Balloon-expandable Transcatheter Heart Valve Research Articles

Deformation of a balloon-expandable transcatheter heart valve during transcatheter aortic valve replacement.

Deformation of a balloon-expandable transcatheter heart valve during transcatheter aortic valve replacement.

Impact of Different Valve-in-Valve Positions on Functional Results of the New Generation of Balloon-Expandable Transcatheter Heart Valve.

Very precise positioning of the transcatheter heart valve (THV) inside the degenerated SAV is a crucial factor for valve-in-valve (ViV) procedure to achieve optimal hemodynamic results. Therefore, our study aimed to investigate the impact of implantation depth on functional results after ViV procedures in a standardized in vitro setting. THV (SAPIEN 3 Ultra 23-mm size) and three SAV models (Magna Ease, Trifecta, and Hancock II-all 21-mm size) were tested at different circulatory conditions in five different positions of the THV (2-6 mm) inside the SAV. Mean pressure gradient (MPG), effective orifice area (EOA), geometric orifice area (GOAmax), and pinwheeling index (PWImean) were analyzed. EOA and MPG of the THV did not differ significantly regarding the position inside the Magna Ease and the Hancock II (p > 0.05). However, EOA differed significantly, depending on the position of the THV inside Trifecta (2 vs. 5 mm; p = 0.021 and 2 vs. 6 mm; p < 0.001). The THV presented the highest EOA (2.047 cm2) and the lowest MPG (5.387 mm Hg) inside the Magna Ease, whereas the lowest EOA (1.335 cm2) and the highest MPG (11.876 mm Hg) were shown inside the Hancock II. Additionally, the highest GOAmax and the lowest PWImean of the THV were noticed inside the Magna Ease. The THV showed lower GOAmax and higher PWImean inside the Trifecta when placed in a deeper position. Deep implantation of the SAPIEN 3 Ultra inside the Trifecta correlates with impaired functional results. In contrast, the implantation position of the SAPIEN 3 Ultra inside the Magna Ease and the Hancock II did not have a significant effect on functional results.

Computed Tomography Geometry of Extremely Undersized SAPIEN 3 Transcatheter Aortic Valves With Balloon Overfilling

Overfilling the balloon-expandable Sapien 3/Ultra (S3) transcatheter heart valves in undersized aortic valve anatomies is associated with favorable outcomes. The expansion of S3 valves beyond nominal values is feasible on benchtop testing. Still, a dearth of information exists on the actual valve area achieved when these valves are filled beyond nominal volumes. We herein assess post-transcatheter aortic valve replacement (TAVR) computed tomography (CT) derived geometry of overfilled, extremely undersized balloon-expandable transcatheter heart valves. A total of 23 patients (mean age 76±7.2 years, 17.4% female) treated had annular undersizing: 10.3±2.0% for 23mm, 7.8±4.8% for 26mm and 12.3±6.3% for 29mm. The mean volumes added to 23mm, 26mm, and 29mm S3 valves were 1.9±0.3 mL, 2.2±0.7mL, 3.2 ±1.3 mL, respectively. CT analysis at 30 days found that no valve achieved an expansion index >1 at the mid-frame portion, i.e., greater than the respective valve’s nominal valve area, but 29mm S3 had an expansion index >1 at inflow and outflow. Aortic valve gradients were favourable, and there was no moderate/severe PVL or transvalvular regurgitation at 30-day follow-up. We hypothesize that the approach of undersizing for annular anatomies and overfilling the balloon may achieve more optimal valve expansion.

Snare technique to facilitate 'tall-in-short' redo-TAVR.

An 82-year-old man with a prior history of transcatheter aortic valve replacement (TAVR) with a 23-mm balloon-expandable transcatheter heart valve (THV) presented with bioprosthetic stenosis.

Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States

BackgroundThe fifth-generation SAPIEN 3 Ultra Resilia valve (S3UR) incorporates several design changes as compared with its predecessors, the SAPIEN 3 (S3) and SAPIEN 3 Ultra (S3U) valves, including bovine leaflets treated with a novel process intended to reduce structural valve deterioration via calcification, as well as a taller external skirt on the 29-mm valve size to reduce paravalvular leak (PVL). The clinical performance of S3UR compared with S3 and S3U in a large patient population has not been previously reported. ObjectivesThe aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR). MethodsPatients enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between January 1, 2021, and June 30, 2023, who underwent TAVR with S3UR or S3U/S3 valve platforms were propensity-matched and evaluated for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes. Results10,314 S3UR patients were propensity matched with 10,314 patients among 150,539 S3U/S3 patients. At 30 days, there were no statistically significant differences in death, stroke, or bleeding, but a numerically higher hospital readmission rate in the S3UR cohort (8.5% vs 7.7%; P = 0.04). At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic valve area (2.1 ± 0.7 cm2 vs 1.9 ± 0.6 cm2; P < 0.0001) than patients treated with S3/S3U. The 29-mm valve size exhibited significant reduction in mild PVL (5.3% vs 9.4%; P < 0.0001). ConclusionsS3UR TAVR is associated with lower mean gradients and lower rates of PVL than earlier generations of balloon expandable transcatheter heart valve platforms.

Redo-TAVI with the ACURATE neo2 and Prime XL for balloon-expandable transcatheter heart valve failure.

There are limited data regarding treatment for failed balloon-expandable transcatheter heart valves (THVs) in redo-transcatheter aortic valve implantation (TAVI). We aimed to assess THV performance, neoskirt height and expansion when performing redo-TAVI with the ACURATE platform inside a SAPIEN 3 (S3) compared to redo-TAVI with an S3 in an S3. Redo-TAVI was performed on the bench using each available size of the S3, the ACURATE neo2 (ACn2) and the next-generation ACURATE Prime XL (AC XL) implanted at 2 different depths within 20 mm/23 mm/26 mm/29 mm S3s serving as the "failed" index THV. Hydrodynamic testing was performed to assess THV function. Multimodality assessment was performed using photography, X-ray, microcomputed tomography (micro-CT), and high-speed videos. The ACURATE in S3 combinations had favourable hydrodynamic performance compared to the S3 in S3 for all size combinations. In the 20 mm S3, redo-TAVI with the ACn2 had lower gradients compared to the S3 (mean gradient 16.3 mmHg for the ACn2 vs 24.7 mmHg for the 20 mm S3 in 20 mm S3). Pinwheeling was less marked for the ACURATE THVs than for the S3s. On micro-CT, the S3s used for redo-TAVI were underexpanded across all sizes. This was also observed for the ACURATE platform, but to a lesser extent. Redo-TAVI with an ACn2/AC XL within an S3 has favourable hydrodynamic performance and less pinwheeling compared to an S3 in S3. This comes at the price of a taller neoskirt.

Contemporary Risk Assessment of Aortic Root Injury for New-Generation Balloon-Expandable Transcatheter Heart Valves

Contemporary Risk Assessment of Aortic Root Injury for New-Generation Balloon-Expandable Transcatheter Heart Valves

Leaflet Mechanical Stress in Different Designs and Generations of Transcatheter Aortic Valves: An in Vitro Study

BackgroundIt is unknown whether bioprostheses used for transcatheter aortic valve implantation will have similar long-term durability as those used for surgical aortic valve replacement. Repetitive mechanical stress applied to the valve leaflets, particularly during diastole, is the main determinant of structural valve deterioration. Leaflet mechanical stress cannot be measured in vivo. The objective of this in vitro/in silico study was thus to compare the magnitude and regional distribution of leaflet mechanical stress in old vs new generations of self-expanding (SE) vs balloon expandable (BE) transcatheter heart valves (THVs). MethodsA double activation simulator was used for in vitro testing of two generations of SE THV (Medtronic CoreValve 26 mm and EVOLUT PRO 26 mm) and two generations of BE THV (Edwards SAPIEN 23 mm vs SAPIEN-3 23 mm). These THVs were implanted within a 21-mm aortic annulus. A noncontact system based on stereophotogammetry and digital image correlation with high spatial and temporal resolution (2000 img/sec) was used to visualize the valve leaflet motion and perform the three-dimensional analysis. A finite element model of the valve was developed, and the leaflet deformation obtained from the digital image correlation analysis was applied to the finite element model to calculate local leaflet mechanical stress during diastole. ResultsThe maximum von Mises leaflet stress was higher in early vs new THV generation (p < 0.05) and in BE vs SE THV (p < 0.05): early generation BE: 2.48 vs SE: 1.40 MPa; new generation BE: 1.68 vs SE: 1.07 MPa. For both types of THV, the highest values of leaflet stress were primarily observed in the upper leaflet edge near the commissures and to a lesser extent in the mid-portion of the leaflet body, which is the area where structural leaflet deterioration most often occurs in vivo. ConclusionsThe results of this in vitro/in silico study suggest that: i) Newer generations of THVs have ∼30% lower leaflet mechanical stress than the early generations; ii) For a given generation, SE THVs have lower leaflet mechanical stress than BE THVs. Further studies are needed to determine if these differences between new vs early THV generations and between SE vs BE THVs will translate into significant differences in long-term valve durability in vivo.

Balloon-expandable transcatheter heart valves for treatment of aortic valve stenosis in patients with large aortic annuli: Evaluation of deployment balloon overfilling strategies.

Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients. Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions. Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented. Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³.

Pressure-regulated deployment for balloon-expandable TAVI is safe, effective and results in superior valve haemodynamics regardless of prosthesis size

Abstract Background A novel pressure-regulated deployment method for balloon-expandable transcatheter heart valves (THVs) has been developed(1) to improve clinical outcomes by regulating maximal annular wall tension during prosthesis expansion – to both optimise prosthesis-annulus apposition and diminish annular injury. The previous feasibility study(1) showed that THV deployment at wall tensions between 3-3.5 MPa may be associated with reduced paravalvular-leak (PVL) severity and avoidance of annular rupture. Objective To prospectively evaluate the safety and efficacy of the pressure-regulated THV deployment strategy. Methods 341 consecutive patients with severe native aortic stenosis and moderate-severe surgical risk who underwent TAVI with Sapien 3 THVs using a pressure-regulated deployment strategy were included. Target (maximal) deployment pressure was adjusted according to valve size: 5 atm for 29mm, 5.5 atm for 26mm and 6.25 atm for 23mm THVs. Key procedural and clinical outcomes were recorded and analysed using uni- and multi-variate analyses. Results The average patient age was 82.1±6.9 years and 28.2% were female (see attached table). 29.3% had moderate-severe subannular calcification and 14.5% had estimated ≥20% THV oversizing based on TAVI CT. 112 patients (32.8%) were considered at high-risk of annular rupture(2). Post-dilatation rate was 8.2% and was independently associated only with the degree of THV oversizing (OR 3.5, p=0.007, for ≤5% oversizing). On TTE prior to discharge, 85.6% had none/trivial PVL and 14.4% had mild PVL with no observed moderate/severe PVL. Mild PVL was independently associated with age (OR 1.07, p=0.02, per year) and degree of THV oversizing (OR 2.4, p=0.02, for ≤5% oversizing). Resulting THV mean gradient on TTE was 9.7±3.5mmHg overall, with similar results between 23mm (10.5±3.2mmHg) and 26/29mm valves (9.6±3.5mmHg, p=0.2). New PPM rate was 9.6% and was independently associated only with pre-existing RBBB (OR 13.5, p&amp;lt;0.001). New LBBB rate was 11.2% was independently associated only with low THV implantation depth (OR 4.3, p=0.009, for ≤60% of THV length above native aortic annulus). There were no cases of aortic/annular rupture. Conclusions The pressure-regulated strategy for balloon-expandable THV deployment is associated with an excellent safety and efficacy outcomes profile. Notably, there was no significant difference in valve haemodynamics and degree of PVL post-implantation between the smaller (23mm) and larger (26/29mm) THV sizes. These findings suggest that standardisation of THV deployment pressure to achieve target wall tension results in improved haemodynamics, particularly in small-sized valves.Main Table (Truncated)PVL and MG according to THV size

Redo-TAVI with SAPIEN 3 in SAPIEN XT or SAPIEN 3 - impact of pre- and post-dilatation on final THV expansion.

When a balloon-expandable transcatheter heart valve (THV) is chosen to treat a failed balloon-expandable THV, there is a risk of underexpansion with a potential impact on performance. We aimed to assess the impact of pre- and post-dilatation on the expansion of balloon-expandable THVs after redo-transcatheter aortic valve implantation (TAVI). Redo-TAVI was performed on the bench with a 23 mm SAPIEN 3 (S3) implanted within a 23 mm SAPIEN XT (SXT) or a 23 mm S3, both of which served as the "failed" THVs. Pre- and/or post-dilatation was performed using a 23 mm non-compliant TRUE balloon. Expansion of the index and redo-THVs were assessed before and after pre-/post-dilatation using microcomputed tomography (micro-CT), and THV hydrodynamic testing was conducted. Without pre- or post-dilatation, the S3 was underexpanded, for all combinations, particularly in the mid-portion of the THV (18.6 mm and 19.7 mm representing 81% and 86% of the nominal diameter inside the SXT and S3, respectively). Pre- and post-dilatation had an additive effect on diameter expansion of the redo-THV, which remained constrained in most combinations. The only combination to achieve nominal expansion was the S3 in S3 when both pre- and post-dilatation were performed. The S3 remained underexpanded inside the SXT despite pre- and post-dilatation (93% in the mid-portion). Improved redo-THV expansion was accompanied by 2.7 mm (12%) overexpansion of the index THV. While all samples had acceptable hydrodynamic performance, the underexpanded samples had worse leaflet pinwheeling. When performing redo-TAVI with a 23 mm S3 inside a 23 mm SXT or S3, only the S3 in S3 with the use of pre- and post-dilatation reached full expansion. This underlines the importance of CT assessment of THV expansion and the role of pre-/post-dilatation.

Implantation depth of balloon-expandable transcatheter heart valves and risks for permanent pacemaker implantation and midterm adverse events.

Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve implantation (TAVI) and its impact on outcome remains controversial. This study aimed to analyze the effects of implantation depth on PPI at 30 days and assess its impact on outcome with the balloon-expandable Sapien 3 (S3) prosthesis. Between 2014 and 2018, 849 patients without previous pacemaker undergoing transfemoral TAVI with the S3 were included. Prosthesis implantation depth was measured and divided into Quintiles. An ordinal logistic regression was used to assess its association with PPI, while a multivariate logistic regression was performed to identify predictors of PPI. Survival analyses were performed with the Kaplan-Meier method and a multivariable Cox regression was performed to ascertain the impact of PPI on mortality. Overall, incidence of PPI at 30 days was 9.7%. Implantation depth decreased consistently from a median of 6.7 mm [5.55-8.00] in 2014 to 2.7 mm [2.30-3.50] in 2018 (p < 0.001). When considering Quintiles of implantation depth, incidence of PPI was significantly higher in upper Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (OR: 0.34, 95% CI: [0.16-0.73]; p = 0.003). In the adjusted multivariable logistic regression implantation depth persisted ad independent predictor of PPI at 30 days. Patients requiring PPI at 30 days displayed significantly higher mortality at 4 years compared to patients without PPI (49.5% vs. 40.0%; log-rank = 0.022). In a multivariate analysis, increased logistic EuroScore, diabetes mellitus, and history of atrial fibrillation, were independent predictors of all-cause mortality at 2 years. Higher prosthesis implantation relative to the virtual aortic annulus was significantly associated with reduced risk for PPI at 30 days. Patients with PPI at 30 days exhibited higher mortality during follow-up, however, only logistic EuroScore, diabetes mellitus, and history of atrial fibrillation were identified as independent predictors of mortality at 2 years.

Valve-in-valve procedures for degenerated surgical and transcatheter aortic valve bioprostheses using a latest-generation self-expanding intra-annular transcatheter heart valve.

Valve-in-valve (ViV) transfemoral transcatheter aortic valve implantation (TAVI) for failing aortic surgical bioprostheses or transcatheter heart valves (THV) has demonstrated a reasonable clinical and hemodynamic efficacy. Traditionally, self-expanding (SE) supra-annular THV are considered to result in superior hemodynamics compared with balloon-expandable intra-annular THV after ViV. However, so far no data are found on latest-generation intra-annular SE THV for aortic ViV procedures which might be superior with regard to coronary access or subsequent valve reintervention. We herein aim to evaluate a latest-generation SE intra-annular THV for aortic ViV procedures. Between May 2022 and November 2022, five consecutive patients (4/5 female with mean age of 76.2 years and mean Society of Thoracic Surgeons predicted risk of mortality score of 2.9%) received ViV TAVI using the Navitor system (Abbott, Chicago, IL, USA) for treatment of failing surgical bioprostheses or THV. Data were retrospectively analyzed according to updated Valve Academic Research Consortium 3 (VARC-3) definitions. At 30 days, absence of mortality and VARC-3 adjudicated clinical endpoints were documented. Echocardiography at 30 days revealed complete absence of paravalvular leakage and single-digit mean transvalvular gradients (mean of 6.0 mmHg) in all patients. The investigated intra-annular SE THV results in excellent 30-day outcomes for aortic ViV procedures for failing surgical bioprostheses or THV. Despite the intra-annular design, hemodynamic results were excellent, even in small bioprostheses. Ease of use of this valve platform is reflected by only two cycles of resheathing in five ViV procedures with hemodynamic stability during all steps of valve deployment.

Results of new-generation balloon vs. self-expandable transcatheter heart valves for bicuspid aortic valve stenosis.

Data comparing new-generation self-expandable (SEV, Evolut R/PRO) vs. balloon-expandable (BEV, SAPIEN 3/3Ultra) transcatheter heart valve replacement (TAVR) in bicuspid aortic valve stenosis (BAV) is limited. Our aim was to compare 30-day results of SEV and BEV implantations in patients with BAV. A total of 2009 patients underwent TAVR between April 2015 and June 2021 at our Centre. From our institutional registry, we identified 106 consecutive patients with BAV who underwent TAVR using SEV and BEV. A 106 patients (n = 68 BEV; n = 38 SEV) were included. Mean age was 74.6 ± 8.8 years (BEV) vs.75.3 ± 8.7 years (SEV) (p = 0.670) and Society of Thoracic Surgeons score was 2.6 ± 1.9 (BEV) vs. 2.6 ± 1.6 (SEV) (p = 0.374), respectively. Device landing zone calcium volume (DLZ-CV) was 1168 ± 811 vs. 945 ± 850 mm3 (p = 0.192). Valve Academic Research Consortium (VARC)-3 device success at 30 days was similar (BEV 80.9% vs. SEV 86.8%; p = 0.433). More post-dilatations were performed in SEVs (23.5% BEV vs. 52.6% SEV; p = 0.002). Overall mean gradient at 30 days follow-up was 11.9 ± 4.6 mmHG (BEV) vs. 9.2 ± 3.0 mmHG (SEV) (p = 0.002). A mild-moderate degree of paravalvular leak (PVL) was detected more often in the SEV group (7.4% vs. 13.2%; p = 0.305). A trend towards higher rate of permanent pacemaker implantation was observed in SEV (11.8% vs. 23.7%; p = 0.109). Treatment of BAV revealed similar performance using BEV and SEV. In this retrospective cohort study, hemodynamics were more favorable with the SEV, although there was a trend toward more PVL and significantly more post-dilations.

Three-step surgical management algorithm for annular rupture in transcatheter aortic valve replacement

ObjectiveWhereas transcatheter aortic valve replacement is widely implemented, annular rupture is a devastating complication and could be highly mortal. However, owing to its rare incidence, the optimal treatment algorithm has not been established. Thus, we evaluated the feasibility and effectiveness of a 3-step algorithm to treat annulus rupture. MethodsFrom 2009 to 2022, 8 patients of 1083 transcatheter aortic valve implantation (0.8%) developed annulus rupture and were treated with the three-step algorithm. The algorithm was composed of a first step (pericardial drainage and protamine neutralization with blood pressure control), second step (manual hemostatic compression via full/partial sternotomy), and a third step (conservative treatment or radical surgical correction). ResultsThe median age at the procedure was 85 (78-88) years and 7 female patients were included in this study. Two (25%) patients had end-stage renal failure under hemodialysis, and median Society of Thoracic Surgeons score was 8.9% (2.1%-23.2%). The implanted transcatheter heart valves (THVs) were 7 balloon-expandable THVs and 1 self-expandable THV with balloon postdilatation. Under this strategy, 8 (100%) patients underwent pericardial drainage as first step and 5 patients achieved hemostasis. Of these, patient 1 demonstrated bleeding from left sinus of Valsalva and required a Bentall procedure. Although the etiology of this phenomenon was not investigated by contrast-enhanced computed tomography, it might be derived from pseudoaneurysm rupture or delayed annular rupture. In 2 patients, the second step treatment was needed for hemostasis. Third-step treatment was conducted in 1 patient. Postoperatively, 6 patients could be discharged without critical complications whereas 2 patients died during the hospitalization. There were no other complications during the followed-up (584 [7-1614]) days. ConclusionsIn accordance with the three-step algorithm, 6 patients, including those with high-risk or inoperative status, survived.

Self-expanding vs. balloon-expandable transcatheter heart valves in small aortic annuli.

Clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is currently in the focus of clinical research. Patients with small aortic annulus are at higher risk to display PPM. Data on incidence and clinical consequences of PPM after TAVR with either balloon-expandable (BEV) or self-expanding (SEV) transcatheter heart valves in small aortic annulus are sparse. Patients with small aortic annulus (perimeter < 72 mm or aortic annulus area < 400 mm2) who underwent BEV or SEV with contemporary transcatheter heart valve types were identified from the institutional TAVR database. Propensity score matching was applied for imbalanced baseline characteristics between patients undergoing BEV or SEV. Echocardiography and clinical follow-up beyond 3 years was reported following VARC-3 recommendations. Primary endpoint was the incidence of pre-discharge PPM and its association with 3-year mortality. From a total of 507 patients with small aortic annulus, 192 matched patient pairs with SEV or BEV were identified. Mean age was 81 ± 7 (SEV) vs. 81 ± 6 (BEV) years (p = 0.5), aortic annulus perimeter was 69 ± 3 vs.69 ± 3 mm, (p = 0.8), annulus area was 357 ± 27 vs.357 ± 27 mm2 (p = 0.8), and EuroScore II was 5.8 ± 6.6 vs.5.7 ± 7.2 (p = 0.9). SEV resulted in less moderate (20% vs. 31%, p < 0.001) and severe pre-discharge PPM (9% vs.18%, p < 0.001) compared to BEV. At discharge (7 ± 4 vs. 12 ± 9 mmHg, p = 0.003) and at 1-year follow-up (7 ± 5 vs.13 ± 3 mmHg, p < 0.001), SEV displayed lower mean gradients compared to BEV. Estimated survival after SEV was 85% (95% confidence interval (CI): 80%-90%) at 1 year, 80% (95% CI: 75%-86%) at 2 years, and 71% (95% CI: 65%-78%) at 3 years; estimated survival after BEV was 87% (95% CI: 82%-92%) at 1 year, 81% (95% CI: 75%-86%) at 2 years, and 72% (95% CI: 66%-79%) at 3 years, with no significant difference among the groups (p = 0.9) Body surface area (OR: 1.35, p < 0.001), implantation of BEV (odds ratio (OR): 3.32, p < 0.001), and the absence of postdilatation (OR: 2.16, p < 0.001) were independent risk factors for any PPM. At 3 years, patients without PPM had a higher 3-year survival compared with patients with ≥moderate PPM (77% vs. 67%, p = 0.03). BEV implantation in patients with small annulus was associated with a twofold higher incidence of pre-discharge severe PPM compared to SEV implantation. Survival at 3 years after TAVR was similar after BEV and SEV. However, patients with the absence of pre-discharge PPM had a higher 3-year survival compared to patients with ≥moderate PPM.

Long-Term Outcomes after Transcatheter Mitral Valve-in-Valve or Valve-in-Ring Procedures.

Redo mitral valve surgery is the standard of care for failed mitral bioprostheses or recurrence of mitral regurgitation after repair. Nonetheless, catheter-based valve-in-valve (ViV) or valve-in-ring (ViR) procedures have increasingly become viable alternatives in high-risk subpopulations. Despite reported good initial results, little is known about longer-term outcomes. Here, we report the long-term outcomes of transcatheter mitral ViV and ViR procedures. All consecutive patients (n = 54) undergoing transcatheter mitral ViV or ViR procedures for failed bioprostheses or recurring regurgitation after mitral repair in the time period between 2011 and 2021 were retrospectively enrolled. The mean age was 76.5 ± 6.5 years, and 30 (55.6%) of the patients were male. The procedures were done using a commercially available balloon-expandable transcatheter heart valve. Clinical and echocardiographic follow-up data were obtained from the hospital's database and analyzed. Follow-up reached up to 9.9 years with a total of 164.3 patient-years. A total 25 patients received a ViV and 29 patients a ViR procedure. Both groups were at high surgical risk with an STS-PROM of 5.9 ± 3.7% in ViV and 8.7 ± 9.0% in ViR patients (p < 0.01). The procedures themselves were mainly uneventful with no intraoperative deaths and a low conversion rate (n = 2/54; 3.7%). VARC-2 procedural success was low (ViV 20.0% and ViR 10.3%; p = 0.45), which was either driven by high rates of transvalvular pressure gradients ">5 mmHg" (ViV 92.0% and ViR 27.6%; p < 0.01) or residual regurgitation ">trace" (ViV 28.0% and ViR 82.7%; p < 0.01). ICU-stay was prolonged in both groups (ViV 3.8 ± 6.8 days and ViR 4.3 ± 6.3 days; p = 0.96) with acceptable hospital stay (ViV 9.9 ± 5.9 days and ViR 13.5 ± 8.0 days; p = 0.13). Despite 30-day mortality being acceptable (ViV 4.0% and ViR 6.9%; p = 1.00), the mean posthospital survival time was disappointingly low (ViV 3.9 ± 2.6 years and ViR 2.3 ± 2.7 years; p < 0.01). Overall survival in the entire group was 33.3%. Cardiac reasons for death were frequent in both groups (ViV 38.5% and ViR 52.2%). Cox-regression analysis identified ViR procedures as a predictor of mortality (HR 2.36, CI 1.19-4.67, p = 0.01). Despite acceptable immediate outcomes in this high-risk subpopulation, long-term results are discouraging. Transvalvular pressure gradients as well as residual regurgitations remained drawbacks in this real-world population. The indication for catheter-based mitral ViV or ViR procedures rather than conventional redo-surgery or conservative treatment must be thoughtfully considered.

Última generación de prótesis percutáneas expandibles con balón y autoexpandibles en la estenosis aórtica bicúspide: estudio TRITON

Introduction and objectivesNo comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. MethodsMulticenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. ResultsA total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. ConclusionsIn patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.Full English text available from:www.revespcardiol.org/en

Myval: A Novel Transcatheter Heart Valve for the Treatment of Severe Aortic Stenosis.

Transcatheter aortic valve implantation (TAVI) performed using femoral arterial access is now a guideline recommended treatment for severe calcific aortic stenosis (AS) in elderly patients. Technological advancements and procedural refinements have focused on making TAVI simpler, safer, more effective and durable. Myval (Meril Lifesciences) is a new generation balloon-expandable transcatheter heart valve (THV) developed in India that possesses novel features to improve deliverability and aid precise deployment. Following the first-in-human study, Myval was approved in India for commercial implantation in October 2018 and was subsequently given a CE mark in April 2019. This article reviews the science, technology and up-to-date clinical evidence for the Myval THV.

Explant vs Redo-TAVR After Transcatheter Valve Failure: Mid-Term Outcomes From the EXPLANTORREDO-TAVR International Registry

BackgroundValve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. ObjectivesThe authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. MethodsFrom May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. ResultsThe incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis–patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). ConclusionsIn this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis–patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.