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J Thorac Cardiovasc Surg 2007;134:106-113
© 2007 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

Midterm results of surgical intervention for congenital heart disease in adults: An Italian multicenter study

^a Pediatric and Congenital Cardiac Surgery Unit, Centro Gallucci, University of Padua Medical School, Padua, Italy
^b Department of Cardiovascular Surgery, Ospedali Riuniti di Bergamo, Bergamo, Italy
^c Department of Pediatric Cardiology, Ospedale G. Pasquinucci CREAS-CNR, Massa, Italy
^d Department of Pediatric Cardiac Surgery, Azienda Ospedaliera S. Orsola-Malpighi, Bologna, Italy
^e Department of Cardiac Surgery, Istituto Policlinico San Donato, Milano, Italy
^f Department of Cardiac Surgery, Ospedale Niguarda Cà Granda, Milano, Italy
^g Pediatric Cardiology and Cardiac Surgery, Second University, A.O. Monaldi, Naples, Italy
^h Department of Cardiology, Centro Gallucci, University of Padua Medical School, Padua, Italy.

Read at the Eighty-sixth Annual Meeting of The American Association for Thoracic Surgery, Philadelphia, Pa, April 29–May 3, 2006.

Received for publication June 28, 2006; revisions received January 13, 2007; accepted for publication January 23, 2007.

^_* Address for reprints: Giovanni Stellin, MD, Pediatric and Congenital Cardiac Surgery Unit, Centro Gallucci, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova Medical School, Via Giustiniani 2 – 35128 Padova, Italy. (Email: giovanni.stellin{at}unipd.it).

	Abstract

Top Abstract Introduction Materials and Methods Results Discussion References

 
Objective: We have analyzed, in a clinical multicenter study, the effect of cardiac surgery in adults with congenital heart disease in Italy.

Methods: We collected clinical data from 856 patients aged 19 years or older who underwent surgical intervention from January 1, 2000, to December 31, 2004. Patients were divided into 3 surgical groups: group 1, palliation (3.1%); group 2, repair (69.7%); and group 3, reoperation (27.4%).

Results: Preoperatively, 34.6% of patients were in New York Heart Association class I, 48.4% were in class II, 14.2% were in class III, and 2.8% were in class IV. Sinus rhythm was present in 83%. There were 1179 procedures performed in 856 patients (1.37 procedures per patient), with a hospital mortality of 3.1%. Overall mean intensive care unit stay was 2.3 days (range, 1–102 days). Major complications were reported in 247 (28.8%) patients, and postoperative arrhythmias were the most frequent. At a mean follow-up of 22 months (range, 1 month–5.5 years; completeness, 87%), late death occurred in 5 (0.5%) patients. New York Heart Association class was I in 79.3%, II in 17.6%, and III in 2.9%, and only 1 (0.11%) patient was in class IV. Overall survival estimates are 82.6%, 98.9%, and 91.8% at 5 years for groups 1, 2, and 3, respectively. Freedom from adverse events at 5 years is 91% for acyanotic patients versus 63.9% for preoperative cyanotic patients (P < .0001).

Conclusions: Surgical intervention for congenital heart disease in adults is a safe and low-risk treatment. However, patients presenting with preoperative cyanosis show a higher incidence of late adverse events and complications.

	Introduction

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Congenital heart malformations are currently treated in pediatric patients. However, adults and adolescents with congenital heart disease are becoming an important entity because recent improved diagnostic and therapeutic tools allow the majority of newborns with congenital heart disease (CHD) to survive to adulthood.¹ Currently, adults with CHD in Italy are calculated to number approximately 80,000.² Thus, the effect of such a huge population on the medical community is expected to be relevant.

For this reason, we have designed a multicenter study involving 7 major Italian cardiac centers, to evaluate the early and midterm outcomes of cardiac surgery in this particular group in our country.

	Materials and Methods

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All major congenital cardiac centers in Italy (12) were invited to be part of this study in a 5-year time frame under the supervision of the Italian Society of Cardiology. Seven centers joined the study by sending complete data and respecting requirements as indicated in a preset database. The database was designed based on demographic, pathologic, surgical, and postoperative data, as requested in the EACTS Congenital Database (www.eactscongenitaldb.org). There is no age restriction in this database as far as the data collection is concerned. All centers are medium-high surgical volume centers, with the number of cases ranging between 200 and 450 cases per year. All the participating centers are tertiary level national centers. Five of the 7 centers have a cardiac transplantation program, and 2 centers are authorized for heart-lung transplantation. Data were collected by one of the authors in every center, and all material was validated by the coordinating authors (M.A.P. and G.S., Padua).

Eight hundred fifty-six patients were enrolled who underwent operations for a variety of CHDs between January 1, 2000, and December 31, 2004. The male/female ratio was 1.13 (455 men [53.2%] and 401 women [46.8%]). Age ranged between 18 and 80 years (mean, 37.2 years; median, 34.2 years). Diagnoses, procedures, extracardiac anomalies, preoperative risk factors, and postoperative complications were classified according to the EACTS Congenital Database classification, as described elsewhere.³ Diagnoses were divided into "anatomic" (as the basic heart malformation) and "leading to surgical intervention" (as the cause for operation, regardless of the basic anatomy) categories (Table E1).

Survival estimates for all patients were analyzed with the Kaplan–Meier method applied to the main cardiac lesion (atrial septal defect [ASD], right heart lesion, left heart lesion, and single ventricle) and to the main lesion stratified in the 3 different operative categories (palliation, repair, and reoperation). The effect of preoperative functional New York Heart Association (NYHA) class III and IV, with or without associated cyanosis, was similarly evaluated. Statistically significant incremental (hazard ratio [HR], >1.0) or decremental (HR, <1.0) risk factors were identified by means of a forward stepwise (P to enter = .05, P to remain = .2) Cox analysis of operative categories of surgical intervention, pathologies, and preoperative risk factors.

	Results

Top Abstract Introduction Materials and Methods Results Discussion References

 
Noninvasive preoperative diagnosis by means of 2-dimensional and Doppler echocardiography (associated or not with other noninvasive techniques) was possible in 530 (61.9%) patients. Cardiac catheterization in association with noninvasive techniques was used in 273 (31.8%) patients, in 39 (4.5%) patients diagnosis was made by means of cardiac catheterization only, and magnetic resonance imaging was sufficient in 13 (1.5%) patients. No data were available for 1 patient.

According to the preoperative clinical and instrumental evaluation, 294 (34.6%) patients were classified in NYHA functional class I, 412 (48.4%) in class II, 120 (14.2%) in class III, and 24 (2.8%) in class IV (2.8%). No data were available for 7 patients.

Preoperative electrocardiography showed sinus rhythm in 83% of patients. Major arrhythmias included atrial fibrillation in 55 (6.4%) patients, supraventricular tachyarrhythmias in 13 (1.5%) patients, complete atrioventricular block in 10 patients (1.1%), and atrial flutter in 6 patients (0.7%). No data were available in 75 patients (8.8%).

Associated extracardiac anomalies were present in 40 patients and included Marfan syndrome in 19 (2.3%), Down syndrome in 12 (1.4%), Williams–Beuren syndrome in 3 (0.3%), and Turner syndrome in 1. Other nonsignificant chromosomal anomalies were found in 4 patients.

We collected 1196 "anatomic diagnoses" in 856 patients. Table E1 shows diagnoses of basic heart malformation and diagnoses "leading to surgical intervention."

There were 1179 surgical procedures performed in 856 patients in 7 centers (mean, 122.3 procedures per center; range, 34-334 procedures). Among these, there were 30 palliative procedures (group 1) performed in 18 patients (2.4%, Table 1), 742 repair procedures (group 2) in 628 patients (69.5%, Table 2), and 322 reoperations (Group 3) in 210 patients (27.4%, Table 3). Types of procedures are shown in Tables 1 through 3.

Twenty-seven patients died within 30 days or before hospital discharge (early overall mortality, 3.1%). The most common causes of death were low cardiac output syndrome in 13 (1.5%) patients, bleeding in 3 patients, and sepsis in 2 patients. The palliation group presented with the highest early mortality (16.6%) when compared with group 2 (1.3%) and group 3 (7.6%). Main causes of death are listed in Table E2.

Cardiac rhythm at the moment of discharge from the hospital showed 90.5% of patients with sinus rhythm by means of electrocardiography, whereas 2.5% showed atrial fibrillation, 0.8% (7 patients) showed complete atrioventricular block, and 2 patients showed atrial flutter. This compares favorably with preoperative electrocardiographic data; however, these differences were not statistically significant. In addition, CAVB incidence is reduced because 3 of the patients affected died at the time of the operation (Table E3).

Overall, there were 48 adverse events among survivors, with arrhythmias and chest effusions (pleural or pericardial) being the most common. Late cardiac death occurred in 4 (0.46%) patients; in one additional case death was non–cardiac related. Reoperation was necessary in 9 (1%) patients, consisting mainly of valve replacement (2 patients) and pacemaker implantation (2 patients); heart transplantation was performed in 1 patient. Interventional cardiology procedures were done in 5 (0.5%) patients and were mainly antiarrhythmia procedures (3 patients). All data are exposed in Table E4.

Statistical Analysis
Overall survival at 5 years for all procedures is 96%. Survival curves according to Kaplan–Meier analysis are shown in the following figures.

Survival estimate is 82.6% at 4 years for palliation procedures, 98.9% for repair, and 91.8% for reoperation at 5 years (P < .0001, Figure 1).

View larger version (12K): [in this window] [in a new window]   Figure 1. Kaplan–Meier survival estimates by surgical category.

View larger version (11K): [in this window] [in a new window]   Figure E1. Survival estimates, preoperative New York Heart Association (NYHA) class IV with or without cyanosis.

View larger version (6K): [in this window] [in a new window]   Figure E2. Kaplan–Meier survival estimates by preoperative New York Heart Association (NYHA) class III.

View larger version (6K): [in this window] [in a new window]   Figure E3. Kaplan–Meier survival estimates by diagnosis of atrial septal defect (ASD).

View larger version (6K): [in this window] [in a new window]   Figure E4. Kaplan–Meier survival estimates by single-ventricle diagnosis.

View larger version (7K): [in this window] [in a new window]   Figure E5. Single ventricle by surgical category.

View larger version (8K): [in this window] [in a new window]   Figure E6. Right heart (RH) lesions. TOF, Tetralogy of Fallot; VSD, ventricular septal defect; MAPCAs, Major aortopulmonary collateral arteries; TV, tricuspid valve; RVOT, right ventricular outflow tract; PV, pulmonary valve.

View larger version (9K): [in this window] [in a new window]   Figure E7. Right heart lesions by surgical category. TOF, Tetralogy of Fallot; VSD, ventricular septal defect; MAPCA, major aortopulmonary collateral arteries; TV, tricuspid valve; RVOT, right ventricular outflow tract; PV, pulmonary valve.

View larger version (8K): [in this window] [in a new window]   Figure E8. Left heart (LH) lesions. AoV, Aortic valve; MV, mitral valve; HLHS, hypoplastic left heart syndrome.

View larger version (8K): [in this window] [in a new window]   Figure E9. Left heart lesions by category. AoV, Aortic valve; MV, mitral valve; HLHS, hypoplastic left heart syndrome.

View larger version (10K): [in this window] [in a new window]   Figure 2. Kaplan–Meir survival estimates by preoperative cyanosis.

View larger version (11K): [in this window] [in a new window]   Figure 3. Overall freedom from adverse events.

View larger version (7K): [in this window] [in a new window]   Figure E10. Freedom from adverse events: cyanotic versus noncyanotic.

According to multivariate Cox analysis, the most powerful decremental risk factors are (1) ASD diagnosis (HR, 0.08; P = .0018) and (2) left heart lesion diagnosis (HR, 0.16; P = .014).

	Discussion

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Very few patients with CHD can survive to adult age without surgical intervention. Since the late 1960s, the success of cardiac medical and surgical therapy has drastically modified the natural history of almost all CHDs. This improvement has selected a growing number of newborns and infants who have survived through adolescence until adulthood. These adults constitute a new medical community that is commonly called Grown-up Congenital Heart disease⁴ or adult CHD.⁵ In the year 2000, the number of adult patients with CHD was calculated to be equal to the number of pediatric patients, and it is expected that 20 years from now, the number of adult patients with CHD will exceed those in pediatric care by a considerable margin.^1,6 Based on an English study model,⁷ it is expected that in Italy there are currently 60,000 to 100,000 adult patients with CHD requiring follow-up.²

The effect of such a peculiar group of patients on the medical community is relevant. This population of adults has special needs and peculiar problems.^1,2,4,8 As outlined by Warnes,⁹ despite great advances in diagnosis and therapy occurring in the last decades, many intracardiac repairs and circulations might still not function normally. Residual problems are common, and they might need a lifelong follow-up, with appropriate treatment and care, either medical or surgical.

Somerville⁴ estimates that almost 20% of admissions to a so-called Grown-up Congenital Heart disease unit are for surgical indications. Adult patients are usually referred for surgical intervention because of an increase in symptoms that is not controllable with medical therapy.⁴ In our experience, before surgical intervention, the majority of patients have been in NYHA class I or II, and surgical intervention was dictated more by the existing diagnosis than symptoms, with the aim of restoring the normal circulation and modifying the natural history of CHD.

The analysis of data collected in our multicenter study indicates that cardiac surgery in patients with adult CHD has been characterized by a relatively low overall operative mortality (3.1%). This is comparable with our previous reported European experience of 2.4%³ and considerably lower than 6.3%, as reported by Srinathan and colleagues.¹⁰ It is of note, however, that we are analyzing patients who, frequently, were preoperatively in good clinical condition (NYHA class I or II in the majority), and ASD was undoubtedly a very common "leading to surgical intervention" diagnosis. This has certainly influenced our good early outcome. For this reason, in our analysis we have extrapolated the survival for patients with a diagnosis other than ASD, and we have found that in this selected group, mortality is still inferior to 6%. This might support the common feeling that precocious diagnosis and surgical treatment before irreversible cardiac decompensation and onset of severe symptoms is a rational strategy to improve results.

In addition, our statistical analysis shows an estimated cumulative survival of 96% at 5 years; when considered by category, it is higher for complete repair (98.9%) compared with reoperations (91.8%) and palliation (82.6%). Thus despite repair of congenital heart defects being performed later than the "proper time," this can still be carried out with a relatively low mortality risk.

In our experience the most represented group is the repair group (group 2), which shows excellent operative results in the early and midterm periods. This is generally true also for patients with single-ventricle anatomy who have undergone a physiologic correction by means of a Fontan repair and one-and-half-ventricle repair. However, our analysis demonstrates that single-ventricle diagnosis is still a considerable risk factor for mortality in the midterm (HR, 2.6; P = .032).

As reported by Srinathan and colleagues,¹⁰ it can be expected that the rate of first repair in adults will decrease as time goes by, whereas redo operations will represent the major portion of these procedures in the near future. About 30% of lesions undergoing repair in our series consisted of ASDs. It is surprising that such a large population of patients in our country are still undergoing surgical, rather than transcatheter, device closure. We could not identify a specific reason in this matter. However, despite presumed advantages of percutaneous closure in adults,¹¹ our experience shows excellent early and midterm results, either in terms of mortality or clinical improvement, with no operative risk. In light of these results, we believe that especially in those patients with a history of transitory ischemic attack or neurological deficit caused by patency of foramen ovale, atrial septal aneurysm, or coagulation disorders, ASD surgical closure still plays an important role in avoiding the persistence of artificial conditions linked to device implantation. Longer follow-up is certainly needed in these patients to outline occurrence of arrhythmic events that are often causes of important morbidity in the long term.¹²

Group 1 (palliation) is the least represented group but presents with the worse results. It is predictable that palliative procedures will soon decrease in number because patients with cyanotic CHDs currently undergo repair in early infancy, with the aim of correcting or avoiding long-term cyanosis. A palliative procedure as an adult is still undertaken to improve temporarily the clinical status in patients with no chance for correction or other substitutive type of operation. A considerable rate of nonfatal complications has doomed the palliation group either in the postoperative course or in the follow-up period. This is predictable because we know that preoperative cyanosis is an important risk factor for early and midterm outcome of patients with adult CHD.^3,10,13 The reason for this common finding is the existence of complex pathology, additional collateral pulmonary and mediastinal vascularization, bleeding disorders, and impaired cardiac function.¹⁴ Our statistical analysis confirms these data and underlines that when cyanosis is associated with NYHA functional class IV or diagnosis of transposition of the great arteries, the patient has an extremely high risk, accounting for HRs of 8.6 and 5.0, respectively.

As the number of patients who are treated for CHD in pediatric age is increasing around the world, a new emerging class is that of adult patients who are now facing the long-term effects of a residual congenital defect, the sequelae of the treatment, or both. Many of them do need a reoperation after primary repair. Limited knowledge exists on optimal timing for reoperations, perioperative risk factors, and long-term benefits. Surgical mortality in this subset of patients varies between 5.6% and 8.6%.^10,13,15,16 In our experience early mortality of 7.6% is higher than for repair, and reoperation is associated with an HR of 2.3. In this group of patients, the intrinsic risk of intraoperative hemorrhage, postoperative hemorrhage, or both by redo sternotomy and management of adherences has to be taken into account. However, redo sternotomy has not been a cause of death in our experience. These patients are often in a more compromised preoperative clinical status, and as expected, they present with a high frequency of postoperative complications (42.4% in the series of Berdat and coworkers¹³ and 36.4% in ours). As also outlined by others,^10,15,16 in our experience postoperative low cardiac output syndrome has been the main complication and cause of death in this subgroup. This finding confirms the current opinion that conditions that might have a negative effect on cardiac function, such as heart failure as an indication for reoperation or cyanosis, are identified as additional risk factors for postoperative death.¹⁰ In addition, we are inclined to think that some of these patients might have benefited from earlier intervention before irreversible myocardial deterioration was established, as proposed by some authors.¹⁷

Diller and associates¹⁸ have recently reported that exercise capacity is decreased in patients with adult CHD as in patients with chronic heart failure, even in mildly symptomatic patients. This retrospective analysis performed in 335 patients with heterogeneous CHD points out the concept that patients with adult CHD represent a very complex group of patients and that even when asymptomatic they hide a less than normal cardiac situation. For this reason, we think that if surgical intervention is meant to be of some help for these patients, 2 things have to be kept in mind: (1) surgical intervention should be performed before it is too late, and therefore surgical indication should be precocious, and (2) it is legitimate to think that postoperative intensive care knowledge in this field needs to be improved to be ready to face this increasing group of demanding patients. A devoted team of caregivers have to be well trained to treat these complex patients appropriately. This complex population is estimated to grow 5% per year.¹⁹ Thus it is imperative that the medical community soon structures a functional care network for adult CHD based on clinicians and surgeons with an adequate training and knowledge of CHD and physiology, together with knowledge of the problems of adult patients. As described by some authors,²⁰ care should be specialized in devoted hospital units where a complete team of cardiologists, congenital cardiac surgeons, a heart and heart-lung transplant team, intensive care specialists, anesthesiologists, and also endocrinology, gynecology, and psychiatry specialists should be involved. In addition, the primary caregiver should be trained in following these patients so as to ensure a close contact with patients.²⁰

In conclusion, the outcome of the surgical treatment of CHD in adults is still uncertain, and a new field is to be discovered. Our analysis predicts good midterm postoperative outcomes that allow surgeons to be relatively optimistic in proposing surgical treatment in this difficult category of patients. Closer follow-up and learning the optimal surgical timing is expected to maintain good results in the long term.

Earn CME credits at http://cme.ctsnetjournals.org

 

	References

Top Abstract Introduction Materials and Methods Results Discussion References

 

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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): Massimo A. Padalino Giulio Rizzoli Giancarlo Crupi Massimo Bernabei Gaetano Gargiulo Alessandro Giamberti Francesco Santoro Carlo Vosa Giovanni Stellin Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Padalino, M. A. Articles by Stellin, G. Search for Related Content PubMed PubMed Citation Articles by Padalino, M. A. Articles by Stellin, G. Related Collections Congenital - cyanotic Related Article