Cost-effectiveness of left atrial appendage occlusion during cardiac surgery in France: An economic evaluation based on the LAAOS III study.

OBJECTIVES: Left atrial appendage occlusion during cardiac surgery is a therapeutic option for stroke prevention in patients with atrial fibrillation. The effectiveness and safety of left atrial appendage occlusion have been evaluated in several studies, including the LAAOS-III trial. While these studies have demonstrated efficacy and safety, the long-term economic impact of this surgical technique has not yet been assessed. Here, we aimed to evaluate the cost-effectiveness and cost-utility of left atrial appendage occlusion during cardiac surgery over a long-term time horizon. METHODS: Our study was based on a model representing an hypothetical cohort with the same characteristics as LAAOS-III trial patients. We modelled the incidence of ischemic strokes and systemic embolisms in each intervention arm: "occlusion" and "no-occlusion," using a one-month cycle length with a 20-year time horizon. Regarding occlusion devices, sutures, staples, or an approved surgical occlusion device (AtriClip™-AtriCure, Ohio, USA) could be used. RESULTS: Our model generated an average cost savings of 607 euros per patient and an incremental gain of 0.062 quality-adjusted life years (QALYs), resulting an incremental cost-utility ratio (ICUR) of €-9,775/QALY. The scenario analysis in which occlusion was systematically performed using the AtriClip™ device generated an ICUR of €3,952/QALY gained. CONCLUSIONS: In the base-case analysis, the strategy proved to be more effective and less costly, confirming left atrial appendage occlusion during cardiac surgery as an economically dominant strategy. The scenario analysis also appeared cost-effective, although it did not result in cost savings. This study provides a new perspective on the assessment of the cost-effectiveness of these techniques.

Use of 5-ALA fluorescence-guided surgery versus white-light conventional microsurgery for the resection of newly diagnosed glioblastomas (RESECT study): a French multicenter randomized phase III study.

OBJECTIVE: Only one phase III prospective randomized study, published in 2006, has assessed the performance of 5-aminolevulinic acid (5-ALA) fluorescence-guided surgery (FGS) for glioblastoma resection. The aim of the RESECT study was to compare the onco-functional results associated with 5-ALA fluorescence and with white-light conventional microsurgery in patients with glioblastoma managed according to the current standards of care. METHODS: This was a phase III prospective randomized single-blinded study, involving 21 French neurosurgical centers, comparing 5-ALA FGS with white-light conventional microsurgery in patients with glioblastoma managed according to the current standards of care, including neuronavigation use and postoperative radiochemotherapy. Randomization was performed in a 1:1 ratio stratified by institution. 5-ALA (20 mg/kg) or placebo (ascorbic acid) was administered orally 3-5 hours before the incision. The primary endpoint was the rate of gross-total resection (GTR) blindly assessed by an independent committee. Patients without a confirmed pathological diagnosis of glioblastoma or with unavailable postoperative MRI studies were excluded from the per-protocol analysis. RESULTS: Between March 2013 and August 2016, a total of 171 patients were assigned to the 5-ALA fluorescence group (n = 88) or to the placebo group (n = 83). Twenty-four cases were excluded because the WHO histological criteria of grade 4 glioma were not met. The proportion of GTR was significantly higher in the 5-ALA fluorescence group (53/67, 79.1%) than in the placebo group (33/69, 47.8%; p = 0.0002). After adjustment for age, preoperative Karnofsky Performance Scale score, and tumor location, GTR was still associated with 5-ALA fluorescence (OR 4.13 [95% CI 1.94-8.79]). The mean 7-day postoperative Karnofsky Performance Scale score (≥ 80% in 49/71, 69.0% [5-ALA group]; 50/71, 70.4% [placebo group], p = 0.86) and the proportion of patients with a worsened neurological status 3 months postoperatively (9/68, 13.2% [5-ALA group]; 9/70, 12.9% [placebo group], p = 0.95) were similar between groups. Adverse events related to 5-ALA intake were rare and consisted of photosensitization in 4/87 (4.6%) patients and hepatic cytolysis in 1/87 (1.1%) patients. The 6-month PFS (70.2% [95% CI 57.7%-79.6%] and 68.4% [95% CI 55.7%-78.1%]; p = 0.39) and 24-month OS (30.1% [95% CI 18.9%-42.0%] and 37.7% [95% CI 25.8%-49.5%]; p = 0.89) did not significantly differ. In multivariate analysis, GTR was an independent predictor of PFS (hazard ratio 0.56 [95% CI 0.36-0.86], p = 0.008) and OS (hazard ratio 0.65 [95% CI 0.42-1.01], p = 0.05). The use of 5-ALA FGS generates a significant extra cost of 2732.36€ (95% CI 1658.40€-3794.11€). CONCLUSIONS: The authors found that 5-ALA FGS is an easy-to-use, cost-effective, and minimally time-consuming technique that safely optimizes the extent of resection in patients harboring glioblastoma amenable to a large resection.

Lower Limb Ischemia in Surgical Femoral Veno-Arterial Extracorporeal Membrane Oxygenation.

OBJECTIVES: To analyze the incidence, clinical impact on survival, and risk factors of lower limb ischemia (LLI) of surgical peripheral femoral venoarterial extracorporeal membrane oxygenation (VA ECMO) in the current era. DESIGN: A retrospective analysis of the authors' institutional database of VA ECMO was performed. Patients were divided into 2 groups according to the occurrence of LLI. The primary endpoint was survival to hospital discharge. Risk factors of LLI were searched with multivariate analyses. SETTING: University hospital. PARTICIPANTS: Adult patients receiving peripheral VA ECMO for refractory cardiogenic shock and cardiac arrest. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: From January 2018 to December 2021, 188 patients (mean age: 52.0 ± 14.1 years; 63.8% male, 36.2% female) received peripheral VA ECMO. Male sex was more prevalent in the group without LLI (65.9% v 33.3%; p = 0.031). Twelve (6.4%) patients developed LLI during VA ECMO support (n = 6) or after VA ECMO removal (n = 6). Survival to hospital discharge was not statistically different between patients with and without LLI (50.0% v 48.3%; p = 0.571). Female sex patients were at increased risk for LLI (odds ratio 4.38, 95% CI 1.21-15.81; p = 0.024). CONCLUSIONS: Peripheral femoral VA ECMO through a surgical approach is associated with a low LLI rate, which does not increase the risk of in-hospital mortality. The female sex is an independent risk factor for LLI.

ICSH guidance for INR and D-dimer testing using point of care testing in primary care.

This guideline has been written on behalf of the International Council for Standardisation in Haematology (ICSH) and focuses on two point of care haematology tests used within primary care, namely International Normalised Ratio (INR) and D-dimer. Primary care covers out of hospital settings and can include General Practice (GP), Pharmacy and other non-hospital settings (although these guidelines would also be applicable to hospital out-patient settings). The recommendations are based on published data in peer reviewed literature and expert opinion; they should supplement regional requirements, regulations or standards.

Potential impact on cost-effectiveness estimates of using immature survival data: a case study based on transcatheter edge-to-edge repair (TEER) used for patients with severe mitral regurgitation at high surgical risk.

OBJECTIVE: To review the survival modelling used in cost-effectiveness studies evaluating an interventional procedure and to discuss implications for decision-makers. DESIGN: A case study of three economic evaluations that each used immature data from the EVEREST II High Surgical Risk (HSR) Study of transcatheter edge-to-edge repair (TEER) for patients with severe mitral regurgitation (MR) who were at high risk of surgery. SETTING: Estimation of patient survival in cost-effectiveness studies. PARTICIPANTS: The EVEREST II HSR Study included 78 patients who had TEER of the mitral valve using the MitraClip device and a retrospectively identified control group of 36 patients who received medical management and were followed up for 12 months. Observed survival (TEER arm only) was updated at 5 years. RESULTS: Two studies used 12-month observed mortality from EVEREST II HSR to model survival over lifetime horizons. Observed and modelled survival were associated with considerable uncertainty due to short follow-up and small numbers of participants. Modelling control patients' survival required an approximate 10-fold extrapolation based on 12-month observation of only 38 patients. Observed 5-year survival in the TEER group differed from that less mature follow-up suggesting that survival modelling based on shorter follow-up was unsatisfactory. No public domain data for the control group are available beyond 12-month follow-up so meaningful estimates using mature data for both arms are currently not possible. A third study developed survival models using incompletely reported transitions between MR grades in EVEREST II HSR and mortality rates observed for different MR grades derived from a study in an unrelated population. CONCLUSIONS: Modelling survival in such small samples followed up for only 12 months is associated with great uncertainty, and cost-effectiveness results based on these analyses should be viewed as premature and used cautiously in reimbursement decisions.

Impact of updated trial data on the cost-effectiveness of percutaneous mitral repair.

When updated clinical trial data becomes available reassessing the cost-effectiveness of technologies may modify estimates and influence decision-making. We investigated the impact of updated trial outcomes on the cost-effectiveness of percutaneous mitral repair (PR) for secondary mitral regurgitation. We updated our previous three-state time-varying Markov model to assess the cost-effectiveness of PR + guideline directed medical treatment (GDMT) versus GDMT alone. Key clinical inputs (overall survival (OS) and heart failure hospitalisations (HFH)) were obtained using the 3-year trial findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) RCT. We calculated incremental cost-effectiveness ratios (ICER) and report how these differ between analyses based on early (2-year) and updated (3-year) evidence. Updated trial data showed an increase in mortality in the intervention arm between two and three years follow-up that was not seen in the control arm. Deterministic and multivariate cost-effectiveness modelling yielded incremental cost effectiveness ratios ICERs of €38,123 and €31,227 /QALY. Compared to our 2-year based estimate (€21,918 / QALY) these results imply an approximate 1.5-fold increase in ICER. The availability of updated survival analyses from the COAPT pivotal trial suggests previous estimates based on 2-year trial findings were over optimistic for the intervention.

Real-world data and evidence in health technology assessment: When are they complementary, substitutes, or the only sources of data compared to clinical trials?

Within the life-cycle assessment of health technologies, real-world data (RWD) have until now been of secondary importance to clinical trial data. The availability of massive, better quality RWD, particularly with the emergence of connected devices, the improvement of methods for characterizing populations, make it possible to have a better insight into the effects of treatment, sometimes on a national scale the importance of RWD is likely to progress in the eyes of health technology assessors, going from being traditionally complementary to possibly replacing clinical trial data. This is the fundamental question that the round table, involving experts from the academic and/or hospital, institutional, and industrial worlds, set out to answer. This work served first to establish the current role of RWD in health technology assessment, by distinguishing the main purposes of RWD, the timing of the evaluation in relation to the life cycle of the technology, and then according to the party commissioning or receiving the outcomes of RWD-based studies. Secondly, the round table proposed six general recommendations for more intensive and decisive use of RWD in the assessment and decision-making process.

Is the assumption of waning of treatment effect applied consistently across NICE technology appraisals? A case-study focusing on disease-modifying therapies for treatment of multiple sclerosis.

OBJECTIVES: Whether the effects of therapies may wane over time is a matter of debate, especially when considering their long-term cost-effectiveness. Here, we examined how the assumption of the waning of treatment effect was applied across the National Institute for Health and Care Excellence (NICE) appraisals for disease-modifying therapies (DMTs) used in multiple sclerosis. METHODS: We undertook a document analysis following a search of the NICE website. The inclusion criteria of the study were as follows: all publicly available documents related to completed appraisals for DMTs (period: January 2000 to July 2021). The exclusion criteria of the study were as follows: all documents that did not meet the inclusion criteria, especially pertaining to drugs used in other disease areas. We extracted information about the waning of treatment effect assumption as considered by companies, assessment groups, and appraisal committees, and we analyzed trends over time. RESULTS: We reviewed fifteen appraisals that reported guidance on sixteen DMTs. Irrespective of the drugs' mechanism of action or their pharmaceutical nature, there was substantial variation in the modalities when the assumption of waning was implemented. We noted the recent preference to use all-cause discontinuation as a proxy. This heterogeneity did not appear to affect acceptance of the DMTs (all but one were recommended for use across the National Health System (NHS)). CONCLUSIONS: Modeling the long-term effect of therapies is challenging, especially given the limited follow-up duration of related trials. This generates recurrent debates on the presence of waning of treatment efficacy and heterogeneity across appraisals. More refined recommendations obtained by consensus among stakeholders could help to achieve greater consistency in decision making.

Impact of procedural success on clinical outcome after MitraClip: Results from the MITRA-FR trial.

BACKGROUND: Differences in procedural success rates have been proposed to explain the divergent results between the MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). AIM: To examine whether MITRA-FR patients who had successful clip implantation achieved a better outcome than the control group. METHODS: Based on the per protocol population of MITRA-FR, we compared the outcome in 71 patients in whom optimal clip implantation was achieved (group 1: mitral regurgitation grade ≤ 1 + at discharge) with that in 23 patients with non-optimal clip implantation (group 2: mitral regurgitation grade ≥ 2 + at discharge) and that in 137 patients in the control group (group 3). The primary endpoint was all-cause death or unplanned hospitalization for heart failure at 24 months. RESULTS: Event-free survival was not different across the groups (42±6% in group 1, 30±10% in group 2 and 31±4% in group 3; log-rank P=0.32). In multivariable analyses, after adjustment for age, sex, rhythm, aetiology, left ventricular ejection fraction and mitral regurgitation severity, group was not associated with variations in outcome: using Group 3 as reference, hazard ratio 0.86, 95% confidence interval 0.58-1.27 (P=0.43) in group 1; and hazard ratio 0.98 95% confidence interval 0.54-1.76 (P=0.94) in group 2. CONCLUSIONS: The clinical outcome of patients in whom optimal procedural result was achieved at discharge was not different compared with the control group. Our results do not support the hypothesis that the differences in rates of residual mitral regurgitation at discharge between MITRA-FR and COAPT explain the divergent results between the two trials.

Outcome of primary graft dysfunction rescued by venoarterial extracorporeal membrane oxygenation after heart transplantation.

BACKGROUND: Primary graft dysfunction remains the leading cause of 30-day mortality after heart transplantation. Few data have been published about the clinical outcome of severe primary graft dysfunction treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO). AIM: To evaluate the prevalence and outcome of severe primary graft dysfunction requiring VA-ECMO, and to identify factors associated with hospital mortality. METHODS: We performed an observational analysis of our institutional database of VA-ECMO for primary graft dysfunction after heart transplantation. Patients with severe primary graft dysfunction, according to the International Society for Heart and Lung Transplantation classification, were included. The primary outcome was survival to hospital discharge. Risk factors for in-hospital mortality were searched with multiple logistic regression analysis using backward stepwise variable elimination. RESULTS: Of the 397 patients who had heart transplantation between January 2007 and December 2018, 60 (15.1%) developed severe primary graft dysfunction requiring VA-ECMO. The median age was 52 (interquartile range 39-59) years, and 73.3% were male. Thirty-nine (65.0%) patients were weaned after a mean duration of VA-ECMO support of 7.2±6.0 days. Thirty-two (53.3%) patients were alive at hospital discharge. Inotropic support in the recipient before heart transplantation (odds ratio [OR] 3.88, 95% confidence interval [CI] 1.04-14.44; P=0.04), total ischaemic time (OR 0.99, 95% CI 0.99-1.00; P=0.01) and 48-hour total blood transfusion (OR 1.14, 95% CI 1.04-1.26; P=0.01) were independent predictors of in-hospital mortality. CONCLUSIONS: Severe primary graft dysfunction requiring VA-ECMO is frequent after heart transplantation. Survival to hospital discharge after VA-ECMO for severe primary graft dysfunction is satisfactory in such a critically ill population.

Delayed hospitalisation for heart failure after transcatheter repair or medical treatment for secondary mitral regurgitation: a landmark analysis of the MITRA-FR trial.

BACKGROUND: In the MITRA-FR trial, transcatheter mitral valve repair (TMVR) was not associated with a 2-year clinical benefit in patients with secondary mitral regurgitation (SMR). AIMS: This landmark analysis aimed at investigating a potential reduction of the hospitalisation rate for heart failure (HF) between 12 and 24 months after inclusion in the MITRA-FR trial in patients randomised to the intervention group (TMVR with the MitraClip device), as compared with patients randomised to the control group (guideline-directed medical therapy [GDMT]). METHODS: The MITRA-FR trial randomised 307 patients with SMR for TMVR on top of GDMT (TMVR group; n=152) or for GDMT alone (control group; n=155). We conducted a 12-month landmark analysis in surviving patients who were not hospitalised for HF within the first 12 months of follow-up. The primary endpoint was the 1-year cumulative number of HF hospitalisations. RESULTS: A total of 140 patients (TMVR group: 67; GDMT group: 73) were selected for this landmark analysis with similar characteristics at inclusion in the trial. The primary endpoint was 28 events per 100 patient-years in the TMVR group, as compared with 60 events per 100 patient-years in the GDMT group (hazard ratio [HR] 0.46, 95% confidence interval [CI]: 0.20-1.02; p=0.057). CONCLUSIONS: In this landmark analysis of the MITRA-FR trial, the cumulative rate of HF hospitalisation between 12 and 24 months among patients treated with TMVR on top of GDMT was approximately half as many as those of patients treated with GDMT alone, a difference which did not reach statistical significance in the setting of a low number of events.

Veno-arterial extracorporeal membrane oxygenation for drug intoxications: A single center, 14-year experience.

BACKGROUND AND AIM OF THE STUDY: Acute cardiovascular failure remains a leading cause of death in severe poisonings. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been increasingly used as a rescue therapeutic option for those cases refractory to optimal conventional treatment. We sought to evaluate the outcomes after VA-ECMO used for drug intoxications in a single-center experience. METHODS: We performed an observational analysis of our prospective institutional database. The primary endpoint was survival to hospital discharge. RESULTS: Between January 2007 and December 2020, 32 patients (mean age: 45.4 ± 15.8 years; 62.5% female) received VA-ECMO for drug intoxication-induced refractory cardiogenic shock (n = 25) or cardiac arrest (n = 7). Seven (21.8%) patients developed lower limb ischemia during VA-ECMO support. Twenty-six (81.2%) patients were successfully weaned after a mean VA-ECMO support of 2.9 ± 1.3 days. One (3.1%) patient died after VA-ECMO weaning for multiorgan failure and survival to hospital discharge was 78.1% (n = 25). In-hospital survivors were discharged from hospital with a good neurological status. Survival to hospital discharge was not statistically different according to sex (male = 75.0% vs. female = 80.0%; p = .535), type of intoxication (single drug = 81.8% vs. multiple drugs = 76.1%; p = .544) and location of VA-ECMO implantation (within our center = 75% vs. peripheral hospital using our Mobile Unit of Mechanical Circulatory Support = 100%; p = .352). Survival to hospital discharge was significantly lower in patients receiving VA-ECMO during on-going cardiopulmonary resuscitation (42.8% vs. 88.0%; p = .026). CONCLUSIONS: VA-ECMO appears to be a feasible therapeutic option with a satisfactory survival rate and acceptable complications rate in poisonings complicated by refractory cardiogenic shock or cardiac arrest.

Impact of a Modified Institutional Protocol on Outcomes After Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-Of-Hospital Cardiac Arrest.

OBJECTIVE: To analyze the impact of the modification of the authors' institutional protocol on outcomes after extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrest (OHCA). DESIGN: An observational analysis. The protocol complied with national recommendations. A further eligibility criterion was added since January 2015: the presence of sustained shockable rhythm at extracorporeal life support (ECLS) implantation. To assess the impact of this change, patients were divided into two groups: (1) from January 2010 to December 2014 (group A) and (2) from January 2015 to December 2019 (group B). The primary endpoint was survival to hospital discharge with good neurologic outcome. Predictors of survival were searched with multivariate analyses. SETTING: University hospital. PARTICIPANTS: Adult patients supported with ECPR for refractory OHCA. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: From January 2010 to December 2019, 85 patients had ECLS for OHCA (group A, n = 68, 80%; group B, n = 17, 20%). The mean age was 42.4 years, 78.8% were male. The rate of implantation of ECLS was significantly lower in group B (p = 0.01). Mortality during ECLS support was significantly lower (58.8 v 86.8%; p = 0.008), and the weaning rate was significantly higher (41.2 v 13.2%; p = 0.008) in group B. Survival to discharge with good neurologic outcome was significantly improved (23.5 v 4.4%; p = 0.027) in group B. A sustained shockable rhythm was the only independent predictor of survival to hospital discharge with good neurologic outcome. CONCLUSIONS: The modification of the authors' institutional protocol throughout the further criterion of sustained shockable rhythm yielded a favorable impact on outcomes after ECPR for OHCA.

Effectiveness of Non-Pharmacological Interventions for Irritable Bowel Syndrome: A Systematic Review.

INTRODUCTION: Given the complexity of the therapeutic management of irritable bowel syndrome (IBS), alternative non-pharmacological therapies are frequently offered to patients. The aim of this study was to conduct a systematic review in order to establish the current evidence base for non-pharmacological interventions (body-directed and mind-body therapies) in the management of IBS. MATERIALS AND METHODS: The literature was searched in several electronic databases (PubMed (including Medline), Web of Science (Clarivate Analytics), Scopus (Elsevier), ScienceDirect (Elsevier), Cochrane Library (Wiley), and Wiley Online Library (Wiley)) for randomized controlled trials (RCTs) published in the English language from 1990 to 2020. Effectiveness outcomes were examined through the change in overall IBS symptoms or abdominal pain up to 12 months after treatment. RESULTS: 11 studies (parallel-group RCTs) were identified that enrolled 1590 participants in total. Body-directed therapies (acupuncture and osteopathic medicine) showed a beneficial effect compared with standard medical treatment for overall IBS symptoms at 6 months follow-up, while no study found any difference between body-directed and sham therapies for abdominal pain or overall IBS symptoms. It was not possible to conclude whether hypnotherapy was superior to standard medical treatment or supportive therapy for overall IBS symptoms or abdominal pain due to discordant results. CONCLUSIONS: Although body-directed therapies such as acupuncture and osteopathic medicine may be beneficial for overall IBS symptoms, higher-quality RCTs are needed to establish the clinical benefit of non-pharmacological interventions for IBS. An important challenge will be the definition of the optimal control groups to be used in non-pharmacological trials.

Percutaneous mitral valve repair in severe secondary mitral regurgitation: Analysis of index hospitalization and economic evaluation based on the MITRA-FR trial.

BACKGROUND: Percutaneous mitral valve repair (pMVR) is reimbursed in France for severe secondary mitral regurgitation (SMR), but French data regarding the hospitalization index stay are lacking. AIMS: Our objectives were to describe the index hospitalization stay and to evaluate the cost of hospital stay for pMVR used in SMR. METHODS: A secondary evaluation based on patients who were randomized to the intervention group of the MITRA-FR study was undertaken. The economic evaluation was conducted according to the French hospital perspective. Medical resource use was estimated using specific data collected from patients enrolled in the MITRA-FR study and non-specific data from national statistics. RESULTS: The population was represented by 144 patients who underwent pMVR at 33 French centres. There was a mean±standard deviation of 7.9±1.5 hospital staff during procedures. The mean procedure duration was 154±68 minutes and increased with the number of implanted clips. Median total length of stay was 8 days. The occurrence of a serious adverse event was not associated with an increased risk of admission to the critical care unit, but was associated with an increased length of stay. The mean total cost was 28,025±3424€, which includes 21,547€ for the cost of medical devices used during pMVR and 6478±3424€ for other costs. CONCLUSION: The cost of pMVR is substantial for patients with SMR, which advocates for further efforts to identify the patients with SMR who are likely to derive a clear clinical benefit from the procedure.

Beating versus arrested heart isolated tricuspid valve surgery: An 11-year experience in the current era.

BACKGROUND AND AIM OF THE STUDY: Data about the beating heart (BH) technique for isolated tricuspid valve (TV) surgery compared to the arrested heart (AH) technique are sparse. We compared the outcomes of isolated TV surgery between BH and AH technique. METHODS: We performed an observational analysis of our database of isolated TV surgery. Patients were divided into two groups according to whether surgery was performed without (BH group) or with (AH group) aortic cross-clamping and cardioplegic arrest. The primary endpoint was survival to hospital discharge. Risk factors for in-hospital mortality were searched with multivariate analyses. We undertook further comparisons after propensity-score matching. RESULTS: From January 2007 to December 2017, we performed 82 isolated TV surgery (BH group, n = 47, 57.3%; AH group, n = 35, 42.7%). The mean age was 59.1 years, 56.1% were female. BH group patients were older (61.8 vs. 55.4 years; p = .035), had greater impaired renal function (glomerular filtration rate, 61.1 vs. 74.6 ml/min; p = .012), were more frequently operated for secondary TR (61.7 vs. 31.4%; p = .008), underwent more frequently a reoperation (53.2 vs. 28.6%; p = .042) and exhibited a higher surgical risk (EuroSCORE II, 3.92 vs. 2.50%; p = .013). In-hospital mortality was not different between both groups, either considering unmatched (BH = 10.6 vs. AH = 5.7%; OR = 1.96, 95% confidence interval [CI] = 0.36-10.77) or matched populations (BH = 10.6 vs. AH = 6.4%; OR = 1.89, 95% CI = 0.36-9.97). Age was the only predictor of in-hospital mortality. CONCLUSIONS: The BH technique showed comparable outcomes to the AH technique for isolated TV surgery despite a higher risk profile.

High-dimensional propensity scores improved the control of indication bias in surgical comparative effectiveness studies.

OBJECTIVES: The objective of the study is to evaluate the performance of high-dimensional propensity scores (hdPSs) for controlling indication bias as compared with propensity scores (PSs) in surgical comparative effectiveness studies. STUDY DESIGN AND SETTING: Patients who underwent interventional transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) between 2013 and 2017 were included from the French nationwide hospitals. At each hospital level, matched pairs of patients who underwent TAVI and SAVR were formed using PSs, considering 20 patient baseline characteristics, and hdPSs, considering the same patient characteristics and 300 additional variables from procedure and diagnosis codes the year before surgery. We compared death, reoperation, and stroke up to 3 years between TAVI and SAVR using Cox or Fine and Gray models. RESULTS: Before matching, 12 of 20 patient characteristics were imbalanced between the included patients who underwent TAVI and SAVR. No significant imbalance persisted after matching with both methods. Hazard ratio of 1-year death, reoperation, and stroke was 1.3 [1.1; 1.4], 1.6 [1.1; 2.4], and 1.4 [1.2; 1.7] for TAVI relative to SAVR with PSs (n = 9,498 pairs) and 1.1 [1.0; 1.3], 1.3 [0.8; 2.0], and 1.3 [1.0; 1.6] with hdPSs (n = 7,157). CONCLUSION: HdPS estimations were more consistent with results seen in randomized controlled trials. The HdPS is a promising alternative for the PS to control indication bias in comparative studies of surgical procedures.