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.

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.

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.

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.

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.

Restructuring Medicare for the next century: what will beneficiaries really need?

Medicare coverage falls short of its original mandate of access to modern medicine and protection against the high costs of medical care. These shortfalls destabilize both health outcomes and the economic viability of older adults and their families. Our proposed revisions would promote, rather than discourage, optimal care for beneficiaries. By replacing incentives for fragmented, episodic care with an orientation toward functional status, care management, and integration with long-term care, we can make an invaluable investment in a successfully aging society.

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.

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.

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.

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.

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.

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.

Port-access bilateral internal mammary artery grafting for left main coronary artery disease: canine feasibility study.

BACKGROUND: To extend the applications of minimal access cardiac surgery, an endovascular cardiopulmonary bypass (CPB) system that allows cardioplegia delivery and cardiac venting was used to perform bilateral internal mammary artery (IMA) bypass grafting in six dogs. METHODS: The left IMA (LIMA) was taken down thoracoscopically from three left lateral chest ports, followed by the right IMA (RIMA) from the right side. One left-sided port was extended medially 5 cm with or without rib resection, to expose the pericardium. Both IMAs were divided and exteriorized through the left anterior mediastinotomy. Flow and pedicle length were satisfactory in all cases. Femoral-femoral bypass was used and the heart arrested with antegrade delivery of cardioplegic solution via the central lumen of a balloon catheter inflated to occlude the ascending aorta. All anastomoses were made through the mediastinotomy under direct vision. In five studies the RIMA was attached to the left anterior descending artery (LAD) and the LIMA to the circumflex, and in one study the RIMA was tunneled through the transverse sinus to the circumflex and the LIMA was anastomosed to the LAD. All animals were weaned from CPB in sinus rhythm without inotropes. CPB duration was 108 +/- 27 minutes (mean +/- SD) and the clamp duration was 54 +/- 10 minutes. RESULTS: Preoperative and postoperative cardiac outputs were 2.9 +/- 0.71/min and 2.4 +/- 0.31/min, respectively (p = NS), and corresponding pulmonary artery occlusion pressures were 6 +/- 3 mmHg and 7 +/- 2 mmHg, respectively (p = NS). All 12 grafts were demonstrated to be fully patent. Postmortem examination revealed well aligned pedicles and correctly grafted target vessels. CONCLUSION: This canine model demonstrates the potential for a less invasive approach to the surgical management of left main coronary artery disease in humans.

Port-access cardiac surgery with cardiopulmonary bypass and cardioplegic arrest.

In the past decade, laparoscopic and thoracoscopiC technology have significantly and irreversibly altered the approach to many general and thoracic surgical diseases. With advances in laparoscopy and thoracoscopy, the concept of a minimally invasive approach to cardiac surgery has been realized.

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.

Delayed time response of the continuous cardiac output pulmonary artery catheter.

Previous studies of the accuracy of pulmonary artery catheters (PAC) which provide continuous cardiac output (CCO) monitoring have investigated the performance during steady-state conditions. We compared the response time to hemodynamic change using a CCO PAC and an ultrasonic flow probe (UFP). In five sheep, a CCO PAC was inserted, and an UFP for measurement of CCO was placed around the pulmonary artery via a left thoracotomy. Six interventions which rapidly alter cardiac output were studied: crystalloid bolus, balloon inflation in the inferior vena cava (IVC), IVC balloon deflation, dobutamine infusion, hemorrhage, and reinfusion of blood. Cardiac output measured before and after each intervention was used to calculate the total change caused by the intervention, and the time intervals from intervention to 20%, 50%, and 80% of that change were noted. For all interventions, the time response of CCO was significantly slower than UFP. The largest differences were seen with the rapid infusion of lactated Ringer's solution for which the time interval for 20% change was 7.3 +/- 2.3 min (mean +/- SD) for CCO versus 0.5 +/- 0.3 min for UFP. The time interval for 80% change was 14.5 +/- 4.1 min for CCO versus 1.8 +/- 0.9 min with UFP. The current study demonstrates clinically important time delays in the response of the CCO catheter. This delay must be considered when rapid alterations of the hemodynamic state may occur.

Echocardiographic monitoring of minimally invasive mitral valve surgery using an endoaortic clamp.

BACKGROUND AND AIMS OF THE STUDY: Twenty-four patients underwent minimally invasive mitral valve repair (n = 16) or mitral valve replacement (n = 8) using the Port-Access system. Intraoperative transesophageal echocardiography (TEE) was used in these patients to: (i) reassess valve pathology preoperatively; (ii) guide and continuously assess placement and position of the aortic endoclamp; (iii) measure aortic root diameters, aortic distensibility and aortic wall appearance prior to and after aortic endoclamping; (iv) evaluate the de-airing procedure; (v) evaluate the results of mitral valve repair; and (vi) guide weaning from cardiopulmonary bypass (CPB). METHODS AND RESULTS: Placement and positioning of the endoclamp was guided effectively in all but one patient who had acute retrograde aortic dissection with the onset of femoro-femoral bypass. The mean position of the tip of the endoclamp was 2.8 +/- 0.5 cm from the aortic valve annulus. The position was stable in all but five patients in whom repositioning and additional clamp volume were required. There was only a poor relationship between balloon volume and sinotubular junction diameter. The dynamic movement of the aorta was well preserved after clamping and the elasticity module did not change significantly (1.6 +/- 0.71 vs. 1.5 +/- 0.75 dynes x 10(6)/cm2). No intimal tears or wall edema was observed after clamp release. De-airing was incomplete in five patients, two of whom had transient ST-elevations with regional wall motion abnormalities. Weaning of CPB was therefore postponed until the ECG had normalized. All mitral valve repairs but one were successful (equal to or less than grade I residual mitral insufficiency). One patient with persistent grade II mitral insufficiency underwent valve replacement using the same approach. CONCLUSIONS: TEE can effectively guide minimally invasive mitral valve surgery using the Port-Access system. Placement and positioning of the endoclamp and its effects on the aortic wall can be evaluated. De-airing, weaning from CPB and the results of the procedure were effectively monitored using TEE.

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.