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1.
Front Cardiovasc Med ; 11: 1384222, 2024.
Article in English | MEDLINE | ID: mdl-38911518

ABSTRACT

Introduction: Intravascular imaging, especially optical coherence tomography (OCT), has significantly improved percutaneous coronary intervention (PCI), yet its routine clinical application faces challenges. This case series introduces the Gentuity® High-Frequency Optical Coherence Tomography (HF-OCT), a novel device designed to enhance intracoronary imaging with a significantly faster pullback and smaller catheter size, potentially offering enhanced navigability in complex lesions. We aimed to assess the image quality of Gentuity® HF-OCT in complex vessel conditions, as well as presenting a case series to illustrate the application of the device in various clinical scenarios. Methods: In this case series, we included all patients who underwent intracoronary HF-OCT imaging at our center. The primary endpoint was image quality assessed by clear image length (CIL). Image quality was assessed in relation to (1) lesion severity assessed by minimum lumen area (MLA); (2) vessel size, differentiating between larger (diameter ≥ 4 mm) and smaller vessel segments; (3) pre- vs. post-PCI conditions, and (4) vessel tortuosity, categorized into none, moderate, and severe. Results: Twenty-four HF-OCT runs from 14 patients were included. No significant differences in CIL were observed across lesion severity terciles (p = 0.449), between small and large vessel segments [mean CIL% difference 1.3%; confidence interval (CI), -9.3 to 11.8; p = 0.802], and pre- vs. post-PCI conditions (mean CIL difference -3.9 mm; CI, -14.0 to 6.1; p = 0.373). Vessel tortuosity significantly impacted image quality, with clear reductions in CIL observed in cases of moderate (74.8; CI, 73.5 to 76.0; vs. 63.9; CI, 56.2 to 71.5; p = 0.043) and severe tortuosity (74.8; CI, 73.5 to 76.0; vs. 65.0; CI, 62.1 to 67.9; p = 0.002) compared to vessels with no tortuosity. Overall, the HF-OCT demonstrated excellent catheter deliverability and crossability, with very satisfactory image quality and no significant adverse events. Conclusion: The Gentuity® HF-OCT is a new OCT device capable of navigating both small- and large-diameter vessels, with similar image quality, but vessel tortuosity seems to have an impact on image quality. It appears to be as usable as conventional OCT for pre-PCI diagnosis and OCT-guided PCI, potentially bringing additional benefits in terms of deliverability, lesion crossover and ease of use in routine clinical practice.

2.
Catheter Cardiovasc Interv ; 103(3): 417-424, 2024 02.
Article in English | MEDLINE | ID: mdl-38297989

ABSTRACT

BACKGROUND: Optimal stent deployment in left main (LM) bifurcation is paramount, and incomplete stent apposition may cause major adverse cardiac events (MACE). Bench studies show that the proximal optimization technique (POT) provides the best stent apposition. AIMS: We aimed to investigate the impact of POT on clinical outcomes in patients treated for unprotected LM (ULM) disease at our institution. METHODS: We identified 162 patients who underwent percutaneous coronary intervention (PCI) for ULM coronary disease in the Cardio-FR database. Out of these, 99 (61%) had undergone POT, while 63 patients were treated without POT. The primary outcome was the bifurcation-oriented composite endpoint (BOCE) of cardiac death, target-bifurcation myocardial infarction and target-bifurcation revascularization at maximal follow-up. RESULTS: Mean age was 76 years, and 69% presented with acute coronary syndrome. Mean follow-up was 2.25 years (822 days). The BOCE occurred in 43 (27%) of which 20 (20%) in the POT group and 23 (37%) in the no-POT group (p = 0.009). Cardiac death occurred in 15 (15%) patients in the POT- and 17 (27%) in no-POT group (p = 0.26). Target bifurcation revascularization occurred in 4 (4%) patients in the POT- and 6 (10%) patients in the no-POT group (p = 0.19). POT In the multivariate analysis, POT was the strongest parameter and was associated with BOCE, cardiac death, occurrence of any revascularization and all-cause mortality. CONCLUSION: The POT improves clinical outcomes. These findings strongly support the systematic use of POT in patients undergoing ULM-PCI.


Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Aged , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/etiology , Treatment Outcome , Death , Coronary Angiography , Risk Factors
4.
Catheter Cardiovasc Interv ; 101(4): 679-686, 2023 03.
Article in English | MEDLINE | ID: mdl-36786485

ABSTRACT

AIMS: Unprotected left main coronary artery (ULMCA) occlusion is a rare and disastrous condition with scarce data on presentation and outcomes. Herein, we report data on patients presenting with acute coronary syndrome due to ULMCA occlusion at four different institutions. METHODS: This is an international multicentre observational study. Baseline characteristics were retro- and prospectively collected. Clinical follow-up was prospective. The primary outcome was in-hospital death. Patients surviving the index hospitalization were compared with nonsurvivors to find predictors of survival. RESULTS: The study population consisted of 55 patients. Eight patients (15%) died in the cath lab, and 23 (42%) died in hospital. Three (6%) deaths were noncardiac and due to major bleeding. Thirty-two (58%) patients survived the index hospitalization and were discharged. These patients were followed for a median of 17.5 months during which three cardiac deaths occurred. Repeat revascularization was performed in 25% (n = 8). Overall mortality at maximum follow-up was 47% (n = 26). The only significant predictor for hospital survival was left ventricular ejection fraction (odds ratio [OR]: 1.10 (per 1 point increase); 95% confidence interval [CI]: 1.02-1.19; p = 0.02). CONCLUSION: ULMCA occlusion carries a high short-term mortality. Patients who survive index hospitalization have similar mortality rates as compared with other st elevation myocardial infarction patients.


Subject(s)
Coronary Artery Disease , Coronary Occlusion , Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Coronary Vessels , Hospital Mortality , Prospective Studies , Stroke Volume , Treatment Outcome , Ventricular Function, Left , Cohort Studies
5.
Blood Press Monit ; 27(6): 402-407, 2022 Dec 01.
Article in English | MEDLINE | ID: mdl-35950543

ABSTRACT

AIMS: The purpose of this study is to evaluate the accuracy of the Senbiosys device in measuring blood pressure (BP) by photoplethysmography (PPG) in patients undergoing coronary angiography. METHODS: This is a substudy within the Senbiosys trial, which is a prospective, single-arm, single-center study, evaluating the accuracy of BP estimation of the Senbiosys device compared to invasive BP. Patients referred for coronary angiography underwent invasive BP measurement and simultaneously wore the Senbiosys ring. SBP and DBP estimations measured by the Senbiosys device were compared with invasive measurements. RESULTS: A total of 25 patients were included. Overall, 708 epochs with adequate PPG signal belonging to 17 patients were analyzed. A total of 84% of the SBP estimates and 99% of the DBP estimates have an absolute error of less than 10 mmHg compared with the invasive measurements. Mean difference was 2.3 ± 7.0 mmHg and 0.5 ± 3.5 mmHg for SBP and DBP, respectively. CONCLUSION: The Senbiosys device is accurate enough to determine BP in a selected population undergoing coronary angiography.


Subject(s)
Blood Pressure Determination , Wearable Electronic Devices , Humans , Blood Pressure/physiology , Coronary Angiography , Prospective Studies , Photoplethysmography
6.
Catheter Cardiovasc Interv ; 100(2): 179-187, 2022 08.
Article in English | MEDLINE | ID: mdl-35621281

ABSTRACT

INTRODUCTION: Long drug-eluting stents may limit the issue of overlapping multiple stents when treating long coronary lesions. AIM: The aim of the study was to assess the safety and efficacy of the 48 mm Xience Xpedition everolimus-eluting stent (48mm-EES) for the treatment of long coronary lesions, in an all-comer population. METHODS: Patients receiving at least one 48mm-EES were prospectively included from March 2014 to December 2018. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 1 year. The main secondary endpoint was the patient-oriented composite endpoint (POCE) defined as a composite of death, stroke, myocardial infarction, and reintervention. RESULTS: A total of 268 patients with 276 long coronary lesions, including 94 chronic total occlusions (CTO), were successfully treated using at least one 48mm-EES. The total stent length per lesion was 66 ± 22 mm. A single 48mm-EES was suitable to successfully treat the target lesion in 48% of cases (60% for non-CTO lesions). One-year follow-up rate was 96.3%. TLF occurred in 13 patients (5.3%), mainly driven by TLR (4.1%). Two cardiac death occurred (0.7%). POCE occurred in 30 patients (11.6%) mainly driven by repeat revascularization (9.7%). Definite stent thrombosis was observed in two patients (0.7%). No difference was observed in one-year outcomes between single 48mm-EES and multiple stents implantation as well as between CTO and non-CTO lesions. CONCLUSION: The 48mm-EES is safe and effective to treat long coronary lesions, including CTOs, and provides attractive cost-effectiveness by limiting multiple stenting.


Subject(s)
Cardiovascular Agents , Drug-Eluting Stents , Myocardial Infarction , Percutaneous Coronary Intervention , Cardiovascular Agents/adverse effects , Death , Everolimus/adverse effects , Humans , Kaplan-Meier Estimate , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Risk Factors , Sirolimus , Time Factors , Treatment Outcome
7.
Eur Heart J Case Rep ; 6(2): ytac026, 2022 Feb.
Article in English | MEDLINE | ID: mdl-35233484

ABSTRACT

BACKGROUND: Acute myocarditis is a common condition, with viral infections being the most common aetiology in North America and Europe. Influenza A myocarditis is however rare. As clinical manifestation may be fulminant, early recognition and management are paramount and may impact overall prognosis by hindering complications such as thromboembolism. A brief review of the literature, diagnostic modalities, work-up and treatment are discussed. CASE SUMMARY: We present the case of a 42-year-old, previously healthy woman with recent flu-like symptoms, developing decompensated heart failure (HF) and cardiogenic shock within a week, due to Influenza A myocarditis. Biventricular thrombi were identified. Pharmacological haemodynamic support, followed by HF therapy, allowed full recuperation of heart function. Intracavitary thrombi disappeared under unfractionated heparin with bridging to rivaroxaban. DISCUSSION: Fulminant myocarditis due to Influenza A is rare and, to the best of our knowledge, has not been associated with intracardiac thrombi formation. Echocardiography is the essential first-line imaging modality. Cardiac magnetic resonance plays a major role in the diagnosis of myocarditis and may preclude the need for an endomyocardial biopsy in selected cases. Coronary angiography may be required to rule out ischaemic aetiology. First-line therapy in fulminant disease is pharmacological and, if required, mechanical haemodynamic support. Standard HF therapy complete the therapeutic options and should be introduced as soon as possible. Complications such as intracardiac thrombi formation, require targeted treatment. Specific drug therapies targeting Influenza A have no proven benefit in myocarditis.

8.
Catheter Cardiovasc Interv ; 99(3): 523-532, 2022 02.
Article in English | MEDLINE | ID: mdl-34173699

ABSTRACT

AIMS: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES). METHODS: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years. RESULTS: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup. CONCLUSION: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.


Subject(s)
Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Drug-Eluting Stents/adverse effects , Everolimus/adverse effects , Humans , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Sirolimus/adverse effects , Stents , Time Factors , Tomography, Optical Coherence , Treatment Outcome
9.
Front Cardiovasc Med ; 8: 620354, 2021.
Article in English | MEDLINE | ID: mdl-34926595

ABSTRACT

Background: The Academic Research Consortium have identified a set of major and minor risk factors in order to standardize the definition of a High Bleeding Risk (ACR-HBR). Aims: The aim of this study is to stratify the bleeding risk in patients included in the Cardio-Fribourg registry, according to the Academic Research Consortium for High Bleeding Risk (ACR-HBR) definition, and to report ischemic and hemorrhagic events at 2-year of clinical follow-up. Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. Patients were considered high (HBR) or low (LBR) bleeding risk depending on the ARC-HBR definition. Primary endpoints were hierarchical major bleeding events as defined by the Bleeding Academic Research Consortium (BARC) grade 3-5, and ARC patient-oriented major adverse cardiac events (POCE) at 2-year follow-up. Results: Follow-up was complete in 1,080 patients. There were 354 patients in the HBR group (32.7%) and 726 patients in the low-bleeding risk (LBR) group (67.2%). At 2-year follow-up, cumulative BARC 3-5 bleedings were higher in HBR (10.5%) compared to LBR patients (1.5%, p < 0.01) and the impact of HBR risk factors was incremental. At 2-year follow-up, POCE were more frequent in HBR (27.4%) compared to LBR group (18.2%, <0.01). Overall mortality was higher in HBR (14.0%) vs. LBR (2.9%, p < 0.01). Conclusions: ARC-HBR criteria appropriately identified a population at a higher risk of bleeding after percutaneous coronary intervention. An increased risk of bleeding is also associated with an increased risk of ischemic events at 2-year follow-up.

11.
Front Cardiovasc Med ; 8: 589426, 2021.
Article in English | MEDLINE | ID: mdl-34660705

ABSTRACT

Background: The Academic Research Consortium has identified a set of major and minor risk factors in order to standardize the definition of a high bleeding risk (ACR-HBR). Oral anticoagulation is a major criterion frequently observed. Aims: The objective of this study is to quantify the risk of bleeding in patients on oral anticoagulation with at least one additional major ACR-HBR criteria in the Cardio-Fribourg Registry. Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. The study population included patients with ongoing long-term oral anticoagulation (OAC) and planned to receive triple antithrombotic therapy. Patients were divided in two groups: patients on OAC with at least one additional major ACR-HBR criteria vs. patients on OAC without additional major ACR-HBR criteria. The primary endpoint was any bleeding during the 24-month follow-up. Secondary bleeding endpoint was defined as Bleeding Academic Research Classification (BARC) ≥3. Results: Follow-up was completed in 142 patients at high bleeding risk on OAC, of which 33 (23%) had at least one additional major ACR-HBR criteria. The rate of the primary endpoint was 55% in patients on OAC with at least one additional ACR-HBR criteria compared with 14% in patients on OAC without additional ACR-HBR criteria (hazard ratio, 3.88; 95%CI, 1.85-8.14; p < 0.01). Patients with additional major ACR-HBR criteria also experienced significantly higher rates of BARC ≥ 3 bleedings (39% at 24 months). Conclusion: The presence of at least one additional ACR-HBR criterion identifies patients on OAC who are at very high risk of bleeding after percutaneous coronary intervention.

12.
Int J Mol Sci ; 22(16)2021 Aug 06.
Article in English | MEDLINE | ID: mdl-34445154

ABSTRACT

The continuous relationship between blood pressure (BP) and cardiovascular events makes the distinction between elevated BP and hypertension based on arbitrary cut-off values for BP. Even mild BP elevations manifesting as high-normal BP have been associated with cardiovascular risk. We hypothesize that persistent elevated BP increases atherosclerotic plaque development. To evaluate this causal link, we developed a new mouse model of elevated BP based on adeno-associated virus (AAV) gene transfer. We constructed AAV vectors to support transfer of the hRenin and hAngiotensinogen genes. A single injection of AAV-Ren/Ang (1011 total viral particles) induced sustained systolic BP increase (130 ± 20 mmHg, vs. 110 ± 15 mmHg in controls; p = 0.05). In ApoE-/- mice, AAV-induced mild BP elevation caused larger atherosclerotic lesions evaluated by histology (10-fold increase vs. normotensive controls). In this preclinical model, atheroma plaques development was attenuated by BP control with a calcium channel blocker, indicating that a small increase in BP within a physiological range has a substantial impact on plaque development in a preclinical model of atherosclerosis. These data support that non-optimal BP represents a risk for atherosclerosis development. Earlier intervention in elevated BP may prevent or delay morbidity and mortality associated with atherosclerosis.


Subject(s)
Atherosclerosis/etiology , Blood Pressure , Hypertension/complications , Animals , Atherosclerosis/physiopathology , Disease Models, Animal , Humans , Hypertension/physiopathology , Male , Mice, Inbred C57BL
13.
BMJ Case Rep ; 14(7)2021 Jul 29.
Article in English | MEDLINE | ID: mdl-34326109

ABSTRACT

Takotsubo syndrome is an acute and often reversible condition, with initial presentation mimicking acute coronary syndrome. Typically, patients present with left ventricular regional wall motion abnormalities, without a corresponding coronary artery obstruction on angiography. Coexistence of a coronary artery disease is possible and may render the distinction between the two entities particularly challenging. We report the case of a 94-year-old woman with chest pain after an emotional upset and acute myocardial injury. Transthoracic echocardiogram (TTE) revealed a severely reduced left ventricular ejection fraction (LVEF) with apical ballooning. Coronary angiogram showed significant stenosis of the distal left main coronary artery and of the mid-left anterior descending artery, as well as a 30%-50% stenosis of the mid-distal right coronary artery. Revascularisation was deferred and antiplatelet as well as heart failure therapy begun. A repeat TTE 6 days later revealed a quasi-normalised LVEF. Ultimately, percutaneous coronary revascularisation of the left main and left anterior descending artery was performed, with favourable outcome at 6-month follow-up.


Subject(s)
Coronary Artery Disease , Takotsubo Cardiomyopathy , Aged , Aged, 80 and over , Coronary Angiography , Coronary Artery Disease/complications , Coronary Artery Disease/diagnostic imaging , Female , Humans , Stroke Volume , Takotsubo Cardiomyopathy/diagnosis , Takotsubo Cardiomyopathy/diagnostic imaging , Ventricular Function, Left
14.
Front Cardiovasc Med ; 8: 681890, 2021.
Article in English | MEDLINE | ID: mdl-34017869

ABSTRACT

Background: Atrial fibrillation (AF) is frequent and causes substantial morbidity through AF-related strokes. Given the increasing prevalence of AF, screening methods are of interest given the potential to initiate timely appropriate anticoagulation. Aims: The HECTO-AF trial aims to determine the efficacy of AF screening with a single-lead electrocardiogram (ECG) handheld device in naïve in-hospital patients. Methods: The HECTO-AF is a single-center, open label, randomized controlled trial. Patients admitted to the general internal medicine ward of the University and Hospital Fribourg without previous diagnosis of AF were invited to participate in a screening program with a 1:1 allocation to either the screening group with intermittent single-lead handheld ECG recordings vs. a control group undergoing detection of AF as per routine clinical practice. The primary outcome was the prevalence of newly diagnosed AF during the hospital stay. Enrolment was terminated for poor patient recruitment and apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Results: A total of 804 patients were included of whom 381 were allocated to the intervention and 423 to the control group. Mean age was 65 ± 16 and 464 (58%) were male. Median CHA2DS2-VASc score was 3 (13% heart failure, 57% hypertension, 19% diabetes mellitus, 14% prior stroke/transient ischemic attack, and 29% arterial disease) and all CHA2DS2-VASc risk factors were equally distributed between groups. The incidence of newly detected AF was 1.4% over a median of 6 hospitalized days. Seven patients (1.8%) were diagnosed with AF in the intervention group vs. 3 (0.7%) in the control group (p = 0.20). Conclusion: There was a trend toward a higher AF detection over a median of 6 hospitalized days in the intervention group, but a definitive conclusion cannot be drawn due to the early termination of the present study. Systematic screening for AF in the hospital setting is resource-consuming, and of uncertain clinical benefit. The interpretation of single-lead handheld ECG is challenging and may result in inaccurate AF diagnosis. Clinical Trial Registration: ClinicalTrials.gov, identifier [NCT03197090].

15.
Rev Med Suisse ; 17(728): 418-423, 2021 Mar 03.
Article in French | MEDLINE | ID: mdl-33656293

ABSTRACT

SARS-CoV-2 affects the cardiovascular system triggering a proinflammatory response which results in direct and indirect myocardial injury. The objective of this article is to describe the underlying mechanisms and clinical implications.


Le système cardiovasculaire est largement affecté par le coronavirus SARS-CoV-2. La maladie à coronavirus 2019 (Covid-19) peut déclencher une réaction inflammatoire intense, responsable de lésions myocardiques directes et indirectes chez environ un quart des patients hospitalisés. L'objectif de cet article est de décrire les mécanismes sous-jacents aux atteintes cardiovasculaires et de discuter les potentielles implications cliniques.


Subject(s)
COVID-19 , Cardiovascular Diseases , Humans , SARS-CoV-2
16.
Echocardiography ; 37(12): 2116-2122, 2020 12.
Article in English | MEDLINE | ID: mdl-33179802

ABSTRACT

Effusive-constrictive pericarditis (eCP) is a rare entity where constriction of the heart occurs through the visceral pericardium, with concomitant presence of a tense effusion in the pericardial space. We present the case of a 65-year-old patient with shortness of breath and pericardial effusion, 4 months after aortic and mitral valve replacement for Streptococcus agalactiae endocarditis. The present report focuses on the echocardiographic features of constrictive pericarditis (CP) and provides a brief overview of the pathophysiology, work-up, and management guidelines.


Subject(s)
Pericardial Effusion , Pericarditis, Constrictive , Aged , Echocardiography , Humans , Male , Pericardial Effusion/diagnostic imaging , Pericardial Effusion/etiology , Pericarditis, Constrictive/complications , Pericarditis, Constrictive/diagnostic imaging , Pericarditis, Constrictive/surgery , Pericardium/diagnostic imaging
17.
Swiss Med Wkly ; 150: w20368, 2020 Nov 02.
Article in English | MEDLINE | ID: mdl-33211904

ABSTRACT

Increased age impacts the first medical contact to revascularisation delay in patients with STEMI. Patients with shorter treatment delays (<90 minutes after first medical contact) have significantly lower major adverse cardiac events rates at 3 years.


Subject(s)
Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Humans , ST Elevation Myocardial Infarction/surgery , Time-to-Treatment , Treatment Outcome
18.
Catheter Cardiovasc Interv ; 94(3): 387-391, 2019 Sep 01.
Article in English | MEDLINE | ID: mdl-30773797

ABSTRACT

BACKGROUND: Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation. OBJECTIVES: We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment. METHODS: This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time. RESULTS: A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] µSv/Gy.cm2 without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] µSv/Gy.cm2 , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm2 without SEPARPROCATH®, p value 0.81). CONCLUSION: SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety.


Subject(s)
Cardiac Catheterization , Occupational Exposure/prevention & control , Radiation Dosage , Radiation Exposure/prevention & control , Radiation Protection/instrumentation , Radiography, Interventional , Surgical Drapes , Cardiac Catheterization/adverse effects , Equipment Design , Humans , Occupational Exposure/adverse effects , Occupational Health , Patient Safety , Pilot Projects , Prospective Studies , Radiation Exposure/adverse effects , Radiography, Interventional/adverse effects , Risk Assessment , Risk Factors , Scattering, Radiation , Time Factors
19.
Trials ; 20(1): 92, 2019 Jan 30.
Article in English | MEDLINE | ID: mdl-30700332

ABSTRACT

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.


Subject(s)
Atrial Fibrillation/diagnosis , Electrocardiography/instrumentation , Inpatients , Atrial Fibrillation/epidemiology , Atrial Fibrillation/physiopathology , Equipment Design , Hospitals, University , Humans , Incidence , Patient Admission , Predictive Value of Tests , Prognosis , Randomized Controlled Trials as Topic , Switzerland/epidemiology , Time Factors
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