Person:

Geisler, Benjamin

Objectives: To estimate the clinical and economic impact of drug-eluting endovascular treatment strategies for femoropopliteal artery disease compared with current standard of care. Design: Systematic literature search to pool target lesion revascularisations (TLR). Model-based per-patient cost impact and quasi-cost-effectiveness projection over 24 months based on pooled TLRs and current reimbursement. Setting: The UK's National Health Service (NHS). Participants: Patients presenting with symptomatic femoropopliteal disease eligible for endovascular treatment. Interventions Current National Institute for Health and Care Excellence (NICE) guideline-recommended treatment with percutaneous transluminal balloon angioplasty (PTA) and bailout bare metal stenting (BMS) versus primary BMS placement, or drug-coated balloon (DCB), or drug-eluting stent (DES) treatment. Primary and secondary outcome measures 24-month per-patient cost impact to NHS (primary outcome). Secondary outcomes: pooled 24-month TLR rates; numbers needed to treat (NNTs); cost per TLR avoided and estimated incremental cost-effectiveness ratio (ICER) in £ per quality-adjusted life year (QALY). Results: N=28 studies were identified, reporting on 5167 femoropopliteal lesions. Over 24 months, DCB, DES and BMS reduced TLRs of de novo lesions from 36.2% to 17.6%, 19.4% and 26.9%, respectively, at an increased cost of £43, £44 and £112. NNTs to avoid 1 TLR in 24 months were 5.4, 6.0 and 10.8, resulting in cost per TLR avoided of £231, £264 and £1204. DCB was estimated to add 0.011 QALYs, DES 0.010 QALYs and BMS 0.005 QALYs, resulting in estimated ICERs of £3983, £4534 and £20 719 per QALY gained. A subset analysis revealed more favourable clinical and economic outcomes for a 3.5 µg/mm2 DCB with urea excipient, compared with the rest of DCBs. A modest reduction of 10% in DCB and DES prices made drug-eluting treatments dominant. Conclusions: Widespread adoption of drug-eluting endovascular therapies for femoropopliteal disease would add meaningful clinical benefit at reasonable additional costs to the NHS. Based on currently available data, DCBs offer the highest clinical and economic value.

Background: Statin use is associated with a decreased rate of severe sepsis. The objective of this paper is to quantify the level of organ dysfunction of patients with and without statin use prior to hospitalization.

Methods: MIMIC-III was searched for adult sepsis patients. Immunosuppressed patients were excluded. Organ dysfunction was defined as alterations in Sequential Organ Failure Assessment (SOFA) score components or laboratory values. Other endpoints examined include 28-day, 90-day, and in-hospital mortality. All analyses were adjusted for Elixhauser comorbidity index components, age, gender, ethnicity, and year of admission and used doubly robust estimation. In a sensitivity analysis, the effect of statin potency on organ dysfunction was analyzed.

Findings: 3,091 statin users and non-users were matched. In the matched cohort, mean age was 72 years, 54% of patients were female, and 31% had diabetes. The odds of mortality at day 28 (0.78), day 90 (0.75), and in the hospital (0.78) were significantly lower for those on statins (p=0.001; p<0.001; and p=0.003, respectively). Central nervous system (CNS, -14% change) and hepatic SOFA (-27% change) component scores were also significantly lower for statin users (p < 0.05). No significant difference was found for other measures of organ failure. Statin potency had statistically significant effects on day-28, day-90, and in-patient mortality, as well as coagulation, hepatic, and CNS components of the SOFA score.

Interpretation: Statin use prior to sepsis was associated with dose-dependent lower short-term mortality that was clinically and statistically significant. This mortality benefit might be explained by neuro- and hepato-protective effects.

Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely calcified coronary artery lesions. Our objective was to explore the cost-effectiveness of OA compared to RA in the Japanese healthcare system. A decision-analytic model calculated reintervention rates and consequent total 1-year costs. Effectiveness inputs were therapy-specific target lesion revascularization (TLR) rates and all-cause mortality, pooled from clinical studies. Index and reintervention costs were determined based on claims data analysis of n = 33,628 subjects treated in 2014–2016. We computed incremental cost-effectiveness in Japanese Yen (JPY) per life year (LY) gained based on differences in 1-year cost and projected long-term survival, assuming OA device cost between JPY 350,000 and ​JPY 550,000. OA was found to be associated with improved clinical outcomes (12-month TLR rate 5.0 vs. 15.7%) and projected survival gain (8.34 vs. 8.16 LYs (+0.17), based on 1-year mortality of 5.5 vs. 6.8%). Total 1-year costs were lower for device cost of JPY 430,000 or less, and reached a maximum ICER of JPY 753,445 per LY at the highest assumed device cost, making OA dominant or cost-effective across the tested range, at ICERs substantially below the willingness-to-pay threshold. In conclusion, orbital atherectomy for the treatment of severely calcified coronary artery lesions, compared to rotational atherectomy, is a cost-effective treatment approach in the Japanese healthcare system due to improved clinical performance.

Objectives The outcomes of critically ill patients who undergo inter-hospital transfer (IHT) are not well understood. Physicians assume that patients who undergo IHT will receive more advanced care that may translate into decreased morbidity or mortality relative to a similar patient who is not transferred. However, there is little empirical evidence to support this assumption. We examined country-level U.S. data from the Nationwide Readmissions Database to examine whether, in mechanically ventilated (MV) patients with sepsis, IHT is associated with a mortality benefit.

Design Retrospective data analysis using complex survey design regression methods with propensity score matching.

Setting The Nationwide Readmissions Database contains information about hospital admissions from 22 States, accounting for roughly half of U.S. hospitalizations; the database contains linkage numbers so that admissions and transfers for the same patient can be linked across one year of follow-up.

Patients From the 2013 NRD Sample, 14,325,172 hospital admissions were analyzed. There were 61,493 patients with sepsis and on MV. Of these, 1630 (2.7%) patients were transferred during their hospitalization. A propensity-matched cohort of 1630 patients who did not undergo IHT was identified.

Interventions None.

Measurements and Main Results The exposure of interest was inter-hospital transfer to an acute care facility. The primary outcome was hospital mortality; the secondary outcome was hospital length of stay (LOS). The propensity score included age, gender, insurance coverage, do not resuscitate (DNR) status, use of renal replacement therapy, presence of shock and Elixhauser co-morbidities index. After propensity matching, IHT was not associated with a difference in in-hospital mortality (12.3% IHT vs 12.7% non-IHT, p=0.74). However, IHT was associated with a longer total hospital LOS (12.8 days IQR 7.7–21.6 for IHT vs 9.1 days IQR 5.1–17.0 for non-IHT, p<0.01).

Conclusions Patients with sepsis requiring MV who underwent IHT did not have improved outcomes compared to a cohort with matched characteristics who were not transferred. The study raises questions about the risk-benefit profile of IHT as an intervention.

Objective—Inter-hospital transfer (IHT), a common intervention, may be subject to healthcare disparities. In mechanically ventilated patients with sepsis, we hypothesize that disparities not disease-related would be found between patients who were and were not transferred. Design—Retrospective cohort study. Setting—Nationwide Inpatient Sample, 2006–2012. Patients—Patients over 18 years of age with a primary diagnosis of sepsis who underwent mechanical ventilation. Interventions—none Measurements and Main Results—We obtained age, gender, length of stay, race, insurance coverage, do not resuscitate status, and Elixhauser co-morbidities. The outcome used was interhospital transfer from a small- or medium-sized hospital to a larger acute care hospital. Of 55,208,382 hospitalizations, 46,406 patients met inclusion criteria. In the multivariate model, patients were less likely to be transferred if the following were present: older age (OR 0.98, 95% CI 0.978–0.982), black race (OR 0.79, 95% CI 0.70–0.89), Hispanic race (OR 0.79, 95% CI 0.69– 0.90), South region hospital (OR 0.79, 0.72–0.88), teaching hospital (OR 0.31, 95% CI 0.28– 0.33), and DNR status (OR 0.19, 95% CI 0.15–0.25). Conclusions—In mechanically ventilated patients with sepsis, we found significant disparities in race and geographic location not explained by medical diagnoses or illness severity.