ImportanceApproximately 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.ObjectiveTo 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 ParticipantsThis 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 MeasuresDeath from any cause, myocardial infarction, or unplanned revascularization (MACE) at 1 year.ResultsAmong 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 RelevanceRoutine 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.
Objective: The main objective of this study was to evaluate the impact of the French national program on home return of chronic heart failure patients (PRADO-IC) in terms of re-hospitalizations for heart failure (HF) during its deployment in the Bas-Rhin (France). Patients and methods: This was a pilot, descriptive, quantitative, retrospective, and bi-centric study (University Hospitals of Strasbourg and Haguenau Hospital Center, France). It included all patients included in the PRADO-IC program from these centers between January 1, 2015 and December 31, 2015. The primary endpoint of our study was the evaluation of the number of 1-year, 6-month, and 30-day re-admissions to the hospital in relation to an acute HF episode, before and after the inclusion of patients in the PRADO-IC program. The secondary endpoints were the number of overall re-hospitalizations (all-cause); the number of days of hospitalization for HF; the time to first re-hospitalization and the average length of hospital stay, before and after inclusion in PRADO-IC; and the overall and cardiovascular mortality rates. Results: 91 patients out of 271 (33,6%) with a mean age of 79.2 years (67–94) were included. They all had chronic HF, essentially class II-III NYHA (90.1%), mostly of ischemic origin (41.9%), with altered left ventricular ejection fraction in 71.4% of cases. A reduction in the mean number of hospitalizations for HF per patient at 30 days, 6 months and 1 year was observed, respectively, from 0.18 ± 0.42 per patient before inclusion to 0.15 ± 0.36 after inclusion (p = 0.56); 0.98 ± 1.04 hospitalizations to 0.53 ± 0.81 at 6 months (p < 0.01); and 1.64 ± 1.14 hospitalizations 1.04 ± 1.05 at 1 year (p < 0.001). Patients were hospitalized less overall after inclusion in the PRADO-IC program. The number of days of hospitalization for HF was reduced after inclusion of patients from 18.02 ± 7.78 days before inclusion to 14.28 ± 11.57 days for the 6 month follow-up (p = 0.006), and from 22.07 ± 10.33 days before inclusion to 16.39 ± 15.94 days for the 1 year follow-up (p < 0.001). In contrast, inclusion in PRADO-IC statistically increased the mean time to first re-hospitalization for HF from mean 99.36 ± 72.39 days before inclusion to 148.11 ± 112.77 days after inclusion (p < 0.001). Conclusion: This study seems to demonstrate that the PRADO-IC program could improve the management of chronic HF patients in ambulatory care, particularly regarding HF re-hospitalization. However, due to the limitations of the methodology used and the small number of patients, it is advisable to consolidate its initial results with a randomized controlled study on a larger number of patients. In our opinion, its results need to be communicated because, to our knowledge, no equivalent study exists.
Background-Fractional flow reserve (FFR) is not firmly established as a guide to treatment in patients with acute coronary syndromes (ACS). Primary goals were to evaluate the impact of integrating FFR on management decisions and on clinical outcome of patients with ACS undergoing coronary angiography, as compared with patients with stable coronary artery disease.Methods and Results-R3F (French FFR Registry) and POST-IT (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease), sharing a common design, were pooled as PRIME-FFR (Insights From the POST-IT and R3F Integrated Multicenter Registries-Implementation of FFR in Routine Practice). Investigators prospectively defined management strategy based on angiography before performing FFR. Final decision after FFR and 1-year clinical outcome were recorded. From 1983 patients, in whom FFR was prospectively used to guide treatment, 533 sustained ACS (excluding acute ST-segment-elevation myocardial infarction). In ACS, FFR was performed in 1.4 lesions per patient, mostly in left anterior descending (58%), with a mean percent stenosis of 58 +/- 12% and a mean FFR of 0.82 +/- 0.09. In patients with ACS, reclassification by FFR was high and similar to those with non-ACS (38% versus 39%; P=NS). The pattern of reclassification was different, however, with less patients with ACS reclassified from revascularization to medical treatment compared with those with non-ACS (P=0.01). In ACS, 1-year outcome of patients reclassified based on FFR (FFR against angiography) was as good as that of nonreclassified patients (FFR concordant with angiography), with no difference in major cardiovascular event (8.0% versus 11.6%; P=0.20) or symptoms (92.3% versus 94.8% angina free; P=0.25). Moreover, FFR-based deferral to medical treatment was as safe in patients with ACS as in patients with non-ACS (major cardiovascular event, 8.0% versus 8.5%; P=0.83; revascularization, 3.8% versus 5.9%;P=0.24; and freedom from angina, 93.6% versus 90.2%; P=0.35). These findings were confirmed in ACS explored at the culprit lesion. In patients (6%) in whom the information derived from FFR was disregarded, a dire outcome was observed.Conclusions-Routine integration of FFR into the decision-making process of ACS patients with obstructive coronary artery disease is associated with a high reclassification rate of treatment (38%). A management strategy guided by FFR, divergent from that suggested by angiography, including revascularization deferral, is safe in ACS.
The objective of this study was to estimate the French national updated reference levels (RLs) for coronary angiography (CA) and percutaneous coronary intervention (PCI) by a dose audit from a large data set of unselected procedures and in standard-sized patients. Kerma-area product (PKA), air kerma at interventional point (Ka,r), fluoroscopy time (FT), and the number of registered frames (NFs) and runs (NRs) were collected from 51 229 CAs and 42 222 PCIs performed over a 12-month period at 61 French hospitals. RLs estimated by the 75th percentile in CAs and PCIs performed in unselected patients were 36 and 78 Gy.cm² for PKA, 498 and 1285 mGy for Ka,r, 6 and 15 min for FT, and 566 and 960 for NF, respectively. These values were consistent with the RLs calculated in standard-sized patients. The large difference in dose between sexes leads us to propose specific RLs in males and females. The results suggest a trend for a time-course reduction in RLs for interventional coronary procedures.
Outcomes of AMI patients have substantially improved over the past 2 decades. Whether similar trends are observed in elderly (≥75 years of age) and younger patients has not been extensively studied. We analysed one-year mortality of elderly vs younger patients in 4 nationwide French survey carried out 5 years apart from 1995 to 2010. Consecutive STEMI and NSTEMI patients (≤48 hours from onset) were recruited over one-month periods. Among 10610 patients included in the 4 surveys, 3389 (32%) were aged 75+. From 1995 to 2010, the proportion of 75+ remained stable in NSTEMI (1995: 36%, 2010: 38%), but decreased in STEMI patients (1995: 30%, 2010: 25.5%, P=0.006). Use of PCI ≤72 hours of admission increased from 6.0% to 54.9% in tin the past 15 years he 75+, and from 19% to 77% in the younger pts, use of new anticoagulants increased from 0 to 62% and 0 to 79%, respectively, and use of recommended secondary prevention medications from 2% to 43% and from 9% to 69% respectively. All clinical outcomes improved both in the 75+ and <75 age groups (Table). Risk of one-year death in 2010 vs 1995 was HR 0.48 (0.40-0.59) in the 75+ and HR 0.38 (0.29-0.50) in younger patients. When early use of PCI, recommended medications and new anticoagulants were added to the models, survey period was no longer significantly associated with one-year death. In these 4 nationwide surveys of AMI pts conducted over a 15-year period, outcomes improved markedly in elderly as in younger patients. Most of the improvement in outcomes appear mediated by improved early management (use of PCI and medications).Abstract 0112 – Table: Evolution of outcomes from 1995 to 2010 across age groupsEmpty Cell<75 years (n=7.221) 1995-2000-2005-2010≥75 years (n=3.389) 1995-2000-2005-2010VF4.0 – 2.3 – 1.5 – 1.2%4.6 – 4.9 – 2.0 – 1.0%AF7.7 – 5.0 – 3.7 – 2.9%21.5 – 16.8 – 9.5 – 10.1%ReinfarctionNA – 2.3 – 1.5 – 0.8%NA – 2.9 – 2.4 – 1.8%StrokeNA – 0.7 – 0.7 – 0.4%NA – 1.6 – 1.4 – 0.5%Shock4.7 – 4.4 – 4.0 – 2.7%11.6 – 13.6 – 9.3 – 6.7%30-day death7.2 – 4.8 – 2.9 – 1.4%25.0 – 16.8 – 13.0 – 8.4%One-year death10.9 – 8.8 – 5.9 – 3.9%36.2 – 30.0 – 26.9 – 20 0% Abstract 0112 – Table: Evolution of outcomes from 1995 to 2010 across age groups
Nous rapportons le cas de Monsieur M. âgé de 78 ans porteur d’une cardiopathie post-hypertensive avec des antécédents de flutter auriculaire paroxystique. Celui-ci consulte son cardiologue traitant pour palpitations et douleurs thoraciques atypiques. L’ECG inscrit un rythme sinusal régulier, un hémibloc antérieur gauche isolé sans trouble de rythme, ni signe d’ischémie. L’échocardiographie transthoracique met en évidence un épanchement péricardique circonférentiel sans tamponnade et une masse ovale hypoéchogène au niveau de la paroi inférieure du ventricule gauche et de l’oreillette gauche. L’IRM cardiaque confirme l’existence d’une masse tissulaire bourgeonnante dans le massif auriculaire (38,5 × 28,9 mm) principalement localisée sur la paroi latérale de l’oreillette gauche, mais s’étendant dans la paroi inférieure et paroi postérieure de l’oreillette droite. Un TDM thoraco-abdomino-pelvien ne retrouve pas d’autre anomalie suspecte, ni d’adénopathie. Une thoracotomie gauche avec drainage péricardique et biopsie sont réalisés. L’analyse histologique est en faveur d’un lymphome B diffus à grande cellule CD 20+; CD 10–. Une chimiothérapie R-COMP (Rituximab; Myocet®, cyclophosphamide; vincristine; prednisone) est alors initiée. L’IRM cardiaque de contrôle montre une régression significative de la tumeur par évolution nécrotique ou rétractile avec persistance de la masse dans le sillon auriculo-ventriculaire gauche.
Coronary heart disease is the first cause of morbidity and mortality in diabetic patients. Its incidence in elderly patients increases with the increase of their life expectancy. The aim of our study was to evaluate the characteristics and the management of elderly patients with diabetes and compared this with non- diabetics patients. This is a comparative retrospective study of 204 elderly patients (>75 years) admitted for ACSin haguenau Hospital center in France, between August 2012 and August 2013. We compared 63 elderly patients diabetics (GI), with 141 elderly patients non-diabetic (GII) The mode age: 80years (GI), 82years (GII). A male predominance noted in the both groups. More risk factors in (GI): hypertension (p=0.002), dyslipidemia (p=0.034), while (GII) is more smoker (p=0.003). More comorbidities for (GI), especially high frequency of renal failure (p<0.001). Predominance of atypical pain in both groups. NSTEMI was predominant in the both groups. At coronary angiography, three-vessel involvement was more frequent in (GI). Percutaneous coronary intervention (PCI) is less used in theGI (62.7%) toGII (69.5%). Hospital complications were higher in diabetics particulary: renal failure (p=0.04). Evolution at6and12month ago shows a more predominance of complications in diabetics. The quality of life of nondiabetic is better than in diabetics. On the other hand, the quality of life of the diabetics after PCI was better to conventional therapy. Elderly diabetic patients are very high cardiovascular risk, characterized by the severity of coronary artery disease. Diabetics are treated less aggressively than non-diabetics yet that diabetics quality of life improves better with angioplasty in comparison with the conventional treatment.
The RAY’ACT project is a nationwide program of multicentre surveys aimed at evaluating patient radiation protection (RP) for coronary angiography (CA) and percutaneous coronary interventions (PCI) in French non-university public hospitals, which represent > 30 % of the national activity for PCIs, and 60 % of the emergency cases. In the second RAY’ACT survey, RP parameters from 48,547 CAs and 40,026 PCIs performed at 61 centres during 2013 (see Table 1) and routinely registered in professional software were extracted and analysed retrospectively. Dose × area product (DAP), fluoroscopy time (FT), number of registered frames (NF) and runs (NR), and total Air Kerma at interventional reference point (AK,r) were analysed separately for CAs and PCIs (elective and ad hoc pooled). All procedures of the year were included. Overall, a highly significant reduction in DAP of 20 %, and in AK,r and NF of 30 % was demonstrated for CA and PCI, while FT and NR decreased of 11 % and 5 %, respectively (all P < 0.0001). In 2013, radiation exposure was homogeneous between the 44 centres participating in both RAY’ACT 1 and 2 surveys, and the 17 new centres. The table shows the medians (quartile 1–quartile 3) of the RP parameters. Between 2010 and 2013, a significant 20 to 30 % reduction was observed in medians and reference levels (Q3) for main RP parameters, including DAP, total Air Kerma, and number of registered frames, in diagnostic and interventional coronary procedures.
Background. - Takotsubo cardiomyopathy (TTC) is a rare condition characterized by a sudden temporary weakening of the heart. TTC can mimic acute myocardial infarction and is associated with a minimal release of myocardial biomarkers in the absence of obstructive coronary artery disease.Aims. - To provide an extensive description of patients admitted to hospital for TTC throughout France and to study the management and outcomes of these patients.Methods. - In 14 non-academic hospitals, we collected clinical, electrocardiographic, biological, psychological and therapeutic data in patients with a diagnosis of TTC according to the Mayo Clinic criteria.Results. - Of 117 patients, 91.5% were women, mean +/- SD age was 71.4 +/- 12.1 years and the prevalence of risk factors was high (hypertension: 57.9%, dyslipidaemia: 33.0%, diabetes: 11.5%, obesity: 11.5%). The most common initial symptoms were chest pain (80.5%) and dyspnoea (24.1%). A triggering psychological event was detected in 64.3% of patients. ST-segment elevation was found in 41.7% of patients and T-wave inversion in 71.6%. Anterior leads were most frequently associated with ST-segment elevation, whereas T-wave inversion was more commonly associated with lateral leads, and Q-waves with septal leads. The ratio of peak B-type natriuretic peptide (BNP) or N-terminal prohormone BNP (NT-proBNP) level to peak troponin level was 1.01. No deaths occurred during the hospital phase. After 1 year of follow-up, 3 of 109 (2.8%) patients with available data died, including one cardiovascular death. Rehospitalizations occurred in 17.4% of patients: 2.8% due to acute heart failure and 14.7% due. to non-cardiovascular causes. There was no recurrence of TTC.Conclusions. - This observational study of TTC included primarily women with atherosclerotic risk factors and mental stress. T-wave inversion was more common than ST-segment elevation. There were few adverse cardiovascular outcomes in these patients after 1-year follow-up. (C) 2015 Elsevier Masson SAS. All rights reserved.
La maladie coronarienne représente la première cause de morbimortalité chez le diabétique. Son incidence chez les sujets âgés augmente avec l'allongement de l'espérance de vie. L'objectif de notre travail est d'évaluer l'utilité et les risques de la stratégie coronaire invasive chez les diabétiques et d'en préciser les résultats, les complications et la mortalité hospitalière. Il s'agit d'une étude rétrospective, comparative menée sur 63 patients âgés (> 75 ans) et diabétiques, admis pour SCA au CH Haguenau entre août 2012 et août 2013. Sur un total de 6 patients âgés de plus de 75 ans diabétiques. L'âge médian était de 80 ± 4,3 ans, 54 % étaient des hommes. L'indication principale était un syndrome coronaire aigu, l'atteinte coronaire souvent tritronculaire. Un premier groupe (n = 21) a eu une coronarographie seule conduisant au renforcement du traitement médical (30,2 %) et au pontage dans 3,2 % cas. Le second groupe (n = 42) a eu une coronarographie suivie d'angioplastie percutanée (42), soit 66,7 % des cas. Le taux de succès primaire de l'ICP a été de 97 % (un seul cas d'echec). La voie radiale a été utilisée dans 57,1 % des procédures. Les échecs d'abord vasculaire et/ou les difficultés de cathétérisme (4,8 %) ont été assez rares. Les complications locales (1 cas d'hématome) et générales (1 cas d'AVC, 9 insuffisances rénales, 7 insuffisances cardiaques congestives, 7 troubles de rythme/conduction, 2 récidives de nécrose en intrahospitalier). Aucune mortalité hospitalière n'a été notée. La coronarographie est réalisable chez les diabétiques préférentiellement par voie radiale avec un taux réduit de complications. Elle permet de proposer une angioplastie coronaire dans les deux tiers des cas. L'angioplastie percutanée coronaire est réalisable avec un taux élevé de succès, un risque acceptable de complications locales et générales. Les auteurs déclarent ne pas avoir d'intérêt direct ou indirect (financier ou en nature) avec un organisme privé, industriel ou commercial en relation avec le sujet présenté.
We report the case of an asymptomatic 70-year-old woman with a liquefaction necrosis of mitral annulus calcification. This mass was discovered incidentally during an echocardiographic examination. Additional treatment was not performed because liquefaction necrosis of mitral calcification usually has a benign prognosic. A scheduled clinical review with an echocardiographic examination and cardiac MRI was planified. The patient is actually healthy without any complication.
Acute coronary syndrome in the elderly patients is a particular clinical entity characterized by increased incidence. Medical advances and improvement of the conditions of life acquires of the elderly person the progression of their autonomy. Our aim is to evaluate the quality of life of elderly patients after ACS treated by angioplasty. We had collected 141 elderly patients (>75 ans) (mean age:80.6± 4.03 years old) admitted for NSTEMI in Haguenau hospital center in France, between august 2012 and august 2013. 58.2% had percutaneous coronary intervention (PCI), 34% medical treatment and 7.8% CABG. In the acute phase after PCI: renal failure 11%(vs 6.3% after medical treatment), heart failure 7.3% (vs 6.3%), recurrence infarction 6.1% (vs: 0%). Mortality of 2.4% (vs: 0%). At 6 month after PCI: renal failure 3.8% (vs: 0%), recurrent infarction 7.5% (vs 4,2%) and heart failure 6.3%(vs 8,3%). Mortality of 1.4%(vs: 0%). The quality of life has improved in 45% after PCI, versus 12,5% after medical treatment. At 1 year after PCI: mortality 1,3% and recurrent infarction1. 3%. The quality of life has improved in 53.2% versus 12.5% after medical treatment. While a stationary quality of life is noted in 72.9% after medical treatment. Angioplasty in elderly patients improves the quality of life, especially of physical health, but with some cases of complications. While medical treatment that maintained a steady state of quality of life with fewer complications.
La maladie coronarienne représente la première cause de morbi-mortalité chez le diabétique. Son incidence chez les sujets âgés augmente avec l’allongement de l’espérance de vie. L’objectif de notre travail est d’évaluer la prise en charge des patients âgés diabétiques. Il s’agit d’une étude rétrospective, comparative menée sur 204 patients âgés (> 75 ans), admis pour SCA au CH Haguenau entre août 2012 et août 2013. On a comparé 63 patients âgés diabétiques (GI), et 141 patients âgés non diabétiques (GII). Mode d’âge (GI) : 80 ans ; 82 ans (GII). Discrète prédominance masculine est notée chez les 2 groupes. Les diabétiques présentent plus de facteurs de risque : fréquence plus élevée d’HTA (p = 0,002), dyslipidémie (p = 0,034), alors que (GI) est plus plutôt tabagique. Plus de comorbidités chez (GI), notamment insuffisance rénale (p < 0,001). SCA sans sus-décalage du segment ST est prédominante dans les 2 groupes. À la coronarographie, l’atteinte tritronculaire était plus fréquente chez (GI). L’angioplastie est moins utilisée dans le (GI) 62,7 % que le (GII) 69,5 %. Les complications hospitalières étaient plus élevées chez les diabétiques notamment, l’insuffisance rénale (p = 0,055). L’évolution à 6 et à 12 mois révèle une légère prédominance des complications chez (GI). La qualité de vie des diabétiques après une angioplastie était meilleure en comparaison au traitement conventionnel. D’autre part, la qualité de vie des non-diabétiques s’améliore mieux que chez les diabétiques, Le sujet âgé diabétique est à très haut risque cardiovasculaire, caractérisé par la sévérité de l’atteinte coronarienne. Les diabétiques sont traités moins agressivement que les non-diabétiques, pourtant que leur qualité de vie s’améliore mieux en comparaison avec le traitement conventionnel.
Background— There is no large report of the impact of fractional flow reserve (FFR) on the reclassification of the coronary revascularization strategy on individual patients referred for diagnostic angiography. Methods and Results— The Registre Français de la FFR (R3F) investigated 1075 consecutive patients undergoing diagnostic angiography including an FFR investigation at 20 French centers. Investigators were asked to define prospectively their revascularization strategy a priori based on angiography before performing the FFR. The final revascularization strategy, reclassification of the strategy by FFR, and 1-year clinical follow-up were prospectively recorded. The strategy a priori based on angiography was medical therapy in 55% and revascularization in 45% (percutaneous coronary intervention, 38%; coronary artery bypass surgery, 7%). Patients were treated according to FFR in 1028/1075 (95.7%). The applied strategy after FFR was medical therapy in 58% and revascularization in 42% (percutaneous coronary intervention, 32%; coronary artery bypass surgery, 10%). The final strategy applied differed from the strategy a priori in 43% of cases: in 33% of a priori medical patients, in 56% of patients undergoing a priori percutaneous coronary intervention, and in 51% of patients undergoing a priori coronary artery bypass surgery. In reclassified patients treated based on FFR and in disagreement with the angiography-based a priori decision (n=464), the 1-year outcome (major cardiac event, 11.2%) was as good as in patients in whom final applied strategy concurred with the angiography-based a priori decision (n=611; major cardiac event, 11.9%; log-rank, P =0.78). At 1 year, >93% patients were asymptomatic without difference between reclassified and nonreclassified patients (Generalized Linear Mixed Model, P =0.75). Reclassification safety was preserved in high-risk patients. Conclusion— This study shows that performing FFR during diagnostic angiography is associated with reclassification of the revascularization decision in about half of the patients. It further demonstrates that it is safe to pursue a revascularization strategy divergent from that suggested by angiography but guided by FFR.
BACKGROUND:The objective of this study is to evaluate the effectiveness and the safety of the FemoSeal mechanical closure system in order to obtain hemostasis of the puncture site following angioplasty procedures performed through femoral arterial approach.METHOD:A single-centre prospective registry was conducted from November 2010 to April 2011, comparing the results of manual compression (n=111 patients), hemostatic bandages compression (n=43 patients) and FemoSeal mechanical closure (n=100 patients). The end points evaluated were the following: successful hemostasis, major and minor complications right after the procedures and major and minor complications at 1 month follow-up. The patients' feedback about their comfort was also collected right after the procedure and after one month.RESULTS:Successful hemostasis with FemoSeal was obtained in 93% of the patients (n=93). Seven patients required additional slight manual compressions or compression bandages. The use of FemoSeal was not associated with any major complications, significantly reducing (P<0.05) the number of complications compared to other compression techniques over the studied period. Only one minor complication was observed with FemoSeal (a 1.5-cm-hematoma, which reabsorbed spontaneously without any issue).CONCLUSION:In our experience, the use of FemoSeal is effective in achieving hemostasis performed through femoral arterial approach up to 7F and is associated with a very low rate of complications.
Patient exposure to radiation from interventional coronary procedures (ICPs) is high. Dose optimization is in part based on comparison with reference levels (RLs). Current RLs, however, have been deduced from small or old multicentre studies. The purpose of this study was to evaluate current practices for patient radiation protection (RP) in French non-university public hospitals, which represent >30% of the national activity for ICPs, and 60% of the emergency cases. RAY’ACT was a nationwide, multicentre survey. RP parameters from 35,257 coronary angiographies (CAs) and 28,604 percutaneous coronary interventions (PCIs) performed at 48 centres during 2010 and routinely registered in professional software were extracted and analysed retrospectively. Dose-area product (DAP), fluoroscopy time (FT), number of acquired frames (NF) and runs (NR), and cumulative dose to interventional reference point (CD-IRP) were analysed separately for CAs and PCIs (elective and ad hoc pooled). Emergency and complex procedures, associated with a high level of radiation, were not excluded. The table shows the new RLs, based on the 75th percentiles of the values for CA and PCI, and comparison with previous RLs.RLs fromRAY’ACT (2010)SENTINEL (2008)EAIA (2007)GACI-PDS (2006)DIMOND (2003)CAN31,0676722,265496600DAP, Gy. cm245.24549.45756FT, min6.38967NF76970010031270876CD-IRP, mGy6956501900––PCIN25,3566621,844317600DAP, Gy. cm294.68512294110FT, min16.215211615NF11931000169113551325CD-IRP, mGy178815002800–– The RAY’ACT survey has allowed the definition of new RLs for DAP, FT, NF and CD-IRP for CA and PCI, based on a large study population. It confirms the trend toward a decrease in radiation doses and FT during CA. The lack of decrease in DAP and FT during PCI should be interpreted according to the likely increase in procedure complexity.
The beneficial effect of a high dose of statin (HDS) compared with lower doses is controversial in secondary prevention. We studied factors impacting the prescription of a HDS at discharge after an Acute Myocardial Infarction [AMI], and assessed effects of this HDS on mortality and cardiovascular morbidity. Participants were 2240 survivors of a STEMI or NSTEMI from the French FAST-MI registry conducted in 2005, with a known statin dose at discharge. Rosuvastatin at any dose, atorvastatin ≥20 mg/d and Simvastatin 40 mg/d were considered as HDS. Factors related to HDS prescription were studied using logistic regression. Impact of HDS prescription on occurrence of death or major cardiovascular events [MACE] (MI, stroke or revascularisation) was studied using a Cox proportional hazards model after propensity score matching. 54.5% of the patients had a HDS prescription at discharge. In crude risk analyses, HDS prescription was associated with a lower risk of death or MACE (HR=0.84 [0.71-0.98], p<0.03). However, patients already under treatment with a HDS before the ACS, patients managed in a university hospital, located in a large city, with a younger age, a STEMI, a high blood pressure at entry (≥140 mmHg) and who were discharged rapidly after their AMI were more likely to benefit from a HDS prescription at discharge. After propensity score matching, the dose of statin the patients received at discharge was not related to death or MACE occurrence in the following 3 years (HR=1.04 [0.77-1.36], p=0.87). Using a more stringent definition for HDS (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) yielded similar results. The issue of long term benefit of HDS therapy compared with lower ones after an AMI remains unanswered in an observational context, because in this “real life” large registry, high doses were preferentially prescribed to patients with a low risk profile, but less commonly to patients with a high risk profile.
Purpose: A large amount of literature suggests that coronary angiography (CA) and percutaneous coronary interventions (PCI) performed by radial route are associated with higher radiation doses to patient. RAY'ACT is a nationwide, multicentre, French survey aimed at evaluating current practices for patient radiation protection (RP) in French non-university public hospitals. The purpose of this study was to compare RP parameters during CAs and PCIs performed via radial and femoral routes. Methods: RP parameters from 31,066/33,931 (91%) CAs and 25,356/27,823 (91%) PCIs performed at 44 centres during 2010, and routinely registered in professional software were retrospectively analyzed. Extreme values were validated and/or corrected by centres. Dose Area Product (DAP in Gy.cm2) and Fluoroscopy time (FT in min), presented as median [quartiles], were compared between procedures performed by radial and femoral routes. Arterial access was missing for 286 CAs and 359 PCIs. Results: Radial route was used in 21 726/30 780 CAs (71%, range of centres 8%-93%) and in 17,134/24,997 PCIs (68%, range 6%-94%). Compared to femoral route, FT was higher in CAs and PCIs performed by radial route (3.5 min [2.1-6.5] vs 3.8 [2.3-6.3] for CA, and 10.1 min [6.2-16.7] vs 10.4 [6.9-16.0] for PCI, respectively, all p<0.01). Conversely, DAP was lower in procedures performed by radial route (26.8 Gy cm2 [15.1-44.5] vs 28.1 [16.4-46.9] by femoral route for CA, and 55.6 Gy cm2 [32.1-92.1] vs 59.4 [34.6-99.9] for PCI, respectively, all p<0.001). The difference in DAP remained significant (p<0.01) after adjustment on age, sex, BMI, emergency procedure, left ventriculography. A significant interaction was found between DAP and the volume of the centre for radial route (p<0.001). DAP was significantly higher by radial than by femoral route in centres with low volume for radial route (34.2 Gy cm2 vs 26.6 for CA, 78.1 vs 76.1 for PCI; p<0.01), and lower in high-volume centres (24.1 Gy cm2 vs 25.3 for CA, 50.8 vs 54.2 for PCI; p<0.01). Conclusions: In this nationwide multicentre survey, radial route was used predominantly for CA and PCI, and was associated with lower radiation doses to patient than the femoral route. Radial route delivered higher radiation doses only in low-volume centres for radial route.
Background— There is no large report of the impact of fractional flow reserve (FFR) on the reclassification of the coronary revascularization strategy on individual patients referred for diagnostic angiography. Methods and Results— The Registre Français de la FFR (R3F) investigated 1075 consecutive patients undergoing diagnostic angiography including an FFR investigation at 20 French centers. Investigators were asked to define prospectively their revascularization strategy a priori based on angiography before performing the FFR. The final revascularization strategy, reclassification of the strategy by FFR, and 1-year clinical follow-up were prospectively recorded. The strategy a priori based on angiography was medical therapy in 55% and revascularization in 45% (percutaneous coronary intervention, 38%; coronary artery bypass surgery, 7%). Patients were treated according to FFR in 1028/1075 (95.7%). The applied strategy after FFR was medical therapy in 58% and revascularization in 42% (percutaneous coronary intervention, 32%; coronary artery bypass surgery, 10%). The final strategy applied differed from the strategy a priori in 43% of cases: in 33% of a priori medical patients, in 56% of patients undergoing a priori percutaneous coronary intervention, and in 51% of patients undergoing a priori coronary artery bypass surgery. In reclassified patients treated based on FFR and in disagreement with the angiography-based a priori decision (n=464), the 1-year outcome (major cardiac event, 11.2%) was as good as in patients in whom final applied strategy concurred with the angiography-based a priori decision (n=611; major cardiac event, 11.9%; log-rank, P=0.78). At 1 year, >93% patients were asymptomatic without difference between reclassified and nonreclassified patients (Generalized Linear Mixed Model, P=0.75). Reclassification safety was preserved in high-risk patients. Conclusion— This study shows that performing FFR during diagnostic angiography is associated with reclassification of the revascularization decision in about half of the patients. It further demonstrates that it is safe to pursue a revascularization strategy divergent from that suggested by angiography but guided by FFR.