Mentorship is an important component to success for many up-and-coming cardiothoracic surgeons. For established surgeons, being a good mentor is equally as important. Vinay Badhwar, MD (West Virginia University) moderates a discussion that includes Shanda H. Blackmon, MD, MPH (Mayo Clinic), Melanie A. Edwards, MD (Saint Louis University), and David D. Odell, MD, MMSc (Northwestern University) talking about how mentorship is critical to the future of the specialty and what STS is doing to promote mentorship for early career surgeons.

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for nearly 14,000 Abbott and Thoratec HeartMate left ventricular assist devices (LVADs). This recall comes after reports of multiple deaths and injuries associated with these devices, which are used to aid patients with advanced heart failure. 

The recalled devices include: 

  • Product names: HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) 
  • Product codes: DSQ 
    • Class 1 Device Recall HeartMate II Left Ventricular Assist System (fda.gov) 
    • Class 1 Device Recall HeartMate 3 Left Ventricular Assist System (fda.gov) 
  • Model numbers:  Full List of Affected Devices 
  • Distribution dates: Starting April 21, 2008 

The problem at the center of this recall is the gradual buildup of biological material in these devices develops over 2 or more years, potentially obstructing the device and diminishing its ability to support the heart's pumping action. This issue can trigger alarms for low blood flow and impair the device's effectiveness. 

Recall Action: This recall is classified as a correction rather than a complete product withdrawal. The FDA has not advised the return of all affected devices. However, heightened vigilance concerning low-flow alarms, which may indicate significant outflow obstructions, is recommended. 

Customers should have received an Urgent Medical Device Correction letter on February 19, 2024, providing detailed guidance on monitoring for and addressing potential obstructions. 

Abbott and Thoratec have made efforts to educate physicians on the importance of heeding persistent low-flow alarms as early indicators of potential obstructions and have shared diagnostic recommendations to identify obstructions and discussed treatment options available for managing such issues.  

If you have questions about this recall, contact Abbott and Thoratec directly at (844) 692-6367. To report a problem with these devices, complete the FDA reporting form

Apr 16, 2024
2 min read
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advocacy Update
As Congress begins to determine appropriations levels for FY25, STS will continue to advocate for robust funding for critical government programs, which are vital for advancing patient care and medical research.
2 min read
Derek Brandt, JD, STS Advocacy

In this panel discussion, STS members exchange viewpoints on a new study that found patients with postoperative PE had increased 30-day mortality, reintubation, and readmission rates, which was presented at the 2024 STS Annual Meeting.

Duration
10 min

In this episode, Dr. David T. Cooke talks with Dr. Angelica Martin, UC Davis Health, and Dr. Lillian Tsai, Stanford Medicine, about their career journeys and the people who have been a positive influence on them. “I come from an underserved community and I’m the first in my family to go to college,” said Dr. Martin. “At first, it felt like I was navigating this career on my own. My mentor has been my north star.” 

1 hr.

In this short video, STS members exchange viewpoints on a new study that found patients with postoperative PE had increased 30-day mortality, reintubation, and readmission rates, which was presented at the 2024 STS Annual Meeting.

Robbin Cohen, MD, Cedars-Sinai at Huntington Hospital, is joined by the study’s lead author, Andrea L. Axtell, MD, MPH, an assistant professor of surgery at the University of Wisconsin School of Medicine and Public Health, Michael Smith, MD, Norton Thoracic Institute, St. Joseph’s Hospital & Medical Center, and John Mitchell, MD, University of Colorado Health, to discuss the research methodology, findings and impact on improving patient care. 

Apr 2, 2024
1 min read

Overview

UC Davis Health, based in Sacramento, California, knew that implementing quality improvement measures required operational and clinical analytics to guide process development and care redesign efforts. This case study explains how the health system addressed clinical documentation challenges through better data, education, communication, and collaboration across disciplines and delivered better patient outcomes. 

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advocacy

In March, Congress passed its annual appropriations package for fiscal year (FY) 2024, allocating nearly $2 trillion to fund the government through September 30, 2024. This package includes resources for essential government agencies and research programs that drive medical advances, enhance care quality, and disseminate best practices.

3 min read
Derek Brandt, JD, STS Advocacy

Abiomed is recalling the instructions for use of its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. The FDA has identified this as a Class I recall-- the most urgent type of recall-- where use of or exposure to a violative product will cause serious adverse health consequences or death. 

The recalled devices include: 

  • US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist ; Impella LD 
  • Product Codes:  See Recall Database Entry 
  • Distribution Dates: October 10, 2021 to October 10, 2023 

During operations, the recalled Impella device could cut through the wall of the left ventricle. Use of the pumps could cause left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. The FDA stated that there have been 129 reported serious injuries, including 49 reports of death. 

Customers of Impella devices should have received an Urgent Medical Device Correction letter from Abiomed on December 27, 2023. The letter requested customers adhere to the following new and revised warnings: 

  • Carefully position the pump catheter during operative procedures 
  • Use imaging when advancing or torquing the pump catheter 
  • Use special care when inserting the pump catheter in patients with certain high-risk conditions or during active CPR 
  • Review the updated warnings in the device’s Instructions for Use 
  • Notify everyone at your facility who needs to be informed of this recall correction 
  • Notify any other facilities where the products have been forwarded the updated Instructions for Use  

If you have questions about this recall, contact Abiomed, Inc. at (978) 646-1400. To report a problem, complete the FDA reporting form

Mar 26, 2024
2 min read