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Circulation. 1995;92:216-222

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(Circulation. 1995;92:216-222.)
© 1995 American Heart Association, Inc.

Articles

Peak Oxygen Consumption and Resting Left Ventricular Ejection Fraction Changes After Cardiomyoplasty at 6-Month Follow-up

Edimar Alcides Bocchi, MD; Guilherme Veiga Guimarães, PhEd; Luiz Felipe P. Moreira, MD; Fernando Bacal, MD; Alvaro Vilela de Moraes, MD; Antonio Carlos Pereira Barreto, MD; Mauricio Wajngarten, MD; Giovanni Bellotti, MD; Noedir Stolf, MD; Adib Jatene, MD; Fulvio Pileggi, MD

From the Heart Institute, São Paulo (Brazil) University Medical School.

Correspondence to Edimar Alcides Bocchi, MD, Rua Oscar Freire, 2077, Apto 161, Cep 05409-011, São Paulo, Brasil. E-mail: dcl_edimar@pinatubo.incor.usp.br.


*    Abstract
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Background The effects of cardiomyoplasty on cardiopulmonary exercise test characteristics are not fully known.

Methods and Results We determined in 19 patients who underwent cardiomyoplasty for treatment of refractory heart failure (New York Heart Association [NYHA] functional class III) before (pre) and at 6-month follow-up (post) maximum oxygen consumption (peak O2), NYHA functional class, and resting left ventricular ejection fraction (LVEF) (MUGA). We analyzed the results according to pre peak O2 < or >14 mL/kg per minute and the correlation between the changes in absolute values of LVEF and peak O2. Pre– and post–peak O2 values were 15.9±4.4 and 18.6±6.4 mL/kg per minute, respectively (P=.059). In the subgroup with pre–peak O2 <14 mL/kg per minute, the peak O2 increased from 11.1±1.9 to 16.4±6.2 mL/kg per minute (P=.02). The subgroup with peak O2 >14 mL/kg per minute showed pre– and post–peak O2 of 19.2±2.6 and of 20.1±7 mL/kg per minute, respectively (P=.06). The pre–total exercise time of the entire group increased from 688.4±222.1 to 833.7±241.6 seconds (P<.04). For the subgroup with preoperative peak O2 <14 mL/kg per minute, exercise time improved from 585±76.9 to 825±186.3 seconds (P<.01). In the subgroup with preoperative O2 >14 mL/kg per minute, the preexercise and postexercise time was 763.6±264.4 and 840±282 seconds, respectively (P=.4). Pre- LVEF increased from 20.6±3.3% to 24.2±7.8% at 6 months of follow-up (P=.02). At 6 months of follow-up, 9 patients were in NYHA functional class I and 10 were in class II. There was no correlation between LVEF values and absolute values of peak O2 before (r=.123, P=.6) and after (r=.27, P=.2) cardiomyoplasty. A weak correlation was observed between the changes in absolute values of peak O2 and LVEF from the preoperative to the postoperative period (r=.48, P=.048).

Conclusions Cardiomyoplasty is a useful method for improving NYHA functional class and LVEF in patients with heart failure. Peak O2 <14 mL/kg per minute before cardiomyoplasty may be a selection criterion with which to determine improved exercise capacity after surgery. The effects of cardiomyoplasty on LVEF appear to be partially associated with maximum exercise capacity changes.


Key Words: cardiomyoplasty • heart failure • exercise


*    Introduction
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Dynamic cardiomyoplasty is a surgical procedure directed toward treatment of heart failure.1 In this procedure, a latissimus dorsi muscle flap is wrapped around the ventricles and stimulated in synchrony with cardiac systolic activity.2 3 In selected patients, studies have shown that the procedure improves New York Heart Association (NYHA) functional class,4 5 6 7 left ventricular function,8 regional left ventricular wall motion with changes in geometry,9 and hemodynamic parameters at rest and during exercise.10 In addition, there has been a report of an increase in left ventricular maximal elastance and reduction of systolic wall stress, end-diastolic circumferential stress, and chamber and muscle stiffness associated with changes in left ventricular diastolic filling.11

Also, improvement in maximum oxygen consumption (peak O2) during exercise has been demonstrated.6 10 12 However, these previous studies did not describe other treadmill exercise characteristics, and they were limited by a small number of patients7 or associated procedures to cardiomyoplasty.12 In addition, these studies did not provide selection criteria for improvement in peak O2 after cardiomyoplasty. Accordingly, the purpose of the present study was to investigate the effects of dynamic cardiomyoplasty on cardiopulmonary treadmill exercise test characteristics and resting left ventricular ejection fraction (LVEF) at 6-month follow-up. Also, we studied the correlation between the absolute values of preoperative peak O2 and its improvement after cardiomyoplasty.


*    Methods
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Study Population
In the study period from May 1988 to March 1993, 32 patients underwent cardiomyoplasty at Heart Institute, University of São Paulo (Brazil) Medical School. None of the patients died in the immediate postoperative period, but one patient had to have heart transplantation. Three patients died before 6-month follow-up. Nine patients were excluded owing to the following reasons: sustained ventricular tachycardiac episode during exercise (1), atrial fibrillation with high ventricular rate during exercise (1), technical limitation in interpreting the test (1), nonadherence to protocol (1 [from Venezuela]), limitations in determining peak O2 because of osteomuscular disease, or any reason other than dyspnea or fatigue, such as obesity (1), anxiety (1), recent respiratory tract infection (1), and not reaching the anaerobic threshold (2). Accordingly, the study group consisted of 19 patients. The selection of patients for cardiomyoplasty was performed with previously described criteria.13 The diagnosis was idiopathic dilated cardiomyopathy in 16 patients, Chagas' heart disease in 1, and ischemic cardiomyopathy in 2. Fifteen patients were men, and mean age was 47±6 years (range, 33 to 55 years). Before cardiomyoplasty, all patients were in New York Heart Association (NYHA) functional class III despite maximal medical therapy with diuretics, digitalis, vasodilators (ECA inhibitors), and potassium reposition beyond the standard treatment of heart failure. The doses of diuretics were reduced or remained the same, and the doses of vasodilators did not change at 6-month follow-up. Patients were asked to provide written special informed consent in accordance with the standards of the Scientific and Ethic Committee of the Heart Institute, University of São Paulo Medical School. Table 1Down shows additional characteristics of patients studied.


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  		Table 1. Patient Characteristics Before Cardiomyoplasty

Surgical Procedure and Muscle Stimulation Protocol
Cardiomyoplasty was performed in accordance with the reinforcement technique described by Chachques et al.14 All operations were performed without cardiopulmonary bypass. Two intramuscular pacing electrodes (Medtronic SP 5528 BV) were implanted in the muscle flap. An intramyocardial sensing lead (Medtronic SP 5548 BV) was implanted in either the left or the right ventricle. The cardiomyostimulator Medtronic SP 1005 BV was used for muscle stimulation.

Electrical stimulation of the skeletal muscle graft was initiated 2 weeks after the operation. The progressive muscle-conditioning protocol proposed by Chachques et al3 was followed. After 2 months of follow-up, the stimulation frequency of 30 Hz was achieved, and the muscle flap was paced at 1:1 with a heart rate <100 beats per minute (bpm) and 2:1 with a heart rate >100 bpm. Supramaximal pulse amplitude values (4.5 to 6 V) were used for muscle stimulation. The delay between the sensed ventricular event and the muscle burst was adjusted to obtain exact synchronization between muscle flap contraction and ventricular systole.10

Study Design
Before and at 6-month follow-up after cardiomyoplasty we determined the following parameters: NYHA functional class, resting LVEF (in percent) by radionuclide scintigraphy, peak O2 normalized for body weight during cardiopulmonary treadmill exercise, total exercise time, heart rate, and maximum pulmonary ventilation. In addition to standard analysis of patient data, we compared the results of two subgroups according to peak O2 before the cardiomyoplasty: >14 and <14 mL/kg per minute. The limit was considered to be 14 mL/kg per minute on the basis of the importance of this value in the indication for heart transplantation, and this limit is related to an unacceptable quality of life.15 The subgroups had similar baseline characteristics before cardiomyoplasty except for peak O2 (Table 1Up). Furthermore, the correlation between resting LVEF changes and peak O2 was studied to clarify the mechanisms of cardiomyoplasty effects. The changes in parameters were calculated according to the differences between the postoperative and preoperative absolute values.

Cardiopulmonary Exercise Test
On the day before the study, treadmill exercise was performed to familiarize the patients with the protocol. On the next day, the subjects underwent 12-lead resting ECG and a progressive treadmill exercise test, with continuous monitoring of ECG, cuff blood pressure, ventilation, and gas exchange during the test, including the recovery period. Subjects were asked to refrain from cigarette smoking and consumption of caffeinated beverages on the day of the test. All patients were studied in an air-conditioned (21°C to 23°C) exercise facility at least 2 hours after a light meal. The exercises were performed on a programmable treadmill (Quinton Instrument Co) according to a modified Naughton protocol.16 After 2 minutes of resting recordings while on the treadmill, all patients were encouraged to exercise until symptoms (fatigue or dyspnea) made them unable to continue. All patients reached the anaerobic threshold. Expired fractions of O2 (by zirconium fuel-cell sensor) and CO2 (infrared absorption) and the rate of air flow were measured by metabolic analyzer and by the linearized pneumotachometer at rest (standing) and throughout the exercise period and recovery with a breathing apparatus consisting of a mouthpiece, nose clamp, and low-resistance two-way valve (dead space, 100 mL; Hans-Rudolph). Ventilatory and gas exchange data were determined on a breath-by-breath basis with a computerized system (model CAD/Net 2001, Medical Graphics Corporation). The following measurements were derived on a breath-by-breath basis: O2 uptake normalized for body weight (O2, mL/kg per minute), CO2 production (CO2, mL/min), end-tidal oxygen partial pressure (PETO2), end-tidal carbon pressure (PETCO2), ventilatory equivalent exchange ratio (RER) (CO2/O2), minute pulmonary ventilation (VE, mL/min), the ventilatory equivalent for oxygen (VE/O2), and the ventilatory equivalent for carbon dioxide (VE/CO2). Peak O2 was considered the highest O2 achieved in a presumed maximal effort exercise test.17 Maximal ventilation was determined by the average of all breaths within a 30-second period surrounding the highest recorded O2. To determine anaerobic threshold (AT), the following criteria were used18 : systematic increase in VE/O2 without increase in VE/CO2, systematic increase in PETO2 without a decrease of PETCO2, and systematic increase in RER.

LVEF
Left ventricular radionuclide scintigraphy was obtained after in vivo labeling of red blood cells with 99mTc. Gated–blood pool imaging was acquired in the left anterior oblique view with an Anger Camera 9, Ohio Nuclear) equipped with an S-500 computer (Sopha Medical Systems, Inc). Left ventricular volumes and LVEF were calculated by standard formulas.

Statistical Analysis
Statistical analysis was performed with Student's t test for paired or nonpaired testing, as appropriate. A value of P<.05 was considered statistically significant. Data are presented as mean±SD. The relations between variables were examined with linear regression analysis.


*    Results
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*Results
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Cardiopulmonary Exercise Test
The mean value of peak O2 before the cardiomyoplasty was 15.9±4.4 mL/kg per minute and at 6 months after the operation was 18.6±6.4 mL/kg per minute (P=.059) (Fig 1Down). The subgroup (11 patients) with preoperative peak O2 >14 mL/kg per minute showed peak O2 of 19.2±2.6 mL/kg per minute before the operation and 20.1±7 mL/kg per minute at 6-month follow-up (P=.06) (Fig 2Down). However, in contrast, the subgroup of patients (8 patients) with preoperative peak O2 <14 mL/kg per minute presented a statistically significant improvement in peak O2. In this subgroup, the peak O2 increased from 11.1±1.9 to 16.4±6.2 mL/kg per minute (P=.02) (Fig 3Down). Fig 4Down shows a plot between preoperative peak O2 values and peak O2 improvement. The values of VE/O2 of the entire group before the operation and at 6-month follow-up were 54±29 and 54±16 (P=NS), respectively; 65±42 and 64±19 (P=NS) in the subgroup with peak O2 <14 mL/kg per minute before the surgery; and 46±9 and 47±10 (P=NS) in the subgroup with preoperative peak O2 >14 mL/kg per minute. The exercise time of the entire group was 688.4±222.1 seconds before cardiomyoplasty and 833.7±241.6 seconds after cardiomyoplasty (P<.04). In the subgroup with preoperative peak O2 <14 mL/kg per minute, the exercise time improved from 585±76.9 to 825±186.3 seconds (P<.01). In the subgroup with preoperative O2 >14 mL/kg per minute, the preexercise and postexercise times were 763.6±264.4 and 840±282 seconds, respectively (P=.4). The maximum heart rate during exercise for the entire group was 149±26 bpm before cardiomyoplasty and 153±22 bpm after cardiomyoplasty (P=NS). In the subgroup with preoperative peak O2 >14 mL/kg per minute, the preoperative and postoperative maximum heart rates were 154±30 and 152±21 bpm, respectively (P=NS). For the subgroup with preoperative peak O2 <14 mL/kg per minute, the preoperative and postoperative maximum heart rates were 140±30 and 155±25 bpm (P=NS) (Fig 5Down).



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  		Figure 1. Plot of maximum oxygen consumption (peak O2; Peak VO2 in FigureUp) during treadmill exercise before and after cardiomyoplasty (CMP) in the entire study group. Pre CMP indicates before CMP; Post CMP, after CMP at 6-month follow-up.



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  		Figure 2. Plot of maximum oxygen consumption (peak O2; Peak VO2 in FigureUp) during treadmill exercise before and after cardiomyoplasty (CMP) in patients with peak O2 >14 mL/kg per minute before surgery. Pre CMP indicates before CMP; Post CMP, after CMP at 6-month follow-up.



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  		Figure 3. Plot of maximum oxygen consumption (peak O2; Peak VO2 in FigureUp) during treadmill exercise before and after cardiomyoplasty (CMP) in patients with peak O2 <14 mL/kg per minute. Pre CMP indicates before CMP; Post CMP, after CMP at 6-month follow-up.



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  		Figure 4. Plot showing preoperative absolute maximum oxygen consumption (peak O2; Peak VO2 in FigureUp) values before the cardiomyoplasty (CMP) and absolute peak O2 changes ({Delta}-peak O2, values after CMP minus values before CMP) from preoperative to postoperative at 6-month follow-up after CMP.



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  		Figure 5. Graph showing heart rate during treadmill exercise test before and after cardiomyoplasty in patients with maximum oxygen consumption (peak O2) <14 mL/kg per minute before the surgery. b · min-1 indicates beats per minute; pts, patients; N, number; Pre, before surgery; and Post, after surgery at 6-month follow-up.

NYHA Functional Class
At 6 months of follow-up 9 patients were in NYHA functional class I, and 10 patients were in class II (Table 2Down). Therefore, cardiomyoplasty determined improvement in NYHA functional class in most surviving patients. Eight patients with peak O2 <14 mL/kg per minute before cardiomyoplasty had improvement of NYHA functional class from class III to class II (5 patients) or to class I (3 patients). In the subgroup with peak O2 >14 mL/kg per minute before the surgery, NYHA functional class increased from class III to class I in 6 patients and to class II in 5 patients.


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  		Table 2. Follow-up Data After Cardiomyoplasty Using Patient-by-Patient Analysis

LVEF
Cardiomyoplasty determined improvement in LVEF from 20.6±3.3% (before surgery) to 24.2±7.8% at 6-month follow-up (P=.02). Fig 6Down shows the individual variation of LVEF from before surgery to 6-month follow-up. In the subgroup with preoperative peak O2 <14 mL/kg per minute, LVEF improved from 20.4±3.7% to 26.1±11% (P=.09). In the subgroup with peak O2 >14 mL/kg per minute before the operation, LVEF increased from 21±2.7% to 24±3.2% (P=.04).



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  		Figure 6. Plot of left ventricular ejection fraction by radionuclide scintigraphy at rest before and after cardiomyoplasty (CMP) in entire study group. Pre CMP indicates before CMP; Post CMP, after CMP at 6-month follow-up.

Correlation Between Changes in LVEF, NYHA Functional Class, and Peak O2
Table 2Up presents an analysis of results on a patient-by-patient basis. There was no correlation between resting LVEF values and absolute peak O2 values before (r=.123, P=.6) and after (r=.27, P=.2) cardiomyoplasty. Also, there was no correlation between NYHA functional class and changes in peak O2 or LVEF. However, a weak correlation was observed for maximum changes in peak O2 and LVEF between before cardiomyoplasty and 6-month follow-up (r=.48, P=.048) (Fig 6Up).


*    Discussion
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 up arrowMethods
up arrowResults
*Discussion
down arrowReferences
 
The results of the present study demonstrate that cardiomyoplasty improves LVEF and NYHA functional class in patients with heart failure by 6-month follow-up. There was a trend that did not achieve statistical significance for peak O2 improvement in the entire group. Cardiomyoplasty improved peak O2 and exercise time in patients with preoperative peak O2 <14 mL/kg per minute. In addition, there was a statistically weak correlation between the changes in left ventricular ejection fraction and peak O2 absolute values from before cardiomyoplasty to 6-month follow-up.

Left ventricular function and functional class results are consistent with results of the US Food and Drug Administration (FDA) Phase II American Cardiomyoplasty Study and other studies that showed improvement in LVEF, left ventricular regional wall motion, and clinical status after cardiomyoplasty.3 8 9 12 19 20 21 22 Multiple mechanisms have been proposed to explain the left ventricular systolic effects of cardiomyoplasty, such as reduction in left ventricular stress,11 23 improvement in ventricular wall motion owing to active reinforcement, passive reinforcement limiting heart dilatation,3 changes in left ventricular geometry,9 decreased myocardial O2, and enhanced coronary revascularization.5 24 25 Concerning NYHA functional class results, despite modest and nonuniform beneficial effects on left ventricular function and peak O2, cardiomyoplasty produced improvement in NYHA functional class in all patients. This finding is confirmed by other studies that had difficulty correlating clinical success with improvement in resting LVEF and resting hemodynamic data after cardiomyoplasty.5 22 26 27 The poor correlation between LVEF at rest and exercise capacity before and after the cardiomyoplasty are corroborated by studies that demonstrated disparity between resting measures of left ventricular function and maximal exercise capacity.28 29 30 31 Also, divergence between improvement in resting LVEF and exercise tolerance with medical treatment has been reported.32 In the present study, we found a weak but statistically significant correlation between changes in LVEF and peak O2 changes. The reasons for these findings are unclear. One could speculate that cardiomyoplasty may have additional effects on other determinants of NYHA functional class or exercise capacity, such as cardiac diastolic function or cardiovascular reserve during exercise and even a placebo effect.

The observed tendency of improvement in peak O2 during cardiopulmonary treadmill tests is in contrast to the FDA Phase II American Cardiomyoplasty Study results.22 However, the improvement is in concordance with previous reports that showed statistically significant improvement in maximal exercise capacity after cardiomyoplasty.12 33 However, the preoperative mean values of peak O2 in these previous studies were lower than values in the present study, except in the FDA American Cardiomyoplasty Phase II Study.22 On the other hand, postoperative data after cardiomyoplasty in our and other investigations showed peak O2 values between 18 and 19 mL/kg per minute.12 27 Also, after successful heart transplantation, peak O2 was close to 19 mL/kg per minute.34 It appears that methods to treat heart failure may have limitations in normalizing peak O2. Thus, the preoperative value of peak O2 should be included among selection criteria aimed at successful cardiomyoplasty. This assumption may be supported by our subgroup results that showed a substantial improvement in patients with preoperative peak O2 <14 mL/kg per minute. Mechanisms of cardiomyoplasty effects determining improvement in peak O2 are not unknown. Also, pathophysiological mechanisms underlying the exercise limitation of patients with chronic heart failure are not clear. It is postulated that in patients with heart failure35 multiple abnormalities may affect exercise capacity, such as central (systolic and diastolic function, pulmonary hemodynamics, and neurohumoral mechanisms), peripheral (blood flow abnormalities, vasodilatory capacity, and skeletal muscle biochemistry), and ventilatory factors (pulmonary pressure, physiological dead space, ventilation-perfusion mismatch, respiratory control, and breathing pattern).36 37 38 It has been postulated that maximal heart rate, maximal cardiac output, and their changes from rest to maximal exercise appear to account for the greatest variances in exercise capacity.30 39 Resting effects of cardiomyoplasty on central factors, including systolic and diastolic left ventricular functions, have been demonstrated.3 8 Resting hemodynamic improvement is not a universal finding. However, evaluations were usually performed at rest and not during exercise. To our knowledge, only one investigation was performed during exercise, and the investigators demonstrated improvement in hemodynamics during treadmill upright exercise after cardiomyoplasty.10 Thus, theoretically one might speculate that a main effect of cardiomyoplasty during exercise would be to provide higher left ventricular stroke volume, probably owing to a beneficial systolic effect and possibly a diastolic effect of exercise. This can be supported by our results showing no statistically significant change in maximal exercise heart rate. It is believed that diastolic dysfunction may contribute to exercise capacity, and a beneficial diastolic effect of cardiomyoplasty has been demonstrated.30 On the other hand, investigators have suggested that abnormalities in the periphery may contribute to exercise performance in chronic heart failure.40 Thus, the increments of cardiac output and peripheral blood flow could lead to an improvement in peripheral components, including muscles. Regarding other factors, cardiomyoplasty did not affect pulmonary ventilation in our study, and it did not change neurohormonal activity and baroreflex sensitivity in patients with heart failure.41 Further studies should be undertaken to investigate the effects of cardiomyoplasty on parameters determinants of exercise.

Study Limitations
This investigation is limited by the small number of study patients in a restricted 6-month follow-up period and the lack of a comparable control group. However, at 6-month follow-up, most conditioned muscle could be evaluated to determine cardiac effects. On the other hand, in a longer mean follow-up, late muscle degenerative changes after cardiomyoplasty were demonstrated.42 The present study was limited in that exercise LVEFs were not determined. Parameters of left ventricular function measured at rest do not necessarily reflect the most important feature of central hemodynamics—the ability to increase the supply of oxygen to the metabolically active tissues, or the reserve capacity of cardiovascular system.43 However, methods for determining left ventricular function reserve are not available for clinical use, and difficulty in obtaining accurate measures during exercise should be considered. Also, peak O2 is influenced not only by the subject's motivation but also by the philosophy of the persons supervising the test concerning when the test should be terminated.44 However, in the present study, the same team supervised all tests. Our study did not include cardiopulmonary exercise tests with on and off conditions for the myostimulator. Differences between these conditions have been reported concerning resting LVEF and hemodynamic data after cardiomyoplasty.9 This issue should be addressed in future studies.

Conclusions and Clinical Implications
Cardiomyoplasty is a useful surgical method for improving NYHA functional class and resting LVEF at 6-month follow-up. With regard to exercise, the cardiomyoplasty may not have a significant impact on peak exercise performance. However, cardiomyoplasty appears to be able to improve peak O2 in selected patients with more restricted exercise capacity and, with the use of selection criteria that include preoperative peak O2, may be associated with better results concerning peak O2. Although peak O2 <14 mL/kg per minute was found, this by no means represents an inflexible guideline, and the ultimate decision to perform cardiomyoplasty should be based on multiple parameters. Effects of cardiomyoplasty on exercise capacity may be influenced by factors other than the resting systolic cardiac effects resulting from the procedure. Further studies should be performed to clarify the effects of cardiomyoplasty on mechanisms determining exercise capacity in patients with heart failure.



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  		Figure 7. Plot of linear regression analysis between left ventricular ejection changes ({Delta}LVEF, difference between postoperative and preoperative values) and peak oxygen consumption changes (peak O2 changes; {Delta}Peak VO2 in FigureUp; difference between postoperative and preoperative absolute values) from before to after the cardiomyoplasty at 6-month follow-up (r=48, P=.046).


*    References
up arrowTop
 up arrowAbstract
 up arrowIntroduction
 up arrowMethods
up arrowResults
up arrowDiscussion
*References
 

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