Relation between detection rate and inappropriate shocks in single versus dual chamber cardioverter-defibrillator--an analysis from the OPTION trial.

The programming of implantable cardioverter-defibrillators (ICDs) influences inappropriate shock rates. The aim of the study is to analyse rates of patients with appropriate and inappropriate shocks according to detection zones in the OPTION trial. All patients received dual chamber (DC) ICDs randomly assigned to be programmed either to single chamber (SC) or to DC settings including PARAD+ algorithm. In a post-hoc analysis, rates of patients with inappropriate and appropriate shocks were calculated for shocks triggered at heart rates ≥ 170 bpm (ventricular tachycardia zone) and at rates ≥ 200 bpm (ventricular fibrillation zone). In the SC group, higher rates of patients with total and inappropriate shocks were delivered at heart rates ≥ 170 bpm than at rates ≥ 200 bpm (total shocks: 21.1% vs. 16.6%; p = 0.002; inappropriate shocks: 7.6% vs. 4.5%, p = 0.016; appropriate shocks: 15.2% vs. 13.5%; p = n.s.). No such differences were observed in the DC group (total shocks: 14.3% vs. 12.6%; p = n.s.; inappropriate shocks: 3.9% vs. 3.6%; p = n.s.; appropriate shocks: 12.2% vs. 10.4%; p = n.s.). The higher frequency of patients with total shocks with SC settings than with DC settings that benefit from PARAD+ was driven by a higher percentage of patients with inappropriate shocks in the VT zone (170-200 bpm) in the SC population.

Percutaneous left atrial appendage closure: Technical aspects and prevention of periprocedural complications with the watchman device.

Transcatheter closure of the left atrial appendage has been developed as an alternative to chronic oral anticoagulation for stroke prevention in patients with atrial fibrillation, and as a primary therapy for patients with contraindications to chronic oral anticoagulation. The promise of this new intervention compared with warfarin has been supported by several, small studies and two pivotal randomized trial with the Watchman Device. The results regarding risk reduction for stroke have been favourable although acute complications were not infrequent. Procedural complications, which are mainly related to transseptal puncture and device implantation, include air embolism, pericardial effusions/tamponade and device embolization. Knowledge of nature, management and prevention of complications should minimize the risk of complications and allow transcatheter left atrial appendage closure to emerge as a therapeutic option for patients with atrial fibrillation at risk for cardioembolic stroke.

Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study.

OBJECTIVES: The OPTION (Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator Patients Without Pacing Indications) trial sought to compare long-term rates of inappropriate shocks, mortality, and morbidity between dual-chamber and single-chamber settings in implantable cardioverter-defibrillators (ICDs) patients. BACKGROUND: The use of dual-chamber ICDs potentially allows better discrimination of supraventricular arrhythmias and thereby reduces inappropriate shocks. However, it may lead to detrimental ventricular pacing. METHODS: This prospective multicenter, single-blinded trial enrolled 462 patients with de novo primary or secondary prevention indications for ICD placement and with left ventricular ejection fractions ≤40% despite optimal tolerated pharmacotherapy. All patients received atrial leads and dual-chamber defibrillators that were randomized to be programmed either with dual-chamber or single-chamber settings. In the dual-chamber setting arm, the PARAD+ algorithm, which differentiates supraventricular from ventricular arrhythmias, and SafeR mode, to minimize ventricular pacing, were activated. In the single-chamber setting arm, the acceleration, stability, and long cycle search discrimination criteria were activated, and pacing was set to VVI 40 beats/min. Ventricular tachycardia detection was required at rates between 170 and 200 beats/min, and ventricular fibrillation detection was activated above 200 beats/min. RESULTS: During a follow-up period of 27 months, the time to the first inappropriate shock was significantly longer in the dual-chamber setting arm (p = 0.012, log-rank test), and 4.3% of patients in the dual-chamber setting group compared with 10.3% in the single-chamber setting group experienced inappropriate shocks (p = 0.015). Rates of all-cause death or cardiovascular hospitalization were 20% for the dual-chamber setting group and 22.4% for the single-chamber setting group and satisfied the pre-defined margin for equivalence (p < 0.001). CONCLUSIONS: Therapy with dual-chamber settings for ICD discrimination combined with algorithms for minimizing ventricular pacing was associated with reduced risk for inappropriate shock compared with single-chamber settings, without increases in mortality and morbidity. (Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator [ICD] Patients Without Pacing Indications [OPTION]; NCT00729703).

Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology).

OBJECTIVES: The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy. BACKGROUND: The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation. METHODS: A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death. RESULTS: The mean CHADS2 score and CHA2DS2-VASc (CHADS2 score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS2 scores of the patient cohort. CONCLUSIONS: LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ASAP]; NCT00851578).

Left Atrial Appendage Occlusion for Stroke Prevention in Patients with Nonrheumatic Atrial Fibrillation.

Introduction: Atrial fibrillation is a common rhythm disorder, which is related to a higher risk of thrombembolism resulting in a high rate of cerebral stroke or transient ischemic attacks. According to the CHADS2- or CHA2DS2Vasc-Score there is an indication for oral anticoagulation to prevent patients from mostly disabling strokes. However, more than 50% of patients are not adequately treated with oral anticoagulation due to different reasons, especially contraindications. More than 90% of thrombi develop in the left atrial appendage (LAA), which lead to the idea of developing devices to exclude the LAA from the systemic circulation to prevent patients from embolisations. Another approach is surgical ligation or removal of the LAA during operation procedures. Content: Different devices and their clinical data are discussed in this review. Available literature for most of the devices is evaluated and last but not least some surgical results are discussed at the end. Existing data of randomized and non-randomized studies show that the concept of LAA-occlusion instead of anticoagulation therapy works. However, complication rates during intervention have to be kept in mind, but with adequate training also new and inexperienced operators can do the procedure safely. Most data and the only randomized studies are available for the Watchman Device. Despite some few complications like pericardial effusions, bleeding complications and thrombus formation on the devices, the data showed a non inferiority of device-implantation in comparison with anticoagulation therapy in the first few years. In long term follow up more than 4 years after implantation, there is even a superiority of the device compared with anticoagulation therapy, safety issues are no longer significantly different despite some periprocedural complications. This has to be reflected with the background, that operators could treat 3 patients with a totally new method, thereafter all patients had to be randomized into the study. So experience was limited in the first phase of this trial. Surgical data vary much due to different techniques of LAA-occlusion. With newer devices results are also promising. Conclusion: LAA-occlusion is a developing field of interventional and surgical techniques. The concept of LAA-occlusion could be proved in one randomized trial. At least for patients contraindicated for anticoagulation therapy, LAA-occlusion is a real alternative to only aspirin therapy or doing nothing. With emerging techniques and lower complication rates, LAA-occlusion might develop to a real alternative to anticoagulation therapy, at least for vitamin-K-antagonists. There are no data available so far in comparison with new oral anticoagulants. Further studies are needed to compare device therapy with new oral anticoagulants.

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).

Optimal timing of invasive angiography in stable non-ST-elevation myocardial infarction: the Leipzig Immediate versus early and late PercutaneouS coronary Intervention triAl in NSTEMI (LIPSIA-NSTEMI Trial).

AIMS: The optimal timing of intervention in non-ST-elevation myocardial infarction (NSTEMI) remains uncertain. The aim of this multicentre trial was to assess whether an immediate invasive approach is superior to an early invasive or a selective invasive approach with respect to reduction of large infarction. METHODS AND RESULTS: Patients with NSTEMI were randomized to either an immediate (<2 h after randomization; n= 201), an early (10-48 h after randomization; n= 200), or a selective invasive approach with high invasive percentage (n= 201). The primary outcome was the peak creatine kinase (CK)-myocardial band (MB) activity during index hospitalization; key secondary clinical endpoints were the composite of (i) death and non-fatal infarction; (ii) death, non-fatal infarction, and refractory ischaemia; (iii) death, non-fatal infarction, refractory ischaemia, and rehospitalization for unstable angina within 6 months. The median time from randomization to angiography was 1.1 h in the immediate vs. 18.6 h in the early and 67.2 h in the selective invasive group (P< 0.001). There was no significant difference in the peak CK-MB activity between groups. The key secondary clinical endpoints were similar between groups at 6-month follow-up: death and infarction: 21.0 vs. 16.0 vs. 14.5%; P= 0.17; death, infarction, refractory ischaemia: 20.9 vs. 21.5 vs. 22.0%; P= 0.98; death, infarction, refractory ischaemia, rehospitalization: 26.0 vs. 26.5 vs. 24.5%; P= 0.91, respectively. CONCLUSIONS: In NSTEMI patients, an immediate invasive approach does not offer an advantage over an early or a selective invasive approach with respect to large myocardial infarctions as defined by peak CK-MB levels, which is supported by similar clinical outcomes. ClinicalTrials.gov NCT00402675.

Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) represent the treatment of choice for primary and secondary prevention of sudden cardiac death but ICD therapy is also plagued by inappropriate shocks due to supraventricular tachyarrhythmias. Dual-chamber (DC) ICDs are considered to exhibit an enhanced discrimination performance in comparison to single-chamber (SC) ICDs, which results in reduction of inappropriate detections in a short- to mid-term follow-up. Comparative data on long-term follow-up and especially on inappropriate shocks are limited. METHODS: The aim of the OPTION study is to assess whether an optimized treatment with DC ICDs improves patient outcome and decreases the rate of inappropriate shocks in comparison to SC ICDs. DC ICD therapy optimization is achieved by optimal customizing of antitachycardia therapy parameters, activation of discrimination algorithms, antitachycardia pacing in the slow ventricular tachycardia zone, and avoidance of right ventricular pacing with the SafeR algorithm mode. The OPTION study, a prospective, multicenter, randomized, single-blinded, parallel study, will randomize 450 patients on a 1:1 allocation to either an SC arm with backup pacing at VVI 40 beats per minute (bpm) or to the DC arm with SafeR pacing at 60 bpm. Patients will be followed for 27 months. Primary outcome measure is the time to first occurrence of inappropriate shock and a combined endpoint of cardiovascular morbidity and all-cause mortality. CONCLUSION: The study will evaluate the relative performance of DC in comparison to SC ICDs in terms of inappropriate shock reduction and patient outcome.

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.

Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.

BACKGROUND: In patients with non-valvular atrial fibrillation, embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. We assessed the efficacy and safety of percutaneous closure of the LAA for prevention of stroke compared with warfarin treatment in patients with atrial fibrillation. METHODS: Adult patients with non-valvular atrial fibrillation were eligible for inclusion in this multicentre, randomised non-inferiority trial if they had at least one of the following: previous stroke or transient ischaemic attack, congestive heart failure, diabetes, hypertension, or were 75 years or older. 707 eligible patients were randomly assigned in a 2:1 ratio by computer-generated randomisation sequence to percutaneous closure of the LAA and subsequent discontinuation of warfarin (intervention; n=463) or to warfarin treatment with a target international normalised ratio between 2.0 and 3.0 (control; n=244). Efficacy was assessed by a primary composite endpoint of stroke, cardiovascular death, and systemic embolism. We selected a one-sided probability criterion of non-inferiority for the intervention of at least 97.5%, by use of a two-fold non-inferiority margin. Serious adverse events that constituted the primary endpoint for safety included major bleeding, pericardial effusion, and device embolisation. Analysis was by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00129545. FINDINGS: At 1065 patient-years of follow-up, the primary efficacy event rate was 3.0 per 100 patient-years (95% credible interval [CrI] 1.9-4.5) in the intervention group and 4.9 per 100 patient-years (2.8-7.1) in the control group (rate ratio [RR] 0.62, 95% CrI 0.35-1.25). The probability of non-inferiority of the intervention was more than 99.9%. Primary safety events were more frequent in the intervention group than in the control group (7.4 per 100 patient-years, 95% CrI 5.5-9.7, vs 4.4 per 100 patient-years, 95% CrI 2.5-6.7; RR 1.69, 1.01-3.19). INTERPRETATION: The efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. Although there was a higher rate of adverse safety events in the intervention group than in the control group, events in the intervention group were mainly a result of periprocedural complications. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation. FUNDING: Atritech.

Percutaneous Left Atrial Appendage Exclusion Therapy: Who, Why and How?

Purpose: Patients with atrial fibrillation are at an increased risk of having a cardio embolic stroke. Stroke is a leading cause of death and disability worldwide. Current guidelines recommend an antithrombotic regimen to prevent thromboembolism in medium and high risk patients with AF. However, a substantial number of patients are not eligible for this therapy. The exclusion of the left atrial appendage (LAA) from circulation seems to be an alternative strategy for stroke prevention in AF. This review focuses on the different strategies for LAA exclusion with special focus on the WATCHMAN Device. Two devices are currently in use for percutaneous transcatheter occlusion of the LAA: the WATCHMAN® - device and the AMPLATZER® -septal occluder. For both devices safety and feasibility data are available. Additionally about 200 patients received a PLAATO® -device- which is currently no more available due to economic reasons. Patients treated with the PLAATO device were at high risk for thromboembolic stroke and had contraindications for oral anticoagulation therapy. The Watchman® -device was implanted in 800 patients that were eligible for long-term anticoagulation therapy with a moderate risk for thromboembolic stroke due to non-valvular AF. Summary: For both devices, a reduction in the risk of stroke was documented and device implantation was shown to be safe and feasible. Provided the ongoing trials show noninferiority to oral anticoagulation, another therapeutic option will become available to prevent ischemic strokes.

ASD and PFO closure with the Solysafe septal occluder - results of a prospective multicenter pilot study.

OBJECTIVE: We report the results of a prospective multicenter pilot study performed in Germany, Sweden, and Switzerland with a new self-centering device for transcatheter closure of an atrial septal defect (ASD) or a patent foramen ovale (PFO) called the Solysafe Septal Occluder. INTERVENTIONS: The device was successfully implanted in 44 patients. In 15 patients with a median age of 40 years (range 6-76 years), a Solysafe device was successfully implanted in an ASD. The median size of the stretched defects was 17 mm (range 10-21 mm). Three 15-mm devices, eight 20-mm devices, and four 25-mm devices were used. Procedure time ranged from 40 to 107 min (median 66 min) and fluoroscopic time from 5.3 to 17.5 min (median 12 min). In 29 patients with a median age of 47 years (range 15-78 years), a Solysafe device was implanted in a PFO. The procedure time ranged from 21 to 155 min (median 51 min) and fluoroscopic time from 3.1 to 31.3 min (median 7.6 min). RESULTS: At discharge, 1 of the 29 patients (3%) had a small shunt. No patient in either the ASD or the PFO group had any major complication. Six months after implantation, the overall closure rate with the Solysafe septal occluder in both groups was 100% (44/44). CONCLUSION: With the self-centering Solysafe Septal Occluder, PFOs, and ASDs with a stretched diameter of up to 21 mm can be effectively closed with very high occlusion rates.

Interventional treatments for stroke prevention in atrial fibrillation with emphasis upon the WATCHMAN device.

PURPOSE OF REVIEW: Stroke is a leading cause of death and disability worldwide. Many strokes occur in patients with atrial fibrillation. Current guidelines recommend an antithrombotic regimen with warfarin to prevent thromboembolism in atrial fibrillation; however, a substantial number of patients are not eligible for this therapy. The exclusion of the left atrial appendage from circulation seems to be an alternative strategy for stroke prevention in atrial fibrillation. The review focuses on the different devices for stroke prevention in patients with atrial fibrillation. RECENT FINDINGS: Recently, two devices developed for percutaneous transcatheter occlusion of the left atrial appendage have been studied: the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) device and the WATCHMAN device. Safety and feasibility data are available for both devices. About 200 patients have received a PLAATO device. These patients were at high risk for thrombembolic stroke and were not candidates for oral anticoagulation therapy. The WATCHMAN device was implanted in 75 patients that were eligible for long-term anticoagulation therapy with a moderate risk for thrombembolic stroke due to nonvalvular atrial fibrillation. SUMMARY: For both devices, a reduction in the risk of stroke was documented, and device implantation was shown to be safe and feasible. Provided the ongoing trials show noninferiority to oral anticoagulation, another therapeutic option will become available to prevent ischemic strokes.

Initial worldwide experience with the WATCHMAN left atrial appendage system for stroke prevention in atrial fibrillation.

OBJECTIVES: This study assessed the feasibility of implanting a device in the left atrial appendage (LAA) in patients with atrial fibrillation (AF) to prevent thromboembolic stroke. BACKGROUND: Meta-analyses confirmed that in cases of left atrial thrombus in nonrheumatic AF patients approximately 90% of them are in the LAA. METHODS: The WATCHMAN Left Atrial Appendage System (Atritech Inc., Plymouth, Minnesota) is a nitinol device implanted percutaneously to seal the LAA. Patients were followed by clinical and transesophageal echocardiography at 45 days and 6 months with annual clinical follow-up thereafter. RESULTS: Sixty-six patients underwent device implantation. Mean follow-up was 740 +/- 341 days. At 45 days, 93% (54 of 58) devices showed successful sealing of LAA according to protocol. Two patients experienced device embolization, both successfully retrieved percutaneously. No embolizations occurred in 53 patients enrolled after modification of fixation barbs. There were 2 cardiac tamponades, 1 air embolism, and 1 delivery wire fracture (first generation) with surgical explantation but no long-term sequelae for the patient. Four patients developed a flat thrombus layer on the device at 6 months that resolved with additional anticoagulation. Two patients experienced transient ischemic attack, 1 without visible thrombus. There were 2 deaths, neither device related. Autopsy documented a stable, fully endothelialized device 9 months after implantation. No strokes occurred during follow-up despite >90% of patients with discontinuation of anticoagulation. CONCLUSIONS: Preliminary data suggest LAA occlusion with the WATCHMAN System to be safe and feasible. A randomized study is ongoing comparing oral anticoagulation with percutaneous closure.

Potential applicability and utilization of left atrial appendage occlusion devices in patients with atrial fibrillation.

BACKGROUND: The WATCHMAN left atrial appendage occluder device (Atritech, Inc, Minneapolis, MN) is currently being tested in a Food and Drug Administration-approved clinical trial, the PROTECT AF trial, for patients who are diagnosed with paroxysmal, persistent, or permanent nonvalvular atrial fibrillation. However, rigorous screening and the study design have resulted in the exclusion of a large number of patients. Hence, the purpose of this study was to assess the potential utility of this device among those who were eligible but excluded for trial criteria and the reasons for exclusion. METHODS: Screening logs from the respective sites participating in the PROTECT AF trial were collected and analyzed for potential utilization outside of a research trial. Only 31 patients were enrolled into the research trail from the screening of 1798 total patients. RESULTS: Information from the excluded patients was examined and it was determined that 79% of these patients would be eligible for the device outside the research trial. Twenty-one percent of patients were not able to receive the device because of long-term warfarin need, contraindications to warfarin, unsuitable anatomy as determined by echocardiography, or the inability to take short-term aspirin and clopidogrel for protocol requirements. CONCLUSIONS: Should a device like the WATCHMAN left atrial appendage occluder be approved, approximately 79% of all patients with atrial fibrillation would be eligible for device placement.

Comparison of bare-metal stenting with minimally invasive bypass surgery for stenosis of the left anterior descending coronary artery: a 5-year follow-up.

BACKGROUND: Randomized trials comparing stenting with minimally invasive direct coronary artery bypass surgery in patients with isolated proximal left anterior descending lesions have shown a significantly higher reintervention rate for stenting and similar results for mortality and reinfarction at short-term follow-up. Long-term follow-up data are sparse. METHODS AND RESULTS: Patients with isolated proximal left anterior descending stenosis were randomized to either surgery (n=110) or bare-metal stenting (n=110). At 5 years, follow-up data were obtained with respect to the primary end point of death, reinfarction, or repeated target vessel revascularization. Clinical symptoms were assessed by the Canadian Cardiovascular Society (CCS) classification. Follow-up information was completed for 216 patients (98.2%), and mean follow-up was 5.6+/-1.2 years. With respect to mortality (surgery, 12%; stenting, 10%; P=0.54) and reinfarctions (surgery, 7%; stenting, 5%; P=0.46), there were no differences between treatment strategies. The need for repeated target vessel revascularization was significantly higher after stenting (32%) compared with surgery (10%; P<0.001). Clinical symptoms improved significantly in both treatment groups compared with baseline; however, there was a favorable trend for surgery (stenting: CCS, 2.6+/-0.9 to 0.5+/-0.8, P<0.001; surgery: CCS, 2.6+/-0.9 to 0.3+/-0.6, P<0.001; P=0.05, stenting versus surgery). CONCLUSIONS: At the 5-year follow-up, minimally invasive bypass surgery and bare-metal stenting showed similar results for the end points of mortality and reinfarctions. However, the reintervention rate is higher after stenting, and the relief in clinical symptoms is slightly better after surgery.

Prospective randomized comparison of early and late results of a carbonized stent versus a high-grade stainless steel stent of identical design: the PREVENT Trial [corrected].

BACKGROUND: Restenosis after coronary interventions with stent implantation is still the main obstacle of interventional cardiology. The aim of this study was to compare a carbonized and high-grade stainless steel stent of identical design with regard to early and late adverse events. METHODS: In this prospective randomized trial the carbonized MAC stent (amg GmbH, Raesfeld-Erle, Germany) was compared with the stainless steel MAC stent of identical design. Primary end point was diameter stenosis at follow-up; secondary end points were angiographic parameters, rate of restenosis, and major cardiac adverse events (MACE; myocardial infarction, reintervention, and death). RESULTS: Between August 1999 and June 2002, 396 patients were randomized in 2 centers of Germany. Diameter stenosis at follow-up (38.6% +/- 23.4% vs 39.1% +/- 22.2%, P = .49) as primary end point, relative late lumen loss (26.8% +/- 23.7% vs 27.7% +/- 22.3%, P = .26), absolute late lumen loss (0.92 +/- 0.71 vs 0.92 +/- 0.66 mm, P = .58), net gain (1.4 +/- 0.8 vs 1.4 +/- 0.8 mm, P = .96), as well as restenosis rates (18.0% vs 19.0%, P = .81) and MACE (13.5% vs 12.2%, P = .71) were not significantly different between the carbonized and the pure stainless steel study arm, respectively. CONCLUSION: The hypothesis of superiority of the carbonized stent over a stainless steel stent of identical design with regard to restenosis and MACE could not be proved. Inactive coating of stents seems to have no advantage over pure stainless steel stents, which was also demonstrated in other trials. The future probably lies in active coating of stents with drugs that reduce the neointimal proliferation process.

Evaluation of the Coroflex Theca-Stent for reduction of restenosis (ECORI).

BACKGROUND: Various stent coatings have been shown to significantly reduce restenosis rates in comparison to non-coated devices. Therefore, the short- and mid-term performance of the new polyphosphazene-coated Coroflex Theca-Stent was investigated. METHODS: 103 patients [63.9 +/- 11 yrs, 5/103 (4.9%) lesion type A, 52/103 (50.5%) type B1, and 46 of 103 (44.6%) type B2] were enrolled for elective single stent deployment into de-novo coronary lesions (stenoses: greater than or equal to 70%, < 100%; reference diameter greater than or equal to 2.75 mm, less than or equal to 4 mm; lesion length: < 16 mm). RESULTS: Deployment and procedural success were 100%, in 57/103 (55.3%) patients without pre-dilatation. 3/103 (2.9%) patients were lost to follow-up. During the 7.1 +/- 2.3 months clinical follow-up, 3 of 100 (3.0%) patients underwent premature target lesion revascularizations, 4 /100 (4%) had non-target lesion-related deaths, and 1 of 100 (1%) suffered myocardial infarction. Among the 77 of 100 (77.0%) patients who underwent angiographic follow-up, the initial stenosis declined from 87.3 +/- 5.7% to 14.2 +/- 8.3% after stenting, and increased to 32.8 +/- 22.7% after 6.4 +/- 1.3 months. The late loss and late loss index were 0.6 +/- 0.7 mm and 0.2 +/- 0.4, respectively; the recurrence rate was 12 of 77 (15.6%), with reintervention required in 11 of 77 (14.3%) of these patients. CONCLUSION: The Coroflex Theca-Stent provides excellent procedural results and a low restenosis rate. Further development of this polymer as the final coating and as the basis for drug-eluting stents seems justified.