Publications by authors named "Helene Eltchaninoff"

162 Publications

Stroke Complicating Infective Endocarditis After Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2021 May;77(18):2276-2287

Emory University School of Medicine, Atlanta, Georgia, USA.

Background: Stroke is one of the most common and potentially disabling complications of infective endocarditis (IE). However, scarce data exist about stroke complicating IE after transcatheter aortic valve replacement (TAVR).

Objectives: The purpose of this study was to determine the incidence, risk factors, clinical characteristics, management, and outcomes of patients with definite IE after TAVR complicated by stroke during index IE hospitalization.

Methods: Data from the Infectious Endocarditis after TAVR International Registry (including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries) was analyzed. Patients were divided into two groups according to stroke occurrence during IE admission (stroke [S-IE] vs. no stroke [NS-IE]).

Results: A total of 57 (10%) patients had a stroke during IE hospitalization, with no differences in causative microorganism between groups. S-IE patients exhibited higher rates of acute renal failure, systemic embolization, and persistent bacteremia (p < 0.05 for all). Previous stroke before IE, residual aortic regurgitation ≥moderate after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size >8 mm were associated with a higher risk of stroke during the index IE hospitalization (p < 0.05 for all). Stroke rate in patients with no risk factors was 3.1% and increased up to 60% in the presence of >3 risk factors. S-IE patients had higher rates of in-hospital mortality (54.4% vs. 28.7%; p < 0.001) and overall mortality at 1 year (66.3% vs. 45.6%; p < 0.001). Surgical treatment was not associated with improved outcomes in S-IE patients (in-hospital mortality: 46.2% in surgical vs. 58.1% in no surgical treatment; p = 0.47).

Conclusions: Stroke occurred in 1 of 10 patients with IE post-TAVR. A history of stroke, short time between TAVR and IE, vegetation size, valve prosthesis type, and residual aortic regurgitation determined an increased risk. The occurrence of stroke was associated with increased in-hospital and 1-year mortality rates, and surgical treatment failed to improve clinical outcomes.
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http://dx.doi.org/10.1016/j.jacc.2021.03.233DOI Listing
May 2021

ST-Segment Elevation Myocardial Infarction Following Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2021 May;77(17):2187-2199

Hospital Universitario Ramón y Cajal, Madrid, Spain.

Background: Among patients with acute coronary syndrome following transcatheter aortic valve replacement (TAVR), those presenting with ST-segment elevation myocardial infarction (STEMI) are at highest risk.

Objectives: The goal of this study was to determine the clinical characteristics, management, and outcomes of STEMI after TAVR.

Methods: This was a multicenter study including 118 patients presenting with STEMI at a median of 255 days (interquartile range: 9 to 680 days) after TAVR. Procedural features of STEMI after TAVR managed with primary percutaneous coronary intervention (PCI) were compared with all-comer STEMI: 439 non-TAVR patients who had primary PCI within the 2 weeks before and after each post-TAVR STEMI case in 5 participating centers from different countries.

Results: Median door-to-balloon time was higher in TAVR patients (40 min [interquartile range: 25 to 57 min] vs. 30 min [interquartile range: 25 to 35 min]; p = 0.003). Procedural time, fluoroscopy time, dose-area product, and contrast volume were also higher in TAVR patients (p < 0.01 for all). PCI failure occurred more frequently in patients with previous TAVR (16.5% vs. 3.9%; p < 0.001), including 5 patients in whom the culprit lesion was not revascularized owing to coronary ostia cannulation failure. In-hospital and late (median of 7 months [interquartile range: 1 to 21 months]) mortality rates were 25.4% and 42.4%, respectively (20.6% and 38.2% in primary PCI patients), and estimated glomerular filtration rate <60 ml/min (hazard ratio [HR]: 3.02; 95% confidence interval [CI]: 1.42 to 6.43; p = 0.004), Killip class ≥2 (HR: 2.74; 95% CI: 1.37 to 5.49; p = 0.004), and PCI failure (HR: 3.23; 95% CI: 1.42 to 7.31; p = 0.005) determined an increased risk.

Conclusions: STEMI after TAVR was associated with very high in-hospital and mid-term mortality. Longer door-to-balloon times and a higher PCI failure rate were observed in TAVR patients, partially due to coronary access issues specific to the TAVR population, and this was associated with poorer outcomes.
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http://dx.doi.org/10.1016/j.jacc.2021.03.014DOI Listing
May 2021

Single-source dual energy CT to assess myocardial extracellular volume fraction in aortic stenosis before transcatheter aortic valve implantation (TAVI).

Diagn Interv Imaging 2021 Apr 23. Epub 2021 Apr 23.

Department of Radiology, Institut du Thorax, INSERM, CNRS, UNIV Nantes, CHU Nantes, 44000 Nantes, France.

Purpose: To assess myocardial extracellular volume fraction (ECV) measurement provided by a single-source dual-energy computed tomography (SSDE-CT) acquisition added at the end of a routine CT examination before transcatether aortic valve implantation (TAVI) compared to cardiac magnetic resonance imaging (MRI).

Materials And Methods: Twenty-one patients (10 men, 11 women; mean age, 86±4.9 years [SD]; age range: 71-92 years) with severe aortic stenosis underwent standard pre-TAVI CT with additional cardiac SSDE-CT acquisition 7minutes after intravenous administration of iodinated contrast material and myocardial MRI including pre- and post-contrast T1-maps. Myocardial ECV and standard deviation (σECV) were calculated in the 16-segments model. ECV provided by SSDE-CT was compared to ECV provided by MRI, which served as the reference. Analyses were performed on a per-segment basis and on a per-patient involving the mean value of the 16-segments.

Results: ECV was slightly overestimated by SSDE-CT (29.9±4.6 [SD] %; range: 20.9%-48.3%) compared to MRI (29.1±3.9 [SD] %; range: 22.0%-50.7%) (P<0.0001) with a bias and limits of agreement of +2.3% (95%CI: -16.1%-+20.6%) and +2.5% (95%CI: -2.1%-+7.1%) for per-segment and per-patient-analyses, respectively. Good (r=0.81 for per-segment-analysis) to excellent (r=0.97 for per-patient-analysis) linear relationships (both P<0.0001) were obtained. The σECV was significantly higher at SSDE-CT (P<0.0001). Additional radiation dose from CT was 1.89±0.38 (SD) mSv (range: 1.48-2.47 mSv).

Conclusion: A single additional SSDE-CT acquisition added at the end of a standard pre-TAVI CT protocol can provide ECV measurement with good to excellent linear relationship with MRI.
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http://dx.doi.org/10.1016/j.diii.2021.03.003DOI Listing
April 2021

Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

Clin Infect Dis 2021 Mar 18. Epub 2021 Mar 18.

Hospital Vall d'Hebron, Barcelona, Spain.

Background: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR.

Methods: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014).

Results: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE ( CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all).

Conclusions: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.
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http://dx.doi.org/10.1093/cid/ciaa1941DOI Listing
March 2021

Prognostic significance of vascular and valvular calcifications in low- and high-gradient aortic stenosis.

Eur Heart J Cardiovasc Imaging 2021 Mar 8. Epub 2021 Mar 8.

University of Lyon, CREATIS UMR5220, INSERM U1044, INSA-15, 7 avenue Jean Capelle 69621 Villeurbanne Cedex, Lyon, France.

Aims: In low-gradient aortic stenosis (LGAS), the high valvulo-arterial impedance observed despite low valvular gradient suggests a high vascular load. Thoracic aortic calcifications (TACs) and valvular aortic calcifications (VACs) are, respectively, surrogates of aortic load and aortic valvular gradient. The aim of this study was to compare the respective contributions of TAC and VAC on 3-year cardiovascular (CV) mortality following TAVI in LGAS vs. high-gradient aortic stenosis (HGAS) patients.

Methods And Results: A total of 1396 consecutive patients were included. TAC and VAC were measured on the pre-TAVI CT-scan. About 435 (31.2%) patients had LGAS and 961 (68.8%) HGAS. LGAS patients were more prone to have diabetes, coronary artery disease (CAD), atrial fibrillation (AF), and lower left ventricular ejection fraction (LVEF), P<0.05 for all. During the 3 years after TAVI, 245(17.8%) patients experienced CV mortality, 92(21.6%) in LGAS and 153(16.2%) in HGAS patients, P=0.018. Multivariate analysis adjusted for age, gender, diabetes, AF, CAD, LVEF, renal function, vascular access, and aortic regurgitation showed that TAC but not VAC was associated with CV mortality in LGAS, hazard ratio (HR) 1.085 confidence interval (CI) (1.019-1.156), P=0.011, and HR 0.713 CI (0.439-1.8), P=0.235; the opposite was observed in HGAS patients with VAC but not TAC being associated with CV mortality, HR 1.342 CI (1.034-1.742), P=0.027, and HR 1.015 CI (0.955-1.079), P=0.626.

Conclusion : TAC plays a major prognostic role in LGAS while VAC remains the key in HGAS patients. This confirms that LGAS is a complex vascular and valvular disease.
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http://dx.doi.org/10.1093/ehjci/jeab039DOI Listing
March 2021

Standardized Measurement of Femoral Artery Depth by Computed Tomography to Predict Vascular Complications After Transcatheter Aortic Valve Implantation.

Am J Cardiol 2021 04 15;145:119-127. Epub 2021 Jan 15.

Normandie Univ, UNIROUEN, Inserm U1096, CHU Rouen, Department of Cardiology, FHU CARNAVAL, F-76000 Rouen, France.

Vascular complications (VCs) are difficult to predict and remain an important issue after transfemoral (TF) transcatheter aortic valve implantation (TAVI) although their incidence has decreased with size reduction of introducers. We aimed to evaluate a standardized measurement of femoral artery depth (FAD) using computed tomography (CT) to predict VCs after TAVI. We performed a retrospective study of 679 TF TAVI patients. We evaluated a standardized CT method to measure FAD immediately above the bifurcation. Sheath-to-femoral-artery ratio (SFAR), calcification, and tortuosity were also evaluated. VCs were defined by the Valve Academic Research Consortium (VARC)-2. Receiver operating characteristic (ROC) curves were used to predict major VCs and the need for a stent-graft. The median values of FAD and SFAR were 49.0 (36.2 to 66.7) mm and 0.95 (0.81 to 1.18), respectively. Major VCs occurred in 37 (5.4%) patients and a stent-graft was required in 49 (7.1%) patients. FAD predicted the need for a stent-graft [0.61 (0.51 to 0.70), p = 0.04] but not major VCs [0.52 (0.40 to 0.63), p = 0.76]. In contrast, SFAR did not predict the need for a stent-graft [0.53 (0.43 to 0.62), p = 0.61] but predicted major VCs [0.70 (0.58 to 0.81), p = 0.001]. Calcification and tortuosity predicted neither major VCs nor the need for a stent-graft. In conclusion, the results of our study suggest that CT measurements of FAD and SFAR provide additional information to predict major VCs and the need for a femoral stent-graft after TF TAVI.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.089DOI Listing
April 2021

Recurrent seizures in a young woman: when video-EEG diagnoses a cardiac cause: a case report.

Eur Heart J Case Rep 2020 Oct 19;4(5):1-6. Epub 2020 Sep 19.

Department of Cardiology, Rouen University Hospital, CHU de Rouen, 1 rue de Germont, 76031 Rouen, France.

Background: While transient loss of consciousness is a frequent presenting symptom, differential diagnosis between syncope and epilepsy can be challenging. Misdiagnosis of epilepsy leads to important psychosocial consequences and eliminates the opportunity to treat patient's true condition.

Case Summary: A 39-year-old woman presenting with recurrent seizures since her childhood was referred to neurological consultation. Electroencephalograms (EEGs) and magnetic resonance imaging previously performed were normal. A sleep-deprived video-EEG was performed and highlighted after 12 h of sleep deprivation a progressive dropping of the heart rate followed by a complete heart block without ventricular escape rhythm and asystole for about 30 s. Her EEG recording later showed diffuse slow waves traducing a global cerebral dysfunction and suffering. The diagnosis of vaso-vagal syncope with predominant cardioinhibitory response was made and a dual-chamber pacemaker with rate-drop response algorithm was implanted. After a 2 years of follow-up, the patient remained free of syncope.

Discussion: Patients presenting with loss of consciousness and convulsion are often diagnosed with epilepsy despite normal EEGs. In patients presenting with recurrent seizures with unclear diagnosis of epilepsy or in a situation of drug-resistant epilepsy, syncope diagnosis should always be considered and a risk stratification is necessary. The benefit of pacemaker implantation in patients with recurrent vaso-vagal syncope is still very controversial. Only patients presenting with spontaneous asystole should be considered for pacemaker implantation in case of recurrent vaso-vagal syncope.
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http://dx.doi.org/10.1093/ehjcr/ytaa236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7780438PMC
October 2020

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

J Am Coll Cardiol 2021 Jan;77(1):1-14

Herzzentrum Duisburg, Duisburg, Germany.

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.

Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).

Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.

Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm vs. 1.37 ± 0.5 cm; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).

Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
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http://dx.doi.org/10.1016/j.jacc.2020.10.053DOI Listing
January 2021

Can permanent His bundle pacing be safely started by operators new to this technique? Data from a multicenter registry.

J Cardiovasc Electrophysiol 2021 Feb 9;32(2):417-427. Epub 2021 Jan 9.

Department of Cardiology, Rouen University Hospital, Rouen, France.

Background: Right ventricular pacing (RVP) induces ventricular asynchrony in patients with normal QRS and increases the risk of heart failure and atrial fibrillation in long term. His bundle pacing (HBP) is a physiological alternative to RVP, and could overcome its drawbacks. Recent studies assessed the feasibility and safety of HBP in expert centers with a vast experience of this technique. These results may not apply to less experienced centers. We aim to evaluate the feasibility and safety of permanent HBP performed by physicians who are new to this technique.

Methods: We included all patients who underwent pacemaker implantation with attempt of HBP in three hospitals between September 2017 and January 2020. Indication for HBP was left to operators' discretion. All the operators were new for HBP. His bundle (HB) electrical parameters were recorded at implant, 3- and 12-month follow-up.

Results: HBP was successful in 141 of 170 patients (82.9%); selective HBP was obtained in 96 patients and nonselective HBP in 45. The mean procedure and fluoroscopy durations were 67.0 ± 28.8 min, and 7.3 ± 8.1 min (3.1 ± 4.1 Gy·cm ), respectively. The mean HB paced QRS duration was 106 ± 18 ms. The mean HB capture threshold was 1.29 ± 0.77 V and did not increase at 3- and 12-month follow-up. The ventricular lead revision was required in five patients. Our results showed a rapid technical learning allowing a high procedure success rate (89.8%) after 15 procedures.

Conclusion: HBP performed by operators new to this technique appeared feasible and safe. This should encourage HBP to be performed in patients expected to experience high RVP burden.
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http://dx.doi.org/10.1111/jce.14860DOI Listing
February 2021

Are routine cryoballoon procedural characteristics predictive of atrial arrhythmia recurrence in the long term?

Arch Cardiovasc Dis 2021 Feb 29;114(2):105-114. Epub 2020 Oct 29.

Department of Cardiology, CHU de Rouen, 76000 Rouen, France.

Background: Cryoballoon ablation is an effective procedure to treat atrial fibrillation (AF). However, AF recurrence rate at 1-year follow-up is approximately 20% despite improvements in ablation technique.

Aim: To find factors predictive of AF recurrence following a first pulmonary vein isolation procedure using a second-generation cryoballoon (PVI-2CB).

Methods: This was an observational, retrospective, single-centre study. From June 2012 to April 2017, all patients who had a PVI-2CB procedure and a scheduled follow-up at Rouen University Hospital were included. The primary endpoint was atrial arrhythmia (AA) recurrence (e.g. AF, flutter or tachycardia), considering a blanking period of 2 months following the procedure. Secondary endpoints were procedural variables for each pulmonary vein (successful isolation, time to disconnection, total cryoballoon application time, number of cryoballoon applications, level of occlusion during cryoballoon application leading to successful disconnection and lowest temperature reached during successful cryoballoon application), occurrence of redo procedures, use of antiarrhythmic drugs and adverse events.

Results: The initial population consisted of 239 patients; six were excluded for lack of procedural variable data, giving an analysed population of 233 patients. The AA recurrence rate was 36.9% (mean follow-up 25±14 months). Mean time to AA recurrence was 10±12 months. No procedural variable was found to be predictive of AA recurrence. Only major left atrial enlargement (defined as diameter>50mm or left atrial area>30cm or left atrial volume>50mL/m) was predictive (odds ratio 2.70, 95% confidence interval 1.54-4.72; P=0.001). Forty-one patients had redo procedures (17.6% of analysed population); in this subgroup, 75.6% had at least one pulmonary vein reconnected, mainly the right inferior pulmonary vein.

Conclusions: At long-term follow-up, up to one-third of patients had AA recurrence after PVI-2CB. Important atrial remodelling was the only factor predictive of AA recurrence, whereas no procedural variable was found to be predictive.
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http://dx.doi.org/10.1016/j.acvd.2020.06.007DOI Listing
February 2021

Very long-term outcomes after catheter ablation of atrioventricular nodal reentrant tachycardia: How does cryoenergy differ from radiofrequency?

J Cardiovasc Electrophysiol 2020 12 11;31(12):3215-3222. Epub 2020 Nov 11.

Department of Cardiology, Rouen University Hospital, Rouen, France.

Introduction: Either cryoenergy or radiofrequency can be used during atrioventricular nodal reentrant tachycardia (AVNRT) ablation. There are still limited data comparing their respective long-term efficacy (>1 year). This study sought to compare the very long-term outcomes of AVNRT ablation using radiofrequency or cryotherapy.

Methods: We retrospectively included all patients who had undergone a first AVNRT ablation in our institution between January 2010 and December 2017. The primary endpoint was recurrence of documented AVNRT.

Results: The study population consisted of 409 patients (274 females; mean age, 49.9 years). Ablation was performed using cryoenergy in 260 patients and radiofrequency in 149. High acute procedural success rate (>98%) was obtained and no permanent AV block was observed using both techniques. During a mean follow-up of 3.3 ± 2.3 years, documented AVNRT recurrence occurred in 24 (9.2%) and 4 patients (2.7%) in the cryoablation (CA) and radiofrequency (RF) group, respectively. The risk of AVNRT recurrence was significantly higher in the CA group as compared with the RF group (hazard ratio [HR] = 3.7; 95% confidence interval [CI], 1.3-5.9). Most of the recurrences after CA occurred between 1- and 6-year follow-up (14/24; 58.3%), with one-third of late recurrences after 3-year follow-up. In multivariable analysis, only Koch's triangle anatomical variant was associated with AVNRT recurrence after CA (HR = 6.7; 95% CI, 2.7-16.3).

Conclusion: While AVNRT recurrence rates were similar at 1 year of follow-up regardless of the energy used, long-term efficacy appeared higher after radiofrequency ablation. Strikingly, recurrences occured much later after cryotherapy compared with radiofrequency ablation.
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http://dx.doi.org/10.1111/jce.14784DOI Listing
December 2020

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

Circulation 2021 Jan 25;143(2):104-116. Epub 2020 Sep 25.

Escola Paulista de Medicina - Universidade Federal de São Paulo, São Paulo, Brazil (M.Simonato, J.H.P., D.F.G.).

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR.

Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate.

Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; <0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; =0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; =0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; =0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; <0.001) were both independently associated with repeat mitral valve replacement.

Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.049088DOI Listing
January 2021

Hospital admissions for acute myocardial infarction before and after lockdown according to regional prevalence of COVID-19 and patient profile in France: a registry study.

Lancet Public Health 2020 10 18;5(10):e536-e542. Epub 2020 Sep 18.

Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université de Paris, Paris, France; French Alliance for Cardiovascular Trials, Paris, France. Electronic address:

Background: The COVID-19 pandemic has had a profound effect on general health care. We aimed to evaluate the effect of a nationwide lockdown in France on admissions to hospital for acute myocardial infarction, by patient characteristics and regional prevalence of the pandemic.

Methods: In this registry study, we collected data from 21 centres participating in the ongoing French Cohort of Myocardial Infarction Evaluation (FRENCHIE) registry, which collects data from all patients admitted for ST segment elevation myocardial infarction (STEMI) or non-ST segment elevation myocardial infarction (NSTEMI) within 48 h of symptom onset. We analysed weekly hospital admissions over 8 weeks: the 4 weeks preceding the institution of the lockdown and the 4 weeks following lockdown. The primary outcome was the change in the number of hospital admissions for all types of acute myocardial infarction, NSTEMI, and STEMI between the 4 weeks before lockdown and the 4 weeks after lockdown. Comparisons between categorical variables were made using χ tests or Fisher's exact tests. Comparisons of continuous variables were made using Student's t tests or Mann-Whitney tests. Poisson regression was used to determine the significance of change in hospital admissions over the two periods, after verifying the absence of overdispersion. Age category, region, and type of acute myocardial infarction (STEMI or NSTEMI) were used as covariables. The FRENCHIE cohort is registered with ClinicalTrials.gov, NCT04050956.

Findings: Between Feb 17 and April 12, 2020, 1167 patients were consecutively admitted within 48 h of acute myocardial infarction (583 with STEMI, 584 with NSTEMI) and were included in the study. Admissions for acute myocardial infarction decreased between the periods before and after lockdown was instituted, from 686 before to 481 after lockdown (30% decrease; incidence rate ratio 0·69 [95% CI 0·51-0·70]). Admissions for STEMI decreased from 331 to 252 (24%; 0·72 [0·62-0·85]), and admissions for NSTEMI decreased from 355 to 229 (35%; 0·64 [0·55-0·76]) following institution of the lockdown, with similar trends according to sex, risk factors, and regional prevalence of hospital admissions for COVID-19.

Interpretation: A marked decrease in hospital admissions was observed following the lockdown, irrespective of patient characteristics and regional prevalence of COVID-19. Health authorities should be aware of these findings, in order to adapt their message if the COVID-19 pandemic persists or recurs, or in case of future major epidemics.

Funding: Recherche Hospitalo-Universitaire en Santé iVasc.
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http://dx.doi.org/10.1016/S2468-2667(20)30188-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7498416PMC
October 2020

Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial).

Am Heart J 2020 10 30;228:27-35. Epub 2020 Jun 30.

Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address:

Background: Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk.

Methods/design: The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life.

Discussion: The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis.

Trial Registration: clinicaltrials.gov: NCT04160130.
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http://dx.doi.org/10.1016/j.ahj.2020.06.016DOI Listing
October 2020

Successful linkage of French large-scale national registry populations to national reimbursement data: Improved data completeness and minimized loss to follow-up.

Arch Cardiovasc Dis 2020 Aug - Sep;113(8-9):534-541. Epub 2020 Jul 22.

Department of Cardiology, CHRU Brest, 29200 Brest, France; RHU STOP-AS, 76000 Rouen, France. Electronic address:

Background: Registries, a cornerstone of contemporary medicine, frequently suffer from incomplete documentation and losses to follow-up. By linking data to a single-payer national claims database, national registries may be enriched and the quality enhanced.

Aims: To explore the value of data from the French Système National des Données de Santé (SNDS) as a resource to enhance the quality of registries when combined with data from electronic case report forms, and to assess the power to minimize data gaps and losses to follow-up.

Methods: A probabilistic algorithm was developed to link and match records in the SNDS with patient data from the electronic case report forms of two registries on transcatheter aortic valve implantation: FRANCE-2 and FRANCE-TAVI. The algorithm created patient profiles from transcatheter aortic valve implantation procedures in the SNDS, matching them as closely as possible to the profiles in the registry databases. The objective was to achieve 90% linkage of the populations. The linked database was analysed for completeness and loss to follow-up. For validation, mortality curves for the linked registry cohorts were compared with those for the original populations.

Results: A total of 34,397 unique registries entries were identified, and 89.9% of patients in the SNDS could be linked. Rates of losses to follow-up over 2 years were 1.0% in the linked FRANCE-TAVI population compared with 40.3% based on electronic case report form documentation. For FRANCE-2, 3-year rates of losses to follow-up were 1.7% and 6.1%, respectively. Mortality curves for populations based on SNDS and electronic case report form data were practically superimposable.

Conclusions: Linking data from a single-payer national claims database to national registries using a probabilistic approach is feasible and can close data gaps and practically abolish losses to follow-up in the registry population.
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http://dx.doi.org/10.1016/j.acvd.2020.04.006DOI Listing
September 2020

General Anesthesia or Conscious Sedation for Transfemoral Aortic Valve Replacement with the SAPIEN 3 Transcatheter Heart Valve.

Int Heart J 2020 Jul 18;61(4):713-719. Epub 2020 Jul 18.

University Heart Center.

Differences in the benefits of conscious sedation (CS) and general anesthesia (GA) during transfemoral aortic valve implantation (TAVI) are unclear.We aimed to assess differences in procedural and clinical outcomes based on the type of anesthesia received during TAVI.We analyzed SOURCE 3 Registry data for patients who received the SAPIEN 3 valve by type of anesthesia used during TAVI.Of the 1694 TAVI patients, 1027 received CS and 667 received GA. Patients were similar at baseline (81.5 years; Society of Thoracic Surgeons risk score 7.0). Compared with the GA group, the CS group had fewer intra-procedural transesophageal echocardiography (TEE) and post implantation dilatations performed, and less contrast medium was used. The CS group had significantly less kidney injury at 7 days post-procedure than the GA group (0.4% versus 1.5%, P = 0.014). Moderate paravalvular leaks (PVL) occurred more frequently in the CS group versus the GA group (2.2% versus 0.8%; P = 0.041). No severe PVL were reported. Median total hospital length of stay (LOS) after TAVI was 10 days in the CS group and 11 days in the GS group. At 30 days, all-cause death was 2.1% in CS and 1.7% in GS (P = 0.47), and myocardial infarction was 0.2% in CS and 0.1% in GS (P = 0.83).Our analyses found no significant major outcome differences between CS and GA during TAVI.
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http://dx.doi.org/10.1536/ihj.19-567DOI Listing
July 2020

Evaluation of length of stay after transfemoral transcatheter aortic valve implantation with SAPIEN 3 prosthesis: A French multicentre prospective observational trial.

Arch Cardiovasc Dis 2020 Jun - Jul;113(6-7):391-400. Epub 2020 May 14.

Normandie University, UNIROUEN, INSERM U1096, Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, 76000 Rouen, France.

Background: Complications decrease after transfemoral transcatheter aortic valve implantation (TAVI), and early discharge is feasible and safe in selected populations.

Aims: To evaluate length of stay (LOS) and reasons for prolonged hospitalisation after transfemoral TAVI in unselected patients.

Methods: Patients with severe aortic stenosis, who had transfemoral TAVI with the SAPIEN 3 prosthesis using exclusively local anaesthesia, were prospectively and consecutively included at five French high-volume centres. LOS was calculated from TAVI procedure to discharge. Reasons for prolonged hospitalisation (i.e.>3 days) were evaluated.

Results: Between 2017 and 2018, 293 patients were included, with a mean age of 82.4±6.5 years and a mean logistic EuroSCORE of 13.7±9.0%. The in-hospital mortality rate was 1.4%. The median LOS was 5 (3-7) days, and varied considerably between centres (from 2 to 7 days). Sixty-four (21.8%) patients were discharged within 3 days after transfemoral TAVI. Reported reasons for prolonged hospitalisation were complications in 62.2%, loss of autonomy in 3.1%, discharge refusal in 2.2% and logistical reasons in 0.9%. In 31.6% of cases, the investigators reported no apparent reasons.

Conclusions: The results of our study suggest that LOS after transfemoral TAVI, using the SAPIEN 3 prosthesis and a minimalist approach, varies considerably between centres. In almost a third of cases, hospitalisation was prolonged without any apparent reason. Efforts should be made to educate centres to reduce LOS.
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http://dx.doi.org/10.1016/j.acvd.2019.11.010DOI Listing
September 2020

Analysis of length of stay after transfemoral transcatheter aortic valve replacement: results from the FRANCE TAVI registry.

Clin Res Cardiol 2021 Jan 25;110(1):40-49. Epub 2020 Apr 25.

Department of Cardiology, Rouen University Hospital, Normandie Univ, UNIROUEN, INSERM U1096, FHU REMOD-VHF, 76000, Rouen, France.

Background: Currently, there are no recommendations regarding the minimum duration of in-hospital monitoring after transfemoral (TF) transcatheter aortic valve replacement (TAVR) and practices are extremely heterogeneous. We, therefore, aimed to evaluate length of stay (LOS) and predictive factors for late discharge after TF TAVR using data from the FRANCE TAVI registry.

Methods: TAVR was performed in 12,804 patients in 48 French centers between 2013 and 2015. LOS was evaluated in 5857 TF patients discharged home. LOS was calculated from TAVR procedure (day 0) to discharge. The study population was divided into three groups based on LOS values. Patients discharged within 3 days constituted the "very early" discharge group, patients with a LOS between 3 and 6 days constituted the "early" discharge group, and patients with a length of stay > 6 days constituted the "late" discharge group.

Results: The median LOS was 7 (5-9) days and was extremely variable among centers. The proportion of patients discharged very early, early, and late was 4.4% (n = 256), 33.7% (n = 1997), and 61.9% (n = 3624) respectively. Variables associated with late discharge were female sex, co-morbidities, major complications, self-expandable valve, general anesthesia, and a significant center effect. In contrast, history of previous pacemaker was a protective factor. The composite of death and re-admission in the very early and early versus late discharge groups was similar at 30 days (3.3% vs. 3.5%, p = 0.66).

Conclusions: LOS is extremely variable after TF TAVR in France. Co-morbidities and complications were predictive factors of late discharge after TAVI. Interestingly, the use of self-expandable prosthesis and general anesthesia may also contribute to late discharge. Our results confirm that early discharge is safe.
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http://dx.doi.org/10.1007/s00392-020-01647-4DOI Listing
January 2021

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction.

J Am Coll Cardiol 2020 04;75(16):1882-1893

Herzzentrum Duisburg, Duisburg, Germany.

Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail.

Objectives: The authors sought to examine outcomes following redo-TAVR.

Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.

Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis-regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm and 1.51 ± 0.57 cm; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.

Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.
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http://dx.doi.org/10.1016/j.jacc.2020.02.051DOI Listing
April 2020

Role for Vascular Factors in Long-Term Outcomes After Transcatheter Aortic Valve Implantation.

Am J Cardiol 2020 06 2;125(12):1884-1889. Epub 2020 Apr 2.

Service de cardiologie, Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France; Université de Lyon; CREATIS UMR5220; INSERM U1044; INSA-15 Lyon, France. Electronic address:

Despite major technological advances, 1-year morbi-mortality after transcatheter aortic valve implantation (TAVI) is still high. Further outcome improvements may be obtained provided proper identification of prognostic factors. A change of prognostic value over time should be the hallmark of an outcome-implicated factor. In 1,425 patients treated by TAVI, the examined prognostic factors were: demographic factors and co-morbidities (age, male gender, glomerular filtration rate, and chronic obstructive pulmonary disease), cardiac function (left ventricular ejection fraction, pulmonary pressure, aortic gradient, dyspnea, and mitral regurgitation), and vascular factors (coronary artery disease, peripheral vascular disease (PVD), previous stroke, and thoracic aortic calcium-TAC-as assessed by CT scan). Cox models were used to analyze cardiovascular and all-cause mortalities over 3 years of follow-up. The time-dependent effects of the factors were analyzed using the distribution of Schoenfeld residuals. During the study period, 375 (26.3%) deaths occurred of whom 248 (17.4%) from cardiovascular causes. Only 2 factors associated with cardiovascular or all-cause mortality showed significant changes over time: dyspnea and PVD. The effect of dyspnea on cardiovascular mortality decreased over time (first- and third-year hazard ratios [95% confidence intervals]: 1.47 [1.10; 1.96] and 0.94 [0.55; 1.63], respectively), whereas the effect of PVD increased (first- and third-year hazard ratios: 0.87 [0.56; 1.35] and 2.58 [1.25; 5.33], respectively). TAC had a stable effect. In conclusion, the detrimental effects of vascular factors remained stable (TAC) or increased (PVD) over time. These factors should be targeted by specific measures to improve post-TAVI outcomes.
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http://dx.doi.org/10.1016/j.amjcard.2020.03.010DOI Listing
June 2020

MDCT planning of trans catheter aortic valve implantation (TAVI): determination of optimal c-arm angulation.

Int J Cardiovasc Imaging 2020 Aug 18;36(8):1551-1557. Epub 2020 Apr 18.

Centre Hospitalier Universitaire de Rouen, Rouen, France.

A fluoroscopic view perpendicular to the aortic valve annulus is required during transcatheter aortic valve implantation (TAVI) for obtaining an optimal deployment of the bioprosthesis. By predicting c-arm angulation, pre-procedural MDCT could decrease the number of aortograms, shorten the time of the procedure and reduce the amount of intra-arterial contrast agent. The aim of our study was to assess the accuracy of MDCT in predicting c-arm angulation at the cath. lab. In this single center study, we investigated MDCT prediction of c-arm angulation in patients having undergone a TAVI procedure using SAPIEN 3® (Edwards Lifesciences, USA). Prior to the procedure, an experienced radiologist had reported the angulation using dedicated software (CT). After the procedure, a blinded experienced radiologist retrospectively measured the angles using the same method (CT). Interobserver variability was drawn from the comparison between CT and CT. Then, the mean angular difference between the predicted MDCT angles (CT) was compared to the working view recorded at the cath. lab. Seventy-nine patients (M/F = 0.65; mean age: 85.2 years ± 5.3) were included. Interobserver variability was 5.9 ± 6.1°. The mean absolute difference between MDCT and fluoroscopy was 8.8 ± 7.1°. The present study showed that MDCT could predict the coplanar fluoroscopic angles prior to TAVI using a balloon-expandable bioprosthesis Sapien 3® placed via a transfemoral approach with a mean angular difference of 8.8 ± 7.1°. Reproducibility was considered good as the mean difference between two independent measures was 5.9 ± 6.1°.
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http://dx.doi.org/10.1007/s10554-020-01846-0DOI Listing
August 2020

Durability of transcatheter aortic valve implantation: A translational review.

Arch Cardiovasc Dis 2020 Mar 26;113(3):209-221. Epub 2020 Feb 26.

Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, 76000 Rouen, France; Normandie université, UNIROUEN, INSERM U1096, 76000 Rouen, France. Electronic address:

Until recently, transcatheter aortic valve implantation was restricted to high-risk and inoperable patients. The updated 2017 European Society of Cardiology Guidelines has widened the indication to include intermediate-risk patients, based on two recently published trials (PARTNER 2 and SURTAVI). Moreover, two other recent trials (PARTNER 3 and EVOLUT LOW RISK) have demonstrated similar results with transcatheter aortic valve implantation in low-risk patients. Thus, extension of transcatheter aortic valve implantation to younger patients, who are currently treated by surgical aortic valve replacement, raises the crucial question of bioprosthesis durability. In this translational review, we propose to produce a state-of-the-art overview of the durability of transcatheter aortic valve implantation by integrating knowledge of the basic science of bioprosthesis degeneration (pathophysiology and biomarkers). After summarising the new definition of structural valve deterioration, we will present what is known about the pathophysiology of aortic stenosis and bioprosthesis degeneration. Next, we will consider how to identify a population at risk of early degeneration, and how basic science with the help of biomarkers could identify and predict structural valve deterioration. Finally, we will present data on the differences in durability of transcatheter aortic valve implantation compared with surgical aortic valve replacement.
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http://dx.doi.org/10.1016/j.acvd.2019.11.007DOI Listing
March 2020

Femoral Versus Nonfemoral Peripheral Access for Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2019 12;74(22):2728-2739

Department of Cardiology, La Cavale Blanche University Hospital Centre, Optimization of Physiological Regulations, Science and Technical Training And Research Unit, University of Western Brittany, Brest, France.

Background: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access.

Objectives: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR.

Methods: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed.

Results: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers.

Conclusions: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.
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http://dx.doi.org/10.1016/j.jacc.2019.09.054DOI Listing
December 2019

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

Circulation 2020 01 16;141(4):243-259. Epub 2019 Nov 16.

Clinique du Tonkin, Service de Cardiologie, Villeurbanne, France (D.C.).

Background: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date.

Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality.

Results: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; <0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; <0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; =0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.

Conclusion: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV.

Clinical Trial Registration: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.043785DOI Listing
January 2020

Infective Endocarditis Following Transcatheter Aortic Valve Replacement: Comparison of Balloon- Versus Self-Expandable Valves.

Circ Cardiovasc Interv 2019 11 7;12(11):e007938. Epub 2019 Nov 7.

Hospital Israelita Albert Einstein, Sao Paulo, Brazil

Background: No data exist about the characteristics of infective endocarditis (IE) post-transcatheter aortic valve replacement (TAVR) according to transcatheter valve type. We aimed to determine the incidence, clinical characteristics, and outcomes of patients with IE post-TAVR treated with balloon-expandable valve (BEV) versus self-expanding valve (SEV) systems.

Methods: Data from the multicenter Infectious Endocarditis After TAVR International Registry was used to compare IE patients with BEV versus SEV.

Results: A total of 245 patients with IE post-TAVR were included (SEV, 47%; BEV, 53%). The timing between TAVR and IE was similar between groups (SEV, 5.5 [1.2-15] months versus BEV, 5.3 [1.7-11.4] months; =0.89). Enterococcal IE was more frequent in the SEV group (36.5% versus 15.4%; <0.01), and vegetation location differed according to valve type (stent frame, SEV, 18.6%; BEV, 6.9%; =0.01; valve leaflet, SEV, 23.9%; BEV, 38.5%; =0.01). BEV recipients had a higher rate of stroke/systemic embolism (20.0% versus 8.7%, adjusted OR: 2.46, 95% CI: 1.04-5.82, =0.04). Surgical explant of the transcatheter valve (SEV, 8.7%; BEV, 13.8%; =0.21), and in-hospital death at the time of IE episode (SEV, 35.6%; BEV, 37.7%; =0.74) were similar between groups. After a mean follow-up of 13±12 months, 59.1% and 54.6% of the SEV and BEV recipients, respectively, had died (=0.66).

Conclusions: The characteristics of IE post-TAVR, including microorganism type, vegetation location, and embolic complications but not early or late mortality, differed according to valve type. These results may help to guide the diagnosis and management of IE and inform future research studies in the field.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.007938DOI Listing
November 2019

Significance of the CAPRI risk score to predict heart failure hospitalization post-TAVI: The CAPRI-HF study.

Int J Cardiol 2019 12 19;296:98-102. Epub 2019 Aug 19.

Cardiology Department, Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France; University of Lyon, CREATIS UMR5220, INSERM U1044, INSA-15 Lyon, France.

Background: Predictors of heart failure (HF) hospitalization after transcatheter aortic valve implantation (TAVI) are not well defined. CAPRI is a score for predicting 1-year post-TAVI cardiovascular and all-cause mortality. The aim of the present study is to assess the prognostic significance of the CAPRI score for HF hospitalization 1 year after TAVI.

Methods And Results: CAPRI-HF is an ancillary study of the C4CAPRI trial, analyzing 409 consecutive patients treated by TAVI. The primary outcome was hospitalization for HF during the first year post-intervention. The prognostic value of the CAPRI score was assessed by multivariable analysis adjusted for diabetes, atrial fibrillation, vascular route, pacemaker implantation, post-TAVI aortic regurgitation, transfusion and pulmonary artery systolic pressure. A subanalysis focused on patients with low-gradient aortic stenosis (LGAS). At 1 year, HF hospitalization occurred in 78 (19.9%) patients. Patients with HF were more prone to have diabetes, atrial fibrillation, renal dysfunction, lower mean aortic gradient, higher logistic EuroSCORE and higher CAPRI score (p < .05 for all associations). In the multivariable analysis, CAPRI score was the sole predictor of HF: hazard ratio (HR) for each 0.1 CAPRI score increase was 1.065, 95% confidence interval (CI) 1.021-1.110. This was confirmed when adjusted for EuroSCORE: HR 1.066, 95% CI 1.024-1.110. The predictive power of the CAPRI score increased for LGAS: HR 1.098, 95% CI 1.028-1.172.

Conclusions: CAPRI score helps predict HF post-TAVI. Including the score in the decision-making process may help selecting candidates for TAVI and identifying patients who need close monitoring post-procedure.
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http://dx.doi.org/10.1016/j.ijcard.2019.08.033DOI Listing
December 2019

Carotid versus femoral access for transcatheter aortic valve implantation: a propensity score inverse probability weighting study.

Eur J Cardiothorac Surg 2019 Dec;56(6):1140-1146

Department of Cardiovascular Surgery, S. Croce Hospital, Cuneo, Italy.

Objectives: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI.

Methods: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment.

Results: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001).

Conclusions: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.
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http://dx.doi.org/10.1093/ejcts/ezz216DOI Listing
December 2019

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

Circ Cardiovasc Interv 2019 04;12(4):e007597

Normandie Univ, UNIROUEN, INSERM U1096, Rouen University Hospital, Department of Cardiology, FHU REMOD-VHF, France (E.D., A.S., C.T., P.Y.L., G.A., A.C., H.E.).

Background: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves.

Methods And Results: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses.

Conclusions: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007597DOI Listing
April 2019