Showing papers by "Stuart J. Head published in 2015"

Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium.

Abstract: Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodelling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of trans- catheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

Guía de práctica clínica de la ESC sobre revascularización miocárdica, 2014

Abstract: Autores/Miembros del Grupo de Trabajo: Stephan Windecker* (coordinador de la ESC) (Suiza), Philippe Kolh* (coordinador de la EACTS) (Bélgica), Fernando Alfonso (España), Jean-Philippe Collet (Francia), Jochen Cremer (Alemania), Volkmar Falk (Suiza), Gerasimos Filippatos (Grecia), Christian Hamm (Alemania), Stuart J. Head (Países Bajos), Peter Jüni (Suiza), A. Pieter Kappetein (Países Bajos), Adnan Kastrati (Alemania), Juhani Knuuti (Finlandia), Ulf Landmesser (Suiza), Günther Laufer (Austria), Franz-Josef Neumann (Alemania), Dimitrios J. Richter (Grecia), Patrick Schauerte (Alemania), Miguel Sousa Uva (Portugal), Giulio G. Stefanini (Suiza), David Paul Taggart (Reino Unido), Lucia Torracca (Italia), Marco Valgimigli (Italia), William Wijns (Bélgica) y Adam Witkowski (Polonia)

CABG, stents, or hybrid procedures for left main disease?

Abstract: Coronary artery bypass graft (CABG) surgery, including grafting of the left internal mammary artery (LIMA) to the left anterior descending artery (LAD) with additional vein or IMA grafts to other vessels, remains the standard technique for treatment of three-vessel coronary artery disease in patients with an intermediate or high SYNTAX score. Unprotected left main coronary disease is most often found in association with multivessel disease. In these patients, CABG has long been considered the gold standard for revascularisation. However, the evidence is being challenged by technological and procedural advances in percutaneous coronary intervention. Especially in patients with low to intermediate anatomic complexity of left main disease, PCI can be an effective and durable treatment option. Left main bifurcation lesions, however, remain a challenging subset for PCI due to possible plaque shift and occlusion of a major side branch. While there is general agreement that coronary bypass revascularisation using the LIMA to the LAD provides the best long-term prognostic benefit, a combination of CABG to the LAD and PCI of the remaining lesions, a hybrid approach, takes advantage of the survival benefit of the LIMA to LAD bypass, while minimising invasiveness and lowering morbidity by avoiding median sternotomy, rib retraction, aortic manipulation, and cardiopulmonary bypass. In particular, elderly patients with severe concomitant diseases may benefit from this approach by avoiding CPB.

Bilateral internal thoracic artery use: will another retrospective study ever strengthen the prospect?

Abstract: Since the introduction of coronary artery bypass grafting (CABG) 50 years ago [1], the conduit choice to bypass coronary artery stenosis continues to be a debate [2]. Already in the early years, CABG was performed using internal thoracic arteries (ITAs). However, it took several decades before evidence supported the use of ITAs, when Loop et al. showed that the left ITA (LITA) to the left anterior descending (LAD) artery prolonged long-term survival when compared with a saphenous vein graft [3]. Several research groups went even further by claiming that bilateral ITA (BITA) grafting was superior to the use of a single ITA (SITA). Although these initial studies were merely retrospective, the use of the LITA to the LAD became widely accepted with >90% of patients receiving this construction in contemporary CABG practice [4]. The fate of BITA grafting has been less fortunate. Over the past 25 years, a staggering number of retrospective and prospective observational studies have published long-term results of BITA versus SITA use. The majority of studies concluded that BITA grafting either reduced mortality or showed to have comparable results with SITA grafting. In a recent meta-analysis that exclusively included studies with long-term follow-up of at least a mean of 9 years (n = 9 studies comprising 15 583 patients with nearly 200 000 patient-years of follow-up), BITA versus SITA grafting significantly reduced mortality with a hazard ratio of 0.79, 95% confidence interval (CI) 0.75–0.84 [5]. Despite these encouraging results, BITA use remains remarkably low. Among patients who underwent CABG in the SYNTAX trial and registry, BITA grafting was performed in 10% in the USA and 25% in Europe [6]. Another ‘real-world’ analysis of 541 368 patients receiving CABG in the USA showed that the rate of BITA use increased over consecutive years but remained low during the entire study period: 3.6% in 2002 to 4.5% in 2005 [7]. The reason for the disappointing adoption of BITA use is multifactorial. The choice to use both ITA conduits depends strongly on the motivation of the surgeon. Surgeons in favour of BITA grafting cite evidence of observational studies that reported improved long-term survival, while those surgeons not particularly in favour of BITA grafting refer to the fact that there is currently no randomized clinical trial with long enough follow-up to confirm that BITA is indeed better than SITA. Moreover, surgeons may be reticent to using both ITA grafts because of the higher complexity of the procedure and the increased risk of sternal wound complications found particularly in diabetic, obese women. Besides patient characteristics like diabetes, body mass index and gender, age is a decisive factor [7], as the benefit of BITA over SITA only occurs after prolonged follow-up. A life expectancy of at least 10 years appears to be needed to show significant benefit of BITA use. In this regard, the current issue of the European Journal of CardioThoracic Surgery includes a retrospective study from Pettinari et al. in which they performed a propensity-matched analysis comparing BITA with SITA in elderly patients >70 years of age, to assess whether the benefit of BITA grafting can be extended to elderly patients [8]. The authors showed that patients who underwent BITA grafting, when compared with patients who received only a SITA, were younger, and less often had peripheral vascular disease, diabetes, chronic obstructive pulmonary disease or a recent myocardial infarction, all factors known to be associated with impaired survival during follow-up. The authors therefore were correct in performing a propensity-matched analysis after which no differences in the BITA and SITA groups existed. In terms of outcomes, BITA grafting showed to have superior survival after 3 months, 1 year and 10 years in the unmatched groups. After matching and as anticipated due to the differences in baseline characteristics, the difference between BITA and SITA was smaller, with BITA grafting only being superior after 10 years of follow-up (multivariate hazard ratio of 0.78, 95% CI 0.64–0.96; P = 0.04) [8]. The authors have to be congratulated for achieving such good results with BITA grafting. However, several significant limitations of the current study should be acknowledged, putting these results in the correct perspective. Of the 1328 and 2168 patients who underwent BITA and SITA grafting, respectively, only 892 propensity-matched pairs could be achieved. The fact that two-thirds of patients could not be matched indicates that these groups were significantly different. Although there were no longer any significant differences between the groups after matching, the authors were unable to match patients on the refinement of the surgical technique; the inclusion was during 1972–2006, with BITA being performed in the later decades, during which the CABG procedure changed considerably with improved outcomes. Furthermore, clinical variables as well as clinical judgement, which

Age Cutoffs for Bioprosthetic vs Mechanical Aortic Valve Replacement

Abstract: focus on process measures as opposed to outcome measures. Nevertheless, we believe that using a comprehensive set of endorsed sign/symptom-based measures could help patients receive timely care as payment models are changed and may prevent financial incentives from resulting in underuse of necessary care. Efforts to develop valid sign/symptom-based quality measures will be challenging; however, as cost pressures increase, they may be necessary to maintain and improve the accuracy of patient diagnosis upon which all subsequent care depends.

Reply to Hernández-Vaquero et al.

Abstract: We thank Hernandez-Vaquero et al. [1] for their insightful comments on our manuscript that was recently published in the European Journal of CardioThoracic Surgery [2]. Hernandez-Vaquero et al. elaborate on the concepts of calibration and discrimination with respect to our analyses of patients who underwent aortic valve replacement (AVR). Firstly, the authors of the letter discuss calibration. The overall observed : expected (O : E) ratio for the EuroSCORE II in AVR patients was good (0.96, 95% confidence interval 0.79–1.13), whereas the EuroSCORE II overpredicted in low-risk patients undergoing AVR, and underpredicted in high-risk patients (Fig. 3 and Table 3 [2]). Especially in high-risk patients, risk prediction is challenging as the lower numbers of patients make the estimates unstable (Conference discussion [2]). Indeed, these issues should be kept in mind when interpreting the data. Secondly, Hernandez-Vaquero et al. questioned the discriminative abilities of the EuroSCORE II (AUC = 0.71; 95% CI, 0.67–0.75) and STS score (AUC = 0.74; 95% CI 0.69–0.78). The results are comparable with a recently published meta-analysis [3]. Nevertheless, we agree with the authors that users of the risk scores should be aware that they are not perfect. Patient selection in clinical settings and for inclusion of randomized trials should not solely be based on risk scores, but rather be the result of multidisciplinary heart team discussions [4–6]. REFERENCES