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St. Jude Medical Valve in Pulmonary Position: Anticoagulation and Thrombosis

Division of Cardiothoracic Surgery Medical University of South Carolina Charleston, South Carolina, USA
Feza Nurozler, MD Tel: 90 533 332 3088 Fax: 90 322 458 5451 email: feza_n{at}hotmail.com Division of Cardiovascular Surgery, Ortadog u Hospital, Ziyapaa Mah. 51. Sok No. 1, Seyhan, Adana 01140, Turkey.

	ABSTRACT

TOP ABSTRACT INTRODUCTION CASE REPORTS DISCUSSION REFERENCES

 
Between 1979 and 1985, 5 patients underwent pulmonary valve replacement with a St. Jude Medical valve. During follow-up ranging from 30 months to 18 years, there were 6 episodes of valve thrombosis in 4 patients. Three episodes were treated by thrombolysis. Reoperation was necessary in 3 patients. Although the St. Jude Medical valve in the pulmonary position can occasionally function long-term without anticoagulation, these cases show the high risk of thrombosis and need for anticoagulation.

	INTRODUCTION

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Pulmonary valve replacement (PVR) to eliminate pulmonary insufficiency subsequent to complete repair of cyanotic heart defects, particularly tetralogy of Fallot, improves right ventricular (RV) function in selected cases with RV failure.¹ The use of mechanical valves in the pulmonary position has largely been abandoned because of a high incidence of clotting complications.^2–4 However, questions remain regarding anticoagulation and treatment of valve thrombosis in patients with a mechanical pulmonary prosthesis already in place. A review of the cardiac surgery database at our institute revealed 5 patients had undergone PVR with a St. Jude Medical (SJM) valve (St. Jude Medical Inc., St. Paul, MN, USA). The operations were carried out between October 1979 and June 1985. During that time, there were no other types of valve implanted or procedures performed to eliminate pulmonary insufficiency. All patients had undergone previous cardiac repairs at 7 days to 13 years of age. Patient characteristics are summarized in Table 1.

	CASE REPORTS

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CASE 2
A patient with a primum atrial septal defect, mitral and tricuspid insufficiency, and pulmonary stenosis underwent repair at 7 years of age. A Hancock valved Dacron conduit (Medtronic Inc., Minneapolis, MN, USA) was placed between the right ventricle and pulmonary arteries because of the tricuspid insufficiency. Obstruction of the Dacron conduit developed 5 years later, so the conduit was removed, right ventricle-to-pulmonary artery continuity was reestablished, and a 21-mm SJM valve was placed in the pulmonary position. The patient was maintained without anticoagulation for 9 years before starting warfarin treatment. The SJM valve has remained functional during 17 years of follow-up.

CASE 3
A 3-year-old patient with tetralogy of Fallot underwent primary repair including placement of an autologous pericardial transannular patch. Five years later, PVR was carried out with a 23-mm SJM valve because of RV failure and pulmonary insufficiency. The patient was maintained without anticoagulation but developed thrombosis and underwent thrombolytic treatment 8 months later. Warfarin therapy was started after thrombolysis. There has been no recurrence of thrombosis in 14 years of follow-up.

CASE 4
A 14-year-old patient with tetralogy of Fallot and no previous palliation, underwent primary repair including placement of a transannular autologous pericardial patch. Three years later, aneurysmal dilatation of the RV outflow tract developed and PVR was carried out with a 23-mm SJM valve. No anticoagulant was given in the first 6 years, then warfarin was started. However, the patient was noncompliant with the anticoagulation and subsequently suffered 3 episodes of valve thrombosis and one pulmonary embolism; the first episode was 9 years after PVR. Following 2 successful thrombolytic treat-ments, the patient underwent reoperation after the 3rd episode, and the SJM valve was replaced with a pulmonary homograft. Intraoperatively, extensive pannus was found around the valve, with a partially immobilizing thrombus on the leaflets. The patient has been doing well without any thromboembolic complication for 14 years after the homograft replacement.

CASE 5
A patient with tetralogy of Fallot and pulmonary atresia underwent palliative RV outflow tract reconstruction with an autologous pericardial patch, in the neonatal period. Ventricular septal defect closure and PVR with a 19-mm SJM valve prosthesis was performed at the age of 20 months, and the patient was maintained without anticoagulation. Thrombosis developed 2.5 years later and the SJM valve was replaced with a CarpentierEdwards bioprosthesis (Baxter Healthcare Corp., Santa Ana, CA, USA). Intraoperatively, there was a small amount of thrombotic material on the hinge points of the valve. The patient was followed up for 2.5 years, but has not been in contact for the last 3 years.

	DISCUSSION

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Anticoagulant or antiplatelet therapies alone or in combination can prevent clotting complications with mechanical valves. The hazards of anticoagulation and problems of dosage control in a child must be weighed against the possibility of thrombosis. Pass and colleagues⁵ suggested not using warfarin after right-sided SJM valve replacement. However, anticoagulation after PVR with a mechanical prosthesis has been widely used since follow-up data showed high thrombosis rates.^2,3 In our patients, valve thrombosis occurred on antiplatelet therapy and warfarin.

Thrombosis of mechanical valves (MVs) in the pulmonary position usually progresses slowly. Because pulmonary insufficiency or pulmonary stenosis caused by MV dysfunction is usually well tolerated compared to left-sided valve thrombosis, many patients are asymp-tomatic.^2–4 The higher incidence of thrombosis of SJM valve prostheses in the pulmonary position compared to those on the left side, suggests a difference in coagulation conditions. This may be due to variations in the pressure difference and turbulent flow to which a sewing collar and adjacent endocardium are exposed. Two approaches can be applied in the management of thrombosed MVs in the pulmonary position: thrombolytic treatment or surgical removal. Successful thrombolysis has been demonstrated in patients with MV thrombosis when there is no accompanying pannus formation.^4,6,7 Avoidance of the risks of reoperation is the major advantage of thrombolytic treatment, but it has its own risks and limitations. These include bleeding, embolization, and need for subsequent anticoagulation to guard against rethrombosis. Moreover, thrombolysis fails in 15% to 30% of cases, usually due to obstruction of the valve by pannus rather than thrombus. An analysis of 26 cases of thrombolysis for thrombosed right-sided MVs reported over the last decade has revealed a primary success rate of approximately 70% and an early rethrombosis rate of 10%.⁸ Rethrombosis after thrombolysis is related to the duration of thrombosis and the presence of concomitant fibrous tissue on the valve. One of our patients did well after thrombolysis whereas another needed redo PVR after 2 successful thrombolytic treatments. No bleeding or embolization occurred at the time of thrombolysis. Replacement of a thrombosed MV with a homograft or a bioprosthetic valve is another option with low operative risk, good long-term results, and freedom from anticoagu-lation. Both of our patients did well after homograft replacement, without a thromboembolic event. An alterna-tive approach, given large central and branch pulmonary arteries and low pulmonary vascular resistance, is removal of the MV without replacement.

Similar to previous reports, our data show a high risk of thrombosis and need for anticoagulation, although the SJM valve in the pulmonary position may occasionally function long-term without anticoagulation. These cases also indicate that fibrinolytic treatment may be reasonable for a first thrombotic episode. However, the surgical approach which is effective with low operative risk, good long-term results, and freedom from anticoagulation is advisable in patients who develop recurrent thrombosis.

	REFERENCES

TOP ABSTRACT INTRODUCTION CASE REPORTS DISCUSSION REFERENCES

 

1. Bove EL, Kavey RE, Byrum CJ, Sondheimer HM, Blackman MS, Thomas FD. Improved right ventricular function following late pulmonary valve replacement for residual pulmonary insufficiency or stenosis. J Thorac Cardiovasc Surg 1985;90:50–5.[Abstract]

2. Ilbawi MN, Lockhart CG, Idriss FS, DeLeon SY, Muster AJ, Duffy CE, et al. Experience with St. Jude Medical valve prosthesis in children. A word of caution regarding right-sided placement. J Thorac Cardiovasc Surg 1987; 93:73–9.[Abstract]

3. Fleming WH, Sarafian LB, Moulton AL, Robinson LA, Kugler JD. Valve replacement in the right side of the heart in children: long-term follow-up. Ann Thorac Surg 1989; 48:404–8.[Abstract]

4. Fyfe DA, Taylor AB, Kline CH, Sade RM, Gillette PC. Doppler echocardiographic evaluation of streptokinase lysis of thrombosed right-sided St. Jude Medical valves in patients with congenital heart defects. Am Heart J 1991;121:1156–60.[Medline]

5. Pass HI, Sade RM, Crawford FA, Hohn AR. Cardiac valve prostheses in children without anticoagulation. J Thorac Cardiovasc Surg 1984;87:832–5.[Abstract]

6. Ilbawi MN, Idriss FS, DeLeon SY, Muster AJ, Duffy CE, Gidding SS, et al. Valve replacement in children: guidelines for selection of prosthesis and timing of surgical intervention. Ann Thorac Surg 1987;44:398–403.[Abstract]

7. Okita Y, Miki S, Kusuhara K, Ueda Y, Tahata T, Sakai T. Replacement of a thrombosed St. Jude Medical prosthesis in pulmonary position after repeated thrombolytic therapy. Thorac Cardiovasc Surgeon 1992;40:99–101.[Medline]

8. Burger W, Kneissl G-D, Hartmann A, Bauersachs R, Döring V, Spengler U, et al. Successful thrombolysis after prosthetic pulmonary valve obstruction under aspirin monotherapy. Ann Thorac Surg 1997;64:255–7.[Abstract/Free Full Text]

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Feza Nurozler Scott M Bradley Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Nurozler, F. Articles by Bradley, S. M Search for Related Content PubMed PubMed Citation Articles by Nurozler, F. Articles by Bradley, S. M Related Collections Congenital - cyanotic Valve disease