Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

AIMS: To compare 5-year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug-eluting stents (DES). METHODS: The EverBio-2 trial (Comparison of Everolimus- and Biolimus-Eluting Coronary Stents with Everolimus-Eluting Bioresorbable Vascular Scaffold) was a single-center, assessor-blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus-eluting (EES) or biolimus-eluting (BES) DES. Clinical follow-up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow-up were asked to return for angiographic follow-up at 5 years. RESULTS: Five-year angiographic follow-up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In-stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow-up was complete in 232 patients (97%) at 5 years. The rate of the device-oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient-oriented composite endpoint occurred in 40% of BVS- and 43% of EES/BES-treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup. CONCLUSION: Five-year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio-2 trial was not powered for clinical and angiographic endpoints at 5 years of follow-up.

Performance of the new SmartCardia wireless, wearable oximeter: a comparison with arterial SaO2 in healthy volunteers.

BACKGROUND: Our goal was to evaluate the performance of a new wearable arm located pulse oximeter. METHODS: Twelve volunteers were monitored with three pulse oximeters and underwent desaturation to 70% SaO2. We compared the accuracy of SpO2 reading from the SmartCardia system with SpO2 using two well established devices (Masimo and Nellcor) as reference. Oximetry was performed at different level of oxygen saturation varying from 70 to 100%. Bias, ARMS and precision were evaluated using Bland-Altman plots. RESULTS: The mean (SD) differences between SaO2 compared to SpO2 and the devices were as follows: SaO2 versus Masimo 2,12 ± 1,01% (95% CI 1,45 to 2,79), SaO2 versus Nellcor 0,78 ± 0,58% (95% CI - 0,29 to 1,65) and SaO2 versus SmartCardia 0,42 ± 0,24% (95% CI - 0,64 to 1,46). The bias between SmartCardia, Masimo, Nellcor devices and SaO2 was 0.16 (95% CI 0.05 to 0.33) and LoA (level of agreements) 2.96 (95% CI - 2,68 to 2,89) for SmartCardia, 2,02 (95% CI 1,49 to 2,54) and LoA - 6 to 11 for Masimo, and 0,76 (95% CI 0,5 to - 1) and LoA - 3,5 to 5,0 for Nellcor. ARMS for the 70-100% SaO2 range was 1,4 for SmartCardia, 5,0 for Masimo and 2,31 for Nellcor. CONCLUSIONS: The new wireless SmartCardia SpO2 measurement system demonstrated in-line results, bias, ARMS and precision in healthy volunteers, when compared with the gold standard SaO2 and with two well established systems, Masimo and Nellcor. TRIAL REGISTRATION: The present trial was prospectively registered at UCSF record (registration number:10-00437), on March 8, 2021.

Efficacy of the SEPARPROCATH® radiation drape to reduce radiation exposure during cardiac catheterization: A pilot comparative study.

BACKGROUND: Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation. OBJECTIVES: We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment. METHODS: This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time. RESULTS: A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] µSv/Gy.cm2 without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] µSv/Gy.cm2 , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm2 without SEPARPROCATH®, p value 0.81). CONCLUSION: SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety.

Ten-year clinical follow-up after sirolimus-eluting stent implantation.

BACKGROUND: Little is known on the "very" long-term incidence of major adverse cardiac events (MACE), target-lesion revascularization (TLR), target-vessel revascularization and stent thrombosis after sirolimus-eluting stent (SES) implantation. We present the first study to provide a 10-year clinical follow-up in an unselected patient population who underwent SES implantation. METHODS AND RESULTS: We ran a systematic 10-year clinical follow-up in a series of 200 consecutive patients treated with unrestricted SES implantation between April 2002 and April 2003 in two Swiss hospitals. Outcomes and follow-up were obtained in all 200 patients. The cumulative 10-year MACE rate was 47% with all-cause death of 20%, cardiac death of 9%, myocardial infarction of 7%, TLR and target-vessel revascularization of 8% and 11% respectively. Academic Research Consortium-defined "definite and probable" stent thrombosis-rate was 2.5%. TLR risk was maximal between 3 to 6 years. New lesion revascularization increased throughout the study period. CONCLUSION: Incidence of TLR was maximal 3 to 6 years after SES implantation and decreased thereafter. MACE and non-TLR revascularization rates steadily increased during the complete follow-up underlining the progression of coronary artery disease.

Predictive Value of HAS-BLED and HEMORR2HAGES Bleeding Risk Scores After Percutaneous Coronary Intervention.

BACKGROUND: Various scoring systems have been developed to assess the risk of bleeding in medical settings. HAS-BLED and HEMORR2HAGES risk scores are commonly used to estimate bleeding risk in patients receiving anticoagulation for atrial fibrillation, but data on their predictive value in patients undergoing percutaneous coronary intervention (PCI) are limited. METHODS: This study evaluated and compared the predictive abilities of the HAS-BLED and HEMORR2HAGES bleeding risk scores in all-comer patients undergoing PCI. The PARIS score, specifically designed for patients undergoing PCI, was used as a comparator. The scores were calculated at baseline and compared with the occurrence of events during a 2-year clinical follow-up period. Between 2015 and 2017, all consecutive patients undergoing PCI we re prospectively enrolled and divided into risk tertiles based on bleeding risk scores. The primary end points were hierarchical major bleeding events, defined by Bleeding Academic Research Consortium types 3 through 5, and patient-oriented composite end points according to Bleeding Academic Research Consortium classification, which were assessed during the 2-year follow-up period. RESULTS: A total of 1,080 patients completed the follow-up period. Two years after index, 189 patients (17.5%) had experienced any bleeding, with 48 events (4.4%) classified as Bleeding Academic Research Consortium types 3 to 5. All bleeding risk scores showed statistically significant predictive ability for bleeding events. The HEMORR2HAGES score (C statistic, 0.73) was more effective than the HAS-BLED score (C statistic, 0.66; P = .07) and the PARIS score (C statistic, 0.66; P = .06) in predicting risk of major bleeding. Patients in high-risk bleeding groups also experienced a higher incidence of patient-oriented composite end points. CONCLUSIONS: The HEMORR2HAGES, HAS-BLED, and PARIS risk scores exhibited good predictive abilities for bleeding events following PCI. Patients at high risk of bleeding also demonstrated increased ischemic risk and higher mortality during the 2-year follow-up period.

Corrigendum: Yield of the electrophysiological study in patients with new-onset left bundle branch block after transcathether aortic valve replacement: The PR interval matters.

[This corrects the article DOI: 10.3389/fcvm.2022.910693.].

Yield of the electrophysiological study in patients with new-onset left bundle branch block after transcathether aortic valve replacement: The PR interval matters.

Background: Studies suggest that performing an electrophysiological study (EPS) may be useful to identify patients with new-onset left bundle branch block (LBBB) post-TAVR at risk of atrioventricular block. However, tools to optimize the yield of such strategy are needed. We therefore aimed to investigate whether 12-lead ECG changes post-TAVR may help identify patients with abnormal EPS findings. Materials and methods: Consecutive patients with new-onset LBBB post-TAVR who underwent EPS were included. PR and QRS intervals were measured on 12-lead ECG pre-TAVR and during EPS. Abnormal EPS was defined as an HV interval > 55 ms. Results: Among 61 patients, 28 (46%) had an HV interval > 55 ms after TAVR. Post-TAVR PR interval and ΔPR (PR-post-pre-TAVR) were significantly longer in patients with prolonged HV (PR: 188 ± 38 vs. 228 ± 34 ms, p < 0.001, ΔPR: 10 ± 30 vs. 34 ± 23 ms, p = 0.001), while no difference was found in QRS duration. PR and ΔPR intervals both effectively discriminated patients with HV > 55 ms (AUC = 0.804 and 0.769, respectively; p < 0.001). A PR > 200 ms identified patients with abnormal EPS results with a sensitivity of 89% and a negative predictive value (NPV) of 88%. ΔPR ≥ 20 ms alone provided a somewhat lower sensitivity (64%) but combining both criteria (i.e., PR > 200 ms or ΔPR ≥ 20 ms) identified almost every patients with abnormal HV (sensitivity = 96%, NPV = 95%). Selecting EPS candidate based on both criteria would avoid 1/3 of exams. Conclusion: PR interval assessment may be useful to select patients with new-onset LBBB after TAVR who may benefit most from an EPS. In patients with PR ≤ 200 ms and ΔPR < 20 ms the likelihood of abnormal EPS is very low independently of QRS changes.

Chest Pain and Hemodynamic Instability in a Young Woman.

We report the case of an 18-year-old female admitted to the hospital for severe hemodynamic instability and fatal outcome within 6 hours following admission. Significant electrocardiographic modifications were noted and are presented with diagnostic options. (Level of Difficulty: Intermediate.).

Short-term outcomes of aortic valve neocuspidization for various aortic valve diseases.

Objectives: Bioprosthetic valve deterioration remains a major limitation following aortic valve replacement. Favorable results have been reported with an autologous pericardium aortic valve neocuspidization. Methods: Seventy patients (31 women and 39 men) (mean age, 62 ± 12 years) with aortic stenosis (n = 52 [74%]) or aortic regurgitation (n = 18 [26%]) underwent the aortic valve neocuspidization procedure. Thirty-four patients (49%) had a tricuspid valve, 35 (50%) had a bicuspid valve, and 1 (1%) had a monocuspid valve. European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons scores were, respectively, 2.2% ± 2% and 2.0% ± 1.8%. Four patients (6%) had active endocarditis and 2 (3%) had endocarditis sequelae. One patient (1%) had fibroelastoma. A combined procedure was performed in 33 patients (46%). Results: The follow-up period was 24 ± 12 months. One patient (1%) died in hospital and 1 patient (1%) underwent conventional valve replacement for significant aortic regurgitation. Postoperative peak and mean pressure gradients were respectively 14 ± 5 and 8 ± 3 mm Hg. Aortic valve area was 2.5 ± 0.6 cm2. During follow-up, no patients died. Reintervention occurred in 2 patients (3%). At last follow-up, peak pressure gradient was 13 ± 7 mm Hg, mean pressure gradient was 7 ± 4 mm Hg, and aortic valve area was 2.3 ± 0.7 cm2. There was 1 recurrence of moderate aortic stenosis (1%). All patients were in New York Heart Association functional class I (90%) or II (10%). Freedom from major valve-related events was 92.1%, (98.5% for death, 95.2% for reintervention, and 95.2% for endocarditis). Conclusions: In our experience, the midterm outcomes of the aortic valve neocuspidization procedure with autologous glutaraldehyde fixed pericardium were acceptable for survival, operative risk and valve-related complications, for our all-comer patient population with various aortic valve diseases.

Bleeding Risk Profile in Patients on Oral Anticoagulation Undergoing Percutaneous Coronary Interventions: A Prospective 24 Months Cohort Study.

Background: The Academic Research Consortium has identified a set of major and minor risk factors in order to standardize the definition of a high bleeding risk (ACR-HBR). Oral anticoagulation is a major criterion frequently observed. Aims: The objective of this study is to quantify the risk of bleeding in patients on oral anticoagulation with at least one additional major ACR-HBR criteria in the Cardio-Fribourg Registry. Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. The study population included patients with ongoing long-term oral anticoagulation (OAC) and planned to receive triple antithrombotic therapy. Patients were divided in two groups: patients on OAC with at least one additional major ACR-HBR criteria vs. patients on OAC without additional major ACR-HBR criteria. The primary endpoint was any bleeding during the 24-month follow-up. Secondary bleeding endpoint was defined as Bleeding Academic Research Classification (BARC) ≥3. Results: Follow-up was completed in 142 patients at high bleeding risk on OAC, of which 33 (23%) had at least one additional major ACR-HBR criteria. The rate of the primary endpoint was 55% in patients on OAC with at least one additional ACR-HBR criteria compared with 14% in patients on OAC without additional ACR-HBR criteria (hazard ratio, 3.88; 95%CI, 1.85-8.14; p < 0.01). Patients with additional major ACR-HBR criteria also experienced significantly higher rates of BARC ≥ 3 bleedings (39% at 24 months). Conclusion: The presence of at least one additional ACR-HBR criterion identifies patients on OAC who are at very high risk of bleeding after percutaneous coronary intervention.

Ischemic and Bleeding Outcomes According to the Academic Research Consortium High Bleeding Risk Criteria in All Comers Treated by Percutaneous Coronary Interventions.

Background: The Academic Research Consortium have identified a set of major and minor risk factors in order to standardize the definition of a High Bleeding Risk (ACR-HBR). Aims: The aim of this study is to stratify the bleeding risk in patients included in the Cardio-Fribourg registry, according to the Academic Research Consortium for High Bleeding Risk (ACR-HBR) definition, and to report ischemic and hemorrhagic events at 2-year of clinical follow-up. Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. Patients were considered high (HBR) or low (LBR) bleeding risk depending on the ARC-HBR definition. Primary endpoints were hierarchical major bleeding events as defined by the Bleeding Academic Research Consortium (BARC) grade 3-5, and ARC patient-oriented major adverse cardiac events (POCE) at 2-year follow-up. Results: Follow-up was complete in 1,080 patients. There were 354 patients in the HBR group (32.7%) and 726 patients in the low-bleeding risk (LBR) group (67.2%). At 2-year follow-up, cumulative BARC 3-5 bleedings were higher in HBR (10.5%) compared to LBR patients (1.5%, p < 0.01) and the impact of HBR risk factors was incremental. At 2-year follow-up, POCE were more frequent in HBR (27.4%) compared to LBR group (18.2%, <0.01). Overall mortality was higher in HBR (14.0%) vs. LBR (2.9%, p < 0.01). Conclusions: ARC-HBR criteria appropriately identified a population at a higher risk of bleeding after percutaneous coronary intervention. An increased risk of bleeding is also associated with an increased risk of ischemic events at 2-year follow-up.

Age-Related Outcomes After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry.

OBJECTIVES: The aim of this study was to investigate age-related outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) as assessed in a nationwide, prospective, multicenter cohort study. BACKGROUND: TAVR is the preferred treatment for elderly patients with severe aortic stenosis and is expanding into lower age groups. METHODS: Data from the SwissTAVI Registry were analyzed. Clinical outcomes were compared between patients 70 years of age or younger (n = 324), 70 to 79 years of age (n = 1,913), 80 to 89 years of age (n = 4,353), and older than 90 years of age (n = 507). Observed deaths were correlated with expected deaths in the general Swiss population using standardized mortality ratios. RESULTS: Between February 2011 and June 2018, 7,097 patients (mean age 82.0 ± 6.4 years, 49.6% women) underwent TAVR at 15 hospitals in Switzerland. Procedural characteristics were similar; however, older patients more often had discharge to the referring hospital or a rehabilitation facility after TAVR. Using adjusted analyses, a linear trend for mortality (30-day adjusted hazard ratio [HRadj]: 1.45; 95% confidence interval [CI]: 1.18 to 1.77; 1-year HRadj: 1.12; 95% CI: 1.01 to 1.24), cerebrovascular accidents (30-day HRadj: 1.35; 95% CI: 1.09 to 1.66; 1-year HRadj: 1.21; 95% CI: 1.02 to 1.45), and pacemaker implantation (30-day HRadj: 1.23; 95% CI: 1.12 to 1.34; 1-year HRadj: 1.19; 95% CI: 1.09 to 1.30) was observed with increasing age. Furthermore, standardized mortality ratios were 12.63 (95% CI: 9.06 to 17.58), 4.09 (95% CI: 3.56 to 4.74), 1.63 (95% CI: 1.50 to 1.78), and 0.93 (95% CI: 0.76 to 1.14) for TAVR patients in relation to the Swiss population <70, 70 to 79, 80 to 89 and ≥90 years of age, respectively. CONCLUSIONS: Increasing age is associated with a linear trend for mortality, stroke, and pacemaker implantation during early and longer-term follow-up after TAVR. Standardized mortality ratios were higher for TAVR patients younger than 90 years of age compared with expected rates of mortality in an age- and sex-matched Swiss population. (SWISS TAVI Registry; NCT01368250).

Closure of ostium secundum atrial septum defect with the Atriasept occluder: early European experience.

OBJECTIVES: This multicentre study sought to report the safety and efficacy of the ATRIASEPT septal occluder to repair atrial septal defect (ASD). BACKGROUND: The ATRIASEPT is a low profile, flexible, double disk occluder with centering system specifically designed for closure of ostium secundum ASD. METHOD: Patients were enrolled from four participating European sites and followed up for 12 months post procedure. Outcomes were evaluated, including closure success and incidence of adverse events. RESULTS: Seventy-six patients received the ATRIASEPT device. Mean size of the defect was 15 +/- 4 mm. Closure success was observed in 69 patients (89%) at the end of the procedure. Sixty-four patients had a six-month follow up with a complete closure by 58 patients (90%). Minor adverse events occurred in two patients. Significant functional improvement was reported by all symptomatic patients. CONCLUSION: Percutaneous closure of ASD ostium secundum type defects with the ATRIASEPT is safe and effective with high success rate and excellent mid-term outcome.

Three-dimensional electroanatomic entrainment map in atypical atrial flutter late after heart transplantation.

Atrial flutter in the donor part of orthotopic heart transplants has been reported and successfully treated by radiofrequency ablation of the cavotricuspid isthmus, but mapping and ablation of atypical flutter circuits may be challenging.(1) Entrainment mapping has been used in combination with activation mapping to define the mechanism of atypical atrial flutter. Here, we report a case where colour-coded three-dimensional (3D) entrainment mapping allowed us to accurately determine and visualize the 3D location of the reentrant circuit and to plan the ablation of a left atrial flutter without the need for activation mapping.

Cardiac Ambulatory Monitoring: New Wireless Device Validated Against Conventional Holter Monitoring in a Case Series.

Background: Cardiac arrhythmias are very common but underdiagnosed due to their transient and asymptomatic nature. An optimization of arrhythmia detection would permit to better treat patients and could substantially reduce morbidity and mortality. The SmartCardia ScaAI wireless patch is a novel CE IIa approved, single-lead electrocardiographic (ECG) ambulatory monitor designed for cardiac arrhythmias detection. Hypothesis: The accuracy of the new SmartCardia wireless patch to detect arrhythmias is comparable to the conventional Holter monitoring. Methods: Patients referred for a suspicion of arrhythmia between February and March 2020 were included in the trial. Simultaneous ambulatory ECG were recorded using a conventional 24-h Holter and the SmartCardia. The primary endpoint was the detection of cardiac arrhythmias over the total wear time of the devices, defined as premature atrial contraction (PAC), supraventricular tachycardia ≥3 beats, premature ventricular contraction (PVC), and ventricular tachycardia ≥3 beats. Conduction abnormalities, pause ≥2 s and atrioventricular block (AVB), were also tracked. McNemar's test was used to compare the matched pairs of data from both devices. Results: A total of 40 patients were included in the trial. Over the total wear time, there was no significant difference between the devices for ventricular and supraventricular arrhythmias detection. Pauses and AVB were equally identified by the two devices in three patients. Conclusion: Over the total wear time, the SmartCardia device showed an accuracy to detect arrhythmia similar to the 24-h Holter monitoring: single-lead, adhesive-patch monitoring might become an interesting alternative to the conventional Holter monitoring.

Impact of first medical contact to revascularisation time on long-term clinical outcomes in ST-segment elevation myocardial infarction patients.

Increased age impacts the first medical contact to revascularisation delay in patients with STEMI. Patients with shorter treatment delays (<90 minutes after first medical contact) have significantly lower major adverse cardiac events rates at 3 years.

Incidence of stent thrombosis and adverse cardiac events 5 years after sirolimus stent implantation in clinical practice.

BACKGROUND: The long-term incidence of stent thrombosis (ST) and complications after sirolimus-eluting stents (SES) implantation is still a matter of debate. METHOD: We conducted a systematic follow-up on the day of their 5-year SES implantation anniversary, in a series of consecutive real-world patients treated with a SES. The use of SES implantation was not restricted to "on-label" indications, and target lesions included in-stent restenosis, vein graft, left main stem locations, bifurcations, and long lesions. The Academic Research Consortium criteria were used for ST classification. RESULTS: Three hundred fifty consecutive patients were treated with SES between April and December 2002 in 3 Swiss hospitals. Mean age was 63 +/- 6 years, 78% were men, 20% presented with acute coronary syndrome, and 19% were patients with diabetes. Five-year follow-up was obtained in 98% of eligible patients. Stent thrombosis had occurred in 12 patients (3.6%) [definite 6 (1.8%), probable 1 (0.3%) and possible 5 (1.5%)]. Eighty-one percent of the population was free of complications. Major adverse cardiac events occurred in 74 (21%) patients and were as follows: cardiac death 3%, noncardiac death 4%, myocardial infarction 2%, target lesion revascularization 8%, non-target lesion revascularization target vessel revascularization 3%, coronary artery bypass graft 2%. Non-TVR was performed in 8%. CONCLUSION: Our data confirm the good long-term outcome of patients treated with SES. The incidence of complications and sub acute thrombosis at 5 years in routine clinical practice reproduces the results of prospective randomized trials.

Significant decrease in in-hospital mortality and major adverse cardiac events in Swiss STEMI patients between 2000 and December 2007.

OBJECTIVES: To evaluate the in-hospital outcome of STEMI (ST elevation myocardial infarction) patients admitted to Swiss hospitals between 2000 and December 2007, and to identify the predictors of in-hospital mortality and major cardiac events. METHODS: Data from the Swiss national registry AMIS Plus (Acute Myocardial Infarction and Unstable Angina in Switzerland) were used. All patients admitted between January 2000 and December 2007 with STEMI or a new LBBB (left bundle branch block) were included in the registry. RESULT: We studied 12 026 STEMI patients admitted to 68 hospitals. The mean age was 64 +/- 13 years and 73% of the patients were male. Incidence of in-hospital death was 7.6% in 2000 and 6% in 2007. Reinfarction fell from 3.7% in 2000 to 0.9% in 2007. Thrombolysis decreased from 40.2% in 2000 to 2% in 2007. Clinical predictors of mortality were: age >65 years, Killips class III or IV, diabetes, Q wave myocardial infarction (at presentation). Patients undergoing percutaneous coronary intervention (PCI) had lower mortality and reinfarction rates (3.9% versus 11.2% and 1.1% versus 3.1% respectively, p <0.001) over time, although their numbers increased from 43% in 2000 to 85% in 2007. Patients admitted to hospitals with PCI facilities had lower mortality than patients hospitalised in hospitals without it, but the demographic characteristics differ widely between the two groups. Both in-hospital mortality and reinfarction decreased significantly over the time, parallel to an increased number of PCI. PCI was also the strongest predictor of survival. CONCLUSION: In-hospital mortality and reinfarction rate have decreased significantly in Swiss STEMI patients in the last seven years, parallel to a significant increase in the number of percutaneous coronary interventions in addition to medical therapy. Outcome is not related to the site of admission but to PCI access.

Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis.

BACKGROUND: Whether the two drug-eluting stents approved by the US Food and Drug Administration-a sirolimus-eluting stent and a paclitaxel-eluting stent-are associated with increased risks of death, myocardial infarction, or stent thrombosis compared with bare-metal stents is uncertain. Our aim was to compare the safety and effectiveness of these stents. METHODS: We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18,023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation. FINDINGS: Mortality was similar in the three groups: hazard ratios (HR) were 1.00 (95% credibility interval 0.82-1.25) for sirolimus-eluting versus bare-metal stents, 1.03 (0.84-1.22) for paclitaxel-eluting versus bare-metal stents, and 0.96 (0.83-1.24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0.81, 95% credibility interval 0.66-0.97, p=0.030 vs bare-metal stents; 0.83, 0.71-1.00, p=0.045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2.11, 95% credibility interval 1.19-4.23, p=0.017 vs bare-metal stents; 1.85, 1.02-3.85, p=0.041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0.70, 0.56-0.84; p=0.0021). INTERPRETATION: The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents.

Outcome after percutaneous closure of a patent foramen ovale using the Intrasept device: a multi-centre study.

OBJECTIVES: This multi-centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept device. BACKGROUND: PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo-embolism. Currently, different devices are used for PFO closure. METHODS: Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo-embolism. Peri-procedural and mid-term complications were reported. RESULTS: Four-hundred thirty patients (mean age 50.7 +/- 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow-up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri-procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid-term follow-up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). CONCLUSION: This multi-centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo-embolic events.