Sponsored by

AAGLAdvancing Minimally Invasive Gynecology Worldwide

Plenary 1: Laparoscopy

MODERATOR

Masoud Azodi, MD

CO-MODERATORS

Yves Leroy M., MD & Richard M. Soderstrom, MD

Jay M. Berman, MDRichard S. Guido, MD

Kiley A. Bernhard, MD Kelly N. Wright, MD

Arturo Garza-Cavazos, MD

Professional Education Information Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Reduction in Uterine and Fibroid Volumes in 135 Consecutive Subjects Following Laparoscopic and Ultrasound-Guided Radiofrequency Ablation of Fibroids: 12-Month Follow-Up R.S. Guido ...................................................................................................................................................... 4 Prospective 12-Month Follow-Up of Menstrual Blood Loss Reduction Following 135 Consecutive Cases of Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids J.M. Berman .................................................................................................................................................. 7 Location of Epigastric Vessels Stratified by BMI A. Garza-Cavazos ......................................................................................................................................... 10 The Impact of Robot Acquisition on Method of Hysterectomy at a Single Institution K.N. Wright ................................................................................................................................................. 13 Hysterectomy Complications among Overweight and Obese Women: Role of 95% Confidence Intervals K.A. Bernhard .............................................................................................................................................. 16 Cultural and Linguistics Competency ......................................................................................................... 19

Plenary 1: Laparoscopy

Moderator: Masoud Azodi

Co-Moderators: Yves Leroy M., Richard M. Soderstrom

Faculty: Jay M. Berman, Kiley A. Bernhard, Arturo Garza-Cavazos, Richard S. Guido, Kelly N. Wright

Course Description

This session provides an array of topics concerning laparoscopic surgery. These topics that will be presented at the session will include change in fibroid volume and amount of blood loss following radiofrequency ablation (RFVTA), mapping of epigastric vessels stratified by BMI, impact of robot acquisition on method of hysterectomy and role of 95% CI in reporting hysterectomy complications among obese women.

Course Objectives

At the conclusion of this session, the participant will be able to: 1) Evaluate the effect of radiofrequency volumetric thermal ablation (RFVTA) on fibroid volume and blood loss in patients with moderate-to-severe menorrhagia; 2) Review alternate location of epigastric vessels with varying BMI; and 3) review the implication of introducing the robot for different routes of hysterectomy.

Course Outline 11:00 Reduction in Uterine and Fibroid Volumes in 135 Consecutive Subjects Following

Laparoscopic and Ultrasound-Guided Radiofrequency Ablation of Fibroids: 12-Month Follow-Up R.S. Guido

11:10 Prospective 12-Month Follow-Up of Menstrual Blood Loss Reduction Following 135 Consecutive Cases of Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids J.M. Berman

11:20 Location of Epigastric Vessels Stratified by BMI A. Garza-Cavazos

11:30 The Impact of Robot Acquisition on Method of Hysterectomy at a Single Institution K.N. Wright

11:40 Hysterectomy Complications among Overweight and Obese Women: Role of 95% Confidence Intervals K.A. Bernhard

11:50 Discussion

12:00 Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Jonathan Solnik Other:  Lecturer ‐ Olympus, Lecturer ‐ Karl Storz Endoscopy‐America  SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical Other: Royalties ‐ CooperSurgical Linda Bradley Grants/Research Support: Elsevier Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm Keith Isaacson Consultant: Karl Storz Endoscopy Rosanne M. Kho Other: Honorarium ‐ Ethicon Endo‐Surgery C.Y. Liu* Javier Magrina* Ceana H. Nezhat Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy‐America Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology William H. Parker Grants/Research Support: Ethicon Women's Health & Urology Consultant: Ethicon Women's Health & Urology Craig J. Sobolewski Consultant: Covidien, CareFusion, TransEnterix Stock Shareholder: TransEnterix Speaker's Bureau: Covidien, Abbott Laboratories Other: Proctor ‐ Intuitve Surgical  FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Richard S. Guido Grants/Research Support: Halt Medical, ikonosys Consultant: Halt Medical    

2

Jay M. Berman Grants/Research: Boston Scientific Corp. Inc., Halt Medical, Minerva Surgical, Thermablate‐EAS Consultant: Aegea Medical, Boston Scientific Corp. Inc. Speakers Bureau: Boston Scientific Corp. Inc., Merck Serono Arturo Garza‐Cavazos* Kelly N. Wright Other: Resident Instructor for pig lab ‐ Ethicon Endo‐Surgery Kiley A. Bernhard* Masoud Azodi Grants/Research Support: Intuitve Surgical Richard M. Soderstrom* Yves Leroy M.*          Asterisk (*) denotes no financial relationships to disclose. 

3

Reduction in Uterine and Fibroid Volumes in 135 Consecutive Subjects Following Laparoscopic and Ultrasound‐guided Radiofrequency Ablation of Fibroids: 12‐Month Follow Up 

Richard S. Guido, MD University of Pittsburgh, Magee‐Women’s Hospital of the UPMC Health System, Pittsburgh, PA

David J. Levine, MD St. John’s Mercy Medical Center, St. Louis, MO

Donald I. Galen, MD Reproductive Science Center of the Bay Area, San Ramon, CA

James A. Macer, MD Pasadena Premier Women’s Health, Pasadena, CA

Janice L. Falls, MD Albert Einstein College of Medicine, Bronx, NY 

Ian B. Tilley, MD  University of Southern California Medical Center, Los Angeles, CA

Scott G. Chudnoff, MD MS Albert Einstein College of Medicine, Bronx, NY

Representing The Halt Study Group

Disclosures

• Grants/Research Support: Halt Medical, Ikonosys

• Consultant: Halt Medical

Objective

To assess outpatient radiofrequency volumetric thermal 

ablation (RFVTA) in women with symptomatic fibroids 

and moderate‐to‐severe heavy menstrual bleeding in 

terms of:

• Uterine volume reduction

• Fibroid volume reduction

• Incidence of surgical re‐intervention within 12 

months post treatment

Radiofrequency Volumetric Thermal Ablation of Fibroids

A Gynecologic Procedure

Combines three basic gynecologic skills:

• Laparoscopy: two trocars, no special suturing p py , p gskills

• Ultrasound: laparoscopic ultrasound probe scans and manipulates

• Tip/needle array placement under ultrasound guidance

The Radiofrequency Handpiece

CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE

The RF Generator and Handpiece

CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE

4

Phase III Study – Design and Setting

• Prospective, multicenter, single‐arm, international 

clinical trial; subjects serve as their own controls

• Study participants (N = 135) diagnosed with 

symptomatic fibroids; moderate‐to‐severe heavy 

menstrual bleeding confirmed by alkaline hematin

testing

• Eleven (11) study centers; 13 investigators

Inclusion / Exclusion Criteria

Inclusion Criteria:• Symptomatic, premenopausal, ≥ 25 yrs old, and 

desires uterine conservation

• No more than 6 fibroids, no one fibroid larger 

than 7 cm in diameter, no more than 300 cm3

total fibroid volume

Exclusion Criteria:• Active pelvic infection or history of PID, 

malignancy, pelvic radiation, DUB, or chronic pelvic pain

• Prior pelvic surgery (except C‐section, tubal, or diagnostic laparoscopy) or uterine‐preserving technique for reduction of menstrual bleeding

• Uterine gestational size ≤ 14 weeks

• Menstrual Blood Loss ≥ 160 to ≤ 500 mL/cycle 

(one or two cycles)

• Normal Pap, normal or correctable coagulation 

profile

• Completed childbearing and practicing stable 

contraception

• Able to provide informed consent

technique for reduction of menstrual bleeding (with the exception of hysteroscopicmyomectomy ≥ 1 year ago)

• Pedunculated or Type 0 fibroids, cervical myoma, significant adhesions, suspected endometriosis or adenomyosis

• Contraindications to laparoscopic surgery including anemia (Hb < 10 or Hct <  30)

• FSH > 25 IU/L

• Any GnRH agonist in the last 3 months

• Implantable fallopian tube devices

Primary Method for Uterine and Fibroid Volume Measurement

• Magnetic Resonance Imaging

• Pre‐contrast Imaging

– T1/T2 axial sagittal and transverse MRI– T1/T2 axial, sagittal and transverse MRI

• Post‐contrast Imaging

– T1 axial and sagittal contrast‐enhanced MRI

Baseline Demographics

Variable Statistic/Response (N= 137)

Age, years 42.4 ± 4.7

Gravida 3.2 ± 2.1

Para 2.3 ± 1.3

Race

White or Caucasian 62 (45.3%)

Black or African American 46 (33.6%)

Hispanic, Hispanic indigenous, Caribbean 27 (19.7%)

Asian 2 (1.5%)

Smoking History

Current 29 (29.2%)

Past 23 (16.8%)

Never 85 (62.0%)

Height, cm 162.6 ± 8.1

Weight, kg 81.0 ± 19.1

Laparoscopic Ultrasound:Number and Location of Treated Fibroids

Parameter N = 135

Number of fibroids per subject 6.1 ± 4.9

Median 4.0; range, 1 – 29

Total number of fibroids 818

Location

Fundal 163 (20 3%)Fundal 163 (20.3%)

Mid uterus 43 (5.3%)

Lower uterine 127 (15.8%)

Anterior 283 (35.2%)

Posterior 273 (34.0%)

Left 173 (21.5%)

Right 195 (24.3%)

Broad Ligament 2 (0.2%)

Not specified 14

Laparoscopic Ultrasound:Types of Treated Fibroids

Type1 N = 135

Subserosal 212 (26.6%)

Intramural 462 (58.0%)

Transmural 39 (4.9%)

Submucosal 173 (21.7%

Not specified 22

1 A fibroid could have been more than one type. Percentages were based on the number of fibroids with nonmissing data.

5

Operative and 12‐Month Results

• Mean duration of procedure: 2.1 ± 1.0 hours

• Total blood loss: 39.2 ± 26.8 mL

• Treated on outpatient basis: 96.2%

• 5 Device‐related AEs: 3.6%

– SAEs: Pelvic abscess in posterior cul de sac, sigmoid serosal tear caused by ultrasound probe

– AEs: severe lower abdominal pain, superficial uterine serosal burn, post procedure vaginal hemorrhage 

• Time to normal activity: 7–10 days

• Re‐intervention rate: 0.7%

Significant Reduction in Mean Uterine Volume, cm3 [p < .001]

361.8

307.3

274

250

300

350

400

0

50

100

150

200

Baseline 3 Months 12 Months

N = 135 N = 134 N = 132

Significant Reduction in Mean Total Fibroid Volume, cm3 [p < .001]

80.4

50 2

60

70

80

90

50.244.9

0

10

20

30

40

50

Baseline 3 Months 12 MonthsN = 135 N = 134 N = 132

Percentage of Change in Uterine and Fibroid Volume From Baseline

‐10

‐5

0

3 Months (N = 134) 12 Months (N = 132)

‐15.8

‐25.1

‐37.7

‐44.3‐50

‐45

‐40

‐35

‐30

‐25

‐20

‐15

Change in Uterine Volume, % Change in Total Fibroid Volume, %

Conclusions

• RFVTA significantly reduces fibroid and uterine 

volume

• RFVTA is associated with a low rate of perioperative 

complicationscomplications

• RFVTA is associated with a low re‐intervention rate

• RFVTA provides an effective outpatient procedure 

for women with fibroids and heavy‐to‐severe 

menstrual blood loss

6

Prospective 12-Month Follow Up of Menstrual Blood Loss Reduction

Following 135 Consecutive Cases of Radiofrequency Volumetric Thermal

Ablation of Symptomatic Fibroids

Erika Banks, MD Albert Einstein College of Medicine, Bronx, NY

Micah Harris, MD Women’s Health Research, Phoenix, AZ

José Garza Leal, MD Hospital Universitario Nuevo Leon, Monterrey, MexicoRodolfo Robles Pemueller, MD Hospital Universitario Esperanza, Guatemala

Scott G. Chudnoff, MD, MS Albert Einstein College of Medicine, Bronx, NY

Karen R. Abbott, MD Athena Gynecology Medical Group, Reno, NV

Jay M. Berman, MD Wayne State University School of Medicine, Detroit, MI

For the Halt Study Group

Disclosures

Jay M. Berman

Grants/Research: Boston Scientific Corp. Inc., Halt Medical, Minerva Surgical, Thernabkate-EAS, g ,Consultant: Aegea Medical, Boston Scientific Corp. Inc.Speakers Bureau: Boston Scientific Corp. Inc., Merck Serono

Objectives

To assess the efficacy and safety of radiofrequency volumetric thermal ablation (RFVTA) in women with symptomatic myomas and moderate-to-severe heavy menstrual bleeding (≥ 160 to ≤ 500 mL), in terms of:

• Mean Menstrual Blood Loss

• Incidence of Device-Related Adverse Events

• Surgical Re-interventions

Radiofrequency Volumetric Thermal Ablation of Myomas

A Gynecologic Procedure

Combines three fundamental gynecologic skills:

• Laparoscopy using 2 trocars and requiring no special p py g q g psuturing skills

• Ultrasound using a laparoscopic ultrasound probe to scan and manipulate

• Tip/array placement under laparoscopic ultrasound guidance

RadiofrequencyAblation Systemfor Symptomatic

Myomas

CAUTION: INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE

Phase III StudyDesign and Setting

• Prospective, multicenter, single-arm, international clinical trial

• Study participants (N = 135) serve as their own controls

• All enrolled subjects diagnosed with: Symptomatic myomas Moderate-to-severe heavy menstrual bleeding

(≥ 160 to ≤ 500 mL)

• Menstrual bleeding confirmed by alkaline hematintesting

• Eleven (11) study centers and 13 investigators

7

Inclusion and Exclusion CriteriaInclusion Criteria• Symptomatic, premenopausal, ≥ 25

yrs old, and desires uterine conservation

• No more than 6 myomas, no one myoma > 7 cm in diameter, total myoma volume not to exceed 300 cm3

• Uterine gestational size ≤ 14 weeks

M t l Bl d L ≥ 160 t ≤ 500

Exclusion Criteria• Active pelvic infection or history of PID,

malignancy, pelvic radiation, DUB, or chronic pelvic pain

• Prior pelvic surgery (except C-section, tubal or diagnostic laparoscopy) or uterine-preserving technique for reduction of menstrual bleeding (except hysteroscopicmyomectomy ≥ 1 year prior)• Menstrual Blood Loss ≥ 160 to ≤ 500

mL/cycle (one or two cycles)

• Normal Pap; normal or correctable coagulation profile

• Childbearing completed and practicing stable contraception

• Able to provide informed consent

myomectomy ≥ 1 year prior)

• Pedunculated or Type “0” myomas, cervical myoma, significant adhesions, suspected endometriosis or adenomyosis

• Contraindications to laparoscopy including anemia (Hb < 10 or Hct < 30)

• FSH > 25 IU/L

• Any GnRH agonist in prior 3 months

• Implantable fallopian tube devices

Menstrual Blood Loss OutcomesMethods of Measurement

• Bleeding outcomes measured by alkaline hematin (AH) analysis

• AH assessment of returned sanitary products (pads / tampons) quantified MBL at baseline and at 3, 6, and 12 months post treatment

• Each subject’s used catamenial products processed at a central laboratory (KCAS, Shawnee, KS)

• Subjects meeting all inclusion criteria underwent LUS-guided radiofrequency volumetric thermal ablation of their symptomatic myomas

• Any surgical re-intervention for heavy menstrual bleeding was reported at 3, 6, and 12 months post treatment

Baseline DemographicsVariable Statistic/Response

(N = 137)

Age, years

Mean 42.4 ± 4.7

Median 43 (range, 30–55)

Gravida 3.2 ± 2.1

Para 2.3 ± 1.3

Height cm 162 6 ± 8 1Height, cm 162.6 ± 8.1

Weight, kg 81.0 ± 19.1

Race

White or Caucasian 62 (45.3%)

Black or African American 46 (33.6%)

Hispanic, Hispanic indigenous, Caribbean 27 (19.7%)

Asian 2 (1.5%)

Baseline AH, mL [Per Protocol Set, N = 124]

Mean 271.3 ± 79.7

Median 248 (range, 160–486)

Number and Types of Myomas DetectedWith Laparoscopic Ultrasound

Variable N = 135 1

Number of myomas per subject 6.1 ± 4.9

Median 4.0; range, 1 – 29

Total number of myomas 818

Type 2

Subserosal 212 (26.6%)

I t l 462 (58 0%)Intramural 462 (58.0%)

Transmural 39 (4.9%)

Submucosal 173 (21.7%)

Not specified 22

1 Two subjects excluded as they did not meet baseline AH inclusion criteria.

2 A myoma could have been more than one type. Percentages are based on the number of myomas with nonmissing data.

Operative and Perioperative Results

• Total procedural blood loss: 39.2 ± 26.8 mL

• Mean duration of procedure: 2.1 ± 1.0 h

• Treated as outpatients: 96.2%

• Device-related AEs/SAEs– 3 AEs: superficial uterine serosal burn, post-procedure vaginal

hemorrhage, severe lower abdominal pain

– 2 SAEs: pelvic abscess in posterior cul de sac, sigmoid serosaltear caused by ultrasound probe

• Time to normal activities: 7–10 days

MBL Outcomes

• 11 subjects (11/135) did not submit catamenial products for evaluation at 12 months Amenorrhea (n = 4), pregnancy (n = 3), voluntary withdrawal (n =

2), lost to follow up (n = 1)

1 subject (1/135) did not collect per protocol requirements

• Remaining 124 subjects demonstrated statistically and clinically significant mean menstrual blood loss reduction from their baseline levels: 88 ± 133 mL at 3 months (–33%) p < .001

113 ± 103 mL at 6 months (–41%) p < .001

103 ± 115 mL at 12 months (–38%) p < .001

8

Re-intervention

• Re-intervention rate: 0.7% (1/135) One subject, who was lost to follow-up at 6-

months post treatment, later pursued p ptreatment by UAE

Bleeding Reduction by Category

Discussion

• Recommendations in the literature for the use of subjective, patient-centered measures in the clinical management of heavy menstrual bleeding [1–3]

• Lukes et al identified the minimum change in MBL that would be meaningful to patients at 6 months aswould be meaningful to patients at 6 months as assessed by the Menorrhagia Impact Questionnaire [1,4]– 36 mL/cycle

– 22% reduction

• In comparison,at the same time point, RFVTA provided MBL reduction of:– 113 mL per cycle

– 41% mean decrease in bleeding

Conclusions

• RFVTA is effective in reducing MBL by statistically and clinically significant margins in women with myomas and moderate-to-severe heavy menstrual bleeding

• This outpatient procedure provides a viable new modality of symptomatic myoma management

References

• Lukes AS, Muse K, Richter HE et al. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin 2010;26(11):2673–8.

• Hallberg I, Nilsson I. Menstrual blood loss and population study. Acta Obstet Gynecol Scand 1996;45:320–51

• Wheeler TL Murphy M Rogers RG et al Clinical practice guideline• Wheeler TL, Murphy M, Rogers RG et al. Clinical practice guideline for abnormal uterine bleeding: hysterectomy versus alternative treatment. J Minim Invasive Gynecol 2012;19(1):81–8.

• Warner PE, Critchley HOD, Lumsden MA et al. Menorrhagia I: measured blood loss, clinical features, and outcome in women with heavy periods: a survey with follow-up data. Am J Obstet Gynecol2004;190:1216–23.

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Location of Epigastric Vessels Stratified by BMI

A. Garza-Cavazos, S. Lay, J. Buedefeldt-Pollard, K. Groesch, R. Robbs, J. Becker, S. SiddiqueGroesch, R. Robbs, J. Becker, S. Siddique

Arturo Garza-Cavazos, M.D.

MIGS Fellow

AAGL Nov 5-9, 2012

Disclosure

I have no financial relationships to disclose.

Objectives

• Review previously established safety zones in normal weight patients.

• Identify safety zones for trocar entry in obese patients.

Background

Laparoscopy: > 2 million cases/year (1)

Abdominal wall vessel injury occurs 0.2 –2% in laparoscopic surgeries (1)2% in laparoscopic surgeries (1)

Previous studies have mapped safe zones for entry at > 8 cm from midline. (2)

1. Fuller et al.,Zaki et al., Aharoni et al., Spitzer et al.

2. Saber et al., Hurd et al., Sriprasad et al., Eptstein et al.

Study Objective

• Determine if the course of the epigastric vessels varies in obese patients

• Establish safe points in obese patients to avoid injury during port placement.

Design

Consecutive selected CT images

Mapped at fixed points

Patients ere di idedPatients were divided according to BMI values divided by WHO criteria

10

Design

Inclusion criteria: Patients 18 years of age and older

Exclusion criteria: < 18 yrs of age, and any condition that may alter y g , y ythe location of the epigastric vessels

Reviewed 310 CT scans. Included 252.

T-test , one-way ANOVA (Tukey)

Results

Normal(68)

OW(51)

Obese I(51)

Obese II(32)

Obese III(32)

p-Value

M1 – R 4.4 (1.0) 5.4 (1.2) 5.8 (1.4) 6.3 (1.6) 7.4 (1.5) .0001

M1 – L 4.9 (1.2) 5.4 (1.1) 6.3 (1.5) 6.7 (1.6) 8.0 (1.8) .0001

ASIS R 4.6 (1.1) 4.9 (1.0) 5.4 (1.0) 6.0 (1.6) 6.8 (1.3) .0001

ASIS L 4.7 (1.2) 5.0 (1.0) 5.4 (1.1) 6.1 (1.5) 6.7 (1.6) .0006

M2 – R 5.1 (1.1) 5.3 (0.9) 5.6 (0.9) 6.2 (1.4) 6.5 (1.2) .0026

M2 - L 5.1 (1.1) 5.2 (0.8) 5.4 (0.8) 6.0 (0.8) 6.4 (1.3) .0079

Results, Tukey’sNormal BMI compared to:

OW Obese I Obese II Obese III

X – R 2.5 (0.7) 2.7 (1.0) 2.8 (0.6) 3.1 (1.0)

X – L 2.3 (0.8) 2.7( 1.0) 2.8 (0.8) 3.2 (1.1)

M1 – R 5.4 (1.2) 5.8 (1.4) 6.3 (1.6) 7.4 (1.5)

= significant

M1 – L 5.4 (1.1) 6.3 (1.5) 6.7 (1.6) 8.0 (1.8)

ASIS R 4.9 (1.0) 5.4 (1.0) 6.0 (1.6) 6.8 (1.3)

ASIS L 5.0 (1.0) 5.4 (1.1) 6.1 (1.5) 6.7 (1.6)

M2 – R 5.3 (0.9) 5.6 (0.9) 6.2 (1.4) 6.5 (1.2)

M2 - L 5.2 (0.8) 5.4 (0.8) 6.0 (0.8) 6.4 (1.3)

PS – R 5.8 (0.7) 6.0 (0.8) 6.2 (0.9) 6.5 (1.0)

PS – L 5.4 (0.7) 5.5 (0.7) 6.0 (0.8) 6.1 (1.2)

6 0

7.0

8.0

4.0

5.0

6.0

Normal Overweight Obese I Obese II Obese IIIMid1‐R Mid1‐L ASIS‐R ASIS‐L Xyphoid‐R Xyphoid‐L Mid2‐R Mid2‐L Pubis‐R Pubis‐L

7.46.36.7

8.0

Mid1‐R Mid1‐L

0 0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

4.45.1

5.86.34.9

5.4

Normal Overweight Obese I Obese II Obese III

Mid‐1

0.0

11

Conclusions

The average distance from midline to the epigastricsincreases with increasing BMI.

Previously described safe zones for lateral laparoscopic port placement remain the same inlaparoscopic port placement remain the same in patients with BMI's < 35.

Ports should be placed > 10 cm from midline in patients with BMI's 35 to minimize vessel injury.

References• Fuller J, Ashar BS, Carey-Corrado J. Trocar-associated injuries and fatalities: an analysis of 1399 reports to the

FDA. J Minim Invasive Gynecol. 2005;12:302-307.

• Zaki H, Penketh R, Newton J. Gynecological laparoscopy audit: Birminham experience. Gynecol Endocrinol. 1995;4:251-257

• Aharoni A, Condea A, Leibovitz Z, et al. A comparative study of Foley catheter and suturing to control trocar-induced abdominal wall hemorrhage. Gynecol Endocrinol. 1997;6:31-32

• Spitzer M, Golden P, Rehwaldt L, et al. Repair of laparoscopic injury to abdominal wall arteries complicated by cutaneous necrosis J Am Assoc Gynecol Laparosc 1996;3:449-452cutaneous necrosis. J Am Assoc Gynecol Laparosc. 1996;3:449-452.

• Saber A, Meslemani A, Davis R, Pimentel R. Safety Zones for Anterior Abdominal Wall Entry During Laparoscopy A CT Scan Mapping of Epigastric Vessels. Ann Surg 2004;239:182-185

• Hurd W, Bude R, DeLancey J, Newman J. The location of abdominal wall blood vessels in relationship to abdominal landmarks apparent at laparoscopy. Am J Obstet Gynecol 1994;171:642-6

• Sriprasad S, Yu D, Muir G, Poulsen J, Sidhu P. Positional Anatomy of Vessels That May Be Damaged at Laparoscopy: New Access Criteria Based on CT and Ultrasonography to Avoid Vascular Injury. Journal of Endourology 2006;20:498-502

• Epstein J, Arora A, Ellis H. Surface Anatomy of the Inferior Epigastric Artery in Relation to Laparoscopic Injury. Clinical Anatomy 2004;17:400-408

12

Kelly N. Wright, MDL h  Cli i  M di l C tLahey Clinic Medical Center

Burlington, MA 

Consultant: Ethicon – Resident suturing lab instructorg

Hysterectomy

600,000 hysterectomies per year

Second most common surgical procedure women undergo

Hysterectomy accounts for over $5 billion health care dollars per yearp y

[AHRQ.gov]

Analysis of U.S. surgical data in 2005 showed the following rates of hysterectomy:

Abdominal (66%), vaginal (22%), and laparoscopic (12%)[Wu, et al]

Changing trends

Despite recommendations by professional organizations and evidence of superior health and economic outcomes, most hysterectomies continue to be performed via a laparotomy

Robotic surgery has been proposed as a way to overcome the difficulties encountered with traditional laparoscopic techniques for hysterectomy 

[Advincula, Wang]

To observe the impact of the acquisition of a surgical robotic system on method of hysterectomy performed in a single gynecology department  

Objectives

department. 

Retrospective cohort analysis

Medium‐sized academic community hospital in an urban location

All gynecological cases performed at Mt Auburn Hospital from January 1, 2006 to April 10, 2012 were obtained from operating room case recordsroom case records

1111 women were identified as undergoing hysterectomy ‐‐ different gynecologic surgeons 

‐‐ sub‐specialists, ‐‐ generalists

13

Results

From 2006 to 2010 (pre‐robot):  Abdominal hysterectomy decreased from 26% to 8% (p<.001) 

Laparoscopic hysterectomy increased from 59%  Laparoscopic hysterectomy increased from 59% to 82% (p<.001) 

From 2011 to 2012 (post‐robot): Abdominal hysterectomy stayed stable at 8‐10%

Laparoscopic hysterectomy decreased from 82% to 46% (p<.001)

Committee guidelines

ACOG and the AAGL have issued guidelines in support of minimally invasive procedures, vaginal hysterectomy in particular, when choosing the method of hysterectomy

We should aim to reduce abdominal hysterectomy when feasible

choosing the method of hysterectomy

How can we increase minimally invasive hysterectomy?

Findings

At our institution, the acquisition of a robot decreased laparoscopic hysterectomy by 44% while abdominal hysterectomy rates remained unchanged

Similar findings by Brenot and Goyert Compared with the 18 months prior to robot acquisition:▪ Laparoscopic hysterectomy decreased by 62% in the 18 months after robot acquisition

▪ Abdominal hysterectomy decreased by 18%

The costs

Barbash and Glied found that, on average, the additional cost of using a robot was $1600 ‐$3200 per procedure

[NEJM]

If the 600,000 hysterectomies performed in the United States each year were all done robotically:

$960 million to $1.6 billion increase in health care costs

14

Conclusions

In an institution where a minimally invasive gynecologic surgery program already exists, the robot decreased laparoscopic hysterectomy

Thi   d   h ld b   li d     i i i   This study should be replicated at an institution where a laparoscopy program has not been established

Further institutional, regional, and national data are needed to truly determine trends in rates of hysterectomy

References

Agency for Healthcare Research and Quality. Health Services Research on Hysterectomy and Alternatives. http://www.ahrq.gov/research/hysterec.htm.

Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003.  Obstet Gynecol 2007;110(5):1091‐5.

Advincula AP, Wang K. Evolving role and current state of robotics in minimally invasive gynecologic surgery. J Minim Invasive Gynecol 2009;16(3):291‐301.

Choosing the Route of Hysterectomy for Benign Disease  ACOG Committee  Choosing the Route of Hysterectomy for Benign Disease. ACOG Committee Opinion 444. Obstet Gynecol 2009;114(5):1156‐8.

AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol 2011;18(1):1‐3.

Jonsdottir GM, Jorgensen S, Cohen SL, Wright KN, Shah NT, Chavan N, Einarsson JI. Increasing minimally invasive hysterectomy: effect on cost and complications. Obstet Gynecol. 2011;117(5):1142‐9.

Brenot K, Goyert GL.  Impact of robotic surgery on obstetric‐gynecologic resident training.  J Reprod Med. 2009 Nov‐Dec;54(11‐12):675‐7.

Barbash GI, Glied SA. New Technology and Health Care Costs ‐The Case of Robot‐Assisted Surgery. N Engl J Med 2010;363(8):701‐4.

15

Gynecologic Surgeons: Profiling At A Glance

Kiley A. Bernhard, MPH1

Hannah Louks BS2Hannah Louks, BS2

Danish S. Siddiqui, MD3

Suneet P. Chauhan, MD4

1Center for Urban Population Health, Milwaukee, WI; 2University of Wisconsin School of Medicine and Public Health;

3Department of Obstetrics and Gynecology, Aurora Sinai Medical Center; 4Eastern Virginia Medical School, Norfolk, Virginia

Disclosures

• I have no financial relationships to disclose.

Learning Objectives

• Identify the strengths and limitations of surgeon report cards and surgeon profiling

• Compare two different mechanisms of reporting surgeon complication rates

1. Rank ordering by means 2. Overlapping 95% confidence intervals

• Illustrate the benefits of examining the overlap between confidence intervals for comparison

• Discuss study limitations and future directions

3

Introduction

• Surgeon report cards have become a popular approach to surgery quality improvement

• Must take careful consideration when presenting data on surgeon performance to prevent consumers from drawing incorrect conclusions

• The majority of the research on surgeon profiling has occurred in cardiac surgery

• Paucity in studies within the specialty of gynecology

(Shahian et al., 2001)

Literature Review

Relevant peer-reviewed publications were identified through searching PubMed using combinations of MeSH and keywords with

MeSH term/KeywordGynecological

SurgeryCardiac Surgery

Benchmarking/Methods 0 7

Benchmarking 6 177

Confidence intervals 89 419

Database management systems 1 3Outcome assessment (health care)/methods 8 69and keywords with

surgical specialties.

Searches yielded considerably more publications within cardiac surgery than gynecological surgery.

5

Patient safety 2 24

Quality improvement 4 26

Quality of health care (methods) 215 684

Risk adjustment 2 137

Registries (methods) 0 0

Prognostic models 3 5

Public reporting 1 41

Quality performance measures 0 0

Report card 0 15

Surgeon performance 0 5

Surgeon profile 0 0

Surgeon rating 0 0

Surgical records 3 4

Total 334 1616

Literature Review

334 PublicationsTotal identified in PubMed search

(published in English between July 2002 and

July 2012)

3 PublicationsStudied the efficacy of various quality improvement methods on improving

surgeon performance.Overall conclusions :

1. Analysis of outcomes with appropriate feedback and education is a powerful tool for quality improvement

27 PublicationsIncluded after title review

and abstraction

11 PublicationsIncluded for full-text

review

5 PublicationsOutlined the methodology used in

studies to report surgeon performance.

powerful tool for quality improvement [Aletti 2009].2. A national system studying the outcomes in gynecologic surgery using a risk-adjusted model would provide a meaningful mechanism in identifying areas in need of quality improvement [Aletti 2007].

•Publications were excluded if they did not study the assessment or describe the methods used to support the evaluation of surgeon performance, surgeon profiling, or surgical outcomes. •Specifically, the project team looked for articles that outlined the data collection methods and analysis techniques used to assess outcomes or articles that discussed the implementation of a quality improvement approach.

16

Methods

• Subjects: 25 surgeons in one tertiary center in an inner city hospital

• Timeframe: 7/9/2007 and 12/30/2011 • Included procedures: Women with BMI>25kg/m2, p g ,

who had hysterectomy for a benign indication• Excluded procedures: Hysterectomy for

malignant or obstetrical indications• Outcome variable: Overall complication rate

- Surgical complications: Urinary tract, bowel, vascular, or nerve injury, ileus, or postoperative hemorrhage

- Wound complications: Dehiscence, vaginal cuff cellulitis, wound infection, wound seroma, abscess, or hematoma

- Medical complications: VTE, urinary complications, febrile morbidity, respiratory complication(s), renal failure, stroke, or retained sponge

7

Data Analysis

• Morbidity among surgeons was compared using 95% confidence intervals

• Non-overlapping 95% CI were considered pp gsignificant

• This is a simple, conservative method for comparing two point-estimates.

30%

40%

50%

60%

Mean Complication Rate by Surgeon

Institutional Mean = 25%

Traditionally surgeons above the mean would be considered to have excess morbidity

‐10%

0%

10%

20%

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

60%

70%

80%

90%

100%

95% CI for Overall Complication by Surgeon

One‐sided CI not includedNon-Overlapping CI

0%

10%

20%

30%

40%

50%

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Limitations

• Sample size restrictions – single hospital• Did not use risk-adjusted outcomes• Possible ambiguity with end points• Surgeon volume – large CIs for few casesSurgeon volume large CIs for few cases

Discussion

• The surgeon report card has been viewed with skepticism by numerous physicians.

• The utility of the report card has expanded beyond the hands of the actual physician and the hospital system and has been made publicly available to current and future patientsmade publicly available to current and future patients.

• It is imperative that the methodology used to produce quality report cards be easily understood but as robust as possible.

17

Future Directions

• Development of a prognostic model for hysterectomies

• Utilization of risk adjusted rates which take into

t hi h i k

Table 1. Patient characteristics and comorbidities for non-overlapping surgeons

Variable All S21 S10 S22 S5

N=538 N=35 N=58 N=75 N=92

Mean/% Mean/% Mean/% Mean/% Mean/%account higher risk patients (i.e. severity of illness)

• Feedback from administration and surgeons regarding interpretation of reporting mechanisms.

BMI (kg/m2) 35 35 33 36 36

Uterine weight (g) 330 412 341 297 333>2 presence of Diabetes, CVD, and/or Pulmonary Disorder

12% 9% 7% 5% 23%

Previous abdominal surgery 40% 34% 45% 44% 40%

• Reporting 95% CI is a conservative method and can be used for single institutions

• Utilizing the 95% CI as a reporting method eliminates ranking of surgeons

Conclusion

• Surgeon report cards need to be simplified for the physician, administration, and the patient

• Hierarchical models with risk-adjusted outcomes are preferred esp. for comparing multiple hospitals

References

• Atelli GD, Dowdy SC, et al. Quality Improvement in the Surgical Approach to Advanced Ovarian Cancer: The Mayo Clinic Experience. J Am Coll Surg. 2009;208:614-620.

• Aletti GD, Santillan A, et al. A new frontier for quality of care in gynecologic oncology surgery: Multi-institutional assessment of short-term outcomes for ovarian cancer using a risk-adjusted model. Gynecologic Oncology. 2007:107:99-106.

• Kondalsamy-Chennakesavan S, Bouman C, et al. Clinical audit in gynecological cancer surgery: development of a risk scoring system to predict adverse events. Gynecol Oncol. 2009 Dec;115(3):329-33. Epub 2009 Sep 15.

• Myers ER, & Steege JF. Risk adjustment for complications of hysterectomy: limitations of routinely collected administrative data. Am J Obstet Gynecol. 1999 Sep;181(3):567-75.

• Pasternak LR & Johns A. Ambulatory gynaecological surgery: risk and assessment. Best Pract Res Clin Obstet Gynaecol. 2005 Aug;19(5):663-79. Epub 2005 Jul 11.

• To T, Williams JI, et al. Comparison of methods to identify outliers observed in health services small area variation studies. Stat Methods Med Res. 2003 Dec;12(6):531-46.

• Tu FF Feinglass J & Milad MP Does physician benchmarking improve performance of laparoscopically assisted vaginal• Tu FF, Feinglass J, & Milad MP. Does physician benchmarking improve performance of laparoscopically assisted vaginal hysterectomy? South Med J. 2005 Sep;98(9):883-7.

• Konig A & Geraedts M. [Development of the quality of surgical gynaecological care in the State of Hesse, Germany under external quality assurance]. Gesundheitswesen. 2006 Feb;68(2):128-33. German.

• Christiansen CL & Morris CN. Improving the Statistical Approach to Health Care Provider Profiling. Ann Intern Med. 1997;127:764-768.

• Dai J, Zhongmin L, & Rocke D. Hierarchical Logistic Regression Modeling with SAS GLIMMIX. University of California, Davis, CA. • Harrell FE, Lee KL, & Mark DB. Multivariable Prognostic Models: Issues in Developing models, Evaluating Assumptions and

Adequacy, and Measuring and Reducing Errors. Statistic in Medicine. 1996;15:361-387.• Shahian DM, Edwards FH, et al. Public Reporting of Cardiac Surgery Performance: Part 1- History, Rationale, Consequences. Ann

Thorac Surg. 2011;92:S2-S11.• Brown ML, Lenoch JR, Schaff HV. Variabiility in data: The Society of Thoracic Surgeons National Adult Cardiac Surgery Database.

J Thorac Cardiovasc Sur. 2010;140:267-73.• Glance LG, Dick A, et al. Impact of Changing the Statistical Methodology on Hospital and Surgeon Ranking: The Case of the New

York State Cardiac Surgery Report Card. Med Care. 2006;44:311-319.• Shahian DM, Torchiana DF, et al Massachusetts Cardiac Surgery Report Card: Implications of Statistical Methodology. Ann Thorac

Surg. 2005;80:2106-13.• Schenker N and Gentleman J. On Judging the Significance of Differences by Examining the Overlap Between Confidence Intervals.

The American Statistician. 2001;55:3:182-186.

18

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

19