Surprisingly few (26.3%) studies mention what pulmonary annulus size "cutoff" was used to decide when to insert a TAP. Z-scores derived from different populations were used by different studies and it is possible that this may have contributed to the varied "cutoffs' quoted. Recommendations to perform valve-sparing surgery in pulmonary annuli as small as -4 may not be warranted. Future papers should record "cutoffs" employing recommended z-score data set.

The use of varied tricuspid valve annuli z-score data sets may have contributed to gross variations in reported "cutoffs" for successful biventricular repair. This could lead to inappropriate surgical pathway allocation.

9547 Background: Immunosuppressed and/or immunocompromised patients are at increased risk for solid tumors and cutaneous malignancies. Limited data exist on the safety and effectiveness of immune checkpoint inhibitors (ICIs) in these patients because they are frequently excluded from clinical trials. Here, we describe the safety and effectiveness results from the initial cohort of immunosuppressed and/or immunocompromised patients with advanced CSCC enrolled in the C.A.S.E. study (NCT03836105). Methods: C.A.S.E. is a prospective, real-world, multi-center, longitudinal study evaluating the effectiveness, safety, quality of life, and survivorship in patients with advanced CSCC treated with cemiplimab. Patients received cemiplimab 350 mg intravenously every 3 weeks per routine standard of care. Patient demographics, disease characteristics, immunosuppression, and relevant medical history were collected. Immunosuppressive regimens varied amongst patients. Investigator assessment of objective response rate (ORR), safety, and tolerability was conducted. Data from 26 immunosuppressed and/or immunocompromised patients with advanced CSCC treated with cemiplimab are presented. Recruitment is ongoing. Results: As of November 17, 2020, 121 patients were enrolled in the C.A.S.E. study, of which 26 patients (median age: 74 years [IQR: 71-84]; 85% male; 89% Caucasian) were designated as immunocompromised or immunosuppressed due to a history of solid organ transplant (n = 6), autoimmune disorder (n = 11), or hematologic malignancy (n = 9). Median duration of cemiplimab exposure was 14 months (IQR: 9.1–42, range: 0, 67). Among 19 immunocompromised or immunosuppressed patients who enrolled in C.A.S.E. prior to their third dose of cemiplimab, ORR per investigator assessment was 47% (95% CI: 24–71); 1 (5%) patient had complete response; 8 (42%) had partial response. One patient had a treatment-related serious adverse reaction of organ transplant rejection. One (3.8%) patient discontinued treatment due to increased alanine aminotransferase (not treatment-related). Immune-related AEs (irAEs) occurred in 23% of patients. No treatment-related AEs led to death. Conclusions: The safety, tolerability, and effectiveness of cemiplimab in this initial cohort of immunosuppressed and/or immunocompromised patients with advanced CSCC appear to be consistent with those observed in clinical trials that excluded these patients. Further follow-up and additional data would add to our general understanding of safety and effectiveness of anti-PD1 therapy in immunocompromised and/or immunosuppressed patient populations overall. Clinical trial information: NCT03836105.

A pseudoaneurysm of the ventricle is formed when there is rupture of the myocardial wall with the discontinuity being roofed over by the pericardium and mural thrombus or fibrous tissue without myocardial elements. Cardiac pseudoaneurysm is a rare and a potentially life-threatening event. Early prophylactic surgical aneurysmectomy has been the treatment of choice. In this context, we report an unusual case of giant left ventricular pseudoaneurysm, as a result of unknown aetiology, appearing like a pulsatile mass, which was easily seen from the chest wall, in a young female, successfully treated with surgery.

Monocusp valves are thought to reduce early operative mortality and morbidity associated with pediatric tetralogy of Fallot repair. As there are no published randomized clinical trials comparing outcomes with and without a monocusp valve, we performed a meta-analysis of observational studies in accordance with established protocols. After systematically searching PubMed, the Cochrane Library, and Google Scholar, 12 studies were included. The operative mortality was compared in 695 patients, and we found no difference between patients with and patients without a monocusp valve. Monocusp valves may not improve operative mortality of tetralogy of Fallot repair in pediatric patients.

Introduction:The prevalence of peripheral arterial disease (PAD) ranges between 4.5% and 57% and is independently associated with cardiovascular disease burden irrespective of symptoms. Two thirds of cases are thought to be asymptomatic and may go unrecognised. Local prevalence and natural progression of asymptomatic PAD is unknown. Methods: This one year, non-interventional longitudinal study, aimed to determine prevalence and progression of asymptomatic PAD in patients with cardiovascular risk factors. Results: Of 217 patients screened, 36% had asymptomatic disease in 113 legs. Of sixty two who returned for follow-up, eight normal legs developed asymptomatic PAD, and 46%, asymptomatic at baseline showed disease progression. Initial baseline ABI showed significant change over 1 year of follow-up (p=0.001) and 21% (13) of patients eventually developed intermittent claudication. Also, 52% of baseline asymptomatic participants having at least one associated cardiovascular risk factor showed disease progression over 1 year. Those developing claudication demonstrated significant ABI deterioration. Having two or more cardiovascular risk factors significantly affected progression of asymptomatic disease, (p = 0.031). Conclusion: Study confirms high prevalence of asymptomatic PAD in our population and significant disease progression in one year.

Since cardiac structuring dimensions inform surgical decisions making, Z-score systematic error impairs surgical decision making and confounds outcome measurement, hence a similar error may affect the Nakata index. In this study, PubMed was searched using the terms: "pulmonary," "artery," "size," "Nakata," "Fontan," and "outcome". Studies that did not describe the outcome of the Fontan procedure and the size of the branch pulmonary arteries were excluded. Outcome measures of interest, in relation to BPA size, included: Operative mortality, Fontan "take-down", length of ICU stay, pleural effusions and functional capacity. The results revealed that of 116 papers retrieved, 9 were included representing 1,042 patients who underwent the Fontan procedure. Six out of 9 papers representing 645 (61.9%) patients reported that BPA size had no relationship with the outcome of the Fontan procedure; while 2 out of 9 papers representing 366 (35.1%) patients found that BPA size did affect the outcome. One paper representing 31 (3%) patients was unable to find any relationship. All the papers that concluded that there was no relationship labelled normal sized BPAs as small because of a systematic error introduced by the Nakata index. Papers that found a relationship did not use the Nakata index. Thus, Nakata index systematic error may impair surgical decision making and confound outcome measurement in Fontan surgery. In addition, continued use of the Fontan index may have similar implications for other congenital heart lesions.

No abstract