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Nobuhiro Handa
Christopher G.A. McGregor
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Richard C. Daly
Joseph A. Dearani
Charles J. Mullany
Thomas A. Orszulak
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Francisco J. Puga
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Ann Thorac Surg 2001;71:1880-1884
© 2001 The Society of Thoracic Surgeons

Original article: cardiovascular

Valvular heart operation in patients with previous mediastinal radiation therapy

Nobuhiro Handa, MDa, Christopher G.A. McGregor, MB, FRCSa, Gordon K. Danielson, MDa, Richard C. Daly, MDa, Joseph A. Dearani, MDa, Charles J. Mullany, MDa, Thomas A. Orszulak, MDa, Hartzell V. Schaff, MDa, Kenton J. Zehr, MDa, Betty J. Anderson, RNa,b, Paula J. Schomberg, MDb, Francisco J. Puga, MDa

a Division of Thoracic and Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota, USA
b Division of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA

Accepted for publication February 20, 2001.

Address reprint requests to Dr McGregor, Mayo Clinic, 6-716 Mary Brigh D, Saint Mary’s Hospital, Rochester, MN 55905
e-mail: mcgregor.christopher{at}mayo.edu


   Abstract
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 Abstract
Introduction
 Material and methods
 Results
 Comment
 References
 
Background. The outcome of valvular heart operations in patients with previous mediastinal radiation therapy was studied.

Methods. This is a single center retrospective study of 60 patients (37 females, 23 males) with a mean age of 62 ± 15 years (28 to 88 years old) operated on from January 1976 to December 1998. Valvular heart operations performed included aortic valve replacements (n = 26), mitral valve procedures (n = 16), tricuspid valve procedures (n = 6), and multiple valve procedures (n = 12). A total of 264 clinical, hemodynamic, electrocardiographic and echocardiographic variables were analyzed.

Results. Total follow-up was 199 patient-years with a mean of 3.3 ± 3.1 years and a range of 0 to 12.4 years old. Early mortality was 7 patients (12%). Early mortality in patients with constrictive pericarditis was 40% (4 of 10) compared with 6% (3 of 50) in patients without constrictive pericarditis. By univariate analysis, early mortality was associated with constrictive pericarditis (p = 0.011), reduced preoperative ejection fraction (p = 0.015), and longer cardiopulmonary bypass times (p = 0.037). A total of 14 patients (23%) required permanent pacemaker placement before (n = 7), during (n = 1), or early (n = 6) after valvular heart operations. There were 19 late deaths (malignancies, 7; heart failures, 5; other cardiac, 4; and other noncardiac, 3). Overall survival and freedom from late cardiac death and cardiac reoperation at 5 years for hospital survivors were 66% ± 8%, 82% ± 7%, and 93% ± 4%, respectively. By univariate analysis, late cardiac death was associated with low ejection fraction (p = 0.002), New York Heart Association (NYHA) functional class IV (p = 0.004), preoperative congestive heart failure (p = 0.02), and preoperative atrial fibrillation (p = 0.038). Eighty-five percent of the discharged patients were in NYHA functional class I or II at follow-up.

Conclusions. Early results of valve replacement after mediastinal radiation therapy were good except in the presence of constrictive pericarditis. Long-term outcome was limited by malignancy and heart failure. Early surgical intervention is recommended before the development of risk factors for late death, namely, severe symptoms, left ventricular dysfunction, and atrial fibrillation.


   Introduction
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 Introduction
Material and methods
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Heart disease is a major cause of late mortality and morbidity in long-term survivors of mediastinal radiation therapy (MRT) for malignant neoplasm [1–4], in particular Hodgkin’s disease and breast cancer [5–6]. The effects of MRT on the heart include pericardial disease, conduction disturbance, myocardial fibrosis, coronary artery disease, and valvular heart disease [7]. Valvular heart disease associated with MRT is characterized by the pathologic features of valvular fibrosis and calcification [8]. Although successful operations for radiation-induced valvular heart disease have been reported in a small numbers of patients [1, 9, 10–17], there are limited data on the early and late outcomes of valvular heart operations (VHOs) in this patient population. In the present study, VHOs in patients after mediastinal radiation therapy were reviewed over a 23-year time period at a single institution.


   Material and methods
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 Introduction
 Material and methods
Results
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 References
 
From the hospital database at the Mayo Clinic from January 1976 through December 1998, patients who had VHOs were matched with malignant neoplasms, which can be potentially treated by MRT. These malignant neoplasms included breast cancer, lymphoma, lung cancer, esophageal cancer, thymoma, and seminoma [18]. A total of 62 patients who had VHOs after MRT were identified. Of these 62 patients, 2 patients who had aortic valve decalcification were excluded from our analysis because this procedure has been abandoned as an operation for valvular heart disease. For this study, operative notes, anesthesia records, clinical case histories, and laboratory investigations including electrocardiogram, echocardiogram, cardiac catheterization data, and radiation oncology records were retrospectively reviewed. Follow-up data were collected from clinic records of inpatient and outpatient visits and correspondence with patients and referring physicians, focusing on functional status, results of echocardiography, and the status of the patient’s malignant disease. A total of 264 clinical, hemodynamic, electrocardiographic and echocardiographic variables were entered into a computerized database and analyzed. Total follow-up was 199 patient-years with a mean of 3.3 ± 3.1 years and a range of 0 to 12.4 years old.

Preoperative demographic and cardiac data in the 60 patients of this study are detailed in Table 1. The mean age was 62 ± 15 years (28 to 88 years old) and 62% of the patients were female. Preoperatively, 93% of patients were in NYHA functional class III (55%) or IV (38%).


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  		Table 1. Preoperative Patient Characteristics

 
Preoperative patient comorbidities associated with radiation therapy are detailed in Table 2. Of note was the incidence of coronary artery disease, esophageal stricture, and pulmonary fibrosis (defined as a vital capacity < 75% predicted value). Constrictive pericarditis was or had been present in 10 patients. Two patients had required previous pericardiectomy. Five patients had concomitant pericardiectomy, and 2 patients had both previous and concomitant redo pericardiectomy at the time of VHO. One patient demonstrated only constrictive physiology.


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  		Table 2. Preoperative Patient Cormorbidities Associated With Mediastinal Radiation Therapy

 
Indications for MRT were breast cancer (n = 29; 48%), Hodgkin’s lymphoma (n = 22; 37%), non-Hodgkin’s lymphoma (n = 6; 10%) lung cancer (n = 1; 2%), thymoma (n = 1; 2%), and seminoma (n = 1; 2%). The mean dose of radiation was 46 Gy with a range of 25 to 70 Gy in 13 patients for whom this information was available. The mean interval between the end of radiation therapy and VHOs in patients who had first time VHOs was 19 ± 10 years (range 0.1 to 45.9 years). Sixteen patients had concomitant chemotherapy.

Valvular operations performed are detailed in Table 3. The most common procedures in this series were single aortic valve replacement (n = 26) and a single mitral valve procedure, either replacement or repair (n = 16). Twelve patients had multiple valve procedures. Associated surgical procedures are detailed in Table 4. Notably, 48% of patients (n = 29) had concomitant coronary artery bypass grafts. Pericardiectomy was performed concomitantly in 7 patients (12%). Aortic root enlargement was required in 8 of the 36 patients who had aortic valve replacement (isolated and combined). Myectomy was performed in 3 patients.


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  		Table 3. Valvular Surgical Procedure

 

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  		Table 4. Associated Surgical Procedures

 
Statistical methods
Comparisons of patient characteristics between the two groups were carried out with {chi}2 or Fisher’s exact test for nominal variables, with two sample t tests or Wilcoxon ranks sum tests for continuous variables and with Wilcoxon ranks sum tests for ordinal variables. Survival and survivorship free of cardiac events and reoperation were estimated as a function of time because surgery used the Kaplan-Meier method. Comparisons of survivorship curves were made with the log rank test. The small numbers of events such as early mortality and late cardiac death prevented meaningful multivariate analyses.


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Perioperative mortality (30 days or in-hospital mortality) occurred in 7 patients (12%) (Table 5). Univariate analysis showed that perioperative mortality was associated with present or previous constrictive pericarditis (p = 0.011), reduced preoperative ejection fraction (p = 0.015), and longer cardiopulmonary bypass time (p = 0.037), but was not associated with preoperative NYHA functional class IV (p = 0.412) or concomitant coronary artery bypass grafts (p = 0.702). Patients with current or previous constrictive pericarditis had a significantly higher early mortality of 40% (4 of 10) compared with 6% (3 of 50) in patients without constrictive pericarditis (p = 0.011). As a continuous variable, preoperative ejection fraction was a significant factor associated with perioperative mortality (p = 0.015). The mean duration of intensive care unit stay was 4.2 ± 6.0 days.


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  		Table 5. Perioperative Mortality

 
Perioperative morbidity is shown in Table 6. Prolonged ventilatory support (> 72 hours) was required in 11 patients (18%) and 4 patients required tracheostomy in the early postoperative period. Reexploration for bleeding was needed in 6 patients (10%). Six patients (10%) required permanent pacemakers (PPMs) in the early postoperative period. Accordingly, a total of 14 patients (23%) required PPMs before (n = 7), during (n = 1), or after (n = 6) VHO. Follow-up was completed in all patients within a minimum 2-month postoperative period. Total follow-up in all patients was 199 patient-years with a mean of 3.3 ± 3.1 years. The range of follow-up was 0 to 12.4 years old. There were 19 late deaths. The main causes of late death are malignancy (n = 7), congestive heart failure (n = 5), stroke (n = 2), sudden cardiac arrest (n = 2), myocardial infarction (n = 1), asphyxia from aspiration (n = 1), and acute tricuspid valve thrombosis (n = 1). One- and 5-year actuarial survival of the 53 discharged patients was 90% ± 4% and 66% ± 8%, respectively (Fig 1). Four patients required cardiac reoperation. One patient required mitral and tricuspid valve replacement after a previous mitral and tricuspid valve repair. A second patient had mitral valve replacement for new mitral regurgitation after a previous aortic valve replacement. A third patient had heart transplantation after mitral valve replacement and tricuspid valve repair. The replaced mitral valve was intact and mild residual tricuspid regurgitation was noted at the time of heart transplant. The remaining patient had mitral valve replacement and aortic valve repair for transfusion requiring hemolytic anemia after aortic valve replacement and mitral valve replacement. Survival free of cardiac death and any open heart reoperation at 5 years was 82% ± 7% and 93% ± 4%, respectively (Fig 1). The mean interval between the original and four cardiac reoperations was 2.4 ± 2.8 years (0.2 to 6.6 years old). New York Heart Association functional class at most recent follow-up was class I (n = 33), class II (n = 13), class III (n = 6), and class IV (n = 1). Therefore, 85% of patients were either NYHA functional class I or class II at most recent follow-up. Univariate comparison showed that late cardiac death was associated with preoperative low ejection fraction (p = 0.002), NYHA functional class IV (p = 0.004), congestive heart failure (p = 0.02), and atrial fibrillation (p = 0.038).


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  		Table 6. Perioperative Morbidity

 


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  		Fig 1. Survival analysis free of all causes of death, late cardiac death, and cardiac reoperation at 5 years.

 

   Comment
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
References
 
This study of the outcome of operations for valvular heart disease after prior mediastinal irradiation for malignant neoplasm at a single institution over a 23-year period disclosed a wide variety of comorbidities associated with MRT, such as concomitant coronary artery disease, pulmonary parenchymal disease, constrictive pericarditis, and anterior skin changes of the chest. These preoperative patient characteristics associated with MRT are similar to our previous study of coronary bypass operations after MRT [19]. It is intuitive that these comorbidities would increase early morbidity and mortality in this patient population. Although the operation procedures performed in this series are heterogeneous including multiple valve procedures (20%) and concomitant coronary artery bypass grafts (48%), univariate analyses demonstrated that increased early mortality was associated with constrictive pericarditis, reduced left ventricular function, and longer cardiopulmonary bypass times. No other factors, including preoperative NYHA functional class, pulmonary parenchymal disease, previous open heart operation, and concomitant coronary artery bypass grafts, were associated with early mortality. Patients who did not have constrictive pericarditis, did have good early results of valve operation despite the extensive associated surgical procedures and the wide spectrum of comorbidities.

Patients with constrictive pericarditis had a mortality rate of 40% compared with 6% in patients without constrictive pericarditis. Constrictive pericarditis may be a marker for greater radiation injury to the heart and mediastinum with resultant diastolic as well as systolic dysfunction [20–21]. It can be difficult to separate constriction from restrictive cardiomyopathy. Heart transplantation should be considered for such patients with this 40% mortality risk. Heart transplantation has been applied successfully in selected patients, but the wide variety of comorbidities and history of malignancy can contraindicate transplantation [22].

The main causes of late death in this series were malignancy, either recurring or new, and heart failure. As a result, actuarial survival rate (free of all cause of death) is only 66% at 5 years, and survival free of cardiac death is 82%. By univariate analysis for late cardiac death, four preoperative factors were identified: (1) NYHA functional class IV symptoms, (2) atrial fibrillation, (3) congestive heart failure, and (4) poor left ventricular function. Therefore, early surgical intervention is indicated before severe symptoms, left ventricular dysfunction, and atrial fibrillation are established.

Another lesson of this study is the frequent need for insertion of PPMs. Seven patients had conduction problems requiring PPM insertion before or at the time of VHO. Another 6 patients required PPM insertion during hospitalization. In addition, 3 patients died from sudden cardiac arrest (1 in the early postoperative period and 2 at follow-up). These findings are consistent with previous reports of radiation damage to the conduction tissue [23–25]. Any conduction problems preoperatively or late, after an operation, require early PPM insertion to prevent sudden death. The high incidence (22%) of aortic root enlargement in patients having aortic valve replacement is of interest. After aortic root enlargement, 8 patients had the insertion of 19-mm St. Jude mechanical prosthesis (St. Jude Medical, St. Paul, MN) (n = 3), 20-mm Medtronic-Hall valve (Medtronic, Inc, Minneapolis, MN) (n = 1), 21-mm St. Jude valve (n = 1), 23-mm Medtronic Hall (n = 1), 25-mm St. Jude (n = 1), and 25-mm Medtronic Hall (n = 1). Septal myectomy was required in 3 patients and left main disease was noted frequently (23%) in this patient population. These findings reflect radiation damage to the aortic root area.

Because 2 of 14 patients with valve repair required late cardiac reoperation, the question arises as to the durability of a valve repair. Because of the progressive nature of valve fibrosis, and the slow and consistent deterioration of heart function [7–9, 18], valve repair may be indicated in only highly selected patients. Further data are required to reach a firm conclusion on this matter.

Although valvular heart operations were clearly successful in this patient population, despite the wide spectrum of radiation-induced perioperative comorbidities, progressive deterioration of heart function was not necessarily halted with surgical treatment. Progression of coronary artery disease and myocardial fibrosis can result in progressive deterioration of heart function ultimately requiring heart transplantation.

Techniques for the delivery of radiation to the mediastinum have evolved significantly over the last several decades. In the past, the heart was thought to be radio resistant and no attempt was made to limit the radiation dose or the volume of heart irradiated. Patients were often exposed unnecessarily to high radiation doses. A better understanding of the late effects of cardiac irradiation has resulted in modification of radiation delivery techniques. These include the use of multiple shaped treatment fields resulting in improved homogeneity of dose delivery and exclusion of normal tissues as well as smaller daily radiation doses. These measures should lower the risk of damage. In addition, improvements in equipment with higher energy beams resulting in improved penetration should further reduce the risk of complications. Currently, state-of-the-art computed tomography based treatment planning systems allow the radiation oncologist to know precisely the radiation dose to the heart and what treatment modifications to make to limit the risk of cardiac damage.

In conclusion, the early results of VHO associated with MRT are good. The presence of constrictive pericarditis had a significant detrimental effect on early results. Early surgical intervention is recommended to avoid late cardiac death before the development of late death risk factors, namely, severe symptoms, left ventricular dysfunction, cardiac failure, or atrial fibrillation; all of these risk factors compromise late results. Close observation of rhythm problems and judicious use of PPM insertion is required.


   References
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 Abstract
 Introduction
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 References
 

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