Why the distribution matters: using discrete event simulation to demonstrate the impact of the distribution of procedure times on hospital operating room utilisation and average procedure cost

Background: Economic evaluations include estimates of surgical procedures costs that have usually been derived by allocating operating room (OR) costs in proportion to the average duration of different procedure types. However, ORs run with average utilisation below 100%, due to idle time between procedures and at the end of the day. Longer and less predictable procedures generate greater OR idle time, for a given tolerance of schedule over-runs. Estimates of surgical procedure costs that are based on average procedure duration alone as a measure of OR resource consumption will not capture the impact of the length and variability of procedure duration on OR idle time and capacity utilisation. Objective: To demonstrate how real-world OR scheduling practices lead to different levels of resource consumption than predicted by simple micro-costing approaches based on average procedure duration, and how those differences can vary between procedures with significantly different distributions of duration. Methods: We use a discrete event simulation model, calibrated with real-world data from a single surgical centre in Belgium, to compare simulated resource consumption, including idle time, for two alternative surgical procedures for ablation for atrial fibrillation. Results: We demonstrate that simple micro-costing approaches can under-estimate effective resource consumption between 31% and 48% for a procedure with long and unpredictable duration. For a shorter and more predictable procedure the under-estimate is only 15%. Conclusion: Simple approaches to estimating procedure costs may under-estimate resource consumption and do so in a way that is biased against technologies with shorter and more predictable procedure duration. For health technology decisions where a substantial part of costs are OR resources, a more sophisticated approach, taking account of the real-world implications of the distribution of procedure durations, should be used to avoid potential bia

Major gaps in the information provided to patients before implantation of cardioverter defibrillators: a prospective patient European evaluation

AIMS: Information provided to patients prior to implantable cardioverter-defibrillator (ICD) insertion and their participation in the decision-making process are crucial for understanding ICD function and accepting this lifelong therapy. The aim of this study is to evaluate the extent to which different aspects related to ICD and quality of life were transmitted to patients prior to ICD implantation. METHODS AND RESULTS: Prospective, multicenter European study with an online questionnaire initiated by the European Heart Rhythm Association. The questionnaire was filled-in directly and personally by the ICD patients who were invited to participate. A total of 1809 patients (majority in their 40s-70s, with 624 women, 34.5%) from 10 European countries participated in the study. The median time from first ICD implantation was 5 years (interquartile range 2-10). Overall, 1155 patients (71.5%) felt optimally informed at the time of device implantation, however many respondents received no information about ICD-related complications (n = 801, 49.6%), driving restrictions (n = 718, 44.5%), and possibility of end-of-life ICD deactivation (n = 408, 25.4%). Of note, women were less frequently involved in the decision-making process than men (47.3% vs. 55.9%, P = 0.003) and reported to be less often optimally informed before ICD implantation than men (61.2% vs. 76.8%, P < 0.001). More women mentioned the desire to have learned more about ICD therapy and the benefit/risk balance (45.4% vs. 33.7% of men; P < 0.001). CONCLUSIONS: This patient-based evaluation provides alarming findings on the lack of information provided to patients prior ICD implantation, particularly for women

Atrial Fibrillation Ablation: A Single Center Comparison Between Remote Magnetic Navigation, Cryoballoon and Conventional Manual Pulmonary Vein Isolation

Contains fulltext : 88398.pdf (publisher's version ) (Open Access)BACKGROUND: The aim of the study was to compare in our center the effect of different ablation techniques on intermediate term freedom from atrial fibrillation (AF) or atrial tachycardia (AT) in patients affected by refractory AF. METHODS AND RESULTS: We retrospectively selected 94 patients who underwent AF ablation in our electrophysiological laboratory from June 2007 to December 2009. 29 patients underwent manual circumferential pulmonary vein isolation (mCPVI), 35 underwent remote magnetic navigation assisted CPVI (rmtCPVI) and 30 cryoballoon CPVI (cCPVI). Antiarrhythmic drugs were systematically stopped 2 months after the procedure (end of the "blanking period"). At a mean follow-up of 12,64 +/- 6,41 months (range 2-31), the success rate for mCPVI group was 65.5% (19 patients), 66.7 % (20 patients) for the rmtCPVI group and 65.7 % (23 patients) for the cCPVI group (p = 0.625). Procedural and fluoroscopy times were significantly reduced in the cCPVI group (both p < 0.001). Univariate Cox regression showed that no clinical variables were independently associated with recurrence. CONCLUSIONS: In our center's experience cCPVI and rmtCPVI have been demonstrated to be as effective as mCPVI. cCPVI seemed to be associated with lower procedural and fluoroscopy times

Regional disparity on patient characteristics and perceptions after implantable cardioverter-defibrillator implantation: results from an EHRA patient survey

AIMS: The aim of this study was to identify potential regional disparities in characteristics of implantable cardioverter-defibrillator (ICD) recipients, patient perceptions and perspectives after implantation and level of information provided to patients. METHODS AND RESULTS: The prospective, multicentre, and multinational European Heart Rhythm Association patient Survey 'Living with an ICD' included patients already implanted with an ICD (median ICD dwell time - 5 years, interquartile range 2-10). An online questionnaire was filled-in by patients invited from 10 European countries. A total of 1809 patients (the majority in their 40s to 70s, 65.5% men) were enrolled, with 877 (48.5%) from Western Europe (group 1), followed by 563 from Central/Eastern Europe (group 2, 31.1%), and 369 from Southern Europe (group 3, 20.4%). A total of 52.9% of Central/Eastern Europe patients reported increased satisfaction after ICD placement compared with 46.6% from Western and 33.1% from Southern Europe (1 vs. 2 P = 0.047, 1 vs. 3 P < 0.001, 2 vs. 3 P < 0.001). About 79.2% of Central/Eastern and 76.0% of Southern Europe patients felt optimally informed at the time of device implantation compared with just 64.6% from Western Europe (1 vs. 2 P < 0.001, 1 vs. 3 P < 0.001, 2 vs. 3 P = ns). CONCLUSIONS: While physicians in Southern Europe should address the patients' concerns about the impact of the ICD on quality of life, physicians from Western Europe should focus on improving the quality of information provided to their prospective ICD patients. Novel strategies to address regional differences in patients' quality of life and provision of information are warranted

Cryoballoon Ablation for Paroxysmal Atrial Fibrillation in Septuagenarians: a Prospective Study

Contains fulltext : 87905.pdf (publisher's version ) (Open Access)AIMS: To evaluate the effects of pulmonary vein isolation (PVI) in terms of feasibility, safety and success rate on a midterm follow-up period in septuagenarians undergoing ablation with the Arctic Front Cryoballoon for atrial fibrillation (AF). METHODS AND RESULTS: We prospectively enrolled 21 patients aged 70 years or older (14 male; age 73 +/- 2.5 years) elected to circumferential PVI with the 28mm cryoballoon for symptomatic drug resistant paroxysmal AF. A total number of 82 pulmonary veins (PV) were evidenced. Successful isolation could be obtained in all 82 (100%) PV ostia at the end of procedure. No major complication occurred during procedure. At a mean follow-up of 11.5 +/- 4.7 months following ablation, 62% of patients did not present recurrence of atrial arrhythmias. CONCLUSION: Cryoballoon ablation may be feasible and safe in older patients. Moreover a large proportion of the latter did not present AF recurrence during follow-up

Abnormally high risk of stroke in Brugada syndrome

BACKGROUND The present study sought to evaluate the incidence of cerebrovascular events in a large cohort of patients with Brugada syndrome (BrS) analysing possible predictors, clinical characteristics and prognosis of cardioembolic events secondary to atrial fibrillation. METHODS A total of 671 consecutive patients (age 42.1 ± 17.0 years; men 63%) with a diagnosis of BrS were retrospectively analysed over a mean follow-up period of 10.8 ± 5.5 years. The diagnosis of ischemic stroke was made according to the AHA/ASA guidelines using computed tomography (CT) and angio-CT in the emergency department. RESULTS Among 671 patients with BrS, 79 (11.8%) had atrial fibrillation. The incidence of cardioembolic stroke in patients with BrS and atrial fibrillation was 13.9% (11 events). These patients had a low CHA2DS2Vasc score (82%, 0 and 1). Patients with transient ischemic attack/stroke were more frequently asymptomatic (91 vs. 25%; P < 0.0001) and older (59.4 ± 11.2 vs. 43.9 ± 16.7; P = 0.004) as compared with those without cerebrovascular events. CONCLUSION The incidence of cardioembolic stroke in patients with BrS and atrial fibrillation was unexpectedly high. The cerebrovascular accidents were often the presenting clinical manifestation and were significantly associated with asymptomatic atrial fibrillation and older age. CHADS2 and CHA2DS2Vasc scores did not predict the unexpectedly high risk of thromboembolic events in this group of patients. The use of more invasive diagnostic tools might be useful in order to increase the rate of atrial fibrillation detection

Antithrombotic treatment management in low stroke risk patients undergoing cardioversion of atrial fibrillation <48 h duration: results of an EHRA survey

Data supporting the safety of cardioversion (CV) of atrial fibrillation (AF) without anticoagulation in patients with AF duration <48 h are scarce. Observational studies suggest that the risk of stroke in these patients is very low when the definite duration of the AF episode is of <48 h and the clinical risk profile as estimated through the CHA2DS2VASc score is low (a score of 0 for men and 1 for women). As the recent 2020 European Society of Cardiology (ESC) guidelines indication for this clinical scenario is based mainly on consensus, we sent out a survey to assess the current clinical practice on anticoagulation prior to and post-CV in patients with AF <24-48 h duration and low stroke risk across centres in Europe. Of the 136 respondents, half were affiliated to university hospitals (68/136; 50%). Non-university hospitals (50/136; 36%) and private hospitals (2/136; 1.4%) accounted over a third of respondents. The main findings of our survey were (i) heterogeneity in the anticoagulation management both before and post-CV in low stroke-risk patients with AF <48 h, (ii) higher utilization of periprocedural low-molecular-weight heparin than of non-vitamin K antagonist oral anticoagulant, (iii) higher utilization of pre-CV transoesophageal echocardiography for electrical CV than for pharmacological CV regardless of the duration of AF, (iv) high adherence to a 4-week post-CV oral anticoagulant (OAC) therapy, mainly for electrical CV, and finally, (v) perceived higher acceptance of lack of post-CV OAC therapy in patients with <24 h than 24-48 h episode duration. The results obtained in this survey highlight the need for more research providing definitive clarification on the safety of CV without anticoagulation in patients with short duration AF

Compatibility assessment of a temperature-controlled radiofrequency catheter with a novel electroanatomical mapping system

BackgroundThe novel DiamondTemp ablation system (DTA) and EnSiteX mapping System (EAM) are both CE-Marked and FDA approved medical devices. The DTA has been validated by its manufacturer only in combination with previous version of EnSite System—EnSite Precision. The aim of this study was to evaluate compatibility of DTA with EnSite X with a previously developed protocol.MethodsThree configurations were tested: 3.1. Medtronic Generator connection Box (GCB) and AmpereConnect cable; 3.2. the Medtronic GCB-E and electrogram out cable from GCB to EAM; 3.3. Direct connection of DTA to EAM using intracardiac out cable with no GCB.ResultsThe previously developed universal method for compatibility assessment of ablation catheters and navigation systems was used with success for assessing DTA and EnSite X EAM compatibility, with reproducible results. Accuracy of DTA visualization with different setups was evaluated with a phantom model measuring distances between DTA and reference points. DTA is compatible with EnSiteX EAM with a safety and reliability profile guaranteed, if within the described specifications. In particular, careful setup is mandatory to achieve good clinical outcomes as only setup 3.2 is viable for both NavX and Voxel Mode and demonstrated satisfactory results and accuracy. Setup 3.3 showed a significant shift immediately after catheter insertion. Catheter position was away from baseline points and the dislocation increased during the radiofrequency delivery.ConclusionsPreviously developed method for compatibility assessment of ablation catheters and navigation systems has been used for a new EAM. DTA is compatible with EnSiteX EAM with proper configuration

Second generation cryoballoon ablation for atrial fibrillation in young adults: midterm outcome in patients under 40 years of age

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