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1.
Eur Heart J ; 2024 May 15.
Article in English | MEDLINE | ID: mdl-38747561

ABSTRACT

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

2.
Ann Cardiol Angeiol (Paris) ; 72(6): 101685, 2023 Dec.
Article in French | MEDLINE | ID: mdl-37918329

ABSTRACT

The CARDIO-ARSIF registry has been continuously collecting comprehensive data on coronary angiography and percutaneous coronary interventions (PCI) performed in the 36 catheterization laboratories across the Île-de-France region since 2000. Over the period from 2003 to 2022, this registry has recorded information from more than 330,000 patients, encompassing more than one million procedures. Among these procedures, 58% consisted of coronary angiography, 13% were percutaneous coronary interventions (PCI), and the remaining 28% were PCI performed on an ad-hoc basis. This extensive dataset serves as a valuable resource for both qualitative and quantitative assessments of practices and the relevance of procedures in the field of coronary invasive cardiology. The results of these analyses undergo annual validation by a dedicated scientific committee and are shared with the teams of investigators. The exploitation of this data has led to scientific publications, with one notable finding being a consistent reduction in the radiation doses received by patients, regardless of the type of procedure.


Subject(s)
Cardiology , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/methods , Coronary Angiography/methods , Registries , France/epidemiology
3.
Echocardiography ; 39(6): 783-793, 2022 06.
Article in English | MEDLINE | ID: mdl-35536700

ABSTRACT

OBJECTIVES: To determine the 4D Flow Cardiac Magnetic Resonance (CMR) thresholds that achieve the best agreement with transthoracic echocardiography (TTE) for grading mitral regurgitation (MR). METHODS: We conducted a single-center prospective study of patients evaluated for chronic primary MR in 2016-2020. MR was evaluated blindly by TTE and 4D Flow CMR, respectively by two cardiologists and two radiologists with decades of experience. MR was graded with both methods as mild, moderate, or severe. 4D Flow CMR measurements included MR regurgitant volume per beat (RV) and mitral anterograde flow per beat (MF). RF was obtained as the ratio RV/MF. Additionally, MF was compared to left ventricular stroke volume (LVSV) by cine-CMR. RESULTS: We included 33 patients in the initial cohort and 33 in the validation cohort. Inter-observer agreement was excellent for 4D Flow CMR ICC = .94 (95% CI, .86-.97, p < 0.0001). Using recommended TTE thresholds (30 ml, 60 ml, 30%, 50%), agreement was moderate for RV and RF. The best agreement between 4D Flow CMR and TTE was obtained with CMR thresholds of 20 and 40 ml for RV (κ = .93; 95% CI, .8-1) and 20% and 37% for RF (κ = .90; 95% CI, .7-.9). In the validation cohort, agreement between TTE and 4D Flow CMR was good with the optimal thresholds (κ = .78; 95% CI, .61-.94). CONCLUSION: We propose CMR thresholds that provide a good agreement between TTE and CMR for grading MR. Further studies are needed to fully validate 4D-Flow CMR accuracy for primary MR quantification.


Subject(s)
Mitral Valve Insufficiency , Echocardiography/methods , Humans , Magnetic Resonance Imaging, Cine/methods , Magnetic Resonance Spectroscopy , Mitral Valve Insufficiency/diagnostic imaging , Prospective Studies , Reproducibility of Results , Severity of Illness Index
4.
Catheter Cardiovasc Interv ; 99(6): 1829-1838, 2022 05.
Article in English | MEDLINE | ID: mdl-35324050

ABSTRACT

OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.


Subject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve Insufficiency , Aged, 80 and over , Bioprosthesis/adverse effects , Cardiac Catheterization/methods , Female , Heart Valve Prosthesis Implantation/methods , Humans , Male , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Prosthesis Failure , Registries , Stroke Volume , Treatment Outcome , Ventricular Function, Left
5.
J Am Coll Cardiol ; 78(19): 1875-1885, 2021 11 09.
Article in English | MEDLINE | ID: mdl-34736563

ABSTRACT

BACKGROUND: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates. OBJECTIVES: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD. METHODS: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year. RESULTS: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02). CONCLUSIONS: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).


Subject(s)
Coronary Artery Bypass , Coronary Artery Disease , Coronary Stenosis , Coronary Vessels , Fractional Flow Reserve, Myocardial/physiology , Percutaneous Coronary Intervention , Postoperative Complications/mortality , Aged , Coronary Angiography/methods , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/methods , Coronary Artery Disease/diagnosis , Coronary Artery Disease/mortality , Coronary Artery Disease/physiopathology , Coronary Artery Disease/surgery , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/etiology , Coronary Stenosis/surgery , Coronary Vessels/diagnostic imaging , Coronary Vessels/physiopathology , Early Termination of Clinical Trials , Female , Humans , Long Term Adverse Effects/mortality , Male , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Predictive Value of Tests , Risk Assessment/methods , Severity of Illness Index
6.
J Cardiothorac Vasc Anesth ; 35(6): 1747-1750, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32948407

ABSTRACT

OBJECTIVE: To report the authors' initial experience of transcarotid transcatheter aortic valve replacement (TAVR) managed with ultrasound-guided intermediate cervical plexus block. DESIGN: A single-center prospective study. SETTING: A teaching hospital in Paris, France. PARTICIPANTS: All consecutive patients undergoing a transcarotid TAVR were included. INTERVENTIONS: The ultrasound-guided intermediate cervical plexus block was performed in 28 of 31 patients. In 3 patients, the procedure was scheduled under general anesthesia: 2 because of failure of previous transfemoral procedures under local anesthesia, and 1 for an emergency procedure in a pulmonary edema context. MEASUREMENTS AND MAIN RESULTS: Anesthesia and all perioperative parameters were recorded, as well as any complications after the procedure. Twenty-eight patients were managed with intermediate cervical plexus block and light sedation without any anesthesia-related complication. No conversion to general anesthesia was required. The use of vasopressor was only required in 11% of the patients. In 2 patients, a loss of consciousness after the common carotid artery cross-clamping test occurred, leading to the use of a temporary femoral-carotid shunt; no other change in consciousness was recorded during the procedure. CONCLUSIONS: Ultrasound-guided intermediate cervical plexus block appeared to be an alternative anesthetic technique for carotid TAVR, providing adequate surgical conditions, continuous neurologic monitoring, and arterial pressure stability.


Subject(s)
Aortic Valve Stenosis , Cervical Plexus Block , Transcatheter Aortic Valve Replacement , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Cervical Plexus Block/adverse effects , France , Humans , Prospective Studies , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , Ultrasonography, Interventional
7.
EuroIntervention ; 17(2): e124-e131, 2021 Jun 11.
Article in English | MEDLINE | ID: mdl-33226003

ABSTRACT

BACKGROUND: Intravascular ultrasound (IVUS)-guided PCI improves the prognosis of left main stem (LMS) PCI and is currently recommended by international guidelines. Although OCT resolution is greater than that of IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data. AIMS: This pilot study aimed to analyse the feasibility, safety and impact of OCT-guided LMS PCI. METHODS: This prospective, multicentre trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis <50% + TIMI 3 flow in all branches + adequate OCT stent expansion (LEMON criteria). RESULTS: Seventy patients were included in the final analysis (median age: 72 [64-81] years, 73% male). The OCT pre-specified protocol was applied in all patients. The primary endpoint was achieved in 86% of subjects. Adequate stent expansion was observed in 86%, significant edge dissection in 30% and residual significant strut malapposition in 24% of the cases. OCT guidance modified the operators' strategy in 26% of the patients. The rate of one-year survival free from major adverse clinical events was 98.6% (97.2-100). CONCLUSIONS: This pilot study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Aged , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Coronary Vessels/diagnostic imaging , Coronary Vessels/surgery , Female , Humans , Male , Percutaneous Coronary Intervention/adverse effects , Pilot Projects , Prospective Studies , Stents , Tomography, Optical Coherence , Treatment Outcome , Ultrasonography, Interventional
8.
Int Heart J ; 61(4): 713-719, 2020 Jul 30.
Article in English | MEDLINE | ID: mdl-32684591

ABSTRACT

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.


Subject(s)
Anesthesia, General/statistics & numerical data , Conscious Sedation/statistics & numerical data , Registries , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male
9.
Am Heart J ; 225: 27-37, 2020 07.
Article in English | MEDLINE | ID: mdl-32473356

ABSTRACT

BACKGROUND: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y12 receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting. METHODS: Assessment of Loading with the P2Y12 inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier). CONCLUSION: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.


Subject(s)
Clopidogrel/therapeutic use , Coronary Disease/therapy , Myocardial Infarction/prevention & control , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Purinergic P2Y Receptor Antagonists/therapeutic use , Ticlopidine/therapeutic use , Aged , Coronary Angiography , Humans , Myocardial Infarction/etiology
11.
Am Heart J ; 223: 113-119, 2020 05.
Article in English | MEDLINE | ID: mdl-32087878

ABSTRACT

BACKGOUND: Performing functional testing (FT) or a computed tomography angiogram (CCTA) before invasive coronary angiogram (ICA) is recommended for coronary artery disease (CAD). We aimed to evaluate, in a real life setting, the rate of strictly normal ICA following a positive noninvasive test result. METHODS: We included all patients who underwent an ICA with a prior positive FT or CCTA. Patients were categorized in 5 subgroups, according to pretest probability (PTP) of having a CAD. Main results of ICA were defined as normal ICA, nonobstructive CAD (non-oCAD), and obstructive CAD (oCAD). RESULTS: For 4,952 patients who underwent ICA following either a positive FT (3276, 66.2%) or CCTA (1676, 33.8%) result, the PTP was (1) low (<15%; n = 968, 19.5%), (2) lower intermediate (15%-35%; n = 1336, 27.0%), (3) higher intermediate (35%-50%; n = 806, 16.3%), (4) high (50%-65%; n = 806, 17.7%), and (5) very high (> 65%; n = 965, 19.5%). ICA showed no CAD (819 patients, 16.5%), non-oCAD (1,193 patients, 24.1%), or oCAD (2940 patients, 59.4%). Without considering the PTP values, CCTA compared to FT showed less frequently normal ICA (7% vs 16.5%), and more frequently CAD (non-oCAD 27.9% vs 22.2%; oCAD 65.1% vs 56.4%) (all P < .0001). When we considered the different PTP values, CCTA always showed lower rates of normal ICA than the FT. In low- and lower intermediate-risk patients, CCTA detected more frequently oCAD compared to FT (P < .001). CONCLUSIONS: CCTA is a better alternative than FT to limit unnecessary ICA regardless of PTP value, without missing abnormal ICA.


Subject(s)
Computed Tomography Angiography , Coronary Angiography/methods , Coronary Artery Disease/diagnostic imaging , Aged , Coronary Angiography/statistics & numerical data , Female , Humans , Male , Middle Aged , Retrospective Studies
12.
JACC Case Rep ; 2(1): 145-149, 2020 Jan.
Article in English | MEDLINE | ID: mdl-34316983

ABSTRACT

A pregnant woman presented with symptomatic bioprosthetic mitral valve stenosis. We discuss the difficulties of decision making in this particular situation where two lives are at stake, the fetus's and the mother's, questioning whether transcatheter mitral valve-in-valve implantation can be an effective and safe option for this challenging condition. (Level of Difficulty: Advanced.).

13.
JACC Case Rep ; 2(14): 2183-2185, 2020 Nov 18.
Article in English | MEDLINE | ID: mdl-34317134
14.
Int J Cardiol ; 307: 24-30, 2020 05 15.
Article in English | MEDLINE | ID: mdl-31668659

ABSTRACT

BACKGROUND: Left atrial appendage occlusion (LAAO) has emerged as a valid alternative to oral anticoagulation therapy for the prevention of systemic embolism in patients with non-valvular atrial fibrillation (NVAF). Microvesicles (MVs) are shed-membrane particles generated during various cellular types activation/apoptosis that carry out diverse biological effects. LAA has been suspected to be a potential source of MVs during AF, but the effects its occlusion on circulating MVs levels are unknown. METHODS: N = 25 LAAO and n = 25 control patients who underwent coronary angiography were included. Blood samples were drawn before and 48 h after procedure for all. A third sample was collected 6 weeks after procedure in LAAO patients. In N = 10 extra patients, samples were collected from right atrium, LAA and pulmonary vein during LAAO procedure. Circulating AnnV + procoagulant, endothelial, platelets, red blood cells/RBC and leukocytes derived-MVs were measured using flow cytometry methods. RESULTS: In the LAAO group, AnnV+, platelets, RBC, and leukocytes MVs were significantly increased following intervention, whereas only AnnV + MVs levels significantly rose in controls. The 6-w analysis showed that RBC-MVs and AnnV + MVs levels were still significantly elevated compared to baseline values in LAAO patients. The in-site analysis revealed that leukocytes and CD62e + endothelial-MVs were significantly higher in left atrial appendage compared to pulmonary vein, suggesting a local increased production. No major adverse event was observed in any patient post procedural course. CONCLUSIONS: LAAO impacts circulating MVs and might create mild pro-coagulant status and potential erythrocytes activation due to the device healing during the first weeks following intervention.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Surgical Procedures , Septal Occluder Device , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Humans , Treatment Outcome
15.
JACC Cardiovasc Interv ; 12(24): 2449-2459, 2019 12 23.
Article in English | MEDLINE | ID: mdl-31857014

ABSTRACT

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).


Subject(s)
Aortic Valve/surgery , Cardiac Catheterization/instrumentation , Cardiac Catheters , Cardiac Pacing, Artificial , Heart Valve Prosthesis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement/instrumentation , Ventricular Function, Left , Ventricular Function, Right , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/economics , Cardiac Catheters/economics , Cardiac Pacing, Artificial/adverse effects , Cardiac Pacing, Artificial/economics , Cost Savings , Cost-Benefit Analysis , Female , France , Heart Valve Prosthesis/economics , Hospital Costs , Humans , Male , Operative Time , Pacemaker, Artificial/economics , Prospective Studies , Radiation Dosage , Radiation Exposure/prevention & control , Risk Factors , Single-Blind Method , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/economics , Treatment Outcome
16.
Am J Cardiol ; 124(5): 688-695, 2019 09 01.
Article in English | MEDLINE | ID: mdl-31307663

ABSTRACT

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.


Subject(s)
Coronary Angiography/methods , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/surgery , Hospital Mortality/trends , Percutaneous Coronary Intervention/methods , Registries , Age Factors , Aged , Chronic Disease , Coronary Occlusion/mortality , Female , France , Humans , Logistic Models , Male , Middle Aged , Percutaneous Coronary Intervention/mortality , Prognosis , Retrospective Studies , Risk Assessment , Severity of Illness Index , Sex Factors , Statistics, Nonparametric , Survival Analysis , Treatment Outcome
17.
JACC Cardiovasc Interv ; 12(5): 413-419, 2019 03 11.
Article in English | MEDLINE | ID: mdl-30772290

ABSTRACT

OBJECTIVES: This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device. BACKGROUND: The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device. METHODS: The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2). RESULTS: A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%. CONCLUSIONS: TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Carotid Arteries , Catheterization, Peripheral , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement/instrumentation , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/mortality , Female , France , Humans , Male , Postoperative Complications/mortality , Postoperative Complications/therapy , Prospective Studies , Prosthesis Design , Punctures , Registries , Risk Assessment , Risk Factors , Time Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Treatment Outcome
18.
Circ Cardiovasc Interv ; 12(1): e007081, 2019 01.
Article in English | MEDLINE | ID: mdl-30608874

ABSTRACT

BACKGROUND: Mortality of ST-segment-elevation myocardial infarction (STEMI) decreased drastically, mainly through reduction in inhospital mortality. Prehospital sudden cardiac arrest (SCA) became one of the most feared complications. We assessed the incidence, outcome, and prognosis' predictors of prehospital SCA occurring after emergency medical services (EMS) arrival. METHODS AND RESULTS: Data were taken between 2006 and 2014 from the e-MUST study (Evaluation en Médecine d'Urgence des Strategies Thérapeutiques des infarctus du myocarde) that enrolls all STEMI managed by EMS in the Greater Paris Area, including those dead before hospital admission. Among 13 253 STEMI patients analyzed, 749 (5.6%) presented EMS-witnessed prehospital SCA. Younger age, absence of cardiovascular risk factors, symptoms of heart failure, extensive STEMI, and short pain onset-to-call and call-to-EMS arrival delays were independently associated with increased SCA risk. Mortality rate at hospital discharge was 4.0% in the nonSCA group versus 37.7% in the SCA group ( P<0.001); 26.8% of deaths occurred before hospital admission. Factors associated with increased mortality after SCA were age, heart failure, and extensive STEMI, while male sex and cardiovascular risk factors were associated with decreased mortality. Among patients admitted alive, PCI was the most important mortality-reduction predictor (odds ratio, 0.40; 95% CI, 0.25-0.63; P<0.0001). CONCLUSIONS: More than 1 of 20 STEMI presents prehospital SCA after EMS arrival. SCA occurrence is associated with a 10-fold higher mortality at hospital discharge compared with STEMI without SCA. PCI is the strongest survival predictor, leading to a twice-lower mortality. This highlights the persistently dramatic impact of SCA on STEMI and the major importance of PCI in this setting.


Subject(s)
Death, Sudden, Cardiac/epidemiology , Out-of-Hospital Cardiac Arrest/mortality , ST Elevation Myocardial Infarction/mortality , Adult , Aged , Death, Sudden, Cardiac/prevention & control , Emergency Medical Services , Emergency Medical Technicians , Female , Hospital Mortality , Humans , Incidence , Male , Middle Aged , Out-of-Hospital Cardiac Arrest/diagnosis , Out-of-Hospital Cardiac Arrest/therapy , Paris/epidemiology , Patient Admission , Patient Discharge , Prognosis , Prospective Studies , Risk Assessment , Risk Factors , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/therapy , Time Factors
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