Although myxomas are the most common cardiac neoplasms in the adult population, they are very rare in pediatric patients. Tricuspid valve myxomas are even more exceptional at all ages, with only 16 cases being reported in the literature. We describe the case of a 10-year-old boy with a myxoma of the tricuspid valve, who was successfully operated without valve replacement.

How to cite: Pessotto, R., Santini, F., Piccin, C., Consolaro, G., Faggian, G., & Mazzucco, A. (1994). Cardiac myxoma of the tricuspid valve: description of a case and review of the literature. The Journal of heart valve disease, 3(3), 344–346.

Between 1981 and 1987 a total of 479 Hancock Extracorporeal bovine pericardial bioprostheses were implanted in 458 patients. During the time period from 1990 to 1993, 21 valves, 15 in the aortic and six in the mitral position, had to be removed 72 to 109 months after implantation. The mean age of these patients at the time of implantation was 49.7 +/- 10.5 years. All 21 removed as well as one unimplanted bioprosthesis were morphologically investigated. Visual examination, radiography, histology and ultrastructural observations were performed using scanning and transmission electron microscopy. In addition, clinical data were correlated to morphological findings. All valves failed due to cusp tears originating at the stent posts. Calcification was minimal in five valves, moderate in 10, and severe in five valves. Only one valve showed no mineralization at all. The late morphologic changes were associated with thickening of valve leaflets, tissue delamination, calcification, degeneration of collageneous network, and extensive insudation of plasma proteins and lipids. The present findings suggest that denatured collagen molecules may be capable of inducing immune response.

How to cite: Vetter, H. O., Krupa, W., Nerlich, A., Welsch, U., Weinhold, C., Schmitz, C., & Reichart, B. (1994). New morphologic aspects of explanted Hancock Extracorporeal pericardial bioprostheses. The Journal of heart valve disease, 3(3), 335–343.

The purpose of the study was to measure the valve sound loudness of eight 25 mm aortic mechanical heart valve prostheses under controlled laboratory conditions in an isolated acoustic environment. A specially designed single-chamber pulse duplicator was constructed within an anechoic box that isolated the sounds of the valve from external noise. The valves were closed with a stimulated aortic pressure waveform of three different amplitudes. Valve sound loudness was measured with ISO-532/B (Zwicker method), which is based on a model of loudness perception that is better than dB(A), the traditional A-weighted sound pressure level. The average loudness for each valve was St. Jude Medical, 0.97 sones; CarboMedics, 0.98 sones; Sorin Biomedica Bicarbon, 1.08 sones; Edwards Tekna, 1.92 sones; Edwards Duromedics, 2.36 sones; Monostrut, 2.48 sones; Sorin Biomedica Carbocast, 3.17 sones; and Medtronic Hall, 3.57 sones. There was a positive trend between valve sound loudness and aortic drive pressure for most valves in the study.

How to cite: Erickson, R. L., Thulin, L. I., & Richard, G. J. (1994). An in vitro study of mechanical heart valve sound loudness. The Journal of heart valve disease, 3(3), 330–334.

Data on the magnitude of forces which can be generated by the myocardium on a prosthetic heart valve ring are not available from the literature. Therefore, we implanted strain gauge mounted 29 mm original specification Edwards-Duromedics mitral valve prostheses in 13 pigs. The valves were implanted in both anatomic and anti-anatomic orientation. In order to estimate the forces on the valve ring, acute in vivo measurements of the dynamic deformation of the valve ring were performed and correlated with the stiffness of the same valves measured in vitro. In the post cardioplegic heart of the anesthetized pigs there was a maximum force developed by the myocardium of 6-8 N on the valve ring with a resulting maximum deformation of 40 microns with valves mounted in the anatomic position. These findings have implications for design of future mechanical mitral valves and for mitral rings used for mitral valvuloplasty. These data can also be used as reference for evaluation of safety limits in existing valves in terms of their physical properties. Based on the direction of the maximum myocardial force acting on the mitral valve ring and the difference in compliance of the valve ring along the pivotal or orthogonal axis, it is indicated from that these acute porcine studies that bileaflet valves in the mitral position are subjected to less deformation when implanted 60 degrees counter-clockwise to the native mitral intercommisural line.

How to cite: Hasenkam, J. M., Nygaard, H., Paulsen, P. K., Kim, W. Y., & Hansen, O. K. (1994). What force can the myocardium generate on a prosthetic mitral valve ring? An animal experimental study. The Journal of heart valve disease, 3(3), 324–329.

It has long been known that mechanical heart valves, when tested for durability using non-physiologic conditions common in accelerated testers, would cavitate. Until recently, cavitation was never observed in vivo. The discovery that a small number of Edwards-Duromedics heart valve explants indicated signs of cavitation erosion prompted a reassessment of the cavitation erosion potential of pyrolytic carbon (PyC). Analyses of the explanted valves indicated that cavitation may be accentuated by porous regions in the pyrolytic carbon coating from which most mechanical heart valves are constructed. Early studies have shown that for PyC (a) the resistance to cavitation erosion is comparable to that of aluminum, (b) the resistance to cavitation erosion is high initially, but with time the erosion rate accelerates, and (c) the cavitation erosion resistance is somewhat variable. In this study, similar experiments were performed utilizing polished pyrolytic carbon as well as microporous surfaces since microporous surfaces have been implicated as accelerating erosion. Within the accuracy of the measurement, we found no contributing acceleration due to the microporous nature of the pyrolytic carbon surfaces tested when compared to the polished surfaces. Examination of cross sections of samples exposed to cavitation conditions revealed the presence of extensive microcracking even without the presence of substantial surface erosion.

How to cite: Haubold, A. D., Ely, J. L., & Chahine, G. L. (1994). Effect of cavitation on pyrolytic carbon in vitro. The Journal of heart valve disease, 3(3), 318–323.

Over a 10-year period a uniform management plan for patients receiving long term oral anticoagulation therapy for prosthetic heart valves and needing dental procedures was instituted. Those undergoing dental extraction or gum hygiene in the presence of gross gum pathology (Group A) had their oral anticoagulation discontinued two days prior to the procedure which was carried out only if the INR was 1.5 or less on the day of the procedure. Patients who needed dental fillings or gum hygiene in the absence of gross gum pathology (Group B) continued their anticoagulation therapy and had these procedures completed provided the INR was 3.0 or less. The main outcome measured were valve thrombosis, thromboembolism and excessive bleeding requiring hospitalization and/or blood transfusion. In Group A, 240 procedures were carried out; 212 dental extractions and 28 dental hygiene in the presence of gross gum pathology. They had a brief period of under-anticoagulation (3-7 days) to an INR of 1.5 or less. In Group B, 156 procedures were performed. No patient developed valve thrombosis or thromboembolism. Two patients, both in Group A needed hospitalization for observation but no blood transfusion. This management plan was easy to implement. Patients needed one extra visit to the anticoagulation clinic within one week of the procedure. It was both safe and effective.

How to cite: Saour, J. N., Ali, H. A., Mammo, L. A., & Sieck, J. O. (1994). Dental procedures in patients receiving oral anticoagulation therapy. The Journal of heart valve disease, 3(3), 315–317.

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How to cite: Butchart E. G. (1994). Anticoagulation management during non-cardiac surgery--time for common sense. The Journal of heart valve disease, 3(3), 313–314.

Pre- and afterload reduction is known to have beneficial effects in patients with chronic mitral regurgitation. To date, no controlled study has been reported analyzing the long term influence of angiotensin-converting enzyme inhibitor treatment on patients with chronic mitral regurgitation. Therefore the aim of this study was to assess the effects of one year angiotensin-converting enzyme inhibition with quinapril on myocardial performance in patients with chronic mitral regurgitation. Twelve patients with moderate to severe isolated chronic mitral regurgitation and no coronary disease on coronary angiography were studied under control conditions and followed up until one year of quinapril therapy (10-20mg/day) using echocardiography and simultaneous right heart catheterization, and radionuclide ventriculography at rest and exercise. As the result of a significant pre- and afterload reduction after one year quinapril treatment regurgitant fraction fell from 0.43 +/- 0.10 at control before therapy to 0.25 +/- 0.08 (p = 0.0001), left ventricular end-diastolic volume was reduced from 146 +/- 26 to 109 +/- 24 ml/m2 (p = 0.0001) and end-systolic volume decreased from 63 +/- 43 to 47 +/- 29 ml/m2 (p = 0.02). Left ventricular ejection fraction at control averaged 0.59 +/- 0.20 at rest, increased to 0.65 +/- 0.21 with maximum exercise and was unchanged after one year quinapril therapy. After one year treatment left ventricular mass was reduced by 15% (p = 0.0004) and septal wall thickness decreased from 11.8 +/- 0.7 to 10.8 +/- 0.8 mm (p = 0.0006). Moreover, there was significant functional improvement of nearly one NYHA class after one year quinapril therapy. In conclusion, in patients with chronic mitral regurgitation long term angiotensin-converting enzyme inhibition with quinapril reduces regurgitation and decreases left ventricular size and mass thereby demonstrating functional improvement. In addition, these data suggest that angiotensin-converting enzyme inhibition might have the potential of delaying mitral valve surgery.

How to cite: Schön, H. R., Schröter, G., Barthel, P., & Schömig, A. (1994). Quinapril therapy in patients with chronic mitral regurgitation. The Journal of heart valve disease, 3(3), 303–312.

Cardiac suction has been previously demonstrated in the normal heart and in cardiac diseases characterized by a normal or reduced end-diastolic ventricular pressure. We report a patient with tight mitral stenosis and severe tricuspid regurgitation who provides the evidence of cardiac suction, despite the presence of increased end-diastolic pressures. The negative diastolic pressures observed in our patient appear to be related to the preservation of a vigorous contraction of both ventricles resulting in small end-systolic volumes. In this setting the elastic potential energy stored in the myocardium during each vigorous contraction is released during diastole, thus creating a negative pressure which sucks blood into the ventricles.

How to cite: Tomai, F., Crea, F., Gaspardone, A., De Paulis, R., & Gioffrè, P. A. (1994). Evidence of cardiac suction in the presence of high end-diastolic filling pressure: a case report. The Journal of heart valve disease, 3(3), 300–302.

Pericardial closure early after open heart surgery has been shown to consistently lower cardiac output and stroke volume, while mean arterial blood pressure is maintained by an increase in systemic vascular resistance. In 10 patients (seven females) (mean age 65 +/- 4 years) undergoing an open heart valve procedure, the effects of a tension-free pericardial closure technique were studied using thermodilution studies and transesophageal echocardiography. The following variables were recorded: mean arterial pressure, mean pulmonary artery pressure, right atrial pressure, cardiac output, stroke volume, systemic vascular resistance, and systolic and diastolic left ventricular dimensions, and left ventricular wall thickness. Observations were made after the heart was decannulated, both while the pericardium was open and after it had been closed by a tension-free technique, and then after closure of the chest. Further observations were made while the chest remained closed, both before and after the pericardium had been reopened by removing the pericardial suture through the chest wall. Closing the pericardium with the tension-free technique while the chest remained open was followed by a fall in cardiac output by 8% and a 15% fall in systemic vascular resistance (both n.s.). These changes caused a 13% reduction in the mean arterial pressure (p = 0.03). Ejection fraction did not change, and systolic and diastolic left ventricular dimensions decreased by 6% and 4% respectively (both n.s.). Opening the pericardium (1.5 to 2 hours after the end of the operation) while the chest remained closed was not followed by significant change in any of the hemodynamic or echocardiographic variables.(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Izzat, M. B., Anderson, M., Wilde, P., Wisheart, J. D., Bryan, A. J., & Angelini, G. D. (1994). Hemodynamic effects and echocardiographic consequences of tension-free pericardial closure after heart valve surgery. The Journal of heart valve disease, 3(3), 295–299.

Left ventricular geometry and function were assessed in 20 patients with mitral stenosis (MS) and in another 20 patients with mitral insufficiency (MI) five days before and 12 days after mitral valve replacement by transthoracic (TTE) and transesophageal (TEE) echocardiography, as well as late postoperatively (mean: 194 days) by TTE. The continuity of the subvalvular apparatus could not be preserved in any of these patients. In mitral stenosis the area ejection fraction (AEF) in the short axis of the left ventricle (LV) did not change significantly early or late postoperatively. There was a significant lengthening of the left ventricular longitudinal axis in the apical four chamber view whereas the transverse axis remained unchanged. This was likely the result of the discontinuity between the mitral valve and the papillary muscles. AEF and ejection fraction (EF) determined in the four chamber view showed a slight tendency to decrease in the postoperative phase. Patients with mitral insufficiency likewise showed a significant increase of the LV longitudinal diameter postoperatively. In the short axis of the left ventricle and in the apical four chamber view a significant reduction of the AEF was observed. Furthermore, left ventricular EF dropped significantly postoperatively. This decrease was caused by the extension of the LV longitudinal axis accompanied by an enlargement of the transverse diameter as well as by an afterload increase, and a masked impairment of left ventricular function preoperatively. Wall motion analysis of the LV in both groups documented new postoperative hypokinesis especially in the septal segments. At late postoperative examination the hypokinesis disappeared in about 50% of the patients.(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Deutsch, H. J., Curtius, J. M., Bongarth, C., Behlke, E., Borowski, A., de Vivie, E. R., & Hilger, H. H. (1994). Left ventricular geometry and function before and after mitral valve replacement. The Journal of heart valve disease, 3(3), 288–294.

Recent reports have emphasized the limitations of aortic valve area estimations using the Gorlin formula based on the Toricelli model. Since aortic valve resistance (AVR) does not use a constant and treats the pressure gradient and the cardiac output without favouring either, it has been proposed as a more accurate index of the severity of aortic stenosis. Though it has previously been calculated using pressure and flow parameters obtained in the catheterization laboratory, it is possible to derive the valve resistance using Doppler echocardiography. Doppler-echo estimates of AVR may be used as an alternative index of aortic stenosis severity; however, no data exists as to its accuracy compared with cardiac catheterization derived AVR. Thirty-nine patients with aortic stenosis undergoing invasive hemodynamic and Doppler-echo evaluations were studied. The AVR was calculated using the formula: (mean pressure gradient)/(flow per systolic ejection period). The cardiac output at catheterization was measured by using thermodilution technique, whilst the Doppler-echo method utilized the product of velocity time integral of the flow in left ventricular outflow tract and its cross sectional area. The Doppler-echo derived AVR (38.5 to 738.2 dyne.sec.cm-5) correlated significantly (r = 0.82, p < 0.0001, S.E.E. = 75.0 dyne.sec.cm-5) with independently derived catheterization values (53.6 to 738.8 dyne.sec.cm-5). There was a good correlation between mean gradient obtained by both modalities.

How to cite: Ho, P. P., Pauls, G. L., Lamberton, D. F., Portnoff, J. S., Pai, R. G., & Shah, P. M. (1994). Doppler derived aortic valve resistance in aortic stenosis: its hemodynamic validation. The Journal of heart valve disease, 3(3), 283–287.

Although data from cardiac catheterization and in vivo studies are available, phonocardiographic and ultrasonic characteristics of the Medtronic Hall valve in the mitral position have not been adequately established. Phonomechanocardiographic, echocardiographic and Doppler echocardiographic examinations were performed in 15 patients (Medtronic Hall group) with a Medtronic Hall mitral valve prosthesis to elucidate the phonocardiographic and ultrasonic characteristics of the normally functioning Medtronic Hall valve in the mitral position. These findings were compared with those obtained from 20 patients (Björk-Shiley group) with a normally functioning Björk-Shiley 60 degrees mitral valve prosthesis. Simultaneous recordings of the phonocardiogram and M-mode echocardiogram of the prosthetic valve in patients in the Medtronic Hall group revealed three opening clicks relating to disc motion. The timing of the three opening clicks correlated with the onset of disc opening, the completion of disc opening, and a notch which appeared about 30 msec after the completion of disc opening. Similar recordings performed in patients in the Björk-Shiley group revealed that the third opening click was detected in only half of the patients and that its timing was nearly twice as early as that noted in the Medtronic Hall group. The Medtronic Hall group had significantly shorter durations of the apical diastolic rumble and the slow filling wave on the apexcardiogram, as well as significantly reduced peak mitral inflow velocity during early diastole and shortened pressure half-time on the mitral inflow velocity curve. Transesophageal Doppler echocardiography demonstrated slight mitral regurgitation in all patients in both the Medtronic Hall and the Björk-Shiley groups.(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Fukuda, N., Oki, T., Tabata, T., Hosoi, K., Iuchi, A., Manabe, K., Kageji, Y., Sasaki, M., Hama, M., & Ito, S. (1994). Comparative phonocardiographic, echocardiographic and Doppler echocardiographic evaluation of normally functioning Medtronic Hall and Björk-Shiley mitral prosthetic valves. The Journal of heart valve disease, 3(3), 275–282.

Transthoracic echocardiography was performed in 141 patients with 90 Omnicarbon valves in the aortic and 66 in the mitral position. Additionally, 53 of them were investigated by transesophageal echocardiography comparing monoplane and multiplane facilities. The opening direction of the disc and the location of the pivot axis could be correctly determined by transthoracic, monoplane, and multiplane transesophageal echocardiography, respectively, in 100%, 80%, and 100% of the mitral and in 53%, 21%, and 82% of the aortic prostheses. Small regurgitation jets were detected in 90% of the aortic valves (1.6 +/- 0.4 cm2) by transthoracic and in all mitral prostheses (2.3 +/- 0.8 cm2) by transesophageal echocardiography. Based on morphological identification of the pivot points structures, origins of leakage jets were clearly identified as "design-related" in 12% (transthoracic echocardiography of aortic valves) to 100% (multiplane transesophageal echocardiography of mitral valves). In the aortic position, values obtained for transprosthetic forward flow velocity measurements exhibited wide scatter which did not allow a firm separation between valve sizes. No better differentiation was possible by using the calculated Doppler gradients or the velocity time integrals, either. Mean gradients and velocity time integrals showed even smaller differences between groups in the mitral valve patients. It is concluded that the Omnicarbon valve has a suitable design for morphological echocardiographic examination, and multiplane transesophageal technique expands the diagnostic capability. Forward flow measurements do not appear to be suited for detecting a beginning obstruction of this mechanical prosthesis.

How to cite: Fehske, W., Kessel, D., Kirchhoff, P. G., Omran, H., Manz, M., & Lüderitz, B. (1994). Echocardiographic profile of the normally functioning Omnicarbon valve. The Journal of heart valve disease, 3(3), 263–274.

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How to cite: Chambers J. B. (1994). The echocardiographic assessment of replacement heart valves: high time for a consensus view. The Journal of heart valve disease, 3(3), 260–262.

A prospective randomized study, comparing the clinical results between two groups of patients undergoing valve replacement with the Monostrut (MS) and Medtronic-Hall (MH) heart valve prosthesis was carried out between January 1985 and December 1988. A MS valve was implanted in 205, the MH in 198 patients selected randomly. Statistical analysis showed a perfect match between the two groups regarding preoperative and operative variables, including implantation site. All patients were given life-long anticoagulant therapy after operation. Follow up was 5.06 years (median) with a total of 1971.1 patient-years (pty) and 96.6% complete. The two groups showed no significant difference in the incidence of the following postoperative events: 30-day mortality, late mortality, reoperation, anticoagulant related bleeding, paravalvular leak, prosthetic valve endocarditis and thromboembolism (TE). Multivariate analysis indicated a borderline increased hazard of TE (2.1 +/- 0.4%/pty versus 0.7 +/- 0.2%/pty) (p = 0.0087, Bonferoni corrected significance) in the MS group. It is concluded that long term outcome is excellent with these two tilting disc valves. The marginally lower incidence of thromboembolism, however, favors the Medtronic Hall prosthesis.

How to cite: Kim, Y. I., Lesaffre, E., Scheys, I., Stalpaert, G., Flameng, W. J., & Daenen, W. J. (1994). The Monostrut versus Medtronic Hall prosthesis: a prospective randomized study. The Journal of heart valve disease, 3(3), 254–259.

Outlet strut fracture of the Björk-Shiley Convexo-Concave (C/C) heart valve is the current paradigm of structural failure of mechanical heart valve prostheses. The estimated risk of fracture for C/C valves varies from 0.02% to 2.5% per patient-year, depending on valve size, opening angle, date of manufacture and position as a mitral or aortic replacement. This report examines our experience with 396 implants, comprising 346 C/C 60 degrees valves and 50 C/C 70 degrees valves. The 30-day mortality was 1.8%. Through April 1993, mean follow up was 8.9 years, incorporating 2971 patient-years and knowledge of the current status of 91.5% (356/389) of operative survivors. Late mortality was 3.7% per patient-year, including one 60 degrees and one 70 degrees outlet strut fracture. To evaluate the risk of semi-elective valve re-replacement at our institution, we reviewed the results of isolated re-replacements of failing or incipiently failing bioprostheses in 65 patients who had no serious co-morbidity and who were NYHA Class III or lower immediately before the procedure. The 30-day mortality was 4.6% and the overall serious morbidity rate was 10.8%, necessitating six repeat reoperations. When these factors were balanced against the life expectancy and general status of five patients with large-size, higher-fracture-risk 70 degrees C/C valves, it was concluded that only two patients remained possible reoperation candidates. Consideration for re-replacement of a normally functioning C/C heart valve should take into account institution-specific experience because structural failure remains a low risk compared to valve-related complications engendered by reoperation.

How to cite: Schöndube, F. A., Althoff, W., Dörge, H. C., Voss, M., Laufer, J. L., Chandler, J. G., & Messmer, B. J. (1994). Prophylactic reoperation for strut fractures of the Björk-Shiley convexo-concave heart valve. The Journal of heart valve disease, 3(3), 247–253.

Bacterial endocarditis may present with acute chest pain due to coronary embolization and mimics acute myocardial infarction secondary to coronary atherosclerosis. We present the first case report of coronary embolization secondary to aortic valve endocarditis treated with standard doses of streptokinase and aspirin. The patient survived but sustained a large myocardial infarction and a major gastrointestinal bleed. Infective endocarditis should be considered in all patients presenting with acute chest pain. When myocardial infarction is due to coronary embolism from endocarditic valves standard thrombolysis regimes should be avoided.

How to cite: Connolly, D. L., Dardas, P. S., Crowley, J. J., Kenny, A., & Petch, M. C. (1994). Acute coronary embolism complicating aortic valve endocarditis treated with streptokinase and aspirin. A case report. The Journal of heart valve disease, 3(3), 245–246.

This paper presents the case report of a 50-year-old woman with a triple valve lesion of rheumatic origin and ischemic coronary disease. The patient underwent successful simultaneous triple valve surgery; the aortic and mitral valves were replaced by mechanical prostheses, and the tricuspid valve was repaired by annuloplasty, together with three aorto-coronary bypasses and endarterectomy of the right coronary artery. The peri- and postoperative courses were uneventful and the patient was discharged from hospital in good clinical condition 12 days after surgery.

how to cite: Fischer, V., Kanalikova, K., Paulikova, Z., Galvanek, J., Hulman, M., & Outrata, R. (1994). Triple valve surgery with triple aorto-coronary bypass and endarterectomy of the right coronary artery. The Journal of heart valve disease, 3(3), 243–244.

Total of 123 patients (mean age: 63.8 +/- 7.3 years, (male/female 65/35 percent) underwent mitral valve surgery combined with coronary artery bypass grafting during a seven year period. Preoperatively 12% of them belonged to NYHA functional class II, 54% to class III, 29% to class IV and 3% was operated under emergency conditions. The mitral valve lesion was most frequently either ischaemic (45%) or rheumatic (33%) in origin. Left ventricle function was moderately decreased in 18% and severely damaged in 3% of the patients as documented by preoperative ventriculography. Coronary surgery was performed in all cases with an average number of distal anastomosis of 2.2 +/- 1.1 per patient. The hospital mortality was 13%. Risk factors for early and late mortality were determined by univariate and multivariate analysis. Advanced preoperative functional class and decreased left ventricular function or ischaemic etiology were identified as significant risk factors for early mortality. The patients were followed for an average of 33 +/- 25 months. The majority of them experienced significant functional improvement postoperatively with 69% belonging to NYHA class I or II. The late survival for the 107 hospital survivors was 94.7% at one year, and 84.7% at five years, respectively. Late survival was independently determined by preoperative functional class or previous myocardial infarction. Freedom from ischemic and valve related complications at five years was 95% and 71.2% respectively. 58.2% of the hospital survivors were in functional class I or II and free of any valve related or ischemic complications at the end of the fifth follow up year.(ABSTRACT TRUNCATED AT 250 WORDS)

How to cite: Szecsi, J., Herijgers, P., Sergeant, P., Daenen, W., Scheys, I., & Flameng, W. (1994). Mitral valve surgery combined with coronary bypass grafting: multivariate analysis of factors predicting early and late results. The Journal of heart valve disease, 3(3), 236–242.

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How to cite: Antunes M. J. (1994). Coronary artery bypass surgery and minor aortic stenosis. To replace or not to replace? An alternative: to repair. The Journal of heart valve disease, 3(3), 235.

The Center for Devices and Radiological Health, Food and Drug Administration, 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 vitro data, and, for those cases where it may not be obvious, to provide an overview of the significance of these data and how FDA interprets them in the approval decision process.

How to cite: Johnson, D. M., Chwirut, D. J., & Regnault, W. F. (1994). FDA's requirements for in-vitro performance data for prosthetic heart valves. The Journal of heart valve disease, 3(3), 228–234.

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How to cite: Bodnar E. (1994). The new FDA guidelines. The Journal of heart valve disease, 3(3), 226–227.