A patient-specific algorithm to achieve commissural alignment with Acurate Neo: The sextant technique.

AIMS: The aim of this proof-of-concept study was to investigate safety and efficacy of a CT-scan based patient-specific algorithm to maximize coronary clearance and secondarily to achieve anatomically correct commissural alignment with the Acurate Neo device. METHOD AND RESULTS: A total of 45 consecutive patients undergoing TAVR with the Acurate Neo THV were prospectively enrolled in the study. Mean age was 81.6 ± 5.5 years, mean STS score was 6.1 ± 3.7. Device success rate was 100%. Aim of the technique was to rotationally deploy the TAVR device with a commissure lying on the bisector between the coronary ostia as calculated on the pre-procedural CT-scan. At post-TAVR CT-scan, coronary clearance was achieved in 98% of patients with no cases of severe coronary artery overlap. In 42 out of 45 patients, THV was aligned or, at most, mildly misaligned; there were 2 cases of moderate misalignment without any case of severe misalignment. Post-TAVR selective coronary artery engagement was attempted and succeeded in all patients (100%). CONCLUSION: Our CT-scan based patient-specific algorithm is safe and proven to be effective in avoiding coronary artery overlap and providing commissural alignment with Acurate Neo in all treated patients.

Clinical considerations and challenges in TAV-in-TAV procedures.

Transcatheter aortic valve replacement (TAVR) has emerged as a viable treatment for aortic valve disease, including low-risk patients. However, as TAVR usage increases, concerns about long-term durability and the potential for addition interventions have arisen. Transcatheter aortic valve (TAV)-in-TAV procedures have shown promise in selected patients in numerous registries, offering a less morbid alternative to TAVR explantation. In this review, the authors aimed to comprehensively review the experience surrounding TAV-in-TAV, summarize available data, discuss pre-procedural planning, highlight associated challenges, emphasize the importance of coronary obstruction assessment and provide insights into the future of this technique.

Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis.

BACKGROUND: Data on valve reintervention after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are limited. OBJECTIVES: The authors compared the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut TAVR vs SAVR. METHODS: Pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR vs SAVR, Evolut vs CoreValve, and Evolut vs SAVR. RESULTS: There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR vs SAVR (2.2% vs 1.5%; P = 0.017), with differences observed early (≤1 year; adjusted subdistribution HR: 3.50; 95% CI: 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR: 1.05; 95% CI: 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs 1.6%; P = 0.006) at 5 years with differences observed early (adjusted subdistribution HR: 0.30; 95% CI: 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR: 0.61; 95% CI: 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut vs SAVR (0.9% vs 1.5%; P = 0.41). CONCLUSIONS: A low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years. Reintervention occurred most often at ≤1 year for TAVR and >1 year for SAVR. Most early reinterventions were with the first-generation CoreValve and managed percutaneously. Reinterventions were more common following CoreValve TAVR compared with Evolut TAVR or SAVR.

Risk of Sinus Sequestration During Redo Transcatheter Aortic Valve Implantation: The Prevalence, Predictors, and Risk Stratification.

The number of patients who underwent transcatheter aortic valve implantation (TAVI) with the potential for reintervention is steadily increasing; however, there is a risk of sinus sequestration (SS) during a redo TAVI. The prevalence, predictors, and risk stratification of the risk for SS remain uncertain. We analyzed computed tomography acquired from 263 patients who underwent TAVI between 2021 and 2022: balloon-expandable valve (BEV) (71%) and self-expandable valve (SEV) (29%). Patients were considered at risk for SS if they met the following: (1) BEV frame > sinotubular junction (STJ) or SEV neocommissure greater than the STJ and (2) valve-to-STJ <2 mm. The risk of left, right, and any SS in 51%, 50%, and 65%, respectively, did not differ between BEV and SEV. The predictors of any SS were the height of the left and right coronary cusp (odds ratio [OR] 0.81 and 0.71, cutoff 18.6 and 19.2 mm, respectively) and STJ minus the annulus diameter (OR 0.65, cutoff 3.7 mm) in BEV, and STJ diameter (OR 0.47, cutoff 27.6 mm) in SEV. The number of predictors stratified the risk of any SS: low risk with BEV at 0 predictors (14% at risk of SS), intermediate risk at 1 predictor (65%), high risk at 2 or 3 predictors (81% and 95%), and low risk with SEV at 0 predictors (33%) versus high risk at 1 predictor (91%). In conclusion, 2/3 of patients who underwent TAVI were at risk of SS. The height of the coronary cusp and the STJ diameter were associated with and adequately stratified the risk of SS.

TAV-in-TAV in Failed Homograft: Redo TAVI in a Patient With 3 Previous Sternotomies.

A 59-year-old male patient with history of rheumatic heart disease with 3 previous surgical aortic valve replacements with the last one being homograft followed by transcatheter aortic valve implantation in failed homograft presented with severe aortic regurgitation and cardiogenic shock requiring urgent TAV-in-TAV-in homograft. (Level of Difficulty: Advanced.).

Risk of Coronary Occlusion Due to Sinus Sequestration by Redo Transcatheter Aortic Valve Implantation in Japanese Patients With SAPIEN 3.

Background: Transcatheter aortic valve (TAV)-in-TAV is an attractive treatment for degenerated TAV. The risk of coronary artery occlusion due to sequestration of the sinus of Valsalva (SOV) in TAV-in-TAV has been reported, but the risk in Japanese patients is unknown. This study aimed to investigate the proportion of Japanese patients who are expected to experience difficulty with the second TAV implantation (TAVI) and evaluate the possibility of reducing the risk of coronary artery occlusion. Methods and Results: Patients (n=308) with an implanted SAPIEN 3 were divided into 2 groups: a high-risk group, which included patients with a TAV-sinotubular junction (STJ) distance <2 mm and a risk plane above the STJ (n=121); and a low-risk group, which included all other patients (n=187). The preoperative SOV diameter, mean STJ diameter, and STJ height were significantly larger in the low-risk group (P<0.05). The cut-off value for predicting the risk of SOV sequestration due to TAV-in-TAV in the difference between the mean STJ diameter and area-derived annulus diameter was 3.0 mm (sensitivity 70%; specificity 68%; area under the curve 0.74). Conclusions: Japanese patients may have a higher risk for sinus sequestration caused by TAV-in-TAV. The risk of sinus sequestration should be assessed before the first TAVI in young patients who are likely to require TAV-in-TAV, and whether TAVI is the best aortic valve therapy must be carefully decided.

A Case of CABG in a Patient with High Risk of Coronary Obstruction during TAV-in-TAV.

A 94-year-old man who underwent transcatheter aortic valve (TAV) replacement 6 years ago was admitted because of exertional dyspnea. Transthoracic echocardiography revealed severe aortic regurgitation owing to TAV dysfunction. The patient was considered to have a high risk of occlusion of the sinus of Valsalva during TAV-in-TAV. Therefore, we performed TAV-in-TAV concomitant with coronary artery bypass grafting (CABG). The postoperative course was uneventful, and computed tomography 9 months later revealed patency of both the grafts. Concomitant CABG could be considered as one of the options in patients with a high risk of coronary occlusion during TAV-in-TAV.

Coronary access after repeat transcatheter aortic valve replacement in patients of small body size: A simulation study.

BACKGROUND: Coronary artery access after repeat transcatheter aortic valve replacement (TAV-in-TAV) is reportedly more difficult because leaflet displacement of the first transcatheter heart valve (THV) impairs coronary cannulation; however, its effects in small patients are unknown. This study aimed to simulate coronary accessibility after TAV-in-TAV in patients of small body size. METHODS: We retrospectively analyzed computed tomography scans after initial THV implantation and classified patients by THV and coronary artery location, valve-to-aorta distance, and valve-to-coronary distance. Risks were compared between the SAPIEN and CoreValve/Evolut series, among THV generations, and between bicuspid and tricuspid aortic valves in the CoreValve/Evolut series. RESULTS: A total of 254 patients (SAPIEN series, n = 164; CoreValve/Evolut series, n = 90) were enrolled. The average body surface area of the patients was 1.44 m2. Patients were classified as "feasible" (26%), "theoretically feasible with low risk" (19.7%), "theoretically feasible with high risk" (8.7%), or "unfeasible" (45.8%). The "unfeasible" rate was significantly higher in the CoreValve/Evolut series than in the SAPIEN series (78.9% vs 26.2%; P < .001). A significantly higher "unfeasible" rate was identified in the current model of SAPIEN (SAPIEN, 8.3%; SAPIENXT, 1.8%; SAPIEN3, 48.2%; P < .001), but not in the CoreValve/Evolut series (CoreValve, 83.3%; Evolut R, 80.0%; Evolut PRO, 71.4%; P = .587). Patients with a bicuspid aortic valve had a lower "unfeasible" rate compared to those with a tricuspid aortic valve (60.0% vs 86.2%; P = .014). CONCLUSIONS: Patients of small body size may have a high probability of "unfeasible" coronary access after TAV-in-TAV, especially when treated with current high-frame devices, suggesting the need for careful strategic planning for initial THV implantation.

The hemodynamics of transcatheter aortic valves in transcatheter aortic valves.

BACKGROUND: The durability of transcatheter aortic valves (TAVs) remains their greatest disadvantage, given that fixed tissue leaflets are not immune to structural degeneration from calcification and thrombosis. Therefore, a second intervention is necessary, especially given that TAV in low-risk patients has shown noninferior outcomes compared with surgery. This study aimed to assess the hemodynamic and turbulent properties of the flow downstream with different TAV-in-TAV configurations, to offer basic hemodynamic guidance for future interventions when currently implanted valves structurally degrade. METHODS: Six TAV-in-TAV configurations were chosen: 23 mm Evolut-in-26 mm Evolut, 23 mm Evolut-in-23 mm SAPIEN 3, 26 mm Evolut-in-26 mm Evolut, 26 mm Evolut-in-23 mm SAPIEN 3, 23 mm SAPIEN3-in-26 mm Evolut, and 23 mm SAPIEN3-in-23 mm SAPIEN 3. Their hemodynamic performance was assessed in a pulse duplicator for 100 cycles. High-speed imaging and particle image velocimetry were performed to assess turbulence. Effective orifice area (EOA), pinwheeling index (PI), and Reynolds shear stress (RSS) were evaluated. RESULTS: The largest mean EOA was obtained with 23 mm SAPIEN-in-26 mm Evolut (2.07 ± 0.06 cm2), and the smallest was obtained with 23 mm Evolut-in-23 mm SAPIEN (1.50 ± 0.04 cm2) (P < .001). The highest mean PI was obtained with SAPIEN-in-SAPIEN (26.5 ± 2.00%), and the lowest was obtained with 26 mm Evolut-in-26 mm Evolut (7.5 ± 1.6%) (P < .01). At peak systole, the least detrimental RSS range was obtained with 23 mm Evolut-in-26 mm Evolut (up to ∼340 Pa), and the most detrimental RSS range was obtained with 23 mm Evolut-in-SAPIEN (∼900 Pa) (P < .01). CONCLUSIONS: This study shows that best hemodynamic parameters are TAV-specific (implanted and to be implanted). In addition, it shows that RSS levels, which are indicative of turbulence levels and associated with blood damage, are 2- to 3-fold higher after TAV-in-TAV.

Study Protocol for Transcatheter Aortic Valve Replacement for a Degenerated Aortic Bioprosthesis in a Japanese Cohort.

Background: The valve-in-valve (VIV) procedure is being increasingly performed in high-risk patients with a degenerated bioprosthesis in an aortic position in Western countries. The early safety and efficacy of the VIV procedure, however, remain unclear in Japanese patients with a small aortic annulus. We present the protocol for a study designed to evaluate the early safety and efficacy of the VIV procedure in the aortic position in Japanese patients. Methods and Results: The prospective, single-center, non-comparative, clinical study of the VIV procedure for the aortic position (AORTIC VIV study) commenced in August 2016 and will end in March 2020. Patients will be monitored for ≥1 month after the VIV procedure. The targeted number of patients is 11. Eligible patients are those who have undergone transcatheter aortic valve replacement for a surgical valve (including stented or stentless bioprosthetic valves), or for a transcatheter heart valve. The VIV procedure is performed in high-operative-risk patients with substantial prosthetic valve stenosis, and regurgitation and heart failure resistant to medical treatment (unless the patient meets an exclusion criterion). The safety and efficacy of the VIV procedure will be evaluated in accordance with the Valve Academic Research Consortium-2 initiative. Conclusions: The AORTIC VIV study will clarify the early safety and efficacy of the VIV procedure in Japanese patients.

Early outcomes of transcatheter aortic valve implantation for degenerated aortic bioprostheses in Japanese patients: insights from the AORTIC VIV study.

OBJECTIVE: The valve-in-valve procedure, in which a transcatheter heart valve (THV) is implanted into a degenerated bioprosthetic valve, is standardized for high-risk patients. However, this procedure is challenging in Japanese patients who have a small aortic annulus. We investigated the feasibility, safety, and therapeutic efficacy of the valve-in-valve procedure involving a degenerated stented bioprosthesis, stentless bioprosthesis, or THV. METHODS: We performed a single-center, non-comparative study of the aortic valve-in-valve procedure (AORTIC VIV study). Beginning in October 2016, the aortic valve-in-valve procedure was performed in seven patients with a stented bioprosthesis, in three patients with a stentless bioprosthesis, and in one patient with a THV. RESULTS: No 30-day post-procedure mortality or severe morbidities occurred. The mean echocardiographic gradient in the aortic position improved from 41 (38-48) to 17 (11-22) mmHg at 30 days (p = 0.01). No paravalvular or mild and more transvalvular leaks were detected. The New York Heart Association functional class improved from 2 (2-2.5) to 1 (1-1) at 30 days postoperatively (p = 0.01). Although the procedure failed in two patients with an implanted stentless bioprosthesis, the third patient with a stentless bioprosthesis and the one patient with a degenerated THV successfully underwent the valve-in-valve procedure. CONCLUSIONS: Feasibility, safety, and potential efficacy of the aortic valve-in-valve procedure were confirmed in selected Japanese patients with a degenerated aortic bioprosthesis. The valve-in-valve procedure for stentless bioprostheses was technically challenging.