December 12th, 2011
Large Analysis Confirms Safety of ADHD Medications
Larry Husten, PHD
The cardiovascular safety of ADHD (attention-deficit/hyperactivity disorder) drugs has been uncertain. Now a large new study published online in JAMA provides reassurance that the drugs are safe.
Laurel Habel and colleagues analyzed data from more than 440,000 adults, including 150,359 users of ADHD medications, and matched nonusers and found “no evidence of an increased risk of MI, SCD, or stroke associated with current use compared with nonuse or remote use of ADHD medications.” Even in a worst-case scenario, the absolute increase in risk is quite small, the authors said.
Here are the adjusted rate ratios and 95% confidence intervals for serious cardiovascular events:
- current use versus nonuse of ADHD medications: 0.83 (CI, 0.72-0.96)
- new users versus nonusers: 0.77 (CI, 0.63-0.94)
- current use versus remote use: 1.03 (CI, 0.86-1.24)
- new use versus remote use: 1.02 (CI, 0.82-1.28)
In an accompanying editorial, Philip Shaw writes that the study “is the most comprehensive assessment to date of the cardiovascular safety of ADHD medications.” He said the study supports the 2006 decision by the FDA not to place a black box warning on ADHD medications and that it “provides no evidence to support routine” ECGS before initiating drug treatment.
December 12th, 2011
More Commentary on Statin Drugs
Heather M Johnson, MD, MS
I was delighted when my friend, Dr. Kevin Pho, accepted my recent post on statin drugs.
As a ‘student’ writer, I was also happy to read more than a couple ‘robust’ comments. No worries here, bike racers and heart docs have thick skin.
I penned six responses on the KevinMD post. The gist of the comment is in bold. (I know; it’s weak using responses to comments as a post.)
Do you have industry sponsorships?
I have no industry relationships. I am just a clinician – a regular doctor. I see patients in the office, ablate arrhythmias and implant (evidenced-based) devices. That’s it. My blog has never made a dime. On the contrary, I pay for its costs myself. Like you would spend for any enjoyable hobby.
Did you know many of the trials of statin drugs are sponsored by pharmaceutical companies?
It is true that most of the statin trials are supported by statin makers. Such relationships are important to consider because of possible bias. But … randomized placebo-controlled clinical trials that look at hard endpoints like death, stroke and heart attack are tough to rig. You would have to posit overt dishonesty of the investigators. Though I think researchers may occasionally exaggerate positive results in lieu of adverse effects, I do not believe industry funding leads to widespread fraud. I believe most in medicine and science are right-minded – human yes, but still right-minded.
Many patients get put on statins instead of counsel on the benefits of living a healthy lifestyle.
It’s ironic that some of the criticisms of my piece stem from my perceived advocacy of statin drugs. In fact, it is the opposite: I don’t like prescribing pills. I consider myself a crusader for healthy living. I believe the best way to prevent and treat heart disease is by consistently making good choices. That said, “we” have yet to find the best means to get people on what I call the ‘program.’ (A side bar here is that I believe Ms. Obama is on the right track – start with the new generation.)
The purpose of my piece was to offer my take on recent evidence for statin efficacy and safety.
Many patients are put on statin drugs for high cholesterol without clear evidence of benefit.
I concur with the notion that the debate on statins for low-risk patients continues. Most experts believe the reason statins show mixed results in low-risk patients stems from low event rates in this cohort. It’s hard to statistically lower an already low event rate.
Statins have been shown to lower CoQ10 levels.
I have read about the CoQ10 depletion idea. Ideas like this are important. Ideas are always good. But thus far, I know of no trial looking at hard outcomes (death, heart attack, stroke) that shows a benefit to adding CoQ10. The danger of promoting ideas as sound medicine is that things that are theoretical, studied only in rats or observed in a chem lab, don’t always prove true when studied in real people. Examples abound here. Think anti-oxidant vitamins.
Though some data exist suggesting that CoQ10 supplements may help relieve statin-induced muscle soreness, the MayoClinic and others say “more studies are needed.”
Statins may cause significant muscle soreness or other adverse effects?
Finally, If your doctor dismisses a potential drug-related side effect, the solution is easy. Get another doc – one who listens, who discusses the evidence base, who partners with you and then allows you to choose your course. This is called ‘patient-centered care.’ It makes for longer office visits.
Wait a minute, are you saying running behind schedule in the office might signify a good doctor?
Grin!
December 9th, 2011
To the Moon and Back in the ICU: It’s Not a Solo Trip
Shanti Bansal, MD
I stepped into Bill’s room in the intensive-care unit (ICU) and caught sight of him lying in bed. I asked him how he was today. In a nervous voice, he told me that he was fine. Monitors flashing lights and pumps chiming in chorus filled the room. With machines ablaze, it was like witnessing a space shuttle launch at NASA’s mission control room. I turned to him and said, “You’ve been through some pretty tough times. You came to us after your heart stopped and we had to restart it. We did a catheterization to look at your arteries and found a lot of blockage. Unfortunately, we ran into problems with bleeding after the procedure but now the bleeding has stabilized. It’s time to go ahead with open heart surgery for your blocked arteries. Tell me your thoughts on this?”
With his melancholy palpable, he said, “I don’t want to have this operation. I have no one to live for. I have a son who is an orthopedist but he doesn’t have time to visit and an ex-wife who doesn’t want to see me either.”
I reflected on his statement. I had recently had an experience after the birth of my child that opened me to the importance of personal connections in health outcomes. While still in the hospital my two-day-old son, Arjun, developed labored breathing. The pediatrician, with a worried look, suggested that we transfer him to the neonatal ICU. There, he was placed into an incubator. Like an astronaut space suit, it provided a special environment designed to protect against infections and noise.
Over the next four days my wife and I planned shifts to be there with him for support during the stay. We spent time feeding him and offering comfort. We witnessed daily improvements and noticed signs that his breathing was growing stronger. Through my time there, I could see numerous other babies in similar situations. However, it was a rare sight to see other families involved in their baby’s care. Curious, I asked one of the nurses the reason for this. She said, “Well, the parents just come by to pick up their baby when the baby is better.” I was surprised to hear that other parents were not as involved in the care of their baby. After several days, Arjun left the ICU and came home well before the other babies.
I knew Bill’s decision whether to undergo the operation was a difficult one for him and I could not make it on his behalf. I turned to him and said, “Well, I think before you make up your mind not to proceed you should ask your son if he can come visit and we can discuss the options you have.” Eventually Bill did agree to the operation after talking with his son and he did well for the remainder of his hospitalization.
In the cases of Arjun and Bill, family support was a powerful form of medicine. As health care providers, physicians should encourage family involvement in the care of patients. Advanced medical illnesses need to be approached with a holistic perspective, which includes patients reaching out to friends and family. Without their support, taking our patients to the moon and back by the use of advanced medical therapies alone to improve health care outcomes is hard won.
December 9th, 2011
FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System
Larry Husten, PHD
Members of the FDA Circulatory System Devices Panel on Thursday recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks.
Panel discussion focused on the CHAMPION trial. In an extraordinary addendum to its main review of the trial, the FDA reviewers raised serious concerns that “the conduct of the trial may have biased the study results.” An audit of the trial by FDA inspectors determined that the sponsor or the principal investigators “routinely contacted investigational sites and made specific therapeutic recommendations for some Treatment Group study subjects.”
December 8th, 2011
How Randomness Affects Quality of Care
John E Brush, MD
Each month I meet with administrators at my hospital to review the quality of our cardiology program. At several meetings I’ve complained that our performance thresholds are too high and fail to account for the random variation that is a part of everyday medicine. My administrators don’t want excuses, though — they aim for perfection. But a discussion at our last meeting about door-to-balloon times for STEMI patients changed their minds.
Last month a STEMI patient presented to the ER and underwent a timely PCI. During the procedure, a second STEMI patient arrived. Plans to quickly finish and transfer the first patient to the ICU were thwarted because the ICU was full. The team developed a work-around solution to take the first patient back to the ER to accommodate the second patient in the catheterization laboratory. Despite fast and creative action, the second patient had a door-to-balloon time of 118 minutes, falling short of the 90-minute threshold.
So how were we to respond to this apparent lapse in quality? As we discussed the situation in our meeting, the answer became clear: No corrective action was required. The team had acted admirably. The lapse was due not to a systems defect but to the uncommon, unpredictable presentation of two STEMI patients simultaneously. The administrators realized how randomness affects our measured outcomes.
Cognitive psychologists tell us that our minds are hardwired to try to find causes for occurrences. We often jump to erroneous conclusions by ascribing unwarranted explanations to events that happen randomly. Intuition can sometimes be helpful, as I’ve discussed in previous blog posts, but it can also lead us astray. Apparently, we evolved the tendency to jump to conclusions long before statistics and probability theory explained random variation.
The quality gurus Walter Shewhart and W. Edwards Deming recognized this when they described “chance causes” versus “assignable causes” of variation. Shewhart also used another term, “special cause variation,” to describe variation that may stem from system deficiencies. Both men recognized that overreacting to “noise” in measurement could lead to wasted quality-improvement efforts or, worse, poor staff morale and even an atmosphere of fear.
Pay-for-performance plans and co-management agreements often have quality thresholds that fail to build in an allowance for the play of chance. Quality thresholds for door-to-balloon time are sometimes aggressively set at 96%. But most hospitals have only about 50 door-to-balloon opportunities per year. If by chance they miss a few, like in the above example, they fall below the 96% threshold. It’s great to set lofty goals, but when you turn goals into reward thresholds, missing the threshold because of chance only discourages diligent practitioners from trying to provide quality care.
Failure to recognize randomness can also affect individual performance. Experts in any field gain experience by using intuition to recognize regularities in their environment. Use of objective measurement and feedback is ideal, but much of what constitutes experience is gained through subjective self-monitoring and observation over time. I suspect that the experts who seem to “get it” are those who can filter out the noise of random variation and focus on the signal observations, which enables them to gain meaningful experience.
We should remain vigilant for trends and patterns in medicine that provide opportunities to improve the quality of care. But clinical medicine also has a Brownian-type motion that is unpredictable and uncontrollable because of randomness. Knowing that our natural tendency is to jump to conclusions about causation, we should remember to account for chance and the inherent randomness of events as we monitor our individual and institutional performance.
December 7th, 2011
CV Risk of Prostate Cancer Therapy Underappreciated
Larry Husten, PHD
Androgen suppression therapy (AST) for prostate cancer may be a serious risk factor for cardiovascular (CV) disease, according to a Viewpoint published online in Heart. The scope of the problem is widely underappreciated and is rarely considered in clinical practice, write Liam Bourke and colleagues. The subject was also the topic of a 2010 scientific statement from the American Heart Association, the American Cancer Society, and the American Urological Association.
The authors estimate that for every 1000 men treated for 5 years with AST, there will be an excess 315 incident cases of coronary heart disease, 360 cases of diabetes, 28 MIs, and 42 strokes.
“The current status quo of no action is, in our view, unsatisfactory for the patient and unlikely to be cost effective,” the authors write. “There is a need to investigate integration of AST specific CVD risk augmentation strategies into standard clinical care.” Cancer nurse specialists, they suggest, are a “potentially cost efficient, efficacious resource to manage CVD risk in these men.”
December 7th, 2011
FDA Undertakes Safety Review of Dabigatran (Pradaxa)
Larry Husten, PHD
The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug.
Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected.”
The FDA notes that it is difficult to compare bleeding complications between dabigatran and warfarin, since complications associated with the older warfarin may be less likely to provoke an adverse event report.
December 6th, 2011
Change in Fitness Appears More Important Than BMI Over Time
Larry Husten, PHD
Experts have been debating the relative roles of obesity and fitness in cardiovascular risk. Now a new report from the Aerobics Center Longitudinal Study, published in Circulation, finds that maintaining or improving cardiorespiratory fitness significantly lowers CV mortality irrespective of changes in BMI.
Duck-chul Lee and colleagues followed 14,435 men for 11.4 years. Compared with people whose fitness deteriorated over time, people with stable fitness or improved fitness had significantly lower rates of all-cause and CV mortality. Here are the hazard ratios and 95% confidence intervals, after multivariate adjustment:
Stable fitness:
- all-cause mortality: HR 0.70 (0.59–0.83)
- CV mortality: HR 0.73 (0.54–0.98)
Fitness gain:
- all-cause mortality: HR 0.61 (0.51–0.73)
- CV mortality: HR 0.58 (0.42–0.80)
The authors calculated that each 1-MET (metabolic equivalents) improvement in fitness conferred a 15% reduction in all-cause mortality and a 19% reduction in CV mortality. After adjustment for other factors and change in fitness, BMI was not independently associated with either all-cause or CVD mortality.
The authors concluded that “the long-term effect of fitness change, primarily resulting from increasing physical activity, is likely to be at least as important as weight loss for reducing premature mortality.”
December 6th, 2011
FDA Reviewers Raise Questions About CardioMEMS CHAMPION Trial Ahead of Advisory Panel
Larry Husten, PHD
FDA reviewers have raised serious questions about the results of the CHAMPION trial of the implantable CardioMEMS HF Pressure Measurement System (HF System), which provides daily pulmonary artery pressure measurements for the purpose of guiding heart failure treatment. On December 8, the FDA’s Circulatory System Devices Panel is scheduled to review the PMA for the device. (Click here for the FDA documents.)
The main FDA review concludes that the trial “met the primary effectiveness endpoint and both primary safety endpoints in the population studied, based upon their pre-specified hypotheses.” But, the review continues: “Although statistically significant, FDA has questions about the clinical significance of the findings, in particular related to the primary effectiveness and several of the secondary effectiveness endpoints (Proportion of subjects hospitalized for heart failure, Days Alive Outside of the Hospital and Quality of Life).” The FDA said it “would like panel input on the overall risk/benefit profile and approvability of the device.”
An addendum to the main FDA review raises additional new concerns about the trial. An earlier report about these concerns was refuted by the company’s CEO and founder, cardiologist Jay Yadav. However, with the release of the FDA documents, it now appears that the earlier rumors were at least partially correct, though there is no evidence to show that CardioMEMS had knowledge of the new FDA concerns at the time.
The addendum to the FDA review discusses information “not present in the PMA submission… based on inspections conducted by” FDA monitors. The FDA reviewers write that the trial may have been biased because the company and the national principal investigators provided additional medical support to patients in the treatment group but not to control patients. It should be noted that the purpose of the single-blind design of the trial was to test whether information received from the device could improve HF treatment. The crux of the difference between the FDA and CardioMEMS therefore appears to be whether the company’s efforts to enforce protocol-mandated treatments fall outside the standard practice of a clinical trial.
Here is the text of the additional question the FDA will ask the panel on Thursday:
Additional Question
FDA is concerned that the conduct of the clinical trial may have biased the study results. Inspections coordinated by FDA’s Division of Bioresearch Monitoring (BIMO) identified evidence that the sponsor, who had knowledge of the randomization assignment, or the principal investigators routinely contacted investigational sites and made specific therapeutic recommendations for some Treatment Group study subjects, including
- titration of medication doses,
- addition or discontinuation of medications,
- recommendations for outpatient intravenous medication administration,
- the addition of medications that were not included in the protocol, and
- sleep study evaluations not included in the protocol.
FDA is concerned that the study results may be biased by these recommendations because investigators did not receive similar treatment recommendations from the sponsor for Control Group study subjects. FDA’s interpretation of the protocol is that therapeutic changes were to be made by the study site investigators.
The information obtained through inspections coordinated by FDA’s Division of Bioresearch Monitoring raises concerns for FDA that specific therapeutic recommendations may have minimized heart failure hospitalizations for Treatment Group study subjects without an equivalent impact for Control Group study subjects. FDA is concerned that the study results may be biased and that the ability to interpret study results may be compromised by the trial conduct.
a. FDA is concerned that the specific treatment recommendations made by the sponsor may have introduced bias into the study results. Please discuss whether or not you agree with this concern.
b. If the specific treatment recommendations introduced bias into the study results, please discuss how this impacts the ability to interpret the study results.
c. FDA is concerned that the measures taken by the sponsor would not be duplicated in a post-market setting, if the device were to be approved. Please discuss how the difference between how the study was conducted and how the device would likely be used in a post-market setting should be taken into account when interpreting the study results.
d. The information identified in the BIMO inspections was not submitted by the sponsor as part of the PMA. Please discuss whether this information is relevant to an evaluation of the safety and effectiveness of the device.
CardioMEMS Responds
In its response to the FDA concerns, CardioMEMS said that “the FDA has not provided to date any evidence from the study to support a finding that either inappropriate contact was made with study site personnel or that legitimate contact with study site personnel, as outlined in the protocol, resulted in bias being introduced into the study results obtained.”
CardioMEMS further explained:
As prespecified within the clinical protocol, when the PA pressures were outside of values that were setup in advance for individual patients and modifiable by investigators, each investigator was required to consider medication changes per the hemodynamic monitoring treatment guidelines in the protocol. Follow-up email contact after pressure alerts, with investigators by CardioMEMS clinical staff, enforced compliance with protocol requirements and ensured that investigators considered all treatment options to lower PA pressures, including the treatment guidelines prespecified in the clinical protocol. The FDA is concerned that similar emails were not sent regarding Control group subjects but as is evident from the study design, emails directed towards reducing PA pressure could not have been sent regarding the Control group subjects. These PA pressure reduction recommendations could have been made for Control patients only if the pressures for Control patients were monitored during the trial.
In addition, the company performed an analysis showing that the emails from the company had at most a negligible impact on treatment.
Two well-known cardiologists who have consulted for CardioMEMS and are familiar with the documents discussed the documents and the CardioMEMS device. Michael Domanski said that he believes “the device has passed the legal test the FDA has to apply: I think it is safe and effective for its intended purpose.” Domanski was not bothered by the additional concerns raised by the FDA, given the single-blind design of the study, since the company advice “falls under the general heading” of getting advice from a colleague. He felt that the FDA would likely mandate post-approval studies which would help settle the question of the role of the device in a real-world setting.
Milton Packer had a somewhat more nuanced perspective about the FDA’s additional concerns. “By definition, the fact that the FDA has raised it makes it an issue,” he said. The company can respond by stating that it will market both the device and a case management system to go with it, he speculated. “In other words,” he said, “what it is commercializing is exactly how the trial was conducted.” Another option is to demonstrate, as the company already has attempted to do, that the communications that occurred didn’t have any impact on the outcome of the trial. The two options are not mutually exclusive, he noted.
December 5th, 2011
CMS Tightening the Screws on Unnecessary Procedures in Florida and 10 Other States
Larry Husten, PHD
After years of criticism that it has paid billions of dollars for unnecessary procedures, the Centers for Medicare & Medicaid Services (CMS) will soon ramp up efforts to rein in costs for unnecessary procedures. In 2012, CMS will perform an audit before paying for several big ticket cardiology and orthopedic procedures in certain key states. The news has provoked strong reactions from cardiologists and Wall Street.
In Florida, in fact, 100% of stent, ICD, and pacemaker implantation procedures will undergo review before payment. Similar programs will take place in California, Michigan, Texas, New York, Louisiana, Illinois, Pennsylvania, Ohio, North Carolina, and Missouri, but the precise percentage and mix of cases that will undergo auditing has not yet been stated.
On November 15, CMS announced the demonstration program:
The Recovery Audit Prepayment Review demonstration will allow Medicare Recovery Auditors (RACs) to review claims before they are paid to ensure that the provider complied with all Medicare payment rules. The RACs will conduct prepayment reviews on certain types of claims that historically result in high rates of improper payments. These reviews will focus on seven states with high populations of fraud- and error-prone providers (FL, CA, MI, TX, NY, LA, IL) and four states with high claims volumes of short inpatient hospital stays (PA, OH, NC, MO) for a total of 11 states. This demonstration will also help lower the error rate by preventing improper payments rather than the traditional “pay and chase” methods of looking for improper payments after they have been made.
On November 21, Juan Aranda, Jr., president of the Florida chapter of the American College of Cardiology (ACC), sent a letter to all ACC members in Florida about the “very serious proposed changes… that you need to be aware of immediately.” Aranda said that the Florida ACC “is fighting these onerous regulations” and that staff at the national ACC headquarters planned to meet with CMS officials.
Details of the CMS initiative only became widely known on Friday, when Wells Fargo analyst Larry Biegelsen issued a report summarizing the initiative in which he cited “reimbursement experts who have all indicated that this initiative seems onerous for hospitals and will likely reduce procedure volume because hospitals will begin making sure that every patient meets the coverage criteria.”
Reaction to the report on Wall Street was immediate. According to an article in Bloomberg News, hospital and medical device stocks plunged after the report was issued on Friday. Tenet Healthcare dropped 11%, while Medtronic lost 6%.
Here is the position of the Florida ACC chapter, as stated by Jerold Saef, the chair of the Third Party Reimbursement committee of the chapter, in the letter to Florida cardiologists:
As of the first of the year, there will be 100% pre-payment audits on all inpatient hospital stays relative to 15 DRG’s [diagnosis-related groups]. 11 of these are cardiac and 4 are orthopedic. This means that all inpatient stays involving a listed DRG will trigger a hold on any payment associated with Part A reimbursement. Hospitals will not be paid for 100% of these admissions pending record review. There will be a 30-60 day period during which the hospital records will be reviewed for whether they support medical necessity for procedures which occurred during the stay. The Part B (physician) payment will proceed. If the determination is made that records do not support necessity, then the entire hospital stay will be denied. The physicians will receive a form letter which will be entitled a “Take-Back Letter” requiring return of any funds paid in conjunction with the affected hospitalization. This will affect all cardiologists and orthopedists involved in the care – both invasive and noninvasive. This may include outpatient reimbursement for follow-up care related to the hospitalization. It’s not clear whether other specialists or primary care physicians will also receive Take-Back Letters.
The premise under which this program is being initiated is that physicians are not adequately documenting the justification for their procedures and that as many as half the procedures performed may be unnecessary. This estimate apparently arises from White House and Congressional concerns that unnecessary procedures are being funded. They draw their conclusions from Comprehensive Error Rate Testing (CERT).
In our discussions with FCSO, we are told this is an instruction from The Center for Medicare and Medicaid Services (CMS), and that it is being implemented nationally. We have confirmed via the National ACC that this is the case in at least 10 other states. We are also told that if, after a matter of months, it appears that the scrutiny being used is unnecessary, there will be a shift in focus away from the initial DRG’s towards other, different DRG’s.
The Chapter leadership is concerned that the Pre-Payment Audit Initiative is being launched at all and, additionally, that it is being launched with little more than 6 weeks warning. The FCACC and the Florida Orthopedic Society both think that the previous Local Coverage Determinations (LCD) that were formulated should have provided FCSO with the necessary tools to fight over-utilization and fraud, and that no additional measures are necessary at this time. It occurs when holidays are imminent and end of the year finances are being addressed. We consider this unfair and unprecedented. We are concerned that cardiology practices, already subject to huge technical component cuts, loss of consult codes, increasing certification overhead, costs of implementation of electronic medical record systems and the Sustainable Growth Rate issue, will now be threatened by unjustified “Take-Back” strategies.
Here is the list of DRGs that will be subject to 100% prepayment medical review in Florida:
- 226 — Cardiac defibrillator implant without (w/o) cardiac catheter with (w/) major complications or comorbidities (MCC)
- 227 — Cardiac defibrillator implant w/o cardiac catheter w/o MCC
- 242 — Permanent cardiac pacemaker implant w/MCC
- 243 — Permanent cardiac pacemaker implant w/CC
- 244 — Permanent cardiac pacemaker implant w/CC or MCC
- 245 — Automatic implantable cardiac defibrillator (AICD) generator procedures
- 247 — Percutaneous cardiovascular procedure w/drug eluding stent w/o MCC
- 251 — Percutaneous cardiovascular procedure w/o coronary artery stent w/o MCC
- 253 — Other vascular procedures w/CC
- 264 — Other circulatory system or procedures
- 287 — Circulatory disorders except acute myocardial infarction (AMI), w/cardiac catheter w/o MCC
- 458 — Spinal fusion except cervical w/spinal curve, malign, or 9+ fusions w/o CC
- 460 — Spinal fusion except cervical w/o MCC
- 470 — Major joint replacement or reattachment of lower extremity w/o MCC
- 490 — Back and neck procedures except spinal fusion w/CC/MCC or disc device/neurostimulator
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