Cost-Effectiveness Analysis of SAPIEN 3 Transcatheter Aortic Valve Implantation Procedure Compared With Surgery in Patients With Severe Aortic Stenosis at Low Risk of Surgical Mortality in France.

OBJECTIVES: The clinical and cost-saving benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis who are at high or intermediate risk of surgical mortality are supported by a growing evidence base. The PARTNER 3 trial (Placement of AoRTic TraNscathetER Valve Trial) demonstrated clinical benefits with SAPIEN 3 TAVI compared with SAVR in selected patients at low risk of surgical mortality. This study uses PARTNER 3 outcomes in combination with a French national hospital claim database to inform a cost-utility model and examine the cost implications of TAVI over SAVR in a low-risk population. METHODS: A 2-stage cost-utility analysis was developed to estimate changes in both direct healthcare costs and health-related quality of life using TAVI with SAPIEN 3 compared with SAVR. Early adverse events associated with TAVI were captured using the PARTNER 3 data set. These data fed into a Markov model that captured longer-term outcomes of patients, after TAVI or SAVR intervention. RESULTS: TAVI with SAPIEN 3 offers meaningful benefits over SAVR in providing both cost saving (€12 742 per patient) and generating greater quality-adjusted life-years (0.89 per patient). These results are robust with TAVI with SAPIEN 3 remaining dominant across several scenarios and deterministic and probabilistic sensitivity analyses. CONCLUSIONS: This model demonstrated that TAVI with SAPIEN 3 was dominant compared with SAVR in the treatment of patients with severe symptomatic aortic stenosis who are at low risk of surgical mortality. These findings should help policy makers in developing informed approaches to intervention selection for this patient population.

Successful linkage of French large-scale national registry populations to national reimbursement data: Improved data completeness and minimized loss to follow-up.

BACKGROUND: Registries, a cornerstone of contemporary medicine, frequently suffer from incomplete documentation and losses to follow-up. By linking data to a single-payer national claims database, national registries may be enriched and the quality enhanced. AIMS: To explore the value of data from the French Système National des Données de Santé (SNDS) as a resource to enhance the quality of registries when combined with data from electronic case report forms, and to assess the power to minimize data gaps and losses to follow-up. METHODS: A probabilistic algorithm was developed to link and match records in the SNDS with patient data from the electronic case report forms of two registries on transcatheter aortic valve implantation: FRANCE-2 and FRANCE-TAVI. The algorithm created patient profiles from transcatheter aortic valve implantation procedures in the SNDS, matching them as closely as possible to the profiles in the registry databases. The objective was to achieve 90% linkage of the populations. The linked database was analysed for completeness and loss to follow-up. For validation, mortality curves for the linked registry cohorts were compared with those for the original populations. RESULTS: A total of 34,397 unique registries entries were identified, and 89.9% of patients in the SNDS could be linked. Rates of losses to follow-up over 2 years were 1.0% in the linked FRANCE-TAVI population compared with 40.3% based on electronic case report form documentation. For FRANCE-2, 3-year rates of losses to follow-up were 1.7% and 6.1%, respectively. Mortality curves for populations based on SNDS and electronic case report form data were practically superimposable. CONCLUSIONS: Linking data from a single-payer national claims database to national registries using a probabilistic approach is feasible and can close data gaps and practically abolish losses to follow-up in the registry population.

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

BACKGROUND: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves. METHODS AND RESULTS: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses. CONCLUSIONS: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.

Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM.

BACKGROUND: Fractional flow reserve estimated using computed tomography (FFRCT) might improve evaluation of patients with chest pain. OBJECTIVES: The authors sought to determine the effect on cost and quality of life (QOL) of using FFRCT instead of usual care to evaluate stable patients with symptoms suspicious for coronary disease. METHODS: Symptomatic patients without known coronary disease were enrolled into 2 strata based on whether invasive or noninvasive diagnostic testing was planned. In each stratum, consecutive observational cohorts were evaluated with either usual care or FFRCT. The number of diagnostic tests, invasive procedures, hospitalizations, and medications during 90-day follow-up were multiplied by U.S. cost weights and summed to derive total medical costs. Changes in QOL from baseline to 90 days were assessed using the Seattle Angina Questionnaire, the EuroQOL, and a visual analog scale. RESULTS: In the 584 patients, 74% had atypical angina, and the pre-test probability of coronary disease was 49%. In the planned invasive stratum, mean costs were 32% lower among the FFRCT patients than among the usual care patients ($7,343 vs. $10,734 p < 0.0001). In the noninvasive stratum, mean costs were not significantly different between the FFRCT patients and the usual care patients ($2,679 vs. $2,137; p = 0.26). In a sensitivity analysis, when the cost weight of FFRCT was set to 7 times that of computed tomography angiography, the FFRCT group still had lower costs than the usual care group in the invasive testing stratum ($8,619 vs. $ 10,734; p < 0.0001), whereas in the noninvasive testing stratum, when the cost weight of FFRCT was set to one-half that of computed tomography angiography, the FFRCT group had higher costs than the usual care group ($2,766 vs. $2,137; p = 0.02). Each QOL score improved in the overall study population (p < 0.0001). In the noninvasive stratum, QOL scores improved more in FFRCT patients than in usual care patients: Seattle Angina Questionnaire 19.5 versus 11.4, p = 0.003; EuroQOL 0.08 versus 0.03, p = 0.002; and visual analog scale 4.1 versus 2.3, p = 0.82. In the invasive cohort, the improvements in QOL were similar in the FFRCT and usual care patients. CONCLUSIONS: An evaluation strategy based on FFRCT was associated with less resource use and lower costs within 90 days than evaluation with invasive coronary angiography. Evaluation with FFRCT was associated with greater improvement in quality of life than evaluation with usual noninvasive testing. (Prospective Longitudinal Trial of FFRCT: Outcomes and Resource Impacts [PLATFORM]; NCT01943903).

Rationale and design of the Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts study.

BACKGROUND: Fractional flow reserve (FFR) measured by coronary computed tomography angiography (FFRCT) has been validated against invasive FFR. However, there are no data on how the use of FFRCT affects patient care and outcomes. The aim of this study is to compare standard practice guided by usual care testing to FFRCT-guided management in symptomatic subjects with suspected coronary artery disease (CAD). METHODS: In this prospective nonrandomized trial, symptomatic patients with suspected CAD will be enrolled in 2 consecutive cohorts: a usual care-guided pathway (cohort 1) and an FFRCT-guided pathway (cohort 2). Each cohort is divided into 2 groups according to whether noninvasive or invasive diagnostic testing was planned before enrollment. In all subjects, the patient's clinical team will review all diagnostic test results and determine a treatment strategy. A total sample size of 580 subjects will be enrolled and followed up for 12 months. RESULTS: The primary end point is the comparison of the percentage of patients with planned invasive testing who have a catheterization (invasive coronary angiography) within 90 days from initial assessment, which does not show a significant stenosis (defined as coronary artery stenosis >50% or invasive FFR ≤0.80). Secondary end points include the rate of invasive coronary angiography without obstructive CAD in those with planned noninvasive testing and, in all groups, noninferiority of resource use, quality of life, medical radiation exposure, and major adverse cardiac events up to 365 days of follow-up. CONCLUSIONS: The study compares clinical and economic outcomes based on diagnostic evaluation using FFRCT with that based on standard diagnostic strategies.

Impact of gender on use of revascularization in acute coronary syndromes: the national observational study of diagnostic and interventional cardiac catheterization (ONACI).

OBJECTIVES: To assess the impact of gender on myocardial revascularization using data collected in a French nationwide registry: the national observational study of diagnostic and interventional cardiac catheterization (ONACI). BACKGROUND: Gender differences in management of patients with acute coronary syndromes (ACS) have been reported. METHODS: We analysed data from a nationwide French prospective multicentre registry including 64,932 suspected ACS patients recruited in 99 centres from 2004 to 2008. RESULTS: Overall, women were older (70.7 ± 12.7 vs. 63.8 ± 12.9 years), had a higher cardiovascular risk profile, and were more frequently admitted with non ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) compared to men (73% vs. 68%). Women had significantly more angiographically normal coronary arteries or non-significant coronary artery disease (CAD) in both STEMI (6% vs. 3%) and NSTEMI/UA (21% vs. 11%) while men had more severe CAD. After adjusting for age, cardiovascular risk factors, and extent of disease, myocardial revascularization (defined as the use of percutaneous coronary intervention (PCI) or coronary artery bypass grafting) was less frequently used in women (adjusted OR = 0.78; 95% CI: 0.77-0.83). For those receiving PCI, in-hospital mortality within 24 hr of intervention was higher in women (3.6% vs. 1.2%; adjusted OR = 1.51; 95% CI: 1.22-1.87). CONCLUSIONS: In the present study, despite having a higher cardiovascular risk profile, women more frequently had normal vessel/non-significant angiographic coronary artery disease. In patients with significant coronary artery disease, myocardial revascularization was less frequently used in women whatever the type of ACS.

Unmet needs of young interventional cardiologists: proceedings from the 2nd summit of the European association of percutaneous cardiovascular interventions.

Every year, the EAPCI Board invites presidents and representatives of the interventional working groups affiliated to EAPCI to discuss issues and strategies surrounding the goals of education and advanced healthcare practices in interventional cardiology. In 2013, the 2nd EAPCI Summit, organised by the EAPCI Board in collaboration with the NIFYI committee, was entirely dedicated to discussing the unmet needs of the young generation of interventional cardiologists. In this article, we highlight a selection of the key points and proposed actions highlighted during the summit.

Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score.

OBJECTIVE: Decision making for intervention in symptomatic aortic stenosis should balance the risks of surgery and of transcatheter aortic valve implantation (TAVI). We identified the factors associated with early mortality after TAVI and aimed to develop and validate a simple risk score. METHODS: A population of 3833 consecutive patients was randomly split into two cohorts comprising 2552 and 1281 patients, used respectively to develop and validate a scoring system predicting 30-day or in-hospital mortality. RESULTS: TAVI was performed using the Edwards Sapien prosthesis in 2551 (66.8%) patients and the Medtronic Corevalve in 1270 (33.2%). Approach was transfemoral in 2801 (73.4%) patients, transapical in 678 (17.8%), subclavian in 219 (5.7%) and other in 117 (3.1%). Early mortality was 10.0% (382 patients). A multivariate logistic model identified the following predictive factors of early mortality: age ≥90 years, body mass index <30 Kg/m(2), New York Heart Association class IV, pulmonary hypertension, critical haemodynamic state, ≥2 pulmonary oedemas during the last year, respiratory insufficiency, dialysis and transapical or other (transaortic and transcarotid) approaches. A 21-point predictive score was derived. C-index was 0.67 for the score in the development cohort and 0.59 in the validation cohort. There was a good concordance between predicted and observed 30-day mortality rates in the development and validation cohorts. CONCLUSIONS: Early mortality after TAVI is mainly related to age, the severity of symptoms, comorbidities and transapical approach. A simple score can be used to predict early mortality after TAVI. The moderate discrimination is however a limitation for the accurate identification of high-risk patients.

Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

Cost of transcatheter aortic valve implantation and factors associated with higher hospital stay cost in patients of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.

BACKGROUND: Currently, several anatomical approaches and intervention sites can be used to perform transcatheter aortic valve implantations (TAVIs), often with no clinical indications for choosing one or another. While these choices can have an impact on resource consumption, no costing study is available in the European context to provide information on resource use and assist decision-making. AIMS: To provide comparative data on the cost of the TAVI procedure, depending on anatomical approach and intervention site used, from a hospital perspective, and to analyze factors associated with cost of hospital stay. METHODS: Multicentre national registry data were collected in 16 centres between January and October 2009. For 287 patients, a descriptive costing study and a multivariable analysis of hospital stay cost were performed. RESULTS: The mean cost of the TAVI procedure was €22,876 and the mean initial hospital stay cost was €35,164. The procedure cost, excluding valve cost, did not differ between anatomical approaches and was highest in the hybrid room and lowest in the catheterization laboratory. Factors associated with higher hospital stay cost were transapical approach, Society of Thoracic Surgeons score>10%, warfarin use at inclusion, complications during procedure and pacemaker implantation following valve implantation. CONCLUSIONS: If clinical considerations do not interfere, hospital staff may find it economically favorable to opt for the catheterization laboratory and against the hybrid room. The mean hospital stay cost is higher than the tariff paid in 2011, a difference that has grown since the change in tariff in 2012, representing an economic disincentive for the uptake of TAVI in France.

Assessment of carotid artery stenosis before coronary artery bypass surgery. Is it always necessary?

BACKGROUND: Extracranial internal carotid artery stenosis is a risk factor for perioperative stroke in patients undergoing coronary artery bypass surgery (CAB). Although selective and non-selective methods of preoperative carotid screening have been advocated, it remains unclear if this screening is clinically relevant. AIM: To test whether selective carotid screening is as effective as non-selective screening in detecting significant carotid disease. METHODS: The case records of patients consecutively undergoing CAB were reviewed. Patients were stratified retrospectively into high- or low-risk groups according to risk factors for significant carotid stenosis and perioperative stroke: peripheral vascular disease (PVD), carotid bruit, diabetes mellitus, age >70 years and/or history of cerebrovascular disease. Prevalence of carotid stenosis detected by ultrasonography, surgical management and perioperative stroke rates were determined in each group. RESULTS: Overall, 205 consecutive patients underwent preoperative carotid screening. The prevalence of significant carotid stenosis was 5.8%. Univariate analysis confirmed that PVD (P=0.005), carotid bruit (P=0.003) and diabetes mellitus (P=0.05) were significant risk factors for stenosis. Carotid stenosis was a risk factor for stroke (P=0.03). Prevalence of carotid stenosis was higher in the high-risk group (9.1%) than the low-risk group (1.2%) (P<0.05). All concomitant or staged carotid endarterectomies/CAB (5/205) and all patients who had perioperative strokes (5/205) were in the high-risk group (P=0.01). CONCLUSION: In our cohort, selective screening of patients aged >70 years, with carotid bruit, a history of cerebrovascular disease, diabetes mellitus or PVD would have reduced the screening load by 40%, with trivial impact on surgical management or neurological outcomes.

Cardiac multislice spiral computed tomography as an alternative to coronary angiography in the preoperative assessment of coronary artery disease before aortic valve surgery: a management outcome study.

BACKGROUND: Conventional coronary angiography (CA) is still recommended before valvular surgery. Preliminary studies suggest that multislice spiral computed tomography coronary angiography (MSCT-CA) can be used to rule out coronary artery disease (CAD). AIM: To assess prospectively the safety of ruling out CAD before surgery solely on the basis of normal MSCT-CA in patients with severe aortic valve disease. METHODS: We included all consecutive patients scheduled for aortic valve surgery. We first estimated the calcium score (Agatston score equivalent [ASE]). Patients underwent injected MSCT if the ASE was<1000. CA was cancelled when MSCT-CA quality was sufficient and showed no significant CAD. Our primary endpoint was the occurrence of perioperative myocardial infarction in patients who underwent surgery with no prior CA. RESULTS: Between 1st July 2005 and 30th June 2008, we included 199 patients with severe aortic valve disease: 118 men (59%); mean age 69+/-12 years; 63 patients (32%) underwent CA directly because the ASE was > or =1000. Of 136 patients who underwent MSCT-CA, 106 (78%) had a normal MSCT-CA and underwent aortic valve surgery without prior CA; CA was performed in 30 patients because of abnormal (n=18) or bad quality (n=12) MSCT-CA. One patient of the 106 (0.94%, 95% confidence interval 0.17-5.15) had a perioperative myocardial infarction. CONCLUSIONS: When the ASE is <1000, MSCT is safe and may be recommended instead of CA as a first-line means of ruling out CAD in patients with severe aortic valve disease.

Accuracy of multislice computed tomography in the preoperative assessment of coronary disease in patients with aortic valve stenosis.

OBJECTIVES: To evaluate multislice computed tomography (MSCT) as an alternative to coronary angiography, we prospectively studied its diagnostic accuracy for the detection of significant coronary artery lesions in patients with significant aortic valve stenosis undergoing valve surgery. BACKGROUND: In patients with aortic valve stenosis, coronary angiography is still recommended before surgery. Multislice computed tomography is a promising noninvasive technique for the detection of significant coronary artery lesions. METHODS: Fifty-five consecutive patients scheduled for coronary angiography in the preoperative assessment of aortic valve stenosis underwent 16-slice MSCT 24 h before coronary angiography. We analyzed coronary lesions, image quality, and arterial calcium score. RESULTS: The sensitivity of the MSCT-based strategy in detecting significant stenosis was 100%, and its specificity 80%. The positive and negative predictive values were respectively 55% and 100%. For calcium scores <1,000 (77% of patients), MSCT detected all patients without coronary artery disease, enabling conventional coronary angiography to be avoided in 35 of 55 cases (80%). For calcium scores >1,000, MSCT enabled conventional coronary angiography to be avoided in only 6% of cases, either because significant stenosis was found with a possible indication of revascularization, or because the examination was not interpretable. CONCLUSIONS: The results of this initial experience in relatively few patients suggest that MSCT-based coronary angiography may serve as an alternative to invasive coronary angiography to rule out significant coronary artery disease in patients scheduled for elective aortic valve replacement. Larger studies are necessary to fully explore the potential of coronary MSCT to improve preoperative risk stratification.

Noninvasive assessment of left main coronary stent patency with 16-slice computed tomography.

We investigated the ability of 16-slice computer tomography (CT) to discriminate any restenosis after left main coronary artery stenting in 29 consecutive patients. CT was able to detect all stents and analyze the lumen properly in 27 of 29 cases. With the exception of arrhythmic or heavily calcified segments, multislice CT provides a noninvasive alternative to conventional coronary angiography in the follow-up of left main angioplasty with stenting.

Assessment of upgrading to biventricular pacing in patients with right ventricular pacing and congestive heart failure after atrioventricular junctional ablation for chronic atrial fibrillation.

AIMS: Effects of cardiac resynchronization therapy (CRT) in patients with right ventricular pacing and congestive heart failure (CHF) have only been reported in limited series. CRT in patients with atrial fibrillation remains controversial. Patients with AV junctional ablation offer a unique opportunity to study the effects of CRT in patients with right ventricular pacing combined with atrial fibrillation. The aims of the present study were to evaluate the effects of upgrading to biventricular pacing patients with CHF, permanent atrial fibrillation, and prior ablation of the atrioventricular (AV) junction followed by conventional right ventricular pacing. METHODS AND RESULTS: We studied 16 consecutive patients with permanent atrial fibrillation treated by AV junctional ablation. After a mean follow-up of 20+/-19 months (6 weeks to 5 years) they were successfully upgraded to biventricular pacing for severe CHF. Parameters were prospectively evaluated at baseline and at 6 months. The 14 surviving patients at 6 months demonstrated significant improvement (P<0.02) in New York Heart Association class but the exercise test parameters remained unchanged. Cardiothoracic ratio decreased by 5% (P=0.04), end-systolic diameter by 8% (P=0.001), end-diastolic diameter by 4% (P=0.08), systolic pulmonary artery pressure by 17% (P<0.0001) and mitral regurgitation area by 40% (P<0.05). Ejection fraction increased by 17% (P=0.11) and fractional shortening by 24% (P=0.01). CONCLUSION: CRT improves left ventricular performance and functional status in patients with permanent atrial fibrillation and prior remote right ventricular pacing.