Publications by authors named "Bart Meuris"

114 Publications

Influence of Tissue Technology on Pannus Formation on Bioprosthetic Heart Valves.

Cardiovasc Eng Technol 2021 Apr 20. Epub 2021 Apr 20.

Cardiac Surgery, Department of Cardiovascular Sciences, University Hospitals Leuven, Leuven, Belgium.

Purpose: Bioprosthetic heart valves have several modes of failure. Tissue degeneration and calcification are the major modes of failure with the highest focus of attention, however pannus formation can also be problematic. We studied the effect of a new tissue technology with the absence of any glutaraldehyde-based storage solution and a stable aldehyde capping process on pannus formation.

Methods: Using a juvenile sheep model of mitral valve replacement, valves with the new tissue technology were compared to control valves with contemporary bovine pericardial tissue, regarding pannus formation. Valves were implanted for either a 5- or 8-month period. Explanted valves were examined macroscopically and histologically. Histological observations were made by an independent pathologist, blinded to group identity.

Results: Pannus area measured macroscopically on the test valves was significantly lower than the pannus on the control tissue. This was confirmed on the histological samples, where the total pannus overgrowth was significantly lower in the test group compared to the control.

Conclusion: The new tissue technology leads to less pannus formation. This may beneficially influence both short- and long-term valve behavior of bioprosthetic valves.
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http://dx.doi.org/10.1007/s13239-021-00530-1DOI Listing
April 2021

Pre-clinical in vivo Models of Vascular Graft Coating in the Prevention of Vascular Graft Infection: A Systematic Review.

Eur J Vasc Endovasc Surg 2021 Apr 8. Epub 2021 Apr 8.

Department of Vascular Surgery, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, Research Unit of Vascular Surgery, KU Leuven, Leuven, Belgium.

Objective: Vascular graft infection (VGI) remains an important complication with a high mortality and morbidity rate. Currently, studies focusing on the role of vascular graft coatings in the prevention of VGI are scarce. Therefore, the aims of this study were to survey and summarise key features of pre-clinical in vivo models that have been used to investigate coating strategies to prevent VGI and to set up an ideal model that can be used in future preclinical research.

Data Sources: A systematic review was conducted in accordance with the Preferred reporting items for Systematic Reviews and Meta-Analysis guidelines. A comprehensive search was performed in MEDLINE (PubMed), Embase, and Web of Science.

Review Methods: For each database, a specific search strategy was developed. Quality was assessed with the Toxicological data Reliability Assessment Tool (ToxRTool). The type of animal model, graft, coating, and pathogen were summarised. The outcome assessment in each study was evaluated.

Results: In total, 4 667 studies were identified, of which 94 papers focusing on in vivo testing were included. Staphylococcus aureus was the organism most used (n = 65; 67.7%). Most of the graft types were polyester grafts. Rifampicin was the most frequently used antibiotic coating (n = 43, 48.3%). In the outcome assessment, most studies mentioned colony forming unit count (n = 88; 91.7%) and clinical outcome (n = 72; 75%). According to the ToxRTool, 21 (22.3%, n = 21/94) studies were considered to be not reliable.

Conclusion: Currently published in vivo models are very miscellaneous. More attention should be paid to the methodology of these pre-clinical reports when transferring novel graft coatings into clinical practice. Variables used in pre-clinical reports (bacterial strain, duration of activity coating) do not correspond well to current clinical studies. Based on the results of this review, a proposal for a complete and comprehensive set up for pre-clinical invivo testing of anti-infectious properties of vascular graft coatings was defined.
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http://dx.doi.org/10.1016/j.ejvs.2021.02.054DOI Listing
April 2021

Geriatric co-management for cardiology patients in the hospital: A quasi-experimental study.

J Am Geriatr Soc 2021 Mar 17. Epub 2021 Mar 17.

Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.

Background/objectives: Older patients admitted to cardiac care units often suffer functional decline. We evaluated whether a nurse-led geriatric co-management program leads to better functional status at hospital discharge.

Design: A quasi-experimental before-and-after study was performed between September 2016 and December 2018, with the main endpoint at hospital discharge and follow-up at 6 months.

Setting: Two cardiac care units of the University Hospitals Leuven.

Participants: One hundred and fifty-one intervention and 158 control patients aged 75 years or older admitted for acute cardiovascular disease or transcatheter aortic valve implantation.

Intervention: A nurse from the geriatrics department performed a comprehensive geriatric assessment within 24 h of admission. The cardiac care team and geriatrics nurse drafted an interdisciplinary care plan, focusing on early rehabilitation, discharge planning, promoting physical activity, and preventing geriatric syndromes. The geriatrics nurse provided daily follow-up and coached the cardiac team. A geriatrician co-managed patients with complications.

Measurements: The primary outcome was functional status measured using the Katz Index for independence in activities of daily living (ADL; one-point difference was considered clinically relevant). Secondary outcomes included the incidence of ADL decline and complications, length of stay, unplanned readmissions, survival, and quality of life.

Results: The mean age of patients was 85 years. Intervention patients had better functional status at hospital discharge (8.9, 95% CI = 8.7-9.3 versus 9.5, 95% CI = 9.2-9.9; p = 0.019) and experienced 18% less functional decline during hospitalization (25% vs. 43%, p = 0.006). The intervention group experienced significantly fewer cases of delirium and obstipation during hospitalization, and significantly fewer nosocomial infections. At 6-month follow-up, patients had significantly better functional status and quality of life. There were no differences regarding length of stay, readmissions, or survival.

Conclusion: This first nurse-led geriatric co-management program for frail patients on cardiac care units was not effective in improving functional status, but significantly improved secondary outcomes.
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http://dx.doi.org/10.1111/jgs.17093DOI Listing
March 2021

Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study.

J Thorac Cardiovasc Surg 2021 Jan 13. Epub 2021 Jan 13.

Cardio-thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Objective: The objective of this study was to report midterm clinical outcomes with a self-expandable sutureless aortic valve.

Methods: Between 2010 and 2013, 658 patients at 25 European institutions received the Perceval sutureless valve (LivaNova Plc, London, United Kingdom). Mean follow-up was 3.8 years; late cumulative follow-up was 2325.2 patient-years.

Results: The mean age of the population was 78.3 ± 5.6 years and 40.0% (n = 263) were 80 years of age or older; mean Society of Thoracic Surgeons-Predicted Risk of Mortality score was 7.2 ± 7.4. Concomitant procedures were performed in 31.5% (n = 207) of patients. Overall duration of cardiopulmonary bypass time was 64.8 ± 25.2 minutes and aortic cross-clamping time was 40.7 ± 18.1 minutes. Thirty-day all-cause mortality was 3.7% (23 patients), with an observed:expected ratio of 0.51. Overall survival was 91.6% at 1 year, 88.5% at 2 years, and 72.7% at 5 years. Peak and mean gradients remained stable during follow-up, and were 17.8 ± 11.3 mm Hg and 9.0 ± 6.3 mm Hg, respectively, at 5 years. Preoperatively, 33.4% of those who received the Perceval valve (n = 210) were in New York Heart Association functional class I or II versus 93.1% (n = 242) at 5 years.

Conclusions: This series, representing, to our knowledge, the longest follow-up with sutureless technology in a prospective, multicenter study, shows that aortic replacement using sutureless valves is associated with low mortality and morbidity and good hemodynamic performance.
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http://dx.doi.org/10.1016/j.jtcvs.2020.12.109DOI Listing
January 2021

Device profile of the Inspiris Resilia valve for aortic valve replacement: overview of its safety and efficacy.

Expert Rev Med Devices 2021 Mar 27;18(3):239-244. Epub 2021 Feb 27.

Department of Cardiovascular Diseases, Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium.

Introduction: The Inspiris Resilia tissue valve was recently introduced into clinical practice. This review summarizes the pre-clinical and clinical studies leading to this new bioprosthesis.

Areas Covered: The novel Resilia tissue was tested extensively in a large animal model. The clinical use of the tissue started in 2011 with the European Feasibility study, followed by a North-American multi-center study. Since 2017, the Inspiris Resilia valve has been in full commercial use. Further prospective evaluations and registries are ongoing.

Expert Opinion: The Inspiris Resilia valve was clinically introduced after pre-clinical tests revealed superiority compared to contemporary therapy such as the Perimount valve. Prospective long-term follow-up studies on Resilia are ongoing since 2011 and reveal no major complications. Full 5-year data show no signs of early degeneration, but longer follow-up is certainly still needed. Several prospective registries are actively monitoring the outcome with the Inspiris Resilia valve now. The novel tissue, designed to mitigate calcification and increase durability, together with the expandable stent, facilitating potential future valve-in-valve (ViV) procedures, are the cutting-edge aspects. Clinical use in younger patients is currently ongoing: their follow-up and outcome will determine the added value of this valve.
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http://dx.doi.org/10.1080/17434440.2021.1886921DOI Listing
March 2021

Perceval: the bottom line.

Ann Thorac Surg 2021 Feb 8. Epub 2021 Feb 8.

University Hospitals Leuven, Cardiac Surgery, Herestraat 49 3000, Leuven, Belgium.

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http://dx.doi.org/10.1016/j.athoracsur.2020.11.071DOI Listing
February 2021

Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis.

J Thorac Cardiovasc Surg 2021 03 14;161(3):920-932. Epub 2020 Dec 14.

Cardio-Thoracic Surgery Department, Heart and Vascular Center, Maastricht University Medical Center (MUMC+), Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.

Objective: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis.

Methods: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year.

Results: At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar.

Conclusions: Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.
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http://dx.doi.org/10.1016/j.jtcvs.2020.11.162DOI Listing
March 2021

Cardiac Microvascular Endothelial Cells in Pressure Overload-Induced Heart Disease.

Circ Heart Fail 2021 Jan 19;14(1):e006979. Epub 2021 Jan 19.

Department of Cardiovascular Sciences (S.T., H.H., S.C., P.P., J.V.W., H.G., D.V., F.W., E.C., J.A.S., F.R., B. Meuris, B. Meyns, W.O., J.D., K.G., J.-U.V., M.-C.H., P.H., A.L., S.J.), KU Leuven, Belgium.

Background: Chronic pressure overload predisposes to heart failure, but the pathogenic role of microvascular endothelial cells (MiVEC) remains unknown. We characterized transcriptional, metabolic, and functional adaptation of cardiac MiVEC to pressure overload in mice and patients with aortic stenosis (AS).

Methods: In mice subjected to transverse aortic constriction or sham surgery, we performed RNA sequencing of isolated cardiac -MiVEC and validated the signature in freshly isolated MiVEC from left ventricle outflow tract and right atrium of patients with AS. We next compared their angiogenic and metabolic profiles and finally correlated molecular and pathological signatures with clinical phenotypes of 42 patients with AS (50% women).

Results: In mice, transverse aortic constriction induced progressive systolic dysfunction, fibrosis, and reduced microvascular density. After 10 weeks, 25 genes predominantly involved in matrix-regulation were >2-fold upregulated in isolated MiVEC. Increased transcript levels of (), , , and were confirmed by quantitative reverse transcription polymerase chain reaction and recapitulated in left ventricle outflow tract-derived MiVEC of AS (<0.05 versus right atrium-MiVEC). Fatty acid oxidation increased >2-fold in left ventricle outflow tract-MiVEC, proline content by 130% (median, IQR, 58%-474%; =0.008) and procollagen secretion by 85% (mean [95% CI, 16%-154%]; <0.05 versus right atrium-MiVEC for all). The altered transcriptome in left ventricle outflow tract-MiVEC was associated with impaired 2-dimensional-vascular network formation and 3-dimensional-spheroid sprouting (<0.05 versus right atrium-MiVEC), profibrotic ultrastructural changes, and impaired diastolic left ventricle function, capillary density and functional status, especially in female AS.

Conclusions: Pressure overload induces major transcriptional and metabolic adaptations in cardiac MiVEC resulting in excess interstitial fibrosis and impaired angiogenesis. Molecular rewiring of MiVEC is worse in women, compromises functional status, and identifies novel targets for intervention.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.120.006979DOI Listing
January 2021

Aortic valve replacement using stented or sutureless/rapid deployment prosthesis via either full-sternotomy or a minimally invasive approach: a network meta-analysis.

Ann Cardiothorac Surg 2020 Sep;9(5):347-363

Ospedale del Cuore Fondazione Toscana "G. Monasterio", Massa, Italy.

Background: New technologies such as sutureless or rapid deployment prosthetic valves and access via minimally invasive incisions offer alternatives to traditional full-sternotomy aortic valve replacement (SAVR). However, a comprehensive comparison of these surgical techniques along with alternative valve prosthesis has not been completed.

Methods: Electronic databases were searched for studies comparing outcomes for SAVR, minimally invasive AVR (MiAVR), sutureless/rapid-deployment AVR (SuAVR) via full-sternotomy, or minimally invasive SuAVR (MiSuAVR) from their inception until September 2018. Early postoperative outcomes and follow-up data were included in a Bayesian network meta-analysis.

Results: Twenty-three studies with 8,718 patients were identified. Compared with standard SAVR, SuAVR had significantly lower incidence of postoperative AF [odds ratio (OR) 0.33, 95% confidence interval (CI): 0.14-0.79, P=0.013] and MiSuAVR greater requirement for postoperative permanent pacemaker (OR 2.27, 95% CI: 1.25-4.14, P=0.008). All sutureless/rapid-deployment procedures had reduced cardiopulmonary bypass and cross-clamp times, by a mean of 25.9 and 25.0 min, respectively. Hospital length of stay (LOS), but not intensive care LOS, was reduced for all groups (MiAVR -1.53 days, MiSuAVR -2.79 days, and SuAVR 3.37 days). A signal towards reduced early mortality, wound infections, and acute kidney injury was noted in both sutureless/rapid-deployment and minimally invasive techniques but did not achieve significance. Sutureless/rapid-deployment procedures had favourable survival and freedom from valve related reoperation, however follow-up times were short and demonstrated significant heterogeneity between intervention groups.

Conclusions: Minimally invasive and sutureless techniques demonstrate equivalent early postoperative outcomes to SAVR and may reduce ventilation time, hospital LOS and postoperative atrial fibrillation (POAF) burden.
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http://dx.doi.org/10.21037/acs-2020-surd-17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7548209PMC
September 2020

Perceval Sutureless Aortic Valve Implantation: Midterm Outcomes.

Ann Thorac Surg 2021 04 28;111(4):1331-1337. Epub 2020 Aug 28.

Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium. Electronic address:

Background: Because our center participated in the first-in-human trial with Perceval (LivaNova, Sallugia, Italy) in 2007, this series represents the longest available clinical follow-up (11 years) with sutureless technology in aortic valve replacement.

Methods: We collected all clinical and echocardiographic follow-up in 468 consecutive patients who received Perceval at our institution between 2007 and 2017. In 57% of cases, surgery was combined with coronary artery bypass grafting (39%), mitral valve surgery (17%), or other procedures (13%).

Results: Mean age was 79 years, mean EuroSCORE II was 5.1 ± 5.5 (range, 0.8-67) and mean Society of Thoracic Surgeons score was 5.8 ± 5.5. Mean cross-clamp times for isolated and combined procedures were 39 and 79 minutes, respectively. Observed all-cause 30-day mortality was 3.2%, with an early stroke rate of 1.8%. Pacemaker implantation rate was 7.9% overall, but only 3.9% in patients without preexisting conduction or rhythm disorders. All-cause mortality at 1 and 2 years was 8.8% ± 1.3% and 13.2% ± 1.6%, respectively. At the latest echocardiographic follow-up (mean, 3 years; range, 1-11 years), peak and mean gradients were 23 ± 10 mm Hg and 13 ± 6 mm Hg, respectively. During follow-up, we explanted 5 valves for endocarditis, and none for structural valve degeneration.

Conclusions: After more than 11 years of continued clinical use of the Perceval sutureless valve, we observe low mortality and stroke rates, with good hemodynamic behavior of the valve. None of our patients was reoperated for structural valve degeneration. Because of the key benefits of this rapid-deployment valve, it has an added value in surgical aortic valve replacement.
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http://dx.doi.org/10.1016/j.athoracsur.2020.06.064DOI Listing
April 2021

Long-term outcome with sutureless valves: 12 years of Perceval experience.

Ann Cardiothorac Surg 2020 Jul;9(4):322-324

Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium.

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http://dx.doi.org/10.21037/acs.2020.04.03DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415690PMC
July 2020

Sutureless and rapid deployment implantation in bicuspid aortic valve: results from the sutureless and rapid-deployment aortic valve replacement international registry.

Ann Cardiothorac Surg 2020 Jul;9(4):298-304

Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy.

Background: Benefits of sutureless and rapid deployment (SURD) bioprostheses in bicuspid aortic valves (BAV) are controversial. The aim of this study is to report the outcomes of patients undergoing aortic valve replacement (AVR) for BAV from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR).

Methods: Of the 4,636 patients who received primary isolated SURD-AVR between 2007 and 2018, 191 (4.1%) BAV patients underwent AVR with SURD valve.

Results: Overall 30-day mortality was 1.6%. The Intuity valve was implanted in 53.9% of cases, whereas the Perceval was implanted in 46.1%. Rate of stroke for isolated AVR was 4.2%. No case of endocarditis, thromboembolism, myocardial infarction, valve dislocation or structural valve deterioration was reported in the early phase. Rate of pacemaker implantation and moderate-severe aortic regurgitation (AR) were 7.9% and 3.7%, respectively.

Conclusions: BAV is not considered a contraindication for the implantation of SURD valves. However, detailed information of aortic root geometry as well as the knowledge of some technical considerations are mandatory for a good outcome.
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http://dx.doi.org/10.21037/acs-2020-surd-33DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415698PMC
July 2020

Cardiac surgery in the time of the novel coronavirus: Why we should think to a new normal.

J Card Surg 2020 Aug 15;35(8):1761-1764. Epub 2020 Jul 15.

Cardiac Surgery Department, Villa Torri Hospital, GVM Care & Research, Bologna, Italy.

On 11 March 2020, the World Health Organization declared the SARS-CoV-2 outbreak a pandemic. At the time of writing, 24 May 2020 more than 5 million individuals have been tested positive and the death toll was over 330 000 deaths worldwide. The initial data pointed out the tight bond between cardiovascular diseases and worse health outcomes in COVID19-patients. Epidemiologically speaking, there is an overlap between the age-groups more affected by COVID-related death and the age-groups in which Cardiac Surgery has its usual base of patients. The Cardiac Surgery Departments have to think to a new normal: since the virus will remain endemic in the society, dedicated pathways or even dedicated Teams are pivotal to treat safely the patients, in respect of the safety of the health care workers. Moreover, we need a keen eye on deciding which pathologies have to be treated with priority: Coronary artery Disease showed a higher mortality rate in patients affected by COVID19, but it is, however, reasonable to think that all the cardiac pathologies affecting the lung circulation-such as symptomatic severe mitral diseases or aortic stenosis-might deserve a priority access to treatment, to increase the survival rate in case of an acquired-Coronavirus infection later on.
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http://dx.doi.org/10.1111/jocs.14741DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404671PMC
August 2020

Minimally invasive access type related to outcomes of sutureless and rapid deployment valves.

Eur J Cardiothorac Surg 2020 11;58(5):1063-1071

Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy.

Objectives: Minimally invasive surgical techniques with optimal outcomes are of paramount importance. Sutureless and rapid deployment aortic valves are increasingly implanted via minimally invasive approaches. We aimed to analyse the procedural outcomes of a full sternotomy (FS) compared with those of minimally invasive cardiac surgery (MICS) and further assess MICS, namely ministernotomy (MS) and anterior right thoracotomy (ART).

Methods: We selected all isolated aortic valve replacements in the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR, n = 2257) and performed propensity score matching to compare aortic valve replacement through FS or MICS (n = 508/group) as well as through MS and ART accesses (n = 569/group).

Results: Postoperative mortality was 1.6% in FS and MICS patients who had a mean logistic EuroSCORE of 11%. Cross-clamp and cardiopulmonary bypass (CPB) times were shorter in the FS group than in the MICS group (mean difference 3.2 and 9.2 min; P < 0.001). Patients undergoing FS had a higher rate of acute kidney injury (5.6% vs 2.8%; P = 0.012). Direct comparison of MS and ART revealed longer mean cross-clamp and CPB times (12 and 16.7 min) in the ART group (P < 0.001). The postoperative outcome revealed a higher stroke rate (3.2% vs 1.2%; P = 0.043) as well as a longer postoperative intensive care unit [2 (1-3) vs 1 (1-3) days; P = 0.009] and hospital stay [11 (8-16) vs 8 (7-12) days; P < 0.001] in the MS group than in the ART group.

Conclusions: According to this non-randomized international registry, FS resulted in a higher rate of acute kidney injury. The ART access showed a lower stroke rate than MS and a shorter hospital stay than all other accesses. All these findings may be related to underlying patient risk factors.
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http://dx.doi.org/10.1093/ejcts/ezaa154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577292PMC
November 2020

Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry.

J Cardiothorac Surg 2020 May 27;15(1):119. Epub 2020 May 27.

Cardiac Surgery, European Hospital, Rome, Italy.

Background: There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR.

Methods: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20-22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life.

Discussion: INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years.

Trial Registration: ClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018).
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http://dx.doi.org/10.1186/s13019-020-01155-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251702PMC
May 2020

Current trends of sutureless and rapid deployment valves: an 11-year experience from the Sutureless and Rapid Deployment International Registry.

Eur J Cardiothorac Surg 2020 11;58(5):1054-1062

Cardiac Surgery Unit, Lancisi Cardiovascular Center, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy.

Objectives: Current evidence on sutureless and rapid deployment aortic valve replacement (SURD-AVR) is limited and does not allow for the assessment of the clinical impact and the evolution of procedural and clinical outcomes of this new valve technology. The Sutureless and Rapid Deployment International Registry (SURD-IR) represents a unique opportunity to evaluate the current trends and outcomes of SURD-AVR interventions.

Methods: Data from 3682 patients enrolled between 2007 and 2018 were analysed. Patients were divided according to the date of surgery into 6 equal groups and by the type of intervention: isolated SURD-AVR (n = 2472) and combined SURD-AVR (n = 1086).

Results: Across the 11-year study period, significant changes occurred in patient characteristics including a decrease in age and in estimated surgical risk. Less invasive approaches for isolated SURD-AVR increased considerably from 49.4% to 85.5%. The overall in-hospital mortality rate was 1.6% and 3.9% in isolated and combined procedures, respectively, with no change over time. The rate of perioperative stroke decreased significantly (from 4% to 0.5%), as did the rates of postoperative pacemaker implantation (from 12.8% to 5.9%) and aortic regurgitation (from 17.8% to 2.7%).

Conclusions: The present study provides a comprehensive analysis of the current trends and results of SURD-AVR interventions. The most notable changes over time were the increasing implantation of SURD valves in a younger population, with more frequent utilization of less invasive techniques. SURD-AVR demonstrated remarkable improvements in clinical outcomes with a significant reduction in the rates of stroke, pacemaker implantation and postoperative aortic regurgitation.
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http://dx.doi.org/10.1093/ejcts/ezaa144DOI Listing
November 2020

Image, geometry and finite element mesh datasets for analysis of relationship between abdominal aortic aneurysm symptoms and stress in walls of abdominal aortic aneurysm.

Data Brief 2020 Jun 20;30:105451. Epub 2020 Mar 20.

Intelligent Systems for Medicine Laboratory, The University of Western Australia, Perth, Western Australia, Australia.

These datasets contain Computed Tomography (CT) images of 19 patients with Abdominal Aortic Aneurysm (AAA) together with 19 patient-specific geometry data and computational grids (finite element meshes) created from these images applied in the research reported in Journal of Surgical Research article "Is There A Relationship Between Stress in Walls of Abdominal Aortic Aneurysm and Symptoms?"[1]. The images were randomly selected from the retrospective database of University Hospitals Leuven (Leuven, Belgium) and provided to The University of Western Australia's Intelligent Systems for Medicine Laboratory. The analysis was conducted using our freely-available open-source software BioPARR (Joldes et al., 2017) created at The University of Western Australia. The analysis steps include image segmentation to obtain the patient-specific AAA geometry, construction of computational grids (finite element meshes), and AAA stress computation. We use well-established and widely used data file formats (Nearly Raw Raster Data or NRRD for the images, Stereolitography or STL format for geometry, and Abaqus finite element code keyword format for the finite element meshes). This facilitates re-use of our datasets in practically unlimited range of studies that rely on medical image analysis and computational biomechanics to investigate and formulate indicators and predictors of AAA symptoms.
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http://dx.doi.org/10.1016/j.dib.2020.105451DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171530PMC
June 2020

Is There a Relationship Between Stress in Walls of Abdominal Aortic Aneurysm and Symptoms?

J Surg Res 2020 08 26;252:37-46. Epub 2020 Mar 26.

Intelligent Systems for Medicine Laboratory, The University of Western Australia, Perth, Western Australia, Australia. Electronic address:

Background: Abdominal aortic aneurysm (AAA) is a permanent and irreversible dilation of the lower region of the aorta. It is typically an asymptomatic condition that if left untreated can expand to the point of rupture. In simple mechanical terms, rupture of an artery occurs when the local wall stress exceeds the local wall strength. It is therefore understandable that numerous studies have attempted to estimate the AAA wall stress and investigate the relationship between the AAA wall stress and AAA symptoms.

Materials And Methods: We conducted computational biomechanics analysis for 19 patients with AAA (a proportion of these patients were classified as symptomatic) to investigate whether the AAA wall stress fields (both the patterns and magnitude) correlate with the clinical definition of symptomatic and asymptomatic AAAs. For computation of AAA wall stress, we used a very efficient method recently presented by the Intelligent Systems for Medicine Laboratory. The Intelligent Systems for Medicine Laboratory's method uses geometry from computed tomography images and mean arterial pressure as the applied load. The method is embedded in the software platform BioPARR-Biomechanics based Prediction of Aneurysm Rupture Risk, freely available from http://bioparr.mech.uwa.edu.au/. The uniqueness of our stress computation approach is three-fold: i) the results are insensitive to unknown patient-specific mechanical properties of arterial wall tissue; ii) the residual stress is accounted for, according to Y.C. Fung's Uniform Stress Hypothesis; and iii) the analysis is automated and quick, making our approach compatible with clinical workflows.

Results: Symptomatic patients could not be identified from the plots (pattern) of AAA wall stress and stress magnitude. Although the largest stress was predicted for a patient who suffered from AAA symptoms, the three patients with the smallest stress were also symptomatic.

Conclusions: The results demonstrate, contrary to the common view, that neither the wall stress magnitude nor the stress distribution appears to be associated with the presence of clinical symptoms.
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http://dx.doi.org/10.1016/j.jss.2020.01.025DOI Listing
August 2020

Predicting hospitalisation-associated functional decline in older patients admitted to a cardiac care unit with cardiovascular disease: a prospective cohort study.

BMC Geriatr 2020 03 20;20(1):112. Epub 2020 Mar 20.

Department of Public Health and Primary Care, KU Leuven - University of Leuven, Leuven, Belgium.

Background: Up to one in three of older patients who are hospitalised develop functional decline, which is associated with sustained disability, institutionalisation and death. This study developed and validated a clinical prediction model that identifies patients who are at risk for functional decline during hospitalisation. The predictive value of the model was compared against three models that were developed for patients admitted to a general medical ward.

Methods: A prospective cohort study was performed on two cardiac care units between September 2016 and June 2017. Patients aged 75 years or older were recruited on admission if they were admitted for non-surgical treatment of an acute cardiovascular disease. Hospitalisation-associated functional decline was defined as any decrease on the Katz Index of Activities of Daily Living between hospital admission and discharge. Predictors were selected based on a review of the literature and a prediction score chart was developed based on a multivariate logistic regression model.

Results: A total of 189 patients were recruited and 33% developed functional decline during hospitalisation. A score chart was developed with five predictors that were measured on hospital admission: mobility impairment = 9 points, cognitive impairment = 7 points, loss of appetite = 6 points, depressive symptoms = 5 points, use of physical restraints or having an indwelling urinary catheter = 5 points. The score chart of the developed model demonstrated good calibration and discriminated adequately (C-index = 0.75, 95% CI (0.68-0.83) and better between patients with and without functional decline (chi = 12.8, p = 0.005) than the three previously developed models (range of C-index = 0.65-0.68).

Conclusion: Functional decline is a prevalent complication and can be adequately predicted on hospital admission. A score chart can be used in clinical practice to identify patients who could benefit from preventive interventions. Independent external validation is needed.
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http://dx.doi.org/10.1186/s12877-020-01510-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7082946PMC
March 2020

Non-physiologic closing of bi-leaflet mechanical heart prostheses requires a new tri-leaflet valve design.

Int J Cardiol 2020 04 23;304:125-127. Epub 2020 Jan 23.

Department for Cardiovascular Surgery, Mayo Clinic, Rochester, USA.

Mechanical heart valve prostheses are based on older designs without changes during the last 40 years. Today, there is an unmet need for less thrombogenic mechanical prostheses. Analysis of the relationship between flow characteristics and thromboembolic complications is possible using numerical and biomolecular flow studies that have shown that the reverse rather than the forward flow is responsible for local platelet activation and thrombosis. After peak flow, leaflets experience flow deceleration and the leaflets are still widely open when the flow becomes zero. The closure of the valve starts with the onset of reverse flow. Therefore, the valve closes extremely fast with most of the leaflet traveling angle occurring in <10 ms with excessively high reverse flow velocities. The pivoting spaces, so-called "Hot Spots" should be eliminated to prevent pathologic shear stress that result in thrombosis. A novel tri-leaflet valve combines favorable hemodynamics with the durability of mechanical heart valve. This valve closes within 60 ms, much slower than bi-leaflet valves and similar to the closing mode of a tissue valve. Micro-particle image velocimetry did not show critical regions of flow stagnation and zones of excessive shear in the pivoting region suggesting low potential for thrombogenic events that should allow to avoid long-term anticoagulation.
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http://dx.doi.org/10.1016/j.ijcard.2020.01.056DOI Listing
April 2020

Intraoperative xenon for prevention of delirium after on-pump cardiac surgery: a randomised, observer-blind, controlled clinical trial.

Br J Anaesth 2020 Jan 28. Epub 2020 Jan 28.

Department of Anaesthesiology, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.

Background: Older patients undergoing cardiac surgery have a 40-60% risk of developing postoperative delirium (POD), which is associated with increased morbidity and mortality. In animals, xenon has been found to be neuroprotective. Little is known about its neuroprotective effects in humans. We evaluated whether xenon anaesthesia prevents POD in patients undergoing cardiac surgery.

Methods: We conducted a randomised, observer-blind, controlled trial in which 190 patients 65 yr or older undergoing on-pump cardiac surgery were randomly allocated to xenon or sevoflurane anaesthesia. During cardiopulmonary bypass, propofol infusion was used for anaesthetic maintenance. Subjects were screened for POD daily during the first 5 postoperative days using the 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM) or with a CAM version for patients in ICU (CAM-ICU). Other methods to detect delirium, such as chart review, were also used. Secondary outcomes included the duration and severity of POD, and postoperative cognitive function.

Results: The overall incidence of POD was 41% (78/190). There was no statistically significant difference in the POD incidence between the xenon and sevoflurane groups (42.7% [41/96] vs 39.4% [37/94], P=0.583). The odds ratio for POD when comparing xenon with sevoflurane was 1.18 (95% confidence interval, 0.65-2.16).

Conclusions: In older patients undergoing cardiac surgery, xenon anaesthesia did not result in a significant reduction in POD. Based on these results alone, use of xenon cannot be recommended for this purpose.

Clinical Trial Registration: EudraCT: 2014-005370-11 (May 13, 2015; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-005370-11).
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http://dx.doi.org/10.1016/j.bja.2019.11.037DOI Listing
January 2020

Minimally Invasive Redo Aortic Valve Replacement: Results From a Multicentric Registry (SURD-IR).

Ann Thorac Surg 2020 08 16;110(2):553-557. Epub 2020 Jan 16.

Cardiac Surgery Unit, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ospedali Riuniti, Ancona, Italy; The Collaborative Research (CORE) Group.

Background: Reoperation for aortic valve replacement can be challenging and is usually associated with an increased risk for complications and mortality. The study aim was to report the results of a multicenter cohort of patients who underwent minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis.

Methods: From 2007 to 2018 data from 3651 patients were retrospectively collected from the Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry. Of them, 63 patients who had previously undergone cardiac surgery represented the study population. In-hospital clinical and echocardiographic outcomes were recorded.

Results: Mean age of the selected 63 patients was 75.3 ± 7.8 years and logistic EuroSCORE 10.1. Surgery was performed by ministernotomy in 43 patients (68.3%) and by anterior right thoracotomy in 20 (31.7%); 31 patients (49.2%) received the Perceval valve (Livanova PLC, London, UK) and 32 (50.8%) the Intuity valve (Edwards Lifesciences, Irvine, CA). Mean cross-clamp time was 57.8 ± 23.2 minutes and cardiopulmonary bypass time 95.0 ± 34.3 minutes. Neither conversion to full sternotomy nor in-hospital deaths occurred. Postoperative events were ischemic cerebral events in 3 patients (4.8%), need for pacemaker implantation in 2 (3.6%), bleeding requiring reoperation in 5 (8.9%), and dialysis in 1 (1.6%). Median intensive care unit stay was 1 day, and median length of hospital stay was 10 days. On echocardiographic evaluation 1 patient showed a significant postoperative aortic regurgitation.

Conclusions: Minimally invasive reoperative aortic valve replacement with a sutureless or rapid-deployment prosthesis is a safe and feasible treatment strategy, resulting in fast recovery and improved postoperative outcome with no mortality and an acceptable complication rate.
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http://dx.doi.org/10.1016/j.athoracsur.2019.11.033DOI Listing
August 2020

Skeletonisation contributing to a reduction of sternal wound complications: a retrospective study in OPCAB patients.

J Cardiothorac Surg 2019 Sep 9;14(1):162. Epub 2019 Sep 9.

Department of Cardiovascular Diseases, Research Unit of Cardiac Surgery, University Hospitals Leuven, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.

Background: Sternal wound complications (SWC) are a rare but potentially life-threatening complication after coronary artery bypass grafting (CABG) surgery. Especially the use of bilateral IMA (BIMA) grafts as opposed to single IMA (SIMA) grafts is associated with an increased risk of SWC. Skeletonised harvesting has been proposed to reduce this risk. The purpose of this study was to retrospectively investigate the effect of skeletonisation on SWC after off-pump coronary artery bypass grafting (OPCAB) in a centre with a high volume of off-pump procedures and high frequencies of BIMA.

Methods: From January 2010 to November 2016, 1900 consecutive patients underwent OPCAB surgery at the University Hospitals of Leuven. The first group (n = 1487) received non-skeletonised IMA grafts, whereas the second group (n = 413) received skeletonised grafts. Optimal wound management was pursued in all patients. A new four-grade classification for SWC was developed. Incidence and grade of SWC as well as overall survival were assessed.

Results: Analysis of diabetic patients showed a lower incidence of SWC in the skeletonised (12/141, 8.5%) compared to the non-skeletonised group (82/414, 19.8%) [odds ratio 0.46, 95% confidence interval (0.23;0.88), p = 0.019] as well as a lower grade [0.45 (0.24;0.871), p = 0.018]. There was no significant effect on overall survival [0.67 (0.19;2.32), p = 0.529]. Subanalysis of this population revealed that the observed effects were most prominent in patients receiving BIMA grafts, with 6/56 (10.7%) SWC in the skeletonised and 62/252 (24.6%) in the non-skeletonised group [0.37 (0.15;0.90), p = 0.028 for incidence], as well as a lower grade [0.36 (0.15;0.88), p = 0.025]. These advantages were not significant in diabetic patients receiving SIMA grafts nor in the full study population.

Conclusions: This study, using a more sensitive classification of SWC, shows in a large group of patients that, in combination with optimized wound management, the skeletonisation technique is associated with a clear reduction in the incidence and grade of SWC in diabetic patients receiving BIMA grafts. This encourages the extension of BIMA use in OPCAB to this risk population.
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http://dx.doi.org/10.1186/s13019-019-0985-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734214PMC
September 2019

Global cardiac surgery: Access to cardiac surgical care around the world.

J Thorac Cardiovasc Surg 2020 03 26;159(3):987-996.e6. Epub 2019 Apr 26.

Department of Cardiac Surgery, UZ Leuven, Leuven, Belgium.

Objective: Cardiovascular disease is the leading cause of death worldwide, responsible for 17.5 million deaths every year, of which 80% occur in low- and middle-income countries. Some 75% of the world does not have access to cardiac surgery when needed because of lack of infrastructure, human resources, and financial coverage. This study aims to map access to cardiac surgery around the world.

Methods: A scoping review was done on access to cardiac surgery for an undifferentiated population. Workforce data were collected from the Cardiothoracic Surgery Network database and used to calculate numbers and ratios of adult and pediatric cardiac surgeons to population.

Results: A total of 12,180 adult cardiac surgeons and 3858 pediatric cardiac surgeons were listed in the Cardiothoracic Surgery Network in August 2017, equaling 1.64 (0-181.82) adult cardiac surgeons and 0.52 (0-25.97) pediatric cardiac surgeons per million population globally. Large disparities existed between regions, ranging from 0.12 adult cardiac surgeons and 0.08 pediatric cardiac surgeons per million population (sub-Saharan Africa) to 11.12 adult cardiac surgeons and 2.08 pediatric cardiac surgeons (North America). Low-income countries possessed 0.04 adult cardiac surgeons and 0.03 pediatric cardiac surgeons per million population, compared with 7.15 adult cardiac surgeons and 1.67 pediatric cardiac surgeons in high-income countries.

Conclusions: This study maps the current global state of access to cardiac surgery. Disparities exist between and within world regions, with a positive correlation between a nation's economic status and access to cardiac surgery. Low early mortality rates in low-resource settings suggest the possibility of high-quality cardiac surgery in low- and middle-income countries. There is the need to increase human and physical resources, while focusing on safety, quality, and efficiency to improve access to cardiac surgery for the 4.5 billion people without.
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http://dx.doi.org/10.1016/j.jtcvs.2019.04.039DOI Listing
March 2020

Assessing the Thrombogenic Potential of Heart Valve Prostheses: An Approach for a Standardized In-Vitro Method.

Cardiovasc Eng Technol 2019 06 6;10(2):216-224. Epub 2019 Mar 6.

Department of Cardiovascular Engineering, Helmholtz Institute of Applied Medical Engineering, RWTH Aachen University, Aachen, Germany.

Purpose: Thrombogenic complications are still a main issue in the general performance of cardiovascular implants, especially heart valves. To date, the thrombogenic potential of those prostheses is pre-clinically assessed in time consuming animal studies with questionable evidence.

Methods: In this study, we present a new in-vitro method to assess and compare deficiencies of heart valve substitutes concerning their thrombogenic performance and locate initial clot formation under physiological conditions using porcine blood. Therefore, an athrombogenic pulse duplicator (THIA3) was developed that simulates the anatomic and hemodynamic conditions in the vicinity of the aortic valve. Validation of this tester was carried out with regard to hemodynamics, reproducibility and using positive and negative control valves and by comparison of clot locations with literature data from chronic animal trials with sheep using a St. Jude bileaflet valve.

Results: Validation of the tester showed quasi-physiological hemodynamics and reproducible clot formation. Identical clot formations were found comparing findings in vitro with chronic animal trials.

Conclusion: The THIA 3 has proven its suitability for valid, reproducible evaluation of thrombogenic potential of heart valves in a short period of time.
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http://dx.doi.org/10.1007/s13239-019-00408-3DOI Listing
June 2019

Minimally invasive aortic valve replacement with sutureless and rapid deployment valves: a report from an international registry (Sutureless and Rapid Deployment International Registry)†.

Eur J Cardiothorac Surg 2019 Oct;56(4):793-799

The Collaborative Research (CORE) Group.

Objectives: The impact of sutureless and rapid deployment (SURD) valves on the clinical outcomes of patients undergoing minimally invasive aortic valve replacement (MI-AVR) has still to be defined. The aim of this study was to assess clinical characteristics and in-hospital results of patients receiving SURD-AVR through less invasive approaches in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR).

Methods: Of the 1935 patients who received primary isolated SURD-AVR between 2009 and 2018, a total of 1418 (73.3%) underwent MI interventions and were included in this analysis. SURD-AVR was performed using upper ministernotomy in 56.4% (n = 800) of cases and anterior right thoracotomy in 43.6% (n = 618). Perceval S was implanted in 1011 (71.3%) patients and Edwards Intuity or Intuity Elite in 407 (28.7%) patients.

Results: Overall in-hospital mortality and stroke rates were 1.7% and 2%, respectively. A definitive pacemaker implantation was reported in 9% of cases and significantly decreased over the observational period, from 20.6% to 5.6% (P = 0.002). The Perceval valve was associated with shorter operative times and was more frequently implanted in patients receiving anterior right thoracotomy incision. The Intuity valve was preferred in younger patients and revealed superior postoperative haemodynamic results.

Conclusions: SURD-AVR was largely performed through less invasive approaches and can be considered as a primary indication in MI surgery. In the SURD-IR cohort, MI SURD-AVR using both Perceval and Intuity valves appeared a safe and reproducible procedure associated with promising early results.
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http://dx.doi.org/10.1093/ejcts/ezz055DOI Listing
October 2019

Operative outcome of patients at low, intermediate, high and 'very high' surgical risk undergoing isolated aortic valve replacement with sutureless and rapid deployment prostheses: results of the SURD-IR registry.

Eur J Cardiothorac Surg 2019 Jul;56(1):38-43

The Collaborative Research (CORE) Group.

Objectives: The ideal strategy for the treatment of severe aortic valve stenosis in patients of varying risk categories has become a debated topic in the last years: should the transcatheter or surgical approach be adopted? The aim of this study was to evaluate the outcomes of low-, intermediate-, high- and very high-risk patients undergoing sutureless, rapid deployment aortic valve replacement.

Methods: From 2007 to 2017, data on a total of 3651 patients were collected from the Sutureless and Rapid Deployment Aortic Valve Replacement International Registry (SURD-IR). Of these, 2057 patients who underwent primary isolated aortic valve replacement were considered for this analysis and classified as being at low (EuroSCORE <5; n = 500), intermediate (EuroSCORE 5-10; n = 901), high (EuroSCORE 11-20; n = 500) and very high (EuroSCORE >20; n = 156) preoperative risk.

Results: Overall, a less invasive approach was used in 74.1% of patients and represented the most frequent (>50%) approach in all risk categories. The Perceval prosthesis was used more frequently than other devices, especially in patients at high and very high risk. Hospital mortality was 1.6%, 0.8%, 1.9% and 2.7% in low-, intermediate-, high- and very high-risk patients, respectively, with no significant differences among subgroups. Similarly, postoperative complication rates were similar across the different risk categories.

Conclusions: Surgical aortic valve replacement using sutureless, rapid deployment biological valve prostheses is associated with excellent results and represents a safe and effective treatment option for patients with severe aortic valve stenosis. This seems to be particularly true in patients with a higher risk profile.
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http://dx.doi.org/10.1093/ejcts/ezy477DOI Listing
July 2019

Clinical outcomes of heart-team-guided treatment decisions in high-risk patients with aortic valve stenosis in a health-economic context with limited resources for transcatheter valve therapies.

Acta Cardiol 2019 Dec 3;74(6):489-498. Epub 2018 Dec 3.

Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.

Transcatheter aortic valve implantation (TAVI) is the preferred treatment modality for patients with severe aortic stenosis at high or prohibitive risk for surgical aortic valve replacement (SAVR). We aimed to evaluate real-world outcomes after treatment according to the decisions of the multidisciplinary heart team in a Belgian health-economic context. Four hundred and five high-risk patients referred to a tertiary centre between 1 March 2008 and 31 December 2015 were screened and planned to undergo SAVR, TAVI or medical treatment (MT). Patients undergoing SAVR had lower Society of Thoracic Surgeons scores and Euroscore-II when compared to TAVI or MT (median [IQR]: 6[4-8]; 7[5-10]; 8[6-13];  < .001 and 6[4-10]; 8[5-15]; 8[4-16];  = .006). At 1 year all-cause mortality was 14, 17 and 51% with SAVR, TAVI and MT, respectively ( < .001). Cardiovascular death and disabling stroke occurred in 9, 7 and 35% ( < .001) and 2, 2.7 and 1.7% ( = .91). According to Valve-Academic-Research-Consortium-II criteria, device success was 95 and 92% for TAVI and SAVR. The combined safety endpoint at 30 days favoured TAVI (22% vs. 47%) ( < .001). The combined efficacy endpoint at 1 year was comparable between groups (38 and 40%;  = .703). Finally, hospital stay was shorter with TAVI vs. SAVR (9[6-14] and 16[12-22] days;  < .001). Limited resources for transcatheter valve therapies in Belgium push a significant number of patients to SAVR, while TAVI in even higher risk patients translates into similar outcomes and shorter hospital stay. These findings underscore the need for broadening indications for TAVI, as well as readjustment of the budgetary allocations for hospitals in Belgium.
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http://dx.doi.org/10.1080/00015385.2018.1522461DOI Listing
December 2019

Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design.

Thorac Cardiovasc Surg 2020 03 29;68(2):114-123. Epub 2018 Nov 29.

Department of Cardiac Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.

Introduction: Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance.

Materials And Methods: PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years.

Discussion: PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.
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http://dx.doi.org/10.1055/s-0038-1675847DOI Listing
March 2020

Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH): study protocol of a prospective before-after effectiveness-implementation study.

BMJ Open 2018 10 21;8(10):e023593. Epub 2018 Oct 21.

Gerontology and Geriatrics, Department of Chronic Diseases, Metabolism and Ageing, KU Leuven-University of Leuven, Leuven, Belgium.

Introduction: Although the majority of older patients admitted to a cardiology unit present with at least one geriatric syndrome, guidelines on managing heart disease often do not consider the complex needs of frail older patients. Geriatric co-management has demonstrated potential to improve functional status, and reduce complications and length of stay, but evidence on the effectiveness in cardiology patients is lacking. This study aims to determine if geriatric co-management is superior to usual care in preventing functional decline, complications, mortality, readmission rates, reducing length of stay and improving quality of life in older patients admitted for acute heart disease or for transcatheter aortic valve implantation, and to identify determinants of success for geriatric co-management in this population.

Methods And Analysis: This prospective quasi-experimental before-and-after study will be performed on two cardiology units of the University Hospitals Leuven in Belgium in patients aged ≥75 years. In the precohort (n=227), usual care will be documented. A multitude of implementation strategies will be applied to allow for successful implementation of the model. Patients in the after cohort (n=227) will undergo a comprehensive geriatric assessment within 24 hours of admission to stratify them into one of three groups based on their baseline risk for developing functional decline: low-risk patients receive proactive consultation, high-risk patients will be co-managed by the geriatric nurse to prevent complications and patients with acute geriatric problems will receive an additional medication review and co-management by the geriatrician.

Ethics And Dissemination: The study protocol was approved by the Medical Ethics Committee UZ Leuven/KU Leuven (S58296). Written voluntary (proxy-)informed consent will be obtained from all participants at the start of the study. Dissemination of results will be through articles in scientific and professional journals both in English and Dutch and by conference presentations.

Trial Registration Number: NCT02890927.
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http://dx.doi.org/10.1136/bmjopen-2018-023593DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6196878PMC
October 2018