Durability of bioprosthetic aortic valves in patients under the age of 60 years - Rationale and design of the international INDURE registry

Background: There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. Methods: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20-22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life. Discussion: INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years. Trial registration: ClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018)

Uncovering the treatable burden of severe aortic stenosis in the UK

Objective: To estimate the population prevalence and treatable burden of severe aortic stenosis (AS) in the UK. Methods: We adapted a contemporary model of the population profile of symptomatic and asymptomatic severe AS in Europe and North America to estimate the number of people aged ≥55 years in the UK who might benefit from surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). Results: With a point prevalence of 1.48%, we estimate that 291 448 men and women aged ≥55 years in the UK had severe AS in 2019. Of these, 68.3% (199 059, 95% CI 1 77 201 to 221 355 people) would have been symptomatic and, therefore, more readily treated according to their surgical risk profile; the remaining 31.7% of cases (92 389, 95% CI 70 093 to 144 247) being asymptomatic. Based on historical patterns of intervention, 58.4% (116 251, 95% CI 106 895 to 1 25 606) of the 199 059 symptomatic cases would qualify for SAVR, with 7208 (95% CI 7091 to 7234) being assessed as being in a high, preoperative surgical risk category. Among the remaining 41.6% (82 809, 95% CI 73 453 to 92 164) of cases potentially unsuitable for SAVR, an estimated 61.7% (51 093, 95% CI 34 780 to 67 655) might be suitable for TAVI. We estimate that 172 859 out of 291 448 prevalent cases of severe AS (59.3%) will subsequently die within 5 years without proactive management. Conclusions: These data suggest a high burden of severe AS in the UK requiring surgical or transcatheter intervention that challenges the ongoing capacity of the National Health Service to meet the needs of those affected

Durability of bioprosthetic aortic valves in patients under the age of 60 years - Rationale and design of the international INDURE registry

Background: There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. Methods: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INS

Single aortic cross-clamp technique in coronary surgery: a prospective randomized study

OBJECTIVE: To test the hypothesis of an improved myocardial and cerebral protection by combining blood cardioplegia and the single aortic cross-clamp technique, 100 patients were enrolled in a prospectively randomized study and stratified for preoperative conditions. METHODS: In Group I, 55 patients underwent myocardial revascularization using crystalloid cardioplegia and the conventional partial occluding clamp technique to perform proximal anastomoses, whereas in Group II, 45 patients were operated on combining blood cardioplegia and the single aortic cross-clamp technique. Unstable angina, emergency procedures, reoperations and preoperative counterpulsation accounted for an higher risk score in group II patients (P < 0.03). Operations were performed by the same surgical team. Aortic cross-clamp time was significantly longer in group II patients (59 +/- 22 vs. 47 +/- 18 min.) (P < 0.001). Other intraoperative variables were not significant. RESULTS: A 70-year-old male in group I died on post-operative day 5 as a consequence of a major neurological event. Length of ventilatory dependency, post-operative bleeding, need for blood transfusions, ICU stay, and hospital stay were similar between the two groups (P = NS). Patients in group I showed a strict correlation between the duration of surgical ischemia and post-operative myocardial necrosis. Analysis of combined mortality and morbidity events (adverse events) between the two groups, led to a significant prevalence in group I patients (P < 0.03) in spite of an higher pre-operative risk score and longer ischemic times in group II patients. Neurological lesions remained confined to group I patients. CONCLUSIONS: The combined use of blood cardioplegia, delivered via the antegrade and retrograde routes, and the single-clamp technique to perform myocardial revascularization, might enhance myocardial and cerebral protection when compared to conventional methods. Larger groups of patients are needed to support this trend