Many fields of drugs are present process a metamorphosis because of the COVID-19 pandemic, as sufferers are avoided clinics as a lot as attainable. Sufferers are actually often visited by their medical doctors over video calls, are requested to carry out sure procedures on their very own, and are prescribed medical gadgets that may usually be utilized by medical workers.
Coronary heart monitoring is crucial element of medical take care of hundreds of thousands of individuals affected by cardiovascular circumstances, significantly these most in danger from COVID-19 issues. However receiving a medical grade electrocardiogram (ECG) usually entails workplace visits, placing among the most susceptible to dangers of publicity to the virus. Shopper gadgets merely don’t present the advanced sign info that the center generates that cardiologists require to supply assured diagnoses.
QT Medical, a agency based mostly exterior of Los Angeles, California just lately made out there the PCA 500 system that enables sufferers themselves to conduct complete ECG exams. The tracings which might be produced rival these which might be generated by hospital ECG machines, and so can be utilized simply as reliably by cardiologists. Sufferers can conduct exams on their very own at house and the information mechanically shared with their medical doctors for an in depth assessment. QT Medical even setup a service referred to as Xpress ECG that gives 12-lead ECG exams physicians can order for his or her sufferers to obtain within the mail.
We had an opportunity to talk with Dr. Ruey-Kang Chang, CEO of QT Medical, in regards to the PCA 500 system, its capabilities, and what it will possibly provide cardiologists working throughout the ongoing pandemic.
Medgadget: QT Medical’s machine permits sufferers to carry out 12-lead ECG tracings on their very own. What was the motivation behind this aim?
Dr. Ruey-Kang Chang, CEO of QT Medical: What we initially got down to do was to create an ECG system that’s pediatric pleasant, particularly for infants. In the course of the technique of growth, we discovered a greater solution to do a 12-lead ECG check, and reinvented the ECG with PCA 500 for the 21st century. We’ve two targets for our ECG: to set a brand new commonplace on how 12-lead ECG exams are carried out, and to democratize 12-lead ECG to all sufferers who can profit from personalised coronary heart illness administration.
Medgadget: Examine the standard of tracings that a affected person can produce utilizing your machine versus what a heart specialist can obtain on the hospital.
Dr. Chang: The market is crammed with all types of single-lead ECG gadgets for private use. There are additionally some claims to be 12 leads, however use fewer electrodes and some calculation algorithms to “create” a 12-lead ECG. PCA 500 is a real medical commonplace 12-lead ECG, not solely the electrode placements comply with the AHA tips, the electrode sensors and supplies are additionally of hospital high quality.
We performed an “equivalence study” and confirmed that PCA 500 produced ECGs, learn by 3 blinded cardiologists, no completely different from that of Philips Pagewriter TC70. One of many feedback we regularly get from cardiologists is that the sign high quality from sufferers’ ECG recordings at house utilizing PCA 500 are sometimes higher than ECGs carried out by technicians within the hospital.
There are good explanations why our ECG sign high quality is healthier: First, a number of noises and artifacts come from the cables and leadwires. Our electrode strip has no cable or leadwires. Second, when the chest electrodes are in a single piece, they assist to stabilize one another and lower noises from muscle groups and actions. Third, we did intensive research to establish noises from a house atmosphere and created proprietary algorithms to take away the noises.
Dr. Chang: As said, PCA 500 is medical grade 12-lead ECG for professional and for personal use. When PCA 500 is used in a physician’s office, it offers several advantages:
- Minimal personnel training is required, which also makes staffing easier;
- All ECGs are managed centrally in the cloud and digital copies of ECG reports in PDF are EMR compatible;
- Single-use pre-positioned electrodes eliminate the cables and leadwires, thus minimizing the risks for COVID transmission, and makes disinfection of the ECG machine between patients much easier.
In response to the surge of needs for telehealth and remote patient monitoring in the pandemic, we now offer the Xpress ECG service. Xpress ECG is an on-demand or periodic 12-lead ECG test the physician orders for his or her patients. First, the physician sets up an online dashboard account with QT Cloud at no cost. From the dashboard, the physician can order Xpress ECG tests and manage all the ECG studies and reports. When the physician’s office orders an Xpress ECG test for a patient, QT Medical receives the order and ships out an Xpress ECG kit, which includes a PCA 500 recorder, an electrode strip, printed instructions, and a postage-paid return envelope. When the patient completes the ECG test, the physician will receive a notification via email with a link to the dashboard. On the dashboard, the physician can review the ECG results, finalize the report, and make management decisions.
Medgadget: How and for whom is it prescribed? What are the use cases?
Dr. Chang: PCA 500 is a medical standard 12-lead ECG that can be used in conventional healthcare settings such as clinics, urgent care centers, and nursing homes. There are many other places where a 12-lead ECG is needed, but often there is no trained personnel to perform the test, such as airlines, cargo ships, mining sites, oil rigs, remote locations, jails and prisons, schools and clinical trials. PCA 500 can fill the gap.
There are many patients who benefit from using PCA 500 at home, but the cost may be prohibitive and insurance may not cover the purchase. To make PCA 500 accessible and affordable to patients, we believe Xpress ECG is the right solution. Xpress ECG is also the right 12-lead ECG solution for physicians who are starting or expanding their telehealth practice. For patients seen in virtual visits and need an ECG test, Xpress ECG delivers high quality 12-lead ECG tests in just few days. Xpress ECG is can be an alternative to ECG tests done in physician’s offices as well. Using Xpress ECG to get ECG tests done at patient’s home instead of in office will enhance workflow in clinic visits, reduce the risks for infection, and lower the cost (no overhead). Furthermore, the reimbursement for Xpress ECG using CPT code 99457 is 3 times higher than the reimbursement for office ECG using CPT code 93000. Using the same code 99457, Xpress ECG can also be used for monthly remote patient monitoring.
Medgadget: How has the COVID-19 pandemic affected cardiac care of patients, and what is your technology’s role to address this now and in the post-pandemic future?
Dr. Chang: PCA 500 electrodes offer a new way of performing a 12-lead ECG test—the electrode placements will be fast, accurate, consistent and standardized. In addition to reducing variations, errors and personnel cost, the single-use PCA 500 electrodes with no cables greatly lower the risks for coronavirus transmission and the time spent on dis-infecting the equipment. We hope not only PCA 500 is an alternative to conventional ECGs in the pandemic, it will become the standard for all 12-lead ECG testing in the future.
Patients with heart disease are at much higher risks for COVID-related morbidity and mortality. It has been a challenge to many physicians to continue providing quality care while minimizing the risks of exposure to potential infection. Xpress ECG offers the solution to telecardiology visits and the increasing needs for remote patient monitoring. The need for 12-lead ECG solution will go beyond the pandemic, as the importance and needs for telehealth, home care and monitoring continue to rise.
Medgadget: Do you foresee that an app may one day be able to automatically review ECG tracings and provide analyses beyond spotting cardiac arrhythmias?
Dr. Chang: Excellent question! We currently provide preliminary ECG interpretation by computer algorithms which are cloud based. Once an ECG is done, the signals are sent to the user’s cloud account, and our cloud algorithms process the signals, filter out the noises, then measure and analyze the ECG patterns. The current algorithms can detect arrhythmias, such as afib, SVT, and structural findings, such as hypertrophy or ST segment elevation. We are now working on machine learning algorithms to make more accurate and extensive ECG analysis and interpretation. I believe a comprehensive 12-lead ECG assessment will not only be diagnostic but also prognostic or predictive in the future. With machine learning, ECG will soon be able to detect ventricular dysfunction (measure ejection fraction), predict the risk for developing afib, heart attack, or heart failure in short term and even possibly long term.
Medgadget: What challenges and opportunities do you foresee in bringing your technology to wider use?
Dr. Chang: The challenges are the same as everyone else, needing more time and money. It is more so in the tech startup because you are running against the clock, trying to get things done before the money runs out, or before competing products emerge in the market.
Our biggest challenge in the market is the amount of efforts needed to educate the doctors and patients, raise brand awareness and demonstrate product effectiveness in improving patient outcomes. We are creating a new product category—12-lead ECG for personal use, which is our biggest opportunity as a market disruptor.
Medgadget: Is it challenging for ECG device companies to scale in revenue?
Dr. Chang: Yes, there are challenges to scale in revenue. Since ECG is a century-old technology, the differentiation among products often is not so clear; there are also many ECG players out there. Thus, establishing a trustable brand among industry giants such as GE and Philips is a huge obstacle but not insurmountable. As said, we will initially focus on certain niche markets, to generate more product traction and raise brand awareness, then gradually establish ourselves penetration of Xpress ECG into the mass market.
Here’s a video showing how to do a personal ECG using the PCA 500:
Link: QT Medical homepage…