Analysis finds cardiac devices recalled for safety reasons infrequently subjected to premarket or postmarket testing

Embargoed for release until 5:00 p.m. ET on Monday 16 September 2024 

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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.      
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1. Analysis finds cardiac devices recalled for safety reasons infrequently subjected to premarket or postmarket testing

Cardiovascular device recalls affect thousands of patients annually

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-00724

Editorial: https://www.acpjournals.org/doi/10.7326/ANNALS-24-01840-C

URL goes live when the embargo lifts       

A cross-sectional study of cardiovascular devices subject to Class I recalls from 2013 through 2022, found that most recalled devices did not undergo clinical testing before authorization and were not required to undergo postmarket surveillance studies. Even when premarket clinical testing was conducted, there was often a lack of evidence to support their original authorization. These findings have important public health implications because recalls affect thousands of patients each year. The study is published in Annals of Internal Medicine.

Researchers from Harvard Medical School, Yale School of Medicine, and the University of California, San Francisco performed a cross-sectional analysis of all Class I recalls involving cardiovascular devices from 1 January 2013 through 31 December 2022 using data from the FDA’s annual log to characterize the device recalls and the clinical evidence supporting their initial authorization. The researchers found that there were 137 Class I recall events affecting 157 unique cardiovascular devices during the study timeframe. About 71% of the recalls were for moderate-risk 510(k) devices and about 28% were for high-risk premarket approval (PMA) devices. Only about 19% of the recalled devices underwent premarket clinical testing and evidence was usually generated from a single nonrandomized, unblinded clinical trial using surrogate measures with no active control. According to the study authors, these findings illustrate the limited clinical evidence supporting the use of cardiovascular devices later found to have serious safety concerns.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Kushal T. Kadakia, MSc, please e-mail kushalkadakia@hms.harvard.edu.   

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2. Children who experience an initial firearm injury at high risk for experiencing another  

Abstract: https://www.acpjournals.org/doi/10.7326/M24-0430

URL goes live when the embargo lifts  

A 10-year retrospective cohort analysis found that children who experienced an index (initial) firearm injury during the study period were at high risk for experiencing a recurrent firearm injury. These findings are important because they underscore the need to understand the patient characteristics and contributing factors that increase the risk for firearm injury and reinjury in the community. The findings are published in Annals of Internal Medicine. 

Firearm injuries are the leading cause of death among children aged 0 to 17 years in the United States. Researchers led by Washington University School of Medicine sought to determine the factors associated with recurrent firearm injury among children who presented with a first nonfatal firearm injury (index injury) at one of four St. Louis adult or pediatric Level I trauma hospitals between 2010 and 2019. Data were collected from the St. Louis Region-Wide Hospital-Based Violence Intervention Program Data Repository (STL-HVIP-DR), a comprehensive repository developed by the study authors tracking patient care across multiple hospitals. The STL-HVIP-DR incorporated data on patient demographics, hospital and diagnostic information, health insurance status, and mortality. The Social Vulnerability Index was used to characterize the social vulnerability of the census tracts of patients’ residences.  Data were linked to the National Death Index to identify recurrent firearm injuries that resulted in death in the prehospital setting (i.e., patients who would not be captured in the STL-HVIP-DR).

The researchers found that during the 10-year study period, 1,340 children had a firearm injury. Most of those patients were black, non-Hispanic males between the ages of 15 and 17 years. 179 (13%) of index firearm injuries occurred in children under the age of 10 years. The estimated risk for firearm reinjury was 6% at 1 year and 14% at 5 years after the first injury, with male children and those being seen at adult hospitals at the highest risk for reinjury. These findings highlight the high cumulative incidence of children experiencing recurrent firearm injury in St. Louis and identifies racial and social vulnerabilities that increase that risk. According to the study authors, this data can inform secondary prevention efforts, such as hospital-based violence intervention programs, which can be tailored to the needs of children at greatest risk.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org.  To speak with corresponding author Kristen Mueller, MD, please e-mail Kristen.Mueller@wustl.edu. 

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3. Improved prognostic model incorporates HBV viral load data to accurately predict liver cancer risk

Abstract: https://www.acpjournals.org/doi/10.7326/M24-0384

Editorial: https://www.acpjournals.org/doi/10.7326/M24-0894 

URL goes live when the embargo lifts       

A new risk prediction model, the Revised REACH-B, demonstrated superior accuracy and reliability in predicting hepatocellular carcinoma, or liver cancer, risk compared to a previous model, offering improved risk stratification for patients. According to researchers, this tool could enable clinicians to better predict and assess liver cancer risk in non-cirrhotic patients with chronic hepatitis B (CHB) virus who do not meet current criteria for antiviral treatment. The study is published in Annals of Internal Medicine.

A multinational cohort study of more than 14,000 treatment-naive, non-cirrhotic adult patients with chronic hepatitis B (HBV) infection revealed a significant non-linear correlation between baseline hepatitis B (HBV) viral load and the risk for developing liver cancer. Notably, patients with a moderate viral load of approximately 6 log₁₀ IU/mL had the highest HCC risk. Researchers from Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea developed and externally validated a new risk prediction model using key patient characteristics such as age, gender, platelet count, ALT levels, and HBeAg positivity. They found that the model demonstrated superior accuracy and reliability in predicting HCC risk compared to the previous REACH-B model. Notably, patients with a moderate viral load of approximately 6 log10 IU/mL were confirmed to have the highest HCC risk. In comparison to patients with a low viral load (≤3 log10 IU/mL), those with a moderate viral load faced an 8.4-fold increase in liver cancer risk within the validation cohort. According to the authors, this study highlights the importance of revisiting treatment guidelines, as those with moderate viral loads may benefit from proactive management to reduce liver cancer risk.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Young-Suk Lim, MD, PhD, please email limys@amc.seoul.kr.  

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