Keeping Pace with EP Advances

Remote monitoring helps save office time, increases level of patient care.
Dave Fornell

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October 30, 2008

There have been numerous new products released in the past year to enhance implantable pacing and defibrillation devices, but new advances in remote monitoring seem to be paving the way of the future.

According to a study by the Cleveland Clinic released in May, wireless technology allowing evaluation of implantable cardiovascular electronic devices from the patient's home is being embraced by patients and may significantly increase the number of patients served without requiring extra resources. The study is the first to show how rapidly evolving technology can increase the number of patient evaluations without directly increasing demands on clinic staff time and resources.

The study tracked ongoing ICD device follow-up patient visits over a four-year period at the clinic. Each patient was offered the option of in-person device follow-up or device follow-up supplemented with remote monitoring. The patients who chose remote monitoring were evaluated from home through Web-based data transmissions. Between 2003-2007, the total number of ICD evaluations increased by 164 percent, allowing for improvements in time management and overall utilization of in-clinic resources. During the study, remote evaluations increased dramatically from 94 to more than 5,000 patients.

“We were increasing the number of checkups each year to the point where we would have to add an extra staff member and another room per year, and that is unsustainable,” said Bruce Wilkoff, M.D., director of the cardiac pacing and tachyarrhythmia devices at Cleveland Clinic’s Implantable Device Clinic. “We follow over 30,000 patients at our own device clinic.”

Just for patients with defibrillators, the clinic had 7,000 scheduled appointments per year. Now 5,000 of those patients are monitored remotely.

When the clinic began its remote monitoring program five years ago, he said it was a matter of survival and a way to enable the clinic to continue to add more patients.

“It started off as a crawl, but it has really taken off,” Dr. Wilkoff said. “In some ways it fulfilled our growth, but it also allowed us to manage that growth.”

He said in the past three years the number of remote device checks grew from 7,000 to 12,000, while the number of patient visits to the clinic has remained the same.

“It frees up time for the doctors and the patients,” Dr. Wilkoff said. “When you are fine, who wants to see a doctor, but when you are sick you want the doctor’s attention right now. These are sick patients, but they are not sick all the time.”

He said the radio antenna range of newer implantable devices allows them to communicate with a bedside monitor that can automatically connect and download patient information while they are sleeping via a phone-based Internet connection. Dr. Wilkoff said the computer system receiving the information at Cleveland Clinic is programmed to look for “interesting events” as defined by the doctor and the patient. When these events occur the doctor is notified. If the results are normal the information is simply downloaded into the patient’s electronic medical record (EMR). That information is available to the patient using a secure Web site.

The remote monitoring system developed by Cleveland Clinic monitors implantable defibrillators or pacemakers made by Medtronic, Boston Scientific, Biotronik, St. Jude, implantable loop recorders made by Transoma and wearable monitors made by CardioNet. Dr. Wilkoff said Biotronik also makes a device that can interface with a cell phone for international calls used so patients anywhere in the world can be monitored.

Remote monitoring has helped patients by not requiring them to be inconvenienced several times a year and coming into the office, while freeing up schedule time to meet with patients who are experiencing problems and want to meet with their doctor.

“People don’t want to bother with these things, they just want it to operate in the background,” Dr. Wilkoff said.
In the old days prior to remote monitoring there was little incentive for manufacturers to build open-architecture devices for better connectivity to interface with nonproprietary computer systems.

Dr. Wilkoff said everyone concentrated on what indications the device could be implanted for, but it seemed gave little thought of how the device would be accessed and data downloaded after a patient goes home. He said the problem is compounded by patients who live great distances from their doctor's office. He said the rise of EMR use has increased the need for open architecture and manufacturers now have an economic incentive to stay competitive by offering connectivity.

“That level of connectivity was not available just a couple years ago,” Dr. Wilkoff said. Today the Cleveland Clinic can monitor patients anywhere. “I am monitoring patients in Calcutta, Mexico and South America.”

Dr. Wilkoff said facilities thinking about installing a remote monitoring system should think through how they currently do things and how this can be translated into an automated format. However, he warns not to use a cookie-cutter format to handle all EP patients, as each is different and will not always fit into the same format for a computer to monitor.

Similar to Cleveland Clinic’s system, Medtronic developed the CareLink Network system to allow wireless communication between its implantable devices and doctors’ offices. The system is placed next to a patient's bed at home and plugs into a standard phone line to gain Web access. CareLink monitors the patient information from the devices via wireless radio signal and it can be programmed to automatically download the patient’s information and send it to a doctor’s office so patients do not have to go in for regular visits.

This system was enhanced earlier this year with FDA clearance of Medtronic’s new Vision 3D portfolio of implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy-defibrillators (CRT-Ds), pacemakers and cardiac resynchronization therapy-pacemakers (CRT-Ps). The company's Conexus Wireless Telemetry is available on all Vision 3D ICDs and CRT-Ds, which automatically transmits patient device data remotely using CareLink. Vision 3D devices also have OptiVol Fluid Status Monitoring, a Medtronic feature that measures intrathoracic impedance in heart failure patients to indicate fluid levels.

Vision 3D devices also introduce automaticity with Complete Capture Management, which continuously and automatically adjusts to changing patient needs. Complete automaticity provides physicians flexibility during in-office device checks and may also reduce battery drain, the company said.

George Crossley, M.D., an electrophysiologist with Saint Thomas Heart who practices at Baptist Hospital in Nashville, TN, was involved in Vision 3D’s development and among the first physicians in the country to implant the devices. Since receiving its first devices in early September, the hospital has implanted them in more than 30 patients.

“What it does is it completes what we have been working on for the past three years,” Dr. Crossley said. “We wanted to follow these devices while the patient is at home.”

He said the system works with the Baptist Hospital’s “exception-based management” model for remote EP monitoring, which is to monitor for and act on rhythms and cardiac issues that are the exception to normal heart function. In between regular office visits or remote checkups, the computer monitoring system will contact the doctor for any abnormal thresholds. Vision 3D defibrillators track and report on abnormal heart rhythms, the number of times the defibrillator was used and how much fluid is present in the patient’s lungs. “It creates a flag and tells us there is a problem,” Dr. Crossley said.

His office schedules about three office visits an hour for regular EP device checkups, but with remote monitoring many more an hour can be conducted. He said an additional advantage is that quarterly, automated patient telemetry downloads can be scheduled on a Sunday night. The nurse or doctor can review the information when they have time and call the patient back by the end of the week. This system helped Baptist Hospital alleviate its nursing shortage by hiring a nurse to review patient telemetry at her home so she can stay with her children.

Guidant and St. Jude also have remote monitoring systems for defibrillators, but Dr. Crossley said, in his opinion, the Medtronic system works the best.

Both Drs. Crossley and Wilkoff warn the main issue with remote monitoring is ensuring clinicians do not become complacent and only look at the information without any contact with the patient. He said the system easily separates the patient and the physician, so it is very important for doctors to communicate with their patients.

“The No. 1 fear of patients was they said, ‘you don’t want to see me anymore,’” Dr. Wilkoff said. “You need to reassure the patient by communicating with the patient... communication is absolutely key.”

Dr. Crossley said this can be done with simple emails or phone calls to follow up. He said an ideal remote monitoring data management system should keep track of patients and give doctors reminders when to contact their patients during the year.


New Pacing, Defibrillation Technology The Cleveland Clinic has seen a recent EP trend in using implantable cardiac monitoring devices, and two such devices were recently introduced. “It’s like having a mobile ICU with the patient,” said Bruce Wilkoff, M.D., director of the cardiac pacing and tachyarrhythmia devices at Cleveland Clinic’s Implantable Device Clinic, of the monitoring capabilities of newer implantable devices. He said this helps patients and their doctors to remotely identify if there is a problem that requires hospitalization, and helps the hospitals keep admissions for nonevents lower. In September, St. Jude Medical received FDA clearance for its SJM Confirm implantable cardiac monitor (ICM), a compact device, and planned to launch sales in October. The monitor enables physicians to evaluate heart rhythm signals over a longer period of time than allowed by standard monitoring tests, and is designed to help them diagnose and document difficult-to-detect rhythm disorders in patients who may suffer from unexplained symptoms, including syncope (the sudden and transient loss of consciousness), palpitations and shortness of breath. The device is the size of a computer thumb drive, which the company says is the smallest implantable cardiac monitor available. It is implanted just under the skin in the upper chest region and can be implanted in an outpatient procedure under local anesthesia. A similar recently introduced device is Medtronic’s Reveal DX and Reveal XT ICMs, which received FDA clearance last December. The monitor is placed just under the skin of the chest and records cardiac rhythm data so a physician can diagnose the patient. The device weighs 15 grams and is also about the size of a memory stick. To store an ECG at the time of an episode, a patient places a hand-held, pager-sized activator over the device and presses a button. Later a physician analyzes the stored information and determines if the episode was caused by an abnormal heart rhythm. Other developments • In August, the Sorin Group received FDA approved for its REPLY family of dual and single chamber pacemakers, which reportedly includes the world’s smallest dual chamber pacemaker at 8 cc’s. REPLY is designed to reduce ventricular pacing and promote natural cardiac function. It integrates Sorin’s SafeR pacing mode, which switches from AAI to DDD in case of AV block detection, is designed to reduce unnecessary pacing in both sinus node disease and unselected AV block patients. The REPLY also features SmartCheck, which lets the user automate follow up tests and provides comprehensive data reporting and recommendations. • In June, St. Jude Medical Inc. received FDA and CE Mark approvals to expand the capabilities of its Frontier II cardiac resynchronization therapy pacemaker (CRT-P) to include the company’s new QuickOpt Timing Cycle Optimization. This will provide physicians a new option to manage therapy for patients based on their individual needs. In about 90 seconds, the QuickOpt feature recommends to physicians which atrial-ventricular and ventricular-ventricular timing values to use to program the devices. This allows physicians to frequently optimize devices as their patients’ needs change over time. The concept is for easier and cheaper customization, instead of using echocardiography. A typical echo procedure takes 30-120 minutes and requires interpretation by a technician, whereas QuickOpt Optimization is performed during patients’ regularly scheduled follow-up visits in about 90 seconds. • In May, the FDA cleared Boston Scientific’s ALTRUA family of pacemakers, which are the company’s first designed to treat bradycardia. The main features include multiple atrial ventricular delay programming options, minute ventilation blended sensor, ventricular rate regulation (VRR) and automatic capture for ventricular pulse management. The device checks every heartbeat to see if the lower chambers of the heart contract in response to the delivered pulse. If no contraction is detected, a backup pace with more energy is delivered. • In March, the FDA cleared the AIGISRX CRMD Anti-Bacterial Envelope by Tyrxpharma, a cardiac rhythm medical device intended to immobilize and reduce bacterial infection of an implanted pacemaker or ICD. The AIGISRX CRMD contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in CRMD related endocarditis, including methicillin Resistant Staphylococcus aureus (MRSA). The envelope is constructed of knitted filaments of polypropylene coated with a proprietary resorbable polymer that elutes the antimicrobial agents for a minimum of seven days. On the horizon In January, an international clinical trial was started to test the Medtronic EnRhythm MRI SureScan pacing system, which the company says will continue to operate normally when a patient undergoes an MRI. The device consists of the new dual-chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads (Model 5086MRI). The pacemaker incorporates all diagnostic and therapeutic features of the commercialized Medtronic EnRhythm. All 350 patients in the trial will receive the pacing system and approximately half of the participants will receive MRI scans. The expected study duration is about 24 months. The multi-center study will take place in hospitals in Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Switzerland, the U.S. and the U.K. Medtronic said it anticipates European CE mark approval in late 2008. An FDA application for the device has not yet been submitted, but expects to do so in the coming months. The company hopes for FDA approval in 2009 or 2010.