REVIEW International Journal of Surgery (2013) 11(S1), S11–S15
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
REVIEW
Impact of new technologies on vascular surgery Carlo Setacci, Pasqualino Sirignano, Francesco Setacci Vascular and Endovascular Surgery Unit, Department of Surgery, University of Siena, Italy
ARTICLE INFO Keywords: New technologies Vascular surgery
1. Introduction At the beginning of the 19th century, Carrel and Leriche developed the techniques of vascular anastomoses, laying the foundations for the very existence of our discipline. 1 In 1948, in Lisbon, Monitz performed the first femoral endarterectomy (under local anesthesia); 2 in the same period, in Paris, Kunlin performed the first reversed saphenous vein femoro-popliteal bypass. 3 Two years later, thanks to the French experience, the boundaries moved even further, when Oudot 4 performed the first bypass for occlusive aortic disease and when, in 1954, we saw the first intervention for abdominal aortic aneurysm by Dubost; 5 the patient died after 8 years because of myocardial infarction. A milestone was the first carotid endarterectomy by Eastcott (London, 1954); 6 although not the first endarterectomy performed, it was the first to appear in the literature. All these surgeons have created our discipline. They have invented the tools to work with and, especially, were the first to understand the natural course of vascular disease. We maintained that brand of leadership until the early 1990s. Our ability and devotion to work hard were the reasons for our success. Looking back over our shoulders, we must admit, however, that our discipline has not changed that much; surely the surgical tools and the medical outcomes of our patients have improved, but not so the techniques at our disposal. At the beginning of the 1990s, a revolution occurred: endovascular techniques rapidly began to spread. The endovascular revolution has radically changed our discipline; in this paper we will try to summarize what has changed in clinical practice. 2. Carotid artery Carotid artery stenting (CAS) has emerged as a useful, potentially less invasive alternative to carotid endarterectomy (CEA) but controversy presently surrounds this procedure. 7,8 During the last decade
there have been important innovations in the device, technical refinements and a better knowledge of patient selection. With the introduction of CAS, vascular surgeons have been challenged to change their point of view in managing severe carotid artery stenosis. Several trials have suggested equivalent results for CAS and CEA. 9–12 Long-awaited results from the CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) study have recently been presented 13 and shed a new light on CEA versus CAS as a critical issue (Fig. 1). CREST compared CAS to CEA for the treatment of carotid
Fig. 1. Intraoperative images of (A) CEA and (B) CAS.
artery stenosis to prevent stroke in symptomatic and asymptomatic patients. More than 2500 patients were enrolled from more than 100 centers in North America and Canada over a 9-year period. The occurrence of the composite primary end-point of any stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke on follow-up, was not significantly different between the CEA and CAS groups: stenting 7.2%, surgery 6.8%. The overall safety and efficacy of the two procedures was largely the same
1743-9191$ – see front matter © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
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with equal benefits for both men and women, and for patients with and without previous neurological symptoms. However, there were more heart attacks (2.3%) in the surgical group compared to 1.1% in the stenting group, and more strokes in the stenting group (4.1%) versus 2.3% for the surgical group in the weeks following the procedure. In particular, few strokes were disabling; the rate of non-disabling stroke was 2.7% for CAS vs. 1.4% for CEA, and the rate of disabling stroke was 1.4% for CAS vs. 0.8% for CEA, without achieving statistical significance. These results did not aim to establish whether stenting or endarterectomy will win the race, but more likely how these two procedures could be selectively and properly applied to individual patients. Depending on patient’s characteristics, one procedure might have an advantage over the other. Recent results allowed experienced operators in both techniques to adapt a treatment strategy tailored to each patient. In this regard, only specialists who can offer both options of treatment will offer the greatest benefit for the patient. 3. Aorta Open surgical repair of lesions of the descending thoracic aorta has been the “state-of-the-art” treatment for many decades. However, in specialized vascular centers, thoracic endovascular aortic repair and hybrid aortic procedures have been implemented as novel treatment options. The current clinical results show that these procedures can be performed with low morbidity and mortality rates. However, due to a lack of randomized trials, the level of reliability of these new treatment modalities remains a matter of discussion. Clinical decision-making is generally based on the experience of the vascular center as well as on individual factors, such as life expectancy, comorbidity, aneurysm aetiology, aortic diameter and morphology. Endovascular aneurysm repair (EVAR) is a minimally invasive surgery for the treatment of aortic aneurisms based on the use of a stent graft, usually deployed inside the aneurysm through femoral access to exclude the sac from the circulation. EVAR requires adequate fixation sites for effective sealing and fixation. These requirements should be carefully assessed and verified prior to surgery with adequate imaging to select suitable patients for endografting (Fig. 2).
Fig. 2. Endovascular treatment of an abdominal aortic aneurism.
Potential advantages of EVAR over open repair (OR) include reduced operative time, avoidance of general anesthesia, less trauma and postoperative pain, reduced hospital length of stay and less need for intensive care unit (ICU), reduced blood loss and reduced immediate postoperative mortality. Potential disadvantages include the risk of incomplete aneurysm sealing, with the development of continuous
refilling of the aneurysm sac, either because the graft does not seal completely at the extremities (Type I endoleak), between segments (Type III endoleak), or because of backfilling of the aneurysm from other small vessels in the aneurysm wall (Type II endoleak). Thoracic endovascular aortic repair (TEVAR) has been proposed to be a less invasive treatment for treatment of thoracic aortic aneurysms. Early clinical results with thoracic aortic stent grafts have shown significantly improved early quality of life versus open surgery and have generally shown a trend toward better perioperative survival and freedom from major complications. 14–17 The original Food and Drug Administration Investigational Device Exemption (FDA IDE) studies that led to approval of the currently available devices, including the Gore TAG (W.L. Gore & Associates, Inc, Flagstaff, AZ), Medtronic Talent (Medtronic, Inc, Minneapolis, MI), and Cook Zenith TX2 stent grafts (Cook Endovascular, Bloomington, IN), specifically looked at patients with favorable anatomy in descending thoracic aortic aneurysms. The early results in these trials were highly favorable toward stent grafts. Open repair of the thoracic aorta is traditionally associated with significant permanent neurologic morbidity and mortality. In recent series from high-volume centers of excellence, mortality and neurologic morbidity rates range from 5.4% to 7.2% for mortality, 2.1% to 6.2% for permanent stroke, 5.7% for permanent paraparesis, and 0.8% to 2.3% for permanent paralysis, respectively. 18,19 In the multicenter open control groups for the Gore TAG, Medtronic Talent, and Cook Zenith TX2 stent grafts, mortality and neurologic morbidity rates range from 5.7% to 11.7% for mortality, 4.3% to 8.6% for permanent stroke, 5.7% for permanent paraparesis, and 3.4% to 8.5% for permanent paralysis, respectively. Similarly, the perioperative results for the 3 stent graft trials in the TEVAR arms showed 1.9% to 2.1% for mortality, 2.4% to 4% for stroke, 4.4% to 7.2% for permanent paraparesis, and 1.3% to 3% for permanent paralysis, respectively. 20–22 Randomized controlled trials, large registries and single-center series comparing EVAR with OR have shown that the minimally invasive approach has lower early morbidity and mortality with low incidence of primary conversion to OR after EVAR, between 0.9% and 5.9%. 23–28 The DREAM trial reported an operative mortality rate of 4.6% in the open repair group and 1.2% in the endovascular repair group, with a higher rate of moderate and severe systemic complications in the open surgical arm. However, cardiac complication rate in this trial was similar in the two groups (5.7% for OR vs 5.3% for EVAR), underlining that even EVAR should be considered a procedure with intermediate to high risk of cardiac complications. 29 The increased use of EVAR has been affected by limitations of the related technology, although the percentage of abdominal aortic aneurysms (AAA) deemed suitable for EVAR has been growing over the past decade, due to improvements in graft design. However, longterm durability is still being questioned especially in case of adverse anatomy, rendering the pre-operative anatomical evaluation crucial for late success of EVAR. Recent experience demonstrates that treatment with new-generation devices is technically feasible and safe, yielding satisfactory results even in challenging aortic anatomies. The duration of procedures, intraoperative contrast use and radiation exposure time are similar compared with treatment of standard anatomies, indirectly demonstrating an absence of additional intraoperative difficulties. The particular characteristics of this device seem to make it appropriate for the treatment of highly angulated and short necks, especially in patients at high surgical risk. The clinical significance is to demonstrate the effectiveness of the new devices even in the case of difficult anatomies, as well as its postoperative safeness in the
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case of off-label indications in patients otherwise considered unfit for surgery. 30 Experience with endovascular exclusion of aneurysms in the chest and abdomen has facilitated the extension of this technology into the treatment of aortic dissection. Endovascular repair of the ascending aorta is not indicated due to limitations of current technology in dealing with the dynamic nature of the ascending aorta and aortic arch. Furthermore, the proximity to and potential for involvement of the coronary arteries and aortic valve in acute type A dissection cannot be dealt with by current technology. Endovascular exclusion of the descending thoracic aorta in type A dissection is gaining traction. Endovascular repair of the descending thoracic aorta has also emerged as an advantageous alternative to traditional surgical techniques in the management of appropriate cases of acute complicated type B aortic dissection. The ultimate goal of open surgical and endovascular treatment of acute aortic dissections is restoration of flow through the true lumen, exclusion of the primary entry tears with the potential for facilitating aortic remodeling, and prevention of potential aneurysmal degeneration. TEVAR has become a preferred therapeutic option for a wide spectrum of aortic pathologies in both the elective and emergent settings. 31–36 Conventional open surgical repair of type B dissection is becoming less common due to the high perioperative morbidity and mortality. The availability of a highly experienced multidisciplinary team is essential because these patients are frequently in critical condition. 37,38 Recently, the Society for Vascular Surgery Outcomes Committee in conjunction with ad hoc members from the American Association for Thoracic Surgery, Society of Thoracic Surgeons, and Society for Interventional Radiology reported 1-year outcomes in patients with chronic Type B aortic dissections treated with TEVAR who presented with rupture or malperfusion with acute (< 14 days), subacute (15–30 days), or chronic (31–90 days) symptom onset until required intervention. These 85 patients were consolidated from 5 centers of excellence with single-center FDA IDE to establish a 30-day mortality with 1-year follow-up. The actuarial mortality estimates observed were 10.8% at 30 days and 29.4% at 1 year. 39 This represents a significantly lower percentage when compared with the older reports of open thoracic aortic surgical repair with 24–35% mortality at 30 days. 40 4. Lower limb The most important revolution in treatment of critical limb ischemia (CLI) is represented by the “new horizons” in the treatment of chronic total occlusion (CTO) in the infrainguinal arteries. Subintimal angioplasty (SIA) is a minimally invasive percutaneous technique for the recanalization of occluded iliac and infrainguinal arteries. 41–43 First described by Bolia et al. 44 in 1989, this technique has been used increasingly as an alternative to lower limb bypass procedures in CLI. 45 It is usually performed under local anesthesia and is based on the creation of a subintimal channel by endoluminal dissection and angioplasty. This minimally invasive technique is well tolerated by most patients and requires only a modest amount of equipment. 46 Success with SIA has been enhanced by the introduction of re-entry devices to facilitate recanalization. 47 The advantages of a percutaneous interventional procedure over bypass surgery are briefer anesthesia, no incision in an ischemic leg, and fewer healing complications, as well as less systemic stress (local anesthesia), faster recovery, and earlier ambulation. Moreover, failed SIA does not preclude the possibility of surgical revascularization. 48 Further, redo percutaneous procedures might be more readily done than repeat surgery, with the possibility of offering future surgical intervention if needed. The procedure, however, needs to be performed by a
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skilled team of trained operators. Generally, antegrade ipsilateral percutaneous femoral access is preferred when at least 5 cm of a patent proximal segment of the superficial femoral artery (SFA) is evident at ultrasonography. A contralateral approach via a crossover long sheath is used only in the presence of SFA occlusion in its origin, high femoral bifurcation (documented by ultrasound), or obesity. A soft, angled hydrophilic 0.035-inch guidewire in combination with a 5-F angled hydrophilic catheter is brought near the origin of the occlusion. An attempt to advance the guidewire through the true lumen is done in all cases. When needed, the subintimal plane is entered by forming a loop at the end of the guidewire and advancing it, along with the catheter, across the occluded arterial segment. Indicators of subintimal dissection include characteristic resistance to wire advancement, a broad helical path taken by the wire during advancement, the guidewire loop adapting to the width of the native vessel, and a subtle release of wire resistance with true lumen reentry near the distal portion of the arterial occlusion. Following confirmation of catheter re-entry into the true lumen, balloon angioplasty is used to dilate the subintimal channel. A re-entry device is used only when recanalization by simple SIA is unsuccessful. Stenting is performed only if there is residual stenosis > 30% or a flowlimiting dissection. Most physicians use a standardized approach: a brief SIA procedure of 30–40 minutes and application of a re-entry device only when accessing the true lumen is difficult, so as not to dissect the popliteal artery or threaten the supragenicular collaterals. If the procedure cannot be concluded safely, suggestion is to continue the intervention surgically or use a hybrid approach. The presence of a vascular surgeon in the team is important inasmuch as the first intervention should not preclude the possibility of further surgical revascularization. 49 In the last year, in the world of Vascular surgery, the “diabetic foot revolution” has begun. 50 Diabetes is a chronic disease that involves 350 million people worldwide, a number that will increase to 440 million by 2030. 51,52 Every year, 1 million people undergo a lower limb amputation as a consequence of diabetes. It is hard to believe that, although 85% of all amputations are preceded by foot ulcers, the prevalence of amputations ranges from 0.2% to 4.8%, with an annual incidence of 46.1 to 936 per 100,000. According to Prompers et al., 53 the presence of arterial obstructive disease greatly increases the risk of amputation, but diabetic sensory motor neuropathy increases only the risk of ulcers; foot infection, which frequently complicates the clinical course of ulcerative lesions of the foot, raises the risk of amputation only if associated with CLI. It is well known that all the complications associated with the diabetic foot are complex and costly, 54,55 so we must know what to do in this particular subgroup of patients. Caravaggi 56 recently reported a well-designed triage protocol for patients with diabetic foot. According to this protocol, the presence of an infectious process indicates a need for urgent treatment. Unfortunately, the literature contains scant data on which is the best treatment option with respect to the degree of ischemia and the infection. However, we suggest that early and aggressive debridement of the infection must always precede the revascularization procedure. This approach is also recommended by most recent guidelines, particularly the International Guidelines on Diabetic Foot Treatment 57 and the European Society of Vascular Surgery guidelines on CLI and diabetic foot. 58 Nonetheless, only a few centers apply this complex and integrated approach, which implies that the dramatic delay in the diagnosis and treatment of diabetic foot will increase not only the risk of major amputation but also of death. We strongly suggest a 4-step approach to patients with diabetic foot:
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Fig. 3. Pre- and post-operative angiogram of a lower limb revascularization.
1. Early diagnosis with a 24-hour on-call diabetic foot team; all the members of the team should be able to perform a duplex scan and to identify an infectious disease, if present. 2. Urgent treatment of severe foot infection with aggressive surgical debridement performed by highly skilled operators in the operating theater. 3. Revascularization (Fig. 3) with a straight flow to the foot. In all cases, the first-line approach should be endovascular (angioplasty ± stenting). 4. Definitive treatment: wound healing, reconstructive surgery, and orthesis. This protocol requires highly skilled professionals working together around the clock toward the goal of avoiding major amputations in patients with diabetic foot. It is a challenging and complex task, but only an integrated, interdisciplinary diabetic foot team can significantly impact the outcome of our patients. 5. Conclusions We must be ‘master surgeons’, capable of working with the same skills in both traditional and endovascular surgical procedures; but we must also be ‘master physicians’, who are entirely managing their patients. We believe this definition is crucial: only those surgeons with these requirements can be defined as vascular surgeons. Funding None. Disclosure statement The authors have no conflicts of interest to declare. References 1. Carrel A. Les anastomoses vasculaires et leurs technique opératoire. Union Med Can 1904:33–97. 2. dos Santos DJ. Sur la désobstruction des thromboses artérielles anciennes. Mem Acad Chir 1947;73:409. 3. Kunlin I. Le traitement de l’artérite obliterante par la greffe veineuse longue. Arc Mal Coeur 1949;42:371. 4. Oudot I. Un deuxième cas de greffe de la bifurcation aortique pour thrombose de la fourche aortique. Mem Acad Chir 1951;77:644. 5. Dubost C, Allary N, Oeconomos N. Resection of aneurysm of abdominal aorta; reestablishment of continuity by a preserved human arterial graft, with result after 5 months. Arch Surg 1952;64:405. 6. Eastcott HH, Pickering GW, Rob CG. Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia. Lancet 1954;267(6846):994–6.
7. Setacci C, Chisci E, de Donato G, Setacci F, Sirignano P, Galzerano G. Carotid artery stenting in a single center: are six years of experience enough to achieve the standard of care? Eur J Vasc Endovasc Surg 2007;34(6):655–62. 8. Rabe K, Sievert H. Carotid artery stenting: state of the art. J Interv Cardiol 2004;17: 417–26. 9. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351:1493–501. 10. Gray WA, Hopkins LN, Yadav S, et al. Protected carotid stenting in high-surgical-risk patients: the ARCHeR results. J Vasc Surg 2006;44:258–68. 11. Hobson RW 2nd. Carotid stenting: should it replace endarterectomy in higher-risk patients? Semin Vasc Surg 2006;19:83–6. 12. CaRESS Steering Committee. Carotid Revascularization Using Endarterectomy or Stenting Systems (CaRESS) phase I clinical trial: 1-year results. J Vasc Surg 2005;42:213–9. 13. Mantese VA, Timaran CH, Chiu D, CREST Investigators. The carotid revascularization endarterectomy versus stenting trial (CREST): stenting versus carotid endarterectomy for carotid disease. Stroke 2010;41(10 Suppl):S31–4. 14. Gopaldas RR, Huh J, Dao TK, et al. Superior nationwide outcomes of endovascular versus open repair for isolated descending thoracic aortic aneurysm in 11,669 patients. J Thorac Cardiovasc Surg 2010;140:1001–10. 15. Andrassy J, Weidenhagen R, Meimarakis G, Rentsch M, Jauch KW, Kopp R. Endovascular versus open treatment of degenerative aneurysms of the descending thoracic aorta: a single center experience. Vascular 2011;19:8–14. 16. Orandi BJ, Dimick JB, Deeb GM, Patel HJ, Upchurch GR Jr. A population-based analysis of endovascular versus open thoracic aortic aneurysm repair. J Vasc Surg 2009;49:1112–6. 17. Abraha I, Romagnoli C, Montedori A, Cirocchi R. Thoracic stent graft versus surgery for thoracic aneurysm. Cochrane Database Syst Rev 2009;1:CD006796. 18. Wong DR, Parenti JL, Green SY, Chowdhary V, Liao JM, Zarda S, et al. Open repair of thoracoabdominal aortic aneurysm in the modern surgical era: contemporary outcomes in 509 patients. J Am Coll Surg 2011;212:569–79. 19. Estrera AL, Miller CC 3rd, Chen EP, et al. Descending thoracic aortic aneurysm repair: 12-year experience using distal aortic perfusion and cerebrospinal fluid drainage. Ann Thorac Surg 2005;80:1290–6. 20. Bavaria JE, Appoo JJ, Makaroun MS, Verter J, Yu ZF, Mitchell RS; Gore TAG Investigators. Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: a multicenter comparative trial. J Thorac Cardiovasc Surg 2007;133:369–77. 21. Fairman RM, Criado F, Farber M, Kwolek C, Mehta M, White R; VALOR Investigators. Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: the VALOR trial. J Vasc Surg 2008;48:546–54. 22. Matsumura JS, Cambria RP, Dake MD, Moore RD, Svensson LG, Snyder S; TX2 Clinical Trial Investigators. International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results. J Vasc Surg 2008;47:247–57. 23. Verhoeven ELG, Tielliu IFJ, Prins TR, et al. Frequency and outcome of reinterventions after endovascular repair for abdominal aortic aneurysm: a prospective cohort study. Eur J Vasc Endovasc Surg 2004;28:357–64. 24. Lyden SP, McNamara JM, Sternbach Y, Illig KA, Waldman DL, Grenn RM. Technical considerations for late removal of aortic endograft. J Vasc Surg 2002;36:674–8. 25. Chaikov EL, Lin PH, Brinkman WT, et al. Endovascular repair of abdominal aortic aneurysms: risk stratified outcomes. Ann Surg 2002;235:833–41. 26. Verzini F, Cao P, De Rango P, et al. Conversion to open repair after endografting for abdominal aortic aneurysm: causes, incidences and results. Eur J Vasc Endovasc Surg 2006;31:136–42. 27. Tiesenhausen K, Hessinger M, Konstantiniuk P, et al. Surgical conversion of abdominal aortic stent-grafts. Outcome and technical considerations. Eur J Vasc Endovasc Surg 2006;31:36–41. 28. Jimenez JC, Moore WS, Quinones-Baldrich WJ. Acute and chronic conversion after endovascular aortic aneurysm repair: a 14-year review. J Vasc Surg 2007;46:642–7. 29. Prinssen M, Verhoeven EL, Buth J, et al. A randomised trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med 2004;351: 1607–18. 30. Setacci F, Sirignano P, de Donato G, et al. AAA with a challenging neck: early outcomes using the Endurant stent-graft system. Eur J Vasc Endovasc Surg 2012;44:274–9. 31. Makaroun MS, Dillavou ED, Wheatley GH, Cambria RP. Five-year results of endovascular treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms. J Vasc Surg 2008;47:912–8. 32. Go MR, Cho JS, Makaroun MS. Mid-term results of a multicenter study of thoracic endovascular aneurysm repair versus open repair. Perspect Vasc Surg Endovasc Ther 2007;19:124–30. 33. Cambria RP, Crawford RS, Cho JS, et al. A multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta. J Vasc Surg 2009;50:1255–64. 34. Eggebrecht H, Bose D, Gasser T, et al. Complete reversal of paraplegia after thoracic endovascular aortic repair in a patient with complicated acute aortic dissection using immediate cerebrospinal fluid drainage. Clin Res Cardiol 2009;98:797–801.
REVIEW C. Setacci et al. / International Journal of Surgery 11S1 (2013) S11–S15 35. Jonker FH, Schlosser FJ, Moll FL, et al. Outcomes of thoracic endovascular aortic repair for aortobronchial and aortoesophageal fistulas. J Endovasc Ther 2009;16: 428–40. 36. Jonker FH, Heijmen R, Trimarchi S, Verhagen HJ, Moll FL, Muhs BE. Acute management of aortobronchial and aortoesophageal fistulas using thoracic endovascular aortic repair. J Vasc Surg 2009;50:999–1004. 37. Sayed S, Thompson MM. Endovascular repair of the descending thoracic aorta: evidence for the change in clinical practice. Vascular 2005;13:148–57. 38. Umana JP, Miller DC, Mitchell RS. What is the best treatment for patients with acute type B aortic dissections—medical, surgical, or endovascular stent-grafting? Ann Thorac Surg 2002;74:S1840–3. 39. White RA, Miller DC, Criado FJ, et al.; Multidisciplinary Society for Vascular Surgery Outcomes Committee. Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee. J Vasc Surg 2011;53(4):1082–90. 40. Bozinovski J, Coselli JS. Outcomes and survival in surgical treatment of descending thoracic aorta with acute dissection. Ann Thorac Surg 2008;85:965–70. 41. London NJ, Srinivasan R, Naylor AR, et al. Subintimal angioplasty of femoropopliteal artery occlusions: the long-term results. Eur J Vasc Endovasc Surg 1994;8:148–55. 42. Nydahl S, Hartshorne T, Bell PR, et al. Subintimal angioplasty of infrapopliteal occlusions in critically ischaemic limbs. Eur J Vasc Endovasc Surg 1997;14:212–6. 43. Bolia A. Percutaneous intentional extraluminal (subintimal) recanalization of crural arteries. Eur J Radiol 1998;28:199–204. 44. Bolia A, Brennan J, Bell PR. Recanalisation of femoro-popliteal occlusions: improving success rate by subintimal recanalisation. Clin Radiol 1989;40:325. 45. Laxdal E, Jenssen GL, Pedersen G, et al. Subintimal angioplasty as a treatment of femoropopliteal artery occlusions. Eur J Vasc Endovasc Surg 2003;25:578–82. 46. Setacci C, Chisci E, de Donato G, et al. Subintimal angioplasty with the aid of a reentry device for TASC C and D lesions of the SFA. Eur J Vasc Endovasc Surg 2009;38:76–87.
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47. Hausegger KA, Georgieva B, Portugaller H, et al. The Outback catheter: a new device for true lumen re-entry after dissection during recanalization of arterial occlusions. Cardiovasc Intervent Radiol 2004;27:26–30. 48. Bolia A, Miles KA, Brennan J, et al. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 1990;13:357–63. 49. Sandford RM, Bown MJ, Sayers RD, et al. Is infrainguinal bypass grafting successful following failed angioplasty? Eur J Vasc Endovasc Surg 2007;34:29–34. 50. Setacci C. Time is tissue. J Endovasc Ther 2012;19(4):515–6. 51. World Health Organization. Diabetes . Fact sheet number 312, August 2011. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/ (last accessed April 21, 2012). 52. International Diabetes Federation. IDF Diabetes Atlas , 5th ed. Brussels, Belgium: International Diabetes Federation, 2011. Available at: http://www.idf.org/ diabetesatlas (last accessed April 21, 2012). 53. Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia 2008;51:747–55. 54. Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, et al. The global burden of diabetic foot disease. Lancet 2005;366:1719–24. 55. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005;293:217–28. 56. Caravaggi C. Integrated surgical protocol for the treatment of the infected diabetic foot. J Cardiovasc Surg (Torino) 2012;53:23–30. 57. International Working Group on the Diabetic Foot. The development of global consensus guidelines on the management and prevention of the diabetic foot 2011 . Available at:http://iwgdf.org/index.php?option5com_content&task5view&id516& Itemid526 (last accessed April 21, 2012). 58. Lepäntalo M, Apelqvist J, Setacci C, et al. Diabetic foot. Eur J Vasc Endovasc Surg 2011;42(Suppl 2):S60–74.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
REVIEW
Impact of new technologies on vascular surgery Carlo Setacci, Pasqualino Sirignano, Francesco Setacci Vascular and Endovascular Surgery Unit, Department of Surgery, University of Siena, Italy
ARTICLE INFO Keywords: New technologies Vascular surgery
1. Introduction At the beginning of the 19th century, Carrel and Leriche developed the techniques of vascular anastomoses, laying the foundations for the very existence of our discipline. 1 In 1948, in Lisbon, Monitz performed the first femoral endarterectomy (under local anesthesia); 2 in the same period, in Paris, Kunlin performed the first reversed saphenous vein femoro-popliteal bypass. 3 Two years later, thanks to the French experience, the boundaries moved even further, when Oudot 4 performed the first bypass for occlusive aortic disease and when, in 1954, we saw the first intervention for abdominal aortic aneurysm by Dubost; 5 the patient died after 8 years because of myocardial infarction. A milestone was the first carotid endarterectomy by Eastcott (London, 1954); 6 although not the first endarterectomy performed, it was the first to appear in the literature. All these surgeons have created our discipline. They have invented the tools to work with and, especially, were the first to understand the natural course of vascular disease. We maintained that brand of leadership until the early 1990s. Our ability and devotion to work hard were the reasons for our success. Looking back over our shoulders, we must admit, however, that our discipline has not changed that much; surely the surgical tools and the medical outcomes of our patients have improved, but not so the techniques at our disposal. At the beginning of the 1990s, a revolution occurred: endovascular techniques rapidly began to spread. The endovascular revolution has radically changed our discipline; in this paper we will try to summarize what has changed in clinical practice. 2. Carotid artery Carotid artery stenting (CAS) has emerged as a useful, potentially less invasive alternative to carotid endarterectomy (CEA) but controversy presently surrounds this procedure. 7,8 During the last decade
there have been important innovations in the device, technical refinements and a better knowledge of patient selection. With the introduction of CAS, vascular surgeons have been challenged to change their point of view in managing severe carotid artery stenosis. Several trials have suggested equivalent results for CAS and CEA. 9–12 Long-awaited results from the CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) study have recently been presented 13 and shed a new light on CEA versus CAS as a critical issue (Fig. 1). CREST compared CAS to CEA for the treatment of carotid
Fig. 1. Intraoperative images of (A) CEA and (B) CAS.
artery stenosis to prevent stroke in symptomatic and asymptomatic patients. More than 2500 patients were enrolled from more than 100 centers in North America and Canada over a 9-year period. The occurrence of the composite primary end-point of any stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke on follow-up, was not significantly different between the CEA and CAS groups: stenting 7.2%, surgery 6.8%. The overall safety and efficacy of the two procedures was largely the same
1743-9191$ – see front matter © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
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with equal benefits for both men and women, and for patients with and without previous neurological symptoms. However, there were more heart attacks (2.3%) in the surgical group compared to 1.1% in the stenting group, and more strokes in the stenting group (4.1%) versus 2.3% for the surgical group in the weeks following the procedure. In particular, few strokes were disabling; the rate of non-disabling stroke was 2.7% for CAS vs. 1.4% for CEA, and the rate of disabling stroke was 1.4% for CAS vs. 0.8% for CEA, without achieving statistical significance. These results did not aim to establish whether stenting or endarterectomy will win the race, but more likely how these two procedures could be selectively and properly applied to individual patients. Depending on patient’s characteristics, one procedure might have an advantage over the other. Recent results allowed experienced operators in both techniques to adapt a treatment strategy tailored to each patient. In this regard, only specialists who can offer both options of treatment will offer the greatest benefit for the patient. 3. Aorta Open surgical repair of lesions of the descending thoracic aorta has been the “state-of-the-art” treatment for many decades. However, in specialized vascular centers, thoracic endovascular aortic repair and hybrid aortic procedures have been implemented as novel treatment options. The current clinical results show that these procedures can be performed with low morbidity and mortality rates. However, due to a lack of randomized trials, the level of reliability of these new treatment modalities remains a matter of discussion. Clinical decision-making is generally based on the experience of the vascular center as well as on individual factors, such as life expectancy, comorbidity, aneurysm aetiology, aortic diameter and morphology. Endovascular aneurysm repair (EVAR) is a minimally invasive surgery for the treatment of aortic aneurisms based on the use of a stent graft, usually deployed inside the aneurysm through femoral access to exclude the sac from the circulation. EVAR requires adequate fixation sites for effective sealing and fixation. These requirements should be carefully assessed and verified prior to surgery with adequate imaging to select suitable patients for endografting (Fig. 2).
Fig. 2. Endovascular treatment of an abdominal aortic aneurism.
Potential advantages of EVAR over open repair (OR) include reduced operative time, avoidance of general anesthesia, less trauma and postoperative pain, reduced hospital length of stay and less need for intensive care unit (ICU), reduced blood loss and reduced immediate postoperative mortality. Potential disadvantages include the risk of incomplete aneurysm sealing, with the development of continuous
refilling of the aneurysm sac, either because the graft does not seal completely at the extremities (Type I endoleak), between segments (Type III endoleak), or because of backfilling of the aneurysm from other small vessels in the aneurysm wall (Type II endoleak). Thoracic endovascular aortic repair (TEVAR) has been proposed to be a less invasive treatment for treatment of thoracic aortic aneurysms. Early clinical results with thoracic aortic stent grafts have shown significantly improved early quality of life versus open surgery and have generally shown a trend toward better perioperative survival and freedom from major complications. 14–17 The original Food and Drug Administration Investigational Device Exemption (FDA IDE) studies that led to approval of the currently available devices, including the Gore TAG (W.L. Gore & Associates, Inc, Flagstaff, AZ), Medtronic Talent (Medtronic, Inc, Minneapolis, MI), and Cook Zenith TX2 stent grafts (Cook Endovascular, Bloomington, IN), specifically looked at patients with favorable anatomy in descending thoracic aortic aneurysms. The early results in these trials were highly favorable toward stent grafts. Open repair of the thoracic aorta is traditionally associated with significant permanent neurologic morbidity and mortality. In recent series from high-volume centers of excellence, mortality and neurologic morbidity rates range from 5.4% to 7.2% for mortality, 2.1% to 6.2% for permanent stroke, 5.7% for permanent paraparesis, and 0.8% to 2.3% for permanent paralysis, respectively. 18,19 In the multicenter open control groups for the Gore TAG, Medtronic Talent, and Cook Zenith TX2 stent grafts, mortality and neurologic morbidity rates range from 5.7% to 11.7% for mortality, 4.3% to 8.6% for permanent stroke, 5.7% for permanent paraparesis, and 3.4% to 8.5% for permanent paralysis, respectively. Similarly, the perioperative results for the 3 stent graft trials in the TEVAR arms showed 1.9% to 2.1% for mortality, 2.4% to 4% for stroke, 4.4% to 7.2% for permanent paraparesis, and 1.3% to 3% for permanent paralysis, respectively. 20–22 Randomized controlled trials, large registries and single-center series comparing EVAR with OR have shown that the minimally invasive approach has lower early morbidity and mortality with low incidence of primary conversion to OR after EVAR, between 0.9% and 5.9%. 23–28 The DREAM trial reported an operative mortality rate of 4.6% in the open repair group and 1.2% in the endovascular repair group, with a higher rate of moderate and severe systemic complications in the open surgical arm. However, cardiac complication rate in this trial was similar in the two groups (5.7% for OR vs 5.3% for EVAR), underlining that even EVAR should be considered a procedure with intermediate to high risk of cardiac complications. 29 The increased use of EVAR has been affected by limitations of the related technology, although the percentage of abdominal aortic aneurysms (AAA) deemed suitable for EVAR has been growing over the past decade, due to improvements in graft design. However, longterm durability is still being questioned especially in case of adverse anatomy, rendering the pre-operative anatomical evaluation crucial for late success of EVAR. Recent experience demonstrates that treatment with new-generation devices is technically feasible and safe, yielding satisfactory results even in challenging aortic anatomies. The duration of procedures, intraoperative contrast use and radiation exposure time are similar compared with treatment of standard anatomies, indirectly demonstrating an absence of additional intraoperative difficulties. The particular characteristics of this device seem to make it appropriate for the treatment of highly angulated and short necks, especially in patients at high surgical risk. The clinical significance is to demonstrate the effectiveness of the new devices even in the case of difficult anatomies, as well as its postoperative safeness in the
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case of off-label indications in patients otherwise considered unfit for surgery. 30 Experience with endovascular exclusion of aneurysms in the chest and abdomen has facilitated the extension of this technology into the treatment of aortic dissection. Endovascular repair of the ascending aorta is not indicated due to limitations of current technology in dealing with the dynamic nature of the ascending aorta and aortic arch. Furthermore, the proximity to and potential for involvement of the coronary arteries and aortic valve in acute type A dissection cannot be dealt with by current technology. Endovascular exclusion of the descending thoracic aorta in type A dissection is gaining traction. Endovascular repair of the descending thoracic aorta has also emerged as an advantageous alternative to traditional surgical techniques in the management of appropriate cases of acute complicated type B aortic dissection. The ultimate goal of open surgical and endovascular treatment of acute aortic dissections is restoration of flow through the true lumen, exclusion of the primary entry tears with the potential for facilitating aortic remodeling, and prevention of potential aneurysmal degeneration. TEVAR has become a preferred therapeutic option for a wide spectrum of aortic pathologies in both the elective and emergent settings. 31–36 Conventional open surgical repair of type B dissection is becoming less common due to the high perioperative morbidity and mortality. The availability of a highly experienced multidisciplinary team is essential because these patients are frequently in critical condition. 37,38 Recently, the Society for Vascular Surgery Outcomes Committee in conjunction with ad hoc members from the American Association for Thoracic Surgery, Society of Thoracic Surgeons, and Society for Interventional Radiology reported 1-year outcomes in patients with chronic Type B aortic dissections treated with TEVAR who presented with rupture or malperfusion with acute (< 14 days), subacute (15–30 days), or chronic (31–90 days) symptom onset until required intervention. These 85 patients were consolidated from 5 centers of excellence with single-center FDA IDE to establish a 30-day mortality with 1-year follow-up. The actuarial mortality estimates observed were 10.8% at 30 days and 29.4% at 1 year. 39 This represents a significantly lower percentage when compared with the older reports of open thoracic aortic surgical repair with 24–35% mortality at 30 days. 40 4. Lower limb The most important revolution in treatment of critical limb ischemia (CLI) is represented by the “new horizons” in the treatment of chronic total occlusion (CTO) in the infrainguinal arteries. Subintimal angioplasty (SIA) is a minimally invasive percutaneous technique for the recanalization of occluded iliac and infrainguinal arteries. 41–43 First described by Bolia et al. 44 in 1989, this technique has been used increasingly as an alternative to lower limb bypass procedures in CLI. 45 It is usually performed under local anesthesia and is based on the creation of a subintimal channel by endoluminal dissection and angioplasty. This minimally invasive technique is well tolerated by most patients and requires only a modest amount of equipment. 46 Success with SIA has been enhanced by the introduction of re-entry devices to facilitate recanalization. 47 The advantages of a percutaneous interventional procedure over bypass surgery are briefer anesthesia, no incision in an ischemic leg, and fewer healing complications, as well as less systemic stress (local anesthesia), faster recovery, and earlier ambulation. Moreover, failed SIA does not preclude the possibility of surgical revascularization. 48 Further, redo percutaneous procedures might be more readily done than repeat surgery, with the possibility of offering future surgical intervention if needed. The procedure, however, needs to be performed by a
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skilled team of trained operators. Generally, antegrade ipsilateral percutaneous femoral access is preferred when at least 5 cm of a patent proximal segment of the superficial femoral artery (SFA) is evident at ultrasonography. A contralateral approach via a crossover long sheath is used only in the presence of SFA occlusion in its origin, high femoral bifurcation (documented by ultrasound), or obesity. A soft, angled hydrophilic 0.035-inch guidewire in combination with a 5-F angled hydrophilic catheter is brought near the origin of the occlusion. An attempt to advance the guidewire through the true lumen is done in all cases. When needed, the subintimal plane is entered by forming a loop at the end of the guidewire and advancing it, along with the catheter, across the occluded arterial segment. Indicators of subintimal dissection include characteristic resistance to wire advancement, a broad helical path taken by the wire during advancement, the guidewire loop adapting to the width of the native vessel, and a subtle release of wire resistance with true lumen reentry near the distal portion of the arterial occlusion. Following confirmation of catheter re-entry into the true lumen, balloon angioplasty is used to dilate the subintimal channel. A re-entry device is used only when recanalization by simple SIA is unsuccessful. Stenting is performed only if there is residual stenosis > 30% or a flowlimiting dissection. Most physicians use a standardized approach: a brief SIA procedure of 30–40 minutes and application of a re-entry device only when accessing the true lumen is difficult, so as not to dissect the popliteal artery or threaten the supragenicular collaterals. If the procedure cannot be concluded safely, suggestion is to continue the intervention surgically or use a hybrid approach. The presence of a vascular surgeon in the team is important inasmuch as the first intervention should not preclude the possibility of further surgical revascularization. 49 In the last year, in the world of Vascular surgery, the “diabetic foot revolution” has begun. 50 Diabetes is a chronic disease that involves 350 million people worldwide, a number that will increase to 440 million by 2030. 51,52 Every year, 1 million people undergo a lower limb amputation as a consequence of diabetes. It is hard to believe that, although 85% of all amputations are preceded by foot ulcers, the prevalence of amputations ranges from 0.2% to 4.8%, with an annual incidence of 46.1 to 936 per 100,000. According to Prompers et al., 53 the presence of arterial obstructive disease greatly increases the risk of amputation, but diabetic sensory motor neuropathy increases only the risk of ulcers; foot infection, which frequently complicates the clinical course of ulcerative lesions of the foot, raises the risk of amputation only if associated with CLI. It is well known that all the complications associated with the diabetic foot are complex and costly, 54,55 so we must know what to do in this particular subgroup of patients. Caravaggi 56 recently reported a well-designed triage protocol for patients with diabetic foot. According to this protocol, the presence of an infectious process indicates a need for urgent treatment. Unfortunately, the literature contains scant data on which is the best treatment option with respect to the degree of ischemia and the infection. However, we suggest that early and aggressive debridement of the infection must always precede the revascularization procedure. This approach is also recommended by most recent guidelines, particularly the International Guidelines on Diabetic Foot Treatment 57 and the European Society of Vascular Surgery guidelines on CLI and diabetic foot. 58 Nonetheless, only a few centers apply this complex and integrated approach, which implies that the dramatic delay in the diagnosis and treatment of diabetic foot will increase not only the risk of major amputation but also of death. We strongly suggest a 4-step approach to patients with diabetic foot:
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Fig. 3. Pre- and post-operative angiogram of a lower limb revascularization.
1. Early diagnosis with a 24-hour on-call diabetic foot team; all the members of the team should be able to perform a duplex scan and to identify an infectious disease, if present. 2. Urgent treatment of severe foot infection with aggressive surgical debridement performed by highly skilled operators in the operating theater. 3. Revascularization (Fig. 3) with a straight flow to the foot. In all cases, the first-line approach should be endovascular (angioplasty ± stenting). 4. Definitive treatment: wound healing, reconstructive surgery, and orthesis. This protocol requires highly skilled professionals working together around the clock toward the goal of avoiding major amputations in patients with diabetic foot. It is a challenging and complex task, but only an integrated, interdisciplinary diabetic foot team can significantly impact the outcome of our patients. 5. Conclusions We must be ‘master surgeons’, capable of working with the same skills in both traditional and endovascular surgical procedures; but we must also be ‘master physicians’, who are entirely managing their patients. We believe this definition is crucial: only those surgeons with these requirements can be defined as vascular surgeons. Funding None. Disclosure statement The authors have no conflicts of interest to declare. References 1. Carrel A. Les anastomoses vasculaires et leurs technique opératoire. Union Med Can 1904:33–97. 2. dos Santos DJ. Sur la désobstruction des thromboses artérielles anciennes. Mem Acad Chir 1947;73:409. 3. Kunlin I. Le traitement de l’artérite obliterante par la greffe veineuse longue. Arc Mal Coeur 1949;42:371. 4. Oudot I. Un deuxième cas de greffe de la bifurcation aortique pour thrombose de la fourche aortique. Mem Acad Chir 1951;77:644. 5. Dubost C, Allary N, Oeconomos N. Resection of aneurysm of abdominal aorta; reestablishment of continuity by a preserved human arterial graft, with result after 5 months. Arch Surg 1952;64:405. 6. Eastcott HH, Pickering GW, Rob CG. Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia. Lancet 1954;267(6846):994–6.
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