March 24th, 2010
ACCORD: Bigger Issues for Our Patients
JoAnne M. Foody, MD
We are now at a point where it is increasingly difficult to demonstrate the incremental value of any preventive therapy, as we are successful in reducing CV risk to lower and lower levels. What is my take on the ACCORD BP study? It’s that we should focus on ensuring that all patients achieve at least the “conservative” risk factor goals that were achieved in ACCORD.
While we argue over which target to achieve for BP, millions of Americans remain unaware of their blood pressure, and few with elevated levels are treated to even conservative goals. To me, this is the bigger issue for our patients and for us as clinicians and healthcare providers.
…what are your thoughts?
March 24th, 2010
Freezing in AF Ablation—Not So Fast, You All
John Mandrola, MD, FACC
CardioExchange welcomes this guest post reprinted with permission from Dr. John M, a blog by private-practice electrophysiologist and CardioExchange member, Dr. John Mandrola.
Freezing the heart is in the news. The STOP-AF trial was presented at ACC, and it sure has generated much excitement about atrial fibrillation ablation. This is a good thing.
However, as is the norm in the era of instantaneous news, the press reports read much differently than reality. The propaganda has an effect. I read one comment from an AF patient, who said he was waiting approval for the Arctic Front balloon before undergoing ablation. Hope his AF isn’t too symptomatic.
Before launching the party favors, here are some musings from the “real world.”
On success rates
The WSJ, LA Times, and Medpage report either 98% success or 70% success rates.These are misleading; the details are important. When using only the cryo-balloon, the pulmonary veins (PVs) were isolated in only 90% of cases. Meaning, in expert hands, one in ten patients had to have a standard RF catheter inserted to complete the PV isolation.
Success in initial PV isolation does not equal successful elimination of AF
In STOP-AF, the technical success of complete PV isolation with both RF and balloon catheters was 98%. This is the same as we achieve now with radiofrequency catheter ablation, but, and it is a huge but, AF recurrence rates are high. In the study, the successful elimination of AF with a single procedure was only 60% –with two procedures it was 70%. This is about equal to, or slightly lower than what is achieved with present day RF ablation.
Historically, one of the knocks on cryo-ablation is the higher recurrence rate after ablation. In far less complicated ablations, like PSVT or typical atrial flutter, these higher recurrence rates of cryo-ablation therapy have limited its widespread acceptance. STOP-AF’s 40 percent AF recurrence rates speaks to either the impermanence of the PV isolation, or the fact that cryo-balloon isolation is more distal in the vein, thereby missing areas that are presently ablated with the more proximal RF approach.
Complications
Herein lies the largest concern. Although, the overall complication rate in STOP-AF was 6%, there are some very concerning specifics. Cryo-ablation is unique in its propensity for injuring the right phrenic nerve. This is really bad.
The phrenic nerve innervates the diaphragm which is the primary breathing muscle. Paralysis of it causes shortness of breath, which is one of the same symptoms of AF—the disease one is trying to eliminate. In most, but not all cases, the paralysis resolved after anentire year. Ouch.
The reason for the paralysis can be explained anatomically. The phrenic nerve courses a few millimeters outside the left atrium adjacent to the right sided pulmonary veins. Radiofrequency lesions are never performed inside the veins, rather in the left atrium proper. Therefore, RF lesions do not injure the right phrenic nerve. Six years and hundreds of cases, and I have never seen it.
On the other hand, cryo-balloon isolation of the right sided veins is deeper in the pulmonary vein. This allows for the potential of collateral damage to the nerve, as evidenced by the 29 phrenic nerve injuries (of only 200 cases) in STOP-AF. This, in the hands of experts. When the less experienced masses get hold of the new balloon, the incidence of complications will surely rise.
Trust a cyclist on this one, AF is better than paralysis of the diaphragm.
History
Every January for the past number of years, I have attended the Boston AF symposium. This same balloon technology was presented many years ago, and the results were similar—including phrenic nerve paralysis. The balloon technology is essentially the same, so I wonder why this data is now generating so much positive press. Could it be that the Arctic Front system is now owned by a fortune 500 medical device company, or that the study was industry funded?
Conclusions
PV isolation is clearly the best ablation strategy for intermittent drug refractory AF, and the cryo-balloon will likely facilitate this presently labor-intensive process. We could use it to isolate the left sided pulmonary veins, and in some cases, the right sided veins may also be amendable. It is clear though, in many cases, an RF catheter may need to be employed in the same procedure. Two catheter technologies in one procedure equates to double the instrument costs, not to mention different sized balloons—each of which will surely be billed separately.
Remember all, this is America, and in our health care system, a new technology from a fortune 500 medical device company will not be cheap. Consider that, even a straight forward SVT ablation is already very expensive. We do PV isolation in 2-3 hours with less than 20 minutes of xray time. The hospital purchasers of equipment will undoubtedly look askance at the marked increase in the cost of adding a second ablation system to complete the job presently done by one. They might even ask about the incidence of phrenic nerve paralysis, or the lack of superiority of success rates compared to RF ablation.
To show superiority of the cryo-balloon, it needs to be compared head to head with RF catheter ablation. We already know PV isolation is superior to medicine in the drug refractory symptomatic AF patient. Also, a future comparative study would have greater clinical relevance if it involved ablators who toil in the “real” world.
Exciting new tools—yes, for sure. But, as is frequently the case, the details are important, and not often elucidated in the immediacy of the press reports.
March 23rd, 2010
• High Blood Pressure in ICU Linked to Better Outcome
• Nissen and JAMA Editors Weigh In on Avandia
• Improving Informed Consent; Beta-Blocker Inventor Dies
Larry Husten, PHD
High Blood Pressure in ICU Linked to Better Outcome: Using data from nearly 120,000 patients admitted to the ICU for chest pain, Swedish investigators found, somewhat unexpectedly, that high systolic blood pressure at the time of admission was associated with improved outcome. The association remained evident even when patients with CHF or who went on to develop CHF were removed from the analysis. The findings, the authors write in their paper in JAMA, should be used only for prognostic purposes: “Our data should not be interpreted as a suggestion not to normalize an elevated BP in patients with acute chest pain.” Nissen and JAMA Editors Weigh In on Avandia: In a commentary in JAMA, Steve Nissen provides a detailed account of events surrounding the Avandia controversy from his perspective as the author of the original meta-analysis that helped start the controversy. Nissen focuses on the deficiencies of the RECORD trial. In an accompanying editorial, JAMA editors Catherine DeAngelis and Phil Fontanarosa propose that, given the deficiencies of RECORD and other industry-sponsored trials, journals should “require that academic researchers have full access to all trial data and that all industry-sponsored trials include independent statistical analysis and assurance.”Improving Informed Consent: The high ideals of patient-centered care are compromised by the deficiencies of informed consent, according to a JAMA commentary by Harlan Krumholz (CardioExchange editor-in-chief). Krumholz proposes sweeping revisions of the current approach to informed consent, utilizing forms “standardized across institutions, with core information written by expert groups.” Krumholz provides a sample informed consent document for elective PCI.Beta-Blocker Inventor Dies: Sir James Black, the pharmacologist who won the Nobel Prize for his invention of beta-blockers, died at the age of 85. In what might be the equivalent of winning back-to-back marathons, Black followed up his earlier invention by playing a key role in the development of cimetidine, the first effective anti-ulcer drug. In 1994, Black delivered the plenary lecture at the American College of Cardiology meeting. (You can read a news report reprinted from 1994 on CardioBrief.)
March 22nd, 2010
• AHA Scientific Statement on Medication Errors in Acute CV Medicine
• BNP-Guided HF Therapy
Larry Husten, PHD
AHA Scientific Statement on Medication Errors in Acute CV Medicine: “Cardiovascular medications are the most common drug class associated with medication errors, and cardiovascular patients remain at high risk in the acute hospital phase, even with the current safety strategies,” said Andrew Michaels, chair of the writing committee for a new AHA scientific statement published in Circulation. According to the statement, by following eight recommendations — from using a simple weight check to using computerized medication orders — healthcare professionals can help reduce medication errors among hospitalized heart and stroke patients.BNP-Guided HF Therapy: Porapakkham et al performed a meta-analysis of randomized controlled trials that tested the use of BNP to guide treatment of heart failure. BNP-guided therapy was associated with a reduction in all-cause mortality, particularly in patients under the age of 75. However, the investigators found no reduction in hospitalizations. The paper appears in Archives of Internal Medicine.
March 19th, 2010
Friday March 19: FDA in the News: Warning About High Dose Simvastatin; Advisory Panel Supports Expanded Indication for CRT-Ds; Watchman Approval Delayed
Larry Husten, PHD
FDA Warns About High Dose Simvastatin– The FDA issued a drug safety communication today about an ongoing review of high dose simvastatin and increased risk of myopathy based on data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial.FDA Panel Supports Expanded Indication for CRT-Ds– The FDA’s Circulatory System Devices Panel voted unanimously to support a broader indication for Boston Scientific CRT-D devices. The expanded indication, based on data from the MADIT-CRT trial, would include NYHA Class I and II patients with LBBB, LVEF ≤ 30% and QRS duration ≥ 130ms. (Boston Scientific press release)FDA Delays Watchman Approval– The FDA has told Atritech Inc that it will have to perform another study to confirm the safety and efficacy of the Watchman Left Atrial Appendage Closure Technology before the device can gain market approval. (Atritech press release)
March 19th, 2010
“Doc, I’m so confused. Do I stop or continue the clopidogrel?”
Richard A. Lange, MD, MBA
A recent study suggested that clopidogrel can be discontinued 12 months after drug-eluting stent placement. What do I tell my patient who had a drug eluting stent placed a year ago? He’s not the only one who’s confused.
I’m concerned that the study was underpowered and the duration of follow-up too short to provide a firm conclusion about the appropriate duration of clopidogrel therapy. I’m not comfortable recommending my patients stop clopidogrel after 12 months. Are you?
How would you explain your opinion to the patient?
March 17th, 2010
March Madness—In the Wake of ACC, Name the Head-to-Head Match-Ups You’d Like to See
Joseph S. Ross, MD, MHS
If you work for the NIH, you’re not allowed to bet on your favorite NCAA basketball team. But here at CardioExchange, you can channel your enthusiasm into a different set of brackets.
The elegant simplicity of March Madness, despite the chaos, is that we get our questions answered: “Who’s better? Syracuse or Georgetown? UCLA or USC? Kansas or Kentucky?” Teams are ranked and placed in brackets, face-off over three weeks, and one team is left undefeated at the end of the Tournament. This year, the ides of March bring us not just to beginning of the NCAA’s March Madness Tournament, but also to the end of the ACC’s Scientific Session. There was no tournament at the ACC, but we did see the results of several interesting head-to-head comparisons:
- Lenient vs. strict heart-rate control for A-Fib in RACE II
- Ablation vs. anti-arrhythmic drug therapy for persistent A-Fib in CABANA
- Sirolimus-eluting stents vs. zotarolimus-eluting stents for PCI in SORT OUT III
- Dual-antiplatelet therapy with clopidrogrel and aspirin vs. aspirin monotherapy after DES placement for PCI from REAL-LATE and ZEST-LATE
This led me to wonder: What if we could set-up head-to-head, comparative-effectiveness research, tournament style? Which “games” would you be most interested in seeing?
Was the valsartan effect on diabetes incidence in NAVIGATOR substantial enough that you’d want to compare valsartan to any of the other ARBs for glucose intolerant hypertensive patients?
Do you want to see amiodarone and dronedarone compared head-to-head for maintenance of sinus rhythm for patients after cardioversion of A-Fib?
What head-to-head comparisons would best inform your clinical practice? Fill in your brackets!
March 17th, 2010
Wednesday, March 17 News: Thoracic Aortic Disease Guidelines Released
Larry Husten, PHD
The AHA and the ACC released new practice guidelines for the management and treatment of thoracic aortic disease. Here is a press release about the guidelines. Here is the Executive Summary, with links to the full text, a slide set, and other material.
March 16th, 2010
Tuesday, March 16 News Roundup: Cryoballoon Ablation Trial; FDA to Review ACCORD data; Trouble for Boston Scientific and Medtronic
Larry Husten, PHD
STOP-AF: The STOP-AF trial compared a novel cryoballoon ablation technology with antiarrhythmic drug (AAD) therapy in 245 AF patients who had failed at least one AAD. Treatment success was achieved in 69.9% of cryoballoon patients versus 7.3% of AAD patients, a highly significant difference (p<0.001). Phrenic nerve palsy occurred in 13.5% of cryoballoon patients and 7.3% of AAD patients. The study was presented on Monday at the ACC.
FDA to Review ACCORD Data: Following the presentation and publication in the New England Journal of Medicine on Sunday of ACCORD, which found no benefit for fenofibrate when given on top of statins in patients with type 2 diabetes, the FDA announced that it would review data from the trial, but stated that “at this time, FDA has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate.”
Boston Scientific Suspends ICD Sales: Boston Scientific announced on Monday that it was suspending all sales of its ICDs and CRT-Ds. The suspension took place after the company “determined that some manufacturing process changes were not submitted for approval” to the FDA.
Medtronic Investigated by U.S. Attorney: In its most recent quarterly report, Medtronic disclosed that it was under investigation by the U.S. Attorney’s office in Massachusetts over the company’s relationship to cardiologists at the Lahey Clinic. (More details are available at CardioBrief.)
March 16th, 2010
Follow Along with Your Colleagues at the ACC, Day 3
Andrew M. Kates, MD
See previous posts (ACC Day 1 and Day 2)
Several Fellows in Cardiology who are attending this week’s ACC meeting are blogging together right here. The Fellows include Shane LaRue, Justin Bachmann, Nihar Desai, Shanti Bansal, and Hansie Mathelier. Check back often to learn about the biggest buzz at the ACC — whether it’s a poster, a presentation, or the word in the hallways.
Hansie Mathelier
3/16 7:05 p.m.
The day started a little later, secondary to having to check out of my hotel. I stayed at a middle scale hotel chain, but I think the fact that it is 100 less a night than their local competitors shows… Next time I am in ATL I might stay in Buckhead.
Off to the conference where the number of people present is noticeably less compared to the days prior. Started the day with a presentation from surgeons. The discussion got heated over the STITCH trial. Also the sole cardiologist talked about how perhaps there should VAD centers. Snuck over to hear Topol talk about personalized medicine but missed the last 10 min b/c over txting with a cofellow I heard that there were raised voices between two prominent surgeons. I am a sucker for a good academic fight.
Lunch time was a good discussion about diabetes and heart failure. Favorite part was a cardiologist from the audience who encouraged talking to the patient as the number one factor in patient outcomes. He challenged anyone in the audience if they were able to modify their patient profile as he did.
…currently on the plane waiting for the door to close….
Nihar Desai
3/16 2:34 p.m.
Dear all,
What a meeting! I am in a cab headed to the airport, just collecting my thoughts and putting together my reflections on ACC 2010….
Overall, I would say I am both exhausted and reinvigorated, tired after busy, long days, but inspired after seeing so much great science, spending time with collaborators and “non-institutional” mentors, and catching up with friends.
Safe travels and all best.
Shane LaRue
3/16 11:52 a.m.
Justin — I am with you on the smoking ban. Last summer I moved from a place with a ban (Madison) to one where the ban becomes effective next year (St. Louis). I am still caught off guard every time people are smoking in bars.
This reminds me, the thing I’ve found most annoying at the meeting is the disclosure ‘flash’. We all understand the role industry plays in funding studies and our education. But, if I am going to give you 12 to 30 minutes of my attn, I would like to be able to read who funds your research and pays you to speak.
As for accommodations, I am staying at a lower end chain hotel by Turner Field ( spent all of my conference $ for the year going to TCT, so I’m on my own dime – cue th eviolins). So, as I was checking in, the woman behind the counter was showing the other the crack pipe found in a room the night before. Awesome.
Currently in a session reviewing antiplt therapy and pci. Interested to see where prasugrel and ticagrelor will go. Also, are people feeling better about using PPIs and clopidogrel?
A final nice touch by the organizers — $10 to check your bag here at the conference and they will get it to your plane. Odds on my bag being in St Louis when I get there?
Safe travels all.
Justin Bachmann
3/16 11:02 a.m.
Well, I’m worn out. I went to the afternoon General Cardiology session and heard a nice talk on preop risk stratification. Then it was over to the exhibit hall to try out some of the portable briefcase-like echo machines. They are incredibly handy. I suspect they will be the wave of the future. It would be nice to have one sitting around Parkland. I could carry it around on rounds and have real-time data.
Then I was off to the convocation, which was a nice ceremony, and some ACC social events up on the suite level of the Marriott. After that an Irish bar with my cofellows and faculty at UT-Southwestern. I reek of cigarettes. It makes me miss the public smoking ban back in Dallas.
Speaking of which, I just returned to the W hotel to find that they burned some sort of incense mixture in my room. I’m sneezing like crazy. The place is like an MC Escher drawing. I keep finding light switches in strange places. I’ll flip one and all of the sudden a metal sculpture on the wall will light up. It would probably take me a good three or four days to figure this place out. Where are the rest of you staying? Are you happy with your lodgings? When I show up to the conference tomorrow smelling like a sandalwood tree, now you know why.
Hansie Mathelier
3/16 12:14 a.m.
My Top Ten Events of the Day (not as creative as “Letterman”)
10. When I go a lecture/spotlight, the ability to sit is key.
9. Before buying coffee or food, scope out multiple venues. My “soup in a pot” was 10x better than my random turkey sandwich
8. Realizing perhaps 10 creative thoughts are ambitious
7. While walking in the exhibit hall trying to make my way to “Heart Songs 3” … being tempted to do the Bruce protocol or checking my cholesterol.
6. Realizing that the South can get as cold as the North. Wondering in the back of your mind if you brought the weather with you.
5. Figuring out what you want to further investigate when you go home….
4. Running into colleagues, friendly faces, and old friends among 10,000 people
3.Trying to figure out how many sessions you can cram into tomorrow before returning to reality.
2. To see a co-chair of a session correct a speaker’s recommendation in order to prevent dissemination of wrong info…. It was awesome!!! Makes you realize why they have co-chairs.
1. My brain hurts from all the education and loving it!!
