Aortic Valve Replacement in Octogenarians

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ORIGINAL ARTICLE

Heart, Lung and Circulation (2014) xx, 1–6 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2014.03.017

Aortic Valve Replacement in Octogenarians Jessica A. Ditchfield, MD a*, Emily Granger, MBBS, FRACS b, Phillip Spratt, MBBS, FRACS b, Paul Jansz, MBBS, FRACS b, Kumud Dhital, MBBS, FRACS b, Alan Farnsworth, MBBS, FRACS b, Chris Hayward, MD c a

Faculty of Medicine, University of New South Wales, Sydney NSW 2052, Australia Department of Cardiothoracic Surgery, St Vincent’s Hospital, Darlinghurst, Sydney NSW 2010, Australia Department of Cardiology, St Vincent’s Hospital, Darlinghurst, Sydney NSW 2010, Australia

b c

Received 4 November 2013; received in revised form 23 February 2014; accepted 5 March 2014; online published-ahead-of-print xxx

Background

With improved life expectancy more octogenarians now present with aortic valve disease. Cardiac surgery in this group of patients has previously been considered high risk due to co-morbidities and challenges of rehabilitation. This study seeks to challenge the concept of octogenarian cardiac surgery ‘‘unsuitability’’ by analysing operative outcomes and long term survival following aortic valve replacement.

Methods

Eighty-seven consecutive patients undergoing aortic valve replacement between 2000 and 2009 at St Vincent’s Hospital were retrospectively identified. Statistical analysis was performed using SPSS (version 15 and 19).

Results

The average age was 82.7  2.4 years. The mean logistic EuroSCORE was 18.86  14.11. Post-operatively, four patients required insertion of a permanent pacemaker (4.6%) and five patients had a myocardial infarction (5.8%). In-hospital mortality was 3.4%. Follow-up was 93.1% complete. One-year survival was 92.9%, three-year survival was 86.7% and five-year survival was 75.0%. At follow-up 98.1% of patients were New York Heart Association (NYHA) Class I or II.

Conclusions

Results were excellent despite reasonable co-morbidities and Euroscore risk. Survival was impressive and the NYHA class reflected the success of the surgery in relieving the pathological aortic valve process. Patient age should not be the primary exclusion for cardiac surgery for aortic valve disease.

Keywords

Cardiac surgery  Aortic valve surgery  Heart valve prothesis  Median sternotomy  Octogenarian  Aortic Valve Replacement

Introduction The prevalence of aortic stenosis in octogenarians is estimated at between 2 and 17% [1]. Untreated aortic stenosis has a three year survival of 49% [2]. Whilst aortic valve replacement (AVR) surgery can offer excellent survival, it is important to select appropriate surgical candidates to ensure they can cope with the demands of surgery. This

has been consistently supported by published studies that demonstrate good results for AVR in octogenarians over the last 30 years [3–5]. Despite a longer and harder recovery process, octogenarians can do well with open valve replacement and as a consequence have been referred, and request referral to, cardiothoracic surgical units for treatment [5]. More recently, the advent of percutaneous aortic valve technologies has questioned the role of surgical valve

*Corresponding author at: 10 Evans St, Wagga Wagga, NSW 2650; Tel.: +614 13 925 586; fax: +612 6933 5100., Emails: [email protected], [email protected] Crown Copyright © 2014 Published by Elsevier Inc on behalf of Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). All rights reserved.

Please cite this article in press as: Ditchfield JA, et al. Aortic Valve Replacement in Octogenarians. Heart, Lung and Circulation (2014), http://dx.doi.org/10.1016/j.hlc.2014.03.017

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replacement in clinical practice. Some literature suggests that this technique will rapidly overtake the surgical AVR as it would avoid the morbidity of sternotomy and cardiopulmonary bypass [6]. The ‘‘attraction’’ of avoiding a surgical incision and sternal division seems to be influencing decision making, rather than consideration of current results in the ‘‘typical’’ surgical patient. This paper seeks to provide up-to-date information in the octogenarian population. The paper will assist in assessment for surgery by looking at the effects of pre-operative risk factors and comorbidities, and how they affect the surgical outcome.

Method Data Source This retrospective single-centre cohort study was conducted with the approval of the St Vincent’s Hospital Institutional Review Board. The Cardiothoracic Patient Records Database (version 2.5) was used to identify 115 patients 80 years and older who underwent AVR at St Vincent’s Hospital, Sydney between 1st January, 2000 and 31st December, 2009 inclusive. Patients were excluded from this study if they had undergone concomitant valve procedures (n = 22) or received a mechanical prosthesis (n = 3). Following this, 87 patients were suitable for review. The database was used to obtain demographic information, pre-operative comorbidities and risk factors, intraoperative data and clinical outcomes for each patient. Information from the database was cross-referenced with medical records to ensure reliability. Echocardiograms, coronary angiograms and pathology results were also reviewed. A total of 133 variables for each patient were extracted from the database and medical records. Standardised definitions were adapted from the Australasian Society of Cardiac and Thoracic Surgeons [7] for each variable to ensure consistency. General practitioners and cardiologists of the patients were then contacted by telephone to obtain current health information and survival data. Follow-up was 93.1% complete. Quality of life was assessed using the criteria of the New York Heart Association (NYHA) functional classes and analysing subsequent hospital admissions.

distribution was not-normally distributed, the Mann Whitney U Test was employed to analyse continuous data from two groups. Continuous variables were analysed against each other using linear regression. Ordinal variables from two independent groups, ordinal variables against nominal variables and ordinal variables against ordinal variables were all analysed using Kendall’s tau-b and Kendall’s tauc statistical tests. ANOVA tests were used to compare ordinal and nominal variables against a normally-distributed continuous variable, while the Kruskal-Wallis Test was used when the normality assumption did not hold. A p-value of <0.05 was considered to be statistically significant. Actuarial survival was analysed univariately using the Kaplan-Meier method, and the groups were compared using log-rank analysis. Variables with a p-value of <0.1 and variables commonly reflected as significant in the literature were then analysed using Cox Regression to determine which variables were independent predictors of decreased survival time. A p-value of <0.05 was considered to be statistically significant.

Results Patient Characteristics Eighty-seven patients were identified from our database as suitable for review, with a mean pre-operative age of 82.7  2.4 years (minimum 80, maximum 90). Of these, 45 patients were male (51.7%). The mean logistic EuroSCORE for this population was 18.86  14.11. The most common presenting symptom was dyspnoea, noted in 93.1% of patients (Table 1). The most common pre-operative risk factor was the presence of hypertension in 78 patients followed by hypercholesterolaemia in 56 patients. There were no cases of infective endocarditis in this cohort and only four cases of rheumatic valve disease (Table 2). Review of pre-operative New York Heart Association (NYHA) Class showed 59.8% of patients were of functional

Table 1 Pre-operative symptoms.

Data Analysis

Symptom

Statistical analysis of the data was performed using SPSS version 15 and SPSS version 19. Univariate analysis was performed to obtain frequency, mean, median, standard deviation, minimum and maximum values for each variant where appropriate. All continuous variables were analysed using the Kolmogorov-Smirnov test for normality. Nominal variables were analysed together using Pearson’s Chi-Square or Fisher’s Exact Test. Independent Samples T-Test was utilised to analyse continuous data from two independent groups when the normality assumption holds. When the continuous

Angina

Patients No. (%) 62 (71.3)

Class 1

10 (11.5)

Class 2 Class 3

24 (27.6) 17 (19.5)

Class 4

11 (12.6)

Stable

44 (50.6)

Unstable

18 (20.7)

Dyspnoea

81 (93.1)

Syncope/Pre-syncope

26 (29.9)

Palpitations

18 (20.7)

Please cite this article in press as: Ditchfield JA, et al. Aortic Valve Replacement in Octogenarians. Heart, Lung and Circulation (2014), http://dx.doi.org/10.1016/j.hlc.2014.03.017

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Do outcomes justify the practice?

Table 2 Clinical Population.

Characteristics

of

the

Study

Table 3 Pre-operative ECHO characteristics. Characteristic

Risk Factor

Patients No. (%)

Ex-smoker Obesity (BMI >30)

35 (40.2) 13 (14.9)

LVEF (%) Mean Normal (>60%)

Value

57.31  11.75 36.8%

Pre-op IABP

1 (1.1)

Mild Impairment (46-60%)

43.7%

Pacemaker

2 (2.3)

Moderate Impairment (30-45%)

14.9%

AF Paroxysmal

28 (32.2)

Severe Impairment (<30%)

6 (6.9)

AV peak velocity (m/s) mean

4.34  0.98

4.6%

Chronic

22 (25.3)

AV peak gradient (mmHg) mean

76.4  26.2

Previous MI

32 (36.8)

AV gradient (mmHg) mean AV Area (cm2) mean

46.3  16.5 0.74  0.31

PA pressure (mmHg) Mean

45.0  13.9

Aortic Stenosis

n = 85 (97.7%)

<30 days pre-operative Previous CVA

7 (8.0) 7 (8.0)

Previous cardiac surgery

12 (13.8)

Hypertension

78 (89.7)

None

n = 2 (2.3%)

Hypercholesterolaemia

56 (64.4)

Moderate

n = 13 (14.9%)

Congestive Cardiac Failure

25 (28.7)

Cerebrovascular disease

24 (27.6)

Peripheral vascular disease

26 (29.9)

Diabetes Mellitus Obstructive lung disease

20 (23) 11 (12.6)

Previous or current malignancy

18 (20.7)

Severe Aortic Regurgitation

n = 72 (82.8%) n = 82 (94.3%)

Mild Moderate

n = 65 (74.7%) n = 15 (17.2%)

Severe

n = 2 (2.3%)

AV = aortic valve, LVEF = left ventricular ejection fraction, PA = pulmonAF = atrial fibrillation, CVA = cerebrovascular accident, IABP = intra-aor-

ary artery.

tic balloon pump, MI = myocardial infarction.

Class III or Class IV. 35.6% of patients had some degree of pre-operative renal impairment, as defined as a serum creatinine level of > 0.1mmol/L, and two patients were on dialysis. Pre-operatively, the patients were assessed by echocardiogram to determine the degree of aortic stenosis, concomitant valve function, left ventricular ejection fraction (LVEF) and the pulmonary artery pressure (Table 3). The mean peak aortic valve gradient was 76.4 mmHg, and the mean aortic valve area for this population was 0.74cm2. The predominant indication for surgery in this cohort was aortic stenosis, with only two patients with isolated severe aortic regurgitation. Peri-Operative results: All patients in this population received a bioprosthetic valve and the average size of the implanted valve was 23.3  1.98 mm. Of this cohort, 15 cases were performed urgently, and 12 cases were a redo sternotomy. 64.4% of the patients underwent concomitant coronary artery bypass graft (CABG) (Table 4). Post-operatively, the median ventilation time was 13 hours, with prolonged intubation (>24 hours) in 16 patients. Twenty-three percent of patients required inotropes for greater than 24 hours in the intensive care unit. 71.3% of patients received blood products while in the intensive care unit. The average length of stay in the intensive care unit was 2.77  2.47 days. The total post-operative length of stay at

Table 4 Surgical Characteristics. Characteristic

Patient Number (%)

Status Elective Urgent Redo Sternotomy

72 (82.8%) 15 (17.2%) 12 (13.8%)

Implanted valve size Mean

23.3  1.98 mm

Median Maximum/Minimum

23mm 29mm/19mm

Intraoperative inotropes

37 (42.5%)

Cross clamp time Mean

89.1  27.4 mins

Bypass Time Mean

120.7  36.5 mins

Intra-operative Blood Products

55 (63.2%)

Additional Cardiac Procedure:

8 (9.2%)

Aortic endarterectomy

2 (2.3%)

Carotid endarterectomy AF ablation

1 (1.1%) 2 (2.3%)

Aortic root enlargement

2 (2.3%)

Ascending aorta graft

1 (1.1%)

Concomitant CABG

56 (64.4%)

AF = atrial fibrillation, CABG = coronary artery bypass graft.

Please cite this article in press as: Ditchfield JA, et al. Aortic Valve Replacement in Octogenarians. Heart, Lung and Circulation (2014), http://dx.doi.org/10.1016/j.hlc.2014.03.017

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St Vincent’s Hospital was a mean of 12.3  9.1 days with a median of nine days. 49.4% of patients were discharged home and 40.2% were transferred for care in another hospital. Factors shown to increase the ICU length of stay included obesity (p = 0.036), ex-smokers (p = 0.003), presence of significant obstructive lung disease defined as FEV1<60% (p = 0.042) and the use of intra-operative inotropes and blood products (p = 0.021 and p = 0.047 respectively). Five patients had an acute myocardial infarction (MI) postoperatively, and 45 (51.7%) of patients had post-operative atrial fibrillation. There were 15 new cases of renal impairment in this population post-operatively, but only two of these required temporary dialysis. Four patients in the cohort required the insertion of a permanent pacemaker during the same admission as their surgery, with two patients representing for insertion of a permanent pacemaker within 12 months of their AVR (Table 5). In this study, increasing age was not found to be a significant predictor of morbidity. No post-operative complications were associated with increasing age. Obesity proved to be a significant predictor of morbidity, increasing the risk of low cardiac output syndrome (p = 0.001), prolonged intubation requirement (p = 0.012) and both ICU length of stay and overall post-operative length of stay (p = 0.036 and p = 0.014 respectively). There were no current smokers in this cohort, but compared to non-smokers, ex-smokers had a higher incidence of pre-operative conduction abnormalities (p = 0.013), obstructive lung disease (p = 0.006) and a longer aortic cross clamp time (p = 0.041). Ex-smokers had a longer stay in ICU (p = 0.003), were more likely to require prolonged intubation (p = 0.044) and had a greater likelihood of being dependent on inotropes to maintain cardiac output (p = 0.040). The development of new cases of renal impairment was also shown to be more common in ex-smokers than non-smokers (p = 0.032). EuroSCORE was not a significant predictor of morbidity, only representing a significant relationship between a higher Table 5 Post-operative Morbidity. Complication AMI

Patients No. (%) 5 (5.8)

CVA

0 (0.0)

Return to theatre for bleeding

5 (5.8)

Sternal dehiscence Post-operative New AF

1 (1.1) 45 (51.7)

Renal impairment (New)

15 (17.2)

New dialysis

2 (2.3)

Deep sternal wound infection

1 (1.1)

Sepsis

5 (5.7)

Early PPM (<30 days)

4 (4.6)

Late PPM (>30 days)

2 (2.3)

AF = atrial fibrillation, AMI = acute myocardial infarction, CVA = cerebrovascular accident, PPM = permanent pacemaker.

EuroSCORE and increased likelihood for the requirement of post-operative inotropes (p = 0.002). Post-operative MIs were more common in cases that were urgent rather than elective (p = 0.034) and in patients that had a higher pre-operative serum creatinine level (p = 0.033). There was no significant relationship between the incidence of post-operative MIs and concomitant CABGs (p = 0.343). Patients requiring a redo sternotomy did not represent any greater morbidity with the exception of an increased risk of developing post-operative conduction abnormalities (p = 0.034). Patients who had a previous cardiac intervention were more likely to have a longer bypass time than those who had not had any prior interventions (p = 0.021). Intraoperatively, patients who had undergone a previous cardiac intervention were less likely to require blood products (p = 0.036) however were more likely to develop conduction abnormalities post-operatively (p = 0.033). The use of intra-operative inotropes was shown to be a significant predictor of post-operative complications. Inotrope use increased the incidence of post-operative respiratory failure (p = 0.012) and hence prolonged intubation time (p = 0.004). Those who received inotropes intra-operatively were more likely to develop a further inotrope dependence in the intensive care unit (p = 0.021). Those patients who did not receive inotropes intra-operatively were less likely to develop post-operative renal failure when pre-op serum creatinine levels were within the normal range (p = 0.038). There was no significant relationship between the use of inotropes intra-operatively and the pre-operative left ventricular ejection fraction (p = 0.089). Results of this study have shown that males were more likely than females to have coronary disease (p = 0.004) and hence were more likely to undergo concomitant CABGs (p < 0.001). Males were more likely to have a history of a prior cardiac intervention (p = 0.023) and a greater likelihood of cerebrovascular disease (p = 0.028). Pre-operative serum creatinine levels of males were higher than females (p = 0.008). Post-operatively, although the incidence of new cases of renal impairment were more common in females (p = 0.046), males were more likely to have moderate to severe renal impairment, while females had milder cases (p = 0.013). It was found that those who spent the least amount of time in ICU were most likely to be discharged home, followed by transfer of care to another hospital then admittance to a nursing home or hostel. Those patients who spent the greatest length of time in ICU were primarily discharged to a rehabilitation facility (p = 0.018).

Short-Term Mortality There were no intra-operative deaths however there were three in-hospital deaths in this population, two of which were in the perioperative period. One patient died on day 7 from a myocardial infarction, one on day 65 from multiple organ failure and one on day 18 due to congestive cardiac failure.

Please cite this article in press as: Ditchfield JA, et al. Aortic Valve Replacement in Octogenarians. Heart, Lung and Circulation (2014), http://dx.doi.org/10.1016/j.hlc.2014.03.017

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Survival Function Survival Function Censored

1.0

Cum Survival

0.8

0.6

0.4

0.2

0.0 0

1000

2000

3000

4000

Survival (Days)

Figure 1 Kaplan-Meier Survival

Long-Term Mortality (Figure 1) Follow-up was 93.1% complete, with six patients lost to follow-up. Mean follow-up time was 1484 days (approximately four years, one month). One-year survival was calculated at 92.9%, three-year survival was 86.7% and five-year survival was 75.0%. At the end of the study, 54 patients were still alive. Of these patients, 45 were NYHA Class I (83.3%) and eight were NYHA Class II (14.8%). No patients were NYHA Class III and only one patient was designated as NYHA Class IV (1.9%). Cox regression analysis revealed that increased preoperative age results in a decreased survival time (p = 0.049). Sex, smoking history, pre-operative NYHA Class, renal disease, pre-operative left ventricular ejection fraction or history of MI or cerebrovascular accident (CVA) were not found to be independent predictors of mortality.

Discussion Prevalence of cardiac surgery in octogenarians has steadily increased since the 1980s with octogenarians now accounting for approximately 5% of the cardiac surgery workload [4]. Despite concerns about the ability of older patients to tolerate cardiopulmonary bypass, the fragility of their tissues and multi-system comorbidities surgery is being requested by both patients and practitioners to alleviate disabling NYHA Class III and IV symptoms of heart disease [3]. With the advent of percutaneous valve technologies, the suitability of aortic valve replacement (AVR) via media sternotomy has been questioned, particularly in older patients. The overall in-hospital mortality for this study was 3.4%, compared to published values of 9-14% in octogenarians [1,2,9–15]. This difference may be attributed to the highly select nature of the patient population, with very high risk patients not offered surgery and referred for percutaneous therapies. The risk of a CVA is increased after AVR due to the manipulation of atheromatous plaques within the aorta

during surgery [16]. The incidence of a CVA postoperatively was identified as between 3% and 9% in the literature [2,9,12]. In this study, no patients suffered a CVA post-operatively and only one patient developed a postoperative TIA. Patients in this study were all assessed with a pre-operative CT scan to examine their ascending aorta. Patients with severe aortic atheroma had cannulation techniques to minimise the risk of atheromatous debris. Patients with a porcelain aorta were not offered surgery. This strategy possibly assisted in minimising the risk of perioperative stroke. Atrial fibrillation (AF) post-AVR is common and can arise as a consequence of trauma induced by the surgery, inadequate cardioplegia preservation, inadequate cooling or dispersion of refractoriness, increasing the risk of stroke [17]. In the literature, the post-operative incidence of AF is highly variable, ranging from 17% to 86% [1,2,10,15]. In this study it was found that 51.7% of patients developed AF post-operatively however there were no statistically significant relationships found between pre-operative or intra-operative factors that may predispose to the onset of AF. The requirement for a permanent pacemaker after surgery represents a significant concern for patients as it requires another surgical procedure. Rates of pacemaker requirement are approximately 2-4% in the literature [1,18]. In this study, 4.6% of patients required insertion of a permanent pacemaker in the peri-operative period, similar to instances represented in the literature. Two patients presented for a late insertion of a permanent pacemaker within 12 months of their aortic valve replacement. Post-operative acute myocardial infarctions represent a significant cause of morbidity and mortality, reducing long-term survival. There is limited data in the literature on the incidence of post-operative MIs in octogenarians, but two sources suggest an incidence of 0% and 4% [1,18]. In this study, 5.8% of patients had an acute MI. Of the perioperative deaths, in two of the three patients the myocardial infarct was a significant factor in their demise. New York Heart Association (NYHA) Class is a frequently used clinician-assigned assessment of quality of life that has shown to be a strong predictor of patient outcomes [19]. In this study a higher NYHA Class did not significantly increase intra-operative or post-operative complications, nor was it an independent predictor of mortality. In the literature, the most common factors associated with decreased survival time include urgent requirement for surgery [10,15,20], patients with diabetes mellitus [18,21,22], the presence of renal disease [18,22,23], history of a CVA [2,15,18], pre-operative NYHA Class [20,21] and lung disease [11,22]. In this study none of these factors were found to be independent predictors of decreased survival time. This may be attributable to the relatively low late mortality due to the short mean follow-up time. Increasing age, however, has been very strongly identified in the literature as an independent predictor of decreased survival [18,20,22,23]. Our research supports this (p = 0.049) as would be expected in an elderly cohort of patients.

Please cite this article in press as: Ditchfield JA, et al. Aortic Valve Replacement in Octogenarians. Heart, Lung and Circulation (2014), http://dx.doi.org/10.1016/j.hlc.2014.03.017

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Limitations One significant limitation to this study is the small sample size. Resultantly, many of the post-operative complications had such small incidences it was difficult to establish significant relationships between confounding variables.

Conclusion In summary, this study demonstrates excellent short and long term outcomes for octogenarians undergoing AVR. The postoperative morbidity is low and patient recovery satisfactory with most patients in NHYA Class I-II at follow-up. The average logistic Euroscore of patients was 18.86, confirming the pre-operative high risk profile of most patients. Percutaneous valve technology must reach high standards to justify an across-the-board practice change in elderly aortic valve disease management. Conventional surgery offers patients relatively safe surgery with good outcomes. Older patients should therefore not be denied the benefits of surgical aortic valve replacement as there can be a significant functional benefit, as well as improved survival time with acceptable operative morbidity and mortality for the majority.

Acknowledgements There has been no financial assistance with this project. Tom Hunter, Cardiothoracic Database Manager, St Vincent’s Hospital, Sydney Cardiothoracic Surgical Unit, St Vincent’s Hospital, Sydney UNSW Clinical Medical School, St Vincent’s Hospital, Sydney The University of New South Wales, Sydney

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Please cite this article in press as: Ditchfield JA, et al. Aortic Valve Replacement in Octogenarians. Heart, Lung and Circulation (2014), http://dx.doi.org/10.1016/j.hlc.2014.03.017