Ilias Ninios

Interbalkan Medical Center

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Vlasis Ninios

Interbalkan Medical Center

Sotirios Evangelou

Interbalkan Medical Center

Harilaos Bogossian

University of Hagen

Bernd Lemke

Klinikum Lüdenscheid

Markus Zarse

Klinikum Lüdenscheid

Dirk Bandorski

Universität Hamburg

Lars Eckardt

University Hospital Münster

Gerrit Frommeyer

University of Münster

G. Papadopoulos

University Hospital of Ioannina

Melchior Seyfarth

Helios Universitätsklinikum Wuppertal

Cooperative Institutions

Institute of Cardiology

Charité - Universitätsmedizin Berlin

Heart Foundation

National and Kapodistrian University of Athens

German Centre for Cardiovascular Research

Hippocration General Hospital

Aristotle University of Thessaloniki

AHEPA University Hospital

Centro de Investigación en Red en Enfermedades Cardiovasculares

Inserm

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Baseline echocardiographic characteristics of patients enrolled in the randomized investigation of MitraClip device in heart failure (RESHAPE HF-2) trial: comparison with COAPT and Mitra-FR

Global Cardiology (2024)

Ralph Stephan von Bardeleben Muhammad Shahzeb Khan Martin Geyer Tim Friede Javed Butler

Background: The RESHAPE-HF2 trial is aimed at evaluating the efficacy of the MitraClip device for the treatment of clinically significant functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline echocardiographic characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. Methods: The RESHAPE-HF2 study is a prospective, randomized, multicenter trial involving patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50%, and moderate-to-severe or severe FMR who are ineligible for isolated mitral valve surgery, despite receiving guideline-directed therapy. Patients were randomized 1:1 to either receive the MitraClip or be placed in a control group without the intervention. Results: For the 505 patients randomized (mean age 70 years, 20% female, mean body mass index 26.8 kg/m2), the mean LVEF in the cohort was 31±8%. The mean regurgitant volume was 37±12 mL, while mean proximal iso-velocity surface area (PISA) radius was 0.72 cm. Less than half of the patients (44%) had MR severity grade 4+. The mean effective regurgitant orifice area (EROA) among patients in RESHAPE-HF2 (0.25 cm2) was lower compared to patients in MITRA-FR (0.31 cm2) and in COAPT (0.40 cm2) trials. Regurgitant volumes in RESHAPE-HF2 were 18% lower than in than in MITRA-FR (45 mL) but 38% higher than in COAPT (27 mL). The mean LV end-diastolic volumes values in the RESHAPE-HF2, COAPT, and MITRA-FR trials were 211 mL, 193 mL, and 250 mL, respectively. Patients in RESHAPE-HF2 (41 mmHg) had a comparatively lower right ventricular systolic pressure than patients in MITRA-FR (54 mmHg) and in COAPT (44 mmHg). Patients in RESHAPE-HF2, MITRA-FR, and COAPT had a similar LVEF of around 31%. Conclusions: The baseline echocardiographic characteristics of patients in the RESHAPE-HF2 trial differ from patients in the MITRA-FR and COAPT trials. Patients enrolled in RESHAPE-HF2 had moderate-to-severe FMR, characterized by a smaller PISA radius, a lesser proportion of MR severity grade of 4+, and lower mean EROA and regurgitant volumes compared to patients in COAPT and MITRA-FR trials. LVEF was largely similar across all trials. RESHAPE-HF2 is testing TEER in a third distinct cohort of patients who have less severe FMR compared to patients in COAPT trial but have high left atrial volumes. The RESHAPE-HF2 population is also echocardiographically different from the MITRA-FR cohort.

MitraClip

10.4081/cardio.2024.40

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Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology

Cardiovascular revascularization medicine (2023)

Vlasis Ninios Ilias Ninios Lauren S. Ranard Torsten Vahl Krzysztof Wróbel

Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described.Three consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system.Technical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients.Longer-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction.We present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.

Mitral valve replacement

10.1016/j.carrev.2023.07.006

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Prevalence of Interatrial Block in a General Population of Elderly People

Annals of Noninvasive Electrocardiology (2007)

Ilias Ninios Christodoulos Pliakos Vlasios Ninios Haralampos Karvounis George Louridas

Background: Interatrial block (IAB: P wave ≥ 110 ms) is highly prevalent in people ≥65 years old living in a community. Methods: We investigated 720 consecutive people age ≥65 years old, from the general population, with the intention of evaluating the prevalence of IAB in their electrocardiogram. After excluding 42 people with atrial fibrillation and atrial flutter (5%) or having a permanent pacemaker (0,83%), we evaluated the electrocardiograms of the remaining 678 people with sinus rhythm. Results: We identified 400 (59%) persons with IAB with a similar distribution between men (58.5%) and women (59.4%). IAB was also identified in 347 from a total of 570 hypertensive people (60,9%) and only in 53 out of 108 (49.1%) nonhypertensive people (P = 0.015). Conclusions: The surprisingly large prevalence of the IAB in the general older population emphasizes the importance of the early recognition of this abnormality from the surface 12‐lead electrocardiogram.

Abnormality

10.1111/j.1542-474x.2007.00178.x

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Three-Plug Technique for Mitral Paravalvular Leak Closure in Marfan Syndrome

Cureus (2025)

Vlasis Ninios G. Papadopoulos Andreas A. Ioannides Sotirios Evangelou Ilias Ninios

Paravalvular leaks (PVLs) represent a challenging complication following surgical mitral valve replacement, particularly in patients with connective tissue disorders such as Marfan syndrome. This report presents the case of a 32-year-old female with Marfan syndrome who presented with progressive dyspnea and New York Heart Association (NYHA) functional class II-III symptoms 10 years post-mitral valve replacement for severe mitral regurgitation. Transthoracic and transesophageal echocardiography identified an 8 × 9 mm paravalvular defect with compliant borders, deemed suitable for percutaneous closure. Surgical re-intervention was considered high risk by the Heart Team, leading to the decision to proceed with a minimally invasive approach. Under general anesthesia, the defect was crossed using a steerable guide catheter and stabilized with a super-stiff wire. A stepwise closure strategy employing three Amplatzer Vascular Plug III devices (two 14 × 5 mm and one 10 × 5 mm) successfully reduced the regurgitation to trace levels. The patient experienced significant symptomatic improvement, achieving NYHA functional class I at six months post-procedure, with echocardiography confirming the durable closure of the defect. This case highlights the technical nuances and innovative use of multiple devices for mitral PVL closure, particularly in the context of connective tissue disorders. Multimodality imaging, strategic device selection, and operator expertise are critical for optimizing outcomes in such high-risk scenarios.

Closure (psychology)

10.7759/cureus.77920

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Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation

New England Journal of Medicine (2024)

Stefan D. Anker Tim Friede Ralph-Stephan von Bardeleben Javed Butler M M Khan

BackgroundWhether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain.MethodsWe conducted a randomized, controlled trial involving patients with heart failure and moderate to severe functional mitral regurgitation from 30 sites in nine countries. The patients were assigned in a 1:1 ratio to either transcatheter mitral-valve repair and guideline-recommended medical therapy (device group) or medical therapy alone (control group). The three primary end points were the rate of the composite of first or recurrent hospitalization for heart failure or cardiovascular death during 24 months; the rate of first or recurrent hospitalization for heart failure during 24 months; and the change from baseline to 12 months in the score on the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS; scores range from 0 to 100, with higher scores indicating better health status).ResultsA total of 505 patients underwent randomization: 250 were assigned to the device group and 255 to the control group. At 24 months, the rate of first or recurrent hospitalization for heart failure or cardiovascular death was 37.0 events per 100 patient-years in the device group and 58.9 events per 100 patient-years in the control group (rate ratio, 0.64; 95% confidence interval [CI], 0.48 to 0.85; P=0.002). The rate of first or recurrent hospitalization for heart failure was 26.9 events per 100 patient-years in the device group and 46.6 events per 100 patient-years in the control group (rate ratio, 0.59; 95% CI, 0.42 to 0.82; P=0.002). The KCCQ-OS score increased by a mean (±SD) of 21.6±26.9 points in the device group and 8.0±24.5 points in the control group (mean difference, 10.9 points; 95% CI, 6.8 to 15.0; P<0.001). Device-specific safety events occurred in 4 patients (1.6%).ConclusionsAmong patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone. (Funded by Abbott Laboratories; RESHAPE-HF2 ClinicalTrials.gov number, NCT02444338.)

10.1056/nejmoa2314328

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Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry

Life (2023)

Matthaios Didagelos Vlasis Ninios Charalampos Kakderis Λάμπρος Λάκκας Antonios Κouparanis

Introduction: The self-expanding, resheathable, repositionable transcatheter aortic heart valve Portico is being used successfully for transcatheter aortic valve implantation procedures (TAVI) in patients with severe aortic stenosis. The aim of this study was to evaluate outcomes at 2 years after TAVI with the Portico valve. Methods: Multicenter registry of clinical, echocardiographic and survival data from consecutive patients treated with the Portico TAVI system (Abbott, Chicago, IL, USA) in three cath labs in Northern Greece and Epirus during 2017–2020. The primary end point was all-cause mortality at 24 months. Secondary end points included procedural outcomes (efficacy and safety) and echocardiographic measurements. Results: A total of 90 patients (81 ± 6 years, 50% females, mean age 81 ± 6 years) were included in the registry. The indication for implantation was severe, symptomatic aortic stenosis (NYHA III, IV) in eighty-two (91.1%) and degeneration of a prosthetic aortic valve in eight (8.9%) patients. All patients were categorized as high surgical risk (mean Logistic Euroscore 25.9 ± 10, Euroscore II 7.7 ± 4.4 and STS score 10.8 ± 8.9). The procedure was performed transfemorally in all patients, under general anesthesia in 95.6%, under TOE guidance in 21.1%, with native valve predilatation in 46.7%, and the “resheath” option was used in 31.1% of the cases. The implantation was successful in 97.8% and there was a need for a second valve in 2.2% of the cases. Complications included permanent pacemaker implantation (16.7%), access cite complications (15.6%), arrythmias (23.3%), paravalvular leak (moderate 7.8%, severe 1.1%), acute kidney injury (7.8%), no strokes and one death during the procedure. Aortic valve peak velocity, peak and mean pressure gradients, were significantly reduced after the procedure. All-cause mortality at 1, 12 and 24 months was 4.4%, 6.7% and 7.8%, respectively. Conclusions: TAVI with the Portico system comprises an effective and safe solution for the management of severe, symptomatic aortic stenosis in high-risk surgical patients.

Clinical endpoint

10.3390/life13081785

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Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the AVENGER multicentre registry

EuroIntervention (2024)

Won‐Keun Kim Moritz Seiffert Andreas Rück David M. Leistner Henryk Dreger

There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]).

10.4244/eij-d-23-00779

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An Unexplained Cause of Oxygen Desaturation Following Heterotopic Tricuspid Valve Replacement

КАРДИОЛОГИЯ УЗБЕКИСТАНА (2024)

Vlasis Ninios Ilias Ninios Sotirios Evangelou Andreas A. Ioannides Maria P. Asimaki

10.1016/j.jcin.2024.01.285

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Transcatheter valve-in-valve implantation in failing tricuspid bioprosthesis of a young adult with tetralogy of Fallot

International Journal of Cardiology Congenital Heart Disease (2021)

Diamantis Kosmidis Ilias Ninios Alexandra Arvanitaki Athanasios Koutsakis Vasilios Thanopoulos

10.1016/j.ijcchd.2021.100143

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Combined mitral and tricuspid TEER with a single TriClip steerable guide catheter: A single-center study

medRxiv (Cold Spring Harbor Laboratory) (2025)

G. Papadopoulos Ilias Ninios Sotirios Evangelou Andreas A. Ioannides Vlasis Ninios

Structured Abstract Background Combined M- and T-TEER typically involves two separate systems, complicating logistics and increasing procedural risks. This study aims to evaluate the safety and efficacy of combined mitral (M-TEER) and tricuspid (T-TEER) transcatheter edge-to-edge repair using a single TriClip® steerable guide catheter (SGC). Methods Patients with moderate-to-severe (3+) or severe (4+) degenerative (DMR) or functional (FMR) mitral regurgitation and massive/torrential or severe functional tricuspid regurgitation (TR), classified as New York Heart Association (NYHA) class III or IV, who underwent combined M- and T-TEER with the same TriClip SGC between January 2022 and December 2024, were included. The primary objectives included procedural outcomes, MR and TR severity reduction, and NYHA class improvement. Results Among 42 patients (64% female; median age: 77 years [IQR: 9]], the implantation success rate was 100%, with mean device and procedure times of 39.2 ± 6.9 and 71.2 ± 9.6 minutes, respectively. There were no in-hospital or 30-day major adverse events (MAEs), except for 2 patients (4.8%) with tricuspid single leaflet device attachment (SLDA), and 1 patient (2.4%) who underwent atrial septal defect (ASD) closure. Over a median follow-up period of 0.91 years, 3 (7.1%) patients were hospitalized for heart failure, with zero mortality. At 1-year follow-up, all patients achieved NYHA class ≤II, along with MR ≤2+ and 34 (81%) patients had only trivial/mild TR. Conclusions Combined M-TEER and T-TEER using the same TriClip SGC demonstrated exceptional safety and efficacy, along with significant functional and echocardiographic improvements.

Single Center

Center (category theory)

10.1101/2025.01.28.25321297

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