A Prospective Pilot Study of Robotic-Assisted Harvest of the Latissmus Dorsi Muscle for FDA 510(K) Approval
John Shuck, M.D., Mark W. Clemens, M.D., Jesse C. Selber, M.D., M.P.H..
M.D. Anderson Cancer Center, Houston, TX, USA.
There are no FDA approved plastic surgery indications for the Da Vinci Robotic Surgical System (Intuitive Surgical, Sunnyvale CA). This prospective study, designed in consultation with the FDA, is intended to demonstrate safety and efficacy in latissimus muscle harvest for 510(K) approval.
Patient demographics, robotic specific operative details and times, as well as overall complications were recorded. Baseline upper extremity function and disability including range of motion, Medical Research Grade grade strength, and quickDASH scores were compared at baseline and specific follow-up intervals. A visual analog scale was used to examine post-operative pain. Analysis included a difference in differences technique between operative and non-operative extremity function with paired t-test.
Fifteen patients enrolled, as recommended by the FDA, with a history of radiation in 93.3% (n=14/15). Mean follow up to date is 12.7 months. Assist access was performed via prior mastectomy/axillary incision (mean = 9.1 cm) with 0/15(0%) requiring conversion to open approach. 87% (n=13/15) of patients underwent concomitant symmetry procedures with mean operative and console times of 309.3 and 67.4 minutes respectively. No significant difference was detected between baseline and 3-6 month follow-op QuickDASH (p= 0.47) and QuickDASH Work modules (p=0.58). Visual analog scores for pain demonstrated progressive improvement to near baseline at 3-6 month follow-up (Figure 1.) No statistically significant differences were detected in function including range of motion and MRC strength grade. (Table1.) Complications included infection (n=2/15, 13.3%), hematoma (n=1/15, 6.7%), wound dehiscence (n=1/15, 6.7%), and seroma (n=1/15, 6.7%).
Latissimus harvest using the Da Vinci Robot is safe and effective with low complication rates and no significant residual functional limitations. Robotic LD harvest should be considered among the indicated uses for this device.
Table 1. Baseline vs. 3-6 month follow-up
|Mean Diff Baseline||Mean Diff 3-6 Mo. Follow-Up||Mean Change||St Dev||p-value|
|Difference in Active Range of Motion (Affected vs. Unaffected Arm) in Degrees|
|Forward Elevation Active||-6.07||-12.29||-6.21||9.50||0.26|
|Forward Elevation Passive||-7.86||-14.43||-6.57||8.68||0.22|
|External Rotation Active||-8.64||-11.29||-2.64||11.57||0.41|
|External Rotation Passive||-6.93||-12.36||-5.43||11.08||0.31|
|Internal Rotation Active||1.79||4.93||3.14||5.10||0.73|
|Internal Rotation Passive||-6.07||-12.29||-6.21||9.50||0.26|
|Cross-body Adduction Active||1.86||4.07||2.21||4.67||0.68|
|Cross-body Adduction Passive||1.79||1.50||-0.29||3.75||0.47|
|Difference in MRC Grade Strength (Affected vs. Unaffected Arm)|
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