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1.
J Extra Corpor Technol ; 39(3): 142-57; discussion 158-9, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17972449

ABSTRACT

Several surveys showed that cardiopulmonary bypass (CPB) is associated with incidents that negatively affect outcome and suggested that improved monitoring and safety could be associated with a decreased rate of incidents. In 2004, the French "Haute Autorité de Santé" (an independent French government advisory agency) and the French College of Perfusion issued recommendations concerning safety and monitoring devices for CPB. The aims of this study were to investigate the difference between the recommendations and the clinical practice of CPB shortly after publication of the recommendations and compare the 2005 situation with the results of a previous survey performed in France and to investigate the rate of perfusion incidents and their outcome. A 62-item questionnaire was sent in January 2006 to all 66 centers performing cardiac surgery and CPB in France. The survey investigated the use of safety and monitoring devices as well as perfusion incidents for 2005. Fifty-seven centers (response rate, 86%) returned the questionnaire, totaling 34,496 CPB procedures. There was a wide difference between the recommendations and the reported use of safety and monitoring devices with no clinically relevant change from the previous French survey concerning 2001. An incident was reported for every 198 CPB procedures with death at a frequency of 1:4864 and permanent sequelae of 1:11,349, respectively (a permanent injury or death in 1:3220 procedures). The three most frequent perfusion incidents were adverse effects to protamine (1:1702), dissection at the arterial cannulation site (1:1792), and coagulation of the circuit (1:4864). In conclusion, this survey showed that an important effort must be made in France to implement into clinical practice the recommendations concerning CPB monitoring and safety devices. The analysis of CPB-related incidents suggest that, with the exception of protamine adverse effects, the majority of deaths and severe permanent injuries in this survey could probably be avoided by improved use of the monitoring and safety devices.


Subject(s)
Cardiac Surgical Procedures/mortality , Cardiopulmonary Bypass/mortality , Cardiovascular Diseases/mortality , Monitoring, Physiologic/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Risk Assessment/methods , Cardiopulmonary Bypass/instrumentation , Data Collection , Equipment Failure Analysis/instrumentation , Equipment Failure Analysis/statistics & numerical data , France/epidemiology , Humans , Incidence , Monitoring, Physiologic/instrumentation , Retrospective Studies , Risk Factors , Survival Analysis , Survival Rate
2.
J Heart Valve Dis ; 11(4): 537-41; discussion 541-2, 2002 Jul.
Article in English | MEDLINE | ID: mdl-12150303

ABSTRACT

BACKGROUND AND AIM OF THE STUDY: The Medtronic Intact porcine bioprosthesis is a second-generation porcine bioprosthesis. This study was designed to evaluate results with this valve implanted in the aortic position at 13 years, notably with regard to the risk of structural valve deterioration (SVD). METHODS: A total of 188 patients (mean age 72.0+/-8.2 years; range: 28-89 years), who underwent aortic valve replacement between June 1987 and December 1990, was reviewed. RESULTS: Operative mortality was 9.0% (n = 17). Mean follow up per patient was 7.2+/-4.2 years (maximum 13.6 years); total follow up was 1,408.4 years. Linearized late mortality rate was 6.8%/patient-year (pt-yr) (n = 96), and the overall survival at 13 years 31.5+/-4.3%. SVD occurred in eight patients (linearized rate 0.57%/pt-yr), and freedom from SVD at 10 and 13 years was respectively 95.8+/-1.9% and 91.0+/-3.3% actuarial, and 97.3+/-1.2% and 95.5+/-1.6% actual. The mean time to onset of SVD was 7.8+/-2.8 years, and was independent of patient age at the time of implantation. Freedom from SVD at 10 and 13 years by age groups was: age < or =60 years, 76.6+/-14.8% and 60.9+/-18.0% actuarial, and 80.0+/-12.6% and 68.6+/-15.1% actual (linearized rate 3.3%/pt-yr); age 61-70 years, 96.3+/-2.6% and 92.4+/-4.5% actuarial, and 96.6+/-2.4% and 94.8+/-2.9% actual (linearized rate 0.37%/pt-yr); and age >70 years, 98.3 1.7% and 95.8+/-3.0% actuarial, and 99.2+/-0.8% and 98.3+/-1.2% actual (linearized rate 0.26%/pt-yr) (p <0.007). CONCLUSION: When implanted in the aortic position, the Medtronic Intact porcine bioprosthesis provides a low rate of SVD at 13 years. The prosthesis can be used in the aortic position in subjects aged over 60 years with a low rate of deterioration, similar to that with other second-generation bioprostheses.


Subject(s)
Aortic Valve/surgery , Bioprosthesis , Cause of Death , Heart Valve Diseases/mortality , Heart Valve Diseases/surgery , Heart Valve Prosthesis , Postoperative Complications/mortality , Actuarial Analysis , Adult , Age Factors , Aged , Aged, 80 and over , Animals , Female , France , Heart Valve Diseases/diagnostic imaging , Humans , Linear Models , Male , Middle Aged , Prosthesis Design , Prosthesis Failure , Retrospective Studies , Risk Assessment , Survival Analysis , Swine , Time Factors , Treatment Outcome , Ultrasonography
3.
Eur J Cardiothorac Surg ; 21(2): 282-7, 2002 Feb.
Article in English | MEDLINE | ID: mdl-11825736

ABSTRACT

OBJECTIVE: To report our experience with surgery of thoracic aortic rupture due to blunt trauma. METHODS: Between October 1976 and October 1999, 50 patients suffering from acute rupture of the thoracic aorta due to blunt trauma were operated on. On admission, 22 patients (44%) presented with hypovolemic shock and all but five (90%) sustained major associated injuries. Thirty-one patients (62%) underwent immediate operation for aortic repair, whereas the procedure was delayed from 6 to 60 days in ten patients because of late diagnosis or coexisting life-threatening lesions thought to largely worsen the operative risk. In 48 patients, the aortic repair was carried out with the aid of cardiopulmonary bypass (CPB) in order to maintain the distal perfusion and to prevent spinal cord injury. An inert 'Gott' shunt and the 'clamp-and-sew' technique were used in one patient each. RESULTS: The hospital mortality amounts to 18% (nine patients). Four patients (8%) died intraoperatively and five patients (10%) died in the postoperative course. In five patients (10%) death was caused by cerebral or pulmonary hemorrhage, possibly worsened by systemic heparinization during CPB. One case of postoperative paraplegia (2%) was observed in a patient operated on with the aid of CPB. There was neither aortic rupture nor sudden death in the group of patients in whom the surgical procedure was delayed. CONCLUSIONS: The immediate outcome of patients suffering from acute traumatic aortic rupture strongly depends on the associated injuries. In some cases, the emergency aortic repair must be favorably delayed because of the necessity of life-sustaining measures and management of major coexisting injuries, which could be worsened by the use of CPB. Conversely, the risk of paraplegia is significantly reduced by the use of CPB and distal perfusion during the time of aortic cross-clamping.


Subject(s)
Aneurysm, Ruptured/surgery , Aortic Aneurysm, Thoracic/surgery , Vascular Surgical Procedures/methods , Accidental Falls , Accidents, Traffic , Adolescent , Adult , Aneurysm, Ruptured/diagnosis , Aneurysm, Ruptured/mortality , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/mortality , Female , Follow-Up Studies , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors , Survival Rate , Time Factors , Treatment Outcome , Vascular Surgical Procedures/mortality
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