Elsevier

The American Journal of Cardiology

Volume 184, 1 December 2022, Pages 90-95
The American Journal of Cardiology

Ambulatory Pulmonary Artery Pressures After Transcatheter Edge-to-Edge Repair of the Mitral Valve in Patients With Heart Failure and Mitral Regurgitation

https://doi.org/10.1016/j.amjcard.2022.08.036Get rights and content

The objective of this study was to assess ambulatory hemodynamics after transcatheter edge-to-edge repair (TEER) of the mitral valve. Pulmonary artery pressure (PAP) measurements from implanted sensors were collected through a remote monitoring database and linked to Medicare fee-for-service claims data. Among patients with linked data, those undergoing TEER were included if the ambulatory PAP monitor was implanted ≥3 months before TEER and ≥3 months of PAP data after TEER were available. The primary end point was diastolic PAP (dPAP) at 3 months after TEER compared with baseline. A total of 50 patients undergoing TEER between July 2014 and March 2020 were included, with an average age of 75 ± 8 years and 70% were men. dPAP was significantly lower at 3 months after TEER than baseline, −1.8 ± 4.8 mm Hg, p = 0.010. The cumulative reduction in dPAP (area under the curve) was significantly lower at 3 months after TEER, 113 ± 267 mm Hg-days, p = 0.004. A reduction in dPAP at 3 months after TEER was independently associated with a significantly lower risk of heart failure hospitalization (p = 0.023). TEER of the mitral valve is associated with a clinically relevant and sustained reduction in dPAP.

Introduction

Secondary or functional mitral regurgitation (MR) is common in patients with heart failure (HF) and is associated with increased HF hospitalizations (HFH) and mortality. However, surgical intervention carries high operative risk, without a consistent improvement in survival.1 Transcatheter edge-to-edge repair (TEER) of the mitral valve in combination with guideline-directed medical therapy (GDMT) improves symptoms, quality of life (QoL), and survival and reduces HFH compared with GDMT alone.2,3 Although reductions in left atrial pressure, and in turn left ventricular volume, are a likely mechanism underlying the improvement in QoL and clinical outcomes observed after TEER for secondary MR, long-term hemodynamics after TEER have not been well evaluated. Recent studies of ambulatory pulmonary artery pressure (PAP) monitoring suggest that an absolute reduction of 3 mm Hg in PAP is clinically relevant and is associated with a 33% reduction in HFH and a 19% reduction in mortality.4, 5, 6 Ambulatory PAP monitoring provides a unique opportunity to assess hemodynamics after medical and/or device-based therapy in patients with HF.7,8 To explore the effects of TEER of the mitral valve on PAP and their relation to clinical outcomes in patients with HF, we examined changes in ambulatory PAP after TEER in patients with HF with secondary MR using a large nationwide cohort.

Section snippets

Methods

This was a retrospective, observational cohort study. Data were sourced from the Centers for Medicare and Medicaid Services (CMS) administrative claims files through the CMS Virtual Research Data Center, a manufacturer (Abbott Vascular, Santa Clara, California) device registration database, and remote monitoring data (Merlin.net, Abbott Vascular, Santa Clara, California). Patient baseline characteristics (age, gender, race, and co-morbidities), TEER procedure date, and outcomes were identified

Results

Figure 1 shows the sequential process of study patient selection. Over 25,000 PAP monitors have been implanted in the United States since Food and Drug Administration approval. Of those implanted with a PAP monitor in the linked CMS dataset, 231 Medicare fee-for-service beneficiaries underwent TEER from July 2014 to March 2020. Of these, 160 patients had sufficient PAP and CMS data available and were not enrolled in the GUIDEd management of HF trial. Approximately 53% of these patients (85/160)

Discussion

In the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation trial, TEER combined with GDMT reduced HFH and mortality and improved QoL compared with GDMT alone in patients with severe functional MR, despite maximally tolerated GDMT.2 In contrast, MITRA-FR found no benefit of TEER over GDMT in patients with severe secondary MR and symptomatic HF.12 Ambulatory hemodynamic monitoring has been shown to reduce HFH in

Disclosures

Dr. Shavelle has received research support and is a consultant for Abbott; Dr. Heywood has received research support and is a consultant for Abbott; Dr. Srivastava has received research support from Abbott; Dr. Agarwal, Dr. Prillinger, Dr. Roberts, and Dr. Yu are employees of Abbott; and Dr. Price has received research support and is a consultant for Abbott.

References (20)

There are more references available in the full text version of this article.

Funding: Abbott Cardiovascular (Plymouth, MN).

View full text