Research Spotlight

Posted January 15th 2017

Long-Term Valve Performance of TAVR and SAVR: A Report From the PARTNER I Trial.

Michael J. Mack M.D.

Michael J. Mack M.D.

Daubert, M. A., N. J. Weissman, R. T. Hahn, P. Pibarot, R. Parvataneni, M. J. Mack, L. G. Svensson, D. Gopal, S. Kapadia, R. J. Siegel, S. K. Kodali, W. Y. Szeto, R. Makkar, M. B. Leon and P. S. Douglas (2016). “Long-term valve performance of tavr and savr: A report from the partner i trial.” JACC Cardiovasc Imaging: 2016 Dec [Epub ahead of print].

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OBJECTIVES: The aim of this study was to evaluate the long-term performance of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) through longitudinal echocardiographic analysis. BACKGROUND: The long-term performance of the SAPIEN TAVR is not well-described. Therefore, we examined the hemodynamic and valvular profile of the SAPIEN TAVR over 5 years. METHODS: All patients receiving TAVR or SAVR with first post-implant (FPI) and 5-year echoes were analyzed for aortic valve (AV) peak velocity, AV mean gradient, AV area, peak left ventricular (LV) outflow tract and in-stent velocities, Doppler velocity index, aortic regurgitation (AR), LV mass index, stroke volume index, and cardiac index. The FPI and 5-year data were compared using a paired t test or McNemar’s analyses. RESULTS: There were 86 TAVR and 48 SAVR patients with paired FPI and 5-year echocardiograms. Baseline characteristics were similar between groups. The AV area did not change significantly 5 years after TAVR (p = 0.35). The AV mean gradient also remained stable: 11.5 +/- 5.4 mm Hg at FPI to 11.0 +/- 6.3 mm Hg at 5 years (p = 0.41). In contrast, the peak AV and LV outflow tract velocities decreased (p = 0.03 and p = 0.008, respectively), as did in-stent velocity (p = 0.015). Correspondingly, the TAVR Doppler velocity index was unchanged (p = 0.07). Among TAVR patients, there was no change in total AR (p = 0.40), transvalvular AR (p = 0.37), or paravalvular AR (p = 0.26). Stroke volume index and cardiac index remained stable (p = 0.16 and p = 0.25, respectively). However, there was a significant regression of LV mass index (p < 0.0001). The longitudinal evaluation among SAVR patients revealed similar trends. There was a low rate of adverse events among TAVR and SAVR patients alive at 5 years. CONCLUSIONS: Longitudinal assessment of the PARTNER I trial (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial) demonstrates that valve performance and cardiac hemodynamics are stable after implantation in both SAPIEN TAVR and SAVR in patients alive at 5 years.


Posted January 15th 2017

Predictors of multidomain decline in health-related quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer.

Daniel A. Hamstra M.D.

Daniel A. Hamstra M.D.

Dess, R. T., W. C. Jackson, S. Suy, P. D. Soni, J. Y. Lee, A. E. Abugharib, Z. S. Zumsteg, F. Y. Feng, D. A. Hamstra, S. P. Collins and D. E. Spratt (2016). “Predictors of multidomain decline in health-related quality of life after stereotactic body radiation therapy (sbrt) for prostate cancer.” Cancer: 2016 Dec [Epub ahead of print].

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BACKGROUND: Stereotactic body radiation therapy (SBRT) for localized prostate cancer involves high-dose-per-fraction radiation treatments. Its use is increasing, but concerns remain about treatment-related toxicity. The authors assessed the incidence and predictors of a global decline in health-related quality of life (HRQOL) after prostate SBRT. METHODS: From 2008 to 2014, 713 consecutive men with localized prostate cancer received treatment with SBRT according to a prospective institutional protocol. Expanded Prostate Cancer Index Composite (EPIC-26) HRQOL data were collected at baseline and longitudinally for 5 years. EPIC-26 is comprised of 5 domains. The primary endpoint was defined as a decline exceeding the clinically detectable threshold in >/=4 EPIC-26 domains, termed multidomain decline. RESULTS: The median age was 69 years, 46% of patients had unfavorable intermediate-risk or high-risk disease, and 20% received androgen-deprivation therapy. During 1 to 3 months and 6 to 60 months after SBRT, 8% to 15% and 10% to 11% of patients had multidomain declines, respectively. On multivariable analysis, lower baseline bowel HRQOL (odds ratio, 1.8; 95% confidence interval, 1.2-2.7; P < .01) and baseline depression (odds ratio, 5.7; 95% confidence interval, 1.3-24.3; P = .02) independently predicted for multidomain decline. Only 3% to 4% of patients had long-term multidomain declines exceeding twice the clinical threshold, and 30% of such declines appeared to be related to prostate cancer treatment or progression of disease. CONCLUSIONS: Prostate SBRT has minimal long-term impact on multidomain decline, and the majority of more significant multidomain declines appear to be unrelated to treatment. This emphasizes the importance of focusing not only on the side effects of prostate cancer treatment but also on other comorbid illnesses that contribute to overall HRQOL.


Posted January 15th 2017

Current Controversies in Management of Calcaneus Fractures.

Jacob R. Zide M.D.

Jacob R. Zide M.D.

Gotha, H. E. and J. R. Zide (2017). “Current controversies in management of calcaneus fractures.” Orthop Clin North Am 48(1): 91-103.

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Displaced intraarticular fractures of the calcaneus represent a technically challenging injury. Although there is conflicting evidence regarding advantages and disadvantages of operative versus nonoperative treatment, a growing body of literature suggests operative management with near-anatomic reduction of the posterior facet and restoration of overall calcaneal morphology offers greater potential for superior short- and long-term outcomes. A thorough understanding of calcaneal anatomy, fracture pattern, and associated injuries, along with careful selection of surgical approach and timing to surgery are critical to minimize the risk of complication and maximize potential for optimal outcomes.


Posted January 15th 2017

2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

Michael J. Mack M.D.

Michael J. Mack M.D.

Grover, F. L., S. Vemulapalli, J. D. Carroll, F. H. Edwards, M. J. Mack, V. H. Thourani, R. G. Brindis, D. M. Shahian, C. E. Ruiz, J. P. Jacobs, G. Hanzel, J. E. Bavaria, E. M. Tuzcu, E. D. Peterson, S. Fitzgerald, M. Kourtis, J. Michaels, B. Christensen, W. F. Seward, K. Hewitt and D. R. Holmes, Jr. (2016). “2016 annual report of the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry.” J Am Coll Cardiol: 2016 Dec [Epub ahead of print].

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BACKGROUND: The STS/ACC Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration (FDA) approved transcatheter valve devices performed in the United States and is mandated as a condition of reimbursement by a Centers for Medicaid and Medicare Services (CMS) OBJECTIVES: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States. METHODS: Data for all patients receiving commercially approved devices from 2012 through December 31, 2015 are entered in the TVT Registry. RESULTS: The 54,782 TAVR patients demonstrated decreases in expected risk of 30-day operative mortality (STS PROM) 7% to 6% and TAVR PROM (TVT PROM) 4% to 3% (both p<.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9% and one-year mortality decreased from 25.8% to 21.6. However, 30-day post procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent TMC in 2015 were similar to 2013-14 patients with hospital mortality of 2% with mitral regurgitation reduced to gradient /= 2 in 87% of patients (p<.0001). The 349 patients who underwent MViV and MViR procedures were high risk with, an STS PROM for MVR of 11%. The observed hospital mortality was 7.2% and 30-day post procedure was 8.5%. SUMMARY: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies. CONDENSED ABSTRACT: The STS/ACC TVT Registry captures all Food and Drug Administration (FDA) approved transcatheter valve devices preformed in the United States and is mandated as a condition for reimbursement by the Centers for Medicare Services. TAVR patients' expected risks of mortality and actual in-hospital mortality decreased. Transcatheter mitral clip procedures had a low mortality with reduced in mitral regurgitation to grade /= 2 in 87%. Mitral valve in valve or valve in ring patients were high risk for mortality, but actual hospital mortality was lower. The TVT Registry is an innovative registry that monitors quality, safety and trends of these evolving technologies.


Posted January 15th 2017

Impact of cost valuation on cost-effectiveness in adult spine deformity surgery.

Richard Hostin M.D.

Richard Hostin M.D.

Gum, J. L., R. Hostin, C. Robinson, M. P. Kelly, L. Y. Carreon, D. W. Polly, R. S. Bess, D. C. Burton, C. I. Shaffrey, J. S. Smith, V. LaFage, F. J. Schwab, C. P. Ames and S. D. Glassman (2017). “Impact of cost valuation on cost-effectiveness in adult spine deformity surgery.” Spine J 17(1): 96-101.

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BACKGROUND CONTEXT: Over the past decade, the number of adult spinal deformity (ASD) surgeries has more than doubled in the United States. The complex surgeries needed to manage ASD are associated with significant resource utilization and high cost, making them a primary target for increased scrutiny. Accordingly, it is important to not only demonstrate value in ASD surgery as clinical effectiveness but also to translate outcome assessment to cost-effectiveness. PURPOSE: To compare the difference between Medicare allowable rates and the actual, direct hospital costs for ASD surgeries. STUDY DESIGN: Longitudinal cohort. PATIENT SAMPLE: Consecutive patients enrolled in an ASD database from a single institution. OUTCOME MEASURES: Short Form (SF)-6D. METHODS: Consecutive patients enrolled in an ASD database from a single institution from 2008 to 2013 were identified. Direct hospital costs were collected from hospital administrative records for the entire inpatient episode of surgical care. Medicare allowable rates were calculated for the same inpatient stays using the year-appropriate Center for Medicare-Medicaid Services Inpatient Pricer Payment System Tool. The SF-6D, a utility index derived from the SF-36v1, was used to determine quality-adjusted life years (QALY). Costs and QALYs were discounted at 3.5% annually. RESULTS: Of 580 surgical ASD patients eligible for 2-year follow up, 346 (60%) had complete baseline and 2-year data, and 60 were Medicare beneficiaries comprising the cohort for the present study. Mean SF-6D gained is 0.10 during year 1 after surgery and 0.02 at year 2, resulting in a cumulative SF-6D gain of 0.12 over 2 years. Mean Medicare allowable rate over the 2 years is $82,050 (range $42,383 to $220,749) and mean direct cost is $99,114 (range $28,447 to $217,717). Mean cost per QALY over 2 years is $683,750 using Medicare allowable rates and $825,950 using direct costs. This difference of $17,181 between the 2 cost calculation represents a 17% difference, which was statistically significant (p<.001). CONCLUSIONS: There is a significant difference in direct hospital costs versus Medicare allowable rates in ASD surgery and in turn, there is a similar difference in the cost per QALY calculation. Utilizing Medicare allowable rates not only underestimates (17%) the cost of ASD surgery, but it also creates inaccurate and unrealistic expectations for researchers and policymakers.