Prevalence of Critical Errors and Insufficient Peak Inspiratory Flow in Patients Hospitalized with COPD in a Department of General Internal Medicine: A Cross-Sectional Study.

Background: The suboptimal use of inhalers in the treatment of patients with chronic obstructive pulmonary disease (COPD) is probably a major but poorly documented problem in hospitalized patients. We aimed to describe the prevalence of misused inhalers among patients hospitalized with COPD in a department of general internal medicine. Methods: We conducted a monocentric cross-sectional study in consecutive patients with a diagnosis of COPD and hospitalized between August 2022 and April 2023 in the internal medicine division of Fribourg Hospital, Switzerland. Patients underwent an assessment of their inhaler technique and peak inspiratory flow (PIF) using the In-Check Dial G16®. The primary outcome was the prevalence of misused inhalers, defined as an inhaler used with a critical error and/or insufficient PIF. Secondary outcomes included the prevalence of inhaler unsuitable to patient characteristics and of patients using at least one misused inhaler. Results: The study included 96 patients and 160 inhalers were assessed at admission. Among these inhalers, 111 (69.4%; 95% confidence interval [CI] 61.6-76.4) were misused; 105 (65.6%; 95% CI 57.7-72.9) due to the presence of a critical error in the inhalation technique and 22 (13.8%; 95% CI 8.8-20.1) due to insufficient PIF. Concerning the secondary outcome, 27 inhalers (16.9%) were unsuitable and 79 patients (82.3%) used at least one misused inhaler. Conclusion: Among patients hospitalized with a diagnosis of COPD, two-thirds of inhalers were misused. Suboptimal use was mainly due to the presence of critical errors, but also to the presence of an insufficient PIF and unsuitable inhalers.

An in-hospital intervention to reduce the proportion of misused inhalers at hospital discharge among patients with COPD: a non-randomised intervention study.

AIMS OF THE STUDY: Misuse of inhalers during chronic obstructive pulmonary disease (COPD) treatment is common and may result from errors in inhalation technique or insufficient peak inspiratory flow (PIF). We aimed to evaluate the impact of an in-hospital intervention to reduce inhaler misuse at hospital discharge among patients with COPD. METHODS: We conducted a monocentric, non-randomised intervention study to compare the proportion of misused inhalers at hospital discharge by patients with COPD between a group with standard care and a group receiving an in-hospital intervention. The control group successively included all patients hospitalised between March and June 2022, and the intervention group included patients hospitalised between August and December 2022. The intervention consisted of (a) an evaluation of inhalation technique and PIF at admission, (b) the provision of a written guide to assist in the selection of an inhaler, and (c) therapeutic education. The primary outcome was the proportion of misused inhalers, defined as an inhaler used with a critical error and/or insufficient PIF, at hospital discharge. The primary outcome was assessed by observing inhalation technique and measuring PIF using the In-Check DIAL G16® . RESULTS: The study included 93 patients: 46 in the control group and 47 in the intervention group. Mean age was 70.5 years (SD 10.9 years), 56 patients (60.2%) were men, and 57 patients (62%) were hospitalised for a COPD exacerbation. Patients used an average of 1.9 inhalers at hospital discharge; 98 inhalers were assessed in the control group and 81 in the intervention group. The proportion of misused inhalers at discharge was 61.2% in the control group and 21.0% in the intervention group (absolute risk reduction 40.2% [95% CI 25.5-55.0]; p <0.01). In the intervention group, the proportion of inhalers used with at least one critical error was reduced by 38.6% (95% CI 24.3-52.3%) and that of inhalers used with insufficient PIF by 13.9% (95% CI 4.2-23.6%). CONCLUSIONS: An in-hospital intervention was associated with a reduction in the proportion of misused inhalers at hospital discharge. This intervention should be considered for hospitalised patients with COPD. The trial was registered with ClinicalTrials.gov (NCT05207631).

Differences in duration of anticoagulation after pulmonary embolism and deep vein thrombosis: Findings from the SWIss Venous ThromboEmbolism Registry (SWIVTER).

BACKGROUND: Although the two manifestations of venous thromboembolism (VTE), deep vein thrombosis (DVT) and pulmonary embolism (PE), vary considerably, the consensus guidelines recommend similar algorithms for therapeutic anticoagulation in both conditions. Real-world data assessing contemporary management strategies in PE and DVT alone may help tailoring future recommendations towards more individualized patient care. METHODS: In the present analysis, we compared demographics, comorbidities, treatment patterns, and clinical outcomes of PE versus DVT only among 2062 consecutive patients with confirmed VTE enrolled by 11 acute care hospitals between November 2012 and February 2015 in the SWIss Venous ThromboEmbolism Registry (SWIVTER). RESULTS: Overall, 1246 (60 %) patients were diagnosed with PE. In comparison to DVT alone, PE patients were older (66 vs. 59 years; p < 0.001), more frequently had acute and chronic comorbidities, less frequently had prior VTE and hormone replacement, and were less often pregnant. VTE was considered similarly often provoked in patients with PE and DVT alone (33.8 % vs. 33.5 %; p = 0.88). Anticoagulation for an indefinite duration was more often prescribed to patients with PE than those with DVT alone (45.7 vs. 19.6 %; p < 0.001), and PE diagnosis was the strongest independent predictor of indefinite anticoagulation (OR 3.21; 95 % CI 2.55-4.06; p < 0.001). Diagnosis of PE was associated with both increased risk of 90-day mortality (HR 2.31, 95 % CI 1.44-3.71; p = 0.001) and major bleeding (HR 3.88, 95 % CI 1.63-9.22; p = 0.002). CONCLUSIONS: Our analysis affirms differences in demographics, risk factors, and clinical outcomes of PE versus DVT alone. In routine clinical practice, duration of anticoagulation is being managed differently between the two manifestations of VTE, in contrast to recommendations of the current consensus guidelines.

Impact of concomitant popliteal vein thrombosis in patients with acute iliofemoral deep vein thrombosis treated with endovascular early thrombus removal.

Background: Catheter-based thrombus removal (CBTR) reduces the risk of moderate to severe post-thrombotic syndrome (PTS) in patients with acute iliofemoral deep vein thrombosis (IF-DVT). However, the impact of concomitant popliteal DVT on clinical and duplex sonographic outcomes is unknown. Patients and methods: In this post-hoc analysis including the entire cohort of the randomized controlled BERNUTIFUL trial (48 patients), we compared clinical (incidence/severity of PTS assessed by Villalta score and revised venous clinical severity scores, rVCSS), disease-specific quality-of-life (QOL, CIVIQ-20 survey) and duplex sonographic outcomes (patency, reflux, post-thrombotic lesions) at 12 months follow-up between patients with IF-DVT with and without concomitant popliteal DVT treated by CBTR. Results: Overall, 48 IF-DVT patients were included (48% men, median age of 50 years), of whom 17 (35%) presented with popliteal DVT. At baseline, patients with popliteal DVT were older, had a higher body mass index and more important leg swelling. At 12 months, freedom from PTS (93% vs 87%, P=0.17), median total Villalta score (1 vs 1.5; P=0.46), rVCSS (2 vs 1.5, P=0.5) and disease-specific QOL (24 points vs 24 points, P=0.72) were similar between patient with and without popliteal DVT, respectively. Duplex sonographic outcomes were similar, except for more frequent popliteal post-thrombotic lesions and reflux (P=0.02) in patients with popliteal DVT. Conclusions: Relevant clinical outcomes 1 year after successful CBTR were favorable, regardless of the presence or absence of concomitant popliteal DVT. However, post-thrombotic popliteal vein lesions and reflux are more frequent in IF-DVT patients with popliteal involvement. Their impact on long-term outcomes remains to be investigated.

Silent brain infarcts impact on cognitive function in atrial fibrillation.

AIMS: We aimed to investigate the association of clinically overt and silent brain lesions with cognitive function in atrial fibrillation (AF) patients. METHODS AND RESULTS: We enrolled 1227 AF patients in a prospective, multicentre cohort study (Swiss-AF). Patients underwent standardized brain magnetic resonance imaging (MRI) at baseline and after 2 years. We quantified new small non-cortical infarcts (SNCIs) and large non-cortical or cortical infarcts (LNCCIs), white matter lesions (WML), and microbleeds (Mb). Clinically, silent infarcts were defined as new SNCI/LNCCI on follow-up MRI in patients without a clinical stroke or transient ischaemic attack (TIA) during follow-up. Cognition was assessed using validated tests. The mean age was 71 years, 26.1% were females, and 89.9% were anticoagulated. Twenty-eight patients (2.3%) experienced a stroke/TIA during 2 years of follow-up. Of the 68 (5.5%) patients with ≥1 SNCI/LNCCI, 60 (88.2%) were anticoagulated at baseline and 58 (85.3%) had a silent infarct. Patients with brain infarcts had a larger decline in cognition [median (interquartile range)] changes in Cognitive Construct score [-0.12 (-0.22; -0.07)] than patients without new brain infarcts [0.07 (-0.09; 0.25)]. New WML or Mb were not associated with cognitive decline. CONCLUSION: In a contemporary cohort of AF patients, 5.5% had a new brain infarct on MRI after 2 years. The majority of these infarcts was clinically silent and occurred in anticoagulated patients. Clinically, overt and silent brain infarcts had a similar impact on cognitive decline. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02105844, https://clinicaltrials.gov/ct2/show/NCT02105844.

Role of age, sex, and specific provoking factors on the distal versus proximal presentation of first symptomatic deep vein thrombosis: analysis of the SWIss Venous ThromboEmbolism Registry (SWIVTER).

We aimed to evaluate the impact of age, sex, and their interactions with provoking risk factors for deep vein thrombosis (DVT). In addition, we intended to provide additional insights on risk factors associated with the isolated distal versus proximal presentation of first symptomatic acute DVT, both being characterized by different prognosis. In the present analysis from the SWIss Venous ThromboEmbolism Registry (SWIVTER), we compared demographic and baseline characteristics in patients with isolated distal (n = 184; 35%) versus proximal (n = 346) DVT of the lower limbs without symptomatic pulmonary embolism, and identified factors related with the presenting thrombosis location. In the overall population, mean age was 59 ± 19 years, 266 (50%) were women, 106 (20%) patients had cancer, 86 (16%) recent surgery, and 52 (10%) acute infection/sepsis. In a multivariable analysis, recent surgery [odds ratio (OR) 2.92, 95% confidence interval (CI) 1.80-4.73] was independently associated with a diagnosis of isolated distal DVT, whereas cancer (OR 2.01, 95% CI 1.20-3.35), male sex aged 41 to 75 years (OR 2.21, 95% CI 1.33-3.67), and acute infection/sepsis (OR 2.71, 95% CI 1.29-5.66) with a diagnosis of proximal DVT. In SWIVTER, age, sex, and several provoking risk factors for VTE appeared to be related with the presenting location of first symptomatic DVT. Cancer, male sex, and acute infection/sepsis were associated with a proximal location of DVT, whereas recent surgery was associated with a distal presentation, likely acting as confounders for the association between thrombosis location and prognosis.

Arterial Preparation by Longitudinal Micro-Incisions Before Balloon Angioplasty of the Superficial Femoral and Popliteal Artery: Acute and 12-Month Results.

PURPOSE: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. MATERIALS AND METHODS: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. RESULTS: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%-100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10-480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. CONCLUSION: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.

Clinical Outcomes of Incidental Venous Thromboembolism in Cancer and Noncancer Patients: The SWIss Venous ThromboEmbolism Registry (SWIVTER).

OBJECTIVE: In patients with cancer-associated venous thromboembolism (VTE), the risk of recurrence is similar after incidental and symptomatic events. It is unknown whether the same applies to incidental VTE not associated with cancer. METHODS AND RESULTS: We compared baseline characteristics, anticoagulation therapy, all-cause mortality, and VTE recurrence rates at 90 days between patients with incidental (n = 131; 52% without cancer) and symptomatic (n = 1,931) VTE included in the SWIss Venous ThromboEmbolism Registry (SWIVTER). After incidental VTE, 114 (87%) patients received anticoagulation therapy for at least 3 months. The mortality rate was 9.2% after incidental and 8.4% after symptomatic VTE for hazard ratio (HR) 1.10 (95% confidence interval [CI] 0.49-2.50). After adjustment for competing risk of death, recurrence rate was 3.1 versus 2.8%, respectively, for sub-HR 1.07 (95% CI 0.39-2.93). These results were consistent among cancer (mortality: 15.9% vs. 12.6%; HR 1.32, 95% CI 0.67-2.59; recurrence: 4.8% vs. 4.7%; HR 1.02, 95% CI 0.30-3.42) and noncancer patients (mortality: 2.9% vs. 2.1%; HR 1.37, 95% CI 0.33-5.73; recurrence: 1.5% vs. 2.3%; HR 0.63, 95% CI 0.09-4.58). Patients with incidental VTE who received anticoagulation therapy for at least 3 months had lower mortality (4% vs. 41%) and recurrence rate (1% vs. 18%) compared with those who did not. CONCLUSION: In SWIVTER, more than half of incidental VTE events occurred in noncancer patients who often received anticoagulation therapy. Among noncancer patients, early mortality and recurrence rates were similar after incidental versus symptomatic VTE. Our findings suggest that anticoagulation therapy for incidental VTE may be beneficial regardless of the presence of cancer.

Characteristics, comorbidities, 30-day outcome and in-hospital mortality of patients hospitalised with COVID-19 in a Swiss area - a retrospective cohort study.

BACKGROUND: Since its first description in December 2019, coronavirus disease 19 (COVID-19) has spread worldwide. There is limited information about presenting characteristics and outcomes of Swiss patients requiring hospitalisation. Furthermore, outcomes 30 days after onset of symptoms and after hospital discharge have not been described. AIMS: To describe the clinical characteristics, outcomes 30 days after onset of symptoms and in-hospital mortality of a cohort of patients hospitalised for COVID-19 in a Swiss area. METHODS: In this retrospective cohort study, we included all inpatients hospitalised with microbiologically confirmed COVID-19 between 1 March and 12 April 2020 in the public hospital network of a Swiss area (Fribourg). Demographic data, comorbidities and outcomes were recorded. Rate of potential hospital-acquired infection, outcomes 30 days after onset of symptoms and in-hospital mortality are reported. RESULTS: One hundred ninety-six patients were included in the study. In our population, 119 (61%) were male and the median age was 70 years. Forty-nine patients (25%) were admitted to the intensive care unit (ICU). The rate of potential hospital-acquired infection was 7%. Overall, 30 days after onset of symptoms 117 patients (60%) had returned home, 23 patients (12%) were in a rehabilitation facility, 18 patients (9%) in a medical ward, 6 patients (3%) in ICU and 32 (16%) patients had died. Among patients who returned home within 30 days, 73 patients (63%) reported persistent symptoms. The overall in-hospital mortality was 17%. CONCLUSION: We report the first cohort of Swiss patients hospitalised with COVID-19. Thirty days after onset of the symptoms, 60% had returned home. Among them, 63% still presented symptoms. Studies with longer follow-up are needed to document long-term outcomes in patients hospitalised with COVID-19.

The well-being of Swiss general internal medicine residents.

BACKGROUND: Physician well-being has an impact on productivity and quality of care. Residency training is a particularly stressful period. OBJECTIVE: To assess the well-being of general internal medicine (GIM) residents and its association with personal and work-related factors. METHODS: We conducted an anonymous electronic survey among GIM residents from 13 Swiss teaching hospitals. We explored the association between a reduced well-being (≥5 points based on the Physician Well-Being Index [PWBI]) and personal and work-related factors using multivariable mixed-effects logistic regression. RESULTS: The response rate was 54% (472/880). Overall, 19% of residents had a reduced well-being, 60% felt burned out (emotional exhaustion), 47% were worried that their work was hardening them emotionally (depersonalisation), and 21% had career choice regret. Age (odds ratio [OR] 1.19, 95% confidence interval [CI] 1.05–1.34), working hours per week (OR 1.04 per hour, 95% CI 1.01–1.07) and <2.5 rewarding work hours per day (OR 3.73, 95% CI 2.01–6.92) were associated with reduced well-being. Administrative workload and satisfaction with the electronic medical record were not. We found significant correlations between PWBI score and job satisfaction (rs = -0.54, p<0.001), medical errors (rs = 0.18, p<0.001), suicidal ideation (rs = 0.12, p = 0.009) and the intention to leave clinical practice (rs = 0.38, p <0.001) CONCLUSIONS: Approximately 20% of Swiss GIM residents appear to have a reduced well-being and many show signs of distress or have career choice regret. Having few hours of rewarding work and a high number of working hours were the most important modifiable predictors of reduced well-being. Healthcare organisations have an ethical responsibility to implement interventions to improve physician well-being.

Venous Thromboembolism and Renal Impairment: Insights from the SWIss Venous ThromboEmbolism Registry (SWIVTER).

Renal impairment (RI) has increased substantially over the last decades. In the absence of data from confirmatory research, real-life data on anticoagulation treatment and clinical outcomes of venous thromboembolism (VTE) in patients with RI are needed. In the SWIss Venous ThromboEmbolism Registry (SWIVTER), 2,062 consecutive patients with objectively confirmed VTE were enrolled. In the present analysis, we compared characteristics, initial and maintenance anticoagulation, and adjusted 90-day clinical outcomes of those with (defined as estimated creatinine clearance < 30 mL/min) and without severe RI. Overall, 240 (12%) patients had severe RI; they were older, and more frequently had chronic and acute comorbidities. VTE severity was similar between patients with and without severe RI. Initial anticoagulation in patients with severe RI was more often performed with unfractionated heparin (44 vs. 24%), and less often with low-molecular-weight heparin (LMWH) (52 vs. 61%) and direct oral anticoagulants (DOACs; 4 vs. 12%). Maintenance anticoagulation in patients with severe RI was more frequently managed with vitamin K antagonists (70 vs. 60%) and less frequently with DOAC (12 vs. 21%). Severe RI was associated with increased risk of 90-day mortality (9.2 vs. 4.2%, hazard ratio [HR]: 2.27, 95% confidence interval [CI]: 1.41-3.65), but with similar risk of recurrent VTE (3.3 vs. 2.8%, HR: 1.19, 95% CI: 0.57-2.52) and major bleeding (2.1 vs. 2.0%, HR: 1.05, 95% CI: 0.41-2.68). In patients with severe RI, the use of LMWH versus any other treatment was associated with reduced mortality (HR: 0.37; 95% CI: 0.14-0.94; p = 0.036) and similar rate of major bleeding (HR: 0.59, 95% CI: 0.17-2.00; p = 0.39). Acute or chronic comorbidities rather than VTE severity or recurrence may explain increased early mortality in patients with severe RI. The higher rate of VTE recurrence, specifically fatal events, than major bleeding reinforces the need for effective anticoagulation in VTE patients with severe RI.

Enhanced Thrombolysis by Ultrasound-Assisted Catheter-Directed Thrombolysis and Microbubbles in an In Vitro Model of Iliofemoral Deep Vein Thrombosis.

There is a need to improve the efficacy and safety of catheter-directed thrombolysis (CDT) for thrombo-occlusive diseases, and ultrasound-assisted CDT (USAT) is a promising approach. We tested if thrombolysis efficacy of USAT can be improved by adding gaseous microbubbles (MB). We developed an in vitro dynamic overflow model for iliofemoral deep vein thrombosis, and added MB to an USAT system with ultrasound energy and dose of tissue plasminogen activator according to clinical practice. A total of 64 clots (mean baseline weight of 8.23 ± 1.12 g, generated from citrated human whole blood from 7 healthy male volunteers) were randomly assigned to 1 of 4 study protocols of 30 minutes' duration: negative control, CDT, USAT, and USAT + MB.Thrombolysis efficacy was assessed by measuring the change in D-dimer levels in the overflow liquid and the percentage of clot weight reduction. Compared to negative control, change in D-dimer increased by 62% (p = 0.017), 128% (p = 0.002), and 177% (p < 0.001) in the CDT, USAT, and USAT + MB groups, respectively. D-dimer increase was greater in the USAT than in the CDT group (p = 0.014), and greater in the USAT + MB than in the USAT group (p = 0.033). Compared to negative control, percentage of clot weight reduction increased by 123% (p = 0.016), 154% (p = 0.002), and 233% (p < 0.001) in the CDT, USAT, and USAT + MB groups, respectively. Percentage of clot weight reduction was greatest in the USAT + MB group (p < 0.05 compared with all other groups). In conclusion, our in vitro study suggests that the thrombolytic efficacy of USAT in human whole blood clots can be improved by local administration of MB.

Relationships of Overt and Silent Brain Lesions With Cognitive Function in Patients With Atrial Fibrillation.

BACKGROUND: Patients with atrial fibrillation (AF) have an increased risk of cognitive decline, potentially resulting from clinically unrecognized vascular brain lesions. OBJECTIVES: This study sought to assess the relationships between cognitive function and vascular brain lesions in patients with AF. METHODS: Patients with known AF were enrolled in a multicenter study in Switzerland. Brain magnetic resonance imaging (MRI) and cognitive testing using the Montreal Cognitive Assessment (MoCA) were performed in all participants. Large noncortical or cortical infarcts (LNCCIs), small noncortical infarcts (SNCIs), microbleeds, and white matter lesions were quantified by a central core laboratory. Clinically silent infarcts were defined as infarcts on brain MRI in patients without a clinical history of stroke or transient ischemic attack. RESULTS: The study included 1,737 patients with a mean age of 73 ± 8 years (28% women, 90% taking oral anticoagulant agents). On MRI, LNCCIs were found in 387 patients (22%), SNCIs in 368 (21%), microbleeds in 372 (22%), and white matter lesions in 1715 (99%). Clinically silent infarcts among the 1,390 patients without a history of stroke or transient ischemic attack were found in 201 patients with LNCCIs (15%) and 245 patients with SNCIs (18%). The MoCA score was 24.7 ± 3.3 in patients with and 25.8 ± 2.9 in those without LNCCIs on brain MRI (p < 0.001). The difference in MoCA score remained similar when only clinically silent LNCCIs were considered (24.9 ± 3.1 vs. 25.8 ± 2.9; p < 0.001). In a multivariable regression model including all vascular brain lesion parameters, LNCCI volume was the strongest predictor of a reduced MoCA (ß = -0.26; 95% confidence interval: -0.40 to -0.13; p < 0.001). CONCLUSIONS: Patients with AF have a high burden of LNCCIs and other brain lesions on systematic brain MRI screening, and most of these lesions are clinically silent. LNCCIs were associated with worse cognitive function, even among patients with clinically silent infarcts. Our findings raise the question of MRI screening in patients with AF.

Handheld ECG Tracking of in-hOspital Atrial Fibrillation The HECTO-AF trial Clinical Study Protocol.

BACKGROUND/RATIONALE: Atrial fibrillation (AF) is frequent and causes great morbidity in the aging population. While initial events may be symptomatic, many patients have silent AF and are at risk of ischemic embolic complications. Timely detection of asymptomatic patients is paramount. The HECTO-AF trial aims to investigate the efficacy of an electrocardiogram (ECG) handheld device for the detection of AF in patients in hospital without a prior diagnosis of AF. METHODS/DESIGN: The "Handheld ECG tracking of in-hospital atrial fibrillation" (HECTO-AF) study is a single-center, open-label, randomized controlled trial. The study population consists of all adult patients admitted to a general medicine ward of the University and Hospital of Fribourg throughout the study period. The study will enroll 1600 patients with 1:1 ratio allocation to either the detection group with one-lead handheld ECG recordings twice daily and extra recordings in the case of palpitations, versus a control group undergoing detection of AF as per routine clinical practice. Recordings will be self-performed after dedicated training, and will be independently adjudicated through a specific web-based interface. All enrolled patients will be followed clinically at 1, 2 and 5 years to assess the occurrence of AF, death, non-fatal stroke, systemic embolism, myocardial infarction and bleeding. The primary outcome is incidence of newly detected AF during the hospital stay. Secondary outcomes are incidence of AF, cardiovascular death, stroke, myocardial infarction and bleeding complications at 1, 2 and 5 years. DISCUSSION: HECTO-AF is an independent randomized study aiming to detect the incidence of silent AF in all-comers hospitalized in general medicine wards. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03197090 . Registered on 23 June 2017. Local ethical Committee (CER-VD) registration number: 2017-01594. There are no conflicts of interest to declare.

Comparative Performance of Clinical Risk Assessment Models for Hospital-Acquired Venous Thromboembolism in Medical Patients.

BACKGROUND: Improved thromboprophylaxis for acutely ill medical patients relies on valid predictions of thrombotic risks. Our aim was to compare the performance of the Improve and Geneva clinical risk assessment models (RAMs), and to simplify the current Geneva RAM. METHODS: Medical inpatients from eight Swiss hospitals were prospectively followed during 90 days, for symptomatic venous thromboembolism (VTE) or VTE-related death. We compared discriminative performance and calibration of the RAMs, using time-to-event methods with competing risk modelling of non-VTE death. RESULTS: In 1,478 patients, the 90-day VTE cumulative incidence was 1.6%. Discrimination of the Improve and Geneva RAM was similar, with a 30-day AUC (areas under the curve) of 0.78 (95% CI [confidence interval]: 0.65-0.92) and 0.81 (0.73-0.89), respectively. According to the Improve RAM, 68% of participants were at low risk (0.8% VTE at 90 days), and 32% were at high risk (4.7% VTE), with a sensitivity of 73%. According to the Geneva RAM, 35% were at low risk (0.6% VTE) and 65% were at high risk (2.8% VTE), with a sensitivity of 90%. Among patients without thromboprophylaxis, the sensitivity was numerically greater in the Geneva RAM (85%) than in the Improve RAM (54%). We derived a simplified Geneva RAM with comparable discrimination and calibration as the original Geneva RAM. CONCLUSIONS: We found comparably good discrimination of the Improve and Geneva RAMs. The Improve RAM classified more patients as low risk, but with possibly lower sensitivity and greater VTE risks, suggesting that a lower threshold for low risk (<2) should be used. The simplified Geneva RAM may represent an alternative to the Geneva RAM with enhanced usability.

Percutaneous increase of mitral leaflet coaptation length after mitral valve repair: results from a preclinical study.

OBJECTIVES: The failure of mitral repairs can be the result of inadequate leaflet coaptation length (CL< 8 mm at the A2-P2 level). A new annuloplasty ring conceived by the authors enables post-surgical CL increase using percutaneous balloon catheter technology. We conducted preclinical studies to assess the in vivo feasibility of the procedure and the safety of the postimplant deformable mitral ring. METHODS: The new annuloplasty ring allows the percutaneous and progressive displacement of each of the 3 anatomical regions of the posterior mitral annulus towards the anterior. Displacement is permanent and induced by an angioplasty balloon catheter inserted in a line connecting the ring to the subcutaneous tissue. Under general anaesthesia and cardiopulmonary bypass, healthy adult sheep had mitral annuloplasty. The device was implanted using the interrupted suture technique. The connection line exited the left atrium and reached the skin. Epicardial echocardiography allowed assessment of valve competence, leaflet CL, the mitral valve area and the mitral valve gradient. The mandrel was removed, and the dedicated catheter balloon was inserted into the connection line. The balloon was inflated in the P2 position under fluoroscopic control, and epicardial echocardiography was used to assess the functional parameters of the valve. One month later, the balloon was inserted again through the connection line; the P1 and P3 areas were deformed to increase CL. Valve parameters were measured again using transthoracic echocardiography. After 6 months, transthoracic echocardiography was used to assess the functional parameters of the valve. The sheep were sacrificed and autopsied. RESULTS: Ten adult sheep survived the procedure. A 30-mm ring was implanted in all the sheep, and the 6-month follow-up was uneventful for all of them. The CL increased by 100% (4.2 ± 2 mm-8.5 ± 2 mm, P < 0.001); the transmitral gradient increased from 2 ± 0.5 mmHg to 4 ± 0.5 mmHg (P < 0.001) and the effective orifice area decreased from 4.5 ± 0.6 cm2 to 3.5 ± 0.6 cm2 (30% reduction, P < 0.001). CONCLUSIONS: The device safely enabled a significant improvement of leaflet CL after mitral annuloplasty with an angioplasty-like technique, and the improvement was stable over time. The reshaping of the mitral annulus provided by this technology should benefit all patients having mitral repairs. The future of mitral regurgitation treatment is towards surgical correction followed by late, iterative, percutaneous adjustments of mitral leaflets coaptation.