Safety of Vertical Augmentation-Mastopexy: Prospective Evaluation of Breast Perfusion Using Laser Fluorescence Imaging

Abstract

Background

Augmentation-mastopexy is often recommended to simultaneously correct breast ptosis and restore upper pole fullness. However, some investigators believe that this procedural combination increases risk and recommend staging the surgery for some patients.

Objectives

This prospective study was undertaken to evaluate the blood supply of the breast and, specifically, the nipples and areolae to determine whether breast implants inserted at the time of a vertical mastopexy compromise blood supply.

Methods

The SPY Elite Intraoperative Perfusion Assessment System was used to provide objective measurements of skin perfusion during surgery. To avoid confounding variables, patients served as their own controls. Twenty-five women (50 breasts) meeting the inclusion criteria (inclusion rate: 96%) were studied. All patients underwent bilateral vertical augmentation-mastopexies using a medial pedicle. No surgery was staged. The mean implant volume was 360 cc (range, 180-575 cc). The breasts were imaged in surgery after completion of bilateral mastopexies with insertion of (unfilled) saline breast implants and a second time after inflation of the implants.

Results

Complications included 1 distal deep venous thrombosis, 1 infection, 1 partial areola necrosis, and 1 case of delayed wound healing. There was no significant difference (P < .01) in intraoperative perfusion measurements comparing absolute and relative values before and after breast implant inflation (saline-filled implants) or insertion (silicone gel implants), including 5 patients undergoing secondary mastopexies.

Conclusions

The insertion of breast implants at the time of a vertical mammaplasty with a medial pedicle does not significantly reduce perfusion of nipple/areola complexes. Staging the procedure is unnecessary.

Level of Evidence

4 Therapeutic

Breast lifts are increasing in popularity.¹ However, mastopexy alone provides minimal upper pole fullness.² Simultaneous implants may be recommended to provide greater fullness of the upper poles of the breasts.³

Augmentation-mastopexy has traditionally been considered a risky procedure.⁴ Many investigators^4-10 recommend staging the surgery for patients with a higher risk of complications. However, 2 operations are inconvenient and more costly for patients. The author has previously studied augmentation-mastopexy patients treated exclusively with the vertical technique and found no increased risk in combining procedures.³ This study was undertaken to evaluate the possibility of compromised circulation caused by inserting breast implants at the time of a mastopexy.

Laser fluorescence imaging is a safe, objective measurement technique to evaluate the perfusion of mastectomy flaps^11-14 and breast reconstruction flaps.¹¹ No existing publications describe its use during augmentation-mastopexy.

METHODS

Patients

In this prospective, controlled study, laser fluorescence imaging was performed in 25 women undergoing mastopexies in combination with breast implants between July 2014 and January 2015. The indications for this procedure were breast ptosis and upper pole volume depletion. The study inclusion criteria consisted of (1) treatment with bilateral vertical mastopexies in combination with breast implants, (2) patient consent, (3) no history of an allergy to iodinated contrast dye, and (4) a Fitzpatrick I to V skin type. There were no exclusion criteria. All patients treated with a vertical mammaplasty were included, regardless of breast tissue resection weights, including 5 patients with >300 g of tissue removed from at least 1 breast, who would qualify as breast reductions plus implants.^2,3 All women undergoing augmentation-mastopexy during the study period met the inclusion criteria, except 1 patient with a Fitzpatrick VI skin type (a high melanin content in the skin can interfere with perfusion measurements), who was excluded, making the inclusion rate 96%. No patient was recommended for staging.

Institutional review board approval was obtained from Chesapeake Institutional Review Board Services, accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. The study was registered with the United States National Institutes of Health ClinicalTrials.gov database.¹⁵ Patients underwent Doppler ultrasound screening of the lower extremities for the detection of deep venous thromboses at the time of their preoperative appointment, 1 day after surgery, and approximately 1 week (range, 4-10 days) after surgery.¹⁶ This screening regimen is used for all plastic surgery procedures, including cosmetic breast surgery performed alone or in combination with abdominoplasty. No chemoprophylaxis was used.

All patients were offered either saline-filled or silicone gel implants. Nineteen women (76%) chose saline-filled implants (Figures 1-4), and 6 women (24%) chose silicone gel implants. Five patients (20%) had undergone previous mastopexies or breast reductions (Figures 5-7). In each case, the original surgeon used a Wise pattern, and surgeries were performed 8 to 20 years previously. A vertical technique was used for all secondary mastopexies. Seven women (28%) had existing breast implants. Two patients (8%) had undergone previous mastopexies and had implants.

Imaging System

The SPY Elite Intraoperative Perfusion Assessment System (LifeCell Corporation, Branchburg, NJ) uses a near-infrared laser to create fluorescence. The contrast agent, indocyanine green, is absorbed at a wavelength of 806 nm.¹⁷ The imaging agent is injected intravenously and is bound to plasma proteins.¹⁷ The dye is metabolized by the liver, and the half-life is 2.5 to 3 minutes.¹² Quick clearance from circulation allows repeated imaging of the same patient during surgery, unlike when fluorescein is used. The imaging equipment was provided by LifeCell Corporation. The cost of the dye kits, paid by the author, was $1300 per patient.

Surgery

The nipple site was determined intraoperatively.³ No mosque-dome or keyhole pattern was used. All procedures were performed by the author at a state-licensed ambulatory surgery center under total intravenous anesthesia using a laryngeal mask airway, secured by tape to allow back elevation during surgery. All patients wore sequential compression devices. The same operative sequence was used in all cases. The breasts were first injected with a mean volume of 155 cc (range, 105-200 cc) of local anesthetic solution, consisting of 0.125% bupivacaine, 0.25% lidocaine, and 1:300,000 epinephrine. The local anesthetic was injected in both breasts before the first incision was made. In the 8 patients who also underwent abdominoplasties (“mommy makeovers”), the breast surgery was performed first to optimize sterility, followed by the body contouring procedures. Warmed fluids and blankets and a Bair Hugger (Arizant Inc., Eden Prairie, MN) were used to avoid hypothermia.

Starting on the right side, the breast implant was inserted submuscularly using an incision on the lower pole of the breast within the vertical elliptical resection pattern (Figure 3A). All saline-filled breast implants (Allergan Inc., Irvine, CA) were round, smooth, and had moderate profiles (Natrelle Style 68). The 6 pairs of silicone gel implants were also round, smooth, and had a midrange profile (Natrelle Style 15). Pre- and postoperative photographs, intraoperative photographs, and imaging studies for 2 patients are provided in Figures 2-7.

In surgery, the saline-filled implant was filled with 50 cc of saline and then aspirated to remove air from lumen of the implant, leaving it clamped with <50 cc saline within the implant. Next, the right vertical mammaplasty was undertaken. The filling tube was left connected to the implant, exiting through the lower mastopexy incision line (Figures 3B,C and 6A). The vertical mammaplasty technique³ with a medially based pedicle¹⁸ was used in all patients. The sequence was repeated for the left breast. Scalpel dissection was performed exclusively. Electrocautery was limited to treatment of individual vessels using a 9½ inch (24 cm) Potts-Smith monopolar, insulated, serrated, 2.0 mm handswitch cautery forceps (Kirwan Surgical Products, Marshfield, MA). No drains were used.

After completion of the augmentation mastopexies, except for implant inflation, 3 cc (7.5 mg) of indocyanine green were injected intravenously, flushed with a 10 cc bolus of saline, and a video was recorded for 136 seconds (Figures 4A and 7A). Next, the implants were filled to their maximum fill volumes, and the filling tubes were withdrawn. The breasts were re-imaged (Figures 4B,C and 7B). For women who chose silicone gel implants, the implants were inserted after the mastopexies (and after the first laser fluorescence imaging) into previously dissected submuscular pockets by opening the vertical limbs. For patients with greater degrees of ptosis, a short, inverted-T modification was used at the bottom of the vertical mastopexy incision (Figure 6) to keep the scar from continuing onto the abdomen. (A supplemental video that demonstrates vertical augmentation mastopexy with intraoperative evaluation of perfusion using laser fluorescence imaging may be viewed at www.aestheticsurgeryjournal.com.)

Perfusion Measurements

By testing skin circulation in the same patient at 2 time points, patients served as their own control. The mean time between injections was 32 minutes (range, 20-78 minutes), allowing sufficient time for dissipation of the contrast dye injected earlier. Two points on each breast were selected overlying the upper pole and lower pole, equidistant from the midline. The areola perfusion was measured at 4 points. Nipple perfusion was also measured. The SPY video recording started immediately after the contrast agent was injected and flushed with 10 cc of normal saline. The perfusion 120 seconds post-flush was measured in all cases. Times were recorded automatically in the bottom left corner of the SPY video images. Both absolute and relative values were tabulated. Percentages were based on a 100% value assigned to the xiphoid reference point. This reference point was chosen because (1) it was not subject to dissection, (2) it was included in the areas injected with local anesthetic and epinephrine, and (3) it was within the field of view.

Statistical Analysis

Statistical analyses were performed using IBM SPSS for Macintosh Version 22.0 (SPSS, IBM Corp., Armonk, NY). Paired t tests were used to compare measurements before and after breast implant inflation/insertion. In view of multiple comparisons, a value of P < .01 was considered significant. To achieve 80% power, with a 2-tailed alpha level of 0.05, sufficient to detect a moderate treatment effect (d = 0.60)¹⁹ using a paired t test, 24 total subjects would be needed.²⁰

RESULTS

Patient data are presented in Table 1. The mean patient age was 45 years (range, 29-69 years). The mean implant volume was approximately 360 cc (range, 180-575 cc). The mean right breast resection weight was 171 g (range, 29-502 g), and the mean left breast resection weight was 173 g (range, 29-520 g). The mean follow-up time was 75 days (range, 4-243 days). Complications occurred in 4 patients (16%). A thrombosis of the left calf veins was discovered at the time of 1 patient's scheduled postoperative ultrasound screening examination 8 days after surgery. This patient also underwent an abdominoplasty and liposuction. She was treated as an outpatient with enoxaparin subcutaneous injections followed by oral rivaroxaban. The popliteal vein was unaffected. A follow-up Doppler ultrasound 5 weeks after surgery showed full resolution of the clot. One patient experienced partial left areola necrosis that spontaneously healed in 2 months with minimal extra scarring and no need for revision. This former smoker had stopped smoking 2 weeks before surgery but resumed smoking postoperatively. Her SPY image (Figure 1) showed intact areola perfusion during surgery. There were no cases of nipple loss. One patient developed a superficial cellulitis that cultured Staphylococcus aureus, sensitive to methicillin, and was successfully treated with oral antibiotics. One patient experienced delayed healing of her right mastopexy wound at the junction of the vertical and short horizontal limbs. This patient's wound was revised 6 weeks after surgery so as to expedite healing and reduce scarring. There were no hematomas or seromas. No implant complications were observed during the study period. No patient experienced an allergic reaction to the contrast dye.

One 57-year-old woman treated with saline-filled implants showed clinical signs of nipple/areola ischemia in surgery after her implants were filled to 270 cc. SPY imaging confirmed reduced nipple/areola perfusion and no additional saline was added. This patient returned 3.5 months later and her implants were filled to their 450 cc maximum fill volume. She had no complications. One patient requested a DD cup size and was treated with implants inflated to 540 cc (Figures 2-4). As an extra precaution, this patient was imaged 3 times: (1) before inflation of the implants, (2) after partial inflation of the implants to 350 cc, and (3) after inflation to the maximum 540 cc fill volume. There was no significant (P < .01) difference in any of the perfusion measurements comparing images recorded before and after implant inflation (saline implants) or insertion (silicone gel implants) comparing absolute values or percentages. To conserve space, combined nipple and areola measurements are shown without the individual nipple and areola (superior, inferior, medial, and lateral) comparisons, which were all nonsignificant (Table 2). The t tests were also performed at an alpha level of 0.05, with no significant differences. Three patient subsets were also studied: secondary mastopexies (5 patients), secondary augmentations (7 patients), and smokers (4 patients). There were no significant differences in pre- and postinflation values for these patient subsets.

DISCUSSION

Advantages of Augmentation-Mastopexy

Rigorous measurements on standardized photographs reveal that efforts to fill the upper pole (“autoaugmentation”) have been unsuccessful.²¹ It is not possible to replicate the effect of an implant using repositioned breast tissue. Indeed, from the perspective of upper-pole filling, an implant is more effective than repositioned breast tissue.² A patient who lifts her breasts by the cups of her hands to show what she wants is unlikely to be satisfied with a mastopexy alone,² hence, the clinical role for augmentation-mastopexy. In the author's practice, the majority (72%) of women undergoing mastopexies elect to have simultaneous implants.³

Safety Concerns

The safety of augmentation-mastopexy has been the subject of controversy.^4-10 Some investigators believe that combining implants with a mastopexy raises the risk of complications,^4-10 even exponentially.²² Other plastic surgeons report no unusual increase in complications for patients treated with implants at the same time as mastopexy.^3,23-25 Beale et al²⁶ recently reported minimal complications among augmentation-mastopexy patients treated with the Wise pattern, but these investigators recommended small (<200 cc) implant volumes to improve safety.

Anatomical Considerations

The clinical safety of vertical augmentation-mastopexy³ suggests that any increased risk of augmentation-mastopexy derives not from combining procedures, but rather from the use of nonvertical mastopexy techniques. A Wise pattern with an inferior pedicle reduces the vascularity of the nipple by severing its superficial circulation on 3 sides, making the nipple/areola perfusion wholly dependent on the deep circulation and a random inferior skin pedicle. When an implant is used simultaneously, an already tenuous circulation may be compromised even further by the additional dissection and possibly the pressure of a breast implant on the pedicle.³ Depending on the degree of ptosis, the inferior pedicle may be lengthy and its base is fixed, so that it is susceptible to tension, compromising circulation to the nipple/areola complex.³

Theoretically, a vertical mammaplasty technique that incorporates a medial pedicle is less likely to jeopardize nipple circulation because the pedicle is free to move up as the breast mound elevates and expands.³ The nipple is repositioned only a few centimeters in most cases and in no cases more than 6.5 cm.² The deepithelialized pedicle is short and preserves a superficial axial blood supply from the intercostal perforating arteries from the internal mammary artery. These vessels provide the dominant superficial circulation to the nipple and areola in 70% of women.^27,28 However, this concept, based on anatomic considerations only, has not been previously tested using objective measurements of tissue perfusion.

Operative Sequence

The operative sequence for this study differed from typical clinical practice (and the author's usual practice) in that the mastopexies were performed before the implants were inflated (or in the case of the silicone gel implants, before insertion) rather than after. It is reasonable to ask whether this practice might cause wound disruption in some patients as the implant is filled. Care was taken not to over-resect the skin of the lower pole. The author makes use of a sturdy parenchymal repair, suturing the lateral and medial pillars in the midline so as to buttress the implant and avoid excessive skin tension. In no cases did the implant inflation cause wound disruption. This sequence resulted in tight, conical lower poles, optimizing breast aesthetics (Figures 2B and 5B,C). By contrast, the traditional Wise pattern is known for producing boxy lower poles.²⁹ Postoperatively, patients may resemble candidates for augmentation-mastopexy (Figure 5A). The aesthetic advantages of simultaneous breast implants at the time of breast reduction have been recently documented.³⁰ It is conceivable that breast and nipple/areola perfusion might be impaired by disproportionate implant size or by over-resection of the skin of the lower pole, even when using the vertical mammaplasty/medial pedicle technique. Considerations of implant size and the extent of the mastopexy resection are no different for the combined procedure than for these procedures when they are performed individually.

Study Design

Different patient characteristics and conditions can affect perfusion, including vascular anatomy, neurohormonal factors affecting skin circulation, anesthetic agents, ambient lighting, and room temperature. Measurements may vary over time, accounting for counterintuitive increases in perfusion measurements at some sites after implant inflation (Figures 4A-C and 7A,B). Using the patient as her own control eliminates almost all uncontrolled variables and is particularly advantageous when the study population is necessarily limited by the high cost of this sophisticated imaging technology. This study design takes advantage of the fact that the implant may be inflated while preserving the same mastopexy dissection. The alternative would be to recruit 2 groups of patients, doubling the number of patients needed and doubling the cost of the study. Two different patient groups, mastopexies versus augmentation-mastopexies, would also allow the influence of numerous confounding variables as discussed above, plus different mastopexy patterns, tissue resection weights, and implant volumes. In an effort to avoid selection bias and maximize study reliability, exclusion criteria were avoided. Patients with previous mastopexies and/or implants and smokers were included to evaluate any possible differences in results for these patient subgroups.

Epinephrine Effect

Epinephrine is a potent vasoconstrictor. When infused before a mammaplasty, blood loss is minimized, making electrodissection unnecessary.³ It would be unethical to withhold such an agent for study purposes. Its tissue concentration may change during the course of surgery. To control for this variable, relative perfusion measurements were made. This method has been used previously by the author in evaluating perfusion of the abdominal flap during abdominoplasty.³¹ Perfusion measurements were compared to the xiphoid reference point. If the tissue epinephrine concentration had changed significantly between the dye injections, one would expect a change in the xiphoid perfusion measurements as well. The finding that mean xiphoid perfusion measurements were similar at the 2 imaging times (21.1 and 19.8) suggests that the tissue epinephrine effect was also similar at the 2 imaging times, which were only 32 minutes apart, on average. Perfusion levels relative to the xiphoid reference point (Table 2), measured in percentages, mirrored the absolute levels, providing additional evidence of the similarity of breast tissue perfusion before and after implant inflation.

Seroma Prevention

The absence of seromas in this sample of 25 patients is consistent with the author's clinical experience using scalpel dissection.³ Lejour³² reported fewer seromas when using scalpel dissection instead of electrocautery. Electrodissection is known to produce an internal burn injury, causing inflammation.³³ Seroma fluid resembles an inflammatory exudate,³⁴ not simply a collection of lymphatic fluid. In a large prospective series,³ the author encountered no seromas after augmentation-mastopexy.

Secondary Mastopexy

Controversy exists regarding whether to use the same mastopexy technique in a patient who has undergone a previous mastopexy.^35-37 In secondary cases, care was taken to preserve a widely deepithelialized pedicle, in some cases 180 degrees (the full superior areola hemicircumference), so as to maximize nipple/areola perfusion. For patients with a previous Wise pattern mammaplasty, the nipple/areola rarely requires transposition (indeed, it is frequently overelevated).³ Similar complication rates^3,36,37 and perfusion measurements suggest that, with these precautions, changing to a vertical mammaplasty pattern for secondary surgery is safe.

Limitations of the Study

In view of the infrequency of skin necrosis (1/25 patients), it is not possible in a study of this size to determine a cutoff value¹³ linking a specific perfusion measurement with an increased risk of skin necrosis. Perfusion levels vary across the breasts. Identifying the exact site for each perfusion measurement involves some subjectivity. An attempt was made to mitigate this variability by measuring multiple sites and comparing means. The sample size is also a limitation, particularly for the patient subset comparisons. There is a possibility of a Type II (false negative) statistical error that might be avoided by using a much larger sample size. However, the lack of significantly decreased perfusion measurements, even with an alpha level of 0.05 (which would be more likely to detect differences at the risk of false positives), makes this possibility unlikely. As a practical matter, the cost of such an investigation in a large number (ie, >100) of patients would be prohibitively expensive in a study that is not supported by outside funding. Nevertheless, 25 patients (and 50 breasts) are sufficient to meet the requirements of a power analysis and sample size calculation to reliably detect a moderate treatment effect. Follow-up times are short (mean, 75 days), but sufficient for detection of any ischemic complications. The study period is much too short to evaluate the long-term complications associated with breast implants, which was not the purpose of the study. This study included only patients with round, smooth breast implants with a moderate profile. It did not evaluate shaped or high-profile implants. The conclusions apply only to a vertical mammaplasty and medial pedicle.

Strengths of the Study

Each patient served as her own control, avoiding multiple confounding variables that can affect perfusion measurements when different patient groups are compared. One surgeon performed the same technique in all cases, avoiding confounders related to surgeon and method. No patients were selected for staging, which avoids selection bias. The manufacturer provided no funding for this study, precluding commercial bias.

CONCLUSIONS

The simultaneous use of breast implants at the time of a vertical mastopexy with a medial pedicle does not impair circulation. A vertical augmentation-mastopexy is clinically safe from the standpoint of perfusion of the breasts and nipple/areola complexes. There is no need to stage surgery when a vertical mammaplasty and medial pedicle are used.

Supplementary Material

This article contains supplementary material located online at www.aestheticsurgeryjournal.com.

Disclosures

The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The author received no financial support for the research, authorship, and publication of this article.

Acknowledgements

The author thanks Jane Zagorski, PhD for statistical analyses and Sarah Maxwell, RN for data collection.

REFERENCES