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The Impact of Functional Dependency on Outcomes After Complex General and Vascular Surgery
1678 Abstracts
precluded by traditional markers of disease quiescence. Clearly there remains a need for therapeutic agents better able to induce and sustain long term remission in patients with GCA and for discovery of more reliable bio markers of disease activity.
Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial Couturaud F, Sanchez O, Pernod G, et al. JAMA 2015;314:31-40. Conclusions: In patients with a first episode of unprovoked pulmonary embolism (PE) treated with 6 months of anticoagulation treatment, an additional 18 months of treatment with warfarin produces an improved composite outcome of recurrent venous thrombosis and major bleeding compared to placebo. However, benefit is not maintained if anticoagulation therapy is discontinued. Summary: It is known that when anticoagulation therapy is stopped after 3 to 6 months of treatment following a first episode of unprovoked venous thromboembolism (VTE) that there is a much higher risk of recurrence of VTE compared to those who initial VTE was provoked by a transient risk factor (Levine MN et al, Thromb Haemost 1995;74:606-11). Also, in high risk patients extending anticoagulation beyond 3 to 6 months is associated with a reduction in the risk of recurrence of VTE as long as treatment is continued (Kearon C et al, N Engl J Med 1999;340:901-7). It is still unclear, however, what is the optimum duration of anticoagulation after a first episode of unprovoked PE. The purpose of this study was to determine the benefits and harms of an additional 18 month period of treatment with warfarin vs placebo after an initial 6 month treatment period with a Vitamin K antagonist. This was a randomized double-blind trial with a treatment period of 18 months and a median follow-up of 24 months. 371 adult patients with a first episode of symptomatic unprovoked PE who were treated initially for 6 uninterrupted months with a vitamin K antagonist were then randomized either to warfarin or placebo for an additional 18 months and followed up between July 2007 and September 2014 in 14 centers in France. Primary outcome was the composite of recurrent VTE and major bleeding 18 months after randomization. Secondary outcomes were the composite at 42 months (treatment period plus 24 month follow-up), as well as each component of the composite endpoint, and death unrelated to PE or major bleeding at 18 and 42 months. Four patients were lost to follow up after randomization; all after month 18. One patient withdrew due to an adverse event. The primary outcome during the 18 month treatment period occurred in 6 of 184 patients (3.3%) in the warfarin group and in 25 of 187 (13.5%) in the placebo group (hazard ratio [HR], 0.22; 95% CI, 0.09-0.55; P ¼ .001). Recurrent VTE occurred in 3 patients in the warfarin group and 25 in the placebo group (HR, 0.15; 95% CI, 0.05-0.43). Major bleeding occurred in 4 patients in the warfarin group and 1 in the placebo group (HR, 3.96; 95% CI, 0.44-35.89). During the 42 month entire study period (including the study treatment and follow up) the composite outcome occurred in 33 patients (20.8% in the warfarin group) and in 42 (24.0%) in the placebo group (HR, 0.76; 95% CI, 0.471.18). Rates of recurrent VTE, major bleeding and unrelated death did not differ between groups. Comment: Clearly, in patients with a proclivity for VTE, particularly in this case PE, the longer the period of anticoagulation the greater the overall decreased risk of recurrence of the VTE event. The downside has always been the potential for bleeding. However, this study suggests that in patients with unprovoked PE there is still an overall benefit of more prolonged anticoagulation. Perhaps eventually the margin of benefit could be increased further with the use of the new anticoagulation agents for prolonged periods of anticoagulation as the bleeding risk with these new agents appears less than with warfarin and treatment efficacy in preventing VTE equal. In addition, it is now known that aspirin also provides some long term benefit in prevention of VTE events in patients with unprovoked VTE. Overall, the study suggests patients with unprovoked PE are likely to benefit from prolonged periods of anticoagulation. Whether this benefit is truly optimized with Vitamin K antagonists, or can be improved with the new anticoagulants or aspirin and can be adjusted according to patient risk factors needs further study.
The Impact of Functional Dependency on Outcomes After Complex General and Vascular Surgery Scarborough JE, Bennett KM, Englum BR, et al. Ann Surg 2015;261:431-7. Conclusions: Preoperative function dependence is an independent risk factor for mortality after major operations. Summary: The American College of Surgeons national surgical quality improvement program (ACS-NSQIP) and the American Geriatric Society recommend that geriatric patients in whom major elective surgery
JOURNAL OF VASCULAR SURGERY December 2015
is being considered be assigned a frailty score using a rules-based measurement tool (Chow WB et al, Am Coll Surgeons 2012;215:453-66). Frailty represents a multifactorial loss of physiologic and cognitive reserves eventually resulting in increased susceptibility to adverse health outcomes. A common frailty rules-based score consists of evaluation of weight loss, exhaustion, low energy expenditure, slowness and weakness and is difficult to measure and implement in routine clinical practice. The basis of this paper is that authors feel functional disability or dependent functional health/ fit status is relatively easier to define and measure than frailty. The objective of this study was to describe outcomes following surgical procedures in a large cohort of patients undergoing one of several complex elective general or vascular surgical procedures and to quantify the degree to which functional dependence may impact the rates of postoperative morbidity and mortality. Patient undergoing one of ten complex general or vascular operations were extracted from the 2005 to 2010 ACS-NSQIP database. Propensity score techniques were used to match patients with or without preoperative functional dependency with respect to known patient-and procedure-related factors. Postoperative outcomes of this matched cohort were then compared. There were a total of 10,246 functionally dependent surgical patients who were included for analysis. These patients were more acutely and chronically ill then functionally independent patients and they had higher rates of mortality and morbidity for each of the ten procedures analyzed. Propensity matching techniques resulted in the creation of cohort of functionally independent and dependent patients who were well matched for known patient-and procedure-related variables. Dependent patients from the matched cohort had a 1.75 greater odds of post-operative death (95% confidence interval, 1.54-1.98, P < .0001) then functionally independent patients. With regard to vascular surgical patients 30-day mortality from carotid endarterectomy in independent vs dependent patients was 0.6% vs 3.3%, that for endovascular AAA repair was 1.2% vs 5.5%, infrainguinal bypass grafting 1.4% vs 5.9% and open AAA repair 3.8% vs 13.7% (all P < .0001). Morbidity rates were equally impressive. For carotid endarterectomy in independent patients the 30 day morbidity rate was 4.2% vs 12.0% for dependent patients. For endovascular aneurysm repair the values were 8.0% vs 23.5%, infrainguinal bypass 14.8% vs 26.6% and for open AAA repair 31.9% vs 46.5% (again all P < .0001). Comment: The data demonstrates the tremendous adverse impact of preoperative functional dependency on outcomes following major vascular surgical procedures, even those thought to be associated with relatively low morbidity and mortality rates such as carotid endarterectomy and endovascular AAA repair. Effects of Statins on Early and Late Clinical Outcomes of Carotid Endarterectomy and the Rate of Post-Carotid Endarterectomy Restenosis AbuRahma AF, Srivastava M, Stone PA, et al. J Am Coll Surg 2015;220:481-8. Conclusions: Statins have no effect on post-carotid endarterectomy (CEA) restenosis but are associated with decreased death rates in patients with diabetes trending to lower both death and stroke rates in diabetic patients with hypercholesterolemia. Summary: There are multiple proposed pleiotropic effects of statins on the vascular system. Favorable outcomes are associated with the use of statins in patients treated for peripheral arterial disease, aneurysm disease and carotid stenosis treated with CEA. This study focused on assessment of the effect of statins on perioperative and late clinical outcomes after CEA and the rate of post CEA restenosis. This was a retrospective analysis of 500 consecutive patients undergoing CEA followed at 1, 6 and 12 months and every year. There were 299 patients on statins vs 201 without. Combined perioperative myocardial infraction (MI)/death rates were 2.7% vs 4% (P ¼ .416) and MI/stroke/death rates were 4% vs 5% (P ¼ .607) for statins vs no statins. At a mean follow up of 27 months MI, stroke, death rates were 9.7%, 2.3%, 2.3% vs 9%, 2.5%, and 4.5% (P ¼ .018) for statins vs no statins, respectively. Diabetic patients not on statins had 4 times more deaths (8.5% vs 2.3%) and twice as many stroke/deaths (4.3% vs 2.2%). Rates of freedom from stroke/MI/death at 1, 2, 3 and 4 years were 94%, 90%, 85% and 77% vs 94%, 89% 85% and 82% (P ¼ .87) for statins vs no statins, respectively. Rates of freedom from death only for patients on statins vs no statins at 1, 2, 3, and 4 years were 98%, 98%, 97.4%, and 97.4% vs 98%, 96%, 94.8%, and 94.8%, respectively (P ¼ .0191). For diabetic patients, rates of freedom from death at 1, 2, 3, and 4 years were 99%, 99%, 97%, and 97% for statins vs 97%, 90%, 90%, and 90% without statins, respectively (P ¼ .048). Post-CEA restenosis rates $50% were not significantly different between statins vs no statins (P ¼ .64). Comment: The study has enough significant weaknesses that one cannot use it as a means to justify not using statins in patients undergoing CEA. Retrospective studies with observational design such as this make it impossible to determine the amount of time the patients have been on statins, the effectiveness of the statins in these patients, dosages of the
precluded by traditional markers of disease quiescence. Clearly there remains a need for therapeutic agents better able to induce and sustain long term remission in patients with GCA and for discovery of more reliable bio markers of disease activity.
Six Months vs Extended Oral Anticoagulation After a First Episode of Pulmonary Embolism: The PADIS-PE Randomized Clinical Trial Couturaud F, Sanchez O, Pernod G, et al. JAMA 2015;314:31-40. Conclusions: In patients with a first episode of unprovoked pulmonary embolism (PE) treated with 6 months of anticoagulation treatment, an additional 18 months of treatment with warfarin produces an improved composite outcome of recurrent venous thrombosis and major bleeding compared to placebo. However, benefit is not maintained if anticoagulation therapy is discontinued. Summary: It is known that when anticoagulation therapy is stopped after 3 to 6 months of treatment following a first episode of unprovoked venous thromboembolism (VTE) that there is a much higher risk of recurrence of VTE compared to those who initial VTE was provoked by a transient risk factor (Levine MN et al, Thromb Haemost 1995;74:606-11). Also, in high risk patients extending anticoagulation beyond 3 to 6 months is associated with a reduction in the risk of recurrence of VTE as long as treatment is continued (Kearon C et al, N Engl J Med 1999;340:901-7). It is still unclear, however, what is the optimum duration of anticoagulation after a first episode of unprovoked PE. The purpose of this study was to determine the benefits and harms of an additional 18 month period of treatment with warfarin vs placebo after an initial 6 month treatment period with a Vitamin K antagonist. This was a randomized double-blind trial with a treatment period of 18 months and a median follow-up of 24 months. 371 adult patients with a first episode of symptomatic unprovoked PE who were treated initially for 6 uninterrupted months with a vitamin K antagonist were then randomized either to warfarin or placebo for an additional 18 months and followed up between July 2007 and September 2014 in 14 centers in France. Primary outcome was the composite of recurrent VTE and major bleeding 18 months after randomization. Secondary outcomes were the composite at 42 months (treatment period plus 24 month follow-up), as well as each component of the composite endpoint, and death unrelated to PE or major bleeding at 18 and 42 months. Four patients were lost to follow up after randomization; all after month 18. One patient withdrew due to an adverse event. The primary outcome during the 18 month treatment period occurred in 6 of 184 patients (3.3%) in the warfarin group and in 25 of 187 (13.5%) in the placebo group (hazard ratio [HR], 0.22; 95% CI, 0.09-0.55; P ¼ .001). Recurrent VTE occurred in 3 patients in the warfarin group and 25 in the placebo group (HR, 0.15; 95% CI, 0.05-0.43). Major bleeding occurred in 4 patients in the warfarin group and 1 in the placebo group (HR, 3.96; 95% CI, 0.44-35.89). During the 42 month entire study period (including the study treatment and follow up) the composite outcome occurred in 33 patients (20.8% in the warfarin group) and in 42 (24.0%) in the placebo group (HR, 0.76; 95% CI, 0.471.18). Rates of recurrent VTE, major bleeding and unrelated death did not differ between groups. Comment: Clearly, in patients with a proclivity for VTE, particularly in this case PE, the longer the period of anticoagulation the greater the overall decreased risk of recurrence of the VTE event. The downside has always been the potential for bleeding. However, this study suggests that in patients with unprovoked PE there is still an overall benefit of more prolonged anticoagulation. Perhaps eventually the margin of benefit could be increased further with the use of the new anticoagulation agents for prolonged periods of anticoagulation as the bleeding risk with these new agents appears less than with warfarin and treatment efficacy in preventing VTE equal. In addition, it is now known that aspirin also provides some long term benefit in prevention of VTE events in patients with unprovoked VTE. Overall, the study suggests patients with unprovoked PE are likely to benefit from prolonged periods of anticoagulation. Whether this benefit is truly optimized with Vitamin K antagonists, or can be improved with the new anticoagulants or aspirin and can be adjusted according to patient risk factors needs further study.
The Impact of Functional Dependency on Outcomes After Complex General and Vascular Surgery Scarborough JE, Bennett KM, Englum BR, et al. Ann Surg 2015;261:431-7. Conclusions: Preoperative function dependence is an independent risk factor for mortality after major operations. Summary: The American College of Surgeons national surgical quality improvement program (ACS-NSQIP) and the American Geriatric Society recommend that geriatric patients in whom major elective surgery
JOURNAL OF VASCULAR SURGERY December 2015
is being considered be assigned a frailty score using a rules-based measurement tool (Chow WB et al, Am Coll Surgeons 2012;215:453-66). Frailty represents a multifactorial loss of physiologic and cognitive reserves eventually resulting in increased susceptibility to adverse health outcomes. A common frailty rules-based score consists of evaluation of weight loss, exhaustion, low energy expenditure, slowness and weakness and is difficult to measure and implement in routine clinical practice. The basis of this paper is that authors feel functional disability or dependent functional health/ fit status is relatively easier to define and measure than frailty. The objective of this study was to describe outcomes following surgical procedures in a large cohort of patients undergoing one of several complex elective general or vascular surgical procedures and to quantify the degree to which functional dependence may impact the rates of postoperative morbidity and mortality. Patient undergoing one of ten complex general or vascular operations were extracted from the 2005 to 2010 ACS-NSQIP database. Propensity score techniques were used to match patients with or without preoperative functional dependency with respect to known patient-and procedure-related factors. Postoperative outcomes of this matched cohort were then compared. There were a total of 10,246 functionally dependent surgical patients who were included for analysis. These patients were more acutely and chronically ill then functionally independent patients and they had higher rates of mortality and morbidity for each of the ten procedures analyzed. Propensity matching techniques resulted in the creation of cohort of functionally independent and dependent patients who were well matched for known patient-and procedure-related variables. Dependent patients from the matched cohort had a 1.75 greater odds of post-operative death (95% confidence interval, 1.54-1.98, P < .0001) then functionally independent patients. With regard to vascular surgical patients 30-day mortality from carotid endarterectomy in independent vs dependent patients was 0.6% vs 3.3%, that for endovascular AAA repair was 1.2% vs 5.5%, infrainguinal bypass grafting 1.4% vs 5.9% and open AAA repair 3.8% vs 13.7% (all P < .0001). Morbidity rates were equally impressive. For carotid endarterectomy in independent patients the 30 day morbidity rate was 4.2% vs 12.0% for dependent patients. For endovascular aneurysm repair the values were 8.0% vs 23.5%, infrainguinal bypass 14.8% vs 26.6% and for open AAA repair 31.9% vs 46.5% (again all P < .0001). Comment: The data demonstrates the tremendous adverse impact of preoperative functional dependency on outcomes following major vascular surgical procedures, even those thought to be associated with relatively low morbidity and mortality rates such as carotid endarterectomy and endovascular AAA repair. Effects of Statins on Early and Late Clinical Outcomes of Carotid Endarterectomy and the Rate of Post-Carotid Endarterectomy Restenosis AbuRahma AF, Srivastava M, Stone PA, et al. J Am Coll Surg 2015;220:481-8. Conclusions: Statins have no effect on post-carotid endarterectomy (CEA) restenosis but are associated with decreased death rates in patients with diabetes trending to lower both death and stroke rates in diabetic patients with hypercholesterolemia. Summary: There are multiple proposed pleiotropic effects of statins on the vascular system. Favorable outcomes are associated with the use of statins in patients treated for peripheral arterial disease, aneurysm disease and carotid stenosis treated with CEA. This study focused on assessment of the effect of statins on perioperative and late clinical outcomes after CEA and the rate of post CEA restenosis. This was a retrospective analysis of 500 consecutive patients undergoing CEA followed at 1, 6 and 12 months and every year. There were 299 patients on statins vs 201 without. Combined perioperative myocardial infraction (MI)/death rates were 2.7% vs 4% (P ¼ .416) and MI/stroke/death rates were 4% vs 5% (P ¼ .607) for statins vs no statins. At a mean follow up of 27 months MI, stroke, death rates were 9.7%, 2.3%, 2.3% vs 9%, 2.5%, and 4.5% (P ¼ .018) for statins vs no statins, respectively. Diabetic patients not on statins had 4 times more deaths (8.5% vs 2.3%) and twice as many stroke/deaths (4.3% vs 2.2%). Rates of freedom from stroke/MI/death at 1, 2, 3 and 4 years were 94%, 90%, 85% and 77% vs 94%, 89% 85% and 82% (P ¼ .87) for statins vs no statins, respectively. Rates of freedom from death only for patients on statins vs no statins at 1, 2, 3, and 4 years were 98%, 98%, 97.4%, and 97.4% vs 98%, 96%, 94.8%, and 94.8%, respectively (P ¼ .0191). For diabetic patients, rates of freedom from death at 1, 2, 3, and 4 years were 99%, 99%, 97%, and 97% for statins vs 97%, 90%, 90%, and 90% without statins, respectively (P ¼ .048). Post-CEA restenosis rates $50% were not significantly different between statins vs no statins (P ¼ .64). Comment: The study has enough significant weaknesses that one cannot use it as a means to justify not using statins in patients undergoing CEA. Retrospective studies with observational design such as this make it impossible to determine the amount of time the patients have been on statins, the effectiveness of the statins in these patients, dosages of the