Publications by authors named "Bart Meyns"

204 Publications

Surgical Treatment of Postinfarction Ventricular Septal Rupture.

JAMA Netw Open 2021 Oct 1;4(10):e2128309. Epub 2021 Oct 1.

Department of Cardiac Surgery, Medical University of Silesia, School of Medicine in Katowice, Katowice, Poland.

Importance: Ventricular septal rupture (VSR) is a rare but life-threatening mechanical complication of acute myocardial infarction associated with high mortality despite prompt treatment. Surgery represents the standard of care; however, only small single-center series or national registries are usually available in literature, whereas international multicenter investigations have been poorly carried out, therefore limiting the evidence on this topic.

Objectives: To assess the clinical characteristics and early outcomes for patients who received surgery for postinfarction VSR and to identify factors independently associated with mortality.

Design, Setting, And Participants: The Mechanical Complications of Acute Myocardial Infarction: an International Multicenter Cohort (CAUTION) Study is a retrospective multicenter international cohort study that includes patients who were treated surgically for mechanical complications of acute myocardial infarction. The study was conducted from January 2001 to December 2019 at 26 different centers worldwide among 475 consecutive patients who underwent surgery for postinfarction VSR.

Exposures: Surgical treatment of postinfarction VSR, independent of the technique, alone or combined with other procedures (eg, coronary artery bypass grafting).

Main Outcomes And Measures: The primary outcome was early mortality; secondary outcomes were postoperative complications.

Results: Of the 475 patients included in the study, 290 (61.1%) were men, with a mean (SD) age of 68.5 (10.1) years. Cardiogenic shock was present in 213 patients (44.8%). Emergent or salvage surgery was performed in 212 cases (44.6%). The early mortality rate was 40.4% (192 patients), and it did not improve during the nearly 20 years considered for the study (median [IQR] yearly mortality, 41.7% [32.6%-50.0%]). Low cardiac output syndrome and multiorgan failure were the most common causes of death (low cardiac output syndrome, 70 [36.5%]; multiorgan failure, 53 [27.6%]). Recurrent VSR occurred in 59 participants (12.4%) but was not associated with mortality. Cardiogenic shock (survived: 95 [33.6%]; died, 118 [61.5%]; P < .001) and early surgery (time to surgery ≥7 days, survived: 105 [57.4%]; died, 47 [35.1%]; P < .001) were associated with lower survival. At multivariate analysis, older age (odds ratio [OR], 1.05; 95% CI, 1.02-1.08; P = .001), preoperative cardiac arrest (OR, 2.71; 95% CI, 1.18-6.27; P = .02) and percutaneous revascularization (OR, 1.63; 95% CI, 1.003-2.65; P = .048), and postoperative need for intra-aortic balloon pump (OR, 2.98; 95% CI, 1.46-6.09; P = .003) and extracorporeal membrane oxygenation (OR, 3.19; 95% CI, 1.30-7.38; P = .01) were independently associated with mortality.

Conclusions And Relevance: In this study, surgical repair of postinfarction VSR was associated with a high risk of early mortality; this risk has remained unchanged during the last 2 decades. Delayed surgery seemed associated with better survival. Age, preoperative cardiac arrest and percutaneous revascularization, and postoperative need for intra-aortic balloon pump and extracorporeal membrane oxygenation were independently associated with early mortality. Further prospective studies addressing preoperative and perioperative patient management are warranted to hopefully improve the currently suboptimal outcome.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.28309DOI Listing
October 2021

Oxygenated machine perfusion at room temperature as an alternative for static cold storage in porcine donor hearts.

Artif Organs 2021 Oct 11. Epub 2021 Oct 11.

Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.

Background: There is a continued interest in ex situ heart perfusion as an alternative strategy for donor heart preservation. We hypothesize that oxygenated machine perfusion of donor hearts at a temperature that avoids both normothermia and deep hypothermia offers adequate and safe preservation.

Methods: Cardioplegia-arrested porcine donor hearts were randomly assigned to six hours of preservation using cold storage (CS, n=5) or machine perfusion using an oxygenated acellular perfusate at 21°C (MP, n=5). Subsequently, all grafts were evaluated using the Langendorff method during 120 minutes. Metabolic parameters and histology were analyzed. Systolic function was assessed by contractility and elastance. Diastolic function was assessed by lusitropy and stiffness.

Results: For both groups, in vivo baseline and post-Langendorff biopsies were comparable, as were lactate difference and myocardial oxygen consumption. Injury markers gradually increased and were comparable. Significant weight gain was seen in MP (p=0.008). Diastolic function was not impaired in MP, and lusitropy was superior from 30 minutes up to 90 minutes of reperfusion. Contractility was superior in MP during the first hour of evaluation.

Conclusion: We conclude that initial functional outcome of MP preserved hearts was transiently superior compared to CS, with no histological injury post-Langendorff. Our machine perfusion strategy could offer a feasible and safe storage of hearts prior to transplantation. Future studies are warranted for further optimization.
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http://dx.doi.org/10.1111/aor.14085DOI Listing
October 2021

A Compliant Model of the Ventricular Apex to Study Suction in Ventricular Assist Devices.

ASAIO J 2021 10;67(10):1125-1133

Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences, Warsaw, Poland.

Ventricular suction is a frequent adverse event in patients with a ventricular assist device (VAD). This study presents a suction module (SM) embedded in a hybrid (hydraulic-computational) cardiovascular simulator suitable for the testing of VADs and related suction events. The SM consists of a compliant latex tube reproducing a simplified ventricular apex. The SM is connected on one side to a hydraulic chamber of the simulator reproducing the left ventricle, and on the other side to a HeartWare HVAD system. The SM is immersed in a hydraulic chamber with a controllable pressure to occlude the compliant tube and activate suction. Two patient profiles were simulated (dilated cardiomyopathy and heart failure with preserved ejection fraction), and the circulating blood volume was reduced stepwise to obtain different preload levels. For each simulated step, the following data were collected: HVAD flow, ventricular pressure and volume, and pressure at the inflow cannula. Data collected for the two profiles and for decreasing preload levels evidenced suction profiles differing in terms of frequency (intermittent vs. every heart beat), amplitude (partial or complete stoppage of the HVAD flow), and shape. Indeed different HVAD flow patterns were observed for the two patient profiles because of the different mechanical properties of the simulated ventricles. Overall, the HVAD flow patterns showed typical indicators of suctions observed in clinics. Results confirmed that the SM can reproduce suction phenomena with VAD under different pathophysiological conditions. As such, the SM can be used in the future to test VADs and control algorithms aimed at preventing suction phenomena.
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http://dx.doi.org/10.1097/MAT.0000000000001370DOI Listing
October 2021

Potential of Medical Management to Mitigate Suction Events in Ventricular Assist Device Patients.

ASAIO J 2021 Sep 9. Epub 2021 Sep 9.

From the Department of Cardiovascular Sciences, Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium Institute of Clinical Physiology, National Research Council, Pisa, Italy Department of Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium.

Ventricular suction is a common adverse event in ventricular assist device (VAD) patients and can be due to multiple underlying causes. The aim of this study is to analyze the potential of different therapeutic interventions to mitigate suction events induced by different pathophysiological conditions. To do so, a suction module was embedded in a cardiovascular hybrid (hydraulic-computational) simulator reproducing the entire cardiovascular system. An HVAD system (Medtronic) was connected between a compliant ventricular apex and a simulated aorta. Starting from a patient profile with severe dilated cardiomyopathy, four different pathophysiological conditions leading to suction were simulated: hypovolemia (blood volume: -900 ml), right ventricular failure (contractility -70%), hypotension (systemic vascular resistance: 8.3 Wood Units), and tachycardia (heart rate:185 bpm). Different therapeutic interventions such as volume infusion, ventricular contractility increase, vasoconstriction, heart rate increase, and pump speed reduction were simulated. Their effects were compared in terms of general hemodynamics and suction mitigation. Each intervention elicited a different effect on the hemodynamics for every pathophysiological condition. Pump speed reduction mitigated suction but did not ameliorate the hemodynamics. Administering volume and inducing a systemic vasoconstriction were the most efficient interventions in both improving the hemodynamics and mitigating suction. When simulating volume infusion, the cardiac powers increased, respectively, by 38%, 25%, 42%, and 43% in the case of hypovolemia, right ventricular failure, hypotension, and tachycardia. Finally, a management algorithm is proposed to identify a therapeutic intervention suited for the underlying physiologic condition causing suction.
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http://dx.doi.org/10.1097/MAT.0000000000001573DOI Listing
September 2021

Antithrombotic Treatment After Surgical and Transcatheter Heart Valve Repair and Replacement.

Front Cardiovasc Med 2021 5;8:702780. Epub 2021 Aug 5.

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

New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of antithrombotic therapy after surgical or transcatheter heart valve repair and replacement increasingly complex. Moreover, due to a lack of large randomized controlled trials many recommendations for antithrombotic therapy are based on expert opinion, reflected by divergent recommendations in current guidelines. Therefore, decision-making in clinical practice regarding antithrombotic therapy for prosthetic heart valves is difficult, potentially resulting in sub-optimal patient treatment. This article compares the 2017 ESC/EACTS and 2020 ACC/AHA guidelines on the management of valvular heart disease and summarizes the available evidence. Finally, we established a convenient consensus on antithrombotic therapy after valve interventions based on over 800 annual cases of surgical and transcatheter heart valve repair and replacement and a multidisciplinary team discussion between the department of cardiovascular diseases and cardiac surgery of the University Hospitals Leuven, Belgium.
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http://dx.doi.org/10.3389/fcvm.2021.702780DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8375148PMC
August 2021

Optimizing cerebral perfusion and hemodynamics during cardiopulmonary bypass through cannula design combining in silico, in vitro and in vivo input.

Sci Rep 2021 Aug 18;11(1):16800. Epub 2021 Aug 18.

Enmodes GmbH, Aachen, Germany.

Cardiopulmonary bypass (CPB) is a standard technique for cardiac surgery, but comes with the risk of severe neurological complications (e.g. stroke) caused by embolisms and/or reduced cerebral perfusion. We report on an aortic cannula prototype design (optiCAN) with helical outflow and jet-splitting dispersion tip that could reduce the risk of embolic events and restores cerebral perfusion to 97.5% of physiological flow during CPB in vivo, whereas a commercial curved-tip cannula yields 74.6%. In further in vitro comparison, pressure loss and hemolysis parameters of optiCAN remain unaffected. Results are reproducibly confirmed in silico for an exemplary human aortic anatomy via computational fluid dynamics (CFD) simulations. Based on CFD simulations, we firstly show that optiCAN design improves aortic root washout, which reduces the risk of thromboembolism. Secondly, we identify regions of the aortic intima with increased risk of plaque release by correlating areas of enhanced plaque growth and high wall shear stresses (WSS). From this we propose another easy-to-manufacture cannula design (optiCAN) that decreases areas burdened by high WSS, while preserving physiological cerebral flow and favorable hemodynamics. With this novel cannula design, we propose a cannulation option to reduce neurological complications and the prevalence of stroke in high-risk patients after CPB.
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http://dx.doi.org/10.1038/s41598-021-96397-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8373878PMC
August 2021

Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD).

JACC Heart Fail 2021 Oct 11;9(10):758-767. Epub 2021 Aug 11.

Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, Rigshospitalet, Copenhagen, Denmark. Electronic address: https://twitter.com/FinnGustafsson.

Objectives: The purpose of this study was to examine whether peak oxygen uptake (pVO) and other cardiopulmonary exercise test (CPET)-derived variables could predict intermediate-term mortality in stable continuous flow LVAD recipients.

Background: pVO is a cornerstone in the selection of patients for heart transplantation, but the prognostic power of pVO obtained in patients treated with a left ventricular assist device (LVAD) is unknown.

Methods: We collected data for pVO and outcomes in adult LVAD recipients in a retrospective, multicenter study and evaluated cutoff values for pVO including: 1) values above or below medians; 2) grouping patients in tertiles; and 3) pVO ≤14 ml/kg/min if the patient was not treated with beta-blockers (BB) or pVO ≤12 ml/kg/min if the patient was taking BB therapy.

Results: Nine centers contributed data from 450 patients. Patients were 53 ± 13 years of age; 78% were male; body mass index was 25 ± 5 kg/m with few comorbidities (stroke: 11%; diabetes: 18%; and peripheral artery disease: 4%). The cause of heart failure (HF) was most often nonischemic (66%). Devices included were the HeartMate II and 3 (Abbott); and Heartware ventricular assist devices Jarvik and Duraheart (Medtronic). The index CPET was performed at a median of 189 days (154-225 days) after LVAD implantation, and mean pVO was 14.1 ± 5 ml/kg/min (47% ± 14% of predicted value). Lower pVO values were strongly associated with poorer survival regardless of whether patients were analyzed for absolute pVO in ml/kg/min, pVO ≤12 BB/14 ml/kg/min, or as a percentage of predicted pVO values (P ≤ 0.001 for all). For patients with pVO >12 BB/14 and ventilation/carbon dioxide relationship (VE/VCO) slope <35, the 1-year survival was 100%.

Conclusions: Even after LVAD implantation, pVO has prognostic value, similar to HF patients not supported by mechanical circulatory support devices. (PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake [pVO] in Recipients of Left Ventricular Assist Devices [PRO-VAD]; NCT04423562).
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http://dx.doi.org/10.1016/j.jchf.2021.05.021DOI Listing
October 2021

Long-term outcomes of atrioventricular septal defect and single ventricle: A multicenter study.

J Thorac Cardiovasc Surg 2021 May 18. Epub 2021 May 18.

Department of Cardiothoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Objective: The study objective was to analyze survival and incidence of Fontan completion of patients with single-ventricle and concomitant unbalanced atrioventricular septal defect.

Methods: Data from 4 Dutch and 3 Belgian institutional databases were retrospectively collected. A total of 151 patients with single-ventricle atrioventricular septal defect were selected; 36 patients underwent an atrioventricular valve procedure (valve surgery group). End points were survival, incidence of Fontan completion, and freedom from atrioventricular valve reoperation.

Results: Median follow-up was 13.4 years. Cumulative survival was 71.2%, 70%, and 68.5% at 10, 15, and 20 years, respectively. An atrioventricular valve procedure was not a risk factor for mortality. Patients with moderate-severe or severe atrioventricular valve regurgitation at echocardiographic follow-up had a significantly worse 15-year survival (58.3%) compared with patients with no or mild regurgitation (89.2%) and patients with moderate regurgitation (88.6%) (P = .033). Cumulative incidence of Fontan completion was 56.5%, 71%, and 77.6% at 5, 10, and 15 years, respectively. An atrioventricular valve procedure was not associated with the incidence of Fontan completion. In the valve surgery group, freedom from atrioventricular valve reoperation was 85.7% at 1 year and 52.6% at 5 years.

Conclusions: The long-term survival and incidence of Fontan completion in our study were better than previously described for patients with single-ventricle atrioventricular septal defect. A concomitant atrioventricular valve procedure did not increase the mortality rate or decrease the incidence of Fontan completion, whereas patients with moderate-severe or severe valve regurgitation at follow-up had a worse survival. Therefore, in patients with single-ventricle atrioventricular septal defect when atrioventricular valve regurgitation exceeds a moderate degree, the atrioventricular valve should be repaired.
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http://dx.doi.org/10.1016/j.jtcvs.2021.05.015DOI Listing
May 2021

Editorial: Science in Mechanical Circulatory Support.

Front Cardiovasc Med 2021 17;8:676595. Epub 2021 May 17.

The Cardiovascular Center, Tufts Medical Center, Boston, MA, United States.

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http://dx.doi.org/10.3389/fcvm.2021.676595DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8165192PMC
May 2021

Heart failure related to adult congenital heart disease: prevalence, outcome and risk factors.

ESC Heart Fail 2021 Aug 7;8(4):2940-2950. Epub 2021 May 7.

Division of Structural and Congenital Cardiology, University Hospitals Leuven, Leuven, Belgium.

Aims: Information on the prevalence, outcome and factors associated with heart failure in patients with adult congenital heart disease (CHD) (ACHD-HF) is lacking. We aimed at assessing the prevalence and outcome of ACHD-HF, the variables associated with ACHD-HF, and the differences between major anatomical/pathophysiological ACHD subgroups.

Methods And Results: We included 3905 patients (age 35.4 ± 13.2 years) under active follow-up in our institution (last visit >2010). Outcome of ACHD-HF cases was compared with sex- and age-matched cases. Univariable and multivariable binary logistic regression with ACHD-HF diagnosis as a dependent variable was performed. Overall prevalence of ACHD-HF was 6.4% (mean age 49.5 ± 16.7 years), but was higher in patients with cyanotic CHD (41%), Fontan circulation (30%), and a systemic right ventricle (25%). All-cause mortality was higher in ACHD-HF cases when compared with controls (mortality rate ratio 4.67 (2.36-9.27); P = 0.0001). In multivariable logistic regression analysis, age at latest follow-up [per 10 years; odds ratio (OR) 1.52; 95% confidence interval (CI) 1.31-1.77], infective endocarditis (OR 4.11; 95%CI 1.80-9.38), history of atrial arrhythmia (OR 3.52; 95%CI 2.17-5.74), pacemaker implantation (OR 2.66; 95% CI 1.50-4.72), end-organ dysfunction (OR 2.41; 95% CI 1.03-5.63), New York Heart Association class (OR 9.28; 95% CI 6.04-14.25), heart rate (per 10 bpm; OR 1.27; 95% CI 1.08-1.50), ventricular dysfunction (OR 3.62; 95% CI 2.54-5.17), and pulmonary hypertension severity (OR 1.66; 95% CI 1.21-2.30) were independently related to the presence of ACHD-HF. Some variables (age, atrial arrhythmia, pacemaker, New York Heart Association, and ventricular dysfunction) were related to ACHD-HF in all anatomical/physiological subgroups, whereas others were not.

Conclusions: ACHD-HF is prevalent especially in complex CHD and is associated with poor prognosis. Our data provide insight in the factors related to ACHD-HF including differences between specific anatomical and physiological subgroups.
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http://dx.doi.org/10.1002/ehf2.13378DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8318399PMC
August 2021

The outcome of patients with peripartum cardiomyopathy and consecutive implantation of a left ventricular assist device.

J Card Surg 2021 Aug 7;36(8):2651-2657. Epub 2021 May 7.

Department of Cardiothoracic Surgery, Heart Centre Cologne, University Hospital Cologne, Cologne, Germany.

Objectives: Peripartum cardiomyopathy (PPCM) is a form of systolic heart failure occurring toward the end of pregnancy or in the period after delivery. Lack of myocardial recovery or therapy-refractory cardiogenic shock are rare complications and left ventricular assist device (LVAD) systems might be used as a life-saving option. The aim of this study was to investigate outcomes of PPCM patients supported with LVAD, registered in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS).

Methods: All patients registered in EUROMACS with a primary diagnosis of PPCM were included in this study. Demographic, preoperative, intraoperative, postoperative, and follow-up data were collected and patients analysed concerning their outcome after initiation of LVAD therapy.

Results: Between May 2011 and September 2018, 16 patients with PPCM and consecutive LVAD implantation were enrolled into EUROMACS. The median age of the patient population was 31 (26;41) years with a mean left ventricular ejection fraction (LV-EF) of 15% ± 6%. In-hospital mortality after LVAD implantation was 6% (n = 1). One-year mortality accounted for 13% (n = 2). Six patients (40%) were transplanted with a median support time of 769 (193;1529) days. Weaning of LVAD support due to ventricular recovery was feasible in 3 (20%) patients.

Conclusion: In patients with severe PPCM, LVAD therapy is associated with considerably low in-hospital mortality, potentially allowing bridging to heart transplantation, or left ventricular recovery. Therefore, durable mechanical support should be considered as a treatment option in this, by nature, young and often otherwise healthy patient population.
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http://dx.doi.org/10.1111/jocs.15598DOI Listing
August 2021

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis.

Eur J Cardiothorac Surg 2021 09;60(3):579-587

Department of Cardiovascular Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

Objectives: The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support).

Methods: A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed.

Results: Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112-771) days for HW and 376 (IQR 100-816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56-67%) vs HM3: 68% 95% CI (63-73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83-1.54), P = 0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84-1.21), P = 0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45-3.71), P < 0.001], neurological dysfunction [SHR 1.29 (1.02-1.61), P = 0.032] and intracranial bleeding [SHR 1.76 (1.13-2.70), P = 0.012].

Conclusions: Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients.
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http://dx.doi.org/10.1093/ejcts/ezab144DOI Listing
September 2021

Oxygen Pathway Limitations in Patients With Chronic Thromboembolic Pulmonary Hypertension.

Circulation 2021 May 15;143(21):2061-2073. Epub 2021 Apr 15.

Baker Heart and Diabetes Institute (E.J.H., S.R.-C., A.L.G., G.C.), Melbourne, Australia.

Background: Exertional intolerance is a limiting and often crippling symptom in patients with chronic thromboembolic pulmonary hypertension (CTEPH). Traditionally the pathogenesis has been attributed to central factors, including ventilation/perfusion mismatch, increased pulmonary vascular resistance, and right heart dysfunction and uncoupling. Pulmonary endarterectomy and balloon pulmonary angioplasty provide substantial improvement of functional status and hemodynamics. However, despite normalization of pulmonary hemodynamics, exercise capacity often does not return to age-predicted levels. By systematically evaluating the oxygen pathway, we aimed to elucidate the causes of functional limitations in patients with CTEPH before and after pulmonary vascular intervention.

Methods: Using exercise cardiac magnetic resonance imaging with simultaneous invasive hemodynamic monitoring, we sought to quantify the steps of the O transport cascade from the mouth to the mitochondria in patients with CTEPH (n=20) as compared with healthy participants (n=10). Furthermore, we evaluated the effect of pulmonary vascular intervention (pulmonary endarterectomy or balloon angioplasty) on the individual components of the cascade (n=10).

Results: Peak Vo (oxygen uptake) was significantly reduced in patients with CTEPH relative to controls (56±17 versus 112±20% of predicted; <0.0001). The difference was attributable to impairments in multiple steps of the O cascade, including O delivery (product of cardiac output and arterial O content), skeletal muscle diffusion capacity, and pulmonary diffusion. The total O extracted in the periphery (ie, ΔAVo [arteriovenous O content difference]) was not different. After pulmonary vascular intervention, peak Vo increased significantly (from 12.5±4.0 to 17.8±7.5 mL/[kg·min]; =0.036) but remained below age-predicted levels (70±11%). The O delivery was improved owing to an increase in peak cardiac output and lung diffusion capacity. However, peak exercise ΔAVo was unchanged, as was skeletal muscle diffusion capacity.

Conclusions: We demonstrated that patients with CTEPH have significant impairment of all steps in the O use cascade, resulting in markedly impaired exercise capacity. Pulmonary vascular intervention increased peak Vo by partly correcting O delivery but had no effect on abnormalities in peripheral O extraction. This suggests that current interventions only partially address patients' limitations and that additional therapies may improve functional capacity.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052899DOI Listing
May 2021

Transplantation of donor hearts after circulatory death using normothermic regional perfusion and cold storage preservation.

Eur J Cardiothorac Surg 2021 Oct;60(4):813-819

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

:

Objectives: Hearts donated after circulatory determination of death are usually preserved with normothermic machine perfusion prior to transplantation. This type of preservation is costly, requires bench time adding to warm ischaemia, and does not provide a reliable evaluation of the unloaded donor heart. We report on 4 successful donation after circulatory death (category III) hearts transplanted after thoraco-abdominal normothermic regional perfusion (NRP) and static cold storage.

Methods: After life sustaining therapy was withdrawn and death was declared, perfusion to thoraco-abdominal organs was restored using extracorporeal circulation via cannulas in the femoral artery and vein and clamping of supra-aortic vessels. After weaning from extracorporeal circulation, cardiac function was assessed. Once approved, the heart was retrieved and stored using classic static cold storage. Data are expressed as median [min-max].

Results: Donor and recipient ages were 44 years [12-60] (n = 4) and 53 years [14-64] (n = 4), respectively. Time from the withdrawal of life sustaining therapy to start of NRP was 22 min [18-31]. Cold storage time was 72 min [35-129]. Thirty-day survival was 100% with a left ventricle ejection fraction of 60% [50-60].

Conclusions: Donation after circulatory death heart transplantation using thoraco-abdominal NRP and subsequent cold storage preservation for up to 129 min was safe for 4 procedures and could be a way to expand the donor heart pool while avoiding costs of machine preservation.
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http://dx.doi.org/10.1093/ejcts/ezab139DOI Listing
October 2021

Managing Patients With Short-Term Mechanical Circulatory Support: JACC Review Topic of the Week.

J Am Coll Cardiol 2021 03;77(9):1243-1256

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

The use of mechanical circulatory support for patients presenting with cardiogenic shock is rapidly increasing. Currently, there is only limited and conflicting evidence available regarding the role of the Impella (a microaxial, continuous-flow, short-term, left or right ventricular assist device) in cardiogenic shock; further randomized trials are needed. Patient selection, timing of implantation, and post-implantation management in the cardiac intensive care unit are crucial elements for success. Particular challenges at the bedside include the practical management of anticoagulation, evaluation of correct device position, and the approach to use in a patient with signs of insufficient hemodynamic support. Profound knowledge of these issues is required to enable the maximal potential of the device. This review provides a comprehensive overview of the short-term assist device and describes a practical approach to optimize care for patients supported with the device.
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http://dx.doi.org/10.1016/j.jacc.2020.12.054DOI Listing
March 2021

Left Impella®-device as bridge from cardiogenic shock with acute, severe mitral regurgitation to MitraClip®-procedure: a new option for critically ill patients.

Eur Heart J Acute Cardiovasc Care 2021 May;10(4):415-421

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

Aims: Patients presenting with cardiogenic shock (CS) related to acute, severe mitral regurgitation (MR) are often considered too ill for immediate surgical intervention. Therefore, other less invasive techniques for haemodynamic stabilization should be explored. The purpose of this exploratory study was to investigate the feasibility and outcomes in patients with CS due to severe MR by using a novel approach combining haemodynamic stabilization with left Impella-support plus MR-reduction using MitraClip®.

Methods And Results: We analysed whether a combined left Impella®/MitraClip®-procedure in a rare population of CS-patients with acute MR requiring mechanical ventilation is a feasible strategy to recovery in patients who had been declined cardiac surgery. Six INTERMACS-1 CS-patients with acute MR were studied at two tertiary cardiac intensive care units. The mean EURO-II score was 39 ± 19% and age 66.8 ± 4.9 years. All patients had an initial pulmonary capillary wedge pressure >20 mmHg and pulmonary oedema necessitating invasive ventilation. Cardiac output was severely impaired (left ventricular outflow tract velocity time index 9.8 ± 1.8 cm), requiring mechanical circulatory support (MCS) (Impella®-CP; mean flow 2.9 ± 1.8 L per minute; mean support 9.7 ± 6.0 days). Despite MCS-guided unloading, weaning from ventilation failed due to persisting pulmonary oedema necessitating MR-reduction. In all cases, the severe MR was reduced to mild using percutaneous MitraClip®-procedure, followed by successful weaning from invasive ventilation. Survival to discharge was 86%, with all surviving and rare readmission for heart failure at 6 months.

Conclusions: A combined Impella®/MitraClip®-strategy appears a novel, feasible alternative for weaning CS-patients presenting with acute, severe MR. Upfront Impella®-stabilization facilitates safe bridging to Mitraclip®-procedure and the staged approach facilitates successful weaning from ventilatory support.
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http://dx.doi.org/10.1093/ehjacc/zuaa031DOI Listing
May 2021

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

Circ Heart Fail 2021 01 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

Implementation of a beating heart system for training in off-pump and minimally invasive coronary artery bypass.

BMC Surg 2021 Jan 6;21(1):26. Epub 2021 Jan 6.

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

Background: Several training devices have been developed to train anastomotic skills in off-pump coronary artery bypass grafting (OPCAB). However, assessment of trainees' improvement remains challenging. The goal of this study was to develop a new practical scoring chart and investigate its reliability and utility for anastomotic skills in OPCAB and minimally invasive direct coronary artery bypass (MIDCAB).

Methods: A training device was used, which included a beating heart model installed in a dedicated box. A soft plastic tube was used as the left anterior descending artery, and a porcine ureter was used as the left internal mammary artery. Five cardiac surgery fellows (Fellows, > 5 year of surgical experience) and five residents or medical students (Residents, ≤ 5 year of surgical experience) were enrolled for this study. Before and after training, skills were evaluated using a scoring chart that took into account anastomotic time, leakage, shape, flow measurement, and self-estimation.

Results: Mean total score of all trainees was 15.4 ± 4.0 at pre-training and 18.5 ± 2.4 at post-training (P = 0.05). Before training, there was a significant difference in the total score between Fellows and Residents (18.6 ± 2.2 vs 12.2 ± 2.4 points, P = 0.002), which disappeared after training (19.4 ± 2.5 vs 17.6 ± 2.2 points, P = 0.262). Residents benefitted from training with improvements in their time, total score, score for time, score for flow and subtraction score; however, these effects were not seen in Fellows. The most evident training effect was improvement of self-estimation, which was also seen in Fellows.

Conclusions: Residents were most likely to derive benefit from these training models with regard to both efficiency and quality. Training models seem to have an important role in making surgeons feel more comfortable with the procedure.
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http://dx.doi.org/10.1186/s12893-020-01023-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789217PMC
January 2021

Pulmonary Valve Replacement in Tetralogy of Fallot: An Updated Meta-Analysis.

Ann Thorac Surg 2020 Dec 27. Epub 2020 Dec 27.

Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, Essen, Germany.

Background: The benefits of pulmonary valve replacement (PVR) for pulmonary insufficiency in patients with repaired tetralogy of Fallot are still incompletely understood, and optimal timing remains challenging.

Methods: We systematically reviewed databases (PubMed/MEDLINE, Embase, Cochrane Central Register of Controlled Trials /Cochrane Controlled Trials Register, ClinicalTrials.gov, Scientific Electronic Library Online, Literatura Latino Americana em Ciências da Saúde, and Google Scholar) and reference lists of relevant articles for studies about PVR in repaired tetralogy of Fallot patients that reported any of the following outcomes: mortality and redo PVR rates, right ventricular (RV) and left ventricular measures, QRS duration, cardiopulmonary exercise test results, or brain natriuretic peptide. In addition to calculating the pooled treatment effects using a random-effects meta-analysis, we evaluated the effect of preoperative measures on PVR outcomes using meta-regressions.

Results: Eighty-four studies involving 7544 patients met the eligibility criteria. Pooled mortality at 30 days, 5 years, and 10 years after PVR was 0.87% (63 of 7253 patients, 80 studies), 2.7% (132 of 4952 patients, 37 studies), and 6.2% (510 of 2765 patients, 15 studies), respectively. Pooled 5- and 10-year redo PVR rates were 3.7% (141 of 3755 patients, 23 studies) and 16.8% (172 of 3035 patients, 16 studies), respectively. The results of the previous meta-analysis could be confirmed. In addition, we demonstrated that after PVR (1) QRS duration, cardiopulmonary exercise test results, and RV and left ventricular measures longitudinal strain do not significantly change; (2) brain natriuretic peptide decreases; and (3) greater indexed RV end-diastolic and end-systolic volumes are associated with lower chances of RV volume normalization after PVR.

Conclusions: This updated meta-analysis provides evidence about the benefits of PVR.
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http://dx.doi.org/10.1016/j.athoracsur.2020.11.040DOI Listing
December 2020

Development of a computational simulator of the extracorporeal membrane oxygenation and its validation with in vitro measurements.

Artif Organs 2021 Apr 7;45(4):399-410. Epub 2020 Dec 7.

Department of Cardiovascular Science, Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.

In the recent years, the use of extracorporeal membrane oxygenation (ECMO) has grown substantially, posing the need of having specialized medical and paramedical personnel dedicated to it. Optimization of the therapy, definition of new therapeutic strategies, and ECMO interaction with the cardiorespiratory system require numerous specific skills and preclinical models for patient successful management. The aim of the present work is to develop and validate a computational model of ECMO and connect it to an already existing lumped parameter model of the cardiorespiratory system. The ECMO model was connected between the right atrium and the aorta of the cardiorespiratory simulator. It includes a hydraulic module that is a representation of the tubing, oxygenator, and pump. The resulting pressures and flows within the ECMO circuit were compared to the measurements conducted in vitro on a real ECMO. Additionally, the hemodynamic effects the ECMO model elicited on the cardiorespiratory simulator were compared with experimental data taken from the literature. The comparison between the hydraulic module and the in vitro measurements evidenced a good agreement in terms of flow, pressure drops across the pump, across the oxygenator and the tubing (maximal percentage error recorded was 17.6%). The hemodynamic effects of the ECMO model on the cardiovascular system were in agreement with what observed experimentally in terms of cardiac output, systemic pressure, pulmonary arterial pressure, and left atrial pressure. The ECMO model we developed and embedded into the cardiorespiratory simulator, is a useful tool for the investigation of basic physiological mechanisms and principles of ECMO therapy. The model was sided by a user interface dedicated to training applications. As such, the resulting simulator can be used for the education of students, medical and paramedical personnel.
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http://dx.doi.org/10.1111/aor.13842DOI Listing
April 2021

First in vivo assessment of RAS-Q technology as lung support device for pulmonary hypertension.

Int J Artif Organs 2021 Apr 10;44(4):243-250. Epub 2020 Sep 10.

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

Objectives: To assess the in vivo hemodynamic effects on the pressure overloaded right ventricle of RAS-Q technology, the world's first gas exchanger with a fully integrated compliance.

Methods: In six acute in vivo trials RAS-Q was implanted in sheep between the pulmonary artery and left atrium. Right ventricular pressure overload was induced by pulmonary artery banding. Pressures and flows were recorded in baseline, moderate and severe pulmonary hypertension conditions. In one trial, RAS-Q was benchmarked against the pediatric Quadrox-i.

Results: With 1.00 and 1.17 L/min, RAS-Q delivered 31% and 39% of the total cardiac output in moderate and severe pulmonary hypertension, respectively. Pulmonary artery pressures and mean pulmonary artery pressure/mean arterial blood pressure ratio successfully decreased, implying a successful right ventricular unloading. Cardiac output was restored to normal levels in both pulmonary hypertension conditions. With both devices in parallel, RAS-Q provided three times higher flow rates and a 10 times higher pressure relief, compared to the pediatric Quadrox-i.

Conclusion: A gas exchanger with a fully integrated compliance better unloads the right ventricle compared to a non-compliant gas exchanger and it can restore cardiac output to normal levels in cases of severe pulmonary hypertension.
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http://dx.doi.org/10.1177/0391398820954217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8041442PMC
April 2021

Critical Coarctation of the Aorta in Selective Fetal Growth Restriction and the Role of Coronary Stent Implantation.

Fetal Diagn Ther 2020 Jul 27:1-9. Epub 2020 Jul 27.

Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium,

Introduction: Monochorionic twins are at increased risk of congenital heart defects (CHDs). Up to 26% have a birth weight <1,500 g, a CHD requiring neonatal surgery, therefore, poses particular challenges.

Objective: The aim of the study was to describe pregnancy characteristics, perinatal management, and outcome of monochorionic twins diagnosed with critical coarctation of the aorta (CoA).

Methods: We included monochorionic twins diagnosed with critical CoA (2010-2019) at 2 tertiary referral centers, and we systematically reviewed the literature regarding CoA in monochorionic twins.

Results: Seven neonates were included. All were the smaller twin of pregnancies complicated by selective fetal growth restriction. The median gestational age at birth was 32 weeks (28-34). Birth weight of affected twins ranged as 670-1,800 g. One neonate underwent coarctectomy at the age of 1 month (2,330 g). Six underwent stent implantation, performed between day 8 and 40, followed by definitive coarctectomy between 4 and 9 months in 4. All 7 developed normally, except for 1 child with neurodevelopmental delay. Three co-twins had pulmonary stenosis, of whom 1 required balloon valvuloplasty. The literature review revealed 10 cases of CoA, all in the smaller twin. Six cases detected in the first weeks after birth were treated with prostaglandins alone, by repeated transcatheter angioplasty or by surgical repair, with good outcome in 2 out of 6.

Conclusions: CoA specifically affects the smaller twin of growth discordant monochorionic twin pairs. Stent implantation is a feasible bridging therapy to surgery in these low birth weight neonates.
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http://dx.doi.org/10.1159/000508305DOI Listing
July 2020

Limiting factors of peak and submaximal exercise capacity in LVAD patients.

PLoS One 2020 9;15(7):e0235684. Epub 2020 Jul 9.

Department of Cardiovascular Sciences, Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium.

Aims: Although patients supported with a Continuous-Flow Left Ventricular Assist Device (CF-LVAD) are hemodynamically stable, their exercise capacity is limited. Hence, the aim of this work was to investigate the underlying factors that lead to peak and submaximal exercise intolerance of CF-LVAD supported patients.

Methods: Seven months after CF-LVAD implantation, eighty three patients performed a maximal cardiopulmonary exercise test and a six minute walk test. Peak oxygen uptake and the distance walked were measured and expressed as a percentage of the predicted value (%VO2p and %6MWD, respectively). Preoperative conditions, echocardiography, laboratory results and pharmacological therapy data were collected and a correlation analysis against %VO2p and %6MWD was performed.

Results: CF-LVAD patients showed a relatively higher submaximal exercise capacity (%6MWD = 64±16%) compared to their peak exertion (%VO2p = 51±14%). The variables that correlated with %VO2p were CF-LVAD parameters, chronotropic response, opening of the aortic valve at rest, tricuspid insufficiency, NT-proBNP and the presence of a cardiac implantable electronic device. On the other hand, the variables that correlated with %6MWD were diabetes, creatinine, urea, ventilation efficiency and CF-LVAD pulsatility index. Additionally, both %6MWD and %VO2p were influenced by the CF-LVAD implantation timing, calculated from the occurrence of the cardiac disease.

Conclusion: Overall, both %6MWD and %VO2p depend on the duration of heart failure prior to CF-LVAD implantation. %6MWD is primarily determined by parameters underlying the patient's general condition, while %VO2p mostly relies on the residual function and chronotropic response of the heart. Moreover, since %VO2p was relatively lower compared to %6MWD, we might infer that CF-LVAD can support submaximal exercise but is not sufficient during peak exertion. Hence concluding that the contribution of the ventricle is crucial in sustaining hemodynamics at peak exercise.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0235684PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7347393PMC
September 2020

Comparison of Hemodynamic Support by Impella vs. Peripheral Extra-Corporeal Membrane Oxygenation: A Porcine Model of Acute Myocardial Infarction.

Front Cardiovasc Med 2020 10;7:99. Epub 2020 Jun 10.

Department of Cardiac Surgery, Hôpital Universitaire Pitié-Salpêtrière, Paris, France.

Several mechanical circulatory assist devices are used to treat critically ill patients requiring hemodynamic support during post-myocardial infarction or cardiogenic shock. However, little guidance is available to choose an appropriate device to match a particular patient's needs. An increased understanding of hemodynamic effects of the pump systems and their impact on myocardial pre-/afterload might help to better understand their behavior in different clinical settings. This was an open-labeled, randomized acute animal experiment. A model of acute univentricular myocardial injury by temporary balloon occlusion was used. The experiment was carried out in 10 juveniles female Piétrain pigs. The animals were randomized to mechanical hemodynamic support either by peripheral veno-arterial (VA-)ECMO or Impella CP. While both devices were able to provide flows above 3 L/min and maintain sufficient end-organ perfusion, support by Impella resulted in a significantly more pronounced immediate effect on myocardial unloading: At the onset of device support, the remaining native cardiac output was reduced by 23.5 ± 15.3% ECMO vs. 66.2 ± 36.2% (Impella, = 0.021). Native stroke volume was significantly decreased by Impella support compared to ECMO, indicating less mechanical work being conducted by the Impella-supported hearts despite similar total assisted cardiac output. Peripheral VA-ECMO and the transaortic Impella pump resulted in contrasting hemodynamic fingerprints. Both devices provided sufficient hemodynamic support and reduce left ventricular end-diastolic pressure in the acute setting. Treatment with the Impella device resulted in a more effective volume unloading of the left ventricle. A significant reduction in myocardial oxygen consumption equivalent was achieved by both devices: The Impella device resulted in a left-shift of the pressure-volume loop and a decreased pressure-volume-area (PVA), while VA-ECMO increased PVA but decreased heart rate. These data highlight the importance of specifically targeting heart rate in the management of AMI patients on hemodynamic support.
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http://dx.doi.org/10.3389/fcvm.2020.00099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299088PMC
June 2020

Haemodynamic Effect of Left Atrial and Left Ventricular Cannulation with a Rapid Speed Modulated Rotary Blood Pump During Rest and Exercise: Investigation in a Numerical Cardiorespiratory Model.

Cardiovasc Eng Technol 2020 08 16;11(4):350-361. Epub 2020 Jun 16.

Innovative Cardiovascular Engineering and Technology Laboratory, Critical Care Research Group, The Prince Charles Hospital, Brisbane, Queensland, Australia.

Purpose: The left atrium and left ventricle are the primary inflow cannulation sites for heart failure patients supported by rotary blood pumps (RBPs). Haemodynamic differences exist between inflow cannulation sites and have been well characterized at rest, yet the effect during exercise with the same centrifugal RBP has not been previously well established. The purpose of this study was to investigate the hemodynamic effect of inflow cannulation site during rest and exercise with the same centrifugal RBP.

Methods: In a numerical cardiorespiratory model, a simulated heart failure patient was supported by a HeartWare HVAD RBP in left atrial (LAC) and left ventricular cannulation (LVC). The RBP was operated at constant speed and sinusoidal co- and counter-pulse and was investigated in cardiovascular conditions of steady state rest and 80-watt bike graded exercise.

Results: Cardiac output was 5.0 L min during rest and greater than 6.9 L min during exercise for all inflow cannulation sites and speed operating modes. However, during exercise, LAC demonstrated greater pressure-volume area and lower RBP flow (1.41, 1.37 and 1.37 J and 5.03, 5.12 and 5.03 L min for constant speed and co- and counter-pulse respectively) when compared to LVC (pressure-volume area: 1.30, 1.27 and 1.32 J and RBP flow: 5.56, 5.71 and 5.59 L min for constant speed and co- and counter-pulse respectively).

Conclusion: For a simulated heart failure patient intending to complete exercise, LVC seems to assure a better hemodynamic performance in terms of pressure-volume area unloading and increasing RBP flow.
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http://dx.doi.org/10.1007/s13239-020-00471-1DOI Listing
August 2020

Comparative analysis of regional outcomes and adverse events after continuous-flow left ventricular assist device implantation: An IMACS analysis.

J Heart Lung Transplant 2020 09 16;39(9):904-914. Epub 2020 May 16.

Department of Cardiothoracic Surgery, Montefiore Medical Center, Bronx, New York.

Introduction: Regional outcomes after implantation of continuous-flow left ventricular assist devices (LVADs) have not been described. We examined differences in patient selection, survival, and adverse events across 3 geographic regions of the world: the Americas, Asia-Pacific, and Europe.

Methods: Using data from The International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support registry, all adult patients implanted with a continuous-flow LVADs were included in this International Society for Heart and Lung Transplantation Mechanically Assisted Circulatory Support analysis (n = 15,560), of whom, 9,988 (64%) received axial-flow devices and 5,572 (36%) received centrifugal-flow devices.

Results: There were significant interregional differences in the rate of implantation of patients aged >70 years (Americas: 14%, Asia-Pacific: 1%, Europe: 5%; p < 0.0001), morbidly obese (Americas: 5%, Asia-Pacific: 1%, Europe: 1%; p < 0.0001), male (Americas: 79%, Asia-Pacific: 77%, Europe: 85%; p < 0.0001), and implanted as destination therapy (Americas: 48%, Asia-Pacific: 4%, Europe: 22%; p < 0.0001). The rates of centrifugal pump usage varied by region (Americas: 30%, Asia-Pacific: 34%, Eu: 74%; p < 0.0001). Survival rates varied by region and the type of pump flow, with survival at 12 and 48 months (axial flow vs centrifugal flow) being 82% vs 82% and 52% vs 53 in Americas; 92% vs 86% and 83% vs 74% in Asia-Pacific; and 80% vs 75% and 69% vs 53% in Europe, respectively (regional survival p < 0.0001).

Conclusion: There are marked global differences in LVAD recipient characteristics, device utilization, and post-operative care. These heterogeneities along with differences in patient management and transplantation rates may impact long-term survival. Regional differences in adverse event incidence warrant further investigation.
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http://dx.doi.org/10.1016/j.healun.2020.05.001DOI Listing
September 2020

Paediatric aortic valve replacement using decellularized allografts.

Eur J Cardiothorac Surg 2020 10;58(4):817-824

Department for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Objectives: Options for paediatric aortic valve replacement (AVR) are limited if valve repair is not feasible. Results of paediatric Ross procedures are inferior to adult Ross results, and mechanical AVR imposes constant anticoagulation with the inherent risks.

Methods: The study design was a prospective, multicentre follow-up of all paediatric patients receiving decellularized aortic homografts (DAHs) for AVR in 8 European centres.

Results: A total of 106 children (77 boys) were operated (mean age 10.1 ± 4.8 years, DAH diameter 20.5 ± 3.8 mm). A total of 60 (57%) had undergone previous surgical interventions: 34 with 1, 15 with 2 and 11 with ≥3. There was one early death in a 12-year-old girl, who underwent her fourth aortic valve operation, due to intracerebral haemorrhage on extracorporeal membrane oxygenation after coronary reimplantation problems following 3-sinus reconstruction 1 year earlier. One 2-year-old patient died due to sepsis 2 months postoperatively with no evidence for endocarditis. In addition, a single pacemaker implantation was necessary and a 2.5-year-old girl underwent successful HTx due to chronic myocardial failure despite an intact DAH. After a mean follow-up of 3.30 ± 2.45 years, primary efficacy end points mean peak gradient (18.1 ± 20.9 mmHg) and regurgitation (mean 0.61 ± 0.63, grade 0-3) were very good. Freedom from death/explantation/endocarditis/bleeding/stroke at 5 years was 97.8 ± 1.6/85.0 ± 7.4/100/100/100% respectively. Calculated expected adverse events were lower for DAH compared to cryopreserved homograft patients (mean age 8.9 years), lower than in Ross patients (9.4 years) and in the same range as mechanical AVR (12.8 years).

Conclusions: Even though the overall number of paediatric DAH patients and the follow-up time span are still limited, our data suggest that DAHs may present a promising additional option for paediatric AVR.
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http://dx.doi.org/10.1093/ejcts/ezaa119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890932PMC
October 2020

Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data.

Eur J Cardiothorac Surg 2020 11;58(5):1045-1053

Department for Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Objectives: Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses.

Methods: A prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement.

Results: One hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 ± 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 ± 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 ± 140, 174 ± 80 and 126 ± 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 ± 0.81 years, the primary efficacy end points peak gradient (mean 11.8 ± 7.5 mmHg) and regurgitation (mean 0.42 ± 0.49, grade 0-3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 ± 1.1%/99.4 ± 0.6%/99.1 ± 0.9%/99.2 ± 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2× more previous procedures.

Conclusions: The initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period.
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http://dx.doi.org/10.1093/ejcts/ezaa100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577293PMC
November 2020

Perioperative Risk Factors for Mortality in Patients Undergoing Surgery for Ebstein's Anomaly at a Single Institution: A Retrospective Analysis.

Heart Surg Forum 2020 04 3;23(2):E193-E199. Epub 2020 Apr 3.

Department of Anesthesiology, University Hospitals of Leuven, Leuven, Belgium.

Background: Mortality after cardiac surgery for Ebstein's anomaly ranges from 2.5% to 31%. Independent predictors for mortality and morbidity remain poorly defined because of the low incidence of this congenital anomaly. To identify potentially modifiable factors, this retrospective study investigates the prognostic value of perioperative variables for mortality and morbidity.

Methods: We reviewed the charts of 171 patients with Ebstein's anomaly who were at one point in follow-up at our center. Only patients who underwent cardiac surgery for this anomaly were included. The primary endpoint was a composite of mortality or rehospitalization for cardiac reasons within 1 year of surgery. Logistic regression and Cox regression models were used to study the predictive value of various variables.

Results: We identified 32 patients (median age 12 years; range 7 days to 70 years) who underwent a total of 49 surgical procedures for Ebstein's anomaly at our institution between November 1987 and March 2015. The following variables were significantly associated with the primary outcome: increased severity of tricuspid valve stenosis (odds ratio 2.089; 95% confidence interval 1.175 to 3.713) and right ventricular dysfunction (1.826; 1.109 to 3.006), partial corrective surgery (versus corrective surgery) (6.709; 1.436 to 31.344), occurrence of major postoperative complications (5.460; 1.419 to 21.008), and increased length of stay in the intensive care unit (1.051; 1.010 to 1.093). A better outcome was observed with the use of intraoperative cardioplegic arrest (0.185; 0.063 to 0.550), atrial septal defect closure during surgery, and longer duration of surgery (0.991; 0.984 to 0.998).

Conclusion: Several patient-specific characteristics and perioperative characteristics were associated with a poorer outcome after cardiac surgery for Ebstein's anomaly. The outcome seems to be primarily determined by the severity of the valve dysfunction and right ventricular performance, with only a minor role for perioperative surgical or anesthetic technical determinants.
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http://dx.doi.org/10.1532/hsf.2755DOI Listing
April 2020
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