Contribution margins and utilization of transcatheter aortic valve replacement versus surgical aortic valve replacement in the Medicare population.
Hospitals and health systems must balance the demand for transcatheter aortic valve replacement (TAVR) against financial sustainability. Patients may be eligible for both TAVR and surgical aortic valve replacement (SAVR), but financial realities for hospitals may affect differential access to those therapies. We sought to understand the landscape of costs and reimbursement for TAVR and SAVR in the US and to understand the association of procedural reimbursement with receipt of either.
We included fee-for-service Medicare beneficiaries undergoing isolated TAVR or SAVR in 2016-2019. For each TAVR and SAVR, inpatient revenues and direct costs were calculated at the claim level. The contribution margin (CM) for each TAVR or SAVR was then calculated as total revenues minus total direct costs, which defines the net profit for the procedure for the hospital. Multivariate logistic regressions were used to identify hospital characteristics associated with positive TAVR CMs. Multivariate linear regression was used to assess the relationship between relative volume of TAVR cases and relative differences in TAVR versus SAVR CMs at the hospital level.
Of 542 sites, 377 (69.6%) had positive CMs, and 165 (30.4%) had negative CMs for TAVR; 505 (93.2%) had positive CMs for SAVR. Median revenues, costs, and CMs for TAVR decreased between 2016 and 2019. The median (IQR) total CM per hospital for TAVR decreased from $10,574 ($1,331-$22,259) in 2016 to $6,744 ($6,099-$17,511) in 2019 (P < 0.001). Teaching hospital status (aOR 1.77, 95% CI 1.07-2.93) and for-profit status (aOR 3.7, 95% CI 1.8-7.6) were associated with increased odds of positive TAVR CMs relative to nonteaching hospital status and nonprofit status, respectively, in multivariate logistic regression models. The median (IQR) proportion of TAVR of total AVR was 76.67% (69.6%-82.5%) compared with 74.6% (66.9%-80.4%) at hospitals with negative TAVR CMs (P = .04). There was no significant linear relationship between hospital-level difference in median TAVR and SAVR CMs and hospital-level proportion of TAVR of total AVR in multivariate models.
Most hospitals had positive CMs for TAVR and nearly all had positive CMs for SAVR. Positive CMs for TAVR for individual hospitals were associated with a significant increase in the utilization of TAVR. However, the magnitude of difference in TAVR versus SAVR CM was not associated with differential procedural use.
Reddy KP
，Shultz K
，Eberly LA
，Khatana SAM
，Fanaroff AC
，Kumbhani DJ
，Elmariah S
，Fiorilli P
，Herrmann H
，Desai ND
，Atluri P
，Szeto WY
，McCarthy F
，Cohen DJ
，Groeneveld PW
，Giri J
，Nathan AS
... -
《-》
Limited versus full sternotomy for aortic valve replacement.
Aortic valve disease is a common condition easily treatable with cardiac surgery. This is conventionally performed by opening the sternum ('median sternotomy') and replacing the valve under cardiopulmonary bypass. Median sternotomy is well tolerated, but as less invasive options become available, the efficacy of limited incisions has been called into question. In particular, the effects of reducing the visibility and surgical access have raised safety concerns with regard to the placement of cannulae, venting of the heart, epicardial wire placement, and de-airing of the heart at the end of the procedure. These difficulties may increase operating times, affecting outcome. The benefits of smaller incisions are thought to include decreased pain; improved respiratory mechanics; reductions in wound infections, bleeding, and need for transfusion; shorter intensive care stay; better cosmesis; and a quicker return to normal activity. This is an update of a Cochrane review first published in 2017, with seven new studies.
To assess the effects of minimally invasive aortic valve replacement via a limited sternotomy versus conventional aortic valve replacement via median sternotomy in people with aortic valve disease requiring surgical replacement.
We performed searches of CENTRAL, MEDLINE and Embase from inception to August 2021, with no language limitations. We also searched two clinical trials registries and manufacturers' websites. We reviewed references of primary studies to identify any further studies of relevance.
We included randomised controlled trials comparing aortic valve replacement via a median sternotomy versus aortic valve replacement via a limited sternotomy. We excluded trials that performed other minimally invasive incisions such as mini-thoracotomies, port access, transapical, transfemoral or robotic procedures. Although some well-conducted prospective and retrospective case-control and cohort studies exist, these were not included in this review.
Two review authors independently assessed trial papers to extract data, assess quality, and identify risk of bias. A third review author provided arbitration where required. We determined the certainty of evidence using the GRADE methodology and summarised results of patient-relevant outcomes in a summary of findings table.
The review included 14 trials with 1395 participants. Most studies had at least two domains at high risk of bias. We analysed 14 outcomes investigating the effects of minimally invasive limited upper hemi-sternotomy on aortic valve replacement as compared to surgery performed via full median sternotomy. Upper hemi-sternotomy may have little to no effect on mortality versus full median sternotomy (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.45 to 1.94; 10 studies, 985 participants; low-certainty evidence). Upper hemi-sternotomy for aortic valve replacement may increase cardiopulmonary bypass time slightly, although the evidence is very uncertain (mean difference (MD) 10.63 minutes, 95% CI 3.39 to 17.88; 10 studies, 1043 participants; very low-certainty evidence) and may increase aortic cross-clamp time slightly (MD 6.07 minutes, 95% CI 0.79 to 11.35; 12 studies, 1235 participants; very low-certainty evidence), although the evidence is very uncertain. Most studies had at least two domains at high risk of bias. Postoperative blood loss was probably lower in the upper hemi-sternotomy group (MD -153 mL, 95% CI -246 to -60; 8 studies, 767 participants; moderate-certainty evidence). Low-certainty evidence suggested that there may be no change in pain scores by upper hemi-sternotomy (standardised mean difference (SMD) -0.19, 95% CI -0.43 to 0.04; 5 studies, 649 participants). Upper hemi-sternotomy may result in little to no difference in quality of life (MD 0.03 higher, 95% CI 0 to 0.06 higher; 4 studies, 624 participants; low-certainty evidence). Two studies reporting index admission costs concluded that limited sternotomy may be more costly at index admission in the UK National Health Service (MD 1190 GBP more, 95% CI 420 GBP to 1970 GBP, 2 studies, 492 participants; low-certainty evidence).
The evidence was of very low to moderate certainty. Sample sizes were small and underpowered to demonstrate differences in some outcomes. Clinical heterogeneity was also noted. Considering these limitations, there may be little to no effect on mortality. Differences in extracorporeal support times are uncertain, comparing upper hemi-sternotomy to full sternotomy for aortic valve replacement. Before widespread adoption of the minimally invasive approach can be recommended, there is a need for a well-designed and adequately powered prospective randomised controlled trial. Such a study would benefit from also performing a robust cost analysis. Growing patient preference for minimally invasive techniques merits thorough quality of life analyses to be included as end points, as well as quantitative measures of physiological reserve.
Kirmani BH
，Jones SG
，Muir A
，Malaisrie SC
，Chung DA
，Williams RJ
，Akowuah E
... -
《Cochrane Database of Systematic Reviews》
Decreasing pacemaker implantation rates with Evolut supra-annular transcatheter aortic valves in a large real-world registry.
Permanent pacemaker implantation (PPI) rates following transcatheter aortic valve replacement (TAVR) remain a concern. We assessed the PPI rates over time in patients implanted with an Evolut supra-annular, self-expanding transcatheter valve from the US STS/ACC TVT Registry.
Patients who underwent TAVR with an Evolut R, Evolut PRO or Evolut PRO+ valve between July 2018 (Q3) and June 2021 (Q2) were included. PPI rates were reported by calendar quarter. In-hospital PPI rates were reported as proportions and 30-day rates as Kaplan-Meier estimates. A Cox regression model was used to determine potential predictors of a new PPI within 30 days of the TAVR procedure.
From July 2018 to June 2021, 54,014 TAVR procedures were performed using Evolut valves. Mean age was 79.3 ± 8.8 years and 49.2 % were male. The 30-day PPI rate was 16.6 % in 2018 (Q3) and 10.8 % in 2021 (Q2, 34.9 % decrease, p < 0.001 for trend across all quarters). The in-hospital PPI rate decreased by 40.1 %; from 14.7 % in 2018 (Q3) to 8.8 % in 2021 (Q2) (p < 0.001 for trend across all quarters). Significant predictors of a new PPI within 30 days included a baseline conduction defect, history of atrial fibrillation, home oxygen, and diabetes mellitus.
From 2018 to 2021, TAVR with an Evolut transcatheter heart valve in over 50,000 patients showed a significant decreasing trend in the rates of in-hospital and 30-day PPI, representing the lowest rate of PPI in any large real-world registry of Evolut. During the same evaluated period, high device success and shorter length of stay was also observed.
Harvey JE
，Puri R
，Grubb KJ
，Yakubov SJ
，Mahoney PD
，Gada H
，Coylewright M
，Poulin MF
，Chetcuti SJ
，Sorajja P
，Rovin JD
，Eisenberg R
，Reardon MJ
... -
《-》
ResearchGate
(全网免费下载)
钛学术
(全网免费下载)
