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Ann Thorac Surg 1998;65:1553-1557
© 1998 The Society of Thoracic Surgeons

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Original articles: cardiovascular

The Ross Procedure: Shorter Hospital Stay, Decreased Morbidity, and Cost Effective

^a Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
^b Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA

Address reprint requests to Dr Jaggers, Cardiothoracic Surgery, Duke University Medical Center, Box 3474, Durham, NC 27710
e-mail: (Jagge003{at}mc.duke.edu)

Presented at the Forty-fourth Annual Meeting of the Southern Thoracic Surgical Association, Naples, FL, Nov 6–8, 1997.

	Abstract

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 
Background. The Ross procedure has become an accepted and sometimes preferred alternative to mechanical aortic valve replacement. One criticism of the Ross procedure is that it may have a higher operative mortality, morbidity, and cost. Several groups have shown that this operation can be performed safely with less than 3% mortality. The issue of higher cost has not been resolved. In this retrospective study we compared a consecutive group of patients undergoing the Ross procedure with an age- and disease-matched group of patients who underwent mechanical aortic valve replacement.

Methods. From 1993 to 1996, 22 consecutive adult patients (age range, 20 to 57 years; mean, 38 ± 14 years) underwent the Ross procedure. Twenty-seven patients (age range, 17 to 57 years; mean, 41 ± 10 years) underwent mechanical aortic valve replacement between 1991 and 1996. The hospital cost (in 1996 dollars) and postoperative length of stay were calculated for each patient using Transition I, a hospital-wide cost accounting system.

Results. There was no hospital mortality in either group. The incidence of significant valve-related complication was 5% (1/22 patients) in the Ross procedure group and 22% (6/27 patients) in the mechanical valve group. There were two late deaths in the group with mechanical aortic valve replacement. The length of stay for the Ross procedure group was 5.9 ± 2.1 days, versus 8 ± 1.85 days for the mechanical valve group (p < 0.01). The mean hospital costs were not significantly different, $23,140 ± $7,825 for the mechanical valve group and $23,226 ± $6,960 for the group having the Ross procedure.

Conclusions. The data from this review demonstrate that the Ross procedure can be done safely, with short hospital stays, decreased morbidity, and costs comparable with those of standard mechanical aortic valve replacement in patients with isolated aortic valve disease.

	Introduction

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 
The pulmonary autograft procedure has received considerable attention in the cardiac surgical literature in the last decade. It has become an acceptable and sometimes the preferred procedure for the treatment of aortic valve disease. Although the initial learning curve over the first 10 years of the operation was steep [1], the operative mortality since that time has diminished significantly and is currently equal to or less than that of simple mechanical aortic valve replacement [2, 3]. There is, however, still skepticism concerning not only the safety of the procedure, but also its cost. Many surgeons and referring physicians have the perception that the Ross procedure carries a higher operative mortality and morbidity rate and that the hospital costs are higher than those of a simple aortic valve replacement. This report addresses this issue in a group of comparably matched patients with isolated aortic valve disease.

	Material and methods

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 
Patients
From May 1993 to March 1997, 22 adult patients underwent Ross procedure aortic valve replacement. The average age of these patients was 39 years, with a range of 20 to 57 years. Of this group, there were 5 female and 17 male patients. Two of these patients had had previous aortic valve replacements with bioprosthetic valves. One patient had had an aortic valvotomy previously, as a child. This group of autograft patients was compared with a cohort of 27 patients who had mechanical aortic valve replacement between 1991 and 1996. This group was selected from more than 850 patients in The Duke Cardiovascular Surgery Valve Database who underwent aortic valve replacement during that time, based upon the selection criteria of (1) age range, 20 to 60 years; (2) lack of concomitant valve or coronary disease; (3) lack of renal dysfunction, peripheral or cerebrovascular disease, or pulmonary disease; and (4) comparable ventricular function and heart failure classification. This group is also believed to have been a concurrent control group, in that the time period for which the patients were selected was coincident with the institution of clinical pathways methodology, with a focus on cost savings and early discharge. Two patients had undergone previous aortic valve replacements (one bioprosthetic valve and one tilting-disk valve). No consideration of hospital costs or outcome was made in the selection of these patients. The average age of patients having mechanical valve replacement was 41 years, with a range of 17 to 57 years. Preoperative demographic data are presented in Table 1.

Chart review
Data concerning demographics, complications, and outcome were gathered by hospital and outpatient record review. Only the hospitalization involving the operation and only the costs related to the operation and postoperative in-hospital course have been considered. Valve-related complications are reported for each group. The mean follow-up time for the group having mechanical valve replacement was somewhat longer than that for the group having the Ross procedure (30 versus 11 months). All Ross procedure patients underwent transthoracic echocardiograms before discharge. Patient hospital and clinic charts were reviewed for postoperative outcome data.

Statistical analysis
Data are expressed as mean ± standard deviation. Data were compared by Student’s t test for unpaired data with a p value of less than or equal to 0.05 indicating statistical significance.

	Results

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 
There was no perioperative mortality in either group. There was no significant perioperative bleeding that necessitated return to the operating room in either group. In the Ross procedure group, there was very little morbidity (Table 2). There were no hemorrhagic, thrombotic, or bleeding complications in the Ross procedure patients. One patient had stenosis of his pulmonary homograft that required replacement of the homograft approximately 2 years after the initial operation. There was also one technical complication of an inadvertent, hemodynamically insignificant ventricular septal deficit and one patient had progression of mild aortic insufficiency to moderate aortic insufficiency over 6 months’ follow-up. Neither of these patients required therapy or intervention. In the mechanical valve group, there were 2 patients who had embolic events. One patient suffered a cerebrovascular accident. Another patient suffered a shower of emboli to the kidneys and bowel and died of multisystem organ failure. Both of these incidents were believed to be caused by noncompliance with warfarin therapy. There was also one patient with significant diverticular hemorrhage, which required transfusion. Further, there were 3 patients who had perivalvar leaks documented by echocardiography. In one patient this was insignificant but the other two required reoperation. One of these patients eventually died 1 year postoperatively of severe congestive heart failure secondary to persistent perivalvar leak. There was also one patient who had a technical complication, an aortoatrial fistula, probably resulting from pseudoaneurysm of the aortic suture line and requiring reoperation. In total there were six major valve-related complications in 27 patients that required intervention in the mechanical aortic valve replacement group and 1 of 22 complications that required intervention in the Ross procedure group. This was statistically significant (p = 0.03). Minor complications were relatively rare in each group and are shown in Table 2.

View larger version (12K): [in this window] [in a new window]   Fig 1. Postoperative length of stay (LOS). Mechanical aortic valve replacement (AVR) has a significantly greater LOS than the Ross procedure (p < 0.01).

View larger version (14K): [in this window] [in a new window]   Fig 2. The total hospital cost for mechanical aortic valve replacement (AVR) and Ross procedure patients. Total costs are indexed for 1996 dollars. There is no statistical difference (p = 0.47).

View larger version (18K): [in this window] [in a new window]   Fig 3. Categorical cost comparison between mechanical aortic valve replacement and Ross procedure patients. (CVS = cardiology diagnostic services costs; Inpatient = inpatient service costs; Rx = pharmacy costs; Surgical Service = operating room and equipment costs; X-Ray = radiology costs.)

	Comment

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 
The Ross procedure is rapidly becoming a widely available surgical option for aortic valve replacement. The rationale for its use has been widely reported and for the most part widely accepted [4, 5]. It is a very safe operation with good long-term results [6]. Despite this, there is still concern about the potential morbidity and cost of the operation. This study was designed to address these concerns. The actual costs (not charges) of the procedure were compared with those of isolated mechanical aortic valve replacement in a matched control group. We used the Transition I cost accounting system, which has been quite helpful in the evaluation of repair strategies for infant tetralogy of Fallot and in evaluating risk factors for increased cost in congenital cardiac surgical patients [7, 8]. We found that despite the increased complexity of the Ross procedure, compared with mechanical valve replacement, patients who underwent the Ross procedure had very little postoperative morbidity and relatively short hospital stays. This may be because of the need for postoperative anticoagulation and the less favorable hemodynamics in the mechanical valve replacement patients. The lengths of hospital stays continue to decrease for all types of cardiac surgery; currently the mean length of stay for patients undergoing the Ross procedure at our institution is 4.5 days and for patients having isolated mechanical aortic valve replacement, the mean length of stay is 6 days.

There are important technical considerations in the performance of the Ross procedure. One patient who had a Ross procedure for a sinus of valsalva aneurysm had moderate annuloaortic ectasia. She currently has moderate aortic insufficiency 6 months after her Ross procedure, but is asymptomatic and has required no therapy or intervention. The data concerning annular reduction and fixation are not completely compelling, but this may have been a patient who would have benefited from this technical modification. Myocardial preservation is also important because of the longer cross-clamp time. One patient in the Ross procedure group sustained a small perioperative myocardial infarction and has not had improvement in his preoperative left ventricular function, although he is in New York Heart Association class I.

Mechanical prostheses are indeed very durable and reliable. However, as we found in this study, even the most favorable patients are at risk for the embolic, thrombotic, hemorrhagic, and technical complications associated with mechanical valves as well as the obligatory anticoagulation therapy. Interestingly, the incidence of perivalvar leak in the mechanical valve replacement group was quite high (11%). Two of these 3 patients required reoperation and one eventually died secondary to persistent insufficiency and heart failure. Two of three of these leaks were in patients with aortic stenosis and heavily calcified annuli. It is our impression that the Ross procedure may be technically better for handling this situation because the autograft can conform to the irregular surface of the calcified annulus.

Overall, the rate of thromboembolism in patients with mechanical aortic valves is approximately 2 (± 0.975) per 100 patient-years [9]. This rate is greatly affected by the compliance with warfarin anticoagulation therapy. Two of the 27 patients in the mechanical valve group had thromboembolic events, both of which were related to noncompliance with anticoagulant therapy. The Ross procedure should be strongly considered in a patient who is either unable or unwilling to take warfarin. Although the duration of follow-up for the mechanical valve patients was longer (30 versus 11 months), all complications in this group occurred within 1 year of the operation, so that the incidence of significant valve-related complications in this study was not simply the result of a longer follow-up period. Patients with acute bacterial endocarditis in both groups had longer lengths of stay and higher hospital costs. However, it may be precisely these patients who have the most to gain from the Ross procedure, with the intrinsic resistance to infection provided by the autograft and the versatility in suturing techniques for managing the destruction of the aortic root by infection.

The mean hospital costs for these two groups were nearly identical. One must be very careful not to generalize conclusions regarding hospital costs from a particular institution to other institutions. It must also be emphasized that these data reflect hospital cost and that hospital charges within the institution vary on an almost day-to-day basis. In the categoric comparison of costs, we found that the mechanical valve patients spent on average 2 days more in the hospital than their Ross procedure counterparts, despite the fact that at our institution clinical pathways have been in place and that, in theory, patient discharge should not be delayed because of inadequate anticoagulation. The rate of convalescence may also be affected by improved hemodynamics of the autograft versus mechanical valve, although this is a clinical impression and is not addressed by the data in this review.

The Ross procedure patients, on the other hand, incurred higher costs in the operating room. Two possible explanations for this are, first, the pulmonary homograft at our institution costs more than a mechanical valve by nearly $3,000, and second, the Ross procedure takes more operative time than the mechanical valve replacement. The average cross-clamp time for a mechanical aortic valve replacement is approximately 55 minutes, whereas the average clamp time for the Ross procedure is nearly double that. This does not include the extra time usually needed for hemostasis. In the operating room, time is money. Despite this, the Ross procedure still costs no more than the mechanical valve replacement.

There are limitations to this type of study. Although the data on complications are interesting, it is difficult to draw meaningful conclusions from such a small sample size. The follow-up in this study was short and we looked at only the postoperative hospital costs. It would indeed be interesting to fashion a study that could incorporate both the in-hospital costs and the subsequent medical therapy and project the cost of potential complications over an extended period of time. The control group was concurrent in that the patients were from a period of time in which therapy, technique, and patient management were uniform and consistent. However, the patients in the mechanical aortic valve replacement group were indeed not consecutive. Despite this being a retrospective study, cost data were collected and analyzed prospectively. However, the availability of these data has likely motivated cost-related changes in patient management during the period of this study. Whereas the follow-up in the Ross procedure patients is shorter than that in the mechanical valve group, there is ample evidence in the literature that one can expect a relative lack of valve-related complications over the next several years. The valve-related complications associated with mechanical aortic valve replacement are linear and time related. Mechanical valves also necessitate endocarditis prophylaxis and some limitation of lifestyle.

In conclusion, the Ross procedure is a safe and reliable operation for patients with isolated aortic valve disease. We have demonstrated that it can be performed with minimal perioperative complication and gives excellent short-term outcome. This study provides a preliminary look at the cost-effectiveness of the procedure. Certainly, safety and efficacy are paramount, but as we try to provide the best options for our patients we must consider all aspects of outcome in our recommendations for their long-term medical care. In this era of managed care and impending capitated health care, each institution will need to have a firm handle on actual costs of procedures. The Ross procedure can be a cost-effective approach to aortic valve disease that requires operative correction. Considering the freedom from prosthetic valve-related morbidity, the Ross procedure should be strongly considered when counseling younger patients who require aortic valve replacement.

	Discussion

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 
DR DONALD N. ROSS (London, England): Thank you very much for the opportunity to comment on this important paper. I am not aware of any other comparative studies, except those of my colleague Dr Yacoub, who has compared the Ross procedure with the homograft, but not with the mechanical valve. Of course, it is music to my ears as I used to spend my time teaching the American surgeons. Now every time I come here you are teaching me something new. I appreciate it very much.

The operation is, as you pointed out, comparable with any other form of aortic valve replacement. I am not surprised that it is cheaper, but I think in the long term it is going to be even cheaper. One thing that shocked me was the price of your homograft valves in this country. I had better not say it too loudly, but it would cost about $1,500 in my country. And my colleague Dr Yacoub, who of course does not sleep and operates all night, takes out a heart or a heart and lung. His assistant then takes out two valves from the recipient, and the next couple of days he puts in both valves. I do not know whether that option is open to you, to use transplantation patients, but it is a very good supply of valves.

The other thing is that in the long term the mechanical valve patient has to have anticoagulant therapy for the rest of his or her life. Has anyone computed the cost of 40 years of anticoagulant therapy? It must be very considerable. Add to that the hematologic costs and check-up costs.

Our patients usually go out after a few days, as yours do, with no medication, and a follow-up once a year. That is pretty cheap. In fact, I had a phone call last week from a patient of mine, in Italy, who had his Ross procedure 10 years ago. He had not bothered to get in touch again because he felt so well. He was wondering how I felt! It is relevant that your long-term costs for mechanical valves are going to be considerable. In addition, you pointed out the increased morbidity with mechanical valves. Each time a patient gets a hemorrhagic condition, or embolism, you probably hospitalize him or her again and that adds to an increase in costs. Therefore I think you could make a stronger case for the cost advantages of the Ross operation.

You pointed out that there was one homograft to be replaced. This worries me because we do not have as much of this problem in my country as you do here. I think it is because of the efficiency and expert cryopreservation that you carry out on your valves. Consequently, those valves are highly antigenic because of having living endothelium. Our valves are usually in a refrigerator at 4°C, the endothelium is absent, and I think we see less reaction than you do. It is something that has to be thought about seriously.

The other thing, of course, is that we are going to need to have an alternative because people are running out of homografts in many countries. And where we cannot get them we are going to have to use pig valves or tissue-engineered valves or valves from transgenic pigs.

DR JAGGERS: I will address Mr Ross on a couple of his points. Thank you for your kind comments.

I actually did do a limited study looking at the cost of warfarin therapy and analysis for the first postoperative year. It costs about $3,000 a year just for that. And what struck me, as I reviewed these charts, was the number of outpatient visits that were required by the mechanical valve. We, as surgeons, do not see that. However, patients are back in the hospital in the emergency departments frequently.

DR JOHN H. CALHOON (San Antonio, TX): I have one brief question for you, and I do not know if you are going to give us the answer. First of all, it is a really nice study and very well presented. But the question would be, what is the cost of a homograft and what was the cost of a mechanical valve, and how do they differ?

DR JAGGERS: Well, the cost of a homograft at our institution is nearly $3,000 more than the mechanical valve. That does not make up the entire difference in surgical service cost, but it is a large portion of it.

	Footnotes

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 
This article has been selected for the open discussion forum on the STS Web site: http://www.sts.org/annals

	References

Top Footnotes Abstract Introduction Material and methods Results Comment Discussion References

 

1. Gula G., Wain W.H., Ross D.N. Ten year experience with pulmonary autograft replacements for aortic valve disease. Ann Thorac Surg 1979;28:392-396.[Abstract]
2. Ross D., Jackson M., Davies J. The pulmonary autograft procedure: a permanent valve. Eur J Cardiothorac Surg 1992;6:113-117.[Abstract]
3. Elkins R.C., Knott-Craig M., Razook J.D., et al. Pulmonary autograft replacement of the aortic valve in the potential parent. J Cardiac Surg 1994;9:198-203.[Medline]
4. Elkins R.C., Knott-Craig C.J., Ward K.E., McCue C., Lane M.M. Pulmonary autograft in children: a realized growth potential. Ann Thorac Surg 1994;57:1387-1394.[Abstract]
5. Elkins R.C. Pulmonary autograft—the optimal substitute for the aortic valve. N Engl J Med 1994;330:59-60.[Free Full Text]
6. Elkins R.C., Lane M.M., McCue C. Pulmonary autograft reoperation, incidence and management. Ann Thorac Surg 1996;62:450-455.[Abstract/Free Full Text]
7. Ungerleider R.M., Kanter R.J., O’Laughlin M., et al. Effect of repair strategy on hospital cost for infants with tetralogy of Fallot. Ann Surg 1997;225:779-784.[Medline]
8. Ungerleider R.M., Bengur A.R., Kessenich A.L., et al. Risk factors for higher cost in congenital heart operations. Ann Thorac Surg 1997;64:44-49.[Abstract/Free Full Text]
9. Edmund L.H., Jr Thrombotic and bleeding complications of prosthetic heart valves. Ann Thorac Surg 1987;44:430-445.[Abstract]

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