Cost-effectiveness of transcatheter aortic valve implantation in patients at low surgical risk in France: a model-based analysis of the Evolut LR trial.

BACKGROUND: In the recent Evolut Low Risk randomized trial, transcatheter aortic valve implantation (TAVI) was shown to be non-inferior to surgery (SAVR) regarding the composite end point of all-cause mortality or disabling stroke at 24 months. AIMS: To evaluate the cost-effectiveness of self-expandable TAVI in low-risk patients, using the French healthcare system as the basis for analysis. METHODS: Mortality, health-related quality of life, and clinical event rates through two-year follow-up were derived from trial data (N = 725 TAVI and N = 678 SAVR; mean age: 73.9 years; mean STS-PROM: 1.9%). Cost inputs were based on real-world data for TAVI and SAVR procedures in the French healthcare system. Costs and effectiveness as quality-adjusted life years (QALYs) were projected to lifetime via a decision-analytic model under assumption of no mortality difference beyond two years. The discounted incremental cost-effectiveness ratio (ICER) was evaluated against a willingness-to-pay threshold of €50,000 per QALY gained. Deterministic and probabilistic sensitivity analyses were conducted, including assumptions about differential long-term survival. RESULTS: For the base case, mean survival was 13.69 vs 13.56 (+ 0.13) years for TAVI and SAVR, respectively. Discounted QALYs were 9.34 vs. 9.21 (+ 0.13) and discounted lifetime costs €52,267 vs. €51,433 (+ €833), resulting in a lifetime ICER of €6368 per QALY gained. In probabilistic sensitivity analysis, TAVI was found dominant or cost-effective in 74.4% of samples. CONCLUSION: TAVI in patients at low surgical risk is a cost-effective alternative to SAVR in the French healthcare system. Longer follow-up data will help increase the accuracy of lifetime survival projections.

Early patient access to health technologies: Is innovation needed for early management?

The question of early patient access to innovative health technologies arises from the assumption that, once a certain level of effectiveness or efficiency is achieved, waiting for mainstream coverage would represent a loss of opportunity for patients or for the community. This was the premise on which the round table based its dialogue. Early access is understood as the funding of a technology that comes within this field and is CE-marked but has not yet attained "mainstream" coverage. There are several early access schemes in France ("forfait innovation", early coverage, exceptional coverage, RIHN). This round table was an opportunity to establish mapping, extended to devices not dedicated to early access but which could nevertheless provide some patients with access to non-mainstreamed technologies (Article 51, ETAPES experiments, DGOS call for projects, local schemes). It is an initial step that would need to be further developed and complemented by the dissemination of common communication materials available to all, including patients. The existing schemes are in fact still poorly known. Consideration would also have to be given to the advisability of developing these schemes in order to adapt them to the new European requirements. More generally, early access schemes must be integrated into an ecosystem that is conducive for their relevance: consideration of procedures associated with medical devices benefiting from early access; short time frames of examination; patient information. Finally, the round table proposes the creation of a new early access scheme, complementary to those that exist and that would be positioned, after CE marking, between the "forfait innovation" and mainstreaming: PRESTO (Prise En charge Sécurisée et Temporaire de technologies innOvantes) (secure and temporary coverage for innovative technologies).

Pacemaker complications and costs: a nationwide economic study.

Aims: Novel leadless pacemakers (LPMs) may reduce complications and associated costs related to conventional pacemaker systems. This study sought to estimate the incidence and associated costs of traditional pacemaker complications, in those patients who were eligible for LPM implantation. Methods: A retrospective analysis was conducted on the French National Hospital Database (PMSI), including all patients implanted with a pacemaker in France in 2012, who could have alternatively received an LPM. Complication rates and their associated costs 3 years post-implantation were estimated from the perspective of the French social security system. Results: From a total of 65,553 patients, 11,770 (18%) met the inclusion criteria. Overall, 618 patients (5.3%) had a record of pacemaker complications during follow-up, of which 89% were related to the lead and pocket. Most common were pocket bleeding, lead- or generator-related mechanical complications, and pneumothorax. Overall, the mean cost of pacemaker complications per patient was €6,674 ± 3,867 at 3 years. Specifically, €7,143 ± 2,685 for pocket bleeding, €5,123 ± 2,676 for pneumothorax, and €6,020 ± 3,272 for mechanical complications. Conclusions: Major complications associated with the lead and pocket of conventional pacemaker systems are still common, and these represent a significant burden to healthcare systems as they generate substantial costs.

Infections and associated costs following cardiovascular implantable electronic device implantations: a nationwide cohort study.

Aims: This study assessed the contemporary occurrence of cardiac device infections (CDIs) following implantation in French hospitals and estimated associated costs. Methods and Results: A retrospective analysis was conducted on the French National Hospital Database (PMSI). Patients with a record of de novo cardiac implantable electronic device (CIED) implantation or replacement interventions in France in 2012 were identified and followed until the end of 2015. Cardiac device infections (CDIs) were identified based on coding using the French classification for procedures [Classification Commune des Actes Médicaux (CCAM)] and International Classification of Diseases (ICD-10). Associated costs were estimated based on direct costs from the perspective of the French social security system. In total 78 267 CIED patients (72% de novo implants) were identified (15% defibrillators; 84% pacemakers). The 36-month infection rate associated with de novo defibrillator-only implants, as well as for cardiac resynchronisation therapy - defibrillators (CRT-Ds) was 1.6%. The CDI risk was 2.9% and 3.9% for replacement ICDs and CRT-Ds. Infection rates were lower for de novo single-chamber pacemaker (SCP)/dual-chamber pacemaker (DCP) (0.5%) and cardiac resynchronisation therapy - pacemaker (CRT-P) implants (1.0%), while for replacement procedures the risk increased to 1.4% (SCP/DCP) and 1.3% (CRT-P). Mean infection-related costs over 24 months were €20 623 and €23 234 for CDIs associated with replacement and de novo procedures, and overall costs were not significantly different between pacemaker and defibrillator patients. Conclusion: Cardiac device infections in France are associated with substantial costs, when considering inpatient hospitalizations. Strategies to minimize the rate of CIED infection should be a priority for health care providers and payers.