News & Media

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. 

FAIRFAX, VIRGINIA (March 11, 2024) - As use of prosthetic heart valves and implanted cardiac devices has increased, so too has the incidence of cardiovascular infection. While accurate diagnosis of this condition is critical for guiding treatment decisions that can prevent death and significant morbidity, current assessment strategies have proven insufficient. Recommendations released by 11 professional medical societies, including the Society of Thoracic Surgeons, detail a standardized approach for using PET/CT and SPECT/CT imaging to improve the evaluation and subsequent outcomes of patients with cardiovascular infection. The expert consensus statement – “18F-FDG PET/CT and Radiolabeled Leukocyte SPECT/CT Imaging for the Evaluation of Cardiovascular Infection in the Multimodality Context” – is published online in the Journal of Nuclear Cardiology, Clinical Infectious Disease, Heart Rhythm Journal, and JACC: Cardiovascular Imaging.

“The stakes are high with cardiovascular infection because the incidence is increasing and there is associated high morbidity and mortality,” says Jamieson M. Bourque, MD, MHS, FASNC, chair of the statement’s multisociety writing committee. “Other guidelines have recognized that FDG PET/CT and SPECT/CT imaging have high diagnostic accuracy with cardiovascular infection and can provide important information on the infection site, severity, cause, and whether the infection has spread outside the heart. This document does what others have not – it provides evidence-based consensus on specific clinical scenarios where FDG PET/CT and SPECT/CT add value for patient care in the context of robust multimodality imaging approaches available.”

Reflecting its multidisciplinary authorship, the statement emphasizes the complementary nature of advanced imaging modalities. It outlines the indications for echocardiography, cardiac computed tomography angiography, radiolabeled leukocyte SPECT/CT and 18F-FDG PET/CT in cardiovascular infection evaluation. The authors then provide a consensus-derived clinical indication rating of "appropriate," "may be appropriate," or "rarely appropriate" for use of 18F-FDG PET/CT and SPECT/CT in 73 clinical scenarios encompassing suspected native and prosthetic valve infective endocarditis, suspected cardiovascular implantable electronic device (CIED) infections, suspected prosthetic material infection, and suspected ventricular assist device (VAD) infection.

The expert consensus recommendations statement also includes:

• Diagnostic algorithmic flowcharts for suspected native or prosthetic valve infective endocarditis or prosthetic material/VAD infection and for suspected CIED infection;
• Teaching images from cases where 18F-FDG PET/CT and SPECT/CT studies were used in  prosthetic valve endocarditis, CIED pocket and lead infection, VAD infection and prosthetic material infection; and
• Teaching case examples where 18F-FDG PET/CT and SPECT/CT were used to assess prosthetic valve endocarditis, suspected lead CIED infection, suspected VAD infection and suspected prosthetic material infection.

“18F-FDG PET/CT and Radiolabeled Leukocyte SPECT/CT Imaging for the Evaluation of Cardiovascular Infection in the Multimodality Context” is the first document in the new American Society of Nuclear Cardiology Imaging Indications (ASNC I2) Series. Eleven partnering organizations participated in writing these recommendations and endorsed the document: The American Society of Nuclear Cardiology (ASNC), the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the American Heart Association (AHA), the American Society of Echocardiography (ASE), the European Association of Nuclear Medicine (EANM), the Heart Rhythm Society (HRS), the Infectious Diseases Society of America (IDSA), the Society of Cardiovascular Computed Tomography (SCCT), the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the Society of Thoracic Surgeons (STS). The writing committee included representatives from each of the partnering organizations.

Read the consensus statement. 

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ABOUT ASNC

The American Society of Nuclear Cardiology and its 5,200 members have been improving cardiovascular outcomes through image-guided patient management for more than 30 years. As the leading society dedicated solely to the field of nuclear cardiology, ASNC establishes standards for excellence in cardiovascular imaging through the development of clinical guidelines, professional medical education, advocacy and research development. ASNC provides peer-reviewed original articles through its official publication, The Journal of Nuclear Cardiology. For more information, visit http://www.asnc.org.

ABOUT STS

Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 7,700 cardiothoracic surgeons, researchers, and allied healthcare professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest. The Society’s mission is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy.

As key members of the multidisciplinary care team, thoracic surgeons play a pivotal role in the patient journey for resectable Non-Small Cell Lung Cancer. This patient journey map, suitable for both surgeons and patients, outlines the stages of treatment of resectable NSCLC from diagnosis and staging, to resection, referral to a medical oncologist, and surveillance. This includes consideration of biomarker testing during the diagnostic biopsy and resection stages, and the potential benefit of perioperative and adjuvant therapies.

Click the image below to view or download the full document.

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Additional Resources

Webinars 

• Biomarker Testing and Neoadjuvant Immunotherapy for Resectable NSCLC
• Sublobar Resection Versus Lobectomy for Early-Stage Lung Cancer: A Debate

Video 

• The Surgeon’s Role in Managing Patients with Resectable NSCLC

The House and Senate just approved a new government funding bill that provides $730 million in relief from Medicare physician payment cuts, boosting reimbursements by 1.68% starting on March 9 and lasting through the end of 2024. 
 
STS has vigorously advocated for this relief, yet the total amount is less than what many stakeholders demanded, including STS, 30 members of the U.S. Senate, and nearly 200 members of the U.S. House of Representatives. We will continue to advocate for the elimination of all payment cuts and insist on systematic reforms that eliminate this threat. This includes H.R. 2474, a bipartisan bill with broad support that would create automatic annual inflation adjustments for Medicare physician payments. Contact Congress on this important issue. 
 
Additional Details

• The relief will apply to services rendered between March 9 and Dec. 31, 2024. 
• After applying the relief, Medicare payments will remain 1.69% lower than in 2023. 
• The payment reduction relief will not apply to claims between Jan. 1 and March 8, 2024. 
• On Jan. 1, 2025, an additional reduction of at least 2.93% will occur, absent congressional action, due to the expiration of temporary relief.

If you have questions, contact advocacy@sts.org.

At a standing-room-only presentation at STS 2024, STS Past President Dr. Mike Mack and Dr. Cherie Erkman presented data from the STS’ first annual survey on surgeon compensation. 

The first-of-its-kind survey, conducted in October 2023, was designed to help US-based cardiothoracic surgeons understand their value and make informed career decisions using reliable benchmarks specific to the specialty. 

“There is a lot of data out there on what cardiothoracic surgeons are paid, but that data is all over the place,” said Dr. Mack, chair of the Compensation Taskforce appointed by STS President Tom MacGillivray. “Understanding compensation begins with accurate data. That was the genesis behind conducting the survey.”

Nearly 850 STS members participated in the survey, a 27% response. Participants provided information on their total annual compensation, including salary and compensation related to RVUs/productivity – which represents about 80% of compensation – and other services provided. The survey also captured subspecialty, career stage, gender, ethnicity, geographic location, service area, and employment model. 

The survey affirmed expected pay differences between specialty, practice, career stage, and geography, as well as gender pay disparities between men and women surgeons, according to Dr. Erkman. Her analysis revealed that women cardiothoracic surgeons earn between 64 to 84 cents for every dollar their male counterparts earn, depending on their specialty.

While cardiothoracic surgeons provide tremendous value to the patients and institutions they serve, it has been a challenge to understand that value and translate it into fair compensation, explained Dr. MacGillivray. “This survey gives us a starting point,” he said. “We need to understand where there are disparities and inequities, and then fix them.”

“I’m proud of STS and Dr. MacGillivray for taking action to help us better understand compensation in our specialty and shine a light on pay disparities,” said Taskforce member Dr. Shanda Blackmon. “This gives women surgeons the knowledge and power we need to advocate for ourselves.”

The limited sample size produced some regional variability, Dr. Mack said, and the data do not reflect that cardiothoracic surgeon residents and fellows are compensated far less than attending surgeons during their many years of training. 

“Cardiothoracic surgeons train for an average of 15 to 16 years and start their first attending job at age 34 or 35,” Dr. Mack explained. “Many accumulate significant debt during medical school and training.” A recent Thoracic Surgery Residents Association survey found that 53% of residents have more than $200,000 in debt.

Workload is not reflected in the report, Dr. Mack said, but US-based cardiothoracic surgeons work 65 to 80 hours per week, sometimes more, performing both scheduled and emergency operations. 

STS is working with consulting firm Gallagher, an expert in physician compensation and valuation services, to collect and analyze data, and produce an annual compensation report. Data collected by Gallagher is confidential and will not be shared with STS, explained Dr. MacGillivray. 

The 2023 Cardiothoracic Surgeon Compensation Report will be available in early February. STS members who participated in the survey will receive it at no cost. Members, nonmembers, and institutions interested in purchasing the report can add their name to the interest list.

“The Society plans to conduct the compensation survey annually. We encourage US cardiothoracic surgeons to participate every year so the report provides the most accurate data, and so they can receive the report for free,” said Dr. Mack.