Prophylactic ICDs Appear Effective In Less Severe HF Patients Reply

ICDs are routinely implanted in heart failure patients with ejection fractions (EFs) of 35% and lower to prevent sudden cardiac death. However, the benefits in patients at the higher end of the spectrum– between 30% and 35%– have not been well demonstrated in clinical trials, since few patients in this range have been enrolled in clinical trials.

Now a new study published in JAMA suggests that the benefits in this group are similar to the benefits in heart failure patients with more severely depressed EFs.

Click here to read the full post on Forbes.


Routine Shock Testing Not Required During ICD Implantation Reply

When cardiologists implant defibrillators in patients at high risk of dying from a heart rhythm disorder they nearly always perform a defibrillation test in which they induce a lethal arrhythmia, ventricular fibrillation, to make sure the device accurately detects the arrhythmia and terminates it with an appropriate shock. But routine defibrillation testing has never been shown to be safe or necessary. In recent years some experts have maintained that routine defibrillation testing may not be necessary.

Now a new study, presented yesterday at the Heart Rhythm Society meeting in San Francisco, offers evidence that although routine testing is generally safe it may increase complications without producing any improvement in outcomes.

Click here to read the full post on Forbes.



Athletes With Defibrillators Don’t Need To Quit Sports Reply

Although the American College of Cardiology and the European Society of Cardiology now advise people with ICDs not to participate in vigorous sports, a new study offers strong support for people with ICDs who want to take part in sports. Although a large number of people with ICDs are elderly heart failure patients who are unlikely to want to participate in sports, ICDs are also implanted in young and otherwise healthy people with genetic diseases that leave them at high risk for lethal arrhythmias.

Now findings from the ICD Sports Safety Registry, published in Circulation, provide vital new information about this important topic. The registry, which was performed with the assistance of patient advocacy groups, included 372 ICD patients between 10 and 60 years of age who participated in sports more vigorous than golf or bowling. The most common reasons for having an ICD among people in the registry were long-QT syndrome in 73 people, hypertrophic cardiomyopathy in 63 people, and arrhythmogenic right ventricular cardiomyopathy in 55. 60 subjects were college age or younger who took part in competitive sports.

Click here to read the full post on Forbes.


HOLLAND, MI - MARCH 7:  Fennville High School ...


Study Questions Role Of Dual-Chamber ICDs For Primary Prevention Reply

Dual-chamber ICDs are implanted in a majority of primary prevention patients without a pacing indication who receive an ICD. Although there are a number of theoretical advantages with dual-chamber devices, these devices are more likely to cause complications. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines from the AHA/ACC and HRS do not specify a single-chamber device.

In a new study published in JAMA, Pamela Peterson and colleagues analyzed data from 32,000 primary prevention patients without a pacing indication who were enrolled in the National Cardiovascular Data Registry (NCDR). 38% received a single-chamber device and 62% received a dual-chamber device. At 1 year there wereno significant differences in mortality, all-cause hospitalization, or heart failure hospitalization between the two groups. However, patients in the dual-chamber group had a higher risk of complications, including a highly significant increase in the 90 day risk of mechanical complications requiring reoperation (1.43% in the single-chamber group versus 2.02% in the dual-chamber group, p < 0.001). A very similar pattern emerged when the investigators performed an analysis that matched patients in the two groups with a propensity model. The analysis suggested “that the choice of a dual-chamber device is relatively random with respect to patient characteristics.

Click here to read the full story on Forbes.



Bruise Control: Continued Warfarin Beats Heparin Bridging During Device Implantation 1

Many patients receiving an ICD or a pacemaker are already receiving oral anticoagulants. Current guidelines recommend replacement of the oral anticoagulant with the temporary use of heparin as a bridging strategy. Now a new study, BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial), offers convincing evidence that this strategy is not beneficial and, in fact, results in an increase in device-pocket hematoma. Results of the trial were presented today at the Heart Rhythm Society meeting in Denver and published simultaneously in the New England Journal of Medicine.

A group of mostly Canadian investigators randomized 681 patients undergoing ICD or pacemaker implantation with an annual risk for thromboembolic events greater than 5% to either heparin bridging or continued warfarin. The trial was terminated early after a prespecified interim analysis by the data and safety monitoring board. The primary outcome — clinically significant device-pocket hematoma, which the investigators defined as a hematoma that led to prolonged hospitalization, interruption of anticoagulation, or hematoma evacuation — was significantly reduced in the continued-warfarin group, as were all three components of the endpoint:

Primary outcome: 3.5% with continued warfarin versus 16% with heparin bridging (RR 0.19, CI 0.10-0.36, p<0.001).

Click here to read the full story on Forbes.


AHA Urges More Education And Support For ICD Patients 1

Despite, and perhaps sometimes because of, their life-saving benefits, ICDs are associated with a host of complex psychosocial problems, but clinicians and caregivers receive little training to deal with these problems. In response to these concerns, the American Heart Association (AHA) has published a scientific statement in Circulation to provide a “comprehensive review of what is and is not known about psychological responses and psychosocial care” for ICD patients and their families.

The authors note that many ICD patients and potential ICD patients don’t fully understand the limitations and implications of the device. For instance, they “have a tendency to believe that the device can ‘undo’ the negative consequences of their cardiac condition, overestimate benefits, and underestimate adverse aspects.”

The document provides an overview of psychological responses to ICD therapy and the quality of life issues that often come up for ICD patients and their families. The effect of ICD shocks on quality of life is discussed in detail. In addition, the impact on the intimate and sexual relationships of patients and their partners is explored.

Although they represent a small percentage of ICD patients, children are a very important subgroup. The document notes that “few data are available to fully understand the psychosocial impact of the ICD on pediatric and adolescent ICD recipients, and no longitudinal studies of psychosocial response over time are available.”

At the other end of life, the authors discuss the difficult issue of ICD deactivation “as a patient’s clinical status worsens and death is near.” Unfortunately, they note, “clinicians and patients rarely engage in discussions about deactivating ICDs, and most devices remain active until death” and “most patients are not even aware that deactivation of the shocking function is an option.”

“A shock from an ICD can be lifesaving, but it can also affect a person’s quality of life and psychological state,” said Sandra Dunbar, the  chair of the statement writing group, in an AHA press release. “It’s important to look at this issue now because 10,000 people have an ICD implanted each month. They range from older people with severe heart failure to healthy children who have a gene that increases the risk of sudden cardiac arrest.”
Click here to read the AHA press release…

ICD Investigation: DOJ Sends Resolution Model To Hospitals 1

Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare Compliance, that summarized the key details of the novel program.

As reported by (free registration), the document sent to hospitals contains “instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act.” Some hospitals, according to the story, “have been asked to provide information of hundreds of cases each.”

Hospitals are being asked to perform audits on their cases and to estimate damages, “with the severity of penalties based on whether the hospital had medical reasons to violate CMS rules; if patient harm resulted; if the hospital had prior knowledge or a statistical pattern of non-guideline implants; and if a hospital compliance program was in place.”

Here is the DOJ Resolution Model Summary Chart (click to enlarge):

Guest Post: Feds Turn Corner in ICD Investigation; Hospital Liability Divided into Categories Reply

Editor’s Note: The following article is reprinted with permission from Report on Medicare Compliance, an independent publication not affiliated with hospitals, government agencies, consultants or associations and published by Atlantic Information Services, Inc. 

The Department of Justice is apparently about to take a big step forward in its national false claims investigation of Medicare billing for implantable cardiac defibrillator (ICD) procedures. After a year of debating the medical-necessity parameters of ICD implants, DOJ now has a blueprint for determining hospital liability, according to attorneys familiar with the case. Some ICD cases will be home free, while others will be the subject of repayment plus interest or triple damages, they say.

“There has been a breakthrough,” one attorney says.

As a result, DOJ will soon send letters to hospitals with instructions for resolving their potential ICD overpayments. Hospitals will be asked to self-audit ICD procedures using an audit tool the federal government developed in collaboration with defense counsel and Navigant Consulting, attorneys say. After the audits are completed, hospitals will report back to DOJ, which will spot check their findings. Then settlement talks presumably will begin, the attorneys say.

“They want to move forward and close these cases that have been pending for close to two years,” says another attorney. The U.S. Attorney’s Office for the Southern District of Florida, which is spearheading the case, had no comment.

The investigation of ICDs, which are small electronic devices that shock the heart back to a normal rhythm, focuses on hospital claims that ran afoul of Medicare’s national coverage decision (NCD 20.4). Initially, DOJ took the position that noncompliant billing for ICD implantation is within the realm of the False Claims Act, but it paused to consider that perhaps medical necessity in this area is not always black and white. “There will be cases that literally or technically are outside of the NCD but the government will not be demanding a repayment because there are just some scenarios that clearly were not contemplated by the authors of the NCD,” one attorney says.

The NCD for ICDs describes nine categories — “covered indications” — that trigger Medicare payment (RMC 10/31/11, p. 1). They are divided into indications for primary prevention, which means the patient did not experience prior episodes of an irregular heartbeat but is still at elevated risk for sudden death due to cardiac arrest, and secondary prevention, which means the patient had prior episodes of an irregular heartbeat.

Only the indications for primary prevention — three through nine — have “timing requirements.” Medicare won’t pay for a patient’s ICD implant within 40 days of an acute myocardial infarction (MI) or within three months of a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA). For example, Medicare covers ICDs for patients with non-ischemic dilated cardiomyopathy and for patients with coronary artery disease with a documented prior MI, as long as acute MI didn’t occur in the previous 40 days. The idea is to first give patients time to recover from the heart attack to determine whether the patient really is at elevated risk for cardiac arrest.

Hospitals May Not Be as Vulnerable

If hospitals billed Medicare for ICD procedures, they may be at risk in the national false claims enforcement action. But they may not take as big a hit as was feared when DOJ first sent out subpoenas and civil investigative demands, lawyers say. “There are some different categories where the hospitals and doctors have good things to say about the medical necessity of the decision to implant. And the government has now acknowledged the decision to implant and no demand for money will be made in those cases,” one attorney says.
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Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS Reply

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS

by Edward J Schloss MD

The St. Jude Riata ICD lead controversy took center stage at last week’s Heart Rhythm Scientific Sessions in Boston, as previously reported here.  Near the end of the meeting a leading figure in the field, Dr. Robert Hauser, of the Minneapolis Heart Institute, summarized the current state of the Riata crisis and discussed its broader implications. Hauser has played key roles in the Riata and several other similar, highly disturbing cases, including those involving the Sprint Fidelis ICD leads and the Prizm 2 DR ICD device malfunction.

In a troubling revelation near the end of his talk, Hauser suggested that St. Jude’s problems may not end with the now discontinued Riata leads, and that the company’s Durata leads may have failure mechanisms not previously reported.

Hauser first discussed an abstract from Steinberg and associates from Quebec.  These investigators used chest x-rays rather than fluoroscopy to detect Riata externalizations:

They, like others, found a far higher incidence of externalized conductors than what has been reported by St. Jude Medical.  And frankly, this and other reports presented at this meeting raise serious questions about the accuracy of the data that the manufacturer has communicated to us.  What we learned today is that this externalized cable process is time dependent.  It seems to be occurring more frequently in the 1580 leads, particularly in the 8 French, and that with time we are going to see progression.  The fact that these investigators were able to use special chest radiographs to identify externalized conductors is interesting and deserves further study by comparing the sensitivity and specificity of their technique to high-resolution cine-flouroscopy

Hauser then discussed the Riata extraction experience from Royal Victoria Hospital in Belfast, and then offered some practical advice:
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Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel 1

The FDA’s Circulatory System Devices panel voted 7-1 on Thursday that the benefits of the Cameron Health subcutaneous ICD system (S-ICD) outweigh the risks in appropriately selected patients.

Unlike all previous ICDs, the S-ICD is much easier to implant because it is does not require threading a lead to connect the device to the heart. Panel member Rick Lange said the S-ICD was an example of “I-should-have-thought-of-that technology”, according to Heartwire reporter Reed Miller on twitter. That sentiment was echoed by device giant Boston Scientific in March when it agreed to acquire Cameron Health for $150 million initially, and as much as $1.2 billion in additional payments based on future performance, according to Reuters.

The advisory panel also voted 7-1 that the S-ICD was effective and 8-0 that it was safe.

Earlier this week, FDA reviewers posted the previously unavailable results of the pivotal trial for the S-ICD. The FDA review set the tone for a generally supportive panel meeting, finding that the trial met its primary safety and efficacy endpoints, though it identified several potential safety issues.

Click here to read the press release from Cameron Health…

FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial Reply

In preparation for Thursday’s meeting of the FDA’s Circulatory System Devices advisory panel, the FDA has released the results of the pivotal trial for the Cameron Health subcutaneous ICD system (S-ICD). The results have not been previously available. Unlike previous ICDs, which require threading a transvenous lead to the heart, the S-ICD system contains no leads to connect the device to the heart.

The S-ICD pivotal trial was a prospective, non-randomized, single-arm study performed at 33 sites. The trial enrolled 330 patients, 314 of whom received the S-ICD system. Mean followup was 321 days.

The FDA found that the trial met the primary safety and effectiveness endpoints.

For safety, the system-complicaton-free rate at 180 dayswas 97.9%, which was well above the performance goal of 79%. 8 patients died during the trial, but none of the deaths were tied to the S-ICD system. Four patients had systemic infections requiring explant of the device, while 14 had incision or superficial infections that did not require an explant. The FDA noted that when compared to traditional transvenous ICDs, the S-ICD system had “higher rates of infection, increased time to delivered therapy, and reduced device service life.”

Inappropriate shocks occurred in 38 patients (11.8%); 32 of these patients were managed noninvasively with system reprogramming and drug therapy. Overall, 30.6% of shocks were deemed inappropriate. The FDA reviewer said that a literature review found that about one-third of shocks were inappropriate in a similar group of patients with standard ICDs.

The efficacy rate was 100%. Acute VF conversion was successful in 304 instances, with no failures. 16 episodes were non-evaluable. The FDA calculated that even if all the non-evaluable cases were assumed to be failures, the lower confidence interval for the efficacy rate would have been 91.7%, still well above the performance goal of 88%.

20 Deaths Linked to New Problem with Riata Leads 1

Electrical malfunctions, not externalized conductors, may be the cause of 20 or more deaths associated with the troubled Riata ICD leads from St. Jude Medical, according to a new report published online in Heart Rhythm.

Robert Hauser and colleagues at the Minneapolis Heart Institute searched the FDA’s MAUDE database and found 22 deaths caused by Riata or Riata ST lead failure. By contrast, only five deaths were caused by failure of the more widely implanted Quattro Secure lead. The authors reported that the Riata deaths “were typically caused by short-circuits between high voltage components. No death was due to externalized conductors.” As reported previously on CardioBrief, Hauser has played an important role in gathering and disseminating information about ongoing concerns about the Riata leads.

“The deaths are rare, but more frequent than you would expect. It’s another example of our flawed regulatory system,” Hauser told the Wall Street Journal. St. Jude told the Wall Street Journal that Hauser’s article contained several errors. Two deaths were counted twice, reducing the total number of lead-related deaths to 20, according to the company. In addition, St. Jude’s chief medical officer, Mark Carlson, said that some of the deaths were “from well-known causes, including wires that were coiled during surgery and ended up rubbing against the defibrillator.”

What To Do When Federal Investigators Knock On The Door 2

For more than a year now the federal investigation of hospitals suspected of improperly implanting ICDs has been the subject of considerable rumor and speculation. Now, two cardiologists who were involved in a federal audit at one hospital have published a detailed account of their experience.

Jonathan Steinberg and Suneet Mittal are Columbia University-affiliated electrophysiologists who also direct the EP program at a large suburban nonteaching hospital. In a special article published in the Journal of the American College of Cardiology, the two authors describe the audit process and subsequent events in the hope that their experience “might provide valuable lessons” to others involved in similar cases.

The initial government analysis had found that 229 cases, representing 8.7% of all de novo ICD implants for primary prevention between 2003 and 2010, did not warrant coverage. Following a more detailed review of the medical records, the authors report that a much smaller number of cases, 34, representing 1.3% of all implants, were truly not indicated. These cases mostly occurred after bypass surgery in the setting of non sustained VT and/or a positive EP study, according to the authors. By contrast, a small number of cases had a clear secondary prevention indication, but the records for the earlier cardiac arrest or VT event were at another hospital.

Most of the cases were somewhat more ambiguous. Steinberg and Mittal list five common types of cases which were difficult to categorize and which “highlighted the complexity of adjudicating between clinical practice and the contemporary regulatory environment.”
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Women and ICDs: More Complications and Fewer Benefits Reply

After consulting an electrophysiologist, women are just as likely as men to receive an ICD but they suffer more complications and are less likely to benefit from the device, according to a new study from Canada published in Annals of Internal Medicine.

Derek MacFadden and colleagues analyzed data from 6,021 patients treated at 18 ICD implantation centers in Canada. 21.4% of the patients were women. The rate of ICD implantation was similar in men and women, but women were more likely to have complications and less likely to receive appropriate shocks or antitachycardia pacing:
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