Use of apixaban in adults with congenital heart disease and atrial arrhythmias: The PROTECT-AR study.

BACKGROUND: Adults with congenital heart disease (ACHD) and atrial arrhythmias (AA) face an increased risk of thromboembolic events. Limited data exist on the use of non-vitamin K oral anticoagulants for thromboprophylaxis in ACHD. We aimed to assess the effectiveness and safety of apixaban in ACHD patients with AA. METHODS: PROTECT-AR (NCT03854149) was a prospective, multicenter, observational study conducted from 2019 to 2023. ACHD patients with atrial fibrillation, atrial flutter, or intra-atrial re-entrant tachycardia on routine apixaban treatment were included. The historical control group consisted of patients previously on vitamin K antagonist (VKA), who were analyzed prior to their transition to apixaban. The primary effectiveness endpoint was the composite of stroke or thromboembolism. The primary safety endpoint was major bleeding. RESULTS: The study enrolled 218 ACHD patients with AA on apixaban, of which 73 were previous VKA users. The analysis covered 527 patient-years of prospective exposure to apixaban and 169 patient-years of retrospective exposure to VKA. The annualized rate of stroke or thromboembolism was 0.6% in the apixaban group and 1.8% in the VKA group (absolute difference - 1.2%; upper limit of one-sided 95% confidence interval [CI] 0.9%, lower than the predefined non-inferiority margin of +1.8%, Pnon-inferiority < 0.001). The annualized rate of major bleeding was 1.5% in the apixaban group and 2.4% in the VKA group (hazard ratio 0.64; 95% CI 0.19-2.10, P = 0.48). CONCLUSION: In ACHD patients with AA, routine apixaban use exhibited a non-inferior rate of stroke or thromboembolism compared to historical VKA use, alongside a similar rate of major bleeding.

Descending aorta to right atrial fistula: Transcatheter embolization of a very rare anomaly with coils.

Key Clinical Message: Descending aorta to right atrial (RA) fistula is a rare and distinct clinical entity mimicking patent ductus arteriosus (PDA) and it may lead to rapid development of pulmonary vascular disease. Correct diagnosis and treatment, especially in the presence of other congenital heart defects, is very important. Interventional management is the treatment of choice. Abstract: We present a case report of a trisomy 21 infant with atrial and ventricular septal defects and small patent ductus arteriosus (PDA) complicated by the presence of descending aorta to right atrial (RA) fistula with large left to right shunt leading to rapid increase in pulmonary vascular resistance. Transcatheter occlusion of the fistula followed by closure of the PDA with Nit-Occlud coil systems led to decreased pulmonary pressure and resistance permitting successful surgical repair of the patient's intracardiac defects with good outcome over 3 years of follow-up. Descending aorta to RA fistula is a rare and distinct clinical entity mimicking PDA and its correct diagnosis and treatment, especially in the presence of other congenital heart defects, is very important as it may lead to rapid development of pulmonary vascular disease.

Abnormal origin of right pulmonary artery from the ascending aorta in an infant ("Hemitruncus").

Key Clinical Message: Anomalous origin of right pulmonary artery from the ascending aorta is a rare congenital malformation and it needs surgical management. Consequences of this condition affect lead to pulmonary hypertension and severe pulmonary vascular disease. Abstract: Anomalous origin of right pulmonary artery from the ascending aorta is a rare congenital heart malformation that results in early infant mortality affecting the right pulmonary artery more than the left. These patients are at risk for the early development of significant pulmonary hypertension. The surgical management during the early period of life is imperative.

Association of Health Status Metrics with Clinical Outcomes in Patients with Adult Congenital Heart Disease and Atrial Arrhythmias.

The prognostic value of health status metrics in patients with adult congenital heart disease (ACHD) and atrial arrhythmias is unclear. In this retrospective cohort study of an ongoing national, multicenter registry (PROTECT-AR, NCT03854149), ACHD patients with atrial arrhythmias on apixaban are included. At baseline, health metrics were assessed using the physical component summary (PCS), the mental component summary (MCS) of the Short-Form-36 (SF-36) Health Survey, and the modified European Heart Rhythm Association (mEHRA) score. Patients were divided into groups according to their SF-36 PCS and MCS scores, using the normalized population mean of 50 on the PCS and MCS as a threshold. The primary outcome was the composite of mortality from any cause, major thromboembolic events, major/clinically relevant non-major bleedings, or hospitalizations. Multivariable Cox-regression analyses using clinically relevant parameters (age greater than 60 years, anatomic complexity, ejection fraction of the systemic ventricle, and CHA2DS2-VASc and HAS-BLED scores) were performed to examine the association of health metrics with the composite outcome. Over a median follow-up period of 20 months, the composite outcome occurred in 50 of 158 (32%) patients. The risk of the outcome was significantly higher in patients with SF-36 PCS ≤ 50 compared with those with PCS > 50 (adjusted hazard ratio (aHR), 1.98; 95% confidence interval [CI], 1.02−3.84; p = 0.04) after adjusting for possible confounders. The SF-36 MCS ≤ 50 was not associated with the outcome. The mEHRA score was incrementally associated with a higher risk of the composite outcome (aHR = 1.44 per 1 unit increase in score; 95% CI, 1.03−2.00; p = 0.03) in multivariable analysis. In ACHD patients with atrial arrhythmias, the SF-36 PCS ≤ 50 and mEHRA scores predicted an increased risk of adverse events.

Real-world implementation of guidelines for heart failure management: A systematic review and meta-analysis.

The real-world implementation of heart failure (HF) guidelines remains unclear. Our present systematic review and meta-analysis aimed to examine the rate of HF patients receiving guideline-directed treatment to identify the proportion of under-treatment patients and those who are treated with optimal doses, to evaluate the correlation of under-treatment patients' characteristics with the prescribed therapy, and finally, to evaluate the combined effect of the above on incidental mortality and rehospitalization. We conducted a systematic review of the literature indexed in Medline. We screened 1224 papers and excluded 1166 as they did not meet the inclusion criteria. Of the remaining 58 papers, which were evaluated by studying the full text, 11 papers that referred to 45866 patients were finally studied in this work. Angiotensin-Converting-Enzyme Inhibitor (ACEI) and Angiotensin II-Receptor Blocker (ARB) use was estimated to be 80.9% (95% CI: 73.9%, 86.4%), ß-blockers' use was 78% (95% CI: 70.4%, 84.1%), Mineralocorticoid Receptor Antagonists' use was 47.4% (95% Cl 41.6%, 53.4%), and cardiac resynchronization therapy's use was 5.8% (95% Cl 3.4%, 9.6%). Meta-regression analysis showed that prescription of more than the half of target dose of ACEI/ARBs was found to be associated with reduced all-cause mortality (Z = -3.61, P = 0.0003), while the relationship with ß-blockers was borderline (Z = -1.56, P = 0.11). A satisfactory adherence to the prescription of guideline-recommended treatment in patients with HF was observed. However, the under titration of the life-saving HF drugs need to be improved as only ultimate adherence to guideline-directed treatments may lead to the reduction of HF burden.

The Adult Congenital Heart Disease Anatomic and Physiological Classification: Associations with Clinical Outcomes in Patients with Atrial Arrhythmias.

The implications of the adult congenital heart disease anatomic and physiological classification (AP-ACHD) for risk assessment have not been adequately studied. A retrospective cohort study was conducted using data from an ongoing national, multicentre registry of patients with ACHD and atrial arrhythmias (AA) receiving apixaban (PROTECT-AR study, NCT03854149). At enrollment, patients were stratified according to Anatomic class (AnatC, range I to III) and physiological stage (PhyS, range B to D). A follow-up was conducted between May 2019 and September 2021. The primary outcome was a composite of death from any cause, any major thromboembolic event, major or clinically relevant non-major bleeding, or hospitalization. Cox proportional-hazards regression modeling was used to evaluate the risks for the outcome among AP-ACHD classes. Over a median 20-month follow-up period, 47 of 157 (29.9%) ACHD patients with AA experienced the composite outcome. Adjusted hazard ratios (aHR) with 95% confidence intervals (CI) for the outcome in PhyS C and PhyS D were 1.79 (95% CI 0.69 to 4.67) and 8.15 (95% CI 1.52 to 43.59), respectively, as compared with PhyS B. The corresponding aHRs in AnatC II and AnatC III were 1.12 (95% CI 0.37 to 3.41) and 1.06 (95% CI 0.24 to 4.63), respectively, as compared with AnatC I. In conclusion, the PhyS component of the AP-ACHD classification was an independent predictor of net adverse clinical events among ACHD patients with AA.

Heart failure and atrial fibrillation: new concepts in pathophysiology, management, and future directions.

A bidirectional pathophysiological link connects heart failure and atrial fibrillation, creating a frequent and challenging comorbidity, which includes neurohormonal hyperactivation, fibrosis development, and electrophysiologic remodeling, while they share mutual risk factors. Management for these devastating comorbidities includes most of the established treatment measures for heart failure as well as rhythm or rate control and anticoagulation mostly for atrial fibrillation, which can be achieved with either pharmaceutical or non-pharmaceutical approaches. The current manuscript aims to review the existing literature regarding the underlying pathophysiology, to present the novel trends of treatment, and to predict the future perspective of these two linked diseases with the numerous unanswered questions.

Anticoagulation for atrial fibrillation in heart failure patients: balancing between Scylla and Charybdis.

The management of heart failure (HF) and atrial fibrillation (AF) in real-world practice remains a debating issue, while the number of HF patients with AF increase dramatically. While it is unclear if rhythm or rate control therapy is more beneficial and under which circumstances, anticoagulation therapy is the cornerstone of the AF-HF patients' approach. Vitamin-K antagonists were the gold-standard during the past, but currently their usage is limited in specific conditions. Non-vitamin K oral anticoagulants (NOACs) have gained ground during the last ten years and considered as gold-standard of a wide spectrum of HF phenotypes. The current manuscript aims to review the current literature regarding the indications and the optimal choice and usage of NOACs in HF patients with AF.

Transradial access through the anatomical snuffbox: Results of a feasibility study.

BACKGROUND: Distal transradial access (dTRA), through the anatomical snuffbox (AS) of the hand, is a novel, potentially beneficial, vascular access for patients undergoing coronary procedures. METHOD: Consecutive patients with an indication for coronary angiography and/or percutaneous coronary intervention (PCI) were enrolled in our tertiary center, from November 2018 to March 2019. The success rate of the procedure, the incidence of local complications, the time required for hemostasis, and the incidence of radial artery occlusion (RAO) were evaluated. RESULTS: Α total of 167 patients were catheterized through the dTRA (79.6% men, 20.4% women), with a median age of 64 years. The indication for catheterization was ACS in 80 (47.9%) patients, stable coronary artery disease in 51 (30.5%) patients, and other reasons in 36 (21.6%) patients. Fifty patients (32.9%) underwent PCI. Successful sheath insertion was recorded in 152 (91.0%) patients. The mean time to hemostasis after sheath removal was 52 ± 11 min. Vascular access site complications were evaluated with ultrasound in 62 (40.8%) of the enrolled patients, 40 ± 15 days after the procedure. Among them, 2 (3.2%) patients presented with arteriovenous fistula, and 2 (3.2%) patients with local occlusion at the puncture site within the AS and distal to the transverse ligament, with preservation of the patency of the radial artery proximal to the radial styloid process. CONCLUSION: The dTRA may be a feasible and safe access site for diagnostic and interventional coronary procedures, with decreased incidence of RAO and time required for hemostasis compared to classical radial artery access.

Severe allergic reaction during angioplasty culminating to fatal acute stent thrombosis: An association with Kounis syndrome.

BACKGROUND: Kounis syndrome is a systemic complication following an allergic reaction, presenting with coronary artery spasm or thrombosis and occasionally with stent thrombosis that can have fatal outcome. OBJECTIVES: Heparins can induce allergic reactions via tissue antigenicity, heparin induced thrombocytopenia and contact system-activating effects of contaminants but allergy bivalirudin has not been reported so far. METHODS: Herein, we describe a patient with fatal acute coronary in-stent thrombosis following an allergic reaction soon after an intra-arterial heparin dose and intravenous administration of bivalirudin during angioplasty. RESULTS: The patient received intense myocardial infarction protocol treatment including angioplasty and defibillation together with antiallergic therapy but despite all of these efforts and measures, he succumbed 2 h later. CONCLUSIONS: Significant suspicion should be raised that life saving drugs such as heparin and bivalirudin could join forces with concurrent medication acting as antigens and induce fulminant and fatal stent thrombosis as a manifestation of Kounis syndrome.

Multicenter Randomized Evaluation of High Versus Standard Heparin Dose on Incident Radial Arterial Occlusion After Transradial Coronary Angiography: The SPIRIT OF ARTEMIS Study.

OBJECTIVES: The aim of this study was to test the hypothesis that more intensive over standard anticoagulation administered during coronary angiography would significantly reduce rates of radial artery occlusion (RAO). BACKGROUND: RAO, although silent, remains a frequent and therefore worrisome complication following transradial coronary angiography. Anticoagulation is effective in reducing RAO, but the optimal heparin dose remains ill defined. METHODS: In this multicenter, randomized superiority trial, a high dose (100 IU/kg body weight administered in divided doses) and a standard dose (50 IU/kg body weight) of heparin during 5- or 6-F coronary angiography were compared. A total of 3,102 patients were randomized, of whom 1,836 patients not proceeding to percutaneous coronary intervention and without need for arterial access crossover entered the trial. Post-catheterization hemostasis did not follow a rigid protocol. RESULTS: A total of 102 early RAOs were found on ultrasonography (incidence 5.6%). In the high-dose heparin group, the rate of RAO was significantly lower compared with the standard-dose heparin group (27 [3.0%] vs. 75 [8.1%]; odds ratio: 0.35; 95% confidence interval: 0.22 to 0.55; p < 0.001), without compromising safety. The time to achieve hemostasis was similar between groups. To avoid 1 RAO, the number of patients needed to treat in the high-dose heparin group was approximately 20. These results were corroborated by our integrated database, showing an 80% reduction of forearm artery occlusions in high versus low heparin dose patients and our updated meta-analysis of randomized controlled trials demonstrating significant benefit of higher over lower anticoagulation intensity. CONCLUSIONS: High compared with standard heparin dose significantly reduced the rate of RAO in patients undergoing coronary angiography. High-intensity anticoagulation should be considered in transradial diagnostic procedures. (High [100IU/Kg] Versus Standard [50IU/Kg] Heparin Dose for Prevention of Forearm Artery Occlusion; NCT02570243).

Effect of heart rate and pacing mode on QRS fragmentation.

BACKGROUND: The study was designed to investigate the effect of heart rate and pacing mode on QRS fragmentation (f-QRS). Moreover, the usefulness of f-QRS in distinguishing patients with impaired left ventricular ejection function (EF) and ventricular tachycardia (VT) from patients with normal EF was assessed. METHODS: Three hundred and six recipients, with dual-chamber device, with intrinsic narrow or wide QRS complex and preserved atrioventricular conduction were grouped into normal-EF or impaired-EF VT. We analyzed intrinsic narrow f-QRS and wide f-QRS as well as ventricular-paced f-QRS following different heart rates (baseline, 100 bpm) and pacing modes. RESULTS: In the baseline state, overall, patients with impaired-EF VT (35 ± 9%), compared to those with normal-EF, had more f-QRS (56% vs 27%, P < .001) and ventricular-paced f-QRS (62% vs 16%, P < .0001). Ventricular pacing conferred both at baseline and at higher heart rate more ventricular-paced f-QRS in patients with impaired-EF VT than in normal-EF (P < .001). Detection of ventricular-paced f-QRS markedly improved overall specificity (84%) and positive predictive value (91%) in identifying patients with impaired-EF VT. CONCLUSIONS: Increased heart rate or/and ventricular pacing uncover QRS fragmentations. Detection of ventricular-paced f-QRS adds value toward noninvasive identification of patients with impaired-EF VT.

Prevention of Radial Artery Occlusions Following Coronary Procedures: Forward and Backward Steps in Improving Radial Artery Patency Rates.

Radial artery (RA) occlusion (RAO) remains the Achilles heel of transradial coronary procedures. Although of silent nature, RAO is relatively frequent, results in graft shortage for future coronary artery bypass surgery, and may occur even after short-lasting, 5F coronary angiography (CAG). The most frequent predictors of RAO are RA size, body size, female gender, and periprocedural anticoagulation intensity. Methods to detect RAO are variable, of which the Barbeau test and ultrasonography have similar diagnostic accuracy. Data indicate that late RAO recanalization may occur. Meticulous handling of RA and the use of appropriate hemostatic devices and techniques along with sufficient heparin dose appear important measures to reduce RAO rates. Recent contradictory studies indicate that the decreasing incidence of RAO overtime is not as uniform as previously thought. In 2 meta-analyses, the benefit of higher over lower anticoagulation intensity became evident. As "it may all be appropriate anticoagulation" for a simplified approach against RAO, the results of an ongoing trial comparing 100 with 50 IU/kg body weight in transradial CAG are eagerly awaited.