Comparison of transcatheter versus surgical aortic valve implantation in high-risk patients : a nationwide study in France

Objective To compare the clinical outcomes and direct costs at 5 years between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) using real-world evidence. Methods We performed a nationwide longitudinal study using data from the French Hospital Information System from 2009 to 2015. We matched, inside hospitals, 2 cohorts of adults who underwent TAVI or SAVR during 2010 on propensity score based on patient characteristics. Outcomes analysis included mortality, morbidity, and total costs and with a maximum 60-month follow-up. Clinical outcomes were compared between cohorts using hazard ratios (HRs) estimated from a Cox proportional hazards model for all-cause death, and from Fine and Gray's competing risk model for morbidity. Results Based on a cohort of 1598 patients (799 in each group) from 27 centers, a higher risk of death was observed after 1 year with TAVI compared with SAVR (16.8% vs 12.8%, respectively; HR, 1.33; 95% confidence interval [CI], 1.02-1.72) and was sustained up to 5 years (52.4% vs 37.2%; HR, 1.56; 95% CI, 1.33-1.84). At 5 years, the risk of stroke was increased (HR, 1.64; 95% CI, 1.07-2.54) as was myocardial infarction (HR, 2.30; 95% CI, 1.12-4.69) and pacemaker implantation (HR, 2.40; 95% CI, 1.81-3.17) after TAVI. The hospitalization costs per patient at 5 years were €69,083 after TAVI and €55,687 after SAVR (P < .001). Conclusions In our study, high-risk patients harbored a greater risk of mortality and morbidity at 5 years after TAVI compared with those who underwent SAVR and higher hospitalizations costs. Those results should encourage caution before expanding the indications of TAVI

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

166 Balloon aortic valvuloplasty in unstable and critically ill patients: analysis of three strategies

AimThanks to improved technology and the advent of transcatheter aortic valve implantation (TAVI), balloon aortic valvuloplasty (BAV) has reappared in the management of high risk patients with severe aortic stenosis in a critical clinical state in three different therapeutic strategies: 1) palliative care [A] 2) bridge to surgery [B] 3) bridge to TAVI [C]. Our main objective was to assess the safety, the effiency and the pertinence of BAV.MethodsThirty six patients with severe aortic stenosis and prohibitive surgical risk (logistic Euroscore>15% or severe commorbidities) underwent 39 BAV: 8 in strategy A, 20 in strategy B, 11 in strategy C. 3 patients underwent a second BAV due to early restenosis.ResultsThere was a significant improvement of the hemodynamic parameters after BAV: the peak to peak transaortic gradient was reduced by 56% (47mmHg vs 30mmHg; p<0.001) and index valve area was increased by 48% (0.35 vs 0.52cm2/m2; p<0.001). There was no severe procedural complication (no death due to procedure, no massive aortic insuffisiency, no tamponade). Two patients (5.1%) needed a pacemaker implantation for postprocedure atrioventricular block and 6 patients (15.4%) had moderate bleeding of the femoral artery site. The mortality and follow up for the three strategies are summarized in the table.ConclusionBAV is a safe and efficient transient therapeutic strategy for patients with severe aortic stenosis with prohibitive surgical risk. BAV appears to be more pertinent in bridge to surgery or brige to TAVI than in palliative care. For patients in critical clinical state, BAV stabilizes the hemodynamic status and allows the assessment of anatomical selection criteria for TAVIStratégy A(n=8)Stratégy B(n=20)Stratégy C(n=11)Age (mean, min-max)80 (61–94)73 (44–85)81 (60–87)Mean logistic Euroscore (%)4822.644.2Death n (%)6 (75)8 (40)5 (45)Cardiovascular death n (%)4 (50)3 (15)2 (18)Time of occurrence (days, min-max)12 (0–47)66 (0–130)155 (10–316)Aortic valve replacement n (%)-14 (70)-TAVI n (%)--2 (18

The optimal treatment strategy for secondary mitral regurgitation: a subject of ongoing debate

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Symptomatic and Asymptomatic Neurological Complications of Infective Endocarditis: Impact on Surgical Management and Prognosis

International audienceObjectives:Symptomatic neurological complications (NC) are a major cause of mortality in infective endocarditis (IE) but the impact of asymptomatic complications is unknown. We aimed to assess the impact of asymptomatic NC (AsNC) on the management and prognosis of IE.Methods: From the database of cases collected for a population-based study on IE, we selected 283 patients with definite left-sided IE who had undergone at least one neuroimaging procedure (cerebral CT scan and/or MRI) performed as part of initial evaluation.Results Among those 283 patients, 100 had symptomatic neurological complications (SNC) prior to the investigation, 35 had an asymptomatic neurological complications (AsNC), and 148 had a normal cerebral imaging (NoNC). The rate of valve surgery was 43% in the 100 patients with SNC, 77% in the 35 with AsNC, and 54% in the 148 with NoNC (p<0.001). In-hospital mortality was 42% in patients with SNC, 8.6% in patients with AsNC, and 16.9% in patients with NoNC (p<0.001). Among the 135 patients with NC, 95 had an indication for valve surgery (71%), which was performed in 70 of them (mortality 20%) and not performed in 25 (mortality 68%). In a multivariate adjusted analysis of the 135 patients with NC, age, renal failure, septic shock, and IE caused by S. aureus were independently associated with in-hospital and 1-year mortality. In addition SNC was an independent predictor of 1-year mortality.Conclusions The presence of NC was associated with a poorer prognosis when symptomatic. Patients with AsNC had the highest rate of valve surgery and the lowest mortality rate, which suggests a protective role of surgery guided by systematic neuroimaging results

Prévention des évènements thrombo-emboliques précoces après plastie mitrale chez les patients en rythme sinusal (étude prospective multicentrique de 185 patients entre 2002 et 2005)

LYON1-BU Santé (693882101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Systematic Venoarterial Extracorporeal Membrane Oxygenation After Surgical Correction of Post-Infarction Ventricular Septal Defect

International audienc

Innovative valve disease therapies, a potential benefit for patients but calling for more clinical evaluation

International audienc

Donor aortic dissection in a heart transplantation recipient

Aortic dissection after orthotopic heart transplantation is a rare condition, and a limited number of reports have been published in the literature. Herein, we report a case of Type A aortic dissection 16 years after heart transplantation