Primary percutaneous coronary intervention for unprotected left main disease in patients with acute st-segment elevation myocardial infarction: The AMIS (Acute Myocardial Infarction in Switzerland) plus registry experience
Pedrazzini G.B.,CardioCentro Ticino |
Radovanovic D.,University of Zürich |
Vassalli G.,CardioCentro Ticino |
Vassalli G.,University of Lausanne |
And 6 more authors.
JACC: Cardiovascular Interventions | Year: 2011
Objectives: This study sought to assess outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) for unprotected left main (LM) disease. Background: Limited data are available on outcomes in patients with ST-segment elevation myocardial infarction undergoing LM PCI. Methods: Of 9,075 patients with ST-segment elevation myocardial infarction enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus registry between 2005 and June 30, 2010, 6,666 underwent primary PCI. Of them, 348 (5.2%; mean age: 63.5 ± 12.6 years) underwent LM PCI, either isolated (n = 208) or concomitant to PCI for other vessel segments (n = 140). They were compared with 6,318 patients (94.8%; mean age: 61.9 ± 12.5 years) undergoing PCI of non-LM vessel segments only. Results: The LM patients had higher rates of cardiogenic shock (12.2% vs. 3.5%; p < 0.001), cardiac arrest (10.6% vs. 6.3%; p < 0.01), in-hospital mortality (10.9% vs. 3.8%; p < 0.001), and major adverse cardiac and cerebrovascular events (12.4% vs. 5.0%; p < 0.001) than non-LM PCI. Rates of mortality and major adverse cardiac and cerebrovascular events were highest for concurrent LM and non-LM PCI (17.9% and 18.6%, respectively), intermediate for isolated LM PCI (6.3% and 8.3%, respectively), and lowest for non-LM PCI (3.8% and 5.0%, respectively). Rates of mortality and major adverse cardiac and cerebrovascular events for LM PCI were higher than for non-LM multivessel PCI (10.9% vs. 4.9%, p < 0.001, and 12.4% vs. 6.4%, p < 0.001, respectively). LM disease independently predicted in-hospital death (odds ratio: 2.36; 95% confidence interval: 1.34 to 4.17; p = 0.003). Conclusions: Emergent LM PCI in the context of acute myocardial infarction, even including 12% cardiogenic shock, appears to have a remarkably high (89%) in-hospital survival. Concurrent LM and non-LM PCI has worse outcomes than isolated LM PCI. © 2011 American College of Cardiology Foundation.
Jeger R.,University of Basel |
Jaguszewski M.,University of Zürich |
Nallamothu B.N.,University of Michigan |
Luscher T.F.,University of Zürich |
And 4 more authors.
International Journal of Cardiology | Year: 2014
Background The optimal strategy for percutaneous coronary intervention (PCI) of ST-segment elevation myocardial infarction (STEMI) in multi-vessel disease (MVD), i.e., multi-vessel PCI (MV-PCI) vs. PCI of the infarct-related artery only (IRA-PCI), still remains unknown. Methods Patients of the AMIS Plus registry admitted with an acute coronary syndrome were contacted after a median of 378 days (interquartile range 371-409). The primary end-point was all-cause death. The secondary end-point included all major adverse cardiovascular and cerebrovascular events (MACCE) including death, re-infarction, re-hospitalization for cardiac causes, any cardiac re-intervention, and stroke. Results Between 2005 and 2012, 8330 STEMI patients were identified, of whom 1909 (24%) had MVD. Of these, 442 (23%) received MV-PCI and 1467 (77%) IRA-PCI. While all-cause mortality was similar in both groups (2.7% both, p > 0.99), MACCE was significantly lower after MV-PCI vs. IRA-PCI (15.6% vs. 20.0%, p = 0.038), mainly driven by lower rates of cardiac re-hospitalization and cardiac re-intervention. Patients undergoing MV-PCI with drug-eluting stents had lower rates of all-cause mortality (2.1% vs. 7.4%, p = 0.026) and MACCE (14.1% vs. 25.9%, p = 0.042) compared with those receiving bare metal stents (BMS). In multivariate analysis, MV-PCI (odds ratio, OR 0.69, 95% CI 0.51-0.93, p = 0.017) and comorbidities (Charlson index ≥ 2; OR 1.42, 95% CI 1.05-1.92, p = 0.025) were independent predictors for 1-year MACCE. Conclusion In an unselected nationwide real-world cohort, an approach using immediate complete revascularization may be beneficial in STEMI patients with MVD regarding MACCE, specifically when drug-eluting stents are used, but not regarding mortality. This has to be tested in a randomized controlled trial. © 2014 Elsevier Ireland Ltd.
News Article | February 28, 2017
RenalGuard Therapy® holds the potential to provide a new standard-of care for preventing cardiac contrast-agent induced acute kidney injury (CI-AKI) in high-risk patients undergoing percutaneous coronary interventions or transcatheter aortic valve replacement, according to a newly published report and companion editorial in JACC: Cardiovascular Interventions. The report, an independent systematic review and meta-analysis of four previously published randomized controlled clinical trials, found that RenalGuard Therapy was associated with a highly significant reduction of CI-AKI (7.76% vs. 21.43%; p<0.00001), a significantly lower need for patient dialysis (0.58% vs. 3.45%; p = 0.02), and a consistent positive trend towards lower rates of mortality, post-procedural acute coronary syndrome, stroke, and acute pulmonary edema. Moreover, the analysis found that most of the patients treated with RenalGuard reached a high urine output despite severely depressed kidney function without significant changes in electrolyte balance or any adverse reactions. The meta-analysis, entitled "Prevention of Contrast-Induced Acute Kidney Injury by Furosemide with Matched Hydration in Patients Undergoing Interventional Procedures," was performed and published by researchers from Cardiocentro Ticino, Lugano, Switzerland and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Milan, Italy. The editorial, entitled "High Urine Output with Matched Hydration for CI-AKI Prevention: 'Saus Per Aquam' (Health through Water)," was authored by Antonio L Bartorelli, MD, Centro Cardiologico Monzino, Istituto IRCCS, Milan, Italy and Giancarlo Marenzi, MD, Department of Biomedical and Clinical Sciences "Luigi Sacco", University of Milan, Milan, Italy. "We are grateful to the authors, whose detailed analysis shows that RenalGuard not only lowers the incidence of CI-AKI, but offers a real benefit for patients and health care payers by significantly reducing the need for dialysis," said Andrew Halpert, President, RenalGuard Solutions™. "This detailed review adds strongly to the growing body of clinical evidence that RenalGuard can significantly lower health care risks arising from the use of medically valuable but potentially toxic contrast agents used today in a variety of diagnostic and interventional coronary procedures. We expect these findings to continue to drive adoption of RenalGuard Therapy in Europe and other areas where it currently available, and we look forward to further adding to these findings through our ongoing U.S. pivotal trial, which we expect to complete around the end of this year." Mr. Halpert noted that RenalGuard System is currently marketed for use in the cardiac catheterization laboratory in Europe, the Middle East, and South Africa, and that the company expects to file for pre-marketing approval with the U.S. Food and Drug Administration in 2018. The meta-analysis authors noted that lowering the incidence of CI-AKI, which would also lead to an associated significant reduction in the need for dialysis, could have a strong positive economic impact on health care costs. According to the United Kingdom's National Health Service Kidney Care program, the annual cost of AKI in the UK is estimated at US $700 million to $1 billion per year -- more than the yearly national expenditures related to either breast cancer or lung and skin cancer combined. CI-AKI is associated with higher in-hospital and long-term morbidity and mortality, persistent loss of kidney function, and risk of progression to end-stage renal disease. There are currently no therapies approved in the United States for the reduction of CI-AKI associated with coronary interventional procedures. RenalGuard measures a patient's urine output and automatically infuses hydration fluid based on that urine output. The system is designed to induce high urine rates, which have been shown to protect the kidney from a range of insults. A number of studies have demonstrated RenalGuard's ability to protect patients from AKI following catheterization procedures when compared to the standard of care, including: MYTHOS, which found RenalGuard to be superior to overnight hydration; REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration; Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) when using RenalGuard during the procedure, compared to standard therapy; and AKIGUARD, which showed significant improvement in long-term outcomes when using RenalGuard vs. standard therapy. RenalGuard Solutions, Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. The company's lead product, RenalGuard, is designed to protect patients from acute kidney injury (AKI), including contrast-induced AKI. Two investigator-sponsored studies in Europe have demonstrated RenalGuard's effectiveness at preventing CI-AKI in at-risk patients. RenalGuard is CE-marked and is sold in Europe and certain countries around the world via a network of distributors. The CIN-RG RenalGuard pivotal study is underway in the United States to support a planned Premarket Approval filing with the U.S. Food and Drug Administration. For further information, please visit the website at http://www.renalguard.com.
Sanders-Van Wijk S.,Maastricht University |
Muzzarelli S.,University of Basel |
Muzzarelli S.,Cardiocentro Ticino |
Neuhaus M.,Kantonsspital Baden |
And 8 more authors.
European Journal of Heart Failure | Year: 2013
Aims: NT-proBNP-guided therapy results in intensification of medical heart failure (HF) therapy and is suggested to improve outcome. However, it is feared that an intensified, NT-proBNP-guided therapy carries a risk of adverse effects. Therefore, the safety and tolerability of NT-proBNP-guided therapy in the Trial of Intensified vs standard Medical therapy in Elderly patients with Congestive Heart Failure (TIME-CHF) was assessed. Methods and results: A total of 495 chronic HF patients, aged ≥60, with an LVEF ≤45%, NYHA class ≥II, randomized to NT-proBNP-guided or symptom-guided therapy and ≥1 month follow-up were included in the present safety analysis. All adverse events (AEs) were recorded during the 18-month trial period. A total of 5212 AEs were noted, 433 of them serious. NT-proBNP-guided therapy led to a higher up-titration of HF medication and was well tolerated, with a dropout rate (12% vs. 11%, P = 1.0) and AE profile [number of AEs/patient-year 4.7 (2.8-9.4) vs. 5.4 (2.7-11.4), P = 0.69; number of severe AEs/patient-year 0.7 (0-2.7) vs. 1.3 (0-3.9), P = 0.21] similar to that of symptom-guided therapy, although most subjects in both treatment groups (96% vs. 95%, P = 0.55) experienced at least one AE. Age and number of co-morbidities were associated with AEs and interacted with the safety profile of NT-proBNP-guided therapy: positive effects were more frequent in younger and less co-morbid patients whereas potential negative effects - although small and related to non-severe AEs only - were only seen in the older and more co-morbid patients. Conclusion: sNT-proBNP-guided therapy is safe in elderly and highly co-morbid HF patients. © The Author 2013.
Bacharova L.,International Laser Center |
Mateasik A.,International Laser Center |
Krause R.,University of Lugano |
Prinzen F.W.,Maastricht University |
And 2 more authors.
Journal of Electrocardiology | Year: 2011
Background: The electrocardiographic (ECG) diagnosis of left ventricular hypertrophy (LVH) is based on the assumption that QRS voltage increases with left ventricular mass. However, most of patients with echocardiographically detected LVH do not have increased QRS voltage. Reduced intercellular coupling has been observed in LVH patients and animal models. The purpose of this study was to show that this uncoupling can explain relatively low QRS voltage in LVH patients. Methods: Electrocardiograms and vectorcardiograms (VCG) were simulated with a realistic large-scale computer model of the human heart and torso that reliably represented the effects of reduced coupling on both propagation and ECG voltage. Results: Uncoupling reduced QRS voltage in all leads except aVL, reflecting a decrease in vector amplitude as well as a leftward axis deviation that suggested left anterior fascicular block. Conclusions: Low QRS voltage does not necessarily contradict a diagnosis of LVH but may be an indication for electrical uncoupling. The diagnostic value of this "relative voltage deficit" needs to be demonstrated in clinical studies. © 2011 Elsevier Inc.
Strik M.,Maastricht University |
Van Deursen C.J.M.,Maastricht University |
Van Middendorp L.B.,Maastricht University |
Van Hunnik A.,Maastricht University |
And 3 more authors.
Circulation: Arrhythmia and Electrophysiology | Year: 2013
Background-Simple conceptual ideas about cardiac resynchronization therapy assume that biventricular (BiV) pacing results in collision of right and left ventricular (LV) pacing-derived wavefronts. However, this concept is contradicted by the minor reduction in QRS duration usually observed. We investigated the electric mechanisms of cardiac resynchronization therapy by performing detailed electric mapping during extensive pacing protocols in dyssynchronous canine hearts. Methods and Results-Studies were performed in anesthetized dogs with acute left bundle-branch block (LBBB, n=10) and chronic LBBB with tachypacing-induced heart failure (LBBB+HF, n=6). Activation times (AT) were measured using LV endocardial contact and noncontact mapping and epicardial contact mapping. BiV pacing reduced QRS duration by 21±10% in LBBB but only by 5±12% in LBBB+HF hearts. Transseptal impulse conduction was significantly slower in LBBB+HF than in LBBB hearts (67±9 versus 44±16 ms, respectively), and in both groups significantly slower than transmural LV conduction (≈30 ms). In both groups QRS duration and vector and the epicardial AT vector amplitude and angle were significantly different between LV and BiV pacing, whereas the endocardial AT vector was similar. During variation of atrioventricular delay while LV pacing, and ventriculo-ventricular delay while BiV pacing, the optimal hemodynamic effect was achieved when epicardial AT and QRS vectors were minimal and endocardial AT vector indicated LV preexcitation. Conclusions-Due to slow transseptal conduction, the LV electric activation sequence is similar in LV and BiV pacing, especially in failing hearts. Optimal hemodynamic cardiac resynchronization therapy response coincides with minimal epicardial asynchrony and QRS vector and LV preexcitation. © 2013 American Heart Association, Inc.
Strik M.,Maastricht University |
Van Middendorp L.B.,Maastricht University |
Houthuizen P.,Maastricht University |
Ploux S.,Maastricht University |
And 4 more authors.
Circulation: Arrhythmia and Electrophysiology | Year: 2013
Background: The relative contribution of electromechanical synchronization and ventricular filling to the optimal hemodynamic effect in cardiac resynchronization therapy (CRT) during adjustment of stimulation-timings is incompletely understood. We investigated whether optimal hemodynamic effect in CRT requires collision of pacing-induced and intrinsic activation waves and optimal filling of the left ventricle (LV). Methods and Results: CRT was performed in dogs with chronic left bundle-branch block (n=8) or atrioventricular (AV) block (n=6) through atrial (A), right ventricular (RV) apex, and LV-basolateral pacing. A 100 randomized combinations of A-LV/A-RV intervals were tested. Total activation time (TAT) was calculated from >100 contact mapping electrodes. Mechanical interventricular dyssynchrony was determined as the time delay between upslopes of LV and RV pressure curves. Settings providing an increase in LVdP/dtmax (maximal rate of rise of left ventricular pressure) of ≥90% of the maximum LVdP/dtmax value were defined as optimal (CRTopt). Filling was assessed by changes in LV end-diastolic volume (EDV; conductance catheter technique). In all hearts, CRTopt was observed during multiple settings, providing an average LVdP/dtmax increase of ≈15%. In AV-block hearts, CRT opt exclusively depended on interventricular-interval and not on AV-interval. In left bundle-branch block hearts, CRTopt occurred at A-LV intervals that allowed fusion of LV-pacing-derived activation with right bundle-derived activation. In all animals, CRTopt occurred at settings resulting in the largest decrease in TAT and mechanical interventricular dyssynchrony, whereas LV EDV hardly changed. Conclusions: In left bundle-branch block and AV-block hearts, optimal hemodynamic effect of CRT depends on optimal interplay between pacing-induced and intrinsic activation waves and the corresponding mechanical resynchronization rather than filling. © 2013 American Heart Association, Inc.
Kappenberger L.,Cardiocentro Ticino
European Heart Journal | Year: 2013
Atrial fibrillation (AF) is the most common arrhythmia and among the leading causes of stroke and heart failure in Western populations. Despite the increasing size of clinical trials assessing the efficacy and safety of AF therapies, achieved outcomes have not always matched expectations. Considering that AF is a symptom of many possible underlying diseases, clinical research for this arrhythmia should take into account their respective pathophysiology. Accordingly, the definition of the study populations to be included should rely on the established as well as on the new classifications of AF and take advantage from a differentiated look at the AF-electrocardiogram and from increasingly large spectrum of biomarkers. Such an integrated approach could bring researchers and treating physicians one step closer to the ultimate vision of personalized therapy, which, in this case, means an AF therapy based on refined diagnostic elements in accordance with scientific evidence gathered from clinical trials. By applying clear-cut patient inclusion criteria, future studies will be of smaller size and thus of lower cost. In addition, the findings from such studies will be of greater predictive value at the individual patient level, allowing for pinpointed therapeutic decisions in daily practice. © The Author 2013.
Demertzis S.,Cardiocentro Ticino |
Trunfio R.,Cardiocentro Ticino |
Faletra F.,Cardiocentro Ticino |
Wyttenbach R.,San Giovanni Hospital |
Siclari F.,Cardiocentro Ticino
Annals of Thoracic Surgery | Year: 2010
Background The PAS-Port system (Cardica, Inc, Redwood City, CA) was used routinely for patients undergoing coronary surgery with at least one venous graft. Graft patency and clinical results were evaluated, respectively, at 6 months and 5 years after surgery. Methods A total of 100 patients (82 males, 18 females; mean age 68.9 ± 12 years) underwent coronary bypass surgery with at least one PAS-Port anastomosis (total number of PAS-Port implants: n = 117). At 6 months after surgery all patients were followed up clinically and 86 patients with 101 PAS-Port implants underwent either a multidetector computed tomographic scan or coronary angiography. Actuarial freedom from MACCE (major adverse cardiac and cerebrovascular events) was assessed at 5 years after surgery. Results Six-month PAS-Port patency was 88%. The inner diameter of the graft at the implant site (measured in 26 patients) did not reveal any pathologic narrowing (mean inner diameter 3.1 ± 0.6 mm). At 5 years, freedom from overall MACCE was 79% ± 5% and freedom from PAS-Port target vessel revascularization was 94% ± 6%. Conclusions The routine use of PAS-Port was associated with good vein graft patency at 6 months and a low incidence of MACCE at 5 years after surgery. No evidence of implant-related graft stenosis was detected. © 2010 The Society of Thoracic Surgeons.
Faletra F.F.,Cardiocentro Ticino |
Pedrazzini G.,Cardiocentro Ticino |
Pasotti E.,Cardiocentro Ticino |
Muzzarelli S.,Cardiocentro Ticino |
And 5 more authors.
JACC: Cardiovascular Imaging | Year: 2014
Guidance of catheter-based procedures is performed using fluoroscopy and 2-dimensional transesophageal echocardiography (TEE). Both of these imaging modalities have significant limitations. Because of its 3-dimensional (3D) nature, 3D TEE allows visualizing the entire scenario in which catheter-based procedures take place (including long segments of catheters, tips, and the devices) in a single 3D view. Despite these undeniable advantages, 3D TEE has not yet gained wide acceptance among most interventional cardiologists and echocardiographists. One reason for this reluctance is probably the absence of standardized approaches for obtaining 3D perspectives that provide the most comprehensive information for any single step of any specific procedure. Therefore, the purpose of this review is to describe what we believe to be the most useful 3D perspectives in the following catheter-based percutaneous interventions: transseptal puncture; patent foramen ovale/atrial septal defect closure; left atrial appendage occlusion; mitral valve repair; and closure of paravalvular leaks. © 2014 by the American College of Cardiology Foundation.