scholarly journals Rate of device-related infections using an antibacterial envelope in patients undergoing cardiac resynchronisation therapy re-operations

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Frausing ◽  
JC Nielsen ◽  
JB Johansen ◽  
OD Joergensen ◽  
C Gerdes ◽  
...  
Keyword(s):  
High Risk ◽  
Propensity Score Analysis ◽  
Controlled Trial ◽  
High Risk Patient ◽  
Cardiac Resynchronisation Therapy ◽  
High Risk Patients ◽  
Cardiac Resynchronisation ◽  
Risk Patients ◽  
Resynchronisation Therapy ◽  
Very High

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Karen Elise Jensen Foundation Background Cardiac resynchronisation therapy (CRT) re-operations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope has been shown to reduce the occurrence of DRIs in a broad population of moderate-to-high risk patients. Purpose To investigate the efficacy of an antibacterial envelope in a very high-risk patient population undergoing CRT re-operation. Methods In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator re-operation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to two years. Results A total of 1943 patients were included in the study; 736 (38%) patients received an antibacterial envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary end point of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group (4.1% vs. 2.3%, adjusted hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.30-0.90, p = 0.021). This difference persisted in propensity score analysis (HR 0.51 95% CI 0.29-0.90, p = 0.019). Conclusion Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT re-operations. Our results were comparable to those recently reported from a large randomized controlled trial, which suggests a proportional effect of the envelope even in very high risk patients.

PO-09 Very high-risk patients: a prospective study of thromboembolic events in patients under thromboprophylaxis

2021 ◽  
Vol 200 ◽  
pp. S22
Author(s):  
J. Liz Pimenta ◽  
K. Ladeira ◽  
A. Teira ◽  
M. Rocha ◽  
P. Gago ◽  
...  
Keyword(s):  
High Risk ◽  
Prospective Study ◽  
Thromboembolic Events ◽  
High Risk Patients ◽  
Risk Patients ◽  
A Prospective Study ◽  
Very High

Acute Safety and 30-Day Outcome After Percutaneous Edge-to-Edge Repair of Mitral Regurgitation in Very High-Risk Patients

2011 ◽  
Vol 108 (10) ◽  
pp. 1478-1482 ◽  
Author(s):  
Sven T. Pleger ◽  
Derliz Mereles ◽  
Marius Schulz-Schönhagen ◽  
Ulrike Krumsdorf ◽  
Emmanuel Chorianopoulos ◽  
...  
Keyword(s):  
High Risk ◽  
Mitral Regurgitation ◽  
High Risk Patients ◽  
Risk Patients ◽  
Very High

scholarly journals Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e054115
Author(s):  
Philippe C Wouters ◽  
Chris van Lieshout ◽  
Vincent F van Dijk ◽  
Peter-Paul HM Delnoy ◽  
Pieter AFM Doevendans ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cardiac Resynchronisation Therapy ◽  
Analytic Model ◽  
Image Guided ◽  
Lead Placement ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Randomised Controlled ◽  
Lead Location

IntroductionAchieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of real-time image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here.Methods and analysisA multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states.Ethics and disseminationThe protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals.Trial registration numberNCT05053568; Trial NL8666.

Abstract P275: Demographic and Clinical Profile of Patients with Risk Factors for Coronary Heart Disease (CHD) Defined by National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III Guidelines

Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
David M Kern ◽  
Sanjeev Balu ◽  
Ozgur Tunceli ◽  
Swetha Raparla ◽  
Deborah Anzalone
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Risk Groups ◽  
Lipid Lowering ◽  
High Risk Patients ◽  
Low Hdl ◽  
Risk Patients ◽  
Artery Disease ◽  
Very High ◽  
Statin Use

Introduction: This study aimed to compare the demographic and clinical characteristics of patients with different risk factors for CHD as defined by NCEP ATP III guidelines. Methods: Dyslipidemia patients (≥1 medical claim for dyslipidemia, ≥1 pharmacy claim for a statin, or ≥1 LDL-C value ≥100 mg/dL [index date]) aged ≥18 y were identified from the HealthCore Integrated Research Environment from 1/1/2007-7/31/2012. Patients were classified as low risk (0 or 1 risk factor): hypertension, age ≥45 y [men] or ≥55 y [women], or low HDL-C), moderate/moderately high risk (≥2 risk factors), high risk (having CHD or CHD risk equivalent), or very high risk (having ACS or other established cardiovascular disease plus diabetes or metabolic syndrome). Demographics, comorbidities, medication use and lipid levels during the 12 months prior, and statin use during the 6 months post-index date were compared across risk groups (very high vs each other risk group). Results: There were 1,524,351 low-risk (mean age: 47 y; 45% men), 242,357 moderate-risk (mean age: 58 y; 59% men), 188,222 high-risk (mean age: 57 y; 52% men), and 57,469 very-high-risk (mean age: 63 y; 61% men) patients identified. Mean Deyo-Charlson comorbidity score differed greatly across risk strata: 0.20, 0.33, 1.26, and 2.22 from low to very high risk (p<.0001 for each). Compared with high-risk patients, very-high-risk patients had a higher rate of ischemic stroke: 5.4% vs 4.1%; peripheral artery disease: 17.1% vs 11.6%; coronary artery disease: 8.5% vs 8.2%; and abdominal aortic aneurysm: 2.3% vs 2.0% (p<.05 for each). Less than 1% of the total population had a prior prescription for each non-statin lipid-lowering medication (bile acid sequestrants, fibrates, ezetimibe, niacin, and omega-3). Very-high-risk patients had lower total cholesterol (very-high-risk mean: 194 mg/dL vs 207, 205, and 198 mg/dL for low-, moderate-/moderately-high-, and high-risk patients, respectively) and LDL-C (very-high-risk mean: 110 mg/dL vs 126, 126, and 116 mg/dL for the other risk groups; p<.0001 for each); higher triglycerides (TG) (very-high-risk mean: 206 mg/dL vs 123, 177, and 167 mg/dL for the other groups; p<.0001 for each); and lower HDL-C (very-high-risk mean: 45 mg/dL vs 57 [p<.0001], 45 [p=.006], and 51 mg/dL [p<.0001]). Statin use was low overall (15%), but higher in the very-high-risk group (45%) vs the high- (29%), moderate-/moderately-high- (18%), and low- (12%) risk groups (p<.0001 for each). Conclusions: Despite a large proportion of patients having high lipid levels, statin use after a dyslipidemia diagnosis was low: ≥80% of all patients (and more than half at very high risk) failed to receive a statin, indicating a potentially large population of patients who could benefit from statin treatment. Prior use of non-statin lipid-lowering medications was also low considering the high TG and low HDL-C levels among high-risk patients.

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