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Cerebral Embolic Protection – A Next Generation Approach for Contemporary TAVR Practice

Protembis are proud to have sponsored a satellite symposium at TCT 2024. In doing so, they brought together world-renowned Co-chairs, with expert speakers and panelists to debate some of the contemporary hot topics related to cerebral protection in TAVR.
Washington DC,
United States
Highlights from the Protembis at TCT

Co-Chairs
Professor Roxana Mehran MD FACC, FACP, FCCP, FESC, FAHA, FSCAI is an interventional cardiologist and a prominent figure in cardiovascular research. She is a Professor of Medicine, Cardiology, and Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, New York

Professor Samir Kapadia MD is a distinguished interventional cardiologist and the Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic. He is also a Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University

Panelists
Prof. Dr.  Nicolas Van Mieghem, MD PhD,
Head of interventional cardiology at the Thorax Center, Rotterdam, Netherlands

PD Dr. Matti Adam, MD
Senior interventional cardiologist at the University Hospital, Cologne, Germany

 

The symposium in detail

Contemporary Perspectives on Cerebral Injury in TAVR

Watch Dr Dwyer give a summary of the consequences of cerebral lesions for patient outcomes. In this presentation he presents the concepts of diaschisis, and the floor effect of lesion baseline burden. He also touches on the relevance and size of the cerebrovascular territories supplied by the arteries arising from the aorta.

Michael G. Dwyer, PhD.
Director of IT and Neuroinformatics Development at the Buffalo Neuroimaging Analysis Centre (BNAC), and Assistant Professor of Neurology and Biomedical Engineering at the University at Buffalo, New York.

Importance of DW-MRI in Cerebral Embolic Protection Trials

Watch Professor Lansky as she presents the recent clinical data from her 2024 landmark publication: “The Clinical Significance of Diffusion-Weighted Brain MRI Lesions After TAVR: Results of a Patient-Level  Pooled Analysis”*. She draws conclusions on the importance that DW-MRI now holds as a surrogate for clinical stroke and discusses whether DW-MRI should become the gold standard efficacy endpoint for pivotal CEP IDE trials.

*Lansky et al. JACC: VOL.84, NO. 8, 202

Alexandra J. Lansky, MD, FACC, FAHA, FESC. Professor of Medicine, Yale University, New Haven, CT
Professor of Medicine in the section of Cardiology at the Yale School of Medicine. Practicing cardiologist at Yale-New Haven Hospital, in New Haven, CT. Director of the Yale Heart and Vascular Clinical Research Program and the Cardiovascular Research Centre

Cerebral Embolic Protection Technology Landscape and Study Designs

Watch Dr Williams give a presentation on the landscape of the new portfolio of CEP devices that are being evaluated. He gives an overview of the current clinical endpoints being assessed, and the range of statistical approaches seen in the various study designs.

Mathew Williams, MD.
Co-Director, NYU Langone Heart. Chief of the Division of Adult Cardiac Surgery. Director of the CVI Structural Heart Disease Program.

The PROTEMBO IDE Study – Novel Endpoint Design

Watch Dr Saville give a structured presentation on the FDA approved landmark PROTEMBO IDE novel study design, including a description of the pre-specified interim analysis, and the Bayesian borrowing principle, which uniquely disconnects the analysis of the treatment effect from the patient number.

Ben Saville, PhD.
President and Lead Statistical Scientist of Adaptix Trials, LLC. World renowned specialist in the design of innovative Bayesian and adaptive clinical trials. With expertise in Bayesian hierarchical models and Bayesian adaptive platform trial designs.

ProtEmbo CPS – Key Procedural Considerations

Watch Dr Rovin as he introduces the ProtEmbo CPS. He meticulously shows the pre-planning, deployment, and retrieval steps with actual case examples in an educational format. He demonstrates how the ProtEmbo system can be integrated into the TAVR procedure with minimal disruption of workflow.

Joshua Rovin, MD FACS.
A founding member and Director of the Morton Plant Hospital (MPH) Valve Clinic. Director of Transcatheter and Aortic Therapies at MPH

ProtEmbo CPS – Case Presentation From the EU

Watch Dr Haussig as he takes us through a recent TAVR case performed with an 3S ULTRA system from Edwards Lifesciences.  He shows the importance of preplanning using routine CT scans and discusses the specific ProtEmbo case steps. In this excellent case he demonstrates that ProtEmbo protects the entire brain discretely, with no impact on the delivery of the TAVR system.

Stephan Haussig, MD PhD.
A senior consultant interventional cardiologist and Co-Director of the Structural Heart program at the Dresden Heart Centre. Also, the Global Co-Principal Investigator of the PROTEMBO IDE Trial

 

About TCT
Founded by Dr. Martin B. Leon, the Transcatheter Cardiovascular Therapeutics® (TCT®) conference is the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®) and the world’s foremost educational forum specializing in interventional cardiovascular medicine. Debuting as a small gathering of 150 in 1988, TCT® now attracts thousands of attendees from around the world. Every year, TCT® features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research. The end goal: improving the survival and quality of life of patients suffering from heart and vascular disease.

The program directors, in collaboration with 40+ world-renowned thought leaders, have designed a comprehensive program to foster engagement and interactive case-based learning with a diverse lineup of faculty in multiple disciplines.