Author + information
- David Mark Shavelle,
- William Abraham,
- Robert Bourge,
- Rita Jermyn,
- Maria Rosa Costanzo and
- Lynne Stevenson
Background: The CardioMEMS HF™ system uses a sensor that is placed within the pulmonary artery via percutaneous femoral venous access that allows remote hemodynamic monitoring of pulmonary artery (PA) pressure. The purpose of the current analysis is to report initial results of the ongoing CardioMEMS post approval study (PAS) regarding the implantation procedure.
Methods: From January 2015 to March 2016, 300 patients participating in the PAS were implanted with the CardioMEMS™ HF system at 53 hospitals. Procedural and system/device related complications were evaluated using criteria as established in the CHAMPION™ trial. Procedural success was defined as completion of right heart catheterization (RHC) with measurement of hemodynamics and successful implantation of the sensor.
Results: Average age was 69±12 years, 62% male, 40% with preserved EF and 47% with ischemic cardiomyopathy. Two hundred ninety-seven (99.0%) of the RHC procedures were successful; 2 were unsuccessful secondary to inability to obtain venous access and 1 was unsuccessful due to inability to advance the pulmonary artery catheter. Sensor implantation was successful in all of the 297 patients (100%) for an overall procedural success rate of 98.7%. There were no sensor failures and 2 (0.7%) device/system related complications. Procedure and sensor implantation times were 48.3 ± 22.7 and 6.2 ± 7.3 mins, respectively. Left side PA implantation was done in 97.3%. Implanting physicians were 39% interventional, 31% heart failure, 22% general and 8% electrophysiology. Seventy percent of patients were discharged on the day of the procedure. Pressures at sensor implantation were: PA systolic 47.8±14.4, PA diastolic 19.8±7.7 and PA mean 31.2+9.6 mm Hg. Heart failure medications were changed at discharge in 23% of patients.
Conclusions: Patients receiving the CardioMEMS™ HF device in a post approval registry have high procedural success with low system/device related complication. The majority of patients received sensor implant as an outpatient procedure. Pulmonary artery pressures were elevated at the time of sensor implant with nearly 25% of patients having an adjustment in their heart failure medications.
Poster Hall, Hall C
Saturday, March 18, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Heart Failure and Cardiomyopathies: Heart Failure Gadgets Galore
Abstract Category: 14. Heart Failure and Cardiomyopathies: Therapy
Presentation Number: 1199-243
- 2017 American College of Cardiology Foundation