Faculty Bibliography

BACKGROUND:Patients with less severe adult spinal deformity undergo surgical correction and often achieve good clinical outcomes. However, it is not well understood how much clinical improvement is due to sagittal correction rather than treatment of the spondylotic process. PURPOSE/OBJECTIVE:Determine baseline thresholds in radiographic parameters that, when exceeded, may result in substantive clinical improvement from surgical correction. STUDY DESIGN/METHODS:Retrospective. METHODS:ASD patients with BL and 2-year(2Y) data were included. Parameters assessed: SVA, PI-LL, PT, T1PA, L1PA, L4-S1 Lordosis, C2-C7 SVA(cSVA), C2-T3, C2 Slope(C2S). Outcomes: Good Outcome(GO) at 2Y: [Meeting either: 1) SCB for ODI(change greater than 18.8), or 2) ODI<15 and SRS-Total>4.5. Binary logistic regression assessed each parameter to determine if correction was more likely needed to achieve GO. Conditional inference tree(CIT) run machine learning analysis generated baseline thresholds for each parameter, above which, correction was necessary to achieve GO. RESULTS:We included 431 ASD patients. There were 223(50%) that achieved a GO by two years. Binary logistic regression analysis demonstrated, with increasing baseline severity in deformity, sagittal correction was more often seen in those achieving GO for each parameter(all P<0.001). Of patients with baseline T1PA above the threshold, 95% required correction to meet Good Outcome(95% vs. 54%,P<0.001). A baseline PI-LL above 10° (74% of patients meeting GO) needed correction to achieve GO (OR: 2.6,[95% CI 1.4-4.8]). A baseline C2 slope above 15° also necessitated correction to obtain clinical success (OR: 7.7,[95% CI 3.7-15.7]). CONCLUSION/CONCLUSIONS:Our study highlighted point may be present at which sagittal correction has an outsized influence on clinical improvement, reflecting the line where deformity becomes a significant contributor to disability. These new thresholds give us insight into which patients may be more suitable for sagittal correction, as opposed to intervention for the spondylotic process only, leading to a more efficient utility of surgical intervention for adult spinal deformity. LEVEL OF EVIDENCE/METHODS:III.

STUDY DESIGN/METHODS:Retrospective review of a cervical deformity database. OBJECTIVE:This study aimed to develop a model that can predict the postoperative DJK angle by using pre and post-operative radiographic measurements. SUMMARY OF BACKGROUND DATA/BACKGROUND:Distal junctional kyphosis (DJK) is a complication following cervical deformity correction that can reduce of patient quality of life and functional status. Although researchers have identified the risk factors for DJK, no model has been proposed to predict the magnitude of DJK. METHODS:The DJK angle was defined as the Cobb angle from LIV to LIV-2 with traditional DJK (tDJK) having a DJK angle change >10°. Models were trained using 66.6% of the randomly selected patients and validated in the remaining 33.3%. Pre-and post-operative radiographic parameters associated with DJK were identified and ranked using a conditional variable importance table. Linear regression models were developed using the factors most strongly associated with the postoperative DJK angle. RESULTS:131 patients were included with a mean follow-up duration of 14±8 months. The mean postoperative DJK angle was 14.6±14° and occurred in 35% of the patients. No significant differences between the training and validation cohort were observed. The variables most associated with post-operative DJK were: preoperative DJK angle (DJKApre), postoperative C2- lower Instrumented vertebral tilt (C2-LIV), and change in cervical lordosis (∆CL). The model identified the following equation as predictive of DJKA: DJKA=9.365 + (0.123*∆CL) - (0.315* ∆C2-LIV) - (0.054*DJKApre). The predicted and actual postoperative DJKA values were highly correlated (R=0.871, R2=0.759, P<0.001). CONCLUSION/CONCLUSIONS:The variables that most increased the DJK angle were the preoperative DJK angle, postoperative alignment within the construct, and change in CL. Future studies can build upon the model developed to be applied in a clinical setting when planning for cervical deformity correction.

PURPOSE/OBJECTIVE:Despite adequate correction, the pelvis may fail to readjust, deemed pelvic non-response. To assess alignment outcomes(pelvic non-response[PNR], PJK, postoperative cervical deformity[CD]) following ASD surgery utilizing different realignment strategies. METHODS:ASD patients with 2-year(2Y) data were included. PNR defined as undercorrected in age-adjusted pelvic tilt(PT) at 6W and maintained at 2Y. Patients classified by alignment utilities: [a] Improvement in SRS-Schwab SVA,[b] Matching in age-adjusted PI-LL,[c] Matching in Roussouly,[d] aligning Global Alignment and Proportionality(GAP) score. Multivariable regression analyses, controlling for age, baseline deformity, and surgical factors, assessed rates of PNR, PJK, and CD development following realignment. RESULTS:686 patients met inclusion criteria. Rates of postop PJK and CD were not significant in the PNR group(both P>0.15). PNR patients less often met substantial clinical benefit in ODI by 2Y(OR: 0.6,[0.4-0.98]). Patients overcorrected in age-adjusted PI-LL, matching Roussouly, or proportioned in GAP at 6W had lower rates of PNR(all P<0.001). Incremental addition of classifications led to 0% occurrence of PNR, PJK and CD. Stratifying by baseline PT severity, Low and Moderate deformity demonstrated the least incidence of PNR(7.7%) when proportioning in GAP at 6W, while severe PT benefited most from matching in Roussouly(all P<0.05). CONCLUSIONS:Following ASD corrective surgery, 24.9% of patients showed residual pelvic malalignment. This occurrence was often accompanied by undercorrection of lumbopelvic mismatch and less improvement of pain. However, overcorrection in any strategy incurred higher rates of PJK. We recommend surgeons identify a middle ground using one, or more, of the available classifications to inform correction goals in this regard. LEVEL OF EVIDENCE/METHODS:III.

STUDY DESIGN/METHODS:Retrospective analysis of outcomes in cervical spine and shoulder arthroscopy patients. OBJECTIVE:The objective of this study is to assess differential improvements in health-related quality of life for cervical spine surgery compared with shoulder surgery. SUMMARY OF BACKGROUND DATA/BACKGROUND:An understanding of outcome differences between different types of orthopedic surgeries is helpful in counseling patients about expected postoperative recovery. This study compares outcomes in patients undergoing cervical spine surgery with arthroscopic shoulder surgery using computer-adaptive Patient-reported Outcome Information System scores. MATERIALS AND METHODS/METHODS:Patients undergoing cervical spine surgery (1-level or 2-level anterior cervical discectomy and fusion, cervical disc replacement) or arthroscopic shoulder surgery (rotator cuff repair±biceps tenodesis) were grouped. Patient-reported Outcome Information System scores of physical function, pain interference, and pain intensity at baseline and at 3, 6, and 12 months were compared using paired t tests. RESULTS:Cervical spine (n=127) and shoulder (n=91) groups were similar in sex (25.8% vs. 41.8% female, P=0.731) but differed in age (51.6±11.6 vs. 58.60±11.2, P<0.05), operative time (148.3±68.6 vs. 75.9±26.9 min, P<0.05), American Society of Anesthesiologists (ASAs) (2.3±0.6 vs. 2.0±0.5, P=0.001), smoking status (15.7% vs. 4.4%, P=0.008), and length of stay (1.1±1.0 vs. 0.3±0.1, P=0.000). Spine patients had worse physical function (36.9 ±12.6 vs. 49.4±8.6, P<0.05) and greater pain interference (67.0±13.6 vs. 61.7±4.8, P=0.001) at baseline. Significant improvements were seen in all domains by 3 months for both groups, except for physical function after shoulder surgery. Spine patients had greater physical function improvements at all timepoints (3.33 vs. -0.43, P=0.003; 4.81 vs. 0.08, P=0.001; 6.5 vs. -5.24, P=<0.05). Conversely, shoulder surgery patients showed better 6-month improvement in pain intensity over spine patients (-8.86 vs. -4.46, P=0.001), but this difference resolved by 12 months. CONCLUSIONS:Cervical spine patients had greater relative early improvement in physical function compared with shoulder patients, whereas pain interference and intensity did not significantly differ between the 2 groups after surgery. This will help in counseling patients about relative difference in recovery and improvement between the 2 surgery types. LEVEL OF EVIDENCE/METHODS:III.

STUDY DESIGN/METHODS:Retrospective review of a multicenter comprehensive cervical deformity (CD) database. OBJECTIVE:To develop a novel risk index specific to each patient to aid in patient counseling and surgical planning to minimize postop DJK occurrence. BACKGROUND:Distal junctional kyphosis(DJK) is a radiographic finding identified after patients undergo instrumented spinal fusions which can result in sagittal spinal deformity, pain and disability, and potentially neurological compromise. DJK is considered multifactorial in nature and there is a lack of consensus on the true etiology of DJK. METHODS:CD pts with baseline(BL) and at least 1-year postoperative(1Y) radiographic follow-up were included. A patient-specific DJK score was created through use of unstandardized Beta weights of a multivariate regression model predicting DJK(end of fusion construct to the 2nd distal vertebra change in this angle by<-10° from BL to postop). RESULTS:110 CD pts included(61yrs, 66.4%F, 28.8kg/m2). 31.8% of these pts developed DJK (16.1% 3M, 11.4% 6M, 62.9% 1Y). At BL, DJK pts were more frail and underwent combined approach more (both P<0.05). Multivariate model regression analysis identified individualized scores through creation of a DJK equation: -0.55+0.009(BL Inclination) -0.078(Pre Inflection)+5.9×10-5(BL LIV angle) + 0.43(combine approach) - 0.002(BL TS-CL)- 0.002(BL PT)- 0.031(BL C2-C7)+ 0.02(∆T4-T12)+ 0.63(Osteoporosis)- 0.03(anterior approach) - 0.036( Frail) - 0.032(3 column osteotomy). This equation has a 77.8% accuracy of predicting DJK. A score ≥81 predicted DJK with an accuracy of 89.3%. The BL reference equation correlated with 2Y outcomes of NSR-Back percentage(P=0.003), reoperation(P=0.04), and MCID for EQ. 5D(P=0.04). CONCLUSIONS:This study proposes a novel risk index of DJK development that focuses on potentially modifiable surgical factors as well as established patient-related and radiographic determinants. The reference model created demonstrated strong correlations with relevant two year outcome measures, including axial pain-related symptoms, occurrence of related reoperations, and the achievement of minimal clinically importance differences for EQ. 5D.

BACKGROUND CONTEXT: Prophylaxis usage has been established in literature as an important component of minimizing the risk of proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) development. However, literature is scarce on the effects of prophylaxis in patients who have achieved adequate postoperative alignment and those who maintained poor alignment postoperatively. PURPOSE: To investigate how PJK prophylaxis impacts rates of PJK and PJF with and without ideal alignment and the associated cost/cost-effectiveness. STUDY DESIGN/SETTING: Retrospective cohort study of a prospective adult thoracolumbar deformity database. PATIENT SAMPLE: This study included 1,541 patients. OUTCOME MEASURES: Radiographic alignment, patient-reported outcome measures (ODI), cost per QALY.
METHOD(S): Operative adult spinal deformity patients (scoliosis >20degree, SVA>5cm, PT>25degree, or TK>60degree) with an UIV at L1 or below and available baseline (BL) and 2-year (2Y) radiographic and HRQL data were included. "Matched" and "unmatched" alignment refers to the age-adjusted alignment criteria. PJK prophylaxis was defined by usage of cement, hooks or tethers. PJF was defined as PJK with reoperation. Costs were calculated using the PearlDiver database, accounting for additional costs of prophylaxis when applicable, through estimates from Medicare pay scales for services within a 30-day window, including estimates regarding costs of postoperative complications, outpatient healthcare encounters, revisions and medical related readmissions. QALY was calculated using SF6D.
RESULT(S): A total of 738 ASD patients or below met inclusion criteria (59.9yrs+/-14.0, 79%F, BMI: 27.7 kg/m2 +/-6.0, CCI: 1.8 +/-1.7). Surgically, patients had a mean level fused of 11.1+/-4.4, LOS of 7.9 days+/-4.4, EBL of 1577 mL, operative time of 377 min, with 63% undergoing an osteotomy. Forty percent of patients had PJK prophylaxis. Controlling for age, CCI, BL osteoporosis, levels fused, usage of 3CO, UIV, BL SVA and BL PI-LL, patients who were matched postoperatively in PT, SVA, or PI-LL had lowered PJF rates (OR:.5, 95% CI:.28-.86, p=.01) with prophylaxis. Among those unmatched in either SVA, PILL, or PT by 6W, prophylaxis significantly reduced the rates of PJK and PJF as well (p <0.05). ANCOVA controlling for age, CCI, BL osteoporosis, levels fused, usage of 3CO, UIV, BL SVA and BL PI-LL shows patients with ideal age-adjusted alignment and prophylaxis resulted in a lower cost per QALY by 2Y ($399,948 vs $514,228, p <.001). Similarly, in unmatched patients, prophylaxis resulted in a substantially lower cost per QALY by 2Y ($466,409 vs 672, 024, p <.001), primarily due to decreased costs of reoperation and greater improvements in QALY among prophylaxis cohorts.
CONCLUSION(S): Despite additional surgical cost, optimization of radiographic realignment in conjunction with utilization of proximal junctional failure prophylactic techniques achieves ideal cost utility, predominately due to the minimization of mechanical failure related reoperations. Even among those not achieving optimal alignment, junctional prophylactic measures improved cost utility, emphasizing its critical role of minimization of junctional failures to achieve cost efficiency in adult spinal deformity surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Indirect decompression technique may be limited in that it does not include direct removal of the offending intervertebral disc or osteophyte protruding into the canal. PURPOSE: This study evaluates resolution of radiculopathy and perioperative complications in lumbar fusion with indirect or direct decompression techniques. STUDY DESIGN/SETTING: Retrospective analysis of large single center academic institution. PATIENT SAMPLE: This study included 116 single-level lumbar fusion patients with preoperative radiculopathy from 2012 to 2021. OUTCOME MEASURES: Resolution of radiculopathy, visual analog scores (VAS), perioperative complications, motor scores.
METHOD(S): Patients 18 years of age diagnosed with preoperative radiculopathy undergoing single-level lumbar fusion with up to two-year follow-up were grouped by indirect and direct decompression. Direct decompression group included TLIF with or without direct decompression procedure as well as ALIF and LLIF with direct decompression procedure. Indirect decompression group included ALIF and LLIF without direct decompression procedure. Propensity score matching (PSM) was used to control for differences in age between groups. Outcome measures were compared between groups using means comparison tests. Logistic regression analysis was used to correlate decompression type with symptom resolution over time.
RESULT(S): A total of 116 patients were included in this analysis: 58 direct decompression (mean 53.9y, 67.2% female) and 58 indirect decompression (mean 54.6y, 61.4% female). Direct decompression patients experienced greater blood loss relative to indirect decompression patients (242.4 +/- 128.5 vs 171.79 +/- 143.9 mL, p=0.007). Additionally, direct decompressionpatients experienced full resolution of radiculopathy at 3 months postop at a greater rate than those in the indirect decompression group (OR: 4.742, [1.97-11.41]; 53.1% vs 13.73%, p=0.002). At 6 months, direct decompression patients demonstrated a significantly larger reduction in VAS score 6 months postop (-2.889 +/- 2.3 vs -0.897 +/- 4.3, p=0.044). With regard to motor function, direct decompression patients had improved motor score with respect to the L5 dermatome at 6 months compared to indirect decompression patients (DELTAmotor score from baseline: 0.1714 +/- 0.453 vs -0.024 +/- 0.154, p=0.019).
CONCLUSION(S): Patients who underwent direct decompression experienced significantly greater resolution of preoperative lower extremity radiculopathy at 3 months compared with those who underwent ID alone. At 6 and 12 months, no differences were noted between the two groups. There were no differences in complication rates. At 6 months postop, direct decompression patients had greater improvement in preoperative motor deficit than ID patients. In particularly debilitated patients, these findings may influence surgeons to perform a direct decompression to achieve more rapid resolution of radiculopathy symptoms. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Prior studies assessed the association between underlying neurological condition and worse outcomes following spinal surgery with recent emphasis of self-reported loss of balance (Imbalance) by Uribe et al. PURPOSE: To investigate if patients with self-reported loss of balance have poorer outcomes following adult spinal deformity (ASD) surgery. STUDY DESIGN/SETTING: Retrospective review of prospectively collected database. PATIENT SAMPLE: ASD patients with baseline and 2-year radiographic and patient-reported outcome measure (PROM) data were included. OUTCOME MEASURES: Demographics, radiographic outcomes, complications, and PROM were compared from baseline to 2-year follow up.
METHOD(S): Patients undergoing a long spinal fusion with no prior history of spine surgery were retained. Patients were grouped according to imbalance and unsteady gait. The groups were propensity matched by age, PI-LL, and surgical invasiveness score. Demographics, radiographic, complications and PROM were compared from baseline to 2-year post-op.
RESULT(S): A total of 212 patients were reported (106 patients in each group). The mean age (64 vs 63 years), BMI (27.2 vs 27.0 kg/m2), and gender (76% vs 87% female) were not significantly different for patients with imbalance and without imbalance respectively (all p >0.05). Patients in the imbalance group had a higher Frailty Index Score compared to patients without imbalance (3.74 vs 2.33, p <0.001). At baseline, the sagittal profile for both groups were comparable with regard to PT, PI-LL, and SVA. Patients with loss of balance had a significantly lower thoracic Cobb angle (25.27degree vs 37.45degree, p <0.001) and lumbar Cobb angle (37.03degree vs 45.53degree, p=0.004), although the global coronal alignment was similar (imbalance:41.51 mm vs 34.25 mm, p=0.155). Patients with imbalance had worse PROM measures, including ODI (45.15 vs 36.62), SF-36 Mental Component Score (44.04 vs 51.76), SF-36 Physical Component Score (30.17 vs 35.10), and SRS-22 Mental domain score (3.28 vs 3.80) (p <0.001 for all). Postoperatively, patients with imbalance had less PT correction (-1.45degree vs -3.60degree, p=0.039) for a comparable correction in their PI-LL (-11.93degree vs-15.08degree, p=0.144) by 2-year follow-up. Both groups demonstrated similar improvements in their coronal plane deformity. Imbalance patients had higher rates of radiographic PJK at 2-year follow-up (26.4% vs 14.2%, p=0.026). Furthermore, patients with reported imbalance have significantly higher rate of implant related complications (47.2% vs 34.0%, p=0.05). After controlling for age, baseline sagittal parameters, PI-LL correction and Charlson Comorbidity Index, patients with imbalance had 2.2 times increased odds of sustaining PJK by 2 years.
CONCLUSION(S): Patients with a self-reported loss of balance and unsteady gait have significantly worse baseline frailty and PROMs, represented by poorer mental health and physical function. Although those patients had higher rates of PJK and implant-related complications, surgical intervention significantly improved their quality of life. Despite the improvement, they remained with lower PROMs by 2-year follow-up. Therefore, in the clinic setting and with limited institutional access to Frailty scores, asking patients if they have loss of balance or unsteady gait is a simple yet powerful question which may trigger their preoperative risk stratification and optimization. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Evidence on long-term surgical recovery in adult spinal deformity (ASD) patients who are both frail and have an invasive procedure is limited. PURPOSE: This study aims to evaluate frail and invasive patients with 5-year recovery kinetics. We hypothesize that patients who are both frail and have invasive surgeries will have adverse postoperative recovery kinetics STUDY DESIGN/SETTING: Retrospective review. PATIENT SAMPLE: A total of 133 ASD patients with complete HRQOL data at preoperative, 1-year, 2-year, 5-year follow-up were included. OUTCOME MEASURES: Integrated Health State Scores (IHS) in Oswestry Disability Index (ODI), Short-form 36 (SF-36) physical (PCS) and mental (MCS) component score, and Scoliosis Research Society (SRS)-22r measures METHODS: ASD-FI scores were used to stratify non-frail (0.3) patients. ASD-SR scores were used to stratify low invasive (90) surgeries. Using ASD-FI and ASD-SR, patients were separated into four cohorts: non-frail low invasive (NFLI), frail low invasive (FLI), non-frail high invasive (NFHI), and frail high invasive (FHI). HRQOLs at 1 year, 2 years, and 5 years were normalized against preoperative values. AUC was calculated across time points to generate an integrated health state score (IHS). Multivariable linear regression was used to compare IHS scores of FLI, NFHI, and FHI to NFLI while controlling for age, gender, comorbidity, and radiographic alignment.
RESULT(S): Of 633 eligible ASD patients, 339 had 5-year follow-up. Of those, 125 patients with complete HRQOL data at preoperative, 1-year, 2-year, and 5-year visits were included; 27.2% (34) were NFLI, 20.0% (25) were FLI, 26.4% (33) were NFHI, and 26.4% (33) were FHI. Using NFLI as the referent, FLI and NFHI did not have differences in ODI, MCS, PCS or SRS-22r IHS scores (P >0.05). On multivariable analysis of integrated health scores, FHI had higher MCS (7.6 vs 5.47; P=0.0188), SRS activity (6.97 vs 5.67; P=0.0004), SRS pain (8.49 vs 6.4; P=0.001), SRS appearance (8.97 vs 6.81; P=0.0014), SRS satisfaction (11.71 vs 7.97; P=0.0033), and SRS total (7.49 vs. 6.09; P=0.0002), indicating more improved recovery over a 5-year period. Patients who were FHI had higher rates of complications (P <0.05).
CONCLUSION(S): Despite having more complications, patients who were frail and underwent more invasive surgeries were more likely to have greater overall improvement in activity, pain, and satisfaction over a 5-year period relative to preoperative baseline. Our results suggest that frailty in combination with invasiveness do not hinder long-term postoperative recovery kinetics, in comparison to frailty or invasiveness alone. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Previous reports indicate postoperative complications have minimal impact on long-term outcomes after ASD surgery. Little data has evaluated the impact of complications on specific heath domains during postoperative period. PURPOSE: To evaluate the impact of specific complications on patient reported health domains compared to patients with no complications. STUDY DESIGN/SETTING: Prospective, multicenter, propensity score matched analysis. PATIENT SAMPLE: ASD patients enrolled into a prospective multi-center study. OUTCOME MEASURES: Oswestry Disability Index, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), postoperative complications.
METHOD(S): Surgically treated ASD patients enrolled into a multicenter study were assessed for postoperative complications requiring surgery including wound (WOUND), pseudoarthrosis (PSEUDO), neurologic (NEURO) and malalignment (MAL) and matched to patients with no complications (NOCOMP) using inverse probability weighting for demographic, radiographic and surgical variables. Health domains for SRS-22r, and SF-36 were evaluated at regular time intervals, domain scores normalized to the date of revision surgery, and compared to patients with no complications at minimum 2-year follow-up.
RESULT(S): A total of 566 of 1130 were analyzed, average 3.6 yrs (range: 1.9 to 9). WOUND (n=12) compared to NOCOMP (n=390) had worse SF-36 physical function(21.7 vs 27.4), social function(19.6 vs 28.9), general health (-7.3 vs 8.9) and vitality (-0.9 vs 26.6,p < 0.05). PSEUDO (n=64) was worse than NOCOMP for SRS-22r function, 1.4 vs 2.1, and SF-36 social function, (17.1 vs 28.9) (p < 0.05). NEURO (n=28) was worse than NOCOMP for SRS-22r (0.9 vs 2.1), SF-36 bodily pain (14.7 vs 35.7) and social function (13.4 vs 28.9) (p < 0.05). MAL (n=72) was worse than NOCOMP for SRS-22r pain, (2.7 vs 3.4), function (1.2 vs 2.1), self-image (3.0 vs 3.9), SF-36 bodily pain (27.6 vs 35.7), physical function (18.7 vs 27.4), and social function (11.6 vs 28.9) (p < 0.05).
CONCLUSION(S): Counter to previous reports, specific postoperative complications requiring surgery uniquely impact specific health domains, resulting in worse patient reported quality of life compared to ASD patients with no complications. Social function was negatively impacted for all complications, while wound complications negatively impacted patient perceived general health and vitality and patients with malalignment requiring surgery reported worse self-image. These data highlight new findings that postoperative complications have a negative impact on specific aspects of ASD quality of life that can undermine the potential benefits of ASD surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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