Single Leg Separation Research Articles

Could It Happen Again?

Most readers of “Twenty-Five–Year Experience With the Bjork-Shiley Convexoconcave Heart Valve: A Continuing Clinical Concern” in this issue of Circulation have not heard of the valve.1 Many elements of its story parallel those of cerivastatin2,3⇓ and rofecoxib,4 but with a twist: Recalling a heart valve may entail greater risks than leaving a possible “time bomb” in place. The Bjork-Shiley story raises many questions about balancing the benefits of drugs and devices with their risks to public safety. For example: See p 2850 My personal involvement began when a lawyer for Shiley, Inc, with a biostatistical degree read our account of the Braunwald-Cutter heart valve and wanted to understand why the University of Alabama at Birmingham and the Mayo Clinic decided to prophylactically remove every one.5 Subsequently, I served on scientific panels, spearheaded a multi-institutional effort to quantify the risks of prosthesis explant,6 and suggested ways to use this information for the tough decision making ahead.7 The Bjork-Shiley heart valve, developed by Shiley, Inc, in collaboration with Dr Viking Bjork of Sweden, was …

An innovative technique to detect the single leg separation (SLS) in the bjork-shiley convexo-concave (BSCC) mechanical heart valves Edmond Rambod, Mostafa Fatemi, James F. Greenleaf. California Institute of Technology, Pasadena, CA, MAYO Clinic, Rochester, MN

An innovative technique to detect the single leg separation (SLS) in the bjork-shiley convexo-concave (BSCC) mechanical heart valves Edmond Rambod, Mostafa Fatemi, James F. Greenleaf. California Institute of Technology, Pasadena, CA, MAYO Clinic, Rochester, MN

The complexity of external acoustic detection of defects in Björk-Shiley convexoconcave heart valves.

Fractures in Björk-Shiley convexoconcave (BScc) heart valves have raised questions about the feasibility of early diagnosis of technical defects by means of acoustic assessment. Three laboratory tests were conducted. To establish acoustic fingerprints, 66 valves with a defect, such as single-leg fracture (SLF) or single-leg separation (SLS), or without a defect were connected with a contact sensor and excited by dropping a small metal ball onto the outlet strut. In the second test, we simulated the valve sound propagation within the thorax. In the third test, intact, SLF, and SLS valves were placed in a mock heart immersed in a large water tank. We observed a resonance frequency corresponding with valve size and presence of defects. The second test showed that both the chest wall and the lungs created numerous reflections. This led to a substantial overlap of the original pulse frequencies and the frequencies measured. The third test confirmed that submersion of the chest in water can significantly reduce chest wall reflections. Reliable noninvasive assessment of BScc valve clicks for the presence of defects of the outlet strut is hampered by complex sound propagation within the thorax and variability of valve excitation. Acoustic fingerprints to diagnose mechanical defects should be integrated in valve design.

Detection of Björk-Shiley Convexo-Concave Heart Valve Outlet Strut Single Leg Separations: Consensus Image Acquisition and Interpretation Using Two Different Cineradiographic Imaging Technologies

Background: Conventional cineradiology has been used clinically to detect partially broken outlet struts (single leg separations, SLSs) in normally functioning Björk-Shiley convexo-concave (C/C) heart valves. The value of radiographic screening has, however, been debated in the medical literature. This study uses the same radiographic technique in sheep implanted with known-status C/C valves in combination with a newly developed geometric image magnification radiography system. This study was designed to test whether sensitivity and specificity of radiographic screening of C/C valves in detecting SLSs could be improved through the combination of readers and imaging modalities. Methods: Twenty-one sheep with mitral C/C valves were studied on both systems. Five were used for extensive scanning training. When operators were expert on both systems, 16 blinded study valves (4 intact and 12 with outlet strut SLSs) were scanned twice on both systems, first on a modified conventional and then a prototype geometric image magnification (Feinfocus^TM) cineradiographic system by two expert physicians working together. Results: Among the 32 scanned valves, the two combined expert physicians were required to evaluate 40 intact legs and 24 with an SLS. For all SLS valves, the conventional and Feinfocus systems separately detected 50 (12/24) and 54% (13/24), respectively. When the two systems were combined, the final consensus score was correct in 67% (16/24) of all SLS valves. Conclusions: Combined modality, paired expert physicians detected 67% of all SLSs. The Feinfocus system might be best reserved for those patients in whom the Siemens screening study demonstrates in minimally suspicious (grade 2) or suspicious (grade 3) appearance of a C/C valve outlet strut leg.

In Vivo Accuracy Of Two Radiographic Systems In The Detection Of Björk-Shiley Convexo-Concave Heart Valve Outlet Strut Single Leg Separations

Objective: Modified cineradiographic systems have been used clinically to detect partially broken outlet struts in normally functioning Björk-Shiley convexo-concave heart valves. Almost all such valves were explanted, presuming that full failure would likely follow. Inasmuch as the clinical setting only rarely permits examination of normally rated valves, the accuracy of radiographic detection cannot be clinically defined. This study uses the clinical radiographic technique in sheep implanted with known-status convexo-concave valves, comparing its accuracy and that of a newly developed, geometric image magnification radiography system. Methods: Twenty-one sheep with mitral convexo-concave valves were studied on both systems. Five were used for extensive training. When operators were expert with both systems, images of four intact valves and 12 valves with outlet strut single leg separations, along with a seventeenth single leg separation valve used for calibration, were integrated into 112 image sets organized into a balanced incomplete block design for evaluation by eight trained, blinded reviewers. Results: Cineradiography sensitivity was 24% versus 31% for direct image magnification. The odds ratio for detection of single leg separation by direct image magnification versus cineradiography was 2.0 (95% confidence interval, 0.76 to 5.9; p = 0.13). Cineradiography specificity was 93% versus 90% for direct image magnification. Sensitivity and specificity varied markedly by reviewer, with sensitivity ranging from 8% to 55% and specificity from 51% to 100% for the combined technologies. Conclusions: The data support the need for more intensive training for convexo-concave valve imaging and further investigation of unconventional radiographic technologies. Clinical cineradiography of convexo-concave valves may detect as little as 25% of valves having a single leg separation, underestimating the prevalence of single leg separations and thereby implying more rapid progression to full fracture than is actually the case. (J Thorac Cardiovasc Surg 1998;115:582-90)

Quantitative assessment of the presence of a single leg separation in Björk-Shiley convexoconcave prosthetic heart valves.

The authors developed an analytic software package for the objective and reproducible assessment of a single leg separation (SLS) in the outlet strut of Björk-Shiley convexoconcave (BSCC) prosthetic heart valves. The radiographic cinefilm recordings of 18 phantom valves (12 intact and 6 SLS) and of 43 patient valves were acquired. After digitization of regions of interest in a cineframe, several processing steps were carried out to obtain a one-dimensional corrected and averaged density profile along the central axis of each strut leg. To characterize the degree of possible separation, two quantitative measures were introduced: the normalized pit depth (NPD) and the depth-sigma ratio (DSR). The group of 43 patient studies was divided into a learning set (25 patients) and a test set (18 patients). All phantom valves with an SLS were detected (sensitivity, 100%) at a specificity of 100%. The threshold values for the NPD and the DSR to decide whether a fracture was present or not were 3.6 and 2.5, respectively. On the basis of the visual interpretations of the 25 patient studies (learning set) by an expert panel, it was concluded that none of the patients had an SLS. To achieve a 100% specificity by quantitative analysis, the threshold values for the NPD and the DSR were set at 5.8 and 2.5, respectively, for the patient data. Based on these threshold values, the analysis of patient data from the test set resulted in one false-negative detection and three false-positive detections. An analytic software package for the detection of an SLS was developed. Phantom data showed excellent sensitivity (100%) and specificity (100%). Further research and software development is needed to increase the sensitivity and specificity for patient data.

Acoustic assessment of the physical integrity of Björk-Shiley convexo-concave heart valves.

Several lines of evidence indicate a two-stage failure mode for the Björk-Shiley convexo-concave (C/C) heart valve, in which one of the two outlet strut legs separates from the flange before the other, potentially providing an opportunity to identify and prophylactically replace failure-prone valves. Radiographic single leg separation (SLS) detection, although successful, is subjective and skill intensive, implying a need for both an objective preliminary screen and subsequent corroboration of the radiographic findings. We developed a time-windowed, power density analysis of C/C valve closing sounds to detect the vibrational resonance that characterizes the presence of an intact outlet strut in clinically functioning, 29-mm-flange size C/C valves. Recordings from more than 800 patients enrolled in radiographic SLS detection studies were analyzed, and the assessment algorithm was evaluated through a blinded test of 32 study valves for which the true status became known consequent to an autopsy or surgical explantation. Valves were objectively scored on a 0-to- 1 scale, with 1 being assuredly intact and scores of < 0.50 indicating a probable SLS. All except five valves (incorrectly designated probable SLS) were classified correctly, for a sensitivity of 1.00 (95% confidence interval, 0.79 to 1.00) and a specificity of 0.69 (0.41 to 0.89). This level of accuracy is sufficient to serve as an effective preliminary screen, potentially allowing a threefold concentration of SLS prevalence among the C/C valves of patients undergoing radiographic assessment. The value of acoustic classification in avoiding unnecessary operations prompted by false-positive radiographs is less certain.

Quantitative detection of outlet strut separations in Björk-Shiley convexo-concave mitral valves.

As of January 31, 1995, 564 outlet strut fractures (OSFs) of Björk-Shiley convexo-concave (BSCC) heart valves had been reported to the Shiley Heart Valve Research Center, of which approximately two thirds resulted in the death of the patient. Previous studies indicate that one leg of the outlet strut separates (single-leg separation, SLS) from the valve before the second leg breaks, which results in complete OSF. To identify those valves at risk of complete OSF, an in vivo radiographic imaging technique is being developed to evaluate the strut leg integrity. The goal of the present study was to develop an objective postprocessing technique to evaluate outlet strut leg integrity quantitatively in these cineradiographic images. Twenty-two sets (12 intact valves, 10 SLS valves) of cineangiographic images were obtained from individuals whose valve status was subsequently verified ex vivo. Several quantitative measures of SLS were evaluated to identify possible loss of metal or gaps in the SLS legs. Two of these measures, decrease in pixel intensity (DIPI) ratio and gap half-width, are diagnostic metrics of SLS: i.e., the maximum likelihood estimate of the area under the receiver operating characteristic curve was 0.892 (SD, 0.066) for a model based on DIPI ratio and 0.802 (SD, 0.093) for gap half-width. We have developed a postprocessing technique that can be used to objectively evaluate outlet strut integrity in cineradiographic images of BSCC heart valves. At an estimated specificity of 1.0, the estimated sensitivity of the objective review was comparable to that of a subjective expert review panel.

Radiographic detection of strut separations in Björk-Shiley convexo-concave mitral valves.

The outlet struts of Björk-Shiley convexo-concave heart valves can occasionally fracture. By December 31, 1994, 564 complete strut fractures had been reported to the manufacturer, approximately two thirds of which were fatal. There are no reliable diagnostic methods to detect valves that may be at risk for strut fracture. The outlet strut has two legs, and one leg often appears to break before the other, potentially permitting detection of the single-leg separation while the valve is still functionally intact. We used high-resolution cineradiography and defined valve profiles to evaluate 315 patients selected on the basis of their having mitral convexo-concave valves with an estimated fracture rate of 0.46 percent or higher per year. Two examinations were scheduled six months apart, with early reimaging performed when initial ratings were indeterminate. Three patients had unsatisfactory studies, the most recent examinations in 277 patients were rated as apparently normal, 23 had findings considered minimally suspicious, and 1 had findings termed suspicious. The number of false negative results in this study group is unknown. Eleven cineradiograms were rated as showing probable or definite single-leg separations. All five "definite" ratings and five of the six "probable" ratings were confirmed by removal of the valves. One valve with a "probable" rating was intact. Two complete outlet-strut fractures occurred three and seven months after apparently normal radiographic examinations. Unsuspected new positive findings were not found at six months among 288 patients who completed the examination cycle. Cineradiographic imaging can detect some single-leg separations in mitral convexo-concave valves and may help the estimated 41,000 patients with these valves worldwide and their physicians decide about elective valve removal.

Processing of prosthetic heart valve sounds for single leg separation classification.

People with serious heart conditions have had their expected life span extended considerably with the development of the prosthetic heart valve especially with the great strides made in valve design. Even though the designs are extremely reliable, the valves are mechanical and operating continuously over a long period; therefore structural failures can occur due to fatigue. In this paper acoustical signal processing techniques developed to process noisy heart valve sounds measured by a sensitive, surface contact microphone are discussed. Measuring heart sounds noninvasively in a noisy environment puts more demands on the signal processing to extract the desired signals from the noise. Heart valve sounds are short-duration (10-20 ms) transients and therefore nonstationary, requiring more sophisticated processing algorithms to achieve the desired signal-to-noise ratios. In this paper the preclassification signal processing is concentrated on exclusively. That is, the signal processing operations performed on the heart valve sounds prior to classification are discussed--a subject that will be developed in a future paper. Efforts are concentrated on the sounds corresponding to the heart valve opening cycle. Valve opening and closing acoustics present additional information about the outlet strut condition--the structural component implicated in valve failure. The importance of the opening sound for single leg separation detection/classification is based on the fact that as the valve opens, the disk passively hits the outlet strut. The opening sounds thus yield direct information about outlet strut condition with minimal amount of disturbance caused by the energy radiated from the disk. Hence the opening sound is a very desirable acoustic signal to extract. Unfortunately, the opening sounds have much lower signal levels relative to the closing sounds and therefore noise plays a more significant role than during the closing event. Because of this it is necessary to screen the sounds for outliers in order to insure a high sensitivity of classification. Because of the sharp resonances appearing in the corresponding spectrum, a parametric processing approach is developed based on an autoregressive model which was selected to characterize the sounds emitted by the Bjork-Shiley convexo-concave (BSCC) valve during opening cycle. First the basic signals and the extraction process used to create an ensemble of heart valve sounds are briefly discussed. Next, a beat monitor capable of rejecting beats that fail to meet an acceptance criteria based on their spectral content is developed.(ABSTRACT TRUNCATED AT 400 WORDS)

Classification of prosthetic heart valve sounds: A parametric approach

People with heart problems have had their lives extended considerably with the development of the prosthetic heart valve. Great strides have been made in the development of the valves through the use of improved materials as well as efficient mechanical designs. However, since the valves operate continuously over a long period, structural failures can occur--even though they are relatively uncommon. Here the development of techniques to classify the valve either as having intact struts or as having a separated strut, commonly called single leg separation, is discussed. In this paper the signal processing techniques employed to extract the required signals/parameters are briefly reviewed and then it is shown how they can be used to simulate a synthetic heart valve database for eventual Monte Carlo testing. Next, the optimal classifier is developed under assumed conditions and its performance is compared to that of an adaptive-type classifier implemented with a probabilistic neural network. Finally, the adaptive classifier is applied to a data set and its performance is analyzed. Based on synthetic data it is shown that excellent performance of the classifiers can be achieved implying a potentially robust solution to this classification problem.

Radiographic assessment of structural defects in Björk-Shiley convexo-concave prostheses.

Following the implantation of Björk Shiley 60 degrees convexo-concave (BS-CC) prostheses, outlet strut fracture rates up to 2.5% per year have been reported. According to experimental results and clinical observations, single leg separations are regarded as the primary mechanisms leading to complete outlet strut fracture after a certain interval. In an experimental study the question was addressed, whether single leg separation can be identified by especially developed radiographic means, before outlet strut fracture occurs. Five BS-CC mitral prostheses (29-31 mm) with intentionally made single leg separations of defined gas sizes (0-75 microns) and one intact mitral prostheses were implanted in sheep in a double-blind study design. Repeat non-invasive investigations were then performed applying a recently developed fluoroscopy imaging technique with direct radiographic magnification (DIMA COR C22). Single leg separations with gap sizes of more than 25 microns were properly detected using DIMA COR C22. Separations 25 microns or less could not be detected with certainty but were evaluated as probable or possible as a result of multiple investigations. The intact prosthesis was correctly identified, but was investigated on only one occasion. Non-invasive control of Björk-Shiley CC mitral prostheses applying especially developed direct radiographic magnification may allow for a reliable assessment of single leg separation with gap sizes of more than 25 microns in sheep. Using this technique of non-invasive serial investigations on particular patients with high probability of outlet strut fracture appears feasible, anticipating single leg separation detectability in humans. This has to be assessed in a second step.(ABSTRACT TRUNCATED AT 250 WORDS)