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Ann Thorac Surg 2001;71:1454-1459
© 2001 The Society of Thoracic Surgeons

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Original article: cardiovascular

Favorable outcome after composite valve-graft replacement in patients older than 65 years

^a Department of Cardiothoracic Surgery, The Mount Sinai Medical Center, New York, New York, USA
^b Department of Biomathematics, The Mount Sinai Medical Center, New York, New York, USA

Accepted for publication December 13, 2000.

Address reprint requests to Dr Ehrlich, Department of Cardiothoracic Surgery, The Mount Sinai Medical Center, One Gustave L. Levy Pl, Box 1028, New York, NY 10029

	Abstract

Top Abstract Introduction Material and methods Results Comment References

 
Background. Concomitant surgical replacement of the aortic valve and ascending aorta is an ideal treatment for aortic root aneurysms, but there may be hesitation in its use in older patients, despite their known increased risk of rupture. This study was conducted to examine our results in 84 patients older than 65 years undergoing elective aortic root resection with composite valve-graft replacement.

Methods. Eighty-four patients older than 65 years were operated on between June 1987 and August 1998. Median age was 74 years (range, 66 to 89 years), and 57 patients were men. Seventeen patients were undergoing reoperation. Aortic insufficiency was present in 70 patients. Forty-seven patients received a conduit using a bioprosthesis, whereas in 37 a mechanical valved conduit (St. Jude) was used. The ascending aorta alone was replaced in 23 patients; 50 had hemi-arch replacement, and in 11 the entire aortic arch was replaced.

Results. Hospital mortality was 8.3% (7 of 84). Sixteen late deaths (19%) were noted during a median follow-up of 3.2 years (range, 0 to 10 years). Only one late death was aorta-related. The incidence of thrombotic or hemorrhagic complications was 2.1/100 patient-years, with equal frequency for both mechanical and bioprosthetic valves.

Conclusions. We conclude that composite valve-graft replacement in elderly patients results in a low operative mortality, yields excellent long-term survival, and averts fatal aneurysm rupture in this high-risk population.

	Introduction

Top Abstract Introduction Material and methods Results Comment References

 
Composite replacement of the ascending aorta and aortic valve, first reported by Bentall and DeBono in 1968 [1], has become a feasible and safe procedure for a variety of pathologic conditions involving the aortic valve, the sinus portion of the aortic root, and the ascending aorta. Operative mortality as well as morbidity rates have steadily decreased, allowing further expansion of operative indications for elective as well as acute composite aortic root replacement. Although results of this procedure with a focus on particular patient subsets, such as those with the Marfan syndrome or ascending aortic aneurysm with severe aortic insufficiency, have been described extensively, few broad overviews of the procedure have included older patients [2, 3]. There is still some controversy as to whether this surgical approach should be used in the elderly, especially those with milder degrees of annuloaortic ectasia, despite their increased risk of aneurysm rupture. The purpose of this study was to analyze our experience and results in patients older than 65 years undergoing elective aortic root resection with a composite valve graft (CVR).

	Material and methods

Top Abstract Introduction Material and methods Results Comment References

 
Patient selection and study protocol
The records of 84 consecutive patients who were older than 65 years at the time of CVR of the aortic valve and ascending aorta between June 1987 and August 1998 were retrospectively reviewed. Data were collected with regard to patient age, sex, indication for procedure, whether Marfan syndrome or bicuspid aortic valve was present, prior history of neurologic symptoms, extent of aortic replacement, whether initial surgery or reoperation, need for concomitant procedures (ie, coronary artery bypass grafting, mitral valve replacement), pump time, cross-clamp time, use and duration of hypothermic circulatory arrest, hospital morbidity, and hospital mortality. All data are prospectively entered into an aortic surgery database maintained at our institution; it is the primary source of data for this report.

Selection of the valve used—whether mechanical or biologic—was related to the individual surgeon’s preference or based on the patient’s choice. Biologic valves were generally advocated in patients with an anticipated life expectancy of less than 10 years or with contraindications to anticoagulation; mechanical valves were chosen in patients in whom anticoagulation was already indicated for chronic arrhythmias or other conditions.

Surgical technique
The classic Bentall procedure was performed in only 2 patients (2.4%), using the inclusion technique as originally described, with the addition of a wrap-to-right-atrial fistula to control oozing. The Cabrol modification was used in 4 patients (4.7%) in the manner originally described by Cabrol, and also often included aortic wrapping and a right atrial fistula. The remaining 78 patients (92.8%) had had the button Bentall technique, a modification originally described by Kouchoukos and associates [4], involving excision of the native aorta. Hypothermic circulatory arrest at a temperature of 12° to 15°C was used in all patients. Our operative technique is described below.

The patient is placed on cardiopulmonary bypass (CPB) using the femoral or right axillary artery and a two-stage catheter in the right atrium. Hypothermic perfusion is begun, and as soon as the heart fibrillates, the ascending aorta is cross-clamped in its midportion and opened proximally. Crystalloid cardioplegic solution is infused into the right and left coronary arteries, and the pericardium is then lavaged with cold saline solution. A left atrial vent is placed by means of the right superior pulmonary vein, the proximal aorta is opened widely, and continuous topical hypothermia with iced saline solution is begun. Cooling on CPB is performed to an esophageal temperature of 15°C, after which the temperature is allowed to drift, with the esophageal and rectal temperatures stabilizing at slightly more than 15°C during this portion of the procedure.

The aortic valve is excised, and the annulus is sized. If decalcification is necessary, the interior of the left ventricle is subsequently copiously irrigated with cold saline solution. A series of pledgeted mattress sutures are then placed from the ventricular to the aortic aspect of the annulus for a heterograft valve, and from the aorta to the ventricular aspect for a prosthetic valve. The sutures are placed less than a millimeter from each other both where they enter the annulus above and where they emerge below the annulus. The number of sutures is usually approximately the same as the diameter of the annulus in millimeters. With selection of a prosthesis of appropriate size to fit snugly into the annulus, and the use of the suture technique as described, bleeding does not occur at the proximal anastomosis. If a mechanical valve is considered, a composite prosthesis consisting of a St. Jude valve (St. Jude Medical, St. Paul, MN) and a Hemashield graft (Meadox Medicals Inc, Oakland, NJ) is used. In cases of biologic valves, a so-called home-made composite graft is fabricated by tacking a Hemashield graft to the sewing ring of a pericardial (usually Baxter Carpentier-Edwards) or porcine valve. The annular sutures are then placed in the sewing ring of the graft or, in the hand-made prosthesis, through the sewing ring and the graft. The prosthesis is then lowered into place, and the sutures are tied and cut.

Excision of the proximal aorta with the exception of the coronary buttons is then performed. The proximal right and left coronary arteries are usually mobilized for a distance of 1 to 1.5 cm. Two small openings in the graft are then cut, and suturing of the left coronary artery (with 4-0 Prolene, Ethicon, Somerville, NJ) is performed first. A thin strip of polytetrafluoroethylene (Teflon) felt is incorporated within the suture line of both coronary anastomoses to reinforce the adventitial surface of the coronary button. After finishing the left coronary anastomosis, the right coronary artery is sutured to its orifice in the graft in a similar fashion.

During completion of the aortic root reconstruction, especially in cases of aortic dissection or aortic arch involvement, in which a more extensive resection is planned, cooling on CPB is reactivated with a blood temperature of 10°C until a jugular venous bulb saturation of 95%, reflecting thorough cooling, has been reached. The head is then placed downward, CPB is discontinued, and the aorta is trimmed up to the base of the innominate artery, or if the arch is enlarged, the entire underside of the arch up to the ligamentum arteriosum is excised, leaving a bevel containing the ostia of the arch vessels and the descending thoracic aorta. The polyethylene terephthalate fiber (Dacron) graft is trimmed to size distally, and an anastomosis to the distal aorta with a running suture of 3-0 Prolene is performed. A 1-cm strip of Teflon felt is placed outside the aorta to reinforce the distal anastomosis.

The last few sutures on the distal ascending aorta are left loose, and the arch vessels are carefully aspirated with a fine-tip suction catheter to remove particulate debris. Flow through the arterial catheter is begun at a rate of 500 to 1,000 mL/min to remove air. When all air has been excluded, the suture line is pulled up and tied. Full CPB is reinstituted, and warming is begun. In cases of acute dissection, the perfusion through the femoral artery is discontinued, and a second catheter is placed within the graft to provide antegrade perfusion during rewarming. When an esophageal temperature of 36°C and a bladder temperature of 30°C are reached, CPB is discontinued, and the cannulas are removed.

Statistical methods
Univariate comparisons between groups were performed using exact tests: Wilcoxon tests for continuous variables and ² tests for categorical and ordinal variables. Kaplan-Meier estimates of overall survival and of cardiac-event-free survival (freedom from cardiac death and valve-related complications) were obtained for all patients and for those who were discharged from the hospital. For each of these, the log rank test was used to compare survival between groups. Analyses were implemented using SAS software on a VAX computer, or Stat-Exact for the PC.

	Results

Top Abstract Introduction Material and methods Results Comment References

 
Preoperative and intraoperative characteristics
Table 1 displays clinical characteristics of the patients, and compares those who underwent biologic (n = 47) and mechanical (n = 37) composite valve replacement. Hypertension was the most common preoperative medical disorder, with an incidence of approximately 60% in both groups. Degenerative aneurysms were the most frequent indication for operation, followed by atherosclerotic aneurysms, dissections, and annuloaortic ectasia: the distribution of these causes was significantly different between patients who underwent biologic and mechanical valve replacement.

Only the ascending aorta was replaced in 23 patients; 50 had hemi-arch replacement; in 8 the entire aortic arch was replaced, and 3 patients had total arch replacement as part of a stage 1 elephant trunk procedure. Twenty-nine patients (34.5%) required concomitant procedures. As shown in Table 1, patients in whom a biologic valve was used were significantly more frequent in the later years of the study and had significantly longer extracorporeal circulation times.

Early mortality
The overall hospital mortality in this series was 8.3% (7 of 84). There were three intraoperative deaths and four additional deaths on postoperative days 1, 12, 41, and 46. Cardiac failure was the most common cause of hospital death (3 patients), followed by stroke (2 patients), endocarditis (1 patient), and pneumonia (1 patient).

The impact of a number of patient and operative variables on hospital mortality was examined. As there were only seven in-hospital deaths in this study, we used a cutoff of p < 0.2 to distinguish factors that might, in a larger study, be shown to be associated with higher risk. Only two of the factors we studied satisfied this criterion. Advancing age was associated with a decreased risk of death, which may be a reflection of patient selection. In-hospital mortality was higher for mechanical valves (14%) than for biologic (4%), but, as will be demonstrated below, this advantage was lost during long-term follow-up. Sex and year of operation, as well as a history of hypertension, coronary artery disease, smoking, neurologic symptoms, and diabetes did not affect outcome, nor did intraoperative variables such as reoperation, need for concomitant procedures, or duration of CPB.

Hospital morbidity and its relationship to hospital mortality are shown in Table 2 for the 81 operative survivors. Cardiac complications, chiefly arrhythmias and myocardial infarction, were most common, occurring in 33% of cases (27 of 84), with a significant impact on hospital mortality (15%, p = 0.01). Respiratory complications, including prolonged ventilation and pneumonia, were also quite frequent, and also affected mortality (p = 0.05). The presence of infection was also an ominous development, leading to death in 4 of 8 patients (p = 0.002).

Late mortality
There were 16 late deaths among the 77 patients discharged alive, with a median follow-up of 3.2 years (range, 0 to 10 years). Only 1 patient died of aortic rupture. Factors such as circulatory arrest time, reoperation, coronary artery disease, extracorporeal circulation time, and any concomitant procedures failed to have a statistical significance on late death, just as they had failed to influence early mortality.

Six patients had cardiac-related complications after discharge—endocarditis or thromboembolism—which led to their death in 3: in 2 patients with mechanical valves and in 1 patient in whom a biologic valve was used. The deaths of the 10 patients who died after discharge of non–cardiac-related complications occurred between 0.2 and 7.4 years (median, 2 years) postoperatively. Three patients who had no known complications but died of cardiac-related causes lived between 2.8 and 2.9 years postoperatively. The overall incidence of thrombotic or hemorrhagic complications was 2.1/100 patient-years.

Survival of discharged patients was similar to that of an age-matched and sex-matched population (Fig 1). Overall probability of survival including hospital deaths was similar for patients with mechanical versus those with biologic valves (Fig 2): the higher operative mortality with mechanical valves was offset by better later survival. Figure 3 shows that event-free survival was also not significantly different between the groups with mechanical and biologic valves. Once having survived the procedure, however, freedom from cardiac death and valve-related complications (Fig 4) was marginally better in patients with mechanical valves. Seventeen patients, with both mechanical and pericardial valves, required reoperation (5%): only 1 patient died (6%).

View larger version (13K): [in this window] [in a new window]   Fig 1. Survival of all elderly patients discharged after composite replacement of the ascending aorta and aortic valve—Bentall procedure—compared with an age-matched control population of elderly patients.

View larger version (14K): [in this window] [in a new window]   Fig 2. Overall survival of all elderly patients with composite replacement of the ascending aorta and aortic valve, comparing outcome with mechanical versus biologic valves.

View larger version (15K): [in this window] [in a new window]   Fig 3. Survival without cardiac or thromboembolic complications, including death and reoperation, in elderly patients after a Bentall procedure with a biologic or mechanical valve.

View larger version (14K): [in this window] [in a new window]   Fig 4. Freedom from cardiac death, reoperation, or valve-related complications after discharge after a Bentall procedure with a biologic or mechanical valve in elderly patients.

	Comment

Top Abstract Introduction Material and methods Results Comment References

This study demonstrates that concomitant ascending aorta and aortic valve replacement can safely be performed in elderly patients with a low operative mortality and excellent long-term survival. The hospital mortality in these older patients was 8.3%, only slightly higher than that reported in other series with younger patients [2]. Our results for CVR also compare favorably with a mortality rate of 4.7% at our institution both in 1,319 patients older than 65 years at the time of coronary artery bypass operations during the same interval and in 152 elderly patients undergoing only aortic valve replacement during the years under scrutiny.

The analysis of hospital mortality did not reveal any independent preoperative or intraoperative risk factors. Patients in whom a mechanical valve was used had a somewhat higher mortality than those with biologic valves, but this difference did not reach statistical significance (p = 0.13) and may reflect differences in patient selection: mechanical valves were more frequently recommended during the earlier years of the experience, and for those patients in a more precarious state preoperatively, in anticipation of a quicker, technically easier procedure. It should be noted, however, that a patient with a mechanical valve who survived until discharge had a long-term outcome at least as good as a patient with a biologic valve, despite the need for long-term anticoagulation. But the preoperative differences between the patient groups, which reflect the lack of randomized valve selection, make it difficult to draw any firm conclusions from this study with regard to whether a mechanical or a biologic valve is a better choice in an elderly patient.

With regard to patient age, hospital mortality seemed to vary inversely with age at the time of operation in these elderly patients, although this trend was not statistically significant: only 1 patient older than 75 years died, and there were no hospital deaths among patients older than 80 at the time of intervention. The reason for this apparent decrease in mortality with increasing age may reflect a selection bias, but the data certainly suggest that advancing age should not be considered a contraindication to operation in otherwise favorable circumstances. Surprisingly, reoperation, concomitant procedures, and era of surgery were also not significant predictors of hospital mortality.

Not surprisingly, several types of postoperative complications were identified as independent risk factors for hospital mortality. These included cardiac complications, the need for tracheostomy, the presence of infection, and the postoperative occurrence of permanent global neurologic deficit or stroke. Temporary neurologic dysfunction, although frequent, had no impact on hospital mortality.

The overall rate of valve-related complications (endocarditis or thromboembolism) in this series, 7.1% after discharge, was low regardless of which valve type was used. The complications were transient in 3 patients, but led to death from stroke in the remaining 3. The overall incidence of thrombotic or hemorrhagic complications was 2.1/100 patient-years. This is somewhat higher than reported in a study including 270 patients at Johns Hopkins, but the mean patient age in this latter series was 38 years [3]. Our anticoagulation protocol after CVR involves warfarin (Coumadin, with an international normalized ratio of 2) for life in patients with mechanical valves, and for 3 months after operation in patients with biologic valves; dipyridamole was administered for 6 months after operation in all patients.

With regard to the appropriate time for elective intervention, the median diameter of the ascending aorta in this series was 7 cm. Because the recommendation for elective resection of the ascending aorta was 6 cm during most of the period of this study, and is currently 5 to 5.5 cm, our patients clearly exceeded the threshold at which the risk of dissection and rupture is thought to increase sharply.

In summary, these results show that aortic root replacement by means of a modified Bentall procedure (coronary button technique) can be performed successfully in elderly patients with a low operative mortality. This procedure yields excellent long-term survival, and prevents fatal aneurysm rupture in this high-risk population.

	References

Top Abstract Introduction Material and methods Results Comment References

 

1. Bentall H.H., DeBono A. A technique for replacement of the ascending aorta. Thorax 1968;23:338-339.[Abstract/Free Full Text]
2. Svensson L.G., Crawford S.E., Hess K.R., Coselli J.S., Safi H.J. Composite valve graft replacement of the proximal aorta: comparison of techniques in 348 patients. Ann Thorac Surg 1992;54:427-439.[Abstract]
3. Gott V.L., Gillinov A.M., Pyeritz R.E., et al. Aortic root replacement—risk factor analysis of a seventeen-year experience with 270 patients. J Thorac Cardiovasc Surg 1995;109:536-545.[Abstract/Free Full Text]
4. Kouchoukos N.T., Wareing T.H., Murphy S.F., et al. Sixteen-year experience with aortic root replacement. Ann Thorac Surg 1991;214:308-320.
5. Midulla P.S., Ergin A.M., Galla J., et al. Three faces of the Bentall procedure. J Card Surg 1994;9:466-481.[Medline]
6. Crawford E.S., Kirklin J.W., Naftel D.C., Svensson L.G., Coselli J.S., Safi H.J. Surgery for acute dissection of the ascending aorta. J Thorac Cardiovasc Surg 1992;104:46-59.[Abstract]
7. Lewis C.T., Cooley D.A., Murphey M.C., Talledo O., Vega D. Surgical repair of aortic root aneurysms in 280 patients. Ann Thorac Surg 1992;53:38-46.[Abstract]
8. Cabrol C., Pavie A., Mesnildrey P., et al. Long-term results with total replacement of the ascending aorta and reimplantation of the coronary arteries. J Thorac Cardiovasc Surg 1996;91:17-25.[Abstract]

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