Transcatheter Aortic Valve Replacement System Research Articles

Effect of bioprosthetic leaflet anisotropy on stent dynamics of Transcatheter Aortic Valve Replacement devices

The assessment of stent fatigue in Transcatheter Aortic Valve Replacement (TAVR) systems is critical for the design of next-generation devices, both in vitro and in vivo. The mechanical properties of the bioprosthetic heart valves (BHVs) have a significant impact on the fatigue life of the metallic stent and thus must be taken into consideration when evaluating new TAVR device designs. This study aims to investigate the relationship between BHV anisotropic behaviour and the asymmetric deflections of the stent frame observed during in vitro testing.An explicit dynamics finite element model of the nitinol stent with attached bioprosthetic valve leaflets was developed to evaluate the deflections of the TAVR device under haemodynamic loading. Our results demonstrate that pericardium behaviour plays a dominant role in determining stent frame deflection. The anisotropic behaviour of the leaflets, resulting from collagen fibre orientation, affects the extent of deflection encountered by each commissure of the frame. This leads to asymmetric variation in frame deflection that can influence the overall fatigue life of the nitinol stent. This study highlights the importance of considering both the flexible nature of the metallic stent as well as the leaflet anisotropic behaviour in the design and fatigue assessment of TAVR systems.

Hemodynamic performance of self-expandable transcatheter aortic valve replacement systems during valve deployment.

Little is known about valve hemodynamic performance during the Evolut and Neo deployment course. We aimed to evaluate transvalvular mean and peak-to-peak gradients over several intraprocedural timepoints during TAVR with Evolut PRO+ (Medtronic) and Neo (Boston Scientific) systems. This was single-center pilot sub-study from the SavvyWire EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI) trial. Participants received either the Evolut PRO+ or Neo for native valve severe aortic stenosis and the SavvyWire (OpSens Medical) was used for device delivery, pacing, and continuous left ventricular and aortic pressure measurements. For the Evolut, evaluation was done for baseline, two-thirds of valve deployment (still recapturable), 90% of valve deployment (no longer recapturable), and post-deployment hemodynamics. For the Neo, analysis was done at baseline, after the first step (top-crown deployment), and at final status. Nineteen patients were included (Evolut = 15; Neo = 4). There were no statistically significant changes in peak-to-peak gradients (44 mm Hg [IQR:33-69] vs 43 mm Hg [IQR:26-62], P = .41) between baseline and two-thirds of valve deployment in the Evolut patients. There was a significant decrease in mean (40 mm Hg [IQR:32-54] vs 14 mm Hg [IQR:10-18], P less than .001) and peak-to-peak (43 mmHg [IQRS:26-62] vs 9 mm Hg [IQR:8-13], P less than .001) transvalvular gradients between two-thirds and 90% of valve deployment for Evolut. Neo patients exhibited a decrease in transvalvular gradients after top-crown deployment (42.5 mm Hg baseline vs 13 mm Hg). Transvalvular gradients did not vary between the point of "no-recapture" compared to baseline values in patients receiving the Evolut, whereas a significant reduction in transvalvular gradients was observed when the valve was deployed at 90% and fully deployed. The Neo valve was slightly obstructive after the first step of deployment.

Transcatheter Aortic Valve Replacement for Isolated Aortic Regurgitation Using a New Self-Expanding TAVR System

BackgroundPatients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. ObjectivesThe authors describe the initial commercial experience of the first Conformité Européenne–marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR. MethodsThis multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions. ResultsThe mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%. ConclusionsTreatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery.

First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System

BackgroundThe latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited. ObjectivesThis study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience. MethodsFrom June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported. ResultsOf 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001). ConclusionsThe Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.

First-in-Man Experience of a Fully Retrievable Self-Expanding Dry-Tissue Transcatheter Aortic Valve Replacement System.

First-in-Man Experience of a Fully Retrievable Self-Expanding Dry-Tissue Transcatheter Aortic Valve Replacement System.

Impact of membranous septum length on pacemaker need with different transcatheter aortic valve replacement systems: The INTERSECT registry

BackgroundNew permanent pacemaker implantation (new-PPI) remains a compelling issue after Transcatheter Aortic Valve Replacement (TAVR). Previous studies reported the relationship between a short MS length and the new-PPI post-TAVR with a self-expanding THV. However, this relationship has not been investigated in different currently available THV. Therefore, the aim of this study was to investigate the association between membranous septum (MS)-length and new-PPI after TAVR with different Transcatheter Heart Valve (THV)-platforms. MethodsWe included patients with a successful TAVR-procedure and an analyzable pre-procedural multi-slice computed tomography. MS-length was measured using a standardized methodology. The primary endpoint was the need for new-PPI within 30 days after TAVR. ResultsIn total, 1811 patients were enrolled (median age 81.9 years [IQR 77.2–85.4], 54% male). PPI was required in 275 patients (15.2%) and included respectively 14.2%, 20.7% and 6.3% for Sapien3, Evolut and ACURATE-THV(p ​< ​0.01).Median MS-length was significantly shorter in patients with a new-PPI (3.7 ​mm [IQR 2.2–5.1] vs. 4.1 ​mm [IQR 2.8–6.0], p ​= ​<0.01). Shorter MS-length was a predictor for PPI in patients receiving a Sapien3 (OR 0.87 [95% CI 0.79–0.96], p ​= ​<0.01) and an Evolut-THV (OR 0.91 [95% CI 0.84–0.98], p ​= ​0.03), but not for an ACURATE-THV (OR 0.99 [95% CI 0.79–1.21], p ​= ​0.91). By multivariable analysis, first-degree atrioventricular-block (OR 2.01 [95% CI 1.35–3.00], p = <0.01), right bundle branch block (OR 8.33 [95% CI 5.21–13.33], p = <0.01), short MS-length (OR 0.89 [95% CI 0.83–0.97], p ​< ​0.01), annulus area (OR 1.003 [95% CI 1.001–1.005], p ​= ​0.04), NCC implantation depth (OR 1.13 [95% CI 1.07–1.19] and use of Evolut-THV(OR 1.54 [95% CI 1.03–2.27], p ​= ​0.04) were associated with new-PPI. ConclusionMS length was an independent predictor for PPI across different THV platforms, except for the ACURATE-THV. Based on our study observations within the total cohort, we identified 3 risk groups by MS length: MS length ≤3 ​mm defined a high-risk group for PPI (>20%), MS length 3–7 ​mm intermediate risk for PPI (10–20%) and MS length > 7 ​mm defined a low risk for PPI (<10%). Anatomy-tailored-THV-selection may mitigate the need for new-PPI in patients undergoing TAVR.

The Technological Basis of a Balloon-Expandable TAVR System: Non-occlusive Deployment, Anchorage in the Absence of Calcification and Polymer Leaflets.

Leaflet durability and costs restrict contemporary trans-catheter aortic valve replacement (TAVR) largely to elderly patients in affluent countries. TAVR that are easily deployable, avoid secondary procedures and are also suitable for younger patients and non-calcific aortic regurgitation (AR) would significantly expand their global reach. Recognizing the reduced need for post-implantation pacemakers in balloon-expandable (BE) TAVR and the recent advances with potentially superior leaflet materials, a trans-catheter BE-system was developed that allows tactile, non-occlusive deployment without rapid pacing, direct attachment of both bioprosthetic and polymer leaflets onto a shape-stabilized scallop and anchorage achieved by plastic deformation even in the absence of calcification. Three sizes were developed from nickel-cobalt-chromium MP35N alloy tubes: Small/23 mm, Medium/26 mm and Large/29 mm. Crimp-diameters of valves with both bioprosthetic (sandwich-crosslinked decellularized pericardium) and polymer leaflets (triblock polyurethane combining siloxane and carbonate segments) match those of modern clinically used BE TAVR. Balloon expansion favors the wing-structures of the stent thereby creating supra-annular anchors whose diameter exceeds the outer diameter at the waist level by a quarter. In the pulse duplicator, polymer and bioprosthetic TAVR showed equivalent fluid dynamics with excellent EOA, pressure gradients and regurgitation volumes. Post-deployment fatigue resistance surpassed ISO requirements. The radial force of the helical deployment balloon at different filling pressures resulted in a fully developed anchorage profile of the valves from two thirds of their maximum deployment diameter onwards. By combining a unique balloon-expandable TAVR system that also caters for non-calcific AR with polymer leaflets, a powerful, potentially disruptive technology for heart valve disease has been incorporated into a TAVR that addresses global needs. While fulfilling key prerequisites for expanding the scope of TAVR to the vast number of patients of low- to middle income countries living with rheumatic heart disease the system may eventually also bring hope to patients of high-income countries presently excluded from TAVR for being too young.

The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease.

Transcatheter aortic valve replacementis a valuable alternative technique to surgery and the spectrum of therapy continues to evolve. The JenaValve Pericaridal transcatheter aortic valve replacement System allows prosthesis fixation in a native, noncalcified aortic annulus with a unique paper clip-like anchorage mechanism. The low rate of paravalvular leakage and permanent pacemaker implantation emphasizes the further widespread use of the JenaValve - despite the limited data available. In May 2021, a CE mark for the transfemoral implantation in both aortic regurgitationand aortic stenosiswas granted. However, no data have been published so far. The ongoing ALIGN trials are expected to provide the pending long-term data.

Myval Transcatheter Heart Valve System in the Treatment of Severe Symptomatic Aortic Stenosis

The transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis (AS) at prohibitive risk for surgery. It is an alternative treatment to surgical aortic valve replacement in patients with AS at intermediate- and high-surgical risk. Although regulatory authorities extend the indications of TAVR to treat patients at low-surgical risk, the limitations of earlier-generation transcatheter heart valve (THV) systems accelerate the development of improved newer generation of THV systems. Myval™ THV (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) is a newer-generation, balloon-expandable TAVR system with features that facilitate accurate positioning of the bioprosthetic valve and favorable procedural and clinical outcomes. This review summarizes existing preclinical and clinical data on Myval THV for the intervention of symptomatic native AS and lays out the plan for future research program.

Learning curve for transcatheter aortic valve replacement for native aortic regurgitation: Safety and technical performance study.

BackgroundTranscatheter aortic valve replacement (TAVR) is a fundamentally new procedure for the treatment of native aortic regurgitation (AR). The number of cases needed to gain proficiency with the procedure is unknown.HypothesisThis study aimed to evaluate the learning curve for TAVR for native AR.MethodsThis study retrospectively reviewed a prospective database from 134 consecutive native AR patients who underwent the J‐valve TAVR system, which performed by a single team interventional cardiologist. The cumulative sum (CUSUM) method was used to analyze the learning curve. Patients were divided into two groups in chronological order, defined by the surgeon's early (group 1: the first 52 cases) and skilled (group 2: the next 82 cases) experience. Demographic data, intraoperative characteristics, and short‐term surgical outcomes were compared between the two groups.ResultsCUSUM plots revealed decreasing procedure time and fluoroscopy time after patients 52 and 43, respectively. The patient date consistently demonstrated that high‐risk scores and major perioperative parameters were comparable between the two groups. The use of contrast dye (group 1, 94.22 ± 30.07 mL; group 2, 70.43 ± 15.02 mL, P<.05), total procedure time (group 1, 84.96 ± 17.76 minutes; group 2, 59.95 ± 12.83 minutes, P<.05), and fluoroscopy time (group 1, 11.52 ± 3.81 minutes; group 2, 6.47 ± 1.53 minutes, P<.05) were significantly reduced in group 2. The overall device success rate in group 1 was 96.2% vs 96.3% in group 2 and remained high (P = 1.0). The overall 30‐day mortality was 3.8% in group 2 (group 1, 0 to group 2, 3.8%; P = .16). The complications rate, such as pulmonary hypertension, chronic kidney disease, and coronary artery disease were higher in group 2.ConclusionsFor a surgeon without previous TAVR experience, 52 cases of performance is the minimal requirement to gain the proficiency of TAVR for native AR. The skilled surgeons have been observed with reduced procedural time, fluoroscopy times, radiation exposure dose, and contrast volume usage. However, the overall prognosis was not significantly different between the two groups.

Preclinical evaluation of a transcatheter aortic valve replacement system for patients with rheumatic heart disease.

Cardiac surgery in middle-income countries differs significantly from that in high-income countries regarding prevailing heart valve pathologies and access to cardiac surgery. Typically, rheumatic aortic regurgitation in the absence of calcification by far outweighs stenosis. As such, entirely different transcatheter aortic valve implantation (TAVI) concepts are required for these regions. The aim of the study was to evaluate the five-month performance of the SAT (Strait Access Technologies, Cape Town, South Africa) pericardial TAVI system in the orthotopic aortic position of juvenile sheep. A self-homing, non-occlusive balloon-expandable TAVI system comprising a hollow balloon, stabilising locator trunks, a scalloped CoCr stent with elevating anchorage arms and decellularised, sandwich-crosslinked pericardium was compared with control surgical valves (Edwards PERIMOUNT) in sheep. The implantation period was five months. The tactile placement of the TAVI valves was accomplished without the need for rapid pacing. At termination, no structural degeneration was observed in either group. The TAVIs were well healed with the stent struts largely embedded in tissue. Correlating with sheep growth (weight gain of 40.4±13.0%) during the implantation period, mean transvalvular gradients increased from 3.08±1.95 mmHg to 8.50±5.38 mmHg (p=0.044) after five months. A single-stage, balloon-expandable, easy to place TAVI system with antigen-depleted and antigen-masked bioprosthetic leaflets promises to address the distinct needs of low- and middle-income countries with regard to TAVI better than conventional systems.

The Lotus Valve System: an In-depth Review of the Technology.

Innovation for transcatheter aortic valve replacement (TAVR) has transformed a medically complex treatment into a standardized procedure. While Edwards SAPIEN and Medtronic CoreValve occupy the market for TAVR in the United States (US), additional valve systems are being developed. The Boston Scientific Lotus Valve system was recently FDA-approved and will represent the third valve in the US market. This evidence-based review will summarize advantages, disadvantages, and projected impact of this new TAVR system. The Lotus Valve system demonstrates superiority in terms of rates of paravalvular leak, with similar rates of mortality and disabling stroke. This benefit is at the expense of increased pacemaker implantation rates, though preliminary data from subsequent iterations of the Lotus Valve suggest decreasing rates over time. There is much anticipation from ongoing trials utilizing the Lotus Edge system, which may perform best for those with pre-existing pacemakers or anatomy that increases likelihood of paravalvular leak.

P1852The clinical experience of J valve transapical transcatheter aortic valve replacement system in high-risk patients with severe pure aortic regurgitation

Abstract Objective Patients with severe pure aortic regurgitation (PAR) undergoing transcatheter aortic valve implantation (TAVI) is still under controversial. J valve™, a China Food and Drug Administration (CFDA) certified device, has specific positioning and anchoring system, which makes this device indicated in PAR patients. We aim to introduce the clinical experience of J valve in the treatment of PAR in high risk patients. Methods A total of 53 severe PAR patients (STS score 6,3±1.8, mean age, 76.4±5.2 years) who underwent TAVI using J valve™ in our Hospital from June 2017 to December 2018 were retrospectively enrolled. All patients underwent echocardiography and contrast-enhanced computed tomography to evaluate their baseline and follow-up characteristics. The 30 days outcomes were reported according to the Valve Academic Research Consortium-2 (VARC) definitions. Results All patients underwent transapical TAVI, and J valve was in implanted successfully in 51 patients (96,2%). J valve was dislodged in two patients, one patient was successful implanted with another J valve and the dislodged valve placed in descending aorta. The other patient was converted to urgent surgery for aortic valve replacement. One patient was converted to surgery due to severe aortic regurgitation after J-valve placement. The 30 days mortality was 9.2% (n=5), 1 patient died of acute heart failure and 2 patients died of infection. During the hospitalization, none of the patients had stroke or transient ischemic attack (TIA) and periprocedural myocardial infarction (MI). There were 5 (n=14.3%) patients presenting with bleeding complications (BARC 4 definition of major bleeding). 1 (2.9%). Pacemaker implantation was performed in 2 (5.7%) patients. Paravalvular regurgitation was none or trace in 90.7% (n=49), mild to moderate in 5.6% (n=3), and moderate to severe 1.8% (n=1) after the procedure. Mean intensive care unit stay was 29.30±15.30 h. Working illustration of J valve Conclusion TAVI by J valve™ can be an alternative option for high risk patients with PAR, but more evidences are still needed to further prove its safety and feasibility.

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial

Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. Boston Scientific (USA).

VitaFlow™ transcatheter valve system in the treatment of severe aortic stenosis: One-year results of a multicenter study.

This study reports the 1-year clinical outcomes of the VitaFlow™ transcatheter aortic valve system in the treatment of severe aortic stenosis. The VitaFlow™ system (MicroPort®, Shanghai, China) was developed as a novel transcatheter aortic valve replacement system to mitigate or circumvent some of the challenges associated with heavily calcified valves and bicuspid valves. From September 2014 to November 2017, a prospective, multicenter, single arm study was conducted in 11 centers in China. The primary end point was all cause mortality at 12 months. One hundred and ten symptomatic aortic stenosis patients (60 men, 50 women; mean age 77.73 ± 4.78 years) at prohibitive or high risk for surgery were enrolled. Mean society of thoracic surgeons score was 8.84 ± 5.58%. All-cause mortality was 2.7% at 1-year. Major stroke, major vascular complication, coronary artery obstruction, new pacemaker implantation occurred in 2.7, 2.7, 1.8, and 19.1% at 1-year follow-up, respectively. No patients had moderate or severe paravalvular leak at 1-year. At 1 year follow-up, 97% of patients had New York heart association ≤II. Patients with bicuspid valves had similar outcomes as those patients with tricuspid aortic valve stenosis. The 12-month clinical results support the safety and efficacy of VitaFlow™ in the treatment of patients with severe aortic stenosis, including patients with bicuspid aortic valve.

PMD101 - COST-EFFECTIVENESS OF TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN INTERMEDIATE-LOW RISK PATIENTS WITH SEVERE AORTIC STENOSIS IN SINGAPORE

Transcatheter aortic valve replacement (TAVR) has been mainly advised for inoperable and high surgical risk patients for treating severe aortic stenosis (AS). We conducted cost-effectiveness analysis on TAVR compared with common practice, surgical AVR (SAVR), in intermediate-low risk patients with severe AS in Singapore. Due to transfemoral (TF) access being dominant in Singapore, TF-TAVR was used in current analysis. A two-phase economic model combining decision tree and Markov model was developed to assess the incremental cost-effectiveness (ICER) of TF-TAVR versus SAVR over18-year horizon from Singapore healthcare system perspective. Event rates of mortality and complications were estimated from the Placement of Aortic Transcatheter Valves (PARTNER) 2 RCT cohort A and Singapore life table. Cost data were retrieved from the National University Heart Centre database. Health utilities were obtained from Singapore population norm based on EQ-5D. Scenario analyses were conducted using shorter horizon and event rates from PARTNER 2 S3 propensity analysis that used newer TAVR systems. Both one-way and probabilistic sensitivity analyses were performed. In base case scenario, the incremental effectiveness of TAVR versus SAVR is 0.30 QALYs. The ICER of TF-TAVR is S$21,062/QALY. In scenario analysis, where horizon was reduced to 10 years, ICER of TF-TAVR is S$27,060/QALY; where event rates from PARTNER 2 S3 propensity analysis was used, ICER of TF-TAVR is S$16,843/QALY and S$21,378/QALY over 18-year and 10-year horizon, respectively. At a willingness to pay threshold of S$65,000/QALY, TF-TAVR, compared with SAVR, has 99.87% probability of been cost-effective after 10,000 simulations. The model is the most sensitive to cost of TF-TAVI procedure, followed by cost of SAVR procedure. TF-TAVR seems to be a highly cost-effective option compared to SAVR for intermediate-low surgical risk patients with severe AS in Singapore. Increased procedure experience and/or technology advance may have further increased the cost-effectiveness of TF-TAVR per scenario analysis.

Transapical transcatheter aortic valve replacement with a novel transcatheter aortic valve replacement system in high-risk patients with severe aortic valve diseases

ObjectivesThe clinical experience of a novel transapical transcatheter aortic valve replacement system, the J-Valve (JC Medical Inc, Burlingame, Calif), in high-risk patients with severe aortic valve diseases is limited. MethodsA total of 107 high-risk patients (mean age, 74.4 ± 5.2 years) underwent transcatheter aortic valve replacement with the J-Valve from March 2014 to July 2015, which included 63 patients with aortic stenoses and 44 patients with aortic regurgitation. Echocardiography and contrast-enhanced computed tomography were used to evaluate patients' baseline characteristics and their follow-up conditions. ResultsThe J-Valve was successfully implanted in 102 patients (95.3%). Five patients (4.7%) underwent conversion to open surgery. The overall mortality was 4.7% (n = 5) at both 30 days and 6 months, whereas subgroup mortality was 6.3% (n = 4) in the aortic stenosis group and 2.3% (n = 1) in the aortic regurgitation group. Permanent pacemakers were implanted in 5 patients (4.7%). In the aortic stenosis group, paravalvular regurgitation was observed as none or trace in 54.2% of patients (n = 32), mild in 42.4% of patients (n = 25), and moderate in 3.4% of patients (n = 2) postprocedure. The mean aortic gradient decreased from 56.7 ± 15.2 mm Hg to 14.4 ± 7.8 mm Hg (P < .01). The peak aortic valve velocity declined from 4.76 ± 0.6 m/s to 2.45 ± 0.57 m/s (P < .01). In the patients with aortic regurgitation, paravalvular regurgitation was none or trace in 74.4% (n = 32), mild in 23.3% (n = 10), and 2.3% (n = 1) after the procedure. Mean aortic gradient was 7.1 ± 2.9 mm Hg. ConclusionsTranscatheter aortic valve replacement by the J-Valve is an adequate clinical option to treat high-risk patients with severe aortic stenosis or aortic regurgitation.

Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family

ObjectivesThe aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system. BackgroundThe Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances. MethodsPatients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria. ResultsA total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24). ConclusionsAcross all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.

Next-Generation Transcatheter Aortic Valve Replacement (TAVR) Clinical Outcomes in Low-Intermediate Risk Patients: Large Single-Centre Experience

Background: TAVR is an established option for high surgical risk patients with severe aortic stenosis. There are limited data on clinical outcomes with next generation TAVR devices (Lotus and Evolut R) in low-intermediate risk patients. Methods: Consecutive patients with STS mortality score <8% who underwent transfemoral TAVR with the Lotus Valve and Evolut R systems were included. Outcomes were assessed in accordance with VARC-2 criteria. Results: 190 patients were analysed (mean age 83.6 years and STS score 3.83%). Baseline characteristics were similar. Clinical outcomes of device success, death and stroke were similar. The Lotus Valve had lower rates of valve-in-valve and significant (moderate or greater) paravalvular regurgitation (PVR). Conclusion: Next-generation TAVR systems perform well in low-intermediate surgical risk patients. While the Lotus Valve has lower rates of valve-in-valve and significant PVR, both devices have acceptable clinical outcomes.

Robotic-assisted real-time MRI-guided TAVR: from system deployment to in vivo experiment in swine model.

Real-time magnetic resonance imaging (rtMRI) guidance provides significant advantages during transcatheter aortic valve replacement (TAVR) as it provides superior real-time visualization and accurate device delivery tracking. However, performing a TAVR within an MRI scanner remains difficult due to a constrained procedural environment. To address these concerns, a magnetic resonance (MR)-compatible robotic system to assist in TAVR deployments was developed. This study evaluates the technical design and interface considerations of an MR-compatible robotic-assisted TAVR system with the purpose of demonstrating that such a system can be developed and executed safely and precisely in a preclinical model. An MR-compatible robotic surgical assistant system was built for TAVR deployment. This system integrates a 5-degrees of freedom (DoF) robotic arm with a 3-DoF robotic valve delivery module. A user interface system was designed for procedural planning and real-time intraoperative manipulation of the robot. The robotic device was constructed of plastic materials, pneumatic actuators, and fiber-optical encoders. The mechanical profile and MR compatibility of the robotic system were evaluated. The system-level error based on a phantom model was 1.14 ± 0.33 mm. A self-expanding prosthesis was successfully deployed in eight Yorkshire swine under rtMRI guidance. Post-deployment imaging and necropsy confirmed placement of the stent within 3 mm of the aortic valve annulus. These phantom and in vivo studies demonstrate the feasibility and advantages of robotic-assisted TAVR under rtMRI guidance. This robotic system increases the precision of valve deployments, diminishes environmental constraints, and improves the overall success of TAVR.