Creation of a medical procedure service in a tertiary medical center: Blueprint and procedural outcomes.

BACKGROUND: Medical Procedure Services (MPS) may represent a solution to the educational gap in procedural training among internal medicine residents and the unmet need for the clinical provision of non-urgent inpatient procedures. However, there is little guidance available to help launch an MPS. Furthermore, procedural outcomes from a newly initiated MPS, including those comparing trainees versus attending physicians, are lacking. OBJECTIVE: To describe the blueprint used in the design, implementation, and ongoing oversight of an MPS and to report its procedural outcomes. DESIGN, SETTINGS AND PARTICIPANTS: Vanderbilt University Medical Center (VUMC), Nashville, Tennessee. INTERVENTION: The launch of an MPS at a large tertiary academic hospital. MAIN OUTCOME AND MEASURES: 6,152 procedural consultations resulting in 5,320 attempted procedures over a four-and-a-half year period. RESULTS: The primary proceduralist was a supervised resident in 58.7% (3124 /5,320) and an attending in 41.3% (2,196/5,320) of procedures. The overall success rate was 91.1% (95% CI: 90.3-91.9%) and the major complication rate was 0.7% (95% CI: 0.5-1.0%). There was no difference in the mean number of attempts required to complete a procedure (1.6 vs 1.5 attempts, p=0.68) and the complication rates between supervised residents and attending proceduralists, respectively (20/3,124 vs 20/2,196, p=0.26). CONCLUSION: At a tertiary academic medical center, the implementation and maintenance of MPS is feasible, safe, and results in high rates of successful procedures performed by supervised residents. Procedures performed by supervised residents require comparable number of attempts for completion and carry similar risks as those performed alone by attendings.

Laparoscopic versus open hepatectomy for intrahepatic cholangiocarcinoma: An individual patient data survival meta-analysis.

BACKGROUND: We compared the outcomes of laparoscopic hepatectomy (LH) vs. open hepatectomy (OH) for intrahepatic cholangiocarcinoma (iCCA). METHODS: A systematic review of the MEDLINE, EMBASE, Scopus, and Cochrane Library databases was performed using PRISMA guidelines (end-of-search date: 08-June-2020). Individual patient data on overall survival (OS) and recurrence-free survival (RFS) were extracted. Random-effects meta-analyses, and one- and two-stage survival analyses were conducted. RESULTS: Eight retrospective cohort studies comparing LH (n = 544) vs. OH (n = 2256) were identified. LH demonstrated lower overall complication (Risk ratio [RR] = 0.64, 95% confidence interval [CI]: 0.46-0.90; p = 0.01), surgical lymphadenectomy (RR = 0.74, 95% CI: 0.58-0.93; p = 0.01) and margin-positive resection (RR = 0.78, 95% CI: 0.62-0.99; p = 0.04) rates, and higher recurrence-free rate (RR = 1.24, 95% CI: 1.01-1.51; p = 0.04) vs. OH. In Cox regression, no difference was observed regarding OS (Hazard Ratio [HR] = 1.11, 95% CI: 0.65-1.91; p = 0.70) and RFS (HR = 1.19, 95% CI: 0.74-1.90; p = 0.47). CONCLUSION: The use of LH should be considered when feasible in well-selected iCCA patients by hepatobiliary surgeons with experience in minimally-invasive surgery.

Medical Procedure Services in Internal Medicine Residencies in the US: a Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: The number of procedures performed by internal medicine residents in the United States (US) is declining. An increasing proportion of residents do not feel confident performing essential invasive bedside procedures and, upon graduation, desire additional training. Several residency programs have utilized the medical procedure service (MPS) to address this issue. We aim to summarize the current state of evidence by systematically evaluating the effect of the MPS on resident education, comfort, and training, as well as patient safety and procedural outcomes in the US. METHODS: We conducted a systematic review of all studies reporting the use of an MPS with supervision from a board-certified physician in internal medicine residencies in the US. Database search was performed on PubMed, Embase, ERIC, and Cochrane Library from January 2000 to November 2020 for relevant studies. Quality of evidence assessment and random-effects proportion meta-analyses were performed. RESULTS: A total of nine studies reporting on 3879 procedures performed by MPS were identified. Procedures were safely performed, with a pooled complication rate of 2.1% (95% CI: 1.0-3.5) and generally successful, with a pooled success rate of 94.7% (95% CI: 90.8-97.7). The range of procedures performed by residents under MPS was 6.7-72.8 procedures per month (n = 9) compared to 4.3-64.4 procedures (n = 4) without MPS. MPS significantly increased confidence, comfort, and use of appropriate safety measures among residents. CONCLUSION: There are a limited number of published studies on MPS supervised by a board-certified physician in US internal medicine residencies. Procedures performed by MPS are generally successfully completed and safe. MPS benefits internal medicine residents training by improving competency, comfort, and confidence.

The Role of Immunotherapy in Hepatocellular Carcinoma: A Systematic Review and Pooled Analysis of 2,402 Patients.

BACKGROUND: Immune checkpoints inhibitors (ICIs) have emerged as a treatment option for several malignancies. Nivolumab, pembrolizumab, nivolumab plus ipilimumab, and atezolizumab plus bevacizumab have been approved for the management of advanced-stage hepatocellular carcinoma (HCC). We aimed to systematically review the literature and summarize the characteristics and outcomes of patients with HCC treated with ICIs. METHODS: A systematic literature search of PubMed, the Cochrane Library, and ClinicalTrials.gov was performed according to the PRISMA statement (end of search date: November 7, 2020). Quality of evidence assessment was also performed. RESULTS: Sixty-three articles including 2,402 patients were analyzed, 2,376 of whom received ICIs for unresectable HCC. Response to ICIs could be evaluated in 2,116 patients; the overall objective response rate (ORR) and disease control rate (DCR) were 22.7% and 60.7%, respectively, and the mean overall survival (OS) was 15.8 months. The ORR, DCR, and OS for nivolumab (n = 846) were 19.7%, 51.1%, and 18.7 months, respectively; for pembrolizumab (n = 435) they were 20.7%, 64.6% and 13.3 months, respectively. The combination of atezolizumab/bevacizumab (n = 460) demonstrated an ORR and DCR of 30% and 77%, respectively. The overall rate of treatment discontinuation because of adverse events was 14.9%. Fifteen patients received ICIs in the liver transplant (LT) setting (one pre-LT for bridging, 14 for post-LT recurrence); fatal graft rejection was reported in 40.0% (n = 6/15) and mortality in 80.0% (n = 12/15). CONCLUSION: ICIs are safe and effective against unresectable HCC, but caution is warranted regarding their use in the LT setting because of the high graft rejection rate. IMPLICATIONS FOR PRACTICE: This systematic review pooled the outcomes from studies reporting on the use of immune checkpoint inhibitors (ICIs) for the management of 2,402 patients with advanced-stage hepatocellular carcinoma (HCC), 2,376 of whom had unresectable HCC. The objective response rate and disease control rate were 22.7% and 60.7%, respectively, and the mean overall survival was 15.8 months. The overall rate of treatment discontinuation because of adverse events was 14.9%. Fifteen patients received ICIs in the liver transplant (LT) setting (one pre-LT for bridging, 14 for post-LT recurrence). Six of these patients experienced graft rejection (40.0%).

Liver Transplantation for Intrahepatic Cholangiocarcinoma: A Meta-analysis and Meta-regression of Survival Rates.

BACKGROUND: Intrahepatic cholangiocarcinoma (iCCA) is a contraindication to liver transplantation in most centers worldwide. Therefore, only a few such cases have been performed in each individual center, and the need for a systematic review and meta-analysis to cumulatively pool these results is apparent. METHODS: A systematic literature review was conducted using the MEDLINE and Cochrane Library databases according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement (end-of-search date: May 29, 2020). Meta-analyses of proportions were conducted to pool the overall survival (OS), recurrence-free survival (RFS), and overall recurrence rates using the random-effects model. Meta-regression was used to examine cirrhosis and incidental diagnosis as confounders on OS and RFS. RESULTS: Eighteen studies comprising 355 patients and a registry study of 385 patients were included. The pooled 1-, 3-, and 5-y OS rates were 75% (95% CI, 64%-84%), 56% (95% CI, 46%-67%), and 42% (95% CI, 29%-55%), respectively. The pooled 1-, 3-, and 5-y RFS rates were 70% (95% CI, 63%-75%), 49% (95% CI, 41%-57%), and 38% (95% CI, 27%-50%), respectively. Cirrhosis was positively associated with RFS, while incidental diagnosis was not. Neither cirrhosis nor incidental diagnosis was associated with OS. The pooled overall recurrence rate was 43% (95% CI, 33%-53%) over a mean follow-up of 40.6 ± 37.7 mo. Patients with very early (single ≤2 cm) iCCA exhibited superior pooled 5-y RFS (67%; 95% CI, 47%-86%) versus advanced iCCA (34%; 95% CI, 23%-46%). CONCLUSIONS: Cirrhotics with very early iCCA or carefully selected patients with advanced iCCA after neoadjuvant therapy may benefit from liver transplantation under research protocols.

Obstetrical and gynecologic challenges in the liver transplant patient.

An increasing number of childbearing agewomen undergo liver transplantation (LT) in the United States. Transplantation in this patient subgroup poses a significant challenge regarding the plans for future fertility, particularly in terms of immunosuppression and optimal timing of conception. Intrapartum LT is only rarely performed as the outcome is commonly dismal for the mother or more commonly the fetus. On the other hand, the outcomes of pregnancy in LT recipients are favorable, and children born to LT recipients are relatively healthy. Counseling on pregnancy should start before LT and continue after LT up until pregnancy, while all pregnant LT recipients must be managed by amultidisciplinary team, including both an obstetrician and a transplant hepatologist. Additionally, an interval of at least 1-2 years after successful LT is recommended before considering pregnancy. Pregnancy-induced hypertension, pre-eclampsia, and gestational diabetes mellitus are reported more commonly during the pregnancies of LT recipients than in the pregnancies of non-transplant patients. As adverse fetal outcomes, such asmiscarriage, abortion, stillbirth, or ectopic pregnancy, may occur more often than in the non-transplant population, early planning or delivery either through a planned induction of labor or cesarean section is critical to minimize the risk of complications. No significant long-term physical or phycological abnormalities have been reported in children born to LT recipients.

Challenges in Abdominal Organ Transplantation During the COVID-19 Pandemic.

As the coronavirus disease 2019 (COVID-19) outbreak has rapidly evolved into a global pandemic, abdominal organ transplantation programs are currently facing multiple challenges. Transplant candidates and recipients are considered high-risk populations for severe disease and death due to COVID-19 as a result of their numerous underlying comorbidities, advanced age and impaired immune function. Emerging reports of atypical and delayed clinical presentations in these patients generate further concerns for widespread disease transmission to medical personnel and the community. The striking similarities between COVID-19 and other outbreaks that took place over the past two decades, like Severe Acute Respiratory Syndrome and Middle East Respiratory Syndrome, highlight the severity of the situation and dictate that extra measures should be taken by the transplant programs to avoid adverse outcomes. Transplant organizations are currently calling for strict screening and isolation protocols to be established in all transplant programs, for both organ donors and recipients. As the situation escalates, more radical measures might be necessary, including a temporary hold on non-urgent transplantations, resulting in serious ethical dilemmas between the survival of these patients and the safety of the community. Further data about these special populations could result in more individualized guidelines for abdominal organ transplantation in the era of COVID-19.