Selected Group Of Patients Research Articles

Remote follow-up after cataract surgery (CORE-RCT): study protocol of a randomized controlled trial

BackgroundCataract surgery has become one of the most performed surgical procedures worldwide. Postoperative management consists of routine clinical examinations to assess post-operative visual function and detect possible adverse events. Due to the low incidence of complications, the majority of clinic visits after cataract surgery are uneventful. Nonetheless, valuable time and hospital resources are consumed. We hypothesize that remote post-operative follow-up involving teleconsultations and self-assessments of visual function and health status, could be a valid alternative to face-to-face clinical examinations in selected patient groups. The practice of remote follow-up after cataract surgery has not yet been evaluated. The aim of this study is to investigate the validity, safety and cost-effectiveness of remote cataract surgery follow-up, and to report on the patients’ experiences with remotely self-assessing visual function.MethodsThis study is a multicenter, open-label, randomized controlled trial. Patients planned for cataract surgery on both eyes, without ocular comorbidities, are eligible for participation. Participants will be allocated (1:1) into one of the two study groups: ‘telemonitoring’ or ‘usual care’. Participants in the ‘telemonitoring’ group will perform in-home assessments after cataract surgery (remote web-based eye exams and digital questionnaires on their own devices). Participants in the ‘usual care’ group will have regular post-operative consultations, according to the study site’s regular practice. Outcome measures include accuracy of the web-based eye exam for assessing visual acuity and refraction, patient-reported outcome measures (visual function and quality of life), adverse events, and cost aspects.DiscussionInvestigating remote follow-up after cataract surgery fits the current trends of digitization of health care. We believe that remote self-care can be a promising avenue to comply with the increasing demands of cataract care. This randomized controlled trial provides scientific evidence on this unmet need and delivers the desired insights on (cost)effectiveness of remote follow-up after cataract surgery.Trial registrationClinicalTrials.gov: NCT04809402. Date of registration: March 22, 2021.

THIRD TIME’S THE CHARM? INDICATIONS AND LONG-TERM OUTCOMES AFTER REDO-REDO ILEAL POUCH ANAL ANASTOMOSIS

Abstract BACKGROUND Pouch failure after redo ileal pouch anal anastomosis (IPAA) occurs in 20-40% of cases. The decision to offer a second redo procedure to maintain intestinal continuity is controversial, and scarce evidence exists regarding long-term pouch survival and functional outcomes after redo-redo IPAA. METHODS We retrospectively analyzed our prospectively collected pouch registry for redo IPAA procedures and identified all patients who underwent a second redo IPAA procedure from 2004 to 2021. Our primary outcome was pouch survival, defined as no pouch excision or rediversion. Figures are frequency (percentage) and median (interquartile range). RESULTS Twenty-three patients met inclusion criteria (65% female, 4% of all redo IPAAs). The index diagnosis was ulcerative colitis in 20 (87%) cases and indeterminate colitis in 3 (13%). The median interval between the index pouch and the second redo was 36 (24 – 90) months, while the median time between the first and second redo was 16 (9 – 36.5) months. Only 8 (35%) of patients had their stoma closed between the first and second redo. In 15 (65%) cases both redo procedures were done at our center. The indication for pouch salvage was the same for the first and second redo in 21 (91%) cases (Figure 1): 20 (87%) patients both redo for septic complications. Second redos were done transabdominally in 21 (91%) of cases, and 14 (61%) involved pouch excision and construction of a neo-pouch. All were handsewn, and the final pouch configuration was “J” in 18 (78%) and “S” in 5 (22%) cases (Figure 2). Twenty (87%) had their stoma closed after the second redo. After a median follow up of 39 months (18.5 – 95.5), 10 (44%) patients experienced pouch failure (due to sepsis in 9 cases of which 3 never had their stoma closed, and poor function in 1). Pouch survival was 81% at 1-year, and 76% at 3-years. The median interval between second redo and pouch failure was 12 months (3 – 50.5). Postoperative Cleveland Global Quality of Life surveys were available for 17 (74%) patients. After a median interval of 14 (6 – 40) months, the overall quality of life score (0 -1) was 0.6 (0.5 – 0.8). The median number of bowel movements was 6 (5 – 8) during daytime, 2 (2 – 4) at night, for a total of 8 (6.5 – 12.5) per 24 hours. Urgency occurring most days of the week was reported by 30%, frequency by 14%, seepage during the day by 71% and at night by 86%. Dietary restrictions were reported by 50% of patients, social restrictions by 44%, work restrictions by 62.5%, and sexual restrictions by 50%. CONCLUSION A second redo pouch procedure may be offered with acceptable outcomes to a very select group of patients who are highly motivated to maintain intestinal continuity.

Preoperative Workup, Staging, and Treatment Planning of Colorectal Cancer

AbstractColorectal cancer (CRC) remains a leading cause of death in the United States. CRC is the second to third most common cancer globally and it impacts both genders. Screening initiatives are of paramount importance to eradicate the disease at a precancerous or early stage. Recommendations for screening are based on multiple factors including age, ethnicity, individual patient risk factors, and family history. Short- and long-term outcomes and survival data correlate with the stage of disease at the time of diagnosis emphasizing the need for appropriate baseline staging. Furthermore, stage of disease determines the necessity for any neoadjuvant or adjuvant therapy and provides recommendations for long-term oncologic follow-up. Preoperative workup includes physical examination, blood tests such as tumor markers and liver function tests, endoscopic evaluation, and cross-sectional imaging. In a select group of patients, genetic testing is part of the initial evaluation as it can impact the treatment plan, long-term follow-up, and testing of potential offspring. In general, surgical intervention remains the predominant treatment modality for stage I to III colon cancers with chemotherapy administration as adjuvant therapy for stages II to III to minimize recurrence or as a palliative modality for patients with stage IV disease. The treatment of rectal cancer remains more complex. Traditionally, early rectal cancer has been treated with surgical resection and locally advanced rectal cancer with neoadjuvant chemoradiation followed by surgical resection and postoperative chemotherapy. In the last decade, several protocols have been implemented to modify the neoadjuvant treatment with a trend toward more extended chemotherapy with the intent to further downstage the rectal cancer. Furthermore, the introduction of various protocols of total neoadjuvant chemoradiation may offer in a select group of patients with complete pathologic response, the possibility of observation without surgery. Finally, the management of stage IV CRC is in continuous evolution with the palliative goal of prolonging survival in most patients while offering the opportunity in some patients with limited metastatic disease to become potential candidates for resection of the primary lesion in addition to the metastatic disease.

Colchicine treatment can be discontinued in a selected group of pediatric FMF patients

ObjectivesFamilial Mediterranean Fever (FMF) patients are required to adhere to a life-long treatment with colchicine, primarily for preventing amyloidosis. As some patients may be asymptomatic for long periods of time, it remains unclear whether it is possible to discontinue colchicine treatment in a selective group of patients. We aimed to identify predictive characteristics for a successful cessation of colchicine therapy.MethodsOut of 646 FMF pediatric patients followed in our referral FMF clinic, colchicine treatment was discontinued in 51 patients. In this study we compared the genetic, demographic, and clinical characteristics between patients for whom a successful cessation of therapy was made (Group 1; n = 21) and patients for whom cessation of therapy was deemed a failure (Group 2; n = 30) and consequently had to resume colchicine therapy.ResultsPatients for whom a successful cessation of therapy was achieved had no biallelic pathogenic MEFV mutations, were less likely to have “severe attacks” (two or more FMF characteristic symptoms) (24% vs 80%; P = 0.000067) and did not require higher than 1 mg/day of colchicine, prior to the drug cessation. Remission duration under colchicine treatment was significantly higher in group 1 compared with group 2 (4.36 years ±2.12 vs 2.53 years ±2; P = 0.0036).ConclusionThis study supports the concept of colchicine free remission in a minority of FMF patients (3%). Holding treatment, under close monitoring, may be reasonable when selecting the appropriate patients.

Association between Pruritus and Psychosocial Well-being: A Population-based Study among 6,809 Subjects.

Pruritus has an extensive impact on functional, social and psychosocial behaviour. The association between pruritus and psychological well-being has mostly been studied among selected patient groups, whereas population-based studies are lacking. The aim of this study was to determine the association between pruritus and insomnia, quality of life, depression and anxiety at the population level in the general population. A cross-sectional population-based study was conducted in 2012 to 2013. Study subjects (n = 6,809) belonging to the Northern Finland Birth Cohort 1966 Study participated in a large follow-up study at the age of 45-47 years. They completed an extensive health questionnaire including questions on pruritus and several previously validated questionnaires regarding symptoms of psychosocial well-being. Pruritus affected 19.9% of the study subjects weekly, being more common in women than in men (p < 0.001). A significant association was found between both localized and generalized pruritus and symptoms of insomnia, depression, anxiety and decreased quality of life. The association was seen even in those with mild psychological symptoms/insomnia, and it affected both sexes. The severity of psychological symptoms increased with increasing frequency of pruritus. In conclusion, pruritus has a multiple effect on psychosocial well-being. Physicians should consider possible psychosocial symptoms in patients with pruritus.

Transabdominal ultrasound-guided oocyte retrieval for oocyte cryopreservation using a vaginal probe: a comparison of applicability, effectiveness, and safety with conventional transvaginal approach.

We aimed to compare the feasibility, effectiveness, and safety of transabdominal ultrasound-guided oocyte retrieval (TUGOR) using a vaginal probe and traditional vaginal approach in virgin patients undergoing oocyte cryopreservation. A total of 116 virgin patients who underwent transabdominal ultrasound-guided oocyte retrieval using a vaginal ultrasound probe and 33 patients matched for BMI, antral follicle count, age, day 3 FSH, estradiol, and AMH who underwent vaginal approach were enrolled. Mean number of total oocytes collected, mean number of cryopreserved MII oocytes, duration of the procedure, duration of stimulation, mean gonadotropin consumption, mature oocyte ratio, and a modified follicle-oocyte index were compared between the groups. No statistical difference was found between the groups in mean number of follicles > 12mm (4.62 ± 4.54 vs. 5.44 ± 4.52), mean number of oocytes collected (4.44 ± 4.14 vs. 5.33 ± 4.52), mean number of cryopreserved MII oocytes (4.01 ± 3.67 vs. 4.53 ± 4.13), mean duration of the procedure (12.4 ± 1.2 vs. 13.4 ± 1.6min), mean days of stimulation (8.05 ± 1.91 vs. 8.35 ± 1.72days), mean gonadotropin consumption (1507.9 ± 475.3 vs. 1571.74 ± 404.6 units), mature oocyte ratio (0.78 ± 0.24 vs. 0.82 ± 0.26), and modified follicle oocyte index (0.86 ± 0.63 vs. 0.84 ± 0.19). In the TUGOR group, superficial epigastric artery injury occurred in two patients and resolved spontaneously. Transabdominal oocyte retrieval using a vaginal ultrasound is a safe, effective, and feasible method of oocyte retrieval in some selected patient groups.

Implantation metastasis of colorectal cancer following percutaneous biliary drainage

Introduction. Malignant biliary obstruction represents a poor prognostic sign of metastatic colorectal carcinoma. Percutaneous transhepatic biliary drainage (PTBD) is the procedure of choice for palliative biliary decompression, and this method has both diagnostic and therapeutic values. One of the wellknown complications following this procedure is the development of catheter tract metastases that occur in 0.6?6% of cases post-PTBD. In this case report, we present a patient with implantation metastases of colorectal cancer following PTBD. Case report. In the last six years, 89 patients underwent PTBD procedure at the Oncology Institute of Vojvodina. Among these patients, catheter tract implantation metastasis developed in one patient (1.1%). In this report, we present a patient who underwent right hemicolectomy in January 2015 at the Oncology Institute due to colon cancer located in the transverse colon. In January of 2018, a computed tomography scan of the abdomen showed metastatic disease and chemotherapy was initiated. However, 29 months following the start of chemotherapy, the patient developed jaundice, and as a result, PTBD procedure was performed. A control computed tomography scan of the abdomen in March of 2021 showed a de novo subcutaneous nodule 20 mm in diameter located at the level of ninth right rib. The nodule had been considered a part of the scar that formed at a place of catheter entry, and was still present eight months after PTBD procedure. Biopsy of the subcutaneous mass and pathohistological analysis confirmed well differentiated colon adenocarcinoma. Conclusion. Catheter tract implantation metastasis is not a rare complication following PTBD for malignant biliary obstruction. It generally has a poor prognosis. Nevertheless, literature review shows that radical surgical excision of the catheter tract tissue with hepatectomy can prolong survival in select group of patients.

Pulsed Radiofrequency of the Auriculotemporal Nerve to Reduce the Intensity of Tinnitus.

Stimulation of the nonauditory nervous systems via the trigeminal nerve pathways can be a promising intervention for patients with tinnitus refractory to medical, conservative, and other treatment options. Therapy of the mandibular division of the trigeminal nerve through the auriculotemporal nerve has been reported as useful for patients with tinnitus. The objective of our study was to study the long-term effects of pulsed radiofrequency of the auriculotemporal nerve in a large group of tinnitus sufferers and to find predictors for a prosperous result. A monocenter backward-looking group study. In a two-year period, 67 tinnitus patients had pulsed radiofrequency of the auriculotemporal nerve. Twentythree (35%) reported reduced tinnitus loudness at the 7-week post-treatment follow-up. These patients valued the improvements as: 61% good, 22% moderate, and 17% slight. In 3% of patients, tinnitus magnified after the treatment. The odds of permanent tinnitus relief after successful pulsed radiofrequency of the auriculotemporal nerve are 68% at 1 year postoperative. In tinnitus patients without cervical pain 62% had an improvement following pulsed radiofrequency of the auriculotemporal nerve compared to 28% in those not fulfilling this criterion (p=0.024). Neuromodulation of the auriculotemporal nerve is an uncomplicated remedy for tinnitus. In a select group of tinnitus patients this treatment can a good relief of their tinnitus for a long period. Especially, tinnitus sufferers without cervical pain will benefit of this therapy.

Glenoid microfracture in active-duty military patients: minimum 5-year follow-up demonstrates 75% survival.

To present midterm patient-reported outcomes and survivorship data of active-duty military patients undergoing microfracture for full-thickness cartilage defects of the glenoid. All consecutive patients from January 2013 through December 2016 who underwent glenoid microfracture for full-thickness cartilage injuries with complete outcome scores were identified. Twenty patients met the final inclusion criteria for the study, and all were active-duty military at the time of surgery. A separate subgroup analysis was performed to determine if dominant-shoulder involvement portends worse outcomes. The mean follow-up was 81.45±19.43 months (range, 60-108). Of the 20 patients, 5 required a secondary surgical procedure within 5 years of their index procedure, with an average time to failure of 45.6±13.15 months. For the 15 patients who did not fail, there was a statistically significant increase in the mean American Shoulder and Elbow Surgeons score (57.20 vs. 88.27, P<.0001) and Single Assessment Numeric Evaluation (45.00 vs. 86.33, P<.0001). Mean pain decreased significantly as measured by the pain visual analog scale (5.40 vs. 1.37, P<.0001). Range of motion in forward elevation, external rotation, and internal rotation did not change significantly postoperatively (P=.4528, .4810, and .1919, respectively). Concomitant procedures did not predict changes in pain, American Shoulder and Elbow Surgeons, or Single Assessment Numeric Evaluation scores. A majority of patients (13/20, 65%) were able to remain on unrestricted military active-duty service, but 7 (35%) underwent medical discharge, including the 5 patients who had experienced treatment failure, plus 2 additional patients. Glenoid microfracture can result in pain relief and symptomatic improvement for a select group of active-duty military patients, with 75% survivorship at 5 years. Approximately one in three (35%) patients, however, were unable to remain on active-duty military service.

Propensity-Matched Outcomes Comparing TAVR in Bicuspid vs Surgery in Tricuspid Aortic Valve Stenosis.

To compare 1-year outcomes in patients at low surgical risk with bicuspid aortic valve stenosis (AS) following transcatheter aortic valve replacement (TAVR) and low-risk patients with tricuspid AS following surgical aortic valve replacement (SAVR). The pivotal randomized, prospective, multicenter TAVR trials compared TAVR vs SAVR in patients with tricuspid AS. No such trials exist for bicuspid AS. The Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled 150 patients from 25 sites in the United States. A screening committee confirmed bicuspid anatomy and valve classification based on computed tomography using the Sievers classification. Annular measurements guided valve sizing. These patients were propensity-matched to the SAVR patients in the randomized Evolut Low Risk Trial using 1:1 5-to-1-digit Greedy method, resulting in 144 matched pairs. For both trials, an independent clinical events committee adjudicated all serious adverse events, and the same independent core laboratory assessed all echocardiograms. The 1-year composite of death, disabling stroke, or aortic valve-related rehospitalization for bicuspid TAVR vs tricuspid SAVR was 6 (4.2%) vs 6 (4.2%) (P = .99). The effective orifice area (2.2 ± 0.7 cm2 vs 2.0 ± 0.6 cm2) was larger and the valve gradient was lower (8.7 ± 3.9 mm Hg vs 11.2 ± 4.7 mm Hg) in the TAVR group at 1 year (both P < .001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; P > .99). In this select group of low-risk bicuspid patients, in the short-term follow-up, TAVR appears to have similar outcomes to those seen in comparable low-risk tricuspid patients undergoing SAVR.

Same-day discharge after transvenous lead extraction: feasibility and outcomes.

Same-day discharge (SDD) is safe for patients undergoing electrophysiology procedures. There is no existing data regarding SDD for patients undergoing transvenous lead extraction (TLE). We report our experience with SDD for patients undergoing TLE. The study group included patients undergoing TLE between February 2020 and July 2021 without an infectious indication. A modified SDD protocol for device implants/ablations was applied to TLE patients. Patient characteristics, extraction details, outcomes, and complications were reviewed. Of 239 patients undergoing TLE, 210 were excluded (94 infections and 116 did not meet SDD criteria). Of the remaining 29 patients, seven stayed due to patient preference and 22 were discharged home the same day. The SDD group had an average age of 65.9 ± 12 (47-84), 41% female, and LVEF of 52.2 ± 18% (10-80). The indication for TLE was malfunction (20), upgrade (4), advisory lead (2), and magnetic resonance imaging compatibility (1). Extractions included four implantable cardioverter-defibrillators (ICDs), 17 pacemakers (PPM), and one cardiac resynchronization therapy (CRT)-P system. The leads were 9.6 years (1.5-21.7) old, and 1.8 leads were removed per patient (1-3); the lead extraction difficulty (LED) score was 11.6 ± 7. Twenty underwent cardiovascular implantable electronic device (CIED) re-implantation (2 ICD, 3 CRT-D, 13 PPM, and 2 CRT-P). For CIED re-implants, patients sent a remote transmission the next day, and all patients received a next-day call. There were no procedure or device-related issues, morbidities, or mortalities in the 30 days after discharge. Same-day discharge after TLE for non-infectious aetiologies is safe and feasible in a select group of patients with early procedure completion who meet strict SDD criteria.

Safety of mRNA COVID-19 vaccinations in patients with allergic diseases

ObjectivesThe aim of this study was to determine the degree of safety and possible risk of acute allergic reactions following mRNA COVID-19 vaccination among a group of patients predisposed to allergic diseases. Study designThe study survey took place between May 2021 and February 2022. Each participant completed an initial pre-vaccination questionnaire during patient eligibility assessment for vaccination, and two subsequent questionnaires were completed approximately 21 days after the first and second doses of vaccination. MethodsThe study included 52 patients aged >18 years. Participants were a select group of patients who, due to a history of severe allergic disease, were not eligible for vaccination at the COVID-19 Vaccination Points available in Poland. ResultsNone of the patients developed serious allergic complications in the form of anaphylaxis. There were no statistically significant differences between the first vaccination and the second vaccination in terms of symptoms, the time of onset and duration. The age of the participants did not correlate statistically with the occurrence of symptoms following the first or second vaccination. ConclusionsBased on the study results, it can be concluded that mRNA COVID-19 vaccines show a favourable safety profile for patients with a history of allergic disease and constitute the optimal strategy for fighting the SARS-CoV-2 pandemic. The study results support the recommendation of COVID-19 vaccinations for people predisposed to allergic diseases due to the clear benefits of vaccination over the possible risk of adverse events.

Dual Graft Living Donor Liver Transplantation for High Acuity Patients: A Single-Center Experience

The outcomes of dual graft living donor liver transplantation (DGLDLT) in high acuity patients remain underreported. The objective of this study was to report long-term outcomes from a single center in this select group of patients. This was a retrospective review of patients who underwent DGLDLT between 2012 and 2017 (n= 10). High acuity patients were defined as patients with model for end stage liver disease (MELD) ≥30 or Child Pugh score ≥11. We looked at 90-day morbidity and mortality and 5-year overall survival (OS). The median MELD score and Child Pugh score were 30 (26.7-35) and 11 (11-11.2). The median recipient weight was 105 (95.2-113.7) and ranged from 82 to 132kg. Out of 10 patients, 4 (40%) required perioperative renal replacement therapy, and 8 (80%) required hospital admission for optimization. The estimated graft to recipient weight ratio (GRWR) with right lobe graft alone was <0.8 in all patients, between 0.75 and 0.65 in 5 (50%) patients, and <0.65 in 5 (50%) patients. The 90-day mortality was 3/10 (30%), and there were 3/10 (30%) deaths during long-term follow-up. Among 155 high acuity patients, the 1-year OS with standard LDLT, standard LDLT with GRWR <0.8, and DGLDLT was 82%, 76%, and 58%, respectively (P= 0.123). With a median follow-up of 40.6 (1.9-74.4) months, the 5-year OS for DGLDLT was 50%. The use of DGLDLT in high acuity patients should be prudent and low GRWR grafts should be considered a viable alternative in selected patients.

Safety of Utilizing Ultrasound as the Sole Modality of Follow-Up after Endovascular Aneurysm Repair

Post-EVAR, surveillance with CTA remains the most common practice, per SVS guidelines. Chronic exposure to both radiation and IV contrast has raised concerns about long-term CTA follow-up. As we have selectively used US as a sole modality for post-EVAR surveillance, we sought to review our outcomes in this subset of patients. Retrospective review of our institution's Vascular Database identified 213 EVAR patients from 2013 to 2021. FEVAR and snorkel reconstructions were excluded. Patient demographics/outcomes, AAA characteristics, and FU modalities and outcomes were analyzed. Unpaired student t-test, ANOVA, and Chi-square test were used to assess group differences. Eighty-five of the 213 EVAR patients (39.9%) were lost to FU within 3 months. Among the 128 remaining patients, 91 underwent FU using initial US, while 37 patients underwent post-EVAR FU initially using CTA. There were no significant differences (p > 0.05) between patient age (75.5 ± 9.4 vs. 75.3 ± 8.5), BMI (27.7 ± 5.4 vs. 28.9 ± 7.4), or mean AAA size (5.6 ± 1.1 vs. 5.9 ± 1.2) in US-surveilled and CT-surveilled groups respectively. Of the 91 patients initially surveilled with US, 15 patients demonstrated endoleak and/or AAA growth (>5 mm). The 15 patients with US demonstrated-endoleak and/or growth underwent confirmatory CTA with 3 patients eventually requiring EVAR revision. Among 37 patients initially surveilled with CT, 10 demonstrated significant growth and 2 patients eventually required EVAR revision. There were no patients with AAA rupture during post-EVAR surveillance. Follow-up data was analyzed among a select lower-risk group of patients (pre-operative AAA diameter ≤ 5.5 cm, BMI ≤ 30, and no endoleak at completion of EVAR). Among this group, there were no surveilled patients that required EVAR reintervention regardless of surveillance modality (US n=32; CT n=4). The average follow-up was 29.5 ± 26.4 months in the US group and 26.4 ± 22.3 months in the CT group (p > 0.05). Although initial CT surveillance following EVAR remains ideal, in select lower-risk patients, ultrasound is a viable alternative even for the initial post-procedure study. Advantages include decreased radiation exposure and cost. Our data suggest that US is a safe sole modality for surveillance following EVAR in selective patients.

Predicting Need for Skilled Nursing or Rehabilitation Facility after Outpatient Total Hip Arthroplasty.

Outpatient classified total hip arthroplasty (THA) is a safe option for a select group of patients. An analysis of a national database was conducted to understand the risk factors for unplanned discharge to a skilled nursing facility (SNF) or acute rehabilitation (rehab) after outpatient classified THA. A query of the National Surgical Quality Improvement Program (NSQIP) database for THA (Current Procedural Terminology [CPT] 27130) performed from 2015 to 2018 was conducted. Patient demographics, American Society of Anesthesiologists (ASA) classification, functional status, NSQIP morbidity probability, operative time, length of stay (LOS), 30-day reoperation rate, readmission rate, and associated complications were collected. A total of 2,896 patients underwent outpatient classified THA. The mean age of patients was 61.2 years. The mean body mass index (BMI) was 29.6 kg/m2 with median ASA 2. The results of univariate comparison of SNF/rehab versus home discharge showed that a significantly higher percentage of females (58.7% vs. 46.8%), age >70 years (49.3% vs. 20.9%), ASA ≥3 (58.0% vs. 25.8%), BMI >35 kg/m2 (23.3% vs. 16.2%), and hypoalbuminemia (8.0% vs. 1.5%) (P<0.0001) were discharged to SNF/rehab. The results of multivariable logistic regression showed that female sex (odds ratio [OR] 1.47; P=0.03), age >70 years (OR 3.08; P=0.001), ASA ≥3 (OR 2.56; P=0.001), and preoperative hypoalbuminemia (<3.5 g/dL) (OR 3.76; P=0.001) were independent risk factors for SNF/rehab discharge. Risk factors associated with discharge to a SNF/rehab after outpatient classified THA were identified. Surgeons will be able to perform better risk stratification for patients who may require additional postoperative intervention.

Safety and Considerations of the Anaesthetic Management during Bronchoscopic Lung Volume Reduction Treatments

Background: Different bronchoscopic lung volume reduction approaches are available for a select group of patients with advanced COPD. General anaesthesia is the recommended method of sedation during these procedures. However, this patient population is at an increased risk of anaesthetic complications, and the best approach to general anaesthesia and mechanical ventilation is unknown. Objectives: The aims of this study were to describe the anaesthetic management techniques used during bronchoscopic lung volume reduction procedures and to investigate the number of anaesthesia-related events. Methods: Data were retrospectively collected from all endobronchial valve and lung volume reduction coil procedures performed between January 2018 and March 2020 in our hospital. Primary outcomes measures were anaesthetic technique including airway management; ventilation mode and settings; and the incidence of anaesthesia-related events, classified as catastrophic, severe, significant, or moderate. Results: 202 procedures were included. One procedure was performed under procedural sedation, 198 (98%) under general anaesthesia with endotracheal intubation, and 3 (1.5%) under general anaesthesia with laryngeal mask airway. Volume-controlled ventilation was used in 64% of the procedures and pressure-controlled in 36%. Patients were ventilated with a median respiration rate of 9.9 (IQR: 9.6–10.6) breaths per minute, mean tidal volume of 5.8 ± 1.4 mL/kg, and median inspiratory to expiratory (I:E) ratio of 1:2.8 (IQR: 1:2.1–1:3.2). No catastrophic anaesthesia-related events were observed. Hypotension was the most observed anaesthesia-related event. Conclusions: Despite the presence of advanced COPD, general anaesthesia and mechanical ventilation are well tolerated by patients undergoing endobronchial valve or lung volume reduction coil treatment. This is presumably strongly linked to the strict selection criteria. Other important considerations are using a low respiratory rate, low tidal volume, and high I:E ratio.

Evolving Role of Catheter Ablation for Atrial Fibrillation: Early and Effective Rhythm Control.

Catheter Ablation (CA) is an effective therapeutic option in treating atrial fibrillation (AF). Importantly, recent data show that CA as a rhythm control strategy not only significantly reduces AF burden, but also substantially improves clinical hard endpoints. Since AF is a progressive disease, the time of Diagnosis-to-Intervention appears crucial. Recent evidence shows that earlier rhythm control is associated with a lower risk of adverse cardiovascular outcomes in patients with early AF. Particularly, CA as an initial first line rhythm control strategy is associated with significant reduction of arrhythmia recurrence and rehospitalization in patients with paroxysmal AF. CA is shown to significantly lower the risk of progression from paroxysmal AF to persistent AF. When treating persistent AF, the overall clinical success after ablation remains unsatisfactory, however the ablation outcome in patients with "early" persistent AF appears better than those with "late" persistent AF. "Adjunctive" ablation on top of pulmonary vein isolation (PVI), e.g., ablation of atrial low voltage area, left atrial posterior wall, vein of Marshall, left atrial appendage, etc., may further reduce arrhythmia recurrence in selected patient group. New ablation concepts or new ablation technologies have been developing to optimize therapeutic effects or safety profile and may ultimately improve the clinical outcome.

Allogeneic Hematopoietic Cell Transplantation in Patients with Relapsed or Refractory Acute Leukemia

Introduction: Current guidelines support allogeneic hematopoietic cell transplantation (allo-HCT) in patients with acute leukemia who achieve complete remission (CR) and are at high risk for relapse. Patients with primary refractory disease or those refractory to re-induction therapy after relapse have a poor prognosis in the absence of allo-HCT. While several studies have addressed the role of allo-HCT in those settings, the measurable benefit of allo-HCT has not been defined in such patients. Most previous studies have included patients who received myeloablative conditioning and did not address the possible impact of molecular genetic risk factors. Objective: The present study assessed outcomes of allo-HCT in patients with refractory or relapsed (R/R) acute leukemia receiving myeloablative (MAC) or reduced intensity conditioning (RIC) regimens. Our goal was to identify novel risk factors associated with improved outcomes to aid patient selection in the setting of R/R acute leukemia. Methods: Patients with R/R acute leukemia undergoing allo-HCT at Memorial Sloan Kettering Cancer Center (MSK) between 2009 and 2020 were included. Patients had a marrow blast count of 5% or more at the time of allo-HCT and were classified into one of the following categories: primary induction failure (PIF), at least 2 lines of induction therapy; not in CR (NCR), no more than one line of induction therapy; untreated relapse (UR); and refractory relapse (RR), no remission after at least one line of re-induction therapy for relapse. Results: We identified 101 patients with acute myeloid leukemia (AML; n=94), acute lymphoblastic leukemia (ALL; n=3), biphenotypic acute leukemia (n=2), and plasmacytoid dendritic cell leukemia (n=2). Table 1 depicts patient and transplant characteristics. Median blast count at the time of allo-HCT was 8% (IQR, 5%,15%). 37 patients had at least one genomic alteration, and 30 patients had circulating blasts at the time of transplant. Grafts were from HLA-identical siblings in 30 patients, from HLA-matched unrelated donors in 51 patients and from HLA-mismatched or HLA-haploidentical donors in 20 patients. 61 and 40 patients received MAC and RIC, respectively. Graft source was unmodified bone marrow (n=8), unmodified peripheral blood stem cells (PBSC; n=80), or CD34+ cellselected peripheral blood stem cells (n=7). Overall survival (OS) at 4 years was 25% (95% CI: 18%, 35%). In univariate analysis, RIC (HR 1.71, p=0.035), presence of circulating blasts (HR 2.21, p=0.002), and high pre-transplant ferritin levels (HR 1.43, p=0.049) were associated with inferior OS. In multivariate analysis, RIC was associated with reduced OS. The 4-year cumulative incidence of relapse/disease progression and non-relapse mortality (NRM) was 54% (95% CI: 43%, 63%) and 24% (CI, 16%, 33%) respectively. In univariate analysis, RIC, presence of circulating blasts, and elevated pre-transplant ferritin levels were associated with increased NRM. In multivariate analysis, RIC and elevated pre-transplant ferritin levels were associated with high NRM. The cumulative incidence of acute graft-vs-host disease (aGVHD) was 45% (95% CI: 35%, 54%) at day 100. There was no statistically significant effect of genomic and molecular parameters on NRM and OS. However, high risk molecular mutations (TP53, RUNX1, ASXL1 or FLT3-ITD) had borderline association with relapse/disease progression (HR 1.7, p=0.073). Conclusion: Allo-HCT provides durable remission in a select group of patients with relapsed or refractory acute leukemia with an OS of 25% at 4 years. The presence of circulating blasts and elevated ferritin levels at the time of allo-HCT was associated with increased NRM and inferior OS in this retrospective analysis. Known high-risk gene mutations did not affect outcomes in this population. The impact of these parameters should be evaluated in a larger cohort of patients. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Abstract 13705: Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure: An Update Meta-Analysis

Introduction: Increasing evidence has suggested improved outcomes in atrial fibrillation (AF) patients with heart failure (HF) undergoing catheter ablation (CA) as compared to medical therapy. We sought to investigate the benefit of CA on outcomes of patients with AF and HF as compared to medical therapy. Methods: A systematic review of PubMed, Embase, and Cochrane Central Register of Clinical Trials was performed for clinical studies evaluating the benefit of CA for patients with AF and HF. Primary endpoint was all-cause mortality. Secondary endpoints included atrial-arrhythmia recurrence and improvement in left ventricular ejection fraction (LVEF). Results: Eight randomized controlled trials were included with a total of 2121 patients (mean age: 65 ± 5 years; 72% male). Mean follow-up duration was 32.9 ± 14.5 months. All-cause mortality in patients who underwent CA was significantly lower than in the medical treatment group (8.8% vs. 13.5%, RR 0.65, 95% CI 0.51-0.83, P=0.0005). A 35% relative risk reduction and 4.7% absolute risk reduction in all-cause mortality was observed with CA. Rates of atrial-arrhythmia recurrence were significantly lower in the CA group (39.9% vs 69.6%, RR 0.55, 95% CI 0.40-0.76, P=0.0003). Improvement in LVEF was significantly higher in patients undergoing CA (+9.4 ±7.6%) as compared to conventional treatment (+3.3±8%) (Mean difference 6.2, 95% CI 3.6-8.8, P&lt;0.00001). Conclusion: CA for AF in patients with HF decreases all-cause mortality, improves atrial-arrhythmia recurrence rate and LVEF when compared to medical management. CA should be considered the treatment of choice to improve survival in this select group of patients. Central Illustration summarizing study outcomes. A) All-cause mortality; B) Change in left ventricular ejection fraction; C) Atrial-arrhythmia recurrence 1

Conservative axillary surgery is emerging in the surgical management of breast cancer.

Axillary lymph node dissection (ALND) has been the standard axillary treatment for breast cancer for a long time. However, ALND is associated with postoperative morbidities, including local sensory dysfunction, reduced shoulder mobility and most notably arm lymphedema. Recently, ALND can be avoided not only in clinically node-negative (cN0) patients with negative sentinel lymph nodes (SLNs), but also in patients with less than 3 positive SLNs receiving breast radiation, axillary radiation, or a combination of the two. Moreover, SLN biopsy has been adopted for use in clinically node-positive (cN +) patients presenting as cN0 after neoadjuvant chemotherapy (NAC); ALND may be avoided in cN + patients who convert to SLN-negative following NAC. Patients who undergo SLN biopsy alone have less postsurgical morbidities than those who undergo ALND. Nevertheless, ALND is still required in a select group of patients. A variety of conservative approaches to ALND have been developed to spare arm lymphatics to minimize arm lymphedema. These conservative procedures seem to decrease the incidence of lymphedema without increasing axillary recurrence. In the era of effective multimodality therapy, full conventional ALND removing all microscopic axillary disease may now be unnecessary in both cN0 patients and cN + patients. Regardless, emerging procedures for ALND should still be considered as investigational approaches, as further studies with longer follow-up are necessary to determine the safety of conservative ALND to spare arm lymphatics.