RESUMEN
Background: This study sought to compare characteristics and outcomes of patients who underwent surgical aortic valve replacement (SAVR) after being referred to a heart team (HT), to those of patients referred directly for SAVR. Methods: An analysis of patients who underwent SAVR from 2015 to 2020 was conducted. Patients were categorized into 3 groups, as follows: (i) H-HT: patients referred to the HT from 2015 to 2017 (historical cohort); (ii) C-HT: patients referred to the HT from 2018 to 2020 (contemporary cohort); and (iii) No-HT: patients referred directly to cardiac surgery from 2018 to 2020. Two subanalyses were performed: H-HT vs C-HT patients, and C-HT vs No-HT patients. The primary outcome was a composite of in-hospital mortality, prolonged intubation, reoperation, sternal wound infection, and stroke. Results: This study consisted of 288 patients, distributed as follows: H-HT (n = 45); C-HT (n = 51); and No-HT (n = 192). The mean ages of H-HT, C-HT, and No-HT patients was 76.3 ± 6.9 years, 73.3 ± 7.6 years, and 69.6 ± 9.7 years, respectively (P = 0.0001). H-HT, C-HT, and No-HT patients had average Society of Thoracic Surgeons scores of 4.8 ± 2.2, 3.2 ± 1.6, and 4.2 ± 2 (P = 0.002), respectively. The composite outcome rate was more than 5 times higher among H-HT patients compared to that among the C-HT patients (20.0 vs 3.9%, P = 0.02), and was numerically higher in No-HT compared to C-HT patients (13.0 vs 3.9%, P = 0.07). Conclusions: Referral to an HT appears to be primarily driven by higher chronological age rather than overall risk profile. Patients assessed by the HT prior to undergoing SAVR have a low incidence of complications, comparable to that among patients referred directly to cardiac surgery.
Contexte: Cette étude visait à comparer les caractéristiques et le devenir de patients ayant subi une chirurgie de remplacement valvulaire aortique après avoir été orientés vers une équipe de cardiologie (EC) à ceux de patients orientés directement en chirurgie cardiaque pour une chirurgie de remplacement valvulaire aortique. Méthodologie: Une analyse portant sur les patients ayant subi une chirurgie de remplacement valvulaire aortique de 2015 à 2020 a été effectuée. Les patients ont été divisés en trois groupes, à savoir : i) CH-POEC : patients orientés vers une EC de 2015 à 2017 (cohorte historique); ii) CC-POEC : patients orientés vers une EC de 2018 à 2020 (cohorte contemporaine); iii) PODC : patients orientés directement en chirurgie cardiaque de 2018 à 2020. Deux sous-analyses ont été effectuées : CH-POEC vs CC-POEC, et CC-POEC vs PODC. Le paramètre d'évaluation principal était composite. Il comprenait la mortalité hospitalière, l'intubation prolongée, la réopération, l'infection de la plaie sternale et l'accident vasculaire cérébral. Résultats: L'étude regroupait 288 patients, répartis comme suit : CH-POEC, n = 45; CC-POEC, n = 51; PODC, n = 192. L'âge moyen dans les groupes CH-POEC, CC-POEC et PODC était respectivement de 76,3 ± 6,9 ans, 73,3 ± 7,6 ans et 69,6 ± 9,7 ans (P = 0,0001). Les groupes CH-POEC, CC-POEC et PODC présentaient des indices STS (Society of Thoracic Surgeons) moyens de 4,8 ± 2,2, 3,2 ± 1,6 et 4,2 ± 2 (P = 0,002), respectivement. Le taux composite d'événements au sein du groupe CH-POEC était plus de cinq fois supérieur à celui noté dans le groupe CC-POEC (20,0 vs 3,9 %, P = 0,02). Il était aussi plus élevé au sein du groupe PODC comparativement au groupe CC-POEC (13,0 vs 3,9 %, P = 0,07). Conclusions: Le principal motif d'orientation vers une EC semble être un âge chronologique avancé plutôt que le profil de risque global. Chez les patients qui sont évalués par une EC avant de subir une chirurgie de remplacement valvulaire aortique, l'incidence de complications est faible et comparable à celle observée chez les patients orientés directement en chirurgie cardiaque.
RESUMEN
This case report describes an initially stabilized transcatheter heart valve that embolized in the ascending aorta, leading to a postprocedural acute type A aortic dissection.
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Disección Aórtica , Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Aorta/cirugía , Estenosis de la Válvula Aórtica/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVE: To describe the evolution of the use and reporting of propensity score (PS) analysis in observational studies assessing a surgical procedure. BACKGROUND: Assessing surgery in randomized controlled trials raises several challenges. Observational studies with PS analysis are a robust alternative for comparative effectiveness research. METHODS: In this methodological systematic review, we identified all PubMed reports of observational studies with PS analysis that evaluated a surgical procedure and described the evolution of their use over time. Then, we selected a sample of articles published from August 2013 to July 2014 and systematically appraised the quality of reporting and potential bias of the PS analysis used. RESULTS: We selected 652 reports of observational studies with PS analysis. The publications increased over time, from 1 report in 1987 to 198 in 2013. Among the 129 reports assessed, 20% (n = 24) did not detail the covariates included in the PS and 77% (n = 100) did not report a justification for including these covariates in the PS. The rate of missing data for potential covariates was reported in 9% of articles. When a crossover by conversion was possible, only 14% of reports (n = 12) mentioned this issue. For matched analysis, 10% of articles reported all 4 key elements that allow for reproducibility of a PS-matched analysis (matching ratio, method to choose the nearest neighbors, replacement and method for statistical analysis). CONCLUSIONS: Observational studies with PS analysis in surgery are increasing in frequency, but specific methodological issues and weaknesses in reporting exist.
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Investigación sobre la Eficacia Comparativa , Estudios Observacionales como Asunto , Evaluación de Resultado en la Atención de Salud/métodos , Procedimientos Quirúrgicos Operativos/normas , Sesgo , Femenino , Francia , Humanos , Masculino , Puntaje de Propensión , Procedimientos Quirúrgicos Operativos/tendenciasRESUMEN
BACKGROUND: A prospective study of survival, functional outcome, living arrangements, daily activities and leisure engagements among octogenarians up to 5 years after cardiac surgery was performed. METHODS: The study consisted of a cohort of 300 consecutive octogenarians with three interviews made at 6-month intervals for a total of 593 postoperative interviews. Functional outcomes were measured using the Barthel index and Karnofsky performance scores and divided into autonomous, semiautonomous, or dependent. Living arrangements and leisure activities within the social, physical, cognitive, and creative domains were recorded in an open-ended questionnaire. RESULTS: There were 150 men and 150 women with a mean age 82.6 years. The 30-day survival was 84.3%. Actuarial survival at 1, 3, and 5 years was 76.6%, 66.6%, and 57.8%, respectively. Among the survivors at the first interview, 2.2 years postoperatively, there were 63.9% autonomous, 31.7% semiautonomous, and 4.3% dependent patients versus at the last interview, 3.6 years postoperatively, in which there were 64.9% autonomous, 28.1% semiautonomous, and 9.2% dependent. At the first interview, 76.4% were at home, 19.2 % in a residence, and 4.3% in a supervised setting. At the third interview, 71.8% were at home, 21.2% in a residence, and 6.9% in a supervised setting. Nearly all patients were involved in leisure activities in the social (98.9%), cognitive (98.4%), and physical (93.1%) domains. At the end of the last interview, activities within the social and cognitive domains were maintained with a small decrease in the physical domain. CONCLUSIONS: Surviving octogenarians remain at home, function independently, and engage in regular leisure activities years after cardiac surgery. This information might help physicians and surgeons regarding long-term outcome of open cardiac surgery in octogenarians.
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Actividades Cotidianas , Anciano de 80 o más Años , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Actividades Recreativas , Características de la Residencia , Sobrevivientes , Procedimientos Quirúrgicos Cardíacos/mortalidad , Puente de Arteria Coronaria , Femenino , Válvulas Cardíacas/cirugía , Humanos , Estado de Ejecución de Karnofsky , Masculino , Calidad de Vida , Factores de Riesgo , Análisis de SupervivenciaRESUMEN
PURPOSE: Combined heart and liver transplant is a rare procedure to treat end-stage cardiac and liver disease. First performed during cardiopulmonary bypass and anticoagulation, subsequent concerns about increased bleeding changed the strategy to performing liver implantation following separation from cardiopulmonary bypass. Considering the overall decrease in transfusion requirements during liver transplant and the potential benefits to the transplanted heart to remain on cardiopulmonary bypass during liver implantation, we revised the strategy for combined heart and liver transplant. We report the clinical course of four consecutive patients who underwent this procedure in our institution. CLINICAL FEATURES: Patient 1 was a 53-yr-old male with familial hypertrophic cardiomyopathy and congestive cirrhosis. Patient 2 was a 57-yr-old male with hypertrophic restrictive cardiomyopathy and congestive cirrhosis. Patient 3 was a 48-yr-old male with dilated cardiomyopathy and hepatitis B cirrhosis. Patient 4 was a 57-yr-old male with ischemic cardiomyopathy and congestive cirrhosis. Each patient underwent combined heart and liver transplant, with liver implantation performed during cardiopulmonary bypass and anticoagulation. Estimated blood loss ranged from 1,000 to 3,000 mL. Intraoperative transfusion included 2-5 U of packed red blood cells, 4-12 U of fresh frozen plasma, 0-20 U of cryoprecipitate, and 5-23 U of platelets. All patients remain well 25-38 months after surgery. CONCLUSION: Combined heart and liver transplant during cardiopulmonary bypass is a viable strategy that may confer benefit to this unique type of patient.
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Puente Cardiopulmonar/métodos , Insuficiencia Cardíaca/cirugía , Trasplante de Corazón/métodos , Fallo Hepático/cirugía , Trasplante de Hígado/métodos , Análisis de los Gases de la Sangre , Terapia Combinada , Humanos , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.
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Difusión de Innovaciones , Procedimientos Quirúrgicos Operativos , Evaluación de la Tecnología Biomédica , Investigación Biomédica , Estudios de Evaluación como Asunto , Medicina Basada en la Evidencia , Humanos , Procedimientos Quirúrgicos Operativos/métodos , Procedimientos Quirúrgicos Operativos/estadística & datos numéricosRESUMEN
Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.
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Estudios de Evaluación como Asunto , Procedimientos Quirúrgicos Operativos , Resultado del Tratamiento , Investigación Biomédica , Ensayos Clínicos como Asunto , Políticas Editoriales , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Apoyo a la Investigación como Asunto , Procedimientos Quirúrgicos Operativos/normasRESUMEN
Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.
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Investigación Biomédica , Procedimientos Quirúrgicos Operativos , Actitud del Personal de Salud , Sesgo , Competencia Clínica , Ensayos Clínicos como Asunto , Estudios de Evaluación como Asunto , Cirugía General , Humanos , Observación , Complicaciones Posoperatorias , Ensayos Clínicos Controlados Aleatorios como Asunto , Procedimientos Quirúrgicos Operativos/clasificación , Procedimientos Quirúrgicos Operativos/educación , Evaluación de la Tecnología BiomédicaRESUMEN
We present two cases of catecholamine-refractory and vasopressin-refractory vasoplegic syndrome associated with intraoperative anaphylaxis during cardiac surgery. One case was related to the administration of protamine and the other case to the administration of aprotinin. Both cases were successfully managed using intravenous methylene blue. The use of methylene blue blocks accumulation of cyclic guanosine monophosphate by competitively inhibiting the enzyme guanylate cyclase. This results in reduced responsiveness of the vasculature to cyclic guanosine monophosphate-mediated vasodilators, such as nitric oxide. This report provides a description of severe anaphylaxis induced by different agents, in which the use of methylene blue was associated with a significant clinical response.
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Anafilaxia/tratamiento farmacológico , Aprotinina/efectos adversos , Hipotensión/tratamiento farmacológico , Azul de Metileno/administración & dosificación , Protaminas/efectos adversos , Enfermedades Vasculares/tratamiento farmacológico , Vasodilatación/efectos de los fármacos , Anciano , Anafilaxia/inducido químicamente , Anafilaxia/fisiopatología , Aprotinina/uso terapéutico , Puente Cardiopulmonar , Catecolaminas/administración & dosificación , Puente de Arteria Coronaria/efectos adversos , Puente de Arteria Coronaria/métodos , Resistencia a Medicamentos , Femenino , Estudios de Seguimiento , Humanos , Hipotensión/inducido químicamente , Hipotensión/fisiopatología , Infusiones Intravenosas , Complicaciones Intraoperatorias/diagnóstico , Complicaciones Intraoperatorias/tratamiento farmacológico , Masculino , Protaminas/uso terapéutico , Medición de Riesgo , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Enfermedades Vasculares/inducido químicamenteRESUMEN
BACKGROUND: In the past two decades, cases involving patients requiring cardiac surgery have become more complex, presenting with more comorbidities. Outcome analysis has become very important in assessing the quality of cardiac surgical care in these patients. The latest version of the Parsonnet scoring system was developed in 2000 and is the most recent system available. OBJECTIVE: To evaluate the accuracy of the Parsonnet scoring system in a major Canadian university-based cardiac surgery centre with a population of high-risk patients. METHODS: Data on 4883 consecutive patients operated on between 2000 and 2005 were prospectively collected, and a standardized mortality rate was calculated using the Parsonnet score as the ratio of observed deaths to expected deaths. Analyses were conducted on the whole group and on subgroups, based on Parsonnet score distribution quantiles, age and surgery status. RESULTS: The mean Parsonnet score was 18.8+/-13.7 (range 0 to 83). The overall mortality rate was 6.4%. The overall standardized mortality ratio was 0.52 (95% CI 0.420 to 0.568), which was statistically significant (P=0.01). The observed mortality rate was significantly lower than expected in all categories. CONCLUSIONS: Despite more complex cases with multiple comorbidities, the results of cardiac surgery in a Canadian university hospital show better results than expected when using the Parsonnet score.
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Procedimientos Quirúrgicos Cardíacos/mortalidad , Evaluación de Resultado en la Atención de Salud/métodos , Medición de Riesgo/métodos , Análisis de Supervivencia , Cirugía Torácica , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Canadá/epidemiología , Instituciones Cardiológicas , Comorbilidad , Femenino , Hospitales Universitarios , Humanos , Masculino , Persona de Mediana Edad , Desarrollo de Programa , Estudios Prospectivos , Factores de RiesgoRESUMEN
Despite its initial description more than 20 years ago, combined orthotopic heart and liver transplantation is still performed infrequently. We report a 53-year-old man with familial hypertrophic restrictive cardiomyopathy who presented with right heart failure and end-stage liver failure and required combined orthotopic heart and liver transplantation. Rather then using a staged approach, the surgery was performed using a technique of simultaneous implantation supported by cardiopulmonary bypass. The relative merits of using a simultaneous approach are discussed. The patient had an uneventful postoperative course and went home on postoperative day 14.
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Puente Cardiopulmonar , Insuficiencia Cardíaca/cirugía , Trasplante de Corazón/métodos , Fallo Hepático/cirugía , Trasplante de Hígado/métodos , Estudios de Seguimiento , Supervivencia de Injerto , Insuficiencia Cardíaca/diagnóstico , Humanos , Fallo Hepático/diagnóstico , Masculino , Persona de Mediana Edad , Medición de Riesgo , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Type 2 heparin-induced thrombocytopenia is an uncommon but often fatal complication of heparin, frequently difficult to diagnose after cardiac surgery. In this series, we record the clinical presentation, temporal relationship, and treatment outcome of patients diagnosed with heparin-induced thrombocytopenia postoperatively. METHODS: Thirty-three consecutive patients (1.1%) with a diagnosis of heparin-induced thrombocytopenia established by a greater than 50% drop in platelet count with or without a thrombotic event and a positive platelet factor-4 assay were reviewed. We recorded the clinical presentation, the time to presentation, treatment, and outcome (thrombosis, mortality). Univariate analysis was performed on 13 preoperative, operative, and postoperative variables. RESULTS: The cohort was at increased mortality risk as a result of age (69.4 years), reduced cardiac function (46.8%), nonbypass operations (57.6%), emergency surgery (21.2%), and implantation of three assist devices. The mean time to suspect heparin-induced thrombocytopenia postoperatively was 5.4 days, with 22 cases (66.6%) occurring within 5 days. All patients had previous (within 3 months) exposure to heparin, and 66.6% had ongoing treatment with heparin before surgery. Overall mortality was 33%; thrombotic complications occurred in 15 patients (45.5%), with a mortality of 7 (46.6%) despite immediate cessation of heparin and treatment with a nonheparin analog. Thrombocytopenia without thrombosis occurred in 18 patients (54.5%), but a subgroup of 5 patients with nonthrombotic complications accounted for the 4 (22.2%) deaths. CONCLUSIONS: Heparin-induced thrombocytopenia after cardiac surgery is uncommon but may occur within 5 days of surgery, further complicating diagnosis and treatment. Thrombotic complications result in a high mortality despite treatment with a nonheparin analog, and a subgroup of patients with thrombocytopenia fared poorly.
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Anticoagulantes/efectos adversos , Procedimientos Quirúrgicos Cardíacos , Heparina/efectos adversos , Complicaciones Posoperatorias/inducido químicamente , Trombocitopenia/inducido químicamente , Anciano , Anciano de 80 o más Años , Anticoagulantes/inmunología , Autoanticuerpos/sangre , Autoanticuerpos/inmunología , Sulfatos de Condroitina/administración & dosificación , Sulfatos de Condroitina/uso terapéutico , Estudios de Cohortes , Dermatán Sulfato/administración & dosificación , Dermatán Sulfato/uso terapéutico , Complicaciones de la Diabetes/epidemiología , Femenino , Gangrena/etiología , Heparina/inmunología , Heparitina Sulfato/administración & dosificación , Heparitina Sulfato/uso terapéutico , Mortalidad Hospitalaria , Humanos , Isquemia/etiología , Masculino , Persona de Mediana Edad , Factor Plaquetario 4/inmunología , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/inmunología , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Periodo Posoperatorio , Estudios Retrospectivos , Factores de Riesgo , Trombocitopenia/clasificación , Trombocitopenia/diagnóstico , Trombocitopenia/inmunología , Trombocitopenia/terapia , Trombosis/tratamiento farmacológico , Trombosis/etiología , Trombosis/mortalidad , Trombosis/prevención & control , Factores de Tiempo , Resultado del TratamientoRESUMEN
Severe, medically unresponsive pulmonary hypertension (PHT) is considered to be a contraindication for orthotopic heart transplantation (OHT). Chronic left ventricular (LV) unloading using a left ventricular assist device (LVAD) might result in reversal of the elevated pulmonary vascular resistance (PVR), allowing successful OHT in such patients. In this study, we present a patient with end-stage ischemic cardiomyopathy and fixed, elevated PVR (7.1 Wood units) who underwent implantation of a Novacor LVAD (Baxter Healthcare Corp., Deerfield, IL, U.S.A.), with a subsequent reduction in PVR to 1.2 Wood units and successful OHT eleven months post-LVAD implantation. Three years after heart transplant, the patient still leads an active life with no right heart failure. In conclusion, OHT is not contraindicated in patients with end-stage heart failure and medically unresponsive PHT in the presence of elevated left atrial pressure. Left ventricular unloading should be considered in these patients to allow reversal of the elevated PVR before OHT.
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Cardiomiopatía Dilatada/cirugía , Corazón Auxiliar , Hipertensión Pulmonar/cirugía , Cardiomiopatía Dilatada/complicaciones , Trasplante de Corazón , Humanos , Hipertensión Pulmonar/etiología , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
The occurrence of late hepatic artery thrombosis after orthotopic liver transplantation can result in gas gangrene of the graft. This clinical scenario has the potential to be rapidly fatal as a result of fulminant hepatic failure, sepsis and multiple-organ-failure syndrome. Emergency operative intervention is indicated to remove the septic source and replace the failed liver. In this report, both cases demonstrated rapid deterioration within 24 h from the onset of symptoms, in spite of maximum supportive care. Intra-operative handling of the gangrenous graft resulted in hemodynamic instability and a technically unfeasible hepatectomy. The use of extra-corporeal veno-atrial bypass, by isolating the septic source, allowed for graft hepatectomy and successful re-transplantation in the second of these reported cases.
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Gangrena Gaseosa/etiología , Gangrena Gaseosa/cirugía , Arteria Hepática/patología , Trombosis/complicaciones , Adulto , Anastomosis Quirúrgica , Arteria Hepática/cirugía , Humanos , Trasplante de Hígado/efectos adversos , Masculino , Persona de Mediana Edad , Trombosis/cirugíaRESUMEN
BACKGROUND: Left ventricular free wall rupture is an uncommon but catastrophic event after myocardial infarction and is associated with a high mortality. After prompt diagnosis some patients may be salvaged with immediate surgical intervention. Surgical techniques used to seal the rupture vary, as few surgeons have experience with this pathologic process. We report our experience using a sutureless patch technique to treat this entity. METHODS: A review of 6 consecutive patients during an 8-year period who were referred to one cardiac unit with postinfarction left ventricular rupture was conducted. RESULTS: There were 3 men and 3 women with an average age of 71.8 years. All were hemodynamically unstable, and 4 were in electromechanical dissociation. Echocardiography confirmed the diagnosis in 5 patients, and cardiac catheterization had been performed in 4 before rupture. All patients were treated promptly with fluid, inotropic agents, and, if needed, cardiopulmonary resuscitation and pericardiocentesis. Resuscitation was continued in the operating room, and the myocardial tear was sealed with a generous patch of unsupported felt secured to the heart with cyanoacrylate glue. Coronary artery bypass grafting was performed in 3 patients if the anatomy was known. All patients survived to the intensive care unit. One death occurred as a result of severe neurologic injury. Five patients were discharged from the hospital, and all were alive 2 months to 7.5 years after operation. CONCLUSIONS: A sutureless patch technique for the treatment of postinfarction rupture is simple, effective, and associated with a favorable outcome.