Accepted Manuscript Endovascular surgery, open surgery and primary amputation in nonagenarians presenting with critical limb ischemia Anne Lejay, MD, PhD, Charline Delay, MD, Yannick Georg, MD, MSc, Adeline Schwein, Sébastien Gaertner, MD, Fabien Thaveau, MD, PhD, Bernard Geny, MD, PhD, Nabil Chakfe, MD, PhD PII:
S0890-5096(16)30023-1
DOI:
10.1016/j.avsg.2015.11.009
Reference:
AVSG 2682
To appear in:
Annals of Vascular Surgery
Received Date: 21 July 2015 Revised Date:
4 November 2015
Accepted Date: 5 November 2015
Please cite this article as: Lejay A, Delay C, Georg Y, Schwein A, Gaertner S, Thaveau F, Geny B, Chakfe N, Endovascular surgery, open surgery and primary amputation in nonagenarians presenting with critical limb ischemia, Annals of Vascular Surgery (2016), doi: 10.1016/j.avsg.2015.11.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Endovascular surgery, open surgery and primary amputation in nonagenarians presenting with critical limb ischemia
RI PT
Anne LEJAY1*, MD, PhD ; Charline DELAY1*, MD ; Yannick GEORG1, MD, MSc ; Adeline Schwein1, Sébastien GAERTNER2, MD ; Fabien THAVEAU1, MD, PhD ; Bernard
SC
GENY3, MD, PhD ; Nabil CHAKFE1, MD, PhD.
1. Department of Vascular Surgery and Kidney Transplantation, University Hospital of
M AN U
Strasbourg, Strasbourg, France.
2. Department of Hypertension, Vascular Diseases and Pharmacology, University of Strasbourg, Strasbourg, France.
3. Department of Physiology, University Hospital of Strasbourg, Strasbourg, France.
Anne LEJAY
EP
Corresponding author:
TE D
* These authors contributed equally to this work.
AC C
Department of Vascular Surgery and Kidney Transplantation University Hospital of Strasbourg, 1 Place de l’hôpital, BP 426, 67091 Strasbourg Cedex Tel: +33 3 69 55 09 07
Fax: +33 3 69 55 17 83
Email : [email protected]
ACCEPTED MANUSCRIPT
ABSTRACT Objectives: The aim was to report the mid-term outcome for nonagenarians with critical limb ischemia (CLI) and to identify factors affecting survival or limb salvage rates.
RI PT
Methods: Nonagenarians who underwent endovascular surgery (ES), open surgery (OS) or primary amputation (PA) for CLI between 2005 and 2014 were included. Cox regression model identified factors affecting survival and limb salvage.
SC
Results: ES was performed in 116 patients (119 limbs), OS in 73 patients (73 limbs) and PA in 54 patients (57 limbs). Mean follow-up was 10.38 months. There was no difference in
M AN U
survival between ES, OS and PA groups: survival rate was 51.2% at 1 year and 38.9% at 2 years after ES, 48.3% at 1 year and 39.6% at 2 years after OS, and 50.6% at 1 years and 40.8% at 2 years after PA (p = 0.58). There was no difference in limb salvage between ES and OS groups: limb salvage rate was 88.2% and 77.8% at 1 and 2 years after ES and 87.3% and 77.6% at 1 and 2 years after OS. Coronary artery disease (HR 1.54; CI 1.04-1.08; p = 0.01)
TE D
was risk factor for death. Fully dependent state was risk factor for death (HR 4.2; CI 3.554.87; p < 0.001) and major amputation (HR 5.3; CI 1.32-1.67; p < 0.001). In fully dependent patients, 1-year and 2-year survival rate was 28.9% and 20.6% respectively, and 1-year and 2-
EP
year limb salvage rate was 61.2% and 44.5% respectively. Conclusion: With acceptable early and late mortality, limb salvage and maintenance of
AC C
functional status and level of independent living, revascularization in nonagenarians is effective as long as the patient is not fully dependent.
Keywords: endovascular surgery, open surgery, primary amputation, critical limb ischemia, nonagenarians, autonomy
ACCEPTED MANUSCRIPT
INTRODUCTION As a result of increasing life expectancy, patients over 90 years of age with critical limb ischemia (CLI) can be referred to vascular units1. The management of CLI in these elderly
RI PT
patients can be challenging because they may have extensive arterial lesions while bearing serious medical comorbidities that may affect the surgery outcome1. As a consequence, general practitioners sometimes hesitate to refer these particular patients to surgical units,
SC
believing that revascularization would be too aggressive in these elderly patients. However, it has been well demonstrated that CLI octogenarians who have successful revascularization show better quality of life and longer survival than patients treated with primary amputation
M AN U
(PA) or conservatively2. It has also been highlighted that revascularization is justified in elderly patients because limb preservation allow to maintain ambulatory status and independent living3-5.
Endovascular surgery (ES) should be considered the first-line option in elderly patients,
TE D
because it is associated with better outcome than open surgery (OS) in terms of survival and limb salvage6-8. However, despite continuous advances in endovascular techniques allowing the treatment of more complex and longer lesions, there are still many CLI patients that
EP
cannot be treated by ES9. OS still remains an option in these patients with extensive lesions, particularly in the setting of CLI because it is essential to restore blood flow until distally.
AC C
The aim of this study was to assess the evolution of treatment strategies over a 10-year period in nonagenarians presenting with CLI, to report the mid-term outcome of revascularization procedures and to identify factors affecting survival or limb salvage rates.
ACCEPTED MANUSCRIPT
METHODS Study design All consecutive patients over 90 years of age who underwent ES, OS or PA for CLI in the
RI PT
setting of infrainguinal lesions between January 2005 and December 2014 in our institution were included in this retrospective descriptive study. Demographic data, procedural details and post-operative outcome were collected prospectively into the department’s database and
SC
examined retrospectively. Preoperative data
M AN U
The preoperative data recorded included age, sex, cardiovascular risk factors, comorbid conditions (coronary artery disease, cerebrovascular disease, pulmonary disease or renal disease), pre-operative autonomy level and indications for surgery (rest pain or ulcers, duration of symptoms, hemodynamic evaluation).
Smoking history was defined as smoking cessation for more than 1 year prior to hospital
TE D
arrival. Diabetes was considered as hyperglycemia requiring oral medication or insulin treatment. Coronary artery disease was defined as a previously documented myocardial infarction and/or ongoing angina pectoris, or previous coronary surgery (bypass or
EP
endovascular). Cerebrovascular disease was defined either as a previous stroke or as previously diagnosed dementia (Alzheimer’s disease, vascular dementia or permanent
AC C
cognitive impairment). Pulmonary disease was defined as a ratio between the 1-second forced expiratory volume and the forced vital capacity less than 0.7 L. Renal disease was defined as estimated glomerular filtration rate less than 30 mL/min. Autonomy level was defined according to Parker score10. The Parker score was measured at admission in all patients because it was a systematic interview performed by the nurses and noted on the patient admission record. When Parker score is higher than or equal to 6, it means that the patients is non dependent, he can get about their homes and walk outdoors
ACCEPTED MANUSCRIPT
without help. When Parker score is lower than 2, the patient is fully dependent and needs help for all daily life activities. Parker score ranging from 2 to 5 indicates that the patient is partially dependent; he doesn’t need assistance at home but cannot walk outdoors alone
RI PT
(Table I). CLI was defined as rest pain or non-healing ulcers, lasting for more than 2 weeks and supported by hemodynamic parameters such as ankle-brachial index (ABI) and/or toe
SC
perfusion pressure according to TASC II recommendations11. Procedural data
M AN U
Procedural data included data concerning lesion characteristics (outflow vessel, TASC classification), treatment strategy (type of surgery, graft materials) and initial results. Our policy was to perform ES as first line option when possible, OS either for complex and calcified lesions or after failed endovascular surgery and PA in fully dependent patients without any possibility of healing associated to infection and/or uncontrollable pain. When ES
TE D
was performed, each vessel was sized visually and stenosis or occlusion was dilated by inflating the selected balloon for 1 minute at nominal pressure. Stenting was performed in case of residual stenosis or dissection in femoropopliteal (FP) lesions and avoided if possible
EP
in below-the-knee (BTK) lesions. When OS was performed, autologous vein grafts were used whenever possible and the quality and suitability of the saphenous vein was assessed by
AC C
duplex ultrasonography preoperatively for each patient. The aim of the revascularization procedures was to restore 1 vessel run-off to the foot. Post-operative data
The following postoperative parameters were recorded: 30-day mortality (death within 30 days of operation), 30-day morbidity (morbidity within 30 days of operation), post-operative length of hospital stay. Morbidity was defined as surgery-related morbidity (revascularization
ACCEPTED MANUSCRIPT
thrombosis, haemorrhagic complication, operative site infection, amputation) or systemic morbidity (renal, pulmonary, cardiac or neurologic failures). Follow-up program consisted of clinical and hemodynamic examination with ABI or skin
RI PT
perfusion pressure measurements and Duplex scan at 1 month, 6 months, 12 months, and then annually. The 30-day Parker score was assessed by the surgical team, during systematic follow-up.
SC
Statistical analysis
Asymmetric quantitative variables are presented as mean, median and range format.
M AN U
Qualitatives variables are presented as effectives and percentages. Fisher exact or alternatively Chi-Squared test, Mann-Withney and alternatively Student tests were used to compare groups, depending on distributions assumptions. Survival and limb salvage rates were calculated by the Kaplan-Meier method. Cox regression analysis was used to assess risk factors associated with poor survival or limb salvage. Demographic data as well as procedural
TE D
data were included in multivariate analysis. Only variables with a p value < 0.2 in univariate analysis were included in regression model. Multivariate analysis was presented with hazard ratio (HR) and confidence interval (CI) and p value. Statistical analysis was performed using
AC C
RESULTS
EP
Graphpad Prism software. Level of significance chosen was p value < 0.05.
Population
Description of cardiovascular risk factors, associated comorbidities, level of autonomy and indications regarding the type of surgery performed is presented in Table II. ES and OS groups were comparable. There were several differences between patients from PA group and patients who underwent revascularization (either ES or OS): the number of diabetic patients was higher (p
S0890-5096(16)30023-1
DOI:
10.1016/j.avsg.2015.11.009
Reference:
AVSG 2682
To appear in:
Annals of Vascular Surgery
Received Date: 21 July 2015 Revised Date:
4 November 2015
Accepted Date: 5 November 2015
Please cite this article as: Lejay A, Delay C, Georg Y, Schwein A, Gaertner S, Thaveau F, Geny B, Chakfe N, Endovascular surgery, open surgery and primary amputation in nonagenarians presenting with critical limb ischemia, Annals of Vascular Surgery (2016), doi: 10.1016/j.avsg.2015.11.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Endovascular surgery, open surgery and primary amputation in nonagenarians presenting with critical limb ischemia
RI PT
Anne LEJAY1*, MD, PhD ; Charline DELAY1*, MD ; Yannick GEORG1, MD, MSc ; Adeline Schwein1, Sébastien GAERTNER2, MD ; Fabien THAVEAU1, MD, PhD ; Bernard
SC
GENY3, MD, PhD ; Nabil CHAKFE1, MD, PhD.
1. Department of Vascular Surgery and Kidney Transplantation, University Hospital of
M AN U
Strasbourg, Strasbourg, France.
2. Department of Hypertension, Vascular Diseases and Pharmacology, University of Strasbourg, Strasbourg, France.
3. Department of Physiology, University Hospital of Strasbourg, Strasbourg, France.
Anne LEJAY
EP
Corresponding author:
TE D
* These authors contributed equally to this work.
AC C
Department of Vascular Surgery and Kidney Transplantation University Hospital of Strasbourg, 1 Place de l’hôpital, BP 426, 67091 Strasbourg Cedex Tel: +33 3 69 55 09 07
Fax: +33 3 69 55 17 83
Email : [email protected]
ACCEPTED MANUSCRIPT
ABSTRACT Objectives: The aim was to report the mid-term outcome for nonagenarians with critical limb ischemia (CLI) and to identify factors affecting survival or limb salvage rates.
RI PT
Methods: Nonagenarians who underwent endovascular surgery (ES), open surgery (OS) or primary amputation (PA) for CLI between 2005 and 2014 were included. Cox regression model identified factors affecting survival and limb salvage.
SC
Results: ES was performed in 116 patients (119 limbs), OS in 73 patients (73 limbs) and PA in 54 patients (57 limbs). Mean follow-up was 10.38 months. There was no difference in
M AN U
survival between ES, OS and PA groups: survival rate was 51.2% at 1 year and 38.9% at 2 years after ES, 48.3% at 1 year and 39.6% at 2 years after OS, and 50.6% at 1 years and 40.8% at 2 years after PA (p = 0.58). There was no difference in limb salvage between ES and OS groups: limb salvage rate was 88.2% and 77.8% at 1 and 2 years after ES and 87.3% and 77.6% at 1 and 2 years after OS. Coronary artery disease (HR 1.54; CI 1.04-1.08; p = 0.01)
TE D
was risk factor for death. Fully dependent state was risk factor for death (HR 4.2; CI 3.554.87; p < 0.001) and major amputation (HR 5.3; CI 1.32-1.67; p < 0.001). In fully dependent patients, 1-year and 2-year survival rate was 28.9% and 20.6% respectively, and 1-year and 2-
EP
year limb salvage rate was 61.2% and 44.5% respectively. Conclusion: With acceptable early and late mortality, limb salvage and maintenance of
AC C
functional status and level of independent living, revascularization in nonagenarians is effective as long as the patient is not fully dependent.
Keywords: endovascular surgery, open surgery, primary amputation, critical limb ischemia, nonagenarians, autonomy
ACCEPTED MANUSCRIPT
INTRODUCTION As a result of increasing life expectancy, patients over 90 years of age with critical limb ischemia (CLI) can be referred to vascular units1. The management of CLI in these elderly
RI PT
patients can be challenging because they may have extensive arterial lesions while bearing serious medical comorbidities that may affect the surgery outcome1. As a consequence, general practitioners sometimes hesitate to refer these particular patients to surgical units,
SC
believing that revascularization would be too aggressive in these elderly patients. However, it has been well demonstrated that CLI octogenarians who have successful revascularization show better quality of life and longer survival than patients treated with primary amputation
M AN U
(PA) or conservatively2. It has also been highlighted that revascularization is justified in elderly patients because limb preservation allow to maintain ambulatory status and independent living3-5.
Endovascular surgery (ES) should be considered the first-line option in elderly patients,
TE D
because it is associated with better outcome than open surgery (OS) in terms of survival and limb salvage6-8. However, despite continuous advances in endovascular techniques allowing the treatment of more complex and longer lesions, there are still many CLI patients that
EP
cannot be treated by ES9. OS still remains an option in these patients with extensive lesions, particularly in the setting of CLI because it is essential to restore blood flow until distally.
AC C
The aim of this study was to assess the evolution of treatment strategies over a 10-year period in nonagenarians presenting with CLI, to report the mid-term outcome of revascularization procedures and to identify factors affecting survival or limb salvage rates.
ACCEPTED MANUSCRIPT
METHODS Study design All consecutive patients over 90 years of age who underwent ES, OS or PA for CLI in the
RI PT
setting of infrainguinal lesions between January 2005 and December 2014 in our institution were included in this retrospective descriptive study. Demographic data, procedural details and post-operative outcome were collected prospectively into the department’s database and
SC
examined retrospectively. Preoperative data
M AN U
The preoperative data recorded included age, sex, cardiovascular risk factors, comorbid conditions (coronary artery disease, cerebrovascular disease, pulmonary disease or renal disease), pre-operative autonomy level and indications for surgery (rest pain or ulcers, duration of symptoms, hemodynamic evaluation).
Smoking history was defined as smoking cessation for more than 1 year prior to hospital
TE D
arrival. Diabetes was considered as hyperglycemia requiring oral medication or insulin treatment. Coronary artery disease was defined as a previously documented myocardial infarction and/or ongoing angina pectoris, or previous coronary surgery (bypass or
EP
endovascular). Cerebrovascular disease was defined either as a previous stroke or as previously diagnosed dementia (Alzheimer’s disease, vascular dementia or permanent
AC C
cognitive impairment). Pulmonary disease was defined as a ratio between the 1-second forced expiratory volume and the forced vital capacity less than 0.7 L. Renal disease was defined as estimated glomerular filtration rate less than 30 mL/min. Autonomy level was defined according to Parker score10. The Parker score was measured at admission in all patients because it was a systematic interview performed by the nurses and noted on the patient admission record. When Parker score is higher than or equal to 6, it means that the patients is non dependent, he can get about their homes and walk outdoors
ACCEPTED MANUSCRIPT
without help. When Parker score is lower than 2, the patient is fully dependent and needs help for all daily life activities. Parker score ranging from 2 to 5 indicates that the patient is partially dependent; he doesn’t need assistance at home but cannot walk outdoors alone
RI PT
(Table I). CLI was defined as rest pain or non-healing ulcers, lasting for more than 2 weeks and supported by hemodynamic parameters such as ankle-brachial index (ABI) and/or toe
SC
perfusion pressure according to TASC II recommendations11. Procedural data
M AN U
Procedural data included data concerning lesion characteristics (outflow vessel, TASC classification), treatment strategy (type of surgery, graft materials) and initial results. Our policy was to perform ES as first line option when possible, OS either for complex and calcified lesions or after failed endovascular surgery and PA in fully dependent patients without any possibility of healing associated to infection and/or uncontrollable pain. When ES
TE D
was performed, each vessel was sized visually and stenosis or occlusion was dilated by inflating the selected balloon for 1 minute at nominal pressure. Stenting was performed in case of residual stenosis or dissection in femoropopliteal (FP) lesions and avoided if possible
EP
in below-the-knee (BTK) lesions. When OS was performed, autologous vein grafts were used whenever possible and the quality and suitability of the saphenous vein was assessed by
AC C
duplex ultrasonography preoperatively for each patient. The aim of the revascularization procedures was to restore 1 vessel run-off to the foot. Post-operative data
The following postoperative parameters were recorded: 30-day mortality (death within 30 days of operation), 30-day morbidity (morbidity within 30 days of operation), post-operative length of hospital stay. Morbidity was defined as surgery-related morbidity (revascularization
ACCEPTED MANUSCRIPT
thrombosis, haemorrhagic complication, operative site infection, amputation) or systemic morbidity (renal, pulmonary, cardiac or neurologic failures). Follow-up program consisted of clinical and hemodynamic examination with ABI or skin
RI PT
perfusion pressure measurements and Duplex scan at 1 month, 6 months, 12 months, and then annually. The 30-day Parker score was assessed by the surgical team, during systematic follow-up.
SC
Statistical analysis
Asymmetric quantitative variables are presented as mean, median and range format.
M AN U
Qualitatives variables are presented as effectives and percentages. Fisher exact or alternatively Chi-Squared test, Mann-Withney and alternatively Student tests were used to compare groups, depending on distributions assumptions. Survival and limb salvage rates were calculated by the Kaplan-Meier method. Cox regression analysis was used to assess risk factors associated with poor survival or limb salvage. Demographic data as well as procedural
TE D
data were included in multivariate analysis. Only variables with a p value < 0.2 in univariate analysis were included in regression model. Multivariate analysis was presented with hazard ratio (HR) and confidence interval (CI) and p value. Statistical analysis was performed using
AC C
RESULTS
EP
Graphpad Prism software. Level of significance chosen was p value < 0.05.
Population
Description of cardiovascular risk factors, associated comorbidities, level of autonomy and indications regarding the type of surgery performed is presented in Table II. ES and OS groups were comparable. There were several differences between patients from PA group and patients who underwent revascularization (either ES or OS): the number of diabetic patients was higher (p
