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J Thorac Cardiovasc Surg 2001;121:879-893
© 2001 The American Association for Thoracic Surgery
Cardiothoracic Transplantation |
From the Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio.
Received for publication May 3, 2000. Revisions requested July 11, 2000; revisions received Nov 21, 2000. Accepted for publication Dec 1, 2000.
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Abstract |
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 Top Abstract IntroductionPatients and methodsResultsDiscussionAppendix: DiscussionReferences |
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Introduction |
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TopAbstractIntroductionPatients and methodsResultsDiscussionAppendix: DiscussionReferences |
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Despite marked improvement in the pharmacologic treatment of end-stage heart failure, the prognosis is still poor with a high mortality rate especially for those who have a dilated heart.
1 Because heart transplantation is limited and expensive, alternate surgical procedures have been investigated for these patients. 2-4 Partial left ventriculectomy (PLV) with reduction of left ventricular (LV) volume leads to reduced wall tension, aims to restore the normal mass/volume ratio, and has been proposed as a treatment modality for heart failure resulting from dilated cardiomyopathy. 5-7 Although early data have been encouraging, with improvement of LV function and reversal of congestive heart failure, patient outcomes have been variable, different surgical techniques have been used, and long-term survival and prolonged beneficial effects have yet to be evaluated. 6,8-12 Furthermore, patient selection criteria remain unclear. 13-15
The Cleveland Clinic, therefore, prospectively evaluated this operation as a surgical option for patients with advanced heart failure resulting from dilated cardiomyopathy. In the initial publication from that series, we made several positive observations, including acute improvement in LV function, mitral regurgitation, and clinical functional class during early follow-up (mean 5 months). 8 We also noted, however, the occurrence of unpredictable early failures (22%) and concluded that the operation warranted investigation, but not widespread dissemination, as an alternative to transplantation until several issues were studied. 8,16 Those issues included long-term durability, the role of associated mitral valve repair, and risk factors that could be useful to determine candidate selection.
The purpose of this article is to assess the later effects of PLV in terms of (1) clinical time-related outcomes, (2) factors predictive of these outcomes with specific attention to the influence of preoperative mitral regurgitation, and (3) assessment of the durability of acute improvement in LV function and mitral valve competence.
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Patients and methods |
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TopAbstractIntroductionPatients and methodsResultsDiscussionAppendix: DiscussionReferences |
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Patient selection was based on the hypothesis that patients with dilated cardiomyopathy without extensive areas of scar would benefit from the procedure. 8 An LV end-diastolic dimension (LVEDD) of more than 7.0 cm as determined by echocardiography was a prerequisite. All but 3 patients were evaluated and accepted as transplant candidates should mechanical circulatory support or cardiac transplantation be necessary after the PLV surgery.
Informed consent was obtained from all patients after verbal and written discussion of risks, alternatives, and perceived benefits of the operation were discussed by the cardiologists, surgeon, and other members of the heart failure/transplant team. The 62 patients were chosen from approximately 3000 referrals. Most often patients were turned down for medical reasons or because the patient was too well, but other patients refused PLV after informed consent discussions and continued toward transplantation or with medical therapy. Patients were reviewed at the weekly heart failure/transplant team meeting as part of the Kaufman Center for Heart Failure. The Cleveland Clinic Institutional Review Board was notified of this prospective study and reviewed and approved protocols regarding blood samples for neurohormones and a study of amiodarone use.
At the time of preoperative evaluation all patients had heart failure. Only patients with heart failure of at least 6 months' duration were eligible (range 6-240 months). All patients referred for surgery were evaluated by at least one heart failure cardiologist from The Cleveland Clinic Foundation and had been optimized with medical therapy. Medications at the time of surgery in the 62 patients were angiotensin-converting enzyme inhibitor, 47 (76%); ß-blocker, 10 (16%); digitalis, 45 (73%); loop diuretic, 50 (81%); metolazone, 6 (10%); amiodarone, 10 (16%); dobutamine or milrinone, 23 (37%); and warfarin, 16 (26%).
Optimal medical therapy for heart failure was reinstituted as soon as possible after surgery, including angiotensinconverting enzyme inhibitors, diuretics, digoxin, and amiodarone. 7,8 ß-Blockers, including carvedilol, were added as tolerated. Beginning in 1997 implantable defibrillators were implanted for most patients before hospital discharge.
Surgical technique
The surgical technique used is a modification of that originally described by Batista and associates 6 and has been published earlier. 8 In brief, a wedge-shaped portion of the left ventricle supplied by the circumflex artery was resected. If possible, the papillary muscles were left intact (n = 29; 47%), but if needed to obtain normal LVEDD, one or both papillary muscles were resected and transferred to an adjoining site on the ventricular wall (n = 33; 53%). A mitral annuloplasty was performed using the Cosgrove-Edwards annuloplasty system (Baxter Healthcare Corp, Edwards Division, Irvine, Calif). In addition, the free edges of the anterior and posterior mitral leaflets were approximated (Alfieri stitch). Due to residual 2+ mitral regurgitation at the end of the operation, 2 patients underwent intraoperative mitral valve replacement. Papillary muscle resection and reimplantation was performed as described 8 in 33 patients (53%); 10 of them (16% of total cases) had both anterior and posterior resections, 3 had only anterior resection, and 20 had only posterior resection. Concomitant surgical procedures included tricuspid valve repair (36 patients), coronary artery bypass grafting (5 patients), and aortic valve repair (1 patient).
Time-related outcomes
End points
The end points were (1) all cause mortality, (2) implantation of an LVAD, (3) return to class IV heart failure (including relisting for transplantation), (4) use of an implantable defibrillator, and (5) the earliest of these end points (event-free survival).
Clinical follow-up
None of the patients were lost to follow-up, which was performed at The Cleveland Clinic whenever possible. Patients were asked to return to The Cleveland Clinic at 3, 6, and 12 months and annually thereafter. Because many patients resided far away, they were not always able to return. Patients unable to return for follow-up were contacted by telephone for determination of clinical events and functional capacity. Referring physicians were also contacted for follow-up, including echocardiograms and functional studies.
Mean follow-up was 24 ± 12 months and encompasses 76 patient-years. The longest follow-up extends to 3.5 years. Among surviving patients, 10% have been followed up for 3 or more years, 73% have been followed up for 2 or more years, and 94% for more than 1 year.
Time-related estimates and their predictors
Nonparametric estimates of outcomes were obtained by the method of Kaplan and Meier. 17 A parametric method was used to resolve the number of phases of instantaneous risks of each event (hazard function) and to estimate their shaping parameters. 18
The multivariable analyses of outcomes were preceded by exploratory analysis of the variables in Table I, including correlation analysis, stratified life-table analyses, and decile risk analysis of ordinal and continuous variables to determine possible transformations of scale needed to calibrate properly the variables to each outcome. Among the potential risk factors screened were several measurements obtained across time preoperatively for each patient, including hemodynamic measures and echocardiographic LV function. In addition, echocardiographic assessments of mitral valve regurgitation required incorporation with an analysis of a time-varying covariable. Thereafter, multivariable analyses were performed sequentially, first considering baseline and demographic variables, then preoperative measures, then immediate postoperative measures, and finally, the sequence of postoperative estimates of mitral valve regurgitation. The analysis used a directed technique of entry of variables into the multivariable model. 19 The P value criterion for retention of variables in the final models was .1.
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LV ejection fraction (LVEF), LVEDD, LV end-diastolic volume index (LVEDVI), and mitral valve regurgitation grade were analyzed by longitudinal data analysis method. 20 A random coefficients model was fitted to the repeated measures to quantify postoperative time trends (Proc mixed in SAS; SAS Institute, Inc, Cary, NC). For the analysis of mitral regurgitation, we used longitudinal repeated-measures modeling for ordinal categorical variables (Proc GenMod in SAS), assuming a multinomial distribution with an ordinal logistic characteristic (link function). All these analyses used the exact time of assessment and all available data, although they were truncated in patients at the time of death, transplantation, or follow-up.
Presentation
Mean values are presented ± 1 SD. Confidence levels (CL) for proportions are 68%, corresponding to 1 SE. Nomograms were constructed by solving each multivariable equation for freedom from each event at 3 years.
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Results |
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TopAbstractIntroductionPatients and methodsResultsDiscussionAppendix: DiscussionReferences |
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). Mode of death included heart failure/arrhythmias (11 patients), unwitnessed sudden death (4 patients), multiorgan failure (4 patients, 1 after transplantation), and stroke, witnessed cardiac arrest, and acute rejection (1 patient each).
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Discussion |
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TopAbstractIntroductionPatients and methodsResultsDiscussionAppendix: DiscussionReferences |
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We observed 80% survival at 1 year, which compares favorably with survival reported from other centers. 6,9-11,21 However, since the freedom from composite events at the same time was only 49%, this indicates that the aggressive use of LVADs and transplantation accounts for this seemingly high survival at 1 year. This is corroborated by the fact that 3-year overall survival was only 60%. It should also be emphasized that varying patient selection and surgical techniques make comparison between centers difficult. Other centers have combined the outcomes for idiopathic dilated cardiomyopathy with patients who underwent PLV for ischemic cardiomyopathy. We excluded our patients with ischemic cardiomyopathy, because reconstruction for ischemic disease has a long history and a much more predictable beneficial effect than does PLV for idiopathic disease. 22,23 Also, unlike others, we did not think it was adequate to simply report survival and, therefore, sought to determine whether patients were significantly improved by creating the composite event for failure, but not necessarily fatal events.
Although the failure rate was high after PLV, a number of event-free survivors had improvement in subjective clinical status and objective measurements (maximum exercise oxygen consumption) even though overall ventricular function was not restored to normal and cardiac output changes were modest. 7,8 These patients did benefit from PLV, and multivariate analysis to assess risk factors has given some insight into the predictors of poor outcome. Earlier analysis based on our smaller patient population with shorter follow-up could only reveal young age and preoperative diastolic function to be risk factors for failure. 13,24 It was further recognized that these younger patients represented a more severely diseased patient population with higher pulmonary artery pressure and a higher requirement for inotropic support. 13 On the basis of the present group of patients and follow-up, we were able to identify further preoperative risk factors including increased systolic pulmonary artery pressure, decreased maximum exercise oxygen consumption, and increased left atrial pressure. Presumably, PLV in patients without these risk factors will increase the 26% subgroup of patients who were alive and well in late follow-up. Emergency surgery, 21 preoperative poor ventricular compliance (ie, diastolic dysfunction), 24 increased myocardial cell diameter, 14,25 and a left dominant coronary artery system 26 are other suggested risk factors for failure. We did not have the tissue analyzed for myocardial cell diameter and, therefore, cannot comment.
The reduction in LV wall stress quantified by echocardiography and magnetic resonance imaging scans and the improvement in LV systolic function may be offset by a reduction in compliance. 24,27-29 Computer modeling and finite element analysis indicate that the reduction in LV diastolic function will blunt the improvement in myocardial efficiency. 29,30 We have clues that suggest that reduced compliance at baseline may contribute to poorer late outcomes, that is, higher pulmonary artery and left atrial pressures in this study, higher pulmonary artery pressures in young patients in the prior study, 13 and compliance function derived from pressure-area loops. 24 Also, late exercise hemodynamics after PLV showed a significant increase in cardiac index with exercise (2.2 ± 0.5 to 3.8 ± 1.6; P = .0077), but a marked increase in pulmonary artery pressures (pulmonary artery systolic 52 ± 20 mm Hg to 79 ± 17 mm Hg; P = .0001: pulmonary artery mean 36 ± 12 mm Hg to 52 ± 10 mm Hg; P = .0003), also suggesting abnormal compliance. 31 We postulate, but cannot absolutely confirm with this small group of patients, that stiff fibrotic hearts are very prone to failure with this operation. To treat these patients without transplantation will require a procedure that decreases wall stress and improves systolic function and myocardial efficiency without impairing diastolic function. Devices in development may bring us much closer to this goal. 32-35
The influence of mitral valve repair per se in PLV is of interest. Indeed, it has been shown that mitral valve repair can reverse LV remodeling and dysfunction in patients with dilated or ischemic cardiomyopathy combined with severe (4+) mitral regurgitation. 36-38 It should be emphasized, though, that in the present patient population (as with most cardiomyopathy patients), the mitral regurgitation was generally less severe. Furthermore, multivariate analysis of risk factors could not distinguish any favorable effects of PLV and mitral valve repair in patients with preoperative moderately severe (3+) or severe (4+) mitral regurgitation in relation to patients with mild (1+) to moderate (2+) mitral regurgitation. If anything, there was a tendency toward a worse outcome for patients with preoperative mitral regurgitation grades 3 to 4 (P = .1). This is also supported by reports on the isolated positive effect of PLV, without mitral valve reconstruction, in patients with dilated cardiomyopathy lacking mitral regurgitation. 39,40 However, to maintain the beneficial effects of PLV, we thought it was important to prevent the return of mitral regurgitation and redilatation of the left ventricle. 8,12 Therefore, we were very aggressive with valve repair to avoid chronic volume overload that we thought might lead to late redilatation and failure. There was a slight increase in the mitral regurgitation during follow-up, but 4+ regurgitation did not develop in any patient and 3+ regurgitation developed in only 1 patient. Mitral regurgitation after surgery was not associated with clinical failure. Whether the repair held up due to the small annuloplasty ring, the Alfieri repair, or the reconstruction of the left ventricle that reduced apical displacement of the papillary musles cannot be determined from this study.
This study answered several other questions about the late effects of PLV. 41 Late redilatation was unusual and, therefore, was not the cause of failure. The modest improvement in LVEF decreased very slowly but was not associated with failure. The incidence of sudden death was relatively low (n = 4) and can be avoided after this operation, in large part by the liberal use of implantable cardioverter/defibrillators and amiodarone. A previous study failed to show that the ventricular tachycardia morphology was related to the surgical scar. 42
Initially there was a discussion that this operation should be evaluated in a randomized trial versus medical therapy or cardiac transplantation. 7,16,39,41,43,44 We resisted this strategy for several reasons. First, comparing the earliest "learning curve" results of this complex operation to establishied therapies without some preliminary experience with patient selection, operative technique, and perioperative care seemed premature. We pursued our strategy of a carefully monitored prospective study to accrue information to determine whether such a study would be warranted, and in which patients. Second, the practical aspects of a large multicenter clinical surgical trial were daunting. These aspects included funding, careful patient selection, uniform surgical technique and postoperative care, as well as management of the medical control population or transplant arm of the study. We did not think this study could be contemplated until clinical follow-up indicated that such a trial warranted the time and expense required. Finally, as events unfolded, we became aware of devices that may be applied to the same patient population, but with the expectation of a lower morbidity and with Food and Drug Administration oversight of clinical trials. 32-35 In this regard we think the Batista operation may be a step along the way (like the Vineberg operation before coronary artery bypass) and that a prospective study is no longer warranted.
Limitations of the study
This is a prospective but not randomized study; therefore, no direct comparison to other surgical procedures or medical therapy alone can be made. Although this study was aimed at investigating the impact of the surgical procedure, it was considered important to maximize pharmacological treatment postoperatively. Therefore, postoperative adjustment of drugs may have contributed to some observed positive effects. Malignant arrhythmias, which were the cause of death in some early patients, may have been avoided by implantation of defibrillators in all patients; this was only routinely done in later patients. Serial comparisons are naturally biased in that only patients reaching follow-up are included in the analysis performed. We attempted to account for this by our statistical analysis of results. Nevertheless, patients whose treatment failed early could not have values obtained later, and some patients lived far from Cleveland and could not return for follow-up. However, follow-up was complete for clinical events.
Clinical inferences
In conclusion, in this pilot study of PLV with mitral valve surgery for dilated cardiomyopathy, we observed a 60% 3-year survival and 26% freedom from failure. Failures were largely unpredictable from preoperative clinical studies, but risk factors included increased left atrial and systolic pulmonary artery pressures and decreased maximum exercise oxygen consumption. Modest improvement in LV systolic function was sustained and late ventricular dilatation was rare. Correction of preoperative mitral regurgitation did not account for the clinical benefit, and some evidence indicates that worsening diastolic function may have contributed to failures. We infer from these observations that the Batista procedure is not a predictable reliable alternative to transplantation. In other cultures and socioeconomic settings this procedure may be further investigated, or in a nontranslant population, or as an alternative to LVADs as a "biologic" bridge-to-transplantation. In our opinion, the experience was not a dead end, however, and may have spawned devices that can be applied with a low morbidity to change LV shape and improve LV function.
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Appendix: Discussion |
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TopAbstractIntroductionPatients and methodsResultsDiscussionAppendix: DiscussionReferences |
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Do you think your approach may have limited in some of your cases the extension of your resection and therefore undermined the full potential of the surgical procedure?
My second question relates to papillary reimplantation. I am slightly uncomfortable about this technique. Do you think this may have affected the long-term ventricular function and perhaps even mitral valve competence? Since you have 2 fairly large groups of patients in whom the mitral valve was repaired, with or without implantation of the papillary muscle, can you describe how these 2 groups did at late follow-up and whether there was any difference?
Dr Franco-Cereceda. Thank you very much, Dr Angelini, for those remarks. The impact of mitral valve repair or replacement in relation to the Batista procedure has attracted a great deal of attention. It is important to realize that what we say is not that the mitral valve repair is not beneficial for the heart. We see, as have others, that with a postoperative return of mitral valve regurgitation the outcome is worse.
We could not see any real differences in outcome between patients undergoing resection of the papillary muscle and those with an intact papillary muscle. The subvalvular apparatus is important for survival in general in mitral valve regurgitation, and preservation of the valve is important to obtain the best possible results, because there will always be some changes in the geometry when the papillary muscles are removed. Basically, all patients received an annuloplasty system and the Alfieri stitch.
As shown in the figures, there is no redilatation, indicating that we have no return of mitral valve regurgitation, and there are essentially no differences between the groups with and without papillary muscle resection.
Dr Hisayoshi Suma (Kamakura, Japan). We continue to perform ventriculoplasty for nonischemic dilated cardiomyopathy and have done 68 cases in 3 years with a 2-year survival of 71%. From this experience, we have learned that some patients with nonischemic dilated cardiomyopathy have a bad septum and a relatively intact lateral wall, which is detectable on intraoperative echocardiography. The ordinary Batista procedure could be dangerous in such cases, so we have used endoventricular anteroseptal patch plasty in 9 patients.
Have you found that the extent of myocardial damage in nonischemic dilated cardiomyopathy is not always homogeneous and some surgical modification is necessary when the weakest part is located in the septum?
Dr Franco-Cereceda. Thank you, Dr Suma, for your remarks and your question. We know of the very elegant studies performed by you and your colleagues in Japan. What we have been trying to do is resect the lateral wall and, if needed, the posterior wall, but I am sure that modifications of the procedure can be done. Such modifications would definitely include patching of the septum. We have not been doing that, and we do not anticipate any more of these operations, so I cannot comment more than that.
Dr O. Howard Frazier (Houston, Tex). In July of 1996, at about the same time this procedure was started in Cleveland, we did our first case. The patient was severely ill with class IV disease and remains well in class I nearly 4 years later. However, our long-term results in general reflect what was so ably presented here. A comparison of our results with those of a nontransplant center in Belgrade, Yugoslavia, though, revealed a very interesting correlation between myocyte diameter and relatively good results, which they experienced, as well as duration of heart failure. This may simply mean that the favorable outcomes may be more reflective in the less ill patients, as I think your data seemed to support—patients with better myocardial oxygen consumptions and low pulmonary pressures. Yet 26% of your patients remain out of class IV. Do you think it could be an alternative to transplantation in a properly selected group?
Dr Franco-Cereceda. Thank you, Dr Frazier, for your remarks and your question. First, let me comment on your studies on myocyte sites and fibrosis. Your suggestion of a histologic classification system regarding these procedures is a very intriguing one. We know of your excellent results, and we also know that you, in comparison with the Belgrade group, have been looking at the different reasons for the differences in outcome.
With regard to your question, I think you are right that it is important not to delay if you are going to operate on these patients. It is probable that the more severe the disease, the more unfavorable the outcome. But, as you mentioned, 26% of our patients are event-free at 3 years' follow-up. There is definitely something to this operation.
The reason that we will not use it at The Cleveland Clinic is that we are a transplant institution. Later in this meeting, Dr Patrick McCarthy will present some other surgical options for these patients. We are definitely not condemning the operation. We are merely stating that it is unpredictable and unreliable and should be restricted to cases not amenable to transplantation or other modes of therapy.
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Footnotes |
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References |
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TopAbstractIntroductionPatients and methodsResultsDiscussionAppendix: DiscussionReferences |
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D. Marelli, H. Laks, J. A. Kobashigawa, J. Bresson, A. Ardehali, F. Esmailian, M. D. Plunkett, and B. Kubak Seventeen-year experience with 1,083 heart transplants at a single institution Ann. Thorac. Surg., November 1, 2002; 74(5): 1558 - 1567. [Abstract] [Full Text] [PDF]
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 B. M. Jackson, J. H. Gorman III, S. L. Moainie, T. S. Guy, N. Narula, J. Narula, M. G. St. John-Sutton, L. H. Edmunds Jr, and R. C. Gorman Extension of borderzone myocardium in postinfarction dilated cardiomyopathy J. Am. Coll. Cardiol., September 18, 2002; 40(6): 1160 - 1167. [Abstract] [Full Text] [PDF]
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S. L. Moainie, J. H. Gorman III, T. S. Guy, F. W. Bowen III, B. M. Jackson, T. Plappert, N. Narula, M. G. St. John-Sutton, J. Narula, L. H. Edmunds Jr, et al. An ovine model of postinfarction dilated cardiomyopathy Ann. Thorac. Surg., September 1, 2002; 74(3): 753 - 760. [Abstract] [Full Text] [PDF]
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P. M. McCarthy, A. Franco-Cerceda, E. H. Blackstone, K. Hoercher, J. A. White, J. B. Young, and R. C. Starling A question of terminology J. Thorac. Cardiovasc. Surg., April 1, 2002; 123(4): 830 - 830. [Full Text]
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M. Murtra The adventure of cardiac surgery Eur. J. Cardiothorac. Surg., February 1, 2002; 21(2): 167 - 180. [Full Text] [PDF]
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 Task Force for the Diagnosis and Treatment of Chro, W. J. Remme, and K. Swedberg Guidelines for the diagnosis and treatment of chronic heart failure Eur. Heart J., September 1, 2001; 22(17): 1527 - 1560. [PDF]
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D. Burkhoff New heart failure therapy: The shape of things to come? J. Thorac. Cardiovasc. Surg., September 1, 2001; 122(3): 421 - 423. [Full Text] [PDF]
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P. M. McCarthy, M. Takagaki, Y. Ochiai, J. B. Young, T. Tabata, T. Shiota, J. X. Qin, J. D. Thomas, T. J. Mortier, R. F. Schroeder, et al. Device-based change in left ventricular shape: A new concept for the treatment of dilated cardiomyopathy J. Thorac. Cardiovasc. Surg., September 1, 2001; 122(3): 482 - 490. [Abstract] [Full Text] [PDF]
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