Cath lab costs in patients undergoing percutaneous coronary angioplasty - detailed analysis of consecutive procedures.

BACKGROUND: Costs of percutaneous coronary interventions (PCI) have an important impact on health care expenditures. Despite the present stress upon the cost-effectiveness issues in medicine, few comprehensive data exist on costs and resource use in different clinical settings. AIM: To assess catheterisation laboratory costs related to use of drugs and single-use devices in patients undergoing PCI due to coronary artery disease. METHODS: Retrospective analysis of 1500 consecutive PCIs (radial approach, n = 1103; femoral approach, n = 397) performed due to ST segment elevation myocardial infarction (STEMI; n = 345) and non ST-segment elevation myocardial infarction (NSTEMI; n = 426) as well as unstable angina (UA; n = 489) and stable angina (SA; n = 241) was undertaken. Comparative cost analysis was performed and shown in local currency units (PLN). RESULTS: The cath lab costs were higher in STEMI (4295.01 ± 2384.54PLN, p < 0.001) compared to NSTEMI (3493.40 ± 1907.43 PLN, p < 0.001), UA (3206.31 ± 1692.82 PLN, p < 0.001) and SA patients (3138.91 ± 1427.62 PLN, p < 0.001). They were higher in males than in females (3668.9 ± 2095.2 vs. 3292.0 ± 1656.0 PLN, p < 0.05). In females PCIs performed via radial approach were more expensive than via femoral approach (3360.4 ± 1540.1 vs. 3135.5 ± 1890.3 PLN, p < 0.01). In all subgroups analysed, costs were positively correlated with X-ray dose, fluoroscopy, and total procedure times. Patients' age negatively correlated with cath lab costs in STEMI/NSTEMI patients. CONCLUSIONS: Cath lab costs were higher in STEMI patients compared to other groups. In STEMI/NSTEMI they were lower in older patients. In all analysed groups costs were related to the level of procedural difficulty. In female patients, the costs of PCI performed via radial approach were higher compared to femoral approach. Despite younger age, male patients underwent more expensive procedures.

Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings.

BACKGROUND: To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT). METHODS: Cost-utility analysis using a combination of a decision tree and Markov process was performed. The clinical effectiveness was determined based on the results of the Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) trial. The mean age of the target population was 62 years, 77% of the patients were males, 64% of the patients had severe FMR and all patients had New York Heart Association functional class III. The epidemiological, cost and utility data were derived from the literature. The analysis was performed from the German statutory health insurance perspective over 10-year time horizon. RESULTS: Over 10 years, the total cost was €36,785 in the PMVR arm and €18,944 in the OMT arm. However, PMVR provided additional benefits to patients with an 1.15 incremental quality-adjusted life years (QALY) and an 1.41 incremental life years. The percutaneous procedure was cost-effective in comparison to OMT with an incremental cost-effectiveness ratio of €15,533/QALY. Results were robust in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis with a willingness-to-pay threshold of €35,000/QALY, PMVR had a 84 % probability of being cost-effective. CONCLUSIONS: Percutaneous mitral valve repair may be cost-effective in inoperable patients with FMR due to heart failure.

3D heart model printing for preparation of percutaneous structural interventions: description of the technology and case report.

BACKGROUND: Structural heart disease, including valvular disease as well as congenital defects, causes important alterations in heart anatomy. As a result, individualised planning for both surgical and percutaneous procedures is crucial for procedural optimisation. Three dimensional (3D) rapid prototyping techniques are being utilised to aid operators in planning structural heart procedures. AIM: We intend to provide a description of 3D printing as a clinically applicable heart modelling technology for the planning of percutaneous structural heart procedures as well as to report our first clinical use of a 3D printed patient-specific heart model in preparation for a percutaneous mitral annuloplasty using the Mitralign percutaneous annuloplasty system. METHODS: Retrospectively gated, contrast enhanced, multi-slice computed tomography (MSCT) scans were obtained. MSCT DICOM data was analysed using software that creates 3D surface files of the blood volume of specific regions of interest in the heart. The surface files are rendered using a software package that creates a solid model that can be printed using commercially available stereolithography machines. RESULTS: The technique of direct percutaneous mitral annuloplasty requires advancement of a guiding catheter through the aorta, into the left ventricle, and requires the positioning of the tip of the catheter between the papillary muscles in close proximity to the mitral annulus. The 3D heart model was used to create a procedural plan to optimise potential device implantation. The size of the deflectable guiding catheter was selected on the basis of the patient's heart model. Target locations for annulus crossing wires were evaluated pre-procedurally using the individual patient's 3D heart model. In addition, the ability to position the Bident Catheter at the appropriate locations under the mitral annulus as well as the manoeuvrability between the papillary muscles were analysed on the heart model, enabling safe completion of the procedure, which resulted in a significant reduction in mitral regurgitation. CONCLUSIONS: 3D printing is a helpful tool in individualised planning for percutaneous structural interventions. Future studies are warranted to assess its role in preparing for percutaneous and surgical heart procedures.

Functional assessment of patients after percutaneous mitral valvuloplasty with Carillon™ device: a preliminary report.

BACKGROUND: Functional mitral regurgitation (MR) due to dilated cardiomyopathy or coronary artery disease remains a significant clinical problem. These clinical entities lead to left ventricular enlargement, which results in annular dilation and MR. Surgical valvuloplasty is associated with a high perioperative risk. This is the reason why percutaneous techniques for mitral valve repair are under development. One of the most advanced devices for mitral annuloplasty is the Carillon™ system. AIM: Functional assessment of patients who have undergone mitral annuloplasty using the Carillon™ device. METHODS: Fourteen consecutive patients with functional MR who had undergone successful implantation of the Carillon™ device were enrolled. The device was implanted into the venous system of the heart and applied tension to the mitral annulus in order to improve coaptation of the cusps and reduce MR. In implanted patients echocardiographic MR parameters (vena contracta, effective regurgitant orifice area) were assessed before, immediately after the procedure and during 1-month follow-up. Furthermore, the 6-minute walk test (6MWT), Naughton stress test and the NYHA functional class assessment were performed before the procedure and at 1 month. Quality of life was evaluated by the Kansas City Cardiomyopathy Questionnaire. One month after the procedure patients were also asked to compare their health status with their baseline condition. RESULTS: In implanted patients improvement of echocardiographic MR parameters was observed, both immediately after the procedure and during 1 month follow-up. These parameters included vena contracta (0.36 ± 0.03 and 0.31 ± 0.03 vs 0.65 ± ± 0.04 cm, both p < 0.001) as well as effective regurgitant orifice area (0.18 ± 0.02 and 0.20 ± 0.02 vs 0.28 ± 0.04 cm², p < 0.05 and p < 0.005, respectively). One month after the procedure the 6MWT (390 ± 26.25 vs 311.9 ± 15.71 m, p < 0.001), Naughton treadmill exercise test (5.06 ± 0.47 vs 3.49 ± 0.27 min, p < 0.005) and NYHA classification (1.93 ± ± 0.20 vs 2.93 ± 0.07, p < 0.005) were significantly improved. Quality of life improved from 67.93 ± 3.30 at baseline to 88.31 ± 4.02 at 1 month (p < 0.001). All the patients reported some degree of improvement at 1 month compared to baseline. CONCLUSIONS: Implantation of the Carillon™ device in patients with functional MR leads to increased exercise capacity and improvement of selected echocardiographic MR parameters. Randomised trials are needed to assess the clinical value of the technique. Kardiol Pol 2011; 69, 3: 228-233.