Meta-long Papyrus: Meta-analysis of mid to long-term outcomes of PK Papyrus covered stent.

BACKGROUND: Although covered stents (CS) represent a potentially life-saving intervention for coronary perforation (CAP), their application has expanded to other contexts, including coronary aneurysms (CAA). However, data regarding mid- and long-term outcomes of CS in these settings scenarios remains limited. AIMS: This meta-analysis aims to evaluate major adverse cardiac events (MACE) from discharge through long-term follow-up in patients undergoing percutaneous coronary intervention with the new generation polyurethane-covered cobalt-chromium PK Papyrus CS. METHODS: We conducted a meta-analysis of data from three observational trials that included long-term follow-up of patients who underwent PK Papyrus CS implantation: Papyrus-Spain, SOS PK Papyrus, and PAST-PERF registry. RESULTS: 332 patients underwent PK Papyrus CS implantation, 236 (71.1%) for CAP, 70 (21.1%) for CAA and 26 (7.8%) for other indications. After a mean follow-up of 16.2 months, the MACE was 14.3%, with Target Lesion Revascularization (TLR) being the most frequent (8.5%), followed by stent thrombosis (ST), 3.3% and cardiac death (CD), 2.6%. Comparing CAP and CAA subgroups, the MACE rate in CAA was significantly higher than CAP (21.4% vs 9.7%, p < 0.01), primary driven by ST (CAA: 8.6% vs CAP: 1.3%; p = 0.0015). CONCLUSIONS: The clinical outcomes following PK Papyrus CS implantation are deemed acceptable, considering the challenging scenarios and the existing alternative treatments. However, MACE rates in patients with CAA who received Papyrus PK CS were significantly higher than in those with CAP, underscoring the importance of meticulous patient selection and optimization of CS in these complex patients and coronary anatomies.

iPhone App compared with standard blood pressure measurement -The iPARR trial.

BACKGROUND: The possibility to use built-in smartphone-cameras for photoplethysmographic (PPG) recording of pulse waves lead to the release of numerous health apps, claiming to measure blood pressure (BP) based on PPG signals. Even though these apps are highly popular, not a single one is clinically validated. Aim of the current study was to test systolic BP (sBP) estimation by a promising new algorithm in a large clinical setting. METHODS: The study was designed based on the European Society of Hypertension International Protocol Revision 2010. Each individual received 7 sequential BP measurements, starting with the reference device - an automated oscillometric cuff device - followed by the PPG recording at the patients' index finger. RESULTS: A total 1,036 subjects were recruited of which 965 could be included for final analysis leading to 2,895 pairs of comparison. Mean (±SD) error between test and reference device was -0.41 (±16.52) mmHg. Only 38.1% of all 2,895 BP comparisons reached a delta within ±5 mmHg, while 29.3% reached a delta larger than 15 mmHg. Bland-Altman plot showed an overestimation of smartphone sBP in comparison to reference sBP in low range and an underestimation in high sBP range. CONCLUSIONS: According to the European Society of Hypertension International Protocol Revision 2010 specifications the algorithm failed validation criteria for sBP measurement and was not commercialized. These findings emphasize that health apps should be rigorously validated according to common guidelines before market release as under- and/or overestimation of BP is potentially exposing persons at health risks in short and long term. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02552030.

PK Papyrus covered stent: Device description and early experience for the treatment of coronary artery perforations.

BACKGROUND: Coronary artery perforation during percutaneous revascularization is associated with considerable morbidity and mortality. The PK Papyrus covered stent provides a physical barrier to seal perforated arteries and prevent associated complications including death. METHODS: In a survey of patients treated for coronary artery perforation with the PK Papyrus stent in 16 countries, procedural and in-hospital outcomes were ascertained. Procedural variables included device delivery, sealing of the perforation, and complications related to the covered stent. RESULTS: Among 80 patients with coronary perforation, Ellis classification was characterized as grade III or III-cavity spilling in 50.0% and 17.5% of events, respectively. The mean (±SD) number of stents attempted for use per patient was 1.25 ± 0.61. The PK Papyrus stent was successfully delivered to the site of perforation in 76 patients (95.0%), and successful sealing was reported in 73 patients (91.3%). Pericardiocentesis was performed in seven patients (8.8%), and in-hospital death occurred in eight patients (10.0%). Among patient deaths, Ellis grade III perforations were reported in all instances (data not reported in one patient), and two cases were associated with unsuccessful sealing of the perforation site. CONCLUSIONS: The PK Papyrus covered stent is designed to overcome limitations of existing therapies and to facilitate device delivery and effectively treat coronary artery perforations. Initial experience demonstrates favorably high rates of successful delivery to and sealing of the perforation site. Despite treatment, in-hospital mortality remains high for patients experiencing Ellis grade III coronary perforations.

Detection of atrial fibrillation with a smartphone camera: first prospective, international, two-centre, clinical validation study (DETECT AF PRO).

AIMS: Early detection of atrial fibrillation (AF) is essential for stroke prevention. Emerging technologies such as smartphone cameras using photoplethysmography (PPG) and mobile, internet-enabled electrocardiography (iECG) are effective for AF screening. This study compared a PPG-based algorithm against a cardiologist's iECG diagnosis to distinguish between AF and sinus rhythm (SR). METHODS AND RESULTS: In this prospective, two-centre, international, clinical validation study, we recruited in-house patients with presumed AF and matched controls in SR at two university hospitals in Switzerland and Germany. In each patient, a PPG recording on the index fingertip using a regular smartphone camera followed by iECG was obtained. Photoplethysmography recordings were analysed using an automated algorithm and compared with the blinded cardiologist's iECG diagnosis. Of 672 patients recruited, 80 were excluded mainly due to insufficient PPG/iECG quality, leaving 592 patients (SR: n = 344, AF: n = 248). Based on 5 min of PPG heart rhythm analysis, the algorithm detected AF with a sensitivity of 91.5% (95% confidence interval 85.9-95.4) and specificity of 99.6% (97.8-100). By reducing analysis time to 1 min, sensitivity was reduced to 89.9% (85.5-93.4) and specificity to 99.1% (97.5-99.8). Correctly classified rate was 88.8% for 1-min PPG analysis and dropped to 60.9% when the threshold for the analysed file was set to 5 min of good signal quality. CONCLUSION: This is the first prospective clinical two-centre study to demonstrate that detection of AF by using a smartphone camera alone is feasible, with high specificity and sensitivity. Photoplethysmography signal analysis appears to be suitable for extended AF screening. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02949180, https://clinicaltrials.gov/ct2/show/NCT02949180.

Third generation drug eluting stent (DES) with biodegradable polymer in diabetic patients: 5 years follow-up.

OBJECTIVE: To report the long-term safety and efficacy data of a third generation drug eluting stent (DES) with biodegradable polymer in the complex patient population of diabetes mellitus after a follow-up period of 5 years. BACKGROUND: After percutaneous coronary intervention patients with diabetes mellitus are under higher risk of death, restenosis and stent thrombosis (ST) compared to non-diabetic patients. METHODS: In 126 centers worldwide 3067 patients were enrolled in the NOBORI 2 registry, 888 patients suffered from diabetes mellitus (DM), 213 of them (14%) being insulin dependent (IDDM). Five years follow-up has been completed in this study. RESULTS: At 5 years, 89.3% of the patients were available for follow-up. The reported target lesion failure (TLF) rates at 5 years were 12.39% in DM group and 7.34% in non-DM group; (p < 0.0001). In the DM group, the TLF rate in patients with IDDM was significantly higher than in the non-IDDM subgroup (17.84 vs. 10.67%; p < 0.01). The rate of ST at 5 years was not different among diabetic versus non-diabetic patients or IDDM versus NIDDM. Only 10 (<0.4%) very late stent thrombotic events beyond 12 months occurred. CONCLUSIONS: The Nobori DES performed well in patients with DM. As expected patients with DM, particularly those with IDDM, had worse outcomes. However, the very low rate of very late stent thrombosis in IDDM patients might have significant clinical value in the treatment of these patients. Clinical trial registration ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10.

Does Simulation-Based Training Improve Procedural Skills of Beginners in Interventional Cardiology?--A Stratified Randomized Study.

OBJECTIVE: To assess whether mentored simulation-based-training can improve the procedural skills of beginners in coronary interventional procedures. BACKGROUND: Simulation based-catheter training is a valuable tool to practice interventional procedures. Whether this type of training enhances the procedural skills of fellows learning percutaneous coronary interventions has never been studied. METHODS: Eighteen cardiology fellows were randomized either into the simulation-based training (n = 9) or the control group (n = 9). The simulation group received 7.5 hours of virtual reality (VR) simulation training, whereas the control group attended 4.5 hours of lectures. Each participant had to perform a simple (pre-evaluation) and a more complex (post-evaluation) catheter intervention on a pulsatile coronary flow model in a catheterization laboratory. All procedures were videotaped, analyzed, and rated by 3 expert interventionalists, who were blinded to the randomization. To assess the individual performance level, a "skills score" was determined, comprising 14 performance characteristics (5-level Likert scale, maximum score of 70 points). RESULTS: The "skills score" increased by 5.8 ± 6.1 points in the VR simulation group and decreased by 6.7 ± 8.4 in the control group (P = 0.003) from the simple stenosis at pre- to the more complex lesion at post-evaluation demonstrating the effectiveness of simulation-based training. CONCLUSION: This pilot study suggests that curriculum-based mentored VR simulation training improves the performance level of cardiology fellows in coronary interventions. Further investigation to evaluate the effect on clinical outcomes is warranted.

Lack of "obesity paradox" in patients presenting with ST-segment elevation myocardial infarction including cardiogenic shock: a multicenter German network registry analysis.

BACKGROUND: Studies have associated obesity with better outcomes in comparison to non-obese patients after elective and emergency coronary revascularization. However, these findings might have been influenced by patient selection. Therefore we thought to look into the obesity paradox in a consecutive network STEMI population. METHODS: The database of two German myocardial infarction network registries were combined and data from a total of 890 consecutive patients admitted and treated for acute STEMI including cardiogenic shock and cardiopulmonary resuscitation according to standardized protocols were analyzed. Patients were categorized in normal weight (≤24.9 kg/m(2)), overweight (25-30 kg/m(2)) and obese (>30 kg/m(2)) according to BMI. RESULTS: Baseline clinical parameters revealed a higher comorbidity index for overweight and obese patients; 1-year follow-up comparison between varying groups revealed similar rates of all-cause death (9.1 % vs. 8.3 % vs. 6.2 %; p = 0.50), major adverse cardiac and cerebrovascular [MACCE (15.1 % vs. 13.4 % vs. 10.2 %; p = 0.53)] and target vessel revascularization in survivors [TVR (7.0 % vs. 5.0 % vs. 4.0 %; p = 0.47)] with normal weight when compared to overweight or obese patients. These results persisted after risk-adjustment for heterogeneous baseline characteristics of groups. An analysis of patients suffering from cardiogenic shock showed no impact of BMI on clinical endpoints. CONCLUSION: Our data from two network systems in Germany revealed no evidence of an "obesity paradox"in an all-comer STEMI population including patients with cardiogenic shock.

Do gender differences in primary PCI mortality represent a different adherence to guideline recommended therapy? a multicenter observation.

BACKGROUND: It is uncertain whether gender differences in outcome after primary percutaneous coronary intervention (PCI) are only attributable to different baseline characteristics or additional factors. METHODS: Databases of two German myocardial infarction network registries were combined with a total of 1104 consecutive patients admitted with acute ST-elevation myocardial infarction (STEMI) and treated according to standardized protocols. RESULTS: Approximately 25% of patients were females. Mean age (69 vs 61 years), incidence of diabetes (28% vs 20%), hypertension (68 vs 58%) and renal insufficiency (26% vs 19%) was significantly higher compared to males. Mean prehospital delay was numerically longer in females (227 vs 209 min) as was in hospital delay (35 vs 30 min). PCI was finally performed in 92% of females and 95% of males with comparable procedural success (95% vs 97%). Use of drug eluting stents (55% vs 68%) and application of GP 2b 3a blockers (75% vs 89%) was significantly less frequent in women. At discharge, prescription of beta blockers and lipid lowering drugs was also significantly lower in females (84% vs 90% and 71% vs 84%). Unadjusted in-hospital mortality was significantly higher in females (10% vs 5%) without attenuation after 12 months. Adjusted mortality however did not differ significantly between genders. CONCLUSION: Higher unadjusted mortality in females after primary PCI was accompanied by significant differences in baseline characteristics, interventional approach and secondary prophylaxis in spite of the same standard of care. Lower guideline adherence seems to be less gender specific but rather a manifestation of the risk-treatment paradox.

Comparison of cardiogoniometry and ECG at rest versus myocardial perfusion scintigraphy.

BACKGROUND: Cardiogoniometry (CGM) is a novel resting electrocardiac method based on computer-generated three-dimensional data derived from cardiac potentials. The purpose of this study was to determine CGM's and electrocardiography's (ECG) accuracy for detecting myocardial ischemia and/or lesions in comparison with stress/rest myocardial perfusion scintigraphy (single photon emission computer tomography [SPECT]). METHOD: A cohort of consecutively enrolled patients (n = 100) with suspected or known coronary artery disease (mean age 67.8 years, 52% female) were examined by CGM and resting ECG before stress/rest myocardial scintigraphy. RESULTS: Pathological scintigraphy findings at adenosine stress perfusion (ASP) and/or rest were conclusively identified in 21 patients. Diagnostic sensitivity was 71% for CGM and 24% for ECG, specificity was 70% for CGM and 95% for ECG. Reversible ischemia was diagnosed in 16 of 21 patients with pathological scintigraphy results. In this subgroup, sensitivity was 67% for CGM and 25% for ECG. CONCLUSIONS: At rest, the sensitivity of a CGM significantly surmounts that of a standard 12-lead ECG for detection of isolated myocardial ischemia or myocardial lesions revealed by scintigraphy/SPECT; specificity is in a reasonable range. CGM's ease of use and its considerable agreement with the results of myocardial scintigraphy, suggests a possible role for patient screening in the primary care setting.

Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial.

BACKGROUND: Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial. METHODS: The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 µg/kg per min (maximum 10 µg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov, NCT00712101. FINDINGS: Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0%vs 7·6%; odds ratio [OR] 0·91; 95% CI 0·64-1·28; p=0·58). The incidence of death (4·5%vs 3·6%; 1·24; 0·78-1·97; p=0·36) and reinfarction (1·8%vs 1·8%; 1·0; 0·51-1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2·4%vs 4·1%; 0·57; 0·33-0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups. INTERPRETATION: In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated. FUNDING: Lilly, Germany. University of Leipzig-Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF).

Comparison of cardiogoniometry and electrocardiography with perfusion cardiac magnetic resonance imaging and late gadolinium enhancement.

AIMS: Cardiogoniometry (CGM) is a spatio-temporal five-lead resting electrocardiographic method utilizing automated analysis. The purpose of this study was to determine CGM's and electrocardiography (ECG)'s accuracy for detecting myocardial ischaemia and/or lesions in comparison with perfusion cardiac magnetic resonance imaging (CMRI) and late gadolinium enhancement (LGE). METHODS AND RESULTS: Forty (n= 40) patients with suspected or known stable coronary artery disease were examined by CGM and resting ECG directly prior to CMRI including adenosine stress perfusion (ASP) and LGE. The investigators visually reading the CMRI were blinded to the CGM and ECG results. Half of the patients (n= 20) had a normal CMRI while the other half presented with either abnormal ASP and/or detectable LGE. Cardiogoniometry yielded an accuracy of 83% (sensitivity 70%) and ECG of 63% (sensitivity 35%) compared with CMRI. CONCLUSIONS: In this pilot study CGM compares more favourably than ECG with the detection of ischaemia and/or structural myocardial lesions on CMRI.

Morbidity and mortality of nonagenarians undergoing CoreValve implantation.

BACKGROUND: Nonagenarians are mostly denied from different therapeutic strategies due to high comorbidity index and risk-benefit calculation. We present the results of nonagenarians with high comorbidity index not eligible for conventional aortic valve surgery undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve system. METHODS: Our retrospective analysis include baseline parameters, procedural characteristics, morbidity, mortality as well as twelve-lead surface ECG and echocardiographic parameters which were revealed preinterventionally, at hospital discharge and at 30-day follow-up. Clinical follow-up was performed 6 months after TAVI. RESULTS: Out of 158 patients 11 nonagenarians with a mean age of 92.6 ± 1.3 years suffering from severe aortic valve stenosis and elevated comorbidity index (logistic EuroSCORE of 32.0 ± 9.5%, STS score 25.3 ± 9.7%) underwent TAVI between January 2008 and January 2011 using the third-generation percutaneous self-expanding CoreValve prosthesis. Baseline transthoracic echocardiography reported a mean aortic valve area (AVA) of 0.6 ± 0.2 cm(2) with a mean and peak pressure gradient of 60.2 ± 13.1 mmHg and 91.0 ± 27.4 mmHg, respectively. The 30-day follow up all cause and cardiovascular mortality was 27.3% and 9.1%, respectively. One major stroke (9.1%), 2 pulmonary embolisms (18.2%), 1 periprocedural (9.1%) and 1 (9.1%) spontaneous myocardial infarction occured. Life-threatening or disabling bleeding occurred in 2 cases (18.2%), and minor bleeding in 7 cases (63.6%). Mean severity of heart failure according to NYHA functional class improved from 3.2 ± 0.8 to 1.36 ± 0.5 while mean AVA increased from 0.6 ± 0.2 cm(2) to 1.8 ± 0.2 cm(2). At 6-months follow-up 8 patients (72.7%) were alive without any additional myocardial infarction, pulmonary embolism, bleeding, or stroke as compared to 30-day follow-up. CONCLUSION: Our case series demonstrate that even with elevated comorbidity index, clinical endpoints and valve-associated results are relatively favorable in nonagenarians treated with CoreValve.

Cost-effectiveness of a photopethysmographic procedure for screening for atrial fibrillation in 6 European countries.

BACKGROUND: Strokes cause an estimated annual health care burden of 170 billion euros across Europe. Atrial fibrillation is one of the major risk factors for stroke and increases the individual risk 4.2-fold. But prevention with anticoagulants may reduce this risk by 70%. Screening methods are employed to detect previously undetected atrial fibrillation. Screening studies in various European countries show a high degree of undetected atrial fibrillation. This study aims to assess the cost-effectiveness of systematic screening with a smartphone application, named Preventicus Heartbeats. It is a hands-on screening tool for use on smartphone to diagnose AF with high sensitivity and specificity. METHODS: A previously published model for calculating screening cost-effectiveness was extended to 6 European countries covering a wide range in terms of treatment costs and epidemiologic parameters. RESULTS: The use of screening lowers the cost per case in countries with comparatively high levels of health care costs (Switzerland: -€75; UK: -€7). Moderate higher costs per case were observed in 4 countries (Greece: €6; Netherlands: €15). Low levels of health care costs result in less or no potential for further cost reduction (Poland: €20; Serbia: €33). In all countries considered, the model showed an increase in effectiveness measures both in the number of strokes avoided and the quality adjusted life years. The number of strokes avoided per 1000 participants ranged from 2.52 (Switzerland) to 4.44 (Poland). Quality-adjusted life-years per case gained from screening ranged from 0.0105 (Switzerland) to 0.0187 (Poland). The screening procedure dominated in two countries (Switzerland, UK). For the remaining countries, the incremental cost effectiveness ratio ranged from €489/QALY (Greece) to €2548/QALY (Serbia). CONCLUSION: The model results showed a strong dependence of the results on the country-specific costs for stroke treatment. The use of the investigated screening method is close to cost-neutral or cost-reducing in the Western European countries and Greece. In countries with low price levels, higher cost increases due to AF screening are to be expected. Lower costs of anticoagulation, which are expected due to the upcoming patent expiry of direct anticoagulants, have a positive effect on the cost result.

Feasibility of digital atrial fibrillation screening in an elderly population : The Ulm heart rhythm weeks.

AIMS: Atrial fibrillation (AF) screening in risk populations has the potential to prevent strokes. The authors tested the feasibility of a digital program with initial photoplethysmographic (PPG) self-screening and cardiologist-attended electrocardiographic (ECG) confirmation of screen-positive cases. METHODS: Inhabitants of the city of Ulm aged ≥ 65 years were invited to participate. After digital consent, participants were given access to a smartphone application for 14 days of self-screening (two recordings per day recommended). Screen-positive participants without known AF were invited to present to a cardiologist for AF confirmation with a 14-day ECG event recorder. PPG recordings were first analyzed by algorithm using a combination of linear and non-linear methods. The quality of pathological (classified by algorithm) PPG and all ECG recordings were checked by a telecare service. Primary outcomes included adherence to the screening protocol defined as the proportion of participants performing at least 14 PPG recordings (or until documentation of absolute arrhythmia) and the proportion of pathological PPG and all ECG recordings rejected by the telecare center. RESULTS: A total of 215 participants registered. Of these, 204 (95%) performed at least one recording and 169 (79%) reached the performance target of two sufficient measurements per day; 75 PPG recordings were automatically classified as pathological by algorithm; 14 (19%) were rejected by the telecare service due to poor quality. Of the 12 participants with a suspected first diagnosis of AF, five visited a cardiologist as part of the study. Of 1090 ECG recordings obtained, 390 (36%) were qualified as non-diagnostic. AF was confirmed in three cases. CONCLUSIONS: A digital AF screening program with initial self-screening and referral of screen-positive cases to a cardiologist-attended ECG-confirmation service is feasible with meaningful results in an elderly risk population. However, the availability of the target population of persons > 65 years of age for such a digital screening program appears to be limited despite extensive public relations activities.

Sealing of Coronary Perforations With a Second-Generation Covered Stent Graft - Results From the PAST-PERF Registry.

BACKGROUND: The PAST-PERF registry was initiated to collect data on the PK Papyrus covered stent, a second-generation device for the treatment of coronary artery perforations with enhanced mechanical properties, but with limited available data. METHODS: Patients treated for coronary artery perforations with the PK Papyrus stent at 14 international centers were retrospectively identified. The primary effectiveness outcome was successful sealing of the perforation. The primary safety outcome was a composite of all-cause mortality, definite or probable stent thrombosis, myocardial infarction and target lesion revascularization. RESULTS: Among the 94 included patients, 72.3% (68/94) had Ellis type III and cavity spilling perforations. Complete sealing was achieved in 93.6% (n = 88), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). Pericardiocentesis was required in 25.0% (n = 23), emergency cardiac surgery was needed in 7.6% (n = 7), acute stent thrombosis was observed in 1.1% (n = 1), and in-hospital mortality occurred in 11.7% (n = 11). The median follow-up duration was 283 (IQR:40;670) days. At 6 and 12 months, the incidence of the primary safety endpoint was 26.6% [95%CI:18.6;37.1] and 32.0% [95%CI:22.8;43.4], mortality 15.0% [95%CI:9.0;24.6] and 19.0% [95%CI:11.3;30.0], and target lesion revascularization 5.5% [95%CI:2.0;14.6] and 7.7% [95%CI:3.1;18.2]. Two definite stent thrombosis occurred, one during the procedure and one on post-procedure day 233. CONCLUSIONS: The registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. ANNOTATED TABLE OF CONTENT: The PAST-PERF registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. Specifically, complete sealing was achieved in 93.6% of patients (n = 88/94), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). The 12-month mortality was 19.0% [95%CI:11.3;30.0], the rate of target lesion revascularization was 7.7% [95%CI:3.1;18.2], and two definite stent thromboses occurred (one during procedure and one on post-procedure day 233).

Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention: design and rationale of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) trial.

BACKGROUND: Intravenous abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction. The hypothesis of this trial is that abciximab bolus intracoronary in comparison to standard intravenous application will improve the outcome of patients undergoing primary PCI in STEMI. STUDY DESIGN: The Abciximab Intracoronary versus intravenously Drug Application in STEMI (AIDA STEMI) study is a 1,912-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of intracoronary versus intravenous bolus abciximab administration during primary PCI with subsequent intravenous infusion for 12 hours. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of AIDA STEMI is the composite of all-cause mortality, recurrent MI, or new congestive heart failure within 90 days of randomization. The primary safety outcome assessment will be major bleeding. CONCLUSIONS: The AIDA STEMI study addresses important questions regarding the efficacy and safety of intracoronary abciximab bolus administration during primary PCI in patients with STEMI, potentially optimizing the route of administration of glycoprotein IIb/IIIa inhibitors in the catheterization laboratory.

Persistent iatrogenic atrial septal defect after a single-puncture, double-transseptal approach for pulmonary vein isolation using a remote robotic navigation system: results from a prospective study.

AIMS: Persistent iatrogenic atrial septal defect (iASD) after transseptal puncture for pulmonary vein isolation (PVI) has been described recently as a complication of PVI. No data exists evaluating systematically the incidence and clinical implications of iASDs after PVI using a remote robotic navigation system (RNS) with sheaths with a distinct larger outer diameter. METHODS AND RESULTS: In this prospective study, 40 patients with either paroxysmal (n = 22, 55%) or persistent symptomatic atrial fibrillation were treated with circumferential PVI using an RNS. In all patients, a single-puncture, double-transseptal approach was used to access the left atrium. Transoesophageal echocardiography was performed before and the day after PVI as well as after a 3 and 6 months follow-up (FU). The day after ablation an iASD was detected in 38 of 40 (95%) patients with a mean diameter of 3.45 +/- 1.5 mm. At 6-month FU, the iASDs were closed in 30 of 39 (78.9%) patients. During the 6-month FU period, no patient died or suffered from cerebral or cardiac embolism. CONCLUSION: After a single-puncture, double-transseptal approach for PVI using the RNS, iASDs show a high spontaneous closure rate of 78.9% after a 6-month FU period. Persistent iASDs following PVI with the RNS are not associated with an increased rate of paradoxical embolism or with relevant shunting.

Oesophageal temperature monitoring and incidence of oesophageal lesions after pulmonary vein isolation using a remote robotic navigation system.

AIMS: Oesophageal lesions (EL), a potential complication after pulmonary vein isolation (PVI), have been described recently. A new remote robotic navigation system (RNS; Hansen Medical) provides enhanced catheter stability along with more effective lesion placement. The aim of this prospective study was to evaluate temperature monitoring and incidence of EL when using RNS with an irrigated tip radiofrequency catheter for PVI. METHODS AND RESULTS: Circumferential PVI using RNS was performed in 73 patients (pts) with paroxysmal (n = 46, 63%) and persistent atrial fibrillation. An oesophageal temperature probe was placed in 58 (79.5%) pts and was integrated in the 3D-map (NavX). Power was limited to 25 W at the posterior wall, and in the case of an increase in temperature power was limited to 20 W. Endoscopy was performed in 42 pts within 24 h after PVI. In 44 of 58 (75.9%) pts, a significant rise in temperature (>39 degrees C) was observed. In 6 of 42 (14.3%) pts, an EL was found during endoscopy. In patients with EL, the body mass index (BMI) was significantly lower than in pts without EL (24.1 +/- 2.0 vs. 29.0 +/- 5.8, P = 0.047). The BMI of all patients with EL was <26, whereas all patients without EL had a BMI above 26. The EL showed brisk healing after re-endoscopy within 2 weeks in all pts. CONCLUSION: In patients undergoing PVI using the RNS, the incidence of EL is 14.3% when using power settings comparable to settings used in manual ablation. Patients with lower BMI (<26) are at higher risk for EL.

Early abciximab use in ST-elevation myocardial infarction treated with primary percutaneous coronary intervention improves long-term outcome. Data from EUROTRANSFER Registry.

BACKGROUND: Primary percutaneous coronary intervention (PCI) is the preferred method of reperfusion in patients with ST elevation myocardial infarction (STEMI). Abciximab is a well established adjunct to primary PCI. The proper timing of abciximab administration in STEMI patients has been investigated in randomised trials, registries and metanalysis, providing conflicting results. METHODS: Consecutive data on STEMI patients, transferred for primary PCI in hospital/ambulance STEMI networks between November 2005 and January 2007, from 15 PCI centres in seven European countries was gathered together for a one-year long-term clinical observation (93% rate of completeness). RESULTS: Data from 1,650 patients was collected in the EUROTRANSFER Registry. Abciximab was administered to 1,086 patients (66%), 727 patients received early (at least 30 minutes prior to first balloon inflation) abciximab (EA), and another 359 patients received late abciximab (LA). One year mortality was 5.8% in the EA group vs 10.3% with LA (p = 0.007). Adjustment for propensity score methods for EA administration did not change the results, still providing a favourable outcome for the EA group (p = 0.004). It was also revealed that only a minority of patients (36%) were treated within the 90-minute recommended time window from first medical contact to PCI (and 60% for the 120-min time delay). CONCLUSIONS: Patients transferred for primary PCI in STEMI hospital networks showed lower rates of death in long-term one-year clinical follow-up when treatment with abciximab was started early.