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Biomedical subjects

L C Siegel

Publications and source records attributed to L C Siegel.

At least 19 recordsLinked to original sources

Predictors of operative time in multicenter port-access valve registry: institutional differences in learning.

BACKGROUND: The predictors of operative time and the effects of learning in isolated valve operations using port-access techniques have not been defined. METHODS: Analysis of covariance was used to examine the determinants of procedure time, pump time, and aortic clamp time. In the largest prospective, registry of patients undergoing isolated aortic valve replacement (AVR, N=199), mitral repair (MVP, N=307), or mitral replacement (MVR, N=232) using port-access techniques 1997-1999 at 27 institutions. RESULTS: Institutional case volume ranged from one to 214 (median 6). Operative time was longer in redo procedures (5.3 +/- 1.6 vs. 4.4 +/- 1.3 hr, p = 0.0001), longer with MVP or MVR vs. AVR (4.8 +/- 1.2 vs. 5.0 +/- 1.5 vs. 3.8 +/- 1.2 hr, p = 0.0001), and decreased with case number (mean decrease 1.00 +/- 0.19 min/case, p = 0.04). Operative time also varied between institutions (p = 0.001). Rate of learning (decrease in time per case) varied significantly between institutions only for MVP (p = 0.03). Similar analysis showed that pump time and clamp times did not significantly change over time (p > 0.17) but varied significantly between institutions. Institutional volume did not affect operative, pump, or clamp times or rate of learning (decrease in operative time/case). CONCLUSIONS: These prospective registry data demonstrate that, for port-access valve procedures, procedure times continue to improve (learning) even after 100 cases. Procedure time and learning are affected by institutional differences and by the type of procedure, but are little affected by institutional volume. This data provides a model to understand learning of new surgical procedures, and this data suggests that port-access valve procedures can be mastered by a variety of institutions.

Analysis of Variance↗

Predictors of outcome in a multicenter port-access valve registry.

BACKGROUND: The aim of this study was to examine the predictors of outcome in patients undergoing isolated valve operation using port-access techniques. METHODS: Logistic regression analysis was performed in a prospective, multi-institutional registry of patients undergoing isolated aortic valve replacement (AVR, n = 252), mitral repair (MVP, n = 491), or mitral replacement (MVR, n = 568) using port-access techniques from 1997 to 1999. RESULTS: Endoaortic balloon occlusion was used in 2% (AVR), 93% (MVP), and 90% (MVR) of cases. Conversion to full sternotomy occurred in 3.8% of all cases. For all patients, early mortality was 50 of 1,311 (3.8%) and onset of new atrial fibrillation occurred in 140 of 1,311 (11%) patients. The determinants of 30-day mortality were redo, age, and MVR or AVR. The determinants of reoperation for bleeding were age, reoperation, and MVR. Age was a predictor for stroke, and age and low or medium volume center were predictors of new atrial fibrillation. CONCLUSIONS: Excellent short-term results can be obtained using port-access techniques in isolated mitral or aortic valve operations. Patient outcome is not related to institutional case volume, and the primary determinants of outcome after port-access valve procedures are generally patient-related factors.

Age Factors↗

Institutional variability in red blood cell conservation practices for coronary artery bypass graft surgery. Institutions of the MultiCenter Study of Perioperative Ischemia Research Group.

OBJECTIVE: To assess whether substantial institutional variability exists in red blood cell conservation practices associated with coronary artery bypass graft (CABG) surgery. DESIGN: Prospective, randomized patient enrollment and data collection. SETTING: Twenty-four U.S. academic institutions participating in the Multicenter Study of Perioperative Ischemia. PARTICIPANTS: A well-defined subset of primary CABG surgery patients (n = 713) expected to be at low risk for bleeding and exposure to allogeneic transfusion. INTERVENTIONS: None (observational study). MEASUREMENTS AND MAIN RESULTS: Frequency of use of red blood cell conservation techniques was determined among institutions. Correlation was determined between use of each technique and transfusion of allogeneic red blood cells and between use of each technique and median institutional blood loss. Significant variability (p < 0.01) was detected in institutional transfusion practice with respect to the use of predonated autologous whole blood, normovolemic hemodilution, red cell salvage, and reinfusion of shed mediastinal blood. The frequency of institutional use of these techniques was not associated with allogeneic transfusion (r2 < 0.15) or blood loss (r2 < 0.10) in the low-risk population of patients examined. CONCLUSIONS: Institutions vary significantly in perioperative blood conservation practices for CABG surgery. Further study to determine the appropriate use of these techniques is warranted.

Blood Loss, Surgical↗

Platelet-rich plasma sequestration, with therapeutic platelet yields, reduces allogeneic transfusion in complex cardiac surgery.

UNLABELLED: Platelet dysfunction is the most common cause of nonsurgical bleeding after cardiopulmonary bypass (CPB). We hypothesized that reinfusion of a therapeutic quantity of platelets sequestered before CPB would decrease the need for allogeneic platelet transfusion, as well as decrease bleeding and total allogeneic transfusion, in cardiac surgery patients at moderately high risk for bleeding. Fifty-five patients undergoing either reoperative coronary artery bypass (CABG) or combined CABG and valve replacement were randomized to control or platelet-rich plasma sequestration (pheresis) groups. All patients received intraoperative epsilon-aminocaproic acid infusions. There was no significant difference between groups with respect to preoperative characteristics, duration of CPB, or target postoperative hematocrit. Mean platelet yields were 6.2 +/- 2.1 units (3.1 x 10(11) platelets). Mean pheresis time was 44 min. Allogeneic platelets (range = 6-12 units) were transfused to 28% of control patients, compared with 0% of pheresis patients (P < 0.01). Allogeneic packed red blood cells were transfused to 45% of control patients (1.2 units per patient) versus 31% of pheresis patients (0. 7 unit per patient) (P = 0.35). Total allogeneic units transfused were significantly reduced in the pheresis group (P < 0.02). Mediastinal chest tube drainage was not significantly decreased in the pheresis group. In this prospective, randomized study, therapeutic platelet yields were obtained before CPB. In contrast with recent studies with low platelet yields, these data support the conclusion that platelet-rich plasma sequestration is effective in reducing allogeneic platelet transfusions and total allogeneic units transfused in cardiac surgery patients at moderately high risk for post-CPB coagulopathy and bleeding. IMPLICATIONS: Transfusion of allogeneic blood products, including platelets, is common during complex cardiac surgical procedures. In the present prospective, randomized study, a significant reduction in allogeneic platelet transfusion and total allogeneic units transfused was observed after the reinfusion of a therapeutic quantity of autologous platelets sequestered before cardiopulmonary bypass.

Aged↗

Safety and efficacy of shed mediastinal blood transfusion after cardiac surgery: a multicenter observational study. Multicenter Study of Perioperative Ischemia Research Group.

OBJECTIVE: To examine the efficacy and safety of shed mediastinal blood (SMB) transfusion in preventing allogenic red blood cell (RBC) transfusion. DESIGN: An observational clinical study. SETTING: Twelve US academic medical centers. PARTICIPANTS: Six hundred seventeen patients undergoing elective primary coronary artery bypass grafting. INTERVENTIONS: Patients were administered SMB transfusion or not, according to institutional and individual practice, without random assignment. MEASUREMENTS AND RESULTS: The independent effect of SMB transfusion on postoperative RBC transfusion was examined by multivariable modeling. Potential complications of SMB transfusion, such as bleeding and infection, were examined. Three hundred twelve of the study patients (51%) received postoperative SMB transfusion (mean volume, 554 +/- 359 mL). Patients transfused with SMB had significantly lower volumes of RBC transfusion than those not receiving SMB (0.86 +/- 1.50 v 1.08 +/- 1.65 units; p < 0.05). However, multivariable analysis showed that SMB transfusion was not predictive of postoperative RBC transfusion. Demographic factors (older age, female sex), institution, and postoperative events (greater chest tube drainage, lower hemoglobin level on arrival to the intensive care unit, and use of inotropes) were significant predictors of RBC transfusion. The volume of chest tube drainage on the operative day (707 +/- 392 v 673 +/- 460 mL; p = 0.30), reoperation for hemorrhage (3.1% v2.5%; p = 0.68), and overall frequency of infection (5.8% v 6.6%; p = 0.81) were similar between patients receiving and not receiving SMB, respectively. However, in patients who did not receive allogenic RBC transfusion, there was a significantly greater frequency of wound infection in the SMB group (3.6% v0%; p = 0.02). CONCLUSION: These data suggest that SMB is ineffective as a blood conservation method and may be associated with a greater frequency of wound infection.

Aged↗

Hematocrit value on intensive care unit entry influences the frequency of Q-wave myocardial infarction after coronary artery bypass grafting. The Institutions of the Multicenter Study of Perioperative Ischemia (McSPI) Research Group.

OBJECTIVES: No data exist regarding "the best" hematocrit value after coronary artery bypass graft surgery. Transfusion practice varies, because neither an optimal hematocrit value nor a uniform transfusion trigger criterion has been determined. METHODS: To investigate the optimal hematocrit value, we studied 2202 patients undergoing coronary bypass. The hematocrit value on entry into the intensive care unit (IHCT) was categorized into three groups: high (> or = 34%), medium (25% to 33%), and low (< or = 24%). Characteristics and adverse events (outcomes) were compared, and the effect of IHCT on the risk of myocardial infarction was determined by logistic regression. RESULTS: High IHCT (> or = 34%) was associated with an increased rate of myocardial infarction (8.3% vs 5.5% vs 3.6%; p < or = 0.03, high, medium vs low) and with more severe left ventricular dysfunction (11.7% vs 7.4% and 5.7%; p=0.006, high, medium vs low). Mortality rate increased with higher IHCT when all the high-risk subgroups were combined (8.6% vs 4.5% vs 3.2%; p < 0.001, high, medium vs low). By multivariate analysis, IHCT remained the most significant predictor of adverse outcomes (relative risk high vs low 2.22, 95% confidence interval: 1.04 to 4.76). No characteristic, event, medication, or transfusion therapy confounded the relationship between IHCT and outcome. CONCLUSION: High IHCT is associated with a higher rate of myocardial infarction and is an independent predictor of infarction. On the basis of the risk of myocardial infarction, there is no rationale for transfusion to an arbitrary level after coronary artery bypass grafting.

Anemia↗

Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the Multicenter Study of Perioperative Ischemia Research Group.

BACKGROUND: An estimated 20% of allogeneic blood transfusions in the United States are associated with cardiac surgery. National consensus guidelines for allogeneic transfusion associated with coronary artery bypass graft (CABG) surgery have existed since the mid- to late 1980s. The appropriateness and uniformity of institutional transfusion practice was questioned in 1991. An assessment of current transfusion practice patterns was warranted. METHODS: The Multicenter Study of Perioperative Ischemia database consists of comprehensive information on the course of surgery in 2,417 randomly selected patients undergoing CABG surgery at 24 institutions. A subset of 713 patients expected to be at low risk for transfusion was examined. Allogeneic transfusion was evaluated across institutions. Institution as an independent risk factor for allogeneic transfusion was determined in a multivariable model. RESULTS: Significant variability in institutional transfusion practice was observed for allogeneic packed red blood cells (PRBCs) (27-92% of patients transfused) and hemostatic blood components (platelets, 0-36%; fresh frozen plasma, 0-36%; cryoprecipitate, 0-17% of patients transfused). For patients at institutions with liberal rather than conservative transfusion practice, the odds ratio for transfusion of PRBCs was 6.5 (95% confidence interval [CI], 3.8-10.8) and for hemostatic blood components it was 2 (95% CI, 1.2-3.4). Institution was an independent determinant of transfusion risk associated with CABG surgery. CONCLUSIONS: Institutions continue to vary significantly in their transfusion practices for CABG surgery. A more rational and conservative approach to transfusion practice at the institutional level is warranted.

Blood Component Transfusion↗

Monitoring considerations for port-access cardiac surgery.

BACKGROUND: A method for monitoring patients was evaluated in a clinical trial of minimally invasive port-access cardiac surgery with closed chest endovascular cardiopulmonary bypass. METHODS AND RESULTS: Cardiopulmonary bypass was conducted in 25 patients through femoral cannulas. An endovascular pulmonary artery vent was placed in the main pulmonary artery through a jugular vein. For mitral valve surgery, a catheter was placed in the coronary sinus for delivery of cardioplegia. A balloon catheter ("endoaortic clamp," EAC) used for occlusion of the ascending aorta, delivery of cardioplegia, aortic root venting, and pressure measurement was inserted through a femoral artery and initially positioned by use of fluoroscopy and transesophageal echocardiography (TEE). Potential migration of the EAC was monitored by (1) TEE of the ascending aorta, (2) pulsed-wave Doppler of the right carotid artery, (3) balloon pressure, (4) comparison of aortic root pressure and right radial artery pressure, and (5) fluoroscopy. TEE, fluoroscopy, and pressure measurement were effective in monitoring catheter insertion and position. With inadequate balloon inflation, migration of the EAC toward the aortic valve could be detected with TEE. During administration of cardioplegia, TEE showed movement of the balloon away from the aortic valve, and migration into the aortic arch was detectable with loss of carotid Doppler flow. Stability of EAC position was demonstrated with appropriate balloon volume. Cardioplegic solution was visualized in the aortic root, and aortic root pressure changed appropriately during administration of cardioplegia. Venous cannula position was optimized with TEE and endopulmonary vent flow measurement. CONCLUSIONS: An effective method has been developed for monitoring patients and the catheter system during port-access cardiac surgery.

Cardiopulmonary Bypass↗

Closed-chest cardiopulmonary bypass and cardioplegia: basis for less invasive cardiac surgery.

BACKGROUND: We developed a method of closed-chest cardiopulmonary bypass to arrest and protect the heart with cardioplegic solution. This method was used in 54 dogs and the results were retrospectively analyzed. METHODS: Bypass cannulas were placed in the right femoral vessels. A balloon occlusion catheter was passed via the left femoral artery and positioned in the ascending aorta. A pulmonary artery vent was placed via the jugular vein. In 17 of the dogs retrograde cardioplegia was provided with a percutaneous coronary sinus catheter. RESULTS: Cardiopulmonary bypass time was 111 +/- 27 minutes (mean +/- standard deviation) and cardiac arrest time was 66 +/- 21 minutes. Preoperative cardiac outputs were 2.9 +/- 0.70 L/min and postoperative outputs were 2.9 +/- 0.65 L/min (p = not significant). Twenty-one-French and 23F femoral arterial cannulas that allowed coaxial placement of the ascending aortic balloon catheter were tested in 3 male calves. Line pressures were higher, but not clinically limiting, with the balloon catheter placed coaxially. CONCLUSIONS: Adequate cardiopulmonary bypass and cardioplegia can be achieved in the dog without opening the chest, facilitating less invasive cardiac operations. A human clinical trial is in progress.

Animals↗

Port-access cardiac operations with cardioplegic arrest.

BACKGROUND: A less invasive approach to cardiac surgery has been propelled by recent advances in video-assisted surgery. Previous obstacles to minimally invasive cardiac operations with cardioplegic arrest included limitations in operative exposure, inadequate perfusion technology, and inability to provide myocardial protection. METHODS: Port-access technology allows endovascular aortic occlusion, cardioplegia delivery, and left ventricular decompression. The endoaortic clamp is a triple-lumen catheter with an inflatable balloon at its distal end. Antegrade cardioplegia is delivered through a central lumen, which also acts as an aortic root vent, a second lumen is used as an aortic root pressure monitor, and a third lumen is used for balloon inflation to provide aortic occlusion. RESULTS: Experimental and clinical studies have demonstrated the feasibility of port-access coronary artery bypass grafting and port-access mitral valve procedures. Endovascular cardiopulmonary bypass using the endoaortic clamp was effective in achieving cardiac arrest and myocardial protection to allow internal mammary artery to coronary artery anastomosis in a still and bloodless field. Intracardiac procedures, such as mitral valve replacement or repair, have been successfully performed clinically. CONCLUSION: The port-access system effectively achieves cardiopulmonary bypass and cardioplegic arrest, thereby enabling the surgeon to perform cardiac procedures in a minimally invasive fashion. This system provides for endovascular aortic occlusion, cardioplegia delivery, and left ventricular decompression.

Cardiac Surgical Procedures↗

Minimally invasive right heart operations: techniques for bicaval occlusion and cardioplegia.

Peripheral cardiopulmonary bypass with cardioplegia has facilitated minimally invasive coronary artery bypass grafting and mitral valve replacement. The cardiopulmonary bypass system was modified to allow bicaval occlusion for right heart operations. In 4 canine studies, three variants of bicaval cannulation techniques were successfully used for atrial septal defect repair via a right minithoracotomy.

Animals↗

Extracorporeal circulation for port-access cardiac surgery.

Minimally invasive techniques for cardiac surgery are a new approach in performing some cardiac operations. Minimally invasive surgery may minimize patient discomfort, length of stay in the hospital and postoperative rehabilitation. These procedures utilize a small thoracotomy for direct visualization of the heart. However, without the use of cardiopulmonary bypass, this approach is limited to some epicardial procedures such as coronary bypass grafting, where the heart rate is pharmacologically reduced. Port-access cardiac surgery is a new approach which provides all the benefits of minimally invasive surgery without sacrificing the advantages of cardiopulmonary bypass and myocardial preservation. Port-access cardiac surgery uses an anterior mediastinotomy and thoracic ports in conjunction with a specially designed set of endovascular catheters. These catheters provide a mode to arrest, preserve and vent the heart through an endoaortic occlusion balloon positioned in the ascending aorta. A pulmonary artery vent and coronary sinus cardioplegia catheter can also be used. These endovascular catheters, integrated with a modified heart-lung machine, provide complete cardiopulmonary support through extrathoracic cannulae inserted in a femoral artery and vein. Maintenance and monitoring of this endovascular cardiopulmonary bypass system requires the use of a kinetic pump in the venous drainage line to augment return to the heart-lung machine. Special guidelines and management parameters exist to optimize bypass with this catheter system. Using this system, port-access, minimally invasive surgery can be applied to a wider range of both epicardial and intracardiac procedures.

Cardiac Surgical Procedures↗

Port-access mitral valve replacement in dogs.

OBJECTIVE: The objective was to assess mitral valve replacement in a minimally invasive fashion by means of port-access technology. METHODS: Fifteen dogs, 28 +/- 3 kg (mean +/- standard deviation), were studied with the port-access mitral valve replacement system (Heartport, Inc., Redwood City, Calif.). Eleven dogs underwent acute studies and were sacrificed immediately after the procedure. Four dogs were allowed to recover and then were sacrificed 4 weeks after operation. Cardiopulmonary bypass was conducted by femoral cannulation with an endovascular balloon catheter for aortic occlusion, root venting, and antegrade delivery of cardioplegic solution. Catheters were inserted in the jugular vein for pulmonary artery venting and retrograde delivery of cardioplegic solution. Through the oval port, a prosthesis (St. Jude Medical, Inc., St. Paul, Minn., or CarboMedics, Inc., Austin, Texas) was inserted through the left atrial appendage and secured to the anulus with sutures. Deairing was performed. RESULTS: Cardiopulmonary bypass duration was 114 +/- 24 minutes and aortic crossclamp time was 68 +/- 14 minutes. All animals were weaned from cardiopulmonary bypass in sinus rhythm. Cardiac output and pulmonary artery occlusion pressure were unchanged (2.8 +/- 0.7 L/min and 7 +/- 3 mm Hg before operation vs 2.6 +/- 0.6 L/min and 9 +/- 4 mm Hg after operation). There was no mitral regurgitation according to left ventriculography in 13 of 15 dogs. In two dogs there was interference with prosthetic valve closure by residual native anterior leaflet tissue. Pathologic examination otherwise showed normal healing without perivalvular discontinuity. Microscopic studies showed no damage to the valve surfaces. Transthoracic echocardiography of the four dogs in the long-term study showed normal ventricular and prosthetic valve function 4 weeks after the operation. CONCLUSION: Mitral valve replacement with a minimally invasive method has been demonstrated in dogs. A clinical trial is in progress.

Animals↗

Minimally invasive cardiopulmonary bypass with cardioplegic arrest: a closed chest technique with equivalent myocardial protection.

Thoracoscopic cardiac surgery is presently under intense investigation. This study examined the feasibility and efficacy of closed chest cardiopulmonary bypass and cardioplegic arrest in comparison with standard open chest methods in a dog model. The minimally invasive closed chest group (n = 6) underwent percutaneous cardiopulmonary bypass and cardiac venting, as well as antegrade cardioplegic arrest through use of a specially designed percutaneous endovascular aortic occluder and cardioplegic solution delivery system. The control group (n = 6) underwent standard sternotomy and conventional open chest cardiopulmonary bypass, aortic crossclamping, and antegrade cardioplegia. Ischemic arrest time was 1 hour in each group. Ventricular pressures and sonomicrometer segment lengths were recorded before bypass and at 30 and 60 minutes after bypass. Left ventricular function did not differ significantly between the two groups, as demonstrated by measurements of elastance and end-diastolic stroke work. Also, the preload recruitable work area was 69% and 60% of baseline at 30 and 60 minutes after bypass in the minimally invasive group versus 65% and 62% in the conventional control group (p = not significant); the stroke work end-diastolic length relationship was 78% and 71% of baseline in the minimally invasive group at these intervals versus 77% and 74% in the conventional control group (p = not significant). Myocardial temperatures were similar throughout bypass in the two groups, and ultrastructural examination of prebypass and postbypass biopsy specimens showed no differences between groups. These results demonstrate that minimally invasive cardiopulmonary bypass with cardioplegic arrest is as feasible, safe, and effective as conventional open chest cardiopulmonary bypass. Thus current technology may allow wider clinical application of closed chest cardiac surgery.

Analysis of Variance↗

Port-access coronary artery bypass grafting: a proposed surgical method.

Minimally invasive surgical methods have been developed to provide patients the benefits of open operations with decreased pain and suffering. We have developed a system that allows the performance of cardiopulmonary bypass and myocardial protection with cardioplegic arrest without sternotomy or thoracotomy. In a canine model, we successfully used this system to anastomose the internal thoracic artery to the left anterior descending coronary artery in nine of 10 animals. The left internal thoracic artery was dissected from the chest wall, and the pericardium was opened with the use of thoracoscopic techniques and single lung ventilation. The heart was arrested with a cold blood cardioplegic solution delivered through the central lumen of a balloon occlusion catheter (Endoaortic Clamp; Heartport, Inc., Redwood City, Calif.) in the ascending aorta, and cardiopulmonary bypass was maintained with femorofemoral bypass. An operating microscope modified to allow introduction of the 3.5x magnification objective into the chest was positioned through a 10 mm port over the site of the anastomosis. The anastomosis was performed with modified surgical instruments introduced through additional 5 mm ports. In the cadaver model (n = 7) the internal thoracic artery was harvested and the pericardium opened by means of similar techniques. A precise arteriotomy was made with microvascular thoracoscopic instruments under the modified microscope on four cadavers. In three other cadavers we assessed the exposure provided by a small anterior incision (4 to 6 cm) over the fourth intercostal space. This anterior port can assist in dissection of the distal internal thoracic artery and provides direct access to the left anterior descending, circumflex, and posterior descending arteries. We have demonstrated the potential feasibility of grafting the internal thoracic artery to coronary arteries with the heart arrested and protected, without a major thoracotomy or sternotomy.

Anastomosis, Surgical↗