2 GENERAL DISCUSSION
2.6 Decision-making
The outcome expectations for CLI treatment are not similar for all patients.
For relatively fi t patients, ulcer healing, pain relief and subsequently sustained or improved ambulatory status may be the main goal, whereas for high-risk
patients limb preservation and prolonged survival may be a reasonable result.
The outcome of bypass is largely multifactorial, with varying predominating factors, depending on the specifi c outcome of interest. Graft patency and subsequent limb salvage are largely determined by the characteristics of the graft (graft type and size) and arterial anatomy (run-off). In contrast, patient survival is more affected by comorbidiites and medication (Schanzer 2009).
With modern infrainguinal bypass techniques, patency and leg salvage rates are good and durable even in suboptimal circumstances. Patient co-morbidities largely determine the overall outcome and should therefore be prioritised in the decision-making because a patent bypass is meaningless unless both life and limb are preserved. Considering the high-risk nature of CLI per se as well as the increasing variety of treatment options, outcome estimation with risk assessment is of paramount importance. For low-risk patients with multilevel PAD not amenable to endovascular revascularization, it is reasonable to perform infrainguinal bypass even in complex circumstances (i.e., redo-operation with arm or spliced vein graft). In contrast, for risk patients, such high-risk bypasses should be avoided and other options such as an endovascular approach, even in the presence of technical challenges, should be attempted. If endovascular revascularization is not feasible, a prosthetic bypass under local or regional anaesthesia might be considered. In elderly high-risk patients, compromises in patency and revascularization durability may be justifi ed, as the life expectancy is short. For non-ambulatory, dependent, high-risk patients with limb-threatening ischaemia, primary amputation for decreasing mortality might be the most appropriate option. The fi ndings of Studies I–VI, with respect to data from the literature, suggest that either the patient’s overall condition, the quality of the graft or outfl ow should be good. If all these factors are suboptimal, the outcome expectations are extremely poor. Moreover, high-risk patients (presence of CAD, low eGFR and age >80 years) who underwent bypass with an arm or spliced vein graft had extremely poor perioperative and 1-year survival, suggesting that patients with the highest operative risk should not be exposed to high-risk procedures.
In the future, the need of vascular surgery will increase signifi cantly as the elderly and diabetic population increases, which emphasises the importance of focusing on those patients that will gain benefi t from infrainguinal bypass.
Therefore, in conclusion, the individual risk of the patient, ambulatory status, outcome expectations, the risk of bypass procedure as well as technical factors such as the suitability of outfl ow anatomy and the available vein material should all be assessed and taken into consideration when deciding on the best revascularization strategy.
CONCLUSIONS
In summary, the fi ndings of Studies I–IV suggest that either the patient’s overall condition or the quality of the graft should be acceptable. If both patient and graft are considered risky, the outcome expectations are extremely poor. The specifi c conclusions were:
1. Renal insuffi ciency—not only renal failure but also moderate impairment in renal function—seems to be a signifi cant risk factor for both limb loss and death after infrainguinal bypass in patients with critical limb ischaemia.
Low estimated GFR (<30 ml/min/1.73 m2) is a strong independent marker of poor prognosis. Estimated GFR is a more accurate predictor of survival and leg salvage after infrainguinal bypass in CLI patients than serum creatinine alone. Therefore, GFR estimation should be used instead of creatinine level alone in the risk evaluation of patients undergoing infrainguinal revascularization for critical limb ischaemia (I).
2. The overall outcome of octogenarians with critical limb ischaemia undergoing infrainguinal revascularization is poor. Endovascular treatment seems to be associated with a better outcome than bypass in terms of survival, leg salvage and amputation-free survival in this fragile patient group and should therefore be considered as the fi rst option, especially in the presence of coronary artery disease (II).
3. The Finnvasc and modifi ed Prevent III risk scoring methods both predict the long-term outcome of patients undergoing both surgical and endovascular infrainguinal revascularization for CLI. The Finnvasc score seems to be more accurate in predicting immediate postoperative outcome. Both risk scoring methods are rather easy to use and might be helpful in clinical practice as an aid in preoperative patient selection and decision-making (III).
4. Low estimated eGFR alone, and especially in combination with advanced age and CAD, is a marker of dismal survival and AFS. A Finnvasc score of 4 and mPIII score of >8 are predictors of particularly poor AFS (I–V).
5. A single-segment great saphenous vein graft is superior to any other autologous vein graft in terms of mid-term patency and leg salvage. It requires signifi cantly fewer maintenance procedures than alternative autologous vein grafts. A non-single segment GSV graft is an independent predictor of both graft stenosis development and graft failure. However, due to active duplex surveillance and graft maintenance procedures, acceptable patency and leg salvage rates can also be achieved with alternative autologous vein grafts (IV).
6. Patients with the combination of high operative risk due to severe comorbidities and risk graft have extremely poor survival, suggesting that only relatively fi t patients should undergo complex bypasses with risk grafts (IV).
7. Arm vein conduits, even when spliced, are superior to prosthetic grafts for infrapopliteal bypasses in patients with CLI. Arm veins are often the last-resource autologous veins for bypass, and they are prone to focal stenoses, indicating that the surveillance and maintenance of these “high-risk grafts”
is important (V). The patency rates of prosthetic bypasses on infrapopliteal arteries are only moderate, but the acceptable limb salvage rates justify prosthetic infrapopliteal bypasses as a last means of limb salvage. This applies especially to high-risk patients with a short life expectancy who do not tolerate long, complex procedures with arm or spliced vein grafts (IV, V).
8. In the prospective, multicentre study on 50 patients, polyester mesh seemed to be a safe and feasible adjunct to infrainguinal bypass using suboptimal autologous vein grafts. However, larger prospective, randomised series and longer follow-up will be required to prove its safety and benefi t with respect to the incidence of vein graft stenosis and graft patency. External scaffolding may, however, enable the use of vein grafts of compromised quality otherwise unsuitable for bypass grafting (VI).
ACKNOWLEDGEMENTS
This study was carried out at the Department of Vascular Surgery, Helsinki University Central Hospital during the years 2006-2011.
I wish to express my deepest gratitude to my supervisors professor Mauri Lepäntalo and docent Anders Albäck. Mauri introduced me to the fi eld of vascular research and continuously encouraged and supported me during this study. Without his enthusiasm and enormous knowledge of vascular surgery this study would not have been possible. It has been a great privilege to work in his clinic. I wish to sincerely thank Anders, whose endless enthusiasm and expertise in vascular surgery has inspired me greatly. I appreciate his ideas and advices during these years. Besides being a supportive supervisor of this study, Anders has shared his excellent skills in surgical technique with me and is a great example of talented vascular surgeon and clinician.
I am deeply grateful to docent Kimmo Mäkinen and docent Antti Vento for their careful and prompt review of this thesis. Their constructive comments, suggestions and valuable advices helped me to improve the manuscript.
I wish to express my warmest thanks to all my co-authors. I sincerely thank Maria Söderström for spending uncountable hours gathering data and generously sharing the research material with me. Her contribution to this work is indispensable. I am deeply grateful to docent Maarit Venermo who has shared not only her expertise in scientifi c work but also her friendship and numerous unforgettably fun moments of life with me. I greatly appreciate docent Fausto Biancari for unselfi shly and kindly helping me preparing manuscripts II and III and for sharing his excellent knowledge of statistics and scientifi c writing.
I would like to thank Pekka-Sakari Aho for kindly providing help not only in statistical but also in many other practical problems. My sincere thanks go to Petteri Kauhanen for his valuable contribution particularly in Study VI as well as for being a supportive and friendly colleague in everyday clinical practice. I would like to express my gratitude to Maria Korhonen for generously sharing the endovascular data with me and to Karoliina Halmesmäki for her efforts in scoring innumerable angiographic images. I owe my appreciation to docent Ilkka Tikkanen for patiently teaching me internal medicine, particularly renal function. I also would like to thank German colleagues professor Thomas Schmitz-Rixen, Dr. Achim Neufang, Dr. Farzin Adili for their co-operation in study VI.
I am grateful to Eeva Parviainen for revising the language of this thesis.
I would like to express special thanks to research nurses. I am particularly grateful to Anita Mäkelä for helping me in numerous valuable ways during this work. I sincerely thank Leena “Lende” Sipilä for guiding me with Husvasc in early phases of this study and for helping me to gather data.
I also want to thank Mrs. Leena Multanen for her continuous, kind help in many practical things.
My warmest thanks go to my all colleagues at the Department of Vascular Surgery; Mikko Jormalainen, Ilkka Kantonen, Milla Kallio, Sani Laukontaus, Mikael Railo, Eeva-Maija Weselius, Pirkka Vikatmaa and Sailaritta Vuorisalo for teaching and encouraging me. I enjoy working with you. I also wish to thank “our” anesthesiologist Leena Capraro for her friendship and support.
The great team of trainees in our clinic, Hanni Alho, Ivika Heinola, Tiia Kukkonen and Katariina Noronen are also warmly appreciated. Furthermore, I am grateful to all nurses in vascular surgical ward and outpatient clinic in Meilahti and Jorvi Hospital. My special thanks belong to our skillful vascular nurses dedicated to graft surveillance.
I also want to thank my colleagues and staff at the South Karelian Central Hospital. Special thanks belong to Dr. Jaakko Permi, the former chief surgeon, who encouraged and trained me to become a surgeon. I also wish to express my gratitude and appreciation to Eija Saimanen, who is an example of dedicated and skillful vascular surgeon and inspired me to specialize in vascular surgery.
I wish to express my warmest gratitude to my dear friends, colleagues and “dream team” members, Mari Metso-Lintula and Pirjo Posio for their friendship and support. Thank you for being there for me and giving so much joy to my life. I am more than happy to have friends like you.
My dearest thanks go to my father Markku for his constant support throughout my life. I also wish to thank his wife Eeva for her warm and friendly presence. My loving thanks go to my sister Linda and brother Janne for their lifelong friendship and support. I am proud to have so wonderful siblings like you. This thesis is also dedicated to the memory of my dear mother Sirkka.
Finally, my heartfelt thanks belong to Jukka. Your optimism, endless support, patience and love have given me enormously strength. You are the love and joy of my life.
This study was fi nancially supported by a grant from the Karin and Einar Stroem Foundation, The Finnish Society for Angiology, Etelä-Karjalan Lääkäriseura, Paavo Ilmari Ahvenainen Foundation, The Vyborg Tuberculosis Foundation and Duodecim.
Helsinki, October 2011 Eva Arvela
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