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COSMETIC 14093: Recommendations for Patient Safety in Body Contouring Surgery After a Review of 4,000 Consecutive Cases

Louis Provenzano — Fri, 21 Nov 2008 16:00:00 GMT

COSMETIC 14093: Recommendations for Patient Safety in Body Contouring Surgery After a Review of 4,000 Consecutive Cases
Christopher K. Patronella, MD, FACS
Amado Ruiz-Razura, MD, FACS; German Newall, MD, FACS; Henry A. Mentz, MD, FACS
ACCEPTED
Topic Selection: Cosmetic IV (1628)
Preferred Presentation Format: Paper
Abstract
In recent years, there has been an increasing demand among plastic surgeons for patient safety that specifically addresses the complications suffered by certain patients regarding deep venous thrombosis (DVT) and pulmonary embolism (PE). In a survey conducted by Broughton et al. [4], he reveals that less than 50% of plastic surgeons use thromboprophylaxis as part of their standard protocol when performing aesthetic surgery. Pulmonary embolism represents the third highest cause of postoperative death in the US. Unfortunately, current data regarding this problem connected to aesthetic surgery is very limited. For this reason, it is our mission to share with fellow plastic surgeons our experiences taken from 17 patients, who have suffered from DVT/PE complications, in a review of 3,871 consecutive procedures performed over the last seven years in our center.
We conducted a retrospective chart review to identity the common factors responsible for causing DVT/PE among those high-risk patients who undergo aesthetic surgery. Of these cases, we have calculated the following incidence rates: 0.46% for DVT, and 0.08% for PE. We discovered that a culmination of factors working in a synergistic way plays a significant role in the development of DVT/PE. We conclude that a carefully planned out, comprehensive, appropriately enforced protocol is necessary to reduce the rate of thromboembolic events. Practical safety measures and technical recommendations are presented that strongly encourages the use of thromboprophylaxis during the preoperative, intraoperative and postoperative phases of aesthetic surgical procedures. Feel that DVT and PE should be an equal partnership between patient and surgeon.

Type of Clinical Question: Therapeutic
Clinical Question: It is the purpose of this study to review 3,871 consecutive high-risk cases and identity common factors that could have contributed to the onset of DVT/PE in 17 patients. The close evaluation of these 17 cases was conducted with an effort to determine if there were contributing factors that we could have been prevented and if not, how to implement a sound and prompt management to these serious problems and finding practical, prompt and efficient ways to prevent them in the future. We present our safety guidelines that resulted from the review of these 17 patients that encountered DVT and PE to be used for the implementation of thromboprophylaxis in the high risk and highest risk patient. We also provide our recommendations for the preoperative, intraoperative, and postoperative phases of surgery based in our experience with these 3,871 cases.
Inclusion/Exclusion Criteria for Study Population: All patients were part of the private group practice, all female, with a preoperative classification as high risk and highest risk cases. They all had an abdominoplasty, high volume liposuction an other added combination procedures performed during one operative session. All had to be discharged at 23 hours post surgery
Intervention/Exposure of Interest: Among those patients who presented complications, we carefully evaluated the following parameters: age, weight, body mass index (BMI), past medical history including medications, surgical, family and social history. In addition, during the course of surgery, we evaluated the duration of the procedure, amount of tumescent infiltration, the patient's total aspiration volume, the amount of tissue removed during surgery, and the patient's temperature throughout the pre, intra, and postoperative periods. A postoperative evaluation was also performed, taking into account any complications, such as the date and time when signs and symptoms were first noticed, and analysis of the different methods used to verify such complications such as the use of venous Doppler scan, Spiral CT Scan, and V/Q Scan.
Outcomes of Interest: After collecting preliminary information from the 3,871 patients, a group of statistics provided several analyses and projections. First, patients were sort in two groups and a sample size was determined for each group. Group Number I involved patients that suffered DVT/PE (sample size = 17), and Group Number II patients that did not presented signs and symptoms of DVT/PE complications (sample size = 3,854 patients). Then, the two-sample t-test was applied to compare both groups and a logistic regression model was created to predict the probability of having DVT complications in patients who undergo aesthetic surgery performed by the Department of Industrial Engineering- Section of Statistics at the University of Houston.
Type of Study: Case Series
Time Period: Retrospective
Controls: N/A
Randomization Method: Computer generated
Allocation Concealment/Blinding: N/A
Study Procedures: The study procedures conducted reflected a median age: 39 years, median height: 5’4”, median weight: 185 lbs, median BMI: 29.9. From the 17 patients with serious complications, 31% were categorized as ASA I, 56% as ASA II, and only 13% oas ASA III. When we combined this data with the Georgetown Risk Assessment Classification model, ALL patients were at the high-risk or highest risk level. Within this Classification , seven patients of the 17 fell into the high-risk category while the other 10 patients fell into the highest risk category. Those that were among the highest risk patients all exhibited more than four of the discovered factors to predispose them to develop DVT and PE. The average surgical duration: 5h 25 min ; average aspiration volume: 6,437 cc; average body temperature: 35.1° C . From the 17 patients, 12 developed deep venous thrombosis, and 3 developed pulmonary embolism, while two patients developed both events. An incidence rate of 0.42% was derived, and no mortality was encountered in this study. Signs and symptoms for DVT/PE complications, initiated from 3 to 23 days post surgery with an average of 11 days. Upon close review, 70% of these patients were diagnosed as having a predisposition for thrombogenesis caused by increased levels of clotting factors or inherited or acquired thrombophilias. At least 58% of the patients, were taking oral contraceptives or undergoing hormone replacement therapy. 80% of the patients using hormone replacement therapy were also ≥ 20% over their ideal body weight. One of our patients tested positive for Lupus another was positive for Factor V Von Leiden mutation. One patient who was taking hormone replacement therapy, tested positive for a prothrombin mutation and exhibited low levels of protein C and S. Another patient had elevated levels of homocysteine.
Statistical Methods: Table IV. Explanation of statistical analysis model used in this study. A logistic regression model in order to predict the probability of having DVT complication based on the values of these characteristics of the patient, the model can be presented as following: Where: Pr(DVT) = probability of the patient having the DVT complication. BMI = the value of Body Mass Index of the patient Temp = the value of the room temperature of the patient in Fahrenheit TT = 1 if the “Tummy Tuck” procedure is performed on the patient, 0 otherwise BodyL = 1 if the “Body Lifting” procedure is performed on the patient, 0 otherwise We used this model to predict the probability of having the DVT complication on 117 patients. The model correctly predicts the result about 90% of the times.
Representation of Data: After performing a number of statistical analyses on two groups of patients Group 1: patients with DVT complication (sample size = 17) and Group 2: patients without DVT complication (sample size = 100), our data indicates: Comparative Analysis Between the Thrombogenic and the Non-Thrombogenic Groups. Category Unit I - Thrombogenic Group N= 17 II - Non- Thrombogenic Group N= 100 p-value for Comparing Mean Mean Standard Deviation Mean Standard Deviation Age (year) 39.94 9.74 39.2 11.1 0.389 Pre-Weight (lbs) 178.5 33.1 165.4 34.6 0.076 Height (cm) 162.11 6.49 165.63 7.95 0.03 BMI (index) 30.95 6.41 27.23 4.59 0.017 Length of Surgery (minutes) 282 135 201 131 0.023 Patient Temperature (0F) 95.23 1.97 95.93 1.57 0.105 Total Fat Removed (cc) 6509 4883 4715 2889 0.08 Intra Venous Fluids (ml) 2533 1767 2174 998 0.228 Proportion of Patient Performed Tummy Tuck 0.706 0.47 0.379 0.488 0.008 Proportion of Patient Performed Body Lifting 0.294 0.47 0.046 0.211 0.024
Answer to Clinical Question: It is not our recommendation that every patient undergoes arduous and costly examinations to determine all genetic disorders and problems, which may arise before performing aesthetic surgery since this is not a realistic approach in terms of cost efficiency. However, the best approach, in our opinion, is for the surgeon to incorporate their own guidelines including the preventive measures discussed above to prevent the increased risk of DVT and PE. Once a preventive plan has been established, the surgeon must educate the patient about the possible signs and symptoms that may occur, and stress the importance of the patient communicating any concerns or symptoms immediately so that the physician can promptly diagnose and treat effectively. We cannot emphasize enough the need to have a thorough understanding and a comprehensive and proactive approach to DVT and PE, not only by the surgeon and anesthesiologist but throughout the entire surgical and nursing staff. Being compulsive and reacting promptly and effectively to early signs of thromboembolism has saved us from many problems and any fatalities. We conclude that all 17 patients that developed DVT and PE complications from the 3,871 consecutive cases reviewed, all were able to recover fully from their complication with no long-term effects from the thromboembolic event, and they are satisfied with the results of their surgery. We appreciate their cooperation in allowing us to collect the much-needed data that enabled us to report our experience intended to promote patient’s safety and the advancement of thromboembolism prophylaxis in aesthetic plastic surgery.
Discussion: We emphasize the effective use of sequential compression devices and anticoagulants to serve as a preventive measure among DVT/PE candidates who present elevated risk factors. It is not cost-effective to conduct extensive tests on all patients for each type of coagulopathy disorder. The plastic surgeon should implement a standard antithrombolytic regimen for those patients who exhibit the aforementioned factors placing them into a high risk category in order to decrease the incidence of DVT/PE. Sequential compression devices should be used as the standard of care in all patients under general anesthesia for 2 hours or more. Further considerations include the temporary discontinuation of hormonal therapy at least 4 weeks prior to surgery to ensure return of fibrinogen to normal level . We advise patients to consume multivitamins that contain folic acid & B complex to avoid elevated homocysteine levels at least two weeks prior to surgery. Reducing the patient's risk of hypothermia may reduce the risk of DVT by avoiding vasoconstriction and venous stasis . We feel that perioperative hypothermia can be accomplished by: 1: Use of "Bear Hugger" gowns; 2: Warming IV fluids and tumescent solutions; 3: Using warm humidified oxygen applied as a circuit warmer 4: Minimizing the surface area of exposure during surgery using sterile warmed blankets. The use of regional infusion pain pumps , to help with early ambulation along with the administration of low-molecular-weight-heparin such as Enoxaparin (Lovenox) 40 mg/day beginning on post operative day 1 and continuing for 2 more days. In this study, an early diagnosis and immediate aggressive treatment was instituted, preventing a potential catastrophic death. There needs to exist an open line of communication between the patient and their family and the surgeon and his staff in order to help promote the prevention and early detection of DVT and PE.

21-Nov-08 10:00 AM

Patronella Spring 2007 Newsletter

Jeremy Hartling — Mon, 21 May 2007 16:00:00 GMT


	What’s new in Cosmetic Surgery? The big story in cosmetic surgery today is the FDA’s approval of Silicone Breast Implants after they were pulled from the market 14 years ago. Both the American Society for Aesthetic Plastic Surgery (ASAPS) and The American Society of Plastic Surgeons (ASPS), the two largest and most respected plastic surgery membership organizations, applauded the FDA’s decision. There are two manufacturers who received an “approval by conditions” letter by the FDA, Allergan Corporation and Mentor Corporation. Both companies have been conducting long-term trials to prove the safety and effectiveness of silicone gel-filled implants. The “approval by conditions” means the implants were FDA approved on the condition that Allergan and Mentor meet several requirements including continuing their implant study through the next 10 years (see www.breastimplantsafety.org/ImplantOptions/trials.php for more about these and other FDA conditions). ASPS statistics page shows 383,886 women elected to have a breast augmentation procedure in 2006. The addition of silicone implants will give women more choices over what goes into their body. When considering the Breast Augmentation or Breast Reconstruction procedures, be sure to ask you surgeon about the differences between saline and silicone so that you may make a well informed decision. ASPS and ASAPS have set up a joint website to help the public understand their choices and make a better informed decision, www.breastimplantsafety.org.	Greetings to everyone and thank you for taking the time to read this first addition of my newsletter. These email newsletters are designed to keep you informed of what’s going on in the field of plastic surgery and what’s new in my practice. It is my hope that you find these newsletters valuable.
		The Surgeon Patient Coordinator The Philosophy Credentials Consultation Added Touch Don't Settle for Less Before & Afters
	Body Liposculpture with Tummy Tuck as an Alternative to Fully Body Lift. A full body lift is the procedure of removing excess skin and fat from the belly, hips, buttocks and thighs. This procedure requires an incision around the entire waist and the removal of a “belt” of skin. Then the skin is pull and sutured together. This may be the best choice for some patients but many patients are finding that a combination of the procedures Liposculpture and Tummy Tuck are a better alternative. Liposculpture is liposuction of specific areas to create a desired look. A tummy tuck (abdominoplasty) is the procedure of tightening the muscles of the abdominal wall and the removal of excess skin and fat from the middle to lower abdomen. For the right candidate, this combination of procedures can achieve a better final appearance with half the scarring. Dr. Patronella has spent years perfecting this technique and is a recognized authority in the plastic surgery community. Recently Dr. Patronella has presented this hot topic at national and international plastic surgery meetings. According to Dr. Patronella, “This innovative technique achieves great retraction of skin without such invasive techniques as circumferential body lifts therefore cutting recovery time and reducing scarring as well as making it more accessible to the general population.” Not everybody is a candidate but certainly many people will benefit from it. To learn more or to view before and after photos visit www.patronella.com.
	Face Lift or Soft Tissue Fillers? The effects of aging occur gradually and many who suffer from the effects of age on the face find themselves in the position where they are not quite ready for a facelift but desire some improvement. Modern medicine has responded with several non-surgical answers to this dilemma. For over 20 years women and men alike have relied on BOTOX to reduce facial wrinkles, one of the most common signs of age. Today there are a range of what are called soft tissue fillers that are injected into wrinkles and/or hollow areas of the face to give it back the fullness it once had. As the years have passed, new and better fillers have hit the market. Some of the more popular ones today include: Hyaluronic acid which included Restylane® and Juvéderm™. Collagen Calcium hydroxylapatite (Radiesse®) Polyactate (Sculptra®) In addition to BOTOX® and the soft tissue fillers mentioned above fat grafting is another great way of restoring a smoother, more youthful-looking face. Fat grafting is the process of harvesting your own fat cells from one area of your body and transplanting those cells to another. Although this process is very safe and there is no risk of an allergic reaction, the number of fat cell that survives the transplant can be a bit unpredictable. However, for many the use of one’s own tissue is an appealing alternative to the fillers listed above. When considering any of the procedures listed above remember that each product is different in its chemical make-up, longevity and cost. Your surgeon can educate you on their differences and help you make the best choice. These fillers are the simplest and least expensive method of re-contouring the face but are not a replacement for a facelift. These fillers can be used for smoothing out wrinkles, giving you fuller lips, correcting hollowness around the eyes or cheeks, smoothing out the jaw line, and correcting a deep furrow.
	ACPS’s Medical Spa Spot: Laser Hair Reduction is now for Everyone: Laser hair reduction has been around for over 30 years. Laser hair removal works by causing localized damage to dark target matter. Basically the dark matter (or melanin in the hair follicle) absorbs the light energy better then the lighter matter. Early lasers worked best when there was a large differentiation between the skin tone and the hair color. Pale individuals with light hair and dark skinned individuals were not good candidates for laser hair reduction. The introduction of the long pulse Nd:YAG lasers with its longer pulsewidths and wavelengths have made it possible to treat patients with darker skin tones and those who have but a small differentiation in skin tone to hair color. Please note that hair with no melanin is still not treatable nor does the Nd:YAG technology offer “permanent hair removal”. Lasers built for the purpose of hair reduction can only penetrate 2 millimeters deep into the skin. The majority of the dermal papilla, the only structure of the hair that can reproduce a new root system, is found approximately 4-7 millimeters deep. Therefore, given enough time most if not all hair will return. The Food and Drug Administration acknowledges that there is currently no hair removal procedure that is permanent and will not permit the use of the term “permanent removal”. Anyone claiming otherwise should be approached with skepticism. The FDA has approved a few lasers to claim “permanent reduction”. These few lasers have proven their superior hair reduction efficacy to the FDA and have been certified to make that claim. At ACPS we are proud to own two Nd:YAG lasers approved by the FDA to claim “permanent reduction”. The Candela corporation’s Gentle:YAG is among the safest and most efficacious lasers on the market. Whether you are fair skinned, dark skinned or well tanned, the GentleYAG can eliminate your need for shaving or waxing. It’s suitable for the delicate small areas like the upper lip and the large areas of a man’s back. Swimsuit weather is approaching fast. The time is now to begin your treatments. Download and print the coupon below to receive $300 off your next treatment or package. We have two locations to serve you. One coupon per patient. To make an appointment call (713) 799-9999.

	Please visit Dr. Christopher Patronella's website or The Aesthetic Center For Plastic Surgery website for further information. For additional information on this Newsletter article, please contact: Jeremy Hartling (713) 799-9999 jhartling@iapc.net Source: Louis Provenzano louis@proagency.com You are currently signed up as: person@gmail.com To not receive further mailings, send a blank email to: optout@iapc.net Newsletter design and layout by Provenzano & Associates, Inc.

21-May-07 11:00 AM

Dr. Patronella wins Best Paper Award

Derrick Fountain — Thu, 30 Nov 2006 17:00:00 GMT

Dr. Christopher K. Patronella, board certified plastic surgeon and founding partner of The Aesthetic Center for Plastic Surgery was recently awarded “The Best Paper Award” at the Annual Meeting of the Texas Society of Plastic Surgeons in Dallas on Saturday, September 23, 2006.

Dr. Patronella presented his impressive results of a comprehensive postoperative protocol implemented in a clinical study that involved 3,519 patients to ensure maximum safety when undertaking extensive body contouring surgery.

A full copy of this paper as presented in the scientific program can be obtained by contacting the ACPS Clinical Research Center under the direction of Amado Ruiz-Razura, M.D., FACS, FICS at 713-799-9999.

30-Nov-06 11:00 AM

The Extreme Makeover Team comes to Texas

Louis Provenzano — Wed, 01 Jun 2005 20:00:00 GMT

Extreme Makeover, Oklahoma edition, recently visited the offices of Dr. Christopher Patronella to document the continuing efforts of one local woman to dramatically change the way she looked and felt about herself. After many years of unsuccessful attempts at dieting and weight loss this patient decided to get serious about her appearance. She set specific goals and with the help of a personal trainer and Dr. Patronella was able to exceed her expected results. First she decided to enlist the help of a personal trainer to not only lose weight, but to also improve her overall stamina and endurance. After losing 68 lbs., she visited nationally recognized plastic surgeon, Dr. Christopher Patronella. Dr. Patronella is an experienced Houston plastic surgeon Board Certified by The American Board of Plastic Surgery. After carefully listening to her goals and a thorough examination, Dr. Patronella agreed to help her reach her goals with a number of highly skilled plastic surgery procedures. Beginning with a total body lift, including a tummy tuck and liposuction of the hips, waist, buttocks, thighs and legs, Dr. Patronella carefully sculpted her body removing the excess fat and sagging skin left behind by her aggressive exercise program. In addition to her total body makeover, she decided to undergo a breast augmentation and lift to complete her body transformation.

On air personality, Terry Hood of KOTV in Oklahoma plans to follow up on the recovery of this amazing extreme makeover and report her findings in yet another video segment to be broadcast later this year.

To learn more about this remarkable extreme makeover by Houston Plastic Surgeon Dr. Christopher Patronella, call 713-799-9999. To enquire about your own extreme makeover, contact Dr. Patronella’s friendly and knowledgeable staff or visit Dr. Patronella online with your questions or comments at www.patronellamd.com.

1-Jun-05 3:00 PM