Impact of temperature on the magnitude and duration of relief after lumbar facets medial branch nerves radiofrequency ablation: a randomized double-blinded study.

INTRODUCTION: There are numerous studies appraising the variables that may influence the clinical outcomes after lumbar thermal radiofrequency ablation (RFA). Expanding the lesion size may increase the likelihood of capturing the target nerves in the lesion, thereby increasing the technical success rate of RFA. However, our literature search has failed to identify a consensus on the optimal target temperature. A retrospective study demonstrated that there seems to be significant functional improvement associated with the temperature of 90°C compared with 80°C. The authors prospectively studied the subject in a double-blinded randomized fashion. METHODS: Patients undergoing RFA for lumbar facetogenic pain were randomized in two cohorts (80°C and 90°C). Physicians and patients were blinded to the temperature used. The primary outcome was self-reported pain scores up to 12 months. Secondary outcomes included: self-reported functional improvement, duration of relief as measured by the time before repeat ablation of the same medial branches nerves, opioids' consumption, and patient satisfaction. RESULTS: Both groups reported pain improvement in all follow-up time points. Overall, both groups achieved statistically significant pain reduction (p<0.05). The median time to repeat RFA in the 80°C group was 112 (49-252) days, while it was 217 (198-348) days in the 90°C group (p<0.04). The univariate analysis emphasized that the RFA temperature is a statistically significant factor for pain improvement of more than 50%, OR 2.7 (1.1 to 6.6) p value=0.031. CONCLUSION: RFA has been demonstrated as an effective therapeutic modality for lumbar facetogenic back pain. Yet, the several factors involved in determining a favorable outcome of this procedure require further research and optimization. This prospective double-blinded randomized trial demonstrated that RFA at both temperatures (80°C, 90°C) provided significance at all the time periods examined. However, RFA at 90°C was superior to 80°C in regard to the duration of relief.

Patient and physician radiation exposure during minimally invasive lumbar decompression: A prospective assessment of X-ray exposure risks.

INTRODUCTION: Minimally invasive lumbar decompression (mild®) is becoming a popular procedure for treating lumbar spinal stenosis (LSS) secondary to hypertrophic ligamentum flavum (LF). The mild® procedure is commonly performed under live fluoroscopic guidance and carries a risk of radiation exposure to the patient and healthcare. METHODS: One physician performed mild® on 41 patients at the Cleveland Clinic Department of Pain Management from October 2019 to December 2021, while wearing a radiation exposure monitor (Mirion Technologies). Mean fluoroscopy time, mean exposure per case, and mean exposure per unilateral level decompressed were the primary outcomes measured. The secondary outcome was to provide a comparison of radiation exposure during similar fluoroscopically guided procedures. RESULTS: Mean patient fluoroscopy exposure time was 2.1 min ±0.9 (range: 1.1-5.6) fluoroscopy time per unilateral level decompressed. The mean patient radiation skin exposure from mild® was 1.1 ± 0.9 mGym2, and the mean total dose was 142.3 ± 108.6 mGy per procedure. On average, the physician was exposed to an average deep tissue exposure of 4.1 ± 3.2 mRem, 2.9 ± 2.2 mRem estimated eye exposure, and 14.7 ± 11.0 mRem shallow tissue exposure per unilateral level decompressed. An individual physician would exceed the annual exposure limit of 5 Rem after approximately 610 mild® procedures per year. CONCLUSIONS: This study is an attempt to quantify the radiation exposure to the physician and patient during the mild® procedure. Compared with other fluoroscopically guided pain management procedures, patient and physician radiation exposure during mild® was low.

The Choice of Spinal Cord Stimulation Versus Targeted Drug Delivery in the Management of Chronic Pain: Validation of an Outcomes Predictive Formula.

OBJECTIVE: In 2020, Mekhail et al published a formula that predicted the likelihood of a successful outcome for those who undergo spinal cord stimulation (SCS) for long-term pain management, based on retrospectively collected clinical and demographic data from one major medical center. The aim of this study is to validate such a predictive formula, prospectively, in a cohort of patients from multiple medical practices that are more representative of real-life clinical practice. MATERIALS AND METHODS: For the study, 939 patients who underwent successful SCS or targeted drug delivery (TDD) trials at multiple independent medical centers in the USA were enrolled into the Medtronic product surveillance registry data base before they underwent SCS or TDD device implantation, from 2018 to 2020. The registry data were collected prospectively but not specifically for this study. The data examined included demographic information, pain diagnosis, pain scores (visual analog scale [VAS]), Oswestry Disability Index scores, and quality-of-life scores at baseline and six months after implant. Because our goal is to validate the previously published predictive formula, in addition to the outcomes data previously mentioned, we collected the variables necessary for such a task: sex, age, depression, the presence of neuropathic pain, spine-related pain diagnosis, and persistent spinal pain syndrome "post laminectomy syndrome." Spine-related pain diagnosis included subjects with chronic spine pain who never had back surgery and whose pain was not radicular nor neuropathic. RESULTS: Of 619 patients with SCS, 138 (22%) achieved ≥ 50% reductions of the baseline VAS at six months. The logistic model predicts SCS success with an area under the receiver operating characteristic curve (AUC) of 80% in the current validation data set. Of 320 patients with TDD, 147 (46%) achieved ≥ 50% reduction of the baseline VAS at six months. The logistic model predicts TDD success with an AUC of 78% in the current validation data set. CONCLUSION: The study provides real life validation of the previously published predictive formula(4).

Impact of biological sex on the outcomes of spinal cord stimulation in patients with chronic pain.

BACKGROUND: Spinal cord stimulation (SCS) continues to gain increasing popularity in the pain management field for the treatment of different painful conditions; however, to-date, the correlation between the SCS effectiveness and biological sex has not been fully established. We aimed to investigate the correlation between the biological sex and SCS outcomes. METHODS: Following Institutional Review Board approval, a retrospective cohort study was performed by collecting data for patients treated with SCS at a tertiary academic center between the years 2002 and 2019. Data was assessed with multivariable linear regression to investigate the association between biological sex and pain scores at baseline, 6-, and 12- months following SCS implantation. Propensity score matching (PSM) was performed based on a set of covariates including age, duration of pain, time since implant, BMI, opioid medications use, smoking, depression and history of alcohol, or substance abuse. RESULTS: Of the patients treated with SCS implants, 418 patients fit the inclusion and exclusion criteria, out of which the majority were females (272, 65%). The pre-matching data reported a significant difference in history of diabetes and depression and was also significant for greater opioid use in male patients at baseline, 6-, and 12-months post-SCS implant. Propensity score matching (PSM) was performed based on the above mentioned covariant. After matching, no statistical difference was found among the variables, in both groups. Furthermore, after matching no significant differences in the pain scores at baseline, 6-, and 12-months post-SCS implant were observed. CONCLUSION: No biological sex-based differences in the analgesic response to SCS therapy was detected at 6- and 12-months post-SCS implant between groups with similar demographics, biomedical, and psychological values.

Trends of Contralateral prophylactic mastectomy at the time of ipsilateral breast tumor recurrence.

BACKGROUND: Contralateral prophylactic mastectomy rates have substantially increased. The study aimed to examine contralateral prophylactic mastectomy (CPM) at the time of ipsilateral breast tumor recurrence (IBTR) and evaluate factors contributing to CPM decision making process. METHOD: Patients who developed IBTR after BCS from 2011 to 2019 were reviewed. Patient and tumor characteristics, genetic testing and reconstruction details were analyzed. RESULTS: Ninety-six patients had IBTR after BCS and were treated with mastectomy, with 30% electing for a CPM. Patients who underwent CPM were younger, had higher BMI and less comorbidities. A genetic mutation was identified in 19% of patients who underwent testing at the time of IBTR. Tumor characteristics and performing surgeon were not predictors for CPM, however, patients were more likely to undergo CPM if they received reconstruction of the ipsilateral breast with IBTR. CONCLUSION: This study shows that age, BMI, genetic testing and breast reconstruction are factors contributing to CPM decision at the time of IBTR.

Mastectomy options for the treatment of ipsilateral breast cancer recurrence after lumpectomy.

BACKGROUND: Mastectomy is the recommended treatment for ipsilateral breast tumor recurrence (IBTR) in patients who initially received breast conservation surgery (BCS) and radiation. We evaluated the 3 types of mastectomies performed for the surgical treatment of IBTR (nipple sparing (NSM), skin sparing (SSM) and total mastectomy (TM)) to assess surgical complications and local control outcomes among groups. METHODS: Patients who developed IBTR after BCS and received mastectomy from 2011 to 2019 were reviewed. Patient characteristics and treatment were analyzed. The incidence of postoperative complications and second breast cancer recurrence were compared. RESULTS: Mastectomy was performed in 113 patients presenting with isolated IBTR (17 NSM, 48 SSM and 48 TM). There was no difference in post-operative complications between groups. At 3-year follow-up, 5 (4%) patients had a second recurrence. Tumor size at IBTR was the only predictor for second recurrence and not mastectomy type or receipt of reconstruction. CONCLUSION: In patients initially treated with BCS who experienced an IBTR, NSM or SSM mastectomy with immediate reconstruction had low complication rates and no increase in local recurrence compared to the TM group.

Five Hundred Patients With Gut Malrotation: Thirty Years of Experience With the Introduction of a New Surgical Procedure.

OBJECTIVES: Define clinical spectrum and long-term outcomes of gut malrotation. With new insights, an innovative procedure was introduced and predictive models were established. METHODS: Over 30-years, 500 patients were managed at 2 institutions. Of these, 274 (55%) were children at time of diagnosis. At referral, 204 (41%) patients suffered midgut-loss and the remaining 296 (59%) had intact gut with a wide range of digestive symptoms. With midgut-loss, 189 (93%) patients underwent surgery with gut transplantation in 174 (92%) including 16 of 31 (16%) who had autologous gut reconstruction. Ladd's procedure was documented in 192 (38%) patients with recurrent or de novo volvulus in 41 (21%). For 80 patients with disabling gastrointestinal symptoms, gut malrotation correction (GMC) surgery "Kareem's procedure" was offered with completion of the 270° embryonic counterclockwise-rotation, reversal of vascular-inversion, and fixation of mesenteric-attachments. Concomitant colonic dysmotility was observed in 25 (31%) patients. RESULTS: The cumulative risk of midgut-loss increased with volvulus, prematurity, gastroschisis, and intestinal atresia whereas reduced with Ladd's and increasing age. Transplant cumulative survival was 63% at 10-years and 54% at 20-years with best outcome among infants and liver-containing allografts. Autologous gut reconstruction achieved 78% and GMC had 100% 10-year survival. Ladd's was associated with 21% recurrent/de novo volvulus and worsening (P > 0.05) of the preoperative National Institute of Health patient-reported outcomes measurement information system gastrointestinal symptom scales. GMC significantly (P ≤ 0.001) improved all of the symptomatology domains with no technical complications or development of volvulus. GMC improved quality of life with restored nutritional autonomy (P < 0.0001) and daily activities (P < 0.0001). CONCLUSIONS: Gut malrotation is a clinicopathologic syndrome affecting all ages. The introduced herein definitive correction procedure is safe, effective, and easy to perform. Accordingly, the current standard of care practice should be redefined in this orphan population.

Nipple-Sparing Mastectomy: Are We Providing Proper Prophylactic Antibiotic Coverage?

BACKGROUND: Infection after nipple-sparing mastectomy (NSM) and implant-based reconstruction (IBR) can be a devastating complication. The retained nipple may act as a portal or nidus for different ductal organisms, and as such, the bacteriology of surgical-site infections (SSIs) in this setting may not be adequately covered by current antibiotic recommendations. This study sought to evaluate SSI and reconstruction outcomes in relation to antibiotic choice and identify the different microbial species implicated. METHODS: A prospective database was reviewed for patients who underwent NSM with IBR from 2010 to 2019. Patient characteristics, operative details, antibiotic regimens, and subsequent treatment details were evaluated. The study analyzed SSI incidence, timing, and type of causative organisms. RESULTS: The study analyzed 571 NSMs with IBR performed for 347 patients (55% with direct implants and 45% with tissue expanders). The preoperative antibiotics consisted of cephalosporin alone for 65% of the patients, a more broad single-antibiotic use for 12% of the patients, and dual-coverage antibiotics for 20% of the patients. During a median follow-up of 1.7 years, SSI developed in 12% of the reconstructions, with 6% requiring prosthesis removal. The most common SSI organism cultured was Staphylococcal species. Neither pre- nor postoperative antibiotic choice was associated with incidence of infection, type of bacteria, or need for prosthetic explanation. CONCLUSION: For patients undergoing NSM with IBR, a more aggressive antibiotic choice is not associated with an improved SSI rate. Patient and treatment factors continue to carry the highest risk for SSI.

Long term outcomes and complications of reno-portal anastomosis in liver transplantation: results from a propensity score-based outcome analysis.

Diffuse splanchnic vein thrombosis (DSVT) remains a serious challenge in liver transplantation (LT). Reno-portal anastomosis (RPA) has previously been reported as a valid option for management of patients with DSVT during LT. The aim of this study was to evaluate post-transplant renal function and surgical outcomes of patients with DSVT who underwent RPA during LT. Between January 2005 and December 2017, 1270 patients underwent LT at our institution, including 16 with DSVT managed with RPA (RPA group). We compared renal function and surgical outcomes in these patients to outcomes in 48 propensity score (PS)-matched patients without thrombosis (control group), using a 1:3 matching model. The two groups had similar rates of postoperative portal vein thrombosis (PVT), renal dysfunction as measured by estimated glomerular filtration rate (eGFR), and overall postoperative complications (Clavien grade III), although the RPA group had a higher incidence of postoperative upper gastrointestinal (GI) bleeding (31.3% vs 4.2%; P = 0.009) that had no clinical consequence. There were no significant differences in five-year graft and patient survival rates between the groups (P = 0.133 and P = 0.166, respectively). RPA is an established technique in the management of patients with DSVT during LT, with comparable outcomes to patients without thrombosis. Our report is the first to demonstrate similar surgical outcomes, including long-term renal function, in LT recipients with or without RPA.

Twenty Years of Gut Transplantation for Chronic Intestinal Pseudo-obstruction: Technical Innovation, Long-term Outcome, Quality of Life, and Disease Recurrence.

OBJECTIVE: To define long-term outcome, predictors of survival, and risk of disease recurrence after gut transplantation (GT) in patients with chronic intestinal pseudo-obstruction (CIPO). BACKGROUND: GT has been increasingly used to rescue patients with CIPO with end-stage disease and home parenteral nutrition (HPN)-associated complications. However, long-term outcome including quality of life and risk of disease recurrence has yet to be fully defined. METHODS: Fifty-five patients with CIPO, 23 (42%) children and 32 (58%) adults, underwent GT and were prospectively studied. All patients suffered gut failure, received HPN, and experienced life-threatening complications. The 55 patients received 62 allografts; 43 (67%) liver-free and 19 (33%) liver-contained with 7 (13%) retransplants. Hindgut reconstruction was adopted in 1993 and preservation of native spleen was introduced in 1999. Immunosuppression was tacrolimus-based with antilymphocyte recipient pretreatment in 41 (75%). RESULTS: Patient survival was 89% at 1 year and 69% at 5 years with respective graft survival of 87% and 56%. Retransplantation was successful in 86%. Adults experienced better patient (P = 0.23) and graft (P = 0.08) survival with lower incidence of post-transplant lymphoproliferative disorder (P = 0.09) and graft versus host disease (P = 0.002). Antilymphocyte pretreatment improved overall patient (P = 0.005) and graft (P = 0.069) survival. The initially restored nutritional autonomy was sustainable in 23 (70%) of 33 long-term survivors with improved quality of life. The remaining 10 recipients required reinstitution of HPN due to allograft enterectomy (n = 3) or gut dysfunction (n = 7). Disease recurrence was highly suspected in 4 (7%) recipients. CONCLUSIONS: GT is life-saving for patients with end-stage CIPO and HPN-associated complications. Long-term survival is achievable with better quality of life and low risk of disease recurrence.

Can CT-Based Stone Impaction Markers Augment the Predictive Ability of Spontaneous Stone Passage?

Introduction: A number of clinical and radiological predictors of either stone impaction or ureteral stone passage (SP) have been proposed. We aimed at identifying the key predictors of successful SP by using readily available CT-based tools/measurements. Methods: Patients presenting to the emergency department from February 2017 to February 2018 with an acute unilateral ureteral stone confirmed on non-contrast CT and managed conservatively were followed for SP. Patients with renal impairment, sepsis or requiring emergent intervention were excluded. Patients were followed at 1 month to confirm SP (stone collection/repeat imaging) or failure of passage. The CT variables analyzed included: Stone factors [location, size, volume, HU density (HUD)], impaction factors [ureteral HUD above and below the stone, maximal ureteral wall thickness (UWT) at the stone site, contralateral UWT, and ureteral diameter above and below the stone]. Binary logistic regression analysis was performed to identify predictors of SP. Results: Forty-nine patients met study inclusion criteria, of whom 32 (65.3%) passed the stone without further intervention. Patients with successful passage were more likely to have smaller, lower volume and less dense stones located in the distal ureter (p < 0.01). Lower ureteral HUD below the stone, lower maximal UWT, and lower ureteral diameter above the stone were associated with successful passage (p < 0.01). On multivariable logistic regression analysis, only maximal UWT at the stone site was a significant independent predictor of SP outcome (p = 0.01). Youden's criterion identified 2.3 mm as the optimal UWT cut-off point, which will accurately predict SP with 82.4% sensitivity and 87.5% specificity. Conclusions: Maximal UWT at the stone site was the most significant predictor of successful passage in acute unilateral ureteral stones, with an optimal cut-off point of 2.3 mm. Further prospective studies are needed to accurately predict spontaneous SP.

The Impact of Age on the Outcomes of Minimally Invasive Lumbar Decompression for Lumbar Spinal Stenosis.

BACKGROUND AND PURPOSE: Minimally invasive lumbar decompression (mild ®) is an effective long-term therapy for patients with symptomatic lumbar spinal stenosis (LSS) resulting primarily from hypertrophic ligamentum flavum (HLF). Most subjects in clinical studies of the mild procedure have been older adults (age≥65). While the incidence of LSS increases with age, a substantial number of adults (age<65) also suffer from neurogenic claudication secondary to HLF. In this report, outcomes of mild were compared between adults and older adults. PATIENTS AND METHODS: All prospective studies of the mild procedure with a 1-year follow-up completed since the beginning of 2012 that allowed the inclusion of adult patients of all ages were reviewed. Outcomes of visual analog scale (VAS), Oswestry Disability Index (ODI), Pain Disability Index (PDI), Roland Morris Low Back Pain and Disability Questionnaire (RMQ), standing time and walking distance were compared for adults and older adults. RESULTS: Four studies met the inclusion criteria, resulting in an analysis of 49 adults and 160 older adults. Patients in both age groups experienced significant mean improvements in all but one outcome measure at 6- and 12-month follow-up. Differences between the two age groups in all scores at 6 and 12 months were not statistically significant. CONCLUSION: Analysis of the four studies indicated that symptom improvements for adults and older adults were significant from baseline, and no statistically significant difference was observed between the two age groups. These results illustrate that mild can be an effective treatment for LSS due primarily to HLF, regardless of the adult patient age.

Choice of spinal cord stimulation versus targeted drug delivery in the management of chronic pain: a predictive formula for outcomes.

Contemporary nonmalignant pain treatment algorithms commence with conservative non-invasive strategies, later progressing from minimally invasive interventions to invasive techniques or implantable devices. The most commonly used implantable devices are spinal cord stimulation (SCS) systems or targeted drug delivery (TDD) devices. Historically, SCS had been considered in advance of TDD, positioning TDD behind SCS failures. Following Institutional Review Board approval, data were extracted from electronic medical records of patients who underwent SCS trial in the Department of Pain Management at Cleveland Clinic from 1994 to 2013. The sample size was analyzed in two cohorts: those who succeeded with SCS and those who failed SCS and consequently proceeded to TDD. Univariate and multivariate analyses were performed and a predictive formula for successful outcomes was created. 945 patients were included in the cohort of which 119 (12.6%) subjects achieved adequate pain relief with TDD after failure of SCS. Gender, age, depression and primary pain diagnosis were significantly different in this subgroup. Males were 52% less likely to experience pain relief with SCS. The odds of SCS success decreased as age increased by 6% per year. Patients with comorbid depression, interestingly, were 63% more likely to succeed with SCS. A logistic model was created to predict SCS success which was used to create a predictive formula. Older male patients diagnosed with spine-related pain were more likely to benefit from TDD than SCS. This observation potentially identifies a subgroup in whom consideration for TDD in advance of SCS failure could prove more efficient and cost effective. These retrospective findings warrant prospective comparative studies to validate this derived predictive formula.

Association of Testosterone Replacement Therapy and the Incidence of a Composite of Postoperative In-Hospital Mortality and Cardiovascular Events in Men Undergoing Cardiac Surgery.

BACKGROUND: Data on testosterone replacement therapy and cardiovascular outcomes are conflicting, with the Food and Drug Administration requiring prescription testosterone preparations to indicate a possible increased cardiovascular risk. Whether patients on testosterone replacement therapy undergoing cardiac surgery have an increased risk of postoperative in-hospital mortality and cardiovascular events remains unknown. We therefore sought to identify the impact of testosterone replacement on the incidence of a composite of postoperative in-hospital mortality and cardiovascular events in men undergoing cardiac surgery. METHODS: After institutional review board approval, data from male American Society of Anesthesiologists III/IV patients ≥40 years of age who underwent cardiac surgery between May 2005 and March 2017 at the Cleveland Clinic (Cleveland, OH) main campus were included. The primary exposure was preoperative testosterone use. The primary outcome was a collapsed composite of postoperative in-hospital mortality and cardiovascular events, including myocardial infarction, stroke, and pulmonary embolism. The secondary outcome was a collapsed composite of minor cardiovascular events, including postoperative rhythm disturbance requiring permanent device, atrial fibrillation, and deep venous thrombosis. We compared patients who received testosterone and those who did not, using propensity score matching within surgical procedure matches. Moreover, as a sensitivity analysis, we used a multivariable logistic regression model to assess the association between testosterone replacement therapy and major or minor cardiovascular events adjusted for potential baseline and intraoperative confounders by including all eligible patients. RESULTS: Among 20,604 patients who met inclusion and exclusion criteria, 301 patients who used testosterone routinely within 1 month before the surgery were matched to 1505 of 20,303 patients who did not use testosterone. Among the matched cohort, 8 (2.7%) patients in the testosterone group and 45 (3.0%) in the nontestosterone group had ≥1 major cardiovascular adverse event after surgery. The adjusted odds ratio was 0.89 (95% CI, 0.41-1.90; P = .756), comparing testosterone to nontestosterone patients. As for the secondary outcomes, 89 (30%) patients in the testosterone group and 525 (35%) patients in the nontestosterone group had ≥1 minor cardiovascular event. The odds of minor events were not significantly different, with an odds ratio of 0.78 (95% CI, 0.60-1.02; P = .074) comparing testosterone to nontestosterone patients. CONCLUSIONS: Preoperative testosterone is not associated with a statistically significant increased incidence of a composite of postoperative in-hospital mortality and cardiovascular events after cardiac surgery.

The Impact of Tobacco Smoking on Spinal Cord Stimulation Effectiveness in Complex Regional Pain Syndrome Patients.

OBJECTIVES: We aim to investigate the correlation of smoking and spinal cord stimulation (SCS) effectiveness for pain relief in complex regional pain syndrome (CRPS) patients while controlling for possible confounding factors including opioid intake. MATERIALS AND METHODS: Following Institutional Review Board approval, a retrospective cohort study was performed by collecting data for all CRPS patients treated with SCS at Cleveland Clinic between 1998 and 2013. We divided patients into three groups based on their smoking status at the time of SCS device implant: Current smokers, former smokers, or nonsmokers. We used a linear mixed modeling to assess the association between smoking status and pain score at baseline and at 3, 6, and 12 months. We then used pairwise t-tests for post hoc comparisons of pain scores. RESULTS: Of the 420 CRPS patients treated with SCS implants, the reduction in pain score was highest among nonsmokers. Nonsmokers demonstrated a consistent and steady decrease in pain scores over time, whereas the current and former smoker cohorts showed an initial reduction in pain at three months compared to baseline which was not sustained to the 12-months benchmark. Nonetheless, former smokers continued to report slightly lower pain scores than current smokers, although not statistically significant. The baseline opioid consumption was least among nonsmokers (30 [0, 62] oral mg morphine sulfate equivalent). We also found a statistically significant association between time postimplant and reported pain score (χ2 = 508.88, p < 0.001). The overall mean pain score for all three cohorts was highest at baseline (7.6 ± 1.7) and showed a decrease at the 3, 6, and 12 months postimplant time points with mean score of 5.7 ± 2.0, 5.6 ± 2.3, and 5.4 ± 2.5, respectively. CONCLUSION: Tobacco cigarette smoking was associated with reduced SCS effectiveness for pain relief.

Management of Five Hundred Patients With Gut Failure at a Single Center: Surgical Innovation Versus Transplantation With a Novel Predictive Model.

OBJECTIVE(S): To define the evolving role of integrative surgical management including transplantation for patients gut failure (GF). METHODS: A total of 500 patients with total parenteral nutrition-dependent catastrophic and chronic GF were referred for surgical intervention particularly transplantation and comprised the study population. With a mean age of 45 ±â€Š17 years, 477 (95%) were adults and 23 (5%) were children. Management strategy was guided by clinical status, splanchnic organ functions, anatomy of residual gut, and cause of GF. Surgery was performed in 462 (92%) patients and 38 (8%) continued medical treatment. Definitive autologous gut reconstruction (AGR) was achievable in 378 (82%), primary transplant in 42 (9%), and AGR followed by transplant in 42 (9%). The 84 transplant recipients received 94 allografts; 67 (71%) liver-free and 27 (29%) liver-contained. The 420 AGR patients received a total of 790 reconstructive and remodeling procedures including primary reconstruction, interposition alimentary-conduits, intestinal/colonic lengthening, and reductive/decompressive surgery. Glucagon-like peptide-2 was used in 17 patients. RESULTS: Overall patient survival was 86% at 1-year and 68% at 5-years with restored nutritional autonomy (RNA) in 63% and 78%, respectively. Surgery achieved a 5-year survival of 70% with 82% RNA. AGR achieved better long-term survival and transplantation better (P = 0.03) re-established nutritional autonomy. Both AGR and transplant were cost effective and quality of life better improved after AGR. A model to predict RNA after AGR was developed computing anatomy of reconstructed gut, total parenteral nutrition requirements, cause of GF, and serum bilirubin. CONCLUSIONS: Surgical integration is an effective management strategy for GF. Further progress is foreseen with the herein-described novel techniques and established RNA predictive model.

Transperitoneal Robot-assisted Partial Nephrectomy with Minimum Follow-up of 5 Years: Oncological and Functional Outcomes from a Single Institution.

BACKGROUND: Robot-assisted partial nephrectomy (RAPN) is an established, minimally invasive nephron-sparing technique with excellent perioperative and intermediate oncological outcomes. However, long-term oncological outcomes have not been reported to date. OBJECTIVE: To report oncological and functional outcomes of RAPN among patients with minimum follow-up of 5 yr. DESIGN, SETTING, AND PARTICIPANTS: Data for consecutive patients undergoing RAPN since October 2006 were extracted from a prospectively-maintained institutional PN database. Patients with benign tumors, genetic mutations, prior radical or ipsilateral PN, and those with follow-up of <5 yr were excluded. INTERVENTION: Transperitoneal RAPN for renal cell carcinoma (RCC). OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS: Demographic, perioperative, postoperative, functional, and oncological data were evaluated. A linear random-effects model was used to estimate the effect of follow-up duration on the estimated glomerular filtration rate (eGFR) after adjustment for potential confounders. Univariable competing-risks regression analyses were performed to evaluate the hazard ratio (HR) for cancer-related events for the variables of interest. RESULTS AND LIMITATIONS: A total of 278 RAPNs for RCC were included. eGFR was significantly lower at follow-up time points than at baseline. At last follow-up (median 46 mo, interquartile range 30-58) the mean eGFR difference was -10.6ml/min (95% confidence interval -12.56 to -8.66; p < 0.0001). There were 28 deaths (10.1%) in the cohort during the follow-up period, of which five (1.8%) were related to metastatic RCC. The 5-yr and 7-yr cumulative incidence of RCC deaths was 1.80% at both 5 and 7 yr, while the cumulative incidence of local recurrence was 3.61% and 4.16%, and that of metastasis was 3.24% and 4.57% at 5 and 7 yr, respectively. Univariable competing-risks regression revealed that higher Fuhrman grade (HR 8.76; p = 0.051), larger tumor size (HR 1.67; p < 0.0001), and tumor necrosis (HR 16.73; p = 0.0019) were independent predictors of RCC death. The retrospective design and potential selection bias due to patient selection in the early RAPN experience may limit the generalizability of the findings. CONCLUSIONS: This is the first study reporting minimum oncological follow-up of 5 yr after RAPN. The results demonstrate excellent long-term oncological outcomes after RAPN in a selected cohort of patients. Our data confirm that the renal functional deterioration after RAPN remains stable over time after the early postoperative decrease. PATIENT SUMMARY: Robot-assisted partial nephrectomy is being more widely used as a standard treatment for small localized renal cell carcinomas. This study reveals excellent long-term cancer control for both local recurrences and distant metastases. Renal function is stable after an initial postoperative deterioration.

Diagnostic Performance of Blood Pressure Measurement Modalities in Living Kidney Donor Candidates.

BACKGROUND AND OBJECTIVES: Precise BP measurement to exclude hypertension is critical in evaluating potential living kidney donors. Ambulatory BP monitoring is considered the gold standard method for diagnosing hypertension, but it is cumbersome to perform. We sought to determine whether lower BP cutoffs using office and automated BP would reduce the rate of missed hypertension in potential living donors. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We measured BP in 578 prospective donors using three modalities: (1) single office BP, (2) office automated BP (average of five consecutive automated readings separated by 1 minute), and (3) ambulatory BP. Daytime ambulatory BP was considered the gold standard for diagnosing hypertension. We assessed both the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7) and the American College of Cardiology/American Heart Association (ACC/AHA) definitions of hypertension in the cohort. Empirical thresholds of office BP and automated BP for the detection of ambulatory BP-diagnosed hypertension were derived using Youden index, which maximizes the sum of sensitivity and specificity and gives equal weight to false positive and false negative values. RESULTS: Hypertension was diagnosed in 90 (16%) prospective donors by JNC-7 criteria and 198 (34%) prospective donors by ACC/AHA criteria. Masked hypertension was found in 3% of the total cohort by JNC-7 using the combination of office or automated BP, and it was seen in 24% by ACC/AHA guidelines. Using Youden index, cutoffs were derived for both office and automated BP using JNC-7 (<123/82 and <120/78 mm Hg) and ACC/AHA (<119/79 and <116/76 mm Hg) definitions. Using these lower cutoffs, the sensitivity for detecting hypertension improved from 79% to 87% for JNC-7 and from 32% to 87% by ACC/AHA definition, with negative predictive values of 95% and 87%, respectively. Missed (masked) hypertension was reduced to 2% and 4% of the entire cohort by JNC-7and ACC/AHA, respectively. CONCLUSIONS: The prevalence of hypertension was higher in living donor candidates using ACC/AHA compared JNC-7 definitions. Lower BP cutoffs in the clinic improved sensitivity and led to a low overall prevalence of missed hypertension in prospective living kidney donors.

Perioperative Outcomes and Complications after Robotic Radical Cystectomy With Intracorporeal or Extracorporeal Ileal Conduit Urinary Diversion: Head-to-head Comparison From a Single-Institutional Prospective Study.

OBJECTIVE: To compare perioperative and oncological outcomes of intracorporeal (ICUD) vs extracorporeal urinary diversion (ECUD) after robot-assisted radical cystectomy (RARC). METHODS: From January 2014 to December 2017, data of consecutive patients who underwent RARC performed by 2 institutional surgeons were prospectively collected in a dedicated database (IRB: 251647). Patients were divided in 2 groups according to the operating surgeon, one performing ECUD, the other ICUD. Groups were compared in perioperative outcomes and Clavien complications (during admission, within 30- and 90-days postoperatively). Univariable and multivariable analyses tested the impact of variables of interest on the occurrence of complications at the different time points. Kaplan-Meier method was used to estimate recurrence and metastasis-free survivals. RESULTS: Sixty to 66 patients underwent RARC with ileal conduit ICUD and ECUD, respectively. ICUD patients were younger (69 vs 73 years old, P = .009). No differences were found in other baseline characteristics and final pathology. Regarding perioperative outcomes, shorter operative time favored ECUD (7 vs 6 hours, P = .0004). Specifically, no differences were found in postoperative complications while admitted, either overall (ICUD: 16 [26.7%] vs ECUD: 23 [34.8%] patients, P = .3) or major (ICUD: 10 [16.7%] vs ECUD: 14 [21.2%], P = .6); same was for reassessment within 30- and 90-days postoperatively. At multivariable analysis, Charlson's Comorbidity Index ≥3 and blood losses >600 mL predicted complications during the admission (P = .02). Male gender, higher body mass index, and ureteral involvement predicted 30-days complications (P = .04). No differences in oncological outcomes. CONCLUSION: At head-to-head comparison of 2 expert surgeons, ICUD and ECUD for ileal conduit had comparable perioperative outcomes.

Perioperative, oncological and functional outcomes after robotic partial nephrectomy vs. cryoablation in the elderly: A propensity score matched analysis.

OBJECTIVE: To compare perioperative, oncological and functional outcomes of robotic partial nephrectomy (RPN) versus cryoablation in elderly patients (>75 years old), accounting for patient's and tumor's related factors. METHODS: Retrospective institutional review of 312 consecutive elderly patients (> 75 years old) who underwent RPN or cryoablation for renal mass (June 2006-December 2016). Demographic, perioperative, functional, and oncological data were evaluated. Sixty-five patients who underwent RPN were propensity-score matched 1:1 to 65 who underwent cryoablation (matching was based on demographics, renal function, comorbidities and tumor characteristics). Perioperative outcomes were compared. Survival analysis was performed to estimate overall (OS), recurrence-free (RFS) and cancer-specific survival (CSS) by Kaplan-Meier method. A linear mixed effect model (LME) estimated the effect of follow-up on estimated glomerular filtration rate (eGFR). RESULTS: After matching, the variables were well balanced with no differences at baseline between groups. Shorter operative time and lower blood losses favored cryoablation (140 vs. 200 min, P < 0.0001 and 100 vs. 195 ml, P = 0.0002, respectively). Overall complications rate was higher for RPN (31% vs. 9%; P = 0.007), but no difference was found in major (Clavien III-IV) complications (6% vs. 1.5%, P = 0.2). At a median follow-up of 37 (29-44) and 46 (38-53) months for RPN and cryoablation, no significant differences were found in CSS (100% vs. 95%, P = 0.3) and OS (80% vs. 75%, P = 0.2) but RFS was higher for RPN (100% vs. 83%, RPN vs. cryoablation, respectively, P = 0.02). eGFR was comparable between the groups at every time point analyzed. CONCLUSIONS: Although with a higher rate of recurrences, our data confirm cryoablation as a lower morbidity profile treatment option for small renal masses in the elderly population, with cancer-specific survival comparable to surgery.