In their first pilot study called the SYNC study, the scientists compared the effectiveness of two cardiac resonance therapies or different therapies to correct heart aberrations with pacemaker implants and defibrillators. The current standard of care, known as Bventricular Rate, uses a two-step pacemaker in
two lower rooms, while a newer approach, called Bunch Step, seeks to attract and restore the heart’s natural physiology.
Both approaches have never been directly compared in direct, head-to-head studies This is the first prospective survey in our area to compare results between different approaches to synchronize heart rate,” said cardiologist Roderick Tung, MD, FHRS, director of cardiac electrophysiology and EP laboratory at the University of Chicago. – With the speed of the connection, we try to touch the normal cord of the heart and restore conductivity as intended by nature.
Previously, we only assumed that we had to move between the two cameras. Tung has led a two-year experience with a medical cardiologist, UChicago Gaurav Upadhyay, FHRS, lead author of this study. Experience includes 40 adult patients in seven facilities in the Midwest. The UChicago Medical Team functions as an independent coordination site. The results of the study were presented as the most frequent study of the Annual Rhythm Association’s Scientific Session on May 9 in San Francisco.
To qualify as the latest study, research must be innovative and unique. This study is also published in the American College of Cardiology. In biventricular stimulation, cables, called water, are implanted to simultaneously stimulate the right and left heart ventricles. Then, the pacemaker sends temporal electric pulses to two cables for synchronized contractions that simulate the heart.
However, about 30% of patients do not respond to bivariate treatment, which has been shown to improve survival in clinical trials.
Tim Tung investigated whether other re-synchronization methods can help reduce this number by comparing clinical trials between Bventricular Pace and its speed.
The latter involves planting one tin at the beginning of the heart wiring system, which then of course has two parts to distribute electric pulses to the pacemaker to the two ventricles.
The level of the constant relationship is around 20 years, but so far no randomized clinical trials have been conducted comparing it with the speed of two years, Thun said.
For the SYNC experience, all patients were in accordance with current guidelines for cardiac synchronization therapy and were randomly selected to receive a bundle or lead of coronary sinus for biventricular pivents. Patients were not informed of the care they received. While the results of the preliminary study do not show excellence in His-CRT, Tung and his team believe that the relationship approach has shown a comparable response rate, which requires further investigation. Studies are limited by the high cutting speeds required by the study protocol if the exact placement of the electrodes cannot be achieved.
Nearly half of patients selected to receive their muscles must be treated with conventional biventricular stimulation because of a condition called interventricular conduction arrest (IVCD). The implant has not improved since it was introduced 10 years ago.
“We need to learn to better identify patients who cannot and do not respond to the package step,” Thun said. “During this pilot study, we learned that the grid is too wide and patients with IVCD cannot be repaired and improved by their muscles.
The SYNC II, our planned follow-up trial, will specifically exclude these patients, and this is probably the biggest valuable lesson from the pilot in addition to the expected effects of treatment. In addition, 26% of patients selected for a two-week schedule usually do not, because due to the nature of the vein, no lead can be placed due to strict criteria for optimizing left ventricular water implantation.
Six months later, the scientists compared the electrical synchronization and structural functions of the hearts of the two groups of patients. Although they expected the speed of their relationship to be better, they did not detect a significant difference between the two groups with comparable electrical resonance and echocardiographic responses. After one year, there was no difference in the number of hospitalizations or deaths at the hospital.
Tung indicated that the size of the pilot study was limited. Pilot studies should never be convincing, he said. They must provide us with information about size, safety and feasibility to help select appropriate patients and do more research.
Tung praised the unprecedented nature of sharing projects, including partnerships with Northwestern University in Chicago, Rush University and Heart Institute, as well as Indiana University, Geisinger Heart Institute and Louisville Baptist Health. The SYNC pilot study was not funded by industry and the team planned to conduct a follow-up study after funding was obtained.