The Evolution of Pacemaker Follow-Up, With Dr. Michael Bergelson

Paceart has been a pioneer in the concept and application of computerized pacemaker follow-up, both for clinical and transtelephonic monitoring. They are the established market leader with over 900 pacemaker and arrhythmia centers utilizing its systems to monitor over 100,000 patients on a daily basis. The company currently provides services to approximately 2,500 implantation cardiologists in the U.S., as well as physicians and hospitals in Europe, Russia, China and Australia. Paceart offers a diverse product mix, including the ECG Speaks software, CardioVoice® system, CardioVoice Phone®, Heart Access event recorders and the CardioVoice® portable transmitter.

EPLD: How was the need for a commercial pacemaker follow-up system discovered? What was the reason for having such a system?

During the late 1970s, the number of pacemaker implants in the United States started to increase dramatically. The leading pacemaker clinics such as Montefiore Hospital in New York (run by Dr. Seymour Furman) or Newark Beth Israel Medical Center in New Jersey (run by Dr. Victor Parsonnet) started to use computers to keep the history of test results of pacemaker patients that were tested in clinics as well as for patients at home over the telephone. These leading pacemaker implanters realized the importance of keeping pacemaker data in a uniformed way. This allows one to determine the longevity of the implanted device and correlate its functioning with patient clinical data. What made pacemaker follow-up systems special purpose devices, rather than just computers that keep manually-entered records and print patient reports, was the need to perform special measurements of pacemaker functioning. This includes electrocardiogram recording, pacemaker pulse measurement and display, transtelephonic data recording from patient s homes, and collection of other data and telemetry. As pacemakers continued to evolve, additional requirements surfaced, such as interfacing with pacemaker programmers and other devices, and communicating via the Internet with referring physicians and patients. The follow-up systems became dedicated, computerized instruments that combined the functions that are typical of a computer system: data storage and retrieval, report generation with ECG recording, a pacemaker pulse analyzer, a transtelephonic receiver, ECG voice mail and many other features that make a pacemaker center staff run more smoothly. To create a system of such specialized functionality, a commercial enterprise was required. In our estimates, there are more than 1,500 commercially available follow-up systems in use today. These follow-up systems are more than just a tool for the most advanced pacemaker centers, they have become a necessary productivity tool for many physician practices.

EPLD: Can you elaborate on your work with Dr. Parsonnet? Have you worked with him since?

At that time, I was assigned by Cordis Corporation to help Dr. Parsonnet in evaluating a pacemaker follow-up system developed by Cordis to run on a DEC minicomputer. Cordis was interested in learning as much as possible from the clinical experience that the Newark Pacemaker Center had accumulated over a period of several years in developing their own follow-up system. The center followed more than 1,000 pacemaker patients who had pacemakers from a variety of manufacturers. That was a complex and versatile system. It required a minicomputer and several measuring instruments: ECG recorders, pacemaker pulse analyzers, transtelephonic receivers and several people operating the center. In 1984, it was a state of the art facility that developed a unique testing procedure and unique report format. In 1986, we had an idea to develop a system based on a PC that would be able to combine many functions of the pacemaker patient testing: ECG recordings, pacemaker pulse analyzer, transtelephonic receiver, patient date, historical data storage including ECG records, pacemaker pulse waveforms and report generation using the popular PC platform1. The idea of combining pacemaker patient data storage, electrophysiologic parameter measurements and communications on one PC, is how Paceart was started. The idea caught on, and follow-up systems have now become a necessity. I remember working with a colleague in 1986, and after explaining my concept to him, he told me, "Listen, this system will probably be bought by 10 of the best and brightest cardiologists who are interested in research, and that will be the end of it. I don t see any potential for commercial success of this system." Now, when we see each other at trade shows, he says to me, "Well, everyone makes mistakes!" I continue to work with Dr. Parsonnet. He is an advisor and a customer. He has several Paceart systems in his Pacemaker Center and continues providing us with access to his laboratory and his ideas. We receive advice from many prominent pacemaker physicians who are our customers, among them Dr. Charles Love from the Ohio State University Medical Center and Dr. Bruce Wilkoff from the Cleveland Clinic.

EPLD: What prompted you to develop the pacemaker follow-up system?

As a computer scientist and an electrical engineer, I worked in the Biomedical field in several seemingly unrelated areas. One area was hyperbaric medicine, where I worked as an engineer and as a scientist building a hyperbaric chamber for cardiac surgery. I also worked studying the effect of oxygenation on red blood cells and brain electrophysiology. Here I was looking at the EEG and evoked potentials. Finally, I began my work in the pacemaker field. I saw the opportunity to make a specialized system for evaluation of the patient with an implanted pacemaker. The objective was that such system would be easy to operate by one person. The system should retain the results of the patient s test over the life of a pacemaker and improve the productivity of the pacemaker center personnel. This instrument should eliminate the necessity for cutting and pasting ECG strips and making manual notes. It should also provide several reports for documenting a patient s testing. What prompted me was simply being in the right place at the right time. The right place was the Newark Pacemaker Centerwhere the many varieties of pacemakers were implanted and followed. The right time was the year 1984, when the personal computers (PCs) were becoming popular and relatively inexpensive. The right people, who believed in computer technology and were leaders in the pacemaker field, were Victor Parsonnet, MD, and his staff, including Dr. Dan Bernstein. In 1986, we created a system that combined all the above-mentioned functions for the pacemaker patient follow-up on one PC. My background includes an MS in electrical engineering and a PhD in Computer Science. Today, Paceart systems are installed in over 900 clinics, physician groups and private offices in the United States and in 18 foreign countries.

EPLD: What, in your view, are the most important benefits for an implanting physician in having a follow-up system?

Besides having an outstanding productivity tool for his/her staff, the follow-up system produces standard reports that would allow a physician to review the device function at a glance for a current patient test, as well as in historic perspective. In order to assess the performance of a device, it is necessary to obtain the results of a pacemaker interrogation, ECG recording (most programmers are now providing the means for surface ECG capture) and print a report on a programmer's printer. Each implant manufacturer is making an output format in accordance with their device specificity and manufacturer s taste. For the proper device assessment, the results of a current test must be compared with previous test results. Such assessment leads to labor-intensive paper shuffling and then assessment documentation. The report itself could serve as a grid in the ECG evaluation: all results of tests are placed in a format that saves the physician time in implant test evaluation. In viewing the report, where the first page contains the most relevant information, a clinician can make a quick assessment of the device performance. EPLD: Describe some of the benefits of follow-up systems to patients. Pacemaker patient follow-up is a service that is beneficial to the patients with implantable devices for several obvious reasons: periodic assessment of the device function in the clinic that includes general evaluation of a patient and device by a physician, unique remote monitoring of a patient s pacemaker, and emotional support for the patient. The use of a follow-up system would allow servicing of more patients more efficiently and reducing the probability of medical errors. Good record-keeping that is permitted by the follow-up system and data representation improves the quality of care. Another benefit to patients is the reduction of testing time. Availability of new communication technology similar to voice mail would allow a patient to contact a physician office at any time (24/7) and transmit information directly to the follow-up system. The system then would notify a physician or nurse on call, via a pager or phone call, that there is a transmitted ECG and message from a patient waiting. The patient s name, phone number and heart rate can be shown on a pager or cell phone with a display. Even a sample of the ECG recording can be presented on a screen. Then, a physician has the option to retrieve the tracing by fax on demand and listen to the patient s message. However, nothing can replace human communication with a patient.

EPLD: Could you describe how your follow-up systems are compatible with all brands of pacemakers, ICDs, transtelephonic transmitters or event recorders?

During clinical testing of a patient with an ICD or a pacemaker, follow-up systems can record surface ECG. Paceart systems, besides recording multi-lead ECG, are capable of detecting the pacemaker spike and measuring its pulse width. ECG recording is universal technology, but detecting pacemaker spikes requires special circuitry that is a part of the Paceart follow-up systems. Nowadays, the device programmers are capable of recording single lead ECG; however, they do not provide special reporting capabilities that reflect the history of previous tests. Paceart systems are also compatible with most implantable device programmer data transfer utilities. That makes clinical testing a more productive process, especially for ICD testing. Paceart systems are compatible with most known pacemaker transtelephonic transmitters. A transtelephonic signal has a standard frequency modulation factor of ECG that is analyzed automatically by the Paceart System. Paceart Systems also recognize different types of encoding of the pacemaker pulse (FSK: binary encoding or pulse width elongation). However, the accuracy of the pulse width measurement can be affected by the noise caused by poor electrode placement or contact by the patients, ambient room noise or telephone line noise.

EPLD: What tools are available now for implantable device follow-up?

Among the tools that are being used for cardiac device follow-up are: programmers for device interrogation in a clinic, transtelephonic receiving station capable of printing an ECG strip, pacemaker transmitters for home monitoring and a computerized device follow-up system. Follow-up systems can be divided into several categories: stationary standalone single user systems, portable single user systems, local area network-based multi-user systems and multi-site wide area network-based multi-user systems. Follow-up systems are interfaced to the device programmers via a serial cable or by wireless means (e.g., floppy disk) for one-direction (from a programmer to the follow-up system) data transfer. Usually a standalone system is often used by a smaller practice, while a multi-user system is employed by a larger practice or a hospital. Portable follow-up systems are used in conjunction with stationary systems by physicians or nurses to visit an outlying clinic or a patient s bedside. Follow-up systems can be interfaced to an Internet/Intranet, thus allowing a referring physician to review a patient s report via an Internet Browser. Proliferation of computer technology over the past 15 years has enabled implanting physicians not only to improve their productivity in patient monitoring, but also to improve communications with a referring physician base.

EPLD: Can you describe each of the systems (standalone station vs. system, and multistation system) separately?

The standalone station is a synonym for a standalone follow-up system that has only one PC to record electrocardiograms, to get transmissions via the telephone, and to generate a report. A multi-user follow-up system is a system that has more than one computer performing these functions. In a multi-user system, the computers are connected via a local or wide area network. This allows several users in different locations to provide patient follow-up simultaneously and store the test results in one database. We have users who utilize more than 20 stations simultaneously in several remote locations. To maintain a common database utilizing communication lines economically, our systems employs data replication technique developed by Microsoft. There are several examples of multi-user systems. A nurse could test a patient in a clinical setting on one system, another operator may obtain a transtelephonic transmission from another patient, while a secretary enters data for a new patient on a third station. A monitoring service may have 5 or more operators who are receiving transtelephonic transmissions from separate patients while a quality control operator reviews the results of the tests and selects data for reports. In addition, a physician visiting a remote clinic could use a portable follow-up system. The data from the portable system are transferred (replicated) to a stationary (networked) system, and will then receive all or some of the data that are recorded on a stationary system since the last update (synchronization) was performed. The multi-user systems allow having follow-up systems in two different locations in different parts of the globe accumulating data in one database simultaneously. It might be an expensive communication link for device monitoring, but the physician s expertise would be more expensive to transport. However, with the use of the Internet, the costs of transferring data may be negligible.

EPLD: What role are services playing in implantable device monitoring?

The services are being used to provide transtelephonic monitoring of implantable devices from each patient s home. Pacemaker physicians are electing to employ such services in order to eliminate office expenses associated with pacemaker transmitters and additional nursing staff. These services are one of Paceart s largest customers. We learn how to manage extensive amounts of transtelephonic ECGs for a significant number of patients by providing Paceart systems to such services. The services supply pacemaker transmitters to patients. Service center operators guide patients through transtelephonic tests and send reports to the referring physicians for assessment. These reports, however, are lacking correlation with clinical tests that could be accomplished only at the implanting physician office that has device programmers. The follow-up systems that are used by most services allow maximizing the productivity of operators and providing referring physicians with reports in a shortest time possible.

EPLD: What is the difference between the follow-up services and Paceart systems?

Paceart systems are used by services that specialize in transtelephonic monitoring of pacemaker and arrhythmia patients. Hospitals, cardiology practices and individual practitioners are using similar Paceart systems. The transtelephonic services are simply Paceart s customers.

EPLD: What is the future of implantable device follow-up?

Implantable device manufacturers are developing their own solutions to streamline device follow-up activities. The information currently available transtelephonically from pacemakers is quite limited and really serves as a screening mechanism for the physician to decide which patients need to come to the office for a full interrogation and evaluation. Device manufacturers are developing technology and systems to transfer the results of complete pacemaker and ICD interrogations in a home environment, either directly to the clinician or to a follow-up service. The communications infrastructure fueled by the Internet explosion and wireless communications allows seamless data transfer from the patient, wherever he/she is, to a follow-up clinic using telephony networks. Medtronic has been actively developing an Internet-based Patient Management Network for the past two years. Medtronic s solution will enable a full interrogation of the patient's implanted device from any place the patient is located, and enable access to the data via the Internet from any place the care provider is located. Interestingly, the patient would also have Internet access to some of the data, bringing the patient into the care pathway. From what I understand from Medtronic s public announcements, the company s long-term vision is to develop a comprehensive Patient Management System that goes far beyond remote device evaluation, providing clinical information management and remote patient monitoring and diagnostics. Also, a recently approved, new family of pacemakers from Biotronik would transmit follow-up data via a cellular telephone network to a proprietary service almost in real-time. The patient s device will be preprogrammed to transfer certain parameters on a predetermined schedule or depending on a change in device status (e.g. battery depletion or lead impedance change). I should also mention the Housecalls proprietary ICD home monitoring equipment by St. Jude Corporation, that is used exclusively by Raytel Medical Corporation. I have only a cursory knowledge of this device which has existed for several years. Housecalls allows the device to be interrogated in the patient s home, and then transfers the data by modem to the monitoring service. These technologies will make a manufacturer s service an attractive alternative for home device monitoring. However, I imagine that physicians will maintain a comprehensive follow-up system in their offices to assess the device function and performance by analyzing all available patient data, including the clinical patient evaluation.

EPLD: You have described two areas of development in two companies, Medtronic and Biotronik. What is the difference between their upcoming products and Paceart's products?

Medtronic's and Biotronik's technologies are designed around proprietary technologies to support their own devices in the remote environment. Paceart systems utilize commonly used transtelephonic technology for home monitoring and supplement the surface ECG recording with programmer data to evaluate patients in the clinic. The systems are really complementary, and we see clinicians using both sets of tools to provide optimal care for their patients.

EPLD: What are the differences between the CardioVoice/Patient Voice Mail and ECG Speaks? Are these both available for use now? Describe how each works.

CardioVoice/Patient Voice Mail is used for unattended transtelephonic ECG recording of arrhythmia and pacemaker patients. It is an add-on to a Paceart System, and functions like "voice mail with a twist". The ECG recording is "attended" by a mobile medical professional (nurse or a physician) via a pager. The pager can obtain a patient name, patient s phone number, patient heart rate and a sample of the ECG record for quality verification. A CardioVoice mobile attendant (physican or nurse) can call back to the CardioVoice, retrieve the patient s message and request a fax on demand. In addition, a physician can review the patient records at a later time on a Paceart System, edit records and print reports. There are over 100 such installations on Paceart Systems. ECG Speaks is standalone software that could be installed on any modern PC that is equipped with a sound card. It converts a PC into transtelephonic ECG recorder. Place a microphone in front of a telephone headset that emits a sound of transtelephonic ECG, and you will be able to view an ECG on the screen of your PC. Since it was designed for one technician s use, it holds a limited number of recording/events (10-20 events, depending on the configuration).

EPLD: What other products do you hope to see developed in the future?

In the field of device follow-up systems, the future development should address the ease of device follow-up. Wireless communication between the device and the physician s follow-up service is one component of such a system. Another component is the physician s access to patient data. The capabilities that are opened by Internet infrastructure should be utilized to a larger extent. Since the devices are able to accumulate a large amount of data and ECG recordings from inside the body, the means to obtain this information, store the information outside of the body and analyze it should be on a par with the device technology. It is important to develop a device knowledge base that will be accessible to physicians. In our field, the database development is as important as the development of the hardware. The tools for data analysis, the uniformity of data collection and the ability to communicate with the experts must meet the complexity that is added to the implants.

EPLD: Are all of Paceart's products available to centers of all sizes?

Absolutely. Paceart's products can run in any pacemaker clinic, from the small lab of about 100 patients to a large clinic, such as The Ohio State University Medical Center and The Cleveland Clinic. In both large and small applications, it is a productivity tool with regards to patient testing, report generation and data analysis. Paceart, over a period of 15 years, developed a report format that permits a quick assessment of pacemaker or ICD function. It allows one to review the device type, lead type, date of implant, programming parameters, etc. Most importantly, the graphs of lead and battery performance data provide a rapid way to determine if a significant change has occurred over time. A long time ago, one of my physician friends told me, "Physicians are so busy, they have no time to turn pages. It is important to put as much information as possible on the front page". At one time, creating a 1-page report represented a challenge to us. It is an even greater challenge now, and I am afraid it could not be met since the addition of ICD and bi-ventricular pacing data has been added. Indeed, this data may hardly fit on two pages.

EPLD: In what areas do you see Paceart growing in the future?

In the near term, we anticipate that arrhythmia follow-up market will grow and that will lead to more Paceart Product sales, specifically of EKG Speaks and Paceart systems with CardioVoice options. Another area of near-term growth is providing our existing customers with the Paceart Web Access option. At the present time, this option is capable of serving any Paceart report to any computer that runs an Internet browser. We would like to extend the Web option functions to display implant tables and other information that is stored in the Paceart database. Paceart is also looking at expanding beyond implant and arrhythmia follow-up services by looking at the opportunities of other cardiology-related computer services: to interface with the existing software packages that are being used in medical offices. Device manufacturers are developing new therapies. These therapies will lead Paceart to add new functionality to our products, thus expanding Paceart options. HIPPA (Health Insurance Privacy and Portability Act) presents new challenges in helping our clients to meet their level of compliance with new government regulations. Looking further forward, we would also like our systems to be compatible with the proprietary technologies and systems being developed by device manufacturers. We are looking forward to interfacing with these new solutions in order to transfer the results of the implant interrogation of patients at home to installed Paceart systems. As I stated in response to a previous question, I believe that the proprietary systems and Paceart's systems are complementary and that clinicians will employ both sets of tools. The Paceart system may serve as a bridge between the proprietary systems and the clinician s office.

For more information on Paceart, please visit www.paceart.com.