Influence of interdisciplinary frailty screening on perioperative complication rates in elderly ovarian cancer patients: results of a retrospective observational study.

PURPOSE: Frailty is a frequent and underdiagnosed multidimensional age-related syndrome, involving decreased physiological performance reserves and marked vulnerability against major stressors. To standardize the preoperative frailty assessment and identify patients at risk of adverse surgical outcomes, commonly used global health assessment tools were evaluated. We aimed to assess three interdisciplinary preoperative screening assessments to investigate the influence of frailty status with in-hospital complications irrespective of surgical complexity and radicality in older women with ovarian cancer (OC). METHODS: Preoperative frailty status was examined by the G8 geriatric screening tool (G8 Score-geriatric screening), Eastern Cooperative Oncology Group performance status (ECOG PS-oncological screening), and American Society of Anesthesiologists Physical Status System (ASA PS-anesthesiologic screening). The main outcome measures were the relationship between perioperative laboratory results, intraoperative surgical parameters and the incidence of immediate postoperative in-hospital complications with the preoperative frailty status. RESULTS: 116 consecutive women 60 years and older (BMI 24.8 ± 5.2 kg/m2) with OC, who underwent elective oncological surgery in University Medical Center Mainz between 2008 and 2019 were preoperatively classified with the selected global health assessment tools as frail or non-frail. The rate of preoperative anemia (hemoglobin ≤ 12 g/dl) and perioperative transfusions were significantly higher in the G8-frail group (65.9% vs. 34.1%; p = 0.006 and 62.7% vs. 41.8%, p = 0.031; respectively). In addition, patients preoperatively classified as G8-frail exhibited significantly more postoperative clinical in-hospital complications (27.8% vs. 12.5%, p = 0.045) independent of chronological age and BMI. In contrast, ECOG PS and ASA PS did not predict the rates of postoperative complications (all p values > 0.05). After propensity score matching, the complication rate in the G8-frail cohort was approximately 1.7 times more common than in the G8-non-frail cohort. CONCLUSION: Preoperative frailty assessment with the G8 Score identified elderly women with OC recording a significantly higher rate of postoperative in-hospital complications. In G8-frail patients, preoperative anemia and perioperative transfusions were significantly more recorded, regardless of chronological age, abnormal BMI and surgical complexity. Standardized preoperative frailty assessment should be added to clinical routine care to enhance risk stratification in older cancer individuals for surgical patient-centered decision-making.

[Heart failure in old age : Current recommendations in view of the revised national treatment guidelines on chronic heart failure]. / Herzinsuffizienz im Alter : Aktuelle Empfehlungen mit Blick auf die überarbeitete Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz.

Clinical symptoms of heart failure in older patients can be similar to those of other diseases in geriatrics. Therefore, the diagnosis should be confirmed by echocardiography. The treatment of older patients with heart failure with reduced left ventricular ejection fraction (HFrEF) should be carried out in accordance with the guidelines with regular control of volume status, renal function and serum electrolytes. Due to the lack of effective treatment of heart failure with preserved ejection faction (HFpEF) blood pressure control as a measure of prevention is important. Patients can benefit from the new treatment options for secondary mitral regurgitation if the patient selection is correct. For older and frail patients a special management would be desirable, with the aim of reducing functional loss through hospitalization. In order to reduce the rehospitalization rate of older patients, it is necessary to improve the collaboration between outpatient and inpatient care providers and nursing personnel should be better qualified.

[Chronic heart failure in older patients : Updated national healthcare guidelines on chronic heart failure from a geriatric perspective]. / Chronische Herzinsuffizienz beim älteren Patienten : Aktualisierte Nationale VersorgungsLeitlinie "Chronische Herzinsuffizienz" aus geriatrischer Perspektive.

The incidence and prevalence of chronic heart failure (CHF) increase with age. In the second edition of the National Disease Management Guidelines (NVL) on CHF, published in August 2017, geriatric aspects are specifically addressed. The paper provides an overview of the recommendations by the guidelines on drug therapy, device therapy and operative therapy as well on the coordination of care focusing on older and multimorbid patients.

Risk of Ischemic Stroke and Transient Ischemic Attack Is Increased up to 90 Days after Non-Carotid and Non-Cardiac Surgery.

BACKGROUND: The risk of stroke after cardiac and carotid surgery is well established. In contrast, stroke risk in association with non-cardiac and non-carotid surgery and its time course are insufficiently known. We investigated the prevalence of recent and planned surgery among patients with stroke and transient ischemic attack (TIA), time dependency of stroke risk, stroke etiology, and interruption of antithrombotic medication in association with surgery. METHODS: Data on type and date of surgery and similar interventions within the last year or planned for the next 2 weeks were anonymously collected together with demographic data, vascular risk factors, stroke severity, handicap before stroke and stroke etiology within a state-wide, mandatory, hospital-based acute stroke care quality monitoring project (Rhineland-Palatinate, Germany) for 1 year (2010). RESULTS: Non-carotid and non-cardiothoracic surgery was reported as performed within 1 year before the index event or as planned for the next 2 weeks thereafter in 532 out of 12,120 patients with ischemic stroke/TIA (4.4%). Compared to 91-365 days before stroke/TIA as reference period, risk of cerebral ischemia (per day analysis) was increased for surgery within 61-90 days before ischemia (rate ratio 2.0, 95% CI 1.5-2.8) and continuously increased along shorter intervals between stroke and surgery (31-60 days: rate ratio 3.6, 95% CI 2.9-4.5; 15-30 days: rate ratio 8.2, 95% CI 6.7-10.1; 8-14 days: rate ratio 13.2, 95% CI 10.3-16.8; 4-7 days: rate ratio 16.5, 95% CI 12.2-22.1) peaking at an interval of 1-3 days before ischemia (rate ratio 34.0, 95% CI 26.9-42.8). On the day of surgery, rate ratio was 14.8 (95% CI 7.8-27.9) and for planned surgery it was 2.7 (95% CI 1.8-4.0). Results were similar for first-ever and for recurrent ischemic stroke. Perioperative stroke/TIA was positively associated with atrial fibrillation and cardioembolic stroke etiology, higher mortality, more severe neurological deficits at discharge, and longer hospital stay; and it was inversely associated with microangiopathic etiology and discharge at home. In 34.5% of patients with recent/planned surgery, prior antithrombotic or anticoagulant medication had been interrupted. CONCLUSIONS: Recent or planned surgery imposes a considerable short-term stroke risk particularly by cardioembolism with cessation of medication as an important contributor. Stroke after surgery is associated with poor outcome and high mortality. Better strategies to reduce the burden of perioperative stroke are urgently required.

E-Health-based, trans-sectoral, geriatric health service - Geriatric Network (GerNe).

Currently, exchange of information between the geriatric clinic and the attending general practitioner (GP) occurs primarily through the doctor's letter after discharging from the clinic. The aim of our study was to reduce readmissions of multimorbid, geriatric patients to the clinic by establishing a new form of care via an electronic case file (ECF) and a consultation service (CS). The discharging geriatric clinic filled out an online ECF. The patient's GP should document quarterly follow-ups in the ECF. The case file was monitored by the discharging clinic due to a consultation service. The primary efficacy endpoint was the rehospitalization rate within one year. The hospitalization rate for patients managed in the project was 83.1/100 person years (PY), while the control group from insurance data had a rate of 69.0/100 PY. The primary endpoint did not show a statistically significant difference (p = 0.15). A total of 195 contacts were documented via CS for 171 participants, mostly initiated by the clinics. The clinical queries primarily concerned drug therapy. The Covid pandemic had an overall impact on hospitalizations. There are many approaches to reducing hospital readmissions after discharge of older patients. Supporting the transition from inpatient to outpatient care by different professional groups or care systems has been shown to have a positive effect. Furthermore, the utilisation of an ECF can also be beneficial in this regard.

Influence of anesthetic technique on survival after tumor debulking surgery of elderly patients with ovarian cancer: Results of a retrospective cohort study.

Epidural analgesia could influence the postoperative oncologic outcomes in patients with specific types of non-metastatic solid neoplasms. The present study aimed to investigate the impact of anesthetic technique on survival in elderly patients with ovarian cancer (OC). The records of all women with OC older than 60 years of age undergoing tumor debulking surgery at the University Medical Center of the Johannes Gutenberg University Mainz (Mainz, Germany) between January 2008 and December 2019 were obtained. The study cohort was divided into two groups based on the use of perioperative epidural anesthesia or not. First, Kaplan-Meier analysis was performed to analyze the prognostic influence of anesthetic technique on survival. Second, multivariate Cox proportional hazards model was adjusted for multiple conventional prognostic factors concerning three main categories: i) Current clinical-pathological tumor characteristics; ii) anesthesiologic parameters, including mean age, American Society of Anesthesiologists Performance Status and preexisting comorbidities summarized in the Charlson Comorbidity Index; and iii) oncological and surgical parameters such as oncological radicality and Surgical complexity Score. A total of 110 patients were included in the study and 71 (64.5%) of them received epidural analgesia. The median survival time was 26.0 months from primary debulking surgery and no significant differences in progression-free (PFS) and overall survival (OS) were noted between the 'Epidural' and 'non-Epidural' cohorts. After adjustment for the selected risk factors from the three categories, the effects of epidural analgesia on PFS and OS remained non-significant [PFS: hazard ratio (HR), 1.26; 95% CI, 0.66-2.39; and OS: HR, 0.79; 95% CI, 0.45-1.40]. The present results did not support the independent association between epidural-supplemented anesthesia and improved PFS or OS in elderly patients with standardized ovarian cancer debulking surgery.

[Interdisciplinary aspects of oral anticoagulation with NOACs in atrial fibrillation]. / Interdisziplinäre Aspekte der oralen Antikoagulation mit NOAKs bei Vorhofflimmern.

Stroke prophylaxis with non-vitamin K-dependent oral anticoagulants (NOAKs) in patients with non-valvular atrial fibrillation (nvVHF) is now firmly established in routine clinical practice. The definition of nvVHF includes the absence of a mechanical heart valve and AF not associated with moderate- or high-grade mitral valve stenosis. The management of oral anticoagulation (OAC) requires a high degree of interdisciplinarity. Not least for this reason, uncertainties are repeatedly observed in practice, which can have far-reaching consequences for the individual patient. For this reason, a committee consisting of representatives from general medicine, geriatrics, cardiology, nephrology and neurology has gathered to identify aspects of practical relevance from the various disciplines and to jointly develop practical guidelines to improve therapy safety for patients in everyday life.

Cost saving analysis of specialized, eHealth-based management of patients receiving oral anticoagulation therapy: Results from the thrombEVAL study.

To evaluate the cost-saving of a specialized, eHealth-based management service (CS) in comparison to regular medical care (RMC) for the management of patients receiving oral anticoagulation (OAC) therapy. Costs of hospitalization were derived via diagnosis-related groups which comprise diagnoses (ICD-10) and operation and procedure classification system (OPS), which resulted in OAC-related (i.e. bleeding/ thromboembolic events) and non-OAC-related costs for both cohorts. Cost for anticoagulation management comprised INR-testing, personnel, and technical support. In total, 705 patients were managed by CS and 1490 patients received RMC. The number of hospital stays was significantly lower in the CS cohort compared to RMC (CS: 23.4/100 py; RMC: 68.7/100 py); with the most pronounced difference in OAC-related admissions (CS: 2.8/100 py; RMC: 13.3/100 py). Total costs for anticoagulation management amounted to 101 EUR/py in RMC and 311 EUR/py in CS, whereas hospitalization costs were 3261 [IQR 2857-3689] EUR/py in RMC and 683 [504-874] EUR/py in CS. This resulted in an overall cost saving 2368 EUR/py favoring the CS. The lower frequency of adverse events in anticoagulated patients managed by the telemedicine-based CS compared to RMC translated into a substantial cost-saving, despite higher costs for the specialized management of patients.Trial registration: ClinicalTrials.gov, unique identifier NCT01809015, March 8, 2013.

Quality monitoring of acute stroke care in Rhineland-Palatinate, Germany, 2001-2006.

BACKGROUND AND PURPOSE: Quality monitoring projects are useful tools to improve the quality and to assess temporal trends of stroke care in larger populations. METHODS: In Rhineland-Palatinate, Germany, a statewide, hospital-based, acute stroke care quality monitoring project was started in 2001. Initially, participation was mandatory for all hospitals with dedicated stroke units and from 2006 onward was mandatory for all hospitals. Quality monitoring included a structured data assessment and quality indicators for procedural measures. RESULTS: Between 2001 and 2006, the numbers of patients registered annually (N=6389 vs N=10 610), admission <3 hours after stroke onset (28.2% vs 34.6%), admission via emergency medical systems (38.1% vs 50.3%), and treatment in stroke units (44.3% vs 59.5%) increased significantly (P<0.0001, respectively). In ischemic stroke, use of thrombolytic therapy increased (for patients admitted <3 hours after onset, 6.5% vs 14.1%), whereas therapy with high-dose heparin declined (24.5% vs 6.0%, P<0.0001). Several quality indicators (performance of neuroimaging and Doppler/duplex sonography, neuroimaging <3 hours after admission) showed stable results at a high level; more patients received echocardiography (62.2% vs 74.0%), but fewer patients were rapidly examined by extracranial Doppler/duplex sonography (68.7% vs 62.8%, P<0.0001). Diagnosis and treatment of hypertension and hyperlipidemia, use of aspirin and combined aspirin/dipyridamole, and diagnosis of atrial fibrillation increased (P<0.0001, respectively). Use of oral anticoagulation remained stable at approximately 38% of patients with cardioembolism. CONCLUSIONS: Although these results reflect high standards of acute stroke care and improvements regarding early admission, thrombolytic therapy, and several secondary preventive measures, there is still the potential for further improvement regarding thrombolysis, use of oral anticoagulation and statins, and admission to stroke units, for example.

A Structured Literature Review and International Consensus Validation of FORTA Labels of Oral Anticoagulants for Long-Term Treatment of Atrial Fibrillation in Older Patients (OAC-FORTA 2019).

INTRODUCTION: Evidence regarding safety and efficacy of oral anticoagulants for the treatment of atrial fibrillation (AFib) in older adults has been assessed regarding the age appropriateness of oral anticoagulants (OAC) according to the FORTA (Fit fOR The Aged) classification (OAC-FORTA). Three years after its first version (OAC-FORTA 2016), an update was initiated to create OAC-FORTA 2019. METHODS: A structured review of randomized controlled clinical trials and summaries of individual product characteristics was performed to detect newly emerged evidence on oral anticoagulants in older patients with AFib. This review was used by an interdisciplinary panel of European experts (N = 10) in a Delphi process to label OACs according to FORTA. RESULTS: A total of 202 records were identified and 11 studies finally included. We found four new trials providing relevant data on efficacy and safety of warfarin, apixaban, dabigatran or rivaroxaban in older patients with AFib. In the majority of studies comparing the non-vitamin-K oral anticoagulants (NOACs) with warfarin, NOACs were superior to warfarin regarding at least one relevant clinical endpoint. The mean consensus coefficient significantly increased from 0.867 (OAC-FORTA 2016) to 0.931 (p < 0.05) and the proposed FORTA classes were confirmed in all cases during the first round (consensus coefficient > 0.8). Warfarin, dabigatran, edoxaban and rivaroxaban were assigned to the FORTA B label, acenocoumarol, fluindione and phenprocoumon were labeled FORTA C and only apixaban was rated as FORTA A. CONCLUSION: OAC-FORTA 2019 confirms that AFib can be successfully treated with positively labeled antithrombotics at advanced age.

Subtherapeutic Anticoagulation Control under Treatment with Vitamin K-Antagonists-Data from a Specialized Coagulation Service.

In contrast to overanticoagulation, evidence on risk factors and outcome of subtherapeutic oral anticoagulation (OAC) with vitamin K-antagonists (VKAs) under optimum care is limited. We investigated the clinical phenotype, anticoagulation control, and clinical outcome of 760 VKA patients who received OAC therapy by a specialized coagulation service in the thrombEVAL study (NCT01809015). During 281,934 treatment days, 278 patients experience ≥ 1 episode of subtherapeutic anticoagulation control and had lower quality of OAC therapy compared to 482 patients without subtherapeutic international normalized ratio: 67.6%, interquartile range (IQR) 54.9%/76.8% versus 81.0%, IQR 68.5%/90.4%; p < 0.001. In Cox regression analysis with adjustment for age, sex, cardiovascular risk factors, comorbidities, and treatment characteristics, female sex (hazard ratio [HR], 1.4, 95% confidence interval [CI], 1.0/1.9; p = 0.03), diabetes (HR, 1.4, 95% CI, 1.0/2.0; p = 0.03), and living alone (HR, 1.5, 95% CI, 1.1/2.1; p = 0.009) were independent risk factors of subtherapeutic anticoagulation control, whereas atrial fibrillation (HR, 0.6, 95% CI, 0.4/0.9; p = 0.02) and self-management of OAC therapy (HR, 0.2, 95% CI, 0.1/0.6; p = 0.001) were protective. In addition, active smoking (HR, 1.7, 95% CI, 0.9/3.0; p = 0.086) and living in a nursing home (HR, 1.6, 95% CI, 0.8/3.2; p = 0.15) indicated an elevated risk at the borderline of statistical significance. For the prediction of recurrent subtherapeutic anticoagulation, living alone was the only independent risk factor (HR, 1.7, 95% CI, 1.1/2.5; p = 0.013). The present study suggests that women, diabetics, and patients living alone experience an increased risk of low-quality VKA therapy and might potentially benefit from treatment with direct-acting anticoagulants.

Relevance of Polypharmacy for Clinical Outcome in Patients Receiving Vitamin K Antagonists.

BACKGROUND: Although polypharmacy is associated with a negative clinical outcome in various settings and commonly observed in patients receiving oral anticoagulation therapy, evidence on the relevance for the clinical outcome of anticoagulated patients is currently limited. The aim of the study was to investigate the effect of polypharmacy on the clinical outcomes among patients taking phenprocoumon. DESIGN: Prospective cohort study. SETTING: Regular medical care. PARTICIPANTS: Information on 2011 individuals receiving vitamin K antagonists was available for analysis from the prospective multicenter thrombEVAL study. MEASUREMENTS: Data were obtained from clinical visits, computer-assisted interviews, and laboratory measurements. Information on clinical outcome was obtained during a 3-year follow-up period and subsequently validated via medical records. RESULTS: The prevalence of polypharmacy (five drugs or more) was 84.1% (n = 1691). Quality of anticoagulation therapy assessed by time in therapeutic range was lower in individuals on five to eight drugs and nine drugs or more (70.7% and 64.7%, respectively) compared with subjects without polypharmacy (73.4%). In addition, a significantly higher variability of international normalized ratio measurements was found in the presence of polypharmacy. The cumulative incidence of bleeding, hospitalization, and all-cause mortality, but not for thromboembolic events, increased across groups of medication. In adjusted Cox regression analysis, polypharmacy is an independent risk factor for bleeding (hazard ratio [HR]≥ 9 drugs vs 1-4 drugs = 1.62; 95% confidence interval [CI] = 1.04-2.52; p = .033); hospitalization (HR≥ 9 drugs vs 1-4 drugs = 1.60; 95% CI = 1.26-2.03; p < .001; and all-cause mortality (HR≥ 9 drugs vs 1-4 drugs = 2.16; 95% CI = 1.43-3.27; p < .001) in a dose-dependent relationship. Per additional drug, bleeding risk was increased by 4%. CONCLUSIONS: Polypharmacy influences the quality of anticoagulation therapy and translates into an elevated risk of adverse events in anticoagulated patients. This suggests that additional medication intake in such patients should be critically reviewed by physicians, and it highlights the importance of initiating investigations aimed at reducing multiple medication intake. J Am Geriatr Soc 67:463-470, 2019.

[Physicians' Opinion on Health Care in Oral Anticoagulation]. / Einschätzung von Ärzten zur medizinischen Versorgung mit oralen Antikoagulanzien.

BACKGROUND: The introduction of direct oral anticoagulants (DOAC) in addition to the established Vitamin K antagonist (VKA) has increased the complexity of antithrombotic therapy leading to numerous treatment options. Studies of the medical evaluation of the current treatment situation by health care providers, which are of great importance for the development of treatment strategies in addition to studies on pharmacovigilance, are limited in the literature. METHODS: 11 700 physicians (Rhineland-Palatinate, Germany) were contacted to participate in the web-based survey on health care with oral anticoagulation (OAC). After detailed quality control, the study was analysed in synopsis with routine care data of VKA patients of the thrombEVAL study programme (N = 2.011). RESULTS: In total, 512 physicians (mean age: 48.0 ±â€Š9.6 years; 74.0 % male) participated in the study. In general, quality of OAC therapy was rated as "average/satisfactory" (2.9 ±â€Š0.9). Comparison of physicians' perception with data from routine care highlighted marked differences regarding time in therapeutic range (+ 6.4 % [95 %-CI 2.7 %; 9.5 %]), duration of control intervals (- 35.0 % [28.0 %; 41.4 %]) and rate of OAC-related complications (+ 61.8 [37.8 %; 83.3 %], which differed additionally and statistically-significant between physician groups. The willingness to use DOAC was approximately 50 % lower in general physicians as compared to specialists (36.6 % [25.4 %; 47.8 %] vs. 72.4 % [66.0 %; 78.9 %]; p < 0.0001). Regarding management of OAC therapy, 73.8 % [69.7 %; 77.9 %] advocated the establishment of a service hotline and 67.3 % [62,9 %; 71.6 %] a specialized coagulation service. DISCUSSION: The present survey among physicians reveals a need for optimization of OAC therapy in daily practice. Specialized care models might facilitate optimized OAC therapy with both VKAs and DOACs.

The public health value of vaccination for seniors in Europe.

Longer life expectancy and decreasing fertility rates mean that the proportion of older people is continually increasing worldwide, and particularly in Europe. Ageing is associated with an increase in the risk and severity of infectious diseases. These diseases are also more difficult to diagnose and manage in seniors who often have at least one comorbid condition (60% of seniors have two or more conditions). Infectious diseases increase the risk of hospitalization, loss of autonomy and death in seniors. Effective vaccines are available in Europe for infectious diseases such as influenza, pneumococcal diseases, herpes zoster, diphtheria, tetanus and pertussis. Their effectiveness has been demonstrated in terms of reducing the rates of hospitalization, disability, dependency and death. The prevention of diseases in seniors also results in savings in healthcare and societal costs each year in Europe. Despite the availability of vaccines, vaccine-preventable diseases affect millions of European citizens annually, with the greatest burden of disease occurring in seniors, and the medical and economic benefits associated with are not being achieved. Vaccination coverage rates must be improved to achieve the full benefits of vaccination of seniors in Europe.

Sustained atrial fibrillation increases the risk of anticoagulation-related bleeding in heart failure.

BACKGROUND: Oral anticoagulation therapy in individuals with atrial fibrillation (AF) reduces the risk of thromboembolic events at cost of an increased bleeding risk. Whether anticoagulation-related outcomes differ between patients with paroxysmal and sustained AF receiving anticoagulation is controversially discussed. METHODS: In the present analysis of the prospective multi-center cohort study thrombEVAL, the incidence of anticoagulation-related adverse events was analyzed according to the AF phenotype. Information on outcome was centrally recorded over 3 years, validated via medical records and adjudicated by an independent review panel. Study monitoring was provided by an independent institution. RESULTS: Overall, the sample comprised 1089 AF individuals, of whom n = 398 had paroxysmal AF and n = 691 experienced sustained AF. In Cox regression analysis with adjustment for potential confounders, sustained AF indicated an independently elevated risk of clinically relevant bleeding compared to paroxysmal AF [hazard ratio (HR) 1.40 (1.02; 1.93); P = 0.038]. For clinically relevant bleeding, a significant interaction of the pattern of AF type with concomitant heart failure (HF) was detected: HRHF 2.45 (1.51, 3.98) vs. HRno HF 0.85 (0.55, 1.34); Pinteraction = 0.003. In HF patients, sustained AF indicated also an elevated risk of major bleeding [HR 2.25 (1.26, 4.20); P = 0.006]. A simplified HAS-BLED score incorporating only information on age (> 65 years), bleeding history, and HF with sustained AF demonstrated better discriminative performance for clinically relevant bleeding than the original version: AUCHAS-BLED: 0.583 vs. AUCsimplifiedHAS-BLED: 0.642 (P = 0.004). CONCLUSIONS: In HF patients receiving oral anticoagulation, sustained AF indicates a substantially elevated risk of bleeding. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov , identifier: NCT01809015.

Management of Oral Anti-Coagulation in Patients with Heart Failure-Insights from the ThrombEVAL Study.

Patients with heart failure (HF) are frequently anti-coagulated with vitamin K-antagonists (VKAs). The use of long-acting VKA may be preferable for HF patients due to higher stability of plasma concentrations. However, evidence on phenprocoumon-based oral anti-coagulation (OAC) therapy in HF is scarce. The aim of this study was to assess the impact of the presence of HF on quality of phenprocoumon-based OAC and the subsequent clinical outcome. Quality of OAC therapy and the incidence of adverse events were analysed in a cohort of regular care (n = 2,011) from the multi-centre thrombEVAL study program (NCT01809015) stratified by the presence of HF. To assess the modifiability of outcome, results were compared with data from individuals receiving specialized care for anti-coagulation (n = 760). Overall, the sample comprised of 813 individuals with HF and 1,160 subjects without HF in the regular care cohort. Quality of OAC assessed by time in therapeutic range (TTR) was 66.1% (47.8%/82.8%) for patients with HF and 70.6% (52.1%/85.9%) for those without HF (p = 0.0046). Stratification for New York Heart Classification (NYHA)-class demonstrated a lower TTR with higher NYHA classes: TTRNYHA-I 69.6% (49.4%/85.6%), TTRNYHA-II 66.5% (50.1%/82.9%) and TTRNYHA-≥III 61.8% (43.1%/79.9%). This translated into a worse net clinical benefit outcome for HF (hazard ratio [HR] 1.63 [1.31/2.02]; p < 0.0001) and an increased risk of bleeding (HR 1.40 [1.04/1.89]; p = 0.028). Management in a specialized coagulation service resulted in an improvement of all, TTR (∆+12.5% points), anti-coagulation-specific and non-specific outcome of HF individuals. In conclusion, HF is an independent risk factor for low quality of OAC therapy translating into an increased risk for adverse events, which can be mitigated by specialized care.

Appropriateness of Oral Anticoagulants for the Long-Term Treatment of Atrial Fibrillation in Older People: Results of an Evidence-Based Review and International Consensus Validation Process (OAC-FORTA 2016).

BACKGROUND: Age appropriateness of anticoagulants for stroke prevention in atrial fibrillation is uncertain. OBJECTIVE: To review oral anticoagulants for the treatment of atrial fibrillation in older (age >65 years) people and to classify appropriate and inappropriate drugs based on efficacy, safety and tolerability using the Fit-fOR-The-Aged (FORTA) classification. METHODS: We performed a structured comprehensive review of controlled clinical trials and summaries of individual product characteristics to assess study and total patient numbers, quality of major outcome data and data of geriatric relevance. The resulting evidence was discussed in a round table with an interdisciplinary panel of ten European experts. Decisions on age appropriateness were made using a Delphi process. RESULTS: For the eight drugs included, 380 citations were identified. The primary outcome results were reported in 32 clinical trials with explicit and relevant data on older people. Though over 24,000 patients aged >75/80 years were studied for warfarin, data on geriatric syndromes were rare (two studies reporting on frailty/falls/mental status) and missing for all other compounds. Apixaban was rated FORTA-A (highly beneficial). Other non-vitamin K antagonist oral anticoagulants (including low/high-intensity dabigatran and high-intensity edoxaban) and warfarin were assigned to FORTA-B (beneficial). Phenprocoumon, acenocoumarol and fluindione were rated FORTA-C (questionable), mainly reflecting the absence of data. CONCLUSIONS: All non-vitamin K antagonist oral anticoagulants and warfarin were classified as beneficial or very beneficial in older persons (FORTA-A or -B), underlining the overall positive assessment of the risk/benefit ratio for these drugs. For other vitamin-K antagonists regionally used in Europe, the lack of evidence should challenge current practice.