Cleveland Clinic Experience Research Articles

Secondary reduction mammaplasty techniques and outcomes: Cleveland Clinic experience

BackgroundInformation on optimal techniques and outcomes following secondary reduction mammaplasty remains sparse with only 280 patient cases reported in the literature to date. Methods7,179 medical charts of patients who underwent non-oncological breast reduction at the Cleveland Clinic Health System from January 2001 to October 2023 were screened to identify whether the procedure was a secondary reduction. Patient charts were then reviewed to extract demographic, surgical, and outcome data. Patients were also contacted through the electronic medical record to fill out the BREAST-Q V2 questionnaire about post-operative satisfaction. Surgical techniques and satisfaction were compared for patients with complications versus those without. ResultsOne hundred and twenty-two (1.7%) patients underwent secondary breast reduction. An inferior pedicle was the most used for both primary (n=59, 48.4%) and secondary (n=64, 52.5%) surgeries. The primary pedicle was re-created in 62 of the 84 (73.8%) re-reductions where a primary pedicle was known. A total of 15 patients (12.3%) completed the BREAST-Q questionnaire. BMI was significantly and negatively associated with satisfaction with outcome (R=-0.66, p=0.01), sexual wellbeing (R=-0.58, p=0.04), and physical wellbeing (R=-0.69, p=0.006). No patients experienced nipple-areolar-complex (NAC) necrosis following secondary reduction. However, 21 (17.2%) of patients experienced complications or breast fat necrosis following re-reduction. Unmatched secondary pedicles showed a trend towards higher complication rates than matched secondary pedicles (31.3% vs. 12.9%, p=0.051). ConclusionWhen known, the primary pedicle can be safely used for secondary reduction mammaplasty with minimal risk of NAC necrosis or complication.

Real life data of KEYNOTE 522: The Cleveland Clinic experience.

e12612 Background: Triple-negative breast cancer (TNBC) constitutes approximately 15% of all breast cancers and predominantly affects younger women with a disproportionate impact on Black and Hispanic ethnicities. Historically, neoadjuvant therapy centered around chemotherapy alone. However, the KEYNOTE 522 trial has demonstrated improved outcomes with the incorporation of the PD-1 inhibitor Pembrolizumab alongside neoadjuvant chemotherapy. Methods: A retrospective cohort analysis of 106 patients treated with the KEYNOTE 522 regimen within Cleveland Clinic from January 2020 to July 2023. The objective is to evaluate the real-life experience, particularly concerning treatment tolerance and pathologic complete response rates (PCR). Results: Among the 106 female patients, 6.6% completed full neoadjuvant therapy without reporting adverse events (AE), achieving a 71.42% PCR rate. Complications were reported in various subgroups: 54.72% associated with paclitaxel and carboplatin, with discontinuation rates of 60.34%, reduction rates of 33.02%, and full continuation rates of 6.9%. The most prevalent AE included cytopenia (46.55%) and febrile neutropenia, along with other infections (27.59%). For patients discontinuing paclitaxel and carboplatin, the PCR was 68.57%, while with dose reductions, it was 68.75%. Complications related to doxorubicin and cyclophosphamide were reported in 16.04% of patients, with 47.06% either discontinuing or reducing dose, and 5.88% continuing full therapy. Febrile neutropenia, along with other infections (64.71%) and cytopenia (23.53%) were the prominent AE. The PCR for patients discontinuing or reduced doxorubicin and cyclophosphamide was 62.50%. Pembrolizumab-related complications were reported in 16.98% of patients, with a 50% discontinuation rate. The most common AE was dermatologic toxicities (27.78%). The PCR for patients discontinuing pembrolizumab was 83.33% versus 62.5% for those continuing full therapy. Conclusions: This retrospective analysis highlights infections and cytopenias as the primary adverse reactions. Notably, the dose reduction or discontinuation of agents did result in a deterioration of PCR rate compared to patients completing full therapy. Remarkably, PCR was improved for the pembrolizumab discontinuation group, perhaps suggesting a correlation between autoimmune toxicities and improved response. Additional prospective study with larger sample size is needed to understand whether all patients benefit from completing the Keynote 522 regimen. [Table: see text]

B-2 | Outcomes of percutaneous pulmonary valve implantation: Cleveland Clinic Experience

B-2 | Outcomes of percutaneous pulmonary valve implantation: Cleveland Clinic Experience

Identification and management of clonal hematopoiesis of indeterminate potential (CHIP) in cancer survivors: The Cleveland Clinic experience.

7010 Background: Clonal hematopoiesis (CH) of indeterminate potential (CHIP) is found in healthy populations as well as cancer patients (pts) and is associated with (w/) cardiovascular disease (CVD), risk of hematologic neoplasms (HN), and all-cause mortality. Germline variants (var) predispose to CHIP. However, described var are nonspecific to solid tumor pts. Identifying CHIP risk factors and mitigation strategies is paramount for improving outcomes. Methods: Pts in breast (BC) and head & neck cancer (HNC) survivorship (2020-2023) following curative treatment (tx) were eligible for our 10 year (yr) prospective study of annual next generation sequencing (NGS) and complete blood count (CBC) to identify CHIP. Mutations (mt) were classified as clinically significant (CS) or var of unknown significance (VUS), and as CH (med. VAF 4.7%) or potentially germline (PG; med. VAF 50%). Pts w/ CHIP were managed in both CHIP Clinic (CC) and Preventive Cardiology (PC) for monitoring and CVD reduction. Fisher’s exact and ANOVA tests were used for analyses. Results: Of 168 pts enrolled (117 BC, 51 HNC), 158 had NGS: 73 yr 1, 85 through yr 2 or 3; 22 pts received chemotherapy (CT), 49 radiation therapy (RT), 72 CT & RT (CRT). Sixty-eight pts (43%) had a mt; 21 (13%) had CHIP (6 w/ PG VUS). CHIP was found to be associated w/ older age (69 vs. 58, p= 0.0002). The most common CHIP mt were DNMT3A (n = 11), PPM1D (6), TET2 (6), JAK2 a nd TP53 (2). Two pts without yr 1 mt developed CHIP in yr 2. For PPM1D, 2 PG VUS were point mt from DNA transitions while 6 CHIP were truncating from transversions and deletions. All pts w/ PPM1D had RT (7/8 CRT), suggesting a molecular signature which varies from transition-driven aging. Six pts had thrombocytopenia (TP), 3 w/ PPM1D CHIP. TP was more common in CHIP (OR 11, p= 0.0356) and PPM1D (OR 29, p= 0.0016). In this cohort, anemia was not seen in pts w/ CHIP ( p= 0.048). Normal CBC was 6x less common in pts w/ CRT ( p= 2.3x10-7). Seven CHIP pts were seen by PC; 4 had yr 2 NGS following PC visit. All pts had addition of new/dose escalation of current CVD medication. Two CHIP pts had stable NGS; 2 CHIP & PG VUS pts had clonal changes including mt disappearance and acquisition. Of note, the PG VUS’s were assessed for institutional incidence in 3,918 HN pts w/ NGS data and in Mastermind (MM) for frequency of occurrence in published literature. Sixteen PG VUS (40%) occurred at our institution (13 found in MM, 7 classified as rare (avg gnomAD MAF 6x10-4)) and associated w/ HN, notably TET2 (n = 3). Conclusions: This ongoing prospective study is one of the largest to report characteristics and outcomes of CHIP pts in CC/PC and is expected to accrue more in expansion. We anticipate highlighting risk factors for CHIP progression and report novel PG VUS, which may portend health risks based on their prevalence in HN. Furthermore, it appears that a strategy for CVD prevention may promote clonal stability in survivorship pts.

Turnbull‐Cutait abdominoperineal pull‐through operation: The Cleveland Clinic experience in the 21st century

<scp>Turnbull‐Cutait</scp> abdominoperineal pull‐through operation: The Cleveland Clinic experience in the 21st century

Directional Stimulation in Parkinson's Disease and Essential Tremor: The Cleveland Clinic Experience

ObjectiveTo assess use of directional stimulation in Parkinson's disease and essential tremor patients programmed in routine clinical care. Materials and MethodsPatients with Parkinson's disease or essential tremor implanted at Cleveland Clinic with a directional deep brain stimulation (DBS) system from November 2017 to October 2019 were included in this retrospective case series. Omnidirectional was compared against directional stimulation using therapeutic current strength, therapeutic window percentage, and total electrical energy delivered as outcome variables. ResultsFifty-seven Parkinson's disease patients (36 males) were implanted in the subthalamic nucleus (105 leads) and 33 essential tremor patients (19 males) were implanted in the ventral intermediate nucleus of the thalamus (52 leads). Seventy-four percent of patients with subthalamic stimulation (65% of leads) and 79% of patients with thalamic stimulation (79% of leads) were programmed with directional stimulation for their stable settings. Forty-six percent of subthalamic leads and 69% of thalamic leads were programmed on single segment activation. There was no correlation between the length of microelectrode trajectory through the STN and use of directional stimulation. ConclusionsDirectional programming was more common than omnidirectional programming. Substantial gains in therapeutic current strength, therapeutic window, and total electrical energy were found in subthalamic and thalamic leads programmed on directional stimulation.

Prognostic factors and clinical outcomes in patients with upper tract urothelial carcinoma undergoing surgery: The Cleveland Clinic experience.

4593 Background: Upper tract urothelial carcinoma (UTUC) is a rare and heterogeneous disease accounting for approximately 5-10% of UC. While tumor grade and stage are known prognostic factors, data on other factors affecting outcomes in UTUC patients (pts) undergoing surgery is scant. We studied effect of various clinical factors and treatment on outcomes in UTUC. Methods: This is a single-institution retrospective study of 607 pts with UTUC undergoing surgery (nephroureterectomy (NU) or ureterectomy (U)) between Jan 2000 and Dec 2020. We studied effect of demographics, clinicopathological features, tumor location, preoperative Neutrophil-to-Lymphocyte ratio (NLR) and Albumin-to-Globulin ratio (AGR) and use of neoadjuvant or adjuvant chemotherapy on overall survival (OS) and recurrence free survival (RFS). Results: Of the 607 pts 401 (66.06%) were males and 355 (58.48%) were &gt; 70 yrs; 232 pts (38.22%) had UTUC of renal pelvis, 242 (39.87%) of ureter and 133 (21.91%) of both. 542 pts (89.29%) underwent radical NU and 65 (10.71%) segmental U; 328 patients (54.04%) were diagnosed with muscle invasive UC (MIUC) ( &gt; / = pT2) and 276 (45.47%) with non-MIUC ( &lt; / = pT2). Only 51 (8.4%) pts had lymph node positive (N+) disease. Lymphovascular invasion (LVI) was identified in 163 (26.85%) and carcinoma- in-situ (CIS) in 163 (26.85%) pts. Surgical margins were positive in 92 pts (15.16%). Median NLR cutoff was 3.25 and AGR cutoff was 1.25 (dichotomized based on literature). 44 pts (7.2%) received Neoadjuvant chemotherapy and 49 pts (8%) received adjuvant chemotherapy. Tumor recurrence occurred in 216 pts (35.58%) of which 65% were at urothelial and 35% at non-urothelial sites. With median follow up of 35.2 mos, median OS was 82.69 mos and 5-yr OS rate was 60%; median RFS was 29.47 mos and 5-yr RFS rate was 40%. High grade, age &gt; / = 70 yrs, high NLR, low AGR, presence of LVI, positive margins, CIS, MIUC, N+ disease were associated with worse outcomes. Pts with only renal pelvis involvement had better OS. Conclusions: In this large, long term follow-up series of UTUC pts, we identified several prognostic factors besides grade and stage that impact outcomes. These findings warrant further validation for use in clinical practice. [Table: see text]

Turnbull-Cutait abdominoperineal pull-through operation: The Cleveland Clinic experience in the 21st century.

The Turnbull-Cutait pull-through procedure (TCO) restores intestinal continuity in the setting of chronic pelvic sepsis, colorectal anastomotic leak, complex pelvic fistulas and technical challenges related to complicated rectal cancer. The aim of this study was to evaluate the outcomes of the TCO for salvaging complex pelvic conditions and to compare it to hand-sewn immediate coloanal anastomosis (CAA). This is a retrospective single-institution study where we searched a prospectively maintained database to identify patients who underwent the TCO. Patient demographics, operative indications and outcomes were analysed. TCO success was defined as maintenance of intestinal continuity and being stoma-free. Kaplan-Meier analysis was employed for stoma-free survival analysis. A total of 81 patients with TCO and 129 patients with CAA were included. The TCO success rate was 69% at a median of 1.4 years' follow-up with 25 (31%) patients ending up with a permanent stoma compared to 22 (17%) in the CAA group with a median follow-up of 4 years (P=0.03). The Kaplan-Meier cumulative incidence of TCO success at 1, 3 and 5 years was 79%, 60% and 51%, respectively, compared to 91%, 81% and 73% after CAA. The TCO has a high success rate for patients with complex pelvic conditions who may be facing a permanent stoma as their only option.

Skeletal and Dental Outcomes after Facial Allotransplantation: The Cleveland Clinic Experience and Systematic Review of the Literature.

Most of the literature surrounding face transplantation focuses on technique, immunology, and psychology. Dental and skeletal outcomes remain persistently underreported. This study critically examined the worldwide face transplant experience to evaluate such outcomes. A systematic review of all composite allografts containing midface and/or mandible was performed. Dental and skeletal complications were recorded. Formal imaging and photographs available in the literature were analyzed using skeletal measurements, soft-tissue cephalometrics, and the Angle classification. Outcomes of our face transplant patients, including condylar assessment and airway volume measurements, is also presented. Twenty-five patients received allografts containing midface (n = 7) or mandible (n = 2), whereas 16 contained a double-jaw. All midface-only transplants developed skeletal deformity; 57 percent developed a palatal fistula. Both partial and full arch transplantation patients developed skeletal deformity. Among double-jaw transplants, 69 percent developed palatal fistula or floor-of-mouth dehiscence, 66 percent developed malocclusion, 50 percent developed trismus, and 31 percent required corrective orthognathic surgery. In 40 percent of patients, malocclusion recurred after corrective orthognathic surgery. Forty percent of all patients developed dental cavities or periodontal disease. All of our patients received midface and/or mandible. One patient required corrective orthognathic surgery. Midfacial segments showed clockwise rotation. Airway volumes decreased over time. Skeletal and dental complications remain extremely common after facial allotransplantation involving either single- or double-jaw composites. Corrective orthognathic surgery and dental extraction is often necessitated. These data will aid face transplant teams during surgical planning and preoperative counseling. Therapeutic, V.

Characteristics and Outcomes of Patients With Acute Coronary Syndrome Who Received Percutaneous Coronary Intervention During Snowy Days.

Acute coronary syndrome (ACS) is affected by several weather conditions. Studies from different geographical locations have yielded mixed results regarding the outcomes of patients presenting with ACS during snowy days, and we aim to report the Cleveland Clinic experience. Patients who presented with an ACS and underwent percutaneous coronary intervention (PCI) from July 1, 2009 to September 30, 2017 were divided into ST-segment elevation myocardial infarction (STEMI), and non-ST segment elevation ACS (NSTE-ACS). According to snowy day arrival, we compared in-hospital mortality, culprit lesion anatomy, and door-to-balloon (DTB) time (in STEMI patients). Findings were confirmed in propensity-score matched cohorts. A total of 6878 patients were included: 1608 patients with STEMI (139 snowy-day vs 1469 non-snowy day PCIs) and 5270 NSTE-ACS (419 snowy-day vs 4851 non-snowy day PCIs). Right coronary artery territories accounted for most of the stented culprit lesions in all STEMI and NSTE-ACS snowy-day PCIs. While left anterior descending artery lesions were predominant in NSTE-ACS non-snowy day PCIs. There was no difference in in-hospital mortality between the snowy-day vs non-snowy day groups (4.3% vs 4.5% in the STEMI group [P=.92] and 1.2% vs 1.7% in the NSTE-ACS group [P=41]). In STEMI patients, mean DTB times were similar (43 ± 55.1 minutes vs 46.7 ± 59.6 minutes; P=.61), which remained true after hours, during weekends and holidays. Outcomes were similar in propensity-score matched cohorts. At our institution, snowy days do not seem to affect in-patient mortality. In STEMI patients, DTB times were similar in those who underwent PCI regardless of the snowfall.

Implementation of an Electronic Medical Record Tool for Early Detection of Deep Vein Thrombosis in the Ambulatory Oncology Setting: The Cleveland Clinic Experience

BACKGROUND:Venous thromboembolism (VTE) is a major cause of morbidity, and the second leading cause of mortality in cancer patients. VTE is associated with delay in cancer directed therapy, increased frequency and duration of hospitalization and overall healthcare costs. However, validated scoring systems for assessing risk of VTE are not widely used in clinical practice. We hypothesized that creation of a computerized risk calculator could help identify at-risk individuals in the ambulatory oncology setting; further, screening for VTE in high risk patients could lead to early detection of deep vein thrombosis (DVT) and avoid potential emergent consequences, including hospitalization.METHODS:A computerized alert was built into the electronic medical record system (EPIC) that automatically calculates a score using a validated risk tool [Khorana Score (KS), Blood 2008] based on the primary site of cancer, leukocyte and platelet counts, hemoglobin, and body mass index. During silent lead-in phase I (8/2016-1/17), we evaluated the accuracy of the electronic alert to detect high-risk patients and prospectively followed them for events. During this period, we limited the test to patients presenting to gastrointestinal, thoracic, genitourinary and lymphoma clinics. Patients presenting for consultation without planned treatment/follow up of at least 3 months at our institution were excluded. In phase II (6/17-12/17), we improved the electronic alert to warn physicians in real time about high risk patients and offered lower extremity ultrasonography as a screening test for early detection. In this phase, we only included patients with KS ≥ 3, and an available CBC <2 weeks from alert.RESULTS:During phase I, the alert identified 194 consecutive patients as being at risk (see table 1). The majority of the patients with a positive alert were male (54%) with the most prevalent malignancy being lung and pancreatic adenocarcinomas. The subsequent rate of DVTs at 6 months in patients with a KS of 4 was 18.75% (3/17), patients with KS of 3 was 16.9% (11/65), KS of 2, 13.1% (8/61), and KS of 1, 6.25% (3/48) (Figure 1). See table 1.Time from score calculation to DVT was an average of 33.2 days. 30% of patients developed a DVT within 4 weeks of alert, 50% within 60 days, and 65% within 90 days. 45% of patients diagnosed with DVT were alerted during their initial or second clinic visit. 55% of patients were diagnosed while inpatient and another 30% in the emergency room. Mean emergency room visits for patients with DVT were 1.75 compared to 0.89 for all patients. Mean all cause admissions and length of stay during this period were 2.43 and 15.01 days for patients with DVT, compared to 0.93 and 5.06 respectively for all 194 patients. Mortality rates were 45% for patients with DVT compared to 17% for the study population.In phase II, 59 patients have been identified as high risk by the alert. Of these, 6 were already on therapeutic anticoagulation or had a recent history of DVT. Of the remainder, screening lower extremity ultrasonography was ordered on 10 patients; three (30%) had a LE DVT and were started on therapeutic anticoagulation. One other patient did not have screening ultrasonography ordered, and was diagnosed with DVT within 14 days and started on therapeutic anticoagulation. Additional data collection is ongoing and will be presented at the meeting.CONCLUSION:An electronic medical record risk calculator can be a valuable clinical tool in earlier detection of DVTs in high-risk cancer patients. An initial silent run-in phase demonstrates the ability of this tool to identify high-risk patients at substantially increased risk for VTE, emergency room visits, hospitalization and mortality. An ongoing phase II pilot of early screening demonstrates high rates of subclinical DVT but low rates of ordering screening tests by providers. Ongoing efforts to increase acceptance of screening ultrasonography and data collection may potentially reduce subsequent hospitalization and other adverse consequences for cancer patients. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Treatment of Cancer Associated Venous Thrombosis; The Cleveland Clinic Experience

Introduction:Current guidelines recommend anticoagulation with low molecular weight heparin (LMWH) over vitamin K antagonists (VKA) for the treatment of cancer associated thrombosis (CAT). The use of direct oral anticoagulants (DOACs) is gaining more popularity amongst patients and prescribers given the ease of administration and lower cost compared to LMWH. However, there is limited published data comparing LMWH vs DOACs for the treatment of CAT. Here we report patient outcomes from our clinical experience in treating CAT.Methods:We evaluated a prospective cohort of patients referred to our centralized CAT clinic at the Cleveland Clinic Taussig Cancer Institute. This clinic provides urgent outpatient consultation for adult cancer patients with clinical concern for VTE. In effort to standardize initial treatment, reduce variation in care, and minimize the need for hospitalization, a care path was created to recommend LMWH as the preferred anticoagulant for treatment of VTE with rivaroxaban as an alternative based on patient preference or cost. We evaluated clinical characteristics, anticoagulation prescription, VTE recurrence rate, and subsequent hospitalization for patients diagnosed with VTE. Continuous variables were analyzed with t-test, chi-square (or Fisher's exact) for unordered categorical data, and Cochran-Armitage test for ordered categorical data. Kruskal Wallis test for age was used when comparing all treatments and Wilcoxon rank sum test for age was used when comparing enoxaparin vs rivaroxaban.Results:Data from 608 patients seen between 8/2014 and 11/2016 were considered for analysis. Sixteen patients were excluded (15 due to missing data and one because he/she was the only patient treated with apixaban), leaving 592 patients. Males comprised 52% (308/592) of the study population, median age was 63 (range 20-95). Hematologic malignancies comprised 21% (123/586) of patients and most patients with solid tumors had metastatic disease (72%, 265/368). Within the study population, 15% (88/584) had history of prior VTE and 54% (289/537) were considered high risk based on the modified Ottawa score. (Table 1)VTE was diagnosed in 34% of patients referred to the clinic: Of these, 29% (174/529) were diagnosed with deep vein thrombosis (DVT), 2 % (12/529) with pulmonary embolism (PE), 3% (17/592) with both DVT and PE and one patient had visceral vein thrombosis. Of patients diagnosed with VTE, 25% of patients were subsequently hospitalized.Gastrointestinal, brain, and lymphoma's had a higher rate of VTE than other tumor types (45-49% vs 29-35%). Breast cancer had a lower rate of VTE than other cancer types (17%, p=0.001)Enoxaparin was the most commonly prescribed drug given to 76% (149/195) of patients. Rivaroxaban was given to 12% (23/195), 8% (16/195) were treated with Coumadin and 7 patients (4%) were not given anticoagulant therapy due to a contraindication. High Ottawa score patients received rivaroxaban less frequently than other treatments (p=0.02). Patients treated with rivaroxaban had less hospitalizations compared to patients treated with other anticoagulants (p=0.04).Of patients diagnosed with VTE, 16 (8%) had a recurrent event. There were no significant associations with sex, age, type of cancer, stage, or type of anticoagulant. Specifically, there was no difference in risk of VTE recurrence in patients treated with LMWH (11 events) vs rivaroxaban (0 events); p=0.36). The Ottawa score did not statistically correlate with recurrent VTE (0%, 6%, and 10%) for low, intermediate, and high risk, respectively (p=0.2). An increased risk of recurrent VTE was seen in patients who had personal history of VTE and in those who were hospitalized after the VTE (p=0.02 and p=0.005, respectively). Table 2Conclusion:The Cleveland Clinic provides centralized care to cancer patients diagnosed with VTE. Among patients referred to our CAT clinic, we found risk of VTE correlates with cancer type and personal history of VTE. Most of our patients received our recommended therapy, enoxaparin, but rivaroxaban was prescribed to some due to patient preference. Patients treated with rivaroxaban had fewer adverse outcomes compared to those treated with other anticoagulants. Limitations include the small sample size and greater use of rivaroxaban in lower risk patients. We found the risk of VTE recurrence was higher in those with history of VTE and in those hospitalized for their VTE event. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Outcomes and management of immune thrombocytopenia secondary to COVID-19: Cleveland clinic experience.

BackgroundImmune thrombocytopenia (ITP) is an acquired disease characterized by thrombocytopenia secondary to autoantibodies against platelets. Here, we report the clinical characteristics of coronavirus disease 2019 (COVID‐19)‐induced ITP cases.Study Design and MethodsWe retrospectively reviewed 3255 COVID‐19 patients. COVID‐19‐induced ITP was diagnosed after excluding possible common causes. Bleeding severity was assessed based on the modified World Health Organization (WHO) bleeding severity score.ResultsWe identified 11 (0.34%) patients with COVID‐19‐induced ITP. Of all patients, 63.6% were males and the median age was 63 years. The median time from COVID‐19 diagnosis to the onset of ITP was 10 days. Bleeding observed in 63.6% of the patients. Clinically significant bleeding (WHO Grade 3) occurred in single patient who required blood transfusion. Standard treatment with glucocorticoids and intravenous immunoglobulin (IVIG) was effective in achieving excellent response in most cases. Of all patients, complete response and response to treatment were achieved in 45.5% and 27.3% patients, respectively. The median time to ITP recovery was 4 days. Eltrombopag was used in three patients who relapsed. Four patients required mechanical ventilation, and none of them survived secondary to hypoxic respiratory failure.ConclusionITP secondary to COVID‐19 usually presents after the first week of symptoms beginning. Most of our patients had WHO Grade 1–2 bleeding scores. Standard treatment with glucocorticoids and IVIG is effective in achieving an excellent response. The safety of eltrombopag is not very well established in COVID‐19 patients, and additional studies are needed for a better safety profile.

Implementing a telemedicine curriculum for internal medicine residents during a pandemic: the Cleveland Clinic experience

Telemedicine training was not a substantial element of most residency programmes prior to the COVID-19 pandemic. Social distancing measures changed this. The Cleveland Clinic Internal Medicine Residency Programme (IMRP) is...

Cardiac Rehabilitation Is Essential in the COVID-19 Era: DELIVERING UNINTERRUPTED HEART CARE BASED ON THE CLEVELAND CLINIC EXPERIENCE.

The unprecedented nature of the COVID-19 pandemic has challenged how and whether patients with heart disease are able to safely access center-based exercise training and cardiac rehabilitation (CR). This commentary provides an experience-based overview of how one health system quickly developed and applied inclusive policies to allow patients to have safe and effective access to exercise-based CR.

Characteristics and Outcomes in Head and Neck Sarcomatoid Squamous Cell Carcinoma: The Cleveland Clinic Experience

To analyze characteristics, treatment outcomes, and prognostic factors of sarcomatoid squamous cell carcinoma of the head and neck. Retrospective chart review. Tertiary care center. Fifty-five patients were treated for sarcomatoid squamous cell carcinoma of the head and neck between 1996 and 2018. Data collection included clinical history, tumor characteristics, pathology, treatment modality, and outcomes. Mean follow up was 17.1 months. Cox univariate analysis was used to evaluate for associations with locoregional recurrence, distant metastasis, and overall survival. Most patients were white males with a smoking history and median age 66 years (range 41-92) at diagnosis. Twenty-two percent had prior head and neck radiation. Tumor site was most frequently oral cavity (41.8%), followed by larynx (29.1%), and oropharynx (16.4%). Half presented with early T stage disease (15.5% T0, 12.7% T1, 30.9% T2) and the remainder with late stage disease (16.4% T3, 34.5% T4). Locoregional recurrence rate was 60.0%, metastatic recurrence was rate 21.8%, with median time to recurrence of 4 months and mean overall survival of 20 months. Presence of lymphovascular space invasion was statistically associated with locoregional recurrence (P = .018, HR 3.55 [95% CI 1.24, 10.14]) and poorer overall survival (P = .015, HR 2.92 [95% CI 1.23, 4.80]). Treatment with multimodality therapy was associated with decreased locoregional recurrence (P = .039, HR 0.39 [95% CI 0.16, 0.95]) but did not impact overall survival. Sarcomatoid squamous cell carcinoma remains a rare and aggressive disease variant with high recurrence rates and high mortality. High risk features such as lymphovascular space may indicate the need for more aggressive therapy.

Abstract 12876: Impact of Anesthesia Type on Short- and Long-term Outcomes After Transcatheter Aortic Valve Replacement: The Cleveland Clinic Experience

Introduction: The early approach was to perform transcatheter aortic valve replacement (TAVR) under general anesthesia (GA). Over time, monitored anesthesia care (MAC) has been introduced as a less invasive option to facilitate TAVR. Objective: We sought to compare short- and long-term outcomes between TAVR patients undergoing GA versus those receiving MAC. Methods: We identified all consecutive patients with severe symptomatic aortic stenosis who underwent Transfemoral (TF)-TAVR at our institution between January 2012 and April 2017. Results: We included 998 patients who met our inclusion criteria. Overall, the mean age was 80.4 ± 9.7 years, 57.4% were males and 95.2% were Caucasians. MAC was used in 43.9%. The mean STS risk score (SD) was lower with MAC (6.7 ± 4.3% vs. 7.6 ± 4.5%; p = 0.004). MAC was associated with lower all-cause mortality at both 30 days (0.5% vs. 4.2%; log-rank p &lt; 0.001), and 1 year (11.7% vs. 16%; log-rank p = 0.024). However, this difference was negated at 3 years (37% vs. 39%; log-rank p = 0.271). Further, there were no differences in major adverse cardiac and cerebrovascular events (MACCE) at either 30 days (4.6% vs. 7.6%; log-rank p = 0.089) or 1 year (21.5% vs. 24.2%; log-rank p = 0.242). There were no differences in the rates of myocardial infarction (1.6% vs. 0.9%; log-rank p = 0.375), stroke or transient ischemic attacks (3.1% vs. 3.4%; log-rank p = 0.817) or heart failure hospitalizations (9.6% vs. 9.5%; log-rank p = 0.815) at 1 year. In multivariate analysis, MAC predicted lower all-cause death at 1 year after TAVR (HR 0.672; 95% CI 0.453 - 0.996; p = 0.048) but not at 3 years (HR 0.882 (0.705 - 1.103; p = 0.271). MAC was not an independent predictor of MACCE (HR 0.851; 95% CI 0.643 - 1.126; p = 0.258). Conclusions: Compared to GA, MAC was associated with lower all-cause mortality at both 30 days and 1 year, but not at 3 years. There were no differences in MACCE between the two groups at either 30 days or 1 year.

Abstract 12850: Isolated and Assisted Transcatheter Coil Embolization of Coronary Artery Lesions: The Cleveland Clinic Experience

Introduction: Transcatheter coil embolization (TCE) has been introduced as a modality in treating several coronary artery lesions including coronary artery fistula (CAF), patent left internal mammary artery (LIMA) side branch, coronary artery perforation (CAP), coronary artery aneurysm (CAA), and coronary artery pseudoaneurysm (CAPA) is limited. Hypothesis: TCE is underutilized in various coronary lesions despite its efficacy. Methods: This is a retrospective, descriptive study of all adult patients who underwent TCE at the Cleveland Clinic between August 2007 and August 2019. A total of 41 patients, including 25 CAF, 7 patent LIMA side branches, 5 CAP, 2 CAA, and 2 CAPA from a total of 121,196 cases, were studied. Results: Successful angiographic closure was performed in 37 out of 41 (90%) cases (100% ,100% ,100%, 88%, 80%, of patent LIMA side branch ,CAA, CAPA, CAF, CAP, respectively). Ampatzer vascular plug was used as an adjunctive device in 10% of the total cohort. No adverse events were directly associated with TCE among the LIMA, CAA, and CAPA lesions, and only one patient with CAF required re-intervention at three months due to coil migration. One patient with a large CAP of the mid-left anterior descending artery died while hospitalized due to cardiogenic shock despite successful embolization. Conclusions: Transcatheter Coil embolization in our institution was safe and effective in treating different coronary circulation abnormalities with successful angiographic results in 90% of treated cases. Additional study on the utilization of vascular plug devices in cases such as LIMA side branch or CAF would be beneficial to better understand the treatment options.

A Contemporary 20-Year Cleveland Clinic Experience of Nonbacterial Thrombotic Endocarditis: Etiology, Echocardiographic Imaging, Management, and Outcomes

BackgroundNonbacterial thrombotic endocarditis, or marantic endocarditis, is rare. Contemporary data on the etiology, echocardiographic evaluation, and management of nonbacterial thrombotic endocarditis are limited. MethodsA single-center retrospective cohort study was performed. Electronic medical records and echocardiographic records were searched for patients ages ≥18 years with a confirmed diagnosis of nonbacterial thrombotic endocarditis between January 1999 and November 2019. Demographic, echocardiographic, and management data were collected. ResultsOf 600,577 transthoracic echocardiograms (TTEs) and 89,264 transesophageal echocardiograms (TEEs), 42 patients had nonbacterial thrombotic endocarditis (mean age: 54 ± 14.5 years; 66.7% were female). The median duration of follow-up was 8.2 (interquartile range 3.3-24.4) months. Seventeen patients (40.5%) had malignancy, 33.3% had systemic lupus erythematosus, and 35.7% had antiphospholipid antibody syndrome. Stroke was the most common presentation (59.5%).TTE enabled the diagnosis in 19 cases (45.2%), compared with TEE, which identified the condition in 33 of 34 (97.1%) cases in which it was utilized. Three-dimensional echocardiography was performed in 17 TEEs. The most common valves involved were mitral (61.9%), and aortic (23.8%) valves. Thirty-two patients were managed with anticoagulation. Ten patients underwent surgery. Sixteen (38.1%) patients died, most of whom had a diagnosis of advanced malignancy. ConclusionIn a contemporary 20-year cohort, TTE and TEE played important roles in diagnosis, with superior diagnostic performance of TEE for nonbacterial thrombotic endocarditis. Mortality was high, and advanced malignancy portended a worse prognosis. Management in most cases was therapeutic anticoagulation. In select cases, surgery provided favorable outcomes.

Clinical Characteristics and Outcomes of Primary Breast Lymphoma: The Cleveland Clinic Experience.

IntroductionPrimary breast lymphoma (PBL) is a rare malignancy that accounts for less than 0.5% of all breast malignancies.Materials and MethodsWe retrospectively analyzed 36 PBL patients to report the clinical characteristics and outcomes of patients with indolent and aggressive histologic subtypes.ResultsThirteen (36%) patients had aggressive and 23 (64%) had indolent PBL. Marginal zone lymphoma was the most common histologic subtype (33%). Stage IE, IIE, and IV disease were seen in 27 (75%), six (17%), and three (8%) patients, respectively. Patients with aggressive PBL more often presented with a breast lump and/or B symptoms (unexplained weight loss, fever, night sweats) (78% vs. 31%, p = 0.005). Commonly used treatment modalities for aggressive vs. indolent PBL were chemotherapy alone (23% vs. 26%, p = 0.8), chemoradiotherapy (46% vs. 9%, p = 0.009), radiotherapy alone (15% vs. 22%, p = 0.6), and observation (0% vs. 26%, p = 0.07), respectively. The five-year overall survival (OS) and progression-free survival (PFS) of PBL patients were 82% (95% CI: 67 - 100) and 63% (95% CI: 45 - 89), respectively. The five-year OS of patients with aggressive vs. indolent PBL were 92% (95% CI: 77 - 100) vs. 80% (95% CI: 63 - 100), respectively (p = 0.6). The five-year OS of patients who received > 1, 1, and 0 treatment modalities were 92% (95% CI: 77 - 100), 86% (95% CI: 63 - 100), and 53% (95% CI: 21 - 100), respectively.ConclusionIn our cohort, the higher utilization of chemoradiotherapy in aggressive PBL was able to overcome the worse prognosis of these patients. At least one treatment modality should be considered in patients with indolent PBL, given that observation alone was associated with a poor prognosis.