Michele DeRobertis

Discrepancies between Doppler and catheter gradients in aortic prosthetic valves in vitro. A manifestation of localized gradients and pressure recovery.

To evaluate possible causes of discrepancy between Doppler and catheter gradients across prosthetic valves, five sizes (19-27 mm) of St. Jude and Hancock valves were studied in an aortic pulsatile flow model. Catheter gradients at multiple sites distal to the valve were compared with simultaneously obtained Doppler gradients. In the St. Jude valve, significant differences between Doppler and catheter gradients measured 30 mm downstream from the valve were found: Doppler gradients exceeded peak catheter gradients of 10 mm Hg or more by 81 +/- 35% (15 +/- 3.6 mm Hg), and mean catheter gradients by 71 +/- 11% (10.3 +/- 2.5 mm Hg). When the catheter was pulled back through the tunnel-like central orifice of the valve, high localized gradients at the valve plane and significant early pressure recovery were found. When the catheter was pulled back through the large side orifices, gradients at the same level were only 46 +/- 6% of the central orifice gradients (mean difference, 7.6 +/- 4.5 mm Hg). Doppler peak and mean gradients showed excellent agreement with the highest central orifice catheter gradients (mean difference, 1.0 +/- 3.1 and 0.9 +/- 1.5 mm Hg, respectively). A significantly better agreement between Doppler and catheter gradients at 30 mm was found for the Hancock valve, although Doppler peak and mean gradients were still slightly greater than catheter gradients. Doppler gradients exceeded catheter gradients by 18 +/- 10% (3.4 +/- 1.9 mm Hg) and 13 +/- 11% (2.1 +/- 0.9 mm Hg), respectively. When the catheter was pulled back through the valve, the highest gradients were found approximately 20 mm distal to the valve ring.(ABSTRACT TRUNCATED AT 250 WORDS)

The St. Jude valve. Thrombolysis as the first line of therapy for cardiac valve thrombosis.

BackgroundThrombolytic therapy is a promising alternative to valve replacement in the management of prosthetic valve thrombosis. We sought to determine the short- and long-term results of treating thrombosed St. Jude heart valves with thrombolytic therapy as the primary treatment modality. Methods and ResultsBetween March 1978 and December 1991, 988 patients underwent implantation of St. Jude prosthetic valves at our medical center, and all patients with thrombosed valves were identified prospectively. During this period, 17 patients (13 women; mean age, 66.8±19.0 years) developed prosthetic valve thrombosis (11 aortic, six mitral). In six patients, Coumadin was stopped in preparation for elective surgery. The clinical presentation was congestive heart failure in 13, syncope and fatigue in two, and a cerebrovascular accident in one; one patient was asymptomatic. The average duration of symptoms was 11.7±12.0 days (range, 1–45 days). Anticoagulation was subtherapeutic in all but one patient at the time of presentation. Cinefluoroscopy was the primary method used for diagnosis and was also used to follow the response to therapy. Twelve patients were treated medically (10 with thrombolytic therapy and two with heparin), three were treated surgically, and two were diagnosed at autopsy. Of the 12 medically treated patients, 10 had marked improvement in leaflet movement and symptoms within 12 hours. Thus, 10 of 12 patients (83%) had a satisfactory response to medical therapy alone. No medically treated patient died or had a major complication resulting in permanent damage. However, four of the 12 medically treated patients had minor complications, including a transient episode of facial weakness in one patient, hematomas in two, and epistaxis in one. Late rethrombosis recurred in two patients in the medically treated group and was successfuly retreated with thrombolytic therapy. At 3 months, all patients were alive and well. ConclusionsThrombolytic therapy can be used as the first line of therapy for thrombosed St. Jude valves with a low risk of permanent side effects and excellent chances of success. In most cases, surgery can be reserved for patients who do not respond to thrombolytic therapy.

Ten-year experience of cardiac surgery in patients aged 80 years and over.

Five hundred twenty-eight consecutive patients aged 80 years and over (mean age, 83.1 +/- 2.7 years) underwent cardiac operations with hypothermia (mean, 21.9 degrees +/- 2.2 degrees C), hyperkalemic cardioplegia, and cardiopulmonary bypass in a 10-year period. Fifty-six percent of the patients were male. Preoperatively, 68% of the patients were in New York Heart Association functional class IV, and 31% were in class III. Among them, 303 patients had isolated coronary artery bypass grafting (CABG) (group I), 132 had aortic valve replacement only or combined with CABG (group II), 42 had mitral valve replacement only or combined with CABG (group III), 31 had mitral valve repair and CABG (group IV), and 20 had double-valve procedure only or combined with CABG (group V). The 30-day or in-hospital mortality was 8.3% in group I, 4.5% in group II, 29% in group III, 23% in group IV, and 30% in group V. Total 30-day or in-hospital mortality was 10.6%. One-year and 5-year actuarial survival rates were as follows: group I, 82% and 62%; group II, 85% and 58%; group III, 61% and 37%; group IV, 56% and 19%; and group V, 63% and 15%. Total 1-year and 5-year actuarial survival were 79% and 54%. At follow-up (mean, 2 years), 70% of overall survivors reported that their general health had improved. Our experience demonstrates that for select patients aged 80 years and over with unmanageable cardiac symptoms, CABG and aortic valve replacement groups had better results in improving quality of life as compared with patients having mitral or combined procedures.

Bileaflet, tilting disc and porcine aortic valve substitutes: In vitro hydrodynamic characteristics

The desire for a low profile mechanical valve with better fluid dynamic performance led to the design and development of the St. Jude Medical bileaflet prosthesis. Comparative in vitro flow studies indicate that it has better pressure drop characteristics than the Björk-Shiley (convexo-concave) and Carpentier-Edwards porcine valves in current clinical use, especially in the small sizes. In the 21 to 27 mm aortic valve size range the St. Jude valve has an average performance index of 0.66, compared with 0.46 and 0.32 for the Björk-Shiley and Carpentier-Edwards valves, respectively. In contrast, the St. Jude valve has larger regurgitant volumes than both the Björk-Shiley and Carpentier-Edwards valves. Velocity measurements with a laser-Doppler anemometer indicate relatively centralized flow with small amounts of turbulence downstream of the St. Jude valve. The flow is unevenly distributed between the central and side orifices. The turbulent shear stresses are, however, large enough to cause sublethal or lethal damage to blood elements. Wall shear stresses are smaller than those measured downstream of the Björk-Shiley valve. Regions of flow separation were observed just downstream from the sewing ring, which could lead to excess tissue growth along the sewing ring. The results of this study indicate that overall in vitro fluid dynamic performance of the St. Jude valve is superior to that of the two other commonly used prostheses.

Intraoperative Doppler color flow mapping for assessment of valve repair for mitral regurgitation

The ability of color Doppler flow mapping to provide intraoperative information about mitral regurgitation (MR) severity and to evaluate adequacy of mitral valve repair was assessed by performing color Doppler echocardiography immediately before and after cardiopulmonary bypass, with the transducer placed directly on the epicardium. In 56 patients, the degree of MR by intraoperative color Doppler correlated well with left ventricular angiography (kappa = 0.80) and with closed-chest preoperative color Doppler (kappa = 0.84) and had good interobserver reproducibility (kappa = 0.88). Good correlation was also seen between closed-chest color Doppler and angiography (kappa = 0.75). After mitral valve repair in 18 patients (15 ischemic MR, 3 cleft valves), color Doppler was used to assess severity of residual MR intraoperatively and postoperatively. Intraoperative color Doppler identified satisfactory repair (MR less than or equal to 2+) in 15 patients and failure (MR greater than or equal to 3+) in 3, whereas conventional surgical assessment of MR by fluid filling of the arrested ventricle failed to provide reliable differentiation. MR severity on subsequent closed-chest color Doppler follow-up did not change significantly compared with intraoperative evaluation after repair. Intraoperative color Doppler provides accurate grading of MR severity, offers instantaneous evaluation of the adequacy of mitral valve repair before chest closure, and appears to predict the degree of postoperative MR seen on subsequent closed-chest follow-up studies.

Doppler assessment of prosthetic valve orifice area. An in vitro study.

BackgroundAlthough Doppler echocardiography has been shown to be accurate in assessing stenotic orifice areas in native valves, its accuracy in evaluating the prosthetic valve orifice area remains undetermined. Methods and ResultsDoppler-estimated valve areas were studied for their agreement with catheterderived Gorlin effective orifice areas and their flow dependence in five sizes (19/20–27 mm) of St. Jude, Medtronic-Hall, and Hancock aortic valves using a pulsatile flow model. Doppler areas were calculated three ways: using the standard continuity equation; using its simplified modification (peak flow/peak velocity); and using the Gorlin equation with Doppler pressure gradients. The results were compared with Gorlin effective orifice areas derived from direct flow and catheter pressure measurements. Excellent correlation between Gorlin effective orifice areas and the three Doppler approaches was found in all three valve types (r=0.93-0.99, SEE=0.07-0.11 cm2). In Medtronic-Hall and Hancock valves, there was only slight underestimation by Doppler (mean difference, 0.003-0.25 cm2). In St. Jude valves, however, all three Doppler methods significantly underestimated effective orifice areas derived from direct flow and pressure measurements (mean difference, 0.40-0.57 cm2) with differences as great as 1.6 cm2. In general, the modified continuity equation calculated the largest Doppler areas. When orifice areas were calculated from the valve geometry using the area determined from the inner valve diameter reduced by the projected area of the opened leaflets, Gorlin effective orifice areas were much closer to the geometric orifice areas than Doppler areas (mean difference, 0.40±0.31 versus 1.04±0.20 cm2). In St. Jude and Medtronic-Hall valves, areas calculated by either technique did not show a consistent or clinically significant flow dependence. In Hancock valves, however, areas calculated by both the continuity equation and the Gorlin equation decreased significantly (p<0.001) with low flow rates. ConclusionsDoppler echocardiography using either the continuity equation or Gorlin formula allows in vitro calculation of Medtronic-Hall and Hancock effective valve orifice areas but underestimates valve areas in St. Jude valves. This phenomenon is due to localized high velocities in St. Jude valves, which do not reflect the mean velocity distribution across the orifice. Valve areas are flow independent in St. Jude and Medtronic-Hall prostheses but decrease significantly with low flow in Hancock valves, suggesting that bioprosthetic leaflets may not open fully at low flow rates.

Combined Valve and Coronary Artery Bypass Procedures in Septuagenarians and Octogenarians: Results in 120 Patients

A consecutive series of 96 septuagenarians (mean age, 74) and 24 octogenarians (mean age, 83) underwent coronary artery bypass (CAB) and valve operations using hypothermia and hyperkalemic cardioplegia in a 45-month period; there was a mean of 2.6 grafts per patient. Most patients were in New York Heart Association (NYHA) class IV (57% of the septuagenarians and 88% of the octogenarians) preoperatively. The early deaths were 19% for septuagenarians and 37% for octogenarians; late deaths were 9% and 6%, respectively, after a mean of 25 months. Of 92 survivors, 78% of the septuagenarians and 87% of the octogenarians improved by one or more NYHA class postoperatively. Of 58 patients with combined CAB and aortic valve replacement, 12 (21%) died; of 38 with combined CAB and mitral valve replacement 19 (50%) died; 2 of 9 (22%) with combined CAB and double valve replacement died; and 2 of 11 (18%) with CAB and MV repair died. In comparison, of patients with isolated valve replacement in the same period, 2 of 30 (7%) in the AVR group died, 5 of 17 (29%) died in the MVR group, 2 of 7 (33%) in the DVR group died. The risk of combined valve procedures and bypass surgery was significantly increased in the elderly and may warrant a less aggressive procedure, especially in the mitral position.

The St. Jude Medical valve: Experience with 1000 cases

We analyzed the long-term results of valve replacement with the St. Jude Medical bileaflet valve (St. Jude Medical, Inc., St. Paul, Minn.) in our first 1000 implantations between 1978 and 1992. A total of 399 patients had mitral valve replacement, 471 aortic valve, and 130 double (mitral and aortic) valve replacement. The average patient age was 64 +/- 15 years and the majority of patients (52%) had concomitant coronary disease. With 4328 patient-years of follow-up, 83% of the mitral group, 76% of the aortic group, and 77% of the double valve group were free of thromboembolism at 10 years after operation, and 87% of the mitral group, 82% of the aortic group, and 85% of the double valve group were free of valve-related hemorrhage. At 10 years, 91% of the mitral group, 84% of the aortic group, and 84% of the double valve group were free of valve-related death. However, overall survival at 10 years was only 42% +/- 4% for the mitral group, 43% +/- 4% for the aortic group, and 43% +/- 6% for the double valve group. For all three groups, age was a highly significant factor stratifying survival (p < 0.001), as was the presence of coronary disease (all p < 0.001). The excellent freedom from valve-related death at 10 years of 84% to 91% is in striking contrast to the overall survivals of 42% to 43% at 10 years. This difference suggests that the primary factors limiting long-term survival after valve replacement with the St. Jude Medical valve are not valve-related factors, but other patient factors such as age and concomitant coronary disease.

Fibrinolytic therapy of St. Jude valve thrombosis under guidance of digital cinefluoroscopy

Fibrinolytic therapy is an alternative to urgent reoperation for patients with St. Jude prosthetic valve thrombosis, but requires an accurate method for repeated assessment of prosthetic function. Since the St. Jude valve is not well visualized by conventional cinefluoroscopy, digital subtraction techniques were developed that improved visualization of the value and allowed assessment of leaflet separation and velocity. A 74 year old woman with prosthetic valve thrombosis 5 years after St. Jude aortic valve placement had an opening angle of 58 degrees (normal range 10 to 13; n = 8) with a maximal opening velocity of 1.37 degrees/ms (normal range 2.46 to 2.93). The closing angle was 125 degrees (normal range 120 to 127) with a maximal closing velocity of 1.38 degrees/ms (normal range 2.24 to 3.60). The patient received 250,000 U of streptokinase intravenously, then 100,000 U/h for 72 hours. Improvement in auscultatory findings occurred at 12 hours; repeat digital cinefluoroscopy showed an opening angle of 20 degrees with a maximal velocity of 2.77 degrees/ms, and a closing angle of 126 degrees with a maximal velocity of 1.91 degrees/ms. Digital cinefluoroscopy 4 weeks after discharge on warfarin and dipyridamole therapy was unchanged. There have been no thromboembolic complications after 6 months of follow-up. Thus, digital cinefluoroscopy is a new noninvasive technique that permits accurate measurement of normal and abnormal St. Jude leaflet function. Intravenous streptokinase dissolution of prosthetic valve thrombosis under digital cinefluoroscopic guidance may be an acceptable alternative to emergency reoperation. The frequency and significance of residual subclinical leaflet dysfunction after fibrinolytic therapy and the indications for elective reoperation require further evaluation.

Cardiac Operations in Patients 90 Years of Age and Older

BACKGROUND Growth of the elderly population worldwide, and specifically in the United States, will continue to accelerate and will have a profound impact on the cost and delivery of health care resources in the future. A medical strategy that allows the elderly to live independently is essential to most cost-effective use of our resources. The question remains as to what will be the future of surgical therapy for this increasing population. METHODS We retrospectively studied the cases of 30 consecutive nonagenarians (mean age, 92.3 +/- 1.8 years) who underwent a cardiac operation within a 9-year period. All patients were in New York Heart Association class III or IV and underwent operation urgently or emergently. RESULTS The 30-day mortality rate was 10%, and the actuarial survival rates were 81% +/- 8% and 75% +/- 9% at 1 year and 2 years, respectively. Seventy-eight percent of survivors were in New York Heart Association class I or II within 2 years after operation and had an improved quality of life. The cost of providing care in this age group was 24% higher than in octogenarians. CONCLUSIONS Advanced age in and of itself (>90 years) should not be a contraindication to an open-heart operation, although morbidity, mortality, and cost may be higher. However, selective criteria identifying risks and benefits for individual patients should be applied. The aging of our population will have a profound impact on the cost and delivery of health care resources in the future. This issue must be addressed in the current debate on the provision of expensive procedures under a realigned national health-care system.