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European Journal of Heart Failure 2006 8(3):314-320; doi:10.1016/j.ejheart.2005.07.014
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© 2005 European Society of Cardiology

Benefits of coronary revascularisation in diabetic and non-diabetic patients with ischaemic cardiomyopathy: Role of myocardial viability

Vittoria Rizzellob, Don Poldermansa,*, Elena Biaginia, Arend F.L. Schinkela, Eric Boersmaa, Abdou Elhendya, Fabiola B. Sozzia, Alexander Maata, Jos R.T.C. Roelandta and Jeroen J. Baxc

a Department of Cardiology Thoraxcenter Room Ba 300, Erasmus MC, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
b Department of Cardiology, The Catholic University Rome, Italy
c Department of Cardiology, Leiden University Medical Center Leiden, The Netherlands

* Corresponding author. Tel.: +31 10 4639222; fax: +31 10 4364957. E-mail address: d.poldermans{at}erasmusmc.nl


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 
Background: Diabetes mellitus in patients with coronary artery disease is associated with poor outcome. In this study, the relation between myocardial viability, diabetes, coronary revascularisation and outcome was evaluated.

Methods: 129 patients (31 diabetic, 98 non-diabetic) with ischaemic cardiomyopathy underwent dobutamine stress echocardiography to assess myocardial viability. Patients with ≥4 viable segments were defined as viable and patients with <<4 viable segments as nonviable. Left ventricular ejection fraction (LVEF) was assessed before and 9–12 months post-revascularisation. At the same time-points, LV volumes were measured to evaluate LV remodelling. Finally, cardiac events were noted during 5-year follow-up.

Results: The extent of viable myocardium was comparable between diabetic and non-diabetic patients. After revascularisation, LVEF increased ≥5% in 44% of diabetic and in 40% of non-diabetic patients. LVEF only improved in patients with viable myocardium. Ongoing LV remodelling occurred in 36% and 35% of diabetic and non-diabetic patients respectively, and was related to non-viability, whereas viability protected against ongoing LV remodelling, both in diabetic and non-diabetic patients. Viability was the only predictor of survival after revascularisation.

Conclusions: Diabetic, viable patients with ischaemic LV dysfunction exhibit improvement in LVEF post-revascularisation with prevention of ongoing LV remodelling, similar to non-diabetic patients. Myocardial viability was also the only predictor of long-term outcome.

Key Words: Diabetes mellitus • Coronary artery disease • Myocardial viability • Coronary revascularisation • Ischaemic cardiomyopathy

Received March 27, 2005; Revised June 4, 2005; Accepted July 26, 2005


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 References
 
Over the last two decades, many studies have demonstrated that revascularisation can significantly improve left ventricular ejection fraction (LVEF) in patients with ischaemic cardiomyopathy [1-5]. However, peri-operative morbidity and mortality are high [6] and therefore appropriate selection of patients who may benefit from revascularisation is needed. Pre-operative assessment of myocardial viability has been shown to identify patients with a high likelihood of improvement in LVEF [1-5]. Indeed, Haas et al. [7] demonstrated a reduction in peri-operative morbidity and mortality, with a better outcome, when only patients with viable myocardium underwent revascularisation. Whether the same holds true for patients with diabetes is currently unclear. This is an important issue, since many patients with diabetes and coronary artery disease develop LV dysfunction over time [8-10]. Moreover, diabetic patients have a worse short- and mid-term outcome after revascularisation as compared to non-diabetic patients [11-13], which highlights the need for identification of patients who may potentially benefit from revascularisation.

Accordingly, in the current study, the relation between pre-operative myocardial viability and the outcome after revascularisation was evaluated in patients with diabetes; the results were compared with non-diabetic patients undergoing viability testing and revascularisation.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 References
 
2.1. Study population
The study population consisted of 129 patients (105 men, mean age 62±9 years) with ischaemic cardiomyopathy (LVEF 31±7%) and symptoms of heart failure, already scheduled for coronary revascularisation. Indications for revascularisation included: clinical criteria such as symptoms of heart failure with (72% of patients) or without angina, evidence of inducible ischaemia during stress tests other than stress echocardiography, and coronary anatomy eligible for revascularisation. In patients with 2- or 3-vessel disease, surgical revascularisation was preferred over percutaneous coronary intervention.

A history of myocardial infarction was present in 119 patients (92%). In these patients, infarction had occurred ≥6 months before study entry. Patients with moderate to severe mitral regurgitation were not included. Diabetes mellitus was present in 31 patients, whereas 98 patients were non-diabetic. Diabetes mellitus was defined as a fasting glucose level ≥7.8 mmol/L or the need for insulin or hypoglycemic agents. Eight patients had insulin-dependent diabetes and 23 patients had non-insulin-dependent diabetes.

2.2. Study protocol
Before revascularisation, all patients underwent radionuclide ventriculography to assess LVEF and dobutamine stress echocardiography (DSE) to assess myocardial viability. LV volumes were derived from resting echocardiographic images. Nine to 12 months after revascularisation, radionuclide ventriculography was repeated to evaluate the improvement in LVEF. In addition, resting 2-dimensional echocardiography was repeated at 9-12 months after revascularisation to assess changes in LV volumes (LV remodelling). Finally, cardiac events (cardiac death, myocardial infarction and hospitalization for heart failure) were evaluated during a 5-year follow-up. The local ethics committee approved the protocol and all patients gave informed consent.

2.3. Echocardiographic studies
All echocardiograms were performed using a Sonos-5500 device (Hewlett-Packard, PMS, Eindhoven, The Netherlands) equipped with a second-harmonic 1.8-3.6 MHz transducer. Standard views of the LV were obtained [14].

2.4. Myocardial viability
Low-high dose DSE (up to 40 µg/kg/min plus 2 mg atropine, if necessary) was performed as described previously [15]. Interpretation of DSE studies was performed off-line from cine-loop images, by 2 experienced observers blinded to the clinical data. Inter- and intra-observer agreement for analysis of DSE studies were 92% and 94%, respectively [16]. Regional function was scored using a 16-segment and 5-point scoring model with 1=normal, 2=mildly hypokinetic, 3=severely hypokinetic, 4=akinetic, 5=dyskinetic [15]. The wall motion score index (WMSI) was calculated by dividing the summed wall motion score by the number of segments. Myocardial viability was evaluated only in severely dysfunctional segments (score 3 to 5). Segments showing a sustained improvement in wall motion up to high dose and segments with biphasic response or worsening of wall motion during DSE were considered viable [17]. Segments with unchanged wall motion or with akinesia becoming dyskinesia were considered nonviable [17]. A patient was defined as viable in the presence of ≥4 viable segments and nonviable in the presence of <4 viable segments [3]. Also, the absolute changes in WMSI (delta, {Delta}) during DSE (low-dose minus rest and peak—minus low-dose DSE) were calculated.

2.5. LV volumes
LV end-diastolic and end-systolic volumes (LVEDV and LVESV) were measured from the resting echocardiographic images. All measurements were performed off-line by two experienced readers blinded to patient data and acquisition time (before or after revascularisation). LV volumes were measured using the biplane Simpson's rule [14]. An increase >15% in the LVEDV or LVESV after revascularisation was considered indicative of ongoing LV remodelling [18].

2.6. Assessment of improvement in left ventricular ejection fraction
Radionuclide ventriculography was performed at rest with the patient in the supine position after the administration of 740 MBq of 99mtechnetium. Images were acquired with a small-field-of-view gamma camera (Orbiter, Siemens Corp, Iselin, NJ, USA), oriented in the 45° left anterior oblique position with a 5-10° caudal tilt. The LVEF was calculated from the 45° left anterior oblique view by an automated technique. An improvement in LVEF ≥5% at 9 to 12 months after revascularisation was considered clinically significant [3].

2.7. Long-term follow-up
The long-term follow-up was obtained by chart review and telephone contact. Events included: cardiac death, myocardial infarction and hospitalization for heart failure. Cardiac death was defined as sudden death, death due to acute myocardial infarction or heart failure. Myocardial infarction was defined according to classical criteria (symptoms, electrocardiographic changes and elevated cardiac enzymes). Hospitalization for heart failure was defined according to the hospital discharge diagnosis.

2.8. Statistical analysis
Continuous data are expressed as mean (SD) and dichotomous data as proportions. Continuous data were compared using the Student's t test for paired and unpaired samples as indicated. Comparison of proportions was performed by chi-square analysis. Cardiac event rate was evaluated using Kaplan-Meier analysis. Differences between curves were tested by log-rank chi-square statistics. Cox regression analysis was performed to identify predictors of cardiac death and all cardiac events. For all tests, a P value <0.05 was considered significant.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 References
 
3.1. Study population
Clinical characteristics were comparable between diabetic patients and non-diabetic patients; however, LVEF before revascularisation was significantly lower in diabetic patients (Table 1). Twelve (9%) patients died early after revascularisation and 12 additional patients refused to undergo assessment of LVEF and LV volumes after revascularisation. These patients were included in the follow-up analysis, but LV volumes and LVEF after revascularisation were not available.


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  		Table 1 Clinical characteristics of diabetic and non-diabetic patients

 
3.2. Resting echo and DSE results
Table 2 summarizes the results of resting echocardiography and stress echocardiography. The number of segments showing severe wall motion abnormalities was comparable in diabetic and non-diabetic patients. Also, baseline LV volumes were similar in the 2 groups. Diabetic patients showed a higher WMSI at rest as compared to non-diabetic patients. The analysis of myocardial viability showed that the number of viable segments was similar in the 2 groups (4.6±3.0 in diabetic and 4.2±3.5 in non-diabetic patients, P=NS). Also, the {Delta} in WMSI at low-dose and peak-dose of dobutamine infusion were comparable (Table 2). Based on the presence of ≥4 viable segments, the population was divided in 4 groups: 18 diabetic viable patients, 13 diabetic nonviable patients, 48 non-diabetic viable patients and 50 non-diabetic nonviable patients.


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  		Table 2 Echocardiographic data at baseline

 
3.3. Improvement in LVEF after revascularisation
An increase in LVEF ≥5% occurred after revascularisation in 11/25 (44%) diabetic patients and in 31/80 non-diabetic patients (40%) (P=NS). In particular, in diabetic, viable patients the LVEF increased from 29±9% to 34±8% (P=0.001), whereas the LVEF did not improve in diabetic, nonviable patients (from 32±6% to 30±8%, P=NS). Similarly, in non-diabetic patients, LVEF increased from 31±9% to 35±11% (P=0.004) in viable patients whereas LVEF did not improve in nonviable patients (from 32±6% to 34±11%, P=NS).

3.4. LV remodelling after revascularisation
After revascularisation, LV remodelling occurred in 9/25 (36%) diabetic and in 28/80 (35%) non-diabetic patients (P=NS). In Fig. 1, the LV volumes are displayed before and after revascularisation, according to diabetes and viability. In non-diabetic patients, LV volumes did increase after revascularisation in nonviable patients (LVEDV increased from 183±51 to 193±50 ml, P<0.01 and LVESV from 116±46 to 124±48 ml, P<0.01). In contrast, LV volumes did not increase in viable patients, indicating prevention of LV remodelling (LVEDV: 170±62 at baseline vs 169±67 ml, P=NS and LVESV: 116±55 vs 111±58 ml, P=NS). Similar results were obtained in diabetic patients. In nonviable patients the LVEDV increased from 181±43 to 196±49 ml (P=0.02), whereas the LVESV increased from 119±43 to 136±45 ml (P=0.03). In viable patients, the LV volumes did not change significantly (LVEDV: 181±54 vs 173±67 ml, P=NS and LVESV: 127±48 vs 125±63 ml, P=NS).


Figure 1
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  		Fig. 1 Bar graphs showing the LV end-diastolic (EDV) and the LV end-systolic (ESV) in diabetic and non-diabetic patients according to the presence or absence of a substantial amount (≥4 viable segments) of viable myocardium.

 
3.5. Cardiac events during follow-up
A total of 68 cardiac events occurred during the 5-year follow-up (median 4.4 years), including 29 cardiac deaths, 3 myocardial infarctions and 36 hospitalizations for decompensated heart failure. Overall, cardiac events were comparable between diabetic and non-diabetic patients (48% vs 54% respectively, P=NS). However, in the non-diabetic patients, the viable patients had a significantly lower event rate during follow-up as compared to the nonviable patients (8 of 48, 17% vs 23 of 50, 46% P=0.03). Cardiac death was more frequent in diabetic as compared to non-diabetic patients although the difference was not statistically significant (32% vs 17%, P=NS). The cardiac death rates according to the presence of diabetes mellitus and a substantial amount of viable myocardium (≥4 viable segments) are shown in Fig. 2. The highest cardiac death rate was observed in the diabetic, nonviable patients (5 of 13, 39%); the lowest cardiac death rate was observed in the non-diabetic, viable patients (2 of 48, 4%). The cardiac death rate was similar in diabetic, viable patients and in non-diabetic, nonviable patients (5 of 18, 28% vs 17 of 50, 34%, P=NS). Of note, the cardiac death rate was significantly less in the non-diabetic patients with viability as compared to the nonviable patients (4% vs 34%, P=0.005) In diabetic patients, although the cardiac death rate was lower in viable patients as compared to nonviable patients, this difference did not reach statistical significance (28% vs 39%, P=NS). The multivariable analysis showed that the presence of substantial amount of viable myocardium was an independent predictor of cardiac death (HR 0.35 , 95% CI 0.15-0.83, P=0.02) whereas diabetes mellitus was not (HR 1.9 , 95% CI 0.9-4.1, P=0.10). Similarly, myocardial viability was also an independent predictor for all cardiac events (HR 0.49, 95% CI 0.26-0.92, P=0.03). Diabetes was associated, although not significantly, with a higher risk of cardiac events (HR 1.18, 95% CI 1.0-3.3, P=0.07). The interaction term between diabetes and viability was borderline significant for cardiac death (P=0.08), but not for all cardiac events (P=0.6).


Figure 2
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  		Fig. 2 Kaplan-Meyer curves showing cardiac death rate according to the presence of myocardial viability and diabetes.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
References
 
The findings in the present study demonstrate that the effect of viability on LVEF and LV remodelling is similar in patients with and without diabetes. In particular, a comparable increase in LVEF post-revascularisation was observed in the two groups. Also, patients with viable myocardium did not exhibit ongoing LV dilatation. In contrast, in patients with limited or no viability, LVEF did not improve and ongoing LV remodelling was observed; the effects were similar in patients with and without diabetes. These observations demonstrate that pre-operative assessment of viability has comparable clinical value in patients with diabetes.

Finally, patients with viable myocardium had a favourable prognosis as compared to patients without viable myocardium. However, diabetic patients with viable myocardium had a similar prognosis as compared to non-diabetic patients without viable myocardium.

4.1. Improvement in left ventricular function
The number of patients with ischaemic cardiomyopathy is increasing rapidly and, despite optimal medical therapy, the prognosis remains poor [19]. In particular, the prevalence of patients with diabetes who develop ischaemic LV dysfunction is rising exponentially [20], and is associated with worse outcome [21-24]. Data from the Framingham Study demonstrated that patients with diabetes have a 4-fold increased risk of developing heart failure after myocardial infarction [21] and in the SOLVD and RESOLVD trials, diabetes was an independent predictor of death [22,23].

Accordingly, aggressive management of patients with diabetes is needed, and revascularisation should be performed if the patient has a high likelihood of benefit. It is known from studies in non-diabetic patients, that improvement in LVEF can occur when a substantial amount of viable myocardium (≥25% of the LV) is present but not in the absence of substantial viability [1-5]. Whether pre-operative assessment of viability is equally predictive in diabetic patients is unclear. Accurate identification of diabetic patients with viable myocardium is important, since revascularisation is associated with significantly higher peri-operative morbidity and mortality as compared to non-diabetic patients, and also long-term outcome after revascularisation is worse in diabetic patients [6,11-13].

In the current study, low-high dose DSE was used to assess viability; this technique has been extensively validated in previous studies in patients with ischaemic cardiomyopathy [25]. In particular, in the present study, 58% of diabetic and 49% of non-diabetic patients showed substantial viability on DSE. Similar findings have been reported using metabolic imaging with positron emission tomography or single photon emission computed tomography [26,27]. In addition, the results in the present study indicate that prediction of functional recovery was comparable between diabetic and non-diabetic patients, with a significant increase in LVEF in 44% of diabetic and 40% of non-diabetic patients.

4.2. Effects beyond improvement of function?
Besides improvement in function, LV remodelling is an important end-point in patients with ischaemic cardiomyopathy. Numerous studies have demonstrated high mortality in patients with a severely dilated left ventricle [28-30]. Moreover, prevention of ongoing remodelling improved survival, both in diabetic and non-diabetic patients [31,32]. In the current study, LV remodelling occurred in 36% of diabetic patients and 35% non-diabetic patients. In particular, LV volumes increased significantly after revascularisation in patients without viability (indicating ongoing LV remodelling), whereas LV volumes did not change significantly in patients with viable tissue (indicating prevention of further LV remodelling). This pattern was observed both in diabetic and non-diabetic patients (Fig. 1). Other factors influencing LV remodelling (history of (anterior) myocardial infarction, baseline LV volumes, medical therapy including ACE-inhibitors and beta-blockers) were comparable between diabetic and non-diabetic patients, suggesting that the effect on LV volumes is related to the presence/absence of viable myocardium.

Limited data are available on long-term prognosis in diabetic patients in relation to viability. It is known from studies in non-diabetic patients that survival is poor in medically treated patients with viable myocardium. In a meta-analysis performed by Allman et al. [33], the mortality rate was 16% in viable patients who were treated medically, in sharp contrast to the 3.2% mortality rate in viable patients who underwent revascularisation. Only one study reported on the inter-relation between viability, diabetes, therapy and long-term outcome. Pasquet et al. [34] demonstrated that medically treated patients with diabetes and viability showed a higher risk of death as compared to non-diabetic patients during 3 years follow-up [34]. This risk was significantly reduced in diabetic patients with viability undergoing revascularisation, but not in diabetic patients without viability [34]. The current study specifically focused on the prognosis in diabetic patients undergoing revascularisation in relation to pre-operative viability. During a 5-year follow-up period, the lowest cardiac death rate after revascularisation was observed in non-diabetic viable patients (4%), in line with the results from the meta-analysis by Allman et al. [33]. Conversely, non-diabetic, nonviable patients had a cardiac death rate of 34% (P=0.005 vs viable patients). Among diabetics, both viable and nonviable patients showed a high cardiac death rate (28% vs 39%, NS). It is of interest that the cardiac death rate of diabetic, viable patients is almost comparable to non-diabetic, nonviable patients (28% vs 34%, NS). This finding suggests that besides viability, diabetes is important for long-term prognosis of patients with ischemic cardiomyopathy undergoing revascularisation and may limit the beneficial effect of revascularisation of viable myocardium. Still, multivariable analysis demonstrated that the presence of viable myocardium was the only independent predictor of prognosis after revascularisation. However, the interaction between viability and diabetes was borderline significant for prediction of cardiac death. This is an important result from a clinical point of view, since an increasing number of patients present with ischemic LV dysfunction and diabetes. In these patients, accurate prediction of outcome is important, since revascularisation is associated with worse short- and mid-term outcome [11-13]. It is conceivable that the relatively small number of diabetic patients included in the current study was responsible for the lack of statistical power. Overall, the present data suggest that the combination of diabetes and viability may be useful for risk stratification before revascularisation. It appears that the presence of diabetes may somewhat decrease the beneficial effect of viability on long-term prognosis. Clearly, larger studies are needed to provide more insight into the prognostic value of viability in diabetic patients with ischaemic LV dysfunction.

In addition, it is of interest that despite a similar improvement in LVEF after revascularisation in diabetic and non-diabetic patients, diabetic patients still had a higher cardiac death rate (32% vs 17%). This observation is in line with previous work by Samady et al., showing that LVEF may not be the only determinant of prognosis after revascularisation of patients with ischemic cardiomyopathy [35]. In particular, progression of coronary artery disease and recurrence of ischaemia are frequently observed in diabetic patients and may significantly affect prognosis. Moreover, severe arrhythmias and/or diastolic dysfunction may also determine outcome.

4.3. Study limitations
A relatively small group of diabetic patients was studied, and larger studies are needed.

After revascularisation, coronary angiography was not repeated. Therefore graft closure or restenosis could not be excluded, and may have influenced the outcome.

Improvement of diastolic function may also be an additional end-point after coronary revascularisation in patients with ischaemic cardiomyopathy. In the present study information on diastolic function was not available, which is a limitation.

4.4. Conclusion
In diabetic patients with ischaemic LV dysfunction, the presence of viable myocardium is associated with an improvement in LVEF post-revascularisation, which is similar to non-diabetic patients. In addition, revascularisation of viable patients prevented ongoing LV remodelling in diabetic patients comparable to non-diabetic patients. Viability was the only predictor of survival after revascularisation, although the interaction of viability and diabetes was borderline significant. Indeed, viable, non-diabetic patients had a better survival compared to viable, diabetic patients. Larger studies are needed to further elucidate this issue.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 References
 

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