20 research outputs found

    Second Percutaneous Mitral Valve Implantation to Treat Acute Hemolysis Complicating Mitral Valve in Ring Implantation

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    We report the case of acute hemolysis after percutaneous transmitral valve implantation in a failed mitral valve repair. Transthoracic echocardiography revealed a high velocity mild mitral regurgitation that could be responsible for the hemolysis. The implantation of a second 26-mm SAPIEN 3 valve (Edwards Lifesciences, Irvine, California) allowed complete regression of the hemolysis. (Level of Difficulty: Intermediate.

    Heart rate increment analysis is not effective for sleep-disordered breathing screening in patients with chronic heart failure.

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    International audienceFrequency domain analysis of heart rate variation has been suggested as an effective screening tool for sleep-disordered breathing (SDB) in the general population. The aim of this study was to assess this method in patients with chronic congestive heart failure (CHF). We included prospectively 84 patients with stable CHF, left ventricular ejection fraction (LVEF) or =15 h(-1) was diagnosed in 57.4% of patients. Percent VLFI was not correlated with AHI (r = 0.12). Receiver-operating characteristic curves constructed using various AHI cut-offs (5-30 h(-1)) failed to identify a %VLFI cut-off associated with SDB. The 2.4% VLFI cut-off recommended for the general population of patients with suspected SDB had low specificity (35%) and low positive and negative predictive values (35% and 54%, respectively). Heart rate increment analysis has several limitations in CHF patients and cannot be recommended as an SDB screening tool in the CHF population

    Impact of previous acute pulmonary oedema after transcatheter aortic valve implantation: insight from French Aortic National CoreValve and Edwards 2 [FRANCE 2]registry

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    International audienceBACKGROUND: The prognostic value of previous pulmonary oedema (PO) has not been thoroughly investigated in a large-cohort of TAVI-patients. The aim of this study was to assess the influence of previous clinical history of acute PO in severe aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: Data were analyzed for 3195 patients enrolled in the French national TAVI registry, FRANCE 2. We compared the clinical outcome of enrolled patients divided broadly into three groups according to the frequency of previous acute PO episode; group 1: no-episode, group 2: single-episode, and group 3: multiple-episodes within the year preceding TAVI. RESULTS: Of the 3195 patients (mean age: 82.7 ± 7.2 years, mean logistic-EuroSCORE: 21.8 ± 14.3) with TAVI, 1880 (58.8%) had no-episode, 937 (29.3%) had single-episode, and 378 (11.9%) had multiple-episode. Both 30-day and cumulative 1-year mortality increased significantly across the 3 groups (7.7% vs. 9.2% vs. 15.9%; p\textless0.001, 14.0% vs. 19.4% vs. 24.1%; p\textless0.001, respectively). In addition, single-PO was not independently associated with an increased mortality at 30-day and 1-year compared to no-PO (HR: 0.99; 95% CI: 0.75-1.30; p=0.923, HR: 1.15; 95% CI: 0.94-1.39; p=0.173, respectively). In contrast multiple-PO was independently associated with an increased risk of both 30-day and cumulative 1-year mortality (HR: 1.51; 95% CI: 1.10-2.01; p=0.012, HR: 1.30; 95% CI: 1.01-1.66; p=0.043, respectively). CONCLUSION: Multiple-PO, but not single, within the year preceding the index procedure is independently associated with increased mortality at short- and mid-term follow up after TAV

    Prognostic value of new onset atrial fibrillation after transcatheter aortic valve implantation: A FRANCE 2 registry substudy

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    International audienceBackground The development of new onset atrial fibrillation (NOAF) post-transcatheter aortic valve implantation (TAVI) is common and may be associated with an adverse prognosis. This study seeks to identify incidence, predictors, and impact of NOAF post-TAVI. Methods From the multicenter study of the French national transcatheter aortic valve implantation registry, FRANCE 2, a total of 1959 patients with sinus rhythm prior to TAVI were enrolled into this study. The incidence of post-TAVI NOAF, predictors of development of NOAF and impact on 30-day and 1-year-mortalities were assessed. Results Of the 1959 TAVI patients (mean-age: 82.6 ± 7.5 years, mean-logistic-EuroSCORE: 21.8 ± 14.3), 149 (7.6%) developed NOAF with the remaining 1810 (92.4%) control patients demonstrating no evidence of AF as defined by the Valve Academic Research Consortium (VARC). Advanced age and major and life-threatening bleeding were independent predictors of NOAF (95% CI: 0.93–0.99; p = 0.006, 95% CI: 1.58–4.00; p < 0.001, 95% CI: 1.09–3.75; p = 0.025, respectively). A trend towards a higher incidence of major and life-threatening bleeding was observed in the patients undergoing TAVI via the transapical (TA)-approach compared with the transfemoral (TF)-approach. Both 30-day and cumulative 1-year-mortalities were significantly higher in patients with NOAF compared to patients without NOAF (3.0% vs. 7.4%; p = 0.005, 9.1% vs. 20.8%; p < 0.001, respectively). In addition, NOAF was an independent predictor of 30-day and 1-year-mortalities (HR: 2.16; 95% CI: 1.06–4.41; p = 0.033, HR: 2.12; 95% CI: 1.42–3.15; p < 0.001, respectively). Conclusion Advanced age and major and life-threatening bleeding were independently associated with increased incidence of NOAF, which itself was an independent predictor of 30-day and 1-year-mortalities. With regards to the various transcatheter approaches, a trend towards a higher incidence of major and life-threatening bleeding was observed only with the TA-approach

    Feasibility limits of transradial primary percutaneous coronary intervention in acute myocardial infarction in the real life (TRAP-AMI).

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    International audienceBACKGROUND: There is growing evidence that transradial (TRI) as compared to transfemoral (TFI) percutaneous coronary intervention (PCI) is associated with improved clinical outcome driven by less hemorrhagic complications, in particular in STEMI patients receiving aggressive antithrombotic treatment. Feasibility rate of TRI in STEMI patients has not yet been evaluated. METHODS/RESULTS: Four-hundred seventy-five consecutive STEMI patients (<12h) without cardiogenic shock were prospectively screened for this all-comer single-centre registry between January 2008 and August 2010. Nine patients were excluded for a priori ineligibility for TRI (forearm shunt for dialysis, prior TRI failure). In the 466 patients enrolled, the operator's opinion about ease of radial puncture was assessed in 4 categories, based on radial pulse quality. Operators were advised not to attempt TRI if ease of puncture was judged "probably difficult/impossible". In case of puncture failure the operator switched immediately to TFI. The mean age of patients was 61±14 (range 27-94) years. Seventy-three percent were men, 17% had diabetes. Nine percent had previous PCI. Glycoprotein inhibitors were used in 70%, and thrombectomy was performed in 70% of patients. PCI was performed using 6F and 5F guiding catheters. Procedural success rate was 98.2% (TIMI flow≥2). In 4.1% (n=19) of patients the operator judged ease of radial puncture "probably difficult/impossible" and no TRI attempt was performed (primary TFI). In the 447 patients with TRI attempt, TRI failure requiring switch to TFI (secondary TFI) was necessary in 22 patients (4.7% of total) following radial puncture failure (n=15), dissection of the radial artery (n=1), prohibitive tortuosities or stenosis of the upper limb axis (n=2), or non-selective position or lack of stability of the guiding catheter (n=2). After the start of the angioplasty procedure, switch from TR to TF was not necessary in any patient. In total, the overall feasibility rate of TRI was 91.2%. Independent predictors of final TFI were age≥80years (adjusted OR: 2.37; 95% CI:1.05-5.34, p=0.037), body weight<60kg (adjusted OR: 2.84; 95% CI:1.22-6.59, p=0.015); and previous PCI (adjusted OR: 3.42; 95% CI:1.40-8.37, p=0.007); female gender was borderline significant (adjusted OR:2.10; 95% CI:0.97-4.54, p=0.059). CONCLUSION: In STEMI patients without cardiogenic shock and without a priori indication for TFI, PCI can be performed via the radial artery in more than 90% of cases with high procedural success rate. Operator's judgement of eligibility for TRI based on radial pulse quality is predictive of successful TRI in 95% of cases. TR failure is significantly more common in the elderly and in patients with low body weight

    Intra-coronary morphine versus placebo in the treatment of acute ST-segment elevation myocardial infarction: the MIAMI randomized controlled trial

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    Abstract Background Experimental studies suggest that morphine may protect the myocardium against ischemia-reperfusion injury by activating salvage kinase pathways. The objective of this two-center, randomized, double-blind, controlled trial was to assess potential cardioprotective effects of intra-coronary morphine in patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous intervention. Methods Ninety-one patients with STEMI were randomly assigned to intracoronary morphine (1 mg) or placebo at reperfusion of the culprit coronary artery. The primary endpoint was infarct size/left ventricular mass ratio assessed by magnetic resonance imaging on day 3–5. Secondary endpoints included the areas under the curve (AUC) for troponin T and creatine kinase over three days, left ventricular ejection fraction assessed by echocardiography on days 1 and 6, and clinical outcomes. Results Infarct size/left ventricular mass ratio was not significantly reduced by intracoronary morphine compared to placebo (27.2% ± 15.0% vs. 30.5% ± 10.6%, respectively, p = 0.28). Troponin T and creatine kinase AUCs were similar in the two groups. Morphine did not improve left ventricular ejection fraction on day 1 (49.7 ± 10.3% vs. 49.3 ± 9.3% with placebo, p = 0.84) or day 6 (48.5 ± 10.2% vs. 49.0 ± 8.5% with placebo, p = 0.86). The number of major adverse cardiac events, including stent thrombosis, during the one-year follow-up was similar in the two groups. Conclusions Intracoronary morphine at reperfusion did not significantly reduce infarct size or improve left ventricular systolic function in patients with STEMI. Presence of comorbidities in some patients may contribute to explain these results. Trial registration ClinicalTrials.gov, NCT01186445 (date of registration: August 23, 2010)

    Sequential FOLFIRI.3 + Gemcitabine Improves Health-Related Quality of Life Deterioration-Free Survival of Patients with Metastatic Pancreatic Adenocarcinoma: A Randomized Phase II Trial

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    <div><p>Background</p><p>A randomized multicenter phase II trial was conducted to assess the sequential treatment strategy using FOLFIRI.3 and gemcitabine alternately (Arm 2) compared to gemcitabine alone (Arm 1) in patients with metastatic non pre-treated pancreatic adenocarcinoma. The primary endpoint was the progression-free survival (PFS) rate at 6 months. It concludes that the sequential treatment strategy appears to be feasible and effective with a PFS rate of 43.5% in Arm 2 at 6 months (26.1% in Arm 1). This paper reports the results of the longitudinal analysis of the health-related quality of life (HRQoL) as a secondary endpoint of this study.</p><p>Methods</p><p>HRQoL was evaluated using the EORTC QLQ-C30 at baseline and every two months until the end of the study or death. HRQoL deterioration-free survival (QFS) was defined as the time from randomization to a first significant deterioration as compared to the baseline score with no further significant improvement, or death. A propensity score was estimated comparing characteristics of partial and complete responders. Analyses were repeated with inverse probability weighting method using the propensity score. Multivariate Cox regression analyses were performed to identify independent factors influencing QFS.</p><p>Results</p><p>98 patients were included between 2007 and 2011. Adjusting on the propensity score, patients of Arm 2 presented a longer QFS of Global Health Status (Hazard Ratio: 0.52 [0.31-0.85]), emotional functioning (0.35 [0.21–0.59]) and pain (0.50 [0.31 – 0.81]) than those of Arm 1.</p><p>Conclusion</p><p>Patients of Arm 2 presented a better HRQoL with a longer QFS than those of Arm 1. Moreover, the propensity score method allows to take into account the missing data depending on patients’ characteristics.</p><p>Trial registration information</p><p>Eudract N° <a href="https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005703-34/FR" target="_blank">2006-005703-34</a>. (Name of the Trial: FIRGEM).</p></div
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