SAPIEN XT Transcatheter Heart Valve Research Articles

Repeat transcatheter aortic valve implantation and implications for transcatheter heart valve performance: insights from bench testing.

THV implantation within failed surgical valves is well established. However, the implications of THV implantation within failed THVs are poorly understood. This study aimed to assess the impact of different transcatheter heart valve (THV) designs and implant positioning strategies on hydrodynamic performance after redo transcatheter aortic valve implantation (TAVI). THVs of varying design (SAPIEN 3, Evolut PRO, ACURATE neo, ALLEGRA, and Portico) and size were implanted inside SAPIEN XT and Evolut R THVs. Hydrodynamic function as per International Organization for Standardization (ISO) specifications was evaluated using a pulse duplicator, and multi-modality imaging was performed. The majority of tested THV-in-THV combinations resulted in stable anchoring of the new implant. However, some combinations resulted in unstable anchoring with the potential for dislodgement or embolisation. Hydrodynamic function was favourable for all tested THV designs implanted in the intra-annular SAPIEN XT THV. SAPIEN 3 implantation within an Evolut THV with supra-annular leaflets must be appropriately sized to ensure adequate anchoring. Avoidance of an intra-annular deployment mitigated leaflet overhang of the Evolut leaflets and optimised hydrodynamic performance. This study demonstrates that most THV designs and implantation strategies can result in favourable hydrodynamic performance following redo TAVI. Whether the leaflets of a failed THV are intra- or supra-annular may have important implications for the positioning of a redo-THV implant. Certain THV designs or implantation positions may be more desirable when performing redo TAVI.

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

Objectives:The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves.Background:Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI.Methods:This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database.Results:The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246).Conclusion:The Myval THV, in comparison with other BEV’s analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE–AU Trial

To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk. Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular complication, and valve-related dysfunction requiring repeat procedure. Other endpoints were device success (successful vascular access, delivery, and deployment; correct position; intended performance mean aortic valve gradient <20 mmHg, mild or less paravalvular aortic regurgitation [PAR]; and only one valve implanted) and New York Heart Association functional class (NYHA). Kaplan-Meier (KM) estimates were calculated for the primary endpoint. At baseline, mean patient (N=199) age was 85.5 years, mean Society of Thoracic Surgeon score was 5.9, and 78.4% were in NYHA class III/IV. The primary composite endpoint KM estimate was 12.1%. Device success was 88.8%. SAPIEN XT was implanted in the proper location in 98.5% (n=2: valve-in-valve procedures, n=1: no implant due to left main coronary artery occlusion). No device malfunctions were reported. The post procedure PAR was mild or less in 93.8% of patients. Mean aortic gradient decreased from baseline (50.0 mmHg) to 2 years (10.3 mmHg). Most patients (90.9%) were in NYHA class I/II at 30 days. New permanent pacemaker rate was 8.1%. Stroke at 30 days was 3.5% (1.5% disabling). SAPIEN XT was safe and improved heart failure symptoms and valve haemodynamics in this cohort of Australian patients.

Outcomes of transcatheter aortic valve implantation for intermediate-risk patients in Australia: the SOLACE-AU trial

Background: Few studies have examined the safety and efficacy of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) in Australian patients. SOLACE-AU was a single-arm, open-label clinical trial conducted in Australian hospitals to determine the safety, performance, and cost implications of TAVI in patients with severe, symptomatic AS at intermediate surgical risk.Methods: This was a prospective, pragmatic, single-arm, multi-center, observational trial of 199 patients with severe, symptomatic AS treated with transfemoral TAVI using the SAPIEN XT transcatheter heart valve (THV) at 11 hospitals in Australia. The primary outcome was Valve Academic Research Consortium-2 (VARC-2) criteria – a composite of seven safety endpoints. Kaplan–Meier (KM) estimates and descriptive analyses were used to evaluate the impact of transfemoral TAVI on safety and valve performance. We also evaluated patient health-related quality of life (QoL) and healthcare resources used throughout the trial.Results: The valve was successfully implanted in 88% of patients. The VARC-2 outcome at 30 days was 12.1% (95% CI: 8.3–17.5%), and almost 90% of patients had improved heart failure symptoms at 1 year based on New York Heart Association functional class criteria. Patient QoL remained stable over time, with mean EQ-5D-3L scores being 0.71 ± 0.20 at baseline and 0.71 ± 0.21 at 2 years. Duration of post-procedure hospitalization (mean: 6.9 ± 4.7 days) decreased as procedural familiarity increased. The median total cost of TAVI decreased 10.1% at 3 years after introduction of the procedure at the sites.Conclusions: The SOLACE-AU trial demonstrated favorable safety and performance of the SAPIEN XT valve in patients with AS at intermediate risk of surgical complications.

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.

Semi-automatic CT-angiography based evaluation of the aortic annulus in patients prior to TAVR: interchangeability with manual measurements.

To compare a semi-automatic software tool for the measurement of aortic annulus dimensions with manual measurements by expert readers and to analyze whether and to what extent interchangeability exists between semi-automatic and manual measurements. We retrospectively included 374 consecutive patients with high-grade aortic stenosis who had undergone CT-angiography of the heart prior to trans-catheter aortic valve replacement (TAVR). In independent analyses, two expert readers manually measured aortic annulus dimensions (long axis, short axis, circumference, area) as well as the distance of the coronary ostia from the annulus plane. A third independent reader performed annulus evaluation using a software tool for semi-automatic detection and measurement of the annulus plane. Intraclass correlation coefficients (ICC) and Bland-Altman analysis was used to compare both manual measurements as well as manual and semi-automatic measurements of annulus parameters. Using the respective measurements we simulated size selection for a Sapien XT transcatheter heart valve (THV). Interchangeability of methods was addressed by calculation of the estimated individual equivalence index γ. There was excellent agreement between both expert observers in manual measurements of the annulus with ICC's in the range 0.89-0.94 for all anatomic parameters. Similar high agreements were observed between semi-automatic and manual measurements, with ICC's in the range of 0.89-0.95. THV size recommendation based on manual versus semiautomatic measurements agreed in 80.7% of cases while agreement between both expert readers concerning THV size recommendation was 80.6%. Semi-automatic measurements of anatomic parameters of the aortic root show high agreement and interchangeability with manual measurements in CT-angiography prior to TAVR.

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

Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking. We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years. The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS. NCT02302131.

A Transcatheter Aortic Valve Implantation Without Aortography Guidance Due To Vascular Access Constraints Or Limitations

Introduction Aortic valve replacement (AVR) is an established treatment modality in patients with severe symptomatic aortic stenosis (AS)., Given the increased mortality and morbidity of AVR for the high-risk patients and the poor long-term results of balloon aortic valvuloplasty, transcatheter aortic valve implantation (TAVI) is increasingly accepted treatment option who are not candidates for AVR. We describe here a case of succesfully implanted Edwards SAPIEN XT transcatheter heart valve without aortography guidance due to multiple arterial access problems and complicated [...]

Transcatheter aortic valve implantation in patients with small aortic annuli using a 20 mm balloon-expanding valve

BackgroundWhile transcatheter aortic valve implantation (TAVI) is established for treating high-operative risk surgical aortic valve replacement candidates, until recently the smallest transcatheter heart valve (THV) measured 23 mm, posing greater...

In vitro evaluation of valve-in-valve combinations using a SAPIEN XT valve implanted within PERIMOUNT and Magna Ease pericardial bioprostheses.

Implantation of a transcatheter heart valve to treat valve failure is an attractive option which is being used more frequently. Despite large clinical experience there is a paucity of in vitro data to support this treatment. Our aim was to provide in vitro performance data on the SAPIEN XT transcatheter heart valve implanted within two types of pericardial surgical heart valve. A SAPIEN XT was implanted within multiple sizes, i.e., 21, 23, 25 of Magna Ease and explanted calcified PERIMOUNT valves. Each combination underwent in vitro testing according to the ISO 5840 guidance. Combinations were evaluated for embolisation and acute and long-term haemodynamic performance. All combinations met the ISO 5840 minimum requirements for effective orifice area (EOA) and regurgitant fraction at the initiation of the study, after 20 million and 200 million cycles. EOA was above 1.4 cm2 for all valve combinations with Magna Ease and above 1.22 cm2 with PERIMOUNT combinations. Regurgitant fraction was ≤7% for SAPIEN XT-Magna Ease combinations and was ≤10% for SAPIEN XT-PERIMOUNT combinations, which also met the ISO requirements. No embolisation was observed. The largest migration was 1.2 mm. In vitro tests demonstrate excellent haemodynamic performance and durability in the six VIV combinations which are commonly seen in clinical practice.

Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: A single-center experience.

AIMTo investigate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (S3-THV) vs the SAPIEN XT valve (XT-THV).METHODSWe retrospectively analyzed 507 patients that underwent TAVI with the XT-THV and 283 patients that received the S3-THV at our institution between March 2010 and December 2015.RESULTSThirty-day mortality (3.5% vs 8.7%; OR = 0.44, P = 0.21) and 1-year mortality (25.7% vs 20.1%, P = 0.55) were similar in the S3-THV and the XT-THV groups. The rates of both major vascular complication and paravalvular regurgitation (PVR) > 1 were almost 4 times lower in the S3-THV group than the XT-THV group (major vascular complication: 2.8% vs 9.9%, P < 0.0001; PVR > 1: 2.4% vs 9.7%, P < 0.0001). However, the rate of new pacemaker implantation was almost twice as high in the S3-THV group (17.3% vs 9.8%, P = 0.03). In the S3 group, independent predictors of new permanent pacemaker were pre-procedural RBBB (OR = 4.9; P = 0.001), pre-procedural PR duration (OR = 1.14, P = 0.05) and device lack of coaxiality (OR = 1.13; P = 0.05) during deployment.CONCLUSIONThe S3-THV is associated to lower rates of major vascular complications and PVR but higher rates of new pacemaker compared to the XT-THV. Sub-optimal visualization of the S3-THV in relation to the aortic valvular complex during deployment is a predictor of new permanent pacemaker.

Improving the accuracy of effective orifice area assessment after transcatheter aortic valve replacement: validation of left ventricular outflow tract diameter and pulsed-wave Doppler location and impact of three-dimensional measurements.

Echocardiographic calculation of effective orifice area (EOA) after transcatheter aortic valve replacement is integral to the assessment of transcatheter heart valve (THV) function. The aim of this study was to determine the most accurate method for calculating the EOA of the Edwards SAPIEN and SAPIEN XT THVs. One hundred intraprocedural transesophageal echocardiograms were analyzed. To calculate the post-transcatheter aortic valve replacement left ventricular outflow tract (LVOT) stroke volume (SV), four diameters were measured using two-dimensional echocardiography: (1) baseline LVOT diameter (LVOTd_PRE), (2) postimplantation LVOT diameter, (3) native aortic annular diameter, and (4) THV in-stent diameter. Four corresponding areas were planimetered by three-dimensional echocardiography. Two LVOT velocity-time integrals (VTI) were measured with the pulsed-wave Doppler sample volume at (1) the proximal (apical) edge of the valve stent or (2) within the valve stent at the level of the THV cusps. LVOT velocity-time integral with the sample volume at the proximal edge of the valve stent was used with the LVOT and aortic annular measurements above, whereas in-stent VTI was paired with the in-stent THV diameter to yield eight different SVs. Right ventricular outflow tract (RVOT) SV was calculated using RVOT diameter and RVOT VTI and was used as the primary comparator. Transaortic VTI was obtained by continuous-wave Doppler, and EOA calculations using each SV measurement were compared with (1) EOA calculated using RVOTSV and (2) planimetered aortic valve area using three-dimensional echocardiography (AVAplanimetry3D). Post-transcatheter aortic valve replacement EOA calculated using LVOTd_PRE was not significantly different from EOA calculated using RVOTSV (1.88±0.33 vs 1.86±0.39cm(2), P=.36) or from AVAplanimetry3D (1.85±0.28, P=.38, n=34). All other two-dimensional EOA calculations were statistically larger than EOA calculated using RVOTSV. All three-dimensional echocardiography-based EOA calculations were statistically different from AVAplanimetry3D. The most accurate EOA after implantation of a balloon-expandable THV is calculated using preimplantation LVOT diameter and VTI.

European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry.

The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting. Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath. The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure. The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p< 0.0001), renal insufficiency (HR: 1.53; p< 0.0001), liver disease (HR: 1.67; p=0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p= 0.0019), porcelain aorta (HR: 1.47; p= 0.0352), and atrial fibrillation (HR: 1.41; p= 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality. The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497).

On-pump fibrillating heart mitral valve replacement with the SAPIEN XT transcatheter heart valve

In some high-risk patients, standard mitral valve replacement can represent a challenging procedure, requiring a risky extensive decalcification of the annulus. In particular, high-risk redo patients and patients with a previously implanted transcatheter aortic valve, who develop calcific mitral disease, would benefit from the development of new, minimally invasive, transcatheter or hybrid techniques for mitral valve replacement. In particular, mixing transcatheter valve therapies and well-established minimally invasive techniques for mitral replacement or repair can help in decreasing the surgical risk and the technical complexity. Thus, placing transcatheter, balloon-expandable Sapien™ XT stent-valves in calcified, degenerated mitral valves through a right thoracotomy, a left atriotomy and on an on-pump fibrillating heart, represents an attractive alternative to standard surgery in redo patients, in patients with concomitant transcatheter aortic stent-valves in place and in patients with a high-risk profile. We describe this hybrid technique in detail.

The Impact of Integration of a Multidetector Computed Tomography Annulus Area Sizing Algorithm on Outcomes of Transcatheter Aortic Valve Replacement: A Prospective, Multicenter, Controlled Trial

This study prospectively investigated the impact of integration of a multidetector computed tomography (MDCT) annular area sizing algorithm on transcatheter aortic valve replacement (TAVR) outcomes. Appreciation of the 3-dimensional, noncircular geometry of the aortic annulus is important for transcatheter heart valve (THV) sizing. Patients being evaluated for TAVR in 4 centers underwent pre-procedural MDCT. Recommendations for balloon-expandable THV size selection were based on an MDCT sizing algorithm with an optimal goal of modest annulus area oversizing (5% to 10%). Consecutive patients who underwent TAVR with the algorithm (MDCT group) were compared with consecutive patients without the algorithm (control group). The primary endpoint was the incidence of more than mild paravalvular regurgitation (PAR), and the secondary endpoint was the composite of in-hospital death, aortic annulus rupture, and severe PAR. Of 266 patients, 133 consecutive patients underwent TAVR (SAPIEN XT THV) in the MDCT group and 133 consecutive patients were in the control group. More than mild PAR was present in 5.3% (7 of 133) of the MDCT group and in 12.8% (17 of 133) in the control group (p = 0.032). The combined secondary endpoint occurred in 3.8% (5 of 133) of the MDCT group and in 11.3% (15 of 133) of the control group (p = 0.02), driven by the difference of severe PAR. The implementation of an MDCT annulus area sizing algorithm for TAVR reduces PAR. Three-dimensional aortic annular assessment and annular area sizing should be considered for TAVR.

Impact of Post-Implant SAPIEN XT Geometry and Position on Conduction Disturbances, Hemodynamic Performance, and Paravalvular Regurgitation

This report sought to study the impact of the balloon-expandable SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve (THV) stent frame geometry and position on outcomes of transcatheter aortic valve replacement (TAVR). Post-implant THV geometry and position might impact atrioventricular conduction, hemodynamic performance, and annular sealing. Eighty-nine consecutive patients who underwent TAVR with a Sapien XT THV had pre- and post-implant multidetector computed tomography, transthoracic echocardiography, and electrocardiograms performed to assess THV stent geometry, atrioventricular conduction, and hemodynamic performance. The THV Circularity (THV eccentricity <10% [eccentricity = minimum stent diameter/maximum stent diameter]) and under-expansion (THV area/nominal THV area <90%) were present in 97.8% (2 of 89) and 0%, respectively. Low THV implantation was associated with new left bundle branch block and complete heart block (3.4 ± 2.0 mm vs. 5.5 ± 2.9 mm, p = 0.01) and with the need for permanent pacemaker implantation (3.5 ± 2.0 mm vs. 7.1 ± 2.5 mm, p = 0.001). In contrast, labeled THV size and THV area oversizing was not associated with atrioventricular conduction disturbances. The relation between inflow stent frame area and annular area was related to paravalvular regurgitation (p = 0.025). Labeled prosthesis size but not prosthesis expansion or eccentricity was related to valve gradient (p = 0.005) and effective orifice area (p < 0.001). Low implantation depth of balloon-expandable THVs is associated with clinically significant new conduction disturbances and permanent pacemaker implantation. Importantly, annular area oversizing was not associated with these complications.