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Ann Thorac Surg 1998;66:1539-1545
© 1998 The Society of Thoracic Surgeons

Late results of bioprosthetic tricuspid valve replacement in Ebstein’s anomaly

^a Division of Thoracic and Cardiovascular Surgery,Mayo Clinic and Mayo Foundation, Rochester, Minnesota USA
^b Section of Pediatric Cardiology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota USA
^c Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, USA

Address reprint requests to Dr Danielson, Department of Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905

Presented at the Thirty-fourth Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, Jan 26–28, 1998.

	Abstract

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Background. Historically, porcine bioprosthetic valves have poor durability in pediatric patients; nearly half will require replacement within 5 years. However, our early experience with patients having Ebstein’s anomaly suggests that tricuspid bioprostheses in this anomaly might have better durability.

Methods. One hundred fifty-eight patients who received a primary tricuspid bioprosthesis because of tricuspid valve anatomy unsuitable for repair between April 1972 and January 1997 were reviewed. Results were analyzed and Kaplan-Meier curves were constructed to estimate patient survival and probability of remaining free of reoperation.

Results. Follow-up of 149 patients (94.3%) who survived 30 days ranged up to 17.8 years (mean, 4.5 years). Ten-year survival was 92.5% ± 2.5% (SE), 129 late survivors (92.1%) were in New York Heart Association class I or II, and 93.6% were free of anticoagulation. Freedom from bioprosthesis replacement was 97.5% ± 1.9% at 5 years and 80.6% ± 7.6% at 10 and 15 years.

Conclusions. Bioprosthesis durability in the tricuspid position in patients with Ebstein’s anomaly compares very favorably with bioprosthesis durability in other cardiac valve positions, especially for pediatric patients, and also compares favorably with tricuspid bioprosthesis durability in patients with other diagnoses.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Significant advances have been made in the understanding and surgical management of Ebstein’s anomaly since the initial report by Hunter and Lillehei in 1958 [1] and subsequent early reports by others [2–6]. Current surgical efforts are directed toward tricuspid valve repair rather than replacement because of the known late problems of prosthetic valves [6–10]. However, tricuspid valve repair is not feasible in some cases because of anatomic factors, which include insufficient valve tissue because of failure of delamination of the anterior leaflet and linear attachment of the leading edge of the anterior leaflet to the right ventricular endocardium. The purpose of this study was to determine the current risk and the early and late results of bioprosthetic tricuspid valve replacement (TVR) in Ebstein’s anomaly.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Patients
Between April 18, 1972, and January 1, 1997, 323 patients underwent operation for Ebstein’s anomaly and associated defects on one cardiac surgery service at the Mayo Clinic. One hundred fifty-eight consecutive patients who had primary TVR with a bioprosthetic valve were identified. Patients who required replacement of a bioprosthetic tricuspid valve implanted at another hospital were not included. From the anatomic standpoint, the study was restricted to patients with atrioventricular and ventriculoarterial concordance; patients having atrioventricular and ventriculoarterial discordance (corrected transposition) were excluded. Also excluded were patients who had complex right heart anomalies with hypoplastic tricuspid valves, such as pulmonary atresia with intact ventricular septum. Indications for operation included New York Heart Association functional class III or IV, progressive exercise intolerance, significant or progressive cyanosis, tachyarrhythmia not controlled by medication, and significant associated defects such as ventricular septal defect and severe pulmonary stenosis. The study interval extended from the first patient to receive a bioprosthetic tricuspid valve on December 21, 1978, to January 1, 1997. There were 93 female and 65 male patients with ages ranging from 9 months to 70.1 years (median, 14.2 years; mean, 19.0 years). Associated cardiac defects are shown in Table 1. The five other defects included partial anomalous pulmonary venous connection, left ventricular diverticulum, mitral valve thrombus, recurrent pericarditis, and stenosis of left vertical pulmonary vein to left atrial anastomosis.

The hemoglobin values ranged from 10.3 to 23.4 g/dL (mean, 15.9 g/dL) and the hematocrit values ranged from 33.0% to 72.0% (mean, 47%). Oxygen saturations ranged from 66.0% to 99.0% (mean, 88.5%) and the cardiothoracic ratio ranged from 0.44 to 0.85 (mean, 0.66).

Follow-up was performed by review of results of any recent examinations at our institution, echocardiography and catheterization reports, and correspondence from referring physicians and patients. A questionnaire was sent to all patients for additional information, including any subsequent hospitalizations or operations, educational, employment, and reproductive status, and current functional capacity and medications. Telephone calls were made to patients or parents to complete information for the study when necessary.

Early mortality was defined as death during hospitalization or within 30 days of operation. The Kaplan-Meier method was used to estimate survival and the probability of remaining free from reoperation as a function of time, and 95% confidence limits were calculated. Survival curves were compared with log-rank tests. The association of continuous variables with survival was assessed with Cox models. The association of discrete risk factors with perioperative death was evaluated with ² tests or with Fisher’s exact tests. The association of continuous variables such as age with perioperative death was evaluated with Student’s t tests or rank-sum tests. Values of p less than 0.05 were considered to be statistically significant.

Operative technique
The operative technique for patients with Ebstein’s anomaly has been reported previously [6, 10] and includes median sternotomy, cannulation of the ascending aorta and both venae cavae, and moderate hypothermia (28° to 32°C, depending on expected duration of aortic cross-clamping). All systemic-pulmonary shunts are closed, and electrophysiologic mapping for localization of accessory pathways is performed in patients with ventricular preexcitation. Cardiac arrest is achieved with cold-blood potassium cardioplegia solution and topical hypothermia. An atrial septal defect is generally closed by excising any attenuated atrial septum and closing the resulting defect with a patch of autologous pericardium. Repair of associated defects is performed, including relief of pulmonary stenosis, interruption of accessory conduction pathways, cryoablation for AV nodal reentry tachycardia, and plication of any thin and noncontractile atrialized right ventricle. Any tricuspid valve tissue obstructing outflow from the right ventricle is excised, and pledgeted mattress sutures are placed around the tricuspid annulus from the ventricular to the atrial side. The sutureline is deviated cephalad to the membranous septum and AV node to avoid injury to the conduction mechanism. The sutureline is also deviated cephalad to the coronary sinus orifice in approximately half of the patients when the distance between the coronary sinus and the AV node appears to be too close. When tissues are thin posterolaterally, the suture line may be deviated cephalad to the annulus to avoid injury to the right coronary artery. Before placement of sutures in the sewing ring of the prosthesis, air is removed from the left heart, the cross-clamp is removed, and the heart is allowed to beat in sinus rhythm or with atrial pacing. In this way, the heart rhythm can be monitored as the valve prosthesis is tied into place. Excision of redundant right atrial wall (right reduction atrioplasty) is performed before closure of the atriotomy.

	Results

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Early results
By definition, all 158 patients in this review received a bioprosthetic tricuspid valve. Valve replacement was performed rather than repair because of insufficient or significantly tethered anterior leaflet tissue or unreconstructable anatomy after a previous repair. The 158 patients constituted 48.9% of the entire series of 323 patients who underwent operation for Ebstein’s anomaly and associated defects in the interval between April 1972 and January 1, 1997. In this same interval, 32 patients (9.9%) received a mechanical tricuspid prosthesis. The types of bioprosthetic valves implanted were Carpentier-Edwards (n = 136), Hancock (n = 20), and Ionescu-Shiley (n = 2). Valve sizes ranged from 21 to 35 mm (median, 33 mm); these sizes of valves were larger than those which usually can be implanted in patients without Ebstein’s anomaly having the same height and weight because the tricuspid valve annulus and right ventricle are characteristically dilated in severe Ebstein’s anomaly.

Resternotomy was necessary in 32 patients (20.3%) at the time of TVR. Associated cardiovascular procedures are shown in Table 3.

Nonfatal complications included renal failure (creatinine 3 mg/dL) in 4 patients (1 required peritoneal dialysis), respiratory insufficiency requiring ventilator support for more than 3 days in 4 patients, and low cardiac output necessitating more than 3 days of inotropic support in 2 patients. Complete heart block occurred in 1 patient as the valve was being tied into place and in another patient at the time of closed-chest massage for resuscitation; both received permanent pacemakers. Another patient received a pacemaker for transient third-degree heart block; she was in second-degree block at hospital discharge and sinus rhythm on follow-up. One additional patient who had second-degree heart block both before and after operation also received a pacemaker. Reoperation for bleeding was required in 3 patients, 2 patients required wound debridement, and relief of cardiac tamponade was necessary in 1 patient. One 3-year-old boy who had giant cardiomegaly required a secondary sternal closure but did not progress satisfactorily; successful cardiac transplantation was performed on the 14th postoperative day.

Duration of hospital stay for the survivors ranged from 5 to 44 days (median, 8 days). Discharge echocardiography was performed on 140 patients. One patient who was thought to have a laminated thrombus on the atriotomy closure site was placed on aspirin. Another patient who had giant cardiomegaly, very poor right and left ventricular function, and a protracted (15 days) postoperative course was found to have one immobile bioprosthesis cusp and some associated thrombus. She was heparinized and sent home on warfarin sodium. Valve function in the remaining patients was normal, and the atrial septum was intact in all patients.

Late results
The 149 early survivors constitute the study population for late results. Some follow-up was obtained in all 149 patients; current follow-up was obtained in 145 patients (97.3%). There were 9 late deaths. Causes of mortality were heart failure (n = 3); sudden, presumed arrhythmic death (n = 3); reoperation for bioprosthesis replacement (n = 1); acute cardiac allograft rejection (n = 1); and unknown (n = 1). Tested possible risk factors for late death included sex, reoperation, late arrhythmia, and age at operation; when age was divided at the median, younger patients had a lower 5-year survival (86.7% ± 4.5% [SE]) than older patients (98.7% ± 1.3%) (p = 0.02). Late survival of the early survivors is shown in Fig 1; survival was 92.5% ± 2.5% at both 10 and 15 years (confidence limits 82.7%, 97.5% and 75.7%, 97.5%, respectively).

View larger version (9K): [in this window] [in a new window]   Fig 1. Late survival of the early (hospital) survivors.

View larger version (9K): [in this window] [in a new window]   Fig 2. Freedom from reoperation for replacement of the tricuspid bioprosthesis, all ages (including one "prophylactic" change elsewhere) (n = 158).

View larger version (18K): [in this window] [in a new window]   Fig 3. Freedom from reoperation for tricuspid bioprosthesis replacement for patients younger than or equal to 18 years in the present series compared with freedom from reoperation for bioprosthesis replacement in all cardiac positions in patients younger than or equal to 18 years previously reported from our institution [11].

Sixty-seven of the 140 late survivors were enrolled in school full-time, 32 were currently working full-time, 12 were homemakers (unrestricted housework, 9; moderate work, 2; light work, 1), 7 were part-time students (3 related to health reasons), 6 were unemployed (3 for health reasons), and 5 were employed only part-time (3 for health reasons). Four were preschoolers, and occupational status was unknown in 7 patients.

New York Heart Association functional class was known in 136 patients; class I, 99 (72.8%); class II, 30 (22.1%); class III, 7 (5.1%). Functional class was not known in 4 patients. Seven patients have had 9 successful pregnancies.

	Comment

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
In Ebstein’s anomaly, deformity and displacement of the tricuspid valve cause severe tricuspid valve insufficiency and right atrial dilation. There is also an attenuation and dilation of the atrialized right ventricle and hypertrophy and dilation of the functioning right ventricle. The pathologic process of this disorder provides an anatomic substrate that increases susceptibility to conduction abnormalities and both atrial and ventricular tachyarrhythmias. An additional source of tachyarrhythmias in Ebstein’s anomaly is the presence of atrioventricular accessory conduction pathways, which were present in 14% to 15% of our surgical series [10, 12]. Of 306 patients who underwent operation for Ebstein’s anomaly, 44 had concomitant surgical ablation of one or more accessory conduction pathways. The pathways were successfully ablated in all patients and survival was 100% at 10 years [12]. More recently, for atrial tachyarrhythmias not related to an accessory conduction pathway, we have performed a right-sided maze procedure, which has significantly decreased the incidence of late atrial tachyarrhythmias [13]. In the present report, only 1 of 14 patients in whom a right-sided maze procedure was performed was not in sinus rhythm on follow-up, and the exception has been followed up for only 4 months.

Our basic repair for Ebstein’s anomaly as reported earlier [6, 10] remains the same, but we have also used various other modifications of valve repair and ventricular plication depending on the anatomy. These modifications include both external and internal lateral plication; various forms of tricuspid annuloplasty, especially those in which the free wall is brought toward the ventricular septum with or without lateral plication of the right ventricle; and two- or three-leaflet repairs, in addition to the monoleaflet repair, if leaflet tissue is adequate. We still consider failure of delamination of the anterior leaflet and linear attachment of the leading edge of the anterior leaflet to the right ventricular endocardium as unfavorable for a good late result with any modification of valve repair.

In our early experience with surgery for Ebstein’s anomaly, we made every effort to correct the tricuspid insufficiency by valve repair rather than replacement with a porcine bioprosthesis because of the reported poor durability of bioprostheses in pediatric patients in our experience [11] and that of others [14–17]. In many cases, we accepted a repair that reduced the tricuspid insufficiency to moderate levels only, particularly in infants, to delay the time of valve replacement. As our experience evolved and the improved longevity of bioprostheses in the tricuspid position in Ebstein’s anomaly became apparent, we began to be more liberal with bioprosthetic valve replacement as opposed to leaving moderate tricuspid insufficiency. Figure 4 shows the freedom from reoperation after TVR (both bioprosthetic and mechanical) compared with the freedom from reoperation after tricuspid valve repair in the entire series [18]. The curve for repair reflects the early experience in which some less-than-ideal repairs were accepted to avoid valve replacement. Our current philosophy is to perform tricuspid valve repair whenever a good to excellent result can be obtained. Tricuspid valve replacement with a bioprosthesis is a reasonable alternative when tricuspid valve tissue is inadequate for a good to excellent result. Because the freedom from reoperation for replacement of a bioprosthetic or mechanical tricuspid valve is similar at 10 years (Fig 5), we believe that a mechanical valve is also a reasonable alternative when TVR is required in selected adult patients with Ebstein’s anomaly, especially those with chronic atrial fibrillation who require warfarin anticoagulation [18].

View larger version (17K): [in this window] [in a new window]   Fig 4. Freedom from reoperation after tricuspid valve replacement (both bioprosthetic and mechanical) compared with freedom from reoperation after tricuspid valve repair [18].

View larger version (15K): [in this window] [in a new window]   Fig 5. Freedom from reoperation after tricuspid valve replacement with a bioprosthesis compared with freedom from reoperation after tricuspid valve replacement with a mechanical valve [18].

	Acknowledgments

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
We thank Merrilee S. Rogotzke for excellent secretarial support and Cathy D. Schleck for advice and support with the statistical analyses.

	References

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 

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