Publications by authors named "Thomas Modine"

166 Publications

Feasibility and safety of transfemoral transcatheter aortic valve implantation performed with a percutaneous coronary intervention-like approach.

Arch Cardiovasc Dis 2021 Apr 21. Epub 2021 Apr 21.

Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, Cardiology, Institut Cœur Poumon, CHU de Lille, Université Lille, 59037 Lille, France.

Background: Transfemoral percutaneous transcatheter aortic valve implantation (TF-TAVI) is a safe, reproducible and established procedure, mainly performed under local anaesthesia, which is mostly administered and monitored by a dedicated anaesthesia team (regular approach). Our centre has developed a standardized pathway of care, and eligible patients are selected for a minimalist TF-TAVI, entirely managed by operators without the presence of the anaesthesia team in the operating room, like most interventional coronary procedures ("percutaneous coronary intervention-like" approach [PCI approach]).

Aim: To compare the safety and efficacy of TF-TAVI performed with the PCI approach versus the regular approach.

Methods: The analysis population comprised all patients who underwent TF-TAVI with the PCI or regular approach in our institution from November 2016 to July 2019. The two co-primary endpoints were early safety composite and early efficacy composite at 30days as defined by the Valve Academic Research Consortium-2. The PCI (n=137) and Regular (n=221) approaches were compared using the propensity score based method of inverse probability of treatment weighting.

Results: No differences were observed after comparison of TAVI performed with the PCI or regular approach regarding the composite safety endpoint (7.3% vs. 11.3%; odds ratio 0.63, 95% confidence interval 0.37 to 1.07; P=0.086) or the composite efficacy endpoint (4.4% vs. 6.3%; odds ratio 0.78, 95% confidence interval 0.41 to 1.49; P=0.45).

Conclusions: This study suggests that the efficacy and safety of TF-TAVI entirely managed by a PCI approach for selected patients are not different to those when TF-TAVI is performed with the attendance of a full anaesthesia care team. The PCI approach appears to be a safe and efficient clinical pathway, providing an appropriate and rational utilization of anaesthesiology resources, and could be used for the majority of TF-TAVI procedures.
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http://dx.doi.org/10.1016/j.acvd.2020.12.007DOI Listing
April 2021

How to eliminate mitral regurgitation definitively: the eternal dilemma?

EuroIntervention 2021 Apr;16(17):1384-1385

Service Médico-Chirurgical, Valvulopathies - Chirurgie Cardiaque - Cardiologie Interventionnelle Structurelle, Hôpital Cardiologique de Haut Lévèque, Bordeaux, France.

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http://dx.doi.org/10.4244/EIJV16I17A252DOI Listing
April 2021

Surgical sutureless and sutured aortic valve replacement in low-risk patients.

Ann Thorac Surg 2021 Mar 29. Epub 2021 Mar 29.

Departments of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor, MI.

Background: Randomized clinical trials have shown that transcatheter aortic valve replacement (TAVR) is noninferior to surgery in low surgical risk patients. We compared outcomes in patients treated with a sutured (stented or stentless) or sutureless surgical valve from the Evolut Low Risk Trial.

Methods: The Evolut Low Risk Trial enrolled patients with severe aortic stenosis and low surgical risk. Patients were randomized to self-expanding TAVR or surgery. Use of sutureless or sutured valves was at the surgeons' discretion.

Results: There were 680 patients who underwent surgical aortic valve implantation (205 sutureless, 475 sutured). The VARC-2 30-day safety composite endpoint was similar in the sutureless and sutured group (10.8% vs 11.0%, P=.93). All-cause mortality between groups was similar between groups at 30 days (0.5% vs 1.5%, P=.28) and 1 year (3.3% vs 2.6%, P=.74). Disabling stroke was also similar at 30 days (2.0% vs 1.5%, P=.65) and 1 year (2.6% vs 2.2%, P=.76). Permanent pacemaker implantation at 30 days was significantly higher in the sutureless compared with the sutured group (14.4% vs 2.9%, P<.001). AV-related hospitalizations occurred more often at 1 year with sutureless valves (9.1% vs 5.1%, P=.04). Mean gradients 1 year after sutureless and sutured AVR were 9.9±4.2 vs 11.7±4.7mm Hg (P<.001).

Conclusions: Among low-risk patients, sutureless versus sutured valve use did not demonstrate a benefit in terms of 30-day complications and produced marginally better hemodynamics, but with an increased rate of pacemaker implantation and valve-related hospitalizations.
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http://dx.doi.org/10.1016/j.athoracsur.2021.03.048DOI Listing
March 2021

Transcatheter Repair for Tricuspid Regurgitation: Ready or Not?

JACC Cardiovasc Interv 2021 Mar 1;14(5):584-585. Epub 2021 Mar 1.

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http://dx.doi.org/10.1016/j.jcin.2020.12.036DOI Listing
March 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.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.047DOI Listing
April 2021

Prognostic value of aerobic capacity and exercise oxygen pulse in postaortic dissection patients.

Clin Cardiol 2021 Feb 31;44(2):252-260. Epub 2020 Dec 31.

CHU Lille, Department of Clinical Physiology & echocardiography, Univ. Lille, Inserm U1011-EGID, Lille, France.

Background: Although recommendations encourage daily moderate activities in post aortic dissection, very little data exists regarding cardiopulmonary exercise testing (CPET) to personalize those patient's physical rehabilitation and assess their cardiovascular prognosis.

Design: We aimed at testing the prognostic insight of CPET regarding aortic and cardiovascular events by exploring a prospective cohort of patients followed-up after acute aortic dissection.

Methods: Patients referred to our department after an acute (type A or B) aortic dissection were prospectively included in a cohort between September 2012 and October 2017. CPET was performed once optimal blood pressure control was obtained. Clinical follow-up was done after CPET for new aortic event and major cardio-vascular events (MCE) not directly related to the aorta.

Results: Among the 165 patients who underwent CPET, no adverse event was observed during exercise testing. Peak oxygen pulse was 1.46(1.22-1.84) mlO2/beat, that is, 97 (83-113) % of its predicted value, suggesting cardiac exercise limitation in a population under beta blockers (92% of the population). During a follow-up of 39(20-51) months from CPET, 42 aortic event recurrences and 22 MCE not related to aorta occurred. Low peak oxygen pulse (<85% of predicted value) was independently predictive of aortic event recurrence, while low peak oxygen uptake (<70% of predicted value) was an independent predictor of MCE occurrence.

Conclusion: CPET is safe in postaortic dissection patients should be used to not only to personalize exercise rehabilitation, but also to identify those patients with the highest risk for new aortic events and MCE not directly related to aorta.
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http://dx.doi.org/10.1002/clc.23537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7852169PMC
February 2021

Percutaneous Chordae Mitral Repair: Is it the Right Way to Fix Mitral Regurgitation?

JACC Basic Transl Sci 2020 Oct 26;5(10):1015-1016. Epub 2020 Oct 26.

Bordeaux University Hospital, Service Médico-Chirurgical de Valvulopathies-Chirurgie Cardiaque-Cardiologie Interventionelle Structurelle, Hôpital Cardiologique de Haut Lévèque, Bordeaux, France.

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http://dx.doi.org/10.1016/j.jacbts.2020.09.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591928PMC
October 2020

Utility and safety of coronary angiography in patients with acute infective endocarditis who required surgery.

J Thorac Cardiovasc Surg 2020 Oct 7. Epub 2020 Oct 7.

USIC et Centre Hémodynamique, Institut Coeur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France; Faculté de Médecine de l'Université de Lille, Lille, France; INSERM UMR 1011, Institut Pasteur de Lille, Lille, France; FACT (French Alliance for Cardiovascular Trials), Paris, France. Electronic address:

Objectives: To assess the benefit/risk ratio to perform a coronary angiography (CA) before surgery for infective endocarditis (IE).

Methods: We conducted a single-center prospective registry including 272 patients with acute IE intended for surgery and compared patients who underwent a preoperative CA (n = 160) with those who did not (n = 112). A meta-analysis of 3 observational studies was also conducted and included 551 patients: 342 who underwent a CA and 209 who did not.

Results: In our registry, combined bypass surgery (CABG) was performed in 17% of the patients with preoperative CA. At 2 years, the rate of the primary composite end point (all-cause death, new systemic embolism, stroke, new hemodialysis) was similar in the CA (38%) and no-CA (37%) groups. In-hospital and 2-year individual end points were all similar between groups. There were only 2 episodes of systemic embolism after CA and only one possibly related to a vegetation dislodgement. In the meta-analysis, combined CABG was performed in 18% of the patients with preoperative CA. All-cause death was similar in both groups: odds ratio, 0.98 [0.62-1.53], P = .92. Only 5 cases of systemic embolism possibly related to a vegetation dislodgement were reported. New hemodialysis was numerically more frequent in the CA group: odds ratio, 1.68 [0.79-3.58] (18% vs 14%, P = .18).

Conclusions: In daily practice, two-thirds of the patients with acute IE who required surgery have a preoperative CA leading to a combined CABG in 18% of the patients. Our results suggest that to perform a preoperative CA in this context is not associated with improved prognosis.
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http://dx.doi.org/10.1016/j.jtcvs.2020.08.117DOI Listing
October 2020

Early Experience With a Novel Transfemoral Mitral Valve Implantation System in Complex Degenerative Mitral Regurgitation.

JACC Cardiovasc Interv 2020 10;13(20):2427-2437

Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada. Electronic address:

Objectives: The aim of this study was to evaluate the feasibility, procedural results, and 6-month outcomes of a novel transfemoral transcatheter mitral valve implantation (TMVI) system (Cephea) in patients with complex primary mitral regurgitation (MR).

Background: TMVI is emerging as an alternative to surgery in patients with severe MR. To date, the great majority of TMVI systems use the transapical surgical approach.

Methods: This study included consecutive patients undergoing transfemoral TMVI with the Cephea valve system. All patients were suboptimal candidates for catheter-based repair for anatomic reasons. Patients underwent clinical, echocardiographic, and computed tomographic angiographic follow-up at 6 months. Main outcomes were procedural success, peri-procedural complications, and valve hemodynamic status early and at 6-month follow-up.

Results: Three patients with severe primary MR (2 women, mean age 79 ± 3 years) at prohibitive surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 13.8 ± 2.4%) were included. The valves were successfully implanted in all patients, with no procedural complications. Post-procedural echocardiography showed normal valve function in all patients (mean transvalvular gradient 3 mm Hg; range: 2 to 4 mm Hg), no moderate to severe valvular or paravalvular leak, and no clinically significant left ventricular outflow tract obstruction. At 6 months, all patients had improved quality of life (mean improvement vs. baseline 16.4 ± 12 points). All valve hemodynamic parameters were maintained. Computed tomographic angiography confirmed annular stability, proper valve geometry and no structural failure.

Conclusions: The transfemoral delivery of a purposely designed mitral prosthesis (Cephea valve) was safe and feasible in prohibitive risk patients. Valve performance was sustained, and clinical outcomes improved at 6 months. Larger clinical studies are required.
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http://dx.doi.org/10.1016/j.jcin.2020.08.006DOI Listing
October 2020

A dedicated Y-shaped percutaneous ECMO cannula for femoral 2-in-1 vascular access during high-risk procedures.

Catheter Cardiovasc Interv 2021 Apr 1;97(5):959-961. Epub 2020 Oct 1.

Institut Cœur Poumon, Cardiology, Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, CHU Lille, Lille, France.

High-risk transcatheter procedures requiring hemodynamic support are growing and require multiple vascular access that may be challenging in cases of peripheral artery disease or lack of radial access and exposure to a higher risk of vascular complications. We report the novel utilization of a Y-shaped arterial extracorporeal membrane oxygenation (ECMO) cannula used as a single femoral access to perform percutaneous coronary intervention (PCI) and aortography during high-risk transcatheter aortic valve replacement (TAVR). The utilization of this 2-in-1 ECMO cannula may simplify vascular access and reduce vascular and bleeding complications during high-risk ECMO-supported transcatheter procedures.
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http://dx.doi.org/10.1002/ccd.29299DOI Listing
April 2021

Massive or Torrential Tricuspid Regurgitation: The Weight of the Flow!

JACC Cardiovasc Interv 2020 09;13(17):2010-2011

Structural Valve Program, Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.

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http://dx.doi.org/10.1016/j.jcin.2020.06.015DOI Listing
September 2020

Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2020 09;76(9):1018-1030

Structural Heart Division, University Heart Center, Hamburg, Hamburg, Germany.

Background: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials.

Objectives: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices.

Methods: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications.

Results: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016).

Conclusions: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).
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http://dx.doi.org/10.1016/j.jacc.2020.07.005DOI Listing
September 2020

Predictors of Outcomes Following Transcatheter Edge-to-Edge Mitral Valve Repair.

JACC Cardiovasc Interv 2020 08;13(15):1733-1748

McGill University Health Center, McGill University, Montreal, Quebec, Canada. Electronic address:

Transcatheter edge-to-edge mitral valve repair is a viable alternative to surgery in patients with severe mitral regurgitation and high surgical risk. Yet the specific group of patients who would optimally benefit from this therapy remains to be determined. Selection of patients for transcatheter strategy is currently based on surgical prognostic scores and technical feasibility. Meanwhile, various clinical, anatomic, and procedural factors have been recently recognized as predictors of adverse outcomes following transcatheter edge-to-edge mitral valve repair, including device failure, recurrent mitral regurgitation, and mortality. Integration of these prognostic factors in the decision-making process of the heart team might improve patient management and outcomes. Herein, the authors review the different factors related to symptomatic status, comorbidity, serum biomarkers, echocardiographic findings, and procedural technique that have been identified as independent predictors of adverse outcome following transcatheter edge-to-edge mitral valve repair and discuss their potential application in everyday clinical practice.
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http://dx.doi.org/10.1016/j.jcin.2020.03.025DOI Listing
August 2020

Utility of Three-Dimensional Transesophageal Echocardiography for Mitral Annular Sizing in Transcatheter Mitral Valve Replacement Procedures: A Cardiac Computed Tomographic Comparative Study.

J Am Soc Echocardiogr 2020 10 25;33(10):1245-1252.e2. Epub 2020 Jul 25.

Department of Clinical Physiology and Echocardiography - Heart Valve Center, CHU Lille, Lille, France; Université de Lille, U1011 - EGID, Lille, France; Inserm, U1011, Lille, France; Institut Pasteur de Lille, Lille, France.

Background: Three-dimensional (3D) transesophageal echocardiographic (TEE) imaging is frequently used as an initial screening tool in the evaluation of patients who are candidates for transcatheter mitral valve replacement (TMVR). However, little is known about the imaging correlation with the gold standard, computed tomographic (CT) imaging. The aims of this study were to test the quantitative differences between these two modalities and to determine the best 3D TEE parameters for TMVR screening.

Methods: Fifty-seven patients referred to the heart valve clinic for TMVR with prostheses specifically designed for the mitral valve were included. Mitral annular (MA) analyses were performed using commercially available software on 3D TEE and CT imaging.

Results: Three-dimensional TEE imaging was feasible in 52 patients (91%). Although 3D TEE measurements were slightly lower than those obtained on CT imaging, measurements of both projected MA area and perimeter showed excellent correlations, with small differences between the two modalities (r = 0.88 and r = 0.92, respectively, P < .0001). Correlations were significant but lower for MA diameters (r = 0.68-0.72, P < .0001) and mitroaortic angle (r = 0.53, P = .0001). Receiver operating characteristic curve analyses showed that 3D TEE imaging had a good ability to predict TMVR screening success, defined by constructors on the basis of CT measurements, with ranges of 12.9 to 15 cm for MA area (area under the curve [AUC] = 0.88-0.91, P < .0001), 128 to 139 mm for MA perimeter (AUC = 0.85-0.91, P < .0001), 35 to 39 mm for anteroposterior diameter (AUC = 0.79-0.84, P < .0001), and 37 to 42 mm for posteromedial-anterolateral diameter (AUC = 0.81-0.89, P < .0001).

Conclusions: Three-dimensional TEE measurements of MA dimensions display strong correlations with CT measurements in patients undergoing TMVR screening. Three-dimensional TEE imaging should be proposed as a reasonable alternative to CT imaging in this vulnerable population.
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http://dx.doi.org/10.1016/j.echo.2020.04.030DOI Listing
October 2020

Transaxillary compared with transcarotid access for TAVR: a propensity-matched comparison from a French multicentre registry.

EuroIntervention 2020 11;16(10):842-849

Heart Team, Institute Cœur-Poumons, CHU Lille, Lille, France.

Aims: No randomised study comparing the outcomes of transcarotid (TC) and transaxillary (TAx) TAVR has been conducted to date. The purpose of this study was to understand which approach should be the preferred alternative by comparing their outcomes using a propensity-matched comparison in a French multicentre registry.

Methods And Results: From 2010 to 2018, a French multicentre prospective registry included 502 patients, with 374 undergoing TC-TAVR and 128 TAx-TAVR for symptomatic aortic stenosis. Patients treated through TAx access were matched 1:2 with patients treated through the TC route by using a propensity score (20 clinical, anatomical and procedural variables) and by date of the procedure. The first outcome was mortality at one-month follow-up. The second outcome was one-month stroke/transient ischaemic attack (TIA). In propensity-matched analyses, the incidence of the primary outcome was similar in the TAx and TC groups (TAx 5.5% vs TC 4.5%, OR 1.23, 95% CI: 0.40-3.70). The secondary outcome was similar in TAx (3.2%) and TC (6.8%, OR 0.52, 95% CI: 0.14-1.84). Minor bleeding (2.7% vs 9.3%, OR 0.26, 95% CI: 0.07-0.92) and main access haematoma (3.6% vs 10.3%, OR 0.034, 95% CI: 0.09-0.92) were significantly more frequent with the TC access. One-month clinical efficacy and safety and one-year mortality did not differ according to the different routes.

Conclusions: One-month mortality, one-month stroke/TIA and one-year mortality are similar with TAx-TAVR and TC-TAVR. However, TC-TAVR is accompanied by more minor bleeding and main access haematoma compared with the transaxillary route.
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http://dx.doi.org/10.4244/EIJ-D-20-00117DOI Listing
November 2020

Aortic morphology post type A acute aortic syndrome: Prognosis significance and association with 24-hour blood pressure-monitoring parameters.

J Card Surg 2020 May 16;35(5):981-987. Epub 2020 Mar 16.

CHU Lille, Institut Cœur Poumon, Lille, France.

Background: After an emergent surgery for type A acute aortic syndrome, medical management is based on optimal blood pressure (BP) control. We assessed the prognostic significance of BP monitoring and its relationship with aortic morphology following type A acute aortic syndrome.

Methods: The data of 120 patients who underwent BP monitoring after a type A acute aortic syndrome from January 2005 to June 2016 were retrospectively collected. The first CT angiogram performed after surgery was used for the morphological analysis.

Results: The population included 79 males, with an overall mean age of 60 ± 12 years. Seven patients (5.8%) died during a median follow-up of 5.5 years. The median delay between BP monitoring and discharge was 3 (1-5) months. The mean 24-hour BP of the cohort was 127/73 mm Hg ± 10/17. During follow-up, different parameters of BP monitoring were not associated with the risk of aortic events. However, the diameter of the false lumen of the descending thoracic aorta was the best predictor associated with the risk of new aortic events during follow-up, particularly for the threshold of 28 mm or more (P < .001; Hazard ratio 4.7[2.7-8.2]). The diameter of the false lumen was associated with night-time systolic BP (P = .025; r = .2), 24-hour pulse pressure (P = .002; r = .28), and night-time pulse pressure (P = .008; r = .24).

Conclusion: The risk of new aortic events following type A acute aortic syndrome is associated with the size of the residual false lumen, but not directly with BP parameters. Night-time BP parameters are associated with the size of the residual false lumen.
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http://dx.doi.org/10.1111/jocs.14512DOI Listing
May 2020

Ultrasound Guidance to Reduce Vascular and Bleeding Complications of Percutaneous Transfemoral Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Comparison.

J Am Heart Assoc 2020 03 16;9(6):e014916. Epub 2020 Mar 16.

Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.

Background Ultrasound (US) guidance provides the unique opportunity to control the puncture zone of the artery during transfemoral transcatheter aortic valve replacement and may decrease major vascular complications (VC) and life-threatening or major bleeding complications. This study aimed to evaluate the clinical impact of US guidance using a propensity score-matched comparison. Methods and Results US guidance was implemented as the default approach for all transfemoral transcatheter aortic valve replacement cases in our institution in June 2013. We defined 3 groups of consecutive patients according to the method of puncture (fluoroscopic/US guidance) and the use of a transcatheter heart valve. Patients in the US-guided second-generation group (Sapien XT [Edwards Lifesciences, Irvine, CA], Corevalve [Medtronic, Dublin, Ireland]) were successfully 1:1 matched with patients in the fluoroscope-guided second-generation group (n=95) with propensity score matching. In a second analysis we described the consecutive patients of the US-guided third-generation group (Evolut-R [Medtronic], Sapien 3 [Edwards Lifesciences], n=308). All vascular and bleeding complications were reduced in the US-guided second-generation group compared with the fluoroscope-guided second-generation group: VC (16.8% versus 6.3%; =0.023); life-threatening or major bleeding (22.1% versus 6%; =0.004); and VC related to vascular access (12.6% versus 4.2%; =0.052). In the US-guided third-generation group the rates of major VC and life-threatening or major bleeding were 3.2% (95% CI, 1.6% to 5.9%) and 3.6% (95% CI, 1.8% to 6.3%). In the overall population (n=546), life-threatening or major bleeding was associated with a 1.7-fold increased mortality risk (=0.02). Conclusions We demonstrated that US guidance effectively reduced VC and bleeding complications for transfemoral transcatheter aortic valve replacement and should be considered the standard puncture method. Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628509.
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http://dx.doi.org/10.1161/JAHA.119.014916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335526PMC
March 2020

Clinical significance of electrocardiographic markers of myocardial damage prior to aortic valve replacement.

Int J Cardiol 2020 May 29;307:130-135. Epub 2020 Jan 29.

CHU Lille, Department of Clinical Physiology and Echocardiography, France; Univ. Lille, U1011 - EGID, F-59000 Lille, France; Inserm, U1011, F-59000 Lille, France; Institut Pasteur de Lille, F-59000 Lille, France.

Background: Pre-operative myocardial fibrosis and remodeling impact on outcomes after aortic valve replacement (AVR). We aimed at investigating the prognostic impact of preoperative electrocardiographic (ECG) markers of left ventricular (LV) myocardial damage, i.e. bundle branch block (BBB) and ECG strain pattern after (surgical or transcatheter) AVR for severe aortic stenosis (AS).

Methods: Between April 2008 and October 2017, we explored consecutive patients referred to our Heart Valve Clinic for first AVR for severe AS. Detailed pre-operative phenotyping and ECG analysis were performed. Patients were followed-up after AVR for major cardiac events (ME), i.e. cardiovascular death, cardiac hospitalization for acute heart failure and stroke.

Results: BBB and ECG strain were respectively observed in 13.5 and 21% of the 1122 patients included. These ECG markers identified a subgroup of older patients, with higher NYHA class and more advanced myocardial disease as detected by echocardiography, i.e. higher LV mass and lower LV ejection fraction, global longitudinal strain and integrated backscatter, than patients without ECG strain or BBB. ME occurred in 212 (18.6%) patients during a mean follow-up of 4.4 ± 1.5 years with higher incidence in case of ECG strain or BBB (HR 1.56, 95%CI 1.13-2.14, p = 0.006; HR 1.47, 95%CI 1.02-2.13, p = 0.04 respectively). The prognostic value of ECG strain remained significant after adjustment for age, diabetes and pre-operative LVEF.

Conclusions: Pre-operative ECG markers of myocardial damage identify a subgroup of AS patients at high risk of post-AVR cardiovascular complications irrespective of other prognostic factors and should help the multiparametric staging of cardiac damage to guide AVR.
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http://dx.doi.org/10.1016/j.ijcard.2020.01.073DOI Listing
May 2020

Do we need alternative access in TAVR anymore?

EuroIntervention 2020 Feb 7;15(15):e1305-e1306. Epub 2020 Feb 7.

Department of Cardiology and Cardiovascular Surgery, Heart Valve Center, Institut Cœur Poumon CHU de Lille, Lille, France.

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http://dx.doi.org/10.4244/EIJV15I15A237DOI Listing
February 2020

Advances in transcatheter mitral and tricuspid therapies.

BMC Cardiovasc Disord 2020 01 7;20(1). Epub 2020 Jan 7.

Cardiology and Cardiovascular Surgery Department, Heart Valve Center, Institut Cœur Poumon CHU de Lille, 2 Av Oscar Lambret, 59037, Lille, France.

Background: While rheumatic mitral stenosis has been effectively treated percutaneously for more than 20 years, mitral and tricuspid regurgitation treatment appear as a contemporary unmet need. The advent of transcatheter therapies offer new treatment options to often elderly and frail patients at high risk for open surgery. We aimed at providing an updated review of fast-growing domain of transcatheter mitral and tricuspid technology.

Main Body: We reviewed the existing literature on mitral and tricuspid transcatheter therapies. Mitraclip is becoming an established therapy for secondary mitral regurgitation in selected patients with disproportionately severe regurgitation associated with moderate left ventricle dysfunction. Evidence is less convincing for primary mitral regurgitation. Transcatheter mitral valve replacement is a promising emerging alternative to transcatheter repair, for secondary as well as primary mitral regurgitation. But further development is needed to improve delivery. Transcatheter tricuspid intervention arrives late after similar technologies have been developed for aortic and mitral valves and is currently at its infancy. This is likely due in part to previously under-recognized impact of tricuspid regurgitation on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on tricuspid annuloplasty and replacement is limited, and more research is warranted.

Conclusion: The future appears bright for transcatheter mitral therapies, albeit their place in clinical practice is yet to be clearly defined. Tricuspid transcatheter therapies might address the unmet need of tricuspid regurgitation treatment.
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http://dx.doi.org/10.1186/s12872-019-01312-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945613PMC
January 2020

Will the PARTNER 3 Low Risk Trial change my practice?

EuroIntervention 2019 Dec 20;15(12):e1077-e1080. Epub 2019 Dec 20.

Royal Berkshire NHS Foundation Trust, Reading, United Kingdom.

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http://dx.doi.org/10.4244/EIJ-D-19-00847DOI Listing
December 2019

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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http://dx.doi.org/10.1016/j.jacc.2019.09.054DOI Listing
December 2019

Valvular heart disease: when does surgery remain the best option?

EuroIntervention 2019 Nov;15(10):831-836

Department of Cardiology, University Hospital of Bern, Bern, Switzerland.

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http://dx.doi.org/10.4244/EIJV15I10A157DOI Listing
November 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: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.043785DOI Listing
January 2020

Sex Differences in Transfemoral Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2019 12 25;74(22):2758-2767. Epub 2019 Sep 25.

Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address:

Background: Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes.

Objectives: This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade.

Methods: The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex.

Results: We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time.

Conclusions: In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.
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http://dx.doi.org/10.1016/j.jacc.2019.09.015DOI Listing
December 2019

Mitral valve regurgitation: a plea for transcatheter mitral valve replacement.

EuroIntervention 2019 Sep;15(7):567-570

Cardiology and Cardiovascular Surgery Department, Heart Valve Center, Institut Cœur Poumon CHU de Lille, Lille, France.

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http://dx.doi.org/10.4244/EIJV15I7A103DOI Listing
September 2019

Uncertainties and challenges in surgical and transcatheter tricuspid valve therapy: a state-of-the-art expert review.

Eur Heart J 2020 05;41(20):1932-1940

Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD Rotterdam, Netherlands.

Tricuspid regurgitation (TR) is a frequent and complex problem, commonly combined with left-sided heart disease, such as mitral regurgitation. Significant TR is associated with increased mortality if left untreated or recurrent after therapy. Tricuspid regurgitation was historically often disregarded and remained undertreated. Surgery is currently the only Class I Guideline recommended therapy for TR, in the form of annuloplasty, leaflet repair, or valve replacement. As growing experience of transcatheter therapy in structural heart disease, many dedicated transcatheter tricuspid repair or replacement devices, which mimic well-established surgical techniques, are currently under development. Nevertheless, many aspects of TR are little understood, including the disease process, surgical or interventional risk stratification, and predictors of successful therapy. The optimal treatment timing and the choice of proper surgical or interventional technique for significant TR remain to be elucidated. In this context, we aim to highlight the current evidence, underline major controversial issues in this field and present a future roadmap for TR therapy.
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http://dx.doi.org/10.1093/eurheartj/ehz614DOI Listing
May 2020

First-in-Human Implant of the Cephea Transseptal Mitral Valve Replacement System.

Circ Cardiovasc Interv 2019 09 12;12(9):e008003. Epub 2019 Sep 12.

CRFSkirball Center for Innovation, Orangeburg, New York (T.V., O.K.K., J.F.G.).

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008003DOI Listing
September 2019