Objectives: Use of intracoronary imaging (ICI) in cases of stent thrombosis (ST) is recommended and tailored treatment appears reasonable. Nevertheless, data supporting such a strategy are lacking. The aim of this study was to evaluate the clinical impact of ICI in the management of ST. Methods: The unadjusted study population was consecutive patients with definite ST presenting in a single tertiary cardiac centre and undergoing percutaneous coronary intervention (PCI). The presumed major mechanism of ST was assigned according to the real-time ICI interpretation by the PCI operator. Propensity score matching was performed with regard to ICI use to form the adjusted population and Kaplan–Meier analysis was applied to compare survival free of cardiac death (CD) or target lesion revascularization (TLR). Results: The unadjusted population included 130 ST patients, with the majority presenting with ST-elevation myocardial infarction (STEMI) (88%) and very late ST (86%). ICI was performed in 45 patients, of whom optical coherence tomography (OCT) was performed in 30 cases. When the individual ST mechanisms were viewed as groups, there was an interaction observed between type of treatment (stent vs. non-stent) and ST mechanism, with non-stent treatment being more prevalent in cases of underexpansion, malapposition, in-stent restenosis and mechanism uncertainty. After application of matching, two groups of 30 patients were formed. ICI-guided management resulted in better survival free of CD–TLR at 2 years (93% vs. 73%, p = 0.037). Conclusions: Intracoronary imaging guidance during PCI for ST had a direct impact on management (stent vs. non-stent) and resulted in a lower event rate at mid-term follow-up when propensity matched analysis was applied.
Coronary artery disease (CAD) remains the leading cause of cardiovascular death in octogenarians. This group of patients represents nearly a fifth of all patients treated with percutaneous coronary intervention (PCI) in real-world practice. Octogenarians have multiple risk factors for CAD and often greater myocardial ischemia than younger counterparts, with a potential of an increased benefit from myocardial revascularization. Despite this, octogenarians are routinely under-treated and belittled in clinical trials. Age does make a difference to PCI outcomes in older people, but it is never the sole arbiter of any clinical decision, whether in relation to the heart or any other aspect of health. The decision when to perform revascularization in elderly patients and especially in octogenarians is complex and should consider the patient on an individual basis, with clarification of the goals of the therapy and the relative risks and benefits of performing the procedure. In ST-segment elevation myocardial infarction (MI), there is no upper age limit regarding urgent reperfusion and primary PCI must be the standard of care. In non-ST-segment elevation acute coronary syndromes, a strict conservative strategy must be avoided; whereas the use of a routine invasive strategy may reduce the occurrence of MI and the need for revascularization at follow-up, with no established benefit in terms of mortality. In stable CAD patients, invasive therapy on top of optimal medical therapy seems better in symptom relief and quality of life. This review summarizes the available data on percutaneous revascularization in the elderly patients and particularly in octogenarians, including practical considerations on PCI risk secondary to ageing physiology. We also analyse technical difficulties met when considering PCI in this cohort and the ongoing need for further studies to ameliorate risk stratification and eventually outcomes in these challenging patients.
Aims: We sought to compare the efficiency of the novel EuroCTO (CASTLE) score with the commonly used Multicentre CTO Registry in Japan (J-CTO) score in predicting procedural success of percutaneous coronary intervention (PCI) for coronary chronic total occlusions (CTOs). Methods and results: We evaluated 660 consecutive CTO PCIs (mean age 66 +/- 11 years, 84% male). The mean J-CTO and EuroCTO (CASTLE) scores were 1.86 +/- 1.2 and 1.74 +/- 1.2, respectively. Antegrade wire escalation, antegrade dissection re-entry and retrograde approach were used in 82%, 14% and 37% of cases, respectively. Receiver operating characteristic analysis demonstrated equal overall discriminatory capacity between the two scores (AUC 0.698, 95% CI: 0.653-0.742, p<0.001 for J-CTO vs AUC 0.676, 95% CI: 0.627-0.725, p<0.001 for EuroCTO; AUC difference: 0.022, p=0.5). However, for more complex procedures (J-CTO >= 3 or EuroCTO [CASTLE] >= 4]), the predictive capacity of the EuroCTO (CASTLE) score appeared superior (AUC 0.588, 95% CI: 0.509-0.668, p=0.03 for EuroCTO [CASTLE] score vs AUC 0.473, 95% CI: 0.393-0.553, p=NS for the J-CTO score, AUC difference: 0.115, p=0.04). Conclusions: In this study, the novel EuroCTO (CASTLE) score was comparable to the J-CTO score in predicting CTO PCI outcome with a superior discriminatory capacity for the more complex cases.
Vascular calcification is a highly prevalent pathophenotype that is associated with aging, atherosclerotic cardiovascular disease, diabetes mellitus, and chronic kidney disease. When present, it portends a worse clinical outcome and predicts major adverse cardiovascular events. Heavily calcified coronary and peripheral artery lesions are difficult to dilate appropriately with conventional balloons during percutaneous intervention, and the use of several adjunctive strategies of plaque modification has been suggested. Intravascular lithotripsy (IVL) offers a novel option for lesion preparation of severely calcified plaques in coronary and peripheral vessels. It is unique among all technologies in its ability to modify calcium circumferentially and transmurally, thus modifying transmural conduit compliance. In this article, we summarize the currently available evidence on this technology, and we highlight its best clinical application through appropriate patient and lesion selection, with the main objective of optimizing stent delivery and implantation, and subsequent improved short- and long-term outcomes. We believe that the IVL balloon will transform the market, as it is easy to use, with predictable results. However, cost-effectiveness of such advanced technology will need to be considered.
Objectives We sought to evaluate mortality predictors and the role of new-generation drug-eluting stents (NG-DES) in stent thrombosis (ST) management. Background No data are available regarding the outcome of patients with ST after interventional management that includes exclusively NG-DES. Methods Patients with definite ST of DES or BMS who underwent urgent/emergent angiography between 2015 and 2018 at our institution were considered for the study. After excluding patients who achieved TIMI-flow<2 after intervention or received an old-generation stent, 131 patients were included. Management classification was stent or non-stent treatment (medical management, thromboaspiration, balloon-angioplasty). Follow-up was performed to document all-cause death (ACD) and target-lesion-revascularization (TLR) that was used for censorship. Results Mode of presentation was STEMI in 88% and UA/NSTEMI in 12%. Type of ST was early, late, and very late in 11, 4, and 85%, respectively. Eighty four patients received stent and 47 non-stent treatment. After 926 +/- 34 days, 21 ACDs, 7 TLRs and no cases of definite, recurrent ST were observed. Univariate predictors of in-hospital mortality were LVEF and presentation with shock or cardiac arrest. For patients discharged alive, non-stent treatment (HR 4.2, p = .01), TIMI-2 flow (HR 7.4, p = .002) and GFR < 60 mL/min (HR 3.8, p = .01) were independent predictors of ACD. The stent-treatment group had significantly better ACD-free survival after discharge, both unadjusted (p = .022) and adjusted (p = .018). Conclusions After ST management, different predictors were observed for in-hospital mortality and mortality in patients discharged alive. The better outcome with NG-DES treatment is a novel observation, warranting further studies to elucidate if it is associated with stent-related or patient-related factors.
BACKGROUND:Evaluation of tolerability, safety, and prognostic implications of adenosine stress myocardial perfusion imaging (MPI) in octogenarians. METHODS:370 octogenarians (49% known coronary artery disease) were studied. Hemodynamic response, MPI-related data, and rest-left ventricular ejection fraction (LVEF) based on echocardiography were registered per patient, and prospective follow-up was performed to document all-cause death (ACD), cardiac death (CD), myocardial infarction (MI), and late revascularization. RESULTS:No deaths or MIs were observed during adenosine infusion or the short-term post-infusion period. 86% of patients were able to tolerate a 6-minute infusion. All side effects terminated spontaneously after infusion cessation, except for one case of pulmonary oedema. After 9.3 years, there were 124 ACDs, 62 CDs, 16 MIs, and 35 revascularizations. Differences between survival curves of summed stress score (SSS)-based risk groups were significant for all end points (P < .001). SSS and LVEF were independent predictors of all end points (P ≤ .01) and lung uptake of cardiac end points. ΔHR <10 bpm (OR = 1.78, P = .004) and inability to increase HR by >10 bpm and decrease systolic blood pressure by >10 mmHg (OR = 2, P = .02) during adenosine infusion were independent predictors of ACD and CD, respectively. Hemodynamic response variables, SSS, and lung uptake provided incremental prognostic value over pre-test data for ACD and CD. CONCLUSIONS:In octogenarians, adenosine stress MPI is well tolerated and provides effective long-term risk stratification.
Aims: The aim of this study was to investigate relocation of minimal lumen area (MLA) after implantation of a bioresorbable scaffold (BRS). Methods and results: In the ABSORB II randomised trial (BRS vs everolimus-eluting stent [EES]), lesions were investigated by serial intravascular ultrasound pre procedure, post procedure, and at three years. MLA relocation was defined as an axial MLA shift of more than 2.4 mm. MLA relocation from post procedure to three years was observed in 163/237 (68.8%) and 75/129 (58.1%) of lesions treated by BRS and EES, respectively (p=0.041). When matching preprocedural MLA site with the same topographical sites post procedure and at three years, BRS showed significant late lumen enlargement and expansive remodelling compensating for significant plaque increase, whereas EES showed significant late lumen narrowing with significant plaque growth not compensated for by expansive remodelling from post procedure to three years. In the multivariate analysis, female gender, previous PCI, BRS implantation, total device length, and maximal pressure (either at device implantation or post-dilatation) were independently associated with MLA relocation from post procedure to three years. Conclusions: MLA relocation from post procedure to three years was more frequent in BRS than EES. Late lumen enlargement and expansive vessel remodelling at the preprocedural MLA site was observed in BRS, but not in EES.
To evaluate differences in side-effects and hemodynamic response between men and women undergoing regadenoson-stress SPECT myocardial perfusion imaging (MPI). The initial population of the study included 858 consecutive patients who underwent regadenoson-stress MPI at our institution. These patients underwent prospective assessment and classification of regadenoson-induced side-effects in six categories and recording of heart rate (HR) and blood pressure (BP) before and after regadenoson administration. From this initial population, after adjustment with 1:1 propensity matching using gender as the dependent variable and age, BMI, diabetes mellitus, hypertension, smoking, presence of coronary artery disease, LVEF, baseline systolic and diastolic blood pressure (BP) and HR, on-going use of cardio-active medications during test, and abnormal MPI scan as independent variables, a population of 279 pairs of opposite gender was formed and studied. Compared with men, women had a significantly higher rate of any side-effect (71% vs. 58%, p = 0.002), chest pain (23% vs. 12%, p < 0.001), gastrointestinal discomfort (20% vs. 12%, p = 0.01), dizziness (12% vs. 5%, p = 0.002), and headache (20% vs. 13%, p = 0.03) and similar rates of dyspnea and other side-effects. Women demonstrated a higher median HR-response compared with men (41% (− 8, 127) vs. 34% (− 5, 106), p = 0.001) while men demonstrated a lower median systolic BP response (− 3% (− 27, 48) vs. 0% (− 36, 68), p = 0.02) compared with women. Gender is independently associated with a differential response to regadenoson with regard to overall side-effects and HR-response. These observations have the potential of important management and prognostic implications respectively.
Objectives and Background We attempted to test the feasibility of application of the MADS classification system in the largest stent trial to date and evaluate the preliminary clinical implications of this approach. Methods In the randomized GLOBAL LEADERS trial, testing two different antiplatelet strategies in patients undergoing PCI with bivalirudin and biolimus-eluting stents, the e-CRF was dedicated to bifurcation treatment according to the MADS classification. Based on this e-CRF, the techniques used for bifurcations treatment in GLOBAL LEADERS were described and compared with two large, all-comer registries of bifurcations treatment (I-BIGIS and COBIS), used as historical controls. Results Among 15,991 patients enrolled in the trial, 22,921 lesions treated at the index and staged procedure were available for analysis and 2,757 of these lesions were bifurcations and 7 were trifurcation lesions. The e-CRF-based MADS classification was achieved in 2,757 of these lesions (100%). 80.3% of bifurcations were treated using a single stent, 18.9% using 2 stents and 0.7% using 3 stents. Overall, the "main across side first" approach (A) was used in 77.4% with the "side branch first" approach (S) being the second most frequently used technique (10.2%). A single stent was used in the majority of the "A" approach (87.9%). A reduction in the use of 2-stent techniques (from 33.9 to 18.9%) was observed between GLOBAL LEADERS and I-BIGIS. The "A" approach was the most frequently used technique in GLOBAL LEADERS, while in COBIS the "S" strategy was most frequently employed. Conclusions Application of the MADS classification through an e-CRF was feasible in the largest stent trial today and provided useful information about the trends observed overtime in the treatment of bifurcation lesions.
The evolution of percutaneous coronary revascularization, after this treatment was introduced in clinical practice in the form of balloon angioplasty, has been characterized by three landmarks, corresponding to the development and application of an equal number of specific device types. In terms of chronologic appearance, these developments can be broadly categorized as bare metal stents, drug eluting stents (DES) and finally bioresorbable scaffolds (BRS). Bare metal stents were able to overcome some of the major drawbacks of balloon angioplasty, most importantly acute vessel closure and recoil, but their application was still plagued by significant rates of restenosis. The introduction of DES, and most importantly their further development in the second generation iterations, effectively managed the problem of restenosis and also reduced to clinically acceptable levels the incidence of an unexpected problem encountered during the long-term follow-up of the first generation DES, namely late stent thrombosis.
Evaluation of the long-term prognostic value of myocardial perfusion imaging (MPI) in octogenarians.
Introduction: It is well recognized that a lesion that does not cause a hemodynamically significant stenosis can trigger a sudden cardiac event through plaque rupture. As a diagnostic tool, intravascular imaging was developed to circumvent limitations of coronary angiography; however, none of the intravascular imaging devices are individually able to provide complete assessment of the plaque morphology, geometry, physiology and biology. Therefore, over the past few years an effort was made to develop hybrid intravascular imaging catheters to provide more complete evaluation of coronary plaque pathobiology.Areas covered: This paper aims to give an overview of the recent developments on 1) single-modality intravascular imaging devices; 2) hybrid intravascular imaging devices and 3) the hemodynamic analysis in models reconstructed from the fusion of intravascular imaging and angiographic data.Expert commentary: Within five years, most of the hybrid imaging techniques which are now in pre-clinical phase will be utilized in the clinical arena, as NIRS-IVUS. Software for online blood simulation is likely to be developed that will enable ESS calculation while the patient is in the catheterization laboratory.
Aims: The Xeltis aortic valve leaflets are made from a bioabsorbable supramolecular polymer that guides the tissue to restoring itself. It is mounted on a self-expanding nitinol frame that includes three feelers and a native leaflet clipping mechanism. We sought to investigate the acute valve performance in a preclinical setting. Methods and results: In 33 sheep, 26 mm Xeltis aortic valves were transapically implanted in a 23 mm native annulus. Aortography (analysable, n = 28) and echocardiography (analysable, n = 20) images were acquired immediately after implantation of the Xeltis aortic valve to assess the acute device performance. On echocardiography, transvalvular peak pressure gradient (PG) was 7.4 (IQR: 6.0-8.9) mmHg, mean PG was 4.0 (IQR: 3.0-5.0) mmHg, and effective orifice area was 2.2 (IQR: 1.6-2.5) cm(2). Trace (n = 6), mild (n = 2) and no (n = 12) transvalvular aortic regurgitation (AR) were seen. Likewise, no paravalvular AR was detected in 7 cases, whereas trace, mild and moderate were seen in 7, 5 and 1 cases, respectively. On quantitative videodensitometric AR (VD-AR) assessment, a median value of 6% (IQR: 1-12%) of AR was seen. Three cases had a VD-AR superior to 17%, which has a prognostic significance. Out of these three cases, two had echocardiographic assessment available, which showed mild and moderate paravalvular regurgitation due to inadequate leaflet clipping. Conclusions: In a transapical ovine model, the novel restorative transcatheter aortic valve with bioabsorbable leaflets demonstrated good haemodynamic performance comparable to commercially available devices. The highly porous polymeric leaflets demonstrated good competence immediately after implantation with no cases having > mild transvalvular AR.
The current standard of treatment of valvular diseases with severe functional and/or clinical consequences is the repair or replacement of the valve, which is usually surgical or, in specific scenarios, percutaneous. The available prosthetic valves, however, are not a magic bullet in the physicians' arsenal for the management of valvular diseases, since the age-dependent structural valve deterioration (SVD) and the need for prolonged systemic anticoagulation in the case of metallic prosthetic valves are not inconsequential during the lifespan of a patient with an implanted prosthetic valve. Based on decades of research combining the scientific disciplines of supramolecular chemistry, electrospinning and regenerative medicine, endogenous tissue restoration has emerged as a very promising domain to provide this magic bullet, in the form of valves, which enables functional restoration by the body itself. The concept of a restorative material that will set the framework for the creation of a new, endogenous valve is very appealing and, recently, proof of concept studies have been completed at both preclinical and clinical levels. These studies have shown favourable pathologic, anatomic and haemodynamic characteristics compared to currently available prosthetic valves, in sheep and in young children undergoing right ventricular outflow tract reconstruction, and may represent an alternative to the bioprosthesis made of xenopericardial tissue. The present manuscript reviews the rationale, background knowledge and historic development of endogenous tissue restoration and presents preliminary data about the Xeltis valve, which appears to have the potential to make restorative valve therapy a reality in clinical practice.
Bioresorbable scaffolds (BRS) were designed more than 30 years ago to overcome the disadvantages related to the permanent implantation of a metallic stent and, at present, a number of these devices have obtained a CE mark on the basis of midterm follow-up studies. However, although BRS have already been introduced into clinical practice, intensive research is ongoing worldwide to clarify their long-term safety and effectiveness. This type of research has captivated the interest of the cardiovascular community after the recent publication of long-term follow-up data from randomised trials demonstrating increased late scaffold thrombosis in the Absorb™ BRS (Abbott Vascular, Santa Clara, CA, USA). In this regard, any long-term follow-up data for BRS are of particular importance, especially when they originate from real-world patients, challenging lesions and scaffolds other than the Absorb GT1™, which is the only available BRS that has been evaluated in a controlled fashion so far versus the current standard, new-generation drug-eluting stents. The session "Long-term data of BRS" on the last day of EuroPCR 2017 (Paris, France) offered some very interesting data on what the global picture for the future of BRS could be.
We attempted to validate the performance of a fast myocardial perfusion imaging (MPI) protocol in diagnostically challenging patients.
To test, if in octogenarians, treadmill exercise with myocardial perfusion imaging (exercise-MPI) can risk stratify for large artery or chronic CAD-related ischemic stroke (LACCIS).
Although the use of myocardial perfusion imaging (MPI) for prognostic purposes in general population is well understood, its role in very elderly patients is not extensively studied.
Objectives/background: Although Duke treadmill score (DTS) is the most widely used risk stratification method in younger patients undergoing exercise treadmill test (ETT) its specific value in the elderly is not established.Methods: 137 patients aged >= 80 years who underwent ETT myocardial perfusion imaging (MPI) were studied. DTS and MPI (including summed stress scores, SSS) related data were registered per patient and follow up was performed to document cardiac death (CD), myocardial infarction (MI) and late (>3 months) revascularization (LR). Kaplan Meir and Cox regression survival analysis were employed to determine the prognostic value of DTS in relation to MPI data for these endpoints.Results: After a median follow up duration of 6.7 years 28 deaths, 7 CDs, 4 non fatal MIs and 12 LRs were observed. Incidence rates of CD/MI were significantly different only between low and high risk SSS categories (p = 0.044). Risk groups by DTS had no significant differences in survival free of CD/MI (p = 0.743) in contrast to risk groups according to SSS (p = 0.026), while both DTS and SSS based risk groups had significantly different survival free of CD/MI or LR. SSS was a significant univariate predictor of both CD/MI (HR 1.088, p = 0.019) and CD/MI or LR (HR 1.095, p < 0.001), but DTS only of the latter endpoint (HR 0.909, p = 0.003).Conclusions: In octogenarians DTS was found to be a significant predictor of the LR related endpoint but not of the hard endpoint of CD/MI, in contrast to SSS which was a powerful predictor of both soft and hard cardiac endpoints. (C) 2014 Elsevier Ireland Ltd. All rights reserved.
After the initial enthusiasm of the preclinical studies of stem cell therapy (SCT) for cardiac diseases a rather rapid translation into clinical trials was accompanied by inconsistent results and at best modest benefit. This has lead to a reverse translation form bedside to bench in order to fully elucidate the fate and mechanism of action of the transplanted cells and find methods to boost their acute engraftment, long term survival and functional effects. Advanced imaging techniques are the only way to achieve this goal in humans. Among them radionuclide imaging is the most mature platform to provide quantitative information on short and long term bio-distribution of the transplanted cells in combination with structural and functional changes of the host organ in clinical practice for the short term future. In this paper we review the contribution of radionuclide imaging in the so far accumulated knowledge regarding SCT for heart diseases, its future potential and challenges.