Prosthetic Malfunction Research Articles

Twenty Year Patient Survival and 17 Year Complications of Isolated Mitral Biocor Standard Porcine Valve

Objective: Performance of the prostheses must be verified in the time domain. We report the 20-year survival of 230 patients operated of mitral replacement with Biocor Standard prosthesis in Padova and Verona and the 17 year prosthetic failure and complications of the series of Padova. Methods: 230 patients, 150 females and 80 males, aged 71 ± 6.3 received 235 isolated mitral Prostheses in Verona (67) and Padova (168), between June 1989 and August 2004. Twenty-year survival including 1698 patient-years was complete. Prosthesis survival was evaluated in the patients of Padova with a 90% goodness of follow-up and included 905 patient-years. Results: Twenty-seven operations were done in the eighties, 168 in the nineties, 52 in this century. Three operations were emergent, 20 urgent. The indication was prosthetic malfunction in 50 cases (21.7%), regurgitation in 114 (49.6%), stenosis in 22 (9.7%), mixed lesion in 44 (19.1%), concomitant CABG (Coronary Artery Bypass Graft) was performed in 23%. Overall survival was 6% (2-13%), Thirty day mortality was 8.9% (5.6-13.3%). The early hazard phase extended to 2.5 years with a linearized rate 1.4%/patient-years vs. a late rate of 7.2%/patient-years. Seventeen years freedom from reoperation was 80.5% (55.3-92.3%), actual 92% (86.4-94.5%), from SVD (Structural Valve Degeneration) 85.2% (52.6-96.1%) actual 94% (88.2-96.7%), from perivalvular leak 92.6% (86.5- 96%), from embolism 83.1% (73-89.7%), from haemorrhage 83.8% (71.5-91.1%), from endocarditis 90.9% (82.4- 95.4%), from pacemaker 77% (60.2-87.5%). Conclusion: Mitral Biocor has optimal durability and average complications. Premature mortality (6% vs. 30% survival of US (United States) matched population) is unrelated to prosthesis performance and suggest failure of our surgical strategy of the past century. Ultra mini abstract: 20 year Survival of patients is disappointing (6%) when compared to the matched US population (30%). The 17 year performance of the Biocor standard device compares with the best available prostheses. This therefore suggests an overall failure of our surgical strategy of the past century.

Postmitral Valve Replacement Biatrial, Septal Macroreentrant Atrial Tachycardia Developing After Perimitral Flutter Ablation

Atypical macroreentrant atrial tachycardias are frequently encountered in patients after cardiac surgery, correction of congenital heart disease, or atrial fibrillation ablation. Ablation of one circuit can produce an abrupt change in atrial activation sequence giving rise to another macroreentrant circuit. In this report, we present a unique case of a biatrial septal macroreentrant atrial tachycardia, which developed after perimitral flutter ablation in a patient with mitral valve replacement. Editor’s Perspective see p 175 A 59-year-old man with a mitral valve replacement (bioprosthesis) in 1983 for a rheumatic mitral stenosis and a rereplacement in 1999 (right-sided approach with a vertical incision of the interatrial septum) with a mechanical prosthesis attributable to the degeneration of the former prosthesis was referred for the ablation of a sustained atrial tachycardia with a stable cycle length of 260 ms. The echocardiogram demonstrated a left ventricular ejection fraction of 45% to 50%, a moderately dilated right atrium (RA) as well as left atrium (LA) without signs of a prosthetic malfunction. The baseline surface 12-lead ECG showed an atypical atrial flutter with a regular, monomorphic atrial activity and an irregular atrioventricular conduction (Figure 1A). With broad positive flutter waves in unipolar lead V1 and inferior limb leads II, III and avF but negative flutter waves in limb leads I and avL, the ECG morphology suggested LA localization. Any significant 12-lead isoelectric interval was absent. Endocardial activation mapping with a quadripolar catheter in the RA and a steerable octapolar catheter in the coronary sinus (CS; Bard Medical, Covington, GA) demonstrated a distal to proximal activation sequence in the CS with a baseline cycle length of 260 ms, suggestive of a lateral to septal activation of the LA posterior wall (Figure 1B). An irrigated tip ablation catheter (Navistar Thermocool, Biosense Webster, Diamond Bar) was advanced into the LA via …

1817 CONCORDANCE BETWEEN PATIENT AND PHYSICIAN ASSESSMENT OF PEYRONIE'S DISEASE DEFORMITY

INTRODUCTION AND OBJECTIVES: The inflatable penile prosthesis is an effective treatment for patients with Peyronie’s disease and erectile dysfunction. Penile prosthetic modeling is often required during implantation and may cause stress to the device. We compare our results of penile prosthetic modeling and malfunction rates. METHODS: We retrospectively reviewed 126 consecutive patients who underwent implantation of three-piece inflatable penile prosthesis (IPP) by a single surgeon (HSC) at our institution from March 2003 to February 2010. We compared those with (7) and without (119) device malfunctions. Variables include age, body mass index (BMI), Peyronie’s disease (PD), diabetes, prior penile prosthetic implant, penile modeling, concomitant artificial urinary sphincter (AUS) placement, operative time and estimated blood loss. Patients were followed for infection, hematoma and malfunction rates. We defined device malfunction as need for removal and/or replacement of device due to non-working components. Standard modeling procedure was always performed during implantation if there was evidence of curvature with or without Peyronie’s plaque. The results were assessed using t-tests and regression analysis with p 0.05 considered statistically significance. RESULTS: In all, 126 men were analyzed. Average age and BMI were 61.1 10 and 28.6 5.4, respectively. Mean follow-up (range) was 17.1 (0.2–87.3) months. There were a total of 7 (5.5%) component malfunctions (median time 30.8 months). Nineteen (15%) patients had PD. Overall, 45 (35.7%) required penile modeling compared to 81(64.3%) without modeling. Of the 7 device malfunctions, only 1 underwent penile modeling. All patients with PD underwent modeling and none had device failure. Fifty-two (41%) were diabetic, 22 (17.4%) had a prior implant and 8 (6.2%) had concomitant AUS placement. On univariate analysis, BMI, diabetes, prior penile implant, and concomitant AUS placement were significant predictors for malfunction (p 0.05). On multivariate analysis, prior penile implant and concomitant AUS placement were significant (p 0.05). Modeling with PD (p 0.13) and modeling without PD (p 0.34) were not significant predictors of malfunction. Infection (p 0.29) and hematoma (p 0.29) rates were similar between the two groups. Lastly, there were no urethral injuries in our series. CONCLUSIONS: Our results indicate that penile modeling with or without Peyronie’s disease at the time of IPP implantation does not affect device malfunction rates.

Arthroplastic and osteosynthetic infections due to Propionibacterium acnes: a retrospective study of 52 cases, 1995–2002

The cases of 52 patients with Propionibacterium acnes infection of orthopaedic implants are summarized: 20 patients with definite infection (sepsis, with P. acnes recovered from multiple specimens per patient), 15 with probable infection (sepsis, with P. acnes recovered from one specimen), and 17 with possible infection (signs of prosthetic malfunction or pseudo-osteoarthritis, with P. acnes recovered from one specimen). The patient population consisted of 37 males and 15 females with a mean age of 51.8 years (range 17-88). Besides bone surgery, 21% of these patients had severe coexisting illness. The study population was very heterogeneous and clinical presentation very polymorphic; infections became clinically apparent through sepsis, prosthetic malfunction, or a delay in consolidation. The diagnosis was highly dependent on the quality of the samples taken and the methodology used by the microbiology laboratory to isolate this bacterium. Culture time was long, on average 11.4 days. Treatment involved a combination of antibiotic treatments (67% of cases) and ablation of the material (83% of cases). Although P. acnes is considered to be weakly pathogenic, this bacterium may be responsible for infections in patients with implanted orthopaedic material. Ablation of the arthroplastic or osteosynthetic material is necessary in the majority of cases.

Infection secondaire de prothèse articulaire. Critères du diagnostic, traitement

Per-operative contamination is the most frequent cause of prosthetic joint infection. In other cases, contamination results from bacteremia which may be symptom-free, and this situation defines secondary infection. Several factors, whether isolated or combined, are important to establish this diagnosis: prolonged symptom-free interval, bacterial agent not usually encountered in per-operative infections, presence of a distant septic focus, positive blood cultures, identical bacteria isolated from the prosthesis and the distant focus or blood cultures. A probability score is being devised in order to attribute a value to each of these parameters. Infection may be acute or chronic with prosthetic malfunction, but an acute transitory episode (dental, ENT, cardiovascular or digestive, etc.) may be elicited through questioning the patient. Microbiological diagnosis is mandatory (joint puncture and deep surgical samples, blood cultures, samples from portal of entry) before initiating antibiotic treatment: this treatment will initially be probabilistic, and secondarily adapted. From the surgical point of view, lavage and synovectomy must be conducted after wide incision, with removal of all suspect tissue. Conservation of foreign material must be tested, although its advantage has not been confirmed. After a lapse of 21 days, prosthetic material should be removed, bone interface should be scrubbed and immediate or delayed material replacement should be conducted. Investigation and treatment of portal of entry should be initiated without delay. Prevention of secondary infection consists mainly in investigating and treating all focal infections. Any invasive procedure, whether consisting or not in implantation of foreign material, may be incriminated: venous, bladder catheterization, wounds, dental care, cancer, endoscopy, urinary tract infection. The benefits versus risks derived from antibiotic prophylaxis have not been documented.

Aortic dissection with fistula to left atrium: Diagnosis by transesophageal echocardiography with successful repair

The aorta-atria fistula is an infrequent complication of aortic dissection, and it is rarely diagnosed before death. A 41-year-old man who 8 years previously had undergone prosthetic aortic valve replacement had an aortic dissection complicated by aorta-left atrial fistula. This patient had acute left heart failure associated with a systolic and diastolic murmur at the lower left sternal border suggesting an aortic prosthetic malfunction. The cardiac diagnosis was made with transesophageal echocardiography and Doppler color flow imaging; it was notable that the cardiac lesions were not detected by transthoracic echocardiography. On the basis of the echocardiographic findings, the patient underwent successful emergency replacement of the dissecting ascending aorta with closure of the aorta-left atrial fistula. Transesophageal echocardiography is the procedure of choice for defining this abnormality. In this case a prompt surgical repair consisting of replacement of the affected segment of the aorta with the prosthesis and closure of the fistula provided optimum resolution of the clinical situation.

Fístula aorta-aurícula derecha como complicación de endocarditis protésica precoz

Early infectious endocarditis occurs in 3% of prostheses in the first 12 months after valvular surgery and is more aggressive than late prosthetic endocarditis. Mortality remains high, especially in early cases, despite combined medical and surgical treatment. Clinical manifestations of early cases are due to both bacteremia and prosthetic malfunction, and is mainly caused by staphylococci. We present a case report of early prosthetic endocarditis in aortic prostheses complicated with severe aortic regurgitation and right atria-aortic root fistula with auriculoventricular and intraventricular disturbance in electrocardiogram.

Bioprosthetic mitral valve thrombosis: Clinical profile, transesophageal echocardiographic features, and follow-up after anticoagulant therapy

Cardiac bioprosthetic valve thrombosis is frequently found on pathologic examination, but preoperative diagnosis is rarely performed. Four hundred six patients with mitral porcine xenograft bioprostheses were examined by transthoracic echocardiography. Transesophageal echocardiography (TEE) was performed in 161 of the patients, with clinical or echocardiographic criteria of prosthetic malfunction. Fairly homogeneous and echodense masses, attached to the ventricular surface of the mitral bioprosthetic cusps, were detected by TEE in 15 patients. Only 10 patients, in whom diagnosis of bioprosthetic thrombosis was confirmed, are included in this study. After TEE, two patients underwent prosthetic replacement and eight patients received anticoagulants. A new TEE was performed 85.6 ± 29.8 days after anticoagulation in these eight patients. Clinical follow-up was continued for 13.6 ± 8.6 months, and one additional patient underwent surgery during the follow-up. Pathologic examination of removed grafts (three cases) identified these masses as being thrombotic tissue. TEE examination after therapeutic anticoagulation demonstrated complete disappearance of the echogenic masses on bioprosthetic cusps and normal mobility of all leaflets in six cases. In the other two cases, cusp masses were notably reduced, but partially restrictive mobility of affected leaflets persisted, suggesting incomplete resolution of thrombi. Mitral valve prosthetic mean gradient decreased from 11.8 ± 4.5 to 7.6 ± 3.7 mm Hg ( p < 0.001), and mitral valve area increased from 1.13 ± 0.3 to 1.72 ± 0.6 cm 2 ( p < 0.001). Long-term symptomatic improvement after anticoagulation was obtained in seven patients. Thus this study shows that mitral bioprosthetic thrombosis is a relatively frequent cause of valve dysfunction, TEE is useful for detecting thrombus in relation to mitral bioprosthetic valves, and oral anticoagulation is effective in resolving thrombosis on bioprostheses.

Clinical experience with rapid acquisition cardiovascular CT imaging (cine CT) in the adult patient.

In this overview of cine-CT technology and its clinical application, the authors discuss the unique features of the imaging unit and describe the scanning programs and projections available for cardiac studies. Application of the unit to physiologic studies (e.g., cardiac output and ejection fractions) are illustrated, and examples of the value of the unit for the diagnosis of septal defects, aortic dissection, valvular regurgitation, prosthetic value malfunction and coronary artery bypass graft occlusion are presented.

Echo-phonocardiographic evaluation of the Björk-Shiley mitral prosthesis

Ninety patients were studied with combined echophonocardiography after Björk-Shiley disc prosthetic mitral valve replacement. They were evaluated every 6 months (mean follow-up 6 years). Nine cases of left ventricular (LV) failure and 6 cases of prosthetic malfunction (5 paravalvular leaks and 1 thrombosis) were detected; 1 case was confirmed at necropsy and the other 5 cases were surgically verified and repaired. The following measures of prosthetic malfunction were evaluated: opening and closing velocity, maximal amplitude of the prosthesis, septal motion 6 months after operation, LV diastolic diameter, protodiastolic hump, variations during same record of the interval between aortic valve closure sound to the phono and mitral valve opening to the echo, and interval between aortic valve closure sound and maximal excursion of the LV posterior wall. All measures studied were useful for detecting prosthetic malfunction, but 2 are more useful in individual cases: variations of the Interval between second heart sound and mitral valve opening and the interval between the aortic valve closure sound and LV posterior wall motion. These 2 intervals also allow discrimination between normal function, prosthetic malfunction and LV failure.

Postoperative Histological Diagnosis in Two Cases of Unsuspected Bioprosthetic Endocarditis

Two cases of preoperatively unsuspected porcine bioprosthetic endocarditis are presented. Both cases, thought to be a sterile thrombosis and a primary tissue failure respectively, were correctly diagnosed only with histological examination. Cultures and histological examination of the explanted tissue are necessary for a definite diagnosis in every case of prosthetic malfunction.

A decade of experience with the Model 103 and 104 Beall valve prostheses

Mitral or tricuspid valve replacement with the Beall Model 103 or 104 prosthesis has been associated with a high incidence of late prosthetic malfunction which has necessitated reoperation. Between 1972 and 1975, 57 patients underwent single valve replacement (55 mitral and two tricuspid) with Beall Model 103 or 104 valvular prostheses and survived at least 2 years. The mean follow-up time was 73.7 months (range 24 to 119 months). Of these patients, 22 required explantation of the prosthesis; there was an operative mortality of 27%. Major prosthetic malfunction occurred in four patients: Two occluders were embolized and two occluders were fixed in the open position. All four patients required urgent operation, and two of them died. The development of symptoms of congestive heart failure, systolic murmur, or hemolysis were the reasons for cardiac catheterizations and possible reoperation. Nineteen patients had cardiac catheterization. Fifteen of these subsequently underwent reoperation, with a mortality of 26%. Three patients were considered inoperable. Cardiac catheterization data revealed significant prosthetic regurgitation in all patients: pulmonary capillary pressure 29.9 mm Hg +/- 6.7 (standard deviation); V wave 31.5 mm Hg +/- 12.0; left ventricular end-diastolic pressure 18.0 mm Hg +/- 7.8. Comparison of hemolysis indicators in this group to those of asymptomatic patients revealed that the former had a significant elevation in lactic dehydrogenase (p = 0.038) and a lowered hematocrit value (p = 0.017). Waiting for severe symptomatic deterioration to justify reoperation risks the development of left ventricular dysfunction and possible emergency reoperation with a high operative mortality.

Endocarditis in patients with bioprostheses: pathology and clinical correlations

We studied 13 porcine bioprostheses removed from patients with endocarditis at our institute during the last 4.5 years. All bioprostheses had been removed at reoperation and were analyzed using anatomical and histological techniques. Each bioprosthesis was found to have developed rather constant lesions which were not related to the type of bioprosthesis. The stage of infection was not related to the duration of implantation. The presence of perivalvular abscesses was an ominous finding, often being the seat of persistent endocarditis. Our good clinical results of reoperation lead us to suggest that this be performed early once valvular or prosthetic malfunction is detected. Bioprostheses are, in our experience, the best choice in the surgical treatement of prosthetic valve endocarditis.

The need for cardiac catheterization and angiography in valvular heart disease is not disproven.

Valve replacement is the most important advance in the management of patients with valvular heart disease, but it cannot be recommended to all patients with valve disease. Cardiac catheterization and angiography, done before surgery, yield valuable and essential information in evaluating these patients. The claim of certain studies that cardiac catheterization and angiography are not needed in these patients cannot be accepted because: The experimental method of these studies was inappropriate; the accuracy and reproducibility of noninvasive techniques in diagnosing the presence and severity of all valve lesions, coronary arterial obstruction, and prosthetic malfunction are not documented; and the studies provide no proof that patients with severe valve disease were not denied surgery, and that patients with mild disease did not have unnecessary operations. Prospective studies that are well designed, well conducted, and scientifically sound are needed. Cardiac catheterization and angiography remain the standard techniques for evaluating patients for valve replacement.

Late thrombotic malfunction of the Björk-Shiley tilting disc valve in the tricuspid position. Principles for recognition and management.

Among 52 consecutive patients surviving tricuspid valve replacement with the Björk-Shiley tilting disc valve, follow-up extends between 1/2-9 years, mean 4.9 years. Four patients suffered thrombotic obstruction of their tricuspid prosthesis on 8 occasions, an incidence of 3.2%/year. Ebstein's anomaly and deficient anticoagulation were identified as likely contributory factors, but the complication remained unexplained in 2/8 instances. Thrombotic malfunction of the tricuspid prosthesis seems to constitute a relatively benign clinical entity with mild manifestations and diagnostic possibilities by non-invasive methods. Relief by means of thrombolytic treatment in the form of streptokinase (Kabikinase) (4) or replacement of the clotted prosthesis (4) involved neither disabling complications nor mortality. Our clinical observations and experimental studies suggest that thrombolytic therapy is effective, provided that prosthetic malfunction is due to a recent red clot, whereas encapsulation of the prosthetic disc by organized white-grey pannus necessitates re-operation. Streptokinase treatment should be attempted before surgery, but it is hardly meaningful to proceed for more than 24 hours. Restored prosthetic function within this time limit indicates the likely resolution of a red clot.

Traumatic cardiac hemolytic anemia: a late complication of a Starr-Edwards mitral valve prosthesis

Severe, traumatic, cardiac, hemolytic anemia developed in a patient nine years after mitral valve replacement with a Starr-Edwards model 6120 prosthesis. Cardiac catheterization failed to demonstrate a perivalvular leak or prosthetic malfunction. Transfusion on two occasions resulted in accelerated hemolysis and failed to maintain an appreciable elevation of the hemoglobin level. At operation, a perivalvular leak was found. Replacement of the valve led to complete resolution of the hemolytic problem. The case demonstrates that cardiac hemolysis may be a good indicator of valve dysfunction.

Traumatic Cardiac Hemolytic Anemia

Severe, traumatic, cardiac, hemolytic anemia developed in a patient nine years after mitral valve replacement with a Starr-Edwards model 6120 prosthesis. Cardiac catheterization failed to demonstrate a perivalvular leak or prosthetic malfunction. Transfusion on two occasions resulted in accelerated hemolysis and failed to maintain an appreciable elevation of the hemoglobin level. At operation, a perivalvular leak was found. Replacement of the valve led to complete resolution of the hemolytic problem. The case demonstrates that cardiac hemolysis may be a good indicator of valve dysfunction. (<i>Arch Intern Med</i>139:374-375, 1979)

Malfunction of Cutter-Smeloff mitral prosthesis: An echocardiographic diagnosis

Progression of intermittent partial or total impaction of the poppet from a prosthetic mitral valve may be difficult to evaluate in patients with chronic obstructive pulmonary disease and atrial fibrillation. Heart sounds may be distant; opening and closing clicks of the poppet are muffled and irregular. Echocardiography provides a noninvasive method to detect early prosthetic malfunction at a time when the patient is clinically asymptomatic.

Echocardiographic study of malfunction of the Bjork-Shiley prosthetic heart valve in the mitral position

This report presents an echocardiographic study of four cases of malfunction of the Bjork-Shiley prosthetic heart valve in the mitral position. The malfunction was proved in all patients by cardiac catheterization, observation at cardiac surgery or findings at postmortem examination. Two distinctive motion patterns of the malfunctioning valves were detected in the echocardiogram. One was a rounded and slowed pattern of opening and closure that correlated with the presence of abnormal clotting on the prosthesis (two patients). The other was an unusual “hump” during the opening phase that correlated with significant perivalve leak (two patients). These patterns along with other observations appear to be valuable in recognizing mitral valve Bjork-Shiley prosthetic malfunction with echocardiography.

Echocardiographic Diagnosis of a Stuck Bjork-Shiley Aortic Valve Prosthesis

A 55-year-old man who had been asymptomatic after replacement of his aortic valve with a Bjork-Shiley prosthesis, suddenly developed heart failure. The clinical suspicion of prosthetic malfunction was not only confirmed, but specified as being a stuck disc secondary to a large thrombus. Surgical removal of the clot resulted in restoration of normal function and return to the expected findings on echocardiogram. The value of echocardiography in such instances, as well as in routinely following-up patients with prostheses postoperatively, is emphasized.