Research Spotlight

Goyal, A., K. Chatterjee, R. O. Mathew, M. S. Sidhu, S. Bangalore, P. A. McCullough and J. Rangaswami (2019). “In-Hospital Mortality and Major Adverse Cardiovascular Events after Kidney Transplantation in the United States.” Cardiorenal Med 9(1): 51-60.

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BACKGROUND: Kidney transplantation (KT) is the treatment of choice for end-stage kidney disease. Cardiovascular disease is a major determinant of morbidity and mortality in patients with KT. Temporal trends in perioperative cardiovascular outcomes after KT are understudied, especially in light of an aging KT waitlist population. METHODS: We performed a retrospective observational cohort study using the National Inpatient Sample for the years 2004-2013. All adult patients undergoing KT were identified using the appropriate International Classification of Diseases, 9th Revision, Clinical Modification codes. Demographic and hospital characteristics, discharge disposition, payer status, and major adverse cardiovascular events (MACEs) were summarized using summary statistics. Multivariate logistic regression was used to identify predictors of MACEs in the perioperative period of KT. RESULTS: A total of 147,431 KTs were performed between 2004 and 2013. The mean age at KT went up from 48.1 to 51.8 years from 2004 to 2013. Medicare was the primary payer for 59.6% of the KTs. Overall average perioperative mortality was 0.5%, median length of stay was 5 days, and 6.5% of patients experienced an MACE, 78% of which were heart failures (HFs). Important predictors of perioperative MACEs were age >/=65 years (OR = 2.14), Medicare as primary payer (OR = 1.51), diabetes (OR = 1.46), recreational drug use (OR = 1.72), pulmonary circulation disorders (OR = 3.28), and malnutrition (OR = 1.91). CONCLUSION: Despite increases in age at the time of KT, the absolute risk of perioperative MACEs has remained stable from 2004 to 2013. HF is a major component of postoperative MACEs in KT. Malnutrition and pulmonary hypertension are major nontraditional predictors of perioperative MACE outcomes.

Giri, J. S., M. Szerlip, C. Devireddy, D. A. Cox, C. Kavinsky, P. Genereux, S. S. Naidu, C. Bruner, J. Struck, J. Kurz and J. Dunham (2019). “SCAI 2018 Think Tank Proceedings: “What should the role of the surgeon be in TAVR, both as a co-operator and in-patient evaluation for TAVR?” Catheter Cardiovasc Interv 93(1): 178-179.

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The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is held annually bringing together expert opinion from interventional cardiologists, administrative partners, and select members of the cardiovascular industry community in a collaborative venue. During the SCAI 2018 Scientific Session, topics in interventional cardiology felt to be relevant to the contemporary practice of the field were identified with the goals of defining the state of the field, current challenges, and future directions. . . Consensus emerged around several points relevant to the specific questions outlined above: 1. Preoperative evaluation by the heart team should remain intact. However, the group felt that the appropriate preprocedure evaluation should consist of a cardiac surgeon and a cardiologist who are both experienced in evaluating patients for TAVR. There was consensus that the current mandate of “TAVR clearance” based on the judgment of two cardiac surgeons is redundant and outdated. Given the equipoise between traditional surgical AVR and TAVR in a growing proportion of cases that is likely to include even low‐risk cases in the near future, it was felt that patients needed to participate in a shared decision‐making model involving a balanced discussion of risk and benefit involving both specialties rather than a perspective from only two cardiac surgeons, who may or may not be familiar with the pros and cons of TAVR. 2. The specialty of a TAVR operator is less important than his/her ability to both evaluate the potential TAVR patient and technically perform the case in a competent fashion. Rather than emphasizing which specialty should be present in the operating room or procedure suite, the group felt that the most important issue was assuring that any operators nominally performing the procedure have both the requisite training and experience to meaningfully contribute to the planned procedure. 3. Given continual advances in the procedure mentioned above, the concept of TAVR continuing to be a mandated two‐operator procedure appears to be a case of “swimming against the tide.” Thus, consensus was reached to recommend against a mandatory 62‐modifier code for TAVR going forward. Rather, an optional 62‐modifier could be used when physicians from two different specialties participated in the procedure or an 82‐modifier when physicians from the same specialty work together. This would allow for either a single operator or two operators from the same or different specialties to perform the TAVR procedure, with potential cost savings in the former scenario. 4. Instead, an optional 62‐modifier code could be used similar to what is done in other procedures in which “co‐surgeons” are deemed necessary to complete a complex procedure. The optional 62‐modifier could be used when physicians from two different specialties participated in the procedure or an 82‐modifier when physicians from the same specialty work together. This would allow for either a single operator or two operators from the same or different specialties to perform the TAVR procedure. Additionally, the heart team evaluation could determine which specific TAVR procedures may benefit from “co‐operators” and which would have good results with a single operator. Importantly, in cases where two operators are deemed advantageous, the heart team would choose the most appropriate two operators to successfully perform the case, regardless of specialty. (Excerpts from text, p. 178-179; no abstract available.)

Elsaid, O., V. Gulati, K. Tecson, M. Friedman and J. Kluger (2018). “Ventricular electrical delay as a predictor of arrhythmias in patients with cardiac resynchronization implantable cardioverter defibrillator.” Scand Cardiovasc J Dec 20: 1-16. [Epub ahead of print].

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BACKGROUND: Left ventricular (LV) remodeling and clinical response to cardiac resynchronization therapy (CRT) is inversely related to electrical dyssynchrony, measured as LV lead electrical delay (QLV). Presence of atrial or ventricular arrhythmia is correlated with worsening heart failure and LV remodeling. OBJECTIVE: We sought to assess the association of QLV with arrhythmic events in CRT recipients. METHODS: We identified patients implanted with a CRT device at our center. QLV interval was measured and corrected for baseline QRS (cQLV). We performed multivariable Logistic regression to assess the effect of cQLV on the occurrence of atrial/ventricular arrhythmic events. RESULTS: Sixty-nine patients were included in analyses. The cQLV was significantly shorter in patients with atria tachycardia/supraventricular tachycardia (AT/SVT) events compared to patients without AT/SVT events (43.4 +/- 22% vs. 60.3 +/- 26.7%, P = 0.006). In contrast, no significant difference in cQLV was observed between patients with and without ventricular tachycardia/fibrillation (VT/VF) events (46.2 +/- 25.4% vs. 56 +/- 25.7%, P = 0.13). cQLV was significantly shorter in patients with new onset AT/SVT events compared to those without (38.3 +/- 22.2% vs. 55.7 +/- 25.7%, P = 0.028). In contrast, no significant difference in cQLV was observed between patients with and without new onset VT/VF events (44.2 +/- 25.2% vs. 56.3 +/- 25.5%, P = 0.069). Following adjusted analyses, cQLV was a significant predictor of AT/SVT, but not for VT/VF. CONCLUSION: cQLV is a simple measure that can identify a vulnerable cohort of CRT patients at increased risk for atrial tachyarrhythmias, and hence can predict reverse remodeling and clinical response to CRT treatment.

Di Leo, A., J. O’Shaughnessy, G. W. Sledge, Jr., M. Martin, Y. Lin, M. Frenzel, M. C. Hardebeck, I. C. Smith, A. Llombart-Cussac, M. P. Goetz and S. Johnston (2018). “Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy.” NPJ Breast Cancer 4: 41.

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CDK4 & 6 inhibitors have enhanced the effectiveness of endocrine therapy (ET) in patients with advanced breast cancer (ABC). This paper presents exploratory analyses examining patient and disease characteristics that may inform in whom and when abemaciclib should be initiated. MONARCH 2 and 3 enrolled women with HR+, HER2- ABC. In MONARCH 2, patients whose disease had progressed while receiving ET were administered fulvestrant+abemaciclib/placebo. In MONARCH 3, patients received a nonsteroidal aromatase inhibitor+abemaciclib/placebo as initial therapy for advanced disease. A combined analysis of the two studies was performed to determine significant prognostic factors. Efficacy results (PFS and ORR in patients with measurable disease) were examined for patient subgroups corresponding to each significant prognostic factor. Analysis of clinical factors confirmed the following to have prognostic value: bone-only disease, liver metastases, tumor grade, progesterone receptor status, performance status, treatment-free interval (TFI) from the end of adjuvant ET, and time from diagnosis to recurrence. Prognosis was poorer in patients with liver metastases, progesterone receptor-negative tumors, high grade tumors, or short TFI (<36 months). Benefit (PFS hazard ratio, ORR increase) from abemaciclib was observed in all patient subgroups. Patients with indicators of poor prognosis had the largest benefit from the addition of abemaciclib. However, in MONARCH 3, for patients with certain good prognostic factors (TFI >/= 36 months, bone-only disease) ET achieved a median PFS of >20 months. These analyses identified prognostic factors and demonstrated that patients with poor prognostic factors derived the largest benefit from the addition of abemaciclib.

Dewan, P., P. S. Jhund, L. Shen, M. C. Petrie, W. T. Abraham, M. Atif Ali, C. H. Chen, A. S. Desai, K. Dickstein, J. Huang, S. Kiatchoosakun, K. S. Kim, L. Kober, W. T. Lai, Y. Liao, U. M. Mogensen, B. H. Oh, M. Packer, J. L. Rouleau, V. Shi, A. S. Sibulo, Jr., S. D. Solomon, P. Sritara, K. Swedberg, H. Tsutsui, M. R. Zile and J. J. V. McMurray (2018). “Heart failure with reduced ejection fraction: comparison of patient characteristics and clinical outcomes within Asia and between Asia, Europe and the Americas.” Eur J Heart Fail Dec 10. [Epub ahead of print].

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AIMS: Nearly 60% of the world’s population lives in Asia but little is known about the characteristics and outcomes of Asian patients with heart failure with reduced ejection fraction (HFrEF) compared to other areas of the world. METHODS AND RESULTS: We pooled two, large, global trials, with similar design, in 13 174 patients with HFrEF (patient distribution: China 833, India 1390, Japan 209, Korea 223, Philippines 223, Taiwan 199 and Thailand 95, Western Europe 3521, Eastern Europe 4758, North America 613, and Latin America 1110). Asian patients were younger (55.0-63.9 years) than in Western Europe (67.9 years) and North America (66.6 years). Diuretics and devices were used less, and digoxin used more, in Asia. Mineralocorticoid receptor antagonist use was higher in China (66.3%), the Philippines (64.1%) and Latin America (62.8%) compared to Europe and North America (range 32.8% to 49.6%). The rate of cardiovascular death/heart failure hospitalization was higher in Asia (e.g. Taiwan 17.2, China 14.9 per 100 patient-years) than in Western Europe (10.4) and North America (12.8). However, the adjusted risk of cardiovascular death was higher in many Asian countries than in Western Europe (except Japan) and the risk of heart failure hospitalization was lower in India and in the Philippines than in Western Europe, but significantly higher in China, Japan, and Taiwan. CONCLUSION: Patient characteristics and outcomes vary between Asia and other regions and between Asian countries. These variations may reflect several factors, including geography, climate and environment, diet and lifestyle, health care systems, genetics and socioeconomic influences.