Vascular Management During Live Donor Nephrectomy: An Online Survey Among Transplant Surgeons

Transcription

1 American Journal of Transplantation 2015; 15: Wiley Periodicals Inc. Brief Communication C Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons doi: /ajt Vascular Management During Live Donor Nephrectomy: An Online Survey Among Transplant Surgeons S. Janki 1, D. Verver 1, K. W. J. Klop 1, A. L. Friedman 2, T. G. Peters 3, L. E. Ratner 4, J. N. M. Ijzermans 1 and F. J. M. F. Dor 1, * 1 Division of HPB & Transplant Surgery, Department of Surgery, Erasmus MC, University Medical Center, Rotterdam, The Netherlands 2 New York Organ Donor Network, New York, NY 3 Department of Surgery, University of Florida Health Sciences Center, Jacksonville, FL 4 Department of Surgery, Columbia University, New York, NY Corresponding author: Frank J. M. F. Dor, f.dor@erasmusmc.nl In 2006, a survey from the American Society of Transplant Surgeons disclosed significant and sometimes fatal hemorrhagic events in live donor nephrectomies (LDN) related to failure of clips, leading to the contraindication of the Weck W Hem-o-lok W clip for control of the renal artery during LDN. A survey regarding vascular control techniques, their perceived safety ratings and their failures was sent to 645 European Society for Organ Transplantation members who profiled their profession as surgeon and selected kidney as organ type. Two hundred forty-three (41%) members responded, of whom 171 (63.3%) independently perform LDN. Their responses were analyzed. For arterial and venous vascular control, the GIA TM and TA TM stapler are used most frequently, and were rated the safest. Of the 121 reported hemorrhagic events, slippage and dislodgement of clips occurred at least 58 times, while stapler malfunction occurred at least 40 times. One donor death from hemorrhage related to clip dysfunction was reported. Hemorrhagic complications of LDN with fatal and non-fatal outcomes still occur. Strikingly, many surgeons do not use the vascular closing technique that they consider most safe. Failure of non-transfixion techniques is associated with greater risks for the donor. Control of major vessels in LDN must employ transfixion techniques for optimal donor safety. Abbreviations: ASTS, American Society of Transplant Surgeons; ESOT, European Society for Organ Transplantation; LDN, live donor nephrectomy Received 22 August 2014, revised and accepted for publication 30 November 2014 Introduction Kidney transplantation is the treatment of choice for many patients suffering from end-stage renal disease (1). As the incidence and prevalence of end-stage renal disease is increasing worldwide (2), the demand for kidney donors is rising. Fortunately, live donor kidney transplantation can contribute to solving the donor shortage, and there continues to be many advantages associated with receiving a live donor kidney (1,3,4). Furthermore, as more LDN procedures are undertaken, there is a general sense that the operation is quite safe (5,6). Recent data determined the mortality risk for live kidney donors at 90 days postoperatively to be 0.03%. One of the most challenging technical tasks during LDN is securing the renal artery and vein (7). The varied vascular control techniques can be categorized into non-transfixion and transfixion techniques. In non-transfixion techniques, simple ties or clips are placed around, but not through the vessel. In transfixion techniques, the suture material penetrates the vessel wall, thus transfixing the staple or suture material to the artery or vein. When transecting a major vessel, there is always a chance of hemorrhage, usually related to technical failure (6,8). American survey Friedman et al became aware of several LDN perioperative deaths, as well as cases of catastrophic hemorrhage resulting from failed vascular control techniques involving the donor renal artery and vein. In 2006, they published results of a survey among members of the American Society of Transplant Surgeons (ASTS). The survey assessed the knowledge and experience of transplant surgeons regarding failures of specific vascular control techniques during LDN. Arterial hemorrhage was deemed more severe than venous bleeding, and transfixion control techniques were far more safe and reliable than clips or simple suture control. Respondents considered transfixion safest whether it was universally applied in their cases or not. Two donor deaths were reported. These were caused by arterial hemorrhage related to failure of multiple non-locking clips. The study concluded that vascular control techniques are a determinative factor as to risks of intra- and postoperative hemorrhagic complications (6). 1701

2 Janki et al Failure of the Weck 1 Hem-o-lock 1 clip causing subsequent donor death has prompted the FDA Black Box Warning that use of this locking hemostatic clip to control the renal artery in LDN is contraindicated (9). However, use of these clips during LDN is still being reported (10). To our knowledge, there are no published reports on failures of renal vascular control techniques, or reports on subsequent hemorrhagic complications and related donor deaths from European centers. However, we are aware that they have likely occurred. The goal of this study is to document any hemorrhagic complications due to failure of vascular control techniques during LDN among members of the European Society for Organ Transplantation (ESOT), and to determine which control techniques may be recommended as the safest and most effective for LDN patients. Methods Study population The ESOT is a professional organization encompassing all European transplant centers, and is comparable to the ASTS. The study population comprised all persons in the ESOT member database who profiled their profession as surgeon and selected kidney as organ type. Online survey The American survey (6) was amended by including questions on respondent s age, gender, country of current employment, experience with independently performing LDNs, number of LDNs performed per respondent per year, and annual number of LDNs in the respondent s center. All questions were pre-categorized. The question on preferred operative techniques was extended by including other techniques. The safety of 11 vascular control techniques was rated on a 5-point Likert scale. Safety ratings of 3 and higher were considered safe, while those of 1 and 2 were deemed unsafe. Data collection The survey was conducted using SurveyMonkey (Palo Alto, CA). An invitation to fill out the survey was sent on April 1, We communicated with respondents who gave their contact details in the survey instrument, in order to complete or complement any missing or incomplete answers. Otherwise, the survey was entirely anonymous. Statistical analysis We used descriptive analyses to define characteristics of the respondents, the frequency of preferred operation and vascular control techniques, and the safety ratings of the various vascular control techniques. Hemorrhagic incidents were assessed for the frequency of arterial and venous events, the use of transfixion or non-transfixion vascular control techniques and donor outcomes (massive blood loss, blood transfusion, conversion to open procedure, re-intervention, re-laparotomy and death). The association of preferred operative techniques with respondent characteristics was evaluated using Pearson Chi-Square and Fisher s Exact Test. A similar approach was used to assess the association of type of vascular control technique (transfixion or non-transfixion) with post- or intraoperative failure and donor outcomes. The association between safety ratings and preferred operation technique was assessed by nonparametric one-way ANOVA (Kruskal Wallis test). All analyses were conducted using SPSS (version 22, SPSS Inc., Chicago, IL). A p value <0.05 (two-sided) was considered statistically significant. No adjustment for multiple tests was performed. Results Respondent characteristics The survey was sent to 645 ESOT members and was completed online by 269 (41.7%). Of that number, 171 (63.5%) respondents who independently perform LDNs comprise the study group. Of these 171 surgeons, 32.5% have an LDN experience of more than 10 years. Most respondents were male (83.0%), and nearly half were aged years (47.7%). The respondents reported working in 37 different countries of which 20 (54%) are within Europe. In the latter group, 81 (47.4%) respondents currently work in Northwestern Europe, 13 (7.6%) respondents currently work in Eastern Europe and 28 (16.4%) respondents currently work in the Mediterranean. Most of the 36 (21.1%) respondents who currently work in countries outside of Europe, covered countries in North America (5.8%) and the Middle East (5.8%). Of 13 respondents, the country of employment is unknown. Preferred operative techniques for LDN Table 1 depicts the reported operative techniques with the arterial and venous vascular control methods employed in those procedures. Most respondents (65.5%) reported a preference for an endoscopic LDN technique, with or without hand-assistance. With increasing numbers of LDN per year per center, the preference for the endoscopic operative techniques increased from 46.7 to 100%. Vascular control techniques during LDN The last column in Table 1 shows the total reported vascular control techniques used during LDN. Respondents were free to select more than one technique, since many surgeons have a whole armamentarium of different techniques that they use in practice. Transfixion techniques were used most frequently, both for closing the arterial and venous stump. Of all responses, 159 transfixion techniques were reported for the renal artery (71.9%) and 172 transfixion techniques for the renal vein (81.9%). The three most frequently applied vascular control techniques for the renal artery all involve transfixion the GIA TM stapler (26.2%), TA TM stapler (20.4%) and suture ligature plus simple tie (13.6%). Similar numbers are reported for control of the renal vein: GIA TM stapler (31.9%), TA TM stapler (21.4%) and oversewing (14.3%). The most infrequently used control techniques for the renal artery and vein were non-transfixion techniques: single simple tie (1.4%) and a single hemostatic clip (0.5%). Respondents who prefer the endoscopic approach mostly reported using both GIA TM and TA TM staplers for closing of the renal arterial and venous stumps. While respondents with a preference for the open procedure mainly use the suture ligature plus simple tie for closing of the renal arterial stump and oversewing for closing of the renal venous 1702 American Journal of Transplantation 2015; 15:

3 Vascular Control in Donor Nephrectomy Table 1: Techniques used to close the renal arterial and venous stump in relation to the operation techniques used during live donor nephrectomy Artery A (n ¼ 43), n 1 (%) (n ¼ 61), n 1 (%) (n ¼ 47), n 1 (%) Total (n ¼ 151), n 1 (%) Total used techniques 62 (100) 93 (100) 66 (100) 221 (100) Transfixion 40 (64.5) 71 (76.3) 48 (72.7) 159 (71.9) Suture ligature 4 (6.4) 4 (4.3) 1 (1.5) 9 (4.1) Suture ligature þ simple tie 21 (33.9) 6 (6.5) 3 (4.5) 30 (13.6) Oversew 10 (16.1) 3 (3.2) 4 (6.1) 17 (7.7) GIA TM surgical stapler 3 (4.8) 29 (31.2) 26 (39.4) 58 (26.2) TA TM surgical stapler 2 (3.2) 29 (31.2) 14 (21.2) 45 (20.4) Non-Transfixion 22 (35.5) 22 (23.7) 18 (27.3) 62 (28.1) Single simple tie 3 (4.8) 0 (0) 0 (0) 3 (1.4) Multiple simple ties 10 (16.1) 3 (3.2) 2 (3.0) 15 (6.8) Single hemostatic clip 3 (4.8) 2 (2.2) 0 (0) 5 (2.3) Multiple hemostatic clips 1 (1.6) 5 (5.4) 5 (7.6) 11 (5.0) Single locking hemostatic clip 2 (3.2) 2 (2.2) 3 (4.5) 7 (3.2) Multiple locking hemostatic clips 3 (4.8) 10 (10.8) 8 (12.1) 21 (9.5) Vein B (n ¼ 45), n 1 (%) (n ¼ 62), n 1 (%) (n ¼ 49), n 1 (%) Total (n ¼ 156), n 1 (%) Total used techniques 69 (100) 81 (100) 60 (100) 210 (100) Transfixion 55 (79.7) 70 (86.4) 47 (78.3) 172 (81.9) Suture ligature 11 (15.9) 3 (3.7) 3 (5.0) 17 (8.1) Suture ligature þ simple tie 11 (15.9) 2 (2.5) 0 (0) 13 (6.2) Oversew 24 (34.8) 5 (6.2) 1 (1.7) 30 (14.3) GIA surgical stapler 4 (5.8) 35 (43.2) 28 (46.7) 67 (31.9) TA surgical stapler 5 (7.2) 25 (30.9) 15 (25.0) 45 (21.4) Non-Transfixion 14 (20.3) 11 (13.6) 13 (21.7) 38 (18.1) Single simple tie 5 (7.2) 0 (0) 0 (0) 5 (2.4) Multiple simple ties 6 (8.7) 0 (0) 2 (3.3) 8 (3.8) Single hemostatic clip 0 (0) 1 (1.2) 0 (0) 1 (0.5) Multiple hemostatic clips 1 (1.4) 1 (1.2) 3 (5.0) 5 (2.4) Single locking hemostatic clip 2 (2.9) 3 (3.7) 1 (1.7) 6 (2.9) Multiple locking hemostatic clips 0 (0) 6 (7.4) 7 (11.7) 13 (6.2), endoscopic with hand-assistance. 1 Respondents were not limited to a single choice, some respondents use multiple techniques. stump. There were no significant differences in the use of transfixion or non-transfixion techniques for closing the renal arterial and venous stumps among the three operative procedures, p ¼ and p ¼ 0.396, respectively. Years of experience in LDN showed no significant difference in the use of vascular control techniques for the artery and vein, p ¼ and p ¼ 0.269, respectively. American Journal of Transplantation 2015; 15: Safety ratings The respondents self-reported safety ratings are depicted in Table 2. All transfixion closing techniques were rated very safe (median ¼ 4) for both the renal artery and vein stump, except for suture ligature, which was rated safe (median ¼ 3). For renal arterial stump closure, only one nontransfixion closing technique has been rated safe by 60.4% of the respondents: multiple locking hemostatic clips. For renal venous stump closure, two non-transfixion techniques have been rated safe by 51.3% and 55.3% of the respondents: multiple simple ties and multiple locking hemostatic clips, respectively. Closing techniques that were rated unsafe (median ¼ 1) most frequently, were a single simple tie and a single hemostatic clip, by 8.7% and 10.7% of the respondents for the arterial stump, and by 15.8% and 8.6% for the venous stump, respectively. The GIA TM and TA TM stapler are considered to be the safest for controlling both the artery and vein by more than 90% of the respondents. The safety ratings are consistent with the most and least frequently used vascular control techniques. Safety ratings of used closing techniques were analyzed in relation to the preferred operative techniques. Firstly, respondents who prefer the endoscopic technique with hand-assistance rated multiple locking hemostatic clips in their top three of most frequently used techniques for renal venous stump closure. However, they have not rated this 1703

4 Janki et al Table 2: Safety ratings of different vascular closing techniques used during LDN in relation to the preferred operation techniques Artery Safety ratings 1 Median (range) A (n ¼ 42) (n¼60) (n ¼ 47) Total (n ¼ 149) Technique Transfixion Suture ligature 3 (1 4) 3 (1 5) 3 (1 5) 3 (1 5) Suture ligature þ simple tie 4 (2 5) 4 (1 5) 3 (1 5) 4 (1 5) Oversew 4 (2 5) 4 (1 5) 3 (1 5) 4 (1 5) GIA TM surgical stapler 3 (1 5) 4 (1 5) 4 (2 5) 4 (1 5) TA TM surgical stapler 3 (1 5) 4 (2 5) 4 (2 5) 4 (1 5) Non-Transfixion Single simple tie 1 (1 4) 1 (1 4) 1 (1 3) 1 (1 4) Multiple simple ties 3 (1 5) 3 (1 5) 2 (1 5) 2 (1 5) Single hemostatic clip 2 (1 3) 1 (1 3) 1 (1 3) 1 (1 3) Multiple hemostatic clips 2 (1 4) 2 (1 5) 2 (1 4) 2 (1 5) Single locking hemostatic clip 3 (1 4) 2 (1 4) 2 (1 4) 2 (1 4) Multiple locking hemostatic clips 3 (1 5) 3 (1 5) 3 (1 5) 3 (1 5) Vein Safety ratings 1 Median (range) B (n ¼ 43) (n ¼ 62) (n ¼ 47) Total (n ¼ 152) Technique Transfixion Suture ligature 3 (1 5) 3 (1 5) 3 (2 5) 3 (1 5) Suture ligature þ simple tie 4 (1 5) 4 (1 5) 4 (2 5) 4 (1 5) Oversew 4 (2 5) 4 (2 5) 4 (2 5) 4 (2 5) GIA TM surgical stapler 3 (1 5) 4 (2 5) 4 (2 5) 4 (1 5) TA TM surgical stapler 3 (1 5) 4 (2 5) 4 (2 5) 4 (1 5) Non-Transfixion Single simple tie 1 (1 5) 2 (1 4) 1 (1 4) 1 (1 5) Multiple simple ties 3 (1 5) 3 (1 5) 3 (1 5) 3 (1 5) Single hemostatic clip 2 (1 3) 1 (1 3) 1 (1 3) 1 (1 3) Multiple hemostatic clips 2 (1 5) 2 (1 4) 2 (1 4) 2 (1 5) Single locking hemostatic clip 2 (1 4) 2 (1 4) 2 (1 4) 2 (1 4) Multiple locking hemostatic clips 3 (1 5) 3 (1 5) 2 (1 5) 3 (1 5), endoscopic with hand-assistance. 1 Respondents were asked to rate the safety from 1 unsafe to 5 extremely safe. technique safe (median ¼ 2). Secondly, respondents who prefer the open technique have rated the single simple tie to be the least safe (median ¼ 1). However, this technique is used by three respondents (4.8%) for closing the renal arterial stump and by five respondents (7.2%) for the renal venous stump. Overall, respondents who prefer the open or endoscopic technique have rated all vascular closing techniques unanimously safe (median 3 5) or unsafe (median 1 2) for closing of both the vein and artery. Surgeons from centers performing 0 25 LDNs per year (9.5%) have rated the single simple tie and single hemostatic clip to be the least safe (median ¼ 2); however, non-transfixion is still used by two respondents (1.2%) to control the renal arterial stump. Respondents working in higher volume centers (more than 50 LDNs per year) all rated both staplers safe (median 3) for renal vascular control. Years of experience in LDN showed no significant difference in safety ratings of all vascular control techniques for the renal artery and vein. Hemorrhagic events There were 121 hemorrhagic events occurring with LDN (Table 3), 21 of which were respondents own cases, and 100 were colleagues cases. Seventy-three (60.3%) control failures were of non-transfixion techniques, while 42 cases failed after vascular transfixion (34.7%). In six cases (5%), the vascular control techniques remain unknown. Sixty-six arterial hemorrhagic events (54.5%) and 55 venous events (45.5%) were reported American Journal of Transplantation 2015; 15:

5 Vascular Control in Donor Nephrectomy Table 3: Techniques used to close the renal arterial and venous stump during LDN in 121 cases of hemorrhagic complications Artery Vein Total Technique n(%) n(%) n(%) Transfixion Vascular clamp 0 (0.0) 2 (1.7) 2 (1.7) GIA TM stapler 4 (3.3) 8 (6.6) 12 (9.9) TA TM stapler 6 (5.0) 10 (8.3) 16 (13.2) Stapler not otherwise defined 7 (5.8) 5 (4.1) 12 (9.9) Subtotal 17 (14.0) 25 (20.7) 42 (34.7) Non-transfixion Single simple tie 7 (5.8) 3 (2.5) 10 (8.3) Multiple simple tie 1 (0.8) 3 (2.5) 4 (3.3) Single haemostatic clip 7 (5.8) 3 (2.5) 10 (8.3) Multiple haemostatic clips 3 (2.5) 0 (0.0) 3 (2.5) Single locking haemostatic clip 14 (11.6) 8 (6.6) 22 (18.2) Multiple locking haemostatic clips 2 (1.7) 0 (0.0) 2 (1.7) Clip and ligature 0 (0.0) 1 (0.8) 1 (0.8) Clip not otherwise defined 13 (10.7) 8 (6.6) 21 (17.4) Subtotal 47 (38.8) 26 (21.5) 73 (60.3) Unknown 2 (1.7) 4 (3.3) 6 (5.0) Total 66 (54.5) 55 (45.5) 121 (100) In the 73 cases of failed non-transfixion techniques, 24 (32.8%) were caused by slippage of clips or ties. One nontransfixion failure (1.4%) was caused by tearing of a simple tie. In the rest of the 48 cases (65.8%) the reason for failure is unknown. In the 42 cases of failure of transfixion techniques, 26 (61.9%) were caused by stapler malfunction (e.g. misfiring, no full row of staples, no closure, no staples) and of the rest of the 16 failures (38.1%) the reason for failure is unknown. Significantly, more arterial events were caused by failure of non-transfixion techniques compared to transfixion technique failure (p ¼ 0.012), 73.4% and 26.6%, respectively. For the venous events, this was 51.0% and 49.0%, respectively. American Journal of Transplantation 2015; 15: Perioperative and postoperative failures and donor outcome Table 4 shows the perioperative and postoperative vascular control technique failures and associated outcome for the donor in the 121 reported LDN hemorrhagic events. Most failures occurred during the operation (77.3%). One respondent reported a donor death due to slippage of a single locking hemostatic clip from the renal arterial stump. It is unknown if this happened perioperatively or postoperatively. Other respondents reported 22 (18.2%) cases with massive blood loss in the donor, of which at least 14 (11.6%) needed a blood transfusion. Twenty (16.5%) donors underwent an intraoperative conversion to the open approach, and 14 (11.6%) donors had to undergo re-operation to control bleeding. Most of the events (21, 17.4%) could be solved intraoperatively, with interventions such as reapplying staples or clips. Arterial events were significantly associated with postoperative failures (p ¼ 0.004), more reoperations (p ¼ 0.027) andmoremassivebloodloss(p¼ 0.002). Non-transfixion techniques were associated with postoperative failures (p < 0.001), less conversions (p ¼ 0.002), more massive blood loss (p¼ 0.002), arterial events (p ¼ 0.012) and more re-operations (p < 0.001). Discussion Since LDN will continue as an important treatment option for end-stage renal disease, transplant surgeons must take all possible precautions to minimize risks to living kidney donors. This study reviewed preferred operative techniques, which vascular control techniques are used most frequently, and which vascular control techniques are deemed safe. It is clear that non-transfixion vascular control techniques are more likely to be associated with hemorrhagic events, potentially major complications, and even death, regardless of the surgical approach to the donor kidney. Most respondents had a preference for an endoscopic LDN technique, with or without hand-assistance. For control of the renal artery and vein, transfixion techniques were used most often and have been rated safe to very safe, by all respondents. Of the non-transfixion control techniques, only the multiple locking hemostatic clips have been rated as safe for the renal artery by respondents. However, we caution that there have been known instances where living kidney donors died from hemorrhage following the postoperative failure of multiple locking clips on the renal arterial stump. For renal venous stump closure, two non- 1705

6 Janki et al Table 4: Perioperative and postoperative failure and patient outcome in 121 cases of hemorrhagic complications during live donor nephrectomy A Type of hemorrhage Morbidity Arterial Venous p value Intraoperative failure, n(%) 23 (19.0) 28 (23.1) Postoperative failure, n(%) 13 (10.7) 2 (1.7) Patient outcome 1 Massive blood loss, n(%) 14 (11.6) 8 (6.6) Conversion, n(%) 9 (7.4) 11 (9.1) Re-intervention 2, n(%) 10 (8.3) 11 (9.1) Blood transfusion, n(%) 8 (6.6) 6 (5.0) Re-operation, n(%) 13 (10.7) 1 (0.8) Death, n(%) 1 (0.8) 0 (0.0) B Technique used Morbidity Transfixion Non-transfixion p value Intraoperative failure, n(%) 36 (29.8) 15 (12.4) <0.001 Postoperative failure, n(%) 1 (0.8) 12 (9.9) <0.001 Patient outcome 1 Massive blood loss, n(%) 7 (5.8) 15 (12.4) Conversion, n(%) 17 (14.0) 3 (2.5) Re-intervention 2, n(%) 12 (9.9) 9 (7.4) Blood transfusion, n(%) 7 (5.8) 7 (5.8) Re-operation, n(%) 1 (0.8) 12 (9.9) <0.001 Death, n(%) 0 (0.0) 1 (0.8) A single case can have multiple patient outcomes. 2 Any kind of re-intervention such as re-stapling, re-clipping, oversew. transfixion techniques have been rated safe: multiple simple ties and multiple locking hemostatic clips, respectively. Our results show that hemorrhagic events occur despite the use of different vascular control techniques. However, most reported events by our respondents were due to failure of non-transfixion techniques. Failure of nontransfixion techniques by our respondents is associated with greater risks. Arterial events caused by failure of nontransfixion techniques occur more frequently in the postoperative period, when rapid arterial bleeding can cause death of the donor before return to the operating room is possible. Failures of transfixion techniques occur as well, though less often. But, these events are usually during the operation, and, thus, before the eyes of the operating team. In such cases, immediate control is likely, and reoperation less likely. The GIA TM and TA TM staplers are most frequently used for the control of the renal arterial and venous stumps. Respondents to our survey have rated both of these devices to be the safest. Although, transfixion techniques are used most frequently, almost 30% of respondents admitted the use of non-transfixion techniques even though these methods are considered unsafe. Of the non-transfixion techniques, only multiple locking hemostatic clips are considered safe, yet these devices are contraindicated for use on the renal artery. And, there were a total of 24 locking clip failures reported herein. This paradox of surgical logic may, if ongoing, endanger living kidney donors, and other patients who require intraoperative control of major vessels. The number of independently performed live donor nephrectomies per year, individual experience and surgeon age appeared not to Influence vascular control choices in LDN. We acknowledge the potential selective responsiveness by the ESOT members that were invited to participate in this survey. It was sent to all ESOT members who profiled themselves as surgeons with kidney as area of expertise. ESOT is an organization in which all European countries are represented. The number of live kidney donor transplantations differs between European centers. The top five high volume centers within Europe are located in Turkey and Northwestern Europe (11). Those countries are well represented in our survey results. The number of European respondents per country seems to be a reflection of the volume of live donor kidney transplantations of the European transplant centers. This is also similar for North America and the Middle East. The preferred operative technique for vascular control might be confounded by costs. Laparoscopic LDN is more expensive than the open technique, especially due to costs attributed to operating room supplies (e.g. staplers) (12). When staplers were compared to Hem-o-lok 1 clips in a center in Iran, the clips cost $20 per donor, while a stapler cost $690 per donor (10). However, from a societal perspective, the laparoscopic procedure is cost-efficient 1706 American Journal of Transplantation 2015; 15:

7 Vascular Control in Donor Nephrectomy mainly due to less productivity losses (13). Moreover, when taking into account the safety of the donor, costs should not play a role in the choice for a vascular control technique. Clips, though less expensive, are associated with greater risks of the donor (6,9,14), and their use is contraindicated. Nonetheless clips, non-locking and locking, are still widely used. Simforoosh et al reported on a single-center experience in Iran of 1834 laparoscopic nephrectomies (of which 1423 were LDNs) in which a Hem-o-lok 1 clip and one medium-large titanium clip were used on the arterial stump. They reported that no complication was clearly related to failure of vascular clips. They concluded that clips, when applied by trained surgeons and according to published safety guidelines, provide a safe and cost-saving option for vascular control in LDNs (10). However, the most recent published article in 2009 on FDA reported technical failures of vascular control techniques suggests the opposite. Clips are not safe for vascular control in LDNs. The article described 92 reported device failures of which 59 (64%) concerned the endoscopic stapler, 21 (23%) concerned the non-locking clip and 12 (13%) the single locking hemostatic clip. The clip failures were associated with greater risks for the donor, with subsequently more deaths and re-laparotomies (7). The data of Friedman et al supported this conclusion (6). They had two reported donor deaths caused by failure of single locking hemostatic clips and concluded that failure of surgical clips appears to be more frequently associated with life-threatening hemorrhage than with other vascular control techniques (6). The association of donor deaths by failing of the Hem-o-lok 1 clip has led to the FDA Black Box warning, contraindicating the use of these clips for the renal artery during live donor nephrectomy. Hemorrhagic complications with LDN have occurred among patients of ESOT members worldwide. Most of these complications follow non-transfixion control of major renal vessels. Based on our results, we conclude that nontransfixion for control of the renal artery and vein during LDN should not be used, since non-transfixion methods are associated with greater donor risk. In order to better understand these risks and outcomes, and to prevent hemorrhagic events of live kidney donors in the future, especially in the era of extended criteria live donors (15), we have developed an online registry ( com) where surgeons can anonymously report technical failures of vascular control during LDN. No living organ donor should face undue risk, and surgeons responsible for these special patients must remain vigilant and aware of all known safety and treatment options and outcomes. Acknowledgments We would like to thank all respondents for participating in this study for sharing their information and experiences. Disclosure The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation. References 1. Wilson CH, Sanni A, Rix DA, Soomro NA. Laparoscopic versus open nephrectomy for live kidney donors. Cochrane Database Syst Rev 2011; CD Jha V, Garcia-Garcia G, Iseki K, et al. Chronic kidney disease: Global dimension and perspectives. Lancet 2013; 382: Nierstichting Nederland., Nierdonatie bij leven Terasaki PI, Cecka JM, Gjertson DW, Takemoto S. High survival rates of kidney transplants from spousal and living unrelated donors. N Engl J Med 1995; 333: Delanaye P, Weekers L, Dubois BE, et al. Outcome of the living kidney donor. Nephrol Dial Transplant 2012; 27: Friedman AL, Peters TG, Jones KW, Boulware LE, Ratner LE. Fatal and nonfatal hemorrhagic complications of living kidney donation. Ann Surg 2006; 243: Hsi RS, Ojogho ON, Baldwin DD. Analysis of techniques to secure the renal hilum during laparoscopic donor nephrectomy: Review of the FDA database. Urology 2009; 74: Lennerling A, Loven C, Dor FJ, et al. Living organ donation practices in Europe - Results from an online survey. Transpl Int 2013; 26: Dekel Y, Mor E. Hem-o-lok clip dislodgment causing death of the donor after laparoscopic living donor nephrectomy. Transplantation 2008; 86: Simforoosh N, Sarhangnejad R, Basiri A, et al. Vascular clips are safe and a great cost-effective technique for arterial and venous control in laparoscopic nephrectomy: Single-center experience with 1834 laparoscopic nephrectomies. J Endourol 2012; 26: Europe Council Newsletter Transplantation Wolf JS Jr., Merion RM, Leichtman AB, et al. Randomized controlled trial of hand-assisted laparoscopic versus open surgical live donor nephrectomy. Transplantation 2001; 72: Kok NF, Adang EM, Hansson BM, et al. Cost effectiveness of laparoscopic versus mini-incision open donor nephrectomy: A randomized study. Transplantation 2007; 83: FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy Ahmadi AR, Lafranca JA, Claessens LA, et al. Shifting paradigms in eligibility criteria for live kidney donation: A systematic review. Kidney Int 2015; 87: Supporting Information Additional Supporting Information may be found in the online version of this article. Figure S1: Selection of ESOT members: profile surgeon and kidney. Survey: Renal vascular management in live kidney donors. American Journal of Transplantation 2015; 15: