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Eur J Cardiothorac Surg 2006;30:762-769
© 2006 Elsevier Science NL

Risk factors for mortality and hospital re-admission after surgical ventricular restoration

Ulrik Sartipya,b,*, Anders Albågea,b, Dan Lindbloma,b

a Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital, Stockholm, Sweden
b Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden

Received 31 July 2006; received in revised form 28 August 2006; accepted 28 August 2006.

* Corresponding author. Address: Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden. Tel.: +46 8 517 728 94; fax: +46 8 33 19 31. (Email: Ulrik.Sartipy{at}karolinska.se).


   Abstract
Top
 Abstract
1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 
Background: Surgical ventricular restoration is an option in patients with coronary artery disease, heart failure, postinfarction left ventricular aneurysm or ischemic dilated cardiomyopathy with or without ventricular tachycardia. The aims of this study were to investigate survival and re-admission for heart failure and to identify predictors for early and long-term mortality and re-admission after surgical ventricular restoration. Methods: Pre- and postoperative data were collected for 136 consecutive patients who underwent surgical ventricular restoration for postinfarction left ventricular aneurysm or ischemic dilated cardiomyopathy during 1994–2005. Survival and risk factors for mortality and hospital re-admission were analyzed by using multivariable models. Results: Early mortality was 10/136 (7.4%). At 1, 3, 5 and 9 years overall actuarial survival was 89%, 80%, 68% and 62%. Increasing age, diabetes and mitral regurgitation grade III–IV were associated with an increased risk for late mortality. Freedom from re-hospitalization due to heart failure or cardiac death in operative survivors at 1, 3 and 5 years was 78%, 72% and 58%. Risk factors for re-hospitalization or cardiac death in operative survivors were increasing age and increasing grade of mitral regurgitation. Conclusions: Surgical ventricular restoration by the Dor procedure can achieve good long-term survival and a high degree of freedom from readmission for heart failure in patients with advanced ischemic heart disease. We found a strong association between increasing grade of mitral regurgitation and both long-term mortality and re-admission for heart failure.

Key Words: Left ventricular reconstruction • Surgical ventricular restoration • Dor procedure • Heart failure surgery • Coronary artery disease


   1. Introduction
Top
 Abstract
 1. Introduction
2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 
Congestive heart failure as a consequence of ischemic heart disease is an increasing medical problem [1]. For end-stage heart failure, heart transplantation is an effective therapeutic option but donor shortage remains an issue. Surgical ventricular restoration (SVR) by means of the Dor procedure is a surgical option in patients with ischemic heart disease and heart failure. After a myocardial infarction (MI), a compensatory left ventricular (LV) dilatation is initiated in the surrounding myocardium [2], a process known as remodeling. This process may be beneficial in the early phase but eventually remodeling results in loss of normal LV elliptical shape and volume. The resultant spherical shape may lead to mitral regurgitation (MR) by different mechanisms, which further promote heart failure [3,4]. LV volume has been recognized as the most important predictor of prognosis after myocardial infarction. Indications for SVR include ischemic dilated cardiomyopathy or LV aneurysm with symptoms of heart failure, angina and/or ventricular tachycardia (VT). The concept of SVR consists of complete revascularization to relieve ischemia, ventricular reconstruction to restore more physiological shape and volume to reduce LV wall stress and improve hemodynamics and, when necessary, endocardectomy and cryoablation to remove substrate for VT [5–7]. Mitral valve repair is performed as needed. Recently, it has been reported that SVR creates a mechanical intraventricular resynchronization in patients without conduction delay, which improves LV performance and may reduce ventricular arrhythmias in the dilated heart [8].

We have previously described our single-center experience of SVR [9] and separately, SVR including surgery for VT [10].

The aims of this study were to investigate survival and freedom from re-hospitalization for heart failure after SVR in patients with ischemic heart disease and heart failure.


   2. Materials and methods
Top
 Abstract
 1. Introduction
 2. Materials and methods
3. Results
 4. Discussion
 5. Conclusions
 References
 
The present study was approved by the regional Human Research Ethics Committee, Stockholm, Sweden. Individual consent was waived.

2.1 Patient selection
Between May 1994 and August 2005, 136 consecutive patients underwent SVR by the Dor procedure for postinfarction dyskinetic LV aneurysm or large non-aneurysmal akinetic LV. Patients were considered suitable for SVR if they demonstrated an enlarged either dyskinetic or akinetic LV accompanied by LV dysfunction after MI and had symptoms of angina and/or heart failure. Assessment of LV volume and geometry was made by ventriculography and late in this series also by magnetic resonance imaging. The mitral valve function was assessed preoperatively by transthoracic echocardiography. Intraoperative transesophageal echocardiography was used in all patients to confirm preoperative findings and to assess valve morphology and postoperative result after weaning from extra corporeal circulation.

2.2 Patient characteristics
There were 104 men and 32 women (n = 136), with a mean age of 64 ± 9.7 (35–80) years. Ninety-four patients (69%) were in New York Heart Association (NYHA) functional class III or IV. Multi-vessel disease was present in 108 patients (79%). The mean preoperative LV ejection fraction was 26% ± 10 (7–50). Baseline characteristics are presented in Table 1 . All patients except one were operated electively. Fifteen patients with spontaneous VT were hospitalized before the operation due to life-threatening arrhythmias. Sixty patients underwent preoperative programmed electrical stimulation and 52 patients had inducible VT preoperatively. Spontaneous VT was present in 33 patients. Indications for surgery are presented in Table 1.


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  		Table 1. Preoperative patient characteristics and indications for surgery (mean ± standard deviation (range) or number of patients)
 
2.3 Surgical technique
The operative procedure has been presented in detail elsewhere [9,10]. In all patients, the LV was reconstructed with an endoventricular patch and in seven cases a sizing device (TRISVRTM, Chase Medical, Richardson, TX, USA) was used to optimize size and shape of the new ventricle. In cases with preoperative confirmed VT, a subtotal non-guided endocardectomy was conducted on the septum and anterior wall and linear cryo lesions (Frigitronics CCS-200, CooperSurgical, Inc., Trumbull, CT, USA) were applied at the edge of the endocardial resection. In three cases the procedure was performed on beating or fibrillating heart without cross-clamping the aorta. A mitral valve procedure was performed in 36 patients. One patient received a mechanical prosthesis. Mitral valve repair was accomplished in two patients with a rigid ring annuloplasty, which in one patient was combined with an Alfieri edge-to-edge plasty. In two patients the edge-to-edge technique was associated with a posterior annuloplasty without a ring as described by Menicanti et al. [3]. In the remaining 31 patients, the edge-to-edge repair was performed without support.

2.4 Data collection and follow-up
A national registration number is allocated to every Swedish citizen. In September 2005, all patients were followed up with respect to survival by use of a continuously updated population register; the Total Register of the Swedish Population, Statistics Sweden. By this procedure all patients could be assigned a date of death or identified as being alive on September 21, 2005. Data collection consisted of review of patients’ records and our clinic's database and data from the national Cause of Death Register and In-patient Register, Centre for Epidemiology at the National Board of Health and Welfare, Sweden. The validity of the diagnosis of heart failure in the Swedish In-patient register has recently been examined and found to be very high (96%) in patients treated at an internal medicine or cardiology department or when heart failure was the primary diagnosis [11]. The cause of death was determined by use of the Cause of Death Register, Centre for Epidemiology at the National Board of Health and Welfare, Sweden, and hospital records. The expected survival, which was used to calculate the relative survival, was derived from survival data of the total Swedish population and matched for gender, age and date of operation (Total Register of the Swedish Population, Statistics Sweden).

2.4.1 End points
The primary end point was all-cause mortality. Secondary end points were early mortality and the combination of first re-admission for heart failure or cardiac death (defined as death due to cardiac failure, ischemic events or sudden death).

2.5 Statistical analysis
Continuous variables are reported as mean and standard deviation. Cumulative survival rates are presented as Kaplan–Meier estimates. Differences between survival curves were analyzed by using the log-rank test. Risk factors for early mortality were identified by bivariate analysis using contingency tables and the Fisher's exact test for categorical variables and Mann–Whitney U-test for continuous variables. Risk factors for long-term mortality were identified by using a Cox proportional hazards model. Survival curves for all-cause mortality were estimated by Kaplan–Meier analysis, stratified by baseline characteristics, and were compared by use of log-rank tests. In this way, a set of potential explanatory variables were isolated and were then used for model fitting. Baseline characteristics considered clinically important were also included. A manual forward and backward variable selection procedure was used to select the final model. A p value of less than 0.05 was chosen as the criterion for variable retention. Risk factors for the composite end-point of cardiac death or re-hospitalization due to heart failure in operative survivors were identified in a similar fashion as risk factors for long-term mortality. Statistical analyses were performed using SPSS 13.0 (SPSS Inc., Chicago, IL).

2.5.1 Definitions
Early mortality was defined as death within 30 days of the operation or death before discharge from the hospital. Survival time was defined as the time from the operation to death or end of follow-up. Status (dead/alive) at late follow-up was ascertained by use of the Total Register of the Swedish Population, Statistics Sweden. Follow-up status was complete except in one case that was due to emigration, this patient was censored at the date of hospital discharge. Survival time was chosen as the dependent variable for the Cox proportional hazard analysis of risk factors for late mortality. Time to readmission was defined as the time from the operation to the composite end-point of first hospital re-admission due to heart failure or cardiac death in operative survivors (n = 126). The date for the first hospital re-admission due to heart failure was established by use of the In-patient Register, Centre for Epidemiology at the National Board of Health and Welfare, Sweden and confirmed by hospital records. The time to readmission was chosen as the dependent variable for the Cox proportional hazard analysis of risk factors for re-admission for heart failure or cardiac death in operative survivors.


   3. Results
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
4. Discussion
 5. Conclusions
 References
 
3.1 Operative data
All patients underwent SVR by means of the Dor procedure, and 129 (95%) patients had concomitant coronary artery bypass grafting (CABG) with a mean of 2.5 ± 1.2 (1–5) grafts. A mitral valve procedure was performed in 36 (26%) patients, using predominantly the Alfieri edge-to-edge technique by the transventricular approach. Operative data are summarized in Table 2 .


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  		Table 2. Perioperative data (mean ± standard deviation (range) or number of patients)
 
3.2 Early findings
Early mortality was 10/136 (7.4%). There were two intraoperative deaths, both due to low output syndrome and seven patients died in the intensive care unit (1–50 days after primary operation) due to low output syndrome, hypoxic brain injury or multiple organ failure. One patient was discharged to his home 7 days after surgery and died on the 20th postoperative day due to an acute myocardial infarction. Two patients underwent re-operation 2 days and 2 weeks after SVR, respectively, because of patch failure. Postoperative stroke occurred in eight patients. In three of these, symptoms had resolved completely before hospital discharge. A summary of postoperative data is presented in Table 3 .


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  		Table 3. Postoperative data (number of patients)
 
3.2.1 Risk factors for early mortality
Bivariate analysis of pre- and perioperative risk factors for early mortality in all patients are presented in Table 4 . Previous cardiac surgery was significantly associated with an increased risk for early mortality. Multivariable analysis was not performed due to limited number of events (10/136).


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  		Table 4. Bivariate analysis of preoperative and surgical risk factors for early mortality in all patients (n = 136)
 
3.3 Long-term findings
The cumulative follow-up was 568 patient-years and median follow-up of operative survivors (n = 126) was 4.2 (interquartile range 1.7–6.7) years. The actuarial survival curve (including early mortality) is shown in Fig. 1 . Overall survival was 89% at 1 year, 80% at 3 years, 68% at 5 years and 62% at 9 years with nine remaining patients at risk. The relative survival is shown in Fig. 1, together with the observed survival in the study group and the expected survival in the normal Swedish population, matched for gender, age and date of operation. The relative survival was calculated as the ratio of the observed to expected rate. Late causes of death were cardiac in 22 cases, non-cardiac in 7 cases (cancer, renal failure, stroke, pneumonia) and undetermined in 1 case. There was no confirmed arrhythmia related death or sudden cardiac death. Four patients received a biventricular pacemaker/implantable defibrillator due to congestive heart failure. Four patients underwent reoperation, 3–13 months after the primary operation, all due to MR. Two of these did not undergo a mitral valve procedure at the primary operation. All four underwent a mitral valve replacement without early mortality. One of these patients later underwent heart transplantation.


Figure 1
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  		Fig. 1. Overall actuarial survival after the surgical ventricular restoration (n = 136). Dotted curves are upper and lower 95% confidence interval (upper graph). Observed and relative survival after surgical ventricular restoration (n = 136). The dotted line represents expected survival in the normal Swedish population matched for gender, age and date of operation (lower graph).

 
3.3.1 Risk factors for late mortality
Survival curves, stratified by dichotomized baseline characteristics, with significant difference in survival are shown in Fig. 2 .


Figure 2
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  		Fig. 2. Kaplan–Meier plots of overall survival after surgical ventricular restoration stratified by pre- and perioperative characteristics (n = 136). (A) Preoperative ejection fraction ≤ 0.30, (B) NYHA class III–IV, (C) diabetes mellitus (treated with insulin or oral anti-diabetics), (D) impaired renal function, (E) preoperative mitral regurgitation grade III–IV, (F) mitral valve surgery.

 
Increasing age, diabetes mellitus and mitral valve regurgitation grade III–IV were strongly and significantly associated with late mortality in the multivariable model (Table 5 ).


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  		Table 5. Risk factors for late mortality (n = 136) and composite endpoint of first postoperative hospital re-admission due to heart failure or cardiac death in operative survivors (n = 126) after surgical ventricular restoration by Cox proportional hazards analysis
 
Preoperative findings of either spontaneous or inducible VT, or surgery for VT, were not found to be significantly associated with early or late mortality.

3.3.2 Hospital re-admission due to heart failure
Freedom from a composite endpoint of first postoperative hospital re-admission due to heart failure or cardiac death in operative survivors was 78% at 1 year, 72% at 3 years and 58% at 5 years.

Increasing grade of mitral valve regurgitation was strongly and significantly associated with hospital re-admission due to heart failure in the age-adjusted multivariable model (Table 5).


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
5. Conclusions
 References
 
The main findings of this study are that SVR can achieve good long-term survival and a high degree of freedom from re-admission for heart failure, in patients with advanced ischemic heart disease. We found a strong association between increasing grade of MR and both long-term mortality and re-admission for heart failure. Diabetes mellitus was also found to be associated with worse survival.

4.1 Surgical ventricular restoration
4.1.1 Aneurysm repair or treatment of heart failure?
In the recent update of the European Society of Cardiology Guidelines for the diagnosis and treatment of chronic heart failure [1], LV aneurysmectomy is indicated in patients with large, discrete LV aneurysms who develop heart failure. Other surgical procedures are mentioned in the Guidelines but are not recommended at this point for treatment of chronic heart failure. In our opinion, SVR should not be regarded as only an aneurysm repair technique but instead as a viable option in modern interventional treatment of heart failure. In selected cases of severe heart failure, SVR could be considered as an alternative to heart transplantation [12].

4.1.2 Shift of indication
The Dor procedure was originally developed as a more physiological LV aneurysm repair technique as compared to simple linear repair and it was based on contributions by Cooley and Jatene. Dor et al. have reported the effects on hemodynamics, functional class and electrophysiology in large single-center series of patients [13]. Di Donato et al. demonstrated that outcome in a large series of SVR patients was more strongly linked to the extent of asynergy than to the type of asynergy (akinetic vs dyskinetic) [14]. The operation has later been applied on patients with ischemic dilated cardiomyopathy and regional asynergy without discrete LV aneurysm [5,15].

4.1.3 Not a standardized technique
Surgical ventricular restoration is not a precisely defined operative procedure but rather a designation of a group of techniques aiming to restore normal LV shape and volume. The endoventricular patch plasty, as originally described by Dor, always includes the use of a patch. McCarthy, Cleveland Clinic, has described a double purse-string suture technique. Mickleborough et al., Toronto, has developed a modified linear closure plus septoplasty, which sometimes includes the use of a patch [16]. Menicanti and Di Donato, Milano, has added the component of inferior plication to the Dor procedure and also advocates the use of a mannequin in order to establish correct shape and volume and to avoid overcorrection [7].

All patients in our series underwent SVR by the Dor procedure, although a limited number of patients late in this series also underwent inferior plication, as described by Menicanti et al. [3]. In seven patients a sizing device was employed. The value of a sizing device has yet to be determined. It is, however, conceivable that a sizing device could be beneficial in patients where a thin walled aneurysm has not yet developed. In our experience, the mannequin can be of help in these cases to guide the surgeon as to where the purse-string suture and patch should be placed and to ensure diastolic capacity.

4.2 Coronary artery bypass grafting for ischemic cardiomyopathy
No randomized clinical trials have investigated the benefit of coronary artery bypass surgery in patients with advanced heart failure and ischemic cardiomyopathy. Coronary artery bypass grafting alone usually does not lead to relief of heart failure symptoms or better left ventricular function in ischemic cardiomyopathy [17–19]. Recent reports [17,18] support the speculation that revascularization alone is not sufficient in the dilated ventricle. Specifically, patients with ischemic cardiomyopathy and a substantial amount of viable myocardium and a high end-systolic volume due to LV remodeling have a decreased likelihood of improvement of global function following myocardial revascularization [18]. Furthermore, patients with a large LV end-systolic volume have a worse long-term prognosis as compared to patients with a smaller LV end-systolic volume [17]. Maxey et al. performed a retrospective analysis of patients with ischemic cardiomyopathy, enlarged LV (end-diastolic dimension ≥6.0 cm) and LV dysfunction (ejection fraction <30%) who underwent operation between 1998 and 2002. Patients underwent either coronary artery bypass alone (n = 39) or coronary artery bypass with SVR (n = 56) and outcomes were compared. The investigators found significantly better late outcome regarding mortality and freedom from heart failure in the group who underwent SVR and coronary artery bypass surgery [20].

We believe that SVR and revascularization is superior to revascularization alone in patients where the ventricle is starting to dilate to prevent further remodeling and functional deterioration. This, however, remains to be proved and an international randomized clinical trial, the STICH trial [21], is designed to test two hypotheses in patients with coronary artery disease and LV dysfunction. The first hypothesis is that coronary artery bypass surgery combined with intensive medical therapy improves long-term survival compared with medical therapy alone. The second hypothesis is that SVR combined with bypass surgery and medical therapy improves survival free of hospitalization compared with bypass surgery and medical therapy without SVR.

A summary of available observational data on survival after SVR is presented in Table 6 .


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  		Table 6. Observational data on early and long-term survival and risk factors after surgical ventricular restoration
 
4.3 Risk factors for mortality
4.3.1 Diabetes mellitus
Diabetes mellitus was associated with increased mortality in our study. This finding is in concordance with previous findings in patients with heart failure and ischemic cardiomyopathy [22].

4.3.2 Mitral regurgitation
Moderate and severe MR was associated with worse long-term survival. There was a tendency for negative impact of even mild MR on long-term mortality, however, there were too few patients in our study to show a significant association. Mild MR has been demonstrated to be an independent predictor of mortality after myocardial infarction [23]. Moderate ischemic MR does not resolve with CABG surgery and is associated with worse survival [23]. Currently, most authors recommend mitral valve repair in conjunction with SVR for moderate to severe MR and it is still unclear if mild MR should be left uncorrected. The SVR procedure may reduce mild MR by restoring LV geometry and volume.

4.4 Hospital re-admission for heart failure
The composite end point of re-hospitalization for heart failure or cardiac death is a very sensitive indicator of clinical efficacy of heart failure treatment. It combines two high prevalence, well defined, end points that may be directly influenced by the therapy. In a large non-randomized multi-center registry of patients who underwent SVR, 5-year freedom from hospital re-admission for heart failure was 78% [5], however the authors state that the criteria for heart failure hospital admission may have varied among centers. Mickleborough et al. [16] defined poor 5-year result as the need for transplantation or repeated (more than one) hospitalization for congestive heart failure or death and identified predictors for poor 5-year result (Table 6).

Our study benefited from several national registers. The date and cause of death could therefore be accurately obtained in all patients. The date for re-admission for heart failure could likewise be ascertained in a national register where the diagnosis of heart failure has been validated [11]. Freedom from re-hospitalization for heart failure or cardiac death was 72% at 3 years and 58% at 5 years in our study and increasing age and increasing grade of MR were found to be associated with the composite end point of re-hospitalization for heart failure or cardiac death. We find it encouraging that at 5 years, 58% of the patients, of which 69% were in NYHA class III–IV preoperatively, were alive and had not been admitted to the hospital due to heart failure. In patients with severe heart failure, the 1-year mortality is more than 50% [1].

4.5 Limitations of the study
The lack of a control group is the major limitation of this study. Another limitation of this series is the lack of postoperative invasive studies or magnetic resonance imaging in most patients, which are needed for detailed analysis of changes in ventricular performance, volume and geometry. We have not had complete follow-up of concurrent medication, but all patients have had regular contact with a cardiologist and/or family physician. The use of beta-blockers and angiotensin-converting enzyme inhibitors for patients with left ventricular dysfunction was common during the study period. Among the strengths of this study is that most patient data have been prospectively collected, patients are consecutive, and that follow-up is complete and accurate due to high quality Swedish national registers.


   5. Conclusions
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
References
 
By applying the concepts of SVR, good long-term survival and a high degree of freedom from readmission for heart failure can be achieved in patients with advanced ischemic heart disease. Increasing grade of MR was strongly associated with poor outcome.


   Acknowledgments
 
This work was supported by grants from the Swedish Heart Lung Foundation and Capio Research Foundation. Expert statistical advice from Magnus Backheden, BSc, Department of Learning, Informatics, Management and Ethics at Karolinska Institutet, Stockholm are gratefully acknowledged. Survival data from the normal population was kindly supplied by Jan Qvist and Hans Lundström, Statistics Sweden.


   References
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusions
 References
 

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