Remote Supervision to Decrease Hospitalization Rate (RESULT) study in patients with implanted cardioverter-defibrillator.

AIMS: The number of patients with heart failure (HF) and implantable cardiac electronic devices has been growing steadily. Remote monitoring care (RC) of cardiac implantable electronic devices can facilitate patient-healthcare clinical interactions and prompt preventive activities to improve HF outcomes. However, studies that have investigated the efficacy of remote monitoring have shown mixed findings, with better results for the system including daily verification of transmission. The purpose of the RESULT study was to analyse the impact of remote monitoring on clinical outcomes in HF patients with implantable cardioverter-defibrillator [ICD/cardiac resynchronization therapy-defibrillator (CRT-D)] in real-life conditions. METHODS AND RESULTS: The RESULT is a prospective, single-centre, randomized trial. Patients with HF and de novo ICD or CRT-D implantation were randomized to undergo RC vs. in-office follow-ups (SC, standard care). The primary endpoint was a composite of all-cause death and hospitalization due to cardiovascular reasons within 12 months after randomization. We randomly assigned 600 eligible patients (299 in RC vs. 301 in SC). Baseline clinical and echocardiographic characteristics were well-balanced and similar in both arms. The incidence of the primary endpoint differed significantly between RC and SC and involved 39.5% and 48.5% of patients, respectively, (P = 0.048) within the 12-month follow-up. The rate of all-cause mortality was similar between the studied groups (6% vs. 6%, P = 0.9), whereas hospitalization rate due to cardiovascular reasons was higher in SC (37.1% vs. 45.5%, P = 0.045). CONCLUSION: Remote monitoring of HF patients with implanted ICD or CRT-D significantly reduced the primary endpoint rate, mostly as a result of a lower hospitalization rate in the RC arm (ClinicalTrials.gov Identifier: NCT02409225).

Impact of Remote Monitoring on Long-Term Prognosis in Heart Failure Patients in a Real-World Cohort: Results From All-Comers COMMIT-HF Trial.

BACKGROUND: Randomized controlled trials demonstrate that remote monitoring (RM) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) may improve quality of care and prognosis in heart failure (HF) patients. However, the impact of RM on long-term mortality in a real-world cohort is still not well examined. METHODS AND RESULTS: This study was designed as a matched cohort study based on the COMMIT-HF trial--a single-center, ongoing prospective observational registry (NCT02536443). Complete patient demographics, medical history, in-hospital results, hospitalizations, and mortality data were collected based on institutional registries and healthcare providers' records. Patients were divided into 2 groups based on RM presence and matched by means of propensity scores according to clinical characteristics. The primary endpoint of this study was the long-term all-cause mortality. Out of 1,429 consecutive patients, 822 patients with a first implantation of an ICD/CRT-D were included in the analysis. The final matched study population contained 574 patients in RM and in a control group. Although demographic and echocardiographic parameters as well as pharmacological treatments were similar in both groups, a significantly lower 1-year mortality was detected in the RM group (2.1% vs. 11.5%, P < 0.0001). This was also maintained during a 3-year follow-up (4.9% vs. 22.3%, P < 0.0001). Multivariate analysis showed that RM was associated with an improved prognosis (hazard ratio 0.187, 95% confidence interval 0.075-0.467, P = 0.0003). CONCLUSION: RM of HF patients with ICDs/CRT-Ds significantly reduced long-term mortality in a real-world clinical condition.

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225).

Effect of Therapeutic Ionizing Radiation on Implantable Electronic Devices: Systematic Review and Practical Guidance.

Cardiac implantable electronic devices (CIEDs) have been in use for over 50 years and their therapeutic value is undisputable. With the rapidly aging population, it is estimated that the number of CIEDs will grow dramatically over the next 2 decades. Given these predictions, the topic of management of concomitant conditions associated with older age becomes more relevant than ever. In particular, the number of patients with an implanted CIED diagnosed with cancer is expected to rise by about 70%, from 14 million in 2012 to 22 million within the next 2 decades. Treatment of most of these tumors and tumor metastases requires radiation therapy. However, the necessary high doses of radiation can potentially interact with the function, longevity, and integrity of the CIEDs and/or cause harm to the patient. The impact of an absence of clear therapeutic guidelines for oncology patients with CIEDs who should undergo radiation therapy is vast; and due to the fear of possible complications related to device failure, many of these patients may not be treated adequately to their needs, which can strongly affect their prognosis. This article summarizes the available data on the management of patients with CIEDs undergoing radiotherapy. It systematically presents possible causes and consequences of direct and scattered radiation on CIEDs, highlights possible complications that may occur during this kind of treatment, and provides practical guidance for this challenging real life clinical setting.

Two professions against two killer diseases: the rationale, organization, and initial experience of a cardio-oncology service.

BACKGROUND: Cardiovascular diseases are the most common factor affecting prognosis in cancer survivors. Cardio­oncology (CO) services have been developed to solve this issue. The outcomes regarding patient demographics and clinical findings are limited and the available data include CO services evaluating patients undergoing only chemotherapy as opposed to those also undergoing radiation therapy. AIMS: We aimed to show initial experiences of the CO service implemented in a tertiary oncology center. METHODS: The CO service was designed to include 2 major domains, general CO and electrotherapy consultations. This observational study included patients referred to the CO service with the following data: baseline demographics, cancer type, reasons for referral, cardiac evaluation, and initial clinical outcomes. RESULTS: All patients with cancer referred to our CO service between March 2016 and December 2019 were included in the study. A total of 2762 patients (77% women) at the mean (SD) age of 62 (12) years were referred (63% on an out­patient basis) for general consultations. The most frequent diagnosis was breast cancer (66%). A total of 18% of patients were referred to the CO service due to cardiovascular complications related to cancer treatment. The CO-cardiac implantable electronic device (CIED) team evaluated 652 patients (515 patients with CIEDs who were qualified for radiotherapy, 48 patients with CIEDs who were assessed with magnetic resonance imaging, and 89 patients with CIEDs who underwent cancer surgery). In the total of 5872 radiotherapy sessions, there were 2 harmful interactions; no other complications during magnetic resonance imaging and surgery were recorded. CONCLUSIONS: The CO­service established within the cancer center seems to be safe and feasible.

Radiation therapy in patients with cardiac implantable electronic devices.

BACKGROUND: The number of patients with cardiac implantable electronic devices (CIEDs) treated with radiation therapy (RT) as an oncological treatment is expected to increase. AIMS: The aim of the study was to assess whether cancer treatment with radiation therapy is associated with any device dysfunctions and device­related threats in patients with CIEDs. METHODS: The risk of all patients with CIEDs undergoing RT was assessed according to guidelines. Device interrogations were performed before the first and after the last RT session. In patients at high risk and/or with an implantable cardioverter­defibrillator or cardiac resynchronization therapy with defibrillator (CRT­D), all sessions were supervised by a cardiologist, and device interrogations were performed before and after every single RT session. Device parameters and events were monitored during thewhole treatment. RESULTS: The study included 157 patients with CIEDs who had palliative (n = 71) or radical (n = 86) RT. Pacemakers were implanted in 113 patients, implantable cardioverter­defibrillators in 36, and CRT­D in 8. During the 2396 RT sessions (median [interquartile range], 5 [5-28] per patient) with cumulative dose up to 78 Gy per patient for the whole RT treatment and maximum energy beam up to 20 MV, 2 events potentially related to radiation were recorded. CONCLUSIONS: Radiation therapy in patients with CIEDs is not associated with substantial risk to the patients assuming the patients' management follows current guidelines.

The clinical value of the routine analysis of cardiac implantable electronic devices after the patient's death in a tertiary cardiovascular center.

INTRODUCTION: The postmortem interrogation of cardiac implantable electronic devices (CIEDs) has not been regularly practiced yet. We presumed that it can provide data not only on the mechanism of the patient's death but also on possible device malfunctions contributing to its occurrence. OBJECTIVES: The study aimed to determine the usefulness of the explantation and interrogation of CIEDs after the patient's death in routine clinical practice, when combined with autopsy findings and clinical follow­up starting from the time after device implantation. PATIENTS AND METHODS: Between August 24, 2008 and August 30, 2018, all patients who underwent autopsy in the tertiary cardiovascular center or partner facilities had the device explanted and interrogated by the qualified electrophysiologist. Clinical characteristics obtained at the time of device implantation and patients' death were obtained from medical records. Device interrogation results were then combined with autopsy report and clinical data. RESULTS: Out of 1200 autopsied patients, the device was removed and analyzed in 61 individuals. Clinical characteristics from the time of implantation and patients' death were available in 53 (86.7%) and 49 (80.3%) patients, respectively. Device­related concerns, undetected during patients' hospital stay, were noted in 6 cases (6.1%) and included 3 programming and 3 hardware issues. CONCLUSIONS: To our knowledge, this is the first study to date to combine the clinical follow­up of patients before death and on admission at the end of life, autopsy results, and postmortem CIED interrogation. Having implemented the device interrogation, we found 6 CIED­related events potentially associated with patients' death, which were not detected before its occurrence.

Electrical storm - still an extremely poor prognosis. Do these acute states of life-threatening arrhythmias require a multidirectional approach from the start?

Electrical storm (ES) is a state of electrical instability of the heart manifesting as multiple and potentially lethal recurring ventricular arrhythmias such as ventricular tachycardia or ventricular fibrillation. This definition is not related to the condition of each patient, who can present from asymptomatic to unconscious and in deep cardiogenic shock. Most patients affected by ES have heart failure (HF) of ischaemic origin. Ischaemia, exacerbation of HF, low ejection fraction, previous ventricular arrhythmias, infection or electrolyte disturbances together with other factors, or a few factors combined, may result in ES. The prognosis of ES survivors is very poor, with 1-year mortality exceeding 40%, which should draw attention to this group of patients as one of extremely high risk. The number of patients with cardioverter-defibrillators is increasing and so is the number of patients suffering from ES. Therefore, each patient should be supported with tailored therapy, and not only restricted to pharmacotherapy or ablation procedures. This paper was written to analyse the most frequent causes of ES and prompt the most appropriate clinical pathways and possibilities, underlining the need for a comprehensive invasive approach to diagnosis, treatment and circulatory stabilization in addition to adequate pharmacotherapy. This approach might help to reduce the mortality rate in this group of patients and improve the prognosis.

Characteristics and Outcomes in Patients With Electrical Storm.

Electrical storm (ES) is a life-threatening condition with diverse clinical presentation, caused by recurrent malignant ventricular arrhythmia--≥3 episodes of ventricular tachycardia (VT) or ventricular fibrillation within 24hours and is associated with high mortality. The aim of this study was analysis of clinical profile, treatment, and prognosis of patients with ES admitted to a high-volume cardiovascular center. We present results of a single-center, retrospective, ongoing observational registry enrolling consecutive patients presenting with ES admitted between 2006 and 2017. Clinical history, results of diagnostic investigations, and treatment were collected for all patients. Follow-up data were collected from hospital documentation, outpatient clinic, remote monitoring systems, and from data gathered from national health services. Registry enrolled 101 consecutive patients admitted with ES. Two-thirds of patients had ischemic cardiomyopathy. Mean left ventricle ejection fraction was 26%. In 56.4% of the patients coronary angiogram was performed and in 20.8% cases percutaneous coronary intervention was needed. 18.8% of the patients underwent VT ablation. 12-month mortality from first ES in our population was 21.8%. NYHA class III and IV, raised N-terminal fragment of prohormone B-type Natriuretic Peptide and creatinine levels, and lower hemoglobin levels were independent predictors of death. In conclusion, most patients admitted with ES have ischemic cardiomyopathy. Over 1/3 of the population had significant narrowing of at least one coronary artery with ES masking ischemia and underwent percutaneous coronary intervention. Nearly 1/5 of the patients were treated with VT ablation. 12-month mortality was high and exceeded 1/4 of patients with ES.

Patients with cardiac implantable electronic devices undergoing radiotherapy in Poland. Expert opinion of the Heart Rhythm Section of the Polish Cardiac Society and the Polish Society of Radiation Oncology.

Older age and high morbidity of the society contribute to a growing number of patients with cardiac implantable electronic devices (CIEDs) requiring effective cancer treatment, including radiotherapy (RT). The effect of RT on a CIED may vary depending on the type and physical parameters of radiation, location of the treated lesion, indications for electrotherapy, and the type of CIED. In the most dramatic scenarios, it may cause an irreversible damage to the CIED, with serious clinical consequences. The lack of precise guidelines may limit the access to RT for many patients with CIEDs who would otherwise benefit from the therapy or may lead to a therapy without taking the necessary precautions, which may worsen the prognosis. Therefore, clear and unequivocal recommendations for assessing patient eligibility for RT are aimed at ensuring that adequate precautions are taken as well as at providing patients with concomitant cardiovascular and oncologic diseases with access to safe and effective RT.

Cardiac resynchronization in Poland - comparable procedural routines? Insights from CRT Survey II.

INTRODUCTION: CRT Survey II was initiated by the European Heart Rhythm Association and the Heart Failure Association, to explore everyday implantation practice of cardiac resynchronization therapy (CRT) devices in a broad spectrum of hospitals in European Society of Cardiology (ESC) member countries. AIM: To compare Polish and European procedural practice. MATERIAL AND METHODS: Procedural details of Polish patients collected in 37 Polish centres (n = 1241 - Poland group) were compared to the patients enrolled throughout Europe (n = 9847 - CRT II Survey group). RESULTS: There were significant differences in: successful implantation (96.1% vs. 97.4%), type of device implanted (for CRT-D: 87% vs. 67.6%), implanting physician subspecialty (for electrophysiologist: 69.2% vs. 79.8%), type of location of procedure (for operating room: 19.4% vs. 8.9%), duration of procedure (117.8 ±44 vs. 97.5 ±46.1 min), left ventricle lead type (for multipolar lead: 50% vs. 57.9%), coronary sinus venogram with occlusion rate (41.4% vs. 47.9%) and peri-procedural complication rate (7.5% vs. 5.3%) between Poland and CRT II Survey groups, respectively. CONCLUSIONS: This study provides important information describing current differences in Polish procedural routines in relation to ESC member countries. Heterogeneous CRT implantation practices across European countries still exist. However, it may be related to different clinical profile of patients qualified for CRT implantation in Poland as well as organization of care.

The impact of remote monitoring of implanted cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy device (CRT-D) patients on healthcare costs in the Silesian population: three-year follow-up.

BACKGROUND: The population of patients with implanted cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D) is constantly growing. The use of remote-monitoring (RM) techniques in this group can significantly improve clinical outcomes, but there are limited data about the impact of RM on healthcare costs from a payer's perspective. AIM: The aim of the study was to assess the impact on costs for the healthcare system of RM in patients with ICD or CRT-D. METHODS: We examined a cohort of 842 patients with ICD or CRT-D. The group was divided into two groups based on RM (or no RM [NRM]), matched according to important clinical characteristics. The subjects were followed for a maximum of three years after implantation (mean follow-up 2.11 ± 0.83 years). The overall costs for the healthcare provider in the follow-up were defined as the primary endpoint. The secondary endpoint was the use of different types of medical contact events: hospitalisation and number of in-clinic and general practitioner visits (without the number of remote transmissions). RESULTS: In the three-year follow-up, the reduction in the costs of treatment for National Health Care in the RM group was 33.5% (median value, p < 0.001). In patients with implanted CRT-D, the reduction reached 42.7% (p = 0.011), and with ICD it was 31.3% (p = 0.007). We observed no significant reduction in the median hospitalisation costs in the three-year follow-up in the RM group (p = NS), despite a 25% drop in the mean value. The costs of outpatient visits were slightly higher in the RM group (p = NS). In the follow-up period, there was no reduction in the number of medical contact events (p = NS). CONCLUSIONS: Remote monitoring in patients with implanted ICD or CRT-D devices reduces the cost for the national healthcare provider.

Complications in recipients of cardioverter-defibrillator or cardiac resynchronization therapy: Insights from Silesian Center Defibrillator registry.

BACKGROUND: Current real-life information from all-comers registries from middle and east Europe about the incidence and type of complications during long-term follow-up of patients with cardioverters-defibrillators (ICD) and cardiac resynchronization devices-defibrillators (CRT-D) is still insufficient. The aim of the study was to assess the incidence and determinants of short- and long-term complications related to implantable ICD and CRT-D. METHODS: We studied 1,105 recipients hospitalized in our center in 2009-2013, followed for a mean of 2.4 years (total of 2,652 patient-years). The independent association between ICD and CRT-D recipients' and implantation-procedures' characteristics with the incidence of complications was analyzed using multivariable Cox regression analysis. RESULTS: In 2-month post-procedural period, 124 (11.2%) patients developed complications. Independent predictors of short-term complications (within 2 months) were: atrial fibrillation, dual chamber ICD implantation, and use of antiplatelet therapy or coumarin. Twenty-seven (2.44%) patients experienced complications, mostly lead-related (n = 21). Independent predictors of long-term complications (2-12 months after implantation) were atrial fibrillation and dual chamber ICD implantation. CONCLUSIONS: Despite significant technological progress and operators' experience, the occurrence of complications in ICD and CRT-D recipients is still substantial. Majority of complications are recorded in the early post-implantation phase. Analysis of independent predictors of complications seem to be essential in helping to reduce adverse events in the future and strongly supports the need for routine follow-up.

Impact of Chronic Total Occlusion of the Coronary Artery on Long-Term Prognosis in Patients With Ischemic Systolic Heart Failure: Insights From the COMMIT-HF Registry.

OBJECTIVES: This study sought to assess the impact of chronic total occlusion (CTO) on long-term prognosis in patients with ischemic cardiomyopathy. BACKGROUND: The presence of concomitant CTO in a nonculprit lesion in acute coronary syndromes is associated with worse prognosis. Coronary artery disease is the main cause of heart failure and in many cases at least 1 CTO is observed. METHODS: The study included all patients with systolic heart failure who underwent elective coronary angiography and were registered from January 2009 to December 2014 in the ongoing single-center COMMIT-HF (COnteMporary Modalities In Treatment of Heart Failure) registry (NCT02536443). The patients were divided into 2 groups with regard to CTO presence. All of the analyzed patients were followed up for at least 12 months with all-cause mortality defined as the primary endpoint. RESULTS: Of the 675 patients fulfilling the inclusion and exclusion criteria, 278 patients (41.2%) had 1 or more CTOs of a major coronary artery (+CTO), and in 397 patients (58.8%) the presence of the CTO was not observed (-CTO). The 12-month mortality for the +CTO and -CTO patients was 19.4 % and 10.3 %, respectively (p < 0.001), evident also after 24 months (26.6% vs. 17.6%; p = 0.01). After a multivariate adjustment for differences in baseline characteristics, the presence of CTO remained significantly associated with higher 12-month mortality (relative risk: 1.84: 95% confidence interval: 1.18 to 2.85; p = 0.006). CONCLUSIONS: Our analysis showed that in patients with ischemic heart failure the presence of the CTO is related to worse long-term prognosis.