vitamin K2 group, compared with the VKA group. Death from any cause, cardiac death, and risk of stroke were not different between the treatment arms, but symptomatic limb ischemia occurred significantly less frequently with rivaroxaban than with VKA. After adjustment for competing risk of death, the hazard ratio for life-threatening and major bleeding compared with the VKA group was 0.39 (95% CI, 0.17 to 0.90; P=0.03) in the rivaroxaban group, 0.48 (95% CI, 0.22 to 1.08; P=0.08) in the rivaroxaban and vitamin K2 group and 0.44 (95% CI, 0.23 to 0.85; P=0.02) in the pooled rivaroxaban groups.ConclusionsIn patients on hemodialysis with atrial fibrillation, a reduced dose of rivaroxaban significantly decreased the composite outcome of fatal and nonfatal cardiovascular events and major bleeding complications compared with VKA.Clinical Trial registry name and registration number:Oral Anticoagulation in Hemodialysis, NCT03799822


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