pivotal results for the valiant navion stent graft system in the valiant evo global clinical trial

Abstract Objective The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic aneurysms. Herein, the 30-day primary safety and efficacy outcomes and secondary end points are presented. Methods The Valiant EVO global clinical trial is a prospective, nonrandomized, single-arm trial. Patient enrollment occurred from April 2016 to October 2017. The primary end point was defined as access and/or deployment failure and/or a major device effect (MDE), including device-related secondary procedures, device-related mortality, conversion to open surgery, or thoracic aortic aneurysm rupture within 30 days of the index procedure. Other measures of stent graft performance including procedural data, rates of secondary procedures, and frequency of endoleaks are also reported. Results Of the 87 consecutive patients undergoing thoracic endovascular aneurysm repair who were enrolled, 33 (37.9%) were female with 61 (70.9%) presenting with severe access artery tortuosity and 66 (85.7%) with high thoracic aortic tortuosity per core laboratory evaluation. The mean procedure duration was 88.7 ± 53.4 minutes and geographical differences existed such as percutaneous access (37/52 [71.2%]) in the United States and surgical cut down in the outside of the U.S. sites (28/35 [80.0%]). There were no access or deployment failures and only 2.3% of the patients (2/87; P Conclusions Access/deployment failures, MDEs, and endoleaks were rare in the first 30 days of the Valiant Evo clinical trial. The Valiant Navion thoracic stent graft system has shown encouraging 30-day results in this challenging cohort and trial patients will continue to be followed through 5 years

Eighteen year clinical and echocardiographic follow-up of the freestyle scentless bioprosthesis

peer reviewe

Insights from the STICH trial: Change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction

ObjectiveThe present analysis of the Surgical Treatment for Ischemic Heart Failure randomized trial data examined the left ventricular volumes at baseline and 4 months after surgery to determine whether any magnitude of postoperative reduction in end-systolic volume affected survival after coronary artery bypass grafting alone compared with bypass grafting plus surgical ventricular reconstruction.MethodsOf the 1000 patients randomized, 555 underwent an operation and had a paired imaging assessment with the same modality at baseline and 4 months postoperatively. Of the remaining 455 patients, 424 either died before the 4-month study or did not have paired imaging tests and were excluded, and 21 were not considered because they had died before surgery or did not receive surgery.ResultsSurgical ventricular reconstruction resulted in improved survival compared with coronary artery bypass grafting alone when the postoperative end-systolic volume index was 70 mL/m2 or less. However, the opposite was true for patients achieving a postoperative volume index greater than 70 mL/m2. A reduction in the end-systolic volume index of 30% or more compared with baseline was an infrequent event in both treatment groups and did not produce a statistically significant survival benefit with ventricular reconstruction.ConclusionsIn patients undergoing coronary artery bypass grafting plus surgical ventricular reconstruction, a survival benefit was realized compared with bypass alone, with the achievement of a postoperative end-systolic volume index of 70 mL/m2 or less. Extensive ventricular remodeling at baseline might limit the ability of ventricular reconstruction to achieve a sufficient reduction in volume and clinical benefit

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry.

OBJECTIVES We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance, and quality of life (QoL) at 1 year were assessed. RESULTS 421 patients were documented with a mean age of 53.5 years, 76.5% being male, and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%), and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95%CI 97.1;99.6) and 81.8% were NYHA I vs. 21.9% at baseline. No patient developed structural valve deterioration Stage 3 (VARC-3). Mean aortic pressure gradient was 12.6 mmHg at 1 year and effective orifice area was 1.9 cm2. CONCLUSIONS The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICALTRIALS NUMBER NCT03666741

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