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1.
Transplant Proc ; 54(4): 1060-1064, 2022 May.
Article in English | MEDLINE | ID: mdl-35523596

ABSTRACT

Orthotopic heart transplantation (OHT) has become one of the most expensive and resource-consuming treatment options for patients with end-stage heart failure. It is therefore useful to review clinical data, such as treatment duration after surgery and midterm follow-up in this group of patients. Contemporary epidemiologic data on early and midterm OHT follow-ups including patient demographics, hospitalization rates and related post-OHT morbidity, and mortality are scarce in Poland. The aim of the study was to determine early survival, hospitalization rates related to OHT and related morbidity, and mortality in Poland in the recent decade.


Subject(s)
Heart Failure , Heart Transplantation , Heart Transplantation/methods , Humans , Poland , Retrospective Studies , Treatment Outcome
2.
Transplant Proc ; 54(4): 1078-1081, 2022 May.
Article in English | MEDLINE | ID: mdl-35581012

ABSTRACT

BACKGROUND: Lung transplantation has changed the course of treatment of lung diseases for the better; however, there are various factors that should be considered to increase the probability of a better outcome. Factors such as the patient's background, level of education, and income could affect their perception and eventually the results of the procedure. METHODS: The present study involved patients who underwent the qualification process for lung transplant along with psychological and sociologic assessment at the Lung Transplant Unit in the Department of Cardiac Surgery and Vascular Surgery, Medical University of Gdansk. The following data were identified in the patients' medical history: marital status, size of the city, source of income, profession, voivodeship, and their Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) score for psychosocial prediction of the outcome. RESULTS: A group of 121 patients were included in the study: 77 (63.64%) men and 44 (36.36%) women. The average age of the patients was 55.4 ± 9.81 years. Eighty (66.12%) lived in the city, and 26 (21.49%) of patients were professionally active with a fixed salary as their source of income. One hundred two patients were married. The median SIPAT score was 10.0 ± 3.0 for men and 10.0 ± 2.75 for women (P = .0974). CONCLUSION: For optimum care and results of the lung transplant procedure, it is important to consider these background patient factors because they play a crucial role in determining the course of the surgery. The analysis of demographic data is undoubtedly one of the elements helpful in the further fate of the whole process.


Subject(s)
Lung Transplantation , Aged , Demography , Female , Humans , Lung Transplantation/adverse effects , Male , Middle Aged
3.
Transplant Proc ; 54(4): 1074-1077, 2022 May.
Article in English | MEDLINE | ID: mdl-35450722

ABSTRACT

BACKGROUND: Coronary artery disease (CAD) has a considerable morbidity and mortality effect on the outcomes of a lung transplant. Currently, coronary angiography is performed as part of the pretransplant evaluation process. Unfortunately, there are no clear guidelines about performing cardiac angiography in lung transplant candidates. BACKGROUND: The aim of our work is to find a correlation between cardiovascular risk and coronary arterial status to optimize the selection of patients for coronary angiography prior transplantation. METHODS: We retrospectively analyzed 48 patients in whom coronary angiography and cardiac catheterization was performed during assessment for bilateral lung transplantation at the Medical University of Gdansk from 2018 to 2021. The coronary artery disease status was classified into 2 categories: without any stenosis and with stenosis. For each patient, the 10-year cardiovascular risk was estimated by using a Systematic COronary Risk Evaluation calculator modified for the Polish population. RESULTS: Coronary stenosis was detected in 15 patients during angiography (31%). The group with coronary stenosis had a median SCORE risk of 8%, which is considered as high risk, and in patients without stenosis it was 5%, which is also considered a high risk. Median mean pulmonary artery pressure in patients with stenosis was the same as that in patients without stenosis (23 mm Hg). CONCLUSIONS: CAD among lung transplant candidates cannot be predicted by risk factors, so coronary angiography is very important as a part of the evaluation process. Because pulmonary hypertension has a big impact on surveillance after transplantation, performing heart catheterization during the qualification process is crucial.


Subject(s)
Coronary Artery Disease , Coronary Stenosis , Lung Transplantation , Constriction, Pathologic , Coronary Angiography , Coronary Artery Disease/diagnosis , Humans , Lung Transplantation/adverse effects , Retrospective Studies , Risk Factors
4.
Transplant Proc ; 54(4): 1177-1179, 2022 May.
Article in English | MEDLINE | ID: mdl-35410720

ABSTRACT

Langerhans cell histiocytosis (LCH) is a rare inflammatory disorder of myeloid dendritic cells with mutations involving KRAS, BRAF and/or NRAS, and MAP2K1 genes. We describe the case of a 58-year-old female previous smoker with multifocal LCH involving the lungs, pituitary gland and mandibular bone. Initial treatment with 6 cycles of cladribine showed improvement in her extrapulmonary lesions, however, her lung disease progressed and after qualification and assessment tests she underwent uncomplicated double lung transplant surgery and was discharged home. We highlight that in select patients with well managed and controlled extrapulmonary LCH, such an invasive procedure as lung transplant is possible.


Subject(s)
Histiocytosis, Langerhans-Cell , Lung Transplantation , Cladribine/therapeutic use , Female , Histiocytosis, Langerhans-Cell/diagnosis , Histiocytosis, Langerhans-Cell/drug therapy , Histiocytosis, Langerhans-Cell/pathology , Humans , Lung Transplantation/adverse effects , Middle Aged , Mutation , Proto-Oncogene Proteins B-raf/genetics , Proto-Oncogene Proteins B-raf/metabolism , Proto-Oncogene Proteins B-raf/therapeutic use
5.
Transpl Immunol ; 71: 101553, 2022 04.
Article in English | MEDLINE | ID: mdl-35167947

ABSTRACT

For lung transplantation, the presence of donor-specific anti-HLA antibodies (DSA) is an important factor of antibody-mediated rejection (AMR) in its hyperacute, acute or chronic form during long-term follow up. The aim of the study was to assess the allosensitization of Polish patients qualified for a lung transplantation in our center. A retrospective study of 161 potential lung allograft recipients, also of 31 patients transplanted in the University Hospital of Gdansk, between June 2018 and December 2020 were performed. 121 potential recipients were thoroughly tested for immunization status before eventual lung transplantation. SAB-testing, PRA-CDC and vPRA assessment, and HLA typing were performed to guide donor-recipient matching and risk stratification. Then 73 patients were separated and qualified for the list of patients awaiting lung transplantation. Then 31 patients were transplanted based on a negative biological crossmatch result. The patients were generally not sensitized, as the median PRA-CDC was 0% (min 0; max 53), and the vPRA, calculated according to HLA ABDR (>2000 cut-off MFI), was 8% (min 0; max 99). If the cut-off was split into 2000 MFI for HLA ABDR, 10,000 MFI for HLAC, and 7000 MFI for HLA-DQ, the vPRA increased to 20% (min 0; max 99). The immunization status was assessed with single antigen-SAB assays. For class I, the number of any detectable alloantibodies was 14 (11.6%) 21 (17.35%) 16 (13.22%) for locus HLA-A/B/C, and 28 (23.14%) 30 (24.8%) 24 (19.8%) for locus HLA-DR/DQ/DP, respectively. The immunization of the transplanted patients was then analyzed in detail. Summarizing, the study is an analysis of the degree of anti-HLA immunization in the population of patients eligible for lung transplantation, which showed that this degree is of low intensity and can be effectively and safely and very precisely diagnosed before transplantation.


Subject(s)
Kidney Transplantation , Lung Transplantation , Graft Rejection/diagnosis , HLA Antigens , Histocompatibility Testing , Humans , Immunization , Isoantibodies , Retrospective Studies
6.
Wideochir Inne Tech Maloinwazyjne ; 14(2): 326-332, 2019 Apr.
Article in English | MEDLINE | ID: mdl-31119001

ABSTRACT

INTRODUCTION: Minimally invasive mitral valve surgery (MIMVS) has become a widely accepted alternative to the standard sternotomy approach for treatment of mitral valve (MV) disease. Because the extent and location of mini-thoracotomies employed for MIMVS vary from center to center, the conclusions regarding superior cosmesis are not generalizable. The totally thoracoscopic periareolar (TTP) - MIMVS technique has been used at our department for minimally invasive cardiac surgery since 2015. AIM: To report early surgical data as well as mid-term outcomes in patients undergoing TTP-MIMVS. MATERIAL AND METHODS: Between 2015 and 2017, 48 consecutive patients (mean age: 65.4 ±10; 83% men; EuroSCORE II: 5.1 ±4%) underwent TTP-MIMVS due to mitral and mitral/tricuspid valve (TV) disease; patients' demographics and clinical outcomes were prospectively collected. Kaplan-Meier estimates of survival and freedom from re-intervention were analyzed as well. RESULTS: Mean follow-up was 1.7 (max 2.5) years. Of 48 patients, 33 (69%) underwent isolated MV repair, 4 (8%) isolated MV replacement and 11 (23%) MV/TV repair. The cardiopulmonary bypass and aortic cross-clamp time was 166 ±70 and 103 ±39 min respectively. There was no conversion to either full sternotomy or a mini-thoracotomy approach. Median (interquartile range) duration of intensive care unit stay was 1.2 (1.0-2.0) days. There was one in-hospital death (2.1%) in the TTP-MIMVS group. No strokes or wound infections were observed. Within the investigated follow-up, the freedom from reoperation rate was 96.4%; remote survival was estimated at 96.9%. CONCLUSIONS: The study proved that TTP-minimally invasive surgery was safe and feasible in mitral and tricuspid valve surgery. It has been associated with superior esthetics. Mitral repairs performed through TTP access are durable in mid-term observation.

7.
Kardiochir Torakochirurgia Pol ; 15(1): 23-26, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29681957

ABSTRACT

INTRODUCTION: High pulmonary vascular resistance (PVR) in orthotopic heart transplantation (OHT) candidates is a risk factor of right ventricle failure after the procedure. However, the increase of PVR may be a consequence of the life-threatening deterioration of the left ventricle function. The use of mechanical circulatory support (MCS) seems to be the best solution, but it is reimbursed only in active OHT candidates. AIM: We performed a retrospective analysis of MCS effectiveness in maintaining PVR at values accepted for OHT. MATERIAL AND METHODS: Starting from the year 2008 we identified 6 patients (all males, 42.8 ±17 years old) with dilated (n = 3), ischemic (n = 2), and restrictive cardiomyopathy (n = 1) in whom MCS - pulsatile left ventricle assist device (LVAD, n = 4), continuous flow LVAD (n = 1), and pulsatile biventricular assist device (BIVAD, n = 1) - was used at a time when PVR was unacceptable for OHT, and the reversibility test with nitroprusside was negative. After an average time of support of 261 ±129 days they were all transplanted. RESULTS: Right heart catheterization (RHC) results before MCS implantation were as follows: pulmonary artery systolic, diastolic, and mean pressure (PAPs/d/m) 60 ±20/28 ±7/40 ±11 mm Hg, pulmonary capillary wedge pressure (PCWP) 21 ±7 mm Hg, transpulmonary gradient (TPG) 19 ±7 mm Hg, cardiac output (CO) 3.6 ±0.8 l/min, PVR 5.7 ±2.1 Wood units (WU). Right heart catheterization results during MCS therapy were as follows: PAPs/d/s 27 ±11/12 ±4/17 ±6 mm Hg, PCWP 10 ±4 mm Hg, TPG 7 ±4 mm Hg, CO 5.1 ±0.7 l/min, PVR 1.4 ±0.6 WU. None of the patients experienced right ventricle failure after OHT with only one early loss due to multiorgan failure. CONCLUSIONS: Mechanical circulatory support is an effective method of pulmonary hypertension treatment for patients disqualified for OHT due to high PVR.

8.
Ann Transplant ; 22: 761-768, 2017 Dec 26.
Article in English | MEDLINE | ID: mdl-29277835

ABSTRACT

BACKGROUND The aim of this study was to investigate serum concentrations of visfatin, irisin, and omentin in patients with end-stage lung diseases (ESLD) before and after lung transplantation (LTx) and to find relationship between adipokines levels and clinical outcomes. MATERIAL AND METHODS Fourteen consecutive lung transplant recipients (six males and seven females; age 32.0±14.2 years; body mass index (BMI) 21.8±5.3 kg/m²) who underwent lung transplantation with initial diagnosis of respiratory failure due to cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) were included. Visfatin, irisin, and omentin serum levels were assayed using commercially available ELISA kits at four time points: the day of LTx (day 0), 72 hours (day 3), one month (day 30) and three months (day 90) after LTx. RESULTS Omentin serum concentration decreased significantly within three days after LTx (350.5±302.0 to 200.0±0.90 ng/mL; p<0.05), while visfatin serum levels decreased later, 30 days after Ltx (4.81±3.78 to 0.78±0.35 [0.4-1.1] pg/mL; p<0.05). Downregulated serum levels of both adipokines remained stable for the next two months (256.0 [201.7-642.9] ng/mL and 0.77±0.76 pg/mL, respectively; p<0.05). Serum levels of irisin were unchanged before and after Ltx. Immunosuppressive regimen did not affect serum levels of the analyzed adipokines. CONCLUSIONS The study showed for the first time serum omentin and visfatin levels to be decreased after LTx in ESLD patients. Successful LTx contributes to the improvement of impaired lung function parameters and attenuation of ongoing inflammatory process, resulting in altered visfatin and omentin serum levels. Additional influence of immunosuppressive treatment on omentin and visfatin serum concentration cannot be excluded.


Subject(s)
Cystic Fibrosis/blood , Cytokines/blood , Fibronectins/blood , Idiopathic Pulmonary Fibrosis/blood , Lectins/blood , Nicotinamide Phosphoribosyltransferase/blood , Pulmonary Disease, Chronic Obstructive/blood , Adolescent , Adult , Body Mass Index , Cystic Fibrosis/surgery , Female , GPI-Linked Proteins/blood , Humans , Idiopathic Pulmonary Fibrosis/surgery , Lung Transplantation , Male , Middle Aged , Postoperative Period , Pulmonary Disease, Chronic Obstructive/surgery , Treatment Outcome , Young Adult
9.
Transpl Infect Dis ; 19(4)2017 Aug.
Article in English | MEDLINE | ID: mdl-28342205

ABSTRACT

Surgical site infections (SSIs) are infections of tissues, organs, or spaces exposed by surgeons during performance of an invasive procedure. SSIs are classified into superficial, which are limited to skin and subcutaneous tissues, and deep. The incidence of deep SSIs in lung transplant (LTx) patients is estimated at 5%. No reports have been published as to the incidence of superficial SSIs specifically in LTx patients. Common sense would dictate that the majority of superficial SSIs would be bacterial. Uncommonly, fungal SSIs may occur, and we believe that no reports exist as to the incidence of viral wound infections in LTx patients, or in any solid organ transplant patients. We report a de novo superficial wound infection with herpes simplex virus following lung transplantation, its possible source, treatment, and resolution.


Subject(s)
Antiviral Agents/therapeutic use , Ganciclovir/therapeutic use , Herpes Simplex/diagnosis , Lung Transplantation/adverse effects , Simplexvirus/isolation & purification , Surgical Wound Infection/diagnosis , Adolescent , Female , Herpes Simplex/drug therapy , Herpes Simplex/etiology , Herpes Simplex/virology , Humans , Surgical Wound Infection/drug therapy , Surgical Wound Infection/etiology , Surgical Wound Infection/virology , Treatment Outcome
10.
Kardiochir Torakochirurgia Pol ; 12(4): 314-7, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26855646

ABSTRACT

INTRODUCTION: The proportion of valve repair procedures is increasing in experienced centers. The aim of the study was to assess the clinical and echocardiographic outcomes after aortic valve reconstruction with a novel surgical technique. MATERIAL AND METHODS: The study group consisted of 30 patients (23 male and 7 female) at a mean age of 35 ± 14 years. In patients with aortic root aneurysm the reimplantation or Florida sleeve technique was used. A sub-commissural annuloplasty, plication of the free edge of the cusp, shaving, and commissurotomy were performed. At this stage of surgery aortic repair was then attempted by cusp extension. Since 2013 the strips have been tailored from extracellular matrix. RESULTS: The mean aortic cross-clamp time was 90 ± 32 min. The mean cardiopulmonary bypass time was 126 ± 38 min. There was no in-hospital death. Re-exploration for bleeding was required in 1 patient. During follow-up, 1 patient needed reoperation at 1 year due to endocarditis. All patients remained alive in New York Heart Association (NYHA) functional class I. The echocardiographic findings remained unchanged in all cases during follow-up. CONCLUSIONS: Our modification of aortic valve repair results in a good outcome.

12.
Kardiol Pol ; 67(9): 989-94, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19838955

ABSTRACT

BACKGROUND: Single lung transplantation, bilateral lung transplantation and combined heart-lung transplantation are the procedures currently being performed in patients with arterial pulmonary hypertension and pulmonary hypertension as a result of end-stage lung disease. In patients with severe pulmonary hypertension, regardless of its aetiology, general anaesthesia and mechanical ventilation could precipitate the onset of cardiac failure and the necessity of extracorporeal circulation employment. AIM: To assess the clinical and prognostic value of the pulmonary artery pressure (PAP) measured during the intra- and early postoperative period in patients undergoing lung transplantation. METHODS: We analysed 20 patients undergoing lung transplantation in the Silesian Centre for Heart Disease in Zabrze, of whom 13 suffered from pulmonary hypertension before the operation. The PAP was measured using Swan-Ganz catheters. RESULTS: Pulmonary artery pressure markedly decreased after transplantation (systolic, diastolic and mean PAP values were 31/19/23 mmHg, respectively) but in 3 recipients the mean PAP exceeded 25 mmHg (45/23/30 mmHg). In all 3 cases a cardiopulmonary bypass was required and single-lung transplantation was performed. Pulmonary hypertension immediately after the operation was the potential marker of lung dysfunction (pulmonary oedema, ischaemia-reperfusion injury, infection) - all 3 patients with increased PAP developed complications. CONCLUSIONS: Lung transplantation is associated with a significant reduction in pulmonary artery pressures immediately after graft implantation. The persistence of pulmonary hypertension in the early postoperative period suggests temporal allograft dysfunction and affects the post-operative outcome.


Subject(s)
Hypertension, Pulmonary/surgery , Lung Transplantation/methods , Monitoring, Intraoperative , Postoperative Care/methods , Adult , Extracorporeal Circulation , Female , Humans , Male , Middle Aged , Prognosis , Pulmonary Wedge Pressure
13.
J Thorac Cardiovasc Surg ; 138(1): 215-21, 221.e1-3, 2009 Jul.
Article in English | MEDLINE | ID: mdl-19577082

ABSTRACT

OBJECTIVE: The aim of this study was to assess the predictive value of microvascular abnormalities and lipofuscin observed in endomyocardial biopsy samples for the development of cardiac allograft vasculopathy. METHODS: The study group consisted of 68 cardiac allograft recipients (63 men and 5 women, 43 +/- 12 years old). We performed a re-evaluation of 1071 endomyocardial biopsy specimens to search for microvascular diseases and lipofuscin in cardiocytes. Endomyocardial biopsy specimens with an International Society for Heart and Lung Transplantation rejection grade of 2 or more and those without arterioles were excluded. Abnormalities found in the remaining 517 specimens were correlated with the grade of rejection. Biopsy specimens obtained 2 weeks, 12 months, and 36 months after transplantation were compared with coronary angiography results, clinical events of cardiac allograft vasculopathies, and survivals. Kaplan-Meier curves were constructed to compare the time to the development of cardiac allograft vasculopathy or death. RESULTS: Enlarged endothelial cells, lymphocytes inside the arteriolar wall, occluded arteriolar lumen, endothelial vacuolization, and hypertrophy of the vascular muscle were significantly correlated with rejection grade. Although none of the vascular abnormalities predicted cardiac allograft vasculopathy, patients with lipofuscin deposits at the 12-month biopsy specimens were characterized by the rapid development of angiography-confirmed cardiac allograft vasculopathy (P < .08) and events related to cardiac allograft vasculopathy (P < .03, log-rank test). CONCLUSION: Microvascular abnormalities correlate with mild cellular rejection, but they do not seem to be predictive for development of cardiac allograft vasculopathy detected by angiography. The presence of lipofuscin in 12-month endomyocardial biopsy specimens may be predictive of development of angiographically confirmed cardiac allograft vasculopathy.


Subject(s)
Coronary Disease/metabolism , Coronary Vessels/pathology , Heart Transplantation/adverse effects , Lipofuscin/metabolism , Myocardium/pathology , Myocytes, Cardiac/metabolism , Adult , Biopsy , Coronary Disease/etiology , Coronary Disease/pathology , Female , Graft Rejection , Humans , Male
14.
Lancet ; 373(9673): 1440-6, 2009 Apr 25.
Article in English | MEDLINE | ID: mdl-19394535

ABSTRACT

BACKGROUND: Application of a tissue-engineered vascular graft for small-diameter vascular reconstruction has been a long awaited and much anticipated advance for vascular surgery. We report results after a minimum of 6 months of follow-up for the first ten patients implanted with a completely biological and autologous tissue-engineered vascular graft. METHODS: Ten patients with end-stage renal disease who had been receiving haemodialysis through an access graft that had a high probability of failure, and had had at least one previous access failure, were enrolled from centres in Argentina and Poland between September, 2004, and April, 2007. Completely autologous tissue-engineered vascular grafts were grown in culture supplemented with bovine serum, implanted as arteriovenous shunts, and assessed for both mechanical stability during the safety phase (0-3 months) and effectiveness after haemodialysis was started. FINDINGS: Three grafts failed within the safety phase, which is consistent with failure rates expected for this high-risk patient population. One patient was withdrawn from the study because of severe gastrointestinal bleeding shortly before implantation, and another died of unrelated causes during the safety period with a patent graft. The remaining five patients had grafts functioning for haemodialysis 6-20 months after implantation, and a total of 68 patient-months of patency. In these five patients, only one intervention (surgical correction) was needed to maintain secondary patency. Overall, primary patency was maintained in seven (78%) of the remaining nine patients 1 month after implantation and five (60%) of the remaining eight patients 6 months after implantation. INTERPRETATION: Our proportion of primary patency in this high-risk cohort approaches Dialysis Outcomes Quality Initiative objectives (76% of patients 3 months after implantation) for arteriovenous fistulas, averaged across all patient populations.


Subject(s)
Arteriovenous Shunt, Surgical , Bioprosthesis , Blood Vessel Prosthesis , Kidney Failure, Chronic/therapy , Renal Dialysis , Tissue Engineering/methods , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Male , Middle Aged , Time Factors , Treatment Outcome , Vascular Patency
15.
J Heart Lung Transplant ; 28(3): 255-9, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19285617

ABSTRACT

BACKGROUND: The appropriate therapy after orthotopic heart transplantation (OHT) is determined by the results of endomyocardial biopsies (EMBs). The Quilty effect (QE) is a recognized cause of discrepancies in EMB grading, but its clinical implications remain unclear. In this study we assess the correlation of the QE with biopsy-proven acute cellular rejection (AR) and coronary artery vasculopathy (CAV). METHODS: We reassessed 5,361 EMB samples, obtained from 429 patients, based on QE occurrence and its impact on EMB score. Next, we divided all patients with at least 1 year of follow-up into two groups: a QE(+) group (n = 202, 58.7% of sample, 172 males/30 females, 44.8 +/- 12 years of age) and a QE(-) group (n = 142, 41.3% of sample, 124 males/18 females, 45.4 +/- 12 years of age), and compared AR and CAV occurrences. RESULTS: The QE was observed in 669 EMBs (12.5%), and at least 1 EMB with QE was found among the 231 patients (53.8%). The initial QE occurrence took place during the first 3 months after OHT in 68% of QE(+) patients, and >1 year post-OHT in 13% of patients. The average EMB score was significantly higher in QE(+) biopsies. A comparison of the two groups revealed a significantly higher number of AR episodes and number of patients with at least one episode of AR in QE(+) patients. There was no significant difference in number of CAV occurrences between groups. CONCLUSIONS: The QE seems to be a marker of the same increased immune system activity that can lead to AR. A relationship between QE and CAV was not supported by the present results.


Subject(s)
Coronary Artery Disease/etiology , Coronary Artery Disease/pathology , Graft Rejection/pathology , Heart Transplantation/adverse effects , Adult , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies
17.
Biomaterials ; 30(8): 1542-50, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19111338

ABSTRACT

We have previously reported the initial clinical feasibility with our small diameter tissue engineered blood vessel (TEBV). Here we present in vitro results of the mechanical properties of the TEBVs of the first 25 patients enrolled in an arterio-venous (A-V) shunt safety trial, and compare these properties with those of risk-matched human vein and artery. TEBV average burst pressures (3490+/-892 mmHg, n=230) were higher than native saphenous vein (SV) (1599+/-877 mmHg, n=7), and not significantly different from native internal mammary artery (IMA) (3196+/-1264 mmHg, n=16). Suture retention strength for the TEBVs (152+/-50 gmf) was also not significantly different than IMA (138+/-50 gmf). Compliance for the TEBVs prior to implantation (3.4+/-1.6%/100 mmHg) was lower than IMA (11.5+/-3.9%/100 mmHg). By 6 months post-implant, the TEBV compliance (8.8+/-4.2%/100 mmHg, n=5) had increased to values comparable to IMA, and showed no evidence of dilation or aneurysm formation. With clinical time points beyond 21 months as an A-V shunt without intervention, the mechanical tests and subsequent lot release criteria reported here would seem appropriate minimum standards for clinical use of tissue engineered vessels.


Subject(s)
Blood Vessels/physiology , Mammary Arteries/physiology , Saphenous Vein/physiology , Tissue Engineering , Aged , Aged, 80 and over , Biomechanical Phenomena , Blood Vessels/cytology , Demography , Female , Humans , Male , Middle Aged , Pressure , Tissue Donors
18.
Regen Med ; 3(6): 925-37, 2008 Nov.
Article in English | MEDLINE | ID: mdl-18947313

ABSTRACT

Despite widespread hype and significant investment through the late 1980s and 1990s, cell-based therapeutics have largely failed from both a clinical and financial perspective. While the early pioneers were able to create clinically efficacious products, small margins coupled with small initial indications made it impossible to produce a reasonable return on the huge initial investments that had been made to support widespread research activities. Even as US FDA clearance opened up larger markets, investor interest waned, and the crown jewels of cell-based therapeutics went bankrupt or were rescued by corporate bailout. Despite the hard lessons learned from these pioneering companies, many of today's regenerative medicine companies are supporting nearly identical strategies. It remains to be seen whether or not our proposed tenets for investment and commercialization strategy yield an economic success or whether the original model can produce a return on investment sufficient to justify the large up-front investments. Irrespective of which approach yields a success, it is critically important that more of the second-generation products establish profitability if the field is to enjoy continued investment from both public and private sectors.


Subject(s)
Cell- and Tissue-Based Therapy/economics , Commerce/economics , Research/economics , Humans
19.
Ann Transplant ; 11(4): 4-11, 2006.
Article in English | MEDLINE | ID: mdl-17715571

ABSTRACT

BACKGROUND: Cardiac surgery is supposed to be a risk factor of PRA formation, however the role of PRA presence in non-transplant subjects is not known. Aim of the study was to assess PRA occurrence in patients undergoing elective cardiosurgery procedures and to evaluate its influence on the perioperative course. MATERIAL AND METHODS: Blood samples were obtained before operation in 44 subjects (36M/8F; 55.9 +/- 8.1 y/o) undergoing primary elective cardiosurgery procedures--CABG (n = 30), CABG + valve (n = 2) or valve procedure (n = 12). PRA results were obtained after the discharge, and patients were retrospectively divided into: Group A (n = 18) with PRA > 1%, and Group B (n = 26) with PRA. < or = 1%. PRA screening was repeated 3 months after the procedure in 41 subjects. They were divided into Group I (n = 13) with PRA > 1%, and Group II (n = 28) with PRA < or = 1%. Comparison was performed of Groups A vs. B, and I vs. II. RESULTS: Differences in pre-operative characteristics and procedure type distribution were insignificant. Post-operative complications were more frequent in Groups A and I (pulmonary hypertension in Group I vs. II: 38 vs. 4%; p = 0.01). Duration of post-operative ICU stay was longer in Group I vs. 11 (2.9 vs. 1.9d.; p = 0.01). Overall hospital stay was longer in Group A vs. B (10.1 vs. 7.8d.; p = 0.054). Increase of PRA titers was observed in 10 subjects (3 pts. /17% from Group A, and 7 pts. /27% from Group B), exceeding 10% in 2 females after valve replacement. 6 months after procedure, detectable PRA was still observed in 7 patients. CONCLUSIONS: Cardiac surgery is not a strong causative factor of PRA formation. The presence of perceptible PRA level may be associated with increased incidence of complications and consequently prolonged in-hospital stay. Influence of PRA on peri-operative course is not dependent on the source of its increased level.


Subject(s)
Coronary Artery Bypass/adverse effects , HLA Antigens/immunology , Heart Valve Prosthesis Implantation/adverse effects , Postoperative Complications/epidemiology , Adult , Antibody Formation , Female , Humans , Incidence , Intensive Care Units , Length of Stay , Male , Middle Aged , Preoperative Care , Retrospective Studies , Sex Factors
20.
Kardiol Pol ; 61(10): 339-48; discusion 349, 2004 Oct.
Article in English, Polish | MEDLINE | ID: mdl-15841115

ABSTRACT

BACKGROUND: Transplanted heart coronary artery disease (TxCAD) is the most frequent casue of death occuring > or =5 years after orthotopic heart transplantation (OHT). Considering three basic therapeutic approaches - percutaneous coronary intervention (PCI), surgical revascularisation and retransplantation - PCI seems to be the superior method due to its safety and good short-term results, however, the long-term efficacy of PCI has been less well established. AIM: To evaluate long-term results of PCI in the treatment of OHT recipients with TxCAD. METHODS: The study group consisted of 20 patients (19 males, aged 24-63, median 45.5 years; 14 (70%) had before OHT), who underwent single or multiple PCI of significant coronary lesions, revealed by elective (n=17) or urgent (n=3) coronary angiography (CAG). The overall number of PCI procedures was 26, including 8 with stent implantation. procedures were performed 9-151 (median 61.5) months after OHT. Analysis of PCI results was based on the follow-up CAGs or autopsy in case of death. RESULTS: Follow-up time was 3-90 (median 28) months. At least one CAG was performed in 17 (85%) patients - the overall number of follow-up CAGs was 53. Progression of TxCAD was revealed by 33 (62%) CAGs - the decision to perform subsequent single or multiple PCI was undertaken in 22 (42%) patients. The overall number of re-PCI procedures was 38 (with stent implantation in 11 cases). Out of 38 PCI procedures without stent implantation, significant restenosis was found on control CAG in 16 (42%) patients, and out of 16 PCI with stents -- in 11 (69%) patients, including 8 haemodynamically significant lesions. TxCAD was the cause of 5 out of 9 deaths that occurred during follow-up. CONCLUSIONS: PCI is unable to stop TxCAD development in the majority of patients. Stent implantation does not improve long-term results of TxCAD treatment.


Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Disease/surgery , Heart Transplantation , Stents , Adult , Female , Follow-Up Studies , Humans , Male , Middle Aged
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