Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices

Resnic, Frederic S.; Gross, Thomas P.; Marinac‐Dabic, Danica; Loyo‐Berríos, Nilsa; Donnelly, Sharon; Normand, Sharon‐Lise T.; Matheny, Michael E.

doi:10.1001/jama.2010.1633

Cited by 55 publications

(46 citation statements)

References 32 publications

(53 reference statements)

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“…9,22,23 To continue matching to the nearest propensity score as the monthly data sets grew, at the end of each month's analysis all matches were released, and a completely new matching was conducted at the next month's analysis. Control subjects were not allowed to match to more than 1 exposure.…”

Section: Risk Adjustment Through Propensity Matchingmentioning

confidence: 99%

“…The feasibility of performing computerized automated prospective surveillance of large clinical outcomes registries was demonstrated by Resnic et al, 9 who applied DELTA to a database of Ͼ74 000 interventional coronary procedures contained in the Massachusetts angioplasty registry. Using a variety of statistical methods, including propensity score matching, DELTA triggered a sustained alert for a specific drug-eluting stent because patients receiving this particular model were having a higher rate of periprocedural myocardial infarction than matched control patients treated with another market-released drug-eluting stent.…”

Section: Hauser Et Al Early Detection Tool 193mentioning

confidence: 99%

“…Recently, such a tool, the Data Extraction and Longitudinal Trend Analysis (DELTA) system (Coping Systems, Inc, Cambridge, MA), was applied to the Massachusetts coronary intervention registry. 9 DELTA accumulates data for multiple devices simultaneously and monitors independent data sets, using bayesian and frequentist inferential methods that have been validated on clinical trial and outcomes databases. 10 -12 Alerts are generated when the specified outcome (rate or value) exceeds the expectation or a probability value meets a prespecified level.…”

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confidence: 99%

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Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool

Hauser

Mugglin

Friedman

et al. 2012

Circ: Cardiovascular Quality and Outcomes

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Background— Postmarket medical device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable cardiac device was underperforming. Methods and Results— For this purpose, we performed simulated prospective monthly full-cohort and propensity-matched comparative survival analyses on our 3-center database of Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads, using a commercially available automated surveillance tool that was preset to trigger an alert if the log rank probability value was <0.05. During the study, 84 of 1035 Fidelis (8.1%) and 23 of 1675 Quattro (1.4%) leads failed. The simulated full-cohort analysis triggered a sustained alert for Fidelis leads beginning 13 months after the first implant and 2 years before Fidelis leads were removed from the market. Of the 1035 patients who had Fidelis leads, up to 969 (93.6%) were successfully matched to Quattro patients. In the propensity-matched analysis, the alert triggered 22 months after the first Fidelis implant and more than 1 year before the lead was recalled. Conclusions— An active automated safety surveillance system could have identified this implantable cardiovascular device problem substantially sooner than was achieved through existing postmarket surveillance methods. Such a tool, when applied to clinical registries and remote monitoring databases, may limit the exposure of large populations to underperforming and potentially hazardous cardiovascular devices.

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Section: Risk Adjustment Through Propensity Matchingmentioning

confidence: 99%

Section: Hauser Et Al Early Detection Tool 193mentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool

Hauser

Mugglin

Friedman

et al. 2012

Circ: Cardiovascular Quality and Outcomes

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“…Beyond the specific findings, the study by Resnic et al 5 represents an important advance in surveillance methodology. It principally supports the feasibility of automated monitoring for device safety signals.…”

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confidence: 94%

Achieving Meaningful Device Surveillance

Rumsfeld¹,

Peterson²

2010

JAMA

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“…It has already been demonstrated that automated safety surveillance of clinical registries for approved cardiovascular devices can provide early warnings regarding the safety of approved cardiovascular devices in clinical practice. 9 It is our belief that similar to what was carried out in the BICIS-1 study, long-term follow-up using a death index would allow safety information such as mortality to be collected prospectively without holding up an approval process. This would be of particular value for high-risk interventions where long-term mortality data are not usually available.…”

Section: Vavalle and Ohman Left Ventricular Support Systems For High-mentioning

confidence: 99%

Left Ventricular Support Systems for High-Risk Percutaneous Coronary Interventions

Vavalle

Ohman

2013

Circulation

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H igh-risk percutaneous coronary interventions (PCI) are becoming more prevalent as the ability to perform complex coronary interventions continues to improve. Patients for whom high-risk interventions are considered generally have severe diffuse coronary artery disease, a single last patent conduit, or significant left main disease with large territories of myocardial ischemia. In addition, these patients also typically have reduced left ventricular function (ejection fraction <25%-35%) with comorbidities that make them high risk for standard coronary artery bypass grafting. Thus, PCI is increasingly used as a viable alternative for coronary revascularization, but it too is associated with a high degree of morbidity and mortality. Article see p 207Coronary ischemia can transiently worsen during PCI through repeated balloon inflations, stent manipulations, and contrast injections that result in a negative inotropic effect. 1In patients with left ventricular dysfunction and large territories of ischemia who have little reserve, this can lead to reductions in blood pressure that make it hard to complete the revascularization. Hemodynamic support during the conduct of the PCI, such as that provided by intra-aortic balloon pump (IABP) counterpulsation or Impella, may therefore maintain perfusion pressure throughout the procedure to reduce the risk associated with these complex interventions.Kahn and colleagues reported the first use of intra-aortic balloon pumps to support high-risk PCI in 1990 among 28 patients with severe LV dysfunction undergoing PCI for 3-vessel or left main coronary artery disease.2 This study established that IABP support in this setting was safe and allowed the PCI to be completed without untoward risk. IABP use for this indication has continued to grow since that time and now is one of the more common reasons for IABP use in the cardiac catheterization laboratory, reflective of the growing number of high-risk PCIs being performed by interventional cardiologists. In an analysis by Brennan and colleagues from the National Cardiovascular Data Registry evaluating the use of PCI as a revascularization strategy for unprotected left main coronary artery stenosis in the United States, they demonstrated that this was being performed in almost 5% of patients with unprotected left main coronary artery stenosis, accounting for almost 6000 PCIs during the interval studied (2004)(2005)(2006)(2007)(2008). 4 Furthermore, the proportion of patients with unprotected left main coronary artery stenosis treated with PCI was increasing during that time. Among the patients included in the National Cardiovascular Data Registry, 95% of those who had unprotected left main coronary artery stenting survived to hospital discharge. However, by 30 months, >40% of these patients had died, indicating the high-risk nature of these interventions and the need for long-term follow-up.The Balloon Pump-Assisted Coronary Intervention Study (BCIS-1) was the first randomized controlled study to assess the efficacy of elective intra-...

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Automated Surveillance to Detect Postprocedure Safety Signals of Approved Cardiovascular Devices

Cited by 55 publications

References 32 publications

Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool

Early Detection of an Underperforming Implantable Cardiovascular Device Using an Automated Safety Surveillance Tool

Achieving Meaningful Device Surveillance

Left Ventricular Support Systems for High-Risk Percutaneous Coronary Interventions

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