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1.
Circulation ; 149(20): 1549-1564, 2024 May 14.
Article in English | MEDLINE | ID: mdl-38606558

ABSTRACT

BACKGROUND: Among patients with pulmonary arterial hypertension (PAH), acute vasoreactivity testing during right heart catheterization may identify acute vasoresponders, for whom treatment with high-dose calcium channel blockers (CCBs) is recommended. However, long-term outcomes in the current era remain largely unknown. We sought to evaluate the implications of acute vasoreactivity response for long-term response to CCBs and other outcomes. METHODS: Patients diagnosed with PAH between January 1999 and December 2018 at 15 pulmonary hypertension centers were included and analyzed retrospectively. In accordance with current guidelines, acute vasoreactivity response was defined by a decrease of mean pulmonary artery pressure by ≥10 mm Hg to reach <40 mm Hg, without a decrease in cardiac output. Long-term response to CCBs was defined as alive with unchanged initial CCB therapy with or without other initial PAH therapy and World Health Organization functional class I/II and/or low European Society of Cardiology/European Respiratory Society risk status at 12 months after initiation of CCBs. Patients were followed for up to 5 years; clinical measures, outcome, and subsequent treatment patterns were captured. RESULTS: Of 3702 patients undergoing right heart catheterization for PAH diagnosis, 2051 had idiopathic, heritable, or drug-induced PAH, of whom 1904 (92.8%) underwent acute vasoreactivity testing. A total of 162 patients fulfilled acute vasoreactivity response criteria and received an initial CCB alone (n=123) or in combination with another PAH therapy (n=39). The median follow-up time was 60.0 months (interquartile range, 30.8-60.0), during which overall survival was 86.7%. At 12 months, 53.2% remained on CCB monotherapy, 14.7% on initial CCB plus another initial PAH therapy, and the remaining patients had the CCB withdrawn and/or PAH therapy added. CCB long-term response was found in 54.3% of patients. Five-year survival was 98.5% in long-term responders versus 73.0% in nonresponders. In addition to established vasodilator responder criteria, pulmonary artery compliance at acute vasoreactivity testing, low risk status and NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels at early follow-up correlated with long-term response and predicted survival. CONCLUSIONS: Our data display heterogeneity within the group of vasoresponders, with a large subset failing to show a sustained satisfactory clinical response to CCBs. This highlights the necessity for comprehensive reassessment during early follow-up. The use of pulmonary artery compliance in addition to current measures may better identify those likely to have a good long-term response.


Subject(s)
Calcium Channel Blockers , Cardiac Catheterization , Pulmonary Arterial Hypertension , Humans , Female , Male , Middle Aged , Retrospective Studies , Pulmonary Arterial Hypertension/drug therapy , Pulmonary Arterial Hypertension/physiopathology , Pulmonary Arterial Hypertension/diagnosis , Pulmonary Arterial Hypertension/mortality , Treatment Outcome , Calcium Channel Blockers/therapeutic use , Pulmonary Artery/physiopathology , Pulmonary Artery/drug effects , Adult , Aged , Antihypertensive Agents/therapeutic use
2.
Eur Heart J ; 45(11): 876-894, 2024 Mar 14.
Article in English | MEDLINE | ID: mdl-38426859

ABSTRACT

Transcatheter tricuspid valve interventions (TTVI) are emerging as alternatives to surgery in high-risk patients with isolated or concomitant tricuspid regurgitation. The development of new minimally invasive solutions potentially more adapted to this largely undertreated population of patients, has fuelled the interest for the tricuspid valve. Growing evidence and new concepts have contributed to revise obsolete and misleading perceptions around the right side of the heart. New definitions, classifications, and a better understanding of the disease pathophysiology and phenotypes, as well as their associated patient journeys have profoundly and durably changed the landscape of tricuspid disease. A number of registries and a recent randomized controlled pivotal trial provide preliminary guidance for decision-making. TTVI seem to be very safe and effective in selected patients, although clinical benefits beyond improved quality of life remain to be demonstrated. Even if more efforts are needed, increased disease awareness is gaining momentum in the community and supports the establishment of dedicated expert valve centres. This review is summarizing the achievements in the field and provides perspectives for a less invasive management of a no-more-forgotten disease.


Subject(s)
Heart Valve Prosthesis Implantation , Tricuspid Valve Insufficiency , Humans , Tricuspid Valve/surgery , Heart Valve Prosthesis Implantation/adverse effects , Quality of Life , Cardiac Catheterization/adverse effects , Tricuspid Valve Insufficiency/etiology , Treatment Outcome
3.
Microvasc Res ; 153: 104659, 2024 05.
Article in English | MEDLINE | ID: mdl-38286222

ABSTRACT

INTRODUCTION: Contrast-associated acute kidney injury (CA-AKI) is characterized as a loss of renal function following radiological contrast media administration. While all contrast media induce variable changes in microvascular endothelial cells in vitro, only few studies report clinical significance of their findings. A comprehensive assessment of the effect of iodinated contrast media on the renal function in vitro and in vivo is essential. The aim of our study was to morphometrically quantify the effect of two different contrast media (Iobitridol and Iodixanol) on vascular endothelial capillaries in vitro and to analyze their effect on the renal function of patients who underwent cardiac catheterization including the intra-arterial administration of contrast media, by measuring serum creatinine concentration (SCr), a byproduct of muscle metabolism, primarily excreted by the kidneys. Our hypothesis suggests that conducting a qualitative comparison of both outcomes will enable identification of differences and similarities between in vitro and in vivo exposure. MATERIAL AND METHODS: In vitro, co-cultures of human dermal fibroblasts and human dermal microvascular endothelial cells forming capillary beds were exposed to a mixture of phosphate buffered saline and either Iobitridol, Iodixanol, or one of their supplements EDTA or Trometamol for 1.5 or 5 min. Negative control co-cultures were exposed exclusively to phosphate buffered saline. Co-cultures were either directly fixed or underwent a regeneration time of 1, 3 or 7 days. An artificial intelligence software was trained for detection of labeled endothelial capillaries (CD31) on light microscope images and measurements of morphometric parameters. In vivo, we retrospectively analyzed data from patients who underwent intra-arterial administration of contrast media and for whom SCr values were available pre- and post-contrast exposition (1, 3, and 7 days following procedure). Temporal development of SCr and incidence of CA-AKI were assessed. Both exposure types were qualitatively compared. RESULTS: In vitro, Iobitridol, Iodixanol and EDTA induced a strong decrease of two morphometric parameters after 3 days of regeneration. In vivo, a significant increase of SCr and incidence of CA-AKI was observed 3 days following procedure in the post-contrast media patients. No difference was observed between groups. DISCUSSION: Two of the morphometric parameters were inversely proportional to the SCr of the patients. If the endothelial damages observed in vitro occur in vivo, it may result in renal hypoxia, inducing a loss of kidney function clinically translated into an increase of SCr. Further development of our in vitro model could allow closer replication of the internal structure of a kidney and bridge the gap between in vitro studies and their clinical findings.


Subject(s)
Acute Kidney Injury , Contrast Media , Iohexol/analogs & derivatives , Triiodobenzoic Acids , Humans , Contrast Media/adverse effects , Creatinine , Retrospective Studies , Endothelial Cells , Artificial Intelligence , Edetic Acid , Cardiac Catheterization/adverse effects , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Phosphates
4.
Cardiol Young ; 33(2): 213-220, 2023 Feb.
Article in English | MEDLINE | ID: mdl-35285439

ABSTRACT

INTRODUCTION: This study evaluated the effect of music intervention on the anxiety and stress responses of patients who underwent an interventional cardiac catheterisation. METHODS: The study design was a pre- and post-test randomised controlled trial that included 94 patients who underwent a transcatheter atrial septal defect closure. Patients were allocated to receive either music intervention (n = 47) or usual care (n = 47) during the interventional cardiac catheterisation. Music intervention effectiveness was examined in terms of anxiety, salivary cortisol level, and heart rate variability. RESULTS: The average age of participants was 45.40 years (±16.04) in the experimental group and 47.26 years (±13.83) in the control group. Two-thirds (66.0%) of the participants in each group were women. State anxiety (F = 31.42, p < 0.001), anxiety-numerical rating scale (F = 20.08, p < 0.001), salivary cortisol levels (F = 4.98, p = 0.021), and low-frequency component/high-frequency component ratio (F = 17.31, p < 0.001) in the experimental group were significantly reduced compared with those in the control group at the end of the music intervention. CONCLUSION: This study provides practical evidence of a reduction in anxiety and stress response from music intervention preceding an interventional cardiac catheterisation, indicating that this intervention should be considered in clinical management.


Subject(s)
Music Therapy , Music , Humans , Adult , Female , Middle Aged , Male , Hydrocortisone , Anxiety/etiology , Anxiety/therapy , Cardiac Catheterization , Research Design
6.
J Pediatr Nurs ; 65: e56-e62, 2022.
Article in English | MEDLINE | ID: mdl-35279331

ABSTRACT

PURPOSE: This study aims to examine the effectiveness of music during pediatric cardiac catheterization procedure on children's pain, fear, anxiety and vital signs. DESIGN AND METHODS: This randomized, blind controlled study was conducted with the guidelines of Consolidated Standards of Reporting Trials (CONSORT). The sample of children was allocated to the Control Group, the Classic Music Group, and the Self-Selected Group. Pain, fear, and anxiety levels were measured before and after the pediatric cardiac catheterization procedure. Vital signs were measured before, during, and after the pediatric cardiac catheterization procedure. RESULTS: There was no significant difference between the groups in terms of demographic status, pain, fear, or anxiety levels and vital signs before the procedure. In post pediatric cardiac catheterization measurement in the recovery phase, pain, fear levels, anxiety levels, heart rate, systolic and diastolic blood pressure of children in the musical intervention groups were lower than the control group. No statistical difference was found in terms of pain, fear and anxiety levels of the children in groups Classic and Self-Selected. CONCLUSION AND PRACTICE IMPLICATIONS: The result of this research reveals that musical intervention applied during the pediatric cardiac catheterization procedure in children affects the reduction of pain, fear and anxiety levels and stabilization of vital signs. This intervention could be an effective nonpharmacological method to improve outcomes.Nurses can improve children's comfort by using musical interventions. CLINICAL REGISTRATION: This study was registered at the U.S. National Library of Medicine Clinical Trials (code: NCT04316754).


Subject(s)
Music Therapy , Music , Anxiety/prevention & control , Cardiac Catheterization , Child , Fear , Humans , Music Therapy/methods , Pain , Vital Signs
7.
Eur Heart J ; 43(28): 2660-2671, 2022 07 21.
Article in English | MEDLINE | ID: mdl-34535989

ABSTRACT

Atrial septal defects (ASDs) represent the most common congenital heart defect diagnosed in adulthood. Although considered a simple defect, challenges in optimal diagnostic and treatment options still exist due to great heterogeneity in terms of anatomy and time-related complications primarily arrhythmias, thromboembolism, right heart failure and, in a subset of patients, pulmonary arterial hypertension (PAH). Atrial septal defects call for tertiary expertise where all options may be considered, namely catheter vs. surgical closure, consideration of pre-closure ablation for patients with atrial tachycardia and suitability for closure or/and targeted therapy for patients with PAH. This review serves to update the clinician on the latest evidence, the nuances of optimal diagnostics, treatment options, and long-term follow-up care for patients with an ASD.


Subject(s)
Heart Septal Defects, Atrial , Pulmonary Arterial Hypertension , Adult , Arrhythmias, Cardiac/complications , Cardiac Catheterization , Heart Septal Defects, Atrial/complications , Heart Septal Defects, Atrial/diagnosis , Heart Septal Defects, Atrial/surgery , Humans , Treatment Outcome
8.
BMC Cardiovasc Disord ; 21(1): 561, 2021 11 22.
Article in English | MEDLINE | ID: mdl-34809565

ABSTRACT

BACKGROUND: Constrictive pericarditis (CP) is characterized by scarring and loss of elasticity of the pericardium. This case demonstrates that mixed martial arts (MMA) is a previously unrecognized risk factor for CP, diagnosis of which is supported by cardiac imaging, right and left heart catheterization, and histological findings of dense fibrous tissue without chronic inflammation. CASE PRESENTATION: A 47-year-old Caucasian male former mixed martial arts (MMA) fighter from the Western United States presented to liver clinic for elevated liver injury tests (LIT) and a 35-pound weight loss with associated diarrhea, lower extremity edema, dyspnea on exertion, and worsening fatigue over a period of 6 months. Past medical history includes concussion, right bundle branch block, migraine headache, hypertension, chronic pain related to musculoskeletal injuries and fractures secondary to MMA competition. Involvement in MMA was extensive with an 8-year history of professional MMA competition and 13-year history of MMA fighting with recurrent trauma to the chest wall. The patient also reported a 20-year history of performance enhancing drugs including testosterone. Physical exam was notable for elevated jugular venous pressure, hepatomegaly, and trace peripheral edema. An extensive workup was performed including laboratory studies, abdominal computerized tomography, liver biopsy, echocardiogram, and cardiac magnetic resonance imaging. Finally, right and left heart catheterization-the gold standard-confirmed discordance of the right ventricle-left ventricle, consistent with constrictive physiology. Pericardiectomy was performed with histologic evidence of chronic pericarditis. The patient's hospital course was uncomplicated and he returned to NYHA functional class I. CONCLUSIONS: CP can be a sequela of recurrent pericarditis or hemorrhagic effusions and may have a delayed presentation. In cases of recurrent trauma, CP may be managed with pericardiectomy with apparent good outcome. Further studies are warranted to analyze the occurrence of CP in MMA so as to better define the risk in such adults.


Subject(s)
Heart Injuries/etiology , Martial Arts/injuries , Pericarditis, Constrictive/etiology , Cardiac Catheterization , Electrocardiography , Heart Injuries/diagnostic imaging , Heart Injuries/physiopathology , Heart Injuries/surgery , Hemodynamics , Humans , Magnetic Resonance Imaging, Cine , Male , Middle Aged , Pericardiectomy , Pericarditis, Constrictive/diagnostic imaging , Pericarditis, Constrictive/physiopathology , Pericarditis, Constrictive/surgery , Recovery of Function , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , Ventricular Function, Left , Ventricular Function, Right
9.
Card Electrophysiol Clin ; 13(2): 293-301, 2021 06.
Article in English | MEDLINE | ID: mdl-33990268

ABSTRACT

"Intracardiac echocardiography (ICE) has evolved into an indispensable tool in the armamentarium of cardiac electrophysiologists not only for understanding the internal cardiac anatomy but also for establishing transseptal access and for monitoring electrophysiology procedures. ICE aids in live monitoring of every step of the procedure including early detection of complications. Access to the left atrium through transseptal catheterization is a vital step to perform atrial fibrillation and accessory pathway ablations, ablation of left ventricular tachycardias, left atrial appendage closures, left ventricular endocardial electrode implantations for cardiac resynchronization therapies, and for selectively sampling the regions of interest during endomyocardial biopsies."


Subject(s)
Cardiac Catheterization/methods , Echocardiography , Electrophysiologic Techniques, Cardiac/methods , Heart Septum , Arrhythmias, Cardiac/surgery , Catheter Ablation , Heart Septum/diagnostic imaging , Heart Septum/surgery , Humans
11.
J Healthc Eng ; 2021: 6692952, 2021.
Article in English | MEDLINE | ID: mdl-33815732

ABSTRACT

Background: The use of electronic health (e-health) resources is emerging as an alternative method to improve the secondary prevention of coronary artery disease (CAD). The aim of this study was to describe the influence of an e-health application in holistic healthcare for patients with CAD. Methods: A quasiexperiment with nonequivalent groups design recruited outpatients with a high risk of CAD admitted for cardiac catheterization. They were divided into two groups. Before the procedure, the control group received traditional patient education, and the intervention group watched videos on Internet-based social media. EQ-5D and FACIT-Sp-12 questionnaires were used as outcome measures of interest, and they were administered before and after the procedure and at the first return visit to the outpatient clinic after discharge. The effect of each intervention was tested using a linear mixed effects model. In addition, the 90-day readmission rate was also studied. Results: A total of 300 patients were divided into intervention and control groups (150 patients in each group). The interaction effect of EQ-5D was not statistically significant; however, improvements in FACIT-Sp-12 were greater in the intervention group from baseline to before discharge (regression coefficient (B) = 1.70, p < 0.001) and from baseline to postdischarge first outpatient visit (B = 1.81, p < 0.001). Moreover, the 90-day readmission rate was significantly lower in the intervention group (14% vs. 18.7%; p=0.016, log-rank test). Conclusions: e-health intervention with easily accessible Internet-based social media is a promising model to meet the holistic needs of patients with CAD in the modern era.


Subject(s)
Aftercare , Telemedicine , Cardiac Catheterization , Delivery of Health Care , Humans , Patient Discharge , Taiwan
12.
Saudi J Kidney Dis Transpl ; 32(5): 1465-1469, 2021.
Article in English | MEDLINE | ID: mdl-35532719

ABSTRACT

A 55-year-old male patient undergoing hemodialysis (HD) had shortness of breath, New York Heart Association (NYHA) class IIm (moderate limitation of physical activity) due to chronic heart failure. His past medical history was remarkable for chronic heart diseases and severe functional mitral regurgitation (MR), with an ejection fraction of only 33%. The cardiologist considered this severe MR as the cause of his symptom. Due to the multiple comorbidities and low cardiac function, transcatheter mitral valve repair (TMVR) using a MitraClip was selected as an alternative to surgery. TMVR with MitraClip was successfully performed. Postoperatively, the degree of MR decreased from severe to trivial, with an obvious improvement in symptoms to NYHA class I. He was discharged without any postoperative complications. TMVR with MitraClip is an effective nonsurgical treatment for mitral valve disease in HD patients with multiple comorbidities.


Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Cardiac Catheterization/adverse effects , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Middle Aged , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/surgery , Renal Dialysis , Stroke Volume , Treatment Outcome
13.
Eur Heart J Cardiovasc Imaging ; 22(2): 236-245, 2021 01 22.
Article in English | MEDLINE | ID: mdl-31998956

ABSTRACT

AIMS: Pulmonary arterial hypertension (PAH) is a progressive condition with high mortality. Quantitative cardiovascular magnetic resonance (CMR) imaging metrics in PAH target individual cardiac structures and have diagnostic and prognostic utility but are challenging to acquire. The primary aim of this study was to develop and test a tensor-based machine learning approach to holistically identify diagnostic features in PAH using CMR, and secondarily, visualize and interpret key discriminative features associated with PAH. METHODS AND RESULTS: Consecutive treatment naive patients with PAH or no evidence of pulmonary hypertension (PH), undergoing CMR and right heart catheterization within 48 h, were identified from the ASPIRE registry. A tensor-based machine learning approach, multilinear subspace learning, was developed and the diagnostic accuracy of this approach was compared with standard CMR measurements. Two hundred and twenty patients were identified: 150 with PAH and 70 with no PH. The diagnostic accuracy of the approach was high as assessed by area under the curve at receiver operating characteristic analysis (P < 0.001): 0.92 for PAH, slightly higher than standard CMR metrics. Moreover, establishing the diagnosis using the approach was less time-consuming, being achieved within 10 s. Learnt features were visualized in feature maps with correspondence to cardiac phases, confirming known and also identifying potentially new diagnostic features in PAH. CONCLUSION: A tensor-based machine learning approach has been developed and applied to CMR. High diagnostic accuracy has been shown for PAH diagnosis and new learnt features were visualized with diagnostic potential.


Subject(s)
Hypertension, Pulmonary , Pulmonary Arterial Hypertension , Cardiac Catheterization , Familial Primary Pulmonary Hypertension , Humans , Hypertension, Pulmonary/diagnostic imaging , Machine Learning , Magnetic Resonance Spectroscopy
14.
Pediatr Cardiol ; 42(2): 289-293, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33048185

ABSTRACT

The objective of this study was to evaluate the safety and efficacy of combining transcatheter pulmonary valve replacement (TPVR) and electrophysiology (EP) procedures. A retrospective review was undertaken to identify TPVR and EP procedures that were concomitantly performed in the cardiac catheterization laboratory at University of Iowa Stead Family Children's Hospital from January 2011 to October 2019. Procedural and follow-up data were compared between patients who underwent TPVR and EP procedures in the same setting to those who received TPVR or EP procedure separately and that were similar in age and cardiac anatomy. A total of 8 patients underwent combined TPVR and EP procedures. One patient was excluded due to lack of adequate control, leaving seven study subjects (57% female; median age at time of procedure 16 years). The median follow-up time was 11.5 months (range 2-36 months). Patients who received combined TPVR and EP had shorter recovery times (combined: median 18.9 h; IQR 18.35-19.5 vs separate: median 27.98 h; IQR 21.42-39.25; p-value 0.031), shorter hospital length of stay (combined: median 27.5 h; IQR 26.47-31.4 vs separate: median 38.4 h; IQR 33.42-51.50; p-value 0.016), and a 51% reduction in total hospital charges (combined: median $171,640; IQR 135.43-219.22 vs separate: median $333,560 IQR 263.20-400.98; p-value 0.016). There were no significant differences in radiation dose or procedure time between the combined and control groups. The median radiation time for those who had the combination procedure was 30.5 min [IQR 29.6-47.9], and the median dose area product was 215 mGy [IQR 158-935]. In conclusion, combining TPVR and EP procedures is feasible, safe, and economically advantageous.


Subject(s)
Cardiac Catheterization/methods , Electrophysiologic Techniques, Cardiac/methods , Heart Diseases/surgery , Heart Valve Prosthesis Implantation/methods , Pulmonary Valve/surgery , Adolescent , Adult , Cardiac Surgical Procedures , Child , Combined Modality Therapy , Electrophysiologic Techniques, Cardiac/economics , Female , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation/economics , Hospital Costs , Humans , Length of Stay , Male , Pulmonary Valve Insufficiency/surgery , Retrospective Studies , Tetralogy of Fallot/surgery , Treatment Outcome , Young Adult
17.
J Pediatr Endocrinol Metab ; 33(11): 1409-1415, 2020 Nov 26.
Article in English | MEDLINE | ID: mdl-33001853

ABSTRACT

Background The thyroid gland of patients with congenital heart disease may be exposed to large doses of iodine from various sources. We assessed the thyroid response after iodine exposure during conventional angiography in cardiac catheterization and angiographic computer tomography in childhood. Methods Retrospective mid- to long-term follow-up of 104 individuals (24% neonates, 51% infants, 25% children) with a median age and body weight of 104 days [0-8 years] and 5.3 kg [1.6-20]. Serum levels of thyroid-stimulating hormone, free triiodthyronine and free thyroxine were evaluated at baseline and after excess iodine. We also assessed risk factors that may affect thyroid dysfunction. Results Baseline thyroidal levels were within normal range in all patients. The mean cumulative iodinate contrast load was 6.6 ± 1.6 mL/kg. In fact, 75% had experienced more than one event involving iodine exposure, whose median frequency was three times per patient [1-12]. During the median three years follow-up period [0.5-10], the incidence of thyroid dysfunction was 15.4% (n=16). Those patients developed acquired hypothyroidism (transient n=14, long-lasting n=2 [both died]) with 10 of them requiring temporary replacement therapy for transient thyroid dysfunction, while four patients recovered spontaneously. 88 individuals (84.6%) remained euthyroid. Repeated cardiac interventions, use of drugs that interfere with the thyroid and treatment in the intensive care unit at the index date were strong predictors for acquired thyroid dysfunction. Conclusions The incidence of acquired hypothyroidism after iodine excess was 15.4%. However, most patients developed only transient hypothyroidism. Systemic iodine exposure seems to be clinically and metabolically well tolerated during long-term follow-up.


Subject(s)
Contrast Media/adverse effects , Heart Defects, Congenital/diagnosis , Heart Defects, Congenital/epidemiology , Iodine/adverse effects , Thyroid Diseases/epidemiology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/methods , Child , Child, Preschool , Computed Tomography Angiography/adverse effects , Computed Tomography Angiography/methods , Computed Tomography Angiography/statistics & numerical data , Female , Follow-Up Studies , Germany/epidemiology , Heart Defects, Congenital/physiopathology , Humans , Incidence , Infant , Infant, Newborn , Longitudinal Studies , Male , Retrospective Studies , Thyroid Diseases/chemically induced , Thyroid Gland/drug effects , Thyroid Gland/physiopathology , Time Factors
19.
Circ Cardiovasc Interv ; 13(7): e008481, 2020 07.
Article in English | MEDLINE | ID: mdl-32674675

ABSTRACT

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) exposes to the risk of device thrombosis in patients with atrial fibrillation who frequently have a contraindication to full anticoagulation. Thereby, dual antiplatelet therapy (DAPT) is usually preferred. No randomized study has evaluated nonvitamin K antagonist oral anticoagulant after LAAC, and we decided to evaluate the efficacy and safety of reduced doses of rivaroxaban after LAAC. METHODS: ADRIFT (Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure) is a multicenter, phase IIb study, which randomized 105 patients after successful LAAC to either rivaroxaban 10 mg (R10, n=37), rivaroxaban 15 mg (R15, n=35), or DAPT with aspirin 75 mg and clopidogrel 75 mg (n=33). The primary end point was thrombin generation (prothrombin fragments 1+2) measured 2 to 4 hours after drug intake, 10 days after treatment initiation. Thrombin-antithrombin complex, D-dimers, rivaroxaban concentrations were also measured at 10 days and 3 months. Clinical end points were evaluated at 3-month follow-up. RESULTS: The primary end point was reduced with R10 (179 pmol/L [interquartile range (IQR), 129-273], P<0.0001) and R15 (163 pmol/L [IQR, 112-231], P<0.0001) as compared with DAPT (322 pmol/L [IQR, 218-528]). We observed no significant reduction of the primary end point between R10 and R15 while rivaroxaban concentrations increased significantly from 184 ng/mL (IQR, 127-290) with R10 to 274 ng/mL (IQR, 192-377) with R15, P<0.0001. Thrombin-antithrombin complex and D-dimers were numerically lower with both rivaroxaban doses than with DAPT. These findings were all confirmed at 3 months. The clinical end points were not different between groups. A device thrombosis was noted in 2 patients assigned to DAPT. CONCLUSIONS: Thrombin generation measured after LAAC was lower in patients treated by reduced rivaroxaban doses than DAPT, supporting an alternative to the antithrombotic regimens currently used after LAAC and deserves further evaluation in larger studies. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03273322.


Subject(s)
Atrial Appendage/physiopathology , Atrial Fibrillation/therapy , Atrial Function, Left , Cardiac Catheterization , Dual Anti-Platelet Therapy , Factor Xa Inhibitors/administration & dosage , Fibrinolytic Agents/administration & dosage , Platelet Aggregation Inhibitors/administration & dosage , Rivaroxaban/administration & dosage , Thrombosis/prevention & control , Aged , Aged, 80 and over , Antithrombin III , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Biomarkers/blood , Blood Coagulation/drug effects , Cardiac Catheterization/adverse effects , Dual Anti-Platelet Therapy/adverse effects , Factor Xa Inhibitors/adverse effects , Female , Fibrin Fibrinogen Degradation Products/metabolism , Fibrinolytic Agents/adverse effects , France , Heart Rate , Humans , Male , Peptide Fragments/blood , Peptide Hydrolases/blood , Pilot Projects , Platelet Aggregation Inhibitors/adverse effects , Prothrombin , Rivaroxaban/adverse effects , Thrombosis/blood , Thrombosis/diagnosis , Thrombosis/etiology , Time Factors , Treatment Outcome
20.
J Cardiovasc Pharmacol Ther ; 25(6): 556-563, 2020 11.
Article in English | MEDLINE | ID: mdl-32578435

ABSTRACT

OBJECTIVE: Although prevention of radial artery thrombosis and cardiac complications after interventions using radial access is well investigated, there is yet no clinical study that completely evaluated access-related complications. However, there is still no consensus on what exact treatment should be used in these patients. In clinical practice, analgesic, anticoagulant, and antiplatelet treatments usually improve symptoms in patients with pain; however, in some patients, complaints may persist and may not respond to these treatments. In these patients, low-risk embolectomy with a small skin incision may be beneficial. METHODS: A total of 102 patients with radial artery thrombosis after cardiac catheterization were included in the study between 2016 March and 2018 December. After the patients' initial evaluation, anticoagulation with enoxaparin or tinzaparin and antiplatelet therapy with acetylsalicylic acid and oral/local analgesic/anti-inflammatory and local anesthetic therapy were administered for 1 month. Patients whose symptoms resolved after medical treatment were followed up as outpatients. Embolectomy was performed in consenting patients who did not respond to the medical treatment. RESULTS: Of 102 patients included in the study, 33 underwent embolectomy, whereas 69 received only medical treatment. None of the patients experienced any complications, morbidity, or mortality in the peroperative period and during the medical treatment. The pretreatment symptom scores of patients who actively use their hands in daily life and profession were significantly higher than the scores of patients who are relatively less active (P = .013). Pretreatment symptom scores were negatively correlated with age (r = -0.584); symptom scores increased significantly with the decrease of patient age. No benefit from medical treatment and need for surgery was significantly greater in patients who are younger and use their hands actively in daily life and profession (P = .028). The decrease in symptom scores after treatment was significantly greater in the surgical group than in the medical group (P = .003). CONCLUSION: Radial access should be exercised with care in patients who may develop significant thrombosis-related complaints and it is necessary to decide whether radial access is essential. If patients have ongoing symptoms despite medical treatment, embolectomy can be considered as a treatment option.


Subject(s)
Anesthesia, Local , Anticoagulants/therapeutic use , Arterial Occlusive Diseases/therapy , Cardiac Catheterization , Catheterization, Peripheral/adverse effects , Embolectomy , Radial Artery/surgery , Thrombosis/therapy , Aged , Anesthesia, Local/adverse effects , Anticoagulants/adverse effects , Arterial Occlusive Diseases/etiology , Embolectomy/adverse effects , Female , Humans , Male , Middle Aged , Prospective Studies , Thrombosis/etiology , Treatment Failure , Turkey
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