Ambulatory Pulmonary Artery Pressures After Transcatheter Edge-to-Edge Repair of the Mitral Valve in Patients With Heart Failure and Mitral Regurgitation
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.
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Cited by (1)
Do We Need to Know and Monitor the Hemodynamics of Patients Treated With Mitral Transcatheter Edge-to-Edge Repair?
2023, American Journal of Cardiology
Funding: Abbott Cardiovascular (Plymouth, MN).