Philips’ Cardiovascular Portfolio Highlighted in Clinical Presentations

March 6, 2023—Royal Philips announced the presentation of clinical study results evaluating three of the company’s cardiovascular offerings at ACC.23/WCC, the American College of Cardiology’s annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana.

Reza Fazel, MD, delivered initial results from a high-quality, real-world evidence study of Medicare data that analyzed more than 1 million patients to evaluate trends in the use of, and outcomes associated with, intravascular imaging (IVI) during percutaneous coronary intervention (PCI) procedures—in both inpatient and outpatient settings—between January 1, 2013, and December 31, 2019. The study was led by Eric Secemsky, MD, who is Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Dr. Fazel is an interventional cardiologist at Beth Israel Deaconess.

As summarized in the company’s press release, Dr. Fazel’s presentation, which included preliminary results from the retrospective study, showed that the use of IVI technologies as an adjunct to angiography rose by 62% during the 7-year period and is associated with superior patient outcomes. Outpatient procedures accounted for 43.3% of all the PCIs included in the analysis.

The study showed that IVI use during PCI procedures was associated with lower rates of 1-year mortality (hazard ratio, 0.96; 95% CI, 0.94-0.98); myocardial infarction; repeat PCI procedures; and major adverse cardiac events.

The company noted that the potential for further strong growth is supported by a “state-of-the-art review” published by Alexander G. Truesdell, MD, et al in the Journal of the American College of Cardiology that “advocates broader use of these technologies as a part of contemporary practice” and recommends that “IVI capability should be included in all U.S. CCLs [United States cardiac catheterization laboratories].” (2023;81:590-605). The JACC review also stated that intravascular ultrasound (IVUS) is “the more flexible of the options and is the one that can be utilized in almost all clinical scenarios.”

Philips’ IVI products include a range of IVUS catheters, coregistration, and automated measurement tools for use on Philips Azurion image-guided therapy system, which is designed to help cardiologists decide, guide, and confirm the right interventional treatment for each patient.

In a second Philips-related presentation at ACC.23/WCC, Sean Pokorney, MD, highlighted results of a study that quantified the improved health care utilization and reduced hospital costs associated with early removal of infected cardiac implantable electronic devices (CIEDs). Dr. Pokorney is Assistant Professor of Medicine and Member of the Duke Clinical Research Institute at Duke University School of Medicine in Durham, North Carolina.

The study was conducted by Dr. Pokorney and colleagues at the Duke Clinical Research Institute. It was supported by a research grant from Philips, but the company had no role in the design of the study or conduct of the analysis.

The CIED Infection Medicare Study of clinical practice analyzed the records of more than one million CIED implant patients in the United States’ 100% Medicare fee-for-service population covering the period January 1, 2006, to December 31, 2019.

As reported by Dr. Pokorney last April at ACC.22, approximately 4 in 5 patients were not treated according to multisociety (ACC, et al) Class I consensus recommendations and guidelines for CIED infection that recommend full system extraction within 3 days. Of the 9,867 patients diagnosed with a CIED infection 12 months or more after implantation, only 13.3% underwent extraction within 6 days and only 5.2% between 7 and 30 days.

The Philips press release advised that Dr. Pokorney’s presentation at ACC.23/WCC highlighted the cumulative incidence of all-cause hospitalization and the associated health care expenditure for these patients during a period of 1 year after infection diagnosis.

Complete device extraction within 6 days of CIED infection diagnosis was associated with lower all-cause hospitalization in follow-up (21% lower) and lower health care expenditure (42% lower) compared with patients who did not undergo extraction.

Timely extraction was also associated with lower hospitalization rates. The patient group for which no device extraction within 30 days of diagnosis took place was characterized by a 68% hospitalization rate compared to a 54% hospitalization rate for the group in which patients underwent CEID extraction within 6 days of diagnosis. Additionally, hospital expenditures in the year following a CIED infection were almost cut in half, with costs being $63,259 for the group with no extraction within 30 days, reducing to $36,815 for extraction within 6 days.

Dr. Pokorney stated in Philips’ press release, “This data highlights a major gap in care among our CIED infection patients, which results in higher mortality, more health care utilization, and higher cost of care. Quality improvement interventions with focused systems of care are needed to optimize patient outcomes.”

John Andriulli, DO, added, “CIED infection is a health care crisis and electronic medical records (EMR) are essential in identifying patients and minimizing time to extraction. It must be ubiquitously shared between hospital systems to improve length of stay and more importantly to impact the potential reduction in mortality. This is especially true for outside hospital transfers. This is when the EMR becomes even more important.”

In the third presentation at ACC.23/WCC highlighting Philips technology, Mohamad Alkhouli, MD, revealed the results of a study demonstrating the real-world safety and performance of Philips’ VeriSight Pro three-dimensional (3D) intracardiac echocardiography catheter (ICE) during a range of image-guided minimally invasive cardiac procedures. Dr. Alkhouli is Professor of Medicine at Mayo Clinic School of Medicine in Rochester, Minnesota.

The Philips ICE Clinical Registry is a prospective, nonrandomized, multicenter, observational study of the safety and performance of VeriSight Pro that was led by Dr. Alkhouli.

According to the company, the study was based on a cohort of 155 patients evaluated for a range of percutaneous cardiac intervention procedures, including left atrial appendage occlusion, cardiac ablation, heart valve replacement, and patent foramen ovale and atrial septal defect repair procedures.

Compared to transesophageal echocardiography (TEE), an ICE catheter, which has a tip-mounted ultrasound transducer that can be routed to the heart via the patient’s blood vessels, is considerably more comfortable than TEE for a majority of patients and requires less sedation or anesthesia, improving patient safety and experience and reducing the number of operating room staff required during a procedure.

During the study, patients were followed until discharge or 48 hours after their procedure. Safety was demonstrated with no periprocedural device-related adverse events.

At ACC.23/WCC, Dr. Alkhouli reported that the Philips VeriSight Pro 3D ICE demonstrated acceptable or better image quality compared to TEE or competitive ICE technology in > 95% of the procedures; the device was considered to be an acceptable or better surrogate to TEE 89.7% of the time, noted the company’s press release.