Laparoscopic donor nephrectomy

Original Articles Surg Endosc (2007) 21: 521–526 DOI: 10.1007/s00464-006-9021-y Ó Springer Science+Business Media, Inc. 2006

Laparoscopic donor nephrectomy Intraoperative safety, immediate morbidity, and delayed complications with 500 cases Edward H. Chin, David Hazzan, Daniel M. Herron, John N. Gaetano, Scott A. Ames, Jonathan S. Bromberg, Michael Edye Department of Surgery, Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY, 10029, USA Received: 11 June 2006/Accepted: 5 July 2006/Online publication: 16 December 2006

Abstract Background: Several large series of laparoscopic donor nephrectomy (LDN) have been published, largely focusing on immediate results and short-term complications. The aim of this study was to examine the results of LDN and collect medium-term and long-term donor followup. Methods: We examined the results of two surgeons who performed 500 consecutive LDNs from 1996 to 2005. Prospective databases were reviewed for both donors and recipients to record demographics, medical history, intraoperative events, and complications. Patients were followed between 1 month and 9 years after surgery to assess for delayed complications, especially hypertension, renal insufficiency, incisional hernia, bowel obstruction, and chronic pain. Results: Left kidneys were procured in 86.2% of cases. Mean operative time was 3.5 h, and warm ischemia time averaged 3.4 min. Hand-assistance was used in 13.8%, and conversion rate was 1.8%. Intraoperative complication rate was 5.8% and was predominantly bleeding (93.1%). Most (86.2%) of the operative complications occurred during the initial 150 cases of a surgeon, compared with 10.3% in the subsequent 150 cases (p = 0.003). Operative time decreased by 87 min after the initial 150 cases (p < 0.001). Immediate graft survival was 97.5%. Delayed graft function occurred in 3.0% of recipients, and acute tubular necrosis occurred in 7.0%. Thirty-day donor complication rate was 9.8%. Mean donor creatinine was 1.24 on the first postoperative day, 1.27 at 2 weeks, and 1.24 at 1 year. At a mean followup of 32.8 months, long-term donor complications consisted of 11 cases of hypertension, 9 cases of prolonged pain or paresthesia, 2 incisional hernias, 1 small bowel obstruction requiring laparoscopic lysis of adhesions, and 1 hydrocele requiring repair.

Correspondence to: M. Edye

Conclusions: LDN can be performed with acceptable immediate morbidity and excellent graft function. Operative time and complications decreased significantly after a surgeon performed 150 cases. Long-term complications were uncommon but included a likely underestimated incidence of hypertension. Key words: Laparoscopy — Complications — Donor nephrectomy — Renal transplant — Kidney

Since the initial report on laparoscopic donor nephrectomy (LDN) in 1995 [11], it has been performed at transplant centers worldwide. The benefits of decreased pain, faster recovery, and improved cosmesis conferred by LDN have been cited as potential reasons for an increase in willing donors. Early concerns of prolonged ischemia times, impaired graft function, and donor safety have been addressed by several large series documenting excellent graft outcomes and low donor morbidity [5, 6, 13]. In addition, cohort studies comparing open donor nephrectomy and LDN confirmed the validity of LDN as a viable alternative [7, 10]. LDN is currently performed by many urologists, transplant surgeons, and general surgeons as the preferred method of kidney procurement. Despite different specialty training, common to all is the requirement for advanced laparoscopic skills, given the potential for significant morbidity and even mortality. Inherent to the donor operation is the belief that preventable morbidity is unacceptable. Unfortunately, there have been at least two donor deaths after LDN in the United States and two cases of renal failure, all secondary to bleeding during surgery [3]. To date, most large series of LDN report the results of a single, tertiary-care institution that performs a large volume of transplants. Furthermore, data regarding delayed complications in donors

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are lacking. Our aim was to examine the results of a large series of consecutive LDNs performed by two surgeons at three different institutions to assess donor safety and graft function and to collect medium-term and long-term followup data on donors.

Materials and methods Patient data From October 1996 to October 2005, all cases of LDN performed by two general surgeons were examined after Institutional Review Board approval. Prospective databases were queried for donor age, sex, height, weight, body mass index (BMI), medical and surgical histories, American Society of Anesthesiologists (ASA) score, and baseline creatinine. Surgical blood loss, operative time, duration of warm ischemia as defined by time from renal artery occlusion to immersion in iced saline bath, and intraoperative complications were recorded prospectively. Transfusion requirement, both during surgery and after, was noted. Postoperative data included length of stay, creatinine level, and complications, including reoperation and readmission. Recipient information was obtained from existing databases. Acute tubular necrosis was defined as failure to achieve a 25% decline in serum creatinine within 24 h of transplant. Delayed graft function was defined as the need for hemodialysis within the first week of transplant. Followup data on donors were obtained from office visits and telephone conversations, with attention paid toward delayed complications and current creatinine levels.

Statistical analysis

Table 1. Patient characteristics (n = 500) Data (mean ± SD) Female Male Age Body Mass Index (BMI) Significant past medical history Prior abdominal surgery ASA scorea Baseline creatinine Preoperative imaging Magnetic resonance angiography (MRA) Computed tomography (CT) Angiogram Left kidney procured Right kidney procured Hospital Mount Sinai Medical Center Westchester Medical Center New York University Medical Center Other Operative details Operative time Warm ischemia time Blood loss Transfused during surgery or after Hand-assistance Conversion to open Postoperative details Length of stay Creatinine (day 1) Creatinine (day 14) a

Data are expressed as mean ± standard deviation (SD). Mantel-Haenszel v2 analysis was used for discrete variables, and the nonparametric Wilcoxon rank test was used for continuous variables. Multiple regression analysis was performed to evaluate the relationship of patient demographics (age, sex, BMI, side) on operative time, complications, and bleeding. All calculations were done using commercially available software with p values of less than 0.05 considered statistically significant.

Surgical technique Patients are positioned in flexed, lateral decubitus with careful padding and arm support. Initial access to the peritoneal cavity has varied over time and includes both open (Hasson cannula) and closed approaches (Veress needle, optical trocar). Four or five trocars are used with an angled telescope. Intra-abdominal pressure limit is 10-15 mmHg. On average, 5 L of fluid are given intraoperatively to maintain brisk urine output, which is supplemented with mannitol and furosemide. Unfractionated heparin (2500–5000 units) is given before renal artery occlusion. A vascular stapler or two locking polymer clips (Weck Closure System, Research Triangle Park, NC) are used to secure the renal artery and vein. Hand-assistance through a LapDisc (Ethicon Endosurgery, Cincinnati, OH) is selectively employed. Extraction is via a 6-7-cm-long Pfannenstiel incision. For left kidneys, initial mobilization of the left colon, spleen, and pancreatic tail is performed. Identification of the left gonadal vein with wide periureteral dissection follows. The gonadal vein is dissected proximally to the left renal vein and, if necessary, divided once vascular control is achieved. The left adrenal vein is dissected and divided. Circumferential dissection of the renal vein and artery is performed. The adrenal gland is carefully freed from the superior pole of the kidney, and the lateral and posterior attachments of the kidney lysed. The ureter is transected distally, and, after sufficient time for heparin circulation, the renal artery and vein are divided. The kidney is removed either within a specimen bag or by hand. For right kidneys, a 5-mm flexible retractor is used for the liver after the right triangular ligament is divided. The right colon and duodenum are mobilized as necessary. The right gonadal vein is left in situ.

56.2% 43.8% 40.3 years ± 12.2 27.3 ± 5.2 11.9% 11.6% 1.4 ± 0.5 0.9 ± 0.2 42.0% 35.3% 22.7% 86.2% 13.8% 55.6% (n = 278) 33.8% (n = 169) 9.0% (n = 45) 1.6% (n = 8) 208.2 ± 55.6 min 207.0 s ± 91.6 197 ± 223.0 ml 0.6% (n = 3) 13.8% (n = 69) 1.6% (n = 8) 2.3 ± 0.8 days 1.24 ± 0.3 1.27 ± 0.3

American Society of Anesthesiologists score

Any mesocolic defects are repaired with pretied loops, clips, or sutures. The Pfannenstiel incision is closed with absorbable, continuous suture. Fascial closure is performed for 10-mm trocar sites; 0.5% bupivicaine is injected for long-acting local anesthesia. Postoperative analgesia has changed with time; a regimen of intravenous ketorolac supplemented with oxycodone/acetaminophen is currently used, with intravenous narcotics rarely required. Clear liquids are begun immediately and advanced rapidly. Urinary catheters are removed the first morning after surgery. Early ambulation and incentive spirometry is stressed.

Results Preoperative characteristics Five hundred cases of LDN were performed during the nine-year period. Demographic information is presented in Table 1. Preoperative imaging changed over time, with computed tomography (CT) and magnetic resonance imaging (MRI) replacing conventional angiography. Reasons for right nephrectomy included multiple left renal arteries, significantly smaller right kidney compared with left, retroaortic and circumaortic left renal veins, atherosclerotic disease of the right renal artery, prior left abdominal surgery, and an unusually long right renal vein. Operative results and complications Operative details are presented in Table 1 and complications in Table 2. There were no mortalities. Intraop-

523 Table 2. Operative complications

Table 4. Immediate graft complications n (% of 500 cases)

Bleeding (>500 ml) Splenic injury requiring splenectomy Staple line bleeding requiring repair Total

27 1 1 29

(5.4%) (0.2%) (0.2%) (5.8%)

n (% of 500 cases) Acute tubular necrosis Delayed graft function Graft loss

20 (7.0%) 8 (3.0%) 7 (2.5%)

Table 5. Delayed donor complications (>30-day) Table 3. Postoperative complications (30-day) n

%

11 3 3 3 3 1 1 24

5.7 1.6 1.6 1.6 1.6 0.5 0.5 12.4a

n (% of 500 cases) Wound infection/hematoma Testicular pain/swelling Ileus Incisional, back, or abdominal pain Urinary tract infection Pneumonia or shortness of breath Re-operation for bleeding Urinary retention Small bowel obstruction Atrial fibrillation requiring cardioversion Deep vein thrombosis Transient acute renal failure Pulmonary edema Dehydration Leg numbness Total

13 8 5 5 3 3 2 2 2 1 1 1 1 1 1 49

(2.6%) (1.6%) (1.0%) (1.0%) (0.6%) (0.6%) (0.4%) (0.4%) (0.4%) (0.2%) (0.2%) (0.2%) (0.2%) (0.2%) (0.2%) (9.8%)

Hypertension requiring medication Incisional hernia Leg pain/numbness Incisional pain Back pain Small bowel obstruction Hydrocele requiring surgery Total a

With 38.6% (n = 193) followup, at mean interval of 32.8 months

erative bleeding was defined as blood loss exceeding 500 ml. In one patient, staple line bleeding from the right renal vein required laparoscopic suturing. Postoperative course Mean length of stay and donor creatinine data are presented in Table 1. Postoperative complications (30 day) occurred in 49 of patients (9.8%), and are presented in Table 3. Graft outcome Immediate graft outcome is presented in Table 4. Graft survival rate was 97.5% (n = 493). Followup data Medium- and long-term followup data were obtained from office visits, inpatient records, and telephone conversations and was available for 193 patients (38.6%), at a mean interval of 32.8 ± 33.4 months (median, 17.1 months; range, 1-109). Delayed donor complications (present beyond 30 days after surgery) were infrequent (n = 24), and are presented in Table 5. Impact of surgeon experience Trends associated with increasing surgeon experience were examined (Fig. 1). Surgeon experience was stratified by 100 cases.

Fig. 1. Trends in donor morbidity with increased surgeon experience.

During the first 100 cases performed by a surgeon, there were 14 operative complications (48.3%), which consisted of 13 bleeding episodes (48.1%) and one splenic injury requiring splenectomy. There were three conversions during this interval (33.3%). During the second 100 cases performed, there were 11 operative complications (37.9%), which included 10 bleeding episodes (37.0%) and a staple line bleed requiring oversewing. There were four conversions (44.4%). During the third 100 cases, there were three operative complications (10.3%), all of which were bleeding episodes (11.1%). There were two conversions (22.2%). During the fourth 100 cases, there were no operative complications or conversions. After 400 cases, there was only one complication (3.4%), was a single bleeding episode (3.7%), and no conversions.

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Fig. 2. Accumulation of bleeds by surgeon experience: 85.2% of bleeds occurred within the first 150 cases performed compared with 11.1% in the subsequent 150 cases. A surgeon was 83% less likely to have a bleed after 150 cases then before (p = 0.005).

A Mantel-Haenszel test confirmed the statistical significance of decreases in both complications and bleeds with experience. For an increase in experience of 100 cases, the odds of an operative complication decreased by 37% (odds ratio [OR], 0.63; 95% confidence interval [CI], 0.47 to 0.84, p = 0.002), and the odds of a bleed decreased by 36% (OR, 0.64; 95% CI, 0.48 to 0.86, p = 0.003) When surgeon experience was plotted continuously, the incidences of both operative complications and bleeding were stable until 150 cases, at which point a plateau was noted (Fig. 2). Most (86.2%) complications occurred during the first 150 cases performed compared with 10.3% in the subsequent 150 cases; the odds of a complication after performing 150 cases were 83% lower than before 150 cases (OR, 0.17; 95% CI, 0.038–0.78; p = 0.003). The odds of a bleed after 150 cases were also 83% lower than before 150 cases (OR, 0.17; 95% CI, 0.05–0.58; p = 0.005). The odds of a complication or bleed after 300 cases were not significantly lower than after 150 cases. Operative time was experience-dependent but did not differ significantly between right and left kidneys (Table 6). Operative time decreased by 87 min after 150 cases were performed (p < 0.001). There was no significant decrease in operative time after 300 cases compared with that after 150 cases. Impact of donor age, sex, BMI, side By multiple regression analysis, differences in operative time and complications were not related to age, sex, BMI, or side procured. BMI > 30 was associated with both complications (OR, 3.4; 95% CI, 1.3–9.3; p = 0.02) and bleeding episodes (OR, 2.9; 95% CI, 1.04–8.1; p = 0.04). Discussion While LDN has been successfully performed since 1995, open donor nephrectomy (ODN) still accounts for

approximately one-half of all living donor nephrectomies. While advantages of decreased pain, faster recovery, and shorter length of stay are appealing to surgeons and potential donors, overall safety and graft success remain paramount. The gold standard procedure of ODN is still associated with a 0.03% mortality worldwide [1]. Bleeding remains a cause of significant morbidity and mortality in donor nephrectomy, whether performed open or laparoscopically. The incidence of bleeding is likely underrepresented in the literature, as highlighted in a recent publication reporting on survey results of American transplant surgeons [3]. With increased attention and awareness for donor safety, we examined our results of 500 consecutive LDNs performed by two surgeons, the majority of which (n = 492) were performed at three different institutions which first began LDN during this period. We separated donor morbidity into operative and postoperative complications, with rates of 5.8% and 9.8%, respectively. The largest series in the literature is from the University of Maryland, which reported a 6.8% intraoperative and 17.1% postoperative complication rate with 738 LDNs [5]. Similar to their program, we began performing LDN in 1996, shortly after this technique was first described in 1995. This early experience with LDN is reflected in the substantial proportion of our patients that underwent preoperative angiography (22.7%), during a time when CT and MRI were inadequate for vascular detail. These pioneering years were marked by intensive scrutiny, reevaluation, and technical refinement, which translated into significant declines in operative time and complications [4]. While other programs may report lower morbidity rates, our series encompasses this early era, with a learning curve for not only the surgeon but also the three institutions at which we started LDN programs. Technical and institutional improvements notwithstanding, operating time and blood loss are still not insignificant with LDN, with values between 196 and 253 min and 128 and 334 ml, respectively [5, 6, 13]. We observed significant improvements in operative time, complications, and bleeding with increased surgeon experience. While we hypothesized that this would be true, the dramatic difference seen before and after 150 cases was unexpected. Our conversion rate was 1.6%. A recent study from the University of California at San Francisco had a 0.2% conversion with 530 cases, but most report a rate of 1.6%–2.8% [5, 6, 13]. Of our nine conversions, all except one were for bleeding or suspicion of injury to a critical renal vessel; the single exception was a nonemergent conversion because of extensive anomalies involving the right renal vein. No conversions occurred after a surgeon performed 300 cases. Although we believe that experience yields increased ability to not only control bleeding laparoscopically but also a decreased likelihood to cause vascular injury, our decline in conversion rate with experience did not reach statistical significance. When bleeding complications occurred, the majority resulted from dissection of left lumbar veins, the renal vein, or renal artery. Four of the 27 cases of bleeding occurred during extraction, all from the divided renal

525 Table 6. Operative time by surgeon experience and side Minutes (mean ± SD) Number of cases 1–100 101–200 201–300 301–400 >400 Side procured Left Right

256.8 205.1 184.7 177.1 174.5

± ± ± ± ±

57.2 45.2 36.4 30.9 41.6

207.3 ± 56.0 214.5 ± 52.9

artery. In addition to bleeding, there was one staple line bleed from a right renal vein that required oversewing and one splenic injury that required splenectomy. We routinely divide all splenic attachments to the left kidney and diaphragm until the gastric fundus is visualized and the spleen lies medially without retraction. The splenic injury occurred within the initial 100 cases of a surgeon. Regarding graft outcome, a systematic review examining all comparative studies of open and laparoscopic donor nephrectomy reported a graft survival of 9%–100% for LDN and 91%–100% for ODN [14]. Delayed graft function was 0%–12% in LDN and 0%–14% for ODN [14]. Similarly, we found graft survival and delayed graft function to be 97.5% and 3%, respectively. Our seven cases of immediate graft loss were secondary to arterial or venous thrombosis (n = 6) or primary nonfunction (n = 1). The use of hand-assistance varies among transplant programs, with some advocating routine use and others citing a benefit for training and early experience [8, 15]. A comparison of 14 laparoscopic and 34 hand-assisted LDNs found a statistically significant decrease in total operative time (3.6 vs. 2.8 h) and warm ischemia time (3.9 vs. 1.6 min) with hand-assistance and no difference in complications or graft outcomes [12]. We favor a selective use of hand-assistance, with the majority of our cases performed completely laparoscopically (86.2%) and hand-assistance used for extraction or when dissection of the renal pedicle proves difficult. A disadvantage of our strategy is the suboptimal location within the Pfannenstiel incision when hand-assistance becomes necessary. Fortunately, relatively few cases require prolonged use of hand-assistance. BMI >30 was associated with an increased risk of bleeding complications in our series. Consequently, in patients with significant obesity, we often use a midline or paramedian incision near the umbilicus for potential hand-port placement and extraction. The largest series of LDN [5, 6, 13] provide excellent data on short-term donor complications but no significant length of donor followup is reported. The longterm impact of LDN remains unknown, and specific concerns regarding the deleterious effects of pneumoperitoneum on renal function, of both the graft and the remaining native kidney, remain unanswered. In a porcine model, prolonged pneumoperitoneum resulted in a significant decrease in renal blood flow, urine output, and creatinine clearance [9]. Vigorous fluid administra-

tion (15 m/kg/h) reversed the decrease in renal blood flow and urine output, but creatinine clearance remained impaired [9]. Accordingly, we maintain a strategy of aggressive hydration with a mean of 5.2 L of crystalloid given intraoperatively, in addition to several doses of intravenous diuretics. Fortunately, most donors are healthy patients without cardiac dysfunction and can tolerate such large fluid shifts. One case of severe pulmonary edema did occur in our series; a 31-year-old male weighing 60 kg received 9 L of fluid based on ventricular filling seen by transesophageal echocardiography. In one of very few studies of long-term renal function in donors after LDN, Lind et al reported a statistically significant increase in postoperative creatinine with LDN compared with ODN at day 1, day 90, and 1 year (99, 113, 94 lmol/L vs. 73, 94, 83 lmol/L, respectively) [7]. In our series, mean preoperative creatinine was 0.9 mg/dl, and mean creatinine at day 1, day 2, and day 14 were 1.24, 1.29, and 1.27, respectively. At 12.0 months, mean creatinine was 1.24. One study followed 250 patients after ODN for a mean of 53 months and found a 20% rate of complications, which included hypertension (5.6%), hernia (3.6%), and bowel obstruction (2%) [2]. We had three cases of small-bowel obstruction in our series; two occurred within 30 days of surgery and one at 26 months after surgery, which required a laparoscopic lysis of adhesions. While LDN is generally expected to decrease the incidence of adhesions and subsequent bowel obstruction, bowel obstruction from trocar site hernias, mesocolic defects, and incisional hernias can also occur. With followup data on 38.6% of our patients, is the development of hypertension in 11 (5.7%) was of concern. Six patients were over 50 years of age at the onset of hypertension. Five patients were between ages 32 and 45, of which two have not required antihypertensive medication yet. A study following ODN patients for 9 to 18 years after surgery found an increased incidence of hypertension in ODN patients, even when adjusted for age, sex, and race [16]. Because many donors are in their 20s, the development of hypertension after prolonged hyperfiltration from a uninephric state must be recognized. At our institution, a prospective study is currently underway that uses 24-h blood pressure monitoring in donors after laparoscopic nephrectomy. The issue of long-term followup of donors after LDN has gained increased attention, and a nationwide donor registry has been proposed by multiple transplant programs. Uniform standards for grading and reporting donor complications have also been advocated [6]. Until such measures are implemented, the large discrepancy between the excellent long-term data collected on recipient outcomes and complications and those of the donor will continue to exist. Conclusions Laparoscopic donor nephrectomy (LDN) can be performed with acceptable immediate morbidity to donors and excellent graft function. Our series includes the

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initial era of LDN, with the introduction of this technique at three institutions. As a consequence, an extremely long learning curve was observed, with statistically significant decreases in operative time and complications after a surgeon performed 150 cases. Surgeons and institutions that start to use LDN today benefit greatly from the collective experience of earlier work and likely require fewer cases to surpass the learning curve effect. We are currently examining the results of recent surgeons at our institution to confirm this belief. Despite adequate training and support, LDN is still associated with real donor morbidity, most notably bleeding, which must be understood by both surgeons and donors. Rather than extrapolating the open donor data, we have begun an intensive effort to follow up all LDN patients and generate accurate information on the longterm risks they face.

Acknowledgments. The authors thank Dr. Paul Hebert, PhD, for providing invaluable assistance with statistical analysis.

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