Publications by authors named "Emmanuel Teiger"

147 Publications

Atrial fibrillation evolution and rhythm control strategy following left appendage closure: new insights from the prospective FLAAC registry.

BMC Cardiovasc Disord 2021 May 3;21(1):227. Epub 2021 May 3.

Inserm, CIC 1430, Henri Mondor University Hospital, Creteil, France.

Background: Percutaneous left atrial appendage (LAA) closure is an alternative to oral anticoagulation (OAC) for atrial fibrillation (AF) patients with high thromboembolism risk, particularly with contraindications to OAC. The LAA itself could possess proarrhythmogenic properties. As patients undergoing LAA closure could be candidates for cardioversion or ablation, we aimed to evaluate AF disease progression following LAA closure and the outcome of patients undergoing a rhythm control strategy after the procedure.

Methods: The prospective multicenter French Nationwide Observational LAA Closure Registry (FLAAC) comprises 33 French interventional cardiology departments. Patients were included if they fulfilled the following criteria: history of non-valvular AF, successful LAA closure and long-term ECG follow-up.

Results: A total of 331 patients with successful LAA closure were enrolled in the study. Patients mean age was 75.4 ± 0.5 years. The study population was characterized by a high thromboembolic risk (CHADS-VASc score: 4.5 ± 0.1) and frequent comorbidities. The median follow-up was 11.9 months. One hundred and nineteen (36.0%) patients were in sinus rhythm (SR) at baseline. Among SR patients, documented AF was observed in 16 (13.4%) patients whereas 15 (7.1%) patients in AF at baseline restored SR, at the end of follow up. Finally, only 13 patients (4%) underwent procedures to restore SR without complications during the follow-up.

Conclusions: The vast majority of patients undergoing LAA closure have the same AF status at baseline and one year after the index procedure. During the follow-up, a very small proportion (4%) of our population underwent procedures to restore SR without complications whatever the post-procedural antithrombotic strategy was.
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http://dx.doi.org/10.1186/s12872-021-01994-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091509PMC
May 2021

Patent Foramen Ovale Closure In Stroke Patients With Migraine In The Close Trial. The Close-Mig Study.

Eur J Neurol 2021 May 3. Epub 2021 May 3.

Stroke unit, Department of Neurology, University Hospital of Nantes, Nantes, France.

Background: The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial.

Methods: Planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists.

Results: Among 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age, 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up.

Conclusions: In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, both in migraine patients with and without aura.
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http://dx.doi.org/10.1111/ene.14892DOI Listing
May 2021

Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure.

J Cardiovasc Transl Res 2021 Apr 21. Epub 2021 Apr 21.

Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Residual or newly acquired leaks are routinely appraised after left atrial appendage closure (LAAC). The Watchman and the Amulet are the two most frequently used devices for LAAC but no randomized study has so far assessed their comparative leak rates after intervention. The "Comparison of Amplatzer Amulet vs Watchman devices in patients undergoing left atrial appendage closure" (Swiss-Apero, clinicaltrial.gov NCT03399851) is an academic-sponsored multicenter, randomized clinical trial comparing Amulet versus Watchman/FLX devices among patients undergoing a clinically indicated LAAC. The study is designed to assess the superiority of Amulet vs. Watchman/FLX in terms of leaks detected by cardiac computed tomography angiography (CCTA) at 45 days (primary endpoint) and 13 months (secondary endpoint) after intervention by an imaging Core Laboratory. The Swiss-Apero study is the first randomized clinical trial comparing Amulet and Watchman/FLX with respect to the prevalence of post-procedural leak as assessed with CCTA.
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http://dx.doi.org/10.1007/s12265-020-10095-4DOI Listing
April 2021

Complete percutaneous angio-guided approach using preclosing for venoarterial extracorporeal membrane oxygenation implantation and explantation in patients with refractory cardiogenic shock or cardiac arrest.

Crit Care 2021 03 7;25(1):93. Epub 2021 Mar 7.

Service de Cardiologie, APHP, Hôpitaux Universitaires Henri Mondor, 41 avenue du Maréchal de Lattre de Tassigny, 94000, Créteil, France.

Background: The approach for veno-arterial extracorporeal membrane oxygenation implantation (VA-ECMO) in patients with cardiogenic shock can be either surgical or percutaneous. Complete angio-guided percutaneous implantation and explantation could decrease vascular complications. We sought to describe the initial results of complete percutaneous angio-guided ECMO implantation and explantation using preclosing.

Methods: All consecutive patients who underwent peripheral femoro-femoral VA-ECMO percutaneous implantation for refractory cardiogenic shock or cardiac arrest were enrolled in a prospective registry (03/2018-12/2020). Percutaneous preclosing using two closing devices (Perclose ProGlide, Abbott) inserted before cannulation was used in both femoral artery and vein. Explantation was performed using a crossover technique under angiographic guidance. The occurrence of vascular complication was recorded.

Results: Among the 56 patients who underwent percutaneous VA-ECMO implantation for cardiogenic shock or refractory cardiac arrest, 41 underwent preclosing. Femoral vessel cannulation was successful in all patients and total cannulation time was 20 (10-40) min. Weaning from ECMO was possible in 22/41 patients (54%) and 12 (29%) patients were alive at day 30. Significant vascular complications occurred in 2/41 patients. Percutaneous decannulation was performed in 20 patients with 19/20 technical success rate. All femoral arteries and veins were properly closed using the pre-closing devices without bleeding on the angiographic control except for one patient in whom surgical closure of the artery was required. No patient required transfusion for access related significant bleeding and no other vascular complication occurred. Furthermore, no groin infection was observed after full percutaneous implantation and removal of ECMO.

Conclusion: Emergent complete percutaneous angio-guided VA-ECMO implantation and explantation using pre-closing technique can be an attractive strategy in patients referred for refractory cardiogenic shock.
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http://dx.doi.org/10.1186/s13054-021-03522-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938494PMC
March 2021

Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study).

Am J Cardiol 2021 04 28;144:118-124. Epub 2020 Dec 28.

Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.

Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate over time and therefore may necessitate a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve study, which evaluated transcatheter aortic valve implantation using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective Valve-in-Valve study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation, or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve transcatheter aortic valve implantation cases. Two-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality rate was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs 7.6%, p = 0.025). Discharge mean gradients ≥20 mm Hg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3 to 22.1]. In patients with failing surgical aortic bioprostheses, valve-in-valve treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.047DOI Listing
April 2021

Prevalence and prognostic value of autonomic neuropathy assessed by Sudoscan® in transthyretin wild-type cardiac amyloidosis.

ESC Heart Fail 2021 Apr 22;8(2):1656-1665. Epub 2020 Dec 22.

Cardiology Department, AP-HP (Assistance Publique-Hôpitaux de Paris), Henri Mondor University Hospital, 51 Avenue du Marechal de Lattre de Tassigny, Créteil, F-94010, France.

Aims: The prevalence of autonomic neuropathy (AN) is high in patients with hereditary transthyretin amyloidosis but remains unknown in transthyretin wild-type cardiac amyloidosis (ATTRwt-CA). This study aimed to determine the prevalence of AN in patients with ATTRwt-CA using Sudoscan®, a non-invasive method used to provide evidence of AN in clinical practice and based on measurement of electrochemical skin conductance at the hands and feet (fESC).

Methods And Results: A series of 62 non-diabetic patients with ATTRwt-CA was prospectively included over 2 years and compared with healthy elderly subjects, matched by age, gender, and body mass index. The presence of AN was defined as electrochemical skin conductance at the hands <60 μS and/or fESC <70 μS, and conductances were analysed according to clinical, biological, and echocardiographic data. Mean fESC was significantly lower in patients with ATTRwt-CA compared with elderly controls: 68.3 (64.1-72.5) vs. 76.9 (75.6-78.1) μS (P < 0.0001), respectively. Prevalence of fESC <70 μS was higher in ATTRwt-CA patients than in controls: 48.4% vs. 19.9%, P < 0.05. Univariate analysis showed that fESC, N-terminal pro-B-type natriuretic peptide, creatinine plasma levels, and echocardiographic global longitudinal strain were associated with decompensated cardiac failure and death. Multivariate analysis revealed that fESC was an independent prognostic factor, and Kaplan-Meier estimator evidenced a greater occurrence of cardiac decompensation and death in patients with fESC <70 μS, P = 0.046.

Conclusions: Reduced fESC was observed in almost 50% of patients with ATTRwt-CA and was associated with a worse prognosis. Sudoscan® could easily be used to screen ATTRwt-CA patients for the presence of AN and identify patients at higher risk for a poor outcome.
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http://dx.doi.org/10.1002/ehf2.13131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006719PMC
April 2021

Timing of aortic valve replacement in high-gradient severe aortic stenosis: impact of left ventricular ejection fraction.

Acta Cardiol 2020 Dec 7:1-8. Epub 2020 Dec 7.

Cardiology Department, AP-HP Henri Mondor University Hospital, Créteil, France.

Background: Patients with high-gradient (HG) severe aortic stenosis (AS) and left ventricular (LV) dysfunction are at high risk of death. The optimal timing for aortic valve replacement (AVR) is not defined by guidelines. The objective was to define the optimal timing to perform isolated AVR in patients with HG-AS and severe LV dysfunction.

Methods: We retrospectively included 233 consecutive patients admitted for severe HG-AS (aortic valve area <1cm and mean gradient ≥40mmHg). Severe LV dysfunction was defined by LV ejection fraction ≤35% (LVEF). All-cause mortality while waiting for AVR and after the intervention (30 days) was compared in patients with ( = 28) and without ( = 205) LVEF ≤35%.

Results: Patients with HG-AS and severe LV dysfunction had a higher risk profile than those with LVEF >35%. AVR was performed in 93% (218/233) of patients, 41% by surgery (SAVR) and 53% by transcatheter (TAVR). TAVR was the preferred method to treat HG-AS patients with LVEF ≤35%. All-cause mortality while waiting for AVR was higher in patients with severe LV dysfunction (22% vs. 2.0%,  < 0.001) and occurred within a shorter time (12 [8-26] days vs. 63 [58-152] days,  = 0.010) compared to those with LVEF >35%. All death in HG-AS patients with a severe LV dysfunction occurred within the first month. Postoperative mortality was low (1.3%), irrespective of LVEF.

Conclusions: AVR should be performed promptly after Heart Team decision in patients with HG severe AS and LVEF ≤35% because of a very high and premature risk of death while waiting for intervention.
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http://dx.doi.org/10.1080/00015385.2020.1851495DOI Listing
December 2020

Acute Coronary Syndrome in the Era of SARS-CoV-2 Infection: A Registry of the French Group of Acute Cardiac Care.

CJC Open 2021 Mar 11;3(3):311-317. Epub 2020 Nov 11.

Univ Paris Est Créteil, INSERM, IMRB, Créteil, France.

Background: In this study, we aimed to report clinical characteristics and outcomes of patients with and without SARS-CoV-2 infection who were referred for acute coronary syndrome (ACS) during the peak of the pandemic in France.

Methods: We included all consecutive patients referred for ST-elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) during the first 3 weeks of April 2020 in 5 university hospitals (Paris, south, and north of France), all performing primary percutaneous coronary intervention.

Results: The study included 237 patients (67 ± 14 years old; 69% male), 116 (49%) with STEMI and 121 (51%) with NSTEMI. The prevalence of SARS-CoV-2-associated ACS was 11% (n = 26) and 11 patients had severe hypoxemia on presentation (mechanical ventilation or nasal oxygen > 6 L/min). Patients were comparable regarding medical history and risk factors, except a higher prevalence of diabetes mellitus in SARS-CoV-2 patients (53.8% vs 25.6%;  = 0.003). In SARS-CoV-2 patients, cardiac arrest on admission was more frequent (26.9% vs 6.6%; < 0.001). The presence of significant coronary artery disease and culprit artery occlusion in SARS-CoV-2 patients respectively, was 92% and 69.4% for those with STEMI, and 50% and 15.5% for those with NSTEMI. Percutaneous coronary intervention was performed in the same percentage of STEMI (84.6%) and NSTEMI (84.8%) patients, regardless of SARS-CoV-2 infection, but no-reflow (19.2% vs 3.3%; < 0.001) was greater in SARS-CoV-2 patients. In-hospital death occurred in 7 SARS-CoV-2 patients (5 from cardiac cause) and was higher compared with noninfected patients (26.9% vs 6.2%; < 0.001).

Conclusions: In this registry, ACS in SARS-CoV-2 patients presented with high a percentage of cardiac arrest on admission, high incidence of no-reflow, and high in-hospital mortality.
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http://dx.doi.org/10.1016/j.cjco.2020.11.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657607PMC
March 2021

Natural history and impact of treatment with tafamidis on major cardiovascular outcome-free survival time in a cohort of patients with transthyretin amyloidosis.

Eur J Heart Fail 2021 Feb 9;23(2):264-274. Epub 2020 Nov 9.

AP-HP (Assistance Publique-Hôpitaux de Paris), Cardiology Department, DHU-ATVB, Henri Mondor University Hospital, Créteil, France.

Aims: Hereditary (ATTRv) and wild-type (ATTRwt) transthyretin amyloidosis are severe and fatal systemic diseases, characterised by amyloid fibrillar accumulation principally in the heart or peripheral nerves (or both). Since 2012, tafamidis has been used in France to treat patients with ATTRv with neuropathy (alone or combined with cardiomyopathy). Recently, the Phase III ATTR-ACT trial showed that tafamidis decreased the relative risk of mortality in ATTR amyloidosis with cardiomyopathy. The aims of this study were to assess the clinical characteristics of ATTR amyloidosis in a real-life population in comparison to the population included in the ATTR-ACT trial and to assess the impact of tafamidis treatment on major cardiovascular outcome (MCO)-free survival time without cardiac decompensation, heart transplant, or death.

Methods And Results: From June 2008 to November 2018, 648 patients with ATTR amyloidosis (423 ATTRwt and 225 ATTRv) consecutively referred to the French Referral Center for cardiac amyloidosis were included. A total of 467 (72%) patients matched the inclusion criteria of the ATTR-ACT trial. For the 631 patients with cardiomyopathy, tafamidis treatment was associated with a longer median MCO-free survival time (n = 98): 1565 (1010-2400) days vs. 771 (686-895) days without treatment (log-rank P < 0.001). This association was confirmed after considering confounding factors (age at inclusion, N-terminal pro-B-type natriuretic peptide and amyloidosis type) with a propensity score (hazard ratio 0.546; P = 0.0132).

Conclusion: In a large cohort of ATTRwt and ATTRv patients, representative of the inclusion criteria of the ATTR-ACT trial, the present results show an association between tafamidis treatment and a lower occurrence of cardiovascular outcomes in a real-life population.
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http://dx.doi.org/10.1002/ejhf.2028DOI Listing
February 2021

Diagnostic Performance of Transesophageal Echocardiography and Cardiac Computed Tomography in Infective Endocarditis.

J Am Soc Echocardiogr 2020 12 25;33(12):1442-1453. Epub 2020 Sep 25.

Radiology Department, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris, Créteil, France; INSERM U955, Team 8, Paris-Est Creteil University, Val-de-Marne, Créteil, France.

Background: Multimodality imaging is essential for infective endocarditis (IE) diagnosis. The aim of this work was to evaluate the agreement between transesophageal echocardiography (TEE) and cardiac computed tomography (CT) findings in patients with surgically confirmed IE.

Methods: Sixty-eight patients (mean age 63 ± 2 years) with a definite diagnosis of left-side IE according to the modified European Society of Cardiology Duke criteria, on both native and prosthetic valves, underwent TEE and cardiac CT before surgery. The presence of valvular (vegetations, erosion) and paravalvular (abscess, pseudoaneurysm) IE-related lesions were compared between both modalities. Perioperative inspection was used as reference.

Results: TEE performed better than CT in detecting valvular IE-related lesions (TEE area under the curve [AUC] = 0.881 vs AUC = 0.720, P = .02) and was similar to CT with respect to paravalvular IE-related lesions (AUC = 0.830 vs AUC = 0.816, P = .835). The ability of TEE to detect vegetation was significantly better than that of CT (AUC = 0.863 vs AUC = 0.693, P = .02). The maximum size of vegetations was moderately correlated between modalities (Spearman's rho = 0.575, P < .001). Computed tomography exhibited higher sensitivity than TEE for pseudoaneurysm detection (100% vs 66.7%, respectively) but was similar with respect to diagnostic accuracy (AUC = 0.833 vs AUC = 0.984, P = .156).

Conclusions: In patients with a definite diagnosis of left-side IE according to the modified European Society of Cardiology Duke criteria, TEE performed better than CT for the detection of valvular IE-related lesions and similar to CT for the detection of paravalvular IE-related lesions.
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http://dx.doi.org/10.1016/j.echo.2020.07.017DOI Listing
December 2020

HIV Infection and Long-Term Residual Cardiovascular Risk After Acute Coronary Syndrome.

J Am Heart Assoc 2020 09 26;9(17):e017578. Epub 2020 Aug 26.

Department of Cardiology Faculty of Medicine AP-HP Hôpitaux de l'Est Parisien Hôpital Saint-Antoine Sorbonne Université Paris France.

Background It is unclear whether HIV infection affects the long-term prognosis after an acute coronary syndrome (ACS). The objective of the current study was to compare rates of major adverse cardiac and cerebrovascular events after a first ACS between people living with HIV (PLHIV) and HIV-uninfected (HIV-) patients, and to identify determinants of cardiovascular prognosis. Methods and Results Consecutive PLHIV and matched HIV- patients with a first episode of ACS were enrolled in 23 coronary intensive care units in France. Patients were matched for age, sex, and ACS type. The primary end point was major adverse cardiac and cerebrovascular events (cardiac death, recurrent ACS, recurrent coronary revascularization, and stroke) at 36-month follow-up. A total of 103 PLHIV and 195 HIV- patients (mean age, 49 years [SD, 9 years]; 94.0% men) were included. After a mean of 36.6 months (SD, 6.1 months) of follow-up, the risk of major adverse cardiac and cerebrovascular events was not statistically significant between PLHIV and HIV- patients (17.8% and 15.1%, =0.22; multivariable hazard ratio [HR], 1.60; 95% CI, 0.67-3.82 [=0.29]). Recurrence of ACS was more frequent among PLHIV (multivariable HR, 6.31; 95% CI, 1.32-30.21 [=0.02]). Stratified multivariable Cox models showed that HIV infection was the only independent predictor for ACS recurrence. PLHIV were less likely to stop smoking (47% versus 75%; =0.01) and had smaller total cholesterol decreases (-22.3 versus -35.0 mg/dL; =0.04). Conclusions Although the overall risk of major adverse cardiac and cerebrovascular events was not statistically significant between PLHIV and HIV- individuals, PLHIV had a higher rate of recurrent ACS. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00139958.
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http://dx.doi.org/10.1161/JAHA.119.017578DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660787PMC
September 2020

Feasibility of Prone Position Coronary Angiography in a Patient With COVID-19 Pneumonia and Refractory Hypoxemia.

JACC Case Rep 2020 Jul 13;2(9):1302-1306. Epub 2020 Jun 13.

Department of Cardiology, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris, Creteil, France.

A 57-year-old woman hospitalized for a COVID-19 (coronavirus disease-2019)-related refractory acute respiratory distress syndrome developed a few days later anteroseptal ST-segment elevation with acute systolic dysfunction. Coronary angiography was performed with the patient in prone (face down) position, owing to the necessity to maintain a reasonable oxygen saturation during the examination. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.06.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7293529PMC
July 2020

Two-year outcomes after percutaneous coronary intervention with drug-eluting stents or bare-metal stents in elderly patients with coronary artery disease.

Catheter Cardiovasc Interv 2021 Apr 6;97(5):E607-E613. Epub 2020 Aug 6.

Cardiology Department Hôpital Cochin, Assistance Publique-Hôpitaux de Paris and, Université de Paris, Paris, France.

Objectives: Report the results at 2 years of the patients included in the SENIOR trial.

Background: Patients above 75 years of age represent a fast-growing population in the cathlab. In the SENIOR trial, patients treated by percutaneous coronary intervention (PCI) with drug eluting stent (DES) and a short duration of P2Y12 inhibitor (1 and 6 months for stable and unstable coronary syndromes, respectively) compared with bare metal stents (BMS) was associated with a 29% reduction in the rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR) at 1 year. The results at 2 years are reported here.

Methods And Results: We randomly assigned 1,200 patients (596[50%] to the DES group and 604[50%] to the BMS group). At 2 years, the composite endpoint of all-cause mortality, MI, stroke and ID-TLR had occurred in 116 (20%) patients in the DES group and 131 (22%) patients in the BMS group (RR 0.90 [95%CI 0.72-1.13], p = .37). IDTLR occurred in 14 (2%) patients in the DES group and 41 (7%) patients in the BMS group (RR 0.35 [95%CI 0.16-0.60], p = .0002). Major bleedings (BARC 3-5) occurred in 27(5%) patients in both groups (RR 1.00, [95%CI 0.58-1.75], p = .99). Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52 [95%CI 0.01-1.95], p = .27).

Conclusion: Among elderly PCI patients, a strategy combining a DES together with a short duration of DAPT is associated with a reduction in revascularization up to 2 years compared with BMS with very few late events and without any increased in bleeding complications or stent thrombosis.
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http://dx.doi.org/10.1002/ccd.29159DOI Listing
April 2021

Efficacy and safety of one-month DAPT followed by 23-month ticagrelor monotherapy in patients undergoing proximal LAD stenting: Insights from the GLOBAL LEADERS trial.

Int J Cardiol 2020 Dec 1;320:27-34. Epub 2020 Aug 1.

Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. Electronic address:

Backgrounds: Data on optimal antiplatelet therapy in patients undergoing stenting of the proximal left anterior descending artery (LAD) are limited.

Methods: This is a post-hoc analysis of the GLOBAL LEADERS trial, a prospective, multi-center, randomized controlled trial, comparing the experimental strategy (1-month dual anti-platelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) with the reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) in relation to stenting of the proximal LAD. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction (MI) and key secondary safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at two years.

Results: Among 15,845 patients included in the analysis, 3823 (23.9%) patients underwent stenting of the proximal LAD, while 12,022 (75.2%) did not. In the proximal LAD stenting group, there was no significant difference in the risk of the primary endpoint between the two antiplatelet strategies (3.38% vs. 3.93%; hazard ratio [HR]:0.86; 95% CI:0.62-1.20; P = 0.951). However, the risk of any MI (2.63% vs. 3.88%; HR:0.68; 95% CI:0.47-0.97; P = 0.015) and any revascularization (7.84% vs. 9.94%; HR:0.78; 95% CI:0.63-0.97; P = 0.058) was significantly lower in the experimental strategy group, while demonstrating a similar risk of BARC type 3 or 5 bleeding between the two antiplatelet strategies (1.93% vs. 1.99%; HR:0.98; 95% CI:0.62-1.54; P = 0.981).

Conclusions: The present study showed patients having stenting to the proximal LAD could potentially benefit from the experimental strategy with lower ischaemic events without a trade-off in major bleeding at two years.
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http://dx.doi.org/10.1016/j.ijcard.2020.07.042DOI Listing
December 2020

Left Ventricle Unloading Through Pulmonary Artery in Patients With Venoarterial Extracorporeal Membrane Oxygenation.

ASAIO J 2021 01;67(1):e49-e51

From the Interventional cardiology, Henri Mondor Hospital, Créteil, France.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) initiation for patients with cardiogenic shock or cardiac arrest is an attractive strategy since it provides a quick restoration of organ perfusion. One major limitation of VA-ECMO is left ventricle (LV) distension which is associated with poor prognosis. To prevent or treat LV distension, LV decompression may be required. Current strategies for LV decompression have some contraindications, carry a high risk of complications and, for some of them concerns remain regarding their effectiveness. We here describe our experience in two adult patients treated with VA-ECMO in whom indirect LV unloading using pulmonary artery venting was performed for the prevention and the treatment of LV distension, respectively. The placement of the venting cannula in the pulmonary trunk was quick, easy and safe and was associated with the resolution of LV distension. These results suggest that pulmonary artery venting may be an attractive strategy for indirect LV decompression during VA-ECMO.
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http://dx.doi.org/10.1097/MAT.0000000000001179DOI Listing
January 2021

Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study.

Eur Heart J 2020 08;41(30):2894-2901

Heart Rhythm Centre at Monzino Cardiac Center, IRCCS, Department of Clinical Sciences and Community Health, University of Milan, Via Francesco Sforza 35, Milan 20122, Italy.

Aims: To evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the Amplatzer™ Amulet™ occluder.

Methods And Results: Patients with atrial fibrillation eligible for LAAO were recruited to a prospective global study. Implant procedures were undertaken with echocardiographic guidance. Transoesophageal echocardiography (TOE) was undertaken 1-3 months post-LAAO. Implant and follow-up TOEs were evaluated by a CoreLab. The primary endpoint was a composite of ischaemic stroke and cardiovascular death at 2 years. Serious adverse events were adjudicated by an independent clinical events committee. A total of 1088 patients were enrolled, aged 75.2 ± 8.5 years; 64.5% were male. CHA2DS2-VASc and HAS-BLED scores were 4.2 ± 1.6 and 3.3 ± 1.1, respectively. A total of 71.7% had prior major bleeding, and 82.8% had contraindications to oral anticoagulants. Implant success was 99.1%. Major adverse events (≤7 days post-procedure) occurred in 4.0%, including death (0.3%), stroke (0.4%), major vascular (1.3%), and device embolization (0.2%). A total of 80.2% of patients were discharged on antiplatelet therapy alone. Peridevice flow was <3 mm in 98.4% at follow-up TOE. Device-related thrombus (DRT) was seen in 1.6% of cases. Cardiovascular death or ischaemic stroke occurred in 8.7% of patients at 2 years. The ischaemic stroke rate was 2.2%/year-a 67% reduction compared to the CHA2DS2-VASc predicted rate. Major bleeding (Bleeding Academic Research Consortium type ≥ 3) occurred at rates of 10.1%/year (year 1) and 4.0%/year (year 2).

Conclusion: Following LAAO with the Amplatzer Amulet device, the ischaemic stroke rate was reduced by 67% compared to the predicted risk. Closure was complete in 98.4% of cases and DRT seen in only 1.6%.
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http://dx.doi.org/10.1093/eurheartj/ehaa169DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7421773PMC
August 2020

Perioperative Outcomes of Adjunctive Hypnotherapy Compared with Conscious Sedation Alone for Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Int Heart J 2020 Jan 17;61(1):60-66. Epub 2020 Jan 17.

Department of Cardiology, Henri Mondor University Hospital.

Transcatheter aortic valve implantation (TAVI) using a transfemoral approach under local anesthesia with conscious sedation (LACS) is becoming an increasingly common TAVI strategy. However, patients who are awake during the TAVI procedure can experience stress, anxiety, and pain, even when LACS is used. Clinical hypnotherapy is an anxiolytic intervention that can be beneficial for patients undergoing invasive surgery. This study aimed to assess the perioperative outcomes of adjunctive hypnotherapy undergoing transfemoral TAVI with LACS.Consecutive patients (n = 143) with symptomatic severe aortic stenosis who underwent transfemoral TAVI with LACS only (n = 107) or with LACS and hypnotherapy (n = 36) between January 2015 and April 2016 were retrospectively included in the study. The clinical outcomes were compared between the two groups. The LACS with hypnotherapy group had a significantly shorter length of stay in the intensive care unit (ICU; LACS only versus LACS with hypnotherapy: 4.0 (4.0-5.5) days versus 3.0 (3.0-5.0) days, P < 0.01). Moreover, the use of anesthetics (propofol and remifentanil) and norepinephrine was significantly lower in the LACS with hypnotherapy group (e.g., for propofol, LACS only versus LACS with hypnotherapy: 96.4 ± 104.7 mg versus 15.0 ± 31.8 mg, P < 0.001). The multiple regression analysis showed that being male, hypnotherapy, and the composite complication score were independently associated with the length of stay in the ICU.The adjunctive hypnotherapy on LACS among transfemoral TAVI patients may facilitate perioperative management. However, a prospective randomized study is necessary to confirm the efficacy of hypnotherapy among TAVI patients.
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http://dx.doi.org/10.1536/ihj.19-296DOI Listing
January 2020

Usefulness of Routine Fractional Flow Reserve for Clinical Management of Coronary Artery Disease in Patients With Diabetes.

JAMA Cardiol 2020 03;5(3):272-281

Department of Cardiologie, Centre Hospitalier La Durance, Avignon, France.

Importance: Approximately one-third of patients considered for coronary revascularization have diabetes, which is a major determinant of clinical outcomes, often influencing the choice of the revascularization strategy. The usefulness of fractional flow reserve (FFR) to guide treatment in this population is understudied and has been questioned.

Objective: To evaluate the usefulness and rate of major adverse cardiovascular events (MACE) of integrating FFR in management decisions for patients with diabetes who undergo coronary angiography.

Design, Setting, And Participants: This cross-sectional study used data from the PRIME-FFR study derived from the merger of the POST-IT study (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease [March 2012-November 2013]) and R3F study (French Study of FFR Integrated Multicenter Registries Implementation of FFR in Routine Practice [October 2008-June 2010]), 2 prospective multicenter registries that shared a common design. A population of all-comers for whom angiography disclosed ambiguous lesions was analyzed for rates, patterns, and outcomes associated with management reclassification, including revascularization deferral, in patients with vs without diabetes. Data analysis was performed from June to August 2018.

Main Outcomes And Measures: Death from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year.

Results: Among 1983 patients (1503 [77%] male; mean [SD] age, 65 [10] years), 701 had diabetes, and FFR was performed for 1.4 lesions per patient (58.2% of lesions in the left anterior descending artery; mean [SD] stenosis, 56% [11%]; mean [SD] FFR, 0.81 [0.01]). Reclassification by FFR was high and similar in patients with and without diabetes (41.2% vs 37.5%, P = .13), but reclassification from medical treatment to revascularization was more frequent in the former (142 of 342 [41.5%] vs 230 of 730 [31.5%], P = .001). There was no statistical difference between the 1-year rates of MACE in reclassified (9.7%) and nonreclassified patients (12.0%) (P = .37). Among patients with diabetes, FFR-based deferral identified patients with a lower risk of MACE at 12 months (25 of 296 [8.4%]) compared with those undergoing revascularization (47 of 257 [13.1%]) (P = .04), and the rate was of the same magnitude of the observed rate among deferred patients without diabetes (7.9%, P = .87). Status of insulin treatment had no association with outcomes. Patients (6.6% of the population) in whom FFR was disregarded had the highest MACE rates regardless of diabetes status.

Conclusions And Relevance: Routine integration of FFR for the management of coronary artery disease in patients with diabetes may be associated with a high rate of treatment reclassification. Management strategies guided by FFR, including revascularization deferral, may be useful for patients with diabetes.
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http://dx.doi.org/10.1001/jamacardio.2019.5097DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990935PMC
March 2020

Aortic Stenosis and Cardiac Amyloidosis: JACC Review Topic of the Week.

J Am Coll Cardiol 2019 11;74(21):2638-2651

Referral Center for Cardiac Amyloidosis, Mondor Amyloidosis Network, GRC Amyloid Research Institute and Cardiology Department, APHP Henri Mondor Hospital, Créteil, France; INSERM Unit U955, Team 8, Paris-Est Creteil University, Val-de-Marne, Créteil, France.

The prevalence of calcific aortic stenosis (AS) and of cardiac amyloidosis (CA) increases with age, and their association is not uncommon in the elderly. The identification of CA is particularly challenging in patients with AS because these 2 conditions share several features. It is estimated that ≤15% of the AS population and ≤30% of the subset with low-flow, low-gradient pattern may have CA. In patients with AS, CA is associated with increased risk of heart failure, mortality, and treatment futility with aortic valve replacement. In case of suspicion of CA, it is thus crucial to confirm the diagnosis to guide therapeutic management of AS and eventually implement recently developed pharmacological treatment dedicated to transthyretin amyloidosis. Given the high surgical risk of patients with AS and concomitant CA, transcatheter aortic valve replacement may be preferred to surgery in these patients.
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http://dx.doi.org/10.1016/j.jacc.2019.09.056DOI Listing
November 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

Time Course of Reendothelialization with Polyzene-F Nanocoated Cobra PzF™ Coronary Stent on Rabbit Iliac Arteries.

Cardiovasc Revasc Med 2020 02 9;21(2):195-199. Epub 2019 Nov 9.

Department of Cardiology, CHRU Lille, Lille, France.

Purpose: Evaluation of reendothelialization with a new thin struts cobalt chromium alloy stent coated with a nano-layer of Polyzene™-F (PzF) in a rabbit iliac artery model.

Methods: Fifteen stented external rabbit iliac arteries were harvested at Day 7 for electron microscopy analysis following Cobra PzF stents implantation to assess reendothelialization and compare to historical data. Ten additional rabbits were used to assess time course of reendothelialization at 3 and 5 days.

Results: At Day 7, almost complete coverage of endothelial cells was observed with a coverage of 99.54 ± 0.25% of the stented area. No thrombus area was noted. At Day 3, more than half of examined pieces was reendothelialized and reached 78.30 ± 3.7% at Day 5 (p < .01 between each group). All stents were well expanded against the arterial wall and no struts were mal-apposed.

Conclusions: Reendothelialization was rapid and complete at Day 7. This is the fastest reendothelization process after stenting in this model. No stent occlusion was observed.
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http://dx.doi.org/10.1016/j.carrev.2019.11.005DOI Listing
February 2020

Computed tomography for transcatheter tricuspid valve development.

Eur Radiol 2020 Feb 26;30(2):682-690. Epub 2019 Aug 26.

Interventional Cardiology, Centre Expert Valvulaire, Centre Hospitalo-Universitaire Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, 94010, Créteil, France.

Background: Patients with severe symptomatic tricuspid regurgitation (TR) are often deemed ineligible for surgical valve repair due to comorbidities. In this setting, transcatheter tricuspid valve replacement (TTVR) is undergoing development, but delivery technique and prosthesis design have yet to be optimized. We sought to assess the challenges of TTVR and the determinants of venous route using computed tomography (CT) analysis.

Methods And Results: A total of 195 end-diastolic cardiac CT performed prior to surgical correction of a severe TR (n = 38), transcatheter aortic valve replacement (n = 89), or left atrial appendage closure (n = 68) were analyzed. Patients with TR (n = 68; 19 primary and 49 secondary) were compared with patients without (n = 127). Continuous variables with normal and non-normal distributions were compared using Student t test or Mann-Whitney test respectively. The angle from the tricuspid annulus (TA) to the inferior vena cava was tighter (mean = 101 ± 18°) with a broader range of value (44° to 164°) than to the superior vena cava (mean = 143 ± 9°). Patients with TR had rounder TA (eccentricity index of 0.88 ± 0.08, p < 0.001), with a larger area (p < 0.0001), and septolateral (45.3 ± 8.0 mm, p < 0.0001) and anteroposterior (44.4 ± 7.4 mm, p < 0.0001) diameters than patients without. The distances from the TA to the coronary sinus, the right ventricular outflow tract, and the moderator band were respectively 11.4 ± 3.8 mm, 17.2 ± 3.4 mm, and 31.0 ± 6.7 mm, without differences between groups.

Conclusion: The transjugular access for TTVR is straighter and more reproducible than the transfemoral access. Prosthesis development may be challenged by the close position of the coronary sinus, the presence of a moderator band, and the large TA size of patients with severe TR.

Key Points: • The tricuspid annulus is larger in patients with severe tricuspid regurgitation, confirming existing data. • The coronary sinus ostium is close to the tricuspid annulus, requiring a prosthesis with a short atrial length. • The transjugular venous route may be the preferred access to the tricuspid annulus, straighter with less inter-individual variations than the transfemoral route.
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http://dx.doi.org/10.1007/s00330-019-06410-6DOI Listing
February 2020

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

Angiography and Percutaneous Coronary Intervention for Chronic Total Coronary Occlusion in Daily Practice (from a Large French Registry [CARDIO-ARSIF]).

Am J Cardiol 2019 09 11;124(5):688-695. Epub 2019 Jun 11.

Interventional Cardiology, University Hospital Henri Mondor, Assistance Publique-Hôpitaux de Paris, France.

The aim of this study was to provide contemporary data on chronic total occlusion (CTO) prevalence and management in a large unselected population representing the daily activity of cathlabs, in the greater Paris area, and to compare percutaneous coronary intervention (PCI) features in patients with and without CTO. Procedures were collected from the CARDIO-ARSIF (Agence Régionale de Santé Ile de France) registry from 2012 to 2015. Patients with acute coronary syndrome or previous coronary artery bypass grafting were excluded. CTO features were assessed and PCIs with and without CTO were compared. Among 128,739 included patients, 10,468 (8.1%) had at least 1 CTO. Cardiovascular risk-factor burden was higher in the CTO group, which had more patients with multivessel disease (74% vs 24%) and with referral for interventional management (59% vs 33%). Of all PCIs during the study period, 5.7% involved a CTO; this proportion increased significantly over the study period. PCI success rate was 75.9% in the CTO group. CTO-PCI volume per center did not correlate with CTO-PCI success rate. In conclusion, CTO is common in patients who underwent scheduled coronary angiography. Invasive management is done more often in patients with than without CTO. The success rate of PCI in CTO is not associated with case volume per center.
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http://dx.doi.org/10.1016/j.amjcard.2019.05.062DOI Listing
September 2019

TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study.

JACC Cardiovasc Interv 2019 05;12(10):923-932

Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.

Objectives: The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation.

Background: Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery.

Methods: VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve.

Results: Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later.

Conclusions: Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298).
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http://dx.doi.org/10.1016/j.jcin.2019.02.029DOI Listing
May 2019

Percutaneous Left Atrial Appendage Closure in Patients With Inferior Vena Cava Filters: A Case Series.

J Invasive Cardiol 2019 May;31(5):128-132

Service de Cardiologie Hôpital Henri Mondor, 51 Avenue du Marechal de Lattre de Tassigny, 94000 Creteil, France.

Objectives: Percutaneous procedures through femoral access in patients with inferior vena cava (IVC) filter may be at risk of complications. We evaluated the feasibility and safety of left atrial appendage (LAA) closure through femoral access in patients previously implanted with IVC filter.

Methods: From November 2011 to March 2018, a total of 5 patients with history of IVC filter implantation were referred to our center for percutaneous LAA closure, representing 3.6% of the 137 procedures performed during the study period. The IVC filter devices were placed from 2 to 26 months before the index procedure.

Results: LAA closure was successfully implanted in all cases using an Amulet device in 3 patients and a Watchman device in 2 patients. A femoral approach was performed in all patients using 12 or 14 Fr sheaths. Before crossing IVC filters, venographies did not detect any thrombus. All steps of IVC filter crossing were performed under fluoroscopic guidance. No immediate or late complications related to the procedure occurred after 10.1 ± 3.9 months of follow-up.

Conclusion: LAA closure in patients with previously implanted IVC filter is safe as long as careful x-ray monitoring is observed.
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May 2019

Peridevice Leak After Left Atrial Appendage Closure: Incidence, Risk Factors, and Clinical Impact.

Can J Cardiol 2019 04 21;35(4):405-412. Epub 2018 Dec 21.

Cardiology Department, Expert Valve Center, Henri Mondor Hospital, Créteil, France. Electronic address:

Background: Limited studies reported the rate and clinical impact of peridevice leaks (PDL) after percutaneous left atrial appendage closure (LAAC).

Methods: All consecutive patients with a nonvalvular atrial fibrillation admitted for LAAC between November 2011 and October 2016 were prospectively enrolled. The follow-up included clinical, transesophageal echocardiography, and/or cardiac computed tomography angiogram (CCTA). PDL was defined by the presence of contrast within the left atrial appendage on CCTA, and Major Adverse Cardiac Event (MACE) included stroke, device-related thrombosis, and cardiovascular death.

Results: Overall, 77 patients (mean CHADS-VASc score = 4.4 ± 1.5 and mean HAS-BLED = 3.4 ± 1.1) were implanted using Amplatzer Cardiac Plug (n = 24), Amulet (n = 37), or Watchman devices (n = 16). Indications were stroke recurrence despite adequate oral anticoagulation (OAC, n = 6) or contraindication to long-term OAC (n = 71). From 3-month to 12-month CCTA follow-up, the PDL rate decreased from 68.5% to 56.7% (P = 0.02), without any difference between the various devices. Patients with PDL were more often in permanent atrial fibrillation, and had a larger landing zone diameter, a lower ratio of device compression, and a more frequent off-axis position of the device. A device compression ratio < 10% was the only parameter associated with PDL occurrence. During follow-up (median 236 days) the MACE rate was 9.1%, with no statistically significant difference between patients with vs without PDL (12% vs 4.3%, P = 0.3).

Conclusions: The PDL rate detected by CCTA after LAAC was high, especially in cases with a low device compression ratio (< 10%), but decreased over time. The incidence of MACE was quantitatively greater with PDL, but the difference was not statistically significant. Larger studies are needed to determine the clinical importance of PDL.
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http://dx.doi.org/10.1016/j.cjca.2018.12.022DOI Listing
April 2019

Outcomes and safety of same-day discharge after percutaneous coronary intervention: A 10-year single-center study.

Catheter Cardiovasc Interv 2019 Jul 31;94(1):105-111. Epub 2019 Jan 31.

Interventional Cardiology Unit, Henri Mondor University Hospital, Assistance Publique Hôpitaux de Paris, Créteil, France.

Aims: Same-day discharge (SDD) after percutaneous coronary intervention (PCI) was safe and cost-effective in randomized and observational studies but faces limited acceptance due to concerns about early adverse events. Our aim was to evaluate early outcomes after SDD PCI in a high-volume urban PCI center over 10 years.

Methods And Results: From 2007 to 2016, 1,635 unselected patients had PCI at our ambulatory cardiac care unit, mainly for stable ischemic heart disease (SIHD). Among them, 1,073 (65.6%), most of whom underwent ad hoc PCI, were discharged on the same day and 562 (34.4%) were admitted, for adverse events during PCI (n = 60) or within the next 4-6 hr (n = 52) or chiefly due to physician preference (n = 450). In the SDD group, radial access was used in 98.5% of patients; 36% and 15% of patients had two- and three-vessel disease, respectively; and two-vessel PCI was performed in 11% of patients. No MACCEs (death, myocardial infarction, stroke, urgent repeat PCI/CABG, and major vascular complications) occurred within 24 hr post-discharge. Two patients were readmitted on the next day for chest pain but did not require repeat PCI.

Conclusion: SDD after successful PCI without complications within the next 4-6 hr is safe and feasible in most patients with SIHD. Among 1,035 SDD patients treated over 10 years, only two required readmission, and none experienced major cardiac adverse events such as death or stent thrombosis. SDD is safe for the patient and cost-effective for the healthcare system and should be implemented more widely.
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http://dx.doi.org/10.1002/ccd.28084DOI Listing
July 2019

Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

Circulation 2018 12;138(23):2597-2607

Department of Cardiology, Parly 2 Hospital, Le Chesnay, France (X.F.).

Background: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry.

Methods: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions.

Results: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%).

Conclusions: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.118.036866DOI Listing
December 2018