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1.
J Thromb Thrombolysis ; 55(1): 141-148, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36326967

ABSTRACT

A lack in patient knowledge of warfarin therapy is associated with poor adherence. This knowledge gap may result in a lower INR Time in Therapeutic Range (TTR). To investigate association between patient anticoagulation knowledge and warfarin control. Michigan Anticoagulation Quality Improvement Initiative (MAQI2) is a Blue Cross Blue Shield of Michigan sponsored consortium of six anticoagulation management services. Patients prescribed warfarin at two MAQI2 sites completed a voluntary Oral Anticoagulation Knowledge (OAK) questionnaire at warfarin initiation and 6-month follow-up. The results of 20 OAK questions and TTRs (excluding 1st month post-initiation) were compared using chi-square tests, t-tests and multivariate analysis adjusting for SAMe-TT2R2 and days on warfarin. Of 1836 surveys distributed at warfarin initiation, 481 (26.2%) patients completed the baseline questionnaire (within 1 month post-initiation): mean OAK score: 14.6 ± 3.4. Of those, 147 (30.6%) completed 6-month follow-up surveys (OAK: 12.7 ± 5.8). Patients with TTR ≥ 70% at baseline scored higher on OAK tests than patients with TTR < 70% in unadjusted analyses (15.1 ± 3.2 v. 14.2 ± 3.5, p = 0.003) and adjusted analysis (p = 0.020). There was no unadjusted or adjusted difference in OAK scores at 6-month follow-up between patients with TTR ≥ 70% and TTR < 70%. For patients who completed baseline and follow-up surveys, there was a decrease of 2.4 points in OAK score between baseline and 6-month follow up (p < 0.001). Higher baseline, but not follow-up, OAK score is associated with better warfarin control and average OAK scores decreased between baseline and follow-up. Further studies are needed to determine what type of patient education may improve patient knowledge retention and warfarin control.


Subject(s)
Atrial Fibrillation , Warfarin , Humans , Warfarin/therapeutic use , Warfarin/pharmacology , Atrial Fibrillation/drug therapy , Anticoagulants/therapeutic use , Anticoagulants/pharmacology , Blood Coagulation , Time Factors , International Normalized Ratio
2.
J Thromb Thrombolysis ; 46(3): 316-324, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29948756

ABSTRACT

Randomized controlled trials (RCTs) examining warfarin use for stroke prevention in atrial fibrillation (AF) may not accurately reflect real-world populations. We aimed to determine the representativeness of the RCT populations to real-world patients and to describe differences in the characteristics of trial populations from trial eligible patients in a real-world setting. We hypothesized that a significant fraction of real-world patients would not qualify for the RE-LY, ROCKET-AF, and ARISTOTLE trials and that real-world patients qualifying for the studies may have more strokes and bleeding events. We compared the inclusion and exclusion criteria, patient characteristics, and clinical outcomes from RE-LY, ROCKET-AF, and ARISTOTLE against data from the Michigan Anticoagulation Quality Improvement Initiative (MAQI2), a regional network of six community- and academic-based anticoagulation clinics. Of the 1446 non-valvular AF patients in the MAQI2 registry taking warfarin, approximately 40-60% would meet the selection criteria used in RE-LY (788, 54.5%), ROCKET-AF (566, 39.1%), and ARISTOTLE (866, 59.9%). The most common reasons for exclusion from one or more trial were anemia (15.1%), other concurrent medications (11.2%), and chronic kidney disease (9.4%). Trial-eligible MAQI2 patients were older, more frequently female, with a higher rate of paroxysmal AF, and lower rates of congestive heart failure, previous stroke, and previous myocardial infarction than the trial populations. MAQI2 patients eligible for each trial had a lower rate of stroke and similar rate of major bleeding than was observed in the trials. A sizable proportion of real-world AF patients managed in anticoagulation clinics would not have been eligible for the RE-LY, ROCKET-AF, and ARISOTLE trials. The expected stroke risk reduction and bleeding risk among real-world AF patients on warfarin may not be congruent with published clinical trial data.


Subject(s)
Atrial Fibrillation/drug therapy , Thromboembolism/prevention & control , Warfarin/therapeutic use , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Female , Humans , Male , Michigan , Patient Selection , Quality Improvement , Randomized Controlled Trials as Topic , Registries , Treatment Outcome
3.
J Thromb Thrombolysis ; 46(1): 7-11, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29605836

ABSTRACT

Many anticoagulation clinics have adapted their services to provide care for patients taking direct oral anticoagulants (DOAC) in addition to traditional warfarin management. Anticoagulation clinic scope of service and operations in this transitional environment have not been well described in the literature. A survey was conducted of United States-based Anticoagulation Forum members to inquire about anticoagulation clinic structure, function, and services provided. Survey responses are reported using summary or non-parametric statistics, when appropriate. Unique clinic survey responses were received from 159 anticoagulation clinics. Clinic structure and staffing are highly variable, with approximately half of clinics (52%) providing DOAC-focused care in addition to traditional warfarin-focused care. Of those clinics managing DOAC patients, this accounts for only 10% of their clinic volume. These clinics commonly have a DOAC follow up protocol (75%). Clinics assign a median of 190.5 (interquartile range 50-300) patients per staff full-time-equivalent, with more patients assigned in phone-based care clinics than in face-to-face based care clinics. Most clinics (68.5%) report receiving reimbursement, which occur either through a combination of patient and insurance provider billing (78.2%), insurance reimbursement only (19.5%) or patient reimbursement only (2.3%). There is wide heterogeneity in anticoagulation clinic structure, function, and services provided. Half of all survey-responding anticoagulation clinics provide care for DOAC-treated patients. Understanding how changes in healthcare policy and reimbursement have impacted these clinics remains to be explored.


Subject(s)
Ambulatory Care Facilities/organization & administration , Anticoagulants/therapeutic use , Administration, Oral , Ambulatory Care Facilities/economics , Anticoagulants/administration & dosage , Humans , Reimbursement Mechanisms/statistics & numerical data , Surveys and Questionnaires , United States , Warfarin/therapeutic use
4.
J Thromb Thrombolysis ; 43(2): 283-288, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27837309

ABSTRACT

Direct oral anticoagulant (DOAC) agents offer several lifestyle and therapeutic advantages for patients relative to warfarin in the treatment of atrial fibrillation (AF). These alternative agents are increasingly used in the treatment of AF, however the adoption practices, patient profiles, and reasons for switching to a DOAC from warfarin have not been well studied. Through the Michigan Anticoagulation Quality Improvement Initiative, abstracted data from 3873 AF patients, enrolled between 2010 and 2015, were collected on demographics and comorbid conditions, stroke and bleeding risk scores, and reasons for anticoagulant switching. Over the study period, patients who switched from warfarin to a DOAC had similar baseline characteristics, risk scores, and insurance status but differed in baseline CrCl. The most common reasons for switching were patient related ease of use concerns (37.5%) as opposed to clinical reasons (16.5% of patients). Only 13% of patients that switched to a DOAC switched back to warfarin by the end of the study period.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Drug Substitution/trends , Warfarin/therapeutic use , Administration, Oral , Aged , Anticoagulants/administration & dosage , Drug Substitution/statistics & numerical data , Female , Humans , Insurance Coverage , Male , Risk Factors , Warfarin/administration & dosage
5.
Pediatr Nephrol ; 31(4): 641-50, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26525198

ABSTRACT

BACKGROUND: Fibromuscular dysplasia (FMD) is a non-inflammatory arteriopathy that causes significant morbidity in children. METHODS: The clinical features, presenting symptoms, and vascular beds involved are reviewed in the first 33 patients aged <18 years who are enrolled in the United States Registry for FMD from five registry sites and compared with 999 adult patients from 12 registry sites. RESULTS: Mean age at diagnosis was 8.4 ± 4.8 years (16 days to 17 years). Compared with adults, pediatric FMD occurs in more males (42.4 vs 6 %, p < 0.001). Children with FMD have a stronger previous history of hypertension (93.9 vs 69.9 %, p = 0.002). Hypertension (100 %), headache (55 %), and abdominal bruits (10.7 %) were the most common presenting signs and symptoms. FMD affects renal vasculature in almost all children (97 vs 69.7 %, p = 0.003). The extra-cranial carotid vessels are less commonly involved in children (23.1 vs 73.3 %, p < 0.001). The mesenteric arteries (38.9 vs 16.2 %, p = 0.02) and aorta (26.3 vs 2.4 %, p < 0.001) are more commonly involved in children. CONCLUSIONS: In the United States Registry for FMD, pediatric FMD affects children from infancy throughout childhood. All children presented with hypertension and many presented with headache and abdominal bruits. In children, FMD most commonly affects the renal vasculature, but also frequently involves the mesenteric arteries and abdominal aorta; the carotid vessels are less frequently involved.


Subject(s)
Aorta, Abdominal/diagnostic imaging , Carotid Arteries/diagnostic imaging , Fibromuscular Dysplasia/diagnostic imaging , Mesenteric Arteries/diagnostic imaging , Renal Artery/diagnostic imaging , Adolescent , Adult , Age of Onset , Aged , Aged, 80 and over , Child , Child, Preschool , Comorbidity , Computed Tomography Angiography , Female , Fibromuscular Dysplasia/epidemiology , Fibromuscular Dysplasia/therapy , Headache/epidemiology , Humans , Hypertension/epidemiology , Infant , Infant, Newborn , Magnetic Resonance Angiography , Male , Middle Aged , Predictive Value of Tests , Prognosis , Registries , Retrospective Studies , Risk Factors , Ultrasonography, Interventional , United States/epidemiology , Young Adult
6.
J Thromb Thrombolysis ; 42(4): 566-72, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27217043

ABSTRACT

All available direct oral anticoagulants (DOACs) are at least partially eliminated by the kidneys. These agents are increasingly being used as alternatives to warfarin for stroke prevention in patients with atrial fibrillation. The aim of this study was to identify changes in renal function and associated DOAC dosing implications in a multicenter cohort of atrial fibrillation patients switched from warfarin to DOAC treatment. We included all patients in the Michigan Anticoagulation Quality Improvement Initiative cohort who switched from warfarin to a DOAC with atrial fibrillation as their anticoagulant indication between 2009 and 2014, and who had at least two creatinine values. Compliance with FDA-recommended dosing based on renal function was assessed. Of the 189 patients switched from warfarin to a DOAC, 34 (18.0 %) had a baseline creatinine clearance <50 mL/min and 23 (12.2 %) experienced important fluctuations in renal function. Of these 23 patients, 6 (26.1 %) should have impacted the DOAC dosing, but only 1 patient actually received an appropriate dose adjustment. Additionally, 15 (7.9 %) of patients on DOACs had a dose change performed, but only one patient demonstrated a change in renal function to justify the dose adjustment. Most atrial fibrillation patients who switched from warfarin to a DOAC had stable renal function. However, the majority of patients who had a change in renal function did not receive the indicated dose change. As the use of DOACs expands, monitoring of renal function and appropriate dose adjustments are critical.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation , Drug Substitution , Kidney , Warfarin/administration & dosage , Administration, Oral , Aged , Aged, 80 and over , Atrial Fibrillation/blood , Atrial Fibrillation/drug therapy , Atrial Fibrillation/physiopathology , Creatinine/blood , Female , Humans , Kidney/metabolism , Kidney/physiopathology , Kidney Function Tests , Male , Middle Aged
8.
Vasc Med ; 20(5): 447-53, 2015 Oct.
Article in English | MEDLINE | ID: mdl-25964292

ABSTRACT

Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular artery FMD involvement in isolation (OR=2.31, p<0.0001) or a history of previous intervention for FMD (OR=1.52, p=0.036). A greater number of anti-HTN medications was evident in isolated renal versus isolated cerebrovascular FMD patients. Factors associated with a greater number of anti-HTN medications were older age (OR=1.03 per year, p<0.0001), history of HTN (OR=24.04, p<0.0001), history of CAD (OR=2.71, p=0.0008) and a history of a previous therapeutic procedure (OR=1.72, p=0.001). In conclusion, in FMD, medication use varies based on vascular bed involvement. Isolated renal FMD patients receive more anti-HTN agents and there is greater anti-platelet agent use among patients with cerebrovascular FMD. Further studies correlating medication use in FMD with clinically meaningful patient outcomes are necessary.


Subject(s)
Antihypertensive Agents/therapeutic use , Blood Platelets/drug effects , Fibromuscular Dysplasia/drug therapy , Platelet Aggregation Inhibitors/therapeutic use , Renal Artery Obstruction/drug therapy , Adult , Aged , Female , Fibromuscular Dysplasia/complications , Humans , Hypertension, Renovascular , Male , Middle Aged , Registries/statistics & numerical data , Renal Artery/drug effects , United States
9.
J Thromb Thrombolysis ; 40(4): 488-93, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26130229

ABSTRACT

It has been suggested that direct oral anticoagulants are being preferentially used in low risk atrial fibrillation (AF) patients. Understanding the changing risk profile of new AF patients treated with warfarin is important for interpreting the quality of warfarin delivery through an anticoagulation clinic. Six anticoagulation clinics participating in the Michigan Anticoagulation Quality Improvement Initiative enrolled 1293 AF patients between 2010 and 2014 as an inception cohort. Abstracted data included demographics, comorbidities, medication use and all INR values. Risk scores including CHADS2, CHA2DS2-VASc, HAS-BLED, SAMe-TT2R2, and Charlson comorbidity index (CCI) were calculated for each patient at the time of warfarin initiation. The quality of anticoagulation was assessed using the Rosendaal time in the therapeutic range (TTR) during the first 6 months of treatment. Between 2010 and 2014, patients initiating warfarin therapy for AF had an increasing mean CHADS2 (2.0 ± 1.1 to 2.2 ± 1.4, p = 0.02) and CCI (4.7 ± 1.8 to 5.1 ± 2.0, p = 0.03), and a trend towards increasing mean CHA2DS2-VASc, HAS-BLED, and SAMe-TT2R2 scores. The actual TTR remained unchanged over the study period (62.6 ± 18.2 to 62.7 ± 17.0, p = 0.98), and the number of INR checks did not change (18.9 ± 5.2 to 18.5 ± 5.1, p = 0.06). Between 2010 and 2014, AF patients newly starting warfarin had mild increases in risk for stroke and death with sustained quality of warfarin therapy.


Subject(s)
Atrial Fibrillation/drug therapy , Warfarin/administration & dosage , Aged , Aged, 80 and over , Atrial Fibrillation/epidemiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Risk Factors , Stroke/chemically induced , Stroke/epidemiology , Time Factors , Warfarin/adverse effects
11.
J Thromb Thrombolysis ; 37(2): 171-6, 2014.
Article in English | MEDLINE | ID: mdl-23653172

ABSTRACT

To more accurately quantify the proportion of anticoagulated patients with atrial fibrillation (AF) that may be inappropriately treated with warfarin for stroke prevention. Patients with AF have an increased risk of stroke, which is lowered by the use of warfarin. However there is likely more potential harm than benefit in patients that do not have additional stroke risk factors. Studies have described overuse of warfarin for stroke prophylaxis in lowest risk patients. However, many of those studies did not assess for electrical cardioversion (ECV) or radiofrequency ablation (RFA) as indications for warfarin therapy. Data from 1852 non-valvular AF patients treated with warfarin between October 2009 and October 2011 at seven anticoagulation centers participating in the Michigan Anticoagulation Quality Improvement Initiative registry were analyzed. Low risk AF patients were risk stratified using the CHADS2 scoring systems, with a score of zero representing lowest risk. 193 (10.4 %) of AF patients receiving warfarin were identified as having the lowest risk of stroke by the CHADS2 score. Of the patients with CHADS2 = 0, 130 (67.4 %) had undergone a recent ECV and/or RFA. Of all AF patients, only 63 (3.4 %) had a CHADS2 score of 0 and no recent ECV or RFA. The vast majority of AF patients receiving anticoagulation in this multi-center registry are doing so in accordance with national and international guidelines. In contrast to prior population-based studies, very few low risk patients are receiving inappropriate warfarin therapy for stroke prophylaxis in AF, when procedure-based indications are also considered.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Stroke/prevention & control , Warfarin/administration & dosage , Aged , Anticoagulants/adverse effects , Atrial Fibrillation/epidemiology , Female , Humans , Male , Michigan/epidemiology , Practice Guidelines as Topic , Retrospective Studies , Risk Factors , Stroke/epidemiology , Warfarin/adverse effects
12.
Circulation ; 125(25): 3182-90, 2012 Jun 26.
Article in English | MEDLINE | ID: mdl-22615343

ABSTRACT

BACKGROUND: Fibromuscular dysplasia (FMD), a noninflammatory disease of medium-size arteries, may lead to stenosis, occlusion, dissection, and/or aneurysm. There has been little progress in understanding the epidemiology, pathogenesis, and outcomes since its first description in 1938. METHODS AND RESULTS: Clinical features, presenting symptoms, and vascular events are reviewed for the first 447 patients enrolled in a national FMD registry from 9 US sites. Vascular beds were imaged selectively based on clinical presentation and local practice. The majority of patients were female (91%) with a mean age at diagnosis of 51.9 (SD 13.4 years; range, 5-83 years). Hypertension, headache, and pulsatile tinnitus were the most common presenting symptoms of the disease. Self-reported family history of stroke (53.5%), aneurysm (23.5%), and sudden death (19.8%) were common, but FMD in first- or second-degree relatives was reported only in 7.3%. FMD was identified in the renal artery in 294 patients, extracranial carotid arteries in 251 patients, and vertebral arteries in 82 patients. A past or presenting history of vascular events were common: 19.2% of patients had a transient ischemic attack or stroke, 19.7% had experienced arterial dissection(s), and 17% of patients had an aneurysm(s). The most frequent indications for therapy were hypertension, aneurysm, and dissection. CONCLUSIONS: In this registry, FMD occurred primarily in middle-aged women, although it presents across the lifespan. Cerebrovascular FMD occurred as frequently as renal FMD. Although a significant proportion of FMD patients may present with a serious vascular event, many present with nonspecific symptoms and a subsequent delay in diagnosis.


Subject(s)
Fibromuscular Dysplasia/diagnosis , Fibromuscular Dysplasia/epidemiology , Registries , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Female , Fibromuscular Dysplasia/therapy , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Retrospective Studies , United States/epidemiology , Young Adult
13.
J Thromb Thrombolysis ; 35(1): 10-4, 2013 Jan.
Article in English | MEDLINE | ID: mdl-22797905

ABSTRACT

Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are associated with high rates of venous thromboembolism (VTE). Anticoagulants, such as warfarin, are commonly used to prevent VTE in such patients. The practice and effectiveness of warfarin in real world populations is not well documented. 595 TKA and THA patients treated with warfarin were followed by two anticoagulation clinics in the Michigan Anticoagulation Quality Improvement Initiative. Length of prescribed anticoagulation, percent time in therapeutic range (%TTR) and time to first therapeutic INR were calculated for each surgical group. For THA, all 300 patients received at least ten days with a 28-day median length of anticoagulation therapy. For TKA, all 295 patients received at least 10 days with a 28-day median length of anticoagulation therapy. For THA patients, time to first therapeutic INR was on average 12.0 ± 8.0 days with a mean %TTR of 36.6 ± 26.8% for goal INR 2.0-3.0. For THA patients, 39 (13%) never reached target INR. For TKA patients, time to first therapeutic INR was on average 12.8 ± 10.3 days with a mean %TTR of 36.0 ± 28.3% for goal INR 2.0-3.0. For TKA patients, 44 (14.9%) never reached target INR. Many orthopaedic surgeons who use warfarin for post-arthroplasty VTE prophylaxis do so in accordance with national guidelines. The time to first therapeutic INR is strikingly long and %TTR markedly low for these patients, raising questions about the efficacy of warfarin therapy in the first 1-2 post-operative weeks. Further studies to investigate the best target INR for warfarin prophylaxis, as well as the composite rates of VTE and clinically relevant bleeding from treatment with warfarin, LMWH and newer anticoagulants are needed.


Subject(s)
Anticoagulants/administration & dosage , Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Postoperative Complications/prevention & control , Venous Thromboembolism/prevention & control , Warfarin/administration & dosage , Female , Humans , International Normalized Ratio/methods , Male , Michigan , Middle Aged , Practice Guidelines as Topic , Time Factors , Venous Thromboembolism/etiology
14.
JACC Clin Electrophysiol ; 9(8 Pt 3): 1719-1729, 2023 08.
Article in English | MEDLINE | ID: mdl-37227359

ABSTRACT

BACKGROUND: Multiple cardiac sarcoidosis (CS) diagnostic schemes have been published. OBJECTIVES: This study aims to evaluate the association of different CS diagnostic schemes with adverse outcomes. The diagnostic schemes evaluated were 1993, 2006, and 2017 Japanese criteria and the 2014 Heart Rhythm Society criteria. METHODS: Data were collected from the Cardiac Sarcoidosis Consortium, an international registry of CS patients. Outcome events were any of the following: all-cause mortality, left ventricular assist device placement, heart transplantation, and appropriate implantable cardioverter-defibrillator therapy. Logistic regression analysis evaluated the association of outcomes with each CS diagnostic scheme. RESULTS: A total of 587 subjects met the following criteria: 1993 Japanese (n = 310, 52.8%), 2006 Japanese (n = 312, 53.2%), 2014 Heart Rhythm Society (n = 480, 81.8%), and 2017 Japanese (n = 112, 19.1%). Patients who met the 1993 criteria were more likely to experience an event than patients who did not (n = 109 of 310, 35.2% vs n = 59 of 277, 21.3%; OR: 2.00; 95% CI: 1.38-2.90; P < 0.001). Similarly, patients who met the 2006 criteria were more likely to have an event than patients who did not (n = 116 of 312, 37.2% vs n = 52 of 275, 18.9%; OR: 2.54; 95% CI: 1.74-3.71; P < 0.001). There was no statistically significant association between the occurrence of an event and whether a patient met the 2014 or the 2017 criteria (OR: 1.39; 95% CI: 0.85-2.27; P = 0.18 or OR: 1.51; 95% CI: 0.97-2.33; P = 0.067, respectively). CONCLUSIONS: CS patients who met the 1993 and the 2006 criteria had higher odds of adverse clinical outcomes. Future research is needed to prospectively evaluate existing diagnostic schemes and develop new risk models for this complex disease.


Subject(s)
Cardiomyopathies , Defibrillators, Implantable , Heart Transplantation , Myocarditis , Sarcoidosis , Humans , Sarcoidosis/diagnosis , Sarcoidosis/epidemiology , Sarcoidosis/complications , Defibrillators, Implantable/adverse effects
15.
Blood Adv ; 6(10): 2977-2980, 2022 05 24.
Article in English | MEDLINE | ID: mdl-35052000

ABSTRACT

Patients' international normalized ratios (INRs) often fall slightly out of range. In these cases, the American College of Chest Physicians (ACCP) guidelines suggest maintaining the current warfarin dose and retesting the INR within the following 2 weeks (watchful waiting). We sought to determine whether watchful waiting or dose changes for slightly out-of-range INRs is more effective in obtaining in-range INRs at follow-up. INRs and management strategies of warfarin-treated patients within the Michigan Anticoagulation Quality Improvement Initiative registry were analyzed. Management strategies included watchful waiting or dose changes. INRs slightly out of range (target range 2.0-3.0) and their associated management were identified. Multilevel mixed-effects logistic regression was used to estimate the probability of the next INR being in range, adjusted for clustering due to multiple out-of-range INRs per patient. A total of 45 351 slightly out-of-range INRs (ranging 1.50-1.99 and 3.01-3.49) from 8288 patients were identified. The next INR was slightly less likely to be in range with watchful waiting than with a dose change (predicted probabilities 58.9% vs 60.0%, P = 0.024). Although a significant statistical difference was detected in the probabilities of the next INR being back in range when managed by a dose change compared with watchful waiting following a slightly out-of-range INR, the magnitude of the difference was small and unlikely to represent clinical importance. Our study supports the current guideline recommendations for watchful waiting in cases of slightly out-of-range INRs values.


Subject(s)
Anticoagulants , Warfarin , Anticoagulants/therapeutic use , Humans , International Normalized Ratio , Warfarin/therapeutic use , Watchful Waiting
16.
JAMA Netw Open ; 5(9): e2231973, 2022 09 01.
Article in English | MEDLINE | ID: mdl-36121653

ABSTRACT

Importance: For some patients receiving warfarin, adding aspirin (acetylsalicylic acid) increases bleeding risk with unclear treatment benefit. Reducing excess aspirin use could be associated with improved clinical outcomes. Objective: To assess changes in aspirin use, bleeding, and thrombosis event rates among patients treated with warfarin. Design, Setting, and Participants: This pre-post observational quality improvement study was conducted from January 1, 2010, to December 31, 2019, at a 6-center quality improvement collaborative in Michigan among 6738 adults taking warfarin for atrial fibrillation and/or venous thromboembolism without an apparent indication for concomitant aspirin. Statistical analysis was conducted from November 26, 2020, to June 14, 2021. Intervention: Primary care professionals for patients taking aspirin were asked whether an ongoing combination aspirin and warfarin treatment was indicated. If not, then aspirin was discontinued with the approval of the managing clinician. Main Outcomes and Measures: Outcomes were assessed before and after intervention for the primary analysis and before and after 24 months before the intervention (when rates of aspirin use first began to decrease) for the secondary analysis. Outcomes included the rate of aspirin use, bleeding, and thrombotic outcomes. An interrupted time series analysis assessed cumulative monthly event rates over time. Results: A total of 6738 patients treated with warfarin (3160 men [46.9%]; mean [SD] age, 62.8 [16.2] years) were followed up for a median of 6.7 months (IQR, 3.2-19.3 months). Aspirin use decreased slightly from a baseline mean use of 29.4% (95% CI, 28.9%-29.9%) to 27.1% (95% CI, 26.1%-28.0%) during the 24 months before the intervention (P < .001 for slope before and after 24 months before the intervention) with an accelerated decrease after the intervention (mean aspirin use, 15.7%; 95% CI, 14.8%-16.8%; P = .001 for slope before and after intervention). In the primary analysis, the intervention was associated with a significant decrease in major bleeding events per month (preintervention, 0.31%; 95% CI, 0.27%-0.34%; postintervention, 0.21%; 95% CI, 0.14%-0.28%; P = .03 for difference in slope before and after intervention). No change was observed in mean percentage of patients having a thrombotic event from before to after the intervention (0.21% vs 0.24%; P = .34 for difference in slope). In the secondary analysis, reducing aspirin use (starting 24 months before the intervention) was associated with decreases in mean percentage of patients having any bleeding event (2.3% vs 1.5%; P = .02 for change in slope before and after 24 months before the intervention), mean percentage of patients having a major bleeding event (0.31% vs 0.25%; P = .001 for change in slope before and after 24 months before the intervention), and mean percentage of patients with an emergency department visit for bleeding (0.99% vs 0.67%; P = .04 for change in slope before and after 24 months before the intervention), with no change in mean percentage of patients with a thrombotic event (0.20% vs 0.23%; P = .36 for change in slope before and after 24 months before the intervention). Conclusions and Relevance: This quality improvement intervention was associated with an acceleration of a preexisting decrease in aspirin use among patients taking warfarin for atrial fibrillation and/or venous thromboembolism without a clear indication for aspirin therapy. Reductions in aspirin use were associated with reduced bleeding. This study suggests that an anticoagulation clinic-based aspirin deimplementation intervention can improve guideline-concordant aspirin use.


Subject(s)
Atrial Fibrillation , Venous Thromboembolism , Adult , Anticoagulants/adverse effects , Aspirin , Atrial Fibrillation/drug therapy , Hemorrhage/chemically induced , Hemorrhage/prevention & control , Humans , Male , Middle Aged , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & control , Warfarin/adverse effects
17.
Am Heart J ; 161(4): 790-796.e1, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21473980

ABSTRACT

BACKGROUND: Performing preoperative coronary angiography (CA) before surgical repair of a type A acute aortic dissection (TA-AAD) remains controversial. Although the information provided by CA may be useful in planning the surgical approach, the potential delay to surgery and complications of CA may confer added risk of death before definitive repair of the aorta. METHODS: We analyzed 1,343 patients from January 27, 1996, to May 3, 2010, with TA-AAD from the International Registry of Acute Aortic Dissection who underwent surgical or endovascular repair during the index hospitalization, with (n = 156) or without (n = 1,187) preoperative CA. The main outcomes measured were in-hospital complications and in-hospital and long-term mortality. RESULTS: Patients who underwent preoperative CA were more likely to have a history of atherosclerosis and present with electrocardiographic signs of myocardial ischemia/infarction. In the preoperative CA group, significant delays from the onset of symptoms to the time of surgery occurred. In-hospital postoperative complications and mortality rates were largely similar between the 2 groups. On multivariable logistic regression analysis, preoperative CA had no significant effect on in-hospital risk-adjusted mortality when compared to the validated International Registry of Acute Aortic Dissection risk score. Long-term mortality was similar between patients receiving preoperative CA and those who did not; long-term rehospitalization rates were higher, although largely insignificantly, among preoperative CA recipients through 5 years of follow-up. CONCLUSIONS: Preoperative CA is infrequently performed on patients with TA-AAD, except, occasionally, on patients at high risk for myocardial ischemia. When performed, preoperative CA was not associated with any significant changes in in-hospital and long-term mortality.


Subject(s)
Aortic Aneurysm, Thoracic/mortality , Aortic Dissection/mortality , Coronary Angiography/mortality , Acute Disease , Aged , Female , Hospital Mortality , Humans , Male , Middle Aged , Registries , Risk Factors
18.
J Am Heart Assoc ; 10(17): e021962, 2021 09 07.
Article in English | MEDLINE | ID: mdl-34459232

ABSTRACT

Background Fibromuscular dysplasia (FMD) is a nonatherosclerotic arterial disease that has a variable presentation including pulsatile tinnitus (PT). The frequency and characteristics of PT in FMD are not well understood. The objective of this study was to evaluate the frequency of PT in FMD and compare characteristics between patients with and without PT. Methods and Results Data were queried from the US Registry for FMD from 2009 to 2020. The primary outcomes were frequency of PT among the FMD population and prevalence of baseline characteristics, signs/symptoms, and vascular bed involvement in patients with and without PT. Of 2613 patients with FMD who were included in the analysis, 972 (37.2%) reported PT. Univariable analysis and multivariable logistic regression were performed to explore factors associated with PT. Compared with those without PT, patients with PT were more likely to have involvement of the extracranial carotid artery (90.0% versus 78.6%; odds ratio, 1.49; P=0.005) and to have higher prevalence of other neurovascular signs/symptoms including headache (82.5% versus 62.7%; odds ratio, 1.82; P<0.001), dizziness (44.9% versus 22.9%; odds ratio, 2.01; P<0.001), and cervical bruit (37.5% versus 15.8%; odds ratio, 2.73; P<0.001) compared with those without PT. Conclusions PT is common among patients with FMD. Patients with FMD who present with PT have higher rates of neurovascular signs/symptoms, cervical bruit, and involvement of the extracranial carotid arteries. The coexistence of the 2 conditions should be recognized, and providers who evaluate patients with PT should be aware of FMD as a potential cause.


Subject(s)
Fibromuscular Dysplasia , Tinnitus , Carotid Arteries , Fibromuscular Dysplasia/diagnostic imaging , Fibromuscular Dysplasia/epidemiology , Humans , Registries , Tinnitus/diagnosis , Tinnitus/epidemiology , United States
19.
Front Microbiol ; 11: 1727, 2020.
Article in English | MEDLINE | ID: mdl-32903334

ABSTRACT

Vibrio parahaemolyticus is a significant seafood-borne pathogen, leading to serious acute gastrointestinal diseases worldwide. In this study, a reliable 4-plex droplet digital PCR (ddPCR) was successfully established and evaluated for the simultaneous detection of V. parahaemolyticus based on tlh, tdh, ureR, and orf8 in food samples using single intact cells. The targets tlh and ureR were labeled with 6-Carboxyfluorescein (FAM), and the targets tdh and orf8 were labeled with 5'-Hexachlorofluorescein (HEX). Due to reasonable proration of primers and probes corresponding into the two fluorescence channels of the ddPCR detecting platforms, the clearly separated 16 (24) clusters based on fluorescence amplitude were obtained. For better results, the sample hot lysis time and the cycle number were optimized. The results showed that the minimum number of "rain" and maximum fluorescence amplification were presented for precise detection in the condition of 25 min of the sample hot lysis time and 55 cycles. The sensitivity of this 4-plex ddPCR assay was 39 CFU/mL, which was in accordance with that of the conventional plate counting and was 10-fold sensitive than that of qPCR. In conclusion, the 4-plex ddPCR assay presented in this paper was a rapid, specific, sensitive, and accurate tool for the detection of V. parahaemolyticus including pandemic group strains and could be applied in the differentiation of V. parahaemolyticus in a wide variety of samples.

20.
J Thromb Haemost ; 18(8): 2025-2030, 2020 08.
Article in English | MEDLINE | ID: mdl-32428998

ABSTRACT

BACKGROUND: Use of bridging anticoagulation increases a patient's bleeding risk without clear evidence of thrombotic prevention among warfarin-treated patients with atrial fibrillation. Contemporary use of bridging anticoagulation among warfarin-treated patients with venous thromboembolism (VTE) has not been studied. METHODS: We identified warfarin-treated patients with VTE who temporarily stopped warfarin for a surgical procedure between 2010 and 2018 at six health systems. Using the 2012 American College of Chest Physicians guideline, we assessed use of periprocedural bridging anticoagulation based on recurrent VTE risk. Recurrent VTE risk and 30-day outcomes (bleeding, thromboembolism, emergency department visit) were each assessed using logistic regression adjusted for multiple procedures per patient. RESULTS: During the study period, 789 warfarin-treated patients with VTE underwent 1529 procedures (median, 2; interquartile range, 1-4). Unadjusted use of bridging anticoagulation was more common in patients at high risk for VTE recurrence (99/171, 57.9%) than for patients at moderate (515/1078, 47.8%) or low risk of recurrence (134/280, 47.86%). Bridging anticoagulation use was higher in high-risk patients compared with low- or moderate-risk patients in both unadjusted (P = .013) and patient-level cluster-adjusted analyses (P = .031). Adherence to American College of Chest Physicians guidelines in high- and low-risk patients did not change during the study period (odds ratio, 0.98 per year; 95% confidence interval, 0.91-1.05). Adverse events were rare and not statistically different between the two treatment groups. CONCLUSIONS: Bridging anticoagulation was commonly overused among low-risk patients and underused among high-risk patients treated with warfarin for VTE. Adverse events were rare and not different between the two treatment groups.


Subject(s)
Venous Thromboembolism , Anticoagulants/adverse effects , Cohort Studies , Heparin, Low-Molecular-Weight , Humans , Registries , Risk Factors , Venous Thromboembolism/diagnosis , Venous Thromboembolism/drug therapy
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