It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is…
Don’t Confuse the Art and Science of Medicine: PCI vs CABG for Left Main Disease
August 20, 2020 by 1 Comment
New ORBITA Findings May Offer Modest Symptomatic Pain Relief To Interventional Cardiologists
May 22, 2018 by 5 Comments
New data presented at EuroPCR from the much debated ORBITA trial may provide some modest temporary lessening of the pain felt by interventional cardiologists in response to the initial negative ORBITA findings. But the pain relief is likely to be only temporary, and might even be fairly compared to a placebo effect, since the major…
More Controversy Over Major Cardiology Clinical Trial
March 30, 2018 by 7 Comments
Think about this: A new article reports that a major NIH-funded trial runs into trouble. The article raises all sorts of fundamental questions about our ability to perform meaningful clinical research. But instead of expressing concern about these legitimate problems, medical leaders ignore these questions and instead focus their ire and criticism on the article authors,…
Cardiology World Erupts Into Controversy Over Change In Major Clinical Trial
March 18, 2018 by 4 Comments
As a major clinical trial in cardiology nears completion it has provoked a storm of criticism and controversy. The brouhaha erupted in response to a late change to one of the most important— and already controversial— trials in cardiovascular medicine. The NIH-funded ISCHEMIA trial was designed back in 2011 to provide a definitive answer to…
Device Companies Fund Courses For Doctors In Training
February 27, 2018 by 1 Comment
At a crucial early stage of their careers young interventional cardiologists attend brief training courses that are considered essential for their careers. It is not generally appreciated that large device and drug companies provide the money that enable these young doctors to attend these meetings. The money from industry covers the cost of travel, hotel, meals,…
Will ORBITA Change Clinical Practice? The Role of Perverse Economic Incentives
December 11, 2017 by 2 Comments
Editor’s note: In this guest post Sanjay Kaul (Cedars-Sinai) explains why it is unlikely that the ORBITA trial will have a big impact on clinical practice. Guest Post: Will ORBITA Change Clinical Practice? The Role of Perverse Economic Incentives. by Sanjay Kaul, MD (Cedars-Sinai Medical Center) Shortly after celebrating the 40th anniversary of PCI, first…
In Defense Of ORBITA
December 10, 2017 by 4 Comments
–The trial investigators respond to their numerous critics. If you’ve been reading about ORBITA then you probably know that the first ever placebo-controlled trial of PCI was interesting and provocative. But you’ve also probably heard that the trial was too small, too short and performed in patients who should not have been studied. Simultaneously, you…
No Benefit Found For PFO Closure In Migraine
November 27, 2017 by 1 Comment
–A sham-controlled trial defies previous expectations. A rigorous sham-controlled trial has failed to demonstrate a significant benefit for patent foramen ovale (PFO) closure in addressing frequent migraine headaches. There has long been a strong suspicion that some migraine headaches may be caused by PFO, but this relationship has never been conclusively demonstrated, and it has…
Why was ORBITA MIA at the AHA?
November 22, 2017 by 1 Comment
By offering a last minute 2-for-1 deal shortly before its annual meeting in Anaheim the American Heart Association signalled its desperation. During the meeting, as the tumbleweed rolled down the lonely halls of the Anaheim Convention Center, the reason for the deal was apparent to everyone. The lack of crowds, the low energy, the paucity…
AHA President Suffers A Heart Attack Monday Morning
November 13, 2017 by 18 Comments
–The AHA reports that he received a stent and is doing well. The president of the American Heart Association, John Warner, had a “mild heart attack” on Monday morning, according to the AHA. Warner received a stent at an undisclosed hospital. The AHA said he is “doing well.” Warner is 52. The attack occurred while…
ORBITA Trial Puts Interventional Cardiologists On The Defensive
November 8, 2017 by 6 Comments
(Updated) Since it’s debut a week ago the ORBITA trial has provoked the most furious debate in cardiology since the COURAGE trial a decade earlier. But the ORBITA debate has proceeded far faster, fuelled by Twitter and its ability to instantaneously deliver point and counterpoint. Although ORBITA has been showered with praise for its innovative…
The Story Behind The NY Times ORBITA Anecdote
November 3, 2017 by 7 Comments
–Brahmajee Nallamothu fills in the details about the patient who didn’t get a stent because of ORBITA. Editor’s note: The New York Times story by Gina Kolata on the ORBITA trial focused on one patient who decided not to have a stent implanted when he heard about the ORBITA trial. Here is a more complete…
Diving Deep Into The ORBITA Trial
November 2, 2017 by 3 Comments
William Boden, Ajay Kirtane, and Dan Mark analyze the ORBITA trial. Editor’s note: I asked a wide variety of cardiologists for their thoughts about ORBITA, presented at the TCT meeting in Denver and published simultaneously in the Lancet. Three of them, William Boden, Ajay Kirtane, and Dan Mark, sent highly detailed comments about the trial….
Small Trial Raises Big Concerns That PCI In Stable Angina Is Just A Placebo
November 2, 2017 by 5 Comments
ORBITA trial may spark a heated debate in the cardiology community. It is only a small trial but it may have an enormous impact as it raises major questions about one of the core beliefs of clinical cardiology as it suggests that PCI for stable coronary disease has no more effect than a sham procedure….
Some Doctors Reluctant To Deactivate LVADs
October 4, 2017 by 3 Comments
–LVAD deactivation is not euthanasia or physician-assisted suicide. Left ventricular assist devices (LVADs) are used increasingly as destination therapy instead of as a temporary bridge until a donor heart becomes available for transplantation. Now patients, their families, and their caregivers are forced to confront the extremely difficult question of when and how to turn off…
FDA’s Gottlieb Preparing To Lower The Bar To Approval
September 28, 2017 by 3 Comments
–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…
What If PCI Is Just A Sham?
September 18, 2017 by 3 Comments
–A small study might upset assumptions about the benefits of stent. What if PCI for stable ischemic heart disease (SIHD) is just a big lie? That is, what if it’s no better than a sham procedure? This may seem like a crazy proposition, but there’s at least an outside chance that a small trial coming…
Julio Palmaz Really Doesn’t Want You To Read This Story
September 11, 2017 by 8 Comments
—Raising questions about a trial provokes a ‘cease-and-desist’ letter. The world stent pioneer Julio Palmaz really doesn’t want you to read this post. After I raised questions about a recent paper involving Palmaz I received a “cease-and-desist” letter from his lawyer. Here is the background to this story: Last year I wrote a brief post…
Off-Pump CABG Raises Long-Term Mortality Risk
August 16, 2017 by Leave a Comment
–Significant risk over on-pump grafting found at 5 years in ROOBY trial. It seemed like a great idea. Perform coronary-artery bypass grafting (CABG) without stopping the heart and you can prevent the dangers of cardiopulmonary bypass. But it didn’t work out. After growing in popularity over the previous decade, in 2009 the first large, well-conducted…
Renal Denervation: Back From The Dead Or Deja Vu All Over Again?
August 14, 2017 by 1 Comment
Renal denervation is back. Or not. The failure of renal denervation (RDN) was one of the most spectacular failures in cardiovascular medicine in recent years. Great expectations for RDN appeared to die with the Simplicity-3 HTN trial, the first rigorous test of the technology, which showed that it was ineffective in the treatment of resistant…
New Stroke Prevention Device May Not Prevent Strokes
June 7, 2017 by Leave a Comment
–There’s no hard evidence the Sentinel Cerebral Protection System reduces stroke in TAVR. Here’s how to get a second generation medical product or add-on product approved: show that the original device isn’t nearly as safe and effective as believed back in, you know, the dark ages before the new product showed up. Until now proponents…
Abbott Pulls Troubled Absorb Stent From European Market
April 6, 2017 by Leave a Comment
(Updated) Abbott Laboratories has sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.” The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from…
More Bad News For The Once Promising Bioresorbable Stent
March 31, 2017 by Leave a Comment
(Updated) –Problems for the Absorb BVS stent just won’t disappear Bad news for the Absorb BVS stent continues to accumulate, though defenders of the device keep looking for a silver lining. When it was approved in the US last summer the novel device appeared to have a bright future, with many prominent interventional cardiologists predicting…
Interventional Cardiologists Face Major Obstruction In Treatment Of Total Blockages
March 29, 2017 by 1 Comment
–Deep divisions over how CTO patients should be treated. In recent years ambitious interventional cardiologists have started to perform PCI on chronic total occlusions (CTOs), though these lesions have long been recognized as among the most difficult to successfully treat. Many other physicians, including some prominent interventional cardiologists, have expressed grave concerns about this expansion…
Scott Gottlieb’s Sham Ideology Rejects Clinical Trials
March 14, 2017 by 3 Comments
Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
Recent Comments