Publications by authors named "Nicolas Van Mieghem"

427 Publications

Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study.

EuroIntervention 2021 Oct 14. Epub 2021 Oct 14.

Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands.

Background: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues.

Aims: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80).

Methods: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR.

Results: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (AUC 0.93; 95% CI: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively.

Conclusions: 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.
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http://dx.doi.org/10.4244/EIJ-D-21-00471DOI Listing
October 2021

Five-year outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: final results of the SYNTAX II study.

Eur Heart J 2021 Oct 7. Epub 2021 Oct 7.

Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Oxford Rd, Manchester M13 9WL, UK.

Aims: The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial.

Methods And Results: SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events' outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35).

Conclusions: Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.
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http://dx.doi.org/10.1093/eurheartj/ehab703DOI Listing
October 2021

Low-gradient severe aortic stenosis with preserved ejection fraction: how fast should we act?

Int J Cardiovasc Imaging 2021 Sep 17. Epub 2021 Sep 17.

Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Postbus 2040, 300 CA, Rotterdam, The Netherlands.

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http://dx.doi.org/10.1007/s10554-021-02396-9DOI Listing
September 2021

Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR.

N Engl J Med 2021 Aug 28. Epub 2021 Aug 28.

From the Department of Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands (N.M.V.M., E.B.); Daiichi Sankyo, Basking Ridge, NJ (M.U., J.J., A.D., C.C.); the Department of Internal Medicine II, Division of Cardiology, Vienna General Hospital, Medical University, Vienna (C.H., I.L.); the Department of Internal Medicine, St. Johannes Hospital, Dortmund (H.M.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Internal Medicine-Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig (H.T.), Bremer Institute for Heart and Circulation Research at Klinikum Links der Weser, Bremen (R.H.), the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg (F.M.), Daiichi Sankyo Europe, Munich (P.L., H.L.), the Department of Neurology, Alfried Krupp Krankenhaus, Essen (R.V.), and the Department of Neurology, University Hospital Heidelberg, Heidelberg (R.V.) - all in Germany; Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York (R. Mehran, G.D.D.); the Department of Cardiology, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela (D.L.-O.), the Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos (L.N.-F.), the Department of Cardiology, University Hospital La Paz (R. Moreno), and the Department of Cardiology, University Hospital Ramon y Cajal (J.L.Z.), Madrid - all in Spain; the Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.S.); the Department of Cardiology, Toyohashi Heart Center, Toyohashi (M.Y.), the Department of Cardiology, Teikyo University School of Medicine (Y.W.), and the Department of Cardiology, Keio University School of Medicine (K.H.), Tokyo, and the Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura (S.S.) - all in Japan; the Department of Cardiology, Jessa Hospital, Hasselt, Belgium (P.V.); Quebec Heart and Lung Institute, Laval University, Quebec, QC, Canada (J.R.-C.); the Division of Cardiovascular Medicine, University Hospital of Strasbourg, Strasbourg, France (P.O.); the Division of Cardiology, Policlinico Hospital, University of Catania, Catania, Italy (P.C.); the Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea (H.-S.K.); the Department of Cardiology, University of Bern, Bern (T.P.), and Cardiocentro Ticino Institute and Department of Biomedical Sciences, University of Italian Switzerland, Lugano (M.V.) - both in Switzerland; the Department of Cardiology, University Hospital of Wales, Cardiff (R.A.), and the Division of Brain Sciences, Imperial College London, London (R.V.) - both in the United Kingdom; the Cardiology Section, University of Oklahoma Health Sciences Center, Oklahoma City (U.B.); and National and Kapodistrian University of Athens, School of Medicine, Athens (G.D.D.).

Background: The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied.

Methods: We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding.

Results: A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P = 0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P = 0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11).

Conclusions: In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).
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http://dx.doi.org/10.1056/NEJMoa2111016DOI Listing
August 2021

Multidimensional Prognostic Index and Outcomes in Older Patients Undergoing Transcatheter Aortic Valve Implantation: Survival of the Fittest.

J Clin Med 2021 Aug 11;10(16). Epub 2021 Aug 11.

Section of Geriatrics, Department of Internal Medicine, Erasmus MC University Medical Center, 3015 GD Rotterdam, The Netherlands.

Selecting patients with a high chance of endured benefit from transcatheter aortic valve implantation (TAVI) is becoming relevant with changing indications and increasing number of TAVI being performed. The aim of our study was to investigate the association of the multidimensional prognostic index (MPI) based on a comprehensive geriatric assessment (CGA) on survival. The TAVI Care & Cure program is a prospective, observational registry of patients referred for TAVI at the Erasmus MC University Medical Center. Consecutive patients who underwent a complete CGA and TAVI were included. CGA components were used to calculate the MPI score. The impact of the MPI score on survival was evaluated using Cox regression. Furthermore, 376 patients were included, 143 (38.0%) patients belonged to the MPI-1 group and 233 (61.9%) patients to the MPI-2-3 group. After 3 years, 14.9% of the patients in the MPI-1 group and 30.5% of the patients in the MPI-2-3 group died ( = 0.001). Patients in MPI-1 had increased chances of overall survival in comparison with patients in MPI group 2-3 Hazard Ratio (HR) 0.57, (95% Confidence Interval (CI) 0.33-0.98)). In this study we found that the MPI tool could be useful to assess frailty and to predict which patient will have a higher chance of enduring benefit from a TAVI procedure.
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http://dx.doi.org/10.3390/jcm10163529DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8397063PMC
August 2021

Prophylactic permanent pacemaker strategy in patients with right bundle branch block undergoing transcatheter aortic valve replacement.

Catheter Cardiovasc Interv 2021 Aug 14. Epub 2021 Aug 14.

The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Objectives: To report on the experience with a selective prophylactic permanent pacemaker (PPx-PPM) implantation strategy in patients with pre-existing right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR).

Background: Pre-existing RBBB is an independent predictor for PPM after TAVR and has been linked to increased mortality.

Methods: Hospital patient flow and longer-term clinical endpoints were compared for TAVR patients with pre-existing RBBB treated in a period with and without selective PPx-PPM strategy (2013-2020).

Results: A total of 260 patients were included: 170 in the early period without PPx-PPM strategy and 90 patients in the late period with selective PPx-PPM strategy. A PPx-PPM was implanted in 44% of patients in the late period. Overall, 69% versus 80% of all patients in the early versus late period ended up with a PPM (p = .06). Streamlined transfemoral TAVR was routinely used from 2017-in this series of patients, both TAVR procedural time and hospital length of stay (LoS) were significantly shorter in the late versus early period (mean procedural time: 70 vs. 83 min and LoS ≥5 days: 15% vs. 40%; p < .05). No difference in all-cause/cardiovascular mortality was observed between both strategies, whereas cardiac rehospitalization was significantly higher for patients treated in the early versus late period (hazard ratio 2.33 [1.04-5.26]; p = .042)-this mainly due to (sub)acute PPM-implantation early after discharge.

Conclusions: Selective prophylactic PPM implantation in TAVR candidates with pre-existing RBBB results in shorter TAVR procedural time and hospital LoS and prevents early cardiac rehospitalization related to complete heart block.
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http://dx.doi.org/10.1002/ccd.29914DOI Listing
August 2021

Transcatheter Edge-to-Edge Repair in Proportionate Versus Disproportionate Functional Mitral Regurgitation.

J Am Soc Echocardiogr 2021 Aug 11. Epub 2021 Aug 11.

Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address:

Background: Functional mitral regurgitation (FMR) can be subclassified on the basis of its proportionality relative to left ventricular (LV) volume and function, indicating potential differences in underlying etiology. The aim of this study was to evaluate the association of FMR proportionality with FMR reduction, heart failure hospitalization and mortality after transcatheter edge-to-edge mitral valve repair (TEER).

Methods: This multicenter registry included 241 patients with symptomatic heart failure with reduced LV ejection fraction treated with TEER for moderate to severe or greater FMR. FMR proportionality was graded on preprocedural transthoracic echocardiography using the ratio of the effective regurgitant orifice area to LV end-diastolic volume. Baseline characteristics, follow-up transthoracic echocardiography, and 2-year clinical outcomes were compared between groups.

Results: Median LV ejection fraction, effective regurgitant orifice area and LV end-diastolic volume index were 30% (interquartile range [IQR], 25%-35%), 27 mm, and 107 mL/m (IQR, 90-135 mL/m), respectively. Median effective regurgitant orifice area/LV end-diastolic volume ratio was 0.13 (IQR, 0.10-0.18). Proportionate FMR (pFMR) and disproportionate FMR (dFMR) was present in 123 and 118 patients, respectively. Compared with patients with pFMR, those with dFMR had higher baseline LV ejection fractions (median, 32% [IQR, 27%-39%] vs 26% [IQR, 22%-33%]; P < .01). Early FMR reduction with TEER was more pronounced in patients with dFMR (odds ratio, 0.45; 95% CI, 0.28-0.74; P < .01) than those with pFMR, but not at 12 months (odds ratio, 0.93; 95% CI, 0.53-1.63; P = .80). Overall, in 35% of patients with initial FMR reduction after TEER, FMR deteriorated again at 1-year follow-up. Rates of 2-year all-cause mortality and heart failure hospitalization were 30% (n = 66) and 37% (n = 76), with no differences between dFMR and pFMR.

Conclusions: TEER resulted in more pronounced early FMR reduction in patients with dFMR compared with those with pFMR. Yet after initial improvement, FMR deteriorated in a substantial number of patients, calling into question durable mitral regurgitation reductions with TEER in selected patients. The proportionality framework may not identify durable TEER responders.
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http://dx.doi.org/10.1016/j.echo.2021.08.002DOI Listing
August 2021

Safety of Endomyocardial Biopsy in New-Onset Acute Heart Failure Requiring Veno-Arterial Extracorporeal Membrane Oxygenation.

Circ Heart Fail 2021 Aug 4;14(8):e008387. Epub 2021 Aug 4.

Department of Cardiology (R.M.A.v.d.B., W.K.d.D., A.C.C., O.C.M., N.M.D.A.v.M., C.d.U.), Erasmus Medical Center Rotterdam, the Netherlands.

Background: Endomyocardial biopsy (EMB) has an important role in determining the pathogenesis of new-onset acute heart failure (new-AHF) when noninvasive testing is impossible. However, data on safety and histopathologic outcomes in patients requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is lacking.

Methods: A retrospective, multicenter cohort of patients undergoing EMB while requiring VA-ECMO for new-AHF between 1990 and 2020 was compared with a cohort of nontransplant related biopsies not requiring VA-ECMO. Primary end point of the study was to determine the safety of EMB. Additionally, we describe the underlying pathogenesis causing new-AHF based on histopathologic examination of the samples obtained.

Results: A total of 23 patients underwent EMB while requiring VA-ECMO (10.0%), 125 (54.3%) during an unplanned admission, and 82 (35.7%) in elective setting. Major complications occurred in 8.3% of all procedures with a significantly higher rate in patients requiring VA-ECMO (26.1% versus 8.0% versus 3.7%, =0.003) predominately due to the occurrence of sustained ventricular tachycardia or need of resuscitation (13.0% versus 3.2% versus 1.2%, =0.02). EMB led to a histopathologic diagnosis in 78.3% of the patients requiring VA-ECMO which consisted primarily of patients with myocarditis (73.9%).

Conclusions: EMB in patients requiring VA-ECMO can be performed albeit with a substantial risk of major complications. The risk of the procedure was offset by a histopathologic diagnosis in 78.3% of the patients, which for the majority consisted of patients with myocarditis. The important therapeutic and prognostic implications of establishing an underlying pathogenesis causing new-AHF in this population warrant further refinement to improve procedural safety.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.121.008387DOI Listing
August 2021

Final 3-year clinical outcomes following transcatheter aortic valve implantation with a supra-annular self-expanding repositionable valve in a real-world setting: Results from the multicenter FORWARD study.

Catheter Cardiovasc Interv 2021 Jul 31. Epub 2021 Jul 31.

Department of Medicine, University of Bonn, Bonn, Germany.

Objectives: The Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3-year clinical follow up of the FORWARD study.

Background: Transcatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long-term clinical outcome data with the Evolut R platform are scarce.

Methods: FORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart-Team assessment. TAVR was attempted in 1039 patients.

Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all-cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all-cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all-cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low.

Conclusions: The Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve-related adverse events were low.
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http://dx.doi.org/10.1002/ccd.29889DOI Listing
July 2021

Left atrial appendage thrombus and cerebrovascular events post-transcatheter aortic valve implantation.

Eur Heart J Cardiovasc Imaging 2021 Jul 28. Epub 2021 Jul 28.

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

Aims: To elucidate the frequency and clinical impact of left atrial appendage thrombus (LAAT) in patients set for transcatheter aortic valve implantation (TAVI).

Methods And Results: All patients undergoing TAVI between January 2014 and June 2020 with analysable multislice computed tomography (MSCT) for LAAT were included. Baseline and procedural characteristics were collected, pre-procedural MSCT's were retrospectively analysed for LAAT presence. The primary endpoint was defined as the cumulative incidence of any cerebrovascular event (stroke or transient ischaemic attack) within the first year after TAVI. A Cox proportional hazards model was used to identify predictors.A total of 1050 cases had analysable MSCT. Median age was 80 [interquartile range (IQR) 74-84], median Society of Thoracic Surgeons' Predicted Risk Of Mortality (STS-PROM) was 3.4% (IQR 2.3-5.5). Thirty-six percent were on oral anticoagulant therapy for atrial fibrillation (AF). LAAT was present in 48 (4.6%) of cases. Patients with LAAT were at higher operative risk [STS-PROM: 4.9% (2.9-7.1) vs. 3.4% (2.3-5.5), P = 0.01], had worse systolic left ventricular function [EF 52% (35-60) vs. 55% (45-65), P = 0.01] and more permanent pacemakers at baseline (35% vs. 10%, P < 0.01). All patients with LAAT had a history of AF and patients with LAAT were more often on vitamin K antagonist-treatment than patients without LAAT [43/47 (91%) vs. 232/329 (71%), P < 0.01]. LAAT [hazard ratio (HR) 2.94 (1.39-6.22), P < 0.01] and the implantation of more than one valve [HR 4.52 (1.79-11.25), P < 0.01] were independent predictors for cerebrovascular events.

Conclusion: Patients with MSCT-identified LAAT were at higher risk for cerebrovascular events during the first year after TAVI.
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http://dx.doi.org/10.1093/ehjci/jeab139DOI Listing
July 2021

Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock.

JACC Case Rep 2020 Oct 23;2(12):1882-1883. Epub 2020 Sep 23.

Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.

High-risk percutaneous coronary intervention may lead to undesirable clinical scenarios such as cardiogenic shock. We describe the hemodynamic changes using pressure-volume loop analyses in percutaneous coronary intervention-induced shock. (PULsecath mechanicaL Support Evaluation [PULSE]; NCT03200990) ().
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http://dx.doi.org/10.1016/j.jaccas.2020.07.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299126PMC
October 2020

Transcatheter Repair and Replacement Technologies for Mitral Regurgitation: a European Perspective.

Curr Cardiol Rep 2021 07 16;23(9):125. Epub 2021 Jul 16.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Office Nt 645, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.

Purpose Of Review: We aimed to picture the contemporary landscape of available catheter-based repair and replacement solutions for mitral regurgitation (MR) in Europe.

Recent Findings: Edge-to-edge repair remains the dominant technique for transcatheter mitral valve repair especially in the context of secondary mitral regurgitation. Two recent randomized trials reported seemingly contradicting clinical results with transcatheter edge-to-edge repair for patients with heart failure and severe secondary MR. A proportionality framework related to secondary MR was proposed to help explain inconsistencies but requires further research. (In)Direct annuloplasty primarily aims to correct secondary MR; however, the scientific basis seems less robust. One dedicated transcatheter heart valve has the CE mark for mitral valve replacement but requires transapical access. Balloon-expandable transcatheter aortic valve platforms are emerging for transvenous transseptal mitral replacement in the context of mitral annular calcification, a failing surgical mitral bioprosthesis, or annuloplasty. Advanced computed tomography imaging techniques improved pre-procedural planning and introduced the option for modeling and simulation. Development of a toolbox of catheter-based technologies, complementary imaging modalities, and refined patient selection offer novel perspectives to high-risk patients with primary or secondary MR. Clinical trials are required to help formulate evidence-based guidelines for the management of mitral valve disease.
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http://dx.doi.org/10.1007/s11886-021-01556-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8285321PMC
July 2021

The effect of transcatheter aortic valve implantation on pulmonary artery pressures in a patient suffering from chronic heart failure: a case report.

Eur Heart J Case Rep 2021 Apr 12;5(4):ytab112. Epub 2021 Apr 12.

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

Background: Pulmonary hypertension (PH) is most commonly caused by left-sided heart disease and may negatively affect the long-term prognosis and quality of life of patients with chronic heart failure (CHF). CardioMEMS (Micro-Electro-Mechanical-System) allows physicians to monitor pulmonary artery (PA) pressures remotely and optimize heart failure treatment based on haemodynamic parameters, which provides further insight into the effect of valvular interventions.

Case Summary: We present a case of a 61-year-old male patient with an ischaemic cardiomyopathy, poor LV function, moderate to severe mitral regurgitation, and severe aortic valve regurgitation in refractory heart failure. Right heart catheterization and CardioMEMS monitoring revealed severe pulmonary hypertension with mean PA pressures of 55 mmHg and a mean pulmonary capillary wedge pressure of 21 mmHg despite up titration of heart failure medication and sildenafil. Pulmonary and systemic causes of pulmonary hypertension were excluded. After heart team consensus, the patient underwent transcatheter aortic valve implantation (TAVI) which resulted in normalization of PA pressures and a significant improvement of functional performance.

Discussion: To the best of our knowledge, this is the first case report describing the direct effects of TAVI on continuous PA pressures in a patient with poor LV function and severe aortic regurgitation. Elective TAVI appeared to be safe and very effective in reverting severe pulmonary hypertension. Most strikingly, drug interventions could not affect the elevated pulmonary pressures, but TAVI corrected the aortic valve insufficiency with normalization of left-sided pulmonary hypertension.
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http://dx.doi.org/10.1093/ehjcr/ytab112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276598PMC
April 2021

Pharmacodynamic Effects of Pre-Hospital Administered Crushed Prasugrel in Patients With ST-Segment Elevation Myocardial Infarction.

JACC Cardiovasc Interv 2021 Jun;14(12):1323-1333

Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands. Electronic address:

Objectives: This study sought to compare the pharmacodynamic effects of pre-hospitally administered P2Y inhibitor prasugrel in crushed versus integral tablet formulation in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).

Background: Early dual antiplatelet therapy is recommended in STEMI patients. Yet, onset of oral P2Y inhibitor effect is delayed and varies according to formulation administered.

Methods: The COMPARE CRUSH (Comparison of Pre-hospital Crushed Versus Uncrushed Prasugrel Tablets in Patients With STEMI Undergoing Primary Percutaneous Coronary Interventions) trial randomized patients with suspected STEMI to crushed or integral prasugrel 60-mg loading dose in the ambulance. Pharmacodynamic measurements were performed at 4 time points: before antiplatelet treatment, at the beginning and end of pPCI, and 4 h after study treatment onset. The primary endpoint was high platelet reactivity at the end of pPCI. The secondary endpoint was impact of platelet reactivity status on markers of coronary reperfusion.

Results: A total of 441 patients were included. In patients with crushed prasugrel, the occurrence of high platelet reactivity at the end of pPCI was reduced by almost one-half (crushed 34.7% vs. uncrushed 61.6%; odds ratio [OR] = 0.33; 95% confidence interval [CI] = 0.22 to 0.50; p < 0.01). Platelet reactivity <150 P2Y reactivity units at the beginning of coronary angiography correlated with improved Thrombolysis In Myocardial Infarction flow grade 3 in the infarct artery pre-pPCI (OR: 1.78; 95% CI: 1.08 to 2.94; p = 0.02) but not ST-segment resolution (OR: 0.80; 95% CI: 0.48 to 1.34; p = 0.40).

Conclusions: Oral administration of crushed compared with integral prasugrel significantly improves platelet inhibition during the acute phase in STEMI patients undergoing pPCI. However, a considerable number of patients still exhibit inadequate platelet inhibition at the end of pPCI, suggesting the need for alternative agents to bridge the gap in platelet inhibition.
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http://dx.doi.org/10.1016/j.jcin.2021.04.022DOI Listing
June 2021

Safety and feasibility of hemodynamic pulmonary artery pressure monitoring using the CardioMEMS device in LVAD management.

J Card Surg 2021 Sep 22;36(9):3271-3280. Epub 2021 Jun 22.

Department of Cardiology, Erasmus MC, Thorax Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.

Background: There is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages.

Methods: Ten consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance.

Results: No safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group.

Conclusion: Remote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.
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http://dx.doi.org/10.1111/jocs.15767DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8453715PMC
September 2021

Discordant severity criteria in patients with moderate aortic stenosis: prognostic implications.

Open Heart 2021 06;8(1)

Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands

Background: The criteria to define the grade of aortic stenosis (AS)-aortic valve area (AVA) and mean gradient (MG) or peak jet velocity-do not always coincide into one grade. Although in severe AS, this discrepancy is well characterised, in moderate AS, the phenomenon of discordant grading has not been investigated and its prognostic implications are unknown.

Objectives: To investigate the occurrence of discordant grading in patients with moderate AS (defined by an AVA between 1.0 cm² and 1.5 cm² but with an MG <20 mm Hg) and how these patients compare with those with concordant grading moderate AS (AVA between 1.0 cm² and 1.5 cm² and MG ≥20 mm Hg) in terms of clinical outcomes.

Methods: From an ongoing registry of patients with AS, patients with moderate AS based on AVA were selected and classified into discordant or concordant grading (MG <20 mm Hg or ≥20 mm Hg, respectively). The clinical endpoint was all-cause mortality.

Results: Of 790 patients with moderate AS, 150 (19.0%) had discordant grading, moderate AS. Patients with discordant grading were older, had higher prevalence of previous myocardial infarction and left ventricular (LV) hypertrophy, larger LV end-diastolic and end-systolic volume index, higher LV filling pressure and lower LV ejection fraction and stroke volume index as compared with their counterparts. After a median follow-up of 4.9 years (IQR 3.0-8.2), patients with discordant grading had lower aortic valve replacement rates (26.7% vs 44.1%, p<0.001) and higher mortality rates (60.0% vs 43.1%, p<0.001) as compared with patients with concordant grading. Discordant grading moderate AS, combined with low LV ejection fraction, presented the higher risk of mortality (HR 2.78 (2.00-3.87), p<0.001).

Conclusion: Discordant-grading moderate AS is not uncommon and, when combined with low LV ejection fraction, is associated with high risk of mortality.
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http://dx.doi.org/10.1136/openhrt-2021-001639DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220503PMC
June 2021

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry.

Catheter Cardiovasc Interv 2021 Jun 12. Epub 2021 Jun 12.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Objectives: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women.

Background: Data on pacemaker insertion complicating TAVR in women are scarce.

Methods: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints.

Results: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups ( HR 0.95, 95% CI 0.60-1.52, p = 0.84 and HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively).

Conclusion: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.
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http://dx.doi.org/10.1002/ccd.29807DOI Listing
June 2021

Predictors and Clinical Impact of Prosthesis-Patient Mismatch After Self-Expandable TAVR in Small Annuli.

JACC Cardiovasc Interv 2021 Jun;14(11):1218-1228

Division of Cardiology, Montefiore Medical Center, Bronx, New York, USA.

Objectives: The aim of this study was to define predictors of prosthesis-patient mismatch (PPM) and its impact on mortality after transcatheter aortic valve replacement (TAVR) with self-expandable valves (SEVs) in patients with small annuli.

Background: TAVR seems to reduce the risk for PPM compared with surgical aortic valve replacement, especially in patients with small aortic annuli. Nevertheless, predictors and impact of PPM in this population have not been clarified yet.

Methods: Predictors of PPM and all-cause mortality were investigated using multivariable logistic regression analysis from the cohort of the TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) registry, which included patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm on computed tomography) treated with transcatheter SEVs: 445 patients with (n = 129) and without (n = 316) PPM were enrolled.

Results: Intra-annular valves conferred increased risk for PPM (odds ratio [OR]: 2.36; 95% confidence interval [CI]: 1.16 to 4.81), while post-dilation (OR: 0.46; 95% CI: 0.25-0.84) and valve oversizing (OR: 0.53; 95% CI: 0.28-1.00) seemed to protect against PPM occurrence. At a median follow-up of 354 days, patients with severe PPM, but not those with moderate PPM, had a higher all-cause mortality rate compared with those without PPM (log-rank p = 0.008). Multivariable Cox regression confirmed severe PPM as an independent predictor of all-cause mortality (hazard ratio: 4.27; 95% CI: 1.34 to 13.6).

Conclusions: Among patients with aortic stenosis and small aortic annuli undergoing transcatheter SEV implantation, use of intra-annular valves yielded higher risk for PPM; conversely, post-dilation and valve oversizing protected against PPM occurrence. Severe PPM was independently associated with all-cause mortality.
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http://dx.doi.org/10.1016/j.jcin.2021.03.060DOI Listing
June 2021

Moderate Aortic Stenosis in Patients With Heart Failure and Reduced Ejection Fraction.

J Am Coll Cardiol 2021 Jun;77(22):2796-2803

Institut universitaire de cardiologie et de pneumologie, Université Laval, Québec, Québec, Canada. Electronic address:

Background: The study investigators previously reported that moderate aortic stenosis (AS) is associated with a poor prognosis in patients with heart failure (HF) with reduced left ventricular ejection fraction (LVEF) (HFrEF). However, the respective contribution of moderate AS versus HFrEF to the outcomes of these patients is unknown.

Objectives: This study sought to determine the impact of moderate AS on outcomes in patients with HFrEF.

Methods: The study included 262 patients with moderate AS (aortic valve area >1.0 and <1.5 cm; and peak aortic jet velocity >2 and <4 m/s, at rest or after dobutamine stress echocardiography) and HFrEF (LVEF <50%). These patients were matched 1:1 for sex, age, estimated glomerular filtration rate, New York Heart Association functional class III to IV, presence of diabetes, LVEF, and body mass index with patients with HFrEF but no AS (i.e., peak aortic jet velocity <2 m/s). The endpoints were all-cause mortality and the composite of death and HF hospitalization.

Results: A total of 262 patients with HFrEF and moderate AS were matched with 262 patients with HFrEF and no AS. Mean follow-up was 2.9 ± 2.2 years. In the moderate AS group, mean aortic valve area was 1.2 ± 0.2 cm, and mean gradient was 14.5 ± 4.7 mm Hg. Moderate AS was associated with an increased risk of mortality (hazard ratio [HR]: 2.98; 95% confidence interval [CI]: 2.08 to 4.31; p < 0.0001) and of the composite of HF hospitalization and mortality (HR: 2.34; 95% CI: 1. 72 to 3.21; p < 0.0001). In the moderate AS group, aortic valve replacement (AVR) performed in 44 patients at a median follow-up time of 10.9 ± 16 months during follow-up was associated with improved survival (HR: 0.59; 95% CI: 0.35 to 0.98; p = 0.04). Notably, surgical AVR was not significantly associated with improved survival (p = 0.92), whereas transcatheter AVR was (HR: 0.43; 95% CI: 0.18 to 1.00; p = 0.05).

Conclusions: In this series of patients with HFrEF, moderate AS was associated with a marked incremental risk of mortality. AVR, and especially transcatheter AVR during follow-up, was associated with improved survival in patients with HFrEF and moderate AS. These findings provide support to the realization of a randomized trial to assess the effect of early transcatheter AVR in patients with HFrEF and moderate AS.
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http://dx.doi.org/10.1016/j.jacc.2021.04.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091313PMC
June 2021

Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices.

Eur Heart J Acute Cardiovasc Care 2021 Jun;10(5):570-583

Department of Adult Intensive Care Unit, Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street, SW3 6NP London, UK.

There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.
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http://dx.doi.org/10.1093/ehjacc/zuab015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245145PMC
June 2021

Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices.

EuroIntervention 2021 Jul 20;17(4):e274-e286. Epub 2021 Jul 20.

Interventional Cardiology Unit San Raffaele Scientific Institute - Milan, Italy.

There has been a significant increase in the use of short-term percutaneous ventricular assist devices (pVADs) as acute circulatory support in cardiogenic shock and to provide haemodynamic support during interventional procedures, including high-risk percutaneous coronary interventions. Although frequently considered together, pVADs differ in their haemodynamic effects, management, indications, insertion techniques, and monitoring requirements. This consensus document summarizes the views of an expert panel by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the Association for Acute Cardiovascular Care (ACVC) and appraises the value of short-term pVAD. It reviews the pathophysiological context and possible indications for pVAD in different clinical settings and provides guidance regarding the management of pVAD based on existing evidence and best current practice.
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http://dx.doi.org/10.4244/EIJY21M05_01DOI Listing
July 2021

Outcomes of Valve-in-Valve Transcatheter Aortic Valve Implantation with and without Bioprosthetic Valve Fracture.

EuroIntervention 2021 05 25. Epub 2021 May 25.

MVZ Department Structural Heart Disease, Asklepios St. Georg, Hamburg, Germany.

Background: Bioprosthetic valve fracture (BVF) is a technique to reduce gradients in valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) procedures. Outcome of VIV-TAVI with BVF has not been compared with VIV-TAVI without BVF.

Aims: To evaluate the outcome of VIV-TAVI with BVF compared to VIV-TAVI without BVF.

Methods: In total, 81 cases of BVF-VIV-TAVI (BVF-group) from 14 centres were compared to 79 cases of VIV-TAVI without BVF (control-group).

Results: VARC-2 defined device success was 93% in the BVF- and 68.4% in the control-group (p<0.001). The mean transvalvular gradient decreased from 37 ± 13mmHg to 10.8 ± 5.9mmHg (p<0.001) in the BVF- and from 35 ± 16mmHg to 15.8 ± 6.8mmHg (p<0.001) in the control-group with a significantly higher final gradient in control (p<0.001). The transvalvular gradients did not significantly change over time. In-hospital major adverse events occurred in 3.7% in BVF- and 7.6% in control-group (p=0.325). A linear mixed model identified BVF, self-expanding transcatheter heart valves (THVs) and other surgical aortic valve (SAV) types other than Mitroflow as predictors for lower transvalvular gradients.

Conclusions: Compared to VIV-TAVI alone, VIV-TAVI with BVF resulted in a significantly lower transvalvular gradient acutely and at follow-up. Independent predictors for lower gradients were the use of self-expanding THVs and the treatment of SAVs other than Mitroflow, irrespective of BVF-performance. BVF significantly reduced the gradient independently from transcatheter or surgical valve type.
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http://dx.doi.org/10.4244/EIJ-D-21-00254DOI Listing
May 2021

Incidence, Causes, and Outcomes Associated With Urgent Implantation of a Supplementary Valve During Transcatheter Aortic Valve Replacement.

JAMA Cardiol 2021 Aug;6(8):936-944

Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands.

Importance: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR.

Objective: To examine the incidence, causes, and outcomes of 2V-TAVR.

Design, Setting, And Participants: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients.

Exposures: Urgent implantation of a supplementary valve during TAVR.

Main Outcomes And Measures: Mortality at 30 days and 1 year.

Results: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR.

Conclusions And Relevance: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.
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http://dx.doi.org/10.1001/jamacardio.2021.1145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8135057PMC
August 2021

Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation and Its Impact on Mortality.

JACC Cardiovasc Interv 2021 Jun 12;14(11):1181-1192. Epub 2021 May 12.

Servicio de Cardiología, Hospital Álvaro Cunqueiro, Vigo, Spain.

Objectives: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR).

Background: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited.

Methods: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared.

Results: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097).

Conclusions: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).
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http://dx.doi.org/10.1016/j.jcin.2021.02.030DOI Listing
June 2021

Bioprosthetic valve fracture: Predictors of outcome and follow-up. Results from a multicenter study.

Catheter Cardiovasc Interv 2021 Oct 15;98(4):756-764. Epub 2021 May 15.

MVZ Department Structural Heart Disease, Asklepios St. Georg, Hamburg, Germany.

Objectives: To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR).

Background: BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing.

Methods: The 81 cases of BVF-VIV-TAVR were collected from 14 international centers.

Results: Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37 ± 13 mmHg to 10.8 ± 5.9 mmHg (p < 0.001). BVF reduced the gradient by 16 mmHg. During follow-up (FU, 281 ± 164 days) mean gradient remained stable (10.8 ± 5.9 mmHg at discharge, 12.4 ± 6.3 mmHg at FU, p = ns). In-hospital major adverse events occurred in 3.7%. Event-free survival at 276 ± 237.6 days was 95.4%. The linear mixed model identified balloon-expandable valves (BEV), Mitroflow surgical valve, stenotic surgical bioprostheses and balloon only 1 mm larger than the true internal diameter of the surgical valve as predictors for higher gradients.

Conclusions: BVF is safe and can significantly reduce gradients, which remain stable at FU. BEV, Mitroflow surgical valve, stenotic bioprostheses and balloon larger than the true internal diameter of the surgical valve of only 1 mm are predictors for higher final gradients.
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http://dx.doi.org/10.1002/ccd.29755DOI Listing
October 2021

Accuracy of three-dimensional computational modeling in prediction of the dynamic neo left ventricular outflow tract with transcatheter mitral valve replacement.

Int J Cardiol 2021 08 19;336:93-96. Epub 2021 May 19.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address:

Background: Transcatheter mitral valve replacement (TMVR) offers a valuable treatment option for inoperable patients suffering from a degenerated mitral valve after previous ring annuloplasty. Dynamic obstruction of the left ventricular outflow tract(LVOT) is a procedural risk with detrimental consequences and can be estimated upfront using a multi-slice computed tomography(MSCT) derived 3D computational model(3DCM). This study explored the accuracy of pre-procedural neo-LVOT prediction in TMVR using 3DCMs of multiple cardiac phases.

Methods: We obtained both pre- and post-procedural MSCT scans of a patient who underwent uncomplicated TMVR and derived 3DCMs from each cardiac phase. Virtual implantations of the deployed valve were performed and neo-LVOT dimensions were semi-automatically calculated in the pre-procedural models and matched with the post-procedural models. Predicted and post-procedural neo-LVOTs were compared between 3DCMs.

Results: From cardiac phases 20-70%, 11 matched 3DCM pairs were generated. The mean difference between predicted and post-TMVR neo-LVOT area was 3 ± 23 mm. The intra-class correlation coefficient for absolute agreement between predicted and post-procedural neo-LVOT area was 0.86 (95%CI 0.56-0.96, p < 0.001).

Conclusion: 3DCMs could accurately predict post-TMVR neo-LVOT dimensions in a patient with a pre-existing mitral annular ring. Prospective research is warranted to demonstrate the accuracy of these models in larger samples and different mitral annular phenotypes.
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http://dx.doi.org/10.1016/j.ijcard.2021.05.002DOI Listing
August 2021

Elastic stent recoil in coronary total occlusions: Comparison of durable-polymer zotarolimus eluting stent and ultrathin strut bioabsorbable-polymer sirolimus eluting stent.

Catheter Cardiovasc Interv 2021 May 7. Epub 2021 May 7.

Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Centre, Rotterdam, The Netherlands.

Objectives: To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs.

Background: Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis.

Methods: Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR.

Results: A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively).

Conclusions: Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR.
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http://dx.doi.org/10.1002/ccd.29739DOI Listing
May 2021
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