The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

Thivilliers, Anne-Pauline; Ladarré, Rémi; Merabti, Océane; François, C.; Fontenay, Sarah; Brink, Hélène van den; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Martelli, Nicolas

doi:10.1017/s0266462320000100

Cited by 9 publications

(6 citation statements)

References 80 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The learning curve in TAVI procedures has been seldomly evaluated in literature; however, within different settings, an appropriate level of experience could be reached after the first 30–50 cases [ 25–27 ] and is associated with both increased procedural safety and better early postoperative outcomes [ 28 , 29 ]. Few studies focused on the contribution of an initial proctorship, but many experiences included authors who were proctors for transcatheter prostheses factories [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Results and insights after 413 TAVI procedures performed by cardiac surgeons on their own

Malvindi

Berretta

Capestro

et al. 2023

Interdisciplinary CardioVascular and Thoracic Surgery

View full text Add to dashboard Cite

Objectives Current evidence on TAVI has been generated exclusively by cardiology studies and no operative data from cardiac surgeons are available. Here we describe the development of our TAVI program and report the results of transfemoral TAVI done by cardiac surgeons on their own. Methods This study included all the TAVI procedures on native valve performed at Cardiac Surgery Unit, Ospedali Riuniti di Ancona, during the period October 2018 – July 2022. Relevant prospectively collected preoperative, intraprocedural and postoperative data were retrieved from the Institutional database. Results A total of 413 patients were included in the study. Mean patients’ age was 82 years and among them 44% (180/413) were male. STS score was 3.1% (2.2 – 4.4). Eighty patients underwent transapical TAVI and 333 patients had a transfemoral approach. We progressively moved from trans-apical TAVI towards trans-femoral procedures that are now routinely performed on conscious sedation and using a fully percutaneous approach. After trans-femoral TAVI, 30-day mortality rate was 1%, cerebral stroke occurred in 2% of the cases, permanent pacemaker implantation was necessary in 23% of the patients and in 6% of the cases there was a moderate/severe degree of aortic regurgitation. There was no association between operators performing TAVI and 30-day mortality. Conclusions The acquisition of catheter-based skills and an adequate training allowed cardiac surgeons to perform on their own awake and fully percutaneous trans-femoral TAVI with similar results when compared with major randomized clinical trials and registries’ experiences.

show abstract

Section: Discussionmentioning

confidence: 99%

Results and insights after 413 TAVI procedures performed by cardiac surgeons on their own

Malvindi

Berretta

Capestro

et al. 2023

Interdisciplinary CardioVascular and Thoracic Surgery

View full text Add to dashboard Cite

show abstract

“…The quality of literature data is poor regarding the learning curve in TAVI, with missing details about proctorship or the number of cases needed to maintain skills 2 . The absence of more than moderate AR following prosthesis deployment was included in the definition of device success 19,24 and was shown to be associated with the number of treated cases.…”

Section: Discussionmentioning

confidence: 99%

“…Transcatheter aortic valve implantation (TAVI) is a technically complex procedure and has a significant learning curve, training protocols being based on proctored sessions, animal models, or on dry laboratory procedures 1,2 . There is currently no consensus regarding the minimum number of procedures required for an operator to achieve expertise, nor any guidelines for initiating a TAVI program 2 …”

Section: Introductionmentioning

confidence: 99%

The effect of the learning curve on paravalvular aortic regurgitation and mid‐term mortality in transfemoral transcatheter aortic valve implantation

et al. 2022

View full text Add to dashboard Cite

Objective Paravalvular aortic regurgitation is an important independent mortality predictor in transcatheter aortic valve implantation (TAVI). Our study evaluated the association between paravalvular aortic regurgitation and mid‐term mortality in relation with the learning curve, in patients with severe aortic stenosis who underwent transfemoral TAVI in the first 3 years since the establishment of the program. Methods Patients with severe aortic stenosis who underwent transfemoral TAVI between 2017 and 2020 were included in the analysis. Paravalvular aortic regurgitation was assessed by transthoracic echocardiography at 48 hours after the procedure. All‐cause mortality was evaluated after 30 days and at mid‐term follow‐up. Results Paravalvular aortic regurgitation ≥grade II was associated with mid‐term all‐cause mortality (OR 4.4; 95%CI 1.82–11.55; p < 0.001), their prevalence declining after the first 60 cases. Baseline characteristics did not significantly differ in the first 60 patients from the rest of the cohort. Male sex (p = 0.006), advanced age (p = 0.04), coronary artery disease (p = 0.003), or elevated STS Score (p = 0.02) influenced mid‐term survival. When adjusting for the presence of these factors, only age (OR 1.1; 95%CI 1.0–1.2), paravalvular aortic regurgitation ≥grade II (OR 3.9; 95%CI 1.3–12.9), and the number of days spent in the intensive care unit (OR 1.4; 95%CI 1.1–1.8) were independent predictors of mid‐term all‐cause mortality. Conclusions In a group of patients with severe aortic stenosis who underwent transfemoral TAVI in the first 3 years since the establishment of the program, paravalvular aortic regurgitation ≥grade II was associated with mid‐term mortality, both declining after the first 60 cases.

show abstract

“…Indeed, the diverse of analyses performed offer the possible range defining the value for money of TAVI and offer important messages to clinicians and decision maker on both the overall value of TAVI, but also on the feasibility of considering the procedure over diverse risk groups, some of which were rarely considered as candidate for TAVI procedure both in view of the limited evidence related to both clinical and economic implications. Further studies may help shed light about CE of TAVI in real-life scenarios, including the impact of the learning curve on health-economic outcomes [47], considering real costs from larger samples and also exploring the perspective of the society to both capture indirect costs and provide insight into the value of the procedure from the patient's point of view [48].…”

Section: Discussionmentioning

confidence: 99%

The cost-effectiveness of transcatheter aortic valve implantation: exploring the Italian National Health System perspective and different patient risk groups

Lorenzoni

Barbieri²,

Saia

et al. 2021

Eur J Health Econ

View full text Add to dashboard Cite

Objectives To assess the cost-effectiveness (CE) of transcatheter aortic valve implantation (TAVI) in Italy, considering patient groups with different surgical risk. Methods A Markov model with a 1-month cycle length, comprising eight different health states, defined by the New York Heart Association functional classes (NYHA I–IV), with and without stroke plus death, was used to estimate the CE of TAVI for intermediate-, high-risk and inoperable patients considering surgical aortic valve replacement or medical treatment as comparators according to the patient group. The Italian National Health System perspective and 15-year time horizon were considered. In the base-case analysis, effectiveness data were retrieved from published efficacy data and total direct costs (euros) were estimated from national tariffs. A scenario analysis considering a micro-costing approach to estimate procedural costs was also considered. The incremental cost-effectiveness ratio (ICER) was expressed both in terms of costs per life years gained (LYG) and costs per quality adjusted life years (QALY). All outcomes and costs were discounted at 3% per annum. Univariate and probabilistic sensitivity analyses (PSA) were performed to assess robustness of results. Results Over a 15-year time horizon, the higher acquisition costs for TAVI were partially offset in all risk groups because of its effectiveness and safety profile. ICERs were €8338/QALY, €11,209/QALY and €10,133/QALY, respectively, for intermediate-, high-risk and inoperable patients. ICER values were slightly higher in the scenario analysis. PSA suggested consistency of results. Conclusions TAVI would be considered cost-effective at frequently cited willingness-to-pay thresholds; further studies could clarify the CE of TAVI in real-life scenarios.

show abstract

The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

Cited by 9 publications

References 80 publications

Results and insights after 413 TAVI procedures performed by cardiac surgeons on their own

Results and insights after 413 TAVI procedures performed by cardiac surgeons on their own

The effect of the learning curve on paravalvular aortic regurgitation and mid‐term mortality in transfemoral transcatheter aortic valve implantation

The cost-effectiveness of transcatheter aortic valve implantation: exploring the Italian National Health System perspective and different patient risk groups

Contact Info

Product

Resources

About