INTUITY and INSPIRIS Aortic Valves

Aortic valve pathologies, including both stenosis and regurgitation, are among the most common valvular heart diseases. According to current guidelines, surgical aortic valve replacement (SAVR) remains the gold standard treatment for young, low-risk patients with these conditions. SAVR is a well-established procedure with continuous advancements in valve prosthesis design. In particular, biological prostheses offer a range of options, such as stented, stentless, sutureless, and rapid-deployment valves, allowing for patient-specific customization that enhances surgical efficiency and long-term durability. This project aimed to assess two next-generation valves: the Intuity and Inspiris Resilia valves. We compared the clinical and hemodynamic outcomes of the Intuity and Inspiris Resilia valves with the historically well-established Magna Ease valve. Data were collected from 2589 patients across two national multicenter registries and one institutional database. A propensity score weighting approach was employed to minimize confounding factors. Our analysis revealed that in isolated SAVR, aortic cross-clamp time was significantly shorter with the Intuity valve. Mortality rates were similar but permanent pacemaker implantation rates were notably lower with the Inspiris valve. Hemodynamic evaluation showed lower trans-prothesis gradients in Intuity and Inspiris group. We also investigated two critical issues: managing patients with a small aortic annulus and prosthesis-patient mismatch (PPM). In the small annulus study, we included patients undergoing isolated or combined SAVR with Magna Ease and Intuity valves (sizes 19 and 21) at our institution. After propensity score weighting, we analyzed 666 patients (367 Magna Ease and 299 Intuity). There were no significant differences in postoperative complications and also mid-term survival and re-hospitalization rates were similar. However, Intuity valves demonstrated significantly lower mean gradients overall and for size 21. In the PPM study, we analyzed 1323 patients who underwent SAVR, with complete hemodynamic data available for 872 at our insitutition. We evaluated both measured PPM (PPMm) and predicted PPM (PPMp), assessing sensitivity, specificity, and overall accuracy. We concluded that PPMp should be used cautiously when implanting small valves to avoid unexpected PPMm. Lastly, a detailed review of current European and American guidelines was conducted to assess the optimal treatment strategy (SAVR vs. TAVR) and the appropriate prosthesis for individual patients. We analyzed 1227 patients from 35 Italian centers, dividing them based on guideline recommendations. About 60% of the patients fell into a grey zone (65-80 years) according to American guidelines. Despite differing baseline characteristics, 30-day outcomes (mortality and stroke) were similar across groups. Finally, we concluded that despite variations in guideline recommendations, outcomes for SAVR patients were comparable across all groups, supporting the need for harmonized guidelines. In conclusion, this study confirms the excellent clinical and hemodynamic performance of both analyzed devices, the Intuity and Inspiris Resilia valves. The Intuity valve may be a more favorable choice in patients with smaller body size or during minimally invasive procedures, whereas the Inspiris Resilia valve could be preferred in younger patients with preoperative conduction disorders.