Use of metamizole and other non-opioid analgesics in Switzerland between 2014 and 2019: an observational study using a large health insurance claims database.

OBJECTIVE: To investigate claims patterns for metamizole and other non-opioid analgesics in Switzerland. To characterise users of these non-opioid analgesics regarding sex, age, comedications and canton of residence. METHODS: We conducted a retrospective descriptive study using administrative claims data of outpatient prescribed non-opioid analgesics of the Swiss health insurance company Helsana between January 2014 and December 2019. First, we evaluated the number of claims and defined daily doses  per year of metamizole, ibuprofen, diclofenac and paracetamol in adults aged 18 years or over. Second, we characterised new users of these non-opioid analgesics in terms of sex, age, claimed comedications and canton of residence. RESULTS: From 2014 to 2019, among the investigated non-opioid analgesics, metamizole showed the highest increase in claims (+9545 claims, +50%) and defined daily doses (+86,869 defined daily doses, +84%) per 100,000 adults. Metamizole users had the highest median age (62 years [IQR: 44-77]) compared to ibuprofen (47 years [IQR: 33-62]), diclofenac (57 years [IQR: 43-71]) and paracetamol (58 years [IQR: 39-75]) users. Metamizole users also more frequently claimed proton pump inhibitors, anticoagulants, platelet aggregation inhibitors and antihypertensive drugs than users of other non-opioid analgesics. While metamizole was most frequently claimed in German-speaking regions of Switzerland, ibuprofen and paracetamol were most frequently claimed in the French-speaking regions and diclofenac in German- and Italian-speaking regions. CONCLUSION: In Switzerland, metamizole was increasingly claimed between 2014 and 2019. Metamizole was most frequently claimed by older adults and patients with comedications suggestive of underlying conditions, which can be worsened or caused by use of nonsteroidal anti-inflammatory drugs. The lack of studies regarding the effectiveness and safety of metamizole in this population warrants further investigation.

Real-world treatment patterns and medical costs of prostate cancer patients in Switzerland - A claims data analysis.

BACKGROUND: Prostate cancer (PC) is the most prevalent cancer in men in Switzerland. However, evidence on the real-world health care use of PC patients is scarce. The aim of this study is to describe health care utilization, treatment patterns, and medical costs in PC patients over a period of five years (2014-2018). METHOD: We used routinely collected longitudinal individual-level claims data from a major provider of mandatory health insurance in Switzerland. Due to the lack of diagnostic coding in the claims data, we identified treated PC patients based on the treatments received. We described health care utilization and treatment pathways for patients with localized and metastatic PC. Costs were calculated from a health care system perspective. RESULTS: A total of 5591 PC patients met the inclusion criteria. Between 2014 and 2018, 1741 patients had outpatient radiotherapy for localized or metastatic PC and 1579 patients underwent radical prostatectomy. 3502 patients had an androgen deprivation therapy (ADT). 9.5% of these patients had a combination therapy with docetaxel, and 11.0% had a combination with abiraterone acetate. Docetaxel was the most commonly used chemotherapy (first-line; n = 413, 78.4% of all patients in chemotherapy). Total medical costs of PC in Switzerland were estimated at CHF 347 m (95% CI 323-372) in 2018. CONCLUSION: Most PC patients in this study were identified based on the use of ADT. Medical costs of PC in Switzerland amounted to 0.45% of total health care spending in 2018. Treatment of metastatic PC accounted for about two thirds of spending.

Patients on vitamin K treatment: is switching to direct-acting oral anticoagulation cost-effective? A target trial on a prospective cohort.

AIMS: Direct-acting oral anticoagulants (DOACs) have, to a substantial degree, replaced vitamin K antagonists (VKA) as treatments for stroke prevention in atrial fibrillation (AF) patients. However, evidence on the real-world causal effects of switching patients from VKA to DOAC is lacking. We aimed to assess the empirical incremental cost-effectiveness of switching patients to DOAC compared with maintaining VKA treatment. METHODS: The target trial approach was applied to the prospective observational Swiss-AF cohort, which enrolled 2415 AF patients from 2014 to 2017. Clinical data, healthcare resource utilisation and EQ-5D-based utilities representing quality of life were collected in yearly follow-ups. Health insurance claims were available for 1024 patients (42.4%). Overall survival, quality-of-life, costs from the Swiss statutory health insurance perspective and cost-effectiveness were estimated by emulating a target trial in which patients were randomly assigned to switch to DOAC or maintain VKA treatment. RESULTS: 228 patients switching from VKA to DOAC compared with 563 patients maintaining VKA treatment had no overall survival advantage over a 5-year observation period (HR 0.99, 95% CI 0.45, 1.55). The estimated gain in quality-adjusted life years (QALYs) was 0.003 over the 5-year period at an incremental costs of CHF 23 033 (€ 20 940). The estimated incremental cost-effectiveness ratio was CHF 425 852 (€ 387 138) per QALY gained. CONCLUSIONS: Applying a causal inference method to real-world data, we could not demonstrate switching to DOACs to be cost-effective for AF patients with at least 1 year of VKA treatment. Our estimates align with results from a previous randomised trial.

Assessing prescription of antibiotics after vaccination against pneumococcal pneumonia; using prescription sequence symmetry analysis.

OBJECTIVES: Prescription sequence symmetry analysis (PSSA) is used to detect adverse event signals using administrative claims databases. In this study, we investigated whether PSSA can be applied to gauge the effects of PCV13 vaccination on antibiotic prescription rates in elderly patients. METHODS: We studied prescription records of patients aged 65 or older between 1 January 2014 and 31 December 2020, from the Helsana Swiss claims database. PSSA was performed to explore the relationship between 13-valent pneumococcal conjugate vaccine (PCV13) and six antibiotics recommended by the Swiss Society of Infectious Diseases for community-acquired pneumonia treatment (amoxicillin-clavulanate, azithromycin, clarithromycin, doxycycline, levofloxacin, and moxifloxacin), three additional antibiotics (amoxicillin, ciprofloxacin, and fosfomycin), and ten control drugs. RESULTS: Amoxicillin-clavulanate, clarithromycin, and levofloxacin were more likely to be prescribed before than after vaccination, for all time windows between 25 and 104 weeks. Adjusted sequence ratio (ASR) values ranged from 0.599 to 0.614, 0.508 to 0.568, and 0.514 to 0.752, respectively. Lower prescription rates after vaccination were also observed for azithromycin (all time windows between 38 and 104 weeks, ASR 0.705-0.739) and moxifloxacin (all time windows between 52 and 104 weeks, ASR 0.658-0.772). PCV13 did not have statistically significant associations with doxycycline, amoxicillin, ciprofloxacin, fosfomycin, or any of the ten controls. DISCUSSION: The lower prescription rate of antibiotics for community-acquired pneumonia after vaccination could be attributed to a protective effect of PCV13. This novel application of PSSA can be used to compare the real-world impact of other vaccines on drug consumption.

Persistent atrial fibrillation without the evidence of low-voltage areas: a prospective randomized trial.

BACKGROUND: An effective therapy of persistent atrial fibrillation beyond pulmonary vein isolation remains unsatisfactory. Targeting endocardial low-voltage areas represents an approach of substrate modification. This prospective, randomized study investigated the efficacy of ablation of low-voltage areas versus PVI and additional linear ablations in patients with persistent atrial fibrillation in terms of single-procedure arrhythmia-free outcome and safety. METHODS AND RESULTS: A total number of 100 patients undergoing de-novo catheter ablation for persistent AF were randomized in a 1:1 ratio into two different treatment arms: group A: pulmonary vein isolation (PVI) and, if low-voltage areas were present, a substrate modification. Group B: PVI and, if atrial fibrillation persisted, additional ablations, such as linear ablation and/or ablation of non-PV triggers. A total of 50 patients were randomized into each group without significant differences in baseline characteristics. During a mean follow-up of 17.64 ± 4.5 months after a single procedure, 34 (68%) patients of group A were free of arrhythmia recurrence versus 28 (56%) patients in group B (p = ns). In group A, 30 (60%) patients did not show endocardial fibrosis and received solely PVI. Both procedures were performed with a low number of complications; no pericardial effusion or stroke were seen in either group. CONCLUSIONS: A significant proportion of patients with persistent atrial fibrillation do not show low-voltage areas. A total of 70% of the patients receiving solely PVI did not show any recurrence of atrial fibrillation, and therefore, extensive additional ablation should be avoided in de-novo patients.

Are Tumor Marker Tests Applied Appropriately in Clinical Practice? A Healthcare Claims Data Analysis.

Tumor markers (TM) are crucial in the monitoring of cancer treatment. However, inappropriate requests for screening reasons have a high risk of false positive and negative findings, which can lead to patient anxiety and unnecessary follow-up examinations. We aimed to assess the appropriateness of TM testing in outpatient practice in Switzerland. We conducted a retrospective cohort study based on healthcare claims data. Patients who had received at least one out of seven TM tests (CEA, CA19-9, CA125, CA15-3, CA72-4, Calcitonin, or NSE) between 2018 and 2021 were analyzed. Appropriate determinations were defined as a request with a corresponding cancer-related diagnosis or intervention. Appropriateness of TM determination by patient characteristics and prescriber specialty was estimated by using multivariate analyses. A total of 51,395 TM determinations in 36,537 patients were included. An amount of 41.6% of all TM were determined appropriately. General practitioners most often determined TM (44.3%) and had the lowest number of appropriate requests (27.8%). A strong predictor for appropriate determinations were requests by medical oncologists. A remarkable proportion of TM testing was performed inappropriately, particularly in the primary care setting. Our results suggest that a considerable proportion of the population is at risk for various harms associated with misinterpretations of TM test results.

Initial prescriptions and medication switches of biological products: an analysis of prescription pathways and determinants in the Swiss healthcare setting.

OBJECTIVES: Biological products have contributed to extraordinary advances in disease treatments over the last decade. However, the cost-saving potential of imitator products, so-called biosimilars, is still under-researched in Switzerland. This study aims to assess biosimilars' prescriptions at treatment initiation and their determinants, as well as biological therapy switches. DESIGN: The study included all patients who had at least one biosimilar available on the market at the time when they were prescribed a biological product. We analysed longitudinal data for biosimilar prescriptions in Switzerland using descriptive statistics and logistic regression to quantify the associations with individual, pharmaceutical and provider-related variables. SETTING: The analysis is based on de-identified claims data of patients with mandatory health insurance at Helsana, one of the Swiss health insurance companies with a substantial enrollee base in mandatory health insurance. PARTICIPANTS: Overall, 18 953 patients receiving at least one biological product between 2016 and 2021 were identified. OUTCOME MEASURES: We differentiated between initial prescriptions and follow-up prescriptions. Our regression focused on initial prescriptions due to evidence indicating that patients tend to follow the medication prescribed at therapy initiation. RESULTS: Although biosimilars' market share was low (28.6%), the number of prescriptions has increased (from 1016 in 2016 to 6976 in 2021). Few patients with medication switches (n=1492, 8.5%) were detected. Increased relative price difference (difference in the price of available biosimilars relative to price of corresponding reference product) was associated with decreased probability of biosimilar prescriptions, whereas male sex, an increase of available imitator drugs on the market, larger packaging sizes, and prescriptions from specialists or physicians in outpatient settings were associated with increased biosimilar use. CONCLUSION: The low number of biosimilar prescriptions, despite the proliferating biosimilar market, indicates a high potential for biosimilar diffusion. The findings indicate that patients typically adhere to the therapy options initially chosen and are less inclined to make changes following the initiation of treatment. Our research highlights the need for awareness initiatives to improve understanding among patients and physicians, enabling informed, shared decision-making about biosimilar prescriptions.

Prevalence, trends, and individual patterns of long-term antidepressant medication use in the adult Swiss general population.

PURPOSE: Antidepressant use has increased in many European countries, mostly driven by longer treatment duration. The aim of this study was to provide prevalence rates of long-term users of antidepressants for the Swiss population over the last decade and to investigate associated factors for longer use. METHODS: We examined the prevalence rates of individuals with at least one prescription for antidepressants using longitudinal health claims data for 2013 to 2021. We defined short- (< one year), medium- (one-two years), and long-term users (> two years) for 2015 to 2019. We applied a binary logistic regression model to investigate the effects of population (gender, age, area of living, language, health insurance plan, and nursing home) and treatment characteristics (psychiatric or psychotherapeutic care) on long-term compared to short- and medium-term users in 2019. RESULTS: In 2021, 9% of the Swiss population (n = 770,698) received at least one antidepressant prescription, which remained stable since 2013. In 2019, the proportion of long-term users was 57.4%, with steady increase since 2015. The proportion of medium- and short-term users has decreased. Older age, being a woman, living in an urban area, living in a nursing home, being enrolled in a standard care plan, and receiving psychiatric or psychotherapeutic care were factors positively associated with being a long-term user. CONCLUSION: The proportion of long-term users in Switzerland is high and steadily increasing. Given the ongoing debate about the confounding effects of relapse and withdrawal, more research is needed to investigate longer use of antidepressants that could indicate overprescribing.

Estimating the cost impact of atrial fibrillation using a prospective cohort study and population-based controls.

AIMS: Atrial fibrillation (AF) costs are expected to be substantial, but cost comparisons with the general population are scarce. Using data from the prospective Swiss-AF cohort study and population-based controls, we estimated the impact of AF on direct healthcare costs from the Swiss statutory health insurance perspective. METHODS: Swiss-AF patients, enrolled from 2014 to 2017, had documented, prevalent AF. We analysed 5 years of follow-up, where clinical data, and health insurance claims in 42% of the patients were collected on a yearly basis. Controls from a health insurance claims database were matched for demographics and region. The cost impact of AF was estimated using five different methods: (1) ordinary least square regression (OLS), (2) OLS-based two-part modelling, (3) generalised linear model-based two-part modelling, (4) 1:1 nearest neighbour propensity score matching and (5) a cost adjudication algorithm using Swiss-AF data non-comparatively and considering clinical data. Cost of illness at the Swiss national level was modelled using obtained cost estimates, prevalence from the Global Burden of Disease Project, and Swiss population data. RESULTS: The 1024 Swiss-AF patients with available claims data were compared with 16 556 controls without known AF. AF patients accrued CHF5600 (EUR5091) of AF-related direct healthcare costs per year, in addition to non-AF-related healthcare costs of CHF11100 (EUR10 091) per year accrued by AF patients and controls. All five methods yielded comparable results. AF-related costs at the national level were estimated to amount to 1% of Swiss healthcare expenditure. CONCLUSIONS: We robustly found direct medical costs of AF patients were 50% higher than those of population-based controls. Such information on the incremental cost burden of AF may support healthcare capacity planning.

The Impact of COVID-19 on Mental Healthcare Utilization in Switzerland Was Strongest Among Young Females-Retrospective Study in 2018-2020.

Objectives: To provide a thorough assessment of the impact of the COVID-19 pandemic on the utilization of inpatient and outpatient mental healthcare in Switzerland. Methods: Retrospective cohort study using nationwide hospital data (n > 8 million) and claims data from a large Swiss health insurer (n > 1 million) in 2018-2020. Incidence proportions of different types of psychiatric inpatient admissions, psychiatric consultations, and psychotropic medication claims were analyzed using interrupted time series models for the general population and for the vulnerable subgroup of young people. Results: Inpatient psychiatric admissions in the general population decreased by 16.2% (95% confidence interval: -19.2% to -13.2%) during the first and by 3.9% (-6.7% to -0.2%) during the second pandemic shutdown, whereas outpatient mental healthcare utilization was not substantially affected. We observed distinct patterns for young people, most strikingly, an increase in mental healthcare utilization among females aged <20 years. Conclusion: Mental healthcare provision for the majority of the population was largely maintained, but special attention should be paid to young people. Our findings highlight the importance of monitoring mental healthcare utilization among different populations.

Does the implementation of an incentive scheme increase adherence to diabetes guidelines? A retrospective cohort study of managed care enrollees.

BACKGROUND: A novel incentive scheme based on a joint agreement of a large Swiss health insurance with 56 physician networks was implemented in 2018. This study evaluated the effect of its implementation on adherence to evidence-based guidelines among patients with diabetes in managed care models. METHODS: We performed a retrospective cohort study, using health care claims data from patients with diabetes enrolled in a managed care plan (2016-2019). Guideline adherence was assessed by four evidence-based performance measures and four hierarchically constructed adherence levels. Generalized multilevel models were used to examine the effect of the incentive scheme on guideline adherence. RESULTS: A total of 6'273 patients with diabetes were included in this study. The raw descriptive statistics showed minor improvements in guideline adherence after the implementation. After adjusting for underlying patient characteristics and potential differences between physician networks, the likelihood of receiving a test was moderately but consistently higher after the implementation of the incentive scheme for most performance measures, ranging from 18% (albuminuria: OR, 1.18; 95%-CI, 1.05-1.33) to 58% (HDL cholesterol: OR, 1.58; 95%-CI, 1.40-1.78). Full adherence was more likely after implementation of the incentive scheme (OR, 1.37; 95%-CI, 1.20-1.55), whereas level 1 significantly decreased (OR, 0.74; 95%-CI, 0.65 - 0.85). The proportions of the other adherence levels were stable. CONCLUSION: Incentive schemes including transparency of the achieved performance may be able to improve guideline adherence in patients with diabetes and are promising to increase quality of care in this patient population.

Opioid prescriptions after knee replacement: a retrospective study of pathways and prognostic factors in the Swiss healthcare setting.

OBJECTIVES: The optimal use of opioids after knee replacement (KR) remains to be determined, given the growing evidence that opioids are no more effective than other analgesics and that their adverse effects can impair quality of life. Therefore, the objective is to examine opioid prescriptions after KR. DESIGN: In this retrospective study, we used descriptive statistics and estimated the association of prognostic factors using generalised negative binomial models. SETTING: The study is based on anonymised claims data of patients with mandatory health insurance at Helsana, a leading Swiss health insurance. PARTICIPANTS: Overall, 9122 patients undergoing KR between 2015 and 2018 were identified. PRIMARY AND SECONDARY OUTCOME MEASURES: Based on reimbursed bills, we calculated the dosage (morphine equivalent dose, MED) and the episode length (acute: <90 days; subacute: ≥90 to <120 days or <10 claims; chronic: ≥90 days and ≥10 claims or ≥120 days). The incidence rate ratios (IRRs) for postoperative opioids were calculated. RESULTS: Of all patients, 3445 (37.8%) received opioids in the postoperative year. A large majority had acute episodes (3067, 89.0%), 2211 (65.0%) had peak MED levels above 100 mg/day and most patients received opioids in the first 10 postoperative weeks (2881, 31.6%). Increasing age (66-75 and >75 vs 18-65) was associated with decreased IRR (0.776 (95% CI 0.7 to 0.859); 0.723 (95% CI 0.649 to 0.805)), whereas preoperative non-opioid analgesics and opioids were associated with higher IRR (1.271 (95% CI 1.155 to 1.399); 3.977 (95% CI 4.409 to 3.591)). CONCLUSION: The high opioid demand is unexpected given that current recommendations advise using opioids only when other pain therapies are ineffective. To ensure medication safety, it is important to consider alternative treatment options and ensure that benefits outweigh potential risks.

Patient clusters and cost trajectories in the Swiss Atrial Fibrillation cohort.

OBJECTIVE: Evidence on long-term costs of atrial fibrillation (AF) and associated factors is scarce. As part of the Swiss-AF prospective cohort study, we aimed to characterise AF costs and their development over time, and to assess specific patient clusters and their cost trajectories. METHODS: Swiss-AF enrolled 2415 patients with variable duration of AF between 2014 and 2017. Patient clusters were identified using hierarchical cluster analysis of baseline characteristics. Ongoing yearly follow-ups include health insurance clinical and claims data. An algorithm was developed to adjudicate costs to AF and related complications. RESULTS: A subpopulation of 1024 Swiss-AF patients with available claims data was followed up for a median (IQR) of 3.24 (1.09) years. Average yearly AF-adjudicated costs amounted to SFr5679 (€5163), remaining stable across the observation period. AF-adjudicated costs consisted mainly of inpatient and outpatient AF treatment costs (SFr4078; €3707), followed by costs of bleeding (SFr696; €633) and heart failure (SFr494; €449). Hierarchical analysis identified three patient clusters: cardiovascular (CV; N=253 with claims), isolated-symptomatic (IS; N=586) and severely morbid without cardiovascular disease (SM; N=185). The CV cluster and SM cluster depicted similarly high costs across all cost outcomes; IS patients accrued the lowest costs. CONCLUSION: Our results highlight three well-defined patient clusters with specific costs that could be used for stratification in both clinical and economic studies. Patient characteristics associated with adjudicated costs as well as cost trajectories may enable an early understanding of the magnitude of upcoming AF-related healthcare costs.

Childhood vaccination coverage and regional differences in Swiss birth cohorts 2012-2021: Are we on track?

AIMS: Many western countries are challenged by delayed and insufficient vaccination coverage rates in children, and thus missing WHO coverage targets. This study aimed to estimate vaccination coverage and timeliness in Swiss children over a decade. Furthermore, we evaluated the impact of COVID-19, regional variations, and the adherence to the amended vaccination schedule in 2019. METHODS: Retrospective observational study with Swiss health insurance claims data including birth cohorts 2012-2021 of children continuously observed until ages 13, 25, and 48 months respectively. We used population-weighted proportions and time-to-event analyses to describe coverage and timeliness of diphtheria/tetanus/pertussis/poliomyelitis/haemophilus influenzae type b (DTaP-IPV-Hib), measles/mumps/rubella (MMR), hepatitis B (HBV), pneumococcal (PCV), and meningococcal (MCV) vaccinations according to the national schedule. The potential impact of COVID-19 and vaccination schedule adherence were evaluated descriptively. Logistic regression was used to investigate regional factors potentially associated with non-vaccination. RESULTS: 120,073 children, representing between 12 and 17 % of all Swiss children born in corresponding years, were included. Coverage remained stable or improved over the years. The 2019 amendment of the national immunization schedule was associated with an increase of ~10 % points in full coverage in Swiss children for DTaP-IPV-Hib, MMR and HBV despite the concurrent COVID-19 pandemic. Nonetheless, full vaccination coverage remained below 90 % with many vaccination series being delayed or not completed. The comparison across the different vaccines revealed large differences in coverage. Moreover, we observed large regional differences in non-vaccination with children living in rural and German-speaking areas more likely to be entirely unvaccinated. CONCLUSION: Full vaccination coverage in Swiss children is still below 90 % with many vaccinations administered delayed. Given regional differences, missed or delayed booster vaccinations, and differences in vaccine-specific acceptability, more effort may be needed to achieve national vaccination targets.

Utilization of Drugs with Pharmacogenetic Dosing Recommendations in Switzerland: A Descriptive Study Using the Helsana Database.

Purpose: In Switzerland 167 drugs on the market contain information about pharmacogenetics in their drug label (PGx drug). Preemptive pharmacogenetic testing is reimbursed by health care insurance for only seven drugs (abacavir, carbamazepine, 6-mercaptopurine, azathioprine, 5-fluorouracil, capecitabine, and irinotecan) although, it is proposed to be a cost-effective approach to personalized medicine. The aim of this study was to describe the use of PGx drugs and their corresponding genes in Switzerland. Methods: We identified 90 drugs with dosing recommendations from the Pharmacogenetic Knowledgebase involving 24 genes. We assessed the utilization of those drugs between 2016 and 2020, using claims data from a large Swiss insurance company (Helsana). Results: Of 841 491 persons with drug claims during the whole study period, 78.7% were exposed to PGx drugs. Ibuprofen, pantoprazole, and tramadol had the highest number of users. Seven genes (CYP2C19, CYP2C9, CYP2D6, SLCO1B1, HLA-B, MT-RNR1, and VKORC1) were responsible for over 95% of all potential drug-gene interactions. Conclusion: The prevalence of PGx drug prescriptions is high in the Swiss population. Therefore, intensified preemptive testing may be a useful option as a substantial amount of the Swiss population might benefit.

Secondary prevention of venous thromboembolism: Predictors and outcomes of guideline adherence in a long-term prospective cohort study.

Background: Prevention of recurrent venous thromboembolism (VTE) is considered a main goal of VTE management. However, the extent to which physicians adhere to the recommendations from evidence-based guidelines is unknown. Aim: From a large, prospective clinical cohort, we aimed to (1) quantify the adherence of treatment recommendations to evidence-based guidelines and establish its predictors, and (2) estimate its impact on clinical outcomes and costs in patients with VTE. Methods: We included 6'243 consecutive patients with VTE treated at the university outpatient unit. Detailed clinical characteristics and treatment recommendations were recorded. Adherence of treatment recommendations to evidence-based guidelines at risk assessment was assessed in terms of duration of anticoagulant treatment. Data on death were obtained from the Swiss Central Compensation Office. Health care claims data recorded between 2014 and 2019 were retrieved from Helsana, one of the largest Swiss health insurance companies. Results: The adherence to evidence-based guidelines was 36.1%. Among patients with non-adherence, overtreatment was present in 70.1%. Significant patient-related predictors of guideline adherence were (a) age above 50 years, (b) male sex, (c) pulmonary embolism, (d) unprovoked VTE, (e) multiple VTE, (f) laboratory tests not ordered, and (g) various cardiovascular comorbidities. Non-adherence was not significantly associated with mortality, hospitalization, admission to nursing home, and costs. Conclusions: The adherence to evidence-based guidelines was low, and several unrelated predictors appeared. Although these results need to be confirmed in other settings, they highlight the need for implementation of evidence-based guidelines in clinical practice.

Evidence-based indicators for the measurement of quality of primary care using health insurance claims data in Switzerland: update of the SQUIPRICA working group.

BACKGROUND: The level of quality of care of ambulatory services in Switzerland is almost completely unknown. Since health insurance claims are the only nationwide applicable and available data source for this purpose, a set of 24 quality indicators (QI) for the measurement of quality of primary care has been previously developed and implemented. The present paper reports on an evidence-based update and extension of the initial QI set. METHODS: Established pragmatic 6-step process based on informal consensus and potential QI extracted from international medical practice guidelines and pre-existing QI for primary care. Experts rated potential QI based on strength of evidence, relevance for Swiss public health, and controllability in the Swiss primary care context. Feasibility of a preliminary set of potential new QI was tested using claims data of persons with basic mandatory health insurance at one of the largest Swiss health insurers. This test built the basis for expert consensus on the final set of new QI. Additionally, two diabetes indicators included in the previous QI set were re-evaluated. RESULTS: Of 23 potential new indicators, 19 of them were selected for feasibility testing. The expert group consented a final set of 9 additional QI covering the domains general aspects/efficiency (2 QI), diagnostic measures (1 QI), geriatric care (2 QI), osteoarthritis (1 QI), and drug safety (3 QI). Two pre-existing diabetes indicators were updated. CONCLUSIONS: Additional QI relating to overuse and intersectoral care aspects extend the options of measuring quality of primary care in Switzerland based on claims data and complement the initial QI set.

Current Knowledge on Factor V Leiden Mutation as a Risk Factor for Recurrent Venous Thromboembolism: A Systematic Review and Meta-Analysis.

Background: Thrombophilia screening is widely done in clinical practice, and it is claimed that the extent of venous thromboembolism (VTE) recurrence risk in patients with common defects is still not fully understood. Aim: We aimed to summarize data of all observational studies prospectively assessing the association of heterozygous factor V Leiden (FVL) mutation and recurrent VTE in patients with VTE, and to calculate pooled relative risks (RR), overall and in various subgroups. Methods: We searched MEDLINE and EMBASE databases for cohort studies prospectively assessing VTE recurrence in patients with and without FVL mutation (PROSPERO: CRD42021182800). Data were extracted on cohort and study-level. The methodological quality was assessed using the Newcastle-Ottawa Scale (NOS). RR were calculated overall and in subgroups using a random-effects model. Results: From 31 cohorts, 24 studies were finally included summarizing 13,571 patients. Heterozygous FVL mutation was identified in 2,840 individuals (21%). The methodological quality was estimated to be high in 20 studies (83%). The overall RR was 1.46 (95% CI: 1.31, 1.64), consistent across subgroups. Conclusions: Pooling all high-quality epidemiological data, the risk of recurrent VTE was increased by 46% in patients with heterozygous FVL mutation. Against the background of established risk factors, the FVL mutation plays only a marginal role in the risk assessment for recurrent VTE.

Pulmonary vein isolation using cryoballoon ablation versus RF ablation using ablation index following the CLOSE protocol: A prospective randomized trial.

BACKGROUND: The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) vary between 80% and 90%. This prospective, randomized study investigated the efficacy of cryoballoon PVI (CBA) versus PVI with radio-frequency (RF)-energy following the CLOSE protocol (ablation index [AI], interlesion distance ≤6 mm, surround flow catheter) in terms of single-procedure arrhythmia-free outcome and safety. METHODS AND RESULTS: A total number of 150 patients undergoing de novo catheter ablation for paroxysmal AF were randomized to two different treatment arms. In group A patients, PVI was performed with the 23 or 28 mm cryoballoon (Artic Front™ Balloon in conjunction with an Achieve Mapping Catheter, Medtronic Inc.). The ablation procedure in group B was performed with RF-energy, using AI and following the CLOSE protocol. PVI using AI incorporates stability, contact force (CF), time, and power. The CLOSE protocol combines AI and ≤6 mm interlesion distance using a surround flow catheter (Biosense Webster Thermocool STSF). A total of 75 patients were randomized into each group without significant differences in baseline characteristics. During a mean follow-up of 12 ± 4.5 months after a single procedure, 64 (85.33%) patients of group A were free of arrhythmia recurrence versus 65 (86.67%) patients in group B (p = ns). A total of 14 patients (group A: 7 [9.33%]; group B: 7 [9.33%]; p = ns) underwent a redo-procedure. No significant difference between both groups was observed in terms of PV recovery (group A: 4 [5.33%] vs. group B: 3 [4%]; p = ns). In two patients of group A and four patients of group B, the PVs were durably isolated, whereas the patients had AF recurrence caused by extra-PV AF sources. Two patients of each group had continued paroxysmal AF but did not undergo redo-procedure. Patients of group A showed significantly more AF recurrence during the blanking period of 3 months (group A: 14 [18.67%] vs. group B: 6 [8%]; p < .05). With regard to the procedural data, the procedure time was significantly shorter in group A (70.53 ± 16.13 vs. 115.35 ± 15.38; p < .01); the flouroscopy time and dose area product showed no significant differences (Table 2). Both procedures were performed with a low number of complications; no pericardial effusion was seen in either group; in group A two patients had a significant hematoma of the groin with the need for surgical repair. CONCLUSIONS: Cryoballoon PVI and PVI using ablation index following the CLOSE protocol are equally efficient in achieving durable PV isolation. In this study, cryoballoon ablation led to significantly more AF recurrence during the blanking period.

Improved durable pulmonary vein isolation with shorter procedure times and lower energy levels using RF ablation with ablation index and a stringent lesion contiguity.

BACKGROUND: The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) varies between 80 and 90%. Ablation index, incorporating contact force, stability, time and power is a more profound parameter of significant lesion size and has been established. Equally important is a stringent contiguity of the lesion set. METHODS AND RESULTS: A total number of 100 consecutive patients undergoing de-novo catheter ablation for paroxysmal atrial fibrillation (PAF) were analyzed between 2016 and 2019. In the first 50 patients (group A) PVI was performed using a surround flow, contact force catheter (Biosense Webster Thermocool STSF, Biosense Webster, USA) with a drag-and-ablate technique to encircle the PVs. In the following 50 patients (group B), PVI was performed using ablation index and a stringent lesion contiguity with an interlesion distance (ILD) of <5 mm. The baseline characteristics showed no significant differences between both groups. During a mean follow-up of 18 ± 3 months after a single procedure, 36 (72%) patients of group A were free of arrhythmia recurrence versus 43 (86%) patients in group B (p = 0.047). A total of 14 patients (group A: 10 (20%), group B: 4 (8%); underwent a redo-procedure. 7 patients of group A (14%) and 2 patients of group B (4%) showed recovered veins. In 3 patients of group A and 2 patients of group B the PVs were durably isolated. In these patients persistent AF recurrence was caused by extra-PV AF sources. Four patients of group A and three patients of group B had continued paroxysmal or persistent AF but did not undergo redo-procedure. With regard to the procedural data, the procedure time, the total energy and the fluoroscopy time were significantly lower in group B (AI and ILD <5 mm) (128.86 ± 18.19 versus 115.35 ± 15.38; p < 0.05; 1619.16 ± 988.56 versus 1186.26 ± 756.34; p < 0.05; 11.49 ± 3.20 versus 9.66 ± 3.86; p = 0.04). Both procedures were performed with a low number of complications, no pericardial effusion was seen in either group. CONCLUSIONS: PVI using ablation index in combination with a stringent lesion contiguity improves clinical outcome after first-time PVI with lower PVI recovery, shorter procedure times, lower total energy and shorter fluoroscopy times and therefore, is more efficient.