| 1. |
- Blomström-Lundqvist, Carina, 1954-, et al.
(författare)
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European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections : endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS)
- 2020
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 22:4, s. 515-516ag
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Tidskriftsartikel (refereegranskat)abstract
- Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.
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| 2. |
- Blomström-Lundqvist, Carina, et al.
(författare)
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European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). : European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections.
- 2020
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Ingår i: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. - : Oxford University Press (OUP). - 1873-734X. ; 57:1
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Tidskriftsartikel (refereegranskat)abstract
- Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.
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| 3. |
- Bongiorni, Maria Grazia, et al.
(författare)
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Current practice in transvenous lead extraction : a European Heart Rhythm Association EP Network Survey
- 2012
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 14:6, s. 783-786
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Tidskriftsartikel (refereegranskat)abstract
- AIM: Current practice with regard to transvenous lead extraction among European implanting centres was analysed by this survey. METHODS AND RESULTS: Among all contacted centres, 164, from 30 countries, declared that they perform transvenous lead extraction and answered 58 questions with a compliance rate of 99.9%. Data from the survey show that there seems to be an overall increasing experience of managing various techniques of lead extraction and a widespread involvement of cardiac centres in this treatment. Results and complication rates seem comparable with those of main international registries. CONCLUSION: This survey gives an interesting snapshot of lead extraction in Europe today and gives some clues for future research and prospective European registries.
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| 4. |
- Bongiorni, Maria Grazia, et al.
(författare)
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EHRA research network surveys : 6 years of EP wires activity
- 2015
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 17:11
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Tidskriftsartikel (refereegranskat)abstract
- Clinical practice should follow guidelines and recommendations mainly based on the results of controlled trials, which are often conducted in selected populations and special conditions, whereas clinical practice may be influenced by factors different from controlled scientific studies. Hence, the real-world setting is better assessed by the observational registries enrolling patients for longer periods of time. However, this may be difficult, expensive, and time-consuming. In 2009, the Scientific Initiatives Committee of the European Heart Rhythm Association (EHRA) has instigated a series of surveys covering the controversial issues in clinical electrophysiology (EP). With this in mind, an EHRA EP research network has been created, which included EP centres in Europe among which the surveys on 'hot topic' were circulated. This review summarizes the overall experience conducting EP wires over the past 6 years, categorizing and assessing the topics regarding clinical EP, and evaluating the acceptance and feedback from the responding centres, in order to improve participation in the surveys and better address the research needs and aspirations of the European EP community.
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| 5. |
- Bongiorni, Maria Grazia, et al.
(författare)
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ELECTRa (European Lead Extraction ConTRolled) Registry-Shedding light on transvenous lead extraction real-world practice in Europe
- 2013
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Ingår i: Herzschrittmachertherapie & Elektrophysiologie. - : Springer Science and Business Media LLC. - 0938-7412 .- 1435-1544. ; 24:3, s. 171-175
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Tidskriftsartikel (refereegranskat)abstract
- With the growing recognition of the clinical need and wider indications for cardiovascular implantable electronic devices (CIED), the number of implant procedures has increased considerably. Consequently, the rate of complications related to these devices has also increased. Transvenous lead extraction (TLE) is the gold standard in the treatment of CIED-related infective complications and is often required in the management of lead malfunction. An increasing number of centers currently perform TLE procedures. The ELECTRa (European Lead Extraction ConTRolled) Registry is the first large prospective multicenter registry of consecutive patients undergoing TLE in Europe, conducted by the European Heart Rhythm Association (EHRA) and managed by the European Society of Cardiology (ESC) EURObservational Research Department. The primary objective of the registry is to evaluate the acute and long-term safety of TLE; the secondary objective is to describe the characteristics of the patients, the leads, the indications for TLE, and the tools and techniques currently used for TLE. About 100 centers will be enrolled on a voluntary basis from European countries; they are anonymous and stratified on the basis of their volume of activity into high-volume centers (> 30 patients/year) and low-volume centers: (≤ 30 patients/year). Each participating center will have to enroll and follow up for 1 year consecutively assessed patients undergoing TLE from November 2012 to January 2014. The target is to achieve a sample size of at least 3,500 patients for statistical analysis. Data will be collected using a Web-based system and will be audited at randomly selected centers. The official start was on 6 November. Eighty-nine centers have joined so far, 65 centers are currently active, those who have already obtained the approval of their own ethics committee, and 1,099 patients were enrolled at the end of June 2013. The independence of the registry, the consecutiveness of the patient enrolment, and the monitoring of the study are characteristics of this registry that will contribute to the scientific validity of the objectives to be achieved.
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| 6. |
- Bongiorni, Maria Grazia, et al.
(författare)
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How European centres diagnose, treat, and prevent CIED infections : Results of an European Heart Rhythm Association survey
- 2012
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 14:11, s. 1666-1669
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Tidskriftsartikel (refereegranskat)abstract
- The purpose of our survey is to analyse the clinical approach used to prevent and treat cardiovascular implantable electronic device (CIED) infections in Europe. The survey involves high-volume implanting centres. According to the survey the incidence of CIED infections shows a slight decrease in most centres and is substantially under 2% in the majority of centres interviewed. However, there are still differences in terms of prophylactic antibiotic therapy: 8.9% of the centres administer oxacillin as preoperative treatment, 4.4% of them do not give any antibiotic therapy, all centres use some kind of skin antisepsis, but only 42.2% use chlorhexidine. In case of local infection, 43.5% of centres perform lead extraction as first approach. In the case of systemic infection or evidence of lead or valvular endocarditis, 95% of centres treat these conditions by extracting the leads, which indicates that the adherence to the lead extraction guidelines is quite good.
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| 7. |
- Bongiorni, Maria Grazia, et al.
(författare)
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Preferred tools and techniques for implantation of cardiac electronic devices in Europe : results of the European Heart Rhythm Association survey
- 2013
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 15:11, s. 1664-1668
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this European Heart Rhythm Association (EHRA) survey was to assess clinical practice in relation to the tools and techniques used for cardiac implantable electronic devices procedures in the European countries. Responses to the questionnaire were received from 62 members of the EHRA research network. The survey involved high-, medium-, and low-volume implanting centres, performing, respectively, more than 200, 100199 and under 100 implants per year. The following topics were explored: the side approach for implantation, surgical techniques for pocket incision, first venous access for lead implantation, preference of lead fixation, preferred coil number for implantable cardioverter-defibrillator (ICD) leads, right ventricular pacing site, generator placement site, subcutaneous ICD implantation, specific tools and techniques for cardiac resynchronization therapy (CRT), lead implantation sequence in CRT, coronary sinus cannulation technique, target site for left ventricular lead placement, strategy in left ventricular lead implant failure, mean CRT implantation time, optimization of the atrioventricular (AV) and ventriculo-ventricular intervals, CRT implants in patients with permanent atrial fibrillation, AV node ablation in patients with permanent AF. This panoramic view allows us to find out the operator preferences regarding the techniques and tools for device implantation in Europe. The results showed different practices in all the fields we investigated, nevertheless the survey also outlines a good adherence to the common standards and recommendations.
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| 8. |
- Bongiorni, Maria Grazia, et al.
(författare)
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The European Lead Extraction ConTRolled (ELECTRa) study : a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes
- 2017
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Ingår i: European Heart Journal. - : OXFORD UNIV PRESS. - 0195-668X .- 1522-9645. ; 38:40, s. 2995-3005
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Tidskriftsartikel (refereegranskat)abstract
- Aims The European Lead Extraction ConTRolled Registry (ELECTRa), is a prospective registry of consecutive transvenous lead extraction (TLE) procedures conducted by the European Heart Rhythm Association (EHRA) in order to identify the safety and efficacy of the current practice of TLE Methods and results European centres performing TLE, invited by the organizing committee on behalf of EHRA, prospectively recruited all consecutive patients undergoing TLE at their institution. The primary endpoint was TLE safety defined by pre-discharge major procedure-related complications including death. Secondary endpoints included clinical and radiological success and overall complication rates. Outcomes were compared between Low Volume (LoV) vs. High Volume (HiV) centers (LoV < 30 and HiV >= 30 procedures/year). A total of 3555 consecutive patients (pts) of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled between November 2012 and May 2014. The primary endpoint of in-hospital procedure-related major complication rate was 1.7% [95% CI 1.3-2.1%] (58/3510 pts) including a mortality of 0.5% [95% CI 0.3-0.8%] (17/3510 pts). Approximately two-thirds (37/58) of these complications occurred during the procedure and one-third (21/58) in the post-operative period. The most common procedure related complications were those requiring pericardiocentesis or chest tube and/or surgical repair (1.4% [95% CI 1.0-1.8%]). Complete clinical and radiological success rates were 96.7% [95% CI 96.1-97.3%] and 95.7% [95% CI 95.2-96.2%], respectively. The all cause in-hospital major complications and deaths were significantly lower in HiV centres vs. LoV centres (2.4% [95% CI 1.9-3.0%] vs. 4.1% [95% CI 2.7-6.0%], P = 0.0146; and 1.2% [95% CI 0.8-1.6%] vs. 2.5% [95% CI 1.5-4.1%] P = 0.0088), although those related to the procedure did not reach statistical significance. Radiological and clinical successes were more frequent in HiV vs. LoV centres. Conclusion The ELECTRa study is the largest prospective registry on TLE and confirmed the safety and efficacy of the current practice of TLE. Lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high volume compared with low volume centres.
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| 9. |
- Chen, Jian, et al.
(författare)
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Catheter ablation for atrial fibrillation : results from the first European Snapshot Survey on Procedural Routines for Atrial Fibrillation Ablation (ESS-PRAFA) Part II
- 2015
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 17:11, s. 1727-1732
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Tidskriftsartikel (refereegranskat)abstract
- The European Snapshot Survey on Procedural Routines in Atrial Fibrillation Ablation (ESS-PRAFA) is a prospective, multicentre snapshot survey collecting patient-based data on current clinical practices during atrial fibrillation (AF) ablation. The participating centres were asked to prospectively enrol consecutive patients during a 6-week period (from September to October 2014). A web-based case report form was employed to collect information of patients and data of procedures. A total of 455 eligible consecutive patients from 13 countries were enrolled (mean age 59 ± 10.8 years, 28.8% women). Distinct strategies and endpoints were collected for AF ablation procedures. Pulmonary vein isolation (PVI) was performed in 96.7% and served as the endpoint in 91.3% of procedures. A total of 52 (11.5%) patients underwent ablation as first-line therapy. The cryoballoon technique was employed in 31.4% of procedures. Procedure, ablation, and fluoroscopy times differed among various types of AF ablation. Divergences in patient selection and complications were observed among low-, medium-, and high-volume centres. Adverse events were observed in 4.6% of AF ablation procedures. In conclusion, PVI was still the main strategy for AF ablation. Procedure-related complications seemed not to have declined. The centre volume played an important role in patient selection, strategy choice, and had impact on the rate of periprocedural complication.
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| 10. |
- Chen, Jian, et al.
(författare)
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Current periprocedural management of ablation for atrial fibrillation in Europe : results of the European Heart Rhythm Association survey.
- 2014
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 16:3, s. 378-81
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Tidskriftsartikel (refereegranskat)abstract
- The purpose of this EP Wire survey was to assess clinical practice in periprocedural management of atrial fibrillation ablation. This survey is based on an electronic questionnaire sent to the European Heart Rhythm Association Research Network members. Responses were received from 78 centres in 20 countries. The results of the survey have shown that periprocedural management is generally in accordance with guidelines and consensus recommendations on ablation for atrial fibrillation ablation, although there are some areas of variation. Differences between high- and low-volume centres are observed with respect to patient selection, antiarrhythmic drug management, and heparin bridging.
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