Device-related Events Research Articles

Medical device postapproval safety monitoring: where does the United States stand?

A recent Food and Drug Administration (FDA) proposal aims to speed the evaluation process for new high-risk medical devices that are intended to address unmet medical needs,1 much like existing expedited approval processes, such as the humanitarian device exemption rule for devices intended to treat rare diseases. Such programs are strongly supported by the medical device industry and some patient advocacy groups, which have criticized the FDA for being too stringent in its evidentiary requirements for investigational devices, leading to delays in the approval of potentially helpful products.2–4 For example, in 2011, the FDA approved a transcatheter aortic valve replacement system that demonstrated significant improvements over conventional treatment options for selected patients with severe aortic stenosis.5,6 However, the United States was the 43rd country to approve the device, roughly 4 years after the European Union.7 Yet expedited approval for high-risk medical devices raises the possibility that these devices will not be as effective as predicted in their limited premarket testing or that they could cause unanticipated harms after approval.8 Of course, well-studied devices may present unexpected safety concerns years after approval,9,10 and even the most rigorous conventional premarket approval process will result in some devices later found to be unsafe or ineffective.11–13 Safety of approved medical devices and the proper scope of premarket testing remain contentious issues after recalls of several widely used devices, including popular models of implantable cardioverter defibrillator leads14,15 and metal-on-metal hip implants.16 Inherent limitations in premarket testing, along with the prospect of lowered evidentiary standards for expedited device reviews, place greater pressures on postapproval monitoring of devices to follow clinical performance and to identify emerging public health problems. Medical device manufacturers routinely perform this sort of vigilance, …

Feasibility of second-generation bioresorbable vascular scaffold implantation in complex anatomical and clinical scenarios.

BackgroundBioresorbable vascular scaffolds (BVS) have become an emerging tool to treat coronary artery disease. However, the current use of BVS is still widely restricted to stable patients and non-complex lesions. In real-world practice patients are far more complex than those with simple type A lesions and the extended use of BVS to complex lesions and high-risk patients needs to be evaluated. Therefore, we sought to investigate the feasibility and performance of BVS in a broad spectrum of patients.Methods106 patients underwent in total 193 BVS implantations. We assessed the device-related (cardiac death, target vessel myocardial infarction, ischemia-driven target lesion revascularization) and patient-related (all-cause death, any reinfarction and any revascularization) composite outcomes.Results90 % of patients (n = 95) had at least one of the following characteristics: >65 years (35 %), ACS (42 %), tortuous vessels (13 %), calcified (17 %) or thrombotic lesions (12 %), lesions defined as AHA type B2/C (42 %), bifurcations (16 %), chronic total occlusions (9 %) or restenosis (14 %). There was no evidence of significant edge dissection, huge thrombus load or incidence of scaffold dislodgement or scaffold disruption in optical coherence tomography pullbacks. Out of 10,157 struts evaluated within 1,117 cross-sections, 302 were classified as malapposed (2.9 %). During a mean follow-up of 147 ± 119 days the rate of device-related events was 2.0 %, whereas patient-related composite events occurred in 6.1 %.ConclusionsOur results strongly suggest that BVS implantation is feasible in a wide spectrum of patients and complex anatomy of coronary lesions. Long-term outcome of BVS should be further investigated in unrestricted settings in randomized controlled trials.Electronic supplementary materialThe online version of this article (doi:10.1007/s00392-014-0757-4) contains supplementary material, which is available to authorized users.

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms

This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. From March 2010 to June 2011, the INNOVATION prospective multicenter trial involving six centers in Europe enrolled and treated 60 asymptomatic patients (95% male; mean age, 74.4 ± 6.9 years) with the INCRAFT System. Main inclusion criteria included proximal aortic neck length of 15 mm or more with a diameter up to 27 mm; distal iliac landing zones with a length greater than 10 mm and a diameter between 9 and 18 mm; and aortic bifurcation >18 mm in diameter and access vessels large enough to accept the 14F outer diameter of the delivery system. The primary end point was technical success at 1 month; 2-year safety end points included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks, and maintenance of device integrity through 2 years of follow-up. Study oversight was provided by a Data Safety Monitoring Board with event adjudication by a Clinical Events Committee and imaging analysis by an independent core laboratory. Of 60 successfully treated patients, two did not come back for their 1-month evaluation but remained enrolled in the study; 56 were evaluated at 1 year and 52 at 2 years. Of the 58 patients, 56 met the 1-month primary safety and effectiveness end point (97%; 95% confidence interval, 88%-100%). All patients were free from aneurysm enlargement through 2 years. There were no type I or III endoleaks at the 2-year time point. All-cause mortality at 2 years was 11.5%, and no death was device or procedure related. In total, three patients required a postprocedure intervention, two to repair a type I endoleak and one for limb occlusion. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration and stent fractures in all patients. The INCRAFT AAA Stent Graft System provides a durable solution for patients with abdominal aortic aneurysms, with a low frequency of device-related events through 2 years of follow-up.

Disease-specific guidelines for reporting adverse events for peripheral vascular medical devices

Disease-specific guidelines for reporting adverse events for peripheral vascular medical devices

Mo1458 Endosonography-Guided Gallbladder Drainage With a Lumen Apposing Stent Reduced Recurrent Biliary Events After Acute Cholecystitis As Compared to Percutaneous Cholecystostomy

Area under the ROC curve was 0.68 (95% CI 0.540.82), p-value 0.05 Mo1457 Endoscopic Ultrasound Correlates With Histology in Patients With Chronic Pancreatitis Undergoing Total Pancreatectomy Elham Afghani*, Amitasha Sinha, Michael Cruise, Mahya Faghih, Martin a. Makary, Kenzo Hirose, Marcia I. Canto, Mouen Khashab, Anne Marie Lennon, Vikesh K. Singh GI, Johns Hopkins, Baltimore, MD; Pathology, Johns Hopkins Hospital, Baltimore, MD; Surgery, Johns Hopkins Hospital, Baltimore, MD Background: Endoscopic ultrasound (EUS) is commonly used to diagnose chronic pancreatitis (CP). However, there have been few studies which have evaluated EUS with histology. Aims: To evaluate the association between EUS scoring with the degree of fibrosis in patients with CP who have undergone total pancreatectomy (TP). Methods: All consecutive adult patients with CP (ageR18 years) who underwent preoperative EUS followed by TP from 8/2011 to 10/2013 were included. EUS criteria were defined by the 9 ductal and parenchymal features. Surgical wedge biopsies were obtained from the head and body/tail during TP and histology was evaluated by a pathologist blinded to the results of EUS. Perilobular and intralobular fibrosis scores were determined from the wedge biopsy specimen for each patient and averaged. Mild fibrosis was defined as a fibrosis score (FS) of 0-6 and severe fibrosis was defined as FS of 7-12. The association between FS and EUS criteria was evaluated using Pearson’s correlation coefficient. The diagnostic accuracy of EUS for predicting severe fibrosis was assessed using the area under receiver operating characteristic curve (AUROC). Results: There were 29 patients (68.9% females, mean age of 44 12 years). All patients underwent EUS at mean time of 27.6 15.3 weeks prior to TP. There were 8 (27.5%) patients with calcifications. There were 13 (44.8%) patients with mild and 16 (55.2%) with severe fibrosis. There was a significant correlation between FS and EUS criteria (rZ0.57, 95% CI 0.28, 0.78, p!0.001) as seen in Figure 1. The diagnostic accuracy of EUS for predicting severe fibrosis by AUROC was 0.65 (95% CI 0.45, 0.85). An EUS cut-off of R6 criteria had a sensitivity of 37.5% but specificity and positive predictive value of 100% for severe fibrosis. Conclusion: EUS correlates with fibrosis but no criteria threshold is accurate enough to predict severe fibrosis. AB444 GASTROINTESTINAL ENDOSCOPY Volume 79, No. 5S : 2014 Mo1458 Endosonography-Guided Gallbladder Drainage With a Lumen Apposing Stent Reduced Recurrent Biliary Events After Acute Cholecystitis As Compared to Percutaneous Cholecystostomy Anthony Y. Teoh*, Takao Itoi, Philip W. Chiu, Raymond S. Tang, Charing C. Chong, Enders K. NG, Francis K.L. Chan, James Y. Lau Surgery, Chinese University of Hong Kong, Hong Kong, Hong Kong; Tokyo Medical University Hospital, Tokyo, Japan; Institute of Digestive Disease, Hong Kong, Hong Kong Background: Endosonography-guided gallbladder drainage (EGBD) has been shown to be feasible in previous studies. However, how the approach compares to percutaneous cholecystostomy (PTC) in patients who were unsuitable for surgery is uncertain. Methods: This was a retrospective case-controlled study of all patients who suffered from acute cholecystitis and were deemed high-risk for surgery, that were admitted to the Prince of Wales Hospital between January 2010 and November 2013. The patients that received EGBD were matched with those that received PTC based on sex, age and American society of anesthesiology grading. EGBD was performed using a linear echoendoscope (GF-UCT180 Olympus, Japan) and a lumen apposing stent (AXIOS, Xlumena, CA, USA) was used to drain the gallbladder in to the stomach or duodenum. Outcome measurements included technical and clinical success, morbidities, mortalities, the number of device-related events and unplanned admissions. Results EGBD was performed in 18 patients and they were case-matched with 18 patients who received PTC. There were no significant differences in background demographics between the EGBD and PTC groups(Table 1). All procedures were technically successful and clinical success was obtained in 88.9% and 94.4% of the patients respectively. 11 patients in the EGBD group underwent cholecystoscopy and all stones were removed in 81.8% of the patients. There were no differences in morbidities (33% vs 33.3%, P Z 1) and mortalities (11.1% vs 5.6%, P Z 1). Patients who underwent PTC suffered from significantly more device related events (61.1% vs 16.7%, P Z 0.015) and required more unplanned admissions (2.11 +/2.32 vs 0.11 +/0.47, P Z 0.002). The causes of device-related events in the PTC group included dislodgement, slipping of anchoring sutures and peri-tubal leak. Conclusion: EGBD and PTC were both effective means of obtaining gallbladder drainage. In the absence of a percutaneous tubing, EGBD was associated with reduced number of device-related events and unplanned admissions. Furthermore, EGBD allowed for removal of gallstones after the procedure. Comparison of outcomes between EGBD and PTC. EGBD N [ 18 PTC N [ 18

Early experience with ovation endograft system in abdominal aortic disease

ObjectiveWe describe our initial experience with the use of the TriVascular Ovation endograft system for the treatment of abdominal aortic aneurysms (AAA).MethodsWe retrospectively reviewed data from patients treated for AAA using the Ovation endograft at two institutions from January 2011 to September 2012. Main outcomes included primary success, survival, complications, and device-related events. The mean follow-up period was 10 months (range 1–22 months).ResultsThirty-seven patients (male: 95%, mean age: 76 yr) were treated for AAA (mean diameter: 54 mm) with the Ovation endograft. Local or regional anesthesia was used in 86.5% of cases. Percutaneous access was utilized in 73% of cases. Primary success was 89.2% (33/37). Four adjunctive procedures were required including two distal extensions (type 1b endoleak and iliac limb disconnection resulting in type III endoleak) and two bypass surgeries (limb graft occlusion and gate cannulation failure). No deaths or major complications were reported during the procedure or in follow-up. No type I, III, or IV endoleak, AAA enlargement, AAA rupture, stent fracture, migration, or endovascular or surgical reintervention were reported during the follow-up period. Type II endoleak was observed in two patients. Asymptomatic narrowing of both iliac limbs was observed in one patient at 6 months.ConclusionsOur initial experience with the Ovation endograft demonstrated encouraging results in patients with AAA.

Effectiveness of remote monitoring of cardiac implantable electronic devices in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry

We read with great interest the article recently published by Dr Ricci et al. 1 entitled ‘Effectiveness of remote monitoring of cardiac implantable electronic devices (CIEDs) in the detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry’. The major favourable impact of Home monitoring (HM) in the management of patients with CIEDs, and particularly in patients with implantable cardiac defibrillators (ICDs), is now well established, as HM reduces the mean reaction time to major cardiovascular events and device malfunction than hospital visits. HomeGuide Registry indicates a time of 55.5 min/health personnel/100 patients/month for reviewing HM sessions. Now, considering that this study included both pacemakers (PMs) and ICDs, and that ICDs and ICD-cardiac …

Risks Associated With Conventional Humidifiers Adapted for High-Flow Nasal Cannula Therapy in Human Infants: Results of a Time and Motion Study

Background: High-flow nasal cannula (HFNC) therapy was introduced into neonatology with novel heating-humidification technology; however, the therapy is currently being applied with adapted conventional humidifiers. Managing the rainout from these adapted systems is labor intensive and may be associated with water aspiration. A time and motion study was designed to evaluate the workflow needs and operational costs between a dedicated, integrated HFNC platform (Vapotherm Precision Flow; VT) and adapted conventional humidifier technology (Fisher & Paykel MR850; FP). Methods: Workflow was evaluated on HFNC devices in routine use. Observations were over 8 hours and staff self-reported device interactions. Workflow parameters included clearing condensate, need for suctioning, interface/tubing changes and charting. Device-related events that impacted workflow included the incidence of water in the airway, irritation and clinical sequelae. Data are reported as the mean number of contacts per device in an 8-hour shift. Results: A total of 48 FP observations and 61 VT observations were collected across three sites. FP showed more therapist interventions (4.5 ± 1.5 vs. 1.5 ± 0.6; P < 0.001), and total unscheduled interventions (1.1 ± 1.6 vs. 0.3 ± 0.7; P < 0.001) compared to VT. Of the interventions, FP required draining tubing 2.1 ± 1.0 times vs. 0 ± 0 with VT (P < 0.001). Rainout aspiration from the FP was associated with the 0.7 ± 1.5 device-related clinical events, versus 0 ± 0 events seen with VT (P < 0.001). Conclusions: HFNC using FP was associated with greater staff workload and patient risk related to the management of the rainout compared with VT. Thus, there may be an unaccounted cost beyond circuit price with the use of conventional technologies for the administration of HFNC. Int J Clin Pediatr. 2014;3(4):99-104 doi: http://dx.doi.org/10.14740/ijcp172w

Healthcare cybersecurity risk management: keys to an effective plan.

Healthcare cybersecurity risk management: keys to an effective plan.

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Introduction: In addition to traditional incident reporting, the MMC can augment the ability to surface AEs. Our objective is to determine the types, severity and preventability of AEs uncovered among patients discussed in a tertiary hospital PICU MMC over a specific time period and compare these with AEs reported for the same cohort through the hospital incident reporting system, the Patient Safety Network (PSN). Methods: Two independent reviewers conducted a systematic retrospective record review of patients discussed in the MMC over 8 months (Nov2011-June2012). AEs were identified and categorized as to type, severity and preventability. Discrepancies were resolved by 2nd-tier review with a PICU attending and nurse. Comparison with AEs reported via the PSN for the same cohort was performed. Descriptive statistical analysis was done, calculating proportions for categorical variables. Results: 48 cases were reviewed with 212 total AEs identified from either the MMC or PSN (4.4 AEs/patient, 29 AEs/100 patient-days). 169/212(79.7%) AEs were identified via the MMC, of which 85/169(40.1%) were specified in the MMC agenda, while 84/169(49.7%) were uncovered via chart review. 52/212(24.5%) AEs were identified via the PSN. Only 9/212(4.2%) AEs were identified through both the MMC and PSN. The most common types of AEs were similar for each group - medication errors (MMC 31.9%, PSN 51.9%), device-related events (MMC 16.0%, PSN 17.3%), and communication issues (MMC 14.2%, PSN 26.9%). MMC AEs were more severe with 60.6% requiring prolonged hospitalization/life-sustaining therapy or contributing to permanent harm/death. PSN AEs were less severe with 61.5% causing no harm and 28.9% causing only temporary harm. MMC AEs ranged in preventability, with 30% certainly preventable and 36.3% likely not preventable. PSN AEs were 98.1% preventable with no non-preventable cases reported. Conclusions: The PICU MMC with targeted chart review is a useful adjunct for AE surveillance in addition to traditional incident reporting. Overlap between the two is minimal, with the MMC providing data on unique, more severe, yet still preventable AEs. Combining data from the two systems results in more accurate AE surveillance.

ICD function and dysfunction in patients with arrhythmogenic cardiac diseases: the role of home monitoring

Background Since their implementation in clinical practice, remote home monitoring systems (HM) have undoubtedly become an added value in patients with implantable devices for cardiac rhythm management. The aim of this study was to investigate the impact of HM on clinical management and outcome in patients with channelopathies and other arrhythmogenic diseases who received an implantable cardioverter defi brillator (ICD).Methods Fifty-four patients (age 6 months - 74 years) were followed by means of HM in our ICD clinic. Alerts and/or device-related clinical events were analysed in all patients and subsequent clinical decisions were made if indicated.Results During an average observation time of 27 months, 46 alerts were received from 32 diff erent patients. Five patients (9%) received appropriate therapies for life-threatening arrhythmias and four patients (8%) inappropriate therapies because of T wave oversensing or supraventricular tachycardias. Three patients had alerts due to electrical noise (two on the atrial, one on the ventricular channel). Overall, 18 alerts (39%) required a modifi cation of the pharmacological therapy or the programming of the device. Mean anticipation of clinical visits based on the alerts was 92.6 ± 56 days (median 97, interquartile range 50-150).Conclusion HM substantially improves the clinical management of patients with cardiac arrhythmogenic disease by early recognition of devicerelated inappropriate therapies and subsequent anticipation of treatment adaptation.

Role of home monitoring in children with implantable cardioverter defibrillators for Brugada syndrome

Implementation of remote home monitoring systems (HM) in clinical practice has become undoubtedly an added value for all patients with implantable cardiac devices. The aim of this study was to investigate the impact of HM in a population of children with Brugada syndrome (BS) who received an implantable cardioverter defibrillator (ICD). Eleven children (age between 6 months and 18 years) implanted with an ICD were followed either by means of HM and with conventional in-hospital visits in our centre. Alerts and/or device-related clinical events were recorded, analysed, and subsequent clinical decisions were made if needed. During an average observation time of 26 months a total of 16 relevant alerts (13 pre-emptive alerts) were recorded in seven patients of our population. One patient experienced appropriate therapies for life-threatening ventricular arrhythmias. Three patients experienced inappropriate therapies due to supraventricular tachycardia and lead dislodgement. By means of HM two patients were discovered to have lead problems because of dislodgement or lead fracture. Mean anticipation of treatment based on the alerts was 76 ± 59 days. Remote monitoring systems substantially improve the proper management of children with BS.

Remote monitoring of patients with cardiac implantable electronic devices: maximizing gains by addressing workflow

This editorial refers to ‘Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry’ by R.P. Ricci et al. , on page 970 and ‘Incidence and predictors of pacemaker reprogramming: potential consequences for remote follow-up’ by E.O. Udo et al. , on page 978. Innovations are usually greeted guardedly, especially those demanding changes in clinical habits. When and how these should be applied are obvious questions to physicians and patients alike. Automatic remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is no exception, over a decade after its introduction. This, despite the need stated by professional societies and impressive trial data.1–3 However, diffidence in the community is reflected in slow adoption. In this issue of the Journal , two large (>1500 patients) prospective registries address some critical aspects of the operating mechanics of this technology. First, Udo et al. 4 aimed to define the candidate population for RM (although, importantly, did not actually test its application). They measured the frequency of non-actionable follow-up encounters in a large cohort of patients with pacemakers. This concept is critical—remote follow-up can only replace conventional in-person scheduled evaluation if the bulk of such appointments do not trigger any changes in patient management, i.e. are ‘non-actionable’. If, on the other hand they are frequently actionable, then discoveries from remote data download will require those patients to be contacted and brought to hospital, duplicating effort rather than promoting efficiencies. The results, however, confirmed that the vast majority (>80%) of patients studied did not need reprogramming changes (‘visits-with-reprogramming’), in keeping with conclusions from implantable cardioverter-defibrillator (ICD) trials. The authors looked at this from another vantage—whether it is possible to identify those patients at high risk of requiring management changes and assign these to …

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)

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.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.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.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.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).

Implantation of an individually computer-designed and manufactured external support for the Marfan aortic root

For the operation of 'personalized external aortic support' (PEARS), the dimensions of the individual patient's aorta are taken from the preoperative MRI or CT digital images. They are used in computer-aided design to make a three-dimensional computer image of the individual patient's aorta. A physical model of the patient's aorta is made of thermoplastic, using a standard engineering process of rapid prototyping. On this physical model is manufactured an external support made of a medical grade polymer fabric mesh with 0.7&emsp14;mm pore size. This fabric is placed around the ascending aorta from the aortoventricular junction to beyond the brachiocephalic artery. Follow-up is complete for the first 34 patients (June 2004 to November 2012) to a total of 127 patient-years. Since we submitted this paper, we have had an early death (the 34th patient) as a result of intraoperative injury to the left main coronary artery. The remaining 33 patients are alive and well from 3 to 103 months free from aortic, aortic valve or device-related events.

Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry

AimsThe HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management.Methods and resultsThe workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients.ConclusionHome Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.

Intracoronary Hemodynamic Effects of Pressure‐Controlled Intermittent Coronary Sinus Occlusion (PICSO): Results from the First‐In‐Man Prepare PICSO Study

Myocardial reperfusion is frequently suboptimal after ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI). Using a balloon-tipped catheter positioned in the coronary sinus (CS), pressure-controlled intermittent coronary sinus occlusion (PICSO) results in an intermittent obstruction of coronary venous outflow of the left anterior descending artery (LAD), and may improve myocardial perfusion by augmenting redistribution of blood to the border zone of ischemic myocardium. We sought to document the intracoronary hemodynamic effects of PICSO during PCI. We included 15 patients with stable angina scheduled for PCI of the LAD. Balloon occlusion of the LAD was performed twice, once with and once without PICSO and lasting maximally 3 minutes each, to document the effect of PICSO on CS pressure and LAD wedge pressure. Catheter delivery was successful in all patients. The study protocol could not be conducted in 5 patients due to initial calibration difficulties (n = 3), a pressure wire problem (n = 1), and a vagal response at the start of the procedure (n = 1). In the remaining 10 patients, CS occlusion caused a marked increase in mean CS pressure (4.1 ± 7.3 mmHg vs. 22.0 ± 12.6 mmHg; P < 0.001) and CS pulse pressure (4.3 ± 0.8 mmHg vs. 36.1 ± 6.3 mmHg; P < 0.001). Concomitantly, mean distal LAD wedge pressure and wedge pulse pressure increased (32.4 ± 12.2 mmHg vs. 35.5 ± 12.6 mmHg; P < 0.001 and 39.1 ± 27.2 mmHg vs. 45.9 ± 26.0 mmHg; P < 0.001, respectively). At 30 day follow-up, no device-related events occurred. PICSO safely augments CS pressure, thereby increasing LAD coronary wedge pressure. These findings support further evaluation of PICSO in the setting of STEMI.

External aortic root support for the Marfan aorta: anatomically normal coronary orifices imaged seven years after surgery†

The occurrence of angina necessitated investigation of a patient seven years after an operation to protect his dilated Marfan aorta. The customized support, manufactured by a process of computer-aided design, had been fitted in May 2004 when the aortic root measured 49 mm. The magnetic resonance imaging appearances of the aorta remained unchanged over a postoperative period of 7 years and he remained completely well until he began to experience exercise-related angina in 2011. Coronary angiography showed the cause of angina to be an atherosclerotic left anterior descending coronary artery stenosis which was successfully stented. Aortography and coronary angiography performed at that time showed widely patent coronary orifices with no sign of impingement of the external support on the smooth lumen of his coronary arteries. The soft pliant nature of the textile from which the support was made, its intimate fit to the aorta and porous nature allowing incorporation into the aortic adventitia were deliberately built into the design. Nevertheless it was affirming to see these features realized on imaging seven years later. The patient is again completely well and angina free. He is one of a consecutive series of 30 patients who have had this device. There have been no device-related events in over 100 patient/years of follow-up, and all the patients remain alive and well.

Long-Term Complications Related to Biventricular Defibrillator Implantation

Background— Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome. Methods and Results— We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P =0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P =0.682). Conclusions— In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01007474.

Safety of Percutaneous Left Atrial Appendage Closure

Background— The Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) randomized trial compared left atrial appendage closure against warfarin in atrial fibrillation (AF) patients with CHADS 2 ≥1. Although the study met the primary efficacy end point of being noninferior to warfarin therapy for the prevention of stroke/systemic embolism/cardiovascular death, there was a significantly higher risk of complications, predominantly pericardial effusion and procedural stroke related to air embolism. Here, we report the influence of experience on the safety of percutaneous left atrial appendage closure. Methods and Results— The study cohort for this analysis included patients in the PROTECT AF trial who underwent attempted device left atrial appendage closure (n=542 patients) and those from a subsequent nonrandomized registry of patients undergoing Watchman implantation (Continued Access Protocol [CAP] Registry; n=460 patients). The safety end point included bleeding- and procedure-related events (pericardial effusion, stroke, device embolization). There was a significant decline in the rate of procedure- or device-related safety events within 7 days of the procedure across the 2 studies, with 7.7% and 3.7% of patients, respectively, experiencing events ( P =0.007), and between the first and second halves of PROTECT AF and CAP, with 10.0%, 5.5%, and 3.7% of patients, respectively, experiencing events ( P =0.006). The rate of serious pericardial effusion within 7 days of implantation, which had made up &gt;50% of the safety events in PROTECT AF, was lower in the CAP Registry (5.0% versus 2.2%, respectively; P =0.019). There was a similar experience-related improvement in procedure-related stroke (0.9% versus 0%, respectively; P =0.039). Finally, the functional impact of these safety events, as defined by significant disability or death, was statistically superior in the Watchman group compared with the warfarin group in PROTECT AF. This remained true whether significance was defined as a change in the modified Rankin score of ≥1, ≥2, or ≥3 (1.8 versus 4.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.24 to 0.82; 1.5 versus 3.7 events per 100 patient-years; relative risk, 0.41; 95% confidence interval, 0.22 to 0.82; and 1.4 versus 3.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.22 to 0.88, respectively). Conclusion— As with all interventional procedures, there is a significant improvement in the safety of Watchman left atrial appendage closure with increased operator experience. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00129545.