Cardiac Ablation Procedures Research Articles

Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study

BackgroundOpen heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis.MethodsOne hundred eighty-seven patients scheduled for open heart surgery were enrolled in a prospective, open-label clinical trial and randomized to concomitant LAACS vs. standard care. Randomization was stratified by usage of oral anticoagulation (OAC) planned to last at least 3 months after surgery. The primary endpoint was a composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic (SCI) lesions.ResultsDuring a mean follow-up of 3.7 years, 14 (16%) primary events occurred among patients receiving standard surgery vs. 5 (5%) in the group randomized to additional LAACS (hazard ratio 0.3; 95% CI: 0.1–0.8, p = 0.02). In per protocol analysis (n = 141), 14 (18%) primary events occurred in the control group vs. 4 (6%) in the LAACS group (hazard ratio 0.3; 95% CI: 0.1–1.0, p = 0.05).ConclusionsIn a real-world setting, LAACS in addition to elective open-heart surgery was associated with lower risk of post-operative ischemic brain injury. The protective effect was not conditional on AF/OAC status at baseline.Trial registrationLAACS study, clinicaltrials.gov NCT02378116, March 4th 2015, retrospectively registered.

The Ability to Reproducibly Record Cardiac Action Potentials From Multiple Anatomic Locations: Endocardially and Epicardially, In Situ and In Vitro.

For cardiac arrhythmia mapping and ablation procedures, the ability to record focal cardiac action potentials could aid in precisely identifying lesions, scarred tissue, and/or arrhythmic foci. Our study objective was to validate the electrophysiologic properties of a routinely employed large mammalian in vitro working heart model. Monophasic action potentials (MAPs) were recorded from 18 swine hearts during viable hemodynamic function both in situ (postmedian sternotomy) and in vitro (using Visible Heart methodologies). We placed specially designed mapping catheters in epicardial and endocardial locations. High-quality MAP signals were recorded for up to 2h, and MATLAB was utilized to evaluate relative duration and temporal/regional changes in waveform morphology. MAPs were reproducibly recorded from both epicardial and endocardial locations in situ and in vitro. No significant differences were noted in right atrial endocardial, right ventricular endocardial, right ventricular epicardial, or left atrial epicardial waveforms, when baseline recordings were compared to all other in situ and in vitro time points. Furthermore, MAP duration between right ventricular endocardial and epicardial waveforms was not significantly different, in situ or in vitro. The use of in vitro models like the Visible Heart is considered invaluable for the study of cardiac arrhythmias, the development of novel therapies, and/or preclinical testing of future cardiac mapping catheters and systems. Preclinical studies assessing in situ and/or in vitro recorded cardiac monophasic action potentials could be critical for the future development and validation of cardiac devices.

PCV85 - The Impact of the Centers for Medicare and Medicaid Services (CMS) 2016 Update to the Two-Midnight Rule On Inpatient/Outpatient Status and Length of Stay for Cardiac Ablation Procedures

CMS released an update to the 2013 2-midnight rule, effective for 2016, expanding a physician’s ability to admit patients under Medicare Part A who are expected to require less than two midnights of hospital care. We sought to quantify the impact of this change on rates of inpatient admissions and lengths of stay (LOS) for patients having cardiac catheter ablation. These procedures had high rates of extended observational outpatient stays based on the original rule. Patient-level de-identified hospital records from 2013-2016 were extracted from the MedAssets hospital database. Visits for adults (age 18+) with a primary diagnosis of atrial fibrillation, atrial flutter, ventricular tachycardia, or supraventricular tachycardia and a procedure code for catheter ablation of the associated arrhythmia were included, provided that they did not have additional codes for AV node ablation, endoscopic or surgical ablation, surgical left atrial appendage exclusion, valve surgery, or cardiac implant. The primary outcomes were inpatient/outpatient visit status and LOS by insurance type (Medicare/commercial) and year. A total of 11,398 commercial and 15,430 Medicare ablation visits met all inclusion criteria. The percentage of inpatient visits remained constant from 2015 to 2016 for patients with commercial insurance (32.4% to 32.7%, p=0.8511) but increased for those with Medicare (45.0% to 50.0%, p=0.0002). Similarly, the percentage of patients with single night LOS remained constant from 2015 to 2016 for the commercially insured (30.1% and 30.1%, p=0.9714) while decreasing for Medicare patients (25.5% to 20.2%, p<0.0001). In cardiac catheter ablation patients, the change to the CMS 2-midnight rule increased the percentage of Medicare patients admitted as inpatients and staying two or more nights. This increase impacts hospital reimbursement rates and patient eligibility for Medicare payment of skilled nursing care upon discharge.

Miniaturized Robotic End-Effector with Piezoelectric Actuation and Fiber Optic Sensing for Minimally Invasive Cardiac Procedures.

Each year 35,000 cardiac ablation procedures are performed to treat atrial fibrillation through the use of catheter systems. The success rate of this treatment is highly dependent on the force which the catheter applies on the heart wall. If the magnitude of the applied force is much higher than a certain threshold the tissue perforates, whereas if the force is lower than this threshold the lesion size may be too large and is inconsistent. Furthermore, studies have shown large variability in the applied force from trained physicians during treatment, suggesting that physicians are unable to manually regulate the levels of the force at the site of treatment. Current catheter systems do not provide the physicians with active means for contact force control and are only at most aided by visual feedback of the forces measured in situ. This paper discusses a novel design of a robotic end-effector that integrates mechanisms of sensing and actively controlling of the applied forces into a miniaturized compact form. The required specifications for design and integration were derived from the current application under investigation. An off-the-shelf miniature piezoelectric motor was chosen for actuation, and a force sensing solution was developed to meet the specifications. Experimental characterization of the actuator and the force sensor within the integrated setup show compliance with the specifications and pave the way for future experimentation where closed-loop control of the system can be implemented according to the contact force control strategies for the application.

Probabilistic guidance for catheter tip motion in cardiac ablation procedures.

Radiofrequency catheter ablation is one of the commonly available therapeutic methods for patients suffering from cardiac arrhythmias. The prerequisite of successful ablation is sufficient energy delivery at the target site. However, cardiac and respiratory motion, coupled with endocardial irregularities, can cause catheter drift and dispersion of the radiofrequency energy, thus prolonging procedure time, damaging adjacent tissue, and leading to electrical reconnection of temporarily ablated regions. Therefore, positional accuracy and stability of the catheter tip during energy delivery is of great importance for the outcome of the procedure. This paper presents an analytical scheme for assessing catheter tip stability, whereby a sequence of catheter tip motion recorded at sparse locations on the endocardium is decomposed. The spatial sliding component along the endocardial wall is extracted from the recording and maximal slippage and its associated probability are computed at each mapping point. Finally, a global map is generated, allowing the assessment of potential areas that are compromised by tip slippage. The proposed framework was applied to 40 retrospective studies of congenital heart disease patients and further validated on phantom data and simulations. The results show a good correlation with other intraoperative factors, such as catheter tip contact force amplitude and orientation, and with clinically documented anatomical areas of high catheter tip instability.

P302An augmented reality approach to guide epicardial access during cardiac ablation procedures

P302An augmented reality approach to guide epicardial access during cardiac ablation procedures

A Tale of Two Cities: Evolution of Academic Physiatry in Boston and Baltimore: Part 1: The Boston Marathon

A Tale of Two Cities: Evolution of Academic Physiatry in Boston and Baltimore: Part 1: The Boston Marathon

Safety and Efficacy of Inpatient Initiation of Dofetilide versus Sotalol for atrial fibrillation

Many clinical challenges have been encountered in electrophysiology laboratories (EP) while implanting intracardiac defibrillators for lethal arrhythmias, using pacemakers for bradyarrhythmias, placing pacemakers with multiple leads in patients with heart failure and cardiac ablation procedures. In this environment, anesthesiology plays a very critical role to ensure patients comfort, as well as maintains operator's convenience and facilitate management of undesired situations. EP laboratories are mostly used for diagnosis of certain heart diseases. Meanwhile, with the exponential increase in interventional procedures in our decade, electrophysiologists' need to cooperate with the anesthesiologists more frequently. The literature is still unclear about the effects of anesthetic agents on cardiac conduction pathways, but as we know with our previous data, the most agents we are using currently have more or less effect on the cardiac conduction systems. In this review, we aimed to describe the safe anesthesia methods in cardiac diagnostic procedures and have a closer look up the anesthetic outcomes of these procedures. This article comprehensively reviews the anesthesia practice encountered in electrophysiology laboratories.

Statistics on the use of cardiac electronic devices and interventional electrophysiological procedures in Africa from 2011 to 2016: report of the Pan African Society of Cardiology (PASCAR) Cardiac Arrhythmias and Pacing Task Forces.

AimsTo provide comprehensive information on the access and use of cardiac implantable electronic devices (CIED) and catheter ablation procedures in Africa.Methods and resultsThe Pan-African Society of Cardiology (PASCAR) collected data on invasive management of cardiac arrhythmias from 2011 to 2016 from 31 African countries. A specific template was completed by physicians, and additional information obtained from industry. Information on health care systems, demographics, economics, procedure rates, and specific training programs was collected. Considerable heterogeneity in the access to arrhythmia care was observed across Africa. Eight of the 31 countries surveyed (26%) did not perform pacemaker implantations. The median pacemaker implantation rate was 2.66 per million population per country (range: 0.14–233 per million population). Implantable cardioverter-defibrillator and cardiac resynchronization therapy were performed in 12/31 (39%) and 15/31 (48%) countries respectively, mostly by visiting teams. Electrophysiological studies, including complex catheter ablations were performed in all countries from Maghreb, but only one sub-Saharan African country (South Africa). Marked variation in cost (up to 1000-fold) was observed across countries with an inverse correlation between implant rates and the procedure fees standardized to the gross domestic product per capita. Lack of economic resources and facilities, high cost of procedures, deficiency of trained physicians, and non-existent fellowship programs were the main drivers of under-utilization of interventional cardiac arrhythmia care.ConclusionThere is limited access to CIED and ablation procedures in Africa. A quarter of countries did not have pacemaker implantation services, and catheter ablations were only available in one country in sub-Saharan Africa.

Developing a checklist to inform data linkage study designs for health technology assessments: a case study linking the Cardiac Rhythm Management (CRM) register to the Secure Anonymised Information Linkage (SAIL) Databank

ABSTRACTObjectivesHealth services researchers are increasingly engaging with the emerging field of data science, but relatively few have the expertise to understand how innovative data linkage methodologies can, and cannot, be successfully applied in practice. There is little published guidance written specifically for this purpose.&#x0D; We aimed to develop study design criteria to help researchers in considering whether these methods are appropriate for their projects. A secondary objective was to test the criteria in a case study, and evaluate the application of the data linkage approach.&#x0D; ApproachClinical procedures requiring further research (according to the National Institute for Health and Care Excellence) were assessed against newly-developed CINDER criteria (Coverage; Identifiers; Numbers; Data; Existing records; Retrieval) to check the suitability of using data linkage methods. The CALON (Cardiac Ablation: Linking Outcomes for NICE) study was then established to evaluate outcomes of cardiac ablation procedures.&#x0D; Records from the UK’s Cardiac Rhythm Management (CRM) register were linked to routinely-recorded primary care, secondary care and mortality data in the Secure Anonymised Information Linkage (SAIL) Databank. Demographic profiles of patients identified from the register were compared with a group identified from SAIL. Outpatient attendances before and after ablation were compared using a Generalised Linear Mixed Model, assuming significance of p&lt;0.05. Kaplan-Meier analyses were used to estimate survival.&#x0D; Evaluation of methodological success concentrated on: adequately characterising patient populations from existing data; matching individuals between datasets; and data completeness/consistency.&#x0D; ResultsThe linked dataset contained 2220 anonymised records. Almost all (99.7%) patients from the register were matched using deterministic and probabilistic techniques. These patients were similar to individuals identified from hospital records with respect to sex and comorbidity score (p&gt;0.05); mean age differed by 1.6 years (95% CI 0.23-3.04; p=0.02).&#x0D; Patients accessed 26.7% fewer hospital outpatient appointments after ablation (95% CI 23.4 to 29.8; p&lt;0.001). There was no significant difference in the number of primary care events before and after ablation (95% CI -4.3 to 4.0; p=0.91). Survival was estimated at 91.0% after 5 years. Insufficient granularity of data precluded subgroup analyses.&#x0D; ConclusionsData linkage can be used to evaluate outcomes of interventions, although there are limitations associated with secondary use of observational data. The CALON study identified a post-ablation reduction in hospital attendances, suggesting an overall improvement in general health.&#x0D; We aim to publish the full CINDER checklist as a generic resource to facilitate assessment of the feasibility of using data linkage methods in other projects.

Preliminary Validation of Transcutaneous CO&amp;lt;sub&amp;gt;2&amp;lt;/sub&amp;gt; Monitoring in Patients Undergoing Cardiac Ablation Using Jet Ventilation

Objectives: There is no data in the current medical literature on efficacy or accuracy of transcutaneous (tcPCO2) monitoring during jet ventilation for cardiac ablation. The use of tcPCO2 during cardiac ablation procedures offers the opportunity to compare end-tidal and transcutaneous methods of CO2 measurement before and after the use of the jet ventilation. Comparison of these measurements with arterial blood gas CO2 levels allows evaluation of the accuracy of the tcPCO2 technique for use during jet ventilation. Design: Observational study; patients served as their own controls. Setting: Cardiac electrophysiology laboratory. Participants: 15 adult patients (9 M), ASA III-IV, aged 26 to 82 years (median 66 years) undergoing radiofrequency ablation for atrial fibrillation. Interventions: Jet ventilation (JV) versus conventional ventilation. Measurements and Main Results: Paired measurements of end-tidal CO2 (EtCO2) and transcutaneous CO2 (tcPCO2) were recorded during periods of conventional ventilation. Paired measurements of arterial blood CO2 (PaCO2) levels and tcPCO2 were recorded during JV. ABG samples were drawn at the anesthesiologist’s discretion to assess the patient’s respiratory status. The level of agreement between the three methods was compared using the Bland Altman plot. We found that tcPCO2 values consistently provided a close approximation to PaCO2 levels. The mean difference between tcPCO2 and EtCO2 values in baseline and post-JV was on the order of 3 - 5 mmHg, with standard deviation of 4 - 6 mmHg. This is well within the range of variability that is accepted in clinical practice. Conclusions: These preliminary results suggest that tcPCO2 provides an acceptable estimate of CO2 concentration in arterial blood during JV, as well as prior to and following JV.

Colchicine for prevention and treatment of cardiac diseases: A meta-analysis.

Colchicine has been suggested to be beneficial in preventing recurrent pericarditis. The goal of this study was to review all randomized controlled trials that assess the use of colchicine for the prevention and treatment of cardiac diseases. We performed a meta-analysis of the effects of colchicine on pericarditis, postpericardiotomy syndrome and postprocedural atrial fibrillation recurrence, in-stent restenosis, gastrointestinal adverse effects, and treatment discontinuation rates. We conducted an EMBASE and MEDLINE search for prospective controlled trials. We identified 17 prospective controlled randomized studies with 2082 patients that received colchicine and 1982 controls with an average follow-up duration of 12months. Treatment with colchicine is associated with reduced risk of pericarditis recurrence/postpericardiotomy syndrome (OR: 0.37; 95% CI: 0.29-0.47; P<0.001) and lower recurrence of atrial fibrillation rates after cardiac surgery and ablation procedures. However, gastrointestinal side effects were more common in patients treated with colchicine (OR: 2.6; 95% CI: 1.82-3.72; P<0.001) in all subgroups except for those treated for prevention of recurrent pericarditis. The higher rates of side effects resulted in higher incidence of treatment discontinuation in patients treated with colchicine. Colchicine appears to be efficacious and well tolerated for recurrent pericarditis/postpericardiotomy syndrome and recurrence of postprocedural atrial fibrillation. However, its efficacy may be limited by its gastrointestinal adverse events and treatment discontinuation rates particularly in postoperative patients.

Applications of Advanced Imaging in Cardiac Electrophysiology.

Imaging modalities such as computed tomography, magnetic resonance, positron emission tomography, and single-photon emission computed tomography are an indispensable component of cardiac arrhythmia management. Over the last two decades, developments in imaging techniques have facilitated safer and more effective cardiac ablation and device implantation procedures. Pre-procedural assessment of arrhythmogenic substrate and integration with electroanatomic data has significantly impacted the management of atrial fibrillation and ventricular tachycardia. Furthermore, cardiovascular imaging enhances patient selection, prognostication, and follow-up of patients undergoing ablation procedures. Imaging also provides valuable anatomic information in patients being considered for cardiac resynchronization therapy (CRT). While the optimal modality for assessing efficacy of resynchronization is currently unclear, further study holds promise in mitigating the substantial burden of CRT non-response. This article aims to highlight the utility and evidence for various advanced imaging modalities in the practice of cardiac electrophysiology with an emphasis on recent developments and future directions.

Cardiac Radiofrequency Ablation: A Clinical Update for Nurses.

The field of electrophysiology (EP) has rapidly evolved from a focus on diagnostic procedures to an emphasis on interventions. Many cardiac arrhythmias traditionally treated with antiarrhythmic agents, cardioversion, or cardiac surgery are now routinely cured with cardiac ablation. To optimally manage the care of cardiac ablation patients, it is essential that nurses have an understanding of the EP procedures and related nursing implications. There are extensive evidence-based resources available in the medical literature; however, there are limited publications geared toward nurses caring for cardiac ablation patients.This article provides an overview of EP diagnostic and cardiac radio-frequency ablation procedures for select atrial and ventricular tachyarrhythmias. Evidence-based nursing practices related to postprocedure care will be addressed. The objective of this article is to increase nurses' knowledge of common cardiac ablation procedures and the nursing management of the patient postprocedure.

부정맥 시술을 위한 마스터-슬레이브 원격제어·로봇 시스템 개발

Recently, the robotic assist system for cardiovascular intervention gets continuously growing interest. The robotic cardiovascular intervention systems are largely two folds, systems for cardiac ablation procedure assist and systems for vascular intervention assist. For the systems, the clinician controls the catheter inserted through blood vessel to the heart via a master console or master manipulator. Most of the current master manipulators have structure of joystick-like pivoting 2 degree of freedom (DOF) handle in the core, which is used in parallel with other sliding switches and input devices. It however is desirable to have customized and optimized design manipulator that can provide clinician with intuitive control of the catheter motion fully utilizing the advantage of the use of robotic structure. A 6 DOF kinematic mechanism that can capture the motion control intention of the clinician in translational 3 DOF and rotational 3 DOF is proposed in this paper. Also, a master-slave motion relationship specially designed for the cardiac catheter manipulation motion is proposed and implemented in an experimental prototype. Design revision for implementation of more efficient motion and experiment in combination with an experimental slave robot system for catheter manipulation are underway.

Interactive training system for interventional electrocardiology procedures.

Recent progress in cardiac catheterization and devices has allowed the development of new therapies for severe cardiac diseases like arrhythmias and heart failure. The skills required for such interventions are very challenging to learn, and are typically acquired over several years. Virtual reality simulators may reduce this burden by allowing trainees to practice such procedures without risk to patients. In this paper, we propose the first training system dedicated to cardiac electrophysiology, including pacing and ablation procedures. Our framework involves the simulation of a catheter navigation that reproduces issues intrinsic to intra-cardiac catheterization, and a graphics processing unit (GPU)-based electrophysiological model. A multithreading approach is proposed to compute both physical simulations (navigation and electrophysiology) asynchronously. With this method, we reach computational performances that account for user interactions in real-time. Based on a scenario of cardiac arrhythmia, we demonstrate the ability of the user-guided simulator to navigate inside vessels and cardiac cavities with a catheter and to reproduce an ablation procedure involving: extra-cellular potential measurements, endocardial surface reconstruction, electrophysiology mapping, radio-frequency (RF) ablation, as well as electrical stimulation. A clinical evaluation assessing the different aspects of the simulation is presented. This works is a step towards computerized medical learning curriculum.

Real-Time MRI-Guided Cardiac Cryo-Ablation: A Feasibility Study.

MRI-based ablation provides an attractive capability of seeing ablation-related tissue changes in real time. Here we describe a real-time MRI-based cardiac cryo-ablation system. Studies were performed in canine model (n = 4) using MR-compatible cryo-ablation devices built for animal use: focal cryo-catheter with 8 mm tip and 28 mm diameter cryo-balloon. The main steps of MRI-guided cardiac cryo-ablation procedure (real-time navigation, confirmation of tip-tissue contact, confirmation of vessel occlusion, real-time monitoring of a freeze zone formation, and intra-procedural assessment of lesions) were validated in a 3 Tesla clinical MRI scanner. The MRI compatible cryo-devices were advanced to the right atrium (RA) and right ventricle (RV) and their position was confirmed by real-time MRI. Specifically, contact between catheter tip and myocardium and occlusion of superior vena cava (SVC) by the balloon was visually validated. Focal cryo-lesions were created in the RV septum. Circumferential ablation of SVC-RA junction with no gaps was achieved using the cryo-balloon. Real-time visualization of freeze zone formation was achieved in all studies when lesions were successfully created. The ablations and presence of collateral damage were confirmed by T1-weighted and late gadolinium enhancement MRI and gross pathological examination. This study confirms the feasibility of a MRI-based cryo-ablation system in performing cardiac ablation procedures. The system allows real-time catheter navigation, confirmation of catheter tip-tissue contact, validation of vessel occlusion by cryo-balloon, real-time monitoring of a freeze zone formation, and intra-procedural assessment of ablations including collateral damage.

Clinical predictors of cardiac magnetic resonance late gadolinium enhancement in patients with atrial fibrillation

This study aims to examine the association of clinical co-morbidities with the presence of left atrial (LA) late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR). Previous studies have established the severity of LA LGE to be associated with atrial fibrillation (AF) recurrence following AF ablation. We sought to determine whether baseline clinical characteristics were associated with LGE extent among patients presenting for an initial AF ablation. The cohort consisted of 179 consecutive patients with no prior cardiac ablation procedures who underwent pre-procedure LGE-CMR. The extent of LA LGE for each patient was calculated using the image intensity ratio, normalized to the mean blood pool intensity, corresponding to a bipolar voltage ≤0.3 mV. The association of LGE extent with baseline clinical characteristics was examined using non-parametric and multivariable models. The mean age of the cohort was 60.9 ± 9.6 years and 128 (72%) were male. In total, 56 (31%) patients had persistent AF. The mean LA volume was 118.4 ± 41.6 mL, and the mean LA LGE extent was 14.1 ± 10.4%. There was no association with any clinical variables with LGE extent by quartiles in the multivariable model. Extent of LGE as a continuous variable was positively, but weakly associated with LA volume in a multivariable model adjusting for age, body mass index, AF persistence, and left ventricular ejection fraction (1.5% scar/mL, P = 0.038). In a cohort of patients presenting for initial AF ablation, the presence of pre-ablation LA LGE extent was weakly, but positively associated with increasing LA volume.

Towards MRI-guided cardiac ablation procedures with no contrast agent: safety and efficacy considerations

Background Efforts are underway to perform MRI-guided cardiac ablations in the magnet. The chief motivations are: 1) the ability to see the effects of treatment, 2) improved catheter positioning during mapping and therapy, and 3) avoiding ionizing radiation and iodinated contrast agent from x-ray. However, current efforts use gadolinium-based contrast agents (GBCAs) to obtain MR Angiogram (MRA) for anatomical context and late gadolinium enhancement (LGE) for enhancement of ablation lesions. There may be motivations to limit use of GBCAs, both in the specific context of an ablation procedure and in general use. The general use motivation is health-based, as the FDA is investigating the risk of gadolinium deposits in the brain after repeated use of GBCAs. Another motivation is for accuracy in assessment of acute lesions, since wash-in/out kinetics make it difficult to infer lesion size from enhancement regions in LGE images, even with carefully chosen timing and imaging parameters. The typical LGE protocol requires waiting 10-15 minutes after contrast agent injection before T1w imaging. This protocol is both unpractical to run repeatedly and limited by contrast-agent dose. It may be possible to perform this procedure without GBCAs. We focus on the acquisition of images for MRA, real-time navigation and lesion assessment. We present proof-of-concept data in swine left ventricle (LV).

Cardiff cardiac ablation patient-reported outcome measure (C-CAP): validation of a new questionnaire set for patients undergoing catheter ablation for cardiac arrhythmias in the UK.

PurposeTo formally test and validate a patient-reported outcome measure (PROM) for patients with cardiac arrhythmias undergoing catheter ablation procedures in the UK [Cardiff Cardiac Ablation PROM (C-CAP)].MethodsA multicentre, prospective, observational cohort study with consecutive patient enrolment from three UK sites was conducted. Patients were sent C-CAP questionnaires before and after an ablation procedure. Pre-ablation C-CAP1 (17 items) comprised four domains: patient expectations; condition and symptoms; restricted activity and healthcare visits; medication and general health. Post-ablation C-CAP2 (19 items) comprised five domains including change in symptoms and procedural complications. Both questionnaires also included the generic EQ-5D-5L tool (EuroQol). Reliability, validity, and responsiveness measures were calculated.ResultsA total of 517 valid pre-ablation and 434 post-ablation responses were received; questionnaires showed good feasibility and item acceptability. Internal consistency was good (Cronbach’s alpha >0.7) and test–retest reliability was acceptable for all scales. C-CAP scales showed high responsiveness (effect size >0.8). Patients improved significantly (p < 0.001) following ablation across all disease-specific and global scales. Minimal clinically important difference was calculated. Improvement beyond the smallest detectable change of 9 points (symptom severity scale), 3 points (frequency and duration of symptoms scale), and 8 points (impact on life scale) indicates an important change. Amendments to the C-CAP questionnaires were identified through the validation process and made to produce the final tools.ConclusionsThe final C-CAP questionnaires are valid, reliable, and responsive tools for measuring symptom change, impact, and expectations in patients undergoing ablation for cardiac arrhythmias. C-CAP questionnaires provide a tool with disease-specific and generic domains to explore how cardiac ablation procedures in the UK impact upon patients’ lives.Electronic supplementary materialThe online version of this article (doi:10.1007/s11136-015-1194-1) contains supplementary material, which is available to authorized users.