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Background: Whether transcatheter mitral-valve repair improves outcomes in patients with heart failure and functional mitral regurgitation is uncertain., Methods: We 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)., Results: A 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%)., Conclusions: Among 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.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: For patients with functional mitral regurgitation (FMR) and symptomatic heart failure (HF), randomized trials of mitral transcatheter edge-to-edge repair (M-TEER) have produced conflicting results., Objectives: This study sought to assess the impact of M-TEER on hospitalization rates, and explore the effects of M-TEER on patients who did or did not have a history of recent HF hospitalizations before undergoing M-TEER., Methods: RESHAPE-HF2 (Randomized Investigation of the MitraClip Device in Heart Failure: 2nd Trial in Patients with Clinically Significant Functional Mitral Regurgitation) included patients with symptomatic HF and moderate to severe FMR (mean effective regurgitant orifice area 0.25 cm 2 ; 14% >0.40 cm 2 , 23% <0.20 cm 2 ) and showed that M-TEER reduced recurrent HF hospitalizations with and without the addition of cardiovascular (CV) death and improved quality of life. We now report the results of prespecified analyses on hospitalization rates and for the subgroup of patients (n = 333) with a HF hospitalization in the 12 months before randomization., Results: At 24 months, the time to first event of CV death or HF hospitalization (HR: 0.65; 95% CI: 0.49-0.85; P = 0.002), the rate of recurrent CV hospitalizations (rate ratio [RR]: 0.75; 95% CI: 0.57-0.99; P = 0.046), the composite rate of recurrent CV hospitalizations and all-cause mortality (RR: 0.74; 95% CI: 0.57-0.95; P = 0.017), and of recurrent CV death and CV hospitalizations (RR: 0.76; 95% CI: 0.58-0.99; P = 0.040), were all lower in the M-TEER group. The RR of recurrent hospitalizations for any cause was 0.82 (95% CI: 0.63-1.07; P = 0.15) for patients in the M-TEER group vs control group patients. Patients randomized to M-TEER lost fewer days due to death or HF hospitalization (13.9% [95% CI: 13.0%-14.8%] vs 17.4% [95% CI: 16.4%-18.4%] of follow-up time; P < 0.0001, and 1,067 vs 1,776 total days lost; P < 0.0001). Patients randomized to M-TEER also had better NYHA functional class at 30 days and at 6, 12, and 24 months of follow-up (P < 0.0001). A history of HF hospitalizations before randomization was associated with worse outcomes and greater benefit with M-TEER on the rate of the composite of recurrent HF hospitalizations and CV death (P interaction  = 0.03) and of recurrent HF hospitalizations within 24 months (P interaction  = 0.06)., Conclusions: These results indicate that a broader application of M-TEER in addition to optimal guideline-directed medical therapy should be considered among patients with symptomatic HF and moderate to severe FMR, particularly in those with a history of a recent hospitalization for HF., Competing Interests: Funding Support and Author Disclosures Prof Ponikowsaki has received a grant from Vifor Pharma; has received consulting fees and/or honoraria from Boehringer Ingelheim, AstraZeneca, Vifor Pharma, Servier, Novartis, Berlin Chemie, Bayer, Abbott Vascular, Novo Nordisk, Pharmacosmos, Moderna, Pfizer, and Abbott Vascular; and has received fees for trial committee work from Boehringer Ingelheim, Vifor Pharma, Novo Nordisk, Pharmacosmos, and Moderna. Dr Friede has received payments to his institution from Abbott; has received grants from Deutsche Forschungsgemeinschaft (DFG), Federal Joint Committee (G-BA), and European Commission; has received consulting fees from Actimed, Bayer, BMS, CSL Behring, Daiichi-Sankyo, Galapagos, Immunic, KyowaKirin, LivaNova, Minoryx, Novartis, RECARDIO, Relaxera, Roche, Servier, Viatris, and Vifor; has received payments from Fresenius Kabi and PINK gegen Brustkrebs; is a trial data monitoring committee member for Aslan, Bayer, Biosense Webster, Enanta, Galapagos, IQVIA, Novartis, PPD, Recordati, Roche, and VICO Therapeutics; and is a trial steering committee member for SCLBehring. Dr von Bardeleben has received an EchoCoreLab IIT grant from Clinical Trial Unit of UMG Göttingen; has received consulting fees from Abbott Vascular, Jenscare, Edwards Lifesciences, and Medtronic; has received honoraria from Abbott Vascular, Jenavalve, Jenscare, Edwards Lifesciences, Medtronic, Philips, Siemens; and is a trial committee member for Medtronic and Heart Valve Society (unpaid), and EU SHD Coalition (unpaid). Dr Butler has received consulting fees from Abbott, American Regent, Amgen, Applied Therapeutic, AskBio, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiac Dimension, Cardiocell, Cardior, Cardiorem, CSL Bearing, CVRx, Cytokinetics, Daxor, Edwards Lifesciences, Element Science, Faraday, Foundry, G3P, Innolife, Impulse Dynamics, Imbria, Inventiva, Ionis, Lexicon, Lilly, LivaNova, Janssen, Medtronic, Merck, Occlutech, Owkin, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Pfize, Prolaio, Regeneron, Renibus, Roche, Salamandra, Sanofi, SC Pharma, Secretome, Sequana, SQ Innovation, Tenex, Tricog, Ultromics, Vifor, and Zoll; and has received honoraria from Novartis, Boehringer Ingelheim-Lilly, AstraZeneca, Impulse Dynamics, and Vifor. Dr Khan has participated in a data safety monitoring board or advisory board for Bayer. Dr Ferrari has received honoraria and support for attending meetings from Servier, Merck Serono, Bayer, Lupin, and Sunpharma. Dr Abraham has received payments from Abbott; has received grants from National Institutes of Health 1 UG3 / UH3 HL140144-01; has received consulting fees from Zoll Respicardia; has received honoraria from Impulse Dynamics, Edwards Lifesciences, and Abbott; and is an advisory board member for Sensible Medical, WhiteSwell, AquaPass, Cordio Medical, and Boehringer Ingelheim. Dr Auricchio has received consulting fees and honoraria from Boston Scientific, Medtronic, Microport CRM, Philips, Xspline, and Abbott. Dr Bayes-Genis has lectured and/or participated in advisory boards for Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Novo Nordisk, Roche Diagnostics, and Vifor. Dr Cleland has received grants from Bristol Myers Squibb, CSL-Vifor, British Heart Foundation, and Pharmacosmos; has received consulting fees from Pharmacosmos, CSL-Vifor, and Biopeutics; and has received honoraria from Pharmacosmos. Dr Filippatos has received honoraria from Bayer, Boehringer Ingelheim, Servier, and Novartis; has served on the trial committee boards for Bayer, Medtronic, Boehringer Ingelheim, Vifor, Amgen, Servier, Impulse Dynamics, Cardior, and Novo Nordisk; and has served on the boards of the Heart Failure Association and JACC Heart Failure. Dr Gustafsson has received consulting fees and/or honoraria from Abbott, Bayer, Pfizer, and AstraZeneca; has participated on the trial committee board of AdJuCor; and has served on the board of the Heart Failure Association. Dr Haverkamp has received consulting fees and/or honoraria from Bayer and AstraZeneca. Dr Kelm has received grants or contracts from Microvision Medical Holding B.V., Edwards Lifesciences, Mars Scientific Advisory Council, Abiomed Europe GmbH, B. Braun Melsungen AG, DFG SFB 1116, EU Horizon 2020, and Daiichi-Sankyo Deutschland GmbH; and has received payment or honoraria from Bayer Vital GmbH, Abiomed Europe GmbH, AstraZeneca, Amarin GmbH, and CTI congress GmbH. Dr Landmesser has received grants from Abbott and Novartis; and has received consulting fees and honoraria from Abbott. Dr Maggioni has participated on trial committee boards for Bayer, AstraZeneca, Novartis, and Sanofi. Dr Metra has received consulting fees from Abbott Structural Heart, Boehringer Ingelheim, AstraZeneca, Roche Diagnostics, Edwards Lifesciences, Novo Nordisk, and Bayer. Dr Petrie has received grants from Boehringer Ingelheim, Roche Diagnostics, SQ Innovations, AstraZeneca, Novartis, Novo Nordisk, Medtronic, Boston Scientific, and Pharmacosmos; has received consulting fees and/or honoraria from Akero, Applied Therapeutics, Amgen, AnaCardio, Biosensors, Boehringer Ingelheim, Corteria, FIRE-1, Biosensors, REPRIEVE, Corvia, Novartis, AstraZeneca, Novo Nordisk, AbbVie, Bayer, Horizon Therapeutics, Takeda, Cardiorentis, Pharmacosmos, Roche Pharma, Siemens, Eli Lilly, Vifor, New Amsterdam, Moderna, Teikoku, LIB Therapeutics, and 3R Lifesciences; and has participated on a data safety monitoring board or advisory board for AstraZeneca, Moderna, and Teikoku. Dr Rassaf has received consulting fees and/or honoraria from BMS, AstraZeneca, Pfizer, Novartis, Bayer, Daiichi-Sankyo, and CVRxInc; and has pending patent applications regarding amelioration and treatment of infarct damage (W02023079141A2), blood pressure lowering composition (EP3646861A1), and Bnip3 peptides for the treatment of reperfusion injury (C=2021015130A2). Dr Ruschitzka has not received personal payments by pharmaceutical companies or device manufacturers in the last 3 years; the Department of Cardiology (University Hospital of Zurich/University of Zurich) has received research, educational, and/or travel grants from Abbott, Abiomed, Alexion, Amgen, AstraZeneca, At the Limits Ltd., Bayer, Berlin Heart, B. Braun, Biosense Webster, Biosensors Europe AG, Biotronik, BMS, Boehringer Ingelheim, Boston Scientific, Bracco, Cardinal Health Switzerland, Concept Medical, Corteria, CSL, Daiichi Sankyo, Diatools AG, Edwards Lifesciences, Guidant Europe NV (BS), Hamilton Health Sciences, IHF, Innosuisse, Johnson/Johnson, Kaneka Corporation, Kantar, Kiniksa, Labormedizinisches Zentrum, MedAlliance, Medical Education Global Solutions, Medtronic, MicroPort, MSD, Mundipharma Medical Company, Novartis, Novo Nordisk, Orion, Pfizer, Quintiles Switzerland Sarl, Recor Medical, Roche Diagnostics, Roche Pharma, Sahajanand IN, Sanofi, Sarstedt AG, Servier, SIS Medical, Sorin CRM SAS, SSS International Clinical Research, Stromal, Terumo Deutschland, Trama Solutions, V-Wave, Vascular Medical, Vifor, Wissens Plus, and ZOLL. Dr Schäfer has received grants, consulting fees, honoraria, and personal fees for consultancies, trial committee work, and/or lectures from Abbott Vascular, Edwards Lifesciences, and Polares Medical. Dr Schulze has received grants from Boehringer Ingelheim, Abiomed Inc, Edwards Lifesciences Inc, Cytosorb Inc, and Boston Scientific; and has received consulting fees and/or honoraria from Bayer, AstraZeneca, Daiichi- Sankyo, Novartis, Actelion, Roche, Sanofi, Pharmacosmos, Medtronic, Thoratec, Boehringer Ingelheim, HeartWare, Coronus, Abbott, Boston Scientific, St. Jude Medical, Abiomed, and DGK, and trial committee work for Abbott, Abiomed. Dr Spargias has received fees for proctoring for Abbott Vascular. Dr Vahanian has participated on a data safety monitoring board for Edwards Lifesciences, VenusTech, and Mayo Clinic. Dr Zamorano has received personal payments or honoraria from Viatris, Bayer, and Novartis. Dr Zeiher has received grants or contracts from or served on scientific advisory boards for AstraZeneca, Boehringer Ingelheim, and Novo Nordisk. Dr Koehler has received grants for Project 5G-MedCamp from the German Federal Ministry of Economics and climate protection (BMWK) and grants for projects RESKRIVER and 6 G Health; consulting fees and/or payments or honoraria from BIOTRONIK, Boehringer Ingelheim, Sanofi Germany GmbH, Novartis Germany (till 2022), and AMGEN Germany (in 2021). Dr Lainscak has received a grant from Slovenian Research Agency; and has received honoraria from Novartis, Boehringer Ingelheim, and AstraZeneca. Drs Mezilis and Theofilogiannakos have received support from Abbott for attending meetings. Dr Chrissoheris has received fees for proctoring for Abbott Vascular and Edwards Lifesciences; and has received honoraria from Edwards Lifesciences. Dr Papadopoulos has received consulting fees and honoraria from GE Healthcare. Dr Smolka has received fees for proctoring for Abbott Vascular. Dr Wojakowski has received consulting fees and/or honoraria from Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr Reczuch has received honoraria for lectures from Abbott. Dr Pinto has received consulting fees and/or honoraria from Boehringer Ingelheim, Daichi-Sankyo, Novartis, Servier, Vifor, and Zydus; and participated on advisory boards for Medtronic, Novartis, Servier, and Vifor. Dr Adamo has received honoraria from Abbott Vascular and Edwards Lifesciences. Dr Ruf has received fees proctoring and consulting for Abbott Laboratories and Edwards Lifesciences. Dr Hasenfuß has received personal fees from AstraZeneca, Boehringer, Corvia, Impulse Dynamics, Novartis, Pfizer, and Servier; and has served on trial committees for AstraZeneca, Boehringer, Corvia (no honoraria), Impulse Dynamics, Novartis, Servier, and Vifor Pharma. Dr Schillinger has received consulting and lecture fees and travel expenses from Abbott Vascular. Dr Anker has received grants and personal fees from Vifor and Abbott Vascular; has received personal fees for consultancies, trial committee work, and/or lectures from Actimed, AstraZeneca, Bayer, Bioventrix, Boehringer Ingelheim, Brahms, Cardiac Dimensions, Cardior, Cordio, CVRx, Cytokinetics, Edwards Lifesciences, Farraday Pharmaceuticals, GSK, HeartKinetics, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Occlutech, Pfizer, Regeneron, Relaxera, Repairon, Scirent, Sensible Medical, Servier, Vectorious, and V-Wave; and is named as coinventor of two patent applications regarding MR-proANP (DE 102007010834 & DE 102007022367), but he does not benefit personally from the related issued patents. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Aim: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials., Methods and Results: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm 2 , respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF., Conclusion: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice., (© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: Acute mitral regurgitation (MR) in the setting of myocardial infarction (MI) may be the result of papillary muscle rupture (PMR). This condition is associated with high morbidity and mortality. We aim to evaluate the feasibility of transcatheter edge-to-edge mitral valve repair (TEER) in this acute setting., Methods and Results: We analysed data from the International Registry of MitraClip in Acute Mitral Regurgitation following acute Myocardial Infarction (IREMMI) of 30 centres in Europe, North America, and the middle east. We included patients with post-MI PMR treated with TEER as a salvage procedure, and we evaluated immediate and 30-day outcomes. Twenty-three patients were included in this analysis (9 patients suffered complete papillary muscle rupture, 9 partial and 5 chordal rupture). The patients' mean age was 68 ± 14 years. Patients were at high surgical risk with median EuroSCORE II 27% (IQR 16, 28) and 20 out of 23 (87% were in cardiogenic shock). All patients were treated with vasopressors, and 17 out of 23 patients required mechanical support. TEER procedure was performed on the median 6 days after the index MI date IQR (3, 11). Procedural success was achieved in 87% of patients. The grade of MR was significantly decreased after the procedure. MR reduction to 0 or 1 + was achieved in 13 patients (57%), to 2 + in 7 patients (30%), P < 0.01. V-Wave was reduced from 49 ± 8 mmHg to 26 ± 10 mmHg post-procedure, P < 0.01. Sixteen out of 23 patients (70%) were discharged from hospital and 5 of them required reintervention with surgical mitral valve replacement. No additional death at 1 year was documented., Conclusions: TEER is a feasible therapy in critically ill patients with PMR due to a recent MI. TEER may have a role as salvage treatment or bridge to surgery in this population., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: A paravalvular leak (PVL) is a complication following valve replacement, which may lead to heart failure and hemolysis. The aim of this study is to investigate whether the clinical outcome after transcatheter PVL closure differs according to the prominent indication of the procedure (symptoms of heart failure or hemolysis)., Methods: The data of consecutive patients who had transcatheter treatment for PVL between July 2011 and September 2022 in five Greek centers were analyzed. The primary endpoint was the technical, and clinical success rates with regards to the prominent indication of paravalvular leak closure. The secondary endpoints included the evaluation and comparison of the clinical and technical success in relation to the type of valve that was treated (aortic or mitral) as well as the survival analysis in relation to the closure indication and type of valve that was treated., Results: In total, 60 patients were retrospectively studied (39% men, mean age 69.5 ± 11 years). Regarding the primary outcomes, the technical success in patients mainly suffering from hemolysis was 86.1%, while in those presenting heart failure it was 95.8%, p = 0.387. Furthermore, the clinical success was 72.2% and 87.5% among hemolysis and heart failure patients, respectively, p = 0.210. During the follow-up period, the two-year survival rates were significantly better for patients treated for the aortic valve (78.94%) compared to those in the mitral position (48.78%), p = 0.014. In total, 25 patients died (41.7%) during 24 months of follow-up., Conclusions: Transcatheter paravalvular leak closure can be performed with high technical and clinical success rates without any difference according to the prominent indication of closure.

Aims: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously., Methods and Results: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01)., Conclusions: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: Remote ischemic preconditioning (RIPC) is being evaluated as a strategy to reduce cardiac injury and inflammation in patients undergoing diverse cardiac invasive and surgical procedures. However, it is unclear whether RIPC has protective effects in patients undergoing the transfemoral- transcatheter aortic valve implantation (TF-TAVΙ) procedure., Methods: Between September 2013 and September 2015, 55 random consecutive patients were prospectively assigned to receive SHAM preconditioning (SHAM, 22 patients) or Remote Ischemic Preconditioning (RIPC) (4 cycles of 5 min intermittent leg ischemia and 5 min reperfusion, 33 patients) prior to TF-TAVI. The primary endpoint was to determine the serum levels of: hs-cTn-I (necrosis), CK-18 (apoptosis), and IL-1b (inflammation). Quantification was performed using commercially available ELISA kits. Patients were sampled 1-day pre TF-TAVΙ and 24-hours post TF-TAVΙ. Secondary endpoints included: total mortality, incidence of periprocedural clinical acute myocardial infarction (AMI), acute kidney injury (AKI), and stroke., Results: 22 SHAM patients and 33 RIPC patients were finally analyzed. Our data revealed no significant difference in serum levels of hs-cTn-I and CK-18 among various groups. However, in the RIPC group, the increase in IL1b level was significantly lower for 24-h post TF-TAVΙ, (p < 0.01). There were no significant differences between groups in the secondary endpoints at the follow-up interval of one month. RIPC-related adverse events were not observed., Conclusions: Our data suggest that RIPC did not exhibit significant cardiac or kidney protective effects regarding necrosis and apoptosis in patients undergoing TF-TAVΙ. However, an important anti-inflammatory effect was detected in the RIPC group., Competing Interests: Conflict of interest The authors declare that they have no conflicts of interest related to the subject matter or materials discussed in this article., (Copyright © 2021 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.)

Background: Paravalvular leak (PVL) is a common complication following valve replacement, which leads to heart failure and hemolysis. Transcatheter PVL closure has emerged as a reliable alternative with promising results. We quote the combined three-center experience of PVL patients treated percutaneously., Methods: Consecutive patients treated percutaneously for PVL were retrospectively studied. Procedural characteristics, inhospital, and long-term clinical outcomes were assessed. Technical (successful deployment) and clinical (NYHA and/or hemolysis improvement) success were evaluated., Results: In total, 39 patients treated for PVL in either the aortic (12 patients) or the mitral (27 patients) position were studied. Amplatzer Vascular Plug III was the most commonly used device among the 45 devices totally implanted. Postprocedurally, the rates of at least moderate PVL (87.5% preprocedurally vs 10.5% at discharge) and functional status (mean NYHA class 2.8 ± 0.7 on admission vs 1.5 ± 0.8 at follow-up) were statistically significantly improved. Total population technical success rate was 89.7%, being comparable between patients treated for mitral or aortic valve PVLs (92.6% vs 83.3%, respectively). Clinical success was achieved in 82.1% of patient cohort without statistical difference among those with isolated aortic or mitral PVL or among those with PVL closure an indication of heart failure or hemolysis. During a mean follow-up of 33.5 months, five patients died, including one periprocedural death., Conclusions: This multicenter recorded experience confirms that percutaneous PVL closure can be performed with high technical and clinical success rates and limited complications that lead to significant PVL reduction and functional status improvement., Competing Interests: Conflict of interest None., (Copyright © 2021 Hellenic Society of Cardiology. Published by Elsevier B.V. All rights reserved.)

Objectives: To assess outcomes in patients with acute mitral regurgitation (MR) following acute myocardial infarction (AMI) who received percutaneous mitral valve repair (PMVR) with the MitraClip device and to compare outcomes of patients who developed cardiogenic shock (CS) to those who did not (non-CS)., Background: Acute MR after AMI may lead to CS and is associated with high mortality., Methods: This registry analyzed patients with MR after AMI who were treated with MitraClip at 18 centers within eight countries between January 2016 and February 2020. Patients were stratified into CS and non-CS groups. Primary outcomes were mortality and rehospitalization due to heart failure. Secondary outcomes were acute procedural success, functional improvement, and MR reduction. Multivariable Cox regression analysis evaluated association of CS with clinical outcomes., Results: Among 93 patients analyzed (age 70.3 ± 10.2 years), 50 patients (53.8%) experienced CS before PMVR. Mortality at 30 days (10% CS vs. 2.3% non-CS; p = .212) did not differ between groups. After median follow-up of 7 months (IQR 2.5-17 months), the combined event mortality/re-hospitalization was similar (28% CS vs. 25.6% non-CS; p = .793). Likewise, immediate procedural success (90% CS vs. 93% non-CS; p = .793) and need for reintervention (CS 6% vs. non-CS 2.3%, p = .621) or re-admission due to HF (CS 13% vs. NCS 23%, p = .253) at 3 months did not differ. CS was not independently associated with the combined end-point (hazard ratio 1.1; 95% CI, 0.3-4.6; p = .889)., Conclusions: Patients found to have significant MR during their index hospitalization for AMI had similar clinical outcomes with PMVR whether they presented in or out of cardiogenic shock, provided initial hemodynamic stabilization was first achieved before PMVR., (© 2021 Wiley Periodicals LLC.)

Patients with severe mitral regurgitation (MR) after myocardial infarction (MI) have an increased risk of mortality. Transcatheter mitral valve repair may therefore be a suitable therapy. However, data on clinical outcomes of patients in an acute setting are scarce, especially those with reduced left ventricle (LV) dysfunction. We conducted a multinational, collaborative data analysis from 21 centers for patients who were, within 90 days of acute MI, treated with MitraClip due to severe MR. The cohort was divided according to median left ventricle ejection fraction (LVEF)-35%. Included in the study were 105 patients. The mean age was 71 ± 10 years. Patients in the LVEF < 35% group were younger but with comparable Euroscore II, multivessel coronary artery disease, prior MI and coronary artery bypass graft surgery. Procedure time was comparable and acute success rate was high in both groups (94% vs. 90%, p = 0.728). MR grade was significantly reduced in both groups along with an immediate reduction in left atrial V-wave, pulmonary artery pressure and improvement in New York Heart Association (NYHA) class. In-hospital and 1-year mortality rates were not significantly different between the two groups (11% vs. 7%, p = 0.51 and 19% vs. 12%, p = 0.49) and neither was the 3-month re-hospitalization rate. In conclusion, MitraClip intervention in patients with acute severe functional mitral regurgitation (FMR) due to a recent MI in an acute setting is safe and feasible. Even patients with severe LV dysfunction may benefit from transcatheter mitral valve intervention and should not be excluded.

Aims: The purpose of this study is to identify echocardiography predictors of clinical response and reverse left ventricular (LV) remodelling in patients with functional mitral regurgitation (FMR) treated with MitraClip., Method and Results: We retrospectively analysed 86 high surgical risk patients with severe FMR; of those, 58 were implanted a MitraClip, and 28 received medical treatment and served as controls. At baseline and at 1-year follow-up, we performed clinical and echocardiography evaluation to assess global longitudinal strain (GLS) and myocardial work [global work index (GWI), global constructive work (GCW), global wasted work (GWW), global work efficiency (GWE)]. Mitral regurgitation was significantly reduced after MitraClip implantation (3.7 ± 0.4 vs. 1.7 ± 0.8, P < 0.001), and the procedure was associated with improvement in brain natriuretic peptide levels (980 ± 1027 vs. 420 ± 338 pg/mL, P < 0.001), New York Heart Association class status (3.2 ± 0.55 vs. 2.0 ± 0.6, P < 0.001), 6-min walking test (233 ± 154 vs. 286 ± 114 m, P = 0.01) at follow-up and reduction of left ventricle end-systolic (LVESV) and left ventricle end-diastolic volumes (LVEDV) (152 ± 68 vs. 136 ± 43 mL, P = 0.004 & 219 ± 74 vs. 193 ± 66 mL, P = 0.001, respectively). MitraClip procedure was associated with improvement of LV performance and significant increase of GWI (607 ± 282 vs. 650 ± 260 mmHg%, P = 0.045) and GCW (854 ± 288 vs. 949 ± 325 mmHg%, P < 0.001). Baseline ejection fraction (EF), GLS, GWI, GCW, and effective regurgitant orifice area were the variables that were associated with reduction of LVEDV 1 year after intervention (P < 0.05 for all) and baseline GCW of the LV was the only variable associated with reduction of LVESV (P = 0.002). Receiver operating characteristic curve analysis identified that a GLS cut-off value of -8.65% (AUC 0.815, P = 0.007) was associated with a 20% reduction of the LVEDV with a sensitivity and specificity of 72% and 70%, respectively, and that a GCW cut-off value of 846 mmHg% (AUC 0.759, P = 0.007) was associated with a 10% reduction of LVESV with sensitivity and specificity 79% and 74%, respectively., Conclusions: Mitral valve repair with MitraClip has positive clinical and echocardiographic impact in patients with FMR 1 year after implantation. Preserved GLS and GCW values appear to be associated with LV reverse remodelling post intervention., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)

This report presents the case of an 82-year-old man with known dextrocardia and situs inversus totalis who presented with increasing dyspnea on exertion and was diagnosed with severe aortic stenosis. Transcatheter aortic valve replacement was performed and required deviation from standard techniques for patients with normal anatomy and left-sided aortic arch. We describe two technical differences required for patients with dextrocardia and right-sided aortic arch that facilitate transcatheter aortic valve replacement in this patient group., (Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system., Methods: In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions., Findings: Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II., Interpretation: This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes., Funding: None., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: Aortic stenosis imposes a chronic pressure overload on the left ventricle, with attendant adaptations in hemodynamics, muscle mass and performance. The hemodynamic changes that occur during the initial 24 h following abrupt removal of the impediment to left ventricular outflow have not been previously examined., Methods: A total of 52 patients with right heart catheterization was evaluated before, within 6 h and at 24 h after successful transcatheter aortic valve replacement (TAVR). Echocardiographic data were examined before and within 30 days of the procedure., Results: TAVR was successful in all 52 patients, and at 24 h after the procedure resulted in: (i) an increase in cardiac index (CI) (from 2.0 ± 0.6 to 3.1 ± 0.7 l/min/ m2, p <0.001) and stroke volume (SV) (from 62.3 ± 18.7 to 76.6 ± 21.3 ml, p <0.001); (ii) reductions in systemic vascular resistance (from 1555 ± 458 to 1021 ± 280 dyne·s/cm5, p <0.001) and pulmonary vascular resistance (from 174 ± 150 to 112 ± 76 dyne·s/cm5, p = 0.001); (iii) reductions in pulmonary capillary wedge pressure (from 24.2 ± 6.7 to 19.7 ± 7.3 mmHg, p <0.001), mean pulmonary artery pressure (from 32.2 ± 9.9 to 27.5 ± 8.8 mmHg, p = 0.002) and in central venous pressure (from 13.5 ± 4.8 to 9.4 ± 3.9 mmHg, p <0.001); and (iv) an increase in systolic arterial pressure (from 127 ± 25 to 135 ± 14 mmHg, p = 0.04), along with a decrease in diastolic arterial pressure (from 58 ± 11 to 53 ± 9 mmHg, p = 0.009)., Conclusions: Successful TAVR results in immediate and sizeable improvements in SV and CI, reductions in left and right ventricular filling pressures, and marked reductions in systemic and pulmonary vascular resistances.

The MitraClip procedure is an important procedure for the treatment of high-risk patients with severe MR, offering an effective and clinically meaningful reduction in the degree of MR, with low perioperative morbidity and mortality. Careful screening of prospective patients and evaluation by the multidisciplinary Heart Team are essential. A dedicated interventional team combining technical skills and advanced imaging is critical for success.

Bioprosthetic heart valves are often preferred over mechanical valves as they may preclude the need for anticoagulation. Reoperation is the standard treatment for structural failure of bioprosthetic valves; however, it carries significant risk especially in inoperable elderly patients. Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) seems to be an effective and promising procedure in patients with degenerated bioprosthetic aortic valves avoiding the risks associated with the use of cardioplegia and redo cardiac surgery. We report an interesting case of a high-risk 74-year-old patient with a degenerated Sorin Freedom Solo stentless valve treated successfully with ViV TAVR.

Introduction: Transcatheter aortic valve replacement (TAVR) is now an established treatment for certain patients with severe aortic valve stenosis (AS). However, as the number of patients screened for TAVR increases, many are found to have absolutely no option for peripheral artery access. Transaortic valve replacement (TAoVR) has been proposed as a new alternative route in patients deemed unsuitable for conventional approaches. We present our first series of TAoVR cases using the Edwards Sapien-XT and the Medtronic CoreValve prostheses., Methods: Twenty-five (25) symptomatic patients (mean age 78 ± 8 years, mean logistic EuroSCORE I 25 ± 11%) with severe AS underwent TAoVR using the Sapien-XT valve (10 patients) or the CoreValve (15 patients)., Results: The mean fluoroscopy time was 15.6 ± 4.2 minutes, the mean time in the intensive care unit was 1.9 ± 1.0 days, and the mean hospital stay was 6.4 ± 1.6 days. The mean effective aortic valve area increased (from 0.68 ± 0.15 cm(2) to 1.82 ± 0.34 cm(2), p<0.001) and the mean transvalvular pressure gradient declined (from 48 ± 15 mmHg to 9 ± 5 mmHg, p<0.05) post implantation. The procedural mortality was 0% and the in-hospital mortality was 4% (one death at day 3 due to cardiogenic shock). The mean NYHA functional class improved from 3.2 ± 0.4 to 1.5 ± 0.9 at 30 days., Conclusions: Our initial experience with the TAoVR approach using both the Edwards Sapien-XT and the Medtronic CoreValve prosthesis demonstrated that it could be performed safely, resulting in substantial acute echocardiographic and early clinical improvement.

Clinically significant mitral prosthetic paravalvular leaks may occur in up to 5% of patients following surgical mitral valve replacement. Successful closure may offer relief from symptoms of heart failure and hemolysis, but surgical closure is associated with increased morbidity and mortality. Alternative transcatheter closure techniques are being developed. We present a patient who was successfully treated via a transapical approach with deployment of an amplatzer duct occluder type I closure device under real-time two-dimensional transesophageal echocardiography.

Introduction: Transcatheter aortic valve replacement (TAVR) is a documented treatment for patients with symptomatic aortic stenosis who are at very high or prohibitive operative risk. We sought to investigate the outcomes of transfemoral procedures with the newer generation valves in four TAVR centres in Athens, Greece., Methods: The ATHENS TAVR Registry included all patients who underwent transfemoral implantation of the newer generation valves in 4 Athens TAVR centres (self-expanding valve 67 patients, balloon-expandable valve 59 patients). We present the procedural and echocardiographic data and the 30-day clinical outcomes according to valve type., Results: A total of 126 patients underwent 126 procedures (67 CoreValve, Medtronic; 59 SAPIEN XT, Edwards Lifesciences). The mean age and logistic EuroSCORE were 80 ± 8 years and 25 ± 13%. The procedural and device success rates were 100% and 98%, respectively. The 30-day mortality was 1% (n=1), the major vascular event rates 9% (similar for both valve types), and a new permanent pacemaker was implanted more often during the same hospitalisation after CoreValve (33% vs. 9%, p=0.001). The mean effective aortic valve area increased and the mean transvalvular pressure gradient declined post implantation (from 0.66 ± 0.15 cm(2) to 1.61 ± 0.43 cm(2), p<0.001; from 51 ± 14 mm Hg to 10 ± 3 mm Hg, p<0.001). The mean grade of aortic insufficiency increased after CoreValve (from 1.2 ± 0.6 to 1.5 ± 0.7, p=0.03) but remained stable after SAPIEN XT (1.0 ± 0.8 and 1.0 ± 0.6, p=0.88) implantation., Conclusions: TAVR outcomes with both the newer generation transfemoral valves in the ATHENS Registry were excellent. We observed a greater need for a new permanent pacemaker and a greater degree of aortic valve insufficiency after CoreValve implantation.

Introduction: Mitral valve (MV) repair is the treatment of choice for degenerative mitral regurgitation (MR), but the surgical options for functional MR are limited. Percutaneous edge-to-edge MV repair using the MitraClip system has evolved as a new tool for the treatment of certain anatomical subsets of both functional and degenerative MR. We present the first Greek series of MV repair using the MitraClip., Methods: Five symptomatic patients (age 75 ± 9 years, logistic EuroSCORE 29 ± 11%) with moderate-tosevere (n=2) or severe (n=3) MR underwent MV repair using the MitraClip. All patients were treated with one clip and there were no primary adverse events., Results: Acute MR reduction by 3 grades was achieved in 2 patients and by 2 grades in 3 patients (reduction 2 grades in 100%). The total procedure time was 2.9 ± 2 hours (median 2 hours), the length of the ICU stay was 1 ± 0 day and the total length of hospital stay was 3.2 ± 0.6 days. All patients reported functional status improvement by 1 month (mean NYHA class improved from 3.0 ± 0.3 to 1.6 ± 0.6)., Conclusion: Our initial experience with percutaneous MV repair using the MitraClip system demonstrated that it can be performed safely, resulting in substantial acute echocardiographic and early clinical improvement.

Dyspnea and heart murmur are common reasons for referrals in cardiology and both are associated with a broad differential diagnosis. Sinus of Valsalva aneurysms are rare abnormalities of the aortic root that should be considered in the differential diagnosis in young and middle aged patients. Sinus of Valsalva aneurysms are often associated with supracristal ventricular septal defects and can be identified on transthoracic echocardiography. Diagnosis of a SVA should trigger a careful search for ventricular septal defect, which may necessitate transesophageal echocardiography.