Clinical Evaluation of the Lillehei-Kaster Pivoting-Disc Valve

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1 Clinical Evaluation of the Lillehei-Kaster Pivoting-Disc Valve Peter J. K. Starek, M.D., Lambert P. McLaurin, M.D., Benson R. Wilcox, M.D., and Gordon F. Murray, M.D. ABSTRACT A four-year clinical evaluation of 133 patients with Lillehei-Kaster pivoting-disc valves has shown that patients with an aortic valve prosthesis have remained free from valve-related problems. Patients with a mitral valve implanted have a satisfactory survival record as calculated by actuarial methods; however, a 10% incidence of valve thrombosis was experienced. Analysis suggests that this may be related to inadequate anticoagulation or use of an inappropriate suturing technique or both. The patients enjoyed significant clinical improvement following operation, with no evidence of hemolysis. A history suggestive of postoperative embolization waspresent in only 1 patient in this series. The purpose of this paper is to report a four-year clinical evaluation of patients who have undergone valve replacement with the Lillehei-Kaster pivoting-disc valve. The concept of a pivoting-disc heart valve was introduced by Kaster and Lillehei in 1967 [31. A clinical version of Kaster s valve first appeared on the market in June, 1970, and since that time has gained wide acceptance, having been utilized by more than 200 cardiac teams in the United States and 300 hospitals in foreign countries. The valve has been implanted in an estimated 25,000 patients to date.* Despite this extensive use, little information has been published on its clinical performance. From the Divisions of Cardiothoracic Surgery and Cardiology, University of North Carolina School of Medicine, Chapel Hill, NC. Presented at the Twelfth Annual Meeting of The Society of Thoracic Surgeons, Jan 26-28, 1976, Washington, DC. Address reprint requests to Dr. Starek, Division of Cardiothoracic Surgery, University of North Carolina School of Medicine, Box 7, Division of Health Affairs, Chapel Hill, NC Telephone conversation January, 1976, with Marshall Kriesel, President, Medical, Inc, 5200 W 78th St, Minneapolis, MN. Patient Selection and Methods An unselected series of 133 patients had the Lillehei-Kaster pivoting-disc valve implanted at the University of North Carolina beginning in October, Preoperatively all patients were in New York Heart Association Functional Class III or IV. Right and left heart catheterization was performed in all individuals. Operation was done utilizing cardiopulmonary bypass with the Bentleyt bubble oxygenator and a Sarnst pulsatile blood flow pump. Three full-time attending cardiothoracic surgeons were involved in the implantation of all valves in this series, either as primary surgeon or as first assistant. The technique of valve implantation and myocardial preservation varied somewhat among the three surgeons. All patients started receiving anticoagulation with Coumadins in the immediate postoperative period. With few exceptions, all patients were maintained on anticoagulants indefinitely. Postoperatively, patients were followed by periodic visits to the hospital outpatient department. Additional information was obtained by telephone or mail contact with patients and referring physicians. One hundred percent follow-up was thereby achieved in this group of patients. Results Five separate groups were identified within the series of 133 patients: Group 1: simple aortic valve replacement Group 2: simple mitral valve replacement tbentley Temptrol Q-100 Disposable Oxygenator, Bentley Laboratories, Inc, Armstrong Ave, Irvine, CA SSarns Model 2000 Pump-Oxygenator System, Sarns, Inc, 6200 Jackson Rd, Ann Arbor, MI Crystalline sodium warfarin, Endo Laboratories, Inc, 1000 Stewart Ave, Garden City, NJ

2 363 Starek et al: Lillehei-Kaster Pivoting-Disc Valve Group 3: multiple-valve replacement Group 4: aortic valve replacement plus other procedures Group 5: mitral valve replacement plus other procedures Additional procedures included coronary artery bypass, ventricular aneurysm resection, major valvuloplasty on another valve, or a combination of these, performed at the same time as the valve replacement. The results are summarized in the Table. Men predominated in the aortic valve replacement as well as the combined replacement groups, whereas women were more numerous when mitral valve replacement was the major procedure. Age varied widely in all groups; however, the average age in Groups 1 and 2 was in the forties. The youngest average age (34 years) was found in Group 3. The average age of Groups 4 and 5 was higher, being 57 and 52 years, respectively. Early Deaths The thirty-day operative mortality in Group 1 includes 1 patient who died of an arrhythmia, 1 who died on the operating table with stone heart, 4 who died of low cardiac output after having sustained intraoperative myocardial infarctions, and 1 who died of renal failure and hyperkalemia. Three of the 5 early deaths in Group 2 were attributable to technical errors. In 1 patient undergoing operation for a stenotic Kay-Shiley valve, a suture embolus to the left coronary artery resulted in a fatal myocardial infarction. Another patient, who required removal of a malfunctioning Starr-Edwards valve, sustained an injury to the circumflex coronary artery and a resultant myocardial infarction. The third patient died when a suture placed around a valve strut did not allow the disc to open fully. Another patient developed bacterial endocarditis that could not be medically controlled. The infected prosthesis was removed, but the patient remained febrile and died with sepsis and in renal failure. The fifth death in Group 2 was in a patient with a severely decompensated left ventricle and postoperative low-output syndrome resulting in hepatic decompensation, disseminated intravascular coagulation, shock, and death. In Group 3,4 of the 5 early deaths were related to low cardiac output associated with gross dilatation of the left ventricle secondary to advanced valvular disease. One patient died of resistant ventricular tachycardia and fibrillation in the early postoperative period. In Groups 4 and 5 the early deaths were all related to the severity of the cardiac disease-either marked left ventricular dysfunction or severe coronary disease manifesting itself in low cardiac output and its associated problems. Late Deaths The late mortality in Group 1 (simple aortic valve replacement) consisted of 2 patients; 1 died of renal carcinoma, and the other had a history of chronic arrhythmias that were poorly controlled medically and ultimately led to a fatal arrhythmia. In Group 2 (mitral valve replacement only) 5 of the 9 late deaths were attributable to ar- Results of Valve Replacement with the Lillehei-Kaster Pivoting-Disc Valve Postop Mortality NYHA Class No. of Sex Group Procedure Patients (MIF) Age (yr) Op Late Emboli Thrombosis I I1 111 IV 1 Simple AVR 45 27/ Simple MVR 48 15/ (42) Multiple valve 15 9/ m (mitral) AVR other (57) MVR + other 9 4/ Total / (Z) AVR = aortic valve replacement; MVR = mitral valve replacement.

3 364 The Annals of Thoracic Surgery Vol 22 No 4 October 1976 rhythmias. These individuals died suddenly after having otherwise done quite well. At postmortem examination no emboli or valve problems were found. One of the 9 patients died of a cerebral hemorrhage associated with improper anticoagulation therapy; 2 others died of thrombosed mitral valves. An intraabdominal catastrophe, very likely an embolus to the mesenteric artery, caused the death of 1 individual, the only patient in the series with a probable embolus. In Group 3 (multiple-valve replacement) 1 patient died of an arrhythmia; no abnormalities of the valve were demonstrated postmortem. Progressive congestive heart failure due to a grossly decompensated left ventricle without evidence of valve malfunction led to the other death in the group. There have been no late deaths in Group 4 (aortic valve replacement plus other procedures). In Group 5 (mitral valve replacement plus other procedures) 1 patient died of a thrombosed mitral valve. The other death was in a patient with subacute bacterial endocarditis and severe tricuspid regurgitation who required reoperation four months postoperatively. The patient did not survive the second procedure. In patients surviving operation, actuarial curves show a four-year survival of 95.7% for patients with simple aortic valve replacement, 86% for patients with mitral valve replacement, and 92% for patients with multiple-valve replacement [ll (Fig 1). Analyzing all patients who were late survivors with an aortic valve in place shows that 55 individuals were followed for 1,329 months, an av- Fig I. Actuarial curves comparing survival of patients with Lillehei-Kaster aortic valves, mitral valves, and multiple valves. E z w 0-4 Multiple Valves 0 I YEARS erage of 24 months per patient, with no incidence of embolization or thrombosis. Fifty-nine late survivors with a mitral valve in place were followed for 1,258 months, an average of 21 months per patient. In this group there has been 1 fatal embolus and 6 instances of mitral valve thrombosis. Of these 6 patients, 3 died without reoperation and 3 were saved by emergency operation. Hemolysis secondary to heart valve replacement was not evident in any of the groups, nor were there problems directly related to mechanical failure of valves. Eight of the 89 surviving patients are in Functional Class III. The remaining 81 patients are evenly distributed between Classes I and 11. Comment Many new prosthetic heart valve designs have been introduced on the market over a period of years. In making a decision to utilize a new heart valve, the surgeon needs information regarding the hemodynamic performance of the valve as well as its clinical performance in terms of freedom from valve-related complications such as embolism, thrombosis, and mechanical failure. As has been recently reported from this institution [4], the Lillehei-Kaster pivoting-disc valve possesses superior hemodynamic properties. Since long-term clinical performance does not necessarily coincide with excellent hemodynamic qualities, however, close scrutiny of the patients clinical course over a number of years is required. The four-year follow-up presented in this paper reveals that patients with a Lillehei-Kaster aortic valve are free from mechanical problems, embolization, hemolysis, and thrombosis. On the other hand, patients with a mitral valve prosthesis have a less satisfactory record. A 10% incidence of mitral valve thrombosis demands a closer look at the problem. Maintenance of careful anticoagulation is quite difficult for many patients from remote rural areas. It seems likely that inadequate anticoagulation was a contributing factor in at least 4 of the valve thromboses, and possibly in all 6. The anticoagulation status is unknown in 1 of the 6 patients with a thrombosed valve. Four of the patients had inadequate anticoagulation with

4 365 Starek et al: Lillehei-Kaster Pivoting-Disc Valve Coumadin, documented shortly before valve thrombosis, and 1 patient was known to have difficulty in following instructions regarding her Coumadin dosage. In 5 of the 6 patients, valve thrombosis progressed rapidly over a period of a few days to either reoperation or death. In retrospect, only 1 patient developed gradually increasing symptoms of thrombosis over a period of months. In 4 of the 5 patients with rapidly progressing thrombosis, the valves had been sewn in with horizontal mattress sutures reinforced by Teflon pledgets placed on the ventricular side of the annulus [2]. With this technique, malfunction of the Lillehei-Kaster valve may be induced by forcing the tissue annulus close to the struts and disc. To analyze this problem suturing techniques were studied in the laboratory. Figure 2A demonstrates the proximity of the annulus and valve struts when pledgets are placed on the ventricular side of the annulus. Conversely, this tissue crowding is less apt to occur when pledgets are placed on the atrial side of the annulus (Fig 2B). Five of the 6 mitral valve thromboses occurred within the first few months after implantation. In 1 patient the valve was found to be stenotic after a year s time. At reoperation tissue ingrowth was seen on the ventricular side without the frank thrombosis found in the other 5 valves. Personal communication in January, 1976, with several other surgeons* utilizing this valve did not reveal the high incidence of mitral valve thrombosis found in our group of patients. Our overall experience with Lillehei-Kaster valves is good. All patients who were in Functional Class I11 or IV preoperatively improved one or two classes following their operation, reflecting the favorable hemodynamic performance of these valves. This four-year follow-up of 133 patients with Lillehei-Kaster pivoting-disc valves shows that the prosthesis performed extremely well in the aortic position. There, the valve has been virtually problem free, and we consider it the prosthesis of choice in the aortic position. In the mitral position, the 10% incidence of valve thrombosis may be the result Robert G. Carlson, M.D., Green Bay, WI; Frederick B. Parker, Jr., M.D., Syracuse, NY; Richard Cardoza, M.D., Hanover, NH; and Richard A. DeWall, Kettering, OH. A Fig2. Comparison of suturing techniques, uentricularuiew. (A) Annulus and value struts are in proximity when pledgets are placed on the ventricular side of the annulus. (B) Pledgets plcced on the atrial side of the annulus. of inadequate anticoagulation or use of an inappropriate suturing technique or both. The late survival, as calculated by actuarial methods, is quite acceptable. References American Joint Committee for Cancer Staging and End Results Reporting: Reporting of Cancer Survival and End Results. Chicago, IL, July 1963, pp 8-12 Isom OW, Williams CO, Folk EA, et al: Long-term evaluation of cloth-covered metallic ball prostheses. J Thorac Cardiovasc Surg 64:356, 1972 Kaster RL, Lillehei CW: A new cageless freefloating pivoting disc prosthetic heart valve: design, development and evaluation, Digest of the 7th International Conference of Medical and Biological Engineering, Stockholm, Sweden, August 1967, p 387 Starek PJK, Wilcox BR, Murray GF: Hemodynamic evaluation of the Lillehei-Kaster pivoting disc valve in patients. J Thorac Cardiovasc Surg 71:123, 1976 Discussion DR. JOHN c. COLES (London, Ont, Canada): I enjoyed Dr. Starek s paper very much. It is highly commendable and very important that major complications be reported. Our own experience with this valve in the mitral position has been dissimilar; perhaps this is related to time. At the University of Western Ontario Victoria Hospital, we have had experience with 175 Lillehei-Kaster valves in 159 patients ranging in age from 20 to 83 years. Our early practice was to use the valve only in high-risk patients, for those over 70 years of age, for infectious endocarditis, for emergency valve re- B

5 366 The Annals of Thoracic Surgery Vol 22 No 4 October 1976 placement, and to replace ball valves. The initial results were so rewarding that we now use this valve routinely. The durability of the Lillehei-Kaster valve, the immediate postoperative cardiac output, and the red blood cell and platelet survival have impressed us. At comparable valve sizes, the gradients are significantly less than for ball valves. Hemolysis is not a problem in the absence of perivalvular leak. It is very important to remove sufficient subvalvular tissue when using this valve in the mitral position, and also to avoid too large a prosthesis. We have had occasion to reoperate on 2 patients who had a Lillehei-Kaster valve in the mitral position. In 1 the disc was impeded from full opening by subvalvular tissue, and we resected the prosthesis and replaced it with a Lillehei-Kaster valve of the same size. The second patient had a No. 28 valve, which was too large. The disc was not opening completely, and it was replaced with a No. 25 prosthesis. I would like to ask Dr. Starek if he thinks this may be one of the reasons for the high incidence of thrombus in the mitral prostheses in his series. DR. DEMETRE M. NICOLOFF (Minneapolis, MN): We have used the Lillehei-Kaster valve since January, 1972, and have placed 364 valves since that time, 269 of them done by myself or my colleague, Dr. William Lindsay. Our operative mortality for aortic valve replacement is 7.7% with a late mortality of 5.8% over the four-year period. For mitralvalve replacement it is 5.6 and 2.8% respectively. Late deaths were not caused by thrombosis of the valve. In all cases, the cause of death was not related to the prosthesis. Twenty-three patients had double-valve replacement (aortic and mitral). The operative mortality was 13% with a late mortality of 13% over the four-year period. Again, we had no prosthesis-related late mortality. As far as late morbidity with aortic valve replacement, we had 1 instance of embolism, which was transient; it occurred three weeks postoperatively and the symptomslasted about two hours. There has been no malfunction of the valve in the aortic position. We have had 3 perivalvular leaks, none requiring reoperation. With mitral replacement we have had 4 embolic episodes, a4vo incidence. Two of these were transient neurological findings, while the other 2 resulted in very firm hemiparesis. There were 3 perivalvular leaks and 3 prosthesis malfunctions. The latter might be a misnomer-it was not the prosthesis that malfunctioned; I think it was the surgeon, who put too large a prosthesis into the mitral annulus. Two of these patients have been reoperated upon, and it was obvious that the prosthesis had been placed into an annulus that was small for the size of the valve and that the ventricular muscle and endocardium had prevented the disc from functioning properly. Postoperative catheterization was done in 43 patients with a Lillehei-Kaster prosthesis in the aortic position at six months to one year following operation. The data show that 10 patients with No. 14 valves have a mean peak systolic gradient of 46 mm Hg (range, 28 to 70) with a functional valve area of 0.8 cm2. All patients who had had the No. 14 valve inserted were women with severe calcific stenosis. There was no operative mortality in this group, and all are now in Class 1 functional status. With valve sizes 16 to 25 the mean peak systolic gradients were 25 to 6 mm Hg, respectively. Functional valve areas for these prostheses were 1.1 to 2.1 cm2. DR. FREDERICK B. PARKER, JR. (Syracuse, NY): We have utilized this valve since 1973 in 144 patients, 72 of whom had mitral valve replacement; 63, aortic valve replacement; and 9, double-valve replacement. Total follow-up has been 1,677 patient-months. Six patients have had peripheral emboli, for an incidence of 4.1 YO. Four were from the mitral position and 2 from the aortic. Four patients had had anticoagulation and 2 had not. None have had residual defects. Unless there is some contraindication, we routinely give anticoagulants to all patients having valve replacement. We have seen 6 late deaths. Two of these were from continued congestive heart failure following valve replacement, 2 from arrhythmias, 1 from valve dysfunction, and 1 was unrelated to the valve replacement. Postmortem examinations were obtained in 4 of the 6 patients. In 1 of the 2 who died from arrhythmia there was clot in the atrium but not on the valve itself. The patient who died of valve dysfunction had clot within the valve that had obstructed valve function. Both of these patients had received anticoagulants. They represent the only disquieting episodes that we have had with this valve. I agree with Dr. Starek that his high incidence of thrombosis probably represents a technical error from placing pledgets on the ventricle side. In about twothirds of our mitral valve replacements we have utilized pledgets, but they have been placed on the atrial side. To date we are very pleased with this valve, particularly in the aortic position. We are still using it in the mitral position but have some reservations about it. Close follow-up is imperative if this prosthesis is to be fully evaluated. DR. RICHARD A. DE WALL (Dayton, Ohio): I have used the Lillehei-Kaster valve in all positions since August of 1971 in 126 patients. This includes 72 patients who received mitral prostheses for whom the observation period is now 122 patient-years. My only bad experiences were due to placing too large a prosthesis in the mitral annulus. This occurred in 3 patients, in whom the prosthesis slowly thrombosed over the course of a few months. All were successfully reoperated upon

6 367 Starek et al: Lillehei-Kaster Pivoting-Disc Valve with replacement by a smaller prosthesis. The prosthesis should be sized to fit easily within the annulus, but not on top of it. Only 1 of these patients had a transient neurological episode, with full recovery. We gave anticoagulants to all mitral valve recipients with the exception of an 8-year-old boy who has been maintained for two years on aspirin therapy alone with no problems. The Lillehei-Kaster prosthesis has also served my patients well in the aortic position. This experience constitutes 54 patients, representing 83 patient-years of use. No complications have been encountered. About two-thirds of these patients have received anticoagulant therapy and one-third have not. We have seen no perivalvular leaks or hemolytic problems. DR. ARTHUR c. BEALL (Houston, TX): I think it is particularly important to reemphasize the necessity of presenting our difficulties with prosthetic valves. However, I also think this needs to be put into context with the patient's disease. We have a benefivrisk ratio to consider, and this is particularly important to keep in mind as we meet in Washington in this day of consumer protection and imminent medical device legislation. Despite occasional prosthetic valve complications, most of the patients are improved considerably. However, these complications again demonstrate the necessity for very careful and permanent follow-up. If there is a change in symptoms or in heart sounds, the patient should be restudied, and with many thrombosed valves or other types of problems the patient can be reoperated on successfully. As an example, among more than 18,000 of the Teflon version of our valves, 29 instances of disc variance have been reported. A large number of these patients have been reoperated on successfully. Many of the deaths could have been avoided if someone had thought to restudy the patients. I reported to you in the past the problem of broken struts with our mitral prosthesis in the original Model 105 configuration with Pyrolite. With the change to the Model 106, which has now been in use for more than two years, there is yet to be a broken strut. I think the problem has been corrected. This paper from Chapel Hill was interesting in regard to the thrombosed valves presented, because one of the supposed advantages of the tilting-disc valve is lower gradients. You cannot completely cover a tilting-disc valve with cloth because the disc descends into the orifice. We accepted that the central-occluder valves probably would have higher gradients, but we could cover their orifices with fabric and therefore decrease the incidence of thromboembolism. However, in the January, 1976, issue of The Journal of Thoracic and Cardiovascular Surgery, the group from Chapel Hill has reported gradients across the Lillehei-Kaster prosthesis that are similar to those seen with central-occluder valves. DR. JOHN c. CALLAGHAN (Edmonton, Aha, Canada): I would like to present our experience and to support Dr. Starek's conceptual thoughts at the end of his paper. Dr. Fisk, before he emigrated from Canada down to the warmer climate of Phoenix, reviewed our studies of the patients in whom we had used the Lillehei- Kaster valve. We too were sensitive to the fact that although a great number of these valves were being put in, there seemed to be very few clinical reports. In this study, during the period March, 1973, to March, 1975, we inserted 150 consecutive Lillehei- Kaster valves. Fifty of these fitted into Dr. Starek's mitral prosthesis group. And suffice it to say, our patients were similar to his with 1 exception: a patient who had no kidneys to start with and none afterward and who died on dialysis about seven months later. There was an average follow-up of one year. We used the same type of suture technique that Dr. Starek described, placing pledgets on the upper (or atrial) side of the annulus. During this study, the finding we were most impressed with was that when we reviewed this series by personal contact with our patients, we did not find a single instance of embolization. We had no surgical deaths, and of the 3 patients who died late, 1 was an Eskimo from the far Arctic who had had no anticoagulation. When he came in we thought there would be thrombus in the valve, but we could find no evidence of it. And there was 1 other patient, with multivalvular disease, who was not treated adequately. We at the University Hospital, Edmonton, are impressed that this appears to be an extremely safe valve. I have had experience with aliquots of almost every other valve developed over the last few years, and I have been impressed that this one causes fewer problems, produces no embolization, and is the most trouble-free valve that I have had the pleasure of putting in. OR. c. WALTON LILLEHEI (St Paul, MN): The pivoting-disc prosthesis has been implanted in more than 25,000 patients during the past five and one-half years. This large experience makes possible some significant observations concerning its comparative freedom from the usual valve-related complications. First is its functional durability. To date, there has not been a single instance of early or late mechanical failure of the valve. This notable record is unique in the history of prosthetic valve replacement. And as you have heard here today from others, the hemodynamic performance has been excellent, the incidence of embolism has been very low, and there has been a uniform absence of hemolysis. However, one caveat is in order. It is possible to misuse this valve in the mitral area by selecting a prosthesis that is too large for the size of the left ventricle. It is not the size of the annulus or of the left

7 368 The Annals of Thoracic Surgery Vol 22 No 4 October 1976 atrium that is important in sizing the mitral prosthesis. Fortunately, there is a considerable margin of safety, but if the prosthesis is grossly oversized in relation to the left ventricle, then it is possible for one of the struts to become imbedded, to a variable degree, in the adjacent mural myocardium and to provoke scar tissue growth that may gradually impede disc motion over a period of some weeks to months. This problem occurred twice early in our series, and at reoperation the cause of the late onset of restenosis was manifest. Since those observations, restraint has been exercised in choice of the size of the mitral prosthesis, correlating it with the size of the left ventricle. No such caution is necessary in the aortic area, where the largest possible prosthesis to fit into the subcoronary area is recommended. Dr. Starek kindly provided me with a copy of his paper, and I have compared the sizes of mitral prostheses used by his group with those used by my associates and me. His group used a preponderance of the larger sizes, with 56% of all patients receiving the largest size (25 mm) compared with only 13% in our series. Likewise, they utilized the three smaller sizes in only 17% of their patients, whereas we have used those same sizes in 57.5%. Due to the considerable safety margin, even this use of substantially larger sizes would not likely have created the frequent late flow problems had it not been for the unusual prosthesis suturing technique described. This method, which narrowed the upper portion of the left ventricle, was utilized in approximately one-third of the Chapel Hill patients. It is significant, as Dr. Starek has emphasized, that 4 of the 6 patients with valve thrombosis came from the minority whose valves were sutured by this method. It is noteworthy that despite this problem, embolism remained low. The final point I wish to make in this regard is the fact that the excellent hemodynamics of this prosthesis make it unnecessary to strive to insert the very largest prosthesis possible into the mitral area. From the postoperative recatheterization data presented here by Dr. Nicoloff, and earlier by Dr. Starek (J Thorac Cardiovasc Surg 71:123,1976), it may be noted that the low diastolic gradients and large functional cross-sectional areas of the pivoting-disc prostheses in the mitral position do not significantly change when the largest (25 mm) and the medium prostheses (22 or 20 mm) are compared. It is difficult to be specific in a clinical matter such as this, but generally, in a woman of small or average stature with a normal-sized left ventricle, we would tend to use a size 18 to 20 prosthesis. In a man of average stature with a normal-sized left ventricle, as seen in mitral stenosis, I would tend to use the 20 to 22 mm sizes, reserving the 25 mm valve only for patients with an enlarged left ventricle. Thus, with these relatively minor safeguards, I believe that patient experience with this prosthesis will continue to be a very happy one, as confirmed by the impressive number of favorable reports from others here today. DR. STAREK: I thank the discussants for their comments. All mentioned the problems created by insertion of a valve too large for a particular tissue annulus. I doubt that improper choice of prosthesis size was a cause of our problems, since the thrombosed valves did not appear early in our series. Five of the valve thromboses occurred in the third year of our experience. Three of the 6 surgeons implanting valves were senior residents. The attending surgeons acted as first assistants for every operation that they did not personally do, so the residents were carefully supervised. The only thing we could temporally correlate with the valve thromboses was the introduction of a new suturing technique. I feel certain that this was the major cause of the valve thrombosis in our series. We have recently reported our hemodynamic evaluation of the Lillehei-Kaster prosthesis and consider it, from that viewpoint, a very superior valve.

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