Highlights of Cardiovascular Disease Prevention Studies Presented at the 2023 American Heart Association Scientific Sessions.

PURPOSE OF REVIEW: Focused review highlighting ten select studies presented at the 2023 American Heart Association (AHA) Scientific Sessions. RECENT FINDINGS: Included studies assessed semaglutide and cardiovascular outcomes in overweight or obese patients without diabetes (SELECT); dapagliflozin in patients with acute myocardial infarction without diabetes (DAPA-MI); effects of dietary sodium on systolic blood pressure in middle-aged individuals (CARDIA-SSBP); long-term blood pressure control after hypertensive pregnancy with physician guided self-management (POP-HT); effect and safety of zilebesiran, an RNA interference therapy, for sustained blood pressure reduction (KARDIA-1); recaticimab add-on therapy in patients with non-familial hypercholesterolemia and mixed hyperlipidemia (REMAIN-2); efficacy and safety of lepodisiran an extended duration short-interfering RNA targeting lipoprotein(a); safety and pharmacodynamic effects of an investigational DNA base editing medicine that inactivates the PCSK9 gene and lowers LDL cholesterol (VERVE-101); automated referral to centralized pharmacy services for evidence-based statin initiation in high-risk patients; and effects of intensive blood pressure lowering in reducing risk of cardiovascular events (ESPRIT). Research presented at the 2023 AHA Scientific Sessions emphasized innovative strategies in cardiovascular disease prevention and management.

Brugada phenocopy secondary to hyperkalemia and hyponatremia in primary adrenal insufficiency.

Introduction: The Brugada phenocopy represents electrocardiogram (ECG) changes nearly identical to the Brugada syndrome but without the congenital abnormality associated with lethal arrhythmias and normalizes with treatment of the underlying etiology. This case highlights the Brugada phenocopy in the setting of moderate hyperkalemia and severe hyponatremia from adrenal insufficiency that resolves with treatment of the underlying metabolic disturbance. Case Report: A 26-year-old man with no prior medical history presented to the emergency department with syncope, and his ECG revealed a Brugada-like pattern. The patient was found to have significant metabolic derangements, including severe hyponatremia (94 mEq/L), moderate hyperkalemia (6.1 mEq/L), severe hypochloremia (<60 mEq/L), acute kidney injury, and rhabdomyolysis. The patient was diagnosed with primary adrenal insufficiency, and electrolyte correction led to resolution of the Brugada phenocopy. Conclusion: The Brugada phenocopy on ECG can occur with severe hyponatremia and moderate hyperkalemia and quickly resolves with electrolyte correction.

Natural Supplements for COVID19-Background, Rationale, and Clinical Trials.

Worldwide, the turmoil of the SARS-CoV-2 (COVID-19) pandemic has generated a burst of research efforts in search of effective prevention and treatment modalities. Current recommendations on natural supplements arise from mostly anecdotal evidence in other viral infections and expert opinion, and many clinical trials are ongoing. Here the authors review the evidence and rationale for the use of natural supplements for prevention and treatment of COVID-19, including those with potential benefit and those with potential harms. Specifically, the authors review probiotics, dietary patterns, micronutrients, antioxidants, polyphenols, melatonin, and cannabinoids. Authors critically evaluated and summarized the biomedical literature published in peer-reviewed journals, preprint servers, and current guidelines recommended by expert scientific governing bodies. Ongoing and future trials registered on clinicaltrials.gov were also recorded, appraised, and considered in conjunction with the literature findings. In light of the controversial issues surrounding the manufacturing and marketing of natural supplements and limited scientific evidence available, the authors assessed the available data and present this review to equip clinicians with the necessary information regarding the evidence for and potential harms of usage to promote open discussions with patients who are considering dietary supplements to prevent and treat COVID-19.

A Novel Procedure of Prepuce Reconstruction Customized to the Religious Needs of Some Individuals.

Background Authors describe a novel procedure in a group of patients for prepuce reconstruction, ensuring complete glans penis coverage who had either been circumcised in childhood or had congenitally short prepuce. Methods Case records of all cases done by the novel method which involved penile degloving and maintenance of neoprepuce, with the help of de-epithelization of glans penis and a few key sutures performed over the period from January 2010 to December 2019 were reviewed retrospectively. A total of 46 patients, 32 had congenitally short prepuce and 14 had previous circumcision. Results All the patients had complete glans penis coverage. None of the patients had complications like urinary infection, meatal stenosis, collection in neoprepucial sac, balanitis, or posthitis. The mean followup was 23.24 months in 37 patients. Nine lost to followup. Conclusions The procedure is simple, gives reliable results, and is customized to the needs of the patients. It does not interfere with penile erections.

Cardiac Magnetic Resonance Stress Perfusion Imaging for Evaluation of Patients With Chest Pain.

BACKGROUND: Stress cardiac magnetic resonance imaging (CMR) has demonstrated excellent diagnostic and prognostic value in single-center studies. OBJECTIVES: This study sought to investigate the prognostic value of stress CMR and downstream costs from subsequent cardiac testing in a retrospective multicenter study in the United States. METHODS: In this retrospective study, consecutive patients from 13 centers across 11 states who presented with a chest pain syndrome and were referred for stress CMR were followed for a target period of 4 years. The authors associated CMR findings with a primary outcome of cardiovascular death or nonfatal myocardial infarction using competing risk-adjusted regression models and downstream costs of ischemia testing using published Medicare national payment rates. RESULTS: In this study, 2,349 patients (63 ± 11 years of age, 47% female) were followed for a median of 5.4 years. Patients with no ischemia or late gadolinium enhancement (LGE) by CMR, observed in 1,583 patients (67%), experienced low annualized rates of primary outcome (<1%) and coronary revascularization (1% to 3%), across all years of study follow-up. In contrast, patients with ischemia+/LGE+ experienced a >4-fold higher annual primary outcome rate and a >10-fold higher rate of coronary revascularization during the first year after CMR. Patients with ischemia and LGE both negative had low average annual cost spent on ischemia testing across all years of follow-up, and this pattern was similar across the 4 practice environments of the participating centers. CONCLUSIONS: In a multicenter U.S. cohort with stable chest pain syndromes, stress CMR performed at experienced centers offers effective cardiac prognostication. Patients without CMR ischemia or LGE experienced a low incidence of cardiac events, little need for coronary revascularization, and low spending on subsequent ischemia testing. (Stress CMR Perfusion Imaging in the United States [SPINS]: A Society for Cardiovascular Resonance Registry Study; NCT03192891).

Oncoplastic Breast Reconstruction in Breast Conservation Surgery: Improving the Oncological and Aesthetic Outcomes.

Breast conservation surgery (BCS) is now the standard of care for patients with early breast cancer. The main contraindications for BCS besides the presence of multicentricity and diffuse microcalcifications are inadequate tumour size to breast size ratio. With the advent of oncoplastic techniques, the indications of BCS may be further extended to patient with larger tumour size and or small volume breast. We prospectively assessed 42 patients undergoing oncoplastic breast conservation surgery for cosmetic and oncologic outcomes. Cosmetic outcome assessment was done by comparison of operated breast to contralateral breast by an independent surgeon, nurse and patient's attendant at 6 months post-surgery. Risk factors for compromised oncologic outcomes included grades II/III tumours and non-ductal histology. Intraoperative margin assessment with frozen section analysis proved to be important in order to achieve negative surgical margins on final histopathology. By univariate analysis, tumours located in central quadrant and medial half of the breast had similar cosmetic outcomes comparable to tumours located in other quadrants. Majority of our patients (90%) had overall good to excellent cosmetic outcomes on Harvard scale. Oncoplastic breast conservation surgery techniques allow for larger parenchymal resections without compromising oncologic and cosmetic results. It further allows extension of BCS to patients otherwise denied for the same based on earlier recommendations for mastectomy. Oncoplastic techniques and intraoperative margin assessment with frozen section are vital in attaining adequate margins and also decrease chance of local recurrence and revision surgery for positive margins.

Surgical Management of Carcinoma Vulva-Case Series and Review of Literature.

The objective of this study was to study the risk factors, management protocols, and the outcome of vulvar cancer cases over a period of 2 years in a tertiary care hospital. This is a case series of early-stage vulvar cancer in the Department of Surgical Oncology in BL Kapur Superspeciality Hospital from Jan 2016 to date. Five patients with histologically proven diagnosis of early-stage vulvar cancer were included. The mean age for the diagnosis of vulvar cancer was 58 years and the peak incidence was seen in postmenopausal age group. All of the cases were squamous cell carcinomas in stage IB except one which was a basisquamous variant. All cases were treated primarily with surgery and vulvar flap reconstruction. Adjuvant therapy was not given in any case. Cases were followed from 6 months to date, and no recurrence noted. The limitations of the study were rarity of disease and less number of cases. As all the cases in our study were in early stage of disease (stages I and II), surgical treatment in the form of modified radical vulvectomy with B/L inguinofemoral lymph node dissection and oncoplastic procedure was the treatment modality chosen for all the patients.

Vascularized fibula with and without extracorporeal radiotherapy for limb salvage surgery in Indian patients.

BACKGROUND: Reconstruction of segmental bone defects following resection of bone sarcomas is a challenging procedure. Vascularised fibula grafts alone or in combination with extracorporeal radiotherapy and reimplantation of tumor bone have long been established as a method of reconstruction of such defects, with satisfying results. Prompted by paucity of data on Indian patients, we report our experience with vascularised fibula graft for patients undergoing limb salvage surgery for sarcomas of bone. MATERIAL AND METHODS: A total of 25 patients underwent the procedure from December 2008 to December 2014. Femur was the commonest site and osteosarcoma was the commonest diagnosis. Intercalary resection was done in 19 patients and arthrodesis in 6 patients. Vascularised fibula was used in combination with extra corporeally irradiated bone in eight patients, and alone in 17 patients. RESULTS: All but one limb could be salvaged, and all but three patients had united at final follow up. Combination of extracorporeal radiotherapy and reimplantation with vascularised fibula fared better than vascularised fibula alone in terms of time to union (9.6 months vs 12.2 months) and rate of graft related complications (14.2% vs 62.5%). CONCLUSION: Reconstruction with VFG with or without ECRT has a good and predictable functional outcome. Though manageable with active intervention, complications were more commonly seen with vascularised fibula alone than a combination of the two techniques.

Reconstruction in Breast Conservation Therapy-Single Tertiary Care Institution Experience with 472 Patients.

Breast conservation therapy (BCT) is now internationally accepted treatment for early breast cancer. Despite of high incidence of carcinoma breast in India, BCT rates are very low as compared to the west. In this article, we wish to share our experience of breast conservation with oncoplasty in Indian women. A retrospective analysis of case records of patients treated with oncoplastic breast conservation from January 2009 to June 2014 in a single surgical oncology unit in a tertiary cancer institute. Demographic patient data, stage of disease, location of primary tumour, use of neo-adjuvant chemotherapy if received, tumour size and breast size ratio, reconstruction method used, post-operative complications and aesthetic score of patients were analysed. Various methods of oncoplasty and partial breast reconstruction used are discussed. Four hundred and seventy-two patient records were found suitable for analysis. Most common stage of presentation was T2N0 in 189 patients (40%). Forty-one patients received neo-adjuvant chemotherapy (NACT). Tumour arising in upper outer quadrant was most common site, seen in 268 (56.7%). The most common method of reconstruction was volume displacement, done in 57.6% patients. Overall surgical complications included wound infection with or without dehiscence, seroma formation, partial flap necrosis and fat necrosis. Cosmesis was found to be excellent in 23.09% and good in 58.47% at 6-month follow-up. Breast conservation with oncoplasty is oncologically safe for early breast cancer treatment and has good cosmetic outcome with high patient satisfaction rates. Its practice should be encouraged in Indian set-up also.

Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Prevention of Breast Cancer-Related Lymphedema-a Preliminary Report.

Lymphatic microsurgical preventing healing approach (LYMPHA) for prevention of breast cancer-related lymphedema (BCRL)-a preliminary report BCRL-is a chronic debilitating condition which impairs quality of life of breast cancer survivors. The aim is to study the feasibility of preventing lymphedema by performing "Lymphatic Microsurgical Preventive Healing Approach (LYMPHA)." Patients undergoing breast cancer surgery with complete nodal dissection were taken up for the study. After the standard axillary nodal dissection, lymphatics were identified by the help of blue dye and were anastomosed with a tributary to the axillary vein. Post-operatively, patients were followed up clinically for development of lymphedema and lymphoscintigraphy was performed after treatment completion. A total of 35 patients were enrolled for the study. The average BMI was 29.5. LYMPHA was feasible in all cases. The number of lymphatics identified was 1 to 5 per axilla. Two patients developed transient lymphedema which resolved with conservative therapy and patients were able to discontinue the compression garment. Follow-up lymphoscintigraphy is performed in two patients, which showed normal lymphatic flow. LYMPHA is a feasible technique, not difficult to perform, takes a short time, is accomplished in same general anesthesia as for axillary dissection, and gives no extra scar. The early results are promising and long-term follow-up may make the procedure as a routine.

Fertility Preservation in Pubertal and Pre-Pubertal Boys with Cancer.

Children diagnosed with cancer continue to have improved survival due to advances in effective treatment options. Increased attention is therefore now focused on quality of life issues once they are cured. Fertility preservation is of paramount concern since gonadotoxic treatments, especially radiation and chemotherapy, often impair future fertility. The importance of family counseling and having an informed discussion about the potential for treatment to impair fertility and the options available for fertility preservation is crucial. However, fertility preservation in prepubertal boys is challenging, but not impossible. Experimental methods are being investigated including cryopreservation of immature testicular tissue, xenografting, and in vitro germ cell maturation. Despite the success and relative ease of sperm banking, barriers exist and affect the number of patients offered treatment. Education and awareness of the possibilities can overcome these barriers. In this way we will continue to preserve young patients' future fertility and quality of life.

Prognostic Factors in Indian Patients Operated for Soft Tissue Sarcomas-a Retrospective Cross-sectional Analysis.

Soft tissue sarcomas are a rare entity. While surgery is established as the mainstay of treatment, the exact role and sequencing of adjuvant therapy is not well defined. Literature on Indian patients with soft tissue sarcoma with respect to clinical profile and prognostic factors is scarce. We retrospectively analysed the data of 112 patients operated for soft tissue sarcoma of extremity or trunk (excluding retroperitoneal and mediastinal sarcomas, round cell histology) at our institute from 1 January 2009 to 31 December 2013. Around half the patients were less than 50 years of age and around a third had size more than 10 cm. Oncological outcome was correlated with various demographic, tumour-related and treatment-related factors using SPSS 22. Overall survival at 5 years was 73.2 % and event-free survival at 5 years was 42.2 %. At final follow-up (mean of 44.85 ± 4.64 months), local recurrence was seen in 31.9 % and distant metastasis was seen in 30.1 % of the patients. Using both univariate and multivariate analysis, younger age (<50 years), larger size (>10 cm, but not >5 cm) and pathologically positive lymph nodes were the only factors found significantly affecting overall survival. The clinical profile and prognosis of Indian patients with soft tissue sarcoma were found to be different from that reported in Western literature. The impact of established prognostic indicators for soft tissue sarcoma also differed in Indian patients, which may have both prognostic and therapeutic implications.

Wilms Tumor With Metastasis to the Vagina: A Case Report.

A 12-year-old female presented with abdominal pain, night sweats, weight loss, constipation, dysmenorrhea, menorrhagia, and vaginal discharge. Examination revealed a palpable flank mass and a large tumor adherent to the anterior vaginal wall. Computed tomography scan demonstrated a 23 cm mass in the left kidney, a separate 10.8 cm pelvic mass, and metastatic disease. Biopsies were consistent with Wilms tumor. Neoadjuvant chemotherapy and a left radical nephrectomy were performed for her stage IV disease as the kidney was amiable to complete resection. The patient received radiation and resumed chemotherapy. She was doing well with improved symptoms at follow-up.

Preservation of Aesthetics of Breast in Pectoralis Major Myocutaneous Flap Donor Site in Females.

BACKGROUND AND OBJECTIVES: In females, raising a pectoralis major myocutaneous flap is challenging and primary closure of flap donor site causes breast deformity with medial displacement of nipple areola complex. To avoid this distortion, a new method of donor site closure is devised. METHODS: A parasternal skin paddle which has better vascularity is planned while doing a pectoralis major myocutaneous flap in females and a lateral flap planned along the lateral breast curve is used to cover the donor site. The lateral flap donor site is primarily closed. This prevents medial displacement of nipple areola complex. RESULTS: A total of 47 patients underwent donor site flap closure technique. Minor complications in form of marginal necrosis near the tip of the flap were observed in 10.6 % patients. The donor breast of all these PMMC flaps had good contour and aesthetic positioning of nipple areola complex. CONCLUSION: Donor site morbidity with respect to breast distortion has not been studied so far in case of females so our study stands unique in this aspect. Using this technique of planning PMMC in females ensures a skin paddle of better vascularity and restores the breast aesthetics.

Sternal Resection and Reconstruction for Malignant Phylloides Tumor.

Malignant phylloides tumor is a locally aggressive breast neoplasm constituting less than 1 % of all breast cancers. It has a tendency for local recurrence and management is multidisciplinary. We hereby report a case of total sternal resection and reconstruction using Biopore HDPE prosthesis for Malignant Phylloides tumor.

Management of Female Anterior Urethral Masses.

OBJECTIVES: Little is known about anterior female urethral masses and their management. Owing to their location, these masses are often missed on physical examination and are diagnosed at an advanced stage. METHODS: We report on 2 anterior urethral masses, with 1 mass arising from an anterior diverticulum. RESULTS: Both masses were difficult to identify on examination but were clearly delineated by magnetic resonance imaging. In both cases, a biopsy was essential for histologic characterization of the mass, predicting prognosis and dictating management options. One patient had high-grade clear-cell adenocarcinoma, necessitating an anterior exenteration. The other patient had a low-grade leiomyoma amenable to conservative management. CONCLUSIONS: Tailored intervention for anterior female urethral masses can provide both symptomatic relief and mortality benefit.

Parotid duct relocation in buccal mucosa cancer resection.

Buccal mucosal cancer is commonly seen in India with patients presenting in advanced stages of the disease. Its excision commonly mandates division of parotid duct as a part of disease or its margin. We have adopted a simple method to salvage the parotid gland by cannulating the duct and rerouting the saliva into the oral cavity at a different site. This has now become a protocol at our center. A total of 562 patients from 2002 to 2012 have undergone this procedure. This has markedly reduced the incidence of sialocele and parotitis in early postoperative period, which may delay wound healing and subsequent radiotherapy.

Squamous cell carcinoma of the superior gingivobuccal sulcus: an 11-year institutional experience of 203 cases.

OBJECTIVE: The report presents an 11-year Institutional experience of 203 cases with superior gingivobuccal sulcus tumours receiving surgical intervention at a comprehensive tertiary cancer care centre. METHODS: A retrospective chart review of patients with a confirmed diagnosis of squamous cell carcinoma of superior gingivobuccal sulcus was done and data related to patient demographic profile; details of surgical procedure, follow-up and survival were collected. RESULTS: Infratemporal fossa clearance was performed in 56 patients. The 10-year overall survival and disease-free survival was observed to be 39 and 52%, respectively, with a median follow-up of 15 months. The overall survival was 40 and 36%, respectively, in cases with and without infratemporal fossa clearance. Similarly, the disease-free survival was found to be 58 and 49%, respectively, in cases with and without infratemporal fossa clearance. CONCLUSION: Patients with higher stage tumours who underwent infratemporal fossa clearance showed better overall and disease-free survival than those who did not undergo infratemporal fossa clearance.

Limb salvage surgery for osteosarcoma: Early results in Indian patients.

BACKGROUND: While limb salvage surgery has long been established as the standard of care for osteosarcoma, large studies from Indian centers are few. Given the diverse socio economic milieu of our patients, it becomes significant to determine the feasibility and outcome of management of osteosarcoma in our population. We analyzed the early outcome of limb salvage surgery with multimodality treatment of osteosarcoma of the extremity/girdle bones at a tertiary North Indian Cancer Centre. MATERIALS AND METHODS: A total of 51 limb salvage surgeries performed during the months between November 2008 and November 2012 were studied. Neoadjuvant/adjuvant chemotherapy was given by the pediatric/adult medical oncology teams as applicable. The mean followup was 19.45 months (range 2-50 months). The oncological outcome was correlated with age, sex, size of tumor, stage at presentation, site, histological subtype, type of chemotherapy protocol followed and necrosis seen on postoperative examination of resected specimen. The functional outcome of the patients was evaluated using the musculoskeletal tumor society (MSTS) scoring system. RESULTS: Out of a total of 37 males and 14 females with an average age of 18.8 years, the 3 year overall survival was 66% and 3 year event free survival was 61.8%. In this group of patients with a short followup, a better oncological outcome was associated with good postoperative tumor necrosis, nonchondroblastic histology and age <14 years. The average MSTS score was highest in patients with proximal or distal femur prosthesis and the lowest in patients undergoing a knee arthrodesis. CONCLUSION: The present study shows oncological and functional outcomes of limb salvage combined with chemotherapy in Indian patients with osteosarcoma comparable to those in world literature. Larger studies on Indian population with longer followup are recommended.

Safety of the "drain and retain" option for defunctionalized urologic prosthetic balloons and reservoirs during artificial urinary sphincter and inflatable penile prosthesis revision surgery: 5-year experience.

OBJECTIVE: To present our 5-year experience using a "drain and retain" option, in which existing urologic prosthetic balloons and reservoirs (UPBR) were emptied but not removed during routine artificial urinary sphincter (AUS)/inflatable penile prosthesis (IPP) reoperation. METHODS: All genitourinary prosthetic surgeries by a single surgeon from July 2007 to September 2012 were reviewed. Patients were included in the study group if they underwent prosthetic replacement (with contralateral new UPBR placement) or subtotal device removal, although having their original UPBR drained and retained. Virgin cases, complete device removals for gross infection, and revision cases using the original UPBR were excluded. The "drain and retain" technique involved defunctionalizing the existing UPBR by aspirating all its fluid, placing the tubing on traction, and cutting proximally. Postoperative outcomes with specific attention to infection were reviewed and compared with patients receiving their first prosthesis (control group). RESULTS: A total of 551 urologic prostheses (251 AUS and 300 IPP) were inserted in 433 men during the 5-year study period. Among 120 reoperative prosthetic cases, UPBR were drained and retained in 55 (46%). The control group consisted of 352 patients undergoing initial AUS (154 cases) and/or IPP (236 cases) placement. No difference in infection rate was identified between the control group (6 of 390; 1.5%) and the "drain and retain" group (1 of 55; 1.8%; chi-square = 0.024; P = .88). CONCLUSION: Retention of defunctionalized uninfected genitourinary prosthetic balloons and reservoirs does not increase complication rate during reoperative AUS and/or IPP surgery.