Research Spotlight

Blankenship, J. C., J. W. Choi, T. S. Das, P. M. McElgunn, D. Mukherjee, L. L. Paxton, R. Piana, J. R. Sauer, C. J. White and P. L. Duffy (2019). “SCAI/ACVP expert consensus statement on cardiovascular catheterization laboratory economics: If the cath lab is your home you should understand its finances: This statement was endorsed by the Alliance of Cardiovascular Professionals (ACVP) in April 2019.” Catheter Cardiovasc Interv May 19. [Epub ahead of print].

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This article is intended for any physician, administrator, or cardiovascular catheterization laboratory (CCL) staff member who desires a fundamental understanding of finances and economics of CCLs in the United States. The authors’ goal is to illuminate general economic principles of CCL operations and provide details that can be used immediately by CCL leaders. Any article on economics in medicine should start by acknowledging the primacy of the principles of medical ethics. While physicians have been trained to act in the best interests of their patients and avoid actions that would harm patients it is vitally important that all professionals in the CCL focus on patients’ needs. Caregivers both at the bedside and in the office must consider how their actions will affect not only the patient they are treating at the time, but others as well. If the best interests of a patient were to conflict with any recommendation in this article, the former should prevail. KEY POINTS: To be successful and financially viable under current payment systems, CCL physicians, and managers must optimize the outcomes and efficiency of care by aligning CCL leadership, strategy, organization, processes, personnel, and culture. Optimizing a CCL’s operating margin (profitability) requires maximizing revenues and minimizing expenses. CCL managers often focus on expense reduction; they should also pay attention to revenue generation. Expense reduction depends on efficiency (on-time starts, short turn-over time, smooth day-to-day schedules), identifying cost-effective materials, and negotiating their price downward. Revenue optimization requires accurate documentation and coding of procedures, comorbidities, and complications. In fee-for-service and bundled payment reimbursement systems, higher volumes of procedures yield higher revenues. New procedures that improve patient care but are expensive can usually be justified by negotiating with vendors for lower prices and including the “halo effect” of collateral services that accompany the new procedure. Fiscal considerations should never eclipse quality concerns. High quality CCL care that prevents complications, increases efficiency, reduces waste, and eliminates unnecessary procedures represents a win for patients, physicians, and CCL administrators.

Basch, E. M., M. Scholz, J. S. de Bono, N. Vogelzang, P. de Souza, G. Marx, U. Vaishampayan, S. George, J. K. Schwarz, E. S. Antonarakis, J. M. O’Sullivan, A. R. Kalebasty, K. N. Chi, R. Dreicer, T. E. Hutson, A. C. Dueck, A. V. Bennett, E. Dayan, M. Mangeshkar, J. Holland, A. L. Weitzman and H. I. Scher (2019). “Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint.” Eur Urol 75(6): 929-937.

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BACKGROUND: Bone metastases in patients with metastatic castration-resistant prostate cancer (mCRPC) are associated with debilitating pain and functional compromise. OBJECTIVE: To compare pain palliation as the primary endpoint for cabozantinib versus mitoxantrone-prednisone in men with mCRPC and symptomatic bone metastases using patient-reported outcome measures. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind phase 3 trial (COMET-2; NCT01522443) in men with mCRPC and narcotic-dependent pain from bone metastases who had progressed after treatment with docetaxel and either abiraterone or enzalutamide. INTERVENTION: Cabozantinib 60mg once daily orally versus mitoxantrone 12mg/m(2) every 3wk plus prednisone 5mg twice daily orally. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was pain response at week 6 confirmed at week 12 (>/=30% decrease from baseline in patient-reported average daily worst pain score via the Brief Pain Inventory without increased narcotic use). The planned sample size was 246 to achieve >/=90% power. RESULTS AND LIMITATIONS: Enrollment was terminated early because cabozantinib did not demonstrate a survival benefit in the companion COMET-1 trial. At study closure, 119 participants were randomized (cabozantinib: N=61; mitoxantrone-prednisone: N=58). Complete pain and narcotic use data were available at baseline, week 6, and week 12 for 73/106 (69%) patients. There was no significant difference in the pain response with cabozantinib versus mitoxantrone-prednisone: the proportions of responders were 15% versus 17%, a -2% difference (95% confidence interval: -16% to 11%, p=0.8). Barriers to accrual included pretreatment requirements for a washout period of prior anticancer therapy and a narcotic optimization period to maximize analgesic dosing. CONCLUSIONS: Cabozantinib treatment did not demonstrate better pain palliation than mitoxantrone-prednisone in heavily pretreated patients with mCRPC and symptomatic bone metastases. Future pain-palliation trials should incorporate briefer timelines from enrollment to treatment initiation. PATIENT SUMMARY: Cabozantinib was not better than mitoxantrone-prednisone for pain relief in patients with castration-resistant prostate cancer and debilitating pain from bone metastases.

Baran, D. A., C. L. Grines, S. Bailey, D. Burkhoff, S. A. Hall, T. D. Henry, S. M. Hollenberg, N. K. Kapur, W. O’Neill, J. P. Ornato, K. Stelling, H. Thiele, S. van Diepen and S. S. Naidu (2019). “SCAI clinical expert consensus statement on the classification of cardiogenic shock: This document was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), the Society of Critical Care Medicine (SCCM), and the Society of Thoracic Surgeons (STS) in April 2019.” Catheter Cardiovasc Interv May 19. [Epub ahead of print].

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BACKGROUND: The outcome of cardiogenic shock complicating myocardial infarction has not appreciably changed in the last 30 years despite the development of various percutaneous mechanical circulatory support options. It is clear that there are varying degrees of cardiogenic shock but there is no robust classification scheme to categorize this disease state. METHODS: A multidisciplinary group of experts convened by the Society for Cardiovascular Angiography and Interventions was assembled to derive a proposed classification schema for cardiogenic shock. Representatives from cardiology (interventional, advanced heart failure, noninvasive), emergency medicine, critical care, and cardiac nursing all collaborated to develop the proposed schema. RESULTS: A system describing stages of cardiogenic shock from A to E was developed. Stage A is “at risk” for cardiogenic shock, stage B is “beginning” shock, stage C is “classic” cardiogenic shock, stage D is “deteriorating”, and E is “extremis”. The difference between stages B and C is the presence of hypoperfusion which is present in stages C and higher. Stage D implies that the initial set of interventions chosen have not restored stability and adequate perfusion despite at least 30 minutes of observation and stage E is the patient in extremis, highly unstable, often with cardiovascular collapse. CONCLUSION: This proposed classification system is simple, clinically applicable across the care spectrum from pre-hospital providers to intensive care staff but will require future validation studies to assess its utility and potential prognostic implications.

Banerjee, T., D. C. Crews, D. E. Wesson, C. E. McCulloch, K. L. Johansen, S. Saydah, N. Rios Burrows, R. Saran, B. Gillespie, J. Bragg-Gresham and N. R. Powe (2019). “Elevated serum anion gap in adults with moderate chronic kidney disease increases risk for progression to end-stage renal disease.” Am J Physiol Renal Physiol 316(6): F1244-f1253.

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Acid retention associated with reduced glomerular filtration rate (GFR) exacerbates nephropathy progression in partial nephrectomy models of chronic kidney disease (CKD) and might be reflected in patients with CKD with reduced estimated GFR (eGFR) by increased anion gap (AG). We explored the presence of AG and its association with CKD in 14,924 adults aged >/=20 yr with eGFR >/= 15 ml.min(-1).1.73 m(-2) enrolled in the National Health and Nutrition Examination Survey III, 1988-1994, using multivariable regression analysis. The model was adjusted for sociodemographic characteristics, diabetes, and hypertension. We further examined the association between AG and incident end-stage renal disease (ESRD) using frailty models, adjusting for demographics, clinical factors, body mass index, serum albumin, bicarbonate, eGFR, and urinary albumin-to-creatinine ratio by following 558 adults with moderate CKD for 12 yr via the United States Renal Data System. Laboratory measures determined AG using the traditional, albumin-corrected, and full AG definitions. Individuals with moderate CKD (eGFR: 30-59 ml.min(-1).1.73 m(-2)) had a greater AG than those with eGFR >/= 60 ml.min(-1).1.73 m(-2) in multivariable regression analysis with adjustment for covariates. We found a graded relationship between the adjusted mean for all three definitions of AG and eGFR categories (P trend < 0.0001). During followup, 9.2% of adults with moderate CKD developed ESRD. Those with AG in the highest tertile had a higher risk of ESRD after adjusting for covariates in a frailty model [relative hazard (95% confidence interval) for traditional AG: 1.76 (1.16-2.32)] compared with those in the middle tertile. The data suggest that high AG, even after adjusting for serum bicarbonate, is a contributing acid-base mechanism to CKD progression in adults with moderate chronic kidney disease.

Badhwar, V., M. Alkhouli, M. J. Mack, V. H. Thourani and G. Ailawadi (2019). “Surgical and transcatheter therapy for secondary mitral regurgitation.” J Thorac Cardiovasc Surg May 21. [Epub ahead of print].

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The importance of myocardial revascularization for viable myocardium is the cornerstone for the management of ischemia whenever appropriate targets exist. For patients with ischemic cardiomyopathy undergoing surgery for secondary MR, incomplete revascularization is a marker of mortality, but evidence that it influences residual MR in all patients remains lacking. For example, patients with chronic severe secondary MR often have papillary muscle fibrosis and the subsequently tethered MV apparatus is unlikely to improve regardless of the revascularization strategy. This is similar to the point that Nappi and colleagues make when discussing their approach to patients with nonviable myocardium. Although their experience with subvalvular papillary muscle repositioning or polytetrafluoroethylene tube reapproximation is compelling, widespread reproducibility of this technique remains limited. The nomenclature and assessment of MR is clear. Prolapse is defined in a patient with primary MR when leaflet motion extends above the annular plane in systole. There is no such entity in secondary MR, as the authors may suggest. In the case of a tethered posterior leaflet following myocardial infarction remodeling, a posteriorly directed jet of MR may be commonly misinterpreted as anterior leaflet prolapse and primary MR when it is in fact best defined as anterior leaflet override and secondary MR. Appropriate identification of pathology directs appropriate management. Nappi and colleagues are to be congratulated for their steadfast outcome reporting of adjunctive subvalvular papillary muscle repair and their institutional results are admirable, yet their recent identification of failures of this technique indicate that it may not actually be for everyone. They report failures of MV annuloplasty and subvalvular repair with MV tenting area ≥3.1 cm2 and left ventricle end-diastolic diameter ≥64 mm. In fact, their findings that patients with significant left ventricle remodeling and MV tenting have a higher incidence of recurrent MR aligns precisely with the recently proposed grading system. The cumulative evidence and surgical outcomes with MV repair and replacement in secondary MR do not amount to forfeiture of this complex disease state to transcatheter therapy. To the contrary, the proposed grading system suggests that MV repair still has a role in at least Grade I secondary MR in patients the heart team believes may benefit from surgical therapy. Perhaps MV annuloplasty and subvalvular repair may have a role in Grade II secondary MR, provided the patient does not have the predictors identified by Nappi and colleagues. (Excerpts from text, article in press, p. e1; refers to Nappi F., Santana O., and Mihos C.G.: Geometric distortion of the mitral valve apparatus in ischemic mitral regurgitation: should we really forfeit the opportunity for a complete repair? J Thorac Cardiovasc Surg 2019.)