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1.
J Am Coll Cardiol ; 74(22): 2728-2739, 2019 12 03.
Article in English | MEDLINE | ID: mdl-31779788

ABSTRACT

BACKGROUND: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access. OBJECTIVES: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR. METHODS: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed. RESULTS: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers. CONCLUSIONS: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.


Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Catheterization, Peripheral/methods , Postoperative Complications/epidemiology , Propensity Score , Registries , Transcatheter Aortic Valve Replacement/methods , Aged, 80 and over , Female , Femoral Artery , Follow-Up Studies , France/epidemiology , Humans , Incidence , Male , Prospective Studies , Severity of Illness Index , Survival Rate/trends , Time Factors
2.
Am J Cardiol ; 103(1): 5-10, 2009 Jan 01.
Article in English | MEDLINE | ID: mdl-19101221

ABSTRACT

Stent thrombosis remains a significant pitfall of percutaneous coronary intervention (PCI). A recent trial observed that an adjusted loading dose (LD) of clopidogrel according to platelet monitoring decreases the rate of major adverse cardiovascular events after PCI. We investigated if such a strategy of a tailored clopidogrel LD according to platelet reactivity monitoring could decrease the rate of stent thrombosis. This multicenter prospective randomized study included 429 patients with a low clopidogrel response after a 600-mg LD undergoing PCI. Patients were randomized to a control group (n = 214) and to a vasodilator-stimulated phosphoprotein (VASP)-guided group (n = 215). In the VASP-guided group, patients received up to 3 additional 600-mg LDs of clopidogrel to obtain a VASP index <50% before PCI. The primary end point was the rate of stent thrombosis at 1 month. Secondary end points were rates of major adverse cardiovascular events and bleeding. Patients in the 2 groups had a high body mass index and were often diabetic (control vs VASP-guided group 28 +/- 5.1 vs 27.9 +/- 4.7 kg/m(2), p = 0.8, and 39% vs 33%, p = 0.2, respectively). PCI was performed in most patients for acute coronary syndrome in the 2 groups (52.3% vs 50.7%, p = 0.8). Despite a 2,400-mg LD of clopidogrel, 8% of patients in the VASP-guided group remained low responders. The rate of stent thrombosis was significantly lower in the VASP-guided group (0.5% vs 4.2%, p <0.01). The rate of major adverse cardiovascular events was also higher in the control group (8.9% vs 0.5%, p <0.001). There was no difference in the rate of bleeding (2.8% vs 3.7%, p = 0.8). In conclusion, a tailored clopidogrel LD according to platelet reactivity monitoring decreases the rate of early stent thrombosis after PCI without increasing bleeding.


Subject(s)
Angina Pectoris/surgery , Blood Platelets/physiology , Coronary Thrombosis/prevention & control , Graft Occlusion, Vascular/prevention & control , Myocardial Revascularization/methods , Platelet Aggregation Inhibitors/administration & dosage , Ticlopidine/analogs & derivatives , Acute Disease , Aged , Angina Pectoris/diagnosis , Blood Platelets/drug effects , Clopidogrel , Coronary Angiography , Coronary Thrombosis/blood , Coronary Thrombosis/diagnostic imaging , Dose-Response Relationship, Drug , Electrocardiography , Female , Follow-Up Studies , Graft Occlusion, Vascular/blood , Graft Occlusion, Vascular/diagnostic imaging , Humans , Male , Monitoring, Physiologic , Prospective Studies , Ticlopidine/administration & dosage , Treatment Outcome
3.
Int J Cardiol ; 128(2): e50-3, 2008 Aug 18.
Article in English | MEDLINE | ID: mdl-17706815

ABSTRACT

Tako-tsubo syndrome is a recently described form of cardiomyopathy. Its pathophysiology remains unknown. However, the main demographic, clinical, electrocardiographic and biologic characteristics of the disease have been described by previous reports. Retrospective studies are essential to help describe this rare disease, although they might have several skews. Previous reports have observed a mortality rate between 0 and 8%. In our serie, demographic, clinical, electrocardiographic and biologic results are similar with those previously reported. However, the mortality rate observed was higher than expected. Refractory ventricular arrhythmias leading to death have been encountered in 15% of patients. Tako-tsubo syndrome may present as sudden death and its mortality rate may have been underestimated in previous reports.


Subject(s)
Bundle-Branch Block/etiology , Death, Sudden, Cardiac/etiology , Tachycardia, Ventricular/etiology , Takotsubo Cardiomyopathy/complications , Ventricular Fibrillation/etiology , Aged , Death, Sudden, Cardiac/epidemiology , Female , France/epidemiology , Humans , Longitudinal Studies , Male , Takotsubo Cardiomyopathy/mortality , Takotsubo Cardiomyopathy/physiopathology , Treatment Outcome , Ventricular Fibrillation/mortality
4.
Heart ; 93(6): 703-7, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17488771

ABSTRACT

OBJECTIVE: To evaluate the effect of pre-procedural acute oral administration of trimetazidine (TMZ) on percutaneous coronary intervention (PCI)-induced myocardial injury. DESIGN: Single-centre, prospective, randomised evaluation study. SETTING: Patients with stable angina pectoris and single-vessel disease undergoing PCI. PATIENTS: 582 patients were prospectively randomised. Patients who underwent more than one inflation during PCI were excluded, resulting in 266 patients randomly assigned to 2 groups. INTERVENTIONS: Patients were randomly assigned to receive or not an acute loading dose of 60 mg of TMZ prior to intervention. MAIN OUTCOME: The frequency and the increase in the level of cardiac troponin Ic (cTnI) after successful PCI. cTnI levels were measured before and 6, 12, 18 and 24 h after PCI. RESULTS: 136 patients were assigned to the TMZ group and 130 to the control group. Although no statistically significant difference was observed in the frequency of cTnI increase between the two groups, post-procedural cTnI levels were significantly reduced in the TMZ group at all time points (6 h: mean (SD) 4.2 (0.8) vs 1.7 (0.2), p<0.001; 12 h: 5.5 (1.5) vs 2.3 (0.4), p<0.001; 18 h: 9 (2.3) vs 3 (0.5), p<0.001; and 24 h: 3.2 (1.2) vs 1 (0.5), p<0.001). Moreover, the total amount of cTnI released after PCI, as assessed by the area under the curve of serial measurement, was significantly reduced in the TMZ group (p<0.05). CONCLUSION: Pre-procedural acute oral TMZ administration significantly reduces PCI-induced myocardial infarction.


Subject(s)
Angina Pectoris/therapy , Angioplasty, Balloon, Coronary/adverse effects , Contrast Media/adverse effects , Heart Injuries/prevention & control , Premedication , Trimetazidine/therapeutic use , Vasodilator Agents/therapeutic use , Administration, Oral , Aged , Angina Pectoris/blood , Coronary Angiography , Female , Humans , Male , Middle Aged , Prospective Studies , Stents , Troponin I/blood
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