Clinical and procedural outcomes with the SAPIEN 3 versus the SAPIEN XT prosthetic valves in transcatheter aortic valve replacement: A systematic review and meta‐analysis

Tummala, Ramyashree; Banerjee, Kinjal; Sankaramangalam, Kesavan; Mick, Stephanie; Krishnaswamy, Amar; White, Jonathon; Fares, Maan; Mehta, Anand; Popović, Zoran B.; Svensson, Lars G.; Kapadia, Samir

doi:10.1002/ccd.27398

Cited by 14 publications

(6 citation statements)

References 54 publications

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“…Furthermore, the 2013 dataset used for procedure and admission costs is derived from treating inoperable and high risk patients only (presumably at a higher cost than intermediate risk), accounts costs from the second generation SAPIEN XT device and not SAPIEN 3, which has been shown to have better outcomes, shorter procedure times, etc. 22 , and finally doesn't reflect the continuous improvement in TAVI procedures and patient management such as use of local anaesthesia and sedation. In comparison, sAVR device costs are not reimbursed separately, but the heterogeneous population of low-to-high risk used to derive admission costs will bias in favour of sAVR due to the high prevalence of low risk (and low cost).…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients

Goodall

Lamotte²,

Ramos³

et al. 2019

Journal of Medical Economics

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Objective: Transcatheter aortic valve implantation (TAVI) has become the therapy of choice for treating severe aortic stenosis in patients at high-risk for surgery or where it is considered too risky to attempt. This uptake varies across geographies however, and its cost or value has frequently been cited as the reason for this. We sought to evaluate the potential cost and clinical impact of TAVI in intermediate risk patients from a French collective perspective. Materials and methods: The analysis was performed using a novel Markov model with data derived from the PARTNER II randomized controlled trial for survival, clinical event rates, and quality-of-life. The simulated time horizon was 15 years, costs were from French sources and presented in 2016 Euros. Discounting of all outcomes was at 4% annually and the effect of uncertainty in model parameters was explored by deterministic and probabilistic sensitivity analysis (PSA). Results: In comparison to surgery, TAVI resulted in improved clinical outcomes (life expectancy and quality-adjusted life expectancy) and lower costs over a lifetime time horizon. The base case results showed increases of 0.42 years and 0.41 QALYs with lifetime cost savings of e439 for TAVI compared to surgery. PSA results showed a >50% likelihood of cost-effectiveness at e0 willingness-to-pay and a 100% likelihood at $e15,000. Limitations: Clinically, survival projections are based on limited follow-up data and introduce uncertainty into the outcomes from the model. Economically, procedure costs are derived from a heterogeneous mix of patient risk groups, although this is much more likely to bias against TAVI and underestimate overall cost savings. Conclusions: In our analyses of intermediate risk patients, TAVI is associated with superior clinical outcomes compared to surgery and is cost saving. It could be expected that cost savings are conservative and likely to increase over time.

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Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients

Goodall

Lamotte²,

Ramos³

et al. 2019

Journal of Medical Economics

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“…Next-generation valves (i.e., Sapien 3) and utilization of stroke prevention devices may help to prevent stroke. [25][26][27] Several limitations could affect our outcomes. First, this was a single-center, retrospective analysis.…”

Section: Discussionmentioning

confidence: 99%

Valve Hemodynamics and Clinical Outcomes After Transcatheter Aortic Valve Replacement for a Small Aortic Annulus

et al. 2019

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The hemodynamics and outcomes in patients with a small aortic annulus (SAA) after transcatheter aortic valve replacement (TAVR) with a second-generation transcatheter heart valve remain unclear. We investigated whether TAVR with a Sapien XT (Edwards Lifesciences, Irvine, California) influences postprocedural valve hemodynamics and long-term outcome in high-risk SAA patients compared with surgical aortic valve replacement (SAVR). We retrospectively identified 94 SAA patients who underwent aortic valve replacement (TAVR = 35 and SAVR = 59). SAA was defined as an aortic annulus diameter !20 mm, measured by preprocedural transesophageal echocardiography. The mean age was 80.2 years. The mean Society of Thoracic Surgeons-Predicted Risk of Mortality was 6.8%. The post-procedural peak transvalvular velocity and mean pressure gradient were significantly lower in the TAVR cohort than in the SAVR cohort, whereas the postprocedural aortic valve area was significantly higher in the TAVR cohort. Severe prosthesis-patient mismatch (PPM) occurred less frequently after TAVR than SAVR (TAVR 2.9% versus SAVR 22.0%, P = 0.01). The two-year mortality in SAA patients was similar between the two groups. TAVR with a Sapien XT in SAA patients improved the valve hemodynamics and reduced the incidence of PPM compared with SAVR. TAVR patients had a similar 2-year mortality despite higher risk baseline characteristics. To avoid PPM and the consequent poor outcomes, TAVR can be considered an alternative option to SAVR in high surgical risk patients with SAA.

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“…It was anticipated that this new-generation valve would facilitate the introduction of the procedural refinements such as the use of a conscious sedation pathway, because it uses a smaller diameter (14F/16F) femoral sheath, allows for percutaneous femoral closure and has an improved delivery system to facilitate precise positioning of the valve based on radiological guidance, as well as a new external skirt designed to minimise the risk of significant aortic regurgitation 36. An increased rate of pacemaker implantation has been reported with the SAPIEN 3 valve compared with the SAPIEN XT in some (but not all) studies; the risk appears to be declining as experience with the valve increases 37–40. There is some evidence the risk may be affected by implantation depth, oversizing and pre-existing right bundle branch block 41 42.…”

Section: Discussionmentioning

confidence: 99%

Effect of procedural refinement of transfemoral transcatheter aortic valve implantation on outcomes and costs: a single-centre retrospective study

et al. 2019

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ObjectivesTo determine the effect of introducing several procedural refinements of transfemoral transcatheter aortic valve implantation (TAVI) on clinical outcomes and costs.DesignRetrospective analysis comparing two consecutive 1-year periods, before and after the introduction of procedural refinements.SettingTertiary hospital aortic valve programme.ParticipantsConsecutive patients undergoing transfemoral TAVI treated between April 2014 and August 2015 using the initial setup (n=70; control group) or between September 2015 and August 2016 after the introduction of procedural refinements (n=89).InterventionsIntroduction of conscious sedation, percutaneous access and closure, omission of transoesophageal echocardiography during the procedure, and an early discharge procedure.Outcome measuresProcedural characteristics, complications and outcomes; length of stay in intensive care unit (ICU) and hospital; hospital-related direct costs associated with TAVI.ResultsThere were no statistically significant differences in the incidence of complications or mortality between the two groups. The mean length of stay in the ICU was significantly shorter in the procedural-refinement group compared with the control group (5.1 vs 57.2 hours, p<0.001), as was the mean length of hospital stay (4.7 vs 6.6 days, p<0.001). The total cost per TAVI procedure was significantly lower, by £3580, in the procedural-refinement group (p<0.001). This was largely driven by lower ICU costs.ConclusionsAmong patients undergoing transfemoral TAVI, procedural refinement facilitated a shorter stay in ICU and earlier discharge from hospital and was cost saving compared with the previous setup.

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Clinical and procedural outcomes with the SAPIEN 3 versus the SAPIEN XT prosthetic valves in transcatheter aortic valve replacement: A systematic review and meta‐analysis

Abstract: Patients receiving the S3V had lower risk of PVL, MVC, bleeding, mortality, and stroke. PPI was somewhat higher in the S3V group. S3V implantation was faster and used less contrast.

Cited by 14 publications

References 54 publications

Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients

Cost-effectiveness analysis of the SAPIEN 3 TAVI valve compared with surgery in intermediate-risk patients

Valve Hemodynamics and Clinical Outcomes After Transcatheter Aortic Valve Replacement for a Small Aortic Annulus

Effect of procedural refinement of transfemoral transcatheter aortic valve implantation on outcomes and costs: a single-centre retrospective study

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