Cost-effectiveness analysis of transcatheter aortic valve implantation in aortic stenosis patients at low- and intermediate-surgical risk in Japan.

OBJECTIVE: To analyze the cost-effectiveness of transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (Edwards Lifesciences, Irvine, CA) compared to surgical aortic valve replacement (SAVR) in low- and intermediate-risk patients from a Japanese public healthcare payer perspective. METHODS: A Markov model cost-effectiveness analysis was developed. Clinical and utility data were extracted from a systematic literature review. Cost inputs were obtained from analysis of the Medical Data Vision claims database and supplemented with a targeted literature search. The robustness of the results was assessed using sensitivity analyses. Scenario analyses were performed to determine the impact of lower mean age (77.5 years) and the effect of two different long-term mortality hazard ratios (TAVI versus SAVR: 0.9-1.09) on both risk-level populations. This analysis was conducted according to the guidelines for cost-effectiveness evaluation in Japan from Core 2 Health. RESULTS: In intermediate-risk patients, TAVI was a dominant procedure (TAVI had lower cost and higher effectiveness). In low-risk patients, the incremental cost effectiveness ratio (ICER) for TAVI was ¥750,417/quality-adjusted-life-years (QALY), which was below the cost-effectiveness threshold of ¥5 million/QALY. The ICER for TAVI was robust to all tested sensitivity and scenario analyses. CONCLUSIONS: TAVI was dominant and cost-effective compared to SAVR in intermediate- and low-risk patients, respectively. These results suggest that TAVI can provide meaningful value to Japanese patients relative to SAVR, at a reasonable incremental cost for patients at low surgical risk and potentially resulting in cost-savings in patients at intermediate surgical risk.

Aortic Stenosis (AS) is the most common valvular heart disease in Japan, and, if left untreated, severe symptomatic AS (sSAS) is associated with a dramatic increase in mortality and morbidity. Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive treatment option for replacing the aortic valve in patients with sSAS and has been associated with similar or better outcomes compared to Surgical Aortic Valve Replacement (SAVR), which involves open-heart surgical replacement of the aortic valve. The objective of this study was to compare the costs and health outcomes associated with TAVI compared to SAVR in Japanese patients deemed low- or intermediate-risk for surgery. Despite the expanding use of TAVI in Japan, a cost-effectiveness analysis (CEA) does not exist that evaluates the economics of TAVI with the current generation SAPIEN 3 implant in patients with low- and intermediate-risk from a public perspective. Our study suggests that TAVI represents strong value for money among low- and intermediate-risk patients in Japan: compared to SAVR, TAVI is associated with better clinical outcomes and quality of life for patients, at a reasonable additional cost for low-risk patients and at a lower cost for intermediate-risk patients.

Cost-effective analysis of transcatheter aortic valve replacement in patients with severe symptomatic aortic stenosis: A prospective multicenter study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis (AS) does not benefit all patients. We performed a prospective multicenter study to investigate the cost-effectiveness of TAVR in a Japanese cohort. METHODS AND RESULTS: We prospectively enrolled 110 symptomatic patients with severe AS who underwent TAVR from five institutions. The quality of life measurement (QOL) was performed for each patient before and at 6 months after TAVR. Patients without an improvement in QOL at 6 months after TAVR were defined as non-responders. Pre-TAVR higher QOL, higher clinical frailty scale predicted the non-responders. Three models, 1) conservative treatment for all patients strategy, 2) TAVR for all patients strategy, and 3) TAVR for a selected patient strategy who is expected to be a responder, were simulated. Lifetime cost-effectiveness was estimated using incremental cost-effectiveness ratio (ICER) and cost per quality-adjusted life-year (QALY) gained. In comparison to conservative therapy for all patients, ICER was estimated to be 5,765,800 yen/QALY for TAVR for all patients and 2,342,175 yen/QALY for TAVR for selected patient strategy patients, which is less than the commonly accepted ICER threshold of 5,000,000 yen/QALY. CONCLUSIONS: TAVR for selected patient strategy model is more cost-effective than TAVR for all patient strategy without reducing QOL in the Japanese healthcare system. TAVR for selected patient strategy has potential benefit for optimizing the TAVR treatment in patients with high frailty and may direct our resources toward beneficial interventions.

Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

BACKGROUND: The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. METHOD/DESIGN: NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device and the day of withdrawal of a trial device), and changes in left ventricular diastolic dimension (7 days after implantation of a trial device and the day of withdrawal of a trial device). ETHICS AND DISSEMINATION: We will disseminate the findings through regional, national, and international conferences and through peer-reviewed journals. TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR; R000033243) registered on 8 September 2017.

Preoperative Assessment of High-Risk Aortic Plaque by Magnetization-Prepared Rapid Acquisition with Gradient-Echo Imaging in a Patient with Total Arch Replacement.

We present a case of a 70-year-old male who underwent surgical repair of an aortic arch aneurysm. Preoperative assessment of high-risk aortic plaque was performed using magnetization-prepared rapid acquisition with gradient-echo (MPRAGE) imaging. This preoperative image was compared with a histological analysis of plaque specimens from the aortic arch and neck vessels. A high signal intensity on MPRAGE images coincided with intraplaque hemorrhage. MPRAGE, which could detect a fragile plaque in the aorta, could be a powerful modality to prevent intraoperative stroke during cardiovascular surgery.

Socioeconomic effects of surgical site infection after cardiac surgery in Japan.

PURPOSE: Surgical site infection (SSI) increases medical costs and prolongs hospitalization; however, there has been no multicenter study examining the socioeconomic effects of SSI after cardiovascular surgery in Japan. METHODS: A retrospective 1:1 matched, case-controlled study on hospital stay and health care expenditure after cardiovascular surgery was performed in four hospitals. Patients selected for the study had undergone coronary artery bypass grafting and/or valve surgery between April, 2006 and March, 2008. Data were obtained for 30 pairs of patients. RESULTS: The mean postoperative stay for the SSI group was 49.1 days, being 3.7 times longer than that for the non-SSI group. The mean postoperative health care expenditure for the SSI group was ¥ 2,763,000 (US$27,630), being five times higher than that for the non-SSI group. Charges for drug infusion and hospitalization for inpatient care were significantly higher for the SSI group than for the non-SSI group. The increased health care expenditure was mainly attributed to the cost of antibiotics and antimicrobial agents. CONCLUSION: SSI after cardiovascular surgery not only prolonged the length of hospital stay, but also increased medical expenditure. Thus, the prevention of SSI after cardiovascular surgery is of great socioeconomic importance.

Length of stay and cost for surgical site infection after abdominal and cardiac surgery in Japanese hospitals: multi-center surveillance.

PURPOSE: This study evaluated the influence of surgical site infections (SSIs) after abdominal or cardiac surgery on the post-operative duration of hospitalization and cost. METHODS: A retrospective 1:1 matched case-control study of length of stay and healthcare expenditures for patients who were discharged from nine hospitals, between April 1, 2006 and March 31, 2008, after undergoing abdominal or cardiac surgery and who did and did not have a SSI. RESULTS: Information was obtained from 246 pairs of patients who had undergone abdominal surgery and 27 pairs of patients who had undergone cardiac surgery. Overall, the mean post-operative hospitalization was 20.7 days longer and the mean post-operative healthcare expenditure was $8,791 higher in the SSI group than for the SSI-free group. Among the patients who had undergone abdominal surgery, development of SSI extended the average hospitalization by 17.6 days and increased the average healthcare expenditure by $6,624. Among the patients who had undergone cardiac surgery, SSI extended the post-operative hospitalization by an average of 48.9 days and increased the post-operative healthcare expenditure by an average of $28,534. CONCLUSIONS: Under the current healthcare system in Japan, the development of SSI after abdominal surgery necessitates extension of hospitalization two-fold and increases the post-operative healthcare expenditure 2.5-fold. Development of SSI after cardiac surgery necessitates extension of hospitalization fourfold and increases the healthcare expenditure six-fold.

Safety and efficacy of sequential and composite arterial grafting to more than five coronary branches in off-pump coronary revascularisation: assessment of intra-operative and angiographic bypass flow.

OBJECTIVE: We sought to delineate the safety and efficacy of sequential and composite coronary artery bypass grafting (CABG) with exclusively arterial grafts to more than five coronary branches including small coronary vessels. METHODS: We reviewed the clinical records of 633 consecutive patients with 2617 bypass grafts who underwent total arterial off-pump complete revascularisation for three-vessel coronary regions without aortic manipulation. Group I consisted of 263 patients with a single in situ internal thoracic artery (ITA), while group II consisted of 370 patients with bilateral in situ ITA. Subgroups I-A and I-B consisted of 242 patients with three or four distal anastomoses and 21 patients with more than five distal anastomoses, respectively. Subgroups II-A and II-B consisted of 199 patients with three or four anastomoses and 171 patients with more than five anastomoses, respectively. RESULTS: The early mortality and morbidity rate and the angiographic graft patency in the groups I and II were similar, while the rate of antegrade flow in group II (92.4%, 1349/1460) was significantly higher than that in group I (89.4%, 638/714, p=0.02). Intra-operative graft flow measured at the proximal portion of the in situ ITA in group II (79+/-35 ml min(-1)) was significantly larger that that in group I (53+/-31 ml min(-1), p<0.0001). The patency rate of bypass grafts to small coronary vessels (1.25 mm or less in diameter) was 97.4% (626/643). The early mortality rates in subgroups I-A and I-B were 1.2% (3/242) and 0% (0/21), respectively (p=0.61). The graft flow and incidence of competitive flow was comparable in subgroups I-A and I-B. The early mortality rates in subgroups II-A and II-B were 0.5% (1/199) and 0.6% (1/177), respectively (p=0.91). The graft flow to five or more coronary branches (81+/-35 ml min(-1)) was significantly greater than that to three branches (67+/-30 ml min(-1), p=0.01). CONCLUSIONS: For more than five target branches, sequential and composite arterial grafting with the ITA and a radial artery was safe and reliable, even when the target vessels were small. Bilateral in situ ITA would be feasible for the patients with multiple stenotic lesions, because of abundant bypass flow and less incidence of competitive flow. Durable completeness of revascularisation can be expected.

[Influence of DPC on cardiovascular surgery].

After a new medical expense system "DPC (Diagnosis Procedure Combination)" had been introduced in 2003, the change in the medical treatment fee was evaluated according to each cardiovascular surgical field. Application of the DPC is limited to hospitalization fee in the general ward by a fixed daily amount The former payment system remains for operation, anesthesia, and some invasive examinations such as cardiac catheterization, therefore, the influence of the DPC introduction on cardiovascular surgery was minimum. A lot of problems are still left, however, for the classification of diagnosis, especially in a congenital heart disease, and the fee setting of intensive care. It is required also to reconsider serious cases, advanced complications and methods of life support. In the field of cardiovacular surgery, the treatment is so risky and so expensive, that more detailed analysis should be necessary by establishment of data base system.