Publications by authors named "René Koning"

25 Publications

  • Page 1 of 1

Is coronary multivessel disease in acute myocardial infarction patients still associated with worse clinical outcomes at 1-year?

Clin Cardiol 2021 Mar 14;44(3):429-437. Epub 2021 Feb 14.

Cardiology Department, Les Hôpitaux de Chartres, Chartres, France.

Background: ST-elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) are associated with a worse prognosis. However, few comparisons are available according to coronary status in the era of modern reperfusion and optimized secondary prevention.

Hypothesis: We hypothesized that the difference in prognosis according to number of vessel disease in STEMI patients has reduced.

Methods: All consecutive STEMI patients undergoing primary percutaneous coronary intervention (PCI) within 24 h of symptoms onset between January 1, 2014 and June 30, 2016 enrolled in the CRAC (Club Régional des Angioplasticiens de la région Centre) France PCI registry were analyzed. Baseline characteristics, management, and outcomes at 1-year were analyzed according to coronary status (one-, two-, and three-VD).

Results: A total of 1886 patients (mean age 62.2 ± 14.0 year; 74% of male) were included. Patients with MVD (two or three-VD) represented 53.7%. They were older with higher cardiovascular risk factor profile. At 1 year, the rate of major adverse cardiovascular events (MACE, defined as all-cause death, stroke or re-MI) was 10%, 12%, and 12% in one-, two, and three-VD respectively (p = .28). In multivariable adjusted Cox proportional hazard regression model, two- and three-VD were not associated with higher rate of MACE compared to patients with single VD (HR, 1.09; 95%CI 0.76-1.56 for two-VD; HR, 0.74; 95%CI 0.48-1.14 for three-VD).

Conclusions: MVD still represents an important proportion of STEMI patients but their prognoses were not associated with worse clinical outcomes at 1-year compared with one-VD patients in a modern reperfusion area and secondary medication prevention.
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March 2021

Incidence, delays, and outcomes of STEMI during COVID-19 outbreak: Analysis from the France PCI registry.

J Am Coll Emerg Physicians Open 2020 Nov 23. Epub 2020 Nov 23.

Cardiology Department Centre Hospitalier Universitaire de Clermont-Ferrand Clermont-Ferrand France.

Objectives: The aim of this study was to assess the impact of the coronavirus disease 2019 (COVID-19) outbreak on incidence, delays, and outcomes of ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI) in France.

Methods: We analyzed all patients undergoing PPCI <24 hours STEMI included in the prospective France PCI registry. The 2 groups were compared on mean monthly number of patients, delays in the pathway care, and in-hospital major adverse cardiac events (MACE: death, stent thrombosis, myocardial infarction, unplanned coronary revascularization, stroke, and major bleeding).

Results: From January 15, 2019 to April 14, 2020, 2064 STEMI patients undergoing PPCI were included: 1942 in the prelockdown group and 122 in the lockdown group. Only 2 cases in the lockdown group were positive for COVID-19. A significant drop (12%) in mean number of STEMI/month was observed in the lockdown group compared with prelockdown (139 vs 122, < 0.04). A significant increase in "symptom onset to first medical contact" delay was found for patients who presented directly to the emergency department (ED) (238 minutes vs 450 minutes; = 0.04). There were higher rates of in-hospital MACE (7.7% vs 12.3%; = 0.06) and mortality (4.9% vs 8.2%; = 0.11) in the lockdown group but the differences were not significant.

Conclusion: According to the multicenter France PCI registry, the COVID-19 outbreak in France was associated with a significant decline in STEMI undergoing PPCI and longer transfer time for patients who presented directly to the ED. Mortality rates doubled, but the difference was not statistically significant.
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November 2020

Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry.

Catheter Cardiovasc Interv 2020 Nov 19. Epub 2020 Nov 19.

Département de Cardiologie, Clinique Saint-Hilaire, Rouen, France.

Objectives: The aim of this study was to determine the 3-year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation.

Background: Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1-year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long-term follow-up of patients treated with BVS are scarce.

Methods: All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3-year scaffold thrombosis and target vessel revascularization (TVR).

Results: Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3-year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS.

Conclusions: Although 3-year mortality was low in this ACS population, device-related events were significant beyond 1 year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long-term follow-up.
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November 2020

Comparative Assessment of Predictive Performance of PRECISE-DAPT, CRUSADE, and ACUITY Scores in Risk Stratifying 30-Day Bleeding Events.

Thromb Haemost 2020 Jul 22;120(7):1087-1095. Epub 2020 Jun 22.

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

Background:  The utility of the PRECISE-DAPT score in predicting short-term major bleeding, either alone, or in comparison with the CRUSADE and ACUITY scores, has not been investigated. This analysis compared the predictive performances of the three bleeding scores in stratifying the risk of 30-day major bleeding postpercutaneous coronary intervention in patients with dual-antiplatelet therapy.

Methods:  In this post hoc subanalysis of the GLOBAL LEADERS trial, the primary safety objective (bleeding according to the Bleeding Academic Research Consortium [BARC] criteria [type 3 or 5]) was assessed at 30 days according to the three scores in the overall population, and in patients with acute (ACS) and chronic coronary syndrome (CCS).

Results:  In a total of 15,968 patients, we calculated all three scores in 14,709 (92.1%). Irrespective of clinical presentation, the PRECISE-DAPT (-statistics: 0.648, 0.653, and 0.641, respectively), CRUSADE (-statistics: 0.641, 0.639, and 0.644, respectively), and ACUITY (-statistics: 0.633, 0.638, and 0.623, respectively) scores were no significant between-score differences in discriminatory performance for BARC 3 or 5 bleeding up to 30 days, and similarly the PRECISE-DAPT score had a comparable discriminative capacity according to the integrated discrimination improvement when compared with the other scores. In ACS, the CRUSADE score had a poor calibration ability (Hosmer-Lemeshow goodness-of-fit [GOF] chi-square = 15.561,  = 0.049), whereas in CCS, the PRECISE-DAPT score had poor calibration (GOF chi-square = 15.758,  = 0.046).

Conclusion:  The PRECISE-DAPT score might be clinically useful in the overall population and ACS patients for the prediction of short-term major bleeding considering its discriminative and calibration abilities.
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July 2020

Analysis of length of stay after transfemoral transcatheter aortic valve replacement: results from the FRANCE TAVI registry.

Clin Res Cardiol 2021 Jan 25;110(1):40-49. Epub 2020 Apr 25.

Department of Cardiology, Rouen University Hospital, Normandie Univ, UNIROUEN, INSERM U1096, FHU REMOD-VHF, 76000, Rouen, France.

Background: Currently, there are no recommendations regarding the minimum duration of in-hospital monitoring after transfemoral (TF) transcatheter aortic valve replacement (TAVR) and practices are extremely heterogeneous. We, therefore, aimed to evaluate length of stay (LOS) and predictive factors for late discharge after TF TAVR using data from the FRANCE TAVI registry.

Methods: TAVR was performed in 12,804 patients in 48 French centers between 2013 and 2015. LOS was evaluated in 5857 TF patients discharged home. LOS was calculated from TAVR procedure (day 0) to discharge. The study population was divided into three groups based on LOS values. Patients discharged within 3 days constituted the "very early" discharge group, patients with a LOS between 3 and 6 days constituted the "early" discharge group, and patients with a length of stay > 6 days constituted the "late" discharge group.

Results: The median LOS was 7 (5-9) days and was extremely variable among centers. The proportion of patients discharged very early, early, and late was 4.4% (n = 256), 33.7% (n = 1997), and 61.9% (n = 3624) respectively. Variables associated with late discharge were female sex, co-morbidities, major complications, self-expandable valve, general anesthesia, and a significant center effect. In contrast, history of previous pacemaker was a protective factor. The composite of death and re-admission in the very early and early versus late discharge groups was similar at 30 days (3.3% vs. 3.5%, p = 0.66).

Conclusions: LOS is extremely variable after TF TAVR in France. Co-morbidities and complications were predictive factors of late discharge after TAVI. Interestingly, the use of self-expandable prosthesis and general anesthesia may also contribute to late discharge. Our results confirm that early discharge is safe.
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January 2021

DAPT Score and the Impact of Ticagrelor Monotherapy During the Second Year After PCI.

JACC Cardiovasc Interv 2020 03;13(5):634-646

Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom. Electronic address:

Objectives: This study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population.

Background: The DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown.

Methods: The study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score.

Results: Of 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups.

Conclusions: The DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year.
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March 2020

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial.

Clin Res Cardiol 2020 Sep 31;109(9):1125-1139. Epub 2020 Jan 31.

Department of Cardiology, NUIG (National University of Ireland, University Road, Galway)Galway, H91 TK33, Ireland.

Background: The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI).

Methods And Results: This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m (adjusted HR 1.24, 95% CI 1.02-1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (p = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m (HR 0.69, 95% CI 0.51-0.94), but not in the ones with BMI ≥ 27 kg/m (p = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies.

Conclusions: Overall, BMI did not influence the treatment effect seen with ticagrelor monotherapy; however, a beneficial effect of ticagrelor monotherapy was seen in ACS patients with BMI < 27 kg/m.

Trial Registration: The trial has been registered with, Number NCT01813435.
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September 2020

Femoral Versus Nonfemoral Peripheral Access for Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2019 12;74(22):2728-2739

Department of Cardiology, La Cavale Blanche University Hospital Centre, Optimization of Physiological Regulations, Science and Technical Training And Research Unit, University of Western Brittany, Brest, France.

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.
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December 2019

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

Circulation 2020 01 16;141(4):243-259. Epub 2019 Nov 16.

Clinique du Tonkin, Service de Cardiologie, Villeurbanne, France (D.C.).

Background: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date.

Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality.

Results: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; <0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; <0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; =0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.

Conclusion: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV.

Clinical Trial Registration: Unique identifier: NCT01777828.
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January 2020

Does helicopter transport delay prehospital transfer for STEMI patients in rural areas? Findings from the CRAC France PCI registry.

Eur Heart J Acute Cardiovasc Care 2020 Dec 31;9(8):958-965. Epub 2019 Aug 31.

Cardiology Department, Les Hôpitaux de Chartres, France.

Aims: The aim of this study was to analyse delays in emergency medical system transfer of ST-segment elevation myocardial infarction (STEMI) patients to percutaneous coronary intervention (PCI) centres according to transport modality in a rural French region.

Methods And Results: Data from the prospective multicentre CRAC / France PCI registry were analysed for 1911 STEMI patients: 410 transferred by helicopter and 1501 by ground transport. The primary endpoint was the percentage of transfers with first medical contact to primary percutaneous coronary intervention within the 90 minutes recommended in guidelines. The secondary endpoint was time of first medical contact to primary percutaneous coronary intervention. With helicopter transport, time of first medical contact to primary percutaneous coronary intervention in under 90 minutes was less frequently achieved than with ground transport (9.8% vs. 37.2%; odds ratio 5.49; 95% confidence interval 3.90; 7.73; <0.0001). Differences were greatest for transfers under 50 km (13.7% vs. 44.7%; <0.0001) and for primary transfers (22.4% vs. 49.6%; <0.0001). The median time from first medical contact to primary percutaneous coronary intervention and from symptom onset to primary percutaneous coronary intervention (total ischaemic time) were significantly higher in the helicopter transport group than in the ground transport group (respectively, 137 vs. 103 minutes; <0.0001 and 261 vs. 195 minutes; <0.0001). There was no significant difference in inhospital mortality between the helicopter and ground transport groups (6.9% vs. 6.6%; =0.88).

Conclusions: Helicopter transport of STEMI patients was five times less effective than ground transport in maintaining the 90-minute first medical contact to primary percutaneous coronary intervention time recommended in guidelines, particularly for transfer distances less than 50 km.
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December 2020

Carotid versus femoral access for transcatheter aortic valve implantation: a propensity score inverse probability weighting study.

Eur J Cardiothorac Surg 2019 Dec;56(6):1140-1146

Department of Cardiovascular Surgery, S. Croce Hospital, Cuneo, Italy.

Objectives: The transcarotid (TC) approach for transcatheter aortic valve implantation (TAVI) is potentially an optimal alternative to the transfemoral (TF) approach. Our goal was to compare the safety and efficacy of TC- and TF-TAVI.

Methods: Patients who underwent TF-TAVI or TC-TAVI in the prospectively collected FRANCE TAVI registry between January 2013 and December 2015 were compared. Propensity score inverse probability weighting methods were employed to minimize the impact of bias related to non-random treatment assignment.

Results: Of the 11 033 patients included in the current study, 10 598 (96%) underwent a TF-TAVI and 435 (4.1%) had a TC-TAVI. Patients in the TC-TAVI access group presented with a higher risk profile but were significantly younger. There were no differences in the perioperative and 2-year mortality rates after adjustment [odds ratio (OR) 1.02, 95% confidence interval (CI) 0.62-1.68; P = 0.99 and hazard ratio 1.03, 95% CI 0.7-1.35; P = 0.83). TC-TAVI was associated with a significant risk of stroke (OR 2.42, 95% CI 2.01-2.92; P < 0.001), ST-elevation myocardial infarction (OR 7.32, 95% CI 3.87-13.87; P < 0.001), infections (OR 2.36, 95% CI 2.04-2.71; P < 0.001), bleeding (OR 2.01, 95% CI 1.76-2.29; P < 0.001), renal failure (OR 2.23, 95% CI 1.90-2.60; P < 0.001) and need for dialysis (OR 2.36, 95% CI 2.01-2.76, P < 0.001). Conversely, TC-TAVI was not confirmed as a risk factor for pacemaker implantation after adjustment (OR 1.05, 95% CI 0.96-1.15; P < 0.28) and was a protective factor for vascular complications (OR 0.37, 95% CI 0.32-0.43; P < 0.001).

Conclusions: TC-TAVI is a safe procedure compared to TF-TAVI, although it holds an increased risk of perioperative complications. It should be considered in case of non-femoral peripheral access as the second access choice, to increase the overall safety of TAVI procedures.
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December 2019

Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry.

Arch Cardiovasc Dis 2019 Feb 7;112(2):113-123. Epub 2019 Jan 7.

Service de cardiologie et maladies vasculaires, CIC-IT 804, hôpital Pontchaillou, CHU de Rennes, 35033 Rennes, France; Inserm U1099, laboratoire de traitement du signal et de l'image, université de Rennes 1, 35000 Rennes, France.

Background: Several randomized studies have shown that bioresorbable vascular scaffold (BVS) technology is associated with an increased risk of stent thrombosis.

Aim: This study aimed to assess the rates of adverse outcomes at 1 year in patients treated with the Absorb BVS (Abbott Vascular, Santa Clara, CA, USA), using data from a large nationwide prospective multicentre registry (FRANCE ABSORB).

Methods: All patients receiving the Absorb BVS in France were included prospectively in the study. Predilatation, optimal sizing and postdilatation were recommended systematically. The primary endpoint was a composite of cardiovascular death, myocardial infarction and target lesion revascularization at 1 year. Secondary endpoints were scaffold thrombosis and target vessel revascularization at 1 year.

Results: A total of 2072 patients at 86 centres were included: mean age 55±11 years; 80% men. The indication was acute coronary syndrome (ACS) in 49% of cases. Predilatation and postdilatation were done in 93% and 83% of lesions, respectively. At 1 year, the primary endpoint occurred in 3.9% of patients, the rate of scaffold thrombosis was 1.5% and the rate of target vessel revascularization was 3.3%. In a multivariable analysis, diabetes and total Absorb BVS length>30mm were independently associated with the occurrence of the primary endpoint, whereas oral anticoagulation and total Absorb BVS length>30mm were independently associated with occurrence of scaffold thrombosis.

Conclusions: The Absorb BVS was implanted in a relatively young population, half of whom had ACS. Predilatation and postdilatation rates were high, and 1-year outcomes were acceptable.
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February 2019

Transcatheter Aortic Valve Replacement in the Catheterization Laboratory Versus Hybrid Operating Room: Insights From the FRANCE TAVI Registry.

JACC Cardiovasc Interv 2018 11;11(21):2195-2203

Paris South Cardiovascular Institute, Jacques-Cartier Private Hospital, Ramsay Générale de Santé, Massy, France.

Objectives: This study sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization laboratory (cath lab) to those undergoing TAVR in a hybrid operating room (OR).

Background: TAVR can be performed in a cath lab or in a hybrid OR. Comparisons between these locations are scarce.

Methods: All TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics.

Results: A total of 12,121 patients were included in this study, 62% of which underwent TAVR in a cath lab versus 38% in a hybrid OR. Mean age was 82.9 ± 7.2 years, 48.9% of patients were men, and mean Logistic EuroScore was 17.9% ± 12.3%. Both procedure locations showed similar, below 2% rates of intraprocedural complications. After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs. 4.8%; infection, 6.1% vs. 3.5%; p < 0.05). Adjusted mortality rates at 1 and 3 years did not differ significantly between groups (for cath lab vs. hybrid OR, respectively: 1 year: 16.2% vs. 15.8%; p = 0.91; 3 years: 38.4% vs. 36.4%; p = 0.49).

Conclusions: Midterm mortality after TAVR was similar between the cath lab and the hybrid OR. These findings support the performance of TAVR in either location, which has important implications on health care organization and costs.
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November 2018

Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes: Insights From the FRANCE TAVI Registry.

JACC Cardiovasc Interv 2018 10 12;11(19):1956-1965. Epub 2018 Sep 12.

Département de Cardiologie, CHU Timone, Marseille, France; Faculté de Médecine, Aix-Marseille Université, Marseille, France; Aix Marseille University, Inserm, Inra, C2VN, Marseille, France. Electronic address:

Objectives: This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR).

Background: Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described.

Methods: TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure.

Results: A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04).

Conclusions: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.
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October 2018

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

J Am Coll Cardiol 2017 Jul;70(1):42-55

Cardiology Service, Saint Martin Private Hospital, Caen, France.

Background: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited.

Objectives: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.

Methods: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.

Results: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.

Conclusions: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).
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July 2017

France: coronary and structural heart interventions from 2010 to 2015.

EuroIntervention 2017 May;13(Z):Z25-Z31

Department of Cardiology, University Hospital of Clermont-Ferrand, UMR 6284 Auvergne University, Clermont-Ferrand, France.

France, with its 66 million inhabitants, has a long tradition in interventional cardiology, with numerous innovations and contributions to the dynamism of European activity. The development of interventional cardiology requires supervised training, organisation and participation in studies. This also translates into an ever-expanding clinical activity since 2010, such as the coronary and structural interventions that are detailed in the present review.
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May 2017

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study.

Circ Cardiovasc Interv 2016 Mar;9(3):e003388

From the Departments of Cardiology and Radiology, Centre Hospitalier Annecy-Genevois, Annecy, France (L. Belle, L.M., A.M.); Department of Cardiology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France (P.M., G.S.); Department of Cardiology, Les Hôpitaux de Chartres, Eure-et-Loir, France (G.R.); Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France (X.M., N.F.); Department of Cardiology, Centre Hospitalier St Luc St Joseph, Lyon, France (O.D.); Department of Cardiology, Centre Hospitalier de Cannes, Cannes, France (G.Z.); Department of Cardiology, Institut Mutualiste Monsouris, Paris, France (C.C., N.A.); Department of Cardiology, Hopital Nord, University hospital of Saint-Étienne, Saint-Étienne, France (K.I.); Department of Cardiology, Centre Hospitalier Universitaire de La Croix Rousse, Lyon, France (R.D.); Department of Cardiology, Clinique Saint Hilaire, Rouen, France (R.K.); Department of Cardiology, Clinique Convert, Bourg en Bresse, France (C.R.); Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France (B.F.); Department of Cardiology, Centre Hospitalier Universaitaire Marseille Nord, France (L. Bonello); Department of Cardiology, Hôpital de Valence, Valence, France (S.C.); Department of Cardiology, Hôpital Cardiologique, Lille university hospital, Lille, France (C.D.); Department of Cardiology, Hospital of Macon, Macon, France (F.C.); Department of Cardiology, Clinical Investigation Center, INSERM 1407, Hôpital Cardiovasculaire Louis Pradel, Lyon, France (N.M.); Clinical Investigation Centre, University Hospital of Grenoble, Grenoble, France (C.G., J.L.B.); and Department of Radiology, Hôpital Nord, University Hospital of Saint-Étienne, Saint-Étienne, France (M.V., P.C.).

Background: Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Methods And Results: In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events.

Conclusions: The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size.

Clinical Trial Registration: URL: Unique identifier: NCT01360242.
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March 2016

Percutaneous occlusion of the left atrial appendage: An expert consensus statement.

Arch Cardiovasc Dis 2015 Aug-Sep;108(8-9):460-7

Atrial fibrillation (AF) is the most common rhythm disturbance. Among the major thromboembolic complications associated with AF, strokes are foremost, with a 4.4% yearly incidence in the absence of preventive treatment. Therefore, the prevention of these embolic accidents is a priority. While proof of the efficacy of oral anticoagulants (OACs) for this indication is long-standing and convincing, they are associated with haemorrhagic complications. Consequently, their prescription is based on an estimate of the risk (haemorrhagic complications)/benefit (thromboembolic prevention) ratio. In a patient subset at high thromboembolic and haemorrhagic risk, whether to prescribe or abstain from prescribing an OAC is a challenging decision, and an alternative means of thromboembolic prevention is desirable. Percutaneous occlusion of the left atrial appendage (LAA) is an alternative, interventional, non-pharmacological treatment that has been used widely in Europe and for a few years in France, with encouraging results. However, it remains an invasive procedure with a low level of proof in comparison with OACs. Moreover, the indications, the procedural environment and pre-per-post procedural patient management are major questions about this technique, with consequences on its efficacy and risk/benefit ratio. This document, composed by consensus among experts in the field, is an in-depth review of this new therapy.
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June 2016

[From FRANCE 2 to FRANCE TAVI: are indications, technique and results of transcatheter aortic valve replacement the same?].

Presse Med 2015 Jul-Aug;44(7-8):752-60. Epub 2015 Jul 22.

CHU de Rennes, service de cardiologie et des maladies vasculaires, 35000 Rennes, France; Université Rennes 1, LTSI, 35000 Rennes, France; Inserm U1099, 35000 Rennes, France.

Transcatheter aortic valve implantation (TAVI) is indicated in patients with severe symptomatic aortic stenosis who are not suitable for surgery or should be considered when there is a high surgical risk as assessed by a heart team. There is a decrease in mean logistic EuroSCORE since January 2010, which translates a gradual evolution in patients' selection. Expertise of geriatricians to further assess frailty is a key step in the risk stratification process of this elderly population (mean age: 83.4±7.3 years). Femoral access is used in 80% of cases with a procedural success rate higher than 95%. In-hospital mortality rate is 5.9%. The main complications of the procedure are aortic annulus rupture (0.9% in FRANCE TAVI), tamponade (2.3%), stroke (2.2%), severe paravalvular leak (1.3%) and permanent pacemaker implantation (15%). The awaited results of PARTNER II and SURTAVI may lead to expand the indications to lower-risk patients if it is shown that TAVI is non-inferior to surgery in this population which has been suggested by the recent randomized NOTION Trial while the CoreValve Pivotal Trial even points in the direction of a possible superiority of the percutaneous technique over surgery.
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January 2016

Drug-eluting stents with biodegradable polymer for the treatment of patients with diabetes mellitus: clinical outcome at 2 years in a large population of patients.

Med Devices (Auckl) 2015 18;8:153-60. Epub 2015 Feb 18.

Dorset County Hospital, Dorchester, UK.

Objective: This study investigates the safety and efficacy of a third-generation drug-eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus (DM).

Clinical Trial Registration: ISRCTN81649913.

Background: Percutaneous coronary interventions in patients with DM are associated with a higher incidence of death, restenosis, and stent thrombosis as compared to non-diabetic patients. The use of a DES has been shown to improve outcomes in diabetic patients.

Methods: Out of 3,067 patients, enrolled in 126 centers worldwide in the NOBORI 2 registry, 888 patients suffered from DM, 213 of them (14%) being insulin-dependent DM (IDDM). Two years' follow-up has been completed in this study.

Results: At 1- and 2-year follow-up, 97% and 95% of the patients, respectively, were available. The reported target lesion failure (TLF) rates at 1- and 2-year follow-up were 6.0% and 7.2% in the DM group, respectively, and 3.0% and 4.2% in the non-DM group, respectively (P<0.001 for both years). Inside the DM group, the TLF rates of 9.9% and 11.7% at the 1- and 2-year follow-ups, respectively, in patients with IDDM were significantly higher than the TLF rates of 4.7% and 5.8%, respectively, in the non-IDDM subgroup (P<0.01 for both years). The rate of stent thrombosis at the 2-year follow-up was 1.0% in the DM group and 0.7% in non-DM patients. There were no cases of late, or very late stent thrombosis in IDDM patients.

Conclusion: The Nobori DES performed well in patients with DM. As expected, patients with DM, particularly those with IDDM, had worse outcomes. However, the absence of late, and very late stent thrombosis in IDDM patients merits further investigation, as this finding might have significant clinical value.
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March 2015

Thrombotic and bleeding events after coronary stenting according to clopidogrel and aspirin platelet reactivity: VerifyNow French Registry (VERIFRENCHY).

Arch Cardiovasc Dis 2014 Apr 29;107(4):225-35. Epub 2014 Apr 29.

Institut de cardiologie, hôpital la Pitié-Salpêtrière, Paris, France.

Background: Dual antiplatelet therapy, comprising aspirin and clopidogrel, is recommended in patients undergoing coronary stenting to avoid the occurrence of stent thrombosis and others ischaemic events. Interindividual response to clopidogrel varies, however, with poor response associated with an increased risk of ischaemic events. New assays are available for testing aspirin and clopidogrel response routinely at the bedside.

Aim: To evaluate the prognostic value of testing antiplatelet response in an intermediate-risk population undergoing stent implantation.

Methods: We prospectively assessed clopidogrel and aspirin response using the VerifyNow assay at the time of coronary stenting in 1001 patients who presented with stable coronary disease or non-ST-segment elevation acute coronary syndrome. The main ischaemic endpoint was the composite of definite and probable stent thrombosis, cardiovascular death or spontaneous myocardial infarction at one year. The safety endpoint was major bleeding.

Results: Overall, 36.0% of patients had high on-clopidogrel platelet reactivity (OCR) and 8.6% had high on-aspirin platelet reactivity (OAR). The main ischaemic composite endpoint occurred in 3.9% of patients with high vs. 2.3% of patients with normal OCR (hazard ratio 1.66, 95% confidence interval 0.78-3.54; P=0.18). Definite or probable stent thrombosis occurred in 1.1% of patients with high vs. 0.3% of patients with normal OCR (P=0.86). There was no significant difference in ischaemic endpoints according to OAR and there was no difference in rates of major bleeding between patients with high versus normal on-treatment platelet reactivity.

Conclusions: On-treatment platelet reactivity was not associated with 1-year ischaemic or bleeding events in an intermediate-risk population undergoing stent implantation.
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April 2014

Early and long-term results of unprotected left main coronary artery stenosis with paclitaxel-eluting stents: the FRIEND (French multicentre RegIstry for stenting of uNprotecteD LMCA stenosis) registry.

EuroIntervention 2011 Oct;7(6):680-8

Cardiology B Department, CHU Rangueil, Toulouse, France.

Aims: To evaluate the angiographic and clinical outcome of patients undergoing paclitaxel-eluting stent (PES) implantation for unprotected left main coronary artery (ULMCA) stenosis in a "real-world" multicentre, prospective registry. Percutaneous coronary intervention (PCI) is an increasingly utilised method of revascularisation in patients with ULMCA.

Methods And Results: A prospective registry including all patients with a significant (>50%) ULMCA stenosis. Of 151 such patients, the target lesion involved the distal bifurcation in 100 patients (66%), which was treated predominantly by a "provisional T-stenting" strategy. In the distal ULMCA disease group, 72% had only one stent implantation while 28% had multiple (either two or three) stents implanted. At a median follow-up of 1,123±80 days, cardiac death occurred in five patients (3.3%) and major adverse cardiac and cerebrovascular events (MACCE) in 32 patients (21.2%). The three-year survival rate was 93.3%.

Conclusions: In the drug-eluting stent era, paclitaxel-eluting stent implantation of ULMCA stenosis provided excellent immediate and long-term results in this selected population, suggesting that this approach may be considered as a safe and effective alternative to CABG for selected patients with ULMCA who are treated in experienced institutions performing large numbers of PCI procedures.
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October 2011

A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA.

J Interv Cardiol 2003 Jun;16(3):217-21

Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle, 1 rue de Germont, 76000 Rouen, France.

Background: The prolonged bed rest following femoral sheath removal after PTCA is a source of discomfort for the patient. We designed a randomized study to evaluate the efficacy and safety of an arterial suture device developed to percutaneously close the vascular access site after PTCA, allowing immediate sheath removal and early ambulation, compared to manual compression.

Methods: After successful PTCA, patients were randomized to manual compression or immediate femoral percutaneous closure. Exclusion criteria were arteritis, age > 80 years and > 3 previous femoral punctures on the same side. The two-needle device was used for the 6F sheath removal and the four-needle device for the 8F sheath. Ambulation was allowed 4 hours after the arterial suture.

Results: One hundred and sixty-seven patients (59 +/- 10 years, 81% males) were randomized to suture device (n = 91) or to manual compression (n = 76). The two groups were similar in terms of age, sex, size of sheath, number of patients with stent implantation (62 vs 61%), procedural anticoagulation. Procedural duration was 8 +/- 6 minutes with percutaneous suture versus 25 +/- 11 minutes with manual compression (P < 0.0001). Procedural success with percutaneous suture was 93% whereas six technical failures were treated with prolonged manual compression. Nonsurgical hematoma occurred in five patients (5%) with the suture device and in two (3%) with manual compression with no need for blood transfusion (P = NS). Uneventful blood oozing occurred in 11 patients (12%) with percutaneous suture and in only 2 (3%) with manual compression (P < 0.06). The tolerance of the hemostasis procedure and the length of post-procedure hospital stay (40 +/- 32 hours) were similar in the two groups.

Conclusion: Percutaneous suture of the femoral artery, allows immediate closure of femoral puncture sites after PTCA, without increasing the incidence of vascular complications. The use of this device should allow earlier discharge and subsequent cost savings.
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June 2003

Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial.

Catheter Cardiovasc Interv 2003 Mar;58(3):285-91

Centre Cardiologique du Nord, Saint-Denis, France.

Clinical trials have shown that coronary stenting is associated with a high level of complications at the access site. Arterial sealing devices have proven their efficacy in obtaining immediate hemostasis after sheath removal, in allowing early ambulation, and in improving patient comfort. However, there is no report showing a reduction of local complications related to their use. The purpose of this multicenter study was to compare randomly the efficacy of Angio-Seal versus compression methods of hemostasis in reducing the rate of access site complications after coronary angioplasty in 612 selected patients with higher risk of local events satisfying at least one of the following high-risk criteria: age > 70, previous puncture at the same site, history of hypertension, treatment with ticlopidine at least 2 days before the procedure, use of abciximab, 8 Fr access, prolonged heparin treatment after the angioplasty, and use of lytics if fibrinogen > 1 g/l. Group A (n = 306) had immediate sheath removal, Angio-Seal implantation, and cessation of bed rest 4 hr after the intervention. Group B (n = 306) had sheath removal according to local practice and cessation of bed rest 6-18 hr after the hemostasis procedure, also according to local practice. Clinical follow-up was done at 1 hr, 4 hr, 24 hr, discharge, and 7 days and a systematic color flow duplex sonography was performed to confirm diagnosis of access site complication. In group A, device deployment and immediate hemostasis were obtained in, respectively, 96.8% and 87% of patients. Time to hemostasis was shorter in group A: 5 vs. 52 min (P < 0.001). Cessation of bed rest was dramatically reduced in group A (438 +/- 450 min) vs. group B (952 +/- 308 min; P < 0.001). The cumulative rate of complications, using a composite primary endpoint, at 7 days was significantly different between the two groups: 5.9% of group A patients and 18% of group B patients (P < 0.001). This difference was mainly due to the dramatic reduction of prolonged bleeding in group A patients. Angio-Seal device use in high-local-risk patients allows immediate sheath removal and hemostasis with a reduction of local event rate despite a higher level of anticoagulation, compared to regular compression techniques, directly related to a dramatic decrease of prolonged bleeding.
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March 2003