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1.
J Card Fail ; 22(10): 797-805, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26777757

RESUMO

BACKGROUND: Left ventricular assist devices (LVADs) improve survival, quality of life (QOL), and functional capacity (FC) among patients with end-stage heart failure. Few data are available regarding characteristics associated with QOL and FC response. METHODS AND RESULTS: Patients enrolled in the Heartmate II clinical trials that were alive with ongoing LVAD support at 6 months were included. QOL response criteria included scoring above the lowest quartile on either the Minnesota Living With Heart Failure Questionnaire or the Kansas City Cardiomyopathy Questionnaire. FC responder criteria included improvement in 6-minute walk distance (6MWD) >70 meters from baseline, a 6MWD >220 meters at 6 months, or New York Heart Association functional class I or II. Independent variables associated with QOL nonresponse included history of diabetes (odds ratio [OR] 1.82, 95% confidence interval [CI] 1.20-2.78), lower mean pulmonary arterial pressure (OR 0.97, 95% CI 0.95-0.99), or a Heartmate II right ventricular risk score >2 (OR 1.77, 95% CI 1.00-3.12). Variables associated with FC nonresponse included history of COPD (OR 1.92, 95% CI 1.22-3.03) or diabetes (OR 1.52, 95% CI 1.01-2.27). Compared with responders, QOL and FC nonresponders had reduced long-term survival. CONCLUSIONS: Preoperative comorbidities, including diabetes, COPD, and right heart failure, may limit the QOL and FC response to LVAD therapy and should be considered during the shared decision-making process.


Assuntos
Causas de Morte , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/cirurgia , Qualidade de Vida , Volume Sistólico/fisiologia , Idoso , Ensaios Clínicos como Assunto , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico por imagem , Testes de Função Cardíaca , Coração Auxiliar , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios/métodos , Medição de Risco , Índice de Gravidade de Doença , Estatísticas não Paramétricas , Análise de Sobrevida , Resultado do Tratamento
2.
JACC Heart Fail ; 12(3): 438-447, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38276933

RESUMO

BACKGROUND: Extended criteria donor (ECD) hearts available with donation after brain death (DBD) are underutilized for transplantation due to limitations of cold storage. OBJECTIVES: This study evaluated use of an extracorporeal perfusion system on donor heart utilization and post-transplant outcomes in ECD DBD hearts. METHODS: In this prospective, single-arm, multicenter study, adult heart transplant recipients received ECD hearts using an extracorporeal perfusion system if hearts met study criteria. The primary outcome was a composite of 30-day survival and absence of severe primary graft dysfunction (PGD). Secondary outcomes were donor heart utilization rate, 30-day survival, and incidence of severe PGD. The safety outcome was the mean number of heart graft-related serious adverse events within 30 days. Additional outcomes included survival through 2 years benchmarked to concurrent nonrandomized control subjects. RESULTS: A total of 173 ECD DBD hearts were perfused; 150 (87%) were successfully transplanted; 23 (13%) did not meet study transplantation criteria. At 30 days, 92% of patients had survived and had no severe PGD. The 30-day survival was 97%, and the incidence of severe PGD was 6.7%. The mean number of heart graft-related serious adverse events within 30 days was 0.17 (95% CI: 0.11-0.23). Patient survival was 93%, 89%, and 86% at 6, 12, and 24 months, respectively, and was comparable with concurrent nonrandomized control subjects. CONCLUSIONS: Use of an extracorporeal perfusion system resulted in successfully transplanting 87% of donor hearts with excellent patient survival to 2 years post-transplant and low rates of severe PGD. The ability to safely use ECD DBD hearts could substantially increase the number of heart transplants and expand access to patients in need. (International EXPAND Heart Pivotal Trial [EXPANDHeart]; NCT02323321; Heart EXPAND Continued Access Protocol; NCT03835754).


Assuntos
Insuficiência Cardíaca , Transplante de Coração , Adulto , Humanos , Sobrevivência de Enxerto , Insuficiência Cardíaca/cirurgia , Transplante de Coração/métodos , Preservação de Órgãos/métodos , Estudos Prospectivos , Estudos Retrospectivos , Doadores de Tecidos
3.
Artif Organs ; 37(1): 102-7, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23305580

RESUMO

The durability of ventricular assist device (VAD) therapy improved steadily over the past years. However, driveline infections remain a challenge. To test whether an improved surgical implantation technique may lower the incidence of infections, we analyzed all patients receiving a VAD implantation in the years 2008 and 2009 (group 1) and compared them with all patients who received a VAD in 2011 (group 2) after we changed our implantation method. The new technique involves tunneling of the driveline into the fascia of the musculus rectus abdominis, resulting in a longer, intrafascial run to achieve a better resistance against ascending infections. We retrospectively analyzed 40 patients in group 1 and 41 patients in group 2. One year after implantation, the infection rate was markedly reduced (22.5% [n = 9] group 1 vs. 4.9% [n = 2] group 2, P < 0.001) by the new implantation method. There was, however, no significant improvement in overall mortality. The Cox regression model identified the implantation method as an independent risk factor for 1 year after implantation driveline infection (P < 0.05). In conclusion, the new tunneling technique marks a great leap forward in long-term VAD treatment. However, overall mortality remains high and needs further improvement.


Assuntos
Cardiopatias/terapia , Coração Auxiliar , Controle de Infecções/métodos , Infecções Relacionadas à Prótese/prevenção & controle , Desenho de Equipamento , Feminino , Cardiopatias/microbiologia , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Resultado do Tratamento
4.
Curr Opin Organ Transplant ; 16(5): 458-61, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21897243

RESUMO

PURPOSE OF REVIEW: Bridging to lung transplantation remains a controversy. Individually, it may be a life-saving therapy to use ventilation and extracorporeal means for gas exchange to keep a patient alive until lung transplantation. Collectively, this may lead to a selection of patients with the worst outcome. New technologies have become available to minimize the adverse events of extracorporeal devices. This may have an impact on the indication and use of such devices and also on the outcome. RECENT FINDINGS: Literature of the last 3 years were reviewed for new aspects of extracorporeal gas exchange (extracorporeal membrane oxygenation, ECMO) in order to define the status quo of these therapeutic tools in bridging to lung transplantation. It was found that new oxygenator technologies as well as pump designs miniaturized ECMO systems. In addition, a variety of possibilities for specific indications were described. Recently, many programs work on concepts to use ECMO no longer in addition to mechanical ventilation, but to avoid or wean from ventilation. This situation represents a paradigm shift in the bridging strategies for lung transplantation. SUMMARY: Bridging to lung transplantation changes to concepts avoiding the sequels mechanical ventilation and thereby offers improvement of lung recipients prior to the transplant procedure.


Assuntos
Oxigenação por Membrana Extracorpórea/métodos , Transplante de Células-Tronco Hematopoéticas/métodos , Doadores Vivos , Transplante de Pulmão/métodos , Cuidados Pré-Operatórios/métodos , Insuficiência Respiratória/cirurgia , Humanos , Resultado do Tratamento
5.
Circ Heart Fail ; 14(4): e006912, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33866829

RESUMO

BACKGROUND: The LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system. METHODS: AEs from the LATERAL trial were evaluated over 2 years postimplant. Data was obtained from the Interagency Registry for Mechanically Assisted Circulatory Support database for 144 enrolled United States and Canadian patients. Temporal AE profiles were expressed as events per patient year. RESULTS: During 162.5 patient years of support, there were 25 driveline infections (0.15 events per patient year), 50 gastrointestinal bleeds (0.31 events per patient year), and 21 strokes (0.13 events per patient year). Longitudinal AE analysis at follow-up intervals of <30 and 30 to 180 days, and 6 to 12 and 12 to 24 months revealed the highest AE rate at <30 days, with a decrease in total AEs within the first 6 months. After 6 months, most AE rates either stabilized or decreased through 2 years, including a 95% overall freedom from disabling stroke. CONCLUSIONS: Two-year follow-up of the LATERAL trial revealed a favorable morbidity profile in patients supported with the HVAD system, as AE rates were more likely to occur in the first 30 days postimplant, and overall AE rates were significantly reduced after 6 months. Importantly, 2-year freedom from disabling stroke was 95%. These data further support the improving AE profile of patients on long-term HVAD support. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02268942.


Assuntos
Insuficiência Cardíaca/terapia , Coração Auxiliar/efeitos adversos , Toracotomia , Idoso , Canadá , Aprovação de Equipamentos , Feminino , Seguimentos , Hemorragia Gastrointestinal/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Acidente Vascular Cerebral/etiologia , Estados Unidos , United States Food and Drug Administration
6.
Ann Thorac Surg ; 112(5): 1687-1697, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-33309728

RESUMO

BACKGROUND: The increasing prevalence of heart failure has led to the expanded use of left ventricle assist devices (VADs) for end-stage heart failure patients worldwide. Technological improvements witnessed the development of miniaturized VADs and their implantation through less traumatic non-full sternotomy approaches using a lateral thoracotomy (LT). Although adoption of the LT approach is steadily growing, a lack of consensus remains regarding patient selection, details of the surgical technique, and perioperative management. Furthermore, the current literature does not offer prospective randomized studies or evidence-based guidelines for LT-VAD implantation. METHODS: A worldwide group of LT-VAD experts was convened to discuss these key topics openly. After a PubMed search and review with all authors, a consensus was reached and an expert consensus paper on LT-VAD implantation was developed. RESULTS: This document aims to guide clinicians in the selection of patients suitable for LT approaches and preoperative optimization. Details of operative techniques are described, with an overview of hemisternotomy and bilateral thoracotomy approaches. A review of the best surgical practices for placement of the pump, inflow cannula, and outflow graft provides advice on the best surgical strategies to avoid device malpositioning while optimizing VAD function. Experts' opinions on cardiopulmonary bypass, postoperative management, and approaches for pump exchange and explant are presented. This review also emphasizes the critical need for multidisciplinary teams and specific training. CONCLUSIONS: This expert consensus review provides a compact guide to LT for VAD implantation, from patient selection through intraoperative tips and postoperative management.


Assuntos
Coração Auxiliar , Implantação de Prótese/métodos , Toracotomia/métodos , Humanos , Desenho de Prótese
7.
Clin Transplant ; 24(5): 709-16, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20047613

RESUMO

BACKGROUND: Lung transplant (LTx) recipients' adherence to regular self-monitoring of lung function (SMLF) is important in maintaining health. This study investigated patients' behavior based on electronic monitoring (EM) and compared these findings with self-reported data. METHODS: This single-center study included 269 patients following LTx. Patients reported on adherence regarding SMLF, and data were compared to electronically stored measurements for the last three months prior to self-reporting. RESULTS: Non-adherence was 59.4% based on EM for a total of 22,052 measurements performed. Main reported reasons for non-adherence were forgetfulness (22%), lack of time (19%), and good self-perception of health status (19%). Determinants for non-adherence were patients constraining beliefs (p ≤ 0.0001), low perceived support from the transplant center (p ≤ 0.008), a history of infections (p ≤ 0.014) and rejections (p ≤ 0.043), and bronchiolitis obliterans (p ≤ 0.006). Multiple logistic regression revealed low-perceived support from the transplant center (OR 3.22; 95% CI 1.32-7.83; p < 0.01), and lack of support from patient organizations (OR 2.19; 95% CI 1.02-4.72; p < 0.04) as independent predictors for non-adherence. CONCLUSIONS: LTx recipients had some difficulties maintaining SMLF on a daily basis. Non-adherence regarding lung function monitoring may provide a clinically relevant estimate of suspect cases for critical events impacting outcomes after LTx.


Assuntos
Rejeição de Enxerto/diagnóstico , Transplante de Pulmão , Monitorização Ambulatorial , Avaliação de Resultados em Cuidados de Saúde , Cooperação do Paciente , Autocuidado , Adolescente , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Retrospectivos , Adulto Jovem
8.
Curr Opin Crit Care ; 16(1): 69-73, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19952734

RESUMO

PURPOSE OF REVIEW: Allocation of grafts for lung transplantation has been directed in many countries to patients in life-threatening conditions. Advances in technology for extracorporeal devices led to new concepts and increased use for bridging to lung transplantation. Taking these two developments into account, it seems that bridging technologies are used more frequently around the world. RECENT FINDINGS: The durability of extracorporeal devices for some weeks was described in many institutional and case reports. The change in technology seems to open a new era of possibilities. Use of this new technology not only in bridge to transplant but also as a bridge to recovery in acute respiratory distress syndrome patients was published most recently. Current and future use of extracorporeal gas exchange as an alternative to mechanical ventilation appears in the literature. Use of low resistance membranes in patients with pulmonary hypertension was described as a new therapeutical option. SUMMARY: Bridge to lung transplantation is of increasing importance with new allocation systems and the increasing demand. New extracorporeal technologies address this demand with reliable function for some weeks. But these developments also raise ethical questions of how to use these new tools wisely individually and also collectively for the field of lung transplantation.


Assuntos
Circulação Extracorpórea/métodos , Transplante de Pulmão , Circulação Extracorpórea/instrumentação , Humanos
9.
Pediatr Transplant ; 14(3): 364-8, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-19793226

RESUMO

Lobar transplantation and peripheral segmental resection allow downsizing of larger lungs for use in smaller recipients, particularly with regard to pediatric patients on the high urgency waiting list. We studied the safety and outcome of these techniques in children. All pediatric patients who underwent reduced size LTx between January 2000 and March 2009 were retrospectively reviewed and compared with pediatric patients who underwent full size LTx during the same period. Patient characteristics, intra-operative variables, and post-operative morbidity and mortality were compared. Among 28 primary LTxs, 16 (57%) were performed in reduced size technique. Preoperatively, there was a trend toward a higher rate of mechanical ventilation and a higher capillary pCO(2) in the reduced size group. Surgical procedures tended to be longer in that group. Post-operative complications, survival and functional parameters were comparable between both groups. Our study demonstrates that reduced size LTx in children is a reliable therapeutic option that provides results comparable to full size LTx. This technique might help to reduce waiting list mortality by expanding the donor pool in pediatric LTx.


Assuntos
Transplante de Pulmão/métodos , Pulmão/anatomia & histologia , Adolescente , Criança , Feminino , Sobrevivência de Enxerto , Humanos , Transplante de Pulmão/mortalidade , Transplante de Pulmão/fisiologia , Masculino , Tamanho do Órgão , Complicações Pós-Operatórias , Modelos de Riscos Proporcionais , Estatísticas não Paramétricas , Doadores de Tecidos/estatística & dados numéricos , Coleta de Tecidos e Órgãos/métodos , Resultado do Tratamento , Listas de Espera
10.
Artif Organs ; 34(9): 721-5, 2010 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20883391

RESUMO

Patient satisfaction with left ventricular assist device (LVAD) external equipment has not yet been reported. We aimed to evaluate the quality of two different systems based on patients' perspective and its interrelationship with quality of life. Differential assessment of the HeartMate II axial flow pump (n = 17; Thoratec, Pleasanton, CA, USA) and the HVAD centrifugal pump (n = 10; HeartWare, Inc., Miramar, FL, USA) was obtained from 27 outpatients by a questionnaire 2 months to 2.9 years after device implantation. In addition, a health-related quality of life questionnaire (Short Form-36 [SF-36]) was completed. Overall patients' satisfaction was high. Severe limitations were attributed to the loudness of the power base unit in HeartMate II patients (P = 0.00), and HVAD patients were dissatisfied by the length of the driveline (P = 0.02). Between HVAD and HeartMate II patients, no significant differences in the quality of life (assessed by SF-36) were reported. While the overall satisfaction of outpatients on LVAD support was high, differences between the systems were found. Patients' perspectives may have an important impact on future modification of external components. Ultimately, this may also contribute to an improvement in the quality of life of chronic LVAD patients.


Assuntos
Insuficiência Cardíaca/terapia , Coração Auxiliar , Satisfação do Paciente , Qualidade de Vida , Adaptação Psicológica , Adulto , Análise de Variância , Feminino , Alemanha , Insuficiência Cardíaca/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
11.
Circ Heart Fail ; 13(3): e006252, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32164438

RESUMO

BACKGROUND: The paucity of available hearts for transplantation means that more patients remain on durable left ventricular support for longer periods of time. The Registry to Evaluate the HeartWare Left Ventricular Assist System was an investigator-initiated multicenter, prospective, single-arm database established to collect post-Conformité Européene mark clinical information on patients receiving the HeartWare ventricular assist device system as a bridge to transplantation. This registry represents the longest multicenter follow-up of primary left ventricular assist device outcomes. METHODS: Data were collected on 254 commercial implants performed between February 2009 and March 2012 from 9 centers in Europe (7) and Australia (2). Patients were followed to device explant, heart transplantation, or death. The outcomes of patients through July/August 2018 were analyzed. Summary statistics were used to describe patient demographics, adverse events, length of support, and outcomes for this extended-term cohort. RESULTS: A total of 122 patients were on support for >2 years, and 34 patients were on support for >5 years. Twenty nine patients are still alive on support (support ranging from 1213 to 3396 days), and 23 of those are on their original HeartWare ventricular assist device system. Kaplan-Meier survival through 7 years was 51%. Through 6 years, freedom from any stroke was 82%, while freedom from severely disabling stroke was 89%. CONCLUSIONS: Low rates of heart transplant now require longer periods of left ventricular assist device support in patients. This analysis demonstrates that long-term support using a HeartWare ventricular assist device system offers survival of 51% through 7 years.


Assuntos
Insuficiência Cardíaca/terapia , Transplante de Coração , Coração Auxiliar , Implantação de Prótese/instrumentação , Função Ventricular Esquerda , Listas de Espera , Austrália , Europa (Continente) , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Implantação de Prótese/efeitos adversos , Implantação de Prótese/mortalidade , Recuperação de Função Fisiológica , Sistema de Registros , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
12.
Ann Thorac Surg ; 110(5): 1512-1519, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32224242

RESUMO

BACKGROUND: Less invasive techniques for left ventricular assist device implantation have been increasingly prevalent over past years and have been associated with improved clinical outcomes. The procedural economic impact of these techniques remains unknown. We sought to study and report economic outcomes associated with the thoracotomy implantation approach. METHODS: The LATERAL clinical trial evaluated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare centrifugal-flow ventricular assist device system (HVAD). We collected UB-04 forms in parallel to the trial, allowing analysis of index hospitalization costs. All charges were converted to costs using hospital-specific cost-to-charge ratios and were subsequently compared with Medicare cost data for the same period (2015-2016). Because thoracotomy implants were off-label for all left ventricular assist devices during that period, the Medicare cohort was assumed to consist predominately of traditional sternotomy patients. RESULTS: Thoracotomy patients demonstrated decreased costs compared with sternotomy patients during the index hospitalization. Mean total index hospitalization costs for thoracotomy were $204,107 per patient, corresponding to 21.6% reduction (P < .001) and $56,385 savings per procedure compared with sternotomy. Across almost all cost categories, thoracotomy implants were less costly. CONCLUSIONS: In LATERAL, a clinical trial evaluating the safety and efficacy of the thoracotomy approach for HVAD, costs were lower than those reported in Medicare patient claims occurring over the same period. Because Medicare data can be presumed to consist of predominately sternotomy procedures, thoracotomy appears less expensive than traditional sternotomy.


Assuntos
Custos e Análise de Custo , Coração Auxiliar , Implantação de Prótese/economia , Implantação de Prótese/métodos , Esternotomia/economia , Toracotomia/economia , Adulto , Idoso , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Medicare , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Estados Unidos
13.
ASAIO J ; 66(8): 855-861, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32740343

RESUMO

This study reports the first analysis regarding cost-effectiveness of left ventricular assist device (LVAD) implantation via thoracotomy. Cost-effectiveness of LVADs implanted via the traditional surgical approach of sternotomy has been improved through the years because of technological advances, along with understanding the importance of patient selection and postimplant management have on positively affecting outcomes. Given the positive clinical outcomes of the thoracotomy approach, we seek to study the cost-effectiveness of a centrifugal LVAD via this less invasive approach. We developed a Markov model. Survival and quality of life inputs (QALY) for the LVAD arm were based on data from the LATERAL clinical trial. For the Medical Management arm, survival was derived from the Seattle Heart Failure Model. The heart transplant probability was derived from INTERMACS. Survival after heart transplantation used International Society for Heart and Lung Transplantation data. Cost inputs were calculated based on Medicare data and past literature. The incremental cost-effectiveness ratio was found to be $64,632 per quality adjusted life year and $57,891 per life year in the bridge to transplant indication. These results demonstrate further improvement in the overall cost-effectiveness of LVAD therapy and confirm implantation of LVADs via a less invasive approach as being cost-effective.


Assuntos
Coração Auxiliar , Toracotomia/economia , Toracotomia/métodos , Idoso , Análise Custo-Benefício , Feminino , Insuficiência Cardíaca/cirurgia , Humanos , Masculino , Cadeias de Markov , Medicare , Pessoa de Meia-Idade , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Estados Unidos
14.
J Heart Lung Transplant ; 38(4): 344-351, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30945636

RESUMO

BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches. METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay. RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point-mean length of initial hospital stay -was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach. CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication.


Assuntos
Insuficiência Cardíaca/cirurgia , Coração Auxiliar , Implantação de Prótese/métodos , Esternotomia , Toracotomia , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Toracotomia/métodos
15.
Transplantation ; 85(4): 524-31, 2008 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-18347530

RESUMO

BACKGROUND: Combined lung and liver transplantation (Lu-LTx) is a therapeutic option for selected patients with coexisting lung and liver disease. For several reasons, Lu-LTx is performed in few centers and information about the technical issues, posttransplant management and long-term outcomes associated with this procedure is limited. METHODS: We analyzed data from 13 consecutive patients who underwent combined Lu-LTx at Hannover Medical School (Hannover, Germany) between April 1999 and December 2003. The main indications were cystic fibrosis, alpha1-proteinase inhibitor deficiency and portopulmonary hypertension. All patients had advanced cirrhosis and severe pulmonary disease manifestation. RESULTS: Ten patients received a sequential double Lu-LTx, one patient received a single Lu-LTx, one received a double lung and split liver transplantation, and one received an en-bloc heart-lung and liver transplantation. Immunosuppression was based on cyclosporine in a triple/quadruple regimen. Postoperative surgical complications occurred in eight patients. There were two perioperative deaths; two patients died during the first year on day 67 and 354, respectively, and one patient died at month 53. The overall patient survival rates at 1, 3, and 5 years were 69%, 62%, and 49%, respectively. CONCLUSION: Combined Lu-LTx is a therapeutic option for highly selected patients with end-stage lung and liver disease with acceptable long-term outcome.


Assuntos
Transplante de Fígado/métodos , Transplante de Pulmão/métodos , Adulto , Feminino , Rejeição de Enxerto/epidemiologia , Sobrevivência de Enxerto , Transplante de Coração-Pulmão/métodos , Transplante de Coração-Pulmão/mortalidade , Humanos , Hipertensão Pulmonar/complicações , Hipertensão Pulmonar/cirurgia , Infecções/epidemiologia , Hepatopatias/complicações , Hepatopatias/cirurgia , Transplante de Fígado/mortalidade , Transplante de Pulmão/mortalidade , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/classificação , Complicações Pós-Operatórias/epidemiologia , Estudos Retrospectivos , Análise de Sobrevida
17.
Infect Control Hosp Epidemiol ; 28(5): 513-8, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17464908

RESUMO

BACKGROUND: Rabies virus was inadvertently transmitted to a lung transplant recipient through donor lungs. The patient was given ventilatory assistance and cared for postoperatively for 6 weeks before a diagnosis of rabies virus infection was made. Postexposure prophylaxis (PEP) was offered to potentially exposed healthcare workers (HCWs). METHODS: Only HCWs classified as belonging to possible and/or proven contact groups (according to a standardized interview) received PEP. The risk of individual HCWs being exposed to rabies virus was reassessed on the basis of viral concentrations measured in the patient's excretions and body fluids. HCWs who were vaccinated as part of PEP were followed up prospectively according to a standardized procedure. RESULTS: Of 179 HCWs and other patient contacts, 132 met the eligibility criteria for PEP (118 [89.4%] with possible contact and 14 [10.6%] with proven contact with the patient's excretions and/or body fluids). One hundred thirty-one individuals started PEP, and 126 met the inclusion criteria for analysis. Of these, 48 (38%) developed at least 1 adverse effect (8 [6.3%] had fever, 37 [29.4%] had headache, 3 [2.4%] had lymphadenopathy, 17 [13.5%] had dizziness, and 6 [4.8%] had paresthesia). No HCW or other patient contact developed rabies or serious PEP-related adverse effects. Reassessment of the individual's risk of infection as a function of the viral concentration in the patient's excretions and/or body fluids (up to 5.12 x 10(7) copies/mL) revealed that 103 HCWs (78.0%) had contact with high-risk substances (89 [67.40%] had possible contact and 14 [10.7%] had proven contact). CONCLUSION: HCWs can be exposed to significant viral concentrations in excretions and/or body fluids from rabies virus-infected lung transplant recipients. Because widespread use of PEP entails the possibility of significant health problems for HCWs considered to be at risk of contracting rabies, applying a rational indication for PEP is crucial.


Assuntos
Busca de Comunicante , Infecção Hospitalar/virologia , Transmissão de Doença Infecciosa , Pessoal de Saúde , Controle de Infecções/métodos , Transplante de Pulmão/efeitos adversos , Vacina Antirrábica/administração & dosagem , Raiva/prevenção & controle , Raiva/transmissão , Transplantes/virologia , Vacinação/estatística & dados numéricos , Quimioprevenção , Infecção Hospitalar/prevenção & controle , Feminino , Alemanha/epidemiologia , Humanos , Transmissão de Doença Infecciosa do Paciente para o Profissional , Unidades de Terapia Intensiva , Entrevistas como Assunto , Masculino , Isolamento de Pacientes , Gravidez , Vacina Antirrábica/efeitos adversos , Vacina Antirrábica/uso terapêutico , Medição de Risco , Escarro/virologia , Vacinação/efeitos adversos
18.
Eur J Cardiothorac Surg ; 32(6): 926-31, 2007 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-17900918

RESUMO

OBJECTIVE: Because of considerable progress in paediatric cardiac surgery life expectancy of patients with congenital heart disease (CHD) has improved significantly over the years. There are a growing number of adults with CHD presenting with progressive decline of cardiopulmonary function and Eisenmenger's syndrome. We analysed our experience with heart-lung and lung transplantation in this patient group. METHODS: Since 1988, a total of 46 heart-lung transplantations and 5 double lung transplantations have been performed in adults with CHD at our institution. Underlying diagnoses were: ventricular septal defect, atrial septal defect, persistent ductus arteriosus and others. Pulmonary hypertension was present in all patients. Twelve patients had undergone previous cardiac procedures. All patients were included in this retrospective analysis. Mean follow up was 5.1+/-4.7 years. Patient survival was estimated with the Kaplan-Meier method and analysed using the log-rank test. RESULTS: Thirty-day mortality was 11.8% (n=6). Survival was 80% at 1 year, 69% at 5 years and 53% at 10 years. Major causes of death were infection and sepsis, chronic rejection, initial graft failure and acute rejection. Compared to the overall mortality after lung and heart-lung transplantation for other indications at our institution there was no significant difference (1 year, 5 years, 10 years: 76%; 60%; 45%), but a tendency towards a better long-time survival of the CHD patients. CONCLUSIONS: Lung and heart-lung transplantation can be performed with an acceptable risk and a favourable long-term outcome in patients with grown-up CHD. Careful patient selection and planning of the surgical strategy is essential in this high-risk patient population.


Assuntos
Cardiopatias Congênitas/cirurgia , Transplante de Pulmão , Adolescente , Adulto , Complexo de Eisenmenger/cirurgia , Métodos Epidemiológicos , Feminino , Rejeição de Enxerto , Comunicação Interventricular/cirurgia , Transplante de Coração-Pulmão , Humanos , Terapia de Imunossupressão/métodos , Masculino , Pessoa de Meia-Idade , Preservação de Órgãos/métodos , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias , Reoperação , Resultado do Tratamento
19.
Int J Hyg Environ Health ; 210(2): 139-45, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17084668

RESUMO

A transmission study was performed to investigate whether organ recipients suffer more transmissions of bacteria than do non-transplanted patients. We chose enterococci for molecular typing because of their high prevalence, transmissibility, and predominance in causing nosocomial infections. Patients staying longer than 48h in a cardiovascular surgery intensive care unit (ICU) were included in our one-year prospective cohort study. Enterococci identified from clinical or surveillance isolates were collected and typed by PFGE. Episodes of transmission were defined by the identification of genetically indistinguishable isolates in two or more patients who were treated during overlapping intervals or within a 9-day window period in the same ICU. Risk factor analysis was performed. Out of 585 patients microbiological specimens were cultured from 336 patients. From 187 of these, enterococci were isolated. From 81 patients 186 enterococci isolates were typed. Out of 105 different enterococci strains, 16 cluster strains were detected and 30 episodes of transmissions occurred. The transmission rate was 7.8 per 1000 patient days. No significant association was found between "being cluster member "and "patient organ transplanted" (OR 1.5, CI(95%) 0.58; 3.98, p=0.38) or "patient treated in a single-room only" (OR 1.06, CI(95%) 0.36;3, 12, p=0.91), respectively. In contrast, "being cluster member" was associated with a prolonged length of stay (OR per additional days of stay 1.05, CI(95%) 1.01-1.09, p<0.01). Thoracic organ transplantation was not found to be a risk factor for bacterial transmission, but transmission was associated with a prolonged length of stay.


Assuntos
Infecção Hospitalar/transmissão , Enterococcus/isolamento & purificação , Infecções por Bactérias Gram-Positivas/transmissão , Transplante de Coração/efeitos adversos , Transplante de Pulmão/efeitos adversos , Transplante de Órgãos/efeitos adversos , Procedimentos Cirúrgicos Cardiovasculares , Infecção Hospitalar/microbiologia , Impressões Digitais de DNA , Enterococcus/genética , Feminino , Infecções por Bactérias Gram-Positivas/microbiologia , Humanos , Unidades de Terapia Intensiva , Tempo de Internação , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Fatores de Risco
20.
Prog Transplant ; 17(2): 136-41, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17624136

RESUMO

BACKGROUND: Lung transplantation has become an established and effective treatment for patients with end-stage pulmonary disease. OBJECTIVE: To investigate health-related quality of life in correlation with occurrence and degree of bronchiolitis obliterans syndrome after transplantation. METHODS: In a cross-sectional study design, 119 consecutive lung transplant recipients (63.9% bilateral and 36.1% single lung transplants) responded voluntarily to a set of standardized questionnaires (12-Item Short-Form Health Survey, Center for Epidemiologic Studies-Depression Scale, Coping With Everyday Life, Beck Anxiety Inventory, Zerssen list of complaints) that covered health-related quality of life and psychological well being. Also, we performed pulmonary function studies to clinically grade bronchiolitis obliterans syndrome in all patients. RESULTS: In this cohort, 41.2% of patients developed bronchiolitis obliterans syndrome at a mean interval of 5.6 years after lung transplantation. Actuarial freedom from bronchiolitis obliterans syndrome was 90.1% +/- 2.3% at 1 year, 79.9% +/- 3.7% at 3 years, and 59.5% +/- 4.8% at 5 years after lung transplantation. Recipients with bronchiolitis obliterans syndrome reported significantly lower well being and quality of life than those without bronchiolitis obliterans syndrome, who scored similar to healthy volunteers. In a subanalysis, body functioning (P < .001) and related areas of coping (P < .001) were mostly affected by bronchiolitis obliterans syndrome. CONCLUSIONS: Quality of life was negatively affected by the onset of bronchiolitis obliterans syndrome. However, even patients who develop bronchiolitis obliterans syndrome reported a temporary benefit from lung transplantation. In addition to optimal medical care and efforts in preventing bronchiolitis obliterans syndrome, psychological support of lung recipients seems to be essential, especially when bronchiolitis obliterans syndrome occurs.


Assuntos
Atitude Frente a Saúde , Bronquiolite Obliterante/etiologia , Bronquiolite Obliterante/psicologia , Transplante de Pulmão , Qualidade de Vida/psicologia , Atividades Cotidianas/psicologia , Análise Atuarial , Adaptação Psicológica , Adolescente , Adulto , Análise de Variância , Bronquiolite Obliterante/diagnóstico , Efeitos Psicossociais da Doença , Estudos Transversais , Intervalo Livre de Doença , Feminino , Nível de Saúde , Humanos , Transplante de Pulmão/efeitos adversos , Transplante de Pulmão/psicologia , Masculino , Saúde Mental , Pessoa de Meia-Idade , Limitação da Mobilidade , Inquéritos e Questionários , Taxa de Sobrevida , Resultado do Tratamento
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