Evaluation of Direct Oral Anticoagulant Reversal Agents in Intracranial Hemorrhage: A Systematic Review and Meta-analysis.

Importance: Direct oral anticoagulant (DOAC)-associated intracranial hemorrhage (ICH) has high morbidity and mortality. The safety and outcome data of DOAC reversal agents in ICH are limited. Objective: To evaluate the safety and outcomes of DOAC reversal agents among patients with ICH. Data Sources: PubMed, MEDLINE, The Cochrane Library, Embase, EBSCO, Web of Science, and CINAHL databases were searched from inception through April 29, 2022. Study Selection: The eligibility criteria were (1) adult patients (age ≥18 years) with ICH receiving treatment with a DOAC, (2) reversal of DOAC, and (3) reported safety and anticoagulation reversal outcomes. All nonhuman studies and case reports, studies evaluating patients with ischemic stroke requiring anticoagulation reversal or different dosing regimens of DOAC reversal agents, and mixed study groups with DOAC and warfarin were excluded. Data Extraction and Synthesis: Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were used for abstracting data and assessing data quality and validity. Two reviewers independently selected the studies and abstracted data. Data were pooled using the random-effects model. Main Outcomes and Measures: The primary outcome was proportion with anticoagulation reversed. The primary safety end points were all-cause mortality and thromboembolic events after the reversal agent. Results: A total of 36 studies met criteria for inclusion, with a total of 1832 patients (967 receiving 4-factor prothrombin complex concentrate [4F-PCC]; 525, andexanet alfa [AA]; 340, idarucizumab). The mean age was 76 (range, 68-83) years, and 57% were men. For 4F-PCC, anticoagulation reversal was 77% (95% CI, 72%-82%; I2 = 55%); all-cause mortality, 26% (95% CI, 20%-32%; I2 = 68%), and thromboembolic events, 8% (95% CI, 5%-12%; I2 = 41%). For AA, anticoagulation reversal was 75% (95% CI, 67%-81%; I2 = 48%); all-cause mortality, 24% (95% CI, 16%-34%; I2 = 73%), and thromboembolic events, 14% (95% CI, 10%-19%; I2 = 16%). Idarucizumab for reversal of dabigatran had an anticoagulation reversal rate of 82% (95% CI, 55%-95%; I2 = 41%), all-cause mortality, 11% (95% CI, 8%-15%, I2 = 0%), and thromboembolic events, 5% (95% CI, 3%-8%; I2 = 0%). A direct retrospective comparison of 4F-PCC and AA showed no differences in anticoagulation reversal, proportional mortality, or thromboembolic events. Conclusions and Relevance: In the absence of randomized clinical comparison trials, the overall anticoagulation reversal, mortality, and thromboembolic event rates in this systematic review and meta-analysis appeared similar among available DOAC reversal agents for managing ICH. Cost, institutional formulary status, and availability may restrict reversal agent choice, particularly in small community hospitals.

Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial.

Objective: Adherence to guideline-recommended medications after acute myocardial infarction (AMI) is suboptimal. Patient fidelity to treatment regimens may be related to their knowledge of the risk of death following AMI, the pros and cons of medications, and to their involvement in treatment decisions. Shared decision-making may improve both patients' knowledge and involvement in treatment decisions. Methods: In a pilot trial, patients hospitalized with AMI were randomized to the use of the AMI Choice conversation tool or to usual care. AMI Choice includes a pictogram of the patient's estimated risk of mortality at 6 months with and without guideline-recommended medications, ie, aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors. Primary outcomes were patient knowledge and conflict with the decision made assessed via post-encounter surveys. Secondary outcomes were patient involvement in the decision-making process (observer-based OPTION12 scale) and 6-month medication adherence. Results: Patient knowledge of the expected survival benefit from taking medications was significantly higher (62% vs 16%, p<0.0001) in the AMI Choice group (n = 53) compared to the usual care group (n = 53). Both groups reported similarly low levels of conflict with the decision to start the medications (13 (SD 24.2) vs 16 (SD 22) out of 100; p=0.16). The extent to which clinicians in the AMI Choice group involved their patients in the decision-making process was high (OPTION12 score 53 out of 100, SD 12). Medication adherence at 6-months was relatively high in both groups and not different between groups. Conclusion: The AMI Choice conversation tool improved patients' knowledge of their estimated risk of short-term mortality after an AMI and the pros and cons of treatments to reduce this risk. The effect on patient fidelity to recommended medications of using this SDM tool and of SDM in general should be tested in larger trials enrolling patients at high risk for nonadherence. Trial Registration Number: NCT00888537.

Temporal Trends in Resource Use, Cost, and Outcomes of Transcatheter Aortic Valve Replacement in the United States.

OBJECTIVE: To evaluate the contemporary trends in outcomes and resource use associated with transcatheter aortic valve replacement (TAVR) in the United States. METHODS: We identified patients who underwent TAVR between January 1, 2012, and December 31, 2017, in the National Readmission Database. We assessed temporal trends in clinical outcomes, length-of-stay, non-home discharges, and cost of the index TAVR hospitalization. We also evaluated the changes in the burden of hospitalizations before and after TAVR. RESULTS: A total of 89,202 patients were included. In-hospital mortality decreased from 5.3% (188) in 2012 to 1.6% (484) in 2017 (adjusted odds ratio: 0.37, 95% CI: 0.30 to 0.46). Risk-adjusted incidences of new dialysis, vascular complications, blood transfusion, and mechanical ventilation decreased, but strokes and pacemaker implantations remained unchanged. Length of stay decreased from median of 7 (interquartile range [IQR]: 4 to 11) to 2 (IQR: 2 to 5) days (P<.001). Risk-adjusted non-home discharges decreased from 32.2% (1134) to 15.5% (386) (P<.001). Median cost of the TAVR hospitalization decreased from $56,022 (IQR: $43,690 to $75,174) to $46,101 (IQR: $36,083 to $59,752) (P<.001). Pre-TAVR admissions at 30, 90, and 180 days decreased from 21.6% (713), 39.5% (1160), and 50.5% (1009) in 2012 to 15.5% (4451), 30.2% (7186), and 36.8% (5928) in 2017, respectively (P<.001). Similarly, re-hospitalizations at 30, 90, and 180 days post-TAVR decreased from 17.5% (531), 27.9% (657), and 34.2% (521) to 12.4% (3486), 21.1% (4783), and 29.1% (4306), respectively (P<.001). The expenditure on index, pre-, and post-TAVR hospitalizations increased from $0.53 to $2.8 billion between 2012 and 2017. CONCLUSION: This study reflects the changes in the characteristics and outcomes of TAVR in the United States between 2012 and 2017. It also shows the temporal decrease in resource use, cost, and burden of hospitalizations among patients undergoing TAVR in the United States, but an increase in the overall expenditure on TAVR-related hospitalizations.

Anticoagulation in COVID-19: A Systematic Review, Meta-analysis, and Rapid Guidance From Mayo Clinic.

A higher risk of thrombosis has been described as a prominent feature of coronavirus disease 2019 (COVID-19). This systematic review synthesizes current data on thrombosis risk, prognostic implications, and anticoagulation effects in COVID-19. We included 37 studies from 4070 unique citations. Meta-analysis was performed when feasible. Coagulopathy and thrombotic events were frequent among patients with COVID-19 and further increased in those with more severe forms of the disease. We also present guidance on the prevention and management of thrombosis from a multidisciplinary panel of specialists from Mayo Clinic. The current certainty of evidence is generally very low and continues to evolve.

Associations Among Practice Variation, Clinician Characteristics, and Care Algorithm Usage: A Multispecialty Vignette Study.

The objective was to quantitatively evaluate clinician characteristics associated with unwarranted practice variation, and how clinical care algorithms influence this variation. Participants (142 physicians, 53 nurse practitioners, and 9 physician assistants in family medicine, internal medicine, and cardiology) described their management of 4 clinical vignettes, first based on their own practice (unguided), then using care algorithms (guided). The authors quantitatively estimated variation in management. Cardiologists demonstrated 17% lower variation in unguided responses than generalists (fold-change 0.83 [95% confidence interval (CI) 0.68, 0.97]), and those who agreed that practice variation can realistically be reduced had 16% lower variation than those who did not (fold-change 0.84 [CI, 0.71, 0.99]). A 17% reduction in variation was observed for guided responses compared with baseline (unguided) responses (fold-change 0.83 [CI, 0.76, 0.90]). Differences were otherwise similar across clinician subgroups and attitudes. Unwarranted practice variation was similar across most clinician subgroups. The authors conclude that care algorithms can reduce variation in management.

Practice variation and practice guidelines: Attitudes of generalist and specialist physicians, nurse practitioners, and physician assistants.

OBJECTIVE: To understand clinicians' beliefs about practice variation and how variation might be reduced. METHODS: We surveyed board-certified physicians (N = 178), nurse practitioners (N = 60), and physician assistants (N = 12) at an academic medical center and two community clinics, representing family medicine, general internal medicine, and cardiology, from February-April 2016. The Internet-based questionnaire ascertained clinicians' beliefs regarding practice variation, clinical practice guidelines, and costs. RESULTS: Respondents agreed that practice variation should be reduced (mean [SD] 4.5 [1.1]; 1 = strongly disagree, 6 = strongly agree), but agreed less strongly (4.1 [1.0]) that it can realistically be reduced. They moderately agreed that variation is justified by situational differences (3.9 [1.2]). They strongly agreed (5.2 [0.8]) that clinicians should help reduce healthcare costs, but agreed less strongly (4.4 [1.1]) that reducing practice variation would reduce costs. Nearly all respondents (234/249 [94%]) currently depend on practice guidelines. Clinicians rated differences in clinician style and experience as most influencing practice variation, and inaccessibility of guidelines as least influential. Time to apply standards, and patient decision aids, were rated most likely to help standardize practice. Nurse practitioners and physicians assistants (vs physicians) and less experienced (vs senior) clinicians rated more favorably several factors that might help to standardize practice. Differences by specialty and academic vs community practice were small. CONCLUSIONS: Clinicians believe that practice variation should be reduced, but are less certain that this can be achieved. Accessibility of guidelines is not a significant barrier to practice standardization, whereas more time to apply standards is viewed as potentially helpful.

Impacts of a care process model and inpatient electrophysiology service on cardiovascular implantable electronic device infections: a preliminary evaluation.

PURPOSE: Cardiovascular implantable electronic device infection (CIEDI) rates are rising. To improve outcomes, our institution developed an online care process model (CPM) and a specialized inpatient heart rhythm service (HRS). METHODS: This retrospective review compared hospital length of stay (LOS), mortality, and times to subspecialty consultation and procedures before and after CPM and HRS availability. RESULTS: CPM use was associated with shortened time to surgical consultation (median 2 days post-CPM vs. 3 days pre-CPM, p = 0.0152), pocket closure (median 4 vs. 5 days, p < 0.0001), and days to new CIED implant (median 7 vs. 8 days, p = 0.0126). Post-HRS patients were more likely to have a surgical consultation (OR 7.01, 95% CI 1.56-31.5, p = 0.011) and shortened time to pocket closure (coefficient - 2.21 days, 95% CI - 3.33 to - 1.09, p < 0.001), compared to pre-HRS. CONCLUSIONS: The CPM and HRS were associated with favorable outcomes, but further integration of CPM features into hospital workflow is needed.

Information needs of generalists and specialists using online best-practice algorithms to answer clinical questions.

OBJECTIVE: To better understand clinician information needs and learning opportunities by exploring the use of best-practice algorithms across different training levels and specialties. METHODS: We developed interactive online algorithms (care process models [CPMs]) that integrate current guidelines, recent evidence, and local expertise to represent cross-disciplinary best practices for managing clinical problems. We reviewed CPM usage logs from January 2014 to June 2015 and compared usage across specialty and provider type. RESULTS: During the study period, 4009 clinicians (2014 physicians in practice, 1117 resident physicians, and 878 nurse practitioners/physician assistants [NP/PAs]) viewed 140 CPMs a total of 81 764 times. Usage varied from 1 to 809 views per person, and from 9 to 4615 views per CPM. Residents and NP/PAs viewed CPMs more often than practicing physicians. Among 2742 users with known specialties, generalists ( N = 1397) used CPMs more often (mean 31.8, median 7 views) than specialists ( N = 1345; mean 6.8, median 2; P < .0001). The topics used by specialists largely aligned with topics within their specialties. The top 20% of available CPMs (28/140) collectively accounted for 61% of uses. In all, 2106 clinicians (52%) returned to the same CPM more than once (average 7.8 views per topic; median 4, maximum 195). Generalists revisited topics more often than specialists (mean 8.8 vs 5.1 views per topic; P < .0001). CONCLUSIONS: CPM usage varied widely across topics, specialties, and individual clinicians. Frequently viewed and recurrently viewed topics might warrant special attention. Specialists usually view topics within their specialty and may have unique information needs.