Prosthetic Leak Research Articles

Early anticoagulation after aortic valve replacement with porcine bioprosthesis randomized control trial (ANTIPRO).

Most evidence for anticoagulation (AC) in aortic bioprosthesis is centred on embolic events, bleeding and reintervention risk. The effect of AC on haemodynamics has not been previously assessed. Our hypothesis was that patients with early AC after aortic valve replacement (AVR) with porcine bioprosthesis have better haemodynamics at 1 year of follow-up. Prospective, randomized, open-label trial conducted at 2 cardiac surgery centres. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The anticoagulated group received warfarin + aspirin and the non-anticoagulated (control) only aspirin. The primary outcome was mean gradient after 1 year of AVR and change in New York Heart Association class. Secondary outcomes were major and minor bleeding, embolic events and prosthetic leak. Of 140 participants in the study, 71 were assigned to the anticoagulated group and 69 to the control group. The mean age of the overall population was 72.4 (SD: 7.1) years. Global EuroSCORE was 7.65 (SD: 5.73). At 1 year, the mean gradient was similar between both groups [18.6 (SD: 1.1 mmHg) and 18.1 (SD: 1.0 mmHg) in the control and anticoagulated groups, respectively, P = 0.701]. No differences in functional class at 3 months or 1 year were found among groups. No differences were found among groups in the secondary outcomes. The addition of 3 months of oral AC to anti-aggregation treatment was not detected to affect bioprosthetic haemodynamics nor functional class at 1 year after AVR. Likewise, AC does not lead to the higher incidence of complications.

TCT-253 Transcatheter Device Closure of Paravalvular Leaks: A Single-Center Experience

Paravalvular prosthetic leak (PVL) leads to hemolysis, heart failure, and increased risk of infective endocarditis. Transcatheter closure (TCC) of PVL is an alternative to surgery; however, it is challenging due to varied anatomy. Retrospective analysis of patients undergoing TCC for PVL over a 6-

Outcomes and predictors of success and complications for paravalvular leak closure: an analysis of the SpanisH real-wOrld paravalvular LEaks closure (HOLE) registry.

The aim of the study was to assess the safety and efficacy of percutaneous closure of paravalvular prosthetic leak (PVL) and to identify the predictors of procedural success and early complications. A total of 514 first-attempt percutaneous PVL closure in 469 patients were included at 19 centres. Technical and procedural success was achieved in 86.6% and 73.2% of the patients, respectively. In multivariate analysis, the independent predictors for procedural success in mitral lesions were the type of device used (AMPLATZER AVP III vs. others, HR 2.68 [1.29-5.54], p=0.008) and the number of procedures performed at the centre (top quartile vs. others, HR 1.93 [1.051-3.53], p=0.03). For aortic leaks the only predictor of procedural success was the leak size (≥10 mm vs. <10 mm, HR 3.077 [1.13-8.33], p=0.027). The overall major adverse events rate (death or emergency surgery or stroke) at 30 days was 5.6%; the only predictor for combined adverse events was New York Heart Association functional Class IV (HR 4.2 [1.42-12.34], p=0.009). Percutaneous closure of PVL can be performed with a reasonable rate of procedural success and a low rate of major complications. The type of device used, the accumulated experience and the leak size are predictors of procedural success.

The Contribution of Echocardiography in the Dysfunctions of Mechanical Prosthesis: Report of 11 Cases

Introduction: The echocardiography has an essential place in the surveillance of prostheses. The aim of our study was to describe the echocardiography aspects of dysfunction of valvular prostheses. Materials and methods: This is a retrospective study, which collected all patients admitted for dysfunction of mechanical prosthesis bileaflet in the cardiology department of Marrakech during a period of 2 years. Results: We included 11 patients. The mean age was 43 years. Seven cases were carrying a mitral prosthesis, 3 patients with aortic prosthesis and one case a double valve. The average age of prostheses was 3.7years. All prosthesis was an ON-X type. The prosthesis dysfunction was revealed by an infectious syndrome (27%), acute heart failure (18%), ischemic stroke (18%), while 36% were asymptomatic. The Transthoracic Echocardiography (TTE) was pathological in 10 cases: a reduction in the functional surface prostheses with increased transprosthetic gradient (54%) significant par prosthetic leak (45%), a thrombus in one case, an anomaly of the movements of leaflet (18%). The Echo-Transesophageal (TEE) made in 8 patients, objectified images of thrombi (3 cases), Para prosthetic leaks (6 patients), abnormal of the movements of leaflet (4 cases). Conclusion: Echocardiography is the gold standard for the diagnosis of prosthetic dysfunction with superiority of TEE over TTE. Keywords: Dysfunction; Mechanical prosthesis bileaflet; Echocardiography; Valvular prosthesis; Mitral prosthesis. Abbreviation: DVI : Doppler Velocity Index EOA : Effective Orifice Area EROA : Effective Regurgitantorifice Area LV : Left Ventricular LVOT : Left Ventricular Outflow Tract MPG : Mean Pressure Gradient PHT : Pression Half Time PHV : Prosthetic Heart Valves R Vol : Regurgitant Volume TEE : Transesophageal Echocardiography TTE : Transthoracic Echocardiography TVI : Time velocity Integral VC : Vennacontracta

Guidance of Treatment of Perivalvular Prosthetic Leaks

Percutaneous closure of paravalvular leaks has grown into becoming a widely considered option for treatment of hemodynamically significant regurgitation in patients with valve prosthesis. Guidance provided by the use of cardiovascular imaging techniques before and during the intervention has proved its relevance to improve accuracy and, with it, the outcome of the procedure. It has also been essential in the successful evolution of the technique and the development of devices specifically designed for it. The present work reviews the role of imaging before, during and after treatment of perivalvular prosthetic leaks and the most recent and significant advances in it.

Transcatheter aortic bioprosthesis dislocation: technical aspects and midterm follow-up

Prosthesis dislocation during transcatheter aortic valve implantation (TAVI) is a rare but important complication. There is scarce data on the performance of prosthesis in the aorta that have become dislocated from their intended anatomical position in the aortic annulus. We investigated the causes of dislocation during TAVI of the self-expanding CoreValve ReValving™ System (CRS) (Medtronic Inc., Minneapolis, MN, USA). This included midterm follow-up of patients experiencing this acute complication. Among 176 consecutive patients undergoing TAVI with the CRS prosthesis, seven (3.9%) experienced acute valve dislocation. A comprehensive analysis of the mechanism of dislocation and clinical outcomes of patients experiencing this complication was performed. Based on the underlying mechanism, all cases of prosthesis displacement were classified into the following three groups: 1) accidental dislocation immediately after valve implantation (n=1; 14.3%); 2) dislocation during the snaring manoeuvre to reposition a low deployment of the CRS prosthesis (lower edge >10 mm) below the aortic annulus accompanied with haemodynamically significant regurgitation (n=4; 57.1%); 3) intentional dislocation performed with the snaring manoeuvre as a bailout in cases of coronary ostia impairment or severe prosthetic leak due to higher deployment for a suboptimal sealing of the device with valve calcifications (n=2; 28.6%). The majority of cases occurred during early experiences with the new Accutrak™ (Medtronic Inc., Minneapolis, MN, USA) delivery system. In six patients a second CRS was implanted in the appropriate position. The dislodged CRS functioned normally, without any evidence of structural deterioration, thrombosis or further distal migration and showed complete apposition against the aortic wall. No thromboembolic events were reported in any patient. Dislocation of a CRS device can be managed effectively with the implantation of a second device in a standard fashion leaving the dislocated device safely in the aorta. Intentional repositioning of a CRS device in the aorta can be accomplished by experienced operators without any serious neurologic or vascular events in the post-procedure period or at midterm follow-up.

Outcomes and adverse events of enlarged tracheoesophageal puncture after total laryngectomy

Enlargement of the tracheoesophageal puncture (TEP) results in aspiration around the voice prosthesis (VP) and may lead to pneumonia. The primary objective was to summarize control of leakage around the VP after conservative management of enlarged TEP. Retrospective cohort study. This 5-year cohort included 194 patients who underwent total laryngectomy (with or without pharyngectomy) and TEP at the University of Texas MD Anderson Cancer Center. Control of leakage around the VP was analyzed at last follow-up after enlarged TEP. Adverse events were compared in patients with and without enlarged TEP. The incidence of enlarged TEP was 18.6% (36 of 194, 95% confidence interval [CI]: 13.0%-24.1%). Conservative methods commonly attempted in lieu of complete TEP closure included placement of an enlarged-flange VP (34 of 36, 94%), temporary VP removal (14 of 36, 39%), and TEP-site injection (8 of 36, 22%). At last follow-up, conservative methods controlled leakage around the VP in 81% (29 of 36) of patients. Only two patients required complete TEP closure due to persistent leakage after enlarged TEP. Unresolved leakage was more common in patients with recurrent cancer after laryngectomy (P = .081) and irregular TEP contour (P = .003). Relative to controls without TEP enlargement, patients with enlarged TEP had a three-fold higher risk of pneumonia (relative risk: 3.4, 95% CI: 1.9-6.2) and aspiration of the prosthesis (relative risk: 3.3, 95% CI: 0.8-14.1). Although the rate of enlarged TEP is relatively low, the complication significantly elevates risk of pneumonia. Prosthetic leakage related to TEP enlargement can often be managed conservatively to avoid complete closure of the TEP.

Percutaneous Transcatheter Closure of a Paravalvular Leak in a 20-Month Old Child

A 20-month-old boy was referred to the cardiac catheterization laboratory for closure of a large prosthetic mitral valve paravalvular leak. At birth, the boy had an unbalanced atrioventricular septal defect with borderline hypoplasia of the mitral component of the common atrioventricular valve and the left ventricle. At the age of 3 months, the boy underwent complete (two-ventricle) repair. The intraoperative findings included deficient left-sided atrioventricular valve tissue. As a result of the surgical septation, the coronary sinus ostium was located in the left atrium. The boy initially did well, but 6 weeks after his initial surgery, progressive and severe mitral regurgitation developed, necessitating mitral valve replacement with a 19-mm St. Jude prosthetic valve in the supraannular position. A small (posteromedial) paravalvular prosthetic mitral leak was noted approximately 6 months after surgery. This leak became progressively worse, resulting in moderate to severe functional mitral regurgitation and worsening left ventricular dilation. A dilated structure posterior to the left atrioventricular groove also was noted to be expanding. This structure was interpreted by echocardiography as an aneurysm of the coronary sinus. Three-dimensional (3D) echocardiography helped to define the anatomy of the leak (Fig. 1a/Movie 1a in supplementry material). At the age of 20 months, the boy was referred for cardiac catheterization with planned closure of the leak.

Transcatheter closure of paravalvular mitral prosthetic leak with resultant hemolysis

Reoperations for mitral prosthetic paravalvular leaks presenting with heart failure or hemolysis are associated with significant morbidity and mortality. Transcatheter options offer an attractive alternative, though the method is under evolution and outcome is varied. This report gives procedural details of transcatheter closure of mitral paravalvular leak with Amplatzer septal occluder device.

Mitral Valve Replacement in a Severely Calcified Posterior Annulus: A Novel Technique

We describe a technique for insertion of a mitral valve prosthesis in the presence of severe posterior annular calcification by plicating the left atrial tissue over the sewing ring. Extensive calcification often creates the technical difficulty of seating the prosthetic valve resulting in peri prosthetic leakage. Extensive decalcification may weaken the annulus and result in prosthetic valve dehiscence and atrioventricular dissociation.

Sustitución valvular urgente en la endocarditis infecciosa: evolución hospitalaria y a largo plazo. Análisis de 45 pacientes

To define the evolution of patients with infective endocarditis who require urgent valve replacement in our environment. We followed 45 consecutive cases of infective endocarditis that require valve replacement during their hospitalization. 32 patients had native valve infective endocarditis, 7 early prosthesis valve endocarditis and 6 late prosthesis valve endocarditis. Patients were followed for a long-term period, clinical and echocardiographycally. In 39 cases valve replacement was performed before ending antibiotic therapy. The main indications for surgery were refractory heart failure (24 patients) and shock (11 patients). The mortality rate was 24%: 19% in native valve infective endocarditis, 43% in early prosthetic valve endocarditis and 33% in late prosthesis valve endocarditis. The first cause of death was septic shock (46%). We followed 31 over 34 survivors for a mean time 65 (DS 49) months. We found two relapses and six deaths (1 sudden death, 2 endocarditis) and 72% of patients presented class I NYHA. We detected 17% prosthetic leaks (34% in the prosthetic valve endocarditis group). The need of urgent valve replacement in the context of infective endocarditis is associated with a high mortality rate, and should be considered a serious condition. Long term prognosis is, however, acceptable, although 17% of patients had prosthesis leak, specially those with prosthetic valve endocarditis.

Overestimation of flow velocity through leaks in mechanical valve prostheses and through small orifices by continuous-wave Doppler

The reliability of continuous-wave Doppler flow velocity measurements through small regurgitant lesions, such as in prosthetic leakage, has not been systematically analyzed. To evaluate the accuracy of continuous-wave Doppler in prosthetic valve leakage and small orifices in an in vitro, steady-flow model-flow velocities through the leaks of twelve intact mechanical prostheses and through six circular nozzles (area 0.5 to 20 mm2) were measured at pressure drops between 30 and 105 mm Hg. These results were compared with those predicted by the modified Bernoulli equation. Laser Doppler anemometry of flow velocities through the nozzles was also performed. Despite high correlation, there was substantial overestimation of Bernoulli predicted velocities by echo Doppler in the prosthetic leaks (mean +12.3% +/- 9.4%; range 90.3% to 143.4%). In the nozzles < or = 10 mm2, but not in the largest (20 mm2) nozzle, there was also overestimation of the Bernoulli predicted velocities (mean +6.2% +/- 2%). Laser Doppler anemometry of flow velocities through the nozzles showed slightly lower values than predicted by the Bernoulli equation. Thus, continuous-wave echo Doppler overestimates flow velocities through small orifices. This apparently is, at least in part, due to transit time effects and should be taken into account when using echo Doppler in small (< 10 mm2) orifices, such as in mild to moderate regurgitant lesions and prosthetic valve leakage.

Clinical outcome and long-term prognosis of late prosthetic valve endocarditis: a 20-year experience.

A prospective study of the clinical characteristics and evolutionary patterns of 59 cases of late prosthetic valve endocarditis (LPVE) that occurred between January 1975 and December 1994 was performed. Of these 59 cases of LPVE, 48 involved mechanical valves and 11 involved biological valves. Etiologies were as follows: streptococci, 41% of cases; staphylococci, 25%; enterococci, 13%; and miscellaneous, 21%. Echocardiography documented vegetations in 21 patients, paravalvular abscesses in 10, and prosthetic leaks in 34. Emboli occurred in 22 patients, and heart failure in 19 patients. Forty-two patients received medical treatment alone, and 17 received medical treatment and underwent valve replacement surgery. The in-hospital mortality rate was 25%; staphylococcal infection caused 67% of deaths, streptococcal infection caused 5%, and other etiologies caused 23% (P = .0004). After adjustment for age and type of prosthesis, multiple logistic regression revealed an odds ratio for death due to nonstreptococcal infections of 9.67. The overall survival rate was 59% at 5 years and 52% at 10 years. During follow-up, 17 patients needed new valves. At the end of follow-up, only 13 patients remained alive and had the same prosthesis that they had at the time of the diagnosis of LPVE.

Endovascular aortic stent-grafts: transcatheter embolization of persistent perigraft leaks.

To assess efficacy of transcatheter embolization of peri prosthetic leaks from aortic stent-grafts Eight patients with a long-standing (3-13 months) perigraft leak after stent-graft implantation underwent transcatheter embolization. Leakage was demonstrated at helical computed tomography (CT). Angiography was performed for evaluation of outflow vessels and transcatheter embolization. All patients underwent helical CT follow-up after the procedure and every 3 months. Embolization was successful in seven patients and resulted in aneurysmal sac thrombosis. A second procedure was necessary in one patient to complete occlusion of the aneurysm. No further aneurysmal growth was detected during 4-9 months follow-up. Right leg paresis was observed in one patient immediately after the procedure, but symptoms disappeared completely after 8 days. Another patient had a minor sensory deficit in the region of the right crural nerve. Transcatheter embolization of perigraft leaks appears to be an effective technique to achieve aneurysmal thrombosis.

Surgical treatment of Brucella endocarditis

Between April 1987 and October 1992, six cases of Brucella endocarditis were operated on in the authors' hospital for valve replacement. They were five men and one woman with a mean(s.d.) age of 52(15) years (range 30–71 years). Three patients were in New York Heart Association (NYHA) class III and three in class IV. Two patients had previous history of rheumatic fever, one was a drug abuser, two had peripheral embolism and one constrictive pericarditis. Most were living in rural areas. Echocardiographic diagnoses were: severe aortic regurgitation in two patients, mixed disease in two and double valve involvement in two. Valve vegetations were demonstrated in two patients, valve calcification in two and annulus abscess in two others. Serological tests were positive in all patients. All patients had valve replacements and three were operated on as emergencies. Surgical findings were: valve vegetations in two patients, cusp perforation in two, annulus abscess in two and prosthetic leak in two. Mean(s.d) cardiopulmonary bypass time was 123(77) min with a mean ischaemic time of 79(43) min. All patients were given specific antibiotic treatment after surgery. There was no intraoperative mortality and the 5-year survival rate was 100%. Early reoperations were needed in three patients, two because of prosthetic leakage causing severe regurgitation and one for tamponade. The results suggests that Brucella endocarditis is rare, but still occurs in Mediterranean areas. Surgical replacement is needed in spite of antibiotic treatment and recurrences with prosthetic leaks are usual.

Surgical Treatment of Brucella Endocarditis

Between April 1987 and October 1992, six cases of Brucella endocarditis were operated on in the authors' hospital for valve replacement. They were five men and one woman with a mean(s.d.) age of 52(15) years (range 30–71 years). Three patients were in New York Heart Association (NYHA) class III and three in class IV. Two patients had previous history of rheumatic fever, one was a drug abuser, two had peripheral embolism and one constrictive pericarditis. Most were living in rural areas. Echocardiographic diagnoses were: severe aortic regurgitation in two patients, mixed disease in two and double valve involvement in two. Valve vegetations were demonstrated in two patients, valve calcification in two and annulus abscess in two others. Serological tests were positive in all patients. All patients had valve replacements and three were operated on as emergencies. Surgical findings were: valve vegetations in two patients, cusp perforation in two, annulus abscess in two and prosthetic leak in two. Mean(s.d.) cardiopulmonary bypass time was 123(77) min with a mean ischaemic time of 79(43) min. All patients were given specific antibiotic treatment after surgery. There was no intraoperative mortality and the 5-year survival rate was 100%. Early reoperations were needed in three patients, two because of prosthetic leakage causing severe regurgitation and one for tamponade. The results suggests that Brucella endocarditis is rare, but still occurs in Mediterranean areas. Surgical replacement is needed in spite of antibiotic treatment and recurrences with prosthetic leaks are usual.

Replacement of the mitral valve in children—an analysis of 130 cases

SummaryReplacement of the mitral valve was performed in 130 children less than 15 years of age—115 for rheumatic and 15 for congenital disease. Early mortality was 5.4%. Of 123 survivors, 112 were followed postoperatively for a mean period of nine years, with 80 of them on anticoagulants. Thromboembolism is the major late problem, with 25 thromboembolic accidents noted in 25 patients (22.3%). Anticoagulation was ineffective or lacking in 72% of them. Bacterial endocarditis was noted in five cases (4.4%) and a prosthetic leak in three (2.6%). Particular problems are observed in this group of young patients. First, recurrence of rheumatic fever in nine patients with an increasing severity of aortic valvar incompetence; second, with growth the prosthesis can become small as observed in six of our patients. A reoperation was needed in 15 patients, with one requiring two reoperations. Late mortality was 21%. Optimal timing for replacement of the valve is crucial. Appropriate anticoagulation and correct prophylaxis of rheumatic fever and bacterial endocarditis is mandatory. Conservative surgery is certainly preferable to valvar replacement, but if replacement proves necessary, large prostheses should be used.

Late Prosthetic Valve Endocarditis: Immediate and Long-term Prognosis

From 1975 to 1989, 307 consecutive episodes of infective endocarditis were diagnosed in our hospital. Of those, 35 were cases of late prosthetic valve endocarditis, defined as those occurring after 12 months of valvular replacement. Blood cultures grew streptococci in 15 patients (43 percent), staphylococci in seven (20 percent), enterococci in five (14 percent), Gram-negative bacilli of HACEK group in four (11.5 percent), and Candida in one. Blood cultures were negative in three cases (prosthetic infection was confirmed at surgery). Heart failure due to prosthetic dysfunction occurred in seven patients (20 percent) and emboli in 12 (34 percent). Early valvular replacement was performed in six patients (17 percent). Complications and mortality were dependent on the infective agent. Overall mortality was 23 percent, no death occurred from streptococcal infection, whereas mortality with endocarditis by organisms of the HACEK group and Staphylococcus was 50 percent and 43 percent, respectively. During a mean follow-up of five years, 11 patients (those with prosthetic leaks diagnosed during the active infection and patients with biologic prostheses) required surgery. There was one relapse in a patient with staphylococcal endocarditis and one recurrence, six years after the initial episode. We conclude that immediate prognosis of late prosthetic valve endocarditis depends on the infective agent. Although the immediate prognosis of streptococcal infections is good, the need for early reoperation during follow-up due to progressive perivalvular leak is high. Also, it appears that deterioration of bioprostheses proceeds swiftly after the cure of infection. (Chest 1992; 101:37-41)

Extended Follow-Up of the Standard Hancock Porcine Bioprosthesis

We have reviewed 665 patients in whom the standard Hancock porcine bioprosthesis (HPB) was used for aortic (AVR = 173), mitral (MVR = 437), and mitral and aortic (MAVR = 55) valve replacement in the time interval from 1970 to 1983. After AVR, HPB-related deaths occurred in 24 patients (1.7% +/- 0.4% per patient-year); 11 had thromboembolic episodes (0.8% +/- 0.2% per patient-year), 6 hemorrhages related to anticoagulants (0.4% +/- 0.2% per patient-year), 9 endocarditis (0.7% +/- 0.2% per patient-year), 7 prosthetic leak (0.5% +/- 0.1% per patient-year), and 59 structural deterioration (4.3% +/- 0.6% per patient-year). At 16 years, actuarial survival is 40% +/- 6%, freedom from thromboembolic episodes 89% +/- 4%, from hemorrhages 90% +/- 5%, from endocarditis 94% +/- 2%, from prosthetic leak 95% +/- 2%, and from structural deterioration 36% +/- 6%. After MVR, HPB-related deaths occurred in 64 patients (1.6% +/- 0.2% per patient-year); 68 had thromboembolic episodes (1.7% +/- 0.2% per patient-year), 28 hemorrhages (0.7% +/- 0.1% per patient-year), 12 endocarditis (0.3% +/- 0.1% per patient-year), 9 prosthetic leak (0.2% +/- 0.1% per patient-year), and 158 structural deterioration (4.0% +/- 0.3% per patient-year). At 18 years, actuarial survival is 33% +/- 4%, freedom from thromboembolic episodes 57% +/- 13%, from hemorrhages 81% +/- 6%, from endocarditis 91% +/- 4%, from prosthetic leak 98% +/- 1%, and from structural deterioration 18% +/- 5%.(ABSTRACT TRUNCATED AT 250 WORDS)

Rectification of the Remnants of the Leaflets - A New Surgical Technique to Avoid Peri prosthetic Leaks in Aortic Valve Replacement

During the last 12 years, we have used a modified suture technique for aortic valve replacement in 450 patients in order to avoid periprosthetic leaks. There were 420 survivors, and reoperation for periprosthetic leaks was necessary in no instance. The "secret" of our technique consists of the uniform distribution of the tensile forces among all sutures, eliminating uneven stresses that favors tearing of the tissues or rupture of the stitches.