Newly published guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) support cardiac monitoring devices in evaluating syncope patients.
The "2017 ACC/AHA/HRS guideline for the evaluation and management of patients with syncope" was recently published online in the Journal of the American College of Cardiology, Circulation and Heartrhythm. American College of Emergency Physicians and the Society for Academic Emergency Medicine also helped draft the guidelines.
The new measures point out the choice of a specific cardiac monitor should be determined on the basis of the frequency and nature of the syncope events.
Both external and implantable cardiac monitors (ICM) are recommended based on symptom frequency in the new guidelines. Implantable cardiac monitors have a stronger recommendation as a result of the strong evidence and randomized controlled trials that support the use of ICMs in unexplained syncope patients.
Earlier this month, Dublin-based Medtronic plc expanded its offerings into the space when it received FDA clearance for its Reveal Linq insertable cardiac monitors with Trurhythm Detection. (See Medical Device Daily, March 14, 2017.)
Medtronic has also developed the Seeq Mct system, an adhesive-backed and water resistant external cardiac monitor that is applied to the chest and can be worn discreetly under clothing, without the need for removal during exercise, showering or while sleeping.
"The new ACC/AHA/HRS syncope guidelines were published to drive better informed clinical decisions and improved patient outcomes," Chris Landon, vice president and general manager of diagnostics, for Medtronic, told Medical Device Daily.
Landon added, "Patients who have experienced frequent symptoms may benefit the most from a short-term external heart monitor such as the Seeq Mct System. Patients who experience less frequent symptoms – more than 30 days between symptoms – may be better suited for long-term cardiac monitors such as the Reveal Linq implantable cardiac monitors with Trurhythm Detection, which can monitor the heart for up to three years."
Medtronic's Reveal Linq for the monitoring of syncope patients was evaluated in the PICTURE clinical study. Data from the trial showed that long-term cardiac monitoring with Reveal Linq led to diagnosis and specific treatment for 78 percent (170 of 218) of patients who experienced recurrent syncope. Of those diagnosed, 75 percent of patients were shown to have had a cardiac cause of their syncopal event. In addition, the study found that patients were evaluated by an average of three different specialists for managing their syncope and underwent a median of 13 inconclusive tests before a Reveal device was implanted.
The cardiac monitoring space is a market teeming with competitors. Other key players in the market are Abbott Laboratories Inc., Boston Scientific Corp., GE Healthcare Inc., Philips Healthcare NV, Biotronik AG, Livanova plc, Cardiac Science Corp., Mortara Instrument Inc. and Schiller AG.
Abbott Laboratories has been making some noise in the space with its Cardiomems HF system. Last week, results were revealed from an observational analysis of Cardiomems system that showed the device could have the potential to reduce heart failure hospitalizations and costs. (See Medical Device Daily, March 21, 2017.) But critics of the study noted it wasn't definitive due to its lack of a control group.
Cardiomems is a battery-free device that monitors blood pressure in the pulmonary artery and wirelessly transmits the results to a bedside monitor, which sends the data along to a doctor's office.
Abbott gained access to Cardiomems through the $25 billion acquisition of St. Jude Medical Inc. The St. Paul, Minn.-based company had actually obtained the technology about two years earlier, as a result of its $455 million Cardiomems Inc. buy. (See Medical Device Daily, June 3, 2014.)