Self-expanding Transcatheter Aortic Valve Implantation Research Articles

Accurate deployment of self-expanding transcatheter aortic valve implantation for permanent pacemaker reduction

Accurate deployment of self-expanding transcatheter aortic valve implantation for permanent pacemaker reduction

Bailout stenting for delayed coronary obstruction after self-expandable transcatheter aortic valve implantation.

Bailout stenting for delayed coronary obstruction after self-expandable transcatheter aortic valve implantation.

Impact of Transjugular Intracardiac Echocardiography-Guided Self-Expandable Transcatheter Aortic Valve Implantation on Reduction of Conduction Disturbances.

A high permanent pacemaker implantation (PPI) risk remains a concern of self-expandable transcatheter aortic valve implantation, despite the continued improvements in implantation methodology. We aimed to assess the impact of real-time direct visualization of the membranous septum using transjugular intracardiac echocardiography (ICE) during transcatheter aortic valve implantation on reducing the rates of conduction disturbances including the need for PPI. Consecutive patients treated with Evolut R and Evolut PRO/PRO+ from February 2017 to September 2022 were included in this study. We compared outcomes between the conventional implantation method using the 3-cusps view (3 cusps without ICE group), the recent method using cusp-overlap view (cusp overlap without ICE group), and our novel method using ICE (cusp overlap with ICE group). Of the 446 patients eligible for analysis, 211 (47.3%) were categorized as the 3 cusps without ICE group, 129 (28.9%) were in the cusp overlap without ICE group, and 106 (23.8%) comprised the cusp overlap with ICE group. Compared with the 3 cusps without ICE group, the cusp overlap without ICE group had a smaller implantation depth (2.2 [interquartile range, 1.0-3.5] mm versus 4.3 [interquartile range, 3.3-5.4] mm; P<0.001) and lower 30-day PPI rates (7.0% versus 14.2%; P=0.035). Compared with the cusp overlap without ICE group, the cusp overlap with ICE group had lower 30-day PPI rates (0.9%; P=0.014), albeit with comparable implantation depths (1.9 [interquartile range, 0.9-2.9] mm; P=0.150). Multivariable analysis showed that our novel method using ICE with the cusp-overlap view was independently associated with a 30-day PPI rate reduction. There were no group differences in 30-day all-cause mortality (1.4% versus 1.6% versus 0%; P=0.608). Our novel implantation method using transjugular ICE, which enable real-time direct visualization of the membranous septum, achieved a predictably high position of prostheses, resulting in a substantial reduction of conduction disturbances requiring PPI after transcatheter aortic valve implantation.

Three-year outcomes following transcatheter versus surgical aortic valve replacement in younger, low surgical risk patients with severe aortic stenosis

Abstract Background/Introduction Prior randomized studies in patients with severe aortic stenosis at low risk for surgery have shown comparable 3-year outcomes with transcatheter aortic valve implantation (TAVI) and surgery. Less is known about the intermediate term outcomes in younger (&amp;lt;75 years) patients at low risk for surgery treated with TAVI or surgery. Purpose To compare 3-year clinical outcomes in younger (&amp;lt;75 years) patients with severe aortic stenosis and low risk for surgery randomly assigned to TAVI or surgery. Methods The Evolut Low Risk randomized trial treated 1414 patients at low surgical risk with a supra-annular, self-expanding TAVI or surgery. Patients less than 75 years of age were selected for this analysis. The primary endpoint was the 3-year occurrence of all-cause mortality or disabling stroke (Kaplan-Meier estimates). Serial echocardiographic outcomes were also compared through 3-year follow-up. Results 703 younger (mean age, 69 years) low-surgical risk (STS PROM, 1.6%) aortic stenosis patients were treated with TAVI (N=352) and SAVR (N=351). At 3 years, the primary endpoint of all-cause mortality or disabling stroke was not different between TAVI (5.7%) or surgery (8.0%, p=0.241). TAVI was associated with lower incidence (0.6%) of disabling stroke compared with surgery (2.9%, p=0.019) and atrial fibrillation (13.3%) compared with surgery (36.4%, p&amp;lt;0.001) while surgery was associated with lower incidence of pacemaker implantation (7.1%) compared with TAVI (21.0%, p&amp;lt;0.001). Valve reintervention rates were low in both groups (1.5% with TAVI; 1.5% with surgery, p=0.962). Mean aortic gradients were significantly lower with TAVI (9.7 mmHg) compared with surgery (12.9 mmHg, p&amp;lt;0.001) and effective orifice areas were significantly larger with TAVI (2.2 cm²) compared with surgery (1.9 cm², p&amp;lt;0.001). There were no differences in the rates of residual moderate or greater paravalvular regurgitation (TAVI: 1.1% and surgery: 0.4%, p=0.626). Conclusion(s) Low risk patients less than 75 years age who underwent TAVI with a supra-annular, self-expanding TAVI had comparable clinical and haemodynamic outcomes with surgery through the 3-year follow-up; additional study through 10 years in these low risk patients is ongoing.

Valve-in-valve transcatheter aortic valve implantation for degenerative stentless versus stented surgical bioprostheses

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Most ViV-TAVI procedures have been performed in failing stented bioprosthetic valves; stentless bioprostheses lack fluoroscopic markers and could be more challenging for transcatheter therapy. Data on more recent patients applying Valve Academic Research Consortium (VARC)-3 defined outcomes are scarce; thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of patients with stentless (SL) versus stented (ST) aortic bioprosthetic device failure undergoing ViV-TAVI. Methods Patients undergoing ViV-TAVI between 2007 and 2022 (53% of cases after 2015) at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 43 (11.8%) SL and 313 (88.2%) ST ViV-TAVI were included. Patients were comparable with regard to age (SL: 77 (74; 82) vs. ST: 78 (75; 83), p=0.08), sex (male: SL 70% vs. ST 56%, p=0.08), clinically relevant baseline comorbidities and surgical risk (STS PROM SL 10.0 (4.8; 12.5) % vs. ST 9.4 (4.5; 11.3) %, p=0.62). Aortic regurgitation was the mode of failure in 33% of SL vs. 8% in ST (p&amp;lt;0.01). The rate of self-expanding TAVI prostheses was 86% and 76% in SL and ST, respectively (p=0.15). The rates of technical success (SL: 84% vs ST: 80%, p=0.55), device success (SL: 67% vs ST: 54%, p=0.11), and early safety (SL: 74% vs ST: 62%, p=0.30) were comparable between groups. There were higher rates of mild/moderate residual aortic regurgitation in SL (77.5% vs. 35%, p&amp;lt;0.01), whereas the remaining mean gradient was higher in ST (11.2 (6.0; 15.5) mmHg vs. 17.0 (11.0; 22.0) mmHg, p&amp;lt;0.01). The 30-day mortality rate (SL: 7.0% vs. ST: 2.6%, p=0.14) and Kaplan-Meier estimated 1-year mortality rates (SL: 9.3% vs. ST: 8.2%, p=0.63) were comparable between groups. Conclusion Both SL and ST ViV-TAVI have comparable short-term outcomes according to VARC-3- defined endpoints and similar low rates of 1-year all-cause mortality. However, against the background of a relevant rate of residual aortic regurgitation in SL and increased gradients in ST, long-term studies are of utmost importance to determine the clinical relevance of those factors.

Cost-effectiveness of transcatheter aortic valve implantation in patients at low surgical risk in France: a model-based analysis of the Evolut LR trial

BackgroundIn the recent Evolut Low Risk randomized trial, transcatheter aortic valve implantation (TAVI) was shown to be non-inferior to surgery (SAVR) regarding the composite end point of all-cause mortality or disabling stroke at 24 months.AimsTo evaluate the cost-effectiveness of self-expandable TAVI in low-risk patients, using the French healthcare system as the basis for analysis.MethodsMortality, health-related quality of life, and clinical event rates through two-year follow-up were derived from trial data (N = 725 TAVI and N = 678 SAVR; mean age: 73.9 years; mean STS-PROM: 1.9%). Cost inputs were based on real-world data for TAVI and SAVR procedures in the French healthcare system. Costs and effectiveness as quality-adjusted life years (QALYs) were projected to lifetime via a decision-analytic model under assumption of no mortality difference beyond two years. The discounted incremental cost-effectiveness ratio (ICER) was evaluated against a willingness-to-pay threshold of €50,000 per QALY gained. Deterministic and probabilistic sensitivity analyses were conducted, including assumptions about differential long-term survival.ResultsFor the base case, mean survival was 13.69 vs 13.56 (+ 0.13) years for TAVI and SAVR, respectively. Discounted QALYs were 9.34 vs. 9.21 (+ 0.13) and discounted lifetime costs €52,267 vs. €51,433 (+ €833), resulting in a lifetime ICER of €6368 per QALY gained. In probabilistic sensitivity analysis, TAVI was found dominant or cost-effective in 74.4% of samples.ConclusionTAVI in patients at low surgical risk is a cost-effective alternative to SAVR in the French healthcare system. Longer follow-up data will help increase the accuracy of lifetime survival projections.Graphical

Intermediate Follow-Up of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annuli

The clinical impact of prosthesis-patient mismatch (PPM) in patients with small aortic annuli who underwent transcatheter aortic valve (AV) implantation with either balloon-expandable (BE) or self-expanding (SE) valves remains controversial. We assessed in-hospital and intermediate clinical outcomes in 573 patients with transfemoral transcatheter AV implantation with a small AV annulus, defined as an AV annulus area ≤430mm2. A total of 337 patients treated with a 23-mm BE valve (SAPIEN 3, Ultra) were compared with 236 patients treated with a 26-mm SE valve (Evolut series). Valve-in-valve cases were excluded, and late echo follow-up (mean 674 ± 438days) was assessed in a subset of 292 patients (51.0%). Well-matched BE and SE cohorts did not differ with respect to major in-hospital outcomes, other than a borderline increase in vascular complications and composite bleeding in patients with SE. Patients with BE had a higher incidence of severe PPM on discharge echocardiography (16.9% vs 6.8%, p <0.002). The mean AV gradient at 30days was higher for patients with BE (12.2 ± 4.2 vs 6.2 ± 7.9mm Hg, p <0.001) and at late follow-up (14.0 ± 8.2 vs 7.2 ± 3.5mm Hg, p <0.001). The follow-up left ventricular ejection fraction and incidence of >mild aortic insufficiency were similar. All-cause mortality for the 2 cohorts was similar, with an overall mean (95% confidence interval) survival time of 61.2months (57.8 to 64.5; p=0.98). There were no significant survival differences between combined patients with BE and SE with no, moderate, or severe PPM, with an overall mean (95% confidence interval) survival time of 32.5 (30.5 to 34.5)months combining valve types (p=0.23). In conclusion, despite an increased incidence of PPM with higher mean AV gradients that persist on late echocardiography in the BE cohort, patients with BE and SE with small aortic annuli have similar clinical outcomes at intermediate follow-up. Moderate and severe PPM had no impact on survival at a mean follow-up of 32.5months.

Impact of different guidewires on the implantation depth using the largest self-expandable TAVI device.

The deployment process of the largest self-expandable device (STHV-34) during transcatheter aortic valve implantation (TAVI) might be challenging due to stabilization issues. Whether the use of different TAVI-guidewires impact the procedural success and outcome is not well-known. Therefore, we sought to evaluate the impact of non-Lunderquist (NLu) vs. the Lunderquist (Lu) guidewires during TAVI using the STHV-34 on the procedural and 30-day outcomes. The primary study endpoint was defined as the final implantation depth (ID) depending on the selected guidewire strategy. Key secondary endpoints included VARC-3-defined complications. The study cohort included 398 patients of four tertiary care institutions, of whom 79.6% (317/398) had undergone TAVI using NLu and 20.4% (81/398) using Lu guidewires. Baseline characteristics did not substantially differ between NLu and Lu patients. The average ID was higher in the Lu cohort (NLu vs. Lu: -5.2 [-7.0-(-3.5)] vs. -4.5 [-6.0-(-3.0)]; p = 0.022*). The optimal ID was reached in 45.0% of patients according to former and only in 20.1% according to nowadays best practice recommendations. There was no impact of the guidewire use on the 30-day outcomes, including conduction disturbances and pacemaker need (NLu vs. Lu: 15.1 vs. 18.5%; p = 0.706). The use of the LunderquistTM guidewire was associated with a higher ID during TAVI with the STHV-34 without measurable benefits in the 30-day course concerning conduction disturbances and associated pacemaker need. Whether using different guidewires might impact the outcome in challenging anatomies should be further investigated in randomized studies under standardized conditions.

Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk

The frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood. To evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery. This post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022. Patients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies. The primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more. Of 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P < .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis. This study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes. ClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374.

Hospital intervention volume affects outcomes of emergency transcatheter aortic valve implantations in Germany

The literature has shown an inverse volume-outcome relationship for transcatheter aortic valve implantation (TAVI). However, little is known about emergency admissions in Germany. Using German national electronic health records, we identified all isolated balloon-expandable and self-expanding transfemoral TAVI in 2018. The focus was on those patients with emergency admission. 17,295 patients were treated with TAVI, including 1682 emergency cases. 49.2% of the emergency admissions were female, the mean age was 81.2 years and the logistic EuroSCORE was 23.3%. The percentage of emergency cases was higher in lower volume than in higher volume centers (p < 0.001): In detail, centers performing < 50 TAVI showed an emergency admission rate of ~ 15%, those with > 200 TAVI a rate of ~ 11%. After propensity score adjustment, analyzing the outcomes for an increase in volume per 10 emergency admissions, higher volume centers showed significantly better outcomes regarding in-hospital mortality (OR = 0.872, p = 0.043), major bleeding (OR = 0.772, p = 0.001), stroke (OR = 0.816, p = 0.044), mechanical ventilation > 48 h (OR = 0.749, p = 0.001), length of hospital stay (risk adjusted difference in days of hospitalization per 10 emergency admissions: − 1.01 days, p < 0.001), and reimbursement (risk adjusted difference in reimbursement per 10 emergency admissions: -€314.89, p < 0.001). Results were not significant for acute kidney injury (OR = 0.951, p = 0.104), postoperative delirium (OR = 0.975, p = 0.480), and permanent pacemaker implantation (OR = 1.010, p = 0.732). In conclusion, regarding transfemoral TAVI, the percentage of emergency cases was higher in lower volume centers in Germany. However, higher volume centers show significantly better outcomes for in-hospital mortality and complication rates as well as resource utilization parameters.

Long-Term Prognosis Value of Paravalvular Leak and Patient–Prosthesis Mismatch following Transcatheter Aortic Valve Implantation: Insight from the France-TAVI Registry

Background: Transcatheter aortic valve implantation (TAVI) is the preferred treatment for symptomatic severe aortic stenosis (AS) in a majority of patients across all surgical risks. Patients and methods: Paravalvular leak (PVL) and patient–prosthesis mismatch (PPM) are two frequent complications of TAVI. Therefore, based on the large France-TAVI registry, we planned to report the incidence of both complications following TAVI, evaluate their respective risk factors, and study their respective impacts on long-term clinical outcomes, including mortality. Results: We identified 47,494 patients in the database who underwent a TAVI in France between 1 January 2010 and 31 December 2019. Within this population, 17,742 patients had information regarding PPM status (5138 with moderate-to-severe PPM, 29.0%) and 20,878 had information regarding PVL (4056 with PVL ≥ 2, 19.4%). After adjustment, the risk factors for PVL ≥ 2 were a lower body mass index (BMI), a high baseline mean aortic gradient, a higher body surface area, a lower ejection fraction, a smaller diameter of TAVI, and a self-expandable TAVI device, while for moderate-to-severe PPM we identified a younger age, a lower BMI, a larger body surface area, a low aortic annulus area, a low ejection fraction, and a smaller diameter TAVI device (OR 0.85; 95% CI, 0.83–0.86) as predictors. At 6.5 years, PVL ≥ 2 was an independent predictor of mortality and was associated with higher mortality risk. PPM was not associated with increased risk of mortality. Conclusions: Our analysis from the France-TAVI registry showed that both moderate-to-severe PPM and PVL ≥ 2 continue to be frequently observed after the TAVI procedure. Different risk factors, mostly related to the patient’s anatomy and TAVI device selection, for both complications have been identified. Only PVL ≥ 2 was associated with higher mortality during follow-up.

Thrombocytopenia following implantation of different types of bioprosthetic aortic valves in severe aortic valve stenosis replacement

Abstract Aim The use of bioprosthetic valves in the surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) of severe aortic stenosis has been associated with post-implantation thrombocytopenia, usually reversible and rarely combined with severe bleeding events. The purpose of this study was to compare the grade of thrombocytopenia and the presence of bleeding events following the implantation of bioprosthetic valves, where either surgery (Solo, Perceval, Trifecta) or transcatheter method (self-expandable TAVI) was followed. Methods 89 patients with severe aortic stenosis were included in the study. All patients underwent either SAVR or TAVI. In each group 3 different types of bioprosthetic valves were used [59 patients in SAVR group: Solo (14), Perceval (27), Trifecta (18), 30 patients in TAVI group: Evolut R (10), Portico (15), Acurate (5)]. All patients had normal or slightly reduced platelet count at baseline. Patients previously receiving anticoagulants, patients with a primary blood disorder affecting the number of platelets, as well as patients with a post-surgery complication that could affect the number of platelets (e.g., HIT syndrome, etc.) were excluded from the study. Blood samples were taken in the morning before intervention and every morning during the first week of follow-up. Platelet count values before and after implantation were compared with paired t-test (SPSS V21.0, Inc., Chicago, IL, USA), while the reduction of platelets was compared between the 4 different valves with independent t-test. P-values of &amp;lt;0.05 were considered significant. Results Mean age was 76.8±5.1 years. There was no statistically significant difference between the 2 groups of patients concerning the baseline characteristics and the administered anticoagulants. Statistically significant reduction of the blood count was observed in all groups [Solo: 136±80x103/μl (p=0.009), Perceval: 129±75x103/μl (p&amp;lt;0.001), Trifecta: 74±32x103/μl (p&amp;lt;0.001, TAVI: 60±103μl)]. There was no observed statistically significant difference between Solo and Perceval group (p=0.85) or Solo and Trifecta group (p=0.053), but in the case of Perceval and Trifecta group, a statistically significant difference was noted (p=0.047). A statistically significant difference in both SAVR and TAVI groups was demonstrated (p=0.040) regarding blood count reduction. There was no occurrence of any major bleeding events. 3 patients (3.3%) presented mild bleeding disorders (1 patient epistaxis and 2 patients mild hematuria). Conclusion Both methods, surgical and transcatheter severe aortic stenosis replacement and all the different bioprosthetic valves that were implanted, were associated with statistically significant reduction of platelet count post-implantation. This reduction was linked to the procedure due to endothelial damage, shear stress injury, inflammation-related platelet consumption, and was not associated with clinically significant bleeding events. Funding Acknowledgement Type of funding sources: None.

Volume-outcome relationship in emergency transcatheter aortic valve implantations in Germany

Abstract Background An inverse volume-outcome relationship in transcatheter aortic valve implantation (TAVI) has been demonstrated in the literature but little is known about emergency cases. Methods All isolated balloon-expandable and self-expanding transfemoral TAVI in 2018 were identified using German national electronic health records. Additionally, those patients with an emergency admission were selected. Results A total of 17,295 patients received TAVI, 1,682 of these cases had an emergency admission. Of the emergency cases, 49.2% were female, mean age was 81.2 years and logistic EuroSCORE was 23.3%. Relatively more emergency cases were treated in lower volume centers than in higher volume centers (p&amp;lt;0.001): Centers performing &amp;lt;50 TAVI had an emergency admission rate of ∼15% while centers performing &amp;gt;200 TAVI were associated with a rate of ∼11%. Analyzing the outcomes for a volume increase per 10 emergency cases using propensity score adjustment, higher volume centers showed significantly better results than lower volume centers for in-hospital mortality (OR=0.872, p=0.043), major bleeding (OR=0.772, p=0.001), stroke (OR=0.816, p=0.044), mechanical ventilation &amp;gt;48h (OR=0.749, p=0.001), length of hospital stay (risk adjusted difference in days of hospitalization per 10 emergency admissions: −1.01 days, p&amp;lt;0.001), and reimbursement (risk adjusted difference in reimbursement per 10 emergency admissions: −€314.89, p&amp;lt;0.001). No correlation was seen in acute kidney injury (OR=0.951, p=0.104), postoperative delirium (OR=0.975, p=0.480), and permanent pacemaker implantation (OR=1.010, p=0.732). Conclusion In transfemoral TAVI, lower volume centers treat relatively more emergency cases in Germany, but higher volume centers provide significantly better outcomes regarding in-hospital mortality and complication rates as well as resource utilization parameters. Funding Acknowledgement Type of funding sources: None.

Transcatheter aortic valve implantation with Allegra: procedural and mid-term outcomes according to experience phase in a high-volume center.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic stenosis. We aimed at appraising effectiveness of a new self-expandable TAVI device. We retrospectively analyzed our institutional experience with Allegra (Biosensors, Morges, Switzerland) for TAVI, focusing on procedural outcomes and 1-month adverse events. We explored the impact of operator experience with this device, dividing patients according to their time of intervention. Between 2018 and 2021, a total of 50 patients underwent TAVI with Allegra, with average age of 81 years, 80% women, and 50% at low or intermediate surgical risk. No major significant difference in baseline patient features were found when comparing Phase 1 and Phase 2, except for baseline left ventricular ejection fraction and New York Heart Association, which were worse in Phase 1. All procedures were performed transfemorally and percutaneously, with predilation in 94% and postdilation in 36%, yielding device success in 98%, and procedural success in 96%. No significant differences in procedural features were found when comparing Phase 1 vs. Phase 2 (all P>0.05). One-month follow-up was also favorable, with no significant difference in adverse outcomes according to phase, and a total of 1 (4%) death, 1 (4%) myocardial infarction, 1 (4%) minor vascular complication, and 4 (8%) permanent pacemaker implantations. Consistent findings were obtained at exploratory 6-month follow-up. The Allegra TAVI device is associated with favorable short-to-midterm outcomes in experienced hands. Operators already proficient with other devices can achieve satisfactory results even in the early phase of adoption of Allegra.

Comparison of Catheterization Versus Echocardiographic-Based Gradients in Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation.

In patients with transcatheter aortic valve implantation (TAVI), accurate assessment of gradients is important to assess valve function and durability, which drives clinical decision-making. We sought to evaluate discrepancies in aortic valve mean gradients with balloon-expandable and self-expanding TAVI. We retrospectively reviewed 507 patients that underwent TAVI and compared mean gradients by catheterization to transthoracic Doppler echocardiography. Mean gradients by Doppler in balloon-expandable (11.0 ± 5.8 mm Hg) and self-expanding devices (8.7 ± 4.5 mm Hg) were significantly higher than catheterization (3.2 ± 4.0 mm Hg vs 3.5 ± 4.1 mm Hg, respectively; P<.001). In a subgroup analysis of skirted valves, Doppler gradients in balloon-expandable (9.8 ± 4.4 mm Hg) and self-expanding devices (8.6 ± 5.1 mm Hg) were significantly higher than catheterization (3.5 ± 4.1 mm Hg vs 4.2 ± 4.8 mm Hg, respectively; P<.001). When the effect of valve size on gradients was analyzed, Doppler gradients were significantly higher than catheterization for all comparisons. When indexed for valve size, patients with large aortas who received a balloon-expandable TAVI had greater pressure differential than those who received a self-expanding TAVI (8.24 ± 0.46 mm Hg vs 5.16 ± 0.66 mm Hg; P<.001). This trend was not seen in patients with a small aorta-to-valve index. Following TAVI, aortic valve mean gradients acquired by Doppler were higher than catheterization and the discrepancy was more pronounced in balloon-expandable than self-expanding prostheses. These differences persist in skirted valves and across valve sizes. These observations may reflect periprocedural hemodynamic changes, differences between prosthetic flow acceleration, and/or pressure recovery.

Perfect is the Enemy of the Good: Outflow Tract Rupture During Self-Expandable Transcatheter Aortic Valve Implantation

Annular rupture is an ambiguous term that refers to a series of infrequent but life-threatening transcatheter aortic valve replacement complications associated with anatomical and clinical risk factors that often require urgent surgical management. We describe a case of annular rupture following self-expandable valve post-dilatation, successfully treated with urgent surgery.

Feasibility of Selective Coronary Angiogram and Percutaneous Coronary Intervention Following Self-Expanding Transcatheter Aortic Valve Implantation – A Systematic Review and Meta-Analysis

Patients with severe aortic valve stenosis often have concomitant coronary artery disease (CAD). Following transcatheter aortic valve implantation (TAVI), patients may thus require coronary angiography (CA) and percutaneous coronary intervention (PCI). However, in the presence of a self-expanding TAVI device, coronary access may be a concern. There is a paucity of studies that appraise the feasibility of CA and PCI post TAVI.

A CT-based technique to predict optimal projection for self-expanding TAVI in patients with different aortic valve anatomies

BackgroundOptimal projection is essential for valve deployment during transcatheter aortic valve implantation (TAVI). The purpose of this study was to propose an approach to predict optimal projection in TAVI candidates with different aortic valve anatomies.Methods331 patients undergoing self-expanding TAVI were included and the so-called non-coronary cusp (NCC)-parallel technique was utilized, which generated the predicted projection by connecting NCC commissures on the transverse plane on the pre-procedural computed tomography images.Results37.8% of the study cohort were bicuspid aortic valve (BAV) patients. Around 80% of both NCC-parallel views and final views were in the right anterior oblique (RAO) and caudal (CAU) quadrant. There was less than 5° change required from the NCC-parallel view to the final implanted view in 79% of tricuspid aortic valve (TAV) patients but only in 27% (13/48) of type 0 BAV patients with coronary arteries originated from the different cusps. After excluding the above mentioned BAV patients, 62.3% (48/77) of BAV patients needed less than 5° change to achieve optimal projection and only in 8 patients, the angular change was larger than 10° in either left/right anterior oblique or cranial/caudal direction.ConclusionsThe NCC-parallel technique provides reliable prediction for optimal projection in self-expanding TAVI in all TAV and most BAV patients, with a vast majority of views in the RAO and CAU quadrant.

The incidence and predictors of high-degree atrioventricular block in patients with bicuspid aortic valve receiving self-expandable transcatheter aortic valve implantation.

BACKGROUNDThe high-degree atrioventricular block (HAVB) in patients with bicuspid aortic valve (BAV) treated with transcatheter aortic valve implantation (TAVI) remains high. The study aims to explore this poorly understood subject of mechanisms and predictors for HAVB in BAV self-expandable TAVI patients.METHODSWe retrospectively included 181 BAV patients for analysis. Using computed tomography data, the curvature of ascending aorta (AAo) was quantified by the angle (AAo angle) between annulus and the cross-section at 35 mm above annulus (where the stent interacts with AAo the most). The valvular anatomy and leaflet calcification were also characterized.RESULTSThe 30-day HAVB rate was 16.0% (median time to HAVB was three days). Type-1 morphology was found in 79 patients (43.6%) (left- and right-coronary cusps fusion comprised 79.7%). Besides implantation below membrane septum, large AAo angle [odds ratio (OR) = 1.08, P = 0.016] and type-1 morphology (OR = 4.97, P = 0.001) were found as the independent predictors for HAVB. Together with baseline right bundle branch block, these predictors showed strong predictability for HAVB with area under the cure of 0.84 (sensitivity = 62.1%, specificity = 92.8%). Bent AAo and calcified raphe had a synergistic effect in facilitating high implantation, though the former is associated with at-risk deployment (device implanted above annulus + prothesis pop-out, versus straight AAo: 9.9% vs. 2.2%, P = 0.031). CONCLUSIONSAAo curvature and type-1 morphology are novel predictors for HAVB in BAV patients following self-expandable TAVI. For patients with bent AAo or calcified raphe, a progressive approach to implant the device above the lower edge of membrane septum is favored, though should be done cautiously to avoid pop-out.

Long term follow up of elderly patients treated with self-expanding transcatheter aortic valve implantation; a single center experience

Abstract Background and aims The information of long term clinical performance of transcatheter heart valves is limited. Our aim is to assess the clinical outcomes and rate of structural valve deterioration (SVD) in patients after self-expanding transcatheter aortic valve implantation (TAVI) at 10-year follow-up. Methods A total of 141 consecutive patients undergoing self-expanding TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2008 and 2012 at our institution were included. We considered SVD as defined for the consensus statement from the European Association of Percutaneous Cardiovascular Interventions (European Society of Cardiology/European Association for Cardio-Thoracic Surgery). SVD cumulative incidence was calculated considering death in the absence of valve damage as a competitive risk. Results At the time of TAVI mean age was 78±5 years, male 44%. Percutaneous prosthesis implanted were self-expanding in 100% of patients (size: 26 mm in 72%, 29 mm in 28%). Mortality at 1, 5, and 10-year follow-up was 14%, 32%, and 72%, respectively. There was one death due to prosthetic valve endocarditis. Of the total cohort, 11 patients had severe SVD, with a cumulative incidence at 10 years of 8,21 (95% CI 4.09- 14.14%). The rate of SVD at 4, 6, 8, and 10 years was 0%, 1.41%, 2.83%, and 8.21%, respectively (Figure 1 and 2). Of the 11 patients with severe SVD, seven died, two patients had reintervention (both had redo TAVI), and the other two patients remain in close follow-up. In survivors at 10-year follow-up (n=41) the median of mean gradient was 8 mmHg (interquartile Rank 6–13 mmHg) and in 8.4% an prosthetic valve regurgitation ≥moderate was detected. Diabetes, chronic obstructive pulmonary disease, chronic kidney disease, previous stroke and high pulmonary systolic pressure were independent predictors of global mortality. SVD was not associated with any of studied variables (Age, arterial hypertension, obesity, chronic kidney disease, atrial fibrillation, previous aortic bioprosthesis, left ventricle function &amp;lt;50%, prosthetic valve regurgitation, valve size and ballon postdilatation) Conclusions A low rate of SVD at 10-year follow-up was observed in this serie of elderly patients with severe aortic stenosis treated with self-expanding TAVI. This study provides insights into the long-term performance of self-expanding TAVI. Funding Acknowledgement Type of funding sources: None. Cumulative incidence of SVD and deathSVD with confidence intervals