News from InHealth

Radionuclide and hybrid imaging of recurrent prostate cancer

Mon, 31 Jan 2011 00:00:00 EST

Prostate cancer is one of the most common cancers in men, leading to substantial morbidity and mortality. After definitive therapy with surgery or radiation, many patients have biochemical relapse of disease—ie, an increase in their prostate-specific antigen level—which often precedes clinically apparent disease by months or even years. Therefore, imaging of the site and extent of tumour recurrence (local, regional, distant, or a combination) is of great interest. Conventional morphological imaging methods showed limited accuracy for assessment of recurrent prostate cancer; however, in recent years, functional and molecular imaging have offered the possibility of imaging molecular or cellular processes of individual tumours, often with more accuracy than morphological imaging. Hybrid imaging modalities (PET—CT, and single-photon emission CT [SPECT]—CT) have been introduced that combine functional and morphological data and allow whole-body imaging. Here, we review the contribution of radionuclide imaging and hybrid imaging for assessment of recurrent prostate cancer (local vs regional vs distant disease). We discuss available data on PET—CT and SPECT—CT, and provide an overview of experimental tracers and their preclinical and clinical development. Finally, we present a perspective on the potential of future hybrid magnetic resonance—PET imaging.

http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(10)70103-0/abstract?rss=yes

Podcast: Dr. Peter Neumann

Mon, 31 Jan 2011 00:00:00 EST

Peter J. Neumann, ScD, director of the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center discusses his recent study published online in the journal Health Economics, which examined individuals’ willingness to take and pay for hypothetical predictive laboratory tests in which there would be no direct treatment consequences. InHealth Vice President for Programs Steve Halasey moderates.

Play Audio(neumann1-31-11)

Lung cancer in 2010: One size does not fit all

Mon, 31 Jan 2011 00:00:00 EST

Lung cancer remains the leading cause of cancer-related mortality in the USA, with an estimated 222,520 new cases and 157,300 deaths anticipated in 2010.1 Just 15 years ago, most patients with advanced non-small-cell lung cancer (NSCLC) received no anti-cancer therapy at all.

http://feeds.nature.com/~r/nrclinonc/rss/current/~3/HaYcNRbipKc/nrclinonc.2010.224

Surgery: Delays may improve outcomes

Mon, 31 Jan 2011 00:00:00 EST

In patients with resectable squamous cell carcinoma (SCC) of the esophagus, the standard of care is surgical resection. This treatment has been augmented by the addition of neoadjuvant chemoradiotherapy, but the optimal time between chemoradiotherapy and surgery has never been identified.

http://feeds.nature.com/~r/nrclinonc/rss/current/~3/atxCDnr-vU4/nrclinonc.2010.214

{issue:2}

{volume:8}

{pages:62-62}

Duke-UNC-CH team testing diagnostic tool

Mon, 31 Jan 2011 00:00:00 EST

Jan. 31, 2011 (McClatchy-Tribune Regional News delivered by Newstex) — Scientists at Duke University and UNC-Chapel Hill have teamed to test a new diagnostic tool that may offer a more accurate way of identifying precancerous cells in the esophagus.

The tool, a tiny light and sensors on an endoscope, was developed by biomedical engineers at Duke University and successfully tested on patients during a clinical trial at UNC-CH.

The device could offer a less invasive method for testing patients suspected of having Barrett’s esophagus, a change in the lining of the esophagus caused by stomach acid seeping into the esophagus. The disorder, which afflicts more than 1percent of the U.S. population, can be a precursor to cancer, making early identification important.

Using an endoscope to reach the esophagus via the nose, physicians shine short bursts of light at locations of suspected disease and sensors capture and analyze the light as it’s reflected back.

“By interpreting the way the light scatters after we shine it at a location on the tissue surface, we can spot the telltale signs of cells that are changing from their healthy, normal state to those that may become cancerous,” said Neil Terry, a Ph.D. student working in the laboratory of Adam Wax, associate professor of biomedical engineering at Duke’s Pratt School of Engineering, who developed the device. The team published their findings online in the January issue of the journal Gastroenterology.

“Specifically, the nuclei of precancerous cells are larger than typical cell nuclei, and the light scatters back from them in a characteristic manner,” Terry said. “When we compared the findings from our system with an actual review by pathologists, we found they correlated in 86 percent of the samples.”

UNC gastroenterologist Dr. Nicholas Shaheen conducted the preliminary clinical trial of the device on 46 patients with Barrett’s esophagus.

“Currently, we take many random tissue samples from areas we where we think abnormal cells may be located,” Shaheen said. “This new system may make our biopsies smarter and more targeted,” Shaheen said. “Early detection is crucial, because the cure rate for esophageal cancer that is caught early is quite high, while the cure rate for advanced disease is dismal, with a 15 percent survival rate after five years.”

Davidson professor honored as mentor

President Barack Obama has named Julio Ramirez, a psychology professor at Davidson College, to receive the Presidential Award for Excellence in Science, Mathematics and Engineering Mentoring.

Ramirez has spent 30 years conducting research with students on neuroscience and recovery from brain injury. He joined the Davidson faculty in 1986 and has involved more than 100 students as research colleagues in his research, according to the college. Many of his students have co-authored research papers for scientific journals.

The mentoring award are administered by the National Science Foundation on behalf of the White House. Recipients are honored at the White House and receive awards of $10,000 to advance their mentoring efforts. Staff reports

Newstex ID: KRTB-0170-100283867

The end of our National Health Service

Sat, 29 Jan 2011 00:00:00 EST

There is a crisis in the National Health Service (NHS). The publication of the Health and Social Care Bill last week heralds dramatic changes for the NHS, which will affect the way public health and social care are provided in the UK. Those changes alone will have huge impact, but it is the formation of an NHS Commissioning Board, and commissioning consortia, that will once and for all remove the word “national” from the health service in England. The result, due to come into force in 2013, will be the catastrophic break up of the NHS.

Maintaining the status quo in the NHS is not an option. The NHS is not delivering the care that patients need. Patients with cancer, for example, are less likely to survive in the UK than in Australia, Canada, Sweden, or Norway. Michel Coleman and colleagues’ Lancet Article, published last month, reports that the survival of patients with primary colorectal, lung, breast, or ovarian cancer is lower in the UK than in other countries with similar wealth, universal access to health care, and good cancer registration data. Survival is, they argue, “the key index of the overall effectiveness of health services in the management of patients with cancer”.

Despite the huge sums of money pumped into the NHS over the past few years—particularly into the salary budget for staff—translation into benefits for patients is hard to identify. Moreover, the unyielding mountain of bureaucracy that is integral to the NHS stifles innovation, such that it is difficult to design the services needed for local populations.

Will the changes outlined in the Health and Social Care Bill solve these problems within the NHS and improve care for patients? The truth is that we do not know. What we do know is that putting general practitioners (GPs) in charge of commissioning health services for their patients is similar, in some respects, to the fundholding experiment in the 1990s. The principle then was that GPs controlled the budgets to buy the specialist care their patients needed. Fundholding took years to implement, but evidence on short-term or long-term benefits for patients is lacking. In the current Bill, health outcomes, including prevention of premature death, will be the responsibility of the NHS Commissioning Board, which has been asked to publish a business plan and annual reports on progress. That business plan is urgently needed to allow transparent appraisal of how the Board plans to monitor patients’ outcomes.

The UK coalition Government has now been in power for about 8 months. Neither the Conservatives nor the Liberal Democrats included the formation of an NHS Commissioning Board, or GPs’ commissioning consortia, in their health manifestos on which the electorate voted. The speed of the introduction of the Health and Social Care Bill is surprising, especially given the absence of relevant detail in the health manifestos. The Conservatives promised, if elected, to scrap “politically motivated targets that have no clinical justification” and called themselves the “party of the NHS”—a commitment that seems particularly hollow now.

Since its establishment in July, 1948, the aim of the NHS has been to offer a comprehensive service to improve health and prevent illness, available to all in England and Wales (and then extended throughout the UK), which is largely free of charge. Health care for all, for free, has been the common ethos and philosophy throughout the NHS. On July 3, 1948, in an editorial entitled “Our Service”, The Lancet commented: “Now that everyone is entitled to full medical care, the doctor can provide that care without thinking of his own profit or his patient’s loss, and can allocate his efforts more according to medical priority. The money barrier has of course protected him against people who do not really require help, but it has also separated him from people who really do.” Now, GPs will return to the market place and will decide what care they can afford to provide for their patients, and who will be the provider. The emphasis will move from clinical need (GPs’ forte) back to cost (not what GPs were trained to evaluate). The ethos will become that of the individual providers, and will differ accordingly throughout England, replacing the philosophy of a genuinely national health service.

Health professionals cannot say that no change is needed—it most certainly is. But there is sufficient uncertainty and concern about the changes outlined in the Health and Social Care Bill to pause, to learn from the past, and to consider what the changes mean for patients’ outcomes. As it stands, the UK Government’s new Bill spells the end of the NHS.

(20K) Press Association Images

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60110-4/fulltext?rss=yes

Hypertension: The Symplicity of renal denervation for patients with treatment-refractory hypertension

Sat, 29 Jan 2011 00:00:00 EST

A new study published in The Lancet has demonstrated that catheter-based renal sympathetic denervation is a viable treatment option for patients with uncontrolled high blood pressure. Short bursts of low-power radiofrequency to the main renal arteries can reduce sympathetic activity and renin release, leading to a decrease in blood pressure and preventing sequelae of hypertension.

http://feeds.nature.com/~r/nrneph/rss/current/~3/sixImERknM0/nrneph.2010.181

What is publication? The case of eltrombopag

Sat, 29 Jan 2011 00:00:00 EST

The birth and rapid growth of the internet has revolutionised many areas of publishing. In most scientific and medical publications, the written word is still consigned irrevocably to the printed page, with errors needing to be addressed by cumbersome corrections, often several weeks or months after the event. Many documents are now first published online followed by print publication, however, and e-publication permits corrections to be made swiftly. This development raises the question of under what circumstances changes to scholarly publications should be made. Should scientific papers—which often require much work by both authors and editors to present research findings clearly and to address issues raised by peer reviewers—remain as sacrosanct as they were at the date of first publication? Or should the new plasticity offered by e-publication be used to allow refinement of published articles as facts or interpretations might change over time?

(69K) Corbis

On Aug 24, 2010, Gregory Cheng and colleagues1 published an article online on The Lancet’s website, reporting on eltrombopag for management of chronic immune thrombocytopenia. Soon after online publication, the authors contacted the journal noting that they wished to correct an error in the paper’s discussion. The word “splenectomised” had been omitted in error from a sentence in the discussion concerning responses to treatment with another drug, romiplostim. More surprisingly, the authors expressed a desire to excise from the same section of the paper a comparison between durable responses to eltrombopag in Cheng and colleagues’ randomised trial and those to romiplostim in a separate trial published in 2008.2 The two drugs are both on the market for treatment of chronic immune thrombocytopenic purpura, and are sold by GlaxoSmithKline and Amgen, respectively. Cheng and colleagues’ study was funded by GlaxoSmithKline, and five of the nine authors (Sandra Vasey, Bhabita Mayer, Manuel Aivado, Michael Arning, and Nicole Stone) are quoted as being employees of, and owning equity in, GlaxoSmithKline. The two published articles share one common author, James Bussel.

In a post-hoc analysis, Cheng and colleagues had noted that 51% of splenectomised patients had a durable response to eltrombopag, by comparison with less than 40% in a group of patients on romiplostim, who should also have been identified as splenectomised. On Oct 4, however, the authors wrote to The Lancet’s editors that “Since the online publication of our paper, the authors have received feedback from Amgen that the post-hoc analysis on durable response and the comparison made to romiplostim data lends itself to conclusions that may not be appropriate.” Further discussions between the authors then apparently led to uncertainty about the scientific appropriateness of their post-hoc analysis of durable response that had been published in electronic form. In an unpublished letter to The Lancet, Cheng and colleagues laid out their new concerns about differences between the two trials in terms of duration of treatment received by patients analysed, the frequency at which platelet counts were obtained, definition of durable response, and use of concomitant treatments, and said that they felt that, in view of these differences, comparison of responses to the two drugs could be misleading. Having noted that the comparison of the long-term efficacy of eltrombopag and romiplostim had been added to the paper at the request of peer reviewers, Cheng and colleagues asked whether the post-hoc analysis might be removed from the paper entirely, or whether relevant sections could be reworded to emphasise these differences and to clarify the definition of durable response.

The Lancet’s editors have decided that Cheng and colleagues’ paper should be published in exactly the same form as it appeared online, accompanied by a Department of Error in the Correspondence section detailing the changes the authors wish to make to the paper. Both of these components are published alongside this Comment. This approach occasions some regrets, because it means that an opportunity to correct some minor errors in the electronic and printed versions of the paper has been lost. It does, however, mean that readers will not be confused by different versions of a published article that they might read or have read. The Lancet’s policy is that minor inadvertent errors detected after e-publication can be corrected in both electronic and printed versions of a given piece, accompanied by a Department of Error explaining the changes made. Substantial changes will not be made without careful thought, and indeed possible reconsultation with peer reviewers, however. In particular, matters of interpretation will not be altered. We welcome readers’ thoughts on the issues raised by this situation.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60024-X/fulltext?rss=yes

Study: Device Recalls in Europe, U.S. Occur at Similar Rates

Fri, 28 Jan 2011 00:00:00 EST

No Safety Benefit from Slower, More-Burdensome FDA Process

A report released by industry association AdvaMed (Washington, DC) indicates that medical device recalls in Europe and the United States occur at about the same rate, even though the approval process in the United States takes significantly longer.

“It’s well documented that it takes longer to bring medical technology to market in the United States than it does in Europe,” said Stephen J. Ubl, AdvaMed president and CEO. “Today’s report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety.”

The report examines the rate of safety recalls for medical devices in Europe from 2005 through 2009 and compares them with the level of similar recalls in the United States. Among the tens of thousands of devices on the market, the study focused on products recalled because of significant health risks. It found an average recall rate in Europe of just 21 devices per year—almost identical to the rate of equivalent recalls in the United States.

“The results of this study suggest little difference between absolute number of serious recalls between the U.S. and EU regulatory systems,” the report says. “The distribution of the serious recalls is similar across therapeutic areas and reasons for recall, suggesting that differences between the two systems do not ultimately affect performance.”

FDA data show that the time required to review and approve a product in the United States has increased substantially in recent years. The report comparing U.S. and EU recall rates appeared less than two weeks after release of the Medical Technology Innovation Scorecard by PricewaterhouseCoopers (PwC), which showed that regulatory approval times in the United States now rank close to the bottom—seventh out of the nine competitor nations that PwC studied. And a recent study by Stanford professor Josh Makower, MD, reported that on average FDA reviews for 510(k) products take two years longer from the point of initial communication with the regulatory agency than reviews for similar products in Europe. For PMA devices, the gap climbs to more than three and a half years.

“FDA should focus on resolving key performance issues to provide patients timely access to life-saving and life-changing medical technology and improve American competitiveness,” Ubl said. “We believe FDA is beginning to recognize these problems and that U.S. policymakers in both parties want to reverse these recent trends. Medical technology companies are committed to working with FDA to improve the efficiency of the review process while continuing to assure that products are safe and effective.”

The AdvaMed-sponsored report was prepared by Scott Davis, Erik Gilbertson and Simon Goodall of Boston Consulting Group, a global business management consulting firm.

Meta-analysis of skeletal mandibular changes during Frankel appliance treatment

Thu, 27 Jan 2011 00:00:00 EST

The purpose of this study was to perform a meta-analysis of articles to verify the mandibular changes produced by the Fränkel-2 (FR-2) appliance during the treatment of growing patients with Class II malocclusions when compared with untreated growing Class II subjects.

The literature published from January 1966 to January 2009 was reviewed with search engines. A quality analysis was performed. The effects on primary end points were calculated with random-effect models. Heterogeneity was assessed using Q statistic and investigated using study-level meta-regression.

A total of nine articles were identified. The quality of the studies ranged from low to medium. Meta-analysis showed that the FR-2 was associated with enhancement of mandibular body length [0.4 mm/year 95 per cent confidence interval (CI) 0.182-0.618], total mandibular length (1.069 mm/year, 95 per cent CI 0.683-1.455), and mandibular ramus height (0.654 mm/year, 95 per cent CI 0.244-1.064). A consistent heterogeneity among studies was found for all the considered linear measurements.

The FR-2 appliance had a statistically significant effect on mandibular growth. Nevertheless, the heterogeneity of the FR-2 effects, the quality of studies, the differences in age, skeletal age, treatment duration, and the inconsistent initial diagnosis seem to overstate the benefits of the FR-2 appliance.

An evidence-based approach to the orthodontic outcomes of FR-2 appliance is needed, by selecting and comparing groups of children with the same cephalometric characteristics with and without treatment.

Meta-analysis of skeletal mandibular changes during Fränkel appliance treatment

1. Letizia Perillo*,

2. Rosangela Cannavale*,

3. Fabrizia Ferro*,

4. Lorenzo Franchi**,

5. Caterina Masucci**,

6. Paolo Chiodini*** and

7. Tiziano Baccetti**

1. Departments of Orthodontics, *Second University of Naples

2. **University of Florence

3. ***Department of Medicine and Public Health, Second University of Naples, Italy

1. Correspondence to: Dr Letizia Perillo, Department of Orthodontics, Second University of Naples, Via De Crecchio, 80100 Naples, Italy. E-mail: letizia.perillo{at}unina2.it

A total of nine articles were identified. The quality of the studies ranged from low to medium. Meta-analysis showed that the FR-2 was associated with enhancement of mandibular body length [0.4 mm/year 95 per cent confidence interval (CI) 0.182–0.618], total mandibular length (1.069 mm/year, 95 per cent CI 0.683–1.455), and mandibular ramus height (0.654 mm/year, 95 per cent CI 0.244–1.064). A consistent heterogeneity among studies was found for all the considered linear measurements.

http://ejo.oxfordjournals.org/cgi/content/short/33/1/84?rss=1

Virtual blood and smoke give gore to student surgeons

Thu, 27 Jan 2011 00:00:00 EST

SPILT blood and burning flesh can now be modelled accurately. But you won’t find the software in a gory shoot-’em-up video game, at least not yet. Instead it will used to make virtual surgery look more lifelike.

Like airline pilots, surgeons practise their trade using simulators. For keyhole surgery routines they use a dummy torso with mock organs and a variety of grasping, cutting and cauterising tools. Transducers in the organs sense the forces exerted by the instruments and feed them to a PC, which screens a virtual representation of how real organs would respond.

But merely simulating how the organs respond to the tools and move against each other in real time takes up most of a top-end PC’s number-crunching power, says Suvranu De, an engineer at Rensselaer Polytechnic Institute in Troy, New York. That means other important aspects of surgery have to go unmodelled, reducing the realism of the simulation.

“Intra-abdominal tissue has a very high density of blood vessels. When a cauterising device cuts it, copious amounts of smoke are generated and bleeding may occur. These effects are hard to incorporate in a simulation,” says De. That’s because such simulations would involve solving fluid dynamics equations every time the blood or smoke moves, something existing technology takes several hours to do.

To get around this problem, De’s team has developed a technique that instead overlays pre-programmed visual effects onto the simulations.

First, they took sample video footage from real keyhole surgery showing how smoke can obscure the surgeon’s view. These clips were of both the dense smoke coming from the tip of the cauterising tool and the wispy smoke further away.

They stored these sequences and wrote an algorithm that enables the PC’s graphics processor to call them up whenever the cauterising tool is used. The software updates the overlaid images at a rate of 30 frames per second – fast enough to give an interactive feel to the simulation. The smoke density in each image depends upon the length of time the tool is used as well as distance from the cauterised site.

To simulate the degree of bleeding, another algorithm consults a database of the vascular density at the point of interest in the body. It then estimates the likely bleeding rate, depending on the depth of the surgeon’s cut, and brings up animation sequences of the appropriate amount of pooling blood to overlay on the simulation.

The team hopes to refine the software further to improve its realism – and could even transfer it to video games. “This is a very clever way to do it,” says Vincent Luboz at Imperial College London, who works on surgery simulators. But he adds that the technique is more suited to general training than to rehearsing an operation on a particular patient.

World’s first brain scanner made for two

Thu, 27 Jan 2011 00:00:00 EST

TWO heads are better than one – particularly if you’re studying the brain activity underlying social interaction. The problem is that imaging technologies such as MRI have only been able to handle one brain at a time – until now. Ray Lee at Princeton University has developed the world’s first dual-headed fMRI scanner. The innovation allows the simultaneous imaging of the brain activity of two people lying in the same scanner.

Usually, a lone person lies inside a scanner’s narrow tunnel, cocooned by powerful magnets and radio-frequency coils which detect how hydrogen atoms in the body respond to magnetic fields, or how the flow of oxygenated blood changes as a result of brain activity. Although it is possible to squeeze two adults into most MRI machines – Willibrord Weijmar Schultz at the University of Groningen in the Netherlands famously scanned the bodies of couples as they copulated inside an MRIMovie Camera – attempting to scan both their brains at once would produce too fuzzy an image.

So Lee designed a pair of coils that fits into a scanner, providing two distinct loops in which to place each participant’s head (see picture). He also fitted a window between the coils so participants can see one another. “This opens up a new area of MRI,” says Lucien Levy, head of neuro-radiology at George Washington University Medical Center in Washington DC. “I haven’t seen anything like this.”

To test the scanner, Lee asked couples to lie facing one another and blink in unison. Brain activity in the fusiform gyrus – involved in facial recognition – was tightly correlated. Lee also asked couples to repeatedly embrace and release one another, and observed similarly synchronised brain activity. He announced his results in November 2010 at the Society for Neuroscience conference in San Diego, California.

“In close proximity, people tend to mimic each other in all kinds of ways, especially through non-verbal signals,” says Marco Iacoboni at the University of California, Los Angeles. “Now we can examine brain activity of an intimate pair copying each other in real time. That hasn’t been done before.”

James Coan at the University of Virginia in Charlottesville is also eager to test the device: “People distribute neural processing across multiple brains when solving problems,” he says. “You essentially contract out part of a given problem to someone else’s mind. Lee’s work would give us the opportunity to see two brains reacting to a problem simultaneously.”

Jesse Rissman at Stanford University in California says it remains unclear just how advantageous scanning people in the same machine will be compared with scanning people in different machines who are linked by video. He points out that if people move around too much inside a scanner, they disrupt the signal, so interactions may be limited to small gestures.

But Coan stresses the potency of even minor actions: “Couples could hold each other or rub each other’s back,” he says, “and simply having another human face inches from their own is a very powerful stimulus. With a little creativity, the sky’s the limit for figuring out how brains respond to each other.”

Ventricular Tachyarrhythmias after Cardiac Arrest in Public versus at Home

Thu, 27 Jan 2011 00:00:00 EST

The incidence of ventricular fibrillation or pulseless ventricular tachycardia as the first recorded rhythm in out-of-hospital cardiac arrest has declined dramatically in the past several decades.1,2 Thirty years ago, 70% of such arrests were characterized by initial ventricular fibrillation or pulseless ventricular tachycardia; today, the incidence is 23%.3,4 This decline is of substantial importance for public health, since more than 300,000 Americans have an out-of-hospital arrest each year, with an estimated survival rate of 7.9% nationally,5 and the majority of survivors are in the subgroup of persons whose initial rhythm is ventricular fibrillation or pulseless ventricular tachycardia.3

Controlled clinical trials have shown that “public access defibrillation” — that is, the use of automated external defibrillators (AEDs) in public settings by trained laypersons — improves survival after an out-of-hospital cardiac arrest.6 In contrast, layperson use of AEDs in residential settings has not proved to be of benefit, possibly owing in part to a lower prevalence of ventricular fibrillation or pulseless ventricular tachycardia as the initial rhythm.7 These observations suggest that the incremental value of certain resuscitation strategies, such as the ready availability of an AED, may be related to the setting in which the arrest occurs.

The purpose of this study was to assess the frequency of initially identified ventricular fibrillation or pulseless ventricular tachycardia and survival among patients whose cardiac arrest was witnessed in a public setting or at home and, in particular, when an AED was applied by a bystander.

Methods

Study Design and Patients

The Epidemiologic Cardiac Arrest Registry of the Resuscitation Outcomes Consortium (ROC Epistry–Cardiac Arrest) is a population-based emergency-medical-services (EMS) registry of out-of-hospital cardiac arrest.3 We carried out a prospective, multicenter, population-based cohort study involving patients who were assessed or treated by one or more of 208 ROC EMS agencies and their receiving institutions at seven U.S. sites (Alabama, Dallas, Iowa, Milwaukee, Pittsburgh, Portland [OR], and Seattle–King County) and at three Canadian sites (Ottawa, Toronto, and British Columbia). The study sites provided data for cardiac arrests that occurred between December 1, 2005, and March 31, 2007.8

Study patients included all persons 19 years of age or older with nontraumatic out-of-hospital cardiac arrest for whom external defibrillation was attempted (by lay bystanders or EMS personnel) or who were treated with chest compressions (by EMS personnel). The study was approved by the institutional review boards of the University of Washington (data coordinating center) and the participating U.S. and Canadian study sites. The requirement for informed consent was waived because the study was considered to meet the criteria for minimal risk.

Data Collection

Information about each subject was collected with the use of uniform definitions developed by the ROC investigators and included Utstein data elements.9 The data elements included demographic characteristics of the patients, circumstances of the arrests, characteristics of care, and survival status. Data were collected by trained personnel who followed uniform procedures to ensure the validity and reproducibility of the data. All data recorded at study entry were subject to error, logic, and cross-form checks, which maximized the accuracy of the data. Routine, random, centralized review confirmed the initial rhythm as a stable, reproducible variable. Data were deidentified in compliance with the Health Insurance Portability and Accountability Act.

Study Definitions

A public location was defined as a street or highway, public building, place of recreation, industrial place, or other public property, excluding health care facilities (hospitals, medical clinics, and other health care institutions). A private location was defined as a home (the principal focus of this study), a residential institution (typically a nursing home), or some other nonpublic setting (usually a rural farmland location). Bystander-witnessed cardiac arrest was defined as an arrest observed by a person who was not part of the EMS system. AED application by a bystander was defined as AED placement (with or without delivery of a shock) by a person (or more than one person) outside the EMS system, including police on the scene before the arrival of EMS personnel. Bystander-administered AED shock was defined as a shock that was delivered by non-EMS personnel before the arrival of EMS personnel. An EMS-witnessed arrest was defined as a cardiac arrest that occurred in the presence of a member of the EMS response team. In the few instances in which it could not be determined whether a bystander had witnessed the arrest or had applied an AED or administered a shock, we assumed that the event was not witnessed or that an AED was not applied. Survival to hospital discharge was determined from available records (hospital or EMS records in most cases and public or media sources in rare cases).

First Recorded Rhythm

Ventricular fibrillation or pulseless ventricular tachycardia was presumed to be the initial cardiac-arrest rhythm if the shock was delivered by a bystander-applied AED. The initial rhythm as assessed by EMS personnel was determined from the electronic electrocardiographic (ECG) recordings (in 25% of cases) or paper rhythm tracings (in 24%) derived from defibrillators or from descriptions of the initial rhythm in the EMS record (in 51%).

To confirm the accuracy of the reported initial rhythm, 30 arrests were randomly selected from each of four strata, defined by the location of the arrest (home vs. public location) and the first recorded rhythm (shockable [ventricular fibrillation or pulseless ventricular tachycardia] vs. nonshockable), and these 120 arrests were independently reevaluated by three of the authors on the basis of the EMS record, defibrillator ECG recordings, or both. The 13 arrests for which source documents could not be obtained were excluded from the reevaluation study. Rhythm diagnoses were completely concordant among the reviewers, who disagreed with a site interpretation of the reported rhythm in only 3 of 107 cases, for an estimated error rate of 3.1% (95% confidence interval [CI], 0.0 to 7.8) (taking into account the sampling rates for the four strata).

Statistical Analysis

Statistical analyses were conducted with the use of R software, version 2.1.1 (R Foundation for Statistical Computing). All statistical tests were two-sided, with a significance level of 0.05.

The frequencies of ventricular fibrillation or pulseless ventricular tachycardia and of survival to hospital discharge were calculated as simple proportions. Multiple logistic-regression analyses were used to assess the independent association between location and initially recorded ventricular fibrillation or pulseless ventricular tachycardia or survival to hospital discharge after adjustment for age, sex, bystander-witnessed cardiac arrest, the delivery of bystander-initiated cardiopulmonary resuscitation (CPR), and EMS response time from the 911 call until the arrival of the EMS vehicle, as appropriate.

Results

Study Population

Between December 2005 and April 2007, a total of 14,420 adult patients were treated by EMS personnel for a cardiac arrest occurring outside a health care facility (Figure 1Figure 1Number of Patients with Cardiac Arrest in Subgroups and According to the Location Where the Arrest Occurred.); complete data were available for 14,059 of these patients. The initial cardiac-arrest rhythm was known or was deemed shockable (i.e., ventricular fibrillation or pulseless ventricular tachycardia) as indicated by receipt of a bystander-administered AED shock in 12,930 patients (92%). Of this group, 5034 patients (39%) had cardiac arrests that were witnessed by a bystander in a home or public location, 273 (2%) had an AED applied by a bystander before the arrival of EMS personnel, and 1115 (9%) had arrests that were witnessed by EMS personnel.

Table 1Table 1Demographic Characteristics, Resuscitation Status, and Outcomes for Patients with Cardiac Arrest, According to the Location of the Arrest. shows the key demographic characteristics and resuscitation status of the patients, including the frequency of ventricular fibrillation or pulseless ventricular tachycardia as the initial recorded rhythm and of survival, according to the location of the arrest. When cardiac arrest occurred in a nonpublic location, it was further characterized as taking place at home, in a residential facility (e.g., nursing home), or in some other private (nonhome) setting. Of 1324 patients in whom the cardiac arrest occurred in a residential institution or other private (nonhome) location, only 41 (3%) survived. This group was excluded from further analysis, so that the principal focus of our study was a comparison of cardiac arrests that occurred in public locations with those that occurred at home. For cardiac arrests that were witnessed by bystanders in public locations, the median time from the 911 call to the arrival of the EMS vehicle at the scene was 5.0 minutes (interquartile range, 3.8 to 6.6); for bystander-witnessed arrests in the home, the median time was 5.6 minutes (interquartile range, 4.3 to 7.1).

Initial Rhythm

The initial ascertainable rhythm was ventricular fibrillation or pulseless ventricular tachycardia (and, in rare cases, a hypotensive supraventricular tachycardia) in 3336 of the 12,930 arrests, for an overall frequency of 26% (Table 1). Of the 3451 patients with bystander-witnessed cardiac arrest that occurred in the home, 1193 (35%) had initial ventricular fibrillation or pulseless ventricular tachycardia on the arrival of EMS personnel, as compared with 600 of 1003 patients (60%) in whom cardiac arrest occurred in a public location (Table 2Table 2Demographic Characteristics, Resuscitation Status, and Outcomes of Patients with Cardiac Arrest at Home or in Public, According to Circumstances of the Event. and Figure 2Figure 2Ventricular Fibrillation (VF) or Pulseless Ventricular Tachycardia (VT) in Subgroup, According to the Location Where the Arrest Occurred.). The multivariable odds ratio for initial ventricular fibrillation or pulseless ventricular tachycardia after a bystander-witnessed arrest in a public location versus an arrest at home (adjusted for age, sex, bystander-administered CPR, and time from the 911 call to the arrival of EMS personnel at the scene) was 2.28 (95% CI, 1.96 to 2.66; P<0.001) (Table 3Table 3Odds Ratios for Initial Ventricular Fibrillation or Pulseless Ventricular Tachycardia (or Shockable Rhythm) in Cardiac Arrests Occurring in Public versus Arrests at Home, According to Circumstances of the Event.).

An AED was applied by a bystander before EMS arrival in 69 patients with cardiac arrests that occurred at home (Table 2 and Figure 1). Of these patients, 25 (36%) had an initial shockable rhythm, as compared with 125 of 159 patients (79%) in whom an AED was applied by a bystander in a public location. The multivariate odds ratio for shockable rhythm in public versus at home (adjusted for sex, age, bystander-witnessed arrest, bystander-administered CPR, and time from the 911 call to EMS arrival) was 4.48 (95% CI, 2.23 to 8.97; P<0.001) (Table 3). Among the 835 cardiac arrests in the home that were witnessed by EMS personnel, the initial rhythm was ventricular fibrillation or pulseless ventricular tachycardia in 207 cases (25%), as compared with 61 of 161 EMS-witnessed cardiac arrests (38%) that occurred in a public location (Table 2 and Figure 2). For EMS-witnessed cardiac arrests, the odds ratio for initial ventricular fibrillation or pulseless ventricular tachycardia in public versus at home (adjusted for age and sex) was 1.63 (95% CI, 1.13 to 2.35; P=0.009) (Table 3).

Survival to Hospital Discharge

Survival outcomes are shown in Table 1 and Table 2. Overall survival among the 12,930 patients whose initial cardiac-arrest rhythm was known was 7%. Survival rates after a cardiac arrest at home were 2% among the 5209 patients whose arrests were not witnessed by a bystander or EMS personnel or who did not have an AED applied by a bystander, 8% among the 3451 patients whose arrests were witnessed by a bystander, and 10% among the 1219 patients who were then given CPR by a bystander.

Among patients who had a cardiac arrest at home before the arrival of EMS personnel and for whom an AED was not applied by a bystander, the likelihood of survival to discharge was significantly increased if the arrest was witnessed by a bystander (odds ratio, 3.76; 95% CI, 3.01 to 4.70; P=0.004) and if the bystander administered CPR (odds ratio, 1.37; 95% CI, 1.10 to 1.70; P=0.004).

The survival rate among 1003 patients with bystander-witnessed cardiac arrests that occurred in a public setting was 20%; in 159 instances in which an AED was applied by a bystander, the survival rate was 34%, and in 124 instances in which an AED shock was administered by a bystander, the rate was 42%. The adjusted odds ratio for survival when an AED was applied by a bystander after a cardiac arrest in a public location versus an arrest at home was 2.49 (95% CI, 1.03 to 5.99; P=0.04). Among those who received a shock from an AED applied by a bystander, survival rates did not differ significantly according to the place where the cardiac arrest occurred (odds ratio for survival after an arrest in a public location vs. an arrest at home, 1.68; 95% CI, 0.58 to 4.88; P=0.34).

Discussion

This study shows that shockable arrhythmias (ventricular fibrillation or pulseless ventricular tachycardia) are a relatively infrequent presentation of out-of-hospital cardiac arrest (with an overall incidence of 26%) and account for a remarkably low proportion of both EMS-witnessed arrests (25%) and bystander-witnessed arrests (35%) in the home. The frequency of shockable arrhythmias was higher for bystander-witnessed cardiac arrests in a public location (60%), particularly those in which an AED was applied by a bystander in a public location (79%) (Figure 2). Therefore, as might be expected, the rate of survival to hospital discharge was significantly higher when an AED was applied by a bystander after a cardiac arrest in a public location (34%, vs. 12% for arrests at home; adjusted model P=0.04).

The limitations of this study should be acknowledged before we consider its implications and possible explanations for the findings. First, we did not have access to the ECG recordings from bystander-applied AED and cannot confirm independently that all shocked rhythms were ventricular fibrillation or pulseless ventricular tachycardia. However, AED rhythm-detection algorithms are considered to be highly sensitive and specific for a shockable arrhythmia, since a shock advisory is strongly correlated with its presence and a no-shock advisory with its absence.10,11

Second, it is possible that delays in calling for EMS help were responsible for the low frequency of ventricular fibrillation or pulseless ventricular tachycardia as the initial rhythm among cardiac arrests at home, including those witnessed by a bystander and those for which a bystander applied an AED. Ascertaining the delay between the time of the witnessed collapse and the call to EMS can be challenging in both the public setting and the home setting, since one must rely on accurate recollections by witnesses. Nevertheless, it is unlikely that such a delay would be greater today than it was in an earlier era, when ventricular fibrillation or pulseless ventricular tachycardia was the initial rhythm in 70% of all cardiac arrests.1,2

With respect to EMS delays, although the median time from the 911 call to EMS arrival was modestly longer for bystander-witnessed cardiac arrests at home than for those in public (Table 2), the EMS response times were less than 7 minutes for more than 75% of the patients in both locations.

A spline-fit analysis (data not shown) relating the incidence of initial ventricular fibrillation or pulseless ventricular tachycardia to EMS response time in the case of bystander-witnessed cardiac arrests in public indicated that the frequency of this arrhythmia diminished from 60% to no less than 50% as the EMS response time increased from zero to 7 minutes. Therefore, it does not seem likely that the much lower frequency of ventricular fibrillation or pulseless ventricular tachycardia observed after cardiac arrest in the home would be accounted for by differences in EMS response time or other delays in the case of home-witnessed arrests. EMS response time was also not significantly related to the incidence of initial ventricular fibrillation or pulseless ventricular tachycardia in the multivariate analysis (Table 3). Furthermore, the frequency of these arrhythmias was similar (25%) for cardiac arrests in the home that were witnessed by EMS personnel, and in such cases, one would expect that the first rhythm was documented promptly after the event.

Survival data reported for the population groups in this study are consistent with previous reports on successful bystander-applied AED shocks and witnessed cardiac arrests in both public and nonpublic locations.12-14 Among the patients in our study who received AED shocks from bystanders in public locations, the survival rate was 42%. This compares favorably with results from a study of cardiac arrests in casinos in which the approximate survival rate was 53% among patients who received AED shocks after the arrests were promptly recognized by means of video cameras on the gaming floor.12 Similarly, in a study of cardiac arrests that occurred in Chicago airports, the survival rate was 60% among patients who received AED shocks delivered by bystanders.14

Studies in Osaka, Japan,15 and in Copenhagen16 came to similar conclusions regarding the incidence of ventricular fibrillation or pulseless ventricular tachycardia in public or workplace settings versus nonpublic ones. However, these studies did not specifically address arrests involving bystander-applied AEDs, nor did they exclude unwitnessed cardiac arrests, for which the interval between the arrest and the initial ECG is likely to be prolonged.

The results of this study have a number of important implications for public health and community strategies to improve survival after cardiac arrest. First, because only 20 to 30% of cardiac arrests in the United States and Canada occur in public settings, our findings suggest that AED programs and education in AED use by lay responders should be focused on these sites.17,18

Second, our findings suggest that the incremental benefit in survival from the use of AEDs in the home, as compared with a strategy that increases the frequency and quality of CPR by bystanders in the home, is likely to be small. The rate of survival after cardiac arrest in the home for the 1219 cases in which a bystander witnessed the event and performed CPR was 10%, which is similar to the 12% survival rate associated with use of a bystander-applied AED in the home. Increasing the rate of CPR by bystanders in the home, perhaps with dispatch assistance, might yield a benefit similar to that achieved with the use of home AEDs.19-21

Another strategy to improve survival is initial continuous chest compression without rescue breathing, which may also be more effective in cardiac arrest with ventricular fibrillation or pulseless ventricular tachycardia than in arrest with other initial rhythms. In experimental studies that propose continuous compression, ventricular fibrillation or pulseless ventricular tachycardia models of cardiac arrest are used.22 Two recently published studies in humans showed no significant difference in survival between patients who were randomly assigned, on the basis of dispatchers’ instructions to bystanders, to receive continuous compression without rescue breathing and those assigned to receive standard CPR with rescue breathing.20,21 In one of the two studies, continuous compression without rescue breathing was associated with increased survival among patients with arrests due to cardiac causes20; in the other study, there was a trend toward increased survival with continuous compression and no rescue breathing among patients with arrests characterized by ventricular fibrillation or pulseless ventricular tachycardia.21 If arrests characterized by ventricular fibrillation or pulseless ventricular tachycardia have better outcomes with continuous compression alone, this could be the more effective resuscitation strategy in the public setting, whereas rescue breathing along with compression might be of greater importance in the home, where the frequency of ventricular fibrillation or pulseless ventricular tachycardia is lower.23

Why is the initial recorded cardiac-arrest rhythm different when cardiac arrest occurs in a public location rather than in the home? One explanation is that the person who has a cardiac arrest in the home is typically older and more likely to have one or more chronic diseases that limit or preclude participation in activities outside the home. Thus, the location of an out-of-hospital cardiac arrest may be a surrogate variable for underlying disease or disease severity and the corresponding risk of ventricular fibrillation or pulseless ventricular tachycardia. For example, treatment with an implanted defibrillator is known to have a smaller effect on survival among patients with more severe heart failure than among those with less severe heart failure, suggesting that the incidence of shockable arrhythmias (ventricular fibrillation or pulseless ventricular tachycardia) differs between these two groups.24

In conclusion, our study shows that the frequency of ventricular fibrillation or pulseless ventricular tachycardia as the initial recorded rhythm is lower among patients with witnessed cardiac arrests in the home than among those with witnessed arrests in a public setting. This finding adds strength to the argument for putting AEDs in public locations. Although the role of AEDs in cardiac arrests that occur in the home will probably continue to evolve, the relatively low incidence of shockable arrhythmias in this setting suggests that a treatment strategy that emphasizes prompt, bystander-delivered CPR of high quality (e.g., with the assistance of a dispatcher) should be as effective in saving lives as the widespread deployment of AEDs in homes.

Supported by cooperative agreements with 10 regional clinical centers and one data coordinating center (5U01 HL077863, HL077881, HL077871, HL077872, HL077866, HL077908, HL077867, HL077885, HL077887, HL077873, and HL077865) from the National Heart, Lung, and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, the U.S. Army Medical Research & Materiel Command, the Canadian Institutes of Health Research–Institute of Circulatory and Respiratory Health, Defence Research and Development Canada, the American Heart Association, and the Heart and Stroke Foundation of Canada.

Dr. Atkins reports receiving support from the American Heart Association as the editor of the CPR Guidelines and having testified as an expert witness on pediatric defibrillation; Dr. Aufderheide, serving as a consultant for the Medtronic Foundation and Jolife; Dr. Ornato, being employed as the American editor of the journal Resuscitation; Dr. Rea, using AEDs supplied by Philips and Physio-Control and receiving funding on behalf of his institution, the University of Washington, from Philips and Physio-Control and the Medtronic Foundation; and Dr. Weisfeldt, receiving royalties both for himself and on behalf of his institution, the Johns Hopkins University School of Medicine, from a patent for a pacemaker.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

No other potential conflict of interest relevant to this article was reported.

Source Information

From Johns Hopkins University, Baltimore (M.L.W.); University of Washington, Seattle (S.E.-S., C.S., T.R., J.P., P.J.K.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Iowa, Iowa City (D.L.A.); University of Toronto, Toronto (B.B., S.C.B., C.F., L.J.M.); University of Alabama, Birmingham (R.G.); and Virginia Commonwealth University, Richmond (J.P.O.).

Address reprint requests to Dr. Weisfeldt at Johns Hopkins University, 1830 E. Monument St., Suite 9026, Baltimore, MD 21287, or at mlw5@jhmi.edu.

F.D.A. Is Studying the Risk of Electroshock Devices

Thu, 27 Jan 2011 00:00:00 EST

DUFF WILSON

Federal regulators are weighing whether to downgrade the risk classification of electroshock devices, reinforcing what many psychiatrists consider a deepening acceptance of electroshock in modern therapy.

The procedure has had a resurgence in recent years. And an estimated 100,000 Americans — two-thirds of them women — undergo the treatment for major depression and other illnesses each year. Patients, anesthetized, receive a jolt of electricity from electrodes for several seconds, inducing a brain seizure and convulsions of up to a minute.

The American Psychiatric Association and other leading specialists are recommending that the Food and Drug Administration downgrade the devices to a medium-risk category from high risk, a move that will be reviewed by an agency advisory panel in Gaithersburg, Md., this week.

To some extent, the review has renewed the debate over electroshock. In 1990, F.D.A. staff proposed declaring the devices safe for major depression, but never took final action amid an uproar by opponents.

If the F.D.A. downgrades the devices to a medium-risk category, the equipment could be promoted and sold without new testing. Such a downgrade would place the devices in the same risk category as syringes and surgical drills.

If the F.D.A. leaves the devices in the high-risk category, however, manufacturers may, depending on the agency, have to withdraw them from the market.

The F.D.A. could require safety and effectiveness tests that have not previously been done. By regulating the devices, the F.D.A. is indirectly regulating the procedure.

The agency could make a formal decision later this year. The F.D.A. usually, but not always, follows recommendations of its advisory panels.

Supporters, including mainstream psychiatrists, say the treatment is much safer than it once was and could pass a rigorous F.D.A. review. But they assert that the device manufacturers cannot afford those tests.

“These tend to be mom-and-pop operations,” said Dr. Matthew V. Rudorfer, a psychiatrist and top specialist at the National Institute of Mental Health. “So I think the dilemma might be that undergoing new expensive clinical trials might be too expensive.”

Opponents, including some groups of former patients, maintain that electroshock can cause memory loss and brain damage that outweigh its short-term benefits.

“It’s all trial and error — it’s all experimental,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection, an advocacy group in New York. “All the years it’s been controversial and there have not been clinical trials. Why not?”

Only two manufacturers, Somatics L.L.C. of Lake Bluff, Ill., and the Mecta Corporation of Lake Oswego, Ore., make the devices in the United States. The F.D.A. has asked them to submit all safety and effectiveness information as part of an agency review to be released before the advisory committee meeting beginning on Thursday.

Dr. Richard Abrams, who founded Somatics in 1983 with Dr. Conrad M. Swartz, and has written a textbook on electroshock, wrote the F.D.A. to say that none of his patients in more than 10,000 sessions over three decades had reported prolonged memory loss.

Dr. Swartz, who, like Dr. Abrams, is a retired psychiatry professor, said in an e-mail that any cognitive side effects from Somatics’ latest device “are distinctly less than they had been.” But he said Somatics could not afford an in-depth safety study that the F.D.A. could require if it left the devices in the high-risk category. That could cost millions of dollars.

“There is not nearly enough money in this industry to begin to pay for clinical trials that would be substantially larger than those already in the medical scientific literature,” Dr. Swartz wrote.

Mecta would not comment. “We always get negative press,” said a woman who answered the telephone at the company’s headquarters and did not give her name. “Too bad, because it’s good equipment.”

Somatics and Mecta each have annual revenue exceeding $1 million, according to Dun & Bradstreet. Dr. Swartz, asked about the revenue figure, said Somatics, like Mecta, was a private company. Their Web sites do not list prices or sales figures.

More than 1,000 hospitals and outpatient clinics in the United States use the two companies’ devices, according to Dr. Charles H. Kellner, a leading researcher, professor and chief of geriatric psychiatry at Mount Sinai School of Medicine in New York.

“It’s a treatment for the most severe form of depression,” Dr. Kellner said. “It can really be life-saving.”

The F.D.A. review was recommended by the Government Accountability Office in 2009 as part of an examination of the regulatory status of electroshock and about 20 other less controversial medical devices, like pacemaker electrodes and implanted blood access devices for hemodialysis. They were grandfathered into F.D.A. regulations when the agency was given more authority over medical devices in 1976.

The G.A.O. said those devices should go through the stringent approval process for high-risk devices or be reclassified as medium or low risk. A medium-risk designation could include adding controls like performance standards and patient registries.

The treatment costs $1,000 to $2,500 a session, and typically involves three sessions a week for two to four weeks, Dr. Kellner said. The fee includes the services of a psychiatrist and anesthesiologist. The equipment itself costs about $15,000 and may last years.

Patients are given short-term full anesthesia, a powerful muscle relaxant to prevent pain and subdue convulsions, and a mouth guard. The electrical current causes a grand mal seizure with convulsions usually lasting less than a minute, doctors say. Five to 10 minutes later, the patient awakens and can usually go home within two hours.

A federally financed study in 2007 found long-term memory loss and other cognitive problems, especially for female patients, from the treatment at seven New York facilities. The study, of 347 patients, was the first such large-scale study of side effects, despite what its authors called “over 50 years of clinical use and ongoing controversy.” The study also said methods and voltage varied widely among practitioners.

Dr. Rudorfer, associate director of treatment research in a division of the National Institute of Mental Health, says modern electroconvulsive therapy, or E.C.T., as its supporters prefer to call it, is much better than earlier practices, like those portrayed in “One Flew Over the Cuckoo’s Nest.”

“As surprising as it might seem, it never went away,” Dr. Rudorfer said of the treatment. “The field has had ample opportunity to get rid of E.C.T. and it’s still with us because it seems to occupy a small but important niche in treatment.”

But Dr. Rudorfer and other scientists still do not know just how the treatment or brain seizures act to improve moods. “We’re still looking,” he said. “It’s been very difficult to tease out the ‘active ingredient’ from among the many changes in the brain that accompany having, and stopping, the therapeutic seizure activity.”

Patients appear to have mixed views, judging from comments to the F.D.A. and electroshock-related Web sites. Some say it saved their lives, some say they suffered too much memory loss, and some say both.

In addition to its use in cases of severe depression, the treatment is used in some cases where speed is essential, like psychosis or suicidal behavior, for catatonia and in elderly patients who take so many other drugs that they cannot safely add a powerful psychiatric drug.

Dr. James H. Scully Jr., medical director and chief executive of the American Psychiatric Association, wrote the F.D.A. recently to say the treatment was “extremely effective and safe.” It provides relief some 80 percent of the time, he wrote. Dr. Scully and the psychiatry association also say there is no evidence it causes brain damage.

A task force is updating the association’s 2001 recommendations on the treatment. Its report is at least a year away.

“People use it because it works,” said Dr. Laura J. Fochtmann, a member of the task force, professor and director of the Electroconvulsive Therapy Service at Stony Brook University Medical Center, Long Island.

“These disorders can be extremely life-threatening, and when it works, it can be dramatically effective,” she said.

Opponents of electroshock include some patient advocacy groups, but the opponents, clearly, are outnumbered among physicians.

Dr. Peter R. Breggin, author of more than a dozen books including one about electroshock and a consultant in personal injury cases involving drugs and the therapy, says he is the only American psychiatrist he knows who publicly opposes the treatment.

“It’s a big money-maker,” he said. “I would say if anything it’s been on the increase because there’s a market that’s been exploited, that is the elderly depressed women on Medicare. The reason for that is they’re covered, and there’s no one to protect them. What commonly stops shock treatment is a family member saying ‘over my dead body.’ ”

Depressed older people, Dr. Breggin said, can be helped more by a pet or conversation.

Last year, two psychology professors, John Read of the University of Auckland, New Zealand, and Richard Bentall of Bangor University, Wales, criticized electroshock after reviewing studies comparing it with simulated treatment. Their findings were published in Epidemiologia e Psichiatria Sociale, a peer-reviewed European psychiatric journal. “The cost-benefit analysis is so poor that its use cannot be scientifically justified,” Dr. Read wrote in an e-mail.

John Breeding, a psychologist and member of the Coalition for Abolition of Electroshock in Texas, said that state had banned electroshock for youths under 16 and required second opinions for treating the elderly, giving it the strictest rules in the nation.

“It’s a very strong treatment for despair and hopelessness,” he said. “It’s a temporary blunting of your feelings, so you feel better for a while, then you feel worse, and now you’ve got the memory loss and brain damage.”

This article has been revised to reflect the following correction:

Correction: January 26, 2011

An article on Monday about the possibility of easing regulations on electroshock therapy devices paraphrased incorrectly from a comment by the psychiatrist and author Dr. Peter R. Breggin. He said he was the only American psychiatrist he knew who publicly opposed electroshock treatment — not the only one to oppose it.

Ventricular Tachyarrhythmias after Cardiac Arrest in Public versus at Home

Thu, 27 Jan 2011 00:00:00 EST

Methods

Study Design and Patients

Data Collection

Study Definitions

First Recorded Rhythm

Statistical Analysis

Statistical analyses were conducted with the use of R software, version 2.1.1 (R Foundation for Statistical Computing). All statistical tests were two-sided, with a significance level of 0.05.

Results

Study Population

Initial Rhythm

Survival to Hospital Discharge

Discussion

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

No other potential conflict of interest relevant to this article was reported.

Source Information

Address reprint requests to Dr. Weisfeldt at Johns Hopkins University, 1830 E. Monument St., Suite 9026, Baltimore, MD 21287, or at mlw5@jhmi.edu.