An Economic Analysis of the Systematic Use of Mapping Systems during Catheter Ablation Procedures: Single Center Experience.

INTRODUCTION: In this study we estimated the cost-effectiveness of adopting 3D Nonfluoroscopic Mapping Systems (NMSs) for catheter ablation (CA). METHODS: This study includes patients who underwent supraventricular tachycardia (SVT) CA and atrial fibrillation (AF) CA from 2007 to 2016. A comparison was conducted between a reference year (2007) and the respective years for the two types of procedure in which the maximum optimization of patients' exposure using NMSs was obtained. We compared the data of all SVT CA performed solely using fluoroscopy in 2007 (Group I) and all SVT CA procedures performed using fluoroscopy together with an NMS in 2011 (Group II). There was also an important comparison made between AF CA procedures performed in 2007 (Group III) and AF CA in 2012 (Group IV), where patients' treatment in both years included the use of an NMS but where the software and hardware versions of the NMS were different. Two cost-effectiveness analyses were carried out. The first method was based on the alpha value (AV): the AV is a monetary reference value of avoided unit of exposure and is expressed as $/mansievert. The second one was based on the value of a statistical life (VSL): the VSL does not represent the cost value of a person's life, but the amount that a community would be willing to pay to reduce the risk of a person's death. The costs estimated from these two methods were compared to the real additional cost of using an NMS during that type of procedure in our EP Lab. RESULTS: The use of NMS reduced the effective dose of about 2.3 mSv for SVT and 23.8 mSv for AF CA procedures. The use of NMS, applying directly AV or VSL values, was not cost-effective for SVT CA for the most countries, whereas the use of an NMS during an AF CA seemed to be cost-effective for most of them. CONCLUSIONS: In our analysis the cost-effectiveness of the systematic use of NMSs strongly depended on the AV and VSL values considered. Nonetheless, the approach seemed to be cost-effective only during AF CA procedures.

Magnetic Resonance Examinations of Patients With Implanted Active Devices. A Low-Cost Approach in Slew Rate Evaluation.

Time-varying magnetic field gradients involved in magnetic resonance examinations can damage implanted electronic systems. The quantity related to this side effect is the gradient slew rate, which is usually not directly available on magnetic resonance console. The present study proposes a low-cost approach in slew rate assessment, which is useful in risks versus benefits evaluation as well as in sequences optimization. The experimental method is based on an analog circuit, which senses the output voltage of the scanner waveform generator. This allows taking easy and reliable slew rate measurements, even during clinical examinations on patients. Whereas previous studies required managing a considerable amount of data, the present work addresses only the maximal slew rate of any clinical sequence. Experimental results show that the smooth gradient mode, selectable on the two scanners examined, is very effective in patient safety improvement. In particular, it reduces slew rate values in the range from 52.4 up to 132.4 T m-1 s-1 , i.e. far below the interval 216-346 T m-1 s-1 , indicated as slew rate tolerance limit of modern implanted electronic devices. Bioelectromagnetics. 2019;40:512-521. © 2019 Bioelectromagnetics Society.

Extensive Use of 3D Nonfluoroscopic Mapping Systems for Reducing Radiation Exposure during Catheter Ablation Procedures: An Analysis of 10 Years of Activity.

PURPOSE: 3D nonfluoroscopic mapping systems (NMSs) are generally used in the catheter ablation (CA) of complex ventricular and atrial arrhythmias. The aim of this study was to evaluate the efficacy, safety, and long-term effect of the extended, routine use of NMSs for CA. METHODS: Our study involved 1028 patients who underwent CA procedures from 2007 to 2016. Initially, CA procedures were performed mainly with the aid of fluoroscopy. From October 2008, NMSs were used for all procedures. RESULTS: The median fluoroscopy time of the overall CA procedures fell by 71%: from 29.2 min in 2007 to 8.4 min in 2016. Over the same period, total X-ray exposure decreased by 65%: from 58.18 Gy⁎cm2 to 20.19 Gy⁎cm2. This reduction was achieved without prolonging the total procedure time. In AF CA procedures, the median fluoroscopy time fell by 85%, with an 86% reduction in total X-ray exposure. In SVT CA procedures, the median fluoroscopy time fell by 93%, with a 92% reduction in total X-ray exposure. At the end of the follow-up period, the estimated probability of disease-free survival was 67.7% at 12 months for AF CA procedures and 97.2% at 3 months for SVT CA, without any statistically significant difference between years. CONCLUSIONS: Our study shows the feasibility of using NMSs as the main imaging modality to guide CA. The extended, routine use of NMSs dramatically reduces radiation exposure, with only slight fluctuations due to the process of acquiring experience on the part of untrained operators, without affecting disease-free survival.

A Cost-Effective Analysis of Systematically Using Mapping Systems During Catheter Ablation Procedures in Children and Teenagers.

The aim of this study is to evaluate the cost-effectiveness of an extended use of 3D non-fluoroscopic mapping systems (NMSs) during paediatric catheter ablation (CA) in an adult EP Lab. This study includes 58 consecutive patients (aged between 8 and 18) who underwent CA from March 2005 to February 2015. We compare the fluoroscopy data of two groups: group I, patients who underwent CA from 2005 to 2008 using only fluoroscopy, and group II, patients who underwent CA from 2008 to 2015 performed also using NMSs. Two cost-effectiveness analyses were carried out: the first method was based on the alpha value (AV), and the second one was based on the value of a statistical life (VSL). For both methods, a children's correction factor was also considered. The reduction cost estimated from all these methods was compared to the real additional cost of using NMSs. The use of an NMS during a CA procedure has led to an effective dose reduction (ΔE) of 2.8 milli-Sievert. All presented methods are based on parameters with a wide range of values. The use of an NMS, applying directly AV values or VSL values, is not cost-effective for most countries. Only considering the children's correction factor, the CA procedure using an NMS seems to be cost-effective. The cost-effectiveness of a systematic use of NMSs during CA procedures in children and teenagers remains a challenging task. A positive result depends on which value of AV or VSL is considered and if the children's correction factor is applied or not.

The Benefit of a General, Systematic Use of Mapping Systems During Electrophysiological Procedures in Children and Teenagers: The Experience of an Adult EP Laboratory.

Standard imaging during electrophysiological procedures (EPs) uses fluoroscopy. The aim of this study was to evaluate the feasibility, efficacy, safety and effect of an extended use of non-fluoroscopic mapping systems (NMSs) for imaging during paediatric EPs in an adult EP laboratory focusing on the amount of X-ray exposure. This study is a retrospective analysis that includes consecutive young patients (83 pts, aged between 8 and 18) who underwent EPs from March 2005 to February 2015. We compare the fluoroscopy data of two groups of pts: Group I, pts who underwent EPs from 2005 to 2008 using only fluoroscopy and Group II, pts who underwent EPs from 2008 to 2015 performed also using NMSs. The use of an NMS resulted in reduced fluoroscopy time in Group II {median value 0.1 min (95 % CI [0.00-1.07])} compared to Group I {median value 3.55 min (95 % CI [1.93-7.83]) (MW test, P < 0.05)}. There was a complementary reduction in the total X-ray exposure from 2.53 Gy cm(2) (95 % CI [1.51-4.66]) in Group I to 0.05 Gy cm(2) in Group II (95 % CI [0.00-1.22]) (MW test, P < 0.05). Regarding ablation procedures, the median effective dose decreased from 3.04 mSv (95 % CI [1.22-6.89]) to 0.25 mSv (95 % CI [0.00-0.60]) (MW test, P < 0.05). The use of an NMS dramatically reduces fluoroscopy time and total X-ray exposure during EPs in children and teenagers in an adult EP laboratory. In our experience, this reduction is mainly related to the systematic day-to-day use of NMSs.

Real time evaluation of overranging in helical computed tomography.

Overranging or overscanning increases the dose delivered to patients undergoing helical Computed Tomography examinations. In order to reduce it, nowadays most of the multidetector tomographs close the X-ray beam aperture at the scan extremes. This technical innovation, usually referred to as dynamic or adaptive collimation, also influences the overranging assessment methods. In particular, the film free approach proposed in previous studies is not suitable for these modern tomographs. The present study aims to introduce a new method of estimating overranging with real time dosimetry, even suitable for tomographs equipped with adaptive collimation. The approach proposed is very easy to implement and time saving because only a pencil chamber is required. It is also equivalent in precision and in accuracy to the film based one, considered an absolute benchmark.

A novel skeleton based quantification and 3-D volumetric visualization of left atrium fibrosis using late gadolinium enhancement magnetic resonance imaging.

This work presents the results of a new tool for 3-D segmentation, quantification and visualization of cardiac left atrium fibrosis, based on late gadolinium enhancement magnetic resonance imaging (LGE-MRI), for stratifying patients with atrial fibrillation (AF) that are candidates for radio-frequency catheter ablation. In this study 10 consecutive patients suffering AF with different grades of atrial fibrosis were considered. LGE-MRI and magnetic resonance angiography (MRA) images were used to detect and quantify fibrosis of the left atrium using a threshold and 2-D skeleton based approach. Quantification and 3-D volumetric views of atrial fibrosis were compared with quantification and 3-D bipolar voltage maps measured with an electro-anatomical mapping (EAM) system, the clinical reference standard technique for atrial substrate characterization. Segmentation and quantification of fibrosis areas proved to be clinically reliable among all different fibrosis stages. The proposed tool obtains discrepancies in fibrosis quantification less than 4% from EAM results and yields accurate 3-D volumetric views of fibrosis of left atrium. The novel 3-D visualization and quantification tool based on LGE-MRI allows detection of cardiac left atrium fibrosis areas. This noninvasive method provides a clinical alternative to EAM systems for quantification and localization of atrial fibrosis.

Identification of left atrial fibrosis with a late-enhancement MR sequence (LE-MR): preliminary results.

PURPOSE: This study was done to identify left atrial fibrosis in a group of consecutive patients with atrial fibrillation (AF) candidate for percutaneous radiofrequency catheter ablation (RFCA) by using a late-enhancement magnetic resonance (LE-MR) sequence, and to validate the technique by comparison with electroanatomical mapping (EAM). MATERIALS AND METHODS: We enrolled 37 patients (29 males; mean age, 61 years) candidate for percutaneous RFCA of AF, who were studied with LE-MR and EAM. To identify left AF we used a three-dimensional LE sequence with cardiac gating and respiratory navigator. The EAM study involved the acquisition of 200 points in the left atrium (LA). The LA was divided into seven segments (pulmonary vein antra, floor, anterior wall, posterior wall-roof). Two blinded radiologists assessed the presence of fibrosis (area of hyperintense signal), reaching a consensus in discordant cases. Inter-observer variability was also evaluated to estimate the reproducibility of the method. We analysed the anatomical agreement between the results obtained with LE-MR imaging and EAM. RESULTS: Five patients were excluded because of to poor image quality. As for the other 32 patients, inter-observer agreement was good [Cohen's kappa κ = 0.72 with 95 % confidence interval (CI) of 0.55, 0.89]. In the classification of LA segments affected by fibrosis, LE-MR had a sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of 66 % (95 % CI 53.7 %, 77.2 %); 87 % (95 % CI 80.9 %, 91.9 %); 69 % (95 % CI 56.5 %, 80.1 %); 85.5 % (95 % CI 79.1 %, 90.6 %) and 81 % (95 % CU 75.1 %, 85.7 %). CONCLUSIONS: Despite the small size of the sample studied, the LE-MR sequence proved more useful for excluding the presence of AF than for confirming its existence. Identification of AF prior to RFCA is paramount to select those patients who are truly amenable to the ablation procedure, which is expensive and not entirely free of risks.

Impact of residual setup error on parotid gland dose in intensity-modulated radiation therapy with or without planning organ-at-risk margin.

PURPOSE: To estimate the dosimetric impact of residual setup errors on parotid sparing in head-and-neck (H&N) intensity-modulated treatments and to evaluate the effect of employing an PRV (planning organ-at-risk volume) margin for the parotid gland. PATIENTS AND METHODS: Ten patients treated for H&N cancer were considered. A nine-beam intensity-modulated radiotherapy (IMRT) was planned for each patient. A second optimization was performed prescribing dose constraint to the PRV of the parotid gland. Systematic setup errors of 2 mm, 3 mm, and 5 mm were simulated. The dose-volume histograms of the shifted and reference plans were compared with regard to mean parotid gland dose (MPD), normal-tissue complication probability (NTCP), and coverage of the clinical target volume (V95% and equivalent uniform dose [EUD]); the sensitivity of parotid sparing on setup error was evaluated with a probability-based approach. RESULTS: MPD increased by 3.4%/mm and 3.0%/mm for displacements in the craniocaudal and lateral direction and by 0.7%/ mm for displacements in the anterior-posterior direction. The probability to irradiate the parotid with a mean dose > 30 Gy was > 50%, for setup errors in cranial and lateral direction and < 10% in the anterior-posterior direction. The addition of a PRV margin improved parotid sparing, with a relative reduction in NTCP of 14%. The PRV margin compensates for setup errors of 3 mm and 5 mm (MPD < or = 30 Gy in 87% and 60% of cases), without affecting clinical target volume coverage (V95% and EUD variations < 1% and < 1 Gy). CONCLUSION: The parotid gland is more sensitive to craniocaudal and lateral displacements. A setup error of 2 mm guarantees an MPD < or = 30 Gy in most cases, without adding a PRV margin. If greater displacements are expected/accepted, an adequate PRV margin could be used to meet the clinical parotid gland constraint of 30 Gy, without affecting target volume coverage.