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Asian Cardiovasc Thorac Ann 2001;9:159-166
© 2001 Asia Publishing EXchange Pte Ltd

EDITORIAL

Surgical Treatments for Endstage Heart Failure Due to Dilated Cardiomyopathy

Kazutomo Minami, MD

Department of Thoracic and Cardiovascular Surgery Heart Center North-Rhine-Westphalia Bad Oeynhausen Ruhr-University of Bochum Bad Oeynhausen, Germany
Prognosis of endstage heart failure, categorized as class III or IV on the New York Heart Association (NYHA) classification, remains extremely poor despite advances in drug therapy, such as angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, and nitric oxide (NO). Of the 100,000 patients in Germany and 400,000 patients in the USA reported as suffering from drug-resistant endstage heart failure, 500 and 370 German patients and 2,500 and 700 American patients undergo heart transplantation and ventricular assist device (VAD) implantation, respectively, every year. Transplantation has been considered the gold standard for treating endstage heart failure until recently. Although the outcome of heart transplantation has improved with advances in immunosuppressants, less than 10% of patients awaiting transplant can actually have a transplant because of a shortage in donor organs.1,2 Consequently, various alternative surgical procedures have been actively performed in recent years to treat drug-resistant endstage heart failure. These include myocardial revascularization for borderline indication due to severe left ventricular dysfunction; volume reduction ventriculectomy such as Batista operation and Dor procedure; implantation of various assisted circulation systems such as intraaortic balloon pump (IABP), percutaneous cardiopulmonary support (PCPS), cardiomyoplasty, extracorporeal membrane oxygenation (ECMO), and ventricular assist device (VAD); orthotopic heart transplantation (HTx); and biventricular pacing.

These alternative treatments are now used even for cases that previously would have undergone transplantation, and cardiac function can be improved in some heart failure patients without transplantation. Thus, the selection of an adequate treatment method is now considered necessary from an economic point of view, as well as from a medical point of view.

In this article, we report on the effectiveness, problems, and further prospects of various surgical treatments for drug-resistant endstage heart failure, based on our experience.

Borderline Indication for Myocardial Revascularization

Myocardial revascularization for severe left ventricular dysfunction, for which surgery had been considered unsuitable, had produced only poor postoperative outcomes until the early 1990s. With advances in surgical techniques, auxiliary techniques such as myocardial protection, and postoperative management, satisfactory early postoperative results have recently been reported. However, long-term results have scarcely been reported. In studies of more than 100 cases, the early mortality and 5-year survival rates were reported to be 1.7–11% and 57.5–75%, respectively.3–6 Di Carli and colleagues7 compared the results of coronary artery bypass grafting (CABG) for severe left ventricular dysfunction with those of drug therapy alone, and reported that the 4-year survival rate was 75% in the CABG group but only 30% in the group receiving drug therapy alone. They concluded that CABG was significantly more effective than drug therapy for treatment of severe left ventricular dysfunction and that positron emission tomography (PET) was useful for the evaluation of myocardial viability.

At our institute, 601 patients with an ejection fraction (EF) of less than 30% underwent CABG, and their data were retrospectively analyzed (mean follow-up period, 63.5 months). The mean age, gender ratio, and the medical problems of the patients are shown in Table 1Go. The operations were performed with aortic crossclamping under cardiopulmonary bypass without cardioplegia. The mean number of bypass grafts per patient was 2.85 ± 0.9 (range, 1 to 6), and arterial grafts were used in 57.5% of the patients. The mean aortic crossclamping time and mean cardiopulmonary bypass time were 25.4 minutes (range, 0 to 46 minutes) and 67.5 minutes (range, 21 to 336 minutes), respectively. There were 14 deaths (2.3%) within 30 days of surgery and 56 deaths (9.3%) between 2 and 120 months after surgery (Figure 1Go). Heart failure recurred in 42 patients (7%); 4 (0.7%) and 22 (3.7%) of these patients required mechanical circulatory support or underwent transplant, respectively. The 5-year and 10-year postoperative survival rates were 86% and 76%, respectively (Figure 1Go). We also found that the 10-year postoperative event-free rate was 70% in patients with good preoperative myocardial viability, assessed using PET, while the 7-year event-free rate was 45% in patients with poor preoperative viability (Figure 2Go). With regard to the coronary artery state, the 10-year postoperative event-free rate was 80% in patients with a good coronary artery state, while the 7-year event-free rate was 15% in diffuse cases. From these results, we deduce that active revascularization for severe left ventricular dysfunction may improve event-free long-term survival if only patients with good preoperative myocardial viability, evaluated using PET, are selected for the procedure.


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  		Table 1. Characteristics of CABG Patients With Ejection Fraction < 30%
 


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  		Figure 1. Actuarial survival rate after coronary artery bypass grafting for patients with an ejection fraction of less than 30%.

 


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  		Figure 2. Freedom from adverse events in relation to myocardial viability assessed using positron emission tomography (PET).

 
Transmyocardial laser revascularization (TMLR) is another surgical method that has been used to treat severe left ventricular dysfunction for several years. Although the effectiveness of TMLR was reported soon after its introduction and its effectiveness was also described in a recent report on TMLR used in combination with off-pump CABG,8 a relatively high perioperative mortality rate, ranging from 5% to 10%, has been shown as the number of cases increase, demonstrating the lack of clinical effectiveness.9 Schofield and colleagues9 reported no significant differences in treadmill exercise time and 12-minute walking distance between TMLR and drug therapy in 188 patients treated with TMLR or drug therapy for 1 year, and that the 1-year survival rate was 89% in the TMLR group and 96% in the drug therapy group, indicating no effectiveness of TMLR. Although TMLR was started at our institute in 1995, we observed no significant clinical effect and have discontinued this treatment.

Volume Reduction Ventriculectomy for Ischemic and Idiopathic Dilated Cardiomyopathy

Recently, volume reduction ventriculectomy, such as Batista operation for idiopathic dilated cardiomyopathy and Dor operation for ischemic cardiomyopathy, has been widely performed because of organ shortage, attracting attention as an alternative technique to heart trans-plantation. Batista and colleagues10 reported from their experience in 120 cases that the early postoperative mortality rate was 22% and the 2-year survival rate was 55%. As reasons for the high early mortality rate and lower 2-year survival rate compared with heart trans-plantation, they thought that many patients with very severe endstage heart failure were included, and that postoperative management and follow-up were inadequate in Brazil. Thus, they concluded that the prognosis could improve if various factors were taken into consideration in the selection of patients and postoperative management were improved. Dor and colleagues11 surgically treated akinetic areas of the left ventricle in 51 patients. They reported that EF increased and the end-diastolic volume index and pulmonary capillary wedge pressure decreased after surgery, and that early postoperative mortality was 10%. Suma and colleagues12 reported that the 2-year survival rates were 77% for ischemic cardiomyopathy and 68% for idiopathic dilated cardiomyopathy, although some of the patients they operated on were in very severe conditions, such as those with idiopathic dilated cardiomyopathy and patients undergoing emergency operation, with a resulting relatively high morbidity and mortality. McCarthy and colleagues13 performed Batista operation on 57 patients. They reported that the hospital mortality rate was 3.5% and the 1-year survival rate was 82%, while 24% died after discharge or were relisted for transplantation. Etoch and colleagues14 compared Batista operation with transplantation. Although they found no significant differences in surgical mortality and the 1-year postoperative survival rate between the two procedures, the percentage of patients who survived or did not need to be relisted for transplantation was 65% after Batista operation and 86% after transplantation. Thus, they concluded that Batista operation is a bridge to trans-plantation, rather than a final treatment method.

At our institute, we have actively performed volume reduction ventriculectomy on patients for whom heart transplantation is indicated. The procedure employed at our institute is similar to Cooley's operation for left ventricular aneurysm,15 but we minimize the patch as much as possible to maintain a sufficient morphology of the left ventricle and to maximize the fraction of contractile ventricular wall. Since long-term results of volume reduction ventriculectomy are lacking, it should be determined whether this method serves just as a bridge to transplantation or VAD implantation, or is an effective final method itself.

Clinical Approach of Various Assisted Circulation Systems

VAD implantation is considered an effective and established method for the treatment of endstage heart failure. Because of organ shortage, it now plays an essential role as a bridge to transplantation. In fact, transplantation is performed after VAD implantation in about 20% of patients.16 However, various problems, such as thrombo-embolism, infection, bleeding, and mechanical problems, have appeared as their use is prolonged, and there are no VADs that can be used permanently at the present time.

VADs are divided into 2 types: paracorporeal and implantable. BioMedicus BP-80 (Medtronic, Inc., Minneapolis, MN, USA), Abiomed BVS 5000 (Abiomed Cardiovascular, Inc., Danvers, MA, USA), Thoratec (Thoratec, Berkeley, CA, USA), and Medos (Medos, Inc., Storberg, Germany) are paracorporeal VADs. Novacor (Baxter Healthcare Corporation, Oakland, CA, USA) and HeartMate (Thermo Cardiosystems Inc., Woburn, MA, USA) are implantable VADs. LionHeart (Arrow International, Inc., Reading, PA, USA) is a recently developed totally implantable VAD, and DeBakey (MicroMED Technology, Inc., Houston, TX, USA) is an axial flow pump used as an implantable VAD.16–19

Paracorporeal VADs have the advantages of implanting easily and assisting not only the left ventricle but both ventricles. Their disadvantages are that they impede patient movement and do not provide long-term support. In contrast, implantable VADs have the advantages of giving long-term support of more than one year and patients can go home. The implantable VAD HeartMate has the additional advantage of not requiring anticoagulation. The disadvantages of implantable VADs are that they are surgically demanding, they do not support the right ventricle, and mechanical problems still occur.

At our institute, 407 patients were implanted with various types of VAD from September 1987 to August 2000. The data described in this article came from 369 patients implanted with a VAD up to June 1999. The VADs were implanted in 228 of these patients as a bridge to transplantation, in 83 patients suffering from post-cardiotomy cardiac failure, and in 58 patients afflicted by various other illnesses. Principally, BioMedicus and Abiomed were used for postcardiotomy cardiac failure; Thoratec was used as a left ventricular assist device (LVAD) as well as a biventricular assist device in bridging to transplantation; and Novacor and HeartMate were implanted as LVADs in bridging to transplantation. The only pump used in an infant was Medos (Table 2Go). The mean support time to transplantation was 49 days (maximum, 386 days) with Thoratec, 148 days (maximum, 989 days) with Novacor, and 124 days (maximum, 810 days) with HeartMate. Sixty-one percent of patients implanted with Thoratec, 54% with Novacor, and 51% with HeartMate eventually had a transplant. Sixty-nine percent of patients implanted with Novacor and 49% with HeartMate could be discharged. As for complications (Table 3Go), perioperative bleeding occurred in 41% of the Thoratec patients, 44% of Novacor, and 46% of HeartMate. Cerebral embolism occurred in 24%, 48%, and 19%, respectively. Drive-line infection occurred in 2%, 26%, and 22%, respectively. Pocket infection occurred in 8% of the Novacor patients and 24% of HeartMate patients. Conduit endocarditis occurred in 5% of the Novacor patients and 3% of HeartMate patients. Although the incidence of mechanical problems was low, 3 patients fitted with Thoratec had problems with the console and 4 patients with HeartMate had bleeding from the junction of the outflow conduit or the inflow cannula, or a rupture of the diaphragm. Frequent causes of death were multiple organ failure (MOF) in patients implanted with Thoratec (29%) because the right ventricle had to be assisted in many cases; cerebral infarction (21%) and MOF (13%) in patients with Novacor; and cerebral infarction (19%) and sepsis (14%) in patients with HeartMate. We have taken the following measures to prevent these com-plications and so far have observed efficacious results. For HeartMate, in which pocket infection often occurs, the surface of the blood pump is covered with a Hemashield graft (Meadox Medicals Inc., Oakland, NJ, USA) to inhibit effusion, which is thought to occur through contact of the patient's tissue with the pump.20 To prevent bleeding from the highly porous outflow conduit of Thoratec and HeartMate, this conduit is wrapped with a Hemashield graft.21


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  		Table 2. Application of Different VADs by Indication
 

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  		Table 3. Complications After VAD Support for Bridging to Transplantation
 
The results of a large number of cases on the use of various VADs and a sufficient amount of long-term results have been reported in the literature. Reexamination of anticoagulation measure and device improvement, including minor changes, are necessary. After VAD implantation, the patient's own cardiac function is considered to be restored if there is improvement in myocardial mitochondria, leading to successful weaning from VAD support in some cases. Some investigators reported a weaning rate of more than 30%,22 but some others reported only less than 5%.23 Clear indicators of cardiac function restoration have not been established and should therefore be determined in order to find out the effectiveness of VADs.

Dynamic cardiomyoplasty has received attention as a biventricular assist system. Dynamic cardiomyoplasty with a latissimus dorsi muscle was first performed by Carpentier and Chachques in 1985.24 Its long-term clinical results were recently reported.25,26 Chachques and colleagues25 reported that its actuarial survival rate at 7 years was 54% for all the patients and 66% for patients in NYHA class III. However, the actuarial survival rate at 7 years for patients in NYHA class IV was only 22%. They concluded that patient selection was the most important determinant of the success of the treatment. Braile and colleagues26 compared patients with Chagas disease and those with non-Chagas disease and reported that the survival rates at 60 months were 12.5% and 49.9%, respectively. They suggested the need for implantable cardioverter-defibrillators because ventricular fibrillation is a frequent cause of death. We deduce from these results that cardiomyoplasty is not sufficient as a treatment for endstage heart failure, but there is room for further investigation.

Totally Implantable VADs and Axial Flow Nonpulsatile Pumps as Next Generation VADs

At our institute, we used a totally implantable VAD, LionHeart, on October 26, 1999, the first case in the world (Figure 3Go).19 The LionHeart was developed by Dr. William S Pierce of Pennsylvania State University and is totally implantable in the body without the need for a percutaneous drive line or external catheter, but instead a transcutaneous energy transmission (TET) system is used. The LionHeart has the advantage of preventing infection and improving patients' quality of life. We have fitted this device in 5 patients to date. Patient 1 has been followed up for 420 days. Although this patient suffered a stroke 55 days after operation, there are signs of improvement. Patients 2 and 3 died 163 and 18 days, respectively, after surgery as a result of MOF persisting from the preimplantation period. Cases 4 and 5 have been followed up for 243 and 125 days, respectively, showing uneventful postoperative courses. The LionHeart is thought to have the potential for permanent use in patients not listed for transplantation, such as those with a history of cancer and aged patients.



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  		Figure 3. A new totally implantable ventricular assist device (LionHeart).

 
The DeBakey axial flow pump has been clinically investigated in Europe since 1999,27 and it has been implanted as a bridge to transplantation in 49 patients up to July 7, 2001.28 At our institute, this device was implanted in 3 patients. Unfortunately, patient 1 died from inflow thrombosis 38 days after surgery, and the other 2 died from MOF persisting from the preoperative period. Patient 3 was implanted with the pump under cardiac massage. Case 1 offered us a very interesting experience. This patient could walk and eat while nonpulsatile flow was maintained. Thus, under nonpulsatile flow, this pump is thought to maintain the patient's general condition and is expected to act as a bridge to transplantation, as with the axial flow pump Jarvik 2000.29

In the future, VADs are expected to be totally implantable; miniature; feasible for infants; pulsatile or nonpulsatile; and not to require anticoagulation. Thus, VADs should be developed not only as a bridge to transplantation but also as a device for permanent use.

The Present State and Problems of Heart Transplantation

In recent years, heart transplantation has provided stable long-term outcome with the introduction of cyclosporine and muromonab-CD3 (Orthoclone OKT3). In the data reported over 30 years by Stanford University, the 5-year and 10-year survival rates following heart transplantation were 41% and 24%, respectively, before 1980 when cyclosporine had not been introduced, but were 68% and 46%, respectively, after 1987 when cyclosporine and muromonab-CD3 were introduced.2 At our institute, the 5-year and 10-year survival rates are 69.4% and 51.7%, respectively. Transplantation is currently the most effective treatment for endstage heart failure. However, in recent years heart transplantation has decreased because of organ shortage. The International Society for Heart and Lung Transplantation reported a drop in heart transplantation since 1996,1 and the same trend has been observed by Eurotransplant and in Germany. In 1999, there were 708 and 480 transplant cases reported by Eurotransplant and in Germany, respectively, compared with 759 and 528 in 1998. At our institute, we performed 1,122 heart/lung transplants from 1989 to 2000, but the number of cases has dropped from the largest number of 148 in 1991 to 72 in 2000 (Figure 4Go).16 The mean waiting time has also been prolonged. Eurotransplant reported that the waiting time was about 200 days in 1988 but increased to about 500 days in 1996. At our institute, the waiting time was 37.6 days in 1989 but increased to more than 100 days in 1992 and extended further to 304 days in 1998, while the mortality rate and the use of VAD during the waiting period have increased.



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  		Figure 4. The number of heart/lung transplants performed at our institute. HTx = heart transplantation, H/LTx = heart/lung transplantation.

 
To achieve a higher success rate in heart transplantation in the future, the use of other treatment methods as a bridge, such as VAD and volume reduction ventricu-lectomy, and relaxation of the criteria for organ donors will be needed.

Biventricular Pacing for Endstage Heart Failure

Biventricular pacing for chronic heart failure was reported by Cazeau and colleagues30 as well as Bakker and colleagues31 in 1994, and large-scale clinical trials of this pacing system demonstrating its effectiveness have been carried out in Europe and the USA.32,33 A left ventricular lead was placed on the epicardium by thoracoscopy in the early days, but it was not effective over the long term because it had a higher stimulation threshold. The lead has been most frequently inserted into the coronary sinus since Daubert and colleagues34 reported fully transvenous permanent biventricular pacing in 1998. The lateral or posterolateral vein is usually selected as the site of implantation. The transseptal approach has also been reported, although it can cause thromboembolism.35 Compared with conventional right ventricular pacing, biventricular pacing has been reported to improve the NYHA class and hemodynamics, increase the diastolic filling time, and reduce mitral or tricuspid regurgitation and sympathetic nerve activity.30–36 Gras and colleagues33 studied 81 patients and could implant a pacemaker in the coronary sinus in 68 (84%) of them. Although 13 patients died during the 10-month follow-up period, no systemrelated complications occurred. They also reported improvement in the NYHA class and the 6-minute walking distance. The mechanisms of biventricular pacing are thought to be reduction of mitral regurgitation; increasing filling time; optimization of left-side mechanical atrio-ventricular delay; and normalization of ventricular electrical activation.36

At our institute, this pacing system has been used for 3 years to treat chronic heart failure. We implant the lead into a coronary vein (Figure 5Go). The suitable coronary vein is selected by electrophysiological examination before implantation. The indications for using this pacing system are NYHA class III or IV despite drug therapy; QRS duration > 120 msec; left bundle branch block; EF < 35%; and left ventricular end-diastolic diameter (LVEDD) > 60 mm. There are various pacing systems, including DDDmode with right ventricular (RV) and left ventricular (LV) stimulation; VVI-mode with RV and LV stimulation; implantable cardiodefibrillator (ICD) with RV and LV stimulation; and LV stimulation without RV stimulation (ICD, DDD, VVI). To date, we have implanted a biventricular pacing system in 73 patients with a mean age of 60 years (range, 35 to 76 years), consisting of 55 males and 18 females. The causative diseases were idiopathic dilated cardiomyopathy in 50 patients and chronic heart failure in 23. The NYHA class, 6-minute walking distance, EF, LVEDD, mean oxygen consumption, mean QRS time, and PQ interval were remarkably improved by biventricular pacing (Table 4Go). Twenty patients (27%) were delisted for transplantation. However, there were also patients relisted for transplantation, or had to change to a different pacing system (ICD), or suffered from complications such as sudden death, cerebral infarction, infection, and pleural effusion.




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  		Figure 5. Chest radiography (A) before and (B) after biventricular pacing.

 

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  		Table 4. Change in Performance After Biventricular Pacing
 
Although no long-term results of biventricular pacing have been obtained, this method has attracted attention as a new therapeutic option for endstage heart failure if revascularization is impossible; or if a VAD cannot be implanted, even though it is needed, because of a history of cerebral infarction, gastric ulcer, or other conditions; or if the patient is delisted for transplantation because of age or previous history.

It is essential to the treatment of endstage heart failure that an adequate method is selected from the various surgical procedures available. The new surgical procedures we have described will reduce the number of patients who require heart transplantation, leading to the effective utilization of the limited number of donor hearts and consequently increasing the survival rate of patients with endstage heart failure. Because there are no definite indicators for these methods at present, clear guidelines on indications and the timing of each method will be needed.

Acknowledgments

I wish to thank all the members of the working group in the heart failure program: Latif Arusoglu, MD; Akira Sezai, MD; Aly El-Banayosy, MD; Gero Tenderich, MD; Bert Hansky, MD; Juergen Vogt, MD; Georg Kleikamp, MD; Dietmar Boethig, MD; and Reiner Körfer, MD.

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