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).

[A Rare Cause of Acute Coronary Occlusion with Inferior ST-Elevation Myocardial Infarction and Out of Hospital Cardiac Arrest]. / Seltene Ursache eines akuten Koronararterienverschlusses mit ST-Hebungsinfarkt der Hinterwand und präklinischer Reanimation.

HISTORY: The 59-year old female was successfully resuscitated after out of hospital cardiac arrest due to ventricular fibrillation. The ECG after return of spontaneous circulation showed elevated ST-segments in the inferior leads. FINDINGS AND DIAGNOSIS: Acute coronary angiography confirmed a complete occlusion of the right coronary artery without collateral flow. However, a few seconds after intracoronary administration of nitroglycerin complete reperfusion was achieved without persistent relevant stenosis. THERAPY AND COURSE: Stenting of the vessel was withheld. After controlled hypothermia and 68 h on respirator therapy the patient was extubated and showed no persistent neurological disorders. On day 6 she received an implantable cardioverter-defibrillator. Two weeks after the index event the patient could be discharged in good condition. Routine intracoronary administration of nitroglycerin before balloon dilatation or stenting is therefore highly recommended, also in the setting of acute coronary syndromes. Because of the high risk of recurrence, patients resuscitated from lethal cardiac arrhythmia, caused by coronary spasm should receive a cardioverter-defibrillator.

[Standard Operating Procedures in Clinical Medicine]. / Standards in der klinischen Medizin.

Standard operating procedures (SOP) in hospital care have the potential to improve treatment quality and transparency. However, after arriving at the decision to generate a SOP for the own hospital or ward, the upcoming question is often, how to start?The present article tries to give some interdisciplinary guidance about reasonable structures and contents of SOPs that could be understood as a basic matrix for individual work.

[Pay for performance approach and its possible future influence on revenues in German interventional cardiology units]. / Der "Pay-for-Performance"-Ansatz im Krankenhausstrukturgesetz.

Pay-for-performance in German health care system is still uncommon but--in view of scheduled legislative projects--could gain more influence in future. Beside others, risc adjusted in-hospital mortality and the door-to-ballon-time inpatients with ST-elevation myocardial infarction could become quality- and performance indicators in interventional cardiology units. As a result, process optimization based on these indicators could have an impact on both patient value (as already today) and revenues (from 2017 onwards).

Incidence and long-term follow-up of silent cerebral lesions after pulmonary vein isolation using a remote robotic navigation system as compared with manual ablation.

BACKGROUND: The incidence of silent cerebral lesions (SCL) after atrial fibrillation (AF) ablation is highly variable, depending on the technology used. Recently, an increased risk for SCL has been described for a novel, nonirrigated ablation tool using multielectrode phased radiofrequency (PVAC). The aim of this prospective study was to evaluate the incidence and long-term follow-up of SCL in patients undergoing robotically assisted pulmonary vein isolation (RA-PVI) as compared with manual PVI. METHODS AND RESULTS: Circumferential PVI using irrigated radiofrequency current was performed on 70 patients (41 patients with paroxysmal AF, 59%). Fifty patients underwent RA-PVI and 20 patients underwent a manual approach. Cerebral MRI was performed the day before and the day after the ablation procedure; follow-up MRI was performed on 9 of 12 (75%) patients after a follow-up period of 21 months. SCLs were found in 12 of 70 (17%) patients in this study; the incidence of SCLs was similar in patients undergoing RA-PVI as compared with manually ablated patients (n=9, 18% versus n=3, 15%; probability value=1.0). In 1 patient undergoing manual PVI (1%), an SCL with asymptomatic subarachnoid hemorrhage was detected; the bleeding completely resolved within 1 month. Transient ischemic attack occurred in 1 (1%) patient 2 days after manual PVI. After a median follow-up period of 21 months, no residual SCLs were detected. CONCLUSIONS: The incidence of SCL using the robotic navigation system was 18% in this study. Incidence and size of SCL appears to be similar after RA-PVI as compared with manual PVI. Repeat MRI showed no residual SCLs at long-term follow-up.

Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease.

BACKGROUND: Percutaneous coronary intervention with stent implantation is limited by the occurrence of re-stenosis and the risk of stent thromboses. OBJECTIVE: To define the impact of paclitaxel-coated balloon angioplasty plus endothelial progenitor cell capturing (EPC) stent implantation in de novo coronary artery disease. This combination may reduce neointimal proliferation within the EPC stent and address the risk of stent thrombosis by facilitating rapid endothelialisation. METHODS: In this prospective single-blind multicentre randomised trial, 120 patients with a de novo lesion in a native coronary artery were randomly assigned to undergo treatment with paclitaxel-coated balloon plus EPC stent or EPC stent alone. Dual antiplatelet therapy was prescribed for 3 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was in-stent late lumen loss. The secondary clinical endpoint was a composite of death from a cardiac cause, myocardial infarction attributed to the target vessel or target lesion revascularisation. RESULTS: There was no difference in patient baseline characteristics or procedural results. The angiographic follow-up rate was 96%. Treatment with paclitaxel-coated balloon plus EPC stent was superior to EPC stent alone, with an in-stent late loss of 0.34±0.45 mm versus 0.88±0.48 mm (p<0.001). The re-stenosis rate was reduced from 23.2% to 5.1% (p=0.006) and the clinical endpoint was reduced from 17.2% to 4.8% (p=0.039). There was no definite or probable stent thrombosis. CONCLUSIONS: Paclitaxel-coated balloon plus EPC stent implantation is superior to EPC stent implantation alone for treatment of de novo coronary artery disease. TRIAL REGISTRATION: NCT00732953.

Abortion of myocardial infarction by primary angioplasty mainly depends on preprocedural TIMI flow.

AIMS: To define frequency and predictors of aborted myocardial infarctions (MI) after primary angioplasty. METHODS AND RESULTS: We analysed 196 consecutive patients with the clinical diagnosis of ST-elevation acute coronary syndrome (ST-ACS) admitted for primary angioplasty to one interventional facility between October 2005 and September 2006. Aborted MI was defined as a creatine increase of less than two times the upper limit of normal, combined with typical evolutionary electrocardiographic changes. Masquerading MI was diagnosed if evolutionary changes were missing or could be attributed to other causes. Thirty-four patients (17,3%) had an aborted and nine (4,6%) a masquerading MI. The main predictor of abortion was Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 prior to procedure. The in-hospital mortality of aborted MI was 0%, the one year mortality 2.9%. Sixteen patients without prior or inter-current myocardial infarction had a preserved ejection fraction on cardiac MR at 12 months; in six patients even without any detection of late enhancement. CONCLUSIONS: There is a substantial proportion of aborted myocardial infarction after primary angioplasty, corresponding to a small or even non detectable scar formation in terms of late enhancement on cardiac MR. Preprocedural TIMI flow 2 or 3 is the main predictor of aborted MI.

Outcome and treatment quality of transfer primary percutaneous intervention in older patients with acute ST-elevation myocardial infarction (STEMI).

The aim of this study was to evaluate the outcome and treatment quality of transfer percutaneous coronary intervention (PCI) in older patients with acute STEMI. In this prospective study all patients with diagnosed acute (pain-to-balloon≤12 h) STEMI transferred to our institution for primary PCI (n=400) between January 2005 and October 2007 were under investigation. Overall 125 older patients with age ≥70 years were included (mean age 77.5±4.9 years; 77 males). Pre-hospital delays were more common in older patients with longer pain-to-balloon: median (range)=85 (5-629) vs. 66 (1-688) p=0.031, and pain-to-first medical-contact-times: median: 206 (84-711) vs. 172 (45-720); p=0.001. A trend towards a higher (non-significant) rate of major 5/125 (5%) vs. 5/275 (1.8%), p=0.195 and minor 10/125 (8%) vs. 14/275 (5.1%). p=0.256 bleeding complications in older patients was evident. In-hospital mortality was significantly higher in older patients compared to the younger patients group: 13/125, 10.4% vs. 8/275, 2.9%, p=0.002). Overall mortality at 30-day follow-up was 11.2% in older and 3.3% in younger patients: 14/125 vs. 9/275, p=0.002. Transfer PCI is an effective treatment strategy for older patients with acute ST-elevation myocardial infarction. Overall-30-day mortality in older STEMI-patients transferred for primary PCI is comparably low.

Remote robotic catheter ablation for atrial fibrillation: how fast is it learned and what benefits can be earned?

INTRODUCTION: Recently, results describing pulmonary vein isolation (PVI) on patients using a robotic navigation system (RNS) in a high-volume center specialized in pulmonary vein isolation were published. The main purpose of this prospective study was to evaluate the learning curve of new users of RNS in a community hospital and to address the effectivity of RNS in electrophysiological settings with fewer patients. Radiation times, procedural times, feasibility, and safety with the RNS were assessed. METHODS: PVI using the RNS was performed on 100 consecutive patients with symptomatic paroxysmal (n = 56, 56%) or persistent atrial fibrillation (AF). To assess the learning curve of practitioners with first-time use of RNS, patients were divided into four groups of 25 patients each (Q1-Q4). Procedural times as well as radiation times, complications, and outcome after a 6-month follow-up period were assessed for each quartile. All patients were ablated by the same physician. RESULTS: Comparing the four patient groups, a continuous and significant reduction of procedural and radiation times was seen in the first 75 patients (Q1-Q3), whereas no further improvement was seen in the consecutive patients (Q3-Q4). One pericardial tamponade occurred in the course of 100 patients (1%). Overall success rate after a 6-month follow-up period was 74% in patients with paroxysmal and persistent AF. Comparing the four quartiles there was a higher but non-significant number of patients with freedom of atrial fibrillation after a 6-month follow-up in the subsequent groups (Q2-Q4) when compared to group 1. CONCLUSIONS: This data suggest that RNS is feasible and safe when performed in a community hospital with a significant reduction of radiation times and procedure times within the first 75 patients and with similar success and complication rates as compared to high-volume centers.

Primary angioplasty for any patient with ST-elevation myocardial infarction? Guideline-adherent feasibility and impact on mortality in a rural infarction network.

AIMS: The aim of this study was to assess the guideline-adherent feasibility of area-wide primary angioplasty in rural German surroundings and its impact on reperfusion and outcome in patients with acute ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: All consecutive patients with acute STEMI (n = 347) admitted to any of the hospitals (5 non invasive and 1 invasive with established 24 h/7 days primary angioplasty service) in a 350.000 inhabitant rural area during the year 2002 (n = 184) and 2005 (n = 163) were included in this registry. In 2002, emergency medical services transferred acute STEMI patients to the nearest emergency room, where reperfusion therapy (fibrinolysis or primary angioplasty) was organised. In 2005, all patients were transferred directly to the cathlab bypassing any emergency room when possible. Primary angioplasty increased from 53 to 89% (p < 0.01), fibrinolysis decreased from 27 to 2% (p < 0.01) and the no revascularisation rate from 21 to 9% (p < 0.01). Onset of pain to balloon time in primary angioplasty was reduced from median 339 to 191 min (p < 0.01), median first medical contact to balloon time in 2005 was 101 min. Overall, 6-month mortality decreased from 19 to 10% (p = 0.03). CONCLUSIONS: After transition to a uniform primary angioplasty concept, an increase in overall reperfusion rates and a decrease in time delays could be observed in a rural German infarction network.

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.

[First diagnosis of an aneurysm of the left atrial appendage in a 69-year-old female patient]. / Erstdiagnose eines Aneurysmas des linken Vorhofohres bei einer 69-jährigen Patientin.

CASE REPORT: A 69-year-old woman was admitted to hospital for cardioversion of persistent atrial fibrillation. She was on anticoagulation with a vitamin K antagonist for several weeks. Transesophageal echocardiography revealed a left atrial appendage aneurysm with a floating thrombus. None of the risk factors for thromboembolism mentioned in the guidelines for the management of patients with atrial fibrillation were present. As the patient refused surgical resection, long-term anticoagulation was recommended. CONCLUSION: Due to their scarcity, patients with left atrial appendage aneurysms are not considered in current management guidelines. Since this anomaly is associated with a potential risk of systemic embolization, surgical resection should be recommended even in asymptomatic patients.

Advances in remote monitoring of implantable pacemakers, cardioverter defibrillators and cardiac resynchronization therapy systems.

Unlike the standard quarterly or semi-annual direct ambulatory device interrogations procedures, state-of-the-art implantable electronic cardiovascular devices (IECD) enable their wireless remote interrogation and monitoring, and automatically send reports and special alerts on a daily basis. This allows physicians to respond more proactively to changes in patient or device status, more appropriately triage patient care, and more efficiently perform the post-implant ambulatory follow-ups. This review presents the-state-of the-art technology of remote IECD monitoring and summarizes the main clinical observations published through June 2008. Cardiovascular remote monitoring systems made by several manufacturers are currently in various phases of development, clinical investigation, and medical applications. Data collected in several completed and ongoing studies strongly suggest that this new technology will make important contributions, particularly with respect to the facilitation of IECD follow-ups, enhancement of patient safety and quality of life, and lowering of medical costs. Further technological advances and a more clear understanding and appreciation of the clinical and economic benefits of telecardiology, will likely increase sharply the use of remote IECD monitoring in upcoming years.