Thrombus formation after left atrial appendage exclusion using an amplatzer cardiac plug device

The feasibility and safety of left atrial appendage closure with the Amplatzer cardiac plug (AGA Medical Corp., Minneapolis, MN) have been recently published; no thrombus formation on the device surface has been reported previously. We describe a case of a 66‐year‐old man with permanent atrial fibrillation, previous stroke, and contraindication for long‐term oral anticoagulant therapy. A 22‐mm ACP device was deployed successfully without complications. The patient was discharged on acetyl salicylic acid 100 mg and clopidogrel 75 mg daily. After 4 weeks, the patient was admitted for a lower gastrointestinal bleeding and clopidogrel was stopped. A 3‐month follow‐up echocardiogram confirmed the exclusion of the LAA but it demonstrated the presence of a thrombus on the atrial surface of the device. It was decided to keep the patient on acetyl salicylic acid 100 mg with the addition of enoxaparin 60 mg bid. Transesophageal echocardiogram demonstrated total resolution of the thrombus after 2 months. © 2011 Wiley Periodicals, Inc.     

Ping-pong snaring of a totally dislodged stent across left main ostium: “All is not lost”

Undeployed stent loss is a rare but potentially serious complication of percutaneous coronary intervention. Its management is not assisted by well-defined guidelines, and it is made even more difficult when the dislodged stent is not protected by in situ guidewire. In this work, we present the case of a total stent loss with a crushed device protruding out of the left main. In this hopeless circumstance, an innovative ping-pong technique was used to contralaterally perform a successful stent retrieval.     

Early restenosis of a direct flow transcatheter aortic valve prosthesis

Due to limited case numbers, severe Direct flow™ transcatheter device restenosis is, until now, a rare event with unknown long-term incidence, but challenging several treatment strategies. This case report gives an overview of possible interventional treatment considerations in this context that might occur more often in the future due to expected valve deterioration processes in the next years.     

Rescue of CardioSEAL PFO closure device malposition with Amplatzer PFO closure device at time of initial implantation.

This case report describes a patient undergoing patent foramen ovale (PFO) closure for recurrent transient ischemic attacks. A CardioSEAL device was placed, but immediately prolapsed into the left atrium in an unstable position. We describe a novel percutaneous technique that allowed capture of the CardioSEAL device and closure of the PFO.     

Feasibility of primary clot extraction prior to percutaneous coronary intervention in acute myocardial infarction

Objectives : To test the feasibility, safety, and in‐hospital outcomes of utilizing the FilterWire EZ to extract clot prior to percutaneous coronary intervention (PCI) in patients presenting with acute myocardial infarction (MI). Background : PCI in patients with acute MI is associated with a higher incidence of distal embolization, no‐reflow, or slow flow partly due to the presence of clot burden. Methods : The authors describe the feasibility, safety, and outcomes of using a FilterWire EZ distal protection device as a clot extraction device in patients who presented with acute MI and documented clot on coronary angiography. Results : Fifteen consecutive male patients with a mean age of 54 ± 8 years presented with acute MI (60% ST elevation MI). MI involved left anterior descending artery (n = 4), circumflex artery (n = 3), and right coronary artery (n = 8). Clot extraction followed by PCI reduced the percent diameter stenosis from 94 ± 12 to 65 ± 11 (P < 0.001) and restored TIMI 3 flow in all patients without distal embolization. The angiographic, procedural, and clinical success rates were 100%. The mean left ventricular ejection fraction (LVEF) was 52 ± 8% (range 30–62%) with only three patients (15%) who had an LVEF <50% and five patients (33%) without apparent wall motion abnormalities on echocardiography. Conclusions : Clot extraction before PCI during acute MI in native coronaries is feasible, safe, and effective in restoring TIMI 3 flow without distal embolization. Whether this approach results in better outcomes and improved LV function compared with standard therapy alone requires further investigation. © 2008 Wiley‐Liss, Inc.     

血管闭合装置在经皮冠状动脉成形术后的应用

目的比较心血管病患者经皮冠状动脉成形术(PCI)后采用经皮血管闭合装置(per-close)止血与人工压迫止血的安全性和疗效。方法280例心血管病患者在行经皮冠状动脉成形术后,分为人工压迫止血组(145例)和per-close止血组(135例),观察2组止血时间、下床活动时间、术后血管并发症等。结果止血组与人工压迫组相比,止血时间与下床活动时间显著缩短,血管并发症明显减少。应用per-close的成功率达95%。结论此研究显示,PCI术后应用经皮血管闭合装置,是一个快速、有效的止血方法,缩短了止血与下床活动时间,并可减少穿刺点并发症发生率及患者不适感。     

Adjunctive use of the Rinspiration system for fluidic thrombectomy during primary angioplasty: The Rinspiration international registry

Background: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST‐elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously “rinses” the vessel with turbulent flow and aspirates thrombus. Methods: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was ≥50% ST‐segment elevation resolution (STR) measured 60 min after PCI by continuous elctrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30‐day major adverse cardiac events (MACE). Results: Mean symptom‐to‐PCI time was 4.7 ± 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush ≥2 in 78%. Rates of STR ≥ 50% and >70% at 60 min were 97 and 80%, respectively. No device‐related complications were observed. Thirty‐day MACE rate was 4.6%. Conclusions: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit. © 2008 Wiley‐Liss, Inc.     

Iatrogenic erosion of the septum primum resulting in an atrial septal defect with left‐to‐right shunt: A rare pitfall of patent foramen ovale percutaneous closure

Iatrogenic erosion of the septum primum after foramen ovale closure is an anecdotal event. We report the case of a 39‐year‐old woman admitted to our institution for multifocal cryptogenic cerebral ischemia and a patent foramen ovale (PFO) associated with an aneurysm of the septum primum. The patient underwent percutaneous closure of the PFO with an Amplatzer PFO Occluder device. At the 6‐months follow up, the device was in the right position, but a jagged defect of the septum primum and evidence of significant left‐to‐right shunting was detected. The atrial septal defect was then repaired by a surgical approach. Although this event is not life‐threatening, it should be considered as a therapeutic pitfall, resulting in a risk of paradoxical embolism recurrences and long‐term hemodynamic impairment. © 2013 Wiley Periodicals, Inc.     

Iatrogenic atrial septal defect, erosion of the septum primum after device closure of a patent foramen ovale as a new medical entity.

Iatrogenic atrial septal defects are described in 2 patients. They occurred after implantation of Amplatzer occluders to close a patent foramen ovale. While device erosions to the extra-atrial space have been described, erosion induced atrial septal defects are a new medical entity. They may be fairly common in the situation of an atrial septal aneurysm whipping the rim of the device incessantly. They are clinically silent and benign and require echocardiography for detection. A second device solved the problem in the cases described.     

The AST petal dedicated bifurcation stent: first-in-human experience.

The aim of this first-in-human study was to evaluate the feasibility and safety of the novel AST petal side-access bifurcation stent. Outcomes following percutaneous coronary intervention for bifurcations remain inferior to those of nonbifurcated lesions. Even with drug-eluting stents, restenosis occurs especially at the side-branch (SB) ostium. The petal stent uniquely deploys strut elements into the SB, supporting the ostium and carina. The primary endpoint of this 13-patient prospective registry was in-hospital major adverse cardiac events (MACE). Secondary end points included acute minimum lumen diameter (MLD) at the SB ostium, lesion success, device success, procedural success, 30-day MACE, and 4-month SB ostial MLD. The study lesion was successfully treated in 13 patients with the study stent being successfully implanted in 12. Target lesions were left anterior descending coronary artery in nine subjects, left circumflex in three, and right coronary artery in one. In-hospital MACE were limited to two non-Q-wave myocardial infarctions. In-stent main branch MLD increased from a mean of 0.63 +/- 0.45 mm to 2.61 +/- 0.47 mm at the index procedure and for this initial bare metal version of the stent, 4-month mean MLD measured 1.02 +/- 0.42 mm and there was target vessel revascularization on two patients. The feasibility of safely deploying this first-generation petal stent was demonstrated in selected patients with challenging coronary bifurcation lesions. It is a promising platform for drug delivery, with unique scaffolding of the side-branch ostium.     

PFO closure complications from the AGA registry

Objectives: To evaluate all complications that occurred during or after cardiac catheterizations for Amplatzer PFO device closure of patent foramen ovale (PFO), determine the cause of the complications and recommend techniques to minimize complications in the future. Background: Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device. Methods: A panel of independent physicians reviewed all complications reported to the manufacturer to determine whether the complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed. Results: A total of 11 events were reported. Only two patients had device related complications (erosion), an incidence of 0.018%. Two patients were found to have additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation). Conclusions: Device related complications after Amplatzer PFO occluder placement are extremely rare. Cardiac catheterization related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires, recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications. © 2008 Wiley‐Liss, Inc.     

First nine‐month complete invasive assessment (angiography,IVUS, and OCT) of the novel NEVO™ sirolimus‐eluting stent with biodegradable polymer

At present, percutaneous coronary intervention with drug‐eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long‐term safety of first‐generation DES have prompted the development of novel DES systems such as the NEVO? (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus‐eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res‐Elution I study. © 2010 Wiley‐Liss, Inc.     

Stingray CART (K14 technique): A novel antegrade dissection reentry strategy

A novel device based CART technique (K14 technique) has been described with 2 case examples to illustrate the same. This CART has been performed after ADR and Reverse-CART were unsuccessful.     

Dual-site right ventricular and left ventricular pacing in a patient with left ventricular systolic dysfunction and atrial fibrillation using a standard CRT-D device

In patients undergoing cardiac resynchronization therapy with defibrillator (CRT-D) implantation for left ventricular systolic dysfunction (LVSD) accompanied by permanent atrial fibrillation (AF), generally, the unused atrial port is plugged at device implantation. We describe an alternative use for the atrial-port in this case report.A 43 year old gentleman with LVSD due to left ventricular non-compaction (LVNC) and AF of unknown duration underwent a CRT-D implantation after optimization of cardiac failure treatment. The atrial-port which would otherwise have been plugged was connected to a high right ventricular septal (RVS) pacing-lead and the shock-lead was positioned at the right ventricular apex (RVA). This approach permitted modified cardiac resynchronization in a high RVS to left ventricular (LV) and RVA pacing sequence using the high RVS and LV pacing combined with a shock vector including the RV apex. A standard CRT-D device with a minimum programmable A–V delay of 30 ms (technically RVS to LV delay in the ‘DDD’ pacing mode) was used. The device was programmed to a ‘DDD’ pacing mode (sequential multi-site ventricular pacing with some programmability). The mode switch operation was programmed ‘OFF’ since atrial sensing is unavailable. Device-delivered shocks did not cardiovert the patient back to sinus rhythm suggesting that the AF was permanent (no prior cardioversion attempts were made on the presumption that the chances of maintaining sinus rhythm, given the underlying cardiac condition, were low). Subsequently, the patient required radio-frequency ablation of the atrio-ventricular node for conducted AF. Symptomatic, echocardiographic and radiological improvement preceded atrio-ventricular node ablation.ConclusionAmongst AF patients with permanent AF undergoing CRT-D implantation, those patients who are likely to have the CRT-D device atrial-ports plugged could benefit from having both the options of (i) a RVA shock vector as well as (ii) a high RVS-pacing feasible, by utilizing the atrial-port of a conventional CRTD device for a RVS pacing lead, should a RVA shock-lead position be preferred. New device programming algorithms will be necessary to make patient-customized programming in this lead configuration flexible, more useful clinically and easy.     

First‐in‐human report of MitraClip G4 implantation for severe degenerative mitral regurgitation

The new MitraClip G4 device (Abbott Vascular) has been recently approved by Food and Drug Administration and is currently in limited release. A patient with a large mitral regurgitation (MR) jet but a relatively small mitral valve area (MVA) was not a surgical repair candidate nor an optimal MitraClip third‐generation device candidate. Therefore, we implanted the new G4 NTW device that resulted in significant MR reduction with a 57% reduction in MVA. To our knowledge, this is the first reported clinical use of the MitraClip G4 NTW device. We find that it may provide better results than a single NTR device and less reduction in MVA than two older generation devices. Further experience is needed to optimize patient selection for the four new G4 devices available.     

Five factors and three characteristics of coronary in-stent restenosis

In the field of interventional cardiology, several patient subsets still present with poor clinical and angiographic outcomes after drug-eluting stent (DES) implantation. The author of this editorial comment supports the idea that in-stent restenosis (ISR) includes three characteristics (severity and extent of stenosis, and tissue characteristics) that are caused by five factors (device, patient, anatomy, procedure, and history). To reduce further revascularization, a tailor-made strategy may be considered in accordance with the factors and characteristics of the individual ISR lesion.     

Day procedure intervention is safe and complication free in higher risk patients undergoing transradial angioplasty and stenting. The discharge study.

OBJECTIVES: To assess the timeframe of postprocedural complications following transradial percutaneous intervention in selected nonlow-risk risk patients as a feasibility study for same day discharge. BACKGROUND: Percutaneous coronary intervention (PCI) is traditionally performed as an inpatient procedure. Transradial access with its lower complication rate facilitates safe and same day discharge. We hypothesize that with current standards of pharmacotherapy and intervention, complications post transradial percutaneous coronary angioplasty even in a nonlow-risk patient cohort will be evident within 6 hr or occur more than 24 hr post procedure. Under these circumstances, overnight stay results in no improvement in patient safety. METHODS: 2,189 patients underwent transradial PCI at our institution between January 2005 and June 2006. Of these 1,174 were assessed as intermediate or high risk and admitted postprocedure. The remaining 1,015 were assessed as low risk and discharged the day of procedure. All 1,174 inpatients were entered into our study database. Information was collected on patient demographics, angiographic characteristics, post procedural complications, and timing of post procedural events. RESULTS: 1,543 ACC type B2 or C lesions were treated in 1,174 patients. All post-procedural complications were identified within 6 hr of the intervention or occurred more than 24 hr later when patients would have been discharged according to overnight admission protocols. CONCLUSIONS: Day case transradial percutaneous intervention with a 6-hr period of post procedure observation is a safe and feasible practice. The presence of higher-risk features should not be considered an absolute indication for overnight admission in patients considered clinically appropriate for discharge.     

Device Therapies: New Indications and Future Directions

Implantable cardioverter-defibrillator (ICDs), cardiac resynchronization (CRT) and combination (CRT-D) therapy have be-come an integral part of the management of patients with heart failure with reduced ejection fraction (HFrEF). ICDs treat ventricular arrhythmia and CRTs improve left ventricular systolic function by resynchronizing ventricular contraction. De-vice therapies (ICD, CRT-D), have been shown to reduce all-cause mortality, including sudden cardiac death. Hospitaliza-tions are reduced with CRT and CRT-D therapy. Major device related complications include device infection, inappropriate shocks, lead malfunction and complications related to extraction of devices. Improvements in device design and implantation have included progressive miniaturization and increasing battery life of the device, optimization of response to CRT, and minimizing inappropriate device therapy. Additionally, better definition of the population with the greatest benefit is an area of active research.     

High-k Fluoropolymers Dielectrics for Low-Bias Ambipolar Organic Light Emitting Transistors (OLETs)

Organic light emitting transistors (OLETs) combine, in the same device, the function of an electrical switch with the capability of generating light under appropriate bias conditions. In this work, we demonstrate how engineering the dielectric layer based on high-k polyvinylidene fluoride (PVDF)-based polymers can lead to a drastic reduction of device driving voltages and the improvement of its optoelectronic properties. We first investigated the morphology and the dielectric response of these polymer dielectrics in terms of polymer (P(VDF-TrFE) and P(VDF-TrFE-CFE)) and solvent content (cyclopentanone, methylethylketone). Implementing these high-k PVDF-based dielectrics enabled low-bias ambipolar organic light emitting transistors, with reduced threshold voltages (<20 V) and enhanced light output (compared to conventional polymer reference), along with an overall improvement of the device efficiency. Further, we preliminary transferred these fluorinated high-k dielectric films onto a plastic substrate to enable flexible light emitting transistors. These findings hold potential for broader exploitation of the OLET platform, where the device can now be driven by commercially available electronics, thus enabling flexible low-bias organic electronic devices.     

Noninfarct related artery embolic protection during primary PCI

A 66‐year old man presented with antero‐lateral STEMI. An ulcerated plaque and thrombus were seen in the proximal LAD. We were unable to pass a thrombectomy catheter down the LAD. To avoid embolisation of debris a Spider FX distal protection device was placed into the circumflex artery. Following stent implantation the patient developed chest pain with inferolateral ST depression. Thrombus was extracted from the circumflex artery within the distal protection device. Noninfract related artery distal protection during primary PCI may be an appropriate safeguard where thrombectomy is not possible in an infarct‐related left coronary branch. © 2010 Wiley Periodicals, Inc.