Research Spotlight

Havers, F. P., J. R. Chung, E. A. Belongia, H. Q. McLean, M. Gaglani, K. Murthy, R. K. Zimmerman, M. P. Nowalk, M. L. Jackson, L. A. Jackson, A. S. Monto, J. G. Petrie, A. M. Fry and B. Flannery (2018). “Influenza Vaccine Effectiveness and Statin Use Among Adults in the United States, 2011-2017.” Clin Infect Dis Oct 27. [Epub ahead of print].

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Background: Statin medications have immunomodulatory effects. Several recent studies suggest that statins may reduce influenza vaccine response and reduce influenza vaccine effectiveness (VE). Methods: We compared influenza VE in statin users and nonusers aged >/=45 years enrolled in the US Vaccine Effectiveness Network study over 6 influenza seasons (2011-2012 through 2016-2017). All enrollees presented to outpatients clinics with acute respiratory illness and were tested for influenza. Information on vaccination status, medical history, and statin use at the time of vaccination were collected by medical and pharmacy records. Using a test-negative design, we estimated VE as (1 – OR) x 100, in which OR is the odds ratio for testing positive for influenza virus among vaccinated vs unvaccinated participants. Results: Among 11692 eligible participants, 3359 (30%) were statin users and 2806 (24%) tested positive for influenza virus infection; 78% of statin users and 60% of nonusers had received influenza vaccine. After adjusting for potential confounders, influenza VE was 36% (95% confidence interval [CI], 22%-47%) among statin users and 39% (95% CI, 32%-45%) among nonusers. We observed no significant modification of VE by statin use. VE against influenza A(H1N1)pdm09, A(H3N2), and B viruses were similar among statin users and nonusers. Conclusions: In this large observational study, influenza VE against laboratory-confirmed influenza illness was not affected by current statin use among persons aged >/=45 years. Statin use did not modify the effect of vaccination on influenza when analyzed by type and subtype.

Grayburn, P. A., J. K. Oh, M. J. Reardon, J. J. Popma, G. M. Deeb, M. Boulware, J. Huang and R. C. Stoler (2018). “Effect of Baseline Aortic Regurgitation on Mortality in Patients Treated With Transcatheter or Surgical Aortic Valve Replacement (from the CoreValve US Pivotal Trial).” Am J Cardiol 122(9): 1527-1535.

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This study was performed to determine if baseline aortic regurgitation (AR) affects the deleterious effects of postprocedure paravalvular leak following transcatheter aortic valve implantation (TAVI). We evaluated the effect of baseline AR on mortality in a large cohort of patients randomized to transcatheter or surgical aortic valve replacement (SAVR). The analysis cohort comprised 739 patients who underwent attempted TAVI (n=386) or SAVR (n=353) in the CoreValve US Pivotal High Risk Trial and had baseline AR measurements. Patients were stratified by the severity of baseline AR into those with none and/or trace and those with >/=mild AR. Echocardiographic measurements were assessed by an independent core laboratory. Of the 386 TAVI patients, 204 (52.9%) had none and/or trace at baseline AR; 182 (47.2%) had >/=mild AR. Of the 353 SAVR patients, 169 (47.9%) had none and/or trace and 184 (52.1%) >/=mild AR. The presence of >/=mild baseline AR was associated with lower all-cause mortality at 1 year following TAVI (9.4% vs 18.6%, p=0.008) or SAVR (13.3% vs 24.4%, p=0.009). Mortality remained lower in the >/=mild baseline AR patients at 3 years after SAVR (p=0.011), but not TAVI. In conclusion, baseline AR appears to provide a protective effect on survival and quality of life in both TAVI and SAVR patients at 1 year; this effect persists out to 3 years in SAVR patients.

Gollub, M. J., S. Arya, R. G. Beets-Tan, G. dePrisco, M. Gonen, K. Jhaveri, Z. Kassam, H. Kaur, D. Kim, A. Knezevic, E. Korngold, C. Lall, N. Lalwani, D. Blair Macdonald, C. Moreno, S. Nougaret, P. Pickhardt, S. Sheedy and M. Harisinghani (2018). “Use of magnetic resonance imaging in rectal cancer patients: Society of Abdominal Radiology (SAR) rectal cancer disease-focused panel (DFP) recommendations 2017.” Abdom Radiol (NY) 43(11): 2893-2902.

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PURPOSE: To propose guidelines based on an expert-panel-derived unified approach to the technical performance, interpretation, and reporting of MRI for baseline and post-treatment staging of rectal carcinoma. METHODS: A consensus-based questionnaire adopted with permission and modified from the European Society of Gastrointestinal and Abdominal Radiologists was sent to a 17-member expert panel from the Rectal Cancer Disease-Focused Panel of the Society of Abdominal Radiology containing 268 question parts. Consensus on an answer was defined as >/= 70% agreement. Answers not reaching consensus (< 70%) were noted. RESULTS: Consensus was reached for 87% of items from which recommendations regarding patient preparation, technical performance, pulse sequence acquisition, and criteria for MRI assessment at initial staging and restaging exams and for MRI reporting were constructed. CONCLUSION: These expert consensus recommendations can be used as guidelines for primary and post-treatment staging of rectal cancer using MRI.

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 (2018). “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 Oct 24. [Epub ahead of print].

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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 . . . Over the past decade, transcatheter aortic valve replacement (TAVR) has been promulgated in the United States under unique circumstances; as a paradigm‐shifting procedure in which two operators from different specialties (interventional cardiology and cardiac surgery) are mandated to perform each case as “co‐surgeons” in order to receive Centers of Medicare and Medicaid Services (CMS) reimbursement for services. This is accomplished by a “mandated 62‐modifier”, which represents the CMS designation for a procedure performed by two operators entitling both to a total of 125% (ie, 62.5% each) of the professional fees assigned to the procedure by the CMS fee schedule. While use of 62‐modifiers is relatively common in a variety of complex procedures, TAVR is unique as the only procedure in which use of the 62‐modifer is mandated in all cases by CMS . . . While this has been the structure of TAVR evaluation and performance since its introduction to the US market, there have been tremendous advances in TAVR over the last decade, both related to technology and processes of care. Examples include: fully percutaneous access, moderate sedation, fast track protocols, dramatically reduced device profiles resulting in an overwhelming majority of cases being performed via transfemoral arterial access, and improvements in pacemaker and paravalvular leak rates. Nearly, all of these advances have served to make the procedure simpler, more consistent, and more efficient. Ongoing improvements in technology aim to further simplify the procedure allowing for rapid, accurate and consistent valve delivery by a single operator. These developments compelled us to re‐evaluate the appropriateness of the current system of care. [Four points of consensus from the SCAI discussions are described.] (Excerpt from text, p. 1-2.)

Feldman, T., R. Smith, 2nd and J. J. Popma (2018). “Primary MR remains undertreated.” Cardiovasc Revasc Med 2018 Oct 15. [Epub ahead of print].

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In their review, Wu et al. she light on contemporary practice for the management of severe primary mitral regurgitation (DMR) and validates other studies that show a large number of patients with this valve lesion do not undergo either repair surgery or catheter intervention. This observation is consistent with prior reports and suggests that undertreatment in recent experience remains problematic. Many patients do not meet criteria for surgery, or their MR may improve with medical therapy. In this report, the group categorized as “medical therapy” is not well described. Were they candidates for surgery, did they meet ACC guidelines criteria for surgery, or were they just not offered surgery? This heterogenous subset plus patients lost to followup appear to be the biggest underserved groups. Structured follow up is the essential. Potentially treating a reading of severe MR on an echo reading as a “critical lab value” that requires an action or specific dismissal would also be helpful. The multidisciplinary “heart team” is a class I indication for the evaluation of patients for TAVR and should be considered for patients with severe MR. Why do so many patients with a highly treatable valve lesion not find their way to therapy? The authors note that many were not referred for surgical consultation. The findings were based upon retrospective chart review so the basis for referral or non-referral could not be ascertained. There are clear reservations for referral of elderly patients for cardiac surgery, both among patients and many physicians, despite the potential for surgical repair, and in more recent practice for a variety of percutaneous repair and replacement options. This report spanned 2011–2016 and thus included only the early time frame after MitraClip approval for high risk patients with DMR in 2013. The use of MitraClip has increased rapidly since then and it would be useful to repeat this kind of analysis in more recent practice. Experience in some other institutions has been different. Goel et al. reported that only 16% of a large DMR cohort went without surgery, which may reflect referral bias or patient selection. The broader experience in US practice is also improving. Isolated primary mitral valve operations reported in the Society of Thoracic Surgeons Adult Cardiac Surgery Database have increased by 24% between 2011 and 2016. (From text of this commentary on S. Wu, et al. Incidence and treatment of severe primary mitral regurgitation in contemporary clinical practice Cardiovasc Revasc Med (2018) [in press].)