Procedural Safety Profile of Cardiomems Heart Failure Sensor Implantation in a Veterans Association Patient Population

Abstract

<h3>Purpose</h3> Implantation of a wireless pulmonary artery pressure monitoring device [CardioMEMS] has been shown to reduce heart failure hospitalization but safety profile and peri-procedural complications have not been well described in real world practice in a Veterans Affairs (VA) patient population. <h3>Methods</h3> Electronic medical records of our single VA institution were retrospectively evaluated for device implantation procedure data and follow up clinic visits between 2017 and 2020. <h3>Results</h3> 63 patients with NYHA Class 3 heart failure were implanted with the device (Table 1A). Average procedure time was 48 minutes with average fluoroscopy time of 13 minutes. Average total volume of contrast used was 23 mL. Estimated blood loss was 10 mL. At device implantation, average right atrial mean pressures were 11 mmHg and pulmonary artery systolic, diastolic, and mean pressures were 51/24/34 mmHg. There were three peri-procedural complications. One patient developed an access related pseudoaneurysm successfully treated with surgical intervention. One patient developed a 2 cm hematoma at the access site managed conservatively. One patient developed proximal sensor migration following device deployment which was re-advanced using a Swan wedge balloon catheter and position was confirmed with chest radiograph and proper waveform analysis on device interrogation. All implants were successful and no patients were lost to follow up at clinic visits. There were no major adverse cardiovascular events (stroke, myocardial infarction and cardiovascular death) in hospital or at 30-day follow up. Procedural complications are summarized in Table 1B as compared to previously published data in the CHAMPION Trial. <h3>Conclusion</h3> This real world study demonstrates that the safety profile of pulmonary artery pressure monitoring device implantation in a single VA healthcare center serving a VA patient population is a feasible and safe management approach to patients with NYHA Class 3 heart failure.