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Pulmonary artery pressure measurement via sensors may improve outcomes in HF
PHILADELPHIA — Two different sensors were able to safety and accurately measure pulmonary artery pressures for remote HF management, which resulted in improvements in symptoms and quality of life, according to data from the SIRONA and MEMS-HF trials presented at the American Heart Association Scientific Sessions.
MEMS-HF trial
Christiane Angermann, MD, professor of cardiology at the University Hospital of Würzburg in Germany, and colleagues analyzed data from 234 patients (mean age, 68 years; 22% women) with HF who underwent sensor implantation (CardioMEMS, Abbott/St. Jude’s Medical) in Germany, the Netherlands and Ireland. These patients had NYHA class III HF, were on optimal HF drug treatment if they had HF with reduced ejection fraction, had at least one HF hospitalization in the past year and a pulmonary artery branch diameter of at least 7 mm.
The primary endpoints were freedom from sensor failure at 1 year and freedom from device- and system-related complications.
At 1 year, freedom from device- and system-related complications was 98.3%, and freedom from sensor failure was 99.6%. Survival during this period was 86.2%.
“So, 13.8% of the patients died, but this was a very, very high-risk population,” Angermann said during the presentation.
HF hospitalization decreased by 62% compared with the year before sensor implantation (HR = 0.38; 95% CI, 0.31-0.48).
Patients with the highest mean pulmonary pressure at baseline had more pronounced declines in pressures after implantation.
“These data are very robust,” Angermann said during the presentation.
Kansas City Cardiomyopathy Questionnaire overall scores increased from 48.5 to 60.7 before and after implantation (P < .0001). This increase was also seen for the clinical summary score (53.4 to 63; P < .0001). Greater increases were seen in patients with a mean pulmonary artery pressure of at least 35 mm Hg. Patient Health Questionnaire sum score decreased from 8.4 before implantation to 6.5 after implantation (P < .0001).
“For the first time, we can show that this mode of monitoring and treatment is associated with very significantly improved health-related quality of life and a reduction in the burden of depressive symptoms,” Angermann said during the presentation.
SIRONA study
In this first-in-human study, Wilfried Mullens, MD, PhD, professor at Ziekenhuis OostLimburg in Genk, Belgium, and colleagues analyzed data from 19 patients (mean age, 70 years; 68% men) with NYHA class III HF who were enrolled to undergo sensor implantation (Cordella PAP Sensor and Cordella HF System, Endotronix), which was used for remote HF management.
“The advantage of this system is that the patient can very easily measure the [pulmonary artery] pressure by just a hand-held device that they can put on the interior wall of their chest,” Mullens said during the presentation. “We have secure communication with the health care providers with a very clear interface through which the health care provider can actually interact with the patient on a continuous basis.”
The primary safety endpoint was freedom from adverse events associated with the HF system up to 30 days after sensor implantation. A primary efficacy endpoint was also evaluated, defined as the accuracy the pulmonary artery pressure measurement from the sensor compared with standard of care at 90 days after sensor implantation.
Of the patients enrolled in the study, four did not undergo sensor implantation because of rapid deterioration of HF, anatomical reasons or consent withdrawal.
Within 30 days after sensor implantation, four patients had adverse events associated with the HF system including minor hemoptysis, transient complete heart block during the procedure and sensor dislodgement after deployment. No events required invasive treatment and were resolved without sequela.
There was no significant difference in the measurement of mean pulmonary artery pressure with the sensor compared with a reference catheter (2.7 mm Hg).
“[The sensor offers] a very accurate measurement of [pulmonary artery] pressure in patients who are ambulatory, walking around,” Mullens said during the presentation.
More than 98% of patients completed daily measurements with the sensor.
“We believe this is strongly related to the way that the patients can measure,” Mullens said during the presentation. “It’s like putting an iPad on your chest for 30 seconds, then immediately you will have [pulmonary artery] pressures.”
Mullens concluded that this ease in use may contribute to improved outcomes.
“It’s a very user-friendly patient interface, which hopefully will facilitate patient engagement and empowerment, resulting in high compliance.” – by Darlene Dobkowski
References:
Mullens W, et al.
Angermann C, et al. Outpatient Strategies for Heart Failure Management. Both presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2019; Philadelphia.
Disclosures: The SIRONA trial is sponsored by Endotronix. The MEMS-HF study is sponsored by Abbott Medical Devices. Mullens reports no relevant financial disclosures. Angermann reports she is chair of the steering committee for several trials including the MEMS-HF trial, member of the executive committee for the EMPULSE study, has received research grants from Vifor Pharma and has other financial relationships with Abbott, Boehringer Ingelheim and Novartis. Please see the abstracts for all other authors’ relevant financial disclosures.
Perspective
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Both of these studies are looking at pulmonary artery pressure sensors or monitors. The idea is that by implanting a device in a person with HF, if you monitor the pulmonary artery pressures, that information would be transmitted remotely and would allow the physicians to adjust therapy and improve outcomes as opposed to usual care.
Both of these trials are relatively small. There’s actually a larger data set out there already that has addressed this. It’s duplicating previous observations, but additional tests of the question are always nice.
The limitations are these are not randomized, prospective, blinded trials, so they’re confirmatory analyses in the kind of data that we have a sense of already that potentially pulmonary artery pressure monitoring could improve outcomes in patients with HF.