Cardiology Month in Review: September 2022

The final weekend of each month, our editorial staff compiles a list of our most popular content from the past month. The top content from September 2022 includes trio of FDA approvals, a TCT headliner, a look back at ESC Congress 22, and a new prognostic biomarker for heart failure.

1. FDA Expands WATCHMAN FLX Approval to Include DAPT Option

The US Food and Drug Administration (FDA) has approved an expanded indication for the current-generation WATCHMAN FLX Left Atrial Appendage Close (LAAC) Device to include a 45-day dual antiplatelet therapy (DAPT) option as an alternative to the postprocedural oral anticoagulation plus aspirin regimen for patients with nonvalvular atrial fibrillation (NVAF), according to an announcement from Boston Scientific.

Announced in a September 6 release, the expanded indication is based on recent clinical evidence submitted to the FDA in support of the safety and efficacy of DAPT as a postprocedural antithrombotic regimen in patients with NVAF seeking an alternative to OAC, including analyses of 8300 patients from the American College of Cardiology Foundation's National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry.

2. LINQ II ICM Receives Historic FDA Clearance for Children Aged 2 Years and Older

The LINQ II insertable cardiac monitor has become the first continuous, long-term ICM cleared by the US FDA for use in pediatric patients, according to a statement from Medtronic.

Announced on September 20, the FDA’s 510(k) clearance of the small, wireless ICM, which has a battery life of up to 4.5 years, is for use in pediatric patients over the age of 2 years who have heart rhythm abnormalities and require long-term, continuous monitoring.

3. PROTECTED TAVR: Cerebral Embolic Protection Devices Do Not Reduce Stroke Risk

Use of a cerebral embolic protection (CEP) device may be effective at capturing debris in patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis, but it did not reduce the risk of stroke in the PROTECTED TAVR trial.

A 3000-patient trial presented at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics conference, results indicate the incidence of stroke within 72 hours did not differ significantly between the CEP group and the control group, but the incidence of disabling stroke was lower among the CEP group.

4. Don't Miss a Beat: ESC Congress 22 Recap

In this episode of Don’t Miss a Beat, hosts Stephen Greene, MD, assistant professor of medicine at the Duke University School of Medicine, and Muthiah Vaduganathan, MD, MPH cardiologist at Brigham and Women's Hospital, provide a recap of the ESC 2022 congress. This recap begins with a discussion on the results of the DELIVER trial, which Vaduganathan served on as an investigator, the ADVOR trial, and REVIVED.

5. Endotrophin Could Serve as Prognostic Biomarker for Heart Failure

Investigators from Penn Medicine have released new data they suggest provide evidence backing use of endotrophin as a prognostic biomarker for patients with heart failure.

An analysis of the TOPCAT trial followed by a patient-level meta-analysis of patients more than 800 patients from other trials and registries, results of the study suggest elevated levels of plasma endotrophin were associated with a more than 70% increase in risk of future death among patients with heart failure with preserved ejection fraction.

6. FDA Approves PASCAL Precision System for TEER in Degenerative Mitral Regurgitation

The US FDA has approved the PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) as a treatment for patients with degenerative mitral regurgitation, according to a release from Edwards Lifsciences Corporation.

Announced on September 15, the FDA’s approval is based on the results of CLASP IID pivotal trial, which Edwards Lifesciences purports is the first randomized controlled trial to directly compare two contemporary TEER therapies.