SAPIEN Transcatheter Heart Valve Research Articles

Outcomes of Transcatheter Mitral Valve Replacement with Sapien Transcatheter Heart Valve for Degenerated Bioprostheses and Failed Annuloplasty Rings: A Meta-Analysis

Outcomes of Transcatheter Mitral Valve Replacement with Sapien Transcatheter Heart Valve for Degenerated Bioprostheses and Failed Annuloplasty Rings: A Meta-Analysis

How to evacuate when Sapien3 transcatheter heart valve cannot pass through a severely calcified aortic valve.

How to evacuate when Sapien3 transcatheter heart valve cannot pass through a severely calcified aortic valve.

Self-Expanding Transcatheter Aortic Valves Optimize Transvalvular Hemodynamics Independent of Intra- Versus Supra-Annular Design

This study sought to characterize transvalvular hemodynamics during the first 30days after transcatheter aortic valve implantation (TAVI) across various transcatheter heart valves (THVs), while adjusting for annular dimensions. This was an observational study of TAVIs from September 2021 to October 2022. The primary outcome was mean transvalvular pressure gradient (TVPG), measured using transthoracic echocardiography at day 0, day 1, and day 30 post-TAVI, and were compared across 3 THV, including the self-expandable intra-annular Portico (Abbott Vascular, Santa Clara, California) valve, the balloon-expandable SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California), and the self-expandable supra-annular Evolut Pro+ (Medtronic, Minneapolis, Minnesota). A total of 560 patients who underwent TAVI were identified, of which 106 (18.9%) received a Portico THV, 176 (31.4%) received a SAPIEN THV, and 278 (49.6%) received an Evolut THV. For Portico THV, the TVPG on day 0 increased from 6.0 (4.7 to 9.0) to 7.0 (6.0 to 10.0) by day 30 (p=0.009). For SAPIEN THV, the TVPG on day 0 increased from 6.5 (5.0 to 8.0) to 12.0 (9.0 to 15.0) by day 30 (p <0.001). For Evolut THV, the TVPG on day 0 increased from 6.0 (5.0 to 9.0) to 7.2 (5.0 to 10.0) by day 30 (p=0.001). Adjusting for time and annular diameter in a multivariable mixed effects model, the SAPIEN group had a significantly greater increase in TVPG over time than the Evolut reference group (p <0.001), while there was no difference in the change of TVPG over time for the Portico group vs. the Evolut group (p=0.874). In conclusion, compared with balloon-expandable valves, self-expanding THV may optimize transvalvular hemodynamics across all annular diameters, independent of their supra-annular and intra-annular design.

Transcatheter Mitral Valve Replacement in Patients with Mitral Annular Calcification: A Review.

Mitral annular calcification (MAC) is a progressive degenerative calcification of the mitral valve (MV) that is associated with mitral stenosis, regurgitation or both. Patients with MAC are poor candidates for MV surgery because of technical challenges and high peri-operative mortality. Transcatheter MV replacement (TMVR) has emerged as an option for such high surgical risk patients. This has been described with the use of the SAPIEN transcatheter heart valve (valve-in-MAC) and dedicated TMVR devices. Careful anatomic assessment is important to avoid complications of TMVR, such as left ventricular outflow tract obstruction, valve migration, embolization and paravalvular mitral regurgitation. In this review, we discuss the pathology, importance of preprocedural multimodality imaging for optimal patient selection, clinical outcomes and complications associated with TMVR in patients with MAC.

Abstract 12383: Large Field-of-View Intravascular Ultrasound for Peri-Procedural Assessment of Stent Frame Expansion After Transcatheter Heart Valve-in-Valve

Introduction. It is unknown whether large field-of-view intravascular ultrasound (IVUS) can be a valid peri-procedural imaging tool to assess actual expansion of transcatheter heart valve (THV) during valve-in-valve procedures. Hypothesis. To compare % expansion of SAPIEN 3 THV measured with peri-procedural IVUS versus post-procedural cardiac gated contrast multi-slice computer tomography (MSCT). Expansion was defined as actual outer frame area/nominal area x 100%. Methods. Studied were patients with successful valve-in-valve for failed surgical mitral and tricuspid bioprosthetic valves. All underwent peri-procedural IVUS using 10MHz Vision PV035 (Philips North America Corporation, Andover, USA) and post-procedural MSCT (SOMATOM Definition Flash, Dual Source, SIEMENS). IVUS and MSCT (Syngo Via, Siemens, Germany) measurements were off -line and done at 1-mm step along the entire height of SAPIEN 3 THV (height 18, 20 and 22 mm for the Sapien THV 23, 26 and 29 mm, respectively). Results. Five patients (68.8±11.2 years, 3 female) were treated for failed surgical mitral (n=3) and tricuspid (2) bioprosthetic valves using SAPIEN 3 THV size 23mm (n=1), 26mm (n=1), and 29mm (n=3). Mean peri-procedural and pre-discharge residual transvalvular gradient differed substantially (1.9±0.9 vs 7.9±1.1mmHg, p=0.001). In total, 104 corresponding cross-sections of the THVs were measured with both IVUS and MSCT. Actual outer-frame SAPIEN 3 expansion was smaller within the lengths of inflow and mid segment (overlapping the ring) than in the outflow, being substantially smaller than nominal (Fig 1). Overall, there was very good agreement between % expansion of THV stent frame assessed in IVUS and MSCT (93.5%±13.3% vs 96.3%±11.3%; r =0.976 and p&lt;0.001). Conclusions. Peri-procedural use of large field-of-view IVUS offers an accurate insight into actual THV expansion deployed valve-in-valve. Figure 1. % expansion of SAPIEN 3 measured in IVUS and MSCT.

Transcatheter Pulmonary Valve Replacement: A Review of Current Valve Technologies

<h2>Abstract</h2> Transcatheter pulmonary valve replacement was first performed by Dr Philip Bonhoeffer, who implanted a Medtronic Melody valve in a human in 2000. Over the past 2 decades, there have been many advances in transcatheter pulmonary valve technology. This includes the use of the SAPIEN transcatheter heart valve in the pulmonary position, modifications and refinements to valve implantation procedures, and development of self-expanding valves and prestents to treat large diameter native or patched right ventricular outflow tracts. This article reviews the current transcatheter pulmonary valve technologies with a focus on valve design, screening process, implant procedure, and clinical outcomes.

DIRECT TRANS-ATRIAL IMPLANTATION OF SAPIEN 3 VALVE FOR MITRAL ANNULAR CALCIFICATION: MULTI CENTER EXPERIENCE

Mitral valve replacement in the presence of severe annular calcification is associated with high morbidity and mortality. As an alternative strategy for addressing severe MAC in patients with high surgical risk, a transcatheter heart valve (THV) can be implanted surgically into the annulus via a trans-atrial approach. This study reports the short and intermediate clinical outcomes of MVR via a direct surgical approach using the SAPIEN3 THV in patients with severe circumferential MAC at two Canadian centers.

Hemodynamic Performance of Two Current-Generation Transcatheter Heart Valve Prostheses in Severely Calcified Aortic Valve Stenosis.

Background: Treatment of severely calcified aortic valve stenosis is associated with a higher rate of paravalvular leakage (PVL) and permanent pacemaker implantation (PPI). We hypothesized that the self-expanding transcatheter heart valve (THV) prostheses Evolut Pro (EPro) is comparable to the balloon-expandable Sapien 3 (S3) regarding hemodynamics, PPI, and clinical outcome in these patients. Methods: From 2014 to 2019, all patients with very severe calcification of the aortic valve who received an EPro or an S3 THV were included. Propensity score matching was utilized to create two groups of 170 patients. Results: At discharge, there was significant difference in transvalvular gradients (EPro vs. S3) (dPmean 8.1 vs. 11.1 mmHg, p ≤ 0.001) and indexed effective orifice area (EOAi) (1.1 vs. 0.9, p ≤ 0.001), as well as predicted EOAi (1 vs. 0.9, p ≤ 0.001). Moderate patient prosthesis mismatch (PPM) was significantly lower in the EPro group (17.7% vs. 38%, p ≤ 0.001), as well as severe PPM (2.9% vs. 8.8%, p = 0.03). PPI and the PVL rate as well as stroke, bleeding, vascular complication, and 30-day mortality were comparable. Conclusions: In patients with severely calcified aortic valves, both THVs performed similarly in terms of 30-day mortality, PPI rate, and PVL occurrence. However, patient prothesis mismatch was observed more often in the S3 group, which might be due to the intra-annular design.

A Modified Buddy-Wire Technique for Crossing of the Interatrial Septum With the Sapien 3 Valve During Transseptal Mitral Valve-in-Valve/Ring Procedures

BackgroundCrossing of the interatrial septum (IAS) with the Edwards Sapien-3 transcatheter heart valve (THV) may fail, despite preparatory balloon septostomy. A planned buddy guidewire placed in the left ventricle may help facilitate crossing of the IAS and mitral bioprosthesis with the THV. MethodsA retrospective study of 12 consecutive patients undergoing transseptal, mitral valve-in-valve or valve-in-ring procedures using the Edwards Sapien-3 THV since 2018 with a planned buddy-wire technique. The primary endpoint was the composite of successful delivery of the buddy wire and deployment of the first intended Sapien 3 within the mitral valve without removal from the body, additional interatrial septal puncture, or placement of a further buddy wire. Secondary objectives included safety endpoints, as follows: access-site bleeding, tamponade, stroke, intraprocedural death, sustained ventricular arrhythmia, and 30-day vascular complications. ResultsFrom January 2018 to March 2022, a total of 12 consecutive patients who underwent transseptal mitral valve-in-valve (9) or valve-in-ring (3) procedures were identified. Three patients (25%) required repeat septostomy on the buddy wire after initial THV crossing failure. Crossing of the IAS and successful deployment in the mitral valve with the THV was achieved in all cases, without removal from the body or need for an additional wire or septal puncture. No access-site bleeding, stroke, tamponade, ventricular arrhythmia, intraprocedural death, or 30-day vascular complication occurred. ConclusionsThe planned buddy-wire technique was successful in all cases and facilitated successful crossing of the IAS and deployment of the THV in the mitral position without removal from the body, additional wires, or septal punctures, with no adverse events.

Transcatheter tricuspid valve-in-valve implantation with bioprosthetic balloon expandable valve.

This study was conducted to evaluate the outcome of the transcatheter valve-in-valve implantation for degenerated tricuspid bioprosthetic valves with transcatheter aortic valves. This retrospective study enrolled all consecutive patients who were considered high risk for reoperations by the heart team and who underwent transcatheter valve-in-valve implantation for degenerated tricuspid bioprosthetic valves in Tehran Heart Center, Tehran, Iran. All the procedures were performed via the transfemoral venous route under echocardiography and fluoroscopy guidance with Edwards SAPIEN transcatheter heart valves (Edwards Lifesciences, Irvine, CA). Ten patients underwent successful transcatheter valve-in-valve implantation in the tricuspid position without any major complications or need for emergency surgical interventions. The mean age was 54.1 ± 17.1years, and 8 patients were female. The median follow-up was 19.5months (16-32.25 mon). The mean period between the last tricuspid valve replacement and transcatheter valve-in-valve implantation was 4.9 ± 2.2years. The bioprosthetic valves were Hancock in three patients, Mosaic in the other three patients, and Biocor, Pericarbon, Perimount, and Epic in the other patients. After the procedure, the clinical and functional status improved significantly in all the patients. The mean transvalvular gradient decreased from 6.75 ± 2.66mm Hg to 2.85 ± 0.89 (P < 0.001), and the postoperative tricuspid regurgitation severity decreased significantly in almost all the patients. The hospitalization period after the procedure was 4.4 ± 1.7days. In high-risk patients, transcatheter valve-in-valve implantation seems to be a safe and minimally invasive alternative to reoperations for degenerated tricuspid bioprosthetic valves.

Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States.

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Early clinical and haemodynamic matched comparison of balloon-expandable valves

ObjectivesThe balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter...

Prosthesis-patient mismatch is an independent predictor of congestive heart failure after transcatheter aortic valve replacement

Little is known about the effect of prosthesis-patient mismatch (PPM) on outcomes after transcatheter aortic valve replacement. We reported previously an increased risk of PPM with the SAPIEN 3 transcatheter heart valve (S3-THV). To investigate the association of PPM with 1-year outcomes in patients with severe aortic stenosis (AS) implanted with S3-THV. Moderate PPM was defined by an indexed effective orifice area (iEOA)≤0.85cm2/m2, and severe PPM by an iEOA<0.65cm2/m2. Inclusion criteria were severe symptomatic AS and implantation with S3-THV. The primary endpoint was hospitalization for congestive heart failure (CHF) at 1 year; the secondary endpoint was all-cause mortality. A total of 208 consecutive patients were included between 2016 and 2018. Male sex was prevalent (53.8%), mean age was 81.9±6.2 years, mean EuroSCORE II was 4.35±3.37, mean LVEF was 57.9±13%. Moderate and severe PPM were observed in 69 (33.2%) and 10 (4.8%) patients. Patients with PPM were younger (80.4±7 vs 82.8±5.41 years; P=0.006), had a larger BSA (1.84±0.19 vs 1.77±0.19 m2; P=0.01), a lower iEOA (0.73±0.08 vs 1.11±0.22 cm2/m2; P<0.001) and a higher mean gradient (14±4.6 vs 11.9±3.9mmHg; P<0.001). CHF occurred in 16.5% vs 7% (P=0.03). By multivariable analysis, PPM was independently associated with CHF (hazard ratio [HR] 3.17, 95% confidence interval [CI] 1.17 to 8.55; P=0.032), especially in patients with mitral regurgitation≥2/4 (HR>100, 95%CI>100 to>1000; P<0.01). PPM did not correlate with all-cause mortality (HR 0.90, 95%CI 0.22 to 3.03; P=0.86). PPM after S3-THV implantation is strongly associated with CHF at 1 year, but is not correlated with overall mortality.

Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial

The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis. The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000,137-40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR. The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.

Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography.

The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography. Expanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR. In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility. After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p=0.009). For these coronary arteries originating below the top of theneo-skirt, the distance between the THV and the aortic wall was<3mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p=0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p=0.121). Absence of THV interference with coronary accessibility canbe expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p=0.005). Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVswith intra-annular leaflet position or low commissural height and large open cells may be preferable intermsofcoronary access after TAVR-in-TAVR.

A bench test study of bioprosthetic valve fracture performed before versus after transcatheter valve-in-valve intervention.

Bioprosthetic valve fracture (BVF) may improve transvalvular gradients and transcatheter heart valve (THV) expansion during VIV interventions. However, the optimal timing of BVF is unknown. We assessed the impact of timing of BVF (before versus after) for valve-in-valve (VIV) intervention, on hydrodynamic function and THV expansion. Three THV designs were assessed, a 23 mm SAPIEN 3 (S3), small ACURATE neo (ACn) and 23 mm Evolut R, deployed into 21 mm Mitroflow bioprosthetic surgical valves. We evaluated each THV in three groups: 1) no BVF, 2) BVF before VIV, and 3) BVF after VIV. Hydrodynamic testing was performed using a pulse duplicator to ISO 5840:2013 standard. Transvalvular gradients were lower when BVF was performed after VIV for the S3 (no BVF 15.5 mmHg, BVF before VIV 8.0 mmHg, BVF after VIV 5.6 mmHg), and the ACn (no BVF 9.8 mmHg, BVF before VIV 8.4 mmHg, BVF after VIV 5.1 mmHg). Transvalvular gradients were similar for the Evolut R, irrespective of performance of BVF or timing of BVF. BVF performed after VIV resulted in better expansion in all three THV designs. The ACn and Evolut R samples all had a mild degree of pinwheeling, and BVF timing did not impact on pinwheeling severity. The S3 samples had severe pinwheeling with no BVF, and significant improvement in pinwheeling when BVF was performed after VIV. BVF performed after VIV was associated with superior THV expansion in all three THV designs tested, with lower residual transvalvular gradients in the S3 and ACn THVs. The Evolut R had similar hydrodynamic performance irrespective of BVF timing. Timing of BVF has potential implications on THV function.

Overexpansion of older generation balloon expandable transcatheter heart valves: An ex-vivo bench study.

The SAPIEN 3 (S3) transcatheter heart valve (THV) can be over-expanded beyond its labeled diameter. Overexpansion can be achieved with use of either a compliant or non-compliant balloon. Objective data regarding the ability to over-expand older generation balloon expandable valves are limited. We sought to assess the effects of over-expanding the SAPIEN and SAPIEN XT (Edwards Lifesciences, Irvine, CA) valve beyond labeled size (diameter) through an ex-vivo bench study. We assessed SAPIEN and SAPIEN XT THVs, sized 23/26 mm and 23/26/29 mm, respectively. The SAPIEN THVs were explanted samples. Valves were expanded to nominal dimensions, and then incrementally overexpanded with balloons sized 1-, 2-, and 3-mm larger than the recommended diameter. When an appropriate sized non-compliant balloon was not available, a compliant balloon was utilized. Valves underwent visual and radiographic assessment of overexpansion. SAPIEN THVs with labeled size of 23 and 26 mm could be incrementally overexpanded to midvalve (MV) diameters of 26.7 and 27.4 mm, respectively. SAPIENT XT THVs with labeled size of 23, 26, and 29 mm could be incrementally overexpanded to MV diameters of 26.8, 28.3, and 28.8 mm, respectively. The desired degree of overexpansion was only achieved with use of non-compliant balloons and not with compliant balloons. The outflow of the SAPIEN and SAPIEN XT had larger diameters than the MV and inflow of the THV. Overexpansion of older generation SAPIEN and SAPIEN XT THVs is possible. Achieving the desired degree of overexpansion was only achieved with use of non-compliant balloons. This has potential implications for the treatment of failed THVs.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system.

Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the RVOT or pulmonary valve. There are no multicentre data on the feasibility and safety of percutaneous pulmonary valve implantation (PPVI) using the SAPIEN 3 (S3) transcatheter heart valve. The aim of this study was to explore the short-term safety, feasibility, and haemodynamic outcomes of PPVI using the S3 transcatheter heart valve. Pulmonic S3 is an observational registry of patients undergoing PPVI with the S3 valve across centres in Europe and Canada. Data for 82 patients (mean age 27.3 years) were obtained. The most common underlying diagnosis was tetralogy of Fallot (ToF) (58.5%), with 16.0% of patients having native RVOT anatomy; 90.2% received pre-stenting. Prosthesis dislodgement occurred in one patient and conduit perforation in another. Both were successfully resolved without the need for open surgery. Peak systolic gradient over the RVOT fell from 46.3 mmHg to 17.2 mmHg, moderate/severe pulmonary regurgitation from 86.3% to 0.0%, and NYHA ≥II from 86.0% to 15.2%. During follow-up, valve thrombosis was observed in two patients which resolved with adequate anticoagulation. No other procedural complications, endocarditis, stent fracture or death were reported within two years. PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes.

Prosthesis patient mismatch is an independent predictor of congestive heart failure after transcatheter aortic valve replacement

Little is known about the impact of prosthesis-patient mismatch (PPM) on outcomes after trans-catheter aortic valve replacement (TAVR). We reported previously an increased risk of PPM with Sapien 3 transcatheter Heart valve (S3-THV). We aimed to investigate the one-year outcomes of patients operated on for severe aortic stenosis (AS) with S3-THV based on the occurrence of PPM. Indexed effective orifice area (iEOA) was estimated by post-procedural echocardiography(TTE). PPM was defined as moderate when 0.65 cm 2 ≤ Ieoa ≤ 0.85 cm 2 , or severe if iEOA < 0.65 cm 2 /m 2 . Inclusion criteria: severe symptomatic AS implanted with S3-THV. Primary endpoint: one-year overall mortality secondary endpoint: hospitalization for congestive heart failure (CHF). A total of 227 consecutives patients were included between January 2015 and December 2016. Of the 208 patients with complete follow-up, mean age was 81.9 ± 6, mean Euroscore2 was 4.35 ± 3.4, mean baseline LVEF was 58 ± 13%. At post-procedural TTE, moderate and severe PPM were observed in 69 (33%) and 10 (4.8%) patients respectively. Patients with PPM were younger (80.4 ± 7 vs. 82.9 ± 5, P = 0.007), had a larger body surface area (1.84 ± 0.19 vs. 1.77 ± 0.19, P = 0.01), a lower iEAO (0.73 ± 0.1 vs. 1.1 ± 0.2, P < 0.001) and a higher mean gradient (12 ± 4 vs. 14 ± 5 mmHg, P < 0.001). At 1 year, the estimated overall mortality was similar between the PPM and non PPM groups (5.1% vs. 5.4%, P = 0.97); the PPM group had a significantly higher incidence of CHF at one year follow-up (16.5% vs. 7%, P = 0.04). By multivariate analysis, PPM (HR = 2.4 [1.02–6], P = 0.04) independently predicted CHF whereas LVEF, Paravalvular leakage ≥1, age and male gender did not. By subgroup analysis, patients with MR ≥2 were more vulnerable to PPM as they experienced a prohibitive risk of CHF (HR = 51.4 [2.61–99], P = 0.006). PPM after TAVR with S3-THV is not a risk factor for midterm mortality but is an independent predictor of CHF, especially in the subset of patients with MR ≥2.

Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra

ABSTRACTIntroduction: Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future.Areas covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the balloon-expandable Edwards SAPIEN valve in patients deemed in-operable and at high-risk, and later on in intermediate-risk patients using the balloon-expandable SAPIEN-XT valve. These trials had laid the groundwork for advancements incorporated in the balloon-expandable SAPIEN-3 system such as the introduction of the anti-leak skirt and improved delivery system. In this review, we summarize the available data on the SAPIEN-3 transcatheter heart valve system and we highlight the special features of the newly designed self-expanding Edwards CENTERA valve, and the latest generation of balloon-expanable SAPIEN-3 Ultra™ system. A detailed literature search on these devices was undertaken using Ovid, PubMed, and Web of Science.Expert commentary: Data from clinical trials show that TAVI with newer-generation of Edwards transcatheter heart valve systems have shown significant improvement in terms of reduced paravalvular leak and have been associated with extremely good clinical outcomes.