Allocation of authorship and patient enrollment among global clinical trials in oncology.

BACKGROUND: Oncology randomized controlled trials (RCTs) are increasingly global in scope. Whether authorship is equitably shared between investigators from high-income countries (HIC) and low-middle/upper-middle incomes countries (LMIC/UMIC) is not well described. The authors conducted this study to understand the allocation of authorship and patient enrollment across all oncology RCTs conducted globally. METHODS: A cross-sectional retrospective cohort study of phase 3 RCTs (published 2014-2017) that were led by investigators in HIC and recruited patients in LMIC/UMIC. FINDINGS: During 2014-2017, 694 oncology RCTs were published; 636 (92%) were led by investigators from HIC. Among these HIC-led trials, 186 (29%) enrolled patients in LMIC/UMIC. One-third (33%, 62 of 186) of RCTs had no authors from LMIC/UMIC. Forty percent (74 of 186) of RCTs reported patient enrollment by country; in 50% (37 of 74) of these trials, LMIC/UMIC contributed <15% of patients. The relationship between enrollment and authorship proportion is very strong and is comparable between LMIC/UMIC and HIC (Spearman's ρ LMIC/UMIC 0.824, p < .001; HIC 0.823, p < .001). Among the 74 trials that report country enrollment, 34% (25 of 74) have no authors from LMIC/UMIC. CONCLUSIONS: Among trials that enroll patients in HIC and LMIC/UMIC, authorship appears to be proportional to patient enrollment. This finding is limited by the fact that more than half of RCTs do not report enrollment by country. Moreover, there are important outliers as a significant proportion of RCTs had no authors from LMIC/UMIC despite enrolling patients in these countries. The findings in this study reflect a complex global RCT ecosystem that still underserves cancer control outside high-income settings.

Cancer Medicines: What Is Essential and Affordable in India?

PURPOSE: The WHO essential medicines list (EML) guides selection of drugs for national formularies. Here, we evaluate which medicines are considered highest priority by Indian oncologists and the extent to which they are available in routine practice. METHODS: This is a secondary analysis of an electronic survey developed by the WHO EML Cancer Medicine Working Group. The survey was distributed globally using a hierarchical snowball method to physicians who prescribe systemic anticancer therapy. The survey captured the 10 medicines oncologists considered highest priority for population health and their availability in routine practice. RESULTS: The global study cohort included 948 respondents from 82 countries; 98 were from India and 67 were from other low- and middle-income countries. Compared with other low- and middle-income countries, the Indian cohort was more likely to be medical oncologist (70% v 31%, P < .001) and work exclusively in the private health system (52% v 17%, P < .001). 14/20 most commonly selected medicines were conventional cytotoxic drugs. Universal access to these medicines was reported by a minority of oncologists; risks of significant out-of-pocket expenditures for each medicine were reported by 19%-58% of oncologists. Risk of catastrophic expenditure was reported by 58%-67% of oncologists for rituximab and trastuzumab. Risks of financial toxicity were substantially higher within the private health system compared with the public system. CONCLUSION: Most high-priority cancer medicines identified by Indian oncologists are generic chemotherapy agents that provide substantial improvements in survival and are already included in WHO EML. Access to these treatments remains limited by major financial burdens experienced by patients. This is particularly acute within the private health system. Strategies are urgently needed to ensure that high-quality cancer care is affordable and accessible to all patients in India.

Defining Essential Childhood Cancer Medicines to Inform Prioritization and Access: Results From an International, Cross-Sectional Survey.

PURPOSE: Access to essential cancer medicines is a major determinant of childhood cancer outcomes globally. The degree to which pediatric oncologists deem medicines listed on WHO's Model List of Essential Medicines for Children (EMLc) essential is unknown, as is the extent to which such medicines are accessible on the front lines of clinical care. METHODS: An electronic survey developed was distributed through the International Society of Pediatric Oncology mailing list to members from 87 countries. Respondents were asked to select 10 cancer medicines that would provide the greatest benefit to patients in their context; subsequent questions explored medicine availability and cost. Descriptive and bivariate statistics compared access to medicines between low- and lower-middle-income countries (LMICs), upper-middle-income countries (UMICs), and high-income countries (HICs). RESULTS: Among 159 respondents from 44 countries, 43 (27%) were from LMICs, 79 (50%) from UMICs, and 37 (23%) from HICs. The top five medicines were methotrexate (75%), vincristine (74%), doxorubicin (74%), cyclophosphamide (69%), and cytarabine (65%). Of the priority medicines identified, 87% (27 of 31) are represented on the 2021 EMLc and 77% (24 of 31) were common to the lists generated by LMIC, UMIC, and HIC respondents. The proportion of respondents indicating universal availability for each of the top medicines ranged from 9% to 46% for LMIC, 25% to 89% for UMIC, and 67% to 100% for HIC. Risk of catastrophic expenditure was more common in LMIC (8%-20%), compared with UMIC (0%-28%) and HIC (0%). CONCLUSION: Most medicines that oncologists deem essential for childhood cancer treatment are currently included on the EMLc. Barriers remain in access to these medicines, characterized by gaps in availability and risks of catastrophic expenditure for families that are most pronounced in low-income settings but evident across all income contexts.

Randomized Controlled Trials in Lung, Gastrointestinal, and Breast Cancers: An Overview of Global Research Activity.

Background: In this study, we compared and contrasted design characteristics, results, and publications of randomized controlled trials (RCTs) in gastrointestinal (GI), lung, and breast cancer. Methods: A PUBMED search identified phase III RCTs of anticancer therapy in GI, lung, and breast cancer published globally during the period 2014−2017. Descriptive statistics, chi-square tests, and the Kruskal−Wallis test were used to compare RCT design, results, and output across the cancer sites. Results: A total of 352 RCTs were conducted on GI (36%), lung (29%), and breast (35%) cancer. Surrogate endpoints were used in 55% of trials; this was most common in breast trials (72%) compared to GI (47%) and lung trials (43%, p < 0.001). Breast trials more often met their primary endpoint (54%) than GI (41%) and lung trials (41%) (p = 0.024). When graded with the ESMO-MCBS, lung cancer trials (50%, 15/30) were more likely to meet the threshold for substantial benefit. GI trials were published in journals with a substantially lower impact factor (IF; median IF 13) than lung (median IF 21) and breast cancer trials (median IF 21) (p = 0.038). Conclusions: Important differences in RCT design and output exist between the three major cancer sites. Use of surrogate endpoints and the magnitude of benefit associated with new treatments vary substantially across cancer sites.

Incidence, Timing, and Outcomes of Venous Thromboembolism in Patients Undergoing Surgery for Esophagogastric Cancer: A Population-Based Cohort Study.

BACKGROUND: Abdominal surgery and chemotherapy are well-established risk factors for venous thromboembolism (VTE) in patients with cancer, but their specific contribution in patients with esophageal and gastric cancer is unclear. We aim to quantify the risk of VTE, identify risk factors associated with VTE, and determine the association between VTE and survival in patients undergoing surgery for esophageal or gastric cancer. METHODS: A retrospective, population-based cohort study was conducted using linked administrative healthcare databases. We used the Ontario Cancer Registry to identify patients with esophageal or gastric cancer between January 1, 2007 and December 31, 2016 who underwent surgical resection. Incidence of first VTE event was identified using International Classification of Diseases 9 and 10 codes. VTE incidence was calculated at clinically relevant time points 180 days before and after surgery. Logistic regression was used to identify factors associated with VTE with odds ratios (OR) and 95% confidence intervals (CI) reported. Cox proportional hazards regression models were used to estimate associations between covariates and survival. Kaplan-Meier method was used to compare overall (OS) and cancer-specific survival (CSS) by VTE status. RESULTS: A total of 4894 patients had esophagectomy or gastrectomy, of which 8% (n = 383/4894) had VTE. VTE risk was 2.5% (n = 123/4894) 180 days before surgery, 2.8% (n = 138/4894) within 30 days of surgery, and 2.5% (n = 122/4894) from 31 to ≤ 180 days after surgery. Of the patients with VTE within 30 days of surgery, 34% (n = 47/138) were diagnosed after discharge from hospital. Receipt of preoperative chemotherapy was associated with VTE 180 days before surgery (odds ratio [OR] 3.84, 95% confidence interval [CI] 2.41, 6.11). Increased hospital length of stay (LOS) was associated with VTE 30 days after surgery (OR 1.08, 95% CI 1.02, 1.14, per week). Patients with VTE had inferior median OS and CSS (2.2 vs. 3.7 years; 2.3 vs. 4.4 years, respectively). In adjusted models VTE was associated with inferior OS (HR 1.36, 95% CI 1.13, 1.63) and CSS (HR 1.42, 95% CI 1.16, 1.75). CONCLUSIONS: The highest risk of VTE is within 30 days of surgery with one third of patients diagnosed after discharge from hospital. Longer hospital LOS and receipt of preoperative chemotherapy are associated with increased risk of VTE. VTE is an independent risk factor for inferior survival in patients with esophageal or gastric cancer.

Trends and Projections in National United States Health Care Spending for Gastrointestinal Malignancies (1996-2030).

BACKGROUND & AIMS: The management of gastrointestinal (GI) cancers is associated with high health care spending. We estimated trends in United States (US) health care spending for patients with GI cancers between 1996 and 2016 and developed projections to 2030. METHODS: We used economic data, adjusted for inflation, developed by the Institute for Health Metrics and Evaluations for the Disease Expenditure Project. Corresponding US age-adjusted prevalence of GI cancers was estimated from the Global Burden of Diseases Study. Prevalence-adjusted temporal trends in the US health care spending in patients with GI cancers, stratified by cancer site, age, and setting of care, were estimated using joinpoint regression, expressed as annual percentage change (APC) with 95% confidence intervals (CIs). Autoregressive integrated moving average models were used to project spending to 2030. RESULTS: In 2016, total spending for GI cancers was primarily attributable to colorectal ($10.50 billion; 95% CI, $9.35-$11.70 billion) and pancreatic cancer ($2.55 billion; 95% CI, $2.23-$2.82 billion), and primarily for inpatient care (64.5%). Despite increased total spending, more recent per-patient spending for pancreatic (APC 2008-2016, -1.4%; 95% CI, -2.2% to -0.7%), gallbladder/biliary tract (APC 2010-2016, -4.3%; 95% CI, -4.8% to -3.8%), and gastric cancer (APC 2011-2016, -4.4%; 95% CI, -5.8% to -2.9%) decreased. Increasing price and intensity of care provision was the largest driver of higher expenditures. By 2030, it is projected more than $21 billion annually will be spent on GI cancer management. CONCLUSIONS: Total spending for GI cancers in the US is substantial and projected to increase. Expenditures are primarily driven by inpatient care for colorectal cancer, although per-capita spending trends differ by GI cancer type.

Access to cancer medicines deemed essential by oncologists in 82 countries: an international, cross-sectional survey.

BACKGROUND: The WHO Essential Medicines List (EML) identifies priority medicines that are most important to public health. Over time, the EML has included an increasing number of cancer medicines. We aimed to investigate whether the cancer medicines in the EML are aligned with the priority medicines of frontline oncologists worldwide, and the extent to which these medicines are accessible in routine clinical practice. METHODS: This international, cross-sectional survey was developed by investigators from a range of clinical practice settings across low-income to high-income countries, including members of the WHO Essential Medicines Cancer Working Group. A 28-question electronic survey was developed and disseminated to a global network of oncologists in 89 countries and regions by use of a hierarchical snowball method; each primary contact distributed the survey through their national and regional oncology associations or personal networks. The survey was open from Oct 15 to Dec 7, 2020. Fully qualified physicians who prescribe systemic anticancer therapy to adults were eligible to participate in the survey. The primary question asked respondents to select the ten cancer medicines that would provide the greatest public health benefit to their country; subsequent questions explored availability and cost of cancer medicines. Descriptive statistics were used to compare access to medicines between low-income and lower-middle-income countries, upper-middle-income countries, and high-income countries. FINDINGS: 87 country-level contacts and two regional networks were invited to participate in the survey; 46 (52%) accepted the invitation and distributed the survey. 1697 respondents opened the survey link; 423 were excluded as they did not answer the primary study question and 326 were excluded because of ineligibility. 948 eligible oncologists from 82 countries completed the survey (165 [17%] in low-income and lower-middle-income countries, 165 [17%] in upper-middle-income countries, and 618 [65%] in high-income countries). The most commonly selected medicines were doxorubicin (by 499 [53%] of 948 respondents), cisplatin (by 470 [50%]), paclitaxel (by 423 [45%]), pembrolizumab (by 414 [44%]), trastuzumab (by 402 [42%]), carboplatin (by 390 [41%]), and 5-fluorouracil (by 386 [41%]). Of the 20 most frequently selected high-priority cancer medicines, 19 (95%) are currently on the WHO EML; 12 (60%) were cytotoxic agents and 13 (65%) were granted US Food and Drug Administration regulatory approval before 2000. The proportion of respondents indicating universal availability of each top 20 medication was 9-54% in low-income and lower-middle-income countries, 13-90% in upper-middle-income countries, and 68-94% in high-income countries. The risk of catastrophic expenditure (spending >40% of total consumption net of spending on food) was more common in low-income and lower-middle-income countries, with 13-68% of respondents indicating a substantial risk of catastrophic expenditures for each of the top 20 medications in lower-middle-income countries versus 2-41% of respondents in upper-middle-income countries and 0-9% in high-income countries. INTERPRETATION: These data demonstrate major barriers in access to core cancer medicines worldwide. These findings challenge the feasibility of adding additional expensive cancer medicines to the EML. There is an urgent need for global and country-level policy action to ensure patients with cancer globally have access to high priority medicines. FUNDING: None.

Application of Value Frameworks to the Design of Clinical Trials: The Canadian Cancer Trials Group Experience.

BACKGROUND: Use of value framework thresholds in the design of clinical trials may increase the proportion of randomized controlled trials that identify clinically meaningful advances for patients. Existing frameworks have not been applied to the research output of a cooperative cancer trials group. We apply value frameworks to the randomized controlled trial output of the Canadian Cancer Trials Group (CCTG). METHODS: Statistical design, study characteristics, and results of all published phase III trials of CCTG were abstracted. We applied the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) and American Society of Clinical Oncology Net Health Benefit to study results and the statistical power calculations to identify the proportion of all trials that were designed to detect a substantial clinical benefit. RESULTS: During 1979 to 2017, CCTG published 113 phase III trials; 52.2% (59 of 113) of these trials were positive. One-half (50.4%, 57 of 113) of the trials were conducted in the palliative setting. In 37.2% (42 of 113) of trials, the primary endpoint was overall survival; disease-free survival or progression-free survival was used in 38.9% (44 of 113) of trials. The ESMO-MCBS could be applied to the power calculation for 69 trials; 73.9% (51 of 69) of these trials were designed to detect an effect size that could meet ESMO-MCBS thresholds for substantial benefit. Among the 51 positive trials for which the ESMO-MCBS could be applied, 41.1% (21 of 51) met thresholds for substantial benefit. CONCLUSIONS: Most CCTG phase III trials were designed to detect clinically meaningful differences in outcome, although less than one-half of positive trials met the threshold for substantial benefit. Application of value frameworks to the design of clinical trials is practical and may improve research efficiency and treatment options for patients.

Breast cancer in transgender female-to-male individuals: A case report of androgen receptor-positive breast cancer.

Highlight the challenges associated with managing breast cancer in female-to-male (FtM) transgender individuals. This is a rare entity, requiring nuanced decision-making regarding surgery as well as adjuvant therapies given the unique hormonal environment seen in individuals taking exogenous androgen as part of their gender identity. Contemporary case report derived from our clinical experience. Discussion focuses on a brief summation of all known cases of female-to-male breast cancer in FtM individuals described in the literature. A 48-year-old FtM transgender individual on exogenous testosterone for 19 years with stage IIA (pT1cN1M0), ER+(8/8), PR+(8/8), Androgen Receptor(AR)+(5%-8%), Her-2-negative invasive ductal carcinoma of the breast. Due to AR positivity in tumor, cessation of testosterone was chosen after careful consideration of potential ramifications from both a cancer treatment as well as gender identity standpoint. Endocrinology consultation reassured the patient that identity affirming changes of facial hair growth and voice depth would persist after cessation of testosterone. Patient did not wish to undergo chemotherapy and as such was treated with combination of radiation to the axilla, adjuvant Anastrozole and testosterone cessation. Although breast cancer is rare in FtM transgender individuals, it can occur. Many FtM individuals take exogenous testosterone. It is important to test the tumor for the androgen receptor as this may have important implications for both gender identity and treatment. Additionally, the mastectomy commonly performed for "top" surgery in this population is not adequate for oncologic control by itself and at present there is no guidance regarding postsurgical screening in this population, especially in those individuals with a strong family history of breast cancer.

Cancer care workforce in Africa: perspectives from a global survey.

BACKGROUND: While the burden of cancer in Africa is rapidly rising, there is a lack of investment in healthcare professionals to deliver care. Here we report the results of a survey of systemic therapy workload of oncologists in Africa in comparison to oncologists in other countries. METHODS: An online survey was distributed through a snowball method via national oncology societies to chemotherapy-prescribing physicians in 65 countries. The survey was distributed within Africa through a network of physicians associated with the African Organisation for Research and Training in Cancer (AORTIC). Workload was measured as the annual number of new cancer patient consults seen per oncologist. Job satisfaction was ranked on a 10-point Likert scale; scores of 9-10 were considered to represent high job satisfaction. RESULTS: Thirty-six oncologists from 18 countries in Africa and 1079 oncologists from 47 other countries completed the survey. Compared to oncologists from other countries, African oncologists were older (median age 51 vs 44 years, p = 0.007), more likely to prescribe chemotherapy and radiation [61% (22/36) vs 10% (108/1079), p < 0.001], less likely to have completed training in their home country [50% (18/36) vs 91% (979/1079), p < 0.001], and more likely to work in the private sector [47% (17/36) vs 34% (364/1079), p = 0.037]. The median number of annual consults per oncologist was 325 in Africa compared to175 in other countries. The proportion of oncologists seeing > 500 consults/year was 31% (11/36) in Africa compared to 12% (129/1079) in other countries (p = 0.001). African oncologists were more likely than global colleagues to see all cancer sites [72% (26/26) vs 24% (261/1079), p < 0.001]. Oncologists in Africa were less likely than other oncologists to have high job satisfaction [17% (6/36) vs 30% (314/1079), p = 0.013]. CONCLUSION: African oncologists within the AORTIC network have a substantially higher clinical workload and lower job satisfaction than oncologists elsewhere in the world. There is an urgent need for governments and health systems to improve the oncologist-to-patient ratio and develop new models of capacity building, retention and skills enhancement to strengthen the wide variety of cancer care systems across continental Africa.

Hyperacute Superior Vena Cava Syndrome associated with Central Venous Catheter Insertion.

Superior vena cava (SVC) syndrome is classically thought of as a complication of malignancy. However, SVC syndrome secondary to indwelling central venous catheters (CVCs) is another important entity. Amongst those with CVCs who develop SVC syndrome, the majority are attributed to thrombosis. Aside from thrombosis, CVCs can lead to SVC syndrome secondary to mechanical obstruction of blood flow in an already narrowed vessel.We present the first case of hyperacute SVC syndrome that developed within 6 hours of insertion of a CVC into a patient's right internal jugular vein alongside a pre-existing right internal jugular tunnelled dialysis line. With removal of the line, the patient's symptoms resolved completely within hours. The patient also was found to have stenosis of superior vena cava, likely secondary to multiple instrumentations.Physicians must be diligent to monitor for this complication in patients who have had previous instrumentations of major vessels when inserting CVCs. HOW TO CITE THIS ARTICLE: Edginton S, Fundytus A. Hyperacute Superior Vena Cava Syndrome associated with Central Venous Catheter Insertion. Indian J Crit Care Med 2019;23(3):152-154.

Medical oncology job satisfaction: Results of a global survey.

BACKGROUND: While physician burnout is increasingly recognized, little is known about medical oncologist job satisfaction, and the factors associated with low satisfaction. Here, we report the results of an international survey of medical oncologists. METHODS: An online survey was distributed using a modified snowball methodology via national oncology societies to chemotherapy-prescribing physicians in 65 countries. Oncologist job satisfaction was assessed by asking, "On a scale of 1-10, how would you rate your satisfaction as an oncologist? 1 = unsatisfying, 10 = satisfying." Low, moderate and high job satisfaction was defined as scores of 1-6, 7-8, and 9-10, respectively. RESULTS: 1,115 physicians from 42 countries completed the survey. Overall job satisfaction rates were 20% (222/1,115), 51% (573/1,115), and 29% (320/1,115) for low-, moderate-, and high-satisfaction, respectively. Respondents with low job satisfaction were younger (P = 0.001) and had fewer years in clinical practice (P = 0.013) compared to those with high satisfaction. Increasing hours worked by per week (p = 0.042), decreasing annual weeks of paid vacation (P = 0.007), being on-call every night (P = 0.016), higher clinic volumes (P = 0.004) and lack of access to on-site radiotherapy (P = 0.049), palliative care (P = 0.005), and chemotherapy pharmacists (P = 0.033) were associated with low-job satisfaction. Respondents with low-job satisfaction were less likely to discuss prognosis with their patients compared to those with moderate or high job satisfaction (median 45% of patients v 65% v 75%, P < 0.001). CONCLUSIONS: Globally, 1 in 5 medical oncologists report low job satisfaction. The main correlates of job satisfaction are related to system-level pressures resulting in less time for quality patient care and personal resilience. Improving oncologist job satisfaction will require new approaches to models of care delivery.

Delivery of Global Cancer Care: An International Study of Medical Oncology Workload.

BACKGROUND: To our knowledge, there is no literature that has described medical oncology (MO) workload in the global context. Here, we report results of an international study of global MO workload. METHODS: An online survey was distributed through a snowball method via national oncology societies to chemotherapy-prescribing physicians in 65 countries. Countries were classified into low- or low-middle-income countries (LMICs), upper-middle-income countries (UMICs), and high-income countries (HICs) on the basis of World Bank criteria. Workload was measured as the annual number of new consultations provided to patients with cancer per oncologist. RESULTS: A total of 1,115 physicians completed the survey: 13% (147 of 1,115) from LMICs, 17% (186 of 1,115) from UMICs, and 70% (782 of 1,115) from HICs. Eighty percent (897 of 1,115) of respondents were medical oncologists, 10% (109 of 1,115) were clinical oncologists, and 10% (109 of 1,115) were other. The median number of annual consults per oncologist was 175 (interquartile range, 75 to 275); 13% (140 of 1,103) saw ≥ 500 new patients in a year. Annual case volume in LMICs (median consults, 425; 40% of respondents seeing > 500 consults) was substantially higher than in UMICs (median consults, 175; 14% > 500) and HICs (median consults, 175; 7% > 500; P < .001). Among LMICs, UMICs, and HICs, median working days per week were 6, 5, and 5, respectively ( P < .001). The highest annual case volumes per oncologist were in Pakistan (median consults, 950; 73% > 500 consults), India (median consults, 475; 43% > 500), and Turkey (median consults, 475; 27% > 500). CONCLUSION: There is substantial global variation in medical oncology case volumes and clinical workload; this is most striking among LMICs, where huge deficits exist. Additional work is needed, particularly detailed country-level mapping, to quantify activity-based global MO practice and workload to inform training needs and the design of new pathways and models of care.

Meta-analysis of the effectiveness and safety of catheter ablation of atrial fibrillation in patients with versus without left ventricular systolic dysfunction.

Catheter ablation is a promising therapy for atrial fibrillation (AF), but its utility in patients with left ventricular systolic dysfunction (LVSD) is uncertain. The objectives of this study were to perform a systematic review and meta-analysis of randomized and observational studies comparing the rates of recurrent AF, atrial tachycardia (AT), and complications after AF catheter ablation in those with versus without LVSD and to summarize the impact of catheter ablation on the left ventricular ejection fraction. Seven observational studies and 1 randomized trial were included (total n = 1,851). Follow-up ranged from 6 to 27 months. In those with LVSD, 28% to 55% were free of AF or AT on follow-up after 1 AF catheter ablation, increasing to 64% to 96% after a mean of 1.4 procedures. The relative risk for recurrent AF or AT in those with versus without LVSD was 1.5 (95% confidence interval 1.2 to 1.8, p <0.001) after 1 procedure and 1.2 (95% confidence interval 0.9 to 1.5, p = 0.2) after multiple procedures. No difference in complications was observed in patients with (3.5%) versus without (2.5%) heart failure (p = 0.55). After catheter ablation, those with LVSD experienced a pooled absolute improvement in the left ventricular ejection fraction of 0.11 (95% confidence interval 0.07 to 0.14, p <0.001). In conclusion, patients with and without LVSD had similar risk for recurrent AF or AT after catheter ablation, but repeat procedures were required more often in those with LVSD. Significant improvements in left ventricular ejection fractions after ablation were observed in those with LVSD. Randomized trials are needed given the limitations of present data.