Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: A Health Economic Analysis.

BACKGROUND: There is increasing evidence that use of intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) is associated with improved clinical outcomes compared with angiography guidance alone. However, concern regarding the cost-effectiveness of IVUS has limited use of this technology worldwide. In this study, we aimed to evaluate the cost-effectiveness of IVUS-guided PCI compared with angiography-guided PCI in patients undergoing drug-eluting stent implantation. METHODS: A decision-analytic Markov model was constructed to compare the cost-effectiveness of IVUS to angiography guidance from the Australian healthcare system perspective. Procedure-related morbidity and mortality were estimated from the literature. Costs were obtained from Australian sources. The population of interest was all-comers undergoing PCI with drug-eluting stent. Outcomes of interest included costs, life-expectancy, and quality-adjusted life years (QALYs) for both treatment groups. RESULTS: In the base case, IVUS guidance was cost-effective compared with angiography guidance alone. With 5% annual discounting, IVUS was associated with increased lifetime costs of Australian dollars (AUD) $823 (USD $597) per person and benefits of 0.04 life years and 0.05 QALYs compared with angiography, yielding an incremental cost-effectiveness ratio of AUD $17 539 (USD $12 730) per QALY gained. Results were robust to sensitivity analyses, with IVUS being cost-effective in 99% of 10 000 Monte Carlo iterations assuming a willingness-to-pay threshold of AUD $50 000 per QALY gained. In a worst-case scenario analysis, IVUS remained the cost-effective option, with an ICER of AUD $36 651 (USD $26 601) per QALY gained. Exploratory subgroup analysis revealed that cost-effectiveness may be greatest among patients with left main and complex coronary lesions. CONCLUSIONS: Use of IVUS guidance during PCI is likely to be cost-effective compared with angiography guidance alone among patients undergoing drug-eluting stent implantation.

Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis.

BACKGROUND: Recent studies have shown that transcatheter aortic valve implantation (TAVI) is non-inferior to surgical aortic valve replacement (SAVR) for treatment of low-risk patients with severe aortic stenosis (AS). However, the cost-effectiveness of TAVI in this population is unknown. We sought to evaluate the cost-effectiveness of both balloon-expandable and self-expanding TAVI compared to SAVR in patients with severe AS at low operative risk. METHODS: We developed a Markov model comparing TAVI to SAVR over a lifetime horizon. Key data inputs were drawn from the Placement of AoRTic TraNscathetER Valve (PARTNER) 3 trial for balloon-expandable TAVI and the Evolut Low-Risk trial for self-expanding TAVI. Costs were obtained from Australian sources. The perspective was that of the Australian health care system. RESULTS: Although procedural costs were higher for TAVI compared to SAVR, these were offset by a shorter length of hospitalisation and lower acute complication costs in the TAVI group. Over a lifetime horizon, balloon-expandable TAVI was associated with increased costs of A$702 compared to SAVR, and increased quality-adjusted survival by 0.20 years, yielding an incremental cost-effectiveness ratio of A$3,521 per quality-adjusted life year (QALY) saved. Self-expanding TAVI was associated with lower lifetime costs compared to SAVR, and increased quality-adjusted survival by 0.08 years, and was therefore economically dominant. In probabilistic sensitivity analyses, balloon-expandable TAVI was cost-effective in 78% of iterations (at a cost-effectiveness threshold of A$50,000 per QALY gained) and self-expanding TAVI was cost-effective in 70% of iterations. CONCLUSIONS: Among low-risk AS patients, both balloon-expandable and self-expanding TAVI are likely to be cost-effective relative to SAVR.

Novel Multiphase Assessment for Predicting Left Ventricular Outflow Tract Obstruction Before Transcatheter Mitral Valve Replacement.

OBJECTIVES: This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo-left ventricular outflow tract (LVOT). BACKGROUND: Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk. METHODS: Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach. RESULTS: Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates. CONCLUSIONS: Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment.

Cost-effectiveness of transcatheter aortic valve implantation compared to surgical aortic valve replacement in the intermediate surgical risk population.

BACKGROUND: The recent PARTNER S3i trial compared transcatheter aortic valve implantation (TAVI) using the third-generation SAPIEN 3 device to surgical aortic valve replacement (SAVR) in intermediate-risk patients with severe symptomatic aortic stenosis. Using data from PARTNER S3i, we performed a contemporary cost-effectiveness analysis of current-generation TAVI versus SAVR from the Australian healthcare system perspective. METHODS: A Markov model with monthly cycles and a ten-year horizon was constructed to estimate costs, life-years and quality adjusted life-years (QALYs) associated with TAVI and SAVR. Efficacy inputs were derived from the PARTNER S3i study. Costs were estimated from published sources. Deterministic and probabilistic sensitivity analyses were performed to assess model uncertainty. RESULTS: TAVI was found to have higher immediate procedural costs than SAVR, driven primarily by the cost of the transcatheter valve. This was offset by a shorter length of hospitalisation following TAVI, such that the combined cost of initial procedure and hospitalisation was lower in TAVI compared to SAVR. With 5% annual discounting, total costs over ten-years were $50,515 AUD in TAVI and $60,144 AUD in SAVR, and TAVI was found to produce 0.33 more life years and 0.31 more QALYs than SAVR. Thus, from a health economic perspective, TAVI was dominant compared to SAVR. Results were robust to sensitivity analyses, with TAVI being dominant in 68% of 10,000 Monte Carlo iterations and cost-effective in 92% of iterations at a willingness-to-pay threshold of $50,000/QALY gained. CONCLUSIONS: TAVI is likely to be highly cost-effective compared to SAVR in intermediate-risk patients with severe aortic stenosis.

Impact of Socioeconomic Status on Clinical Outcomes in Patients With ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: Low socioeconomic status (SES) has been previously shown to be associated with worse cardiovascular outcomes. However, unlike in Australia, many of these studies have been performed in countries without universal healthcare where SES may be expected to have a greater impact on care and outcomes. We sought to determine whether there is an association between SES and baseline characteristics, clinical outcomes and use of secondary prevention therapy in patients with ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: We prospectively collected data on 5665 consecutive ST-segment-elevation myocardial infarction PCI patients between 2005 and 2015 from 6 government-funded hospitals participating in a multicenter registry. Patients were categorized into SES quintiles using the Index of Relative Socioeconomic Disadvantage system, a score allocated to each residential postcode based on factors like income, educational level, and employment status by the Australian Bureau of Statistics. In our study, lower SES patients were more likely to have diabetes mellitus, smoke, and initially present to a non-PCI capable hospital (all P≤0.01). Among primary PCI patients, the median time to reperfusion was slightly higher in lower SES groups (211 [144-337] versus 193 [145-285] minutes, P<0.001). Drug-eluting stent use was higher in the higher SES groups ( P<0.001). At 12 months after PCI, lower SES patients had higher rates of ongoing smoking and lower use of guideline-recommended secondary prevention therapy (both P<0.01). Despite these differences, SES group was not found to be an independent predictor of 12-month major adverse cardiovascular events. CONCLUSIONS: Lower SES patients have more comorbidities and experienced slightly longer reperfusion times but otherwise similar care. Despite these baseline differences, clinical outcomes after ST-segment-elevation myocardial infarction PCI were similar regardless of SES.