Resonancia magnética para portadores de dispositivos cardiovasculares. Consenso SEC-GT CRMTC/SEC-Asociación del Ritmo Cardiaco/SERAM/SEICAT / Magnetic resonance in patients with cardiovascular devices. SEC-GT CRMTC/SEC-Heart Rhythm Association/SERAM/SEICAT consensus document

La resonancia magnética se ha convertido en técnica de imagen de primera línea en muchas situaciones clínicas. El número de pacientes portadores de dispositivos cardiovasculares, como los dispositivos cardiovasculares electrónicos implantables, ha crecido de modo exponencial. Aunque se han descrito complicaciones y efectos adversos cuando estos pacientes se someten a exploraciones de resonancia magnética, la evidencia clínica actual respalda la seguridad de realizar estos estudios cuando se cumplen unas normas y recomendaciones dirigidas a minimizar los posibles riesgos. El Grupo de Trabajo de Cardiorresonancia Magnética y Cardiotomografía Computarizadas de la Sociedad Española de Cardiología (SEC-GT CRMTC), la Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología (SEC-Asociación del Ritmo Cardiaco de la Sociedad Española de Cardiología), la Sociedad Española de Radiología Médica (SERAM) y la Sociedad Española de Imagen Cardiotorácica (SEICAT) han elaborado el presente documento, que revisa la evidencia disponible en este campo y establece las recomendaciones necesarias para que los pacientes portadores de dispositivos cardiovasculares electrónicos implantables y otros dispositivos puedan acceder con seguridad a este instrumento diagnóstico (AU)

Magnetic resonance has become a first-line imaging modality in various clinical scenarios. The number of patients with different cardiovascular devices, including cardiac implantable electronic devices, has increased exponentially. Although there have been reports of risks associated with exposure to magnetic resonance in these patients, the clinical evidence now supports the safety of performing these studies under specific conditions and following recommendations to minimize possible risks. This document was written by the Working Group on Cardiac Magnetic Resonance Imaging and Cardiac Computed Tomography of the Spanish Society of Cardiology (SEC-GT CRMTC), the Heart Rhythm Association of the Spanish Society of Cardiology (SEC-Heart Rhythm Association), the Spanish Society of Medical Radiology (SERAM), and the Spanish Society of Cardiothoracic Imaging (SEICAT). The document reviews the clinical evidence available in this field and establishes a series of recommendations so that patients with cardiovascular devices can safely access this diagnostic tool (AU)

Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial.

BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Long-Term Follow-Up of DANISH (The Danish Study to Assess the Efficacy of ICDs in Patients With Nonischemic Systolic Heart Failure on Mortality).

BACKGROUND: DANISH (The Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillators [ICDs] in Patients With Nonischemic Systolic Heart Failure on Mortality) found that primary-prevention ICD implantation was not associated with an overall survival benefit in patients with nonischemic systolic heart failure during a median follow-up of 5.6 years, although there was a beneficial effect on all-cause mortality in patients ≤70 years. This study presents an additional 4 years of follow-up data from DANISH. METHODS: In DANISH, 556 patients with nonischemic systolic heart failure were randomized to receive an ICD and 560 to receive usual clinical care and followed until June 30, 2016. In this long-term follow-up study, patients were followed until May 18, 2020. Analyses were conducted for the overall population and according to age (≤70 and >70 years). RESULTS: During a median follow-up of 9.5 years (25th-75th percentile, 7.9-10.9 years), 208/556 patients (37%) in the ICD group and 226/560 patients (40%) in the control group died. Compared with the control group, the ICD group did not have significantly lower all-cause mortality (hazard ratio [HR] 0.89, [95% CI, 0.74-1.08]; P = 0.24). In patients ≤70 years (n = 829), all-cause mortality was lower in the ICD group than the control group (117/389 [30%] versus 158/440 [36%]; HR, 0.78 [95% CI, 0.61-0.99]; P = 0.04), whereas in patients >70 years (n = 287), all-cause mortality was not significantly different between the ICD and control group (91/167 [54%] versus 68/120 [57%]; HR, 0.92 [95% CI, 0.67-1.28]; P = 0.75). Cardiovascular death showed similar trends (overall, 147/556 [26%] versus 164/560 [29%]; HR, 0.87 [95% CI, 0.70-1.09]; P = 0.20; ≤70 years, 87/389 [22%] versus 122/440 [28%]; HR, 0.75 [95% CI, 0.57-0.98]; P = 0.04; >70 years, 60/167 [36%] versus 42/120 [35%]; HR, 0.97 [95% CI, 0.65-1.45]; P = 0.91). The ICD group had a significantly lower incidence of sudden cardiovascular death in the overall population (35/556 [6%] versus 57/560 [10%]; HR, 0.60 [95% CI, 0.40-0.92]; P = 0.02) and in patients ≤70 years (19/389 [5%] versus 49/440 [11%]; HR, 0.42 [95% CI, 0.24-0.71]; P = 0.0008), but not in patients >70 years (16/167 [10%] versus 8/120 [7%]; HR, 1.34 [95% CI, 0.56-3.19]; P = 0.39). CONCLUSIONS: During a median follow-up of 9.5 years, ICD implantation did not provide an overall survival benefit in patients with nonischemic systolic heart failure. In patients ≤70 years, ICD implantation was associated with a lower incidence of all-cause mortality, cardiovascular death, and sudden cardiovascular death. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00542945.

Generic ICD programming and outcomes.

INTRODUCTION: Generic ICD programming, where shock-reduction programming is extrapolated from trials of one manufacturer to another, may reduce non-essential ICD therapies beyond that seen in randomized trials. However, the benefits and risks are unknown. The purpose of this retrospective cohort study was to evaluate the impact of a standardized programming protocol, based on generic programming, across manufacturers. METHODS: We included all new ICDs in a single center (2009-2019). In 2013 a standardized programming protocol based on generic programming was introduced, incorporating high detection rates (200 bpm for primary prevention) and long detection (30/40 or equivalent in VF zone) for all patients. Patients were classified into three groups based on implant programming: pre-guideline (PS), post-guideline and guideline compliant (GC) and post-guideline but not guideline compliant (NGC). The end-points were the first occurrence of any device therapy (ATP or shock), ICD shock, syncope and all-cause mortality. Survival analysis was used to evaluate outcomes. RESULTS: 1003 patients were included (mean follow-up 1519 ± 1005 days). In primary prevention patients (n = 583) freedom from ICD therapy (91.5% vs. 73.6%, p < .001) or shock (94.7% vs 84.8%, p = .02) were significantly higher in GC compared to PS patients, without significant increase in syncope or mortality. In secondary prevention patients (n = 420) freedom from any ICD therapy or any shock were non-significantly higher in GC compared to PS patients, without an increase in syncope or mortality. CONCLUSIONS: In primary prevention patients a standardized programming protocol, incorporating generic programming, reduced the burden of ICD therapy without an increase in adverse outcomes.

Coexistence of deep brain stimulators and cardiac implantable electronic devices: A systematic review of safety.

As the number of patients implanted with deep brain stimulation systems increases, coexistence with cardiac implantable electronic devices (CIEDs) poses questions about safety. We systematically reviewed the literature on coexisting DBS and CIED. Eighteen reports of 34 patients were included. Device-device interactions were reported in 6 patients. Sources of complications were extensively reviewed and cautious measures which could be considered as part of a standard checklist for careful consideration are suggested.

Mejora progresiva de los umbrales de captura auricular y ventricular, detección e impedancias en los cables de estimulación epicárdica en adultos jóvenes que se someten a conversión de Fontan. / Progressive improvement of atrial and ventricular capture thresholds, sensing, and impedances in epicardial pacing leads in young adults undergoing Fontan conversion.

OBJECTIVES: Patients with univentricular hearts who require permanent pacing systems typically require placement of epicardial leads. It is frequently difficult to find a position with good thresholds due to epimyocardial fibrosis or fat. The goal of the study is to assess the progression of capture thresholds (CT), sensing parameters (P waves and R waves), and impedances (imp) of steroid eluting epicardial pacing leads in young adults who underwent Fontan conversion and a pacemaker implant. METHODS: All patients undergoing Fontan conversion in two institutions were retrospectively identified. Demographic data, congenital heart defects, pacing leads used, and pacing parameters were analyzed at implant, at 6 weeks and 12 months after implant. RESULTS: Twenty patients were identified (twelve males); mean age at conversion was 24.9 ± 5.4 years (range 18-35). Epicardial bipolar steroid eluting leads were used. The site of implant both in the atria and the ventricles varied depending on the parameters. At implant, mean atrial and ventricular impedances were 617 ± 171 Ω and 1061 ± 771 Ω, respectively, mean P wave amplitude was 2 ± 0.7 mV, and mean R wave amplitude was 12.5 ± 7.7 mV. Mean CT was 1.7 ± 0.8 V at 0.5 ms for the atrium and 2.2 ± 1.2 V at 0.5 ms for the ventricle. Ventricular CT and impedance showed an improvement within the first 12 months after implant, with four patients having a decrease in threshold of more than 2 V. CONCLUSION: In patients undergoing Fontan conversion, implant ventricular CT and impedances are frequently higher than expected but typically improve during follow-up. Acceptance of higher initial threshold values may be a potential strategy in this patient population.

OBJETIVO: Los pacientes con corazón univentricular que requieren estimulación cardíaca reciben sistemas de estimulación epicárdicos. Debido a la presencia de fibrosis o grasa epi-miocárdica es dificultoso en esta población encontrar sitios con adecuados parámetros de estimulación. El objetivo de este estudio es determinar la progresión de los umbrales de captura, los parámetros de sensado (medición de las ondas P y R) e impedancias (imp) de los catéteres epicárdicos con liberación de esteroides implantados en adultos jóvenes sometidos a cirugía de reconversión de Fontan e implante de marcapasos. MÉTODOS: Los pacientes sometidos a cirugía de reconversión de Fontan en dos instituciones fueron analizados retrospectivamente. Los datos demográficos, el tipo de cardiopatía congénita, de catéteres de estimulación y los parámetros de estimulación fueron analizados al momento del implante, a las 6 semanas y al año. RESULTADOS: Se identificaron 20 pacientes (12 de ellos de sexo masculino); la edad media al momento de la reconversión fue de 24.9 ± 5.4 años (rango 18-35). Se utilizaron catéteres epicárdicos bipolares de fijación pasiva y con liberación de esteroides en todos los casos. El sitio de implante en las aurículas y en los ventrículos fue variable de acuerdo a los parámetros. En el momento del implante las impedancias medias fueron 617 ± 171 W y 1061 ± 771 W respectivamente, la amplitud media de la onda P fue 2 ± 0.7 mV y la media de amplitud de la onda R fue de 12.5 ± 7.7 mV. Las medias de los umbrales de captura fueron 1.7 ± 0.8 V at 0.5 ms para los catéteres auriculares y 2.2 ± 1.2 V at 0.5 ms para los ventriculares. Los umbrales de captura y las impedancias ventriculares mostraron una mejoría en los 12 meses posteriores al implante, y en 4 pacientes esa mejoría en el umbral de captura ventricular fue mayor a 2 V. CONCLUSIONES: En pacientes sometidos a una cirugía de reconversión de Fontan e implante de marcapasos, los umbrales de captura e impedancias ventriculares son más elevados que los esperados, pero mejoran durante el seguimiento. La aceptación de valores más elevados puede potencialmente constituir una alternativa en esta población de pacientes.

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial.

BACKGROUND: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. METHODS: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points. RESULTS: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%. CONCLUSIONS: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02433379.

Predictors of Subcutaneous Implantable Cardioverter-Defibrillator Shocks and Prognostic Impact in Patients With Structural Heart Disease.

BACKGROUND: In this study we aimed to assess long-term outcomes in subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients with structural heart disease by focussing especially on shock incidence, predictors, and associated prognoses. METHODS: In this multicenter registry‒based study, we retrospectively included all patients who underwent S-ICD implantation at 3 tertiary centers. The prognostic impact of S-ICD shock was assessed with a composite outcome that included all-cause death and hospitalisation for heart failure. RESULTS: A total of 351 patients with underlying cardiomyopathy were included in the investigation. Using multivariable Fine and Gray regression models, secondary prevention, left ventricular ejection fraction (LVEF), conditional shock threshold, and QRS duration appeared to be independent predictors of appropriate S-ICD shock occurrence. In the multivariate Cox regression model adjusted for age, baseline LVEF, underlying cardiomyopathy subtype, New York Heart Association class, and appropriate shocks were significantly associated with increased composite prognostic outcome risk (hazard ratio [HR], 2.61; 95% confidence interval [CI], 1.21-5.65; P = 0.014), whereas inappropriate shocks were not (HR, 1.35; 95% CI, 0.75-4.48; P = 0.18). The analysis of each component of the composite prognostic outcome highlighted that the occurrence of appropriate shocks was associated with an increased risk of hospitalisation for heart failure (HR, 3.10; 95% CI, 1.26-7.58; P = 0.013) and a trend for mortality (HR, 2.19; 95% CI, 0.78-6.16; P = 0.14). CONCLUSIONS: Appropriate S-ICD shocks were associated with a 3-fold increase in acute heart failure admission, whereas inappropriate shocks were not. Conditional shock threshold programming is an independent predictor of S-ICD shock, and its prognostic impact should be investigated further in patients with structural heart disease.

Challenges in activation of remote monitoring in patients with cardiac rhythm devices during the coronavirus (COVID-19) pandemic.

BACKGROUND: Remote monitoring (RM) technology embedded in cardiac rhythm devices permits continuous monitoring of device function, and recording of selected cardiac physiological parameters and cardiac arrhythmias and may be of utmost utility during Coronavirus (COVID-19) pandemic, when in-person office visit for regular follow-up were postponed. However, patients not alredy followed-up via RM represent a challenging group of patients to be managed during the lockdown. METHODS: We reviewed patient files scheduled for an outpatient visit between January 1, 2020 and May 11th, 2020 to assess the proportion of patients in whom RM activation was possible without office visit, and compared them to those scheduled for visit before the lockdown. RESULTS: During COVID-19 pandemic, RM activation was feasible in a minority of patients (7.8% of patients) expected at outpatient clinic for a follow-up visit and device check-up. This was possible in a good proportion of complex implantable devices such as cardiac resynchronization therapy and implantable cardioverter defibrillator but only in a minority of patients with a pacemaker the RM function could be activated during the period of restricted access to hospital. CONCLUSIONS: Our experience strongly suggest to consider the systematic activation of RM function at the time of implantation or - by default programming - in all cardiac rhythm management devices.

Patients' and Nurses' Experiences and Perceptions of Remote Monitoring of Implantable Cardiac Defibrillators in Heart Failure: Cross-Sectional, Descriptive, Mixed Methods Study.

BACKGROUND: The new generation of implantable cardioverter-defibrillators (ICDs) supports wireless technology, which enables remote patient monitoring (RPM) of the device. In Sweden, it is mainly registered nurses with advanced education and training in ICD devices who handle the arrhythmias and technical issues of the remote transmissions. Previous studies have largely focused on the perceptions of physicians, and it has not been explored how the patients' and nurses' experiences of RPM correspond to each other. OBJECTIVE: Our objective is to describe, explore, and compare the experiences and perceptions, concerning RPM of ICD, of patients with heart failure (HF) and nurses performing ICD follow-up. METHODS: This study has a cross-sectional, descriptive, mixed methods design. All patients with HF and an ICD with RPM from one region in Sweden, who had transitioned from office-based visits to implementing RPM, and ICD nurses from all ICD clinics in Sweden were invited to complete a purpose-designed, 8-item questionnaire to assess experiences of RPM. The questionnaire started with a neutral question: "What are your experiences of RPM in general?" This was followed by one positive subscale with three questions (score range 3-12), with higher scores reflecting more positive experiences, and one negative subscale with three questions (score range 3-12), with lower scores reflecting more negative experiences. One open-ended question was analyzed with qualitative content analysis. RESULTS: The sample consisted of 175 patients (response rate 98.9%) and 30 ICD nurses (response rate 60%). The majority of patients (154/175, 88.0%) and nurses (23/30, 77%) experienced RPM as very good; however, the nurses noted more downsides than did the patients. The mean scores of the negative experiences subscale were 11.5 (SD 1.1) for the patients and 10.7 (SD 0.9) for the nurses (P=.08). The mean scores of the positive experiences subscale were 11.1 (SD 1.6) for the patients and 8.5 (SD 1.9) for the nurses (P=.04). A total of 11 out of 175 patients (6.3%) were worried or anxious about what the RPM entailed, while 15 out of 30 nurses (50%) felt distressed by the responsibility that accompanied their work with RPM (P=.04). Patients found that RPM increased their own (173/175, 98.9%) and their relatives' (169/175, 96.6%) security, and all nurses (30/30, 100%) answered that they found RPM to be necessary from a safety perspective. Most patients found it to be an advantage with fewer office-based visits. Nurses found it difficult to handle different systems with different platforms, especially for smaller clinics with few patients. Another difficulty was to set the correct number of alarms for the individual patient. This caused a high number of transmissions and a risk to miss important information. CONCLUSIONS: Both patients and nurses found that RPM increased assurance, reliance, and safety. Few patients were anxious about what the RPM entailed, while about half of the nurses felt distressed by the responsibility that accompanied their work with RPM. To increase nurses' sense of security, it seems important to adjust organizational routines and reimbursement systems and to balance the workload.

Effects of exercise training on physical activity in heart failure patients treated with cardiac resynchronization therapy devices or implantable cardioverter defibrillators.

OBJECTIVE: This study elucidated the effects of exercise training on physical activity, 6-min walk distance, and all-cause hospitalization rates in patients with chronic heart failure, and evaluated factors contributing to changes in physical activity. DESIGN: Prospective cohort observational study. PATIENTS AND METHODS: Patients (n =62) who completed an exercise training programme after implantable cardioverter-defibrillator or cardiac resynchronization therapy treatment between May 2017 and May 2018 were included. Patients exercised for 20-50 min 3-5 times weekly for 3 months and were assigned to the active (≥ 10 min/day) or non-active (< 10 min/day) group based on changes in walking times between baseline and 3 months, as assessed by the International Physical Activity Questionnaire. RESULTS: The 6-min walk distance improved in both groups with exercise training. Physical activity level did not increase in some patients, despite improvements in exercise tolerance. Depression improved significantly in the active group, but no correlation was found with physical activity. Factors contributing to physical activity changes were not identified. The all-cause hospitalization rate was lower in the active group during follow-up (mean 10.5 months). CONCLUSION: Exercise training effectively increased 6-min walk distance regardless of physical activity. Non-active patients experienced increased all-cause hospitalizations. Increasing physical activity improves patient outcomes.

Management of Cardiac Implantable Electrical Devices in Patients Undergoing Radiofrequency Ablation for Spine Pain: Physician Survey and Review of Guidelines.

BACKGROUND: More patients with cardiac implantable electrical devices (CIEDs) are presenting to spine and pain practices for radiofrequency ablation (RFA) procedures for chronic pain. Although the potential for electromagnetic interference (EMI) affecting CIED function is known with RFA procedures, available guidelines do not specifically address CIED management for percutaneous RFA for zygapophyseal (z-joint) joint pain, and thus physician practice may vary. OBJECTIVES: To better understand current practices of physicians who perform RFA for chronic z-joint pain with respect to management of CIEDs. Perioperative CIED management guidelines are also reviewed to specifically address risk mitigation strategies for potential EMI created by ambulatory percutaneous spine RFA procedures. STUDY DESIGN: Web-based provider survey and narrative review. SETTING: Multispecialty pain clinic, academic medical center. METHODS: A web-based survey was created using Research Electronic Data Capture (REDCap). A survey link was provided via e-mail to active members of the Spine Intervention Society (SIS), American Society of Regional Anesthesia and Pain Medicine, as well as distributed freely to community Pain Physicians and any receptive academic departments of PM&R or Anesthesiology. The narrative review summarizes pertinent case series, review articles, a SIS recommendation statement, and multi-specialty peri-operative guidelines as they relate specifically to spine RFA procedures. RESULTS: A total of 197 clinicians participated in the survey from diverse clinical backgrounds, including anesthesiology, physical medicine and rehabilitation, radiology, neurosurgery, and neurology, with 81% reporting fellowship training. Survey responses indicate wide variability in provider management of CIEDs before, during, and after RFA for z-joint pain. Respondents indicated they would like more specific guidelines to aid in management and decision-making around CIEDs and spine RFA procedures. Literature review yielded several practice guidelines related to perioperative management of CIEDs, but no specific guideline for percutaneous spine RFA procedures. However, combining the risk mitigation strategies provided in these guidelines, with interventional pain physician clinical experience allows for reasonable management recommendations to aid in decision-making. LIMITATIONS: Although this manuscript can serve as a review of CIEDs and aid in management decisions in patients with CIEDs, it is not a clinical practice guideline. CONCLUSIONS: Practice patterns vary regarding CIED management in ambulatory spine RFA procedures. CIED presence is not a contraindication for spine RFA but does increase the complexity of a spine RFA procedure and necessitates some added precautions. KEY WORDS: Radiofrequency ablation, neurotomy, cardiac implantable electrical device, zygapophyseal joint, spondylosis, neck pain, low back pain, chronic pain.

Guideline-concordant-phenotyping: Identifying patient indications for implantable cardioverter defibrillators from electronic health records.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) have been shown to reduce sudden cardiac death in appropriately selected patients, but they remain underutilized among indicated patients. OBJECTIVE: To develop a new approach to identifying guideline indications among patients implanted with ICDs by creating algorithms that extract data from electronic health records (EHR). METHODS: Published guidelines providing recommendations for ICD use were distilled into categories of diagnoses, measures, procedures, and terminologies. Criteria for each indication category were translated into clinical algorithms using administrative codes, search terms, and other required data. Cardiologists with guideline-development expertise reviewed these algorithms. After developing applications using a subset of data, phenotypes were evaluated against a curated Optum® de-identified EHR dataset, including 94,441 patients with ≥1 procedure codes for ICD implantation or follow-ups from 47 US provider networks. RESULTS: Guideline-concordant indications were identified in 83.7 % of 49,560 patients with new ICD implants. The percentage of ICD patients with guideline-concordant indications ranged from 69.4%-88.1% for patients whose initial EHR records were 0-6 days to >365 days prior to implant, respectively. Many guideline criteria used data which could only be derived from unstructured provider notes and required significant algorithm development. CONCLUSIONS: Defibrillator implant indications were detected in >80 % of patients receiving ICDs using rule-based algorithms in a curated EHR dataset. Computable phenotypes may enable researchers to analyze EHRs in more reproducible ways, by identifying guideline indications in patients with specific therapies such as ICDs, and, by extension, identifying patients who meet indications yet do not yet have indicated therapies.

Spasm Provocation Tests under Medication May Help Decide on Medical or Mechanical Therapy in Patients with Aborted Sudden Cardiac Death due to Coronary Spasm.

Objective The decision to perform medical or mechanical therapy in patients with aborted sudden cardiac death (ASCD) due to coronary spasm is controversial. The Japanese Circulation Society guidelines for the diagnosis and treatment of patients with coronary spastic angina mentioned that implantable cardioverter-defibrillator (ICD) is one option in patients with ASCD due to coronary spasm. We investigated the usefulness of spasm provocation tests under medications in five patients with ASCD due to coronary spasm. Methods We performed the spasm provocation tests under medications in five ASCD patients due to coronary spasm. Pharmacological spasm provocation tests, including five acetylcholine (ACh) tests, two ergonovine (ER) tests, and two ACh added after ER tests, were performed to estimate the effect of medications to suppressing the next fatal spasms. Results ACh tests under medications did not provoke spasm in one patient but did provoke in two patients. In the remaining two patients, neither the ACh test nor the ER test provoked spasm, but the ACh added after ER test induced a focal spasm in one coronary artery. We increased the medication dosage in four patients. An ICD was implanted in two patients, including one with refractory spasm and one with left main trunk spasm. One patient died due to pulseless electrical activity without ventricular fibrillation, while the remaining four patients survived. Conclusion Spasm provocation tests under medication in patients with ASCD due to coronary spasm may be an option when deciding on medical or mechanical therapy.