Benign Intravalvular Strut Leak After Placement of the Inspiris Resilia Valve.

OBJECTIVES: To investigate the incidence of intravalvular leak after aortic valve replacement with the Inspiris Resilia valve. DESIGN: This study was a retrospective chart review. SETTING: This study used data from a single tertiary care academic center. PARTICIPANTS: A total of 81 patient charts and echo images were reviewed. INTERVENTIONS: All patients underwent an aortic valve replacement using the Inspiris Resilia valve. Pediatric patients and patients receiving an aortic valve conduit were excluded. MEASUREMENTS AND MAIN RESULTS: Transesophageal echocardiography (TEE) images were reviewed independently by 2 echocardiographers for the incidence and severity of intravalvular leak after Inspiris Resilia valve placement. Outpatient follow-up imaging was then compared to intraoperative findings. Valve size and mean gradients were documented as well. Of the 81 TEEs that were reviewed, 56 (69.1%) were found to have a strut leak at the time of implantation. Among these 56 cases, 30 were classified as trace regurgitation, 21 as mild regurgitation, and 5 as moderate regurgitation. Only 1 case necessitated a return to cardiopulmonary bypass owing to persistent intravalvular leak. Follow-up transthoracic echocardiography reports were available for 50 of the patients with no persistent leaks. CONCLUSIONS: This pattern of intravalvular leak is unique to the Inspiris Resilia valve and is commonly found in the intraoperative period. While many hypotheses exist for the origin of this leak, the exact mechanism is unclear. Given the high frequency of this postprocedure finding, it is essential that intraoperative echocardiographers be able to distinguish this clinically insignificant leak based on its origin, severity, and direction and to provide appropriate recommendations to our surgical colleagues.

Early and mid-term outcomes after aortic valve replacement using a novel tissue bioprosthesis: a systematic review.

OBJECTIVES: While current data show a clear trend towards the use of bioprosthetic valves during aortic valve replacement (AVR), durability of bioprosthetic valves remains the most important concern. We conducted a 1st systematic review of all available evidence that analysed early and mid-term outcomes after AVR using the Inspiris RESILIA™ bioprosthesis. METHODS: A systematic literature search was performed to identify all relevant studies evaluating early and mid-term outcomes after AVR using the Inspiris RESILIA bioprosthesis and including at least 20 patients with no restriction on the publication date. Subgroup meta-analysis was performed to compare Inspiris RESILIA and PERIMOUNT Magna Ease bioprosthesis and to pool the early postoperative mortality and stroke rates. RESULTS: A total of 416 studies were identified, of which 15 studies met the eligibility criteria. The studies included a total of 3202 patients with an average follow-up of up to 5.3 years. The average age of patients across the studies was 52.2-75.1 years. Isolated AVR was performed in 39.0-86.4% of patients. In-hospital or 30-day postoperative mortality was 0-2.8%. At the mid-term follow-up, freedom from all-cause mortality was up to 85.4%. Among studies with mid-term follow-up, trace/mild paravalvular leak was detected in 0-3.0%, while major paravalvular leak was found only in up to 2.0% of patients. No statistically significant differences in terms of mortality (P = 0.98, odds ratio 1.02, 95% confidence interval 0.36-2.83) and stroke (P = 0.98, odds ratio 1.01, 95% confidence interval 0.38-2.73) between the Inspiris RESILIA bioprosthesis and PERIMOUNT Magna Ease bioprosthesis were observed in the subgroup meta-analysis. CONCLUSIONS: Mid-term data on the safety and haemodynamic performance of the novel aortic bioprosthesis are encouraging. Further comparative studies with other bioprostheses and longer follow-up are still required to endorse durability and safety of the novel bioprosthesis.

Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease.

OBJECTIVES: The INSPIRIS aortic valve combines the RESILIA proprietary tissue preservation process and an expandable stent frame to benefit future transcatheter valve-in-valve procedures. As the INSPIRIS valve became commercially available in 2017, mid-term outcome reports are scarce. We aimed to evaluate mid-term safety and echocardiographic performance of the INSPIRIS valve in comparison to its predecessor, the Carpentier Edwards Perimount Magna Ease (ME). METHODS: This study was a retrospective single-centre study. Clinical results included early postoperative outcomes, mid-term mortality and readmission for cardiovascular cause or stroke. Echocardiographic follow-up (FU) was performed at discharge and 1-3, 6, 12 and 24 months. Clinical end point analyses were accomplished with a propensity score matching analysis and FU echocardiographic data comparisons using pairwise analyses and linear mixed-effect models. RESULTS: We included 953 patients who received an INSPIRIS (n = 488) or ME (n = 463) bioprosthesis between January 2018 and July 2021. In the matched population (n = 217 per group), no significant difference in short-term outcomes was observed, survival was similar at 30 months (INSPIRIS: 94% vs ME: 91%, P = 0.89), but freedom from readmission was higher in the INSPIRIS group (94% vs 86%, P = 0.014). INSPIRIS valves had a lower gradient at discharge (∼10 vs 14 mmHg, P < 0.001), 1-3 months (∼10 vs 12 mmHg, P < 0.001) and 24 months (∼11 vs 17 mmHg, P < 0.001) in paired analyses and significantly lower evolution of mean transvalvular gradients compared to ME. CONCLUSIONS: This study represents the largest comparative evaluation of the INSPIRIS to the ME valves, which demonstrated safe clinical outcomes and favourable haemodynamic performance at 2 years. Long-term FU is underway.

Structural hemodynamic valve deterioration durability of RESILIA-tissue versus contemporary aortic bioprostheses.

Aim: Durability of aortic valve replacement is becoming increasingly important. Aortic bioprostheses with RESILIA tissue have demonstrated outstanding outcomes thus far, but only in single-arm studies. Methods: We compared structural valve deterioration (SVD)-related hemodynamic valve deterioration (HVD) of grade ≥2 of RESILIA tissue valves from the COMMENCE trial (n = 689) to those from the PARTNER 2A contemporary AVR arm (n = 936) based upon annual core laboratory echocardiograms through 5 years of follow-up. Results: SVD-related HVD in the COMMENCE and PARTNER 2A cohorts were 1.8 versus 3.5%, respectively (one-sided 95% lower-bound hazard ratio of 0.92; p = 0.07). In propensity-matched cohorts (n = 239), these outcomes were 1.0 versus 4.8%, respectively (one-sided 95% lower-bound hazard ratio of 1.15; p = 0.03). Conclusion: RESILIA tissue-based AVR exhibited reduced SVD-related HVD compared with a contemporary AVR cohort devoid of RESILIA tissue.

Clinical performance of a novel bioprosthetic surgical aortic valve in a German high-volume center.

BACKGROUND AND AIM: Bioprosthetic surgical aortic valve replacement (SAVR) is increasingly adopted in younger patients. We aimed to analyze mid-term follow-up data after SAVR to assess the performance of the prosthesis. METHODS: Data were collected from a single-center series of 154 patients, who underwent SAVR with a bioprosthetic heart valve with the RESILIA tissue at our Heart Centre in Siegburg. All procedural and midterm patient outcomes were documented. RESULTS: Patients had a mean age of 56.8 ± 9.9 years, 35.7% were female, and the mean logistic European system for cardiac operative risk evaluation (EuroSCORE) was 3.4 ± 3.6%. Diabetes (12.3%), atrial fibrillation (10.4%), and chronic obstructive pulmonary disease (COPD) (5.8%) were common comorbidities. The mean surgery duration was 163.8 ± 73.4 min, with the 23 mm (34.4%) and 25 mm (33.8%) heart valves being most frequently implanted. At 3-year follow-up, mean pressure gradient was 13.9 ± 5.9 mmHg, peak gradient was 23.6 ± 7.7 mmHg, and effective orifice area (EOA) was 1.9 ± 0.4 cm². No patient died during the operation, 3 (2.1%) patients within 30 days, and 4 (2.7%) thereafter with an overall mortality of n = 7. Of the surviving patients, 97.8% were in New York Heart Association (NYHA) class I/II and none had structural valve deterioration (SVD). CONCLUSION: Results of our single-center study indicate favorable procedural outcomes. The safety outcomes confirm preliminary earlier results of this novel bioprosthesis but include more patients and a longer midterm follow-up.

The first report of transcatheter aortic valve-in-valve implantation within the expandable Inspiris Resilia® bioprosthetic valve.

A 61-year-old male who underwent aortic valve replacement with an Inspiris Resilia® aortic bioprosthetic through an upper partial sternotomy due to severe aortic valve stenosis was presented 1 year later to our hospital suffering from dyspnoea and chest pain. The transthoracic echocardiography demonstrated moderate haemodynamic structural valve deterioration with a mean gradient of 29 mmHg and a valve area of 0.9 cm2. Due to relatively high-risk of reoperation, valve-in-valve transcatheter aortic valve replacement with Sapien 3® 29 mm, followed by balloon valvuloplasty, was successfully performed. To the best of our knowledge, this is the first published case of valve-in-valve transcatheter aortic valve replacement into a degenerated Inspiris Resilia® aortic valve.

The effect of stent and decalcification on mitral annular motion after aortic valve replacement.

OBJECTIVE: The purpose of this study was to evaluate the changes in mitral annular motion after surgery in patients with aortic stenosis. METHODS: Patients receiving Edwards (Edwards) valves were included in the study. Echocardiographic findings were compared among the three treatments postoperatively, at discharge, and at 1 year after the surgery. Mitral annular motion was evaluated by e prime, using tissue doppler imaging. RESULTS: There were 111 patients receiving Inspiris, 30 patients receiving Intuity and 241 patients receiving Sapien 3. The patients receiving Sapien 3 were significantly older, (Inspiris: 71 ± 6.7 years vs. Intuity: 75 ± 5.2 years vs. Sapien 3: 84 ± 5.1 years, p < .001), and prevalence of hemodialysis were significantly higher in patients receiving Intuity (Inspiris: 11.7% vs. Intuity: 46.7% vs. Sapien 3: 0.0%, p < .001). There was a significant improvement in mean pressure gradient in all groups (Inspiris: 55 ± 21.2-13 ± 5.2 mmHg, p < .001; Intuity: 48 ± 17.6-12 ± 4.9 mmHg, p < .001, Sapien 3: 55 ± 16.6-14 ± 5.2 mmHg, p < .001). Decalcification was associated with increase in e prime after surgery (no decalcification: 0.10 ± 1.280 cm/s vs. decalcification: 0.68 ± 1.405 cm/s, p < .001) Further, existence of stent was associated with less increase in e prime after surgery (no stent: 0.83 ± 1.210 cm/s vs. stent: 0.10 ± 1.356; p < .001). Multivariate analysis showed that existence of stent but not decalcification of the aortic valve was independently associated with changes in e prime after surgery (ß: -.4679, 95% confidence interval: -0.93389 to -0.00200, p = .049). CONCLUSIONS: Although improvement in pressure gradient was achieved in all treatments, existence of stent inhibited mitral annular motion after surgery.

The First 100 Cases of Two Innovations Combined: Video-Assisted Minimally Invasive Aortic Valve Replacement Through Right Anterior Mini-Thoracotomy Using a Novel Aortic Prosthesis.

INTRODUCTION: Aortic valve replacement (AVR) via right anterior mini-thoracotomy (RAMT) is less traumatic than via other surgical routes; using a novel aortic valve may confer long-term resistance against valve deterioration, and thus be useful in younger, more active patients. Here we aim to validate using the INSPIRIS RESILIA valve with minimally invasive RAMT. METHODS: Between April 2017 and June 2019, 100 patients underwent video-assisted minimally invasive AVR by RAMT, using the INSPIRIS RESILIA aortic valve. Cannulation for cardiopulmonary bypass (CPB) was through femoral vessels. Clinical data were prospectively entered into our institutional database. RESULTS: Cardiopulmonary bypass (CPB) and cross-clamping times were 79 ± 38 and 41 ± 17 min. Surgical access was successful in 100% of cases. There were no cases of intraoperative mortality, 30-day mortality, cerebrovascular events, rethoracotomy for bleeding, valve-related reoperation, right internal mammary artery injury, or conversion to sternotomy. Intensive care and hospital stays were 2 ± 1 and 6 ± 3 days, respectively. One patient had a pacemaker fitted. Postoperative dialysis was necessary in one patient. Trace to mild aortic valve regurgitation occurred in two patients. No structural valve deterioration (SVD) and paravalvular leak were seen. At 1-year follow-up mean effective orifice area (EOA) was 1.8 ± 0.1 cm2, peak gradient was 22.1 ± 3.1 mmHg, and mean gradient was 11.5 ± 2.3 mmHg. CONCLUSION: Our preliminary experience suggests that RAMT for AVR using the INSPIRIS RESILIA aortic valve is safe, effective, and reproducible. Larger studies are needed to evaluate the long-term efficacy and durability of this new valve.

Early results of the Resilia Inspiris aortic valve in the old age patients - a retrospective comparison with the Carpentier Edwards Magna Ease.

Introduction: The Inspiris Resilia aortic valve® (INSPIRIS) is a pericardial bio-prosthesis with a new sterilization procedure that shows promising results in terms of reduced calcification. Methods: The 30-day mortality and morbidity were analyzed, comparing the INSPIRIS implanted between May 2017 and the end of January 2019, with its "predecessor", the Carpentier-Edwards Perimound Magna Ease (ME). Echocardiography was performed one-week after surgery. 125consecutively operated patients were included (59 INSPIRIS, 66 ME). Results: One patient in the ME group died and one patient in the INSPIRIS group had a complicated postoperative course due to right heart failure. Two patients (one INSPIRIS, one ME patient) suffered a perioperative stroke. The hemodynamic evaluation shows an effective reduction of mean transvalvular pressure gradients after surgery in both groups. INSPIRIS tended to have lower trans-prosthetic pressure gradients (9 mm Hg, Interquartile range [IQR] 11-7 mm Hg versus 12 mm Hg, IQR 15-9 mmHg; P = 0.001), reduced trans-prosthetic blood flow acceleration (209 cm/s, IQR 220-190 cm/s versus227 cm/s, IQR 263-191 cm/s; P = 0.003) and increased permeability indices (57%, IQR 67%- 47% versus42%, IQR 48%-38%; P8%; P < 0.001). Conclusion: There are only few clinical data available from INSPIRIS, and the present analysis confirms good results initial postoperatively with a tendency towards possibly improved hemodynamics compared to ME.

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).