Database

During this session, investigators unveiled findings from the largest multicenter study of post-arterial switch operations (ASO) that resulted in increased survival rates for adolescents and adult patients – as well as an increase in the potential for these patients to require cardiac reoperations to address arterial switch related complications that arise later in life.

At day two's presentation on “Burden of Reoperative  Cardiac Surgery among Adolescents and Adults Who Have Undergone Prior Arterial Switch Operation: Society of Thoracic Surgeons Database Analysis,” Bret Mettler, MD, from Johns Hopkins University, examined a multi-year assessment of the prevalence and types of cardiac surgical interventions in patients who previously underwent ASO using data from the STS National Database. 

“Anatomical repair of transposition of the great arteries (TGA) and related anomalies by arterial switch operation (ASO) achieves a normal anatomic and physiologic cardiac configuration,” said Dr. Mettler.  “And as survival rates have increased, so have the potential for these patients to require cardiac reoperations to address resulting ASO-related complications.”

As most reoperations involved multiple procedures, the presentation examined how a hierarchical stratification of procedure categories was established, with each eligible surgical hospitalization assigned to the single highest applicable hierarchical category.
  
Dr. Mettler's presentation also examined implications for surgical counseling, post-operative clinical surveillance, and therapeutic management. An analysis of the role of procedural prevalence, timing, categories, trends, and the growing number of reoperations was discussed.

Shortly after the 60th STS Annual Meeting began, a packed crowd attended the "Trends and Research from the STS Adult Cardiac Surgery Database (ACSD)" session, beginning with a presentation by Michael E. Bowdish, MD, of the Smid Heart Institute, Cedars-Sinai Medical Center. He looked back at the origins of the ACSD, which was established in 1989 to collect information on cardiac surgery procedures, track outcomes, and provide insights into opportunities for quality improvement. 

Today – more than three decades later – the Database offers more than nine million recorded procedures making it one of the most comprehensive, robust, and sophisticated contemporary clinical databases in use.   

For example, 95% of centers performing coronary artery bypass grafting (CABG) in the United States, and 97% of patients receiving CABG are included in the STS ACSD. Every year 10% of the participating sites undergo a data audit assessing data accuracy and completeness with strict thresholds to pass quality control. Continuous education of data managers is a further element to ensure data quality. 

"STS ACSD is a vital source of data for outcomes research quality improvement, with overall volumes that are stable with notable trends in aortic surgery," said Dr. Bowdish.

The STS ACSD has provided the foundation for national benchmarking in adult cardiac surgery through the development of regularly updated and recalibrated risk models and performance metrics, the availability of feedback reports to database participants and individual surgeons, quality-improvement efforts, voluntary public reporting, and comparative effectiveness research. 

On day one of STS 2024, meeting goers attended numerous sessions that explored the growing debate between SAVR and TAVR as treatment options,

"Improved Longitudinal Outcomes with Surgical Aortic Valve Replacement with Atrial Fibrillation Management over Transcatheter Aortic Valve Replacement Alone," part of the larger "Bring SAVR Back" session given by J Hunter Mehaffey, MD, unveiled Class I guideline recommendations that support atrial fibrillation (AF) treatment during surgical aortic valve replacement (SAVR). And how recently, many low to intermediate risk patients with AF and aortic stenosis (AS) are managed by transcatheter aortic valve replacement (TAVR). And finally, they evaluated real-world longitudinal outcomes of TAVR vs SAVR with or without AF treatment. 

"We concluded that in Medicare beneficiaries with AF who required aortic valve replacement, SAVR with concomitant treatment of AF was associated with improved longitudinal survival and freedom from stroke compared to TAVR," noted Dr. Mehaffey. "Consideration should be given for SAVR with AF treatment as a first-line approach for patients with AF requiring aortic valve replacement." 

In his discussion of "Robotic Aortic Valve Replacement versus Transcatheter Aortic Valve Replacement: A Propensity Matched Analysis," Vikrant Jagadeesan, MD, presented findings on contemporary data that supports equipoise between surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) for the management of symptomatic severe aortic stenosis (AS). He further explained that controversy exists around the optimal management of patients in low to intermediate risk categories, and how the study compared outcomes of surgical robotic aortic valve replacement (RAVR) to TAVR. 

"Compared to TAVR, RAVR was associated with lower stroke and PPM rates, less PVL, and improved 1 year survival," said Dr. Jagadeesan. "And RAVR may provide a safe and effective minimally invasive first-line alternative for low to intermediate risk patients presenting with symptomatic AS."

In a late breaking session titled, "Cardiac Surgery after Transcatheter Aortic Valve Replacement: Trends and Outcomes," Michael Bowdish, MD, illustrated how his research team set out to document trends and outcomes in cardiac surgery following transcatheter aortic valve replacement (TAVR), a topic gaining importance as reports of subsequent cardiac operations and early TAVR explantations increase. Using the Society of Thoracic Surgeons Adult Cardiac Surgery Database, the study covers adult patients who underwent cardiac surgery after an initial TAVR from January 2012 to March 2023. 

"The study findings underscore the escalating need for both aortic and non-aortic valve cardiac surgeries following TAVR," explained Dr. Bowdish. "They note a substantial increase in the frequency of these surgeries, emphasizing the importance of understanding outcomes."  He observed elevated risk in these cases, as indicated by mortality and stroke rates, which calls for careful consideration, particularly given the expanding use of TAVR across a broader range of age and risk profiles. Finally, the study suggests the need for ongoing assessment and longitudinal evidence to inform decision-making in the evolving landscape of TAVR applications. 

On Saturday, January 27 at 9:45 a.m. CT, Christopher Mehta, MD, from Northwestern Memorial Hospital in Chicago, will present “Age-Stratified Surgical Aortic Valve Replacement for Aortic Stenosis: An Analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database (ACSD).” 

The study is part of the STS 2024 session titled, “Trends and Research from the STS ACSD.” During his talk, Dr. Mehta will provide insight into how comprehensive data help inform multidisciplinary heart teams in making decisions between surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) for patients. 

Attendees will learn how the national landscape for SAVR and TAVR changed between 2011 and 2022, as experts evaluated age-specific trends and outcomes in surgical aortic valve replacement (AVR) in patients with bicuspid (BAV) or tricuspid (TAV) aortic valve by analyzing data from the STS ACSD. 

Throughout the 11-year study, which followed more than 200,000 adult patients with BAV or TAV who underwent AVR for moderate and severe aortic stenosis, age-specific trends and outcomes were evaluated. 

On behalf of STS’s 7,600 member surgeons and their clinician partners, Thomas MacGillivray, MD, president of The Society of Thoracic Surgeons, testified before the US House of Representatives Committee on Energy and Commerce, Subcommittee on Health, about Medicare coverage pathways for innovative drugs, medical devices, and technology that saves lives.

In his statement, Dr. MacGillivray highlighted how the STS’s National Database provides a true clinical benchmark and contains data on more than 9.4 million cardiothoracic surgeries performed by more than 4,300 surgeons. The Database is a powerful quality improvement tool that facilitates increased patient access to break-through technology. He explained the value of real-world evidence and using data to monitor new technology and expand indications for new therapies.  And he underscored that through big data, cardiothoracic surgeons across the country and around the world can work together to find solutions and transform patient care.

Dr. MacGillivray’s key talking points:

• The STS National Database is the gold standard for clinical registries.
• The Database allows hospitals and cardiothoracic surgeons to identify best practices and potential gaps, and evaluate their performance against national and regional competitors. The Database is updated continuously and participants can monitor their progress and make critical decisions daily.
• Without ongoing evidence collection in the real-world setting coupled with access to longitudinal claims data, the efficacy and appropriateness of emerging innovative technologies is uncertain, impairing physicians’ ability to make the best decisions for our patients.
• The STS believes it is essential that any reforms to coverage for emerging therapies:
  • Prioritize the collection of real-world data, particularly for new, innovative medical devices.  Data collection creates opportunities to fill post-market evidence gaps and better define patient benefits and risks.
  • Permit early discussions and coordination between the agency and relevant stakeholders to allow sufficient time for the appropriate application, design, and implementation of any CED requirements.
  • Provide flexibility for data collection mechanisms to adjust based on new developments in the evidence.
  • Registries need timely, cost-effective, and continuous access to Medicare claims data to perform longitudinal studies.    
  • Dr. MacGillivray urged Congress to advance reforms such as the H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act of 2021, from Reps. Larry Bucshon, MD, and Kim Schrier, MD, which would require that enhanced access to Medicare claims data be provided to clinician-led registries, such as the STS National Database.

Watch Dr. MacGillivray's testimony.