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1.
Physiol Res ; 68(2): 233-243, 2019 04 30.
Article in English | MEDLINE | ID: mdl-30628823

ABSTRACT

In the pulmonary circulation, resistive and compliant properties overlap in the same vessels. Resistance varies nonlinearly with pressure and flow; this relationship is driven by the elastic properties of the vessels. Linehan et al. correlated the mean pulmonary arterial pressure and mean flow with resistance using an original equation incorporating the distensibility of the pulmonary arteries. The goal of this study was to validate this equation in an in vivo porcine model. In vivo measurements were acquired in 6 pigs. The distensibility coefficient (DC) was measured by placing piezo-electric crystals around the pulmonary artery (PA). In addition to experiments under pulsatile conditions, a right ventricular (RV) bypass system was used to induce a continuous pulmonary flow state. The Linehan et al. equation was then used to predict the pressure from the flow under continuous flow conditions. The diameter-derived DC was 2.4%/mmHg (+/-0.4%), whereas the surface area-based DC was 4.1 %/mmHg (+/-0.1%). An increase in continuous flow was associated with a constant decrease in resistance, which correlated with the diameter-based DC (r=-0.8407, p=0.044) and the surface area-based DC (r=-0.8986, p=0.028). In contrast to the Linehan et al. equation, our results showed constant or even decreasing pressure as flow increased. Using a model of continuous pulmonary flow induced by an RV assist system, pulmonary pressure could not be predicted based on the flow using the Linehan et al. equation. Measurements of distensibility based on the diameter of the PA were inversely correlated with the resistance.


Subject(s)
Pulmonary Artery/physiology , Pulmonary Circulation/physiology , Pulsatile Flow/physiology , Vascular Resistance/physiology , Ventricular Function, Right/physiology , Animals , Swine
4.
Ann Biomed Eng ; 43(6): 1370-84, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25186435

ABSTRACT

The aim of this study was to reconcile some of our own previous work and the work of others to generate a physiologically realistic numerical simulation environment that allows to virtually assess the performance of BMHVs. The model incorporates: (i) a left ventricular deformable model to generate a physiological inflow to the aortic valve; (ii) a patient-specific aortic geometry (root, arch and descending aorta); (iii) physiological pressure and flow boundary conditions. We particularly studied the influence of downstream geometry, valve size and orientation on leaflet kinematics and functional indices used in clinical routine. Compared to the straight tube geometry, the patient-specific aorta leads to a significant asynchronous movement of the valve, especially during the closing of the valve. The anterior leaflet starts to close first, impacts the casing at the closed position and remains in this position. At the same time, the posterior leaflet impacts the pivoting mechanisms at the fully open position. At the end of systole, this leaflet subsequently accelerates to the closed position, impacting the casing with an angular velocity of approximately -477 rad/s. The valve size greatly influences the transvalvular pressure gradient (TPG), but does not change the overall leaflet kinematics. This is in contrast to changes in valve orientation, where changing valve orientation induces large differences in leaflet kinematics, but the TPG remains approximately the same.


Subject(s)
Aorta , Aortic Valve , Arterial Pressure , Heart Valve Prosthesis , Models, Cardiovascular , Systole , Adult , Aorta/pathology , Aorta/physiopathology , Aortic Valve/pathology , Aortic Valve/physiopathology , Biomechanical Phenomena , Humans , Male , Organ Size
5.
Cell Prolif ; 45(4): 378-85, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22691137

ABSTRACT

OBJECTIVE: The aim of this study was to repopulate decellularized heart valve matrices with ovine mesenchymal stem cells (oMSCs) by the use of platelet gel (PG) supernatant, a storage vehicle for growth factors. METHODS: oMSCs were exposed to different concentrations of PG-released supernatant and cell proliferation was evaluated using the MTS assay. oMSC motility and invasiveness were assayed using a Boyden chamber. A quantitative sandwich enzyme immunoassay was used to examine amounts of bFGF and TGF-ß1 in the PG supernatant. Repopulation of acellular heart valve matrices was stimulated by seeding matrices with oMSCs supplemented with the PG supernatant. RESULTS: The most significant increase in proliferation induced by PG supernatant appeared at 1 × 10(5) plts/ml concentration. Higher concentrations evoked reduction of the stimulatory process. oMSC motility was most significantly stimulated at 1 × 10(6) plts/ml. Stimulating invasiveness of oMSCs needed the much higher concentration of 2 × 10(6) plts/ml. Immunoassays revealed that sheep PG supernatant contains 184.8 pg/ml bFGF and 60.5 ng/ml TGF-ß1. Moreover, repopulation of acellular heart valve matrices was significantly enhanced by PG supernatant addition and resulted in upregulation of the myofibroblast marker alpha-smooth muscle actin. CONCLUSIONS: Growth factors released from platelets had the potential to induce cell repopulation in a heart valve tissue engineering procedure, through stimulation of mesenchymal stem-cell migration and invasion.


Subject(s)
Blood Platelets , Culture Media , Heart Valves/cytology , Animals , Cell Proliferation , Female , Gels , Immunoenzyme Techniques , Immunohistochemistry , Mesenchymal Stem Cells/cytology , Sheep
6.
Perfusion ; 26(6): 496-502, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21719530

ABSTRACT

BACKGROUND: Two types of surface coating for cardiopulmonary bypass (CPB) are used: bioactive (heparin, nitric oxide) and biopassive (albumin, polyethyleneoxide (PEO), phosphorylcholine). When haemocompatible coatings are combined with the separation of pleuro-pericardial aspiration, attenuation of both the coagulation and complement cascades, as well as better platelet preservation, has been demonstrated. This study wants to investigate if the combination of a bioactive with a biopassive coating (unfractionated heparin embedded in a phosphorylcholine matrix) combines the beneficial effects of both approaches. MATERIALS AND METHODS: Thirty patients undergoing elective CABG were prospectively randomized into two groups of 15 patients. The sole exclusion criterion was an ejection fraction of less than 40%. In the control group (PC), the whole CPB circuit was coated with phosphorylcholine (PC). In the study group (XPC), unfractionated heparin was embedded in the PC matrix of the oxygenator and arterial line filter. RESULTS: No differences were found for haemolytic index, thrombin-anti-thrombin complex (TAT), IL-6, IL-10 and blood loss. PF4 plasma concentration increased from 27.6±22.0 IU/mL to 165.7±43.9 IU/mL (p<0.001) at 15 minutes of CPB in the PC and from 16.0±9.7 IU/mL to 150.9 ± 61.3 IU/mL (p<0.001) in the XPC group. Terminal complement complex (TCC) increased over time in both groups until the end of CPB (Figure 2A). Within each group, TCC generation was statistically significantly higher after the release of the aortic cross-clamp (p<0.001) and at the end of CPB (p<0.001). Total TCC generation was statistically significantly higher in the XPC group compared to the PC group (p=0.026). The difference was statistically significant after the release of the aortic cross-clamp (p=0.005) and at the end of CPB (p=0.001). CONCLUSIONS: Based on our results, there is no additional benefit in combining phosphorylcholine with unfractionated heparin in elective patients undergoing coronary artery bypass grafting (CABG). Massive haemodilution leads to enhanced complement activation.


Subject(s)
Cardiopulmonary Bypass/instrumentation , Coated Materials, Biocompatible/metabolism , Coronary Artery Bypass/instrumentation , Heparin/metabolism , Oxygenators , Phosphorylcholine/metabolism , Aged , Cardiopulmonary Bypass/adverse effects , Complement Activation , Coronary Artery Bypass/adverse effects , Female , Hemolysis , Humans , Interleukin-10/blood , Interleukin-6/blood , Male , Middle Aged , Prospective Studies
7.
Acta Chir Belg ; 109(3): 306-11, 2009.
Article in English | MEDLINE | ID: mdl-19943584

ABSTRACT

BACKGROUND: Surgical management of concomitant pulmonary and cardiac disease remains controversial. There is no consensus on the use of a one- or two-staged procedure, the timing of heparinization and the utilisation of cardio-pulmonary bypass. METHODS: We performed a retrospective review of 27 patients who underwent pulmonary and cardiac surgery, from 2000 to 2008, in two institutions. We focused on early postoperative morbidity and mortality. RESULTS: 24 men and 3 women, with a mean age of 68 years, were treated. Cardiac procedures consisted of coronary artery bypass grafting (n = 22), heart valve surgery (n = 3) or a combination of both (n = 2). Pulmonary resection included segmental resection (n = 1), lobectomy (n = 21), bilobectomy (n = 2) and pneumonectomy (n = 3). Histology of the pulmonary lesion was squamous cell carcinoma in 14 patients (52%), adenocarcinoma in 10 (37%), large cell neuroendocrine tumour in 1 (3%) and typical carcinoid in 1 (3%). The stage of the pulmonary malignancy was IA in 8 patients (31%), stage IB in 11 (42%), stage IIB in 5 (19%) and stage IIIB in 2 (8%). A benign lesion was found in 1 patient (3%). There was no in-hospital mortality. Postoperative complications occurred in 16 patients (59%) consisting of supraventricular arrhythmias in 11 (41%), pneumonia in 8 (30%), atelectasis in 6 (22%), ventricular arrhythmias in 2 (7%), pneumothorax in 1 (3%), pleural effusion in 1 (3%), and renal insufficiency in 1 patient (3%). Revision for bleeding was necessary in 3 patients (11%). The mean follow-up was 30,7 months with a median survival for all patients of 46 months. CONCLUSIONS: Simultaneous procedures for cardiac disease and pulmonary lesions can be performed without life-threatening morbidity and no in-hospital mortality.


Subject(s)
Cardiac Surgical Procedures/methods , Heart Diseases/surgery , Lung Neoplasms/surgery , Pneumonectomy/methods , Aged , Aged, 80 and over , Belgium/epidemiology , Female , Follow-Up Studies , Heart Diseases/complications , Heart Diseases/mortality , Humans , Lung Neoplasms/complications , Lung Neoplasms/mortality , Male , Middle Aged , Retrospective Studies , Survival Rate/trends , Time Factors , Treatment Outcome
8.
Perfusion ; 23(4): 215-21, 2008 Jul.
Article in English | MEDLINE | ID: mdl-19181753

ABSTRACT

Protein adsorption onto polymers remains a problem. In recent years, several protein-repellent PVC tubings have been developed. Although several studies report the interaction between plasma coagulation proteins and PVC, few address the interaction with other plasma proteins. Two commercial brands of untreated medical grade PVC tubing, phosphorylcholine-coated PVC tubing, triblock-copolymer (polycaprolactone-polydimethylsiloxane-polycaprolactone)-treated PVC tubing and poly-2-methoxyethylacrylate (PMEA)-coated tubing were exposed for 60 minutes to human plasma. A broad spectrum of plasma proteins was found on all tubing. The adsorbed albumin to total protein ratio is lower than the similar ratio in plasma while alpha1 and alpha2 globulins are over-represented in the protein spectrum. On PMEA tubing, not only alpha globulins, but also beta and gamma globulins, are found in high concentrations in the adsorbed protein. PMEA tubing and uncoated PVC tubing of brand B had a higher amount of protein adsorbed compared against all other tubing (p < 0.05). There were no statistical differences in protein adsorption between the triblock-copolymer-treated tubing, the phosphorylcholine-coated tubing and the uncoated PVC tubing of brand A. The average thickness of the protein layer was 23 nm. Plasma protein adsorption still exists on uncoated and protein-repellent tubing and can initiate a systemic inflammatory reaction.


Subject(s)
Blood Proteins/metabolism , Polyvinyl Chloride/metabolism , Acrylates/chemistry , Acrylates/metabolism , Blood Proteins/chemistry , C-Reactive Protein/chemistry , C-Reactive Protein/metabolism , Humans , Materials Testing , Phosphorylcholine/chemistry , Phosphorylcholine/metabolism , Polymers/chemistry , Polymers/metabolism , Polyvinyl Chloride/chemistry , Protein Binding , Surface Properties
9.
Acta Chir Belg ; 108(6): 638-44, 2008.
Article in English | MEDLINE | ID: mdl-19241910

ABSTRACT

Optimal delivery of health care is a common goal of individual physicians, professional organizations, hospital structures and governmental authorities. A growing concern has emerged from the public, media and third payer organizations concerning the quality of care and the amount of resources spending. In the United States, large databases, guidelines and performance evaluation have been elaborated by medical societies, particularly in the area of cardiac surgery. These tools are useful for improvement of patients' care, resources distribution, pay for performance and public and practitioners' awareness. The evaluation of quality is based on composite models combining structure, process and outcome indices. However, pitfalls such as patients' selection, and risk avoidance in order to improve results must been prevented by adjustment of the treated populations' risk factors by specific scores. The Belgian Health authorities have built a structure directed at delivery of care improvement based on "Care Programs", monitored by Colleges formed by delegates of professional organizations. The College of Cardiac Surgery has promoted several studies aimed at data collection and evaluation. In 2007, a survey was addressed to all the Belgian Cardiac surgeons to define their opinion as to the best indicators of care in their specialty. These results will serve to define further avenues of research. By maintaining the responsibility of care evaluation in the hands of the involved professionals, this kind of cooperation between governmental and physicians' organizations seems to serve the best interests of the public and the practitioners.


Subject(s)
Cardiac Surgical Procedures/standards , Quality Assurance, Health Care/standards , Belgium , Health Care Surveys , Humans , Quality of Health Care
10.
Lab Anim ; 40(4): 341-52, 2006 Oct.
Article in English | MEDLINE | ID: mdl-17018206

ABSTRACT

The feasibility of an anaesthetic protocol developed for surgery during right heart bypass in sheep is reported. Seven female Suffolk sheep, weighing 25-35 kg, were selected for the study. Premedication consisted of midazolam and methadone (both 0.1 mg kg(-1) intravenously). Anaesthesia was induced with propofol (2-4 mg kg(-1)) and maintained with isoflurane in oxygen and continuous rate infusions of propofol (5-7 mg kg(-1 )h(-1)) and fentanyl (5 microg kg(-1) bolus, 5 microg kg(-1) h(-1)). Cisatracurium (0.2 mg kg(-1)) provided muscle relaxation. A standard roller pump was used for the extracorporeal circulation. Drugs administered to maintain blood pressure and heart rate within acceptable levels included phenylephrine (3-4 microg kg(-1)), ephedrine (0.1-0.2 mg kg(-1)), nitroglycerine (50-150 microg kg(-1) h(-1)) and metoprolol succinate (30-80 microg kg(-1)). Electrolytes were infused as needed. Postoperative analgesia was provided by an intercostal block (15 mL 0.5% bupivacaine + epinephrine), carprofen (4 mg kg(-1)) and an opioid (methadone 0.1 mg kg(-1) or buprenorphine 0.01 mg kg(-1)). One sheep became hypoxic during the bypass (PaO(2) 47.7 mmHg). Irregularities of the electrocardiogram were observed during manipulation of the heart in all animals. During the initial phase of the bypass, blood pressure decreased in all sheep, accompanied by dilatation of the heart and large intrathoracic veins in five sheep. With appropriate treatment, blood pressure was restored and easily maintained until the end of the bypass. Weaning from the bypass, using an infusion of nitrates, was smooth. One sheep required a blood transfusion because of severe blood loss and another sheep died postoperatively from respiratory complications. Minor irregularities of the electrocardiogram observed during manipulation of the heart were not life threatening and required no treatment. Decreases in blood pressure at the beginning of the bypass can be expected and require treatment. Nitrates are useful in avoiding volume overload during weaning. The anaesthetic protocol is acceptable for surgery under right heart bypass in sheep.


Subject(s)
Anesthesia/veterinary , Anesthetics/administration & dosage , Aortic Valve/surgery , Heart Bypass, Right/methods , Heart Valve Prosthesis , Pulmonary Artery/surgery , Sheep , Anesthesia/methods , Anesthetics/pharmacology , Animals , Blood Pressure/drug effects , Female , Heart Rate/drug effects
12.
Acta Chir Belg ; 105(5): 497-503, 2005.
Article in English | MEDLINE | ID: mdl-16315833

ABSTRACT

BACKGROUND: The purpose of this study is to assess the current management of atrial septal defect closure in an era of increasing feasibility of transcatheter device occlusion. METHODS: Atrial septal defect (ASD) closure was performed surgically through complete sternotomy in 165 patients (group 1) and through partial inferior sternotomy in 53 patients (group 2). Transcatheter device occlusion was achieved in 82 patients with only ASD type II and patent foramen ovale (group 3). RESULTS: Overall complications were minor and more frequent in group 1: 26.7% versus 13.2% in group 2 and 14.6% in group 3 (p = 0.04). Compared to complete sternotomy, a partial sternotomy led to less chest tube loss (7.1 +/- 2.9 versus 11.6 +/- 14.5 ml/kg) (p < 0.05) and less postoperative pericardial effusion (11.3% versus 13.5%)(p = 0.55). ASD closure was effective in 99.4% in group 1, 100% in group 2 but only in 86.6% in group 3 (p < 0.05). Two major complications of device implantation required early surgery: 1 femoral arteriovenous fistula and 1 device embolization. Hospital stay was significantly shorter in group 3, as well as in group 2 compared to group 1 (8.3 +/- 4.2 versus 5.9 +/- 1.1 versus 2.1 +/- 7.3 days) (p < 0.05). Midterm results were excellent, with only 1 non-cardiac death and 1 re-operation for residual shunt in group 1, and 1 device removal for thrombosis in group 3. CONCLUSION: Transcatheter device occlusion has become an established treatment for ASD closure, achieving optimal results in older children and adults with anatomically suited ASD type II and PFO. However, a partial inferior sternotomy offers a valuable and complementary operative approach for all ASD variants, maintaining the predictable success of surgery, with the obvious advantages of minimal access in terms of morbidity, cosmetics and hospital stay.


Subject(s)
Cardiac Surgical Procedures/methods , Heart Septal Defects, Atrial/surgery , Postoperative Complications , Prosthesis Implantation/methods , Adolescent , Adult , Aged , Catheterization , Child , Child, Preschool , Female , Humans , Infant , Length of Stay , Male , Middle Aged , Morbidity , Retrospective Studies , Sternum/surgery
13.
Pediatr Cardiol ; 26(4): 350-5, 2005.
Article in English | MEDLINE | ID: mdl-16374683

ABSTRACT

In a retrospective study of 32 consecutive patients undergoing a total cavopulmonary connection (TCPC), we tried to determine if the trend for decreasing age at Fontan completion and reducing the intervals between the staged procedures during the past decade was associated with a change in morbidity and outcome. In 8 patients the Fontan circulation was completed in one stage and in 24 patients an intermediate step by hemi-Fontan or bidirectional cavopulmonary anastomosis was performed before Fontan completion. Mean age at TCPC and mean interval since the previous palliation have decreased significantly during the past decade. Although major complications were significantly reduced over time the occurrence and duration of postoperative pleural effusions were not. Decreasing age as well as intervals in staged Fontan palliation have beneficial influence on major complications and outcome, without significantly affecting the duration of pleural effusions at Fontan completion.


Subject(s)
Fontan Procedure/mortality , Heart Defects, Congenital/surgery , Palliative Care/methods , Child, Preschool , Female , Follow-Up Studies , Heart Defects, Congenital/epidemiology , Humans , Male , Morbidity/trends , Retrospective Studies , Survival Rate/trends , Treatment Outcome
14.
Eur Surg Res ; 37(3): 137-43, 2005.
Article in English | MEDLINE | ID: mdl-16088178

ABSTRACT

The aim of this study was to evaluate and compare the calcification potential of kangaroo and porcine aortic valves after glutaraldehyde fixation at both low (0.6%) and high (2.0%) concentrations of glutaraldehyde in the rat subcutaneous model. To our knowledge this is the first report comparing the time-related, progressive calcification of these two species in the rat subcutaneous model. Twenty-two Sprague-Dawley rats were each implanted with two aortic valve leaflets (porcine and kangaroo) after fixation in 0.6% glutaraldehyde and two aortic valve leaflets (porcine and kangaroo) after fixation in 2% glutaraldehyde respectively. Animals were sacrificed after 24 h and thereafter weekly for up to 10 weeks after implantation. Calcium content was determined using inductively coupled plasma-mass spectrometry and confirmed histologically. Mean calcium content per milligram of tissue (dry weight) treated with 0.6 and 2% glutaraldehyde was 116.2 and 110.4 microg/mg tissue for kangaroo and 95.0 and 106.8 microg/mg tissue for porcine valves. Calcium content increased significantly over time (8.8 microg/mg tissue per week) and was not significantly different between groups. Regression analysis of calcification over time showed no significant difference in calcification of valves treated with 0.6 or 2% glutaraldehyde within and between the two species. Using the subcutaneous model, we did not detect a difference in calcification potential between kangaroo and porcine aortic valves treated with either high or low concentrations of glutaraldehyde.


Subject(s)
Aortic Valve/transplantation , Calcinosis/chemically induced , Fixatives/adverse effects , Glutaral/adverse effects , Heart Valve Diseases/chemically induced , Macropodidae , Swine , Transplantation, Heterologous , Animals , Aortic Valve/metabolism , Aortic Valve/pathology , Calcinosis/metabolism , Calcinosis/pathology , Calcium/metabolism , Dose-Response Relationship, Drug , Glutaral/administration & dosage , Heart Valve Diseases/metabolism , Heart Valve Diseases/pathology , Rats , Rats, Sprague-Dawley , Tissue Fixation
16.
Eur J Neurol ; 11(11): 749-54, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15525296

ABSTRACT

We compared the cerebrovascular response to various cognitive tasks of cardiovascular patients and healthy controls by using transcranial Doppler ultrasonography (TCD). Cognitive task-induced cerebral blood flow velocity (BFV) changes in 66 candidates for coronary artery bypass graft surgery (mean age 59.4 +/- 7.5) were compared with the functional BFV measurement of 60 healthy controls (mean age 58 +/- 7). Absolute BFV values during baseline and activation were monitored with TCD. Relative increase of the BFV was calculated from the immediately preceding rest period to the following activation. A manova with group (patients versus controls) as between-subjects factor showed no differences in absolute BFV during the rest period. For absolute BFV during activation, a significant difference between the two groups was found. Although for each test the percentage change was smaller in the cardiac group, the difference just failed to reach significance. An explorative multivariate linear regression analysis with the absolute activation and percentage change as dependent variables and coronary risk factors as independent variables revealed no significant predictors. Using functional TCD we found that BFV values during activation were significantly lower in cardiac patients compared with healthy controls. Future research should focus on the possible explanations of this phenomenon.


Subject(s)
Cardiovascular Diseases/diagnostic imaging , Cardiovascular Diseases/physiopathology , Cognition/physiology , Hemodynamics/physiology , Blood Flow Velocity/physiology , Cerebrovascular Circulation/physiology , Female , Humans , Language , Linear Models , Male , Middle Aged , Neuropsychological Tests , Psychomotor Performance/physiology , Reading , Ultrasonography, Doppler, Transcranial , Visual Perception/physiology
17.
Acta Chir Belg ; 104(4): 440-4, 2004 Aug.
Article in English | MEDLINE | ID: mdl-15469158

ABSTRACT

BACKGROUND: to determine the advantages and/or risks of minimal access aortic valve replacement compared to standard sternotomy procedure. METHODS: from January 1997 to December 2001, 271 consecutive adult patients underwent isolated aortic valve replacement of which 174 underwent a minimal access procedure (Group 1) and 97 a standard procedure (Group 2). The preoperative variables of both groups were comparable. Retrospective analysis of postoperative outcome was performed. RESULTS: follow-up was complete and ranged from 6 months to 4 years. Overall in-hospital mortality was 3.3% (respectively 2.8 and 4.1%). No statistical difference was noted regarding operative time variables, mortality rate and hospital stay. There was a significant higher incidence of revision (p = 0.018) and late pericardial effusion (p = 0.022) in the minimal access group. Also trends were in favour of the standard group for incidence of postoperative pneumothorax and pericarditis constrictiva. CONCLUSIONS: minimal access aortic valve replacement is a safe and reliable technique, but carries the risk of incision-related morbidity. Proper patient selection and perioperative management is mandatory.


Subject(s)
Aortic Valve Insufficiency/surgery , Heart Valve Prosthesis Implantation/methods , Minimally Invasive Surgical Procedures/methods , Postoperative Complications , Aged , Female , Hospital Mortality/trends , Humans , Male , Middle Aged , Pericardial Effusion/etiology , Retrospective Studies , Treatment Outcome
18.
Verh K Acad Geneeskd Belg ; 65(3): 135-80, 2003.
Article in Dutch | MEDLINE | ID: mdl-12870184

ABSTRACT

In the past major problems with artificial valves occurred partially due to the absence of a specific legislation in Belgium. In order to prevent some of those incidents new heart valve prosthesis need to be evaluated by specific tests before being allowed to appear on the Belgian market. Done by: in the following order 1. In vitro testing. At least three samples will be tested in vitro (in the aortic and in the mitral position) in a pulse-duplicator system under static and dynamic conditions. Results of durability testing over long period of time will not be repeated if provided by the companies. 2. Preclinical in vivo testing. Using an experimental animal model. Three different prostheses implanted in an international approved animal model for a minimum period of 5 months. After explanation the valves will be examined (macroscopically, radiographically and pathologically) and compared to the standard prostheses results. 3. Clinical testing. Initially done in heart centers with a large experience of heart valve operations. A minimum of 20 valves, divided over at least 2 centers, will be evaluated over a minimum period of 1 year with strict follow up and report of all complications. Long-term studies will give even more information. 4. Evaluation of the tests. All results will be screened by experts of the Evaluation Committee for Medical Implants (in office since 04/04/2002). If positive the valves will be admitted on the Belgian market to be provided with a fair reimbursement price.


Subject(s)
Aortic Valve , Heart Valve Prosthesis/standards , Mitral Valve , Animals , Belgium , Follow-Up Studies , Humans , Models, Animal , Postoperative Complications , Stroke Volume
19.
Cardiovasc Surg ; 11(1): 80-4, 2003 Feb.
Article in English | MEDLINE | ID: mdl-12543578

ABSTRACT

OBJECTIVE: The aim of the study is to explore the feasibility and mid-term patency of an easier anastomotic technique for Minimally Invasive Direct Coronary Bypass Grafting (MIDCAB). METHODS: Eight mongrel dogs (+/-15 kg) underwent direct anastomosis between the left internal thoracic artery (LITA) and the left anterior descending coronary artery (LAD) via inferior sternotomy on the beating heart. After positioning the graft, the distal part of the LAD was opened to allow retrograde filling of the LITA-graft. The anastomosis was secured by the use of biological glue (BioGlue, Cryolife, Marietta, GA, USA). No intravascular suture material was used. Ischemic time averaged 6 min. The proximal LAD was occluded upstream the arteriotomy. All survivors were angiographically controlled for patency after 6-8 weeks. Consequently, four dogs were sacrificed after 6 weeks and the remaining after 3 months for anatomo-pathological and histological examination by light and electron microscopy of the anastomotic site. RESULTS: All procedures were successful except for one animal that died of uncontrollable bleeding at the anastomotic site. Another sustained post-operative transmural anterior myocardial infarction due to a late graft occlusion. All angiographically controlled grafts were patent with two vascular strings near the anastomotic site. Histology showed early macrophage infiltration into the glue. At post-mortem examination, new endothelialization was noticed in 80% of the cases. However, ultrastructural examination detected marked differences in endothelial fibroblastic lining compared to normal histology. CONCLUSIONS: Good mid-term permeability of the LITA grafts was observed in this new anastomotic technique for MIDCAB in the canine model. Although neo-endothelialization was present in most cases, ultrastructural differences were noticed after 3 months in the neo-intima compared to normal.


Subject(s)
Coronary Artery Bypass/methods , Minimally Invasive Surgical Procedures/methods , Tissue Adhesives/therapeutic use , Anastomosis, Surgical/methods , Animals , Coronary Vessels/surgery , Disease Models, Animal , Dogs , Endothelium, Vascular/ultrastructure , Feasibility Studies , Female , Suture Techniques , Thoracic Arteries/surgery , Tunica Intima/ultrastructure , Vascular Patency
20.
Cardiovasc Surg ; 11(1): 75-9, 2003 Feb.
Article in English | MEDLINE | ID: mdl-12543577

ABSTRACT

OBJECTIVE: In a retrospective study, we compared two groups of consecutive patients operated by the same team during the year 2000 for coronary artery disease with the use of extracorporeal circulation (group 1, n=230) or on the beating heart using the Octopus II plus stabiliser (group 2, n=228). High-risk patients were identified by a EuroSCORE plus 6. EuroSCORE definitions and predicted risk models were utilized to compare the variables of the groups. METHODS: There were no significant differences between the preoperative variables of the groups in age, gender, left ventricular function, diabetes and peripheral vascular and renal disease as is indicated by the Euroscore (resp. 4.7/5.1 p=0.107). Calcification of the ascending aorta and chronic obstructive lung disease were statistically significant more prevalent in the beating heart group. No differences in preoperative variables in the high-risk patients group (Euroscore 8.5/8.1 p=0.356) except for calcification of the ascending aorta. RESULTS: All patients underwent a full revascularisation through a midline sternotomy. Significant more distal anastomoses were performed in group 1 (3.7 per patient (1-6)) with regard to group 2 (2.9 per patient (1-6)). Anesthesia, postoperative treatment and follow up were equal for both groups. A significant lower incidence of atrial fibrillation (p=0.010), shorter ICU stay (p=0.031) and renal insufficiency (p=0.033) was reported in group 2. In the low risk group, we could not diagnose any difference between the two groups, except for atrial fibrillation. The benefits of the beating heart surgery however were more pronounced in the high-risk patient as is indicated by a significant reduction of the ICU stay by 1 day (3.5d/2.5d (p=0.028)), better preservation of the renal function (p=0.017) and a significant reduction of the length of hospital stay by more than two days (p=0.040). A lower incidence of atrial fibrillation, however not significant. CONCLUSION: In our experience, beating heart surgery is a safe alternative for conventional coronary heart surgery. High-risk patients do benefit most from this technique. It became our first choice in the elderly patient and patients presenting with higher co-morbidities.


Subject(s)
Cardiopulmonary Bypass , Coronary Artery Bypass/methods , Coronary Disease/surgery , Acute Kidney Injury/etiology , Aged , Atrial Fibrillation/etiology , Female , Heart Arrest, Induced , Humans , Intensive Care Units , Length of Stay , Male , Middle Aged , Postoperative Complications , Retrospective Studies , Risk Assessment/methods
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