Pigtail catheter for the treatment of ascites associated with ovarian hyperstimulation syndrome

M.I. Abuzeid1,2,4, Z. Nassar2, Z. Massaad2, M. Weiss3, M. Ashraf1,2 and M. Fakih2

1 Division of Reproductive Endocrinology, Hurley Medical Center, Flint, MI 48503, 2 IVF Michigan, Rochester Hills, MI 48307 and 3 Department of Radiology, Hurley Medical Center, Flint, MI 48503, USA

4 To whom correspondence should be addressed at: Division of Reproductive Endocrinology, Hurley Medical Center, Two Hurley Plaza, Suite 109, Flint, MI 48503-5993, USA. e-mail: reprod1{at}hurleymc.com


    Abstract
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
BACKGROUND: Severe ovarian hyperstimulation syndrome (OHSS) is potentially dangerous. The study aim was to evaluate the efficacy and safety of percutaneous pigtail catheter drainage for the management of ascites complicating severe OHSS. METHODS: This was a prospective trial conducted at a private IVF centre and a tertiary teaching medical centre. A total of 26 patients with severe OHSS was recruited. Patients were divided into two groups. Patients in group 1 (n = 13) were hospitalized, while patients in group 2 (n = 13) were managed on an outpatient basis. A pigtail catheter was inserted under transabdominal ultrasound guidance and kept in place until drainage ceased. The main outcome measures were resolution of OHSS as determined by symptomatology and laboratory values, time to removal of catheter, patient tolerance of the procedure and complication rate. RESULTS: The catheter was successfully placed in all patients following one attempt and was kept in place for a mean ± SD of 12.9 ± 4.3 days (range 7–24). Average amount of fluid drained was 11.2 ± 4.3 l (range: 3.35–18.5). An improvement of symptoms and signs was noted 24–48 h after catheter placement in all patients in both groups. Procedure was well tolerated and no complications reported. CONCLUSIONS: Percutaneous placement of a pigtail catheter is a safe and effective treatment modality for severe OHSS. It may represent an attractive alternative to multiple vaginal or abdominal paracentesis.

Key words: ascites/OHSS/pigtail catheter


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Ovarian hyperstimulation syndrome (OHSS) is a recognized complication of ovulation induction, occurring in 1–10% of IVF and embryo transfer cycles (Brinsden et al., 1995Go). It has been described following the administration of all ovulation induction medications, whether used for the treatment of an ovulatory disorder or controlled ovarian stimulation for IVF (Rizk and Aboulghar, 1991Go; Mordel and Schenker, 1993Go). This iatrogenic condition is characterized by a spectrum of clinical and laboratory manifestations ranging from a mild condition that usually resolves spontaneously to a severe life-threatening condition.

Ascites and pleural effusion are among the serious manifestations of OHSS. While the exact mechanism responsible for fluid collection is still unclear, ascites results in increased abdominal pressure, compromising venous returns, cardiac output and renal perfusion (Navot et al., 1992Go). Paracentesis is frequently needed as prompt drainage of fluid produces significant clinical and biochemical improvement, including spontaneous diuresis and hastening the resolution of the process (Borenstein et al., 1989Go; Aboulghar et al., 1990Go, 1993; Padilla et al., 1990Go).

However, in critical cases of OHSS, multiple paracentesis may be required for complete drainage to relieve symptoms and avoid serious sequelae of haemoconcentration, hypotension, decreased renal perfusion and severe respiratory compromise. The placement of a catheter instead of multiple needle paracentesis would permit complete drainage through one, rather than several, interventions. Pigtail catheters have already been used for such purposes in several situations including drainage of pleural effusion (Gammie et al., 1999Go; Maier et al., 2000Go; Saffran et al., 2000Go), pericardial effusion (Wu et al., 1996Go), abdominal abscesses (Jansen et al., 1999Go) and fluid collections in acute pancreatitis (Leeder et al., 1997Go). They have also been used as central venous catheters (Merry et al., 1999Go), nephrostomy tubes (Maheshwari et al., 2000Go), and biliary stents (Davis et al., 1999Go; Jain et al., 2000Go).

The objective of this study was to evaluate the efficacy and safety of pigtail catheters in the treatment of ascites associated with severe OHSS.


    Materials and methods
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Patients presenting with severe OHSS manifested by ascites, hydrothorax, haemoconcentration, coagulation abnormalities, acute respiratory distress or oliguria (Golan et al., 1989) were considered eligible. Between June 1999 and February 2001, 1240 women underwent controlled ovarian stimulation including 931 ICSI/IVF cycles and 109 intrauterine insemination (IUI) cycles. A previously described protocol for ovarian stimulation and luteal support was used (Abuzeid and Sasy, 1996Go). A total of 26 patients (2.1%) who fulfilled the criteria for severe OHSS was identified. Mean ± age was 31.0 ± 4.1 years (range: 25–42). Presenting symptoms and signs were recorded including nausea and/or vomiting, abdominal discomfort, dyspnoea, increased abdominal girth, oliguria, ascites and pleural effusion. Symptoms developed between 3 and 10 days after oocyte retrieval or IUI. All patients underwent an ultrasound evaluation to check for the presence of ascites and bilateral ovarian enlargement. Blood studies including a complete blood count, blood urea nitrogen, creatinine, electrolytes, serum albumin, total protein, coagulation panel and quantitative hCG were done. Urine output, weight and abdominal girth were measured.

All patients were offered treatment using the pigtail catheter as an alternative to paracentesis. The procedure and its potential benefits, risks and complications were discussed in full detail, and appropriate consent was obtained. This study was approved by the local ethics committee. The catheter (6–0 French, 2.0 mm; Boston Scientific, Quincy, MA, USA) was placed by an interventional radiologist as an outpatient procedure under local anaesthesia. The catheter was then introduced through the abdominal wall into the largest accessible pocket of fluid. This was performed under transabdominal ultrasound guidance with special caution to avoid injury to the adjacent ovaries, bowel loops and abdominal wall blood vessels. The catheter was anchored to the skin with a 2–0 silk suture and a gauze dressing was then applied. The catheter was then connected to a draining bag that was strapped to the patient’s thigh. Drainage was intermittent (twice daily) and the catheter was kept in place until drainage ceased and ascites had resolved completely. The total volume of fluid drained and duration of drainage were recorded. Prophylactic antibiotics were not administered.

Patients were then subdivided into two groups based on whether hospitalization was necessary or not. Group 1 (n = 13) included patients with severe OHSS that were admitted to the hospital while group 2 (n = 13) comprised those that were managed on an outpatient basis. Indications for hospitalization included haemodynamic instability, severe dyspnea, respiratory compromise, severe oliguria, marked hypoalbuminaemia or haemoconcentration. Patients in group 1 were admitted over a 24–48 h period, during which i.v. albumin and fluid infusion were administered. Vital signs were assessed every 2–4 h with daily measurement of complete blood count, electrolytes, and liver function tests. Baseline prothrombin and partial thromboplastin time were also measured. Daily weight and abdominal girth were recorded. Chest X-ray with abdominal shield and pulse oximetry were mandatory for any patient with shortness of breath or any other signs of respiratory compromise. Although patients in group 2 had severe OHSS and met the criteria for hospitalization, it was decided to manage these patients on an outpatient basis, based on the results from the initial experience in 13 patients in group 1. Careful evaluation of the patients in group 1 revealed dramatic improvement in symptoms and signs of severe OHSS once the pigtail catheter was inserted and the initial drainage was achieved. Patients in group 2 were asked to maintain oral hydration through the frequent intake of small volumes of fluid. Patients were also asked to measure their weight, abdominal girth and 24 h urine collection and report them to the office on a daily basis. They were advised to stay home from work during the treatment period and were followed up with daily telephone calls and frequent visits to the reproductive endrocrinologist. Tolerance of the procedure including the placement of the catheter and its management at home were recorded. Patients were also asked to report the development of fever, redness at the puncture site, increase in abdominal girth, excessive weight gain, dyspnoea and oliguria. Outcome measures recorded included resolution of OHSS as determined by symptoms, clinical signs, laboratory values, time to complete resolution of ascites after catheter placement and amount of drainage.

Statistical analysis
All parameters, reported as mean ± SD, were compared using Student’s t-test and {chi}2-analysis where appropriate.


    Results
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Demographic and cycle characteristics of patients in group 1 (hospitalization) and group 2 (outpatient management) with severe OHSS were compared. Mean age was 31.3 ± 3.7 and 32.5 ± 4.6 years for groups 1 and 2 respectively. There was no statistically significant difference between the two groups when age, duration and cause of infertility were compared. Days of stimulation were 11.1 ± 2.1 versus 11.1 ± 1.4, and total numbers of ampoules of gonadotrophin used were 32.4 ± 7.0 versus 32.4 ± 6.5 respectively. Peak estradiol levels on day of hCG administration were 2606.85 ± 931.89 versus 3157.77 ± 1302.73 pg/ml, and numbers of embryos transferred were 4.6 ± 1.4 versus 4.4 ± 1.0 respectively. There was no statistically significant difference between the two groups in all the parameters measured.

Presenting symptoms and signs in patients with severe OHSS are shown in Table I. Abdominal discomfort was the main presenting complaint (12 patients in group 1 versus 13 in group 2). Nausea and/or vomiting were reported in 11 versus nine patients respectively, dyspnoea in four versus six, oliguria in three versus two, and pleural effusion in three versus four. One patient in group 1 presented with labial swelling. Ascites and bilateral multiple corpora lutea cysts were the predominant signs, and ultrasound findings were recorded in all patients with severe OHSS.


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Table I. Clinical signs and symptoms and laboratory results in the two groups of patients with severe OHSS
 
The catheter was successfully placed at first attempt in all 26 patients with no complications noted at the time of insertion including bleeding or bowel injury. There was immediate partial resolution of symptoms and signs in all patients following the drainage of ~1 l of ascitic fluid. Complete improvement of clinical and biochemical parameters occurred within 24–48 h after insertion of the pigtail catheter. No recurrence of symptoms or signs occurred in any of the patients. In addition, there was immediate improvement in urine output and biochemical parameters, including haemoglobin, haematocrit and K+ levels and albumin levels. The catheter was kept in place for an average of 12.3 ± 3.6 days in group 1 versus 13.5 ± 5.0 days in group 2, and drained an average of 11.1 ± 4.9 l in group 1 versus 11.3 ± 3.8 l in group 2. The difference between the two groups was not statistically significant. There was no reported incidence of wound or intra-abdominal infection. Only one patient reported redness around the site of the wound. The catheter was removed and wound swab culture was negative for microorganisms. No patients complained of inconvenience related to management at home. Three patients in group 1 who had a history of OHSS with repeated abdominal paracentesis in previous IVF cycles reported more convenience with the use of the pigtail catheter.

A total of 16 patients became pregnant (nine singletons, three twins, one triplet and three miscarriages) with clinical pregnancy and delivery rates per embryo transfer of 61.5 and 50.0% respectively. There was no difference in pregnancy rates between the two groups. Outcome after catheter placement in patients with severe OHSS is shown in Table II.


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Table II. Outcome after catheter placement in patients with severe ovarian hyperstimulation syndrome
 

    Discussion
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Recognizing the OHSS high-risk profile is probably the most important measure of prevention the physician can take before beginning any ovarian stimulation cycle. Among the risk factors for this iatrogenic condition are young age, low body weight, GnRH agonist protocols, high, or rapidly rising, estradiol levels, size and number of stimulated follicles, number of oocytes retrieved, evidence of polycystic ovary syndrome, hCG supplementation in the luteal phase, and finally pregnancy. However, there remains a constant threat of OHSS to patients undergoing ovarian stimulation despite all strategies to minimize its risk. With early recognition of severe OHSS, prompt and aggressive management through vigilant fluid replacement, thrombosis prevention and treatment of ascites, cases rarely result in clinical sequalae (Whelan and Vlahos, 2000Go). Even though severe OHSS can be managed on an outpatient basis, many physicians still recommend hospitalization of patients presenting with this condition.

In cases of severe ascites associated with OHSS, treatment may require drainage of fluid twice to three times weekly. Repeated abdominal paracentesis has been proposed for treatment of OHSS in patients with respiratory compromise due to massive ascites. Following abdominal paracentesis, the decreased intra-abdominal pressure has been shown to increase the cardiac output, stroke volume, and uterine perfusion (Knaur and Lowe, 1967Go; Chen et al., 1998Go). Improvement in the respiratory symptoms in patients with pleural effusion has also been noted following abdominal paracentesis (Gammie et al., 1999Go).

Outpatient management with repeated abdominal paracentesis has been proposed as a safe and effective modality of treatment (Shrivastav et al., 1994Go; Fluker et al., 2000Go). However, such management protocols often include multiple visits to the reproductive endocrinologist and drainage procedures with increased cost and inconvenience. In addition, repeated transvaginal ultrasonographic-guided aspiration of fluid is still performed successfully although there may be a danger of ascending infection. Furthermore, a closed system Dawson–Mudler indwelling peritoneal catheter has been used under abdominal ultrasound guidance in three cases of OHSS resulting in resolution of ascites (Al-Ramahi et al., 1997Go). An indwelling vaginal pigtail catheter has also been tried when abdominal paracentesis was not feasible (Raziel et al., 1998Go). To our knowledge, no studies regarding the use of transabdominal pigtail catheters in the management of ascites in severe OHSS have been reported.

This study illustrates our experience with the use of percutaneous pigtail catheter for drainage of ascites under local anaesthesia and transabdominal ultrasound guidance. Catheter placement is a relatively simple procedure that requires a short period of time as opposed to the time needed to gradually aspirate any fluid accumulation using a needle paracentesis. In addition, it also avoids the need for repeated aspiration procedures. However, the most important finding in our study was the immediate relief of symptoms and signs of severe OHSS after the pigtail catheter was placed and the lack of recurrence of any of the symptoms as long as the catheter remained in place. Furthermore, a pigtail catheter was used in 13 patients with severe OHSS managed on an outpatient basis, avoiding the need for possible hospitalization. Pigtail catheter placement not only avoided the need for hospitalization of patients in group 2 but might have helped to shorten the hospital stay for patients in group 1. Eleven patients in group 1 were hospitalized for 24–48 h and only two patients needed prolonged hospitalization (4 and 5 days respectively). After discharge from the hospital, patients in group 1 were managed on an outpatient basis, similar to that of patients in group 2.

Another finding in our study in support of the use of transabdominal pigtail catheter in the management of OHSS is the fact that no infection was reported. Even though no prophylactic antibiotics were administered, none of the 26 patients developed wound, intra-abdominal or pelvic infection and/or abscess formation.

It is imperative to stress the fact that prevention of severe OHSS should be the main goal. In this report, the incidence of severe OHSS was 2.1%. Currently, this rate is considered high, especially in the presence of effective methods for prevention, such as coasting. In our unit we use coasting more frequently, with excellent results. We have also implemented a strict policy for patients at risk, which includes: lower dose of gonadotrophin, more frequent monitoring, coasting and avoidance of luteal phase supplementation with HCG.

In conclusion, this preliminary report suggests that percutaneous placement of a pigtail catheter is a safe and effective treatment modality for the management of ascites in severe OHSS. It may represent an attractive alternative to multiple paracentesis. However, further studies are needed to compare the pigtail catheter and multiple paracentesis for the management of severe OHSS.


    Acknowledgement
 
The authors would like to thank Cheryl Anderson and Linda Rutherford for preparation of this manuscript.


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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
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Submitted on May 7, 2002; accepted on October 30, 2002.