Publications by authors named "Geraud Souteyrand"

87 Publications

Prognostic significance of vascular and valvular calcifications in low- and high-gradient aortic stenosis.

Eur Heart J Cardiovasc Imaging 2021 Mar 8. Epub 2021 Mar 8.

University of Lyon, CREATIS UMR5220, INSERM U1044, INSA-15, 7 avenue Jean Capelle 69621 Villeurbanne Cedex, Lyon, France.

Aims: In low-gradient aortic stenosis (LGAS), the high valvulo-arterial impedance observed despite low valvular gradient suggests a high vascular load. Thoracic aortic calcifications (TACs) and valvular aortic calcifications (VACs) are, respectively, surrogates of aortic load and aortic valvular gradient. The aim of this study was to compare the respective contributions of TAC and VAC on 3-year cardiovascular (CV) mortality following TAVI in LGAS vs. high-gradient aortic stenosis (HGAS) patients.

Methods And Results: A total of 1396 consecutive patients were included. TAC and VAC were measured on the pre-TAVI CT-scan. About 435 (31.2%) patients had LGAS and 961 (68.8%) HGAS. LGAS patients were more prone to have diabetes, coronary artery disease (CAD), atrial fibrillation (AF), and lower left ventricular ejection fraction (LVEF), P<0.05 for all. During the 3 years after TAVI, 245(17.8%) patients experienced CV mortality, 92(21.6%) in LGAS and 153(16.2%) in HGAS patients, P=0.018. Multivariate analysis adjusted for age, gender, diabetes, AF, CAD, LVEF, renal function, vascular access, and aortic regurgitation showed that TAC but not VAC was associated with CV mortality in LGAS, hazard ratio (HR) 1.085 confidence interval (CI) (1.019-1.156), P=0.011, and HR 0.713 CI (0.439-1.8), P=0.235; the opposite was observed in HGAS patients with VAC but not TAC being associated with CV mortality, HR 1.342 CI (1.034-1.742), P=0.027, and HR 1.015 CI (0.955-1.079), P=0.626.

Conclusion : TAC plays a major prognostic role in LGAS while VAC remains the key in HGAS patients. This confirms that LGAS is a complex vascular and valvular disease.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjci/jeab039DOI Listing
March 2021

Transcatheter aortic valve thrombosis: Data from a French multicenter cohort analysis.

Catheter Cardiovasc Interv 2021 Feb 21. Epub 2021 Feb 21.

Department of Cardiology, CHU Clermont-Ferrand, CNRS UMR 6602, Université Clermont Auvergne, Clermont-Ferrand, France.

Objectives: To evaluate the effectiveness of anticoagulant therapies in patients with clinical transcatheter heart valve (THV) thrombosis, to describe complications, and to assess their risk profile was the objectives.

Background: Little research has been conducted on clinical THV thrombosis.

Methods: Patients with clinical THV thrombosis were identified based on greater than 50% increased transvalvular gradient on transthoracic echocardiogram confirmed by 4-dimensional computed tomography, transesophageal echocardiogram, or regression with anticoagulant therapy. A cohort free from thrombosis for more than 1,100 days postprocedure was used for comparison.

Results: Fifty-four patients with clinical THV thrombosis were identified. Most subjects (98.1%) received anticoagulant therapy which was effective (≥50% reduction in transvalvular gradient or return to postprocedure value) in 96%. The rate of serious hemodynamic or embolic complications in the thrombosis population was 31.5%. A multivariate analysis of subjects with and without thrombosis indicated a significantly increased risk of thrombosis from preexisting thrombocytopenia (odds ratio [OR] 9.96), absence of predilatation (OR = 5.67), renal insufficiency (OR = 4.84), and >10 mmHg mean transvalvular gradient postprocedure (OR = 3.36). No recurrence of thrombosis was identified during on average 685 days follow-up.

Conclusions: These data, from one of the largest cohorts with clinical THV thrombosis confirm anticoagulants appear effective. The rate of serious associated complications was high. The findings underline the importance of recognizing risk factors for thrombosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.29555DOI Listing
February 2021

Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact.

Clin Nutr 2021 Jan 9. Epub 2021 Jan 9.

Cardiology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France and Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, F-63000, Clermont-Ferrand, France; F-CRIN, INI-CRCT, Nancy, France.

Background & Aims: Sarcopenia is a multifactorial syndrome resulting in a decrease in both muscle mass and function. Little is known about the prevalence and prognostic impact of sarcopenia in patients with acutely decompensated chronic heart failure (ADHF). We aimed to evaluate the prevalence (main endpoint) and impact of sarcopenia on ADHF patients.

Methods: 140 ADHF patients were enrolled between November 2014 and September 2018 in a multicenter prospective longitudinal study. A similar, independent multi-departmental cross-sectional study in 165 ADHF patients was used for external validation of prevalence data. All subjects were assessed on the European Working Group on Sarcopenia criteria.

Results: Ninety-one patients (65%) had sarcopenia (vs. 53.6% in the external replication regional cohort). Patients with sarcopenia were older and more likely to have eGFR <60 ml/min/1.73 m (p < 0.001 and p = 0.002). Sarcopenia was associated with impaired functional status [lower 6 min walking test (220 ± 108 vs. 279 ± 170, p = 0.03) and 4 m gait speed (0.56 ± 0.24 vs. 0.80 ± 0.37, p < 0.001)] and autonomy [Instrumental activities of daily living: 6.7 ± 1.4 vs. 7.3 ± 1.2, p = 0.005]. Over up to 4 years' follow-up, 30 cardiovascular (CV) deaths and 42 non-CV deaths occurred. In a multivariable analysis, sarcopenia was associated with time to first non-CV hospitalization (hazard ratio 1.93; 95% confidence interval 1.14-3.24; p = 0.014) but not with any other hospitalization, any mortality endpoint, or a composite endpoint of CV death and HF hospitalization.

Conclusions: The prevalence of sarcopenia in ADHF patients is high and associated with greater risk of non-CV hospitalizations, highlighting the importance of identifying and managing the condition in a multidisciplinary approach.

Clinical Trial Registration: NCT03153774.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.clnu.2020.12.033DOI Listing
January 2021

Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study).

Am J Cardiol 2021 04 28;144:118-124. Epub 2020 Dec 28.

Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.

Patients with symptomatic aortic stenosis are often treated with a surgical valve replacement. Surgical bioprosthetic valves degenerate over time and therefore may necessitate a redo surgery. This analysis reports the 2-year clinical outcomes of the Valve-in-Valve study, which evaluated transcatheter aortic valve implantation using the CoreValve and Evolut R devices in patients with degenerated surgical aortic bioprostheses at high risk for surgery. The prospective Valve-in-Valve study enrolled 202 eligible patients with failing surgical aortic bioprostheses due to stenosis, regurgitation, or a combination of both. The Evolut R bioprosthesis was used in 90.5% of valve-in-valve transcatheter aortic valve implantation cases. Two-year all-cause and cardiovascular mortality rates were 16.5% and 11.1%, respectively. Other clinical events included stroke (7.9%), disabling stroke (1.7%), and new pacemaker implantation (10.1%). The 2-year all-cause mortality rate was significantly higher in patients with discharge mean gradients ≥20 mmHg vs. those with lower mean gradients (21.0% vs 7.6%, p = 0.025). Discharge mean gradients ≥20 mm Hg were associated with smaller surgical bioprostheses (OR, 7.2 [95% CI 2.3 to 22.1]. In patients with failing surgical aortic bioprostheses, valve-in-valve treatment using a supra-annular self-expanding bioprosthesis provides significant functional improvements with acceptable rates of complications, especially if a postprocedural mean gradient of <20 mmHg can be achieved.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.amjcard.2020.12.047DOI Listing
April 2021

National French Registry of Spontaneous Coronary Artery Dissections: Prevalence of Fibromuscular Dysplasia and Genetic Analyses.

EuroIntervention 2020 12 15. Epub 2020 Dec 15.

Department of Cardiology, CHU Clermont-Ferrand, CNRS, Université Clermont Auvergne, Clermont-Ferrand, France.

Aims: Obtain European data on SCAD, determine the prevalence of FMD and enable genetic analyses in this population.

Methods And Results: Data from a national French registry of SCAD cases, were analysed prospectively and retrospectively. Clinical and angiographic data and management strategy were collected. Major adverse cardiovascular events (MACE) were analysed after one-year follow-up. Subjects were screened for fibromuscular dysplasia (FMD) and blood was collected for DNA extraction. From June 2016 to August 2018, 373 SCAD cases were confirmed by the core lab. Mean age was 51.5 years. Patients were mostly women (90.6%) and 54.7% of cases had less than two cardiovascular risk factors. At 1 year, 295 patients (79.1%) were treated conservatively and the MACE rate was 12.3%, and no case of mortality. Recurrence rate of SCAD was 3.3%. FMD was found at ³ 1 arterial site in 45.0% of cases. We also confirmed the genetic association between the PHACTR1 locus and SCAD (odds ratio=1.66, P=7.08×10 -8 ).

Conclusions: Here we describe the largest European SCAD cohort where FMD was found in 45% of cases and the genetic association with PHACTR1 was confirmed. This nationwide cohort is a valuable resource for future clinical and genetic investigation to understand SCAD aetiology.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJ-D-20-01046DOI Listing
December 2020

Optical Coherence Tomography to Guide Percutaneous Coronary Intervention of the Left Main Coronary Artery: the LEMON study.

EuroIntervention 2020 Nov 24. Epub 2020 Nov 24.

Department of Cardiology, Institut Mutualiste Montsouris, Paris, France.

Aims: IVUS is currently recommended by international guidelines to guide left main stem (LMS) PCI. Although OCT resolution outmatches IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data. This pilot study aimed to analyze the feasibility, safety and impact of OCT-guided LMS PCI.

Methods And Results: This prospective, multicenter trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis <50% + TIMI 3 flow in all branches + adequate OCT stent expansion (LEMON criteria). Seventy patients were included in the final analysis (median age: 72 (64-81) y, 73% male). The OCT pre-specified protocol was applied in all patients. The primary endpoint was achieved in 86 % of subjects. Adequate stent expansion was observed in 86%, significant edge dissection in 30% and residual significant struts malapposition in 24% of the cases. OCT guidance modified operators' strategy in 26% of the patients. The one-year survival free from major clinical adverse events was 98.6 (97.2-100) %.

Conclusions: This study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJ-D-20-01121DOI Listing
November 2020

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry.

Catheter Cardiovasc Interv 2020 Oct 21. Epub 2020 Oct 21.

Cardiology Department, Rangueil University Hospital, Toulouse, France.

Objectives: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS).

Background: CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP.

Methods: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST).

Results: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion.

Conclusions: The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.29328DOI Listing
October 2020

Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial.

Can J Cardiol 2020 Nov 25;36(11):1805-1814. Epub 2020 Jan 25.

Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France.

Background: Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain.

Methods: The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy.

Results: A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials.

Conclusions: We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cjca.2020.01.019DOI Listing
November 2020

Response by Vincent et al to Letter Regarding Article, "Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry".

Circulation 2020 Jun 15;141(24):e910-e911. Epub 2020 Jun 15.

Institut Coeur Poumon, Cardiology, Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Centre Hospitalier Universitaire de Lille, France (F.V., C.D., N.D., A.C., S.P., E.V.B.).

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCULATIONAHA.120.047270DOI Listing
June 2020

Role for Vascular Factors in Long-Term Outcomes After Transcatheter Aortic Valve Implantation.

Am J Cardiol 2020 06 2;125(12):1884-1889. Epub 2020 Apr 2.

Service de cardiologie, Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France; Université de Lyon; CREATIS UMR5220; INSERM U1044; INSA-15 Lyon, France. Electronic address:

Despite major technological advances, 1-year morbi-mortality after transcatheter aortic valve implantation (TAVI) is still high. Further outcome improvements may be obtained provided proper identification of prognostic factors. A change of prognostic value over time should be the hallmark of an outcome-implicated factor. In 1,425 patients treated by TAVI, the examined prognostic factors were: demographic factors and co-morbidities (age, male gender, glomerular filtration rate, and chronic obstructive pulmonary disease), cardiac function (left ventricular ejection fraction, pulmonary pressure, aortic gradient, dyspnea, and mitral regurgitation), and vascular factors (coronary artery disease, peripheral vascular disease (PVD), previous stroke, and thoracic aortic calcium-TAC-as assessed by CT scan). Cox models were used to analyze cardiovascular and all-cause mortalities over 3 years of follow-up. The time-dependent effects of the factors were analyzed using the distribution of Schoenfeld residuals. During the study period, 375 (26.3%) deaths occurred of whom 248 (17.4%) from cardiovascular causes. Only 2 factors associated with cardiovascular or all-cause mortality showed significant changes over time: dyspnea and PVD. The effect of dyspnea on cardiovascular mortality decreased over time (first- and third-year hazard ratios [95% confidence intervals]: 1.47 [1.10; 1.96] and 0.94 [0.55; 1.63], respectively), whereas the effect of PVD increased (first- and third-year hazard ratios: 0.87 [0.56; 1.35] and 2.58 [1.25; 5.33], respectively). TAC had a stable effect. In conclusion, the detrimental effects of vascular factors remained stable (TAC) or increased (PVD) over time. These factors should be targeted by specific measures to improve post-TAVI outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.amjcard.2020.03.010DOI Listing
June 2020

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

JACC Cardiovasc Interv 2019 12 28;12(24):2449-2459. Epub 2019 Sep 28.

Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.

Objectives: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation.

Background: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR).

Methods: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days.

Results: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001).

Conclusions: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2019.09.029DOI Listing
December 2019

Outcomes of transfemoral balloon expandable transcatheter aortic valve implantation: Comparison of two subsequent valve generations.

Catheter Cardiovasc Interv 2020 10 3;96(4):930-939. Epub 2019 Dec 3.

Interventional Cardiology Unit, University Padua, Padua, Italy.

Background: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI).

Objectives: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population.

Methods: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group).

Results: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3.

Conclusions: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.28621DOI Listing
October 2020

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: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCULATIONAHA.119.043785DOI Listing
January 2020

New-Onset Left Bundle Branch Block After TAVI has a Deleterious Impact on Left Ventricular Systolic Function.

Can J Cardiol 2019 10 14;35(10):1386-1393. Epub 2019 May 14.

Department of Cardiology, CHU Clermont-Ferrand, Clermont-Ferrand, France and Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, Clermont-Ferrand, France; INI-CRCT F-CRIN, Nancy, France.

Background: Transcatheter aortic valve implantation (TAVI) has revolutionized the management of severe aortic stenosis. The development of a new-onset complete left bundle branch block (LBBB) is, however, a frequent complication. The objective of the present study was to assess the impact of a new-onset LBBB after TAVI on the evolution of left ventricular ejection fraction (LVEF).

Methods: Forty consecutive patients were included after the development of a new-onset LBBB after TAVI and were matched for age and LVEF with 40 patients implanted during the same period who did not develop an LBBB. The primary endpoint was evolution of the LVEF measured by echocardiography before implantation and between 6 and 12 months after TAVI.

Results: The development of an LBBB was associated with a 5-point decrease in LVEF [-12.5; 2.5], contrary to the non-LBBB group (1.5 [-6.5; 9.5], P = 0.007) at 8 months, with the persistence of the LBBB (n = 23) exacerbating this decrease (-7 [-13; 2], P = 0.009). When left ventricular dysfunction (LVEF < 50%) was present before TAVI, the appearance of an LBBB was associated with a reduction in LVEF (-2 [-8; 2]) contrary to the non-LBBB group (20 [9; 22], P = 0.02).

Conclusions: The appearance of a new-onset LBBB after TAVI has a pejorative impact on left ventricular systolic function, particularly in patients with an initial LVEF < 50%, due to a lack of recovery of the latter, thereby potentially affecting their prognosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cjca.2019.05.012DOI Listing
October 2019

Significance of the CAPRI risk score to predict heart failure hospitalization post-TAVI: The CAPRI-HF study.

Int J Cardiol 2019 12 19;296:98-102. Epub 2019 Aug 19.

Cardiology Department, Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France; University of Lyon, CREATIS UMR5220, INSERM U1044, INSA-15 Lyon, France.

Background: Predictors of heart failure (HF) hospitalization after transcatheter aortic valve implantation (TAVI) are not well defined. CAPRI is a score for predicting 1-year post-TAVI cardiovascular and all-cause mortality. The aim of the present study is to assess the prognostic significance of the CAPRI score for HF hospitalization 1 year after TAVI.

Methods And Results: CAPRI-HF is an ancillary study of the C4CAPRI trial, analyzing 409 consecutive patients treated by TAVI. The primary outcome was hospitalization for HF during the first year post-intervention. The prognostic value of the CAPRI score was assessed by multivariable analysis adjusted for diabetes, atrial fibrillation, vascular route, pacemaker implantation, post-TAVI aortic regurgitation, transfusion and pulmonary artery systolic pressure. A subanalysis focused on patients with low-gradient aortic stenosis (LGAS). At 1 year, HF hospitalization occurred in 78 (19.9%) patients. Patients with HF were more prone to have diabetes, atrial fibrillation, renal dysfunction, lower mean aortic gradient, higher logistic EuroSCORE and higher CAPRI score (p < .05 for all associations). In the multivariable analysis, CAPRI score was the sole predictor of HF: hazard ratio (HR) for each 0.1 CAPRI score increase was 1.065, 95% confidence interval (CI) 1.021-1.110. This was confirmed when adjusted for EuroSCORE: HR 1.066, 95% CI 1.024-1.110. The predictive power of the CAPRI score increased for LGAS: HR 1.098, 95% CI 1.028-1.172.

Conclusions: CAPRI score helps predict HF post-TAVI. Including the score in the decision-making process may help selecting candidates for TAVI and identifying patients who need close monitoring post-procedure.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2019.08.033DOI Listing
December 2019

Sequential coronary bifurcation revascularization with the Xposition S™ self-apposing stent: a comparative fractal bench study.

Heart Vessels 2020 Jan 27;35(1):132-135. Epub 2019 Jun 27.

Cardiology Department, Cardiovascular Hospital and INSERM U-1060, Lyon, France.

Coronary bifurcation revascularization needs to take account of the diameter differential between vessels and to limit side-branch obstruction (SBO). The self-apposing properties of the Xposition S™ stent (STENTYS, France) seem interesting in this regard. The present experimental fractal bench study determined the best provisional stenting technique using Xposition S™. Three sequential strategies were compared (n = 5/group): implantation alone, side-branch inflation (SBI), and re-POT (initial proximal optimization technique (POT) + SBI + final POT). 2D- and 3D-OCT analyses and micro-CT scan were performed to quantify the main mechanical results at each step. Of the three groups, SBI and re-POT provided better final results than implantation alone in terms of residual SBO (respectively, 24.6 ± 5.6% and 24.8 ± 5.0% vs. 46.5 ± 10.3%, p < 0.05) and malapposition (respectively, 0.9 ± 0.6% and 0.8 ± 0.4% vs. 3.8 ± 1.9%, p < 0.05). Unlike SBI, the two POTs of the re-POT sequence did not improve the final result. SBI, alone or as part of re-POT, systematically led to one connector breakage, whereas implantation alone maintained complete stent integrity (p < 0.05). In Xposition S™ implantation, SBI should be systematic, but not post-dilatation specifically dedicated to bifurcation stenting (i.e., POTs). However, global post-dilatation is still mandatory to prevent stent underexpansion due to untreated stenosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00380-019-01460-8DOI Listing
January 2020

TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study.

JACC Cardiovasc Interv 2019 05;12(10):923-932

Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.

Objectives: The VIVA (Valve in Valve) trial was designed to systematically and prospectively collect data regarding the use of transcatheter aortic valve replacement in patients with failing surgical aortic bioprostheses at high-risk for reoperation.

Background: Surgical aortic valve replacement has been the standard of care in symptomatic patients with aortic valve disease. However, bioprosthetic valves degenerate over time, requiring redo surgery.

Methods: VIVA is an international, observational, single-arm, postmarket study conducted at 23 sites that enrolled 202 patients with symptomatic degeneration of an aortic bioprosthesis eligible for elective treatment with a CoreValve or Evolut R self-expanding transcatheter aortic valve.

Results: Patients were elderly (mean age 79.9 years), 47.5% were men, and they had a mean Society of Thoracic Surgeons score of 6.6%. Although 41.8% of patients had surgical bioprostheses with labeled size ≤21 mm, valve hemodynamic parameters were markedly improved from baseline (mean aortic valve gradient 35.0 ± 16.3 mm Hg) to discharge (17.5 ± 8.6 mm Hg) and were sustained at 1 year (15.5 ± 7.5 mm Hg). At 1 year, total aortic regurgitation greater than mild was measured in 1.1% of patients. Clinical outcomes at 30 days demonstrated low mortality (2.5%), no disabling strokes, a 0.5% rate of acute kidney injury, and an 8.0% rate of new pacemaker implantation. At 1 year, the mortality rate remained low (8.8%), with 1 disabling stroke (0.6%). Five patients (2.5%) experienced coronary artery obstructions, 3 during and 1 immediately after the procedure and 1 several months later.

Conclusions: Degenerated surgical bioprostheses can be safely treated with the CoreValve or Evolut R platform using the catheter-based valve-in-valve procedure. Excellent 1-year clinical and hemodynamic outcomes were achieved in this real-world patient population. (CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis; NCT02209298).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2019.02.029DOI Listing
May 2019

Evolution of chronic kidney disease after surgical aortic valve replacement or transcatheter aortic valve implantation.

Arch Cardiovasc Dis 2019 Mar 14;112(3):162-170. Epub 2019 Jan 14.

Service de cardiologie, institut Pascal, université Clermont-Auvergne, CHU de Clermont-Ferrand, 63000 Clermont-Ferrand, France.

Background: Immediate improvement in kidney function has been reported after surgical aortic valve replacement or transcatheter aortic valve implantation. Long-term data, however, are not available.

Aim: To assess the evolution of kidney function in chronic kidney disease stage 3b-5, 1 year after surgical aortic valve replacement or transcatheter aortic valve implantation.

Methods: All patients with chronic kidney disease stage 3b-5 undergoing surgical aortic valve replacement or transcatheter aortic valve implantation for aortic stenosis in a single centre were included. Kidney function was assessed 1 year postprocedure. Improvement or deterioration in estimated glomerular filtration rate was defined by an increase or decrease of 5mL/min/1.73 m, respectively.

Results: Overall, 127 procedures were analysed (54 surgical aortic valve replacements and 73 transcatheter aortic valve implantations). Kidney function improved in 51% of patients at 1 year (45% of the surgical aortic valve replacement group versus 57% of the transcatheter aortic valve implantation group; P=0.21), and deteriorated in only 14% of patients at 1 year (18% of the surgical aortic valve replacement group versus 10% of the transcatheter aortic valve implantation group; P=0.22). Almost a quarter of patients (23%) had an improvement in estimated glomerular filtration rate of>15mL/min/1.73 m, and this was consistent at later follow-up. Few patients went onto chronic dialysis at 1 year (three after surgical aortic valve replacement and one after transcatheter aortic valve implantation). Acute kidney injury was an independent prognostic factor for long-term deterioration in kidney function (odds ratio 2.1, 95% confidence interval 1.4-3.6; P=0.006).

Conclusion: Aortic valve replacement, whether by surgical aortic valve replacement or transcatheter aortic valve implantation, improved estimated glomerular filtration rate at 1 year in more than half of patients with chronic kidney disease stage 3b-5.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.acvd.2018.10.003DOI Listing
March 2019

Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

Circulation 2018 12;138(23):2597-2607

Department of Cardiology, Parly 2 Hospital, Le Chesnay, France (X.F.).

Background: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry.

Methods: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions.

Results: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%).

Conclusions: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCULATIONAHA.118.036866DOI Listing
December 2018

Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry.

Clin Res Cardiol 2019 Jul 14;108(7):763-771. Epub 2018 Dec 14.

Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany.

Background: Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year.

Methods And Results: Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010).

Conclusions: In current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL.

Gov Number: NCT02698956.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00392-018-1404-2DOI Listing
July 2019

Benefits of final proximal optimization technique (POT) in provisional stenting.

Int J Cardiol 2019 Jan 13;274:71-73. Epub 2018 Sep 13.

Department of Interventional Cardiology, Cardiovascular Hospital and Claude Bernard University and INSERM Unit 1060 CARMEN, Lyon, France.

Aims: Initial proximal optimization technique (POT) in provisional stenting improves global malapposition, side-branch (SB) obstruction (SBO) and conservation of arterial circularity. The specific mechanical effects of a final POT sequence concluding the main provisional stenting techniques, on the other hand, are unknown.

Methods And Results: Synergy™ stents were implanted on fractal coronary bifurcation bench models using the main provisional stenting techniques (n = 5 per group): kissing-balloon inflation (KBI), snuggle, and rePOT (initial POT + SB inflation + final POT). Final results were quantified on 2D and 3D OCT before and after final POT. Whichever the technique, final POT significantly decreased global malapposition (from 7.6 ± 5.3% to 2.2 ± 2.5%, p < 0.05) and proximal elliptic deformation (from 1.15 ± 0.07 to 1.09 ± 0.04, p < 0.05), without impact on SBO (from 11.5 ± 9.6% to 12.9 ± 10.6%, NS). However, final POT failed to completely correct the elliptic deformation induced by balloon juxtaposition during the KBI and snuggle techniques, with final elliptic ratios of 1.11 ± 0.03 and 1.11 ± 0.04 respectively, significantly higher than with the complete rePOT sequence: 1.05 ± 0.02 (p < 0.05).

Conclusions: Like initial POT, final POT is recommended whatever the provisional stenting technique used. However, final POT fails to completely correct all proximal elliptic deformation associated with "kissing-like" techniques, in contrast to results with the rePOT sequence.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2018.09.041DOI Listing
January 2019

The fate of spontaneous coronary artery dissection: insight from intravascular imaging at a late follow-up.

EuroIntervention 2019 Jan;14(13):1406-1407

Department of Cardiology, Institut Mutualiste Montsouris, Paris, France.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJ-D-18-00709DOI Listing
January 2019

Long-Term Mortality and Early Valve Dysfunction According to Anticoagulation Use: The FRANCE TAVI Registry.

J Am Coll Cardiol 2019 01 25;73(1):13-21. Epub 2018 Aug 25.

ACTION Study Group, Sorbonne Université, INSERM UMR_S 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France. Electronic address:

Background: The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used according to the patient profile. Whether this approach may affect clinical outcome is unknown.

Objectives: FRANCE TAVI (French Transcatheter Aortic Valve Implantation) is a prospective, multicenter, nationwide French registry. The study objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD), defined as increased prosthetic gradient ≥10 mm Hg or new gradient ≥20 mm Hg.

Methods: To account for missing values, multiple imputations were performed. Stepwise multivariable Cox regression and logistic regression were used for all-cause mortality and bioprosthesis valve dysfunction was used, respectively. Sensitivity analysis retaining only patients with complete data were also performed.

Results: Of 12,804 patients included in the registry between January 1, 2013, and December 31, 2015, a total of 11,469 (mean ± SE age: 82.8 ± 0.07 years; logistic European System for Cardiac Operative Risk Evaluation: 17.8 ± 0.1%; mean duration of follow-up: 495 ± 3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. A total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. One-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n = 3,836). Neither aspirin nor clopidogrel was independently associated with mortality. Male sex (adjusted hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.44 to 1.84; p < 0.001), history of atrial fibrillation (aHR: 1.41; 95% CI: 1.23 to 1.62; p < 0.001), and chronic renal failure (aHR: 1.37; 95% CI: 1.23 to 1.53; p < 0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adjusted odds ratio [aOR]: 0.54; 95% CI: 0.35 to 0.82; p = 0.005) and a nonfemoral approach (aOR: 0.53; 95% CI: 0.28 to 1.02; p = 0.049) were independently associated with lower rates of BVD, whereas chronic renal failure (aOR: 1.46; 95% CI: 1.03 to 2.08; p = 0.034) and prosthesis size ≤23 mm (aOR: 3.43; 95% CI: 2.41 to 4.89; p < 0.001) yielded higher risk of BVD.

Conclusions: Sex, renal failure, and atrial fibrillation affected mortality the most at the 3-year follow-up. In contrast, anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2018.08.1045DOI Listing
January 2019

Innovative invasive management without stent implantation guided by optical coherence tomography in acute coronary syndrome.

Arch Cardiovasc Dis 2018 Nov 20;111(11):666-677. Epub 2018 Jun 20.

Cardiology Department, CHU Clermont-Ferrand, ISIT-CAVITI, UMR 6284, UdA-CNRS, 63000 Clermont-Ferrand, France.

Background: A two-step strategy of invasive management without stenting, guided by optical coherence tomography (OCT), in selected patients with acute coronary syndrome (ACS), might avoid systematic stent implantation and allow medical therapy alone.

Aims: To assess the feasibility and safety of such a procedure, and to define coronary imaging characteristics in a specific population.

Methods: This single-centre proof-of-concept study included all patients with ACS who benefited from a two-step revascularization procedure with optimal reperfusion during primary percutaneous coronary intervention followed by delayed angiography and OCT. OCT imaging determined medical therapy treatment alone without stenting in case of absence of vulnerable plaque rupture and <70% stenosis. Follow-up consisted of screening for major adverse cardiac events (MACE) at 12months.

Results: Forty-six patients were included, mainly men (86.9%) and smokers (65.2%), with a mean age of 47.1years. Most cases (80.4%) were large thrombus burden lesions. Delayed angiography and OCT were performed in a median period of 6 [3-10] days. No adverse events occurred between the initial and second angiograms. Plaque rupture was detected in 39.1% of patients, plaque erosion in 54.3% and calcified nodule in 6.5%. Twenty-three patients benefited from systematic delayed OCT over a median period of 171days, showing an increase in minimal lumen area. At 12months, two patients (4.3%) presented MACE and were stented. No sudden death or myocardial infarction recurrence occurred.

Conclusions: Analysing ACS mechanisms by OCT might facilitate treatment decisions in patients with ST-segment elevation myocardial infarction managed by a two-step procedure. Conservative treatment with antithrombotic therapy without stenting seems to be a reliable option in a selected population.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.acvd.2017.10.006DOI Listing
November 2018

Development of a Risk Score Based on Aortic Calcification to Predict 1-Year Mortality After Transcatheter Aortic Valve Replacement.

JACC Cardiovasc Imaging 2019 01 16;12(1):123-132. Epub 2018 May 16.

Cardiology Department, Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France; University of Lyon, CREATIS UMR5220, INSERM U1044, INSA-15 Lyon, France.

Objectives: The aim of this study was to develop a new scoring system based on thoracic aortic calcification (TAC) to predict 1-year cardiovascular and all-cause mortality.

Background: A calcified aorta is often associated with poor prognosis after transcatheter aortic valve replacement (TAVR). A risk score encompassing aortic calcification may be valuable in identifying poor TAVR responders.

Methods: The CCAPRI (4 Cities for Assessing CAlcification PRognostic Impact) multicenter study included a training cohort (1,425 patients treated using TAVR between 2010 and 2014) and a contemporary test cohort (311 patients treated in 2015). TAC was measured by computed tomography pre-TAVR. CAPRI risk scores were based on the linear predictors of Cox models including TAC in addition to comorbidities and demographic, atherosclerotic disease and cardiac function factors. CAPRI scores were constructed and tested in 2 independent cohorts.

Results: Cardiovascular and all-cause mortality at 1 year was 13.0% and 17.9%, respectively, in the training cohort and 8.2% and 11.8% in the test cohort. The inclusion of TAC in the model improved prediction: 1-cm increase in TAC was associated with a 6% increase in cardiovascular mortality and a 4% increase in all-cause mortality. The predicted and observed survival probabilities were highly correlated (slopes >0.9 for both cardiovascular and all-cause mortality). The model's predictive power was fair (AUC 68% [95% confidence interval [CI]: 64% to 72%]) for both cardiovascular and all-cause mortality. The model performed similarly in the training and test cohorts.

Conclusions: The CAPRI score, which combines the TAC variable with classical prognostic factors, is predictive of 1-year cardiovascular and all-cause mortality. Its predictive performance was confirmed in an independent contemporary cohort. CAPRI scores are highly relevant to current practice and strengthen the evidence base for decision making in valvular interventions. Its routine use may help prevent futile procedures.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcmg.2018.03.018DOI Listing
January 2019

Clinical impact of optical coherence tomography findings on culprit plaque in acute coronary syndrome: The OCT-FORMIDABLE study registry.

Catheter Cardiovasc Interv 2018 12 10;92(7):E486-E492. Epub 2018 May 10.

"Città della Scienza e della Salute", Department of Cardiology, University of Turin, Turin, Italy.

Background: Aim of this study was to evaluate the clinical impact of the culprit plaque features assessed by optical coherence tomography (OCT) in patients with acute coronary syndrome (ACS).

Methods: The OCT-FORMIDABLE register enrolled retrospectively all consecutive patients who perform OCT on culprit plaque in patients with ACS in nine European centres. The primary endpoint was the prevalence of culprit plaque rupture (CPR) in patients experiencing major adverse cardiovascular events (MACEs). Secondary endpoint was the prevalence necrotic core with macrophage infiltrations (NCMI) in the patients experiencing MACEs.

Results: Two-hundred and nine patients were included in the study. Mean age was 60.1 ± 12.9 years old, 19.1% were females. Main clinical presentation was ST-elevation myocardial infarction (55%). At OCT analysis, CPR was observed in 71.8% patients, while 31.6% presented NCMI. During follow-up (12.6 ± 14.5 months), 11% of the patients experienced MACEs. The presence of CPR (HR 3.7,1.4-9.8, P < .01) and NCMI (HR 3.3,1.6-6.6, P < .01) were independent predictors for MACEs, while dual antiplatelet therapy with prasugrel/ticagrelor at discharge (HR 0.2,0.1-0.6, P < .01) were protective. The protective impact of new antiplatelet drugs was reported only in patients with CPR while in patients without any of the baseline clinical or procedural features impacted on MACEs.

Conclusions: CPR and the presence of NCMI are independent predictors of worse outcome. Patients with CPR seem to benefit more of an intensive therapy, both from a pharmacological and interventional point of view. (NCT02486861).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.27633DOI Listing
December 2018

Benefit of a new provisional stenting strategy, the re-proximal optimisation technique: the rePOT clinical study.

EuroIntervention 2018 06 8;14(3):e325-e332. Epub 2018 Jun 8.

Department of Interventional Cardiology, Cardiovascular Hospital and Claude Bernard University and INSERM Unit 1060 CARMEN, Lyon, France.

Aims: A new coronary bifurcation provisional stenting technique without kissing balloon, rePOT, associating the proximal optimisation technique (POT), side branch inflation and final POT, showed excellent mechanical results in a bench test. The present study sought to use optical coherence tomography (OCT) to quantify the mechanical results of rePOT in vivo in a large patient sample with complex coronary bifurcations.

Methods And Results: A total of 106 patients with coronary bifurcations were included in a multicentre prospective registry (left main, 40.6%; true Medina bifurcation, 39.6%). Three OCT runs were performed, at baseline, just after stent implantation and after the complete rePOT sequence, quantifying global malapposition, side branch obstruction (SBO), and various geometric arterial criteria. RePOT was completed systematically. RePOT significantly reduced global strut malapposition from 18.9±13.4% just after stent implantation to 3.2±3.9% (p<0.05), residual SBO from 44.3±12.9% to 17.0±14.3% (p<0.05), and ellipticity index from 1.19±0.11 to 1.13±0.12 (p<0.05). Exhaustive six-month follow-up found only one mother-vessel target lesion revascularisation.

Conclusions: This clinical study of a large sample of complex coronary bifurcations with OCT analysis showed the benefit of the rePOT sequence in provisional stenting, replicating in vivo the excellent in vitro geometric results previously reported, and confirming ease of implementation and medium-term safety.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJ-D-17-00941DOI Listing
June 2018

Bioimpedance analysis is safe in patients with implanted cardiac electronic devices.

Clin Nutr 2019 04 2;38(2):806-811. Epub 2018 Mar 2.

Université Clermont Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, and CHU Clermont-Ferrand, Cardiology Department, F-63003 Clermont-Ferrand, France. Electronic address:

Background & Aims: There is an increase in the number of patients worldwide with cardiac implantable electronic devices (CIEDs). Current medical practice guidelines warn against performing bioimpedance analysis (BIA) in this group of patients in order to avoid any electromagnetic interference. These recommendations restrict using the BIA in patients undergoing heart failure or with nutrition disorders in whom BIA could be of major interest in detecting peripheral congestion and to help guide treatment. The present study was conducted to evaluate whether BIA caused electromagnetic interference in patients having CIEDs.

Methods: Patient enrollment was conducted during routine face-to-face consultations for scheduled CIEDs interrogations. Device battery voltage, lead impedance, pacing thresholds and device electrograms were recorded before and after each BIA measurement to detect any electromagnetic interference or oversensing.

Results: A total of 200 patients were enrolled. During BIA, no significant changes in battery voltage, lead impedance or pacing thresholds were detected, nor were there any inappropriate over- or undersensing observed in intracardiac electrograms. Furthermore, 6- and 12-month follow-up did not reveal any changes in CIEDs.

Conclusions: This study shows no interference in patients equipped with CIEDs and suggests that BIA can be securely performed in these patients. Trial registered under the identifier NCT03045822.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.clnu.2018.02.029DOI Listing
April 2019

Characteristics of stent thrombosis in bifurcation lesions analysed by optical coherence tomography.

EuroIntervention 2018 04 6;13(18):e2174-e2181. Epub 2018 Apr 6.

Cardiology Department, Institut Mutualiste Montsouris, Paris, France.

Aims: This work aimed to investigate a cohort of patients presenting with stent thrombosis (ST) explored by optical coherence tomography (OCT) to identify the underlying mechanical abnormalities in case of bifurcation lesions.

Methods And Results: The PESTO study was a prospective national registry involving 29 French catheterisation facilities. Patients with acute coronary syndromes were prospectively screened for presence of definite ST and analysed by OCT after culprit lesion reopening. The cohort involved 120 subjects, including 21 patients (17.5% of the global PESTO group; median age: 62.6 yrs; 76% male) with bifurcation lesions. The clinical presentation was acute or subacute ST in 34%, late ST in 5% and very late ST in 62% of the patients. The main underlying mechanisms were strut malapposition in 33%, stent underexpansion in 19% and isolated strut uncoverage in 19% of the cases. The proximal main branch was involved in 71%, distal main branch in 52% and jailed side branch in 5% of the patients.

Conclusions: In this cohort, bifurcation lesions represented a limited number of all ST cases. Different sections of the bifurcation could be involved. Although the underlying mechanisms were various, strut malapposition was the most frequently observed cause.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJ-D-17-00794DOI Listing
April 2018