Calcification of surgical aortic bioprostheses and its impact on clinical outcome.

AIMS: Aortic valve calcification (AVC) of surgical valve bioprostheses (BP) has been poorly explored. We aimed to evaluate in-vivo and ex-vivo BP AVC and its prognosis value. METHODS AND RESULTS: Between 2011 and 2019, AVC was assessed using in-vivo computed tomography (CT) in 361 patients who had undergone surgical valve replacement 6.4±4.3 years earlier. Ex-vivo CT scans were performed for 37 explanted BP. The in-vivo CT scans were interpretable for 342 patients (19 patients [5.2%], were excluded). These patients were 77.2±9.1 years old and 64.3% were male. Mean in-vivo AVC was 307±500 Agatston unit (AU). The AVC was 562±570 AU for the 183 (53.5%) patients with structural valve degeneration (SVD) and 13±43 AU for those without SVD (p<0.0001). In-vivo and ex-vivo AVC were strongly correlated (r=0.88, p<0.0001). An in-vivo AVC>100 AU (n=147, 43%) had a specificity of 96% for diagnosing Stage 2-3 SVD (area under the curve=0.92). Patients with AVC>100 AU had a worse outcome compared with those with AVC≤100 AU (n=195). In multivariable analysis, AVC was a predictor of overall mortality (hazard ratio [HR] and 95% confidence interval=1.16[1.04-1.29]; p=0.006), cardiovascular mortality (HR=1.22[1.04-1.43]; p=0.013), cardiovascular events (HR=1.28 [1.16-1.41]; p<0.0001), and re-intervention (HR=1.15 [1.06-1.25]; p<0.0001). After adjustment for Stage 2-3 SVD diagnosis, AVC remained a predictor of overall mortality (HR=1.20 [1.04-1.39]; p=0.015) and cardiovascular events (HR=1.25 [1.09-1.43]; p=0.001). CONCLUSION: CT scan is a reliable tool to assess BP leaflet calcification. An AVC>100 AU is tightly associated with SVD and it is a strong predictor of overall mortality and cardiovascular events.

Standardized Bench Test Evaluation of Biomechanical Characteristics of Stents Used in Right Ventricular Outflow Tract Revalvulation.

PURPOSE: Pre-stenting of the right ventricular outflow tract (RVOT) is commonly performed before percutaneous pulmonary valve implantation (PPVI), to relieve obstruction, prevent valved stent fractures, and provide a landing zone. This study aimed to evaluate the biomechanical characteristics of the stents currently used to perform pre-stenting of the RVOT. METHODS: We assessed five commercially available stents: Cheatham-Platinum Stent ("CP Stent"), AndraStent XL, AndraStent XXL, Optimus XL, and Optimus XXL. Following stent deployment at nominal pressure, radial and longitudinal elastic recoils and radial resistance were measured. The bending stiffness of the stents crimped onto the balloons was also evaluated. RESULTS: Three samples were tested for each stent. Our study showed no significant difference between the stent platforms in terms of radial elastic recoil, which was relatively low (< 10%). The longitudinal elastic recoil was also low for all the devices (< 5%). Significant differences were observed in radial resistance (P < 0.001). CP Stent and AndraStent XL exhibited the highest radial resistances. The bending stiffnesses of the stents crimped on their balloons were significantly different (P < 0.00001). Optimus XL and XXL were more flexible than the other stents. CONCLUSION: This study highlights the significant differences between the stents currently used in RVOT pre-stenting. Stents with good radial resistance are preferred, especially for calcified vessels, and flexibility is crucial for tortuous vessels. We proposed an algorithm for selecting the most suitable stent according to the need for radial force and flexibility, which will help inform clinicians considering RVOT revalvulation.

Rationale and design of the ULYSS trial: A randomized multicenter evaluation of the efficacy of early Impella CP implantation in acute coronary syndrome complicated by cardiogenic shock.

CONTEXT: Despite 20 years of improvement in acute coronary syndromes care, patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) remains a major clinical challenge with a stable incidence and mortality. While intra-aortic balloon pump (IABP) did not meet its expectations, percutaneous mechanical circulatory supports (pMCS) with higher hemodynamic support, large availability and quick implementation may improve AMICS prognosis by enabling early hemodynamic stabilization and unloading. Both interventional and observational studies suggested a clinical benefit in selected patients of the IMPELLAⓇ CP device within in a well-defined therapeutic strategy. While promising, these preliminary results are challenged by others suggesting a higher rate of complications and possible poorer outcome. Given these conflicting data and its high cost, a randomized clinical trial is warranted to delineate the benefits and risks of this new therapeutic strategy. DESIGN: The ULYSS trial is a prospective randomized open label, 2 parallel multicenter clinical trial that plans to enroll patients with AMICS for whom an emergent percutaneous coronary intervention (PCI) is intended. Patients will be randomized to an experimental therapeutic strategy with pre-PCI implantation of an IMPELLAⓇ CP device on top of standard medical therapy or to a control group undergoing PCI and standard medical therapy. The primary objective of this study is to compare the efficacy of this experimental strategy by a composite end point of death, need to escalate to ECMO, long-term left ventricular assist device or heart transplantation at 1 month. Among secondary objectives 1-year efficacy, safety and cost effectiveness will be assessed. CLINICAL TRIAL REGISTRATION: NCT05366452.

Coronary artery assessment on pre transcatheter aortic valve implantation computed tomography may avoid the need for additional coronary angiography.

PURPOSE: The purpose of this study was to evaluate the percentage of coronary angiography that can be securely avoided by the interpretation of coronary arteries on pre transcatheter aortic valve implantation CT (TAVI-CT), using CT images obtained with deep-learning reconstruction and motion correction algorithms. MATERIAL AND METHOD: All consecutive patients who underwent TAVI-CT and coronary angiography, from December 2021 to July 2022 were screened for inclusion in the study. Patients who had previous coronary artery revascularization or who did not undergo TAVI were excluded. All TAVI-CT examinations were obtained using deep-learning reconstruction and motion correction algorithms. On TAVI-CT examinations, quality and stenosis of coronary artery were analyzed retrospectively. When insufficient image quality and/or when diagnosis or doubt of one significant coronary artery stenosis, patients were considered as having possible coronary artery stenosis. The results of coronary angiography were used as the standard of reference for significant CAS. RESULTS: A total of 206 patients (92 men; mean age, 80.6 years) were included; of these 27/206 (13%) had significant coronary artery stenosis on coronary angiography and were referred for potential revascularization. Sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of TAVI-CT to identify patients requiring coronary artery revascularization was 100% (95% confidence interval [CI]: 87.2-100%), 100% (95% CI: 96.3-100%), 54% (95% CI: 46.6-61.6), 25% (95% CI: 17.0-34.0%) and 60% (95% CI: 53.1-66.9%) respectively. Intra- and inter observer variability was substantial agreement for quality and decision to recommend coronary angiography. Mean reading time was 2 ± 1.2 (standard deviation) min (range: 1-5 min). Overall, TAVI-CT could potentially rule out indication for revascularization for 97 patients (47%). CONCLUSION: Analysis of coronary artery on TAVI-CT using deep-learning reconstruction and motion correction algorithms can potentially safely avoid coronary angiography in 47% of patients.

Management and outcomes of ventricular septal defects after acute myocardial infarction: A multicenter retrospective study.

BACKGROUND AND AIM: The mortality rate of patients with post-myocardial infarction (MI) ventricular septal defects (VSDs) is high, and the benefit of surgery is unclear. We aimed to investigate the management and outcomes of post-MI VSD over a 10-year period in a large cohort. METHODS: Data of patients with post-MI VSD admitted in three French university hospitals from 2008 to 2019 were examined. The characteristics of those who underwent surgery were compared with those who received medical treatment. Mortality risk factors, survival curves, and outcomes at 30 days and 1 year after treatment were determined. RESULTS: Of the 92 patients whose data were examined, 50 underwent surgery and 42 received exclusive medical treatment. All patients were critically ill. Overall, 76.1% of patients received inotropic support, and 63% received mechanical ventilation. Circulatory assistance, mainly via intra-aortic balloon pump and extra-corporeal membrane oxygenation, was provided to 46.7% patients, with 14.1% requiring a second assistance. The median time to surgery was 4 days. At 1 year, mortality was 46% in those who underwent surgery and 83.3% in those treated medically (p < .001). Survival curves at 1 and 3 months showed major differences, and the survival rate showed little change 30 days after treatment. Cardiogenic shock and cardiac arrest emerged as risk factors for mortality. CONCLUSIONS: In our retrospective, multicenter study, the mortality resulting from post-MI VSD did not seem to improve over the last decade. Although surgery carried considerable risks, it improved survival.

Outcomes of emergency transcatheter aortic valve replacement in patients with cardiogenic shock: A multicenter retrospective study.

Rescue transcatheter aortic valve replacement (TAVR) in patients with cardiogenic shock is challenging, and there is limited literature on these critical patients. The aim of this study was to determine the characteristics and outcomes of patients undergoing TAVR, feasibility and safety of the procedure, and 1-year mortality factors. Thirty-eight patients with severe aortic disease and cardiogenic shock admitted to two French hospitals from 2015 to 2019 were included. The patients were critical, 78.9% of them had a left ventricular ejection fraction of <30%, and all of them received inotropic support. "Valve-in-valve" procedures were performed in 15.8% and 13.2% underwent balloon aortic valvuloplasty before TAVR. Edwards Sapien3® and Medtronic CoreValve EvolutR® were used. The survival probability remained reasonable for patients with cardiogenic shock who underwent rescue TAVR. The 30-day mortality rate was 7.9% and 21.1% at 1 year. No patient died during the intervention. The procedure was safe, with few complications except for acute kidney failure, the development of a left bundle branch block, and the need for pacemaker implantation. Both functional and echocardiographic results were good at 1 year, although 29% of the patients underwent rehospitalization within 1 year. The development of a left bundle branch block was found to be a mortality risk factor. This procedure is a safe and effective therapy with acceptable survivorship in critically ill patients. The benefits to their quality of life should be evaluated in future studies, and the need for providing early cardiac resynchronization therapy must be emphasized.

Economic evaluation of fractional flow reserve-guided versus angiography-guided multivessel revascularisation in ST-segment elevation myocardial infarction patients in the FLOWER-MI randomised trial.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) who have multivessel disease, the FLOWER-MI trial found no significant clinical benefit to fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared to angiography-guided PCI. AIMS: Our aim was to estimate the cost-effectiveness and cost-utility of FFR-guided PCI, the secondary endpoint of the FLOWER-MI trial. METHODS: Costs, major adverse cardiovascular events (composite of all-cause death, non-fatal myocardial infarction [MI], and unplanned hospitalisation leading to urgent revascularisation), and quality-adjusted life years were calculated in both groups. The incremental cost-effectiveness and cost-utility ratios were estimated. Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the health care provider with a time horizon of one year. RESULTS: At one year, the average cost per patient was 7,560€ (±2,218) in the FFR-guided group and 7,089€ (±1,991) in the angiography-guided group (p-value<0.01). The point estimates for the incremental cost-effectiveness and cost-utility ratios found that the angiography-guided strategy was cost saving and improved outcomes, with a probabilistic sensitivity analysis confirming dominance. CONCLUSIONS: The FFR-guided strategy at one year is unlikely to be cost effective compared to the angiography-guided strategy on both clinical and quality of life outcomes.

Sapien 3 Embolization From Ventricle to Aorta in the Setting of Noncalcified Aortic Regurgitation.

Transcatheter aortic valve replacement is currently used off-label for noncalcified aortic valve regurgitation and therefore is restricted to selected cases. In this setting we describe a rare complication of Sapien 3 (Edwards Lifesciences, Irvine, California) embolization from the left ventricle to the descending aorta. Given their technical challenges, such procedures require specific considerations and management. (Level of Difficulty: Advanced.).

Carotid versus femoral access for transcatheter aortic valve replacement: comparable results in the current era.

OBJECTIVES: The carotid approach for transcatheter aortic valve replacement (TAVR) has been shown to be feasible and safe. The goal of this study was to compare the 30-day outcomes of trans-carotid (TC) and transfemoral (TF) TAVR. METHODS: This retrospective study enrolled 500 consecutive patients treated by TC-TAVR (n = 100) or TF-TAVR (n = 400) with percutaneous closure between January 2018 and January 2020 at the Nantes University Hospital. The primary end-point was the occurrence of cardiovascular death and cerebrovascular events at 30 days. RESULTS: The mean age was 79.9 ± 8.1 in the TC group and 81.3 ± 6.9 (P = 0.069) in the TF group. The TC group had more men (69% vs 50.5%; P = 0.001) and more patients with peripheral vascular disease (86% vs 14.8%; P < 0.0001). Cardiac characteristics were similar between the groups, and the EuroSCORE II was 3.8 ± 2.6% vs 4.6 ± 6.0%, respectively (P = 0.443). The 30-day mortality was 2% in the TC group versus 1% in the TF group (P = 0.345). TC-TAVR was not associated with an increased risk of stroke (2% vs 2.5%; P = 0.999) or major vascular complications (2% vs 4%; P = 0.548). More permanent pacemakers were implanted in the TF group (14.9% vs 5.6%; P = 0.015), and no moderate or severe aortic regurgitation was observed in the TC group (0 vs 3.3%; P = 0.08). TC-TAVR was not associated with an increased risk of mortality or stroke at 30 days (odds ratio 1.32; 95% confidence interval 0.42-4.21; P = 0.63) in the multivariable analysis. CONCLUSIONS: No statistically significant differences between TC-TAVR and TF-TAVR were observed; therefore, TC-TAVR should be the first alternative in patients with anatomical contraindications to the femoral route.

Standardized fractal bench test evaluation of coronary stents: Performances in bifurcation lesions treated by the re-proximal optimization technique.

BACKGROUND: Bifurcation lesions in coronary arteries are complex to treat with coronary stents, which are not designed for that purpose and can be unproperly deployed. Moreover, devices are constantly evolving, and so are angioplasty techniques. OBJECTIVES: The aim of this study was to determine the performances of different stents in the treatment of bifurcation lesions using the re-proximal optimization technique (rePOT). METHODS: Eleven stent platforms were evaluated: Xience Sierra (Abbott), Xience Alpine (Abbott), Synergy (Boston), Coroflex Isar (Bbraun), Cobra PzF (Celonova), Ultimaster (Terumo), Resolute Integrity (Medtronic), Resolute Onyx (Medtronic), Optimax (Hexacath), Orsiro (Biotronik), and Absorb (Abbott). Stents were deployed in a silicone fractal bifurcation model using the rePOT. Micro-computed tomography was performed to assess side branch ostium coverage and strut malapposition, as well as the effect of rePOT on stent cell area. RESULTS: Our study showed significant differences between stent platforms regarding side branch ostium coverage (p = .002). The Synergy and Cobra PzF stents were the most performant devices to avoid ostium coverage. Strut malapposition varied significantly between devices (p = .008) but the percentage of malapposed struts was relatively low. Significant differences were observed between stents regarding the cell area before (p = .002) and also after rePOT (p = .003), and the increase in cell area caused by rePOT varied considerably between devices (p = .08). CONCLUSION: This study highlighted significant differences in the performances of stent platforms deployed in a fractal bifurcation model using rePOT, with a variable impact of the procedure on stent cell area.

Radiopacity of Coronary Stents, an In Vitro Comparative Study.

PURPOSE: Interventional cardiology devices and especially stents are constantly evolving. A good radiopacity is essential to properly position the stent and to reduce the risk of complications during percutaneous coronary intervention (PCI). We wanted to assess the radiopacity of coronary stents. METHODS: 9 stents were evaluated. Stents were deployed in a silicon bifurcation model and several pulsed fluoroscopy acquisitions (7.5 and 15 pulses/s) of each device were performed in a catheterization laboratory. Quantitative radiopacity assessment was performed using a radiopacity visual scale and qualitative radiopacity assessment was performed by showing the images to three experienced operators, single-blind. RESULTS: Our study showed statistically significant differences between stents regarding radiopacity assessed in a quantitative analysis (p < 0.000001) or a qualitative analysis (p < 0.000001), whether the acquisitions were made in 7.5 or 15 pulses/s. Resolute Onyx and Synergy were the most radio-opaque in both qualitative and qualitative analysis. Moreover, there was a statistically significant correlation between the radiopacity of stents, their strut thickness (p < 0.0001) and the presence of platinum in their metallic alloy (p < 0.0001). CONCLUSION: This study highlighted significant differences in the radiopacity of coronary stents deployed in a bench test model. The strut thickness and the presence of platinum increased the radiopacity.

Effect of oral anticoagulation on clinical outcomes and haemodynamic variables after successful transcatheter aortic valve implantation.

BACKGROUND: The effect of oral anticoagulation on clinical and haemodynamic outcomes following successful transcatheter aortic valve implantation is unclear. AIMS: To evaluate the effect of oral anticoagulation within the first year after transcatheter aortic valve implantation. METHODS: All patients undergoing transcatheter aortic valve implantation in two French tertiary centres from 2010 to 2016 were included prospectively. The composite outcome of death, stroke, readmission for heart failure or major/life-threatening bleeding according to Valve Academic Research Consortium 2 criteria within 1year was evaluated. Valvular haemodynamic deterioration was defined as mean transprosthetic gradient ≥20mmHg or an increase of ≥10mmHg during echocardiographic follow-up. RESULTS: Of the 1139 patients included, 400 (35.1%) were discharged on oral anticoagulation. The primary endpoint was more frequent in the group with versus without oral anticoagulation (29.4% vs. 17.3% 21.5%; hazard ratio 1.83, 95% confidence interval 1.42-2.35). Composite endpoint risk factors were chronic pulmonary and kidney diseases, previous atrial fibrillation, left ventricular ejection fraction ≤30% at discharge and no femoral vascular approach, but not oral anticoagulation prescription at discharge. Conversely, 58 patients were identified with valvular haemodynamic deterioration, including 11 (19%) in the group with oral anticoagulation and 47 (81%) in the group without oral anticoagulation. Valvular haemodynamic deterioration risk factors were absence of oral anticoagulation exposure, increased body mass index, use of a balloon-expandable bioprosthesis and use of a bioprosthesis with diameter ≤23mm. Antithrombotic treatment crossover (i.e. oral anticoagulation interruption or introduction during follow-up) occurred in 9.6% of patients, and was a risk factor for death (adjusted hazard ratio 3.39, 95% confidence interval 1.63-7.07). CONCLUSIONS: Baseline characteristics, rather than oral anticoagulation prescription at discharge, were associated with adverse outcomes following successful transcatheter aortic valve implantation. Conversely, oral anticoagulation was associated with reduced valvular haemodynamic deterioration.

Adult-onset Still's disease revealed by a complete atrioventricular block, totally regressive under corticosteroid therapy.

We report the case of a 40-year-old veterinary surgeon who was admitted for spiking fevers, arthralgia, and a complete atrioventricular block. Tests revealed an inflammatory syndrome, hepatic cytolysis, neutrophilic leukocytosis, and increased troponin levels. Cardiac magnetic resonance imaging showed a small myocarditis but no tissue abnormality on the conduction pathways. In the absence of evidence-based infection and favorable evolution under broad spectrum antibiotherapy, an adult-onset Still's disease was suspected and corticosteroid therapy administered. Evolution was then impressively favorable, with a persistent sinus heart rhythm 3 days later. Learning objective: Febrile conductive disorders occurring during a systemic disorder with negative infection and auto-immunity work-up should lead to consider an adult-onset Still's disease, which can be treated and cured, especially with steroids. Moreover, fever, polyarthritis, neutrophilic leukocytosis, pericarditis, and myocarditis should lead to consideration of adult-onset Still's disease.

Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations.

BACKGROUND: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI). OBJECTIVES: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population. METHODS: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group). RESULTS: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3. CONCLUSIONS: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations.

Incidence of, risk factors for and impact of readmission for heart failure after successful transcatheter aortic valve implantation.

BACKGROUND: The incidence of and risk factors for readmission for heart failure after successful transcatheter aortic valve implantation (TAVI) are unclear. AIMS: We sought to evaluate the incidence of, risk factors for and clinical impact of readmission for heart failure after successful TAVI in an unselected patient population. METHODS: All patients who underwent successful TAVI in two high-volume French tertiary centres from February 2010 to December 2016 were included prospectively and followed up for 1 year. A Cox multivariable model was used to assess risk factors for readmission for heart failure and mortality. RESULTS: A total of 1139 patients (mean age 82.4±7.7years; 52.2% male sex) were included. Readmission for heart failure occurred in 99 (9.2%) patients. Risk factors for readmission for heart failure were previous atrial fibrillation (adjusted hazard ratio [adjHR] 1.62, 95% confidence interval [CI] 1.09-2.40), diabetes mellitus (adjHR 1.67, 95% CI 1.11-2.50), chronic kidney disease (adjHR 1.72, 95% CI 1.13-2.62), chronic pulmonary disease (adjHR 1.81, 95% CI 1.17-2.81) and left ventricular ejection fraction after TAVI ≤ 35% (adjHR 2.12, 95% CI 1.20-3.75). Readmission for heart failure was strongly associated with mortality (adjHR 3.11, 95% CI 1.95-4.94), along with increased Society of Thoracic Surgeons' score (adjHR 1.07, 95% CI 1.03-1.12), chronic pulmonary disease (adjHR 1.45, 95% CI 1.00-2.09), previous atrial fibrillation (adjHR 2.11, 95% CI 1.52-2.93) and shock during the index hospitalization (adjHR 2.56, 95% CI 1.41-4.65). CONCLUSIONS: Readmission for heart failure occurs in one in 10 patients after successful TAVI, and is a strong risk factor for mortality. Co-morbidities and left ventricular ejection fraction after TAVI≤35% are the main risk factors for readmission for heart failure.

Is the MitraClip® procedure profitable in a high-volume French hospital?

BACKGROUND: Mitral regurgitation is the second most frequent valvulopathy managed by surgery in Europe. For patients who have a contraindication to surgery or a high surgical risk, the percutaneous MitraClip® implantation procedure has emerged as a favourable alternative approach, but elevated procedural costs are a medicoeconomic concern. AIM: The objective of this study was to evaluate whether the MitraClip® procedure is profitable in a high-volume French hospital. METHODS: Patients eligible for mitral valve repair with a MitraClip® device, and covered by the French National Health Service, were included retrospectively in this single-centre study between September 2016 and June 2018. Subgroups were considered based on medicoeconomic severity level. The study primary endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary endpoints included profit based on severity level, breakdown of costs and adverse events during hospitalization. RESULTS: Twenty-two patients were included in the study. The mean hospital cost and revenue were €30,039±2476 and €30,331±2720 per patient, respectively, resulting in a profit of €292±2039 per patient. The total estimated profit was €6429 for the whole study period. The largest benefits were observed for patients assigned to the higher medicoeconomic severity levels (levels 2 and 3). Profit increased following a reduction in the device cost (€1136±2415 per patient). The price of the device represented 78% of the total costs. CONCLUSIONS: Percutaneous MitraClip implantation is a financially neutral procedure for a French university hospital, but this depends on patient severity level.

A comparative profitability analysis of transcatheter versus surgical aortic valve replacement in a high-volume French hospital.

BACKGROUND: Current scientific guidelines have extended the indication for transcatheter aortic valve replacement (TAVR) to patients who present an intermediate risk for surgery and have been so far considered for conventional surgery. We previously demonstrated that the TAVR procedure generated profits despite elevated costs, but comparison with surgery has not been performed. The objective of this study was to assess the profitability of the TAVR procedure compared with conventional surgery in a high-volume French hospital. Consecutive patients eligible for transfemoral TAVR or surgical aortic valve replacement (SAVR) were included retrospectively in this single-centre study between September 2014 and December 2015. The primary endpoint was the profitability of each procedure (defined as the ratio between the profit and total revenues), calculated for each patient. Secondary composite endpoints included major adverse events in the 30 days following procedure and breakdown of costs. RESULTS: Two hundred and thirty-eight patients were included in the TAVR group and 341 in the SAVR group. TAVR patients presented higher operative risk scores and more comorbidities. Compared with SAVR, TAVR was associated with higher profits (€2732 ± 1768 per patient vs. €2177 ± 2437 per patient, P < 0.001) but also higher costs (€27,778 ± 4961 vs. €17,813 ± 6071, P < 0.001) resulting in lower profitability (9.3 ± 5.7% vs. 11.7 ± 10.1%, P < 0.001). The price of the bioprosthesis represented 70% of the TAVR total cost. CONCLUSIONS: TAVR performed in carefully selected patients was associated with higher profits than SAVR, but also higher costs resulting in lower profitability.

Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry.

BACKGROUND: Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year. METHODS AND RESULTS: Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010). CONCLUSIONS: In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. GOV NUMBER: NCT02698956.