[Show abstract][Hide abstract] ABSTRACT: Aims: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios. Methods and results: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted. Conclusions: Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient and lesion scenarios, and management of complications, were identified.
[Show abstract][Hide abstract] ABSTRACT: Aims. To compare 30-day performance of three different type of transcatheter aortic valve implantation (TAVI) prosthesis: Direct Flow Medical (DFM), Medtronic Corevalve (MCV), and Edwards Sapien XT (ES).Methods and results. Forty consecutive patients treated with DFM for severe aortic stenosis were matched to an equal sample of patients undergoing TAVI with MCV and ES (1:1:1 propensity score-matching). Primary end-point was 30-day safety, defined according to the valve academic research consortium (VARC-2) criteria. Secondary end-points were: (i) immediate post-TAVI transaortic gradient reduction, (ii) device success and (iii) thirty-day mortality. Patients treated with DFM had higher 30-day safety rate compared to MCV and ES (respectively: 95.0% vs. 67.5% vs. 82.5%; p=0.006). Immediate post-TAVI transaortic gradient reduction was similar for DFM, MCV and ES subgroups (respectively: 8.3 ± 5.2 mmHg vs. 5.3 ± 3.7 mmHg vs. 5.6 ± 5.1 mmHg; p=0.15); likewise, device success did not differ significantly (respectively: 100% vs. 92.5% vs. 92.5%; p=0.19). Mortality rates were also similar (respectively: 0% vs. 7.5% vs. 7.5%; p=0.190). In the pooled binary logistic regression analysis blood transfusion was associated to 30-day safety (HR 0.156, 95%CI 0.049-0.500, p=0.002), while a significant trend was observed for the vascular closure device type (favoring Proglide vs. Prostar: HR 0.239, 95% CI 0.049 – 1.160, p=0.076).Conclusions. In high-risk patients with aortic stenosis undergoing TAVI, device success and short-term mortality were comparable between DFM, MCV and ES. In contrast, the 30-day VARC-defined safety primary end-point was met significantly more frequently in patients treated with DFM. This result was mainly driven by differences in major vascular complications, associated to differences in vascular closure devices between the different valve subgroups. This article is protected by copyright. All rights reserved.
Catheterization and Cardiovascular Interventions 01/2015; · 2.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims: Clinical data on the early and midterm outcomes of bioresorbable vascular scaffolds (BVS) in routine clinical practice are limited. To fill this gap, we report on the early and midterm clinical outcomes of PCI with everolimus-eluting BVS from the large multicentre GHOST-EU registry. Methods and results: Between November 2011 and January 2014, 1,189 patients underwent percutaneous coronary intervention with one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 10 European centres. The primary outcome of interest was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR). A total of 1,731 Absorb BVS were implanted at a mean of 12.3±3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 (interquartile range 8-227) days after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at six months. The annualised rate of TLF was 10.1%. At six months, the rate of cardiac death was 1.0%, target vessel myocardial infarction was 2.0%, TLR was 2.5%, and target vessel revascularisation was 4.0%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio 2.41, 95% confidence interval: 1.28-4.53; p=0.006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at six months, with 16 of 23 cases occurring within 30 days. Conclusions: "Real-world" outcomes of BVS showed acceptable rates of TLF at six months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible.
[Show abstract][Hide abstract] ABSTRACT: 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 inter-ventional 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.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2014; 10(1):47-9. · 3.17 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The purpose of this study was to determine whether the clinical presentation of lead-associated endocarditis (LAE) is related to the size of lead vegetations and how size is related to bacteriology and clinical outcomes.
Cardiac implantable electronic device (CIED) infection may present as either local pocket infection or bloodstream infection with or without LAE. LAE is associated with significant morbidity and mortality.
The clinical presentation and course of LAE were evaluated by the MEDIC (Multicenter Electrophysiologic Device Cohort) registry, an international registry enrolling patients with CIED infection. Consecutive LAE patients enrolled in the MEDIC registry between January 1, 2009 and December 31, 2012 were analyzed. The clinical features and outcomes of 2 groups of patients were compared based on the size of the lead vegetation detected by echocardiography (> or <1 cm in diameter).
There were 129 patients with LAE enrolled into the MEDIC registry. Of these, 61 patients had a vegetation <1 cm in diameter (Group I) whereas 68 patients had a vegetation ≥1 cm in diameter (Group II). Patients in Group I more often presented with signs of local pocket infection, whereas Group II patients presented with clinical evidence of systemic infection. Staphylococcus aureus was the organism most often responsible for LAE, whereas infection with coagulase-negative staphylococci was associated with larger vegetations. Outcomes were improved among those who underwent complete device removal. However, major complications were associated with an open surgical approach for device removal.
The clinical presentation of LAE is influenced by the size of the lead vegetation. Prompt recognition and management of LAE depends on obtaining blood cultures and echocardiography, including transesophageal echocardiography, in CIED patients who present with either signs of local pocket or systemic infection.
[Show abstract][Hide abstract] ABSTRACT: Percutaneous coronary intervention (PCI) with drug-eluting stents is an accepted alternative to surgery for the treatment of unprotected left main coronary artery (ULMCA) disease, but the long-term outcome in elderly patients is unclear. Aim of our study was to compare the clinical outcomes of octogenarians with ULMCA disease treated either with PCI with drug-eluting stents or coronary artery bypass grafting (CABG). The primary study end point was the composite of death, cerebrovascular accident, and myocardial infarction at follow-up. A total of 304 consecutive patients with ULMCA stenosis treated with PCI or CABG and aged ≥80 years were selected and analyzed in a large multinational registry. Two hundred eighteen were treated with PCI and 86 with CABG. During the hospitalization, a trend toward a higher mortality rate was reported in PCI-treated patients (3.5% vs 7.3%, p = 0.32). At a median follow-up of 1,088 days, the incidence of the primary end point was similar in the 2 groups (32.6% vs 30.2%, p = 0.69). Incidence of target vessel revascularization at follow-up was higher in PCI-treated patients (10% vs 4.2%, p = 0.05). At multivariate analysis, left ventricular ejection fraction was the only independent predictor of the primary end point (hazard ratio 0.95, 95% confidence interval 0.91 to 0.98, p = 0.001). After adjustment with propensity score, the revascularization strategy was not significantly correlated to the incidence of the primary end point (hazard ratio 0.98, 95% confidence interval 0.57 to 1.71, p = 0.95). In octogenarians, no difference was observed in the occurrence of the primary end point after PCI or CABG for the treatment of ULMCA disease. However, the rate of target vessel revascularization was higher in the PCI group.
The American journal of cardiology 04/2014; · 3.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background
Cardiovascular implantable electronic device (CIED) pocket infections are often related to recent CIED placement or manipulation, but these infections are not well characterized. The clinical presentation of CIED pocket infection, based on temporal onset related to last CIED procedure, deserves further study.Methods
The MEDIC (Multicenter Electrophysiologic Device Infection Cohort) prospectively enrolled subjects with CIED infection. Subjects were stratified into those whose infection occurred <12 months (early) or ≥12 months (late) since their last CIED-related procedure.ResultsThere were 132 subjects in the early group and 106 in the late group. There were more females (P = 0.009) and anticoagulation use (P = 0.039) in the early group. Subjects with early infections were more likely to have had a generator change or lead addition as their last procedure (P = 0.03) and had more prior CIED procedures (P = 0.023). Early infections were more likely to present with pocket erythema (P < 0.001), swelling (P < 0.001), and pain (P = 0.007). Late infections were more likely to have pocket erosion (P = 0.005) and valvular vegetations (P = 0.009). In bacteremic subjects, early infections were more likely healthcare-associated (P < 0.001). In-hospital and 6-month mortality were equivalent.ConclusionA total of 45% of patients with CIED pocket infection presented >12 months following their last CIED-related procedure. Patients with early infection were more likely to be female, on anticoagulation, and present with localized inflammation, whereas those with late infection were more likely to have CIED erosion or valvular endocarditis.
Pacing and Clinical Electrophysiology 03/2014; · 1.75 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Women typically present with coronary artery disease later than men with more unfavorable clinical and anatomic characteristics. It is unknown whether differences exist in women undergoing treatment for unprotected left main coronary artery (ULMCA) disease. Our aim was to evaluate long-term clinical outcomes in women treated with percutaneous coronary intervention (PCI) with drug-eluting stents versus coronary artery bypass grafting (CABG). All consecutive women from the Drug-Eluting stent for LefT main coronary Artery disease registry with ULMCA disease were analyzed. A propensity matching was performed to adjust for baseline differences. In total, 817 women were included: 489 (59.8%) underwent treatment with PCI with drug-eluting stents versus 328 (40.2%) with CABG. Propensity score matching identified 175 matched pairs, and at long-term follow-up there were no differences in all-cause (odds ratio [OR] 0.722, 95% confidence interval [CI] 0.357 to 1.461, p = 0.365) or cardiovascular (OR 1.100, 95% CI 0.455 to 2.660, p = 0.832) mortality, myocardial infarction (MI; OR 0.362, 95% CI 0.094 to 1.388, p = 0.138), or cerebrovascular accident (CVA; OR 1.200, 95% CI 0.359 to 4.007, p = 0.767) resulting in no difference in the primary study objective of death, MI, or CVA (OR 0.711, 95% CI 0.387 to 1.308, p = 0.273). However, there was an advantage of CABG in major adverse cardiovascular and cerebrovascular events (OR 0.429, 95% CI 0.254 to 0.723, p = 0.001), driven exclusively by target vessel revascularization (OR 0.185, 95% CI 0.079 to 0.432, p <0.001). In women with significant ULMCA disease, no difference was observed after PCI or CABG in death, MI, and CVA at long-term follow-up.
The American journal of cardiology 01/2014; · 3.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objectives
To determine the diagnostic performance of non-invasive FFR derived from standard acquired coronary computed tomography angiography (CTA) datasets (FFRCT) for the diagnosis of myocardial ischemia in patients with suspected stable coronary artery disease (CAD).
Fractional flow reserve (FFR) measured during invasive coronary angiography (ICA) is the gold standard for lesion-specific coronary revascularization decisions in patients with stable CAD. The potential for FFRCT to non-invasively identify ischemia in patients with suspected CAD has not been sufficiently investigated.
This prospective multicenter trial included 254 patients scheduled to undergo clinically indicated ICA for suspected CAD. Coronary CTA was performed prior to ICA. Evaluation of stenosis (>50% lumen reduction) in coronary CTA was performed by local investigators and in ICA by an independent Core Laboratory. FFRCT was calculated and interpreted in a blinded fashion by an independent Core Laboratory. Results were compared to invasively measured FFR, with ischemia defined as FFRCT or FFR ≤0.80.
The area under the receiver operating characteristic curve (95% CI) for FFRCT was 0.90 (0.87-0.94) versus 0.81 (0.76-0.87) for coronary CTA (p=0.0008). Per-patient sensitivity and specificity to identify myocardial ischemia were 86% (95% CI: 77%-92%) and 79% (72%-84%) for FFRCT versus 94% (86%-97%) and 34% (27%-41%) for coronary CTA, and 65% (53%-74%) and 83% (77%-83%) for ICA, respectively. In patients (n=235) with intermediate stenosis (30%-70%) the diagnostic accuracy of FFRCT remained high.
FFRCT provides high diagnostic accuracy, and discrimination for the diagnosis of hemodynamically significant CAD with invasive FFR as the reference standard. When compared to anatomic testing by coronary CTA, FFRCT leads to a marked increase in specificity.
Clinical trial info
Journal of the American College of Cardiology 01/2014; · 15.34 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims: Safety and efficacy of percutaneous coronary interventions using the Pantera Lux paclitaxel-coated balloon has been demonstrated in the PEPPER first-in-man trial. This prospective, multicentre, clinical registry aims to evaluate its safety and efficacy in an international real-world setting in a larger cohort of patients. Methods and results: Between April 2010 and April 2011, 1,064 patients were treated for predominantly diffuse and proliferative in-stent restenosis of bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR), or for de novo lesions. Clinical device success was obtained in 98.2% of the patients. The study endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction and clinically driven target vessel revascularisation, and was 8.5% in the overall, 6.0% in the BMS-ISR, 11.5% in the DES-ISR and 7.0% in the de novo population at six months, and 15.1%, 11.6%, 20.6% and 9.4% at 12 months, respectively. Definitive stent thrombosis occurred in 0.4% of the patients within 12 months. Conclusions: Safety and efficacy of the Pantera Lux paclitaxel-coated balloon was confirmed in a real-world setting with low major adverse cardiac event rates in patients with in-stent restenosis or de novo lesions. (ClinicalTrials.gov: NCT01081366).
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 12/2013; · 3.17 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to compare, in a large all-comer registry, the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery (ULMCA) stenosis.
Limited data are available regarding clinical outcomes following DES implantation at the different ULMCA sites.
Patients with ULMCA stenosis treated by PCI with DES were analyzed in this multinational registry.
A total of 1,612 patients were included: 482 were treated for ostial/mid-shaft lesions versus 1,130 for distal bifurcation lesions. At a median follow-up period of 1,250 (interquartile range: 987 to 1,564) days, PCI for distal bifurcation lesions was associated with a higher incidence of major adverse cardiac events (propensity-score adjusted hazard ratio [HR]: 1.48, 95% confidence interval [CI]: 1.16 to 1.89; p = 0.001), largely because of the higher target vessel revascularization rate observed in this group as compared to the ostial/mid-shaft lesions group (propensity-score adjusted HR: 1.68, 95% CI: 1.19 to 2.38; p = 0.003). These results were sustained following propensity-score matched analysis. With regard to all-cause death and the composite endpoint of all-cause death and myocardial infarction, propensity-score adjusted analysis suggested a trend toward higher rates of these in the distal ULMCA PCI group, although this was not observed in the propensity-score matched analysis.
This study demonstrates that PCI for ostial/mid-shaft lesions is associated with better clinical outcomes than are distal bifurcation lesions in ULMCA, largely because there is a lower need for repeat revascularization in ostial/mid-shaft lesions.
[Show abstract][Hide abstract] ABSTRACT: Aims: Data regarding the impact on clinical outcomes of PCI with DES implantation vs. CABG to treat unprotected left main coronary artery (ULMCA) disease in diabetic patients are still insufficient. The present study evaluated the short-term and long-term results of percutaneous and surgical revascularisation in diabetic patients with ULMCA disease in a large population. Methods and results: A total of 826 diabetic patients with ULMCA stenosis who received DES (n=520) or underwent CABG (n=306) were selected and analysed from the DELTA registry. In-hospital MACCE was significantly higher in the CABG group, mainly driven by a higher incidence of MI. At four-year follow-up, freedom from death and the composite endpoint of death, MI and cerebrovascular accident (CVA) was similar in the two treatment groups (CABG 87.4%, PCI 82.5%, p=0.124, and CABG 85.4%, PCI 78.9%, p=0.11, respectively). Conversely, freedom from TVR and MACCE was significantly higher in the CABG compared to the PCI group (CABG 95.4%, PCI 79.4%, p<0.001, and CABG 81.9%, PCI 64.7%, p<0.001). Conclusions: In diabetic patients with ULMCA disease with/without concomitant multivessel disease, PCI and CABG led to similar results in terms of death, MI and CVA. However, CABG was associated with less MACCE at long-term follow-up, primarily due to the higher repeat revascularisation rate with DES.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 11/2013; 9(7):803-8. · 3.17 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVES: To analyze age dependencies in patients currently undergoing transcatheter aortic valve implantation (TAVI) based on the German TAVI registry. BACKGROUND: TAVI is a promising, less invasive treatment option for surgical high-risk patients with symptomatic aortic valve stenosis, with the majority being octogenarians treated so far. Younger patients with significant co-morbidities are now increasingly considered for this procedure, but little is known about this population. METHODS: The German TAVI registry is an ongoing non-randomized national multicenter study. Consecutive patients who underwent TAVI between January 2009 and June 2010 were included in this analysis. We compared baseline characteristics, procedural characteristics, and short-term clinical outcome up to 30-day follow-up. RESULTS: A total of 1386 patients were divided into 4 roughly equally-sized groups: group A, n = 347, mean age 73.4 ± 4.5 years; group B, n = 350, mean age 80.6 ± 1.1 years; group C, n = 382, mean age 84.5 ± 1.1 years; and group D, n = 312, mean age 88.9 ± 2.2 years. Patient characteristics varied significantly, with more co-morbidities in younger patients. Technical success rates were similar in all groups (96.6%-97.7%; P=NS). 30-day major adverse event rates were similar with an all-cause mortality rate of 7.2% (A), 7.1% (B), 9.7% (C) and 8.7% (D; P=NS). Postprocedural improvement of both New York Heart Association and self-reported health status was significant in all groups, with significantly better improvements in the categories 'mobility' and 'ability for self-care' in younger patients. CONCLUSION: TAVI appears to be similarly safe and effective across different age groups with currently applied enrollment criteria, but younger patients present with significantly more co-morbidities. All patient populations experience functional improvements, but this is particularly pronounced for younger patients.
The Journal of invasive cardiology 10/2012; 24(10):531-536. · 1.57 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: INTRODUCTION. The ILCOR-Guidelines recommend that unconscious adult patients
with a spontaneous circulation after cardiac arrest should be cooled to 32–34 �C for 24 h to
improve outcome parameters. However, the rate of infections during mild therapeutic
hypothermia is significant elevated [1, 2]. Body temperature and hemodynamic parameters
(HR, BP) seem to be weak criteria for infection in cooled and sedated patients.
OBJECTIVES. To describe the time course of biomarkers (CRP, WBC) during mild
therapeutic hypothermia and the influence of antibiotic prophylaxis.
METHODS. In this single-hospital study patients after cardiac arrest and mild therapeutic
hypothermia were retrospectively investigated. Data collected: age, gender, initial rhythm,
ICU-LOS, Hospital-LOS, CRP/WBC time course (admission[day 10), signs of infection
(infiltrate on X-ray, positive urine sample, positive blood culture), outcome (poor outcome
defined as death, vegetative state or severe disability).
RESULTS. 36 patients were included between January 2010 and July 2011. The median
age of the patients was 64 (43–84) with 69 % male. Initial rhythm was ventricular fibrillation
in 69 % of all cases. Infections during the hypothermia period were observed in 36 %.
Antibiotic agents were prescribed in 72 % due to prophylactic intention. The time course of
biomarkers CRP and WBC showed no significant difference between the groups infection/
No Infection and AB-Prophylaxis/No AB-Prophylaxis. CRP rises up to the peak value at day
3/4 with a slow decrease until day 10, whereas WBC-values stayed in a smaller range.
CONCLUSIONS. CRP and WBC are unspecific biomarkers and mirrors rather an
inflammatory reaction or reperfusion damage than true underlying infection, limiting the
diagnostic potential for early antibiotic stewardship in these patients, especially in the first
REFERENCES. 1. Hypothermia after Cardiac Arrest Study Group. Mild therapeutic
hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med
2002;346:549–56. 2. Fries M, Stoppe C, Brucken D, Rossaint R, Kuhlen R. Influence of
mild therapeutic hypothermia on the inflammatory response after successful resuscitation
from cardiac arrest. J Crit Care 2009;24:453–7.
Intensive Care Medicine 10/2012; 38(Sup 1-38):273. · 5.54 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Coronary in-stent restenosis (ISR) continues to be a therapeutic challenge especially after drug eluting stent (DES) implantation. We studied patients with ISR to investigate safety and efficacy of a novel drug coated balloon (DCB) incorporating paclitaxel into a microcrystalline structure by applying the inert excipient butyryltri-n-hexyl citrate (BTHC) in a prospective First-in-Man trial.
Eighty-one patients were enrolled at 9 European sites, thereof 43 (53.1%) presenting with bare metal stent (BMS)-ISR and 38 (46.9%) with DES-ISR. The primary study endpoint was in-stent late lumen loss (LLL) independently assessed by a quantitative coronary angiography laboratory at 6 months. A secondary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction, clinically driven target vessel revascularization after 6 and 12 months.
At 6 months, overall LLL was 0.07±0.31 mm showing differences in BMS-ISR and DES-ISR treatment (-0.05±0.28 mm vs. 0.19±0.29 mm, respectively, P=.001). Overall MACE rates at 6 and 12 months were 6.5% and 11.8%. At the 12-month follow-up, one myocardial infarction, and no cardiac death nor stent thrombosis had occurred.
Application of a novel paclitaxel coated balloon using BTHC as an excipient in patients with ISR is safe and results in very low LLL, revascularization- and MACE-rates at follow-up. (ClinicalTrials.gov:NCT00961181).
Cardiovascular revascularization medicine: including molecular interventions 08/2012; 13(5):260-4.
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE: To examine the prevalence and impact of concomitant coronary artery disease (CAD) on short-term outcome after transcatheter aortic valve implantation (TAVI). BACKGROUND: The prevalence of CAD in patients undergoing surgical aortic valve replacement is estimated at 30-50 % and its presence increases procedural risk. The prevalence and impact of CAD on outcome after TAVI are not well defined. METHODS: We analyzed 1,382 patients enrolled in the German TAVI registry; the majority (81 %) received the Medtronic CoreValve. The presence of coronary lesions with ≥50 % stenosis on pre-TAVI angiography defined the existence of concomitant CAD. RESULTS: 859 patients (62.2 %) had concomitant CAD, of which 534 (62.3 %) had multi-vessel and 83 (9.7 %) left main disease. Patients with CAD were younger (81.5 ± 6.1 vs. 82.1 ± 6.3 years, p < 0.05), more commonly males (49.4 vs. 30.0 %, p < 0.0001) and diabetics (36.9 vs. 31.2 %, p < 0.05), and had a worse Canadian Cardiovascular Society angina class at baseline compared to patients with no CAD. During TAVI patients with CAD more often required additional coronary intervention and had longer procedures, but procedural success rates were similar (97.1 vs. 97.7 %). Crude in-hospital mortality was higher in patients with CAD (10.0 vs. 5.5 %, OR 1.90, 95 % CI 1.23-2.93), but this was not significant after adjustment for confounders (adjusted OR 1.41, 95 % CI 0.85-2.33). Both groups had significant improvement in 30-day symptoms and quality of life. CONCLUSION: The prevalence of CAD in contemporary TAVI patients is high. Its presence characterizes a high-risk population and is associated with increased crude short-term mortality, largely explained by co-morbidities, but does not limit functional improvement after TAVI.
Clinical Research in Cardiology 07/2012; · 4.17 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to compare, in a large all-comers registry, major adverse cardiac and cerebrovascular events (MACCE) after percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) in unprotected left main coronary artery (ULMCA) stenosis.
Percutaneous coronary intervention with DES implantation in ULMCA has been shown to be a feasible and safe approach at midterm clinical follow-up.
All consecutive patients with ULMCA stenosis treated by PCI with DES versus CABG were analyzed in this multinational registry. A propensity score analysis was performed to adjust for baseline differences in the overall cohort.
In total 2,775 patients were included: 1,874 were treated with PCI versus 901 with CABG. At 1,295 (interquartile range: 928 to 1,713) days, there were no differences, at the adjusted analysis, in the primary composite endpoint of death, cerebrovascular accidents, and myocardial infarction (MI) (adjusted hazard ratio [HR]: 1.11; 95% confidence interval [CI]: 0.85 to 1.42; p = 0.47), mortality (adjusted HR: 1.16; 95% CI: 0.87 to 1.55; p = 0.32), or composite endpoint of death and MI (adjusted HR: 1.25; 95% CI: 0.95 to 1.64; p = 0.11). An advantage of CABG over PCI was observed in the composite secondary endpoint of MACCE (adjusted HR: 1.64; 95% CI: 1.33 to 2.03; p < 0.0001), driven exclusively by the higher incidence of target vessel revascularization with PCI.
In our multinational all-comers registry, no difference was observed in the occurrence of death, cerebrovascular accidents, and MI between PCI and CABG. An advantage of CABG over PCI was observed in the incidence of MACCE, driven by the higher incidence of target vessel revascularization with PCI.