Sentinel dual-filter system to reduce stroke during Transcatheter Aortic Valve Replacement (TAVR or TAVI)

TAVI

In the realm of cardiovascular medicine, transcatheter aortic valve replacement (TAVR or TAVI) stands as a revolutionary procedure, offering renewed hope to individuals suffering from aortic valve stenosis. This minimally invasive intervention has transformed the landscape of cardiac care, providing an effective alternative for patients with respect to traditional open-heart surgery.

While the benefits outweigh the risks, undergoing TAVI still carries some potential complications such as stroke. In both open-heart surgical aortic valve replacement and TAVI, neurocognitive decline may occur. It is crucial to reduce stroke risk and preserve cognitive function for a better quality of life. Here at The Heart & Vascular Centre, we utilise the Sentinel dual-filter system – the SENTINEL cerebral protection system – during TAVI that has been shown to reduce the risk of disabling stroke during the procedure. We are privileged to have introduced the Sentinel cerebral protection system into Southeast Asia and to perform TAVI with cerebral protection.

What is TAVI and how is it performed?

TAVI is a cutting-edge procedure designed to treat aortic valve stenosis, a condition where narrowing of the aortic valve opening occurs. When this narrowing happens, blood flow to the rest of the body is affected, increasing the risks of heart failure, heart rhythm problems (arrhythmias), and sudden cardiac death.

TAVI typically involves:

  1. The insertion of a catheter through a blood vessel in the groin. 
  2. The doctor then navigates the catheter to the aortic valve in the heart, using X-ray for guidance.
  3. Once the catheter reaches the site of the diseased valve, a new valve is implanted, restoring normal blood flow.
  4. The catheter is removed once the new valve is securely in place.

How does the Sentinel dual-filter system work during TAVI?

Inadvertently, there is debris released during the TAVI procedure, which increases the risk for stroke. By using the SENTINEL cerebral protection system (Boston Scientific, Marlborough, MA, USA), which is a United States FDA-approved cerebral protection device for use during TAVI, the debris is filtered away, significantly reducing stroke risk. This Sentinel dual-filter system consists of two mesh filters made from polyurethane, each with tiny 140-nanometer pores, attached to a flexible metal frame. It is inserted through a small tube in the right wrist or arm and guided to the heart using a thin wire. One filter is placed in the innominate artery (supplies blood to the right arm, head, and neck), and the other in the left carotid artery (supplies blood to the left head and neck), covering 85%–90% of the brain’s blood flow. The first filter protects the right side of the brain, while the second filter protects the left side, reducing the amount of debris reaching the brain during TAVI. 

Proven effectiveness of the Sentinel dual-filter system during TAVI

In the Protect TAVR study published in the top medical journal, New England Journal of Medicine, TAVI with Sentinel CPS resulted in a reduced risk of major stroke as compared to TAVI without the Sentinel CPS. In our local peer-reviewed study (entitled “Clinical and neurocognitive outcomes after transcatheter aortic valve implantation (TAVI) with cerebral protection: initial experience with a novel dual-filter device in Southeast Asia”, that was published in the Singapore Medical Journal in 2022), we showed that the Sentinel filter device was successfully deployed in 95% of patients, achieving a 100% procedural success rate. Additionally, there were no filter-related complications, and no strokes or deaths occurred at 30 days. There was no significant change in overall cognitive function before and after the procedure.

Who should undergo TAVI?

TAVI is primarily recommended for individuals diagnosed with severe aortic valve stenosis who are elderly (≥80 years), and is an equal option to surgical valve replacement in patients between 65 to 79 years of age. In addition, most patients are also suitable for the Sentinel dual-filter system. Consultations are essential to determine the most suitable treatment approach for each patient.

Conclusion about TAVI and the Sentinel dual-filter system

The introduction of the Sentinel dual-filter system alongside TAVI marks a significant advancement in cardiovascular medicine. TAVI, with its minimally invasive approach and favourable outcomes, has revolutionised the treatment of aortic valve disease. The addition of the Sentinel dual-filter system during TAVI further enhances this procedure by significantly reducing the risk of major stroke and preserving cognitive function, thereby improving overall patient outcomes. As technology continues to evolve and clinical experience grows, the integration of such protective measures ensures that TAVI remains at the forefront of cardiac care, offering renewed hope and an improved quality of life for patients with severe aortic stenosis.

Contact us at The Heart & Vascular Centre to find out more about TAVI and discuss possibilities for yourself today.

References

  1. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. 2022. Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, Gooley R, Satler L, Stoler RC, Messé SR, Baron SJ, Seeger J, Kodali S, Krishnaswamy A, Thourani VH, Harrington K, Pocock S, Modolo R, Allocco DJ, Meredith IT, Linke A; PROTECTED TAVR Investigators. N Engl J Med. 387(14):1253-1263. doi: 10.1056/NEJMoa2204961.
  2. Clinical and neurocognitive outcomes after transcatheter aortic valve implantation (TAVI) with cerebral protection: initial experience with a novel dual-filter device in Southeast Asia. 2022. Chiam PTL, Chan NS, Lim YT, Lim CP, Nair D, Lim TT, Soon CY, Khoo BCH, Lim J, Tan KS, Lam L, Yan P, Ooi YW, Chong MS. Singapore Med J. 63(5):268-273. doi: 10.11622/smedj.2022030. Epub 2022 Feb 24.

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