Mehmet K. Aktas

ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs)

We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.

Health Monitoring and Management Using Internet-of-Things (IoT) Sensing with Cloud-Based Processing: Opportunities and Challenges

Among the panoply of applications enabled by the Internet of Things (IoT), smart and connected health care is a particularly important one. Networked sensors, either worn on the body or embedded in our living environments, make possible the gathering of rich information indicative of our physical and mental health. Captured on a continual basis, aggregated, and effectively mined, such information can bring about a positive transformative change in the health care landscape. In particular, the availability of data at hitherto unimagined scales and temporal longitudes coupled with a new generation of intelligent processing algorithms can: (a) facilitate an evolution in the practice of medicine, from the current post facto diagnose-and-treat reactive paradigm, to a proactive framework for prognosis of diseases at an incipient stage, coupled with prevention, cure, and overall management of health instead of disease, (b) enable personalization of treatment and management options targeted particularly to the specific circumstances and needs of the individual, and (c) help reduce the cost of health care while simultaneously improving outcomes. In this paper, we highlight the opportunities and challenges for IoT in realizing this vision of the future of health care.

Time-dependent risk of Fidelis lead failure.

The Medtronic Sprint Fidelis leads (models 6930, 6931, 6948, 6949) are 6.6-F bipolar high-voltage implantable cardioverter-defibrillator electrodes that were first introduced in September 2004. In October 2007, Fidelis leads were removed from the market. We sought to determine the time-dependent hazard of the Fidelis failure rate to date. A retrospective chart review was conducted in all patients who underwent implantation of a Sprint Fidelis lead (426 leads) at our center. We primarily implanted models 6931 and 6949. With 1,056 years of combined follow-up (average 2.3 +/- 1), 38 of 426 (8.92%) Sprint Fidelis leads failed (3.6%/year). The hazard of fracture increased exponentially over time by a power of 2.13 (95% confidence interval [CI] 1.98 to 2.27, p <0.001) and the 3-year survival was 90.8% (95% CI 87.4 to 94.3). If a Fidelis lead was functioning normally at 1 year, the chance it would survive another year was 97.4% (95% CI 95.7 to 99.1); if functioning at 2 years, the chance of surviving another year was 94.7% (95% CI 91.8 to 97.7); and if functioning at 3 years, the chance of surviving 1 more year was 86.7% (95% CI 78.8 to 95.5). Other commonly used implantable cardioverter-defibrillator leads showed no evidence of increased failure rates. In conclusion, to date, the hazard of Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturers performance update. Further accumulative data are needed because it remains unknown if the fracture rate will level off or continue to increase.

Assessment of cloud-based health monitoring using Homomorphic Encryption

Current financial and regulatory pressure has provided strong incentives to institute better disease prevention, improved patient monitoring, and push U.S. healthcare into the digital era. This transition requires that data privacy be ensured for digital health data in three distinct phases: I. acquisition, II. storage, and III. computation. Each phase comes with unique challenges in terms of proper implementation and privacy. While the privacy of the data can be ensured with existing AES encryption techniques in phases I (acquisition) and II (storage), to enable healthcare organizations to take advantage of cloud computing using resources such as Amazon Web Services, phase III (computation) must also enable the privacy of the data. Currently, there exists no system to enable direct computation in the cloud while assuring data privacy. Fully Homomorphic Encryption (FHE) is an emerging cryptographic technique to permit computation on encrypted data directly in the cloud without the need to bring the data back to the computational node. However, this promising technique comes with significant performance- and storage-related challenges. While it will take more years before true FHE is mainstream, we provide a feasibility study for its application to a simple longterm patient ECG-data monitoring system.

Emerging security mechanisms for medical cyber physical systems

The following decade will witness a surge in remote health-monitoring systems that are based on body-worn monitoring devices. These Medical Cyber Physical Systems (MCPS) will be capable of transmitting the acquired data to a private or public cloud for storage and processing. Machine learning algorithms running in the cloud and processing this data can provide decision support to healthcare professionals. There is no doubt that the security and privacy of the medical data is one of the most important concerns in designing an MCPS. In this paper, we depict the general architecture of an MCPS consisting of four layers: data acquisition, data aggregation, cloud processing, and action. Due to the differences in hardware and communication capabilities of each layer, different encryption schemes must be used to guarantee data privacy within that layer. We survey conventional and emerging encryption schemes based on their ability to provide secure storage, data sharing, and secure computation. Our detailed experimental evaluation of each scheme shows that while the emerging encryption schemes enable exciting new features such as secure sharing and secure computation, they introduce several orders-of-magnitude computational and storage overhead. We conclude our paper by outlining future research directions to improve the usability of the emerging encryption schemes in an MCPS.

Clinical Impact, Safety, and Efficacy of Single‐ versus Dual‐Coil ICD Leads in MADIT‐CRT

Current data on efficacy, safety and impact on clinical outcome of single‐ versus dual‐coil implantable cardioverter‐defibrillator (ICD) leads are limited and contradictory.

ISHNE/EHRA Expert Consensus on Remote Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs)

We are in the midst of a rapidly evolving era of technology‐assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers, implantable cardioverter defibrillators, devices for cardiac resynchronization therapy (both with and without defibrillation properties), loop recorders, and hemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology and the European Heart Rhythm Association combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.

Effect of cardiac resynchronization therapy with implantable cardioverter defibrillator versus cardiac resynchronization therapy with pacemaker on mortality in heart failure patients : results of a high-volume, single-centre experience

There are limited and contradictory data on the effects of CRT with implantable cardioverter defibrillator (CRT‐D) on mortality as compared with CRT with pacemaker (CRT‐P).

The perceived role of Islam in immigrant Muslim medical practice within the USA: an exploratory qualitative study

Background: Islam and Muslims are underrepresented in the medical literature and the influence of physician’s cultural beliefs and religious values upon the clinical encounter has been understudied. Objective: To elicit the perceived influence of Islam upon the practice patterns of immigrant Muslim physicians in the USA. Design: Ten face-to-face, in-depth, semistructured interviews with Muslim physicians from various backgrounds and specialties trained outside the USA and practising within the the country. Data were analysed according to the conventions of qualitative research using a modified grounded-theory approach. Results: There were a variety of views on the role of Islam in medical practice. Several themes emerged from our interviews: (1) a trend to view Islam as enhancing virtuous professional behaviour; (2) the perception of Islam as influencing the scope of medical practice through setting boundaries on career choices, defining acceptable medical procedures and shaping social interactions with physician peers; (3) a perceived need for Islamic religious experts within Islamic medical ethical deliberation. Limitations: This is a pilot study intended to yield themes and hypotheses for further investigation and is not meant to fully characterise Muslim physicians at large. Conclusions: Immigrant Muslim physicians practising within the USA perceive Islam to play a variable role within their clinical practice, from influencing interpersonal relations and character development to affecting specialty choice and procedures performed. Areas of ethical challenges identified include catering to populations with lifestyles at odds with Islamic teachings, end-of-life care and maintaining a faith identity within the culture of medicine. Further study of the interplay between Islam and Muslim medical practice and the manner and degree to which Islamic values and law inform ethical decision-making is needed.

Association Between Frequency of Atrial and Ventricular Ectopic Beats and Biventricular Pacing Percentage and Outcomes in Patients With Cardiac Resynchronization Therapy

BACKGROUND A high percentage of biventricular pacing is required for optimal outcome in patients treated with cardiac resynchronization therapy (CRT), but the influence of ectopic beats on the success of biventricular pacing has not been well established. OBJECTIVES This study sought to determine if increased ectopic beats reduce the chance of high biventricular pacing percentage and are associated with subsequent adverse outcomes. METHODS From the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy), 801 patients with an implanted CRT-defibrillator device with data available on biventricular pacing percentage and pre-implantation 24-h Holter recordings were included. Using logistic regression, we estimated the influence of ectopic beats on the percentage of biventricular pacing. Reverse remodeling was measured as reductions in atrial and left ventricular end-systolic volumes (LVESV) at 1 year. Cox models were used to assess the influence of ectopic beats on the outcomes of heart failure (HF) or death, ventricular tachyarrhythmias (VTAs), and death. RESULTS In the pre-implantation Holter recording, ectopic beats accounted for a mean 3.2 ± 5.5% of all beats. The probability of subsequent low biventricular pacing percentage (<97%) was increased 3-fold (odds ratio: 3.37; 95% confidence interval: 1.74 to 6.50; p < 0.001) in patients with 0.1% to 1.5% ectopic beats and 13-fold (odds ratio: 13.42; 95% confidence interval: 7.02 to 25.66; p < 0.001) in patients with >1.5% ectopic beats compared with those with <0.1% ectopic beats. Patients with ≥0.1% ectopic beats had significantly less reverse remodeling (percent reduction in LVESV 31 ± 15%) than patients with <0.1% ectopic beats (percent reduction in LVESV 39 ± 14%; p < 0.001). The risk of HF/death and VTA was increased significantly in those with 0.1% to 1.5% ectopic beats (hazard ratio: 3.13 and 1.84, respectively) and for >1.5% ectopic beats (hazard ratio: 2.38 and 2.74, respectively). CONCLUSIONS Relatively low frequencies of ectopic beats (≥0.1%) dramatically increase the probability of low biventricular pacing (<97%), with reduced CRT efficacy by less reverse remodeling and higher risk of HF/death and VTA. This supports pre-implantation Holter monitoring of patients selected for CRT for optimal outcome. (MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy; NCT00180271).