The webpage "Mechanical Heart Valves" from Abbott (n.d.-e) introduces the Masters HP 15mm Mitral Mechanical Heart Valves, it is the only mechanical heart valve in the world designed to treat paediatric patients, (Abbott, n.d.-e). The Masters HP 15mm valve is considered the gold standard, and it is the most trusted mechanical heart valve in the world. According to Abbott (n.d.-e), the valve has successfully treated over 3 million patients, which contribute to its low rate of long-term complications . One of its primary functions is to serve as an artificial valve, replacing damaged ones and regulating the normal flow of blood in and out of the heart (MyHealthAlberta, 2022). In terms of features, it boasts a bi-leaflet design that opens to an 85-degree angle during heart contractions. The valve minimises its carbon surface area to reduce thrombogenicity, presenting a low-valve implant height of 2.2mm and an overall height of 8.5mm. It utilises a controlled torque rotation mechanism for both rotation and intraoperative adjustments as outlined by Abbott (n.d.-c). Remarkably, with a diameter of just 15mm, it holds the distinction of the smallest valve in the world according to Abbott (n.d.-e). The Masters HP 15mm valve marks a substantial improvement over the Epic™ Plus Mitral stented tissue valve, owing to its compact size and exceptional durability. Tailored with paediatric patients in mind, it offers them a chance at a healthier life with fewer potential long-term complications.
Abbott (n.d.-c) highlights a significant advancement in reducing the diameter of the mechanical valve, which now measures a mere 15mm. Previously, the challenge in treating paediatric patients with smaller mitral valves stemmed from the incompatibility of larger valves with the size of children's hearts (Abbott, n.d.-c). The valve's minute size has enabled doctors to effectively treat paediatric patients with smaller mitral valves. In contrast, larger valves like the Epic™ Plus Mitral stented tissue valves, which Abbott mentions, typically range in size from 25-33mm (Abbott, n.d.-b). As discussed by (Panicker et al., 2021), the discrepancy between the larger mechanical valve and the smaller mitral annular size in children results in the reduced valve functionality and increased turbulence (Becsek et al., 2020). This consequently raises the likelihood of operative mortality (Elmahrouk et al., 2021). However, with the minute size of the Masters HP 15mm valve offered by Abbott, the risk of operative mortality has now been significantly reduced.
Another notable feature is the valve’s remarkable durability, guarding against possible calcification, a concern linked to the Epic™ Plus Mitral stented tissue valve (Abbott, n.d.-e). The Masters Series valves have demonstrated prolonged durability through experiences of over 3 million successful implants spanning multiple decades (Abbott, n.d.-d). This assures patients that they are unlikely to require further valve replacement procedures. Furthermore, the valve is specifically designed for paediatric patients, who often have a longer lifespan due to their age. For them, durability becomes a crucial consideration. This is where the Masters HP 15mm valve offers a significant advantage over tissue valves like the Epic™ Plus Mitral valve, which often wear out after 12 to 15 years according to Conte (2017).
The Masters HP 15mm valve requires lifelong anticoagulation therapy to prevent blood clots from forming on the valve’s metal surfaces, potentially increasing the risk of bleeding (U.S. Food & Drug Administration, 2018). Improper administration of blood thinners could result in blood clot formation, potentially leading to strokes or impairing the valves’ functionality, as emphasized by Conte (2017). Indeed, there is compelling evidence that the Masters HP 15mm offers paediatric patients a fresh start to a healthy life. Sadie Rutenberg (Abbott, n.d.-e), the initial recipient of the Masters HP 15mm valve, is now a healthy 3-year-old, demonstrating the valve's remarkable success in achieving lasting durability, inhibiting the chance of her needing another round of replacement. Additionally, the valve's low thrombogenicity minimizes clot formation, addressing lifelong anticoagulation therapy. Abbott's mechanical valves have shown fewer cases of thromboembolism, thrombosis, and bleeding, even at lower international normalized ratio levels (Abbott, n.d.-a). This underscores that the mechanical valve's benefits outweigh its drawbacks, signifying a notable advancement over other mechanical and tissue valves, such as the Epic™ Plus Mitral valve.
In summary, the Masters HP 15mm valve, with its minute size and remarkable durability, signifies a ground-breaking stride in addressing mitral regurgitation in paediatric patients. It surpasses the precision and longevity previously attainable with the Epic™ Plus Mitral stented tissue valve. By leveraging these extraordinary attributes, the Masters HP 15mm valve emerges as a crucial instrument in the effective treatment of paediatric patients, granting them a new beginning with minimal potential long-term issues.
References
Abbott. (n.d.-a). Abbott Mechanical Heart Valves. https://gamida.co.il/medical/wp-content/uploads/sites/3/2022/01/9-EH-1-12392-01-06-2021_MHV-Brochure.pdf
Abbott. (n.d.-b). Epic™ Plus Mitral and Aortic. https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/surgical-valve-solutions/epic-tissue-valve.html
Abbott. (n.d.-c). FDA approves the world's smallest mechanical heart valve for pediatric patients with heart defects. https://abbott.mediaroom.com/2018-03-06-FDA-Approves-the-Worlds-Smallest-Mechanical-Heart-Valve-for-Pediatric-Patients-with-Heart-Defects
Abbott. (n.d.-d). Key Mitral MHV selection considerations: durability, size range, hemodynamics, and implantability. https://www.structuralheart.abbott/fileadmin/content/clinical-research/clinical-insights/46704_Global_Masters_Clinical_Insights.pdf
Abbott. (n.d.-e). Mechanical Heart Valves. https://www.structuralheart.abbott/int/products/mechanical-heart-valve/regent-valve-masters-series-mechanical-heart-valve#c2068
Becsek, B. E. M., Pietrasanta, L., & Obrist, D. (2020, September 29). Turbulent Systolic flow downstream of a Bioprosthetic aortic Valve: Velocity spectra, wall shear stresses, and turbulent dissipation rates. Frontiers in Physiology,
https://www.frontiersin.org/articles/10.3389/fphys.2020.577188/full
Conte, V. (2017, May 2). Deciding Between a Tissue and a Mechanical Valve.
https://ctsurgerypatients.org/deciding-between-a-tissue-and-a-mechanical-valve#:~:text=Age%20is%20one%20of%20the,patient%20survival%20are%20both%20unpredictable
Elmahrouk, A. F., Mashali, M. H., Ismail, M., Arafat, A. A., Alamri, R., Baho, H., Shihata, M., & Jamjoom, A. (2021, July 27). Mitral valve replacement in infants and younger children. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8316334/
MyHealthAlberta (2022, September 7). Learning About Life With a Mechanical Heart Valve. https://myhealth.alberta.ca/Health/aftercareinformation/pages/conditions.aspx?hwid=abk2194
U.S. FOOD & DRUG ADMINISTRATION. (2018, March 6). FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world. https://www.fda.gov/news-events/press-announcements/fda-expands-approval-replacement-heart-valve-smallest-mechanical-valve-size-approved-world
Panicker, V. T., Sreekantan, R., & Lokanath, N. (2021, July 9). Preoperative mitral annulus size – Can we get it right? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8404588/
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