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How to cite: Geiger, A. W., & Scheld, H. M. (1994). Quality control of replacement heart valves. The Journal of heart valve disease, 3(4), 460.

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How to cite: Antunes M. J. (1994). Open mitral commissurotomy or percutaneous mitral commissurotomy?. The Journal of heart valve disease, 3(4), 458–459.

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How to cite: Koyanagi H. (1994). Hemodynamic effects and echocardiographic consequences of tension-free pericardial closure after heart valve surgery. The Journal of heart valve disease, 3(4), 457.

During dissections of porcine aortic valves, we noted clusters of spherical droplets, roughly 50 micrometers in size, within the central spongiosa of the valve cusps. Oil red-O staining of fresh tissues confirmed that the clusters were lipids, and thin layer chromatography showed that they consisted mainly of free cholesterol and triglycerides, with some cholesterol ester. The distribution of these clusters in 60 cusps from 20 porcine aortic valves was mapped using computerized morphometry. The ventricularis was peeled back to expose the spongiosa, and the spatial distribution of the lipid droplets was analyzed using a stereological point counting method. Computer averaging of lipid density images was done to obtain a mean distribution map of lipid occurrence. This distribution map suggests that porcine aortic valve lipids are found predominantly at the base of the valve cusps, and are conspicuously absent from the coaptation regions and the free edge. Moreover, 19/20 valves had lipids in the left coronary cusp and all 20 valves had lipids in at least two of the three cusps. Endogenous lipids are therefore ubiquitous in porcine aortic valves and may play a role in the calcification of xenograft bioprostheses.

How to cite: Vesely, I., Macris, N., Dunmore, P. J., & Boughner, D. (1994). The distribution and morphology of aortic valve cusp lipids. The Journal of heart valve disease, 3(4), 451–456.

A new bovine pericardial bioprosthesis (AMB bioprosthesis) with a bileaflet geometry was designed and developed, with the aim of achieving uniform stress distribution within the prosthesis. The ultimate goal was to limit tissue degeneration to a minimum by attaining optimum fluid dynamics, thereby obtaining an extended clinical durability. The two-leaflet, dome-shaped geometry with a central hinge allowed a very low profile, low ventricular projection in the mitral position, large effective orifice area and low gradients. The design of the thin Delrin stent and the centrally crossing bridge was developed using finite element analysis. Pre-clinical laboratory investigations showed very low trans-valvular gradients and no mechanical or tissue failure after 400 million cycle accelerated wear test. The final model of the prosthesis was manufactured by Baxter-Edwards CVS Division and tested in sheep with good results for up to five months. A limited clinical trial was started in January 1990 and stopped one year later encompassing 12 aortic and six mitral implants. The patients were followed clinically and by echocardiography three, six and 12 months, and four years after surgery. Mean gradients were 4 mmHg in the mitral and 10 mmHg in the aortic position with only minimum regurgitation and no tissue failure. We conclude that early and mid term results with this new pericardial bioprosthesis appear to be favorable and intend to closely monitor further outcome within the limited patient population.

How to cite: Arpesella, G., Mikus, P. M., Cirillo, M., Bombardini, T., Pierangeli, A., Fiume, C., Vivirito, M., Piccinino, C., De Gasperis, C., & Morea, M. (1994). New bileaflet bioprosthesis: early and mid term results. The Journal of heart valve disease, 3(4), 445–450.

Due to significant improvements in myocardial protection, old techniques are being re-explored today in search for the ideal solution for aortic valve disease. We reviewed all patients who underwent non-prosthetic aortic valve surgery between July 1988 and March 1994. There were 361 such patients with a mean age of 22.18 years, mean preoperative functional class of 2.65 and sinus rhythm in 89.75%. The etiology was rheumatic in 65.65% and congenital in 26.37%. Simultaneous mitral surgery was performed in 44% of the cases with repair in 76.73%. A homograft was used in 11 patients with one hospital death, no late deaths and no reoperations. A pulmonary autograft was used in 58 with no hospital deaths, one (1.72%) late death (car accident) and three (5.17%) reoperations due to progressive regurgitation in two. Reconstruction with pericardium was performed in 76 patients with no hospital deaths, three (3.95%) late deaths (one car accident) and four (5.26%) reoperations due to endocarditis in two and valve failure in two. Repair was done in 216 patients with eight (3.7%) hospital and nine (4.32%) late deaths, and 25 (12%) reoperations. Excluding those patients with mitral surgery, there were no thromboembolic events with only two patients (1.02%) anticoagulated. The total actuarial survival was 91.76 +/- 2.40% at 66 months. It is concluded that non-prosthetic aortic valve surgery offers a very attractive alternative for our patient population.

How to cite: Duran, C. M., Gometza, B., & al-Halees, Z. (1994). Non-prosthetic aortic valve surgery. The Journal of heart valve disease, 3(4), 439–444.

Between January 1978 and September 1992, 127 patients with isolated mitral regurgitation due to prolapse underwent mitral valve reconstruction. There were 74 men and 53 women whose mean age was 49.7 years, ranging from 16 to 74 years. Follow up was 99.2% complete and totaled 483.0 patient-years (mean: 3.8 years). One hundred and forty-eight procedures were carried out to repair the prolapses using four types of techniques: (1) leaflet plication in 97 patients; (2) artificial chordal replacement with polytetrafluoroethylene sutures in 30 patients; (3) chordal shortening in 16 patients; and (4) commissural imbrication in five patients. In order to repair the annular dilation, commissural plications were done in 75 and ring prostheses were implanted in 15 patients. There were one hospital and eight late deaths. One (cerebral infarction) of all deaths was related to the reconstructed mitral valve. There were 14 reoperations (11.0%) for recurrent mitral incompetence with a freedom from reoperation of 89.0% at five, and 81.1% at 10 years. There were four cases of thromboembolism (one fatal, three non-fatal) with freedom from thromboembolism of 96.7% at five, and 93.3% at 10 years. No endocarditis or hemorrhagic complications were noted. Linearized incidence of recurrent mitral regurgitation according to repair technique for the prolapse was 1.44%/pty in the leaflet plication series, 1.45%/pty with chordal replacement, 4.37%/pty after chordal shortening and 8.67%/pty following commissural imbrication. The linearized rate of failure in annuloplasty was 2.91%/pty after commissural plication and 1.74%/pty after ring annuloplasty. Statistically significant difference was confirmed only between leaflet plication and chordal shortening.(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Eishi, K., Kawazoe, K., Sasako, Y., Kosakai, Y., Kitoh, Y., & Kawashima, Y. (1994). Comparison of repair techniques for mitral valve prolapse. The Journal of heart valve disease, 3(4), 432–438.

The aim of the study was Doppler echocardiographic assessment of the effect of mitral stenosis (MS) on pulmonary venous flow (PVF), and of any changes occurring after mitral valve replacement. Fifty patients with MS (22 in atrial fibrillation (AF)) and 28 healthy subjects (control group) underwent transthoracic echocardiographic evaluation of PVF. Fourteen of the 22 patients in AF were submitted in addition to transesophageal echo study before and after mitral valve replacement. Pulmonary wedge pressure was measured in 18 patients. Patients in sinus rhythm (SR) and more than mild MS showed significantly decreased peak velocity and flow velocity time integral of the systolic forward PVF. This finding was more exaggerated in MS with AF. Concerning diastolic forward PVF, patients in SR showed significantly decreased peak velocity and velocity time integral, irrelevant of the degree of MS, while patients with AF exhibited adequate signs of flow. In all patients duration, deceleration time (D-DT) and pressure half-time (D-PHT) of the diastolic forward PVF were significantly increased. The last two parameters correlated with the corresponding variables of mitral flow and with echocardiographically determined mitral valve area and the D-DT of the pulmonary wedge pressure. Concerning reversed PVF, patients with more than mild MS exhibited significantly increased peak velocity and velocity time integral. After mitral valve replacement, a significant increase of diastolic forward peak velocity and velocity time of the PVF were detected. The duration of diastolic forward peak velocity of PVF, D-DT and D-PHT decreased. The systolic forward phase did not change significntly after the valve replacement.(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Kranidis, A. I., Kostopoulos, K. G., Filippatos, G. B., Kardaras, F. G., Kappos, K. G., Koulouris, S. N., Fehske, W., Lolas, C. T., & Anthopoulos, L. P. (1994). Doppler echocardiographic study of pulmonary venous flow in mitral stenosis and early after mitral valve replacement. The Journal of heart valve disease, 3(4), 425–431.

Chronic aortic regurgitation leads to progressive left ventricular dilatation and hypertrophy. It is important to be able to measure these variables for clinical decision making on the timing of aortic valve replacement. M-mode and two-dimensional echocardiography are widely utilized in clinical practice for a qualitative assessment of left ventricular size and function. Recent recommendations have been proposed for the use of quantitative assessment by left ventricular size and left ventricular mass by two-dimensional echocardiography; there has been no study examining the validity of these measurements in patients with aortic regurgitation. The purpose of this study was to prospectively examine the various geometric models of echocardiographically determined left ventricular mass and volumes in patients with chronic aortic regurgitation compared with cine-computed tomographic scanning. Twenty-two patients with chronic aortic regurgitation were prospectively identified and underwent two-dimensional echocardiographic and cine-computed tomographic scanning. M-mode and two-dimensional echocardiographic images were analyzed on an off-line measurement digital system. Seven previously described geometric models were used in this study for quantitative analysis. Both left ventricular mass and left ventricular volume were calculated from real-time ultrafast tomographic scans. Left ventricular mass determinations by two-dimensional echocardiography correlated more than M-mode determinations (r = 0.84 vs. r = 0.75, standard error of the estimate (SEE) = 38 g vs. 139 g). Biplane two-dimensional echocardiography formulas using Simpson's rule construct yielded more accurate values for left ventricular end-diastolic volumes (r = 0.92, SEE = 24 ml) than either the single-plane Simpson's rule (r = 0.58, SEE = 73 mL) or methods using predetermined models of left ventricular shape (r = 0.80, SEE = 38 ml).(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Rihal, C. S., Nishimura, R. A., Rumberger, J. A., & Tajik, A. J. (1994). Quantitative echocardiography: a comparison with ultrafast computed tomography in patients with chronic aortic regurgitation. The Journal of heart valve disease, 3(4), 417–424.

From April 1979 to October 1993, 126 adult patients underwent reoperative cardiac valve surgery. Patients were divided into two groups: 53 patients who underwent surgery before January 1990 (group 1) and 73 patients who underwent surgery after January 1990 (group 2). After January 1990, a clinical strategy for reducing homologous blood transfusions was implemented, including the use of predonation of autologous blood in the operating room, reduced heparin doses, an elevated threshold of indication for blood transfusion, and autotransfusion of shed, drained blood after surgery. In group 1, 44 patients (93.0%) received an average of 3785 +/- 1251 ml of homologous blood transfusions. In group 2, only 26 patients (35.6%) needed homologous blood transfusions and had a smaller amount (2985 +/- 1521 ml) on average. Furthermore, only seven patients needed fresh blood transfusion in group 2.

How to cite: Okita, Y., Miki, S., Ueda, Y., Tabata, T., Sakai, T., & Matsuyama, K. (1994). Reduction of homologous blood transfusion in reoperative valve surgery. The Journal of heart valve disease, 3(4), 411–416.

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How to cite: Taylor K. M. (1994). Blood conservation in cardiac surgery. The Journal of heart valve disease, 3(4), 410.

We have studied warm heart surgery, deemed as continuous warm blood cardioplegia and normothermic cardiopulmonary bypass (CPB), as an alternative to the technique of intermittent cold cardioplegia for valvular surgery. Between August 1990 and January 1994, 137 consecutive patients underwent valve repair or replacement using normothermic CPB. Eighty-six of these patients received continuous normothermic retrograde blood cardioplegia via the coronary sinus (CNRC). Fifty-one patients received intermittent cold blood cardioplegia (ICBC). All procedures were performed by the same surgeon (RWMF). The two groups were matched for age, sex, NYHA class, preoperative ejection fraction, diagnosis, procedure and activated clotting time. Warm blood cardioplegia was delivered continuously via the coronary sinus after antegrade arrest (oxygenated blood 1:4 to 1:3, 37 degrees C, 250-300 ml/min, maintaining coronary sinus pressures of 40-60 mmHg. Perioperative myocardial infarction was significantly less prevalent (4.6 vs. 8.0%; p < 0.05) in the warm cardioplegia group. Cardiac output immediately after bypass was significantly higher than before bypass only in the CNRC group (4.1 +/- 0.8 to 5.2 +/- 0.9 L/min; p < 0.01). CNRC patients had significantly higher incidence of spontaneous resumption of sinus rhythm at cross-clamp removal (80 of 86, 93%) compared to the hypothermic patients (14 of 51, 27%, p < 0.001). The time from removal of the aortic cross-clamp to discontinuation of CPB (reperfusion time) was significantly shorter in the warm cardioplegia group (43 +/- 7.4 versus 75 +/- 10.2 min; p < 0.001.(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Martella, A. T., Hoffman, D. M., Nakao, T., & Frater, R. W. (1994). Continuous normothermic retrograde cardioplegia for valve surgery. The Journal of heart valve disease, 3(4), 404–409.

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How to cite: Beyersdorf, F., & Buckberg, G. D. (1994). Myocardial protection with blood cardioplegia during valve operations. The Journal of heart valve disease, 3(4), 388–403.

The use of pulmonary autograft for aortic valve replacement (Ross procedure) offers an excellent option for the younger patient with its potential for growth and long term viability. We report our experiences of 61 patients with a mean age of 17.0 years undergoing Ross procedure over a four year period. Rheumatic disease was the cause of aortic valve disease in 48 (79.0%) patients. Mitral valve surgery was required in 18 (29.5%) patients. There was no hospital death, endocarditis or thromboembolism in the series. There was one late death from non-cardiac cause and three (4.9%) reoperations. Two of the reoperations were for progressive autograft regurgitation whilst the third was for mitral valve repair failure. Echocardiographic profiles of 37 of these patients followed beyond six months after surgery show a tendency towards progression of the autograft regurgitation. The long term effects of rheumatic disease on the transplanted valves remain to be evaluated.

How to cite: Kumar, N., Gallo, R., Gometza, B., al-Halees, Z., & Duran, C. M. (1994). Pulmonary autograft for aortic valve replacement in rheumatic disease--an ideal solution?. The Journal of heart valve disease, 3(4), 384–387.

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How to cite: Yankah A. C. (1994). Surgical management of infective endocarditis: pulmonary autograft or allograft?. The Journal of heart valve disease, 3(4), 380–383.

Follow up data is presented on the management of aortic infective endocarditis by root replacement using the pulmonary autograft. Twenty consecutive patients have been managed with this surgical procedure. Included are specific case discussions high-lighting advantages to the procedure as well as technical features consistent with surgery on an infected space. There continues to be no mortality and no recurrent infections.

How to cite: Oswalt J. (1994). Management of aortic infective endocarditis by autograft valve replacement. The Journal of heart valve disease, 3(4), 377–379.

Bacterial endocarditis of the native or prosthetic aortic valve is associated with significant morbidity and mortality despite aggressive medical and surgical treatment, especially when invasion of perivalvular tissue occurs. The currently recommended treatment for these advanced infections, in addition to thorough debridement, is aortic valve or root replacement with a homograft, although it appears that equally good results can be achieved with prosthetic valved conduits. Enthusiasm for the use of the pulmonary autograft as described by Ross for the treatment of non-infective aortic valve disease is increasing, but use of the pulmonary autograft in the treatment of aortic valve endocarditis is uncommon. This paper describes successful use of the Ross operation as total root replacement in six young patients between 10 and 32 years of age with aortic valve endocarditis. Three of the patients had active endocarditis and five patients had advanced disease, i.e. endocarditis with perivalvular tissue invasion and destruction. Follow up extending to 18 months continues to show excellent results with no mortality and no re-infection. We conclude that the Ross operation as total root replacement may be the best procedure for young patients with aortic valve endocarditis. The pulmonary autograft appears to be technically particularly well-suited, has growth potential, excellent hemodynamics, and a low risk of re-infection, thrombosis, and embolic complications without anticoagulation. Based on the long term results of the Ross operation in non-infected patients, excellent long term results are expected in this group as well.

How to cite: Joyce, F., Tingleff, J., Aagaard, J., & Pettersson, G. (1994). The Ross operation in the treatment of native and prosthetic aortic valve endocarditis. The Journal of heart valve disease, 3(4), 371–376.

Bacterial endocarditis of the native or prosthetic aortic valve is associated with significant morbidity and mortality despite aggressive medical and surgical treatment, especially when invasion of perivalvular tissue occurs. The currently recommended treatment for these advanced infections, in addition to thorough debridement, is aortic valve or root replacement with a homograft, although it appears that equally good results can be achieved with prosthetic valved conduits. Enthusiasm for the use of the pulmonary autograft as described by Ross for the treatment of non-infective aortic valve disease is increasing, but use of the pulmonary autograft in the treatment of aortic valve endocarditis is uncommon. This paper describes successful use of the Ross operation as total root replacement in six young patients between 10 and 32 years of age with aortic valve endocarditis. Three of the patients had active endocarditis and five patients had advanced disease, i.e. endocarditis with perivalvular tissue invasion and destruction. Follow up extending to 18 months continues to show excellent results with no mortality and no re-infection. We conclude that the Ross operation as total root replacement may be the best procedure for young patients with aortic valve endocarditis. The pulmonary autograft appears to be technically particularly well-suited, has growth potential, excellent hemodynamics, and a low risk of re-infection, thrombosis, and embolic complications without anticoagulation. Based on the long term results of the Ross operation in non-infected patients, excellent long term results are expected in this group as well.

How to cite: Joyce, F., Tingleff, J., Aagaard, J., & Pettersson, G. (1994). The Ross operation in the treatment of native and prosthetic aortic valve endocarditis. The Journal of heart valve disease, 3(4), 371–376.

Fifty-four consecutive patients underwent aortic valve replacement with a pulmonary autograft (Ross operation) over an 18-month period. It was inserted as an intra-aortic cylinder in 13 patients and as a total aortic root replacement in 41; unwrapped in 16, partially wrapped with autologous pericardium in 12 and completely wrapped with bovine pericardium in 13. There were two cardiac deaths, one death from mediastinitis, and two early reoperations to replace an incompetent autograft. Comparison of postoperative echocardiographic data showed a higher incidence of moderate and severe autograft incompetence in the intra-aortic cylinder group and also in the subset without previous operation which had a total root replacement without a complete wrap. Autograft function was best in the group which received a total root replacement with a complete wrap and in those with previous cardiac surgery who received an unwrapped autograft. This preliminary information with short follow up supports the use of complete wrapping of the autograft when it is used as a total root replacement particularly in older patients without previous cardiac surgery in whom future autograft growth is not desirable.

How to cite: Pacifico, A. D., Kirklin, J. K., McGiffin, D. C., Matter, G. J., Nanda, N. C., & Diethelm, A. G. (1994). The Ross operation--early echocardiographic comparison of different operative techniques. The Journal of heart valve disease, 3(4), 365–370.

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How to cite: Oury, J. H., Eddy, A. C., & Cleveland, J. C. (1994). The Ross procedure: a progress report. The Journal of heart valve disease, 3(4), 361–364.

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How to cite: Ross D. N. (1994). Aortic root replacement with a pulmonary autograft--current trends. The Journal of heart valve disease, 3(4), 358–360.

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How to cite: Elkins R. C. (1994). Pulmonary autograft: expanding indications and increasing utilizations. The Journal of heart valve disease, 3(4), 356–357.

The Food and Drug Administration (FDA) has recently revised its "Replacement Heart Valve Guidance". That document lists the data FDA deems necessary to support the approval of new prosthetic heart valves of all designs, and which should be contained in Premarket Approval Applications for these devices. The guidance covers detailed data requirements for in vitro, animal, and clinical data. This paper is intended to briefly summarize FDA's requirements for in vivo and clinical data. The clinical study must establish that the device is both safe and effective, as compared to currently marketed replacement heart valves. It is possible to achieve this goal using hypothesis testing to compare the results of an observational study against a set of Objective Performance Criteria (OPC) which have been established by the FDA. The establishment of the OPCs was facilitated by a standardized set of definitions of complications published by the American Association of Thoracic Surgery and Society of Thoracic Surgeons (AATS/STS) in 1987/1988. Papers published in peer reviewed journals have utilized this set of definitions for data analysis, providing an ample pool of data from which to establish OPCs. The number of patients required to establish the safety and efficacy of a replacement heart valve, using this approach, is 800 valve years, 400 in the aortic and 400 in the mitral position. Advantages of this approach are reduction in the number of patients and duration of the study.

how to cite: Johnson, D. M., & Sapirstein, W. (1994). FDA's requirements for in-vivo performance data for prosthetic heart valves. The Journal of heart valve disease, 3(4), 350–355.

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How to cite: Nolan S. P. (1994). The International Standard Cardiovascular implants--Cardiac Valve Prostheses (ISO 5840:1989) and the FDA Draft Replacement Heart Valve Guidance (Version 4.0). The Journal of heart valve disease, 3(4), 347–349.