Research Spotlight

Posted June 24th 2020

Relative Costs of Surgical and Transcatheter Aortic Valve Replacement and Medical Therapy.

Molly Szerlip M.D.

Molly Szerlip M.D.

Goldsweig, A. M., H. J. Tak, L. W. Chen, H. D. Aronow, B. Shah, D. Kolte, N. R. Desai, M. Szerlip, P. Velagapudi and J. D. Abbott (2020). “Relative Costs of Surgical and Transcatheter Aortic Valve Replacement and Medical Therapy.” Circ Cardiovasc Interv 13(5): e008681.

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BACKGROUND: The number of patients treated for aortic valve disease in the United States is increasing rapidly. Transcatheter aortic valve replacement (TAVR) is supplanting surgical aortic valve replacement (SAVR) and medical therapy (MT). The economic implications of these trends are unknown. Therefore, we undertook to determine the costs, inpatient days, and number of admissions associated with treating aortic valve disease with SAVR, TAVR, or MT. METHODS: Using the Nationwide Readmissions Database, we identified patients with aortic valve disease admitted 2012 to 2016 for SAVR, TAVR, and disease symptoms (congestive heart failure, unstable angina, non-ST-elevation myocardial infarction, syncope). Patients not undergoing SAVR or TAVR were classified as receiving MT. Beginning with the index admission, we estimated inpatient costs, days, and admissions over 6 months. RESULTS: Among 190 563 patients with aortic valve disease, the average aggregate 6-month inpatient costs were $59 743 for SAVR, $64 395 for TAVR, and $23 460 for MT. Mean index admission was longer for SAVR (10.0 days) than for TAVR (7.0 day) or MT (5.3 days), but the average number of unplanned readmission inpatient days was 2.0 for SAVR, 3.0 for TAVR, and 4.3 for MT; the average number of total admissions was 1.3 for SAVR, 1.5 for TAVR, and 1.7 for MT (P<0.01 for all). TAVR index admission costs decreased over time to become similar to SAVR costs by 2016. CONCLUSIONS: Aggregate costs were higher for TAVR than SAVR and were significantly more expensive than MT alone. However, TAVR costs decreased over time while SAVR and MT costs remained unchanged.


Posted June 24th 2020

A change of heart: Preliminary results of the US 2018 adult heart allocation revision.

Shelley A. Hall, M.D.

Shelley A. Hall, M.D.

Goff, R. R., K. Uccellini, K. Lindblad, S. Hall, R. Davies, M. Farr, S. Silvestry and J. G. Rogers (2020). “A change of heart: Preliminary results of the US 2018 adult heart allocation revision.” Am J Transplant May 14. [Epub ahead of print].

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In 2018, the Organ Procurement and Transplantation Network (OPTN) modified adult heart allocation to better stratify candidates and provide broader access to the most medically urgent candidates. We analyzed OPTN data that included waiting list and transplant characteristics, geographical distribution, and early outcomes 1 year before (pre: October 18, 2017-October 17, 2018) and following (post: October 18, 2018-October 17, 2019) implementation. The number of adult heart transplants increased from 2954 pre- to 3032 postimplementation. Seventy-eight percent of transplants in the post era were for the most medically urgent (statuses 1-3) compared to 68% for status 1A in the pre era. The median distance between the donor hospital and transplant center increased from 83 to 216 nautical miles, with an increase in total ischemic time from 3 to 3.4 hours (all P < .001). Waiting list mortality was not different across eras (14.8 vs 14.9 deaths per 100 patient-years pre vs post respectively). Posttransplant patient survival was not different, 93.6% pre and 92.8% post. There is early evidence that the heart allocation policy has enhanced stratification of candidates by their medical urgency and broader distribution for the most medically urgent candidates with minimal impact on overall waiting list mortality and posttransplant outcomes.


Posted June 24th 2020

Analysing risk in heart failure: a Kalium check.

Peter McCullough, M.D.

Peter McCullough, M.D.

Glenister, R. T. and P. A. McCullough (2020). “Analysing risk in heart failure: a Kalium check.” Eur J Heart Fail May 10. [Epub ahead of print].

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This article refers to ‘Cardiovascular risk associated with serum potassium in the context of mineralocorticoid receptor antagonist use in patients with heart failure and left ventricular dysfunction’ by P. Rossignol et al ., published in this issue on pages xxx. [No abstract; excerpt from text].


Posted June 24th 2020

Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.

Tricia A. Meyer, PharmD

Tricia A. Meyer, PharmD

Gan, T. J., K. G. Belani, S. Bergese, F. Chung, P. Diemunsch, A. S. Habib, Z. Jin, A. L. Kovac, T. A. Meyer, R. D. Urman, C. C. Apfel, S. Ayad, L. Beagley, K. Candiotti, M. Englesakis, T. L. Hedrick, P. Kranke, S. Lee, D. Lipman, H. S. Minkowitz, J. Morton and B. K. Philip (2020). “Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.” Anesth Analg May 27. [Epub ahead of print].

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This consensus statement presents a comprehensive and evidence-based set of guidelines for the care of postoperative nausea and vomiting (PONV) in both adult and pediatric populations. The guidelines are established by an international panel of experts under the auspices of the American Society of Enhanced Recovery and Society for Ambulatory Anesthesia based on a comprehensive search and review of literature up to September 2019. The guidelines provide recommendation on identifying high-risk patients, managing baseline PONV risks, choices for prophylaxis, and rescue treatment of PONV as well as recommendations for the institutional implementation of a PONV protocol. In addition, the current guidelines focus on the evidence for newer drugs (eg, second-generation 5-hydroxytryptamine 3 [5-HT3] receptor antagonists, neurokinin 1 (NK1) receptor antagonists, and dopamine antagonists), discussion regarding the use of general multimodal PONV prophylaxis, and PONV management as part of enhanced recovery pathways. This set of guidelines have been endorsed by 23 professional societies and organizations from different disciplines (Appendix 1). WHAT OTHER GUIDELINES ARE AVAILABLE ON THIS TOPIC?: Guidelines currently available include the 3 iterations of the consensus guideline we previously published, which was last updated 6 years ago; a guideline published by American Society of Health System Pharmacists in 1999; a brief discussion on PONV management as part of a comprehensive postoperative care guidelines; focused guidelines published by the Society of Obstetricians and Gynecologists of Canada, the Association of Paediatric Anaesthetists of Great Britain & Ireland and the Association of Perianesthesia Nursing; and several guidelines published in other languages. WHY WAS THIS GUIDELINE DEVELOPED?: The current guideline was developed to provide perioperative practitioners with a comprehensive and up-to-date, evidence-based guidance on the risk stratification, prevention, and treatment of PONV in both adults and children. The guideline also provides guidance on the management of PONV within enhanced recovery pathways. HOW DOES THIS GUIDELINE DIFFER FROM EXISTING GUIDELINES?: The previous consensus guideline was published 6 years ago with a literature search updated to October 2011. Several guidelines, which have been published since, are either limited to a specific populations or do not address all aspects of PONV management. The current guideline was developed based on a systematic review of the literature published up through September 2019. This includes recent studies of newer pharmacological agents such as the second-generation 5-hydroxytryptamine 3 (5-HT3) receptor antagonists, a dopamine antagonist, neurokinin 1 (NK1) receptor antagonists as well as several novel combination therapies. In addition, it also contains an evidence-based discussion on the management of PONV in enhanced recovery pathways. We have also discussed the implementation of a general multimodal PONV prophylaxis in all at-risk surgical patients based on the consensus of the expert panel.


Posted June 24th 2020

Watchman outcomes comparing post-implantation anticoagulation with warfarin versus direct oral anticoagulants.

Ethan M. Fry, D.O.

Ethan M. Fry, D.O.

Fry, E., H. Bollempali, K. Suarez, J. Banchs and J. Michel (2020). “Watchman outcomes comparing post-implantation anticoagulation with warfarin versus direct oral anticoagulants.” J Interv Card Electrophysiol June 5. [Epub ahead of print].

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PURPOSE: As left atrial appendage occlusion devices (LAAO) implantation rates grow, continued evaluation on best patient practices is important. We report pooled Watchman outcomes at a multicenter Texas healthcare system with an emphasis on clinical outcomes and post-implantation anticoagulation with direct oral anticoagulants (DOACs) versus warfarin. METHODS: Data for 163 patients with atrial fibrillation (AF) undergoing Watchman implantation was collected via retrospective chart review between June 2016 and June 2018. A Fisher’s exact test was utilized to evaluate associations in bivariate comparisons of categorical data. Tests of non-inferiority, applied between DOACs and warfarin, utilized a ratio of 2. RESULTS: Outcomes were significant for similar rates of stroke, disabling stroke, major bleeds, and all-cause mortality when compared to published clinical trials. Most patients with cerebrovascular events were found to have >5 mm peri-device leaks (PDLs), were on warfarin at the time of the event (75%), and all occurred within the first 6 months post implant. A significant number of patients were discharged on DOACs (42%). DOACs were shown to be non-inferior to warfarin with respect to stroke (p = 0.0048), disabling stroke (p = 0.0383), gastrointestinal bleeding (p = 0.0287), mortality (p = 0.0165), and combined adverse outcomes (p = 0.0040). DOACs were associated with less combined adverse outcomes (p = 0.021). CONCLUSION: Our findings suggest that additional imaging or aggressive management of PDLs in Watchman recipients within the initial 6-month follow-up may aid in reducing stroke rates. Additionally, anticoagulation with DOACs’ post Watchman implantation was found non-inferior to warfarin, with some evidence of lower risk for adverse outcomes favoring DOACs.