: Safety and Efficacy Frances R. Batzer, MD, MBE Clinical Professor, Obstetrics & Gynecology Thomas Jefferson University Hospital Philadelphia, PA Safety and Efficacy Learning Objectives Describe patient and site preparations for safe and efficient cyst aspiration Demonstrate how cyst fluid evaluation can be useful in diagnosis and treatment Understand the concordance between sonographic picture and pelvic pathology in relationship to fluid aspiration Appreciate the use of transvaginal probe for performing a form of minimally invasive operative endoscopy with regard to fluid aspiration Transvaginal Sonographic Guidance of Puncture Procedures: Minimally Invasive Surgery Sonographically Guided Operative and Puncture Procedures Puncture Procedures 1) Oocyte retrieval 2) Ovum/pelvic cyst aspiration 3) Transmyometrial embryo transfer 4) Ectopic pregnancy treatment 5) Culdocentesis 6) Pelvic fluid/abscess drainage 7) Selective fetal reduction 8) Chorionic villus sampling/early amniocentesis Technique for Transvaginal Sonographically Guided Puncture Procedures 1) Preliminary scan to confirm findings, biopsy guide on monitor, etc.; document findings 2) Placement of IV for sedation (optional) 3) Antibiotic oral or IV (optional) 4) Vaginal prep (saline or providine iodine 10% solution) 5) Placement of local anesthesia or paracervical block (optional) 6) Attachment of biopsy needle guide to probe 1
Technique for Transvaginal Sonographically Guided Puncture Procedures 7) Attach aspirating needle to IV connector tubing and syringe or pump 8) Fill aspirating needle with local anesthesia (optional) or normal saline 9) Place probe in vagina; advance needle injecting local anesthesia if desired 10) Aspirate/inject 11) Remove needle and observe for several minutes; document findings 12) Observe patient for 30-60 minutes in recovery area Needle Guide on Monitor Screen Note cm markings indicate depth of penetration Needle gauge: no larger than 15 gauge will pass through guide Transvaginal Sonographically Guided Operative and Puncture Procedures Applications beyond the limits of fertility Preparation of the patient s vagina: Sterile water/normal saline for oocyte retrieval Provodine iodine solution 10% Other fluid aspirations 2
Infection Rate: Rare Related to pelvic pathology Oral or IV antibiotic coverage may be appropriate PUNCTURE PROCEDURES OOCYTE RETRIEVAL DEVELOPMENT OF ULTRASOUND- GUIDED FOLLICULAR PUNCTURE 1982 LENZ Transabdominal ultrasound-guided follicular puncture through the full bladder 1984 DELLENBACH and NISAND Transvaginal follicular puncture guided by abdominal ultrasound 1985 PARSONS Transurethral follicular puncture guided by abdominal ultrasound Jan. POPP 1985 First vaginosonographically guided vaginal follicular puncture Needle Movement Manual Automated Needle Puncture System (Timor-Trisch) () Manual Needle Technique: Single Vaginal Entry Angle Probe to Facilitate Aspirating Multiple Areas Oocyte Retrieval Automated Needle Puncture System Precise Depth of Penetration Programmed Thinner Needle Utilized Due to Force of System Separate Vaginal Punctures for Each Target Timor -Tritsch 3
Needle Choice Single Versus Double Lumen Various Sonographically Marked Document: Before and After Inspection of Pelvis/Cul-de-sac at Beginning and Conclusion Patient Observation for 15-30 Minutes Patient must be Accompanied for the Following 12-24 Hours Complications after Transvaginal Ultrasound Guided Oocyte Aspiration for IVF < 2% Pelvic abscess/infection 0.5% Vaginal hematoma Persistent vaginal bleeding: Treat with pressure/suture Persistent intra-abdominal bleeding Perforated appendicitis Dicker et al F&S 1993, Barber et al J Ultrasound Med 1988 4
Transabdominal Guidance for Punctures: Transabdominal Retrieval Transvaginal Retrieval Transurethral Retrieval Transvaginal Guidance for Oocyte Retrieval Transvaginal Retrieval Transmyometrial Retrieval Freehand Technique for Cyst Aspiration Maintaining Sonographic Visualization of Full Needle Length without Attached Biopsy Guide is Difficult especially when the ovary is: Lateral Free Fixed Behind Uterus Bimanual Technique To Help Visualize Ovaries To Stabilize Ovary 5
Follicle flushing: Low Complication Rate Especially for Infection Prior to Initiation of Ovulation Induction: Follicle flushing: Initially felt to yield more oocytes Increased time of retrieval Larger double lumen needle used initially Obstructs visualization due to air entry Questionably more fertilizable oocytes Questionable increased pregnancy rate Evidence not necessary (Ritz, Fertil Steril 1990) Transmyometrial oocyte retrieval (Wisanto et al, Human Reprod 1989) Trans Myometrial Embryo Transfer Application: In Presence of Severe Cervical Stenosis Success rates comparable (Katos, et al Fertil Steril 1993) OVARIAN FOLLICULAR LOOK-ALIKE 1. INTERNAL ILIAC ARTERY/VEIN 2. BOWEL 3. HYDROSALPINX 4. OVARIAN CYST 5. PARATUBAL CYST 6
Follow-up of Transvaginal Aspiration of Ovarian Cysts in 35 Patients Over a 12 Month Period Puncture Procedures: Ovum/pelvic cyst aspiration Follow-up (months) Weinrab Z et al. Transvaginal Aspiration of Ovarian Cysts: Prognosis Based on Outcome Over a 12 Month Period. J Ultrasound Med 1994;13:275-79 Comparison of Relevant Clinical Parameters on Success and Failure of Aspiration after 1 Month Success Failure Statistical Parameters Range Median Range Median Significance Age 17-63 yr 35 yr 20-76 yr 45 yr P<0.01 Preaspiration 3.5-10.6 cm 6 cm 4.5-12 cm 7.4 cm P<0.05 maximal diameter Preaspiration 3.3-10 cm 5.5 cm 3.5-10 cm 6.1 cm P<0.05 mean diameter Aspiration 20-460 ml 98 ml 30-700 ml 145 ml NS(P>0.20) volume Weinrab Z et al. Transvaginal Aspiration of Ovarian Cysts: Prognosis Based on Outcome Over a 12 Month Period. J Ultrasound Med 1994;13:275-79 Sonographic Risk Assessment of Ovarian Cysts Sonographic Scoring System Color Flow Doppler CA 125 levels Sonographic Evaluation of Adnexal Masses 90% of Ovarian Tumors: Benign Functional Cysts: Most Common Ovarian Cysts: Most Common Gynecological Cause of Hospital Admission CORRELATION OF OVARIAN CYST FLUID PARAMETERS TO TRANSVAGINAL SONOGRAPHIC APPEARANCE AND SURGICAL PATHOLOGY IN ATTEMPTS TO DEFINE BENIGN VERSUS MALIGNANT CRITERIA 7
Methods Ultrasound including transvaginal evaluation of pelvic masses Cyst fluid aspiration: guidance by Transvaginal sonography Laparoscopy Following intact surgical removal at laparoscopy 64 patients Age range 18-80 Serum Ca 125 (Units/mL) Range 0-1503 Carcinoma Endometriomas Cystadenomas Other Benign Range 10-1,503 3-74 7-27 0-27 Results Median 109 8 7 Carcinoma Dermoids Cyst Fluid Ca 125 (Units/mL) Range 0-7900 Endometriomas Cystadenomas Other Benign Range 7-13,600 10-1,610 8-7,900 7-5,300 0-2,500 Median 250 133 45 7 Batzer et al - 1993 Significantly elevated cyst fluid Ca 125 levels (>1000) 13,600 Mucinous Cystadenocarcinoma 7,900 Serous Cystadenoma 5,300 Dermoid 2,550 Paratubal Mesotheliam-Lined Cyst 1,610 Endometrioma *Cyst Ca 125 levels not helpful in distinguishing benign vs malignant cysts Batzer et al - 1993 Endometriosis Serum Ca 125: range 3-75 Cyst Ca 125: range 10-1610 Often: Cyst Ca 125 > Serum Ca 125 Cyst fluid color important Batzer et al - 1993 Cyst Estradiol Levels (pg/ml) All corpus luteum cysts > 3600 All estradiol levels > 1500 were either corpus luteum or simple cyst < 5 cm in size revealing clear fluid at puncture and thereafter resolved Cyst Progesterone Levels (ng/ml) Pattern Parallels Estradiol Levels Batzer et al - 1993 ULTRASOUND ALL SIMPLE CYSTS ON ULTRASOUND CORRESPONDED TO BENIGN CYSTS (OVARIAN OR PARATUBAL) COMPLEX, MULTILOCULAR OR SEPTATED CYSTS: BOTH BENIGN AND MALIGNANT ALL MALIGNANT NEOPLASMS ASSOCIATED WITH COMPLEX MASSES ON US Batzer et al 1993 8
CONCLUSIONS Cyst fluid: hormonal levels when elevated, significant; possibly diagnostic? Serum CA 125: not diagnostic. US appearance and size: not diagnostic except when simple cyst. Cyst CA 125 if > serum, less likely to be malignant. Batzer et al 1993 Risk Assessment Evaluation Sonographic scoring systems (Sassone, Obstet Gynecol 1991 and Kurjak et al, J of US in Med 1991) Classification Criteria of Adnexal Masses Size (5cm or greater) Location (i.e. ovarian,paraovarian, uterine) Internal consistency (i.e. cystic, solid, fat, calcium, etc.) Associated abnormalities (i.e. intraperitoneal fluid, uni- or bilateral lesion) 1 Values Inner Wall Structure Smooth Variables Wall Thickness (mm) Thin < 3 mm Septa (mm) No septa Echogenicity Sonolucent HEMORRHAGIC OVARIAN CYST 2 3 4 5 MAX Irregularities < 3 mm Papillarities > 3 mm Not applicable, mostly solid 4 Thick > 3 mm Not applicable mostly solid 3 Thin < 3 mm Thick > 3 mm 3 Low echogenicity Low echogenicity echogenic core Mixed echogenicity High echogenicity 5 Scoring system for evaluation of abnormal ovaries and extrauterine masses of unclear origin. Sassone AM et al, Obstet Gynecol 78,70, 1991 9
Sonographic Differential Diagnosis of Pelvic Mass Cystic Completely cystic Physiologic ovarian cysts Cystadenomas Endometrioma Paraovarian cyst Hydatid cyst of Morgani Multiple Endometriomas Multiple follicular cysts Septated Cystadenoma (carcinoma) Mucinous Serous Papillary Complex Predominantly cystic Cystadenomas Tubo-ovarian abscess Ectopic pregnancy Hydrosalpinx Cystic teratoma Predominantly solid Cystadenoma (carcinoma) Germ cell tumor Solid Uterine Leiomyoma (sarcoma) Endometrial carcinoma, sarcoma Extrauterine Solid ovarian tumor, e.g. fibroma, thecoma, granulosa cell Based on most common appearance. (The Principles and Practice of Ultrasonography in Obstetrics and Gynecology, Fourth Edition, Fleischer AC, Romero R, Manning FA, Jeanty P, James Jr AE (eds), Chapter35, Fleischer AC, Entmann SS, pps 537-556, Appleton and Lange, 1991) Controversy: Potential Change in Status and Prognosis with Cyst Fluid Spillage in the Pelvis Similar to arguments against laparoscopic aspiration (Granberg, J US Med 1991) Cyst aspiration for asymtomatic pain relief: high recurrence rate (Crispigny, 1991) Endometrioma aspiration: Diagnostic: clotted thick material Scores and technique Remnant ovarian syndrome (Morrison et al, Roentgenol 1992) Conclusion Regarding Characterization of Adnexal Mass Determine origin: ovarian or extraovarian No solid component: benign [simple cyst, hemorrhagic cyst, endometrioma] Hyperechoic solid component [teratoma] Non-hyperechoic solid component location of flow, + peritoneal fluid, septations, suspect malignancy Brown et al 1998, Geomini et al 2006 Sclerotherapy Tetracycline sclerotherapy developed to treat tuberculosis pneumonitis Used to treat malignant pleural effusion/ascites Treatment of endometrioma (Aboulghar et al J Assist Reprod Genetics 1993) ETOH Similar Effect: (Okagaki 1999, Noma 2001, Koike 2002) 10
Sclerotherapy with Tetracycline: Treatment for Recurrent Endometriomas Prior to IVF (Fisch and Sher, Fertil Steril 2004) Sclerotherapy with Tetracycline: Local or conscious sedation Cyst sequentially aspirated and flushed with saline until all chocolate material removed 5% tetracycline solution equal to cyst volume injected in cyst 200-300 cc s of saline injected/aspirated from cul-de-sac to minimize any peritoneal discomfort from antibiotic (Fisch & Sher, Fertil Steril 2004) Sclerotherapy Endometriomas were resolved completely in 24/32 (75%) patients at 6 wks 8 patients had residual simple cysts aspirated of watery, brownish fluid and all showed resolution of their cysts four weeks later 2 patients required repeat treatment Only one patient did not respond to the procedure and elected not to pursue further treatment Fisch and Sher, Fertil Steril, 2004 Sclerotherapy All patients tolerated the procedure well, with mild abdominal cramping immediately following the procedure in 6 patients Cycle day 3 FSH levels were repeated in 6 patients and were not different from pretreatment values 28 patients subsequently have undergone IVF treatment 16 (57%) conceived an on-going gestation in the next cycle Fisch and Sher, Fertil Steril 2004 PUNCTURE PROCEDURES Pelvic Fluid/Abscess Drainage ± Catheter Placement Peritoneal cysts with attempted sclerosis (alcohol, tetracycline) Paratubal/ovarian cysts Inflammatory cysts Culdocentesis Efficacy of Transvaginally Sonographically Guided Aspiration and Drainage of Pelvic Abscess 41: Collections successfully aspirated 27: 18 purulent 9 suggestive of infection Outcome: 17 resolved without surgery 4 surgery for other reasons 6 required surgery 14 nonpurulent Outcome: 11 resolved without surgery 3 required surgery Conclusion: 78% (32) success: resolved without surgery 22% (9) required surgery Feld et al. AJR 1994;163:1141 11
Early ultrasound-guided transvaginal drainage of tuboovarian abscesses: a randomized study Pelvic Abscess Success Failure n % n % Initial Study (n=20) 18 90 2 10 Control (n=20) 13 65 7 35 Follow-up Study (n=18) 17 94 1 6 Control (n=13) 10 77 3 23 Modified from Perez-Medina et al. Ultrasound Obstet Gynecol 1996;7:435-438 Directed procedure: mutiple areas aspirated Placement of drainage catheter: pig tail angiocath Cul-de-sac fluid: flush possible (Van Sonnenberg et al 1992, McArdle, OB GYN 1984, Peisala, Br J OB GYN 1990) Peritoneal Cyst Clear Brown secondary to hemorrhage Negative hormonal levels Peritoneal Drainage: Ovarian Hyperstimulation Syndrome Accidental aspiration Antibiotic coverage Surgical removal if not pregnant Hydrosalpinx 12
Culdocentesis: Directed Procedure (not blind) Office or ER diagnostic test Immediacy of diagnosis Obsolete (Mermsh et al, Am J OB GYN 1990, Nyberg, Radiology 1990) Ectopic Pregnacy treatment: Directed Injection/Aspiration Methotrexate dosage to be determined (10-50mg) KCL particularly when heterotopic pregnancy Vasopressin Prostaglandin (Timor-Tritsch, Porreco 1990, Tulandi 1991) Cervical Pregnancy 13