More than 35,000 physicians, allied healthcare providers and industry representatives descended on the cavernous convention center in Boston’s up-and-coming Seaport section for the Heart Rhythm Society’s annual meeting.
And although the top item of discussion was St. Jude Medical (NYSE:STJ) – its recalled Riata leads and whether its next-generation Durata leads ought to be suspect too (answer: seemingly not) – there was plenty of other news at the show.
Here’s a look back at the world’s largest gathering of electrophysiologists, which wrapped up over the weekend here in The Hub:
Riata’s survival rate ‘significantly worse’
A study comparing recalled defibrillator leads made by St. Jude Medical (NYSE:STJ) with 1 from rival Medtronic (NYSE:MDT) found 1 St. Jude model’s survival rate to be "significantly worse."
The study, presented at the Heart Rhythm Society’s annual meeting in Boston, examined data from 7 centers that used the 3 lead models – St. Jude’s recalled Riata and Riata ST and Medtronic’s Quattro – to calculate long-term survival rates.
Is Cameron Health’s ‘leadless’ ICD a niche product or a game-changer?
The so-called "leadless" implantable cardiac defibrillator made by Cameron Health made its debut at the Heart Rhythm Society’s annual meeting this week, generating considerable excitement among physicians here in Boston.
Two studies presented at the conference, 1 sponsored by Cameron Health to back its investigational device exemption application with the FDA and a 2nd, "real-world" evaluation of European patients, both showed that the subcutaneous ICD has comparable safety and effectiveness rates as more traditional transvenous ICDs.
Boston Scientific’s Watchman as effective as Warfarin
A medical device made by Boston Scientific (NYSE:BSX) designed to trap blood clots in the heart could be an important tool for preventing stroke in high-risk atrial fibrillation patients, researchers said at the annual Heart Rhythm Society meeting in Boston.
A study comparing the Watchman left atrial appendage closure device with the anticoagulant drug Warfarin found the device to be more effective in preventing stroke in patients who can’t tolerate the drug. A previous trial showed that the Watchman device was the drug’s equal in preventing stroke in high-risk AF patients, but patients in that trial were treated with Warfarin for 6 weeks until LAA closure could be demonstrated.
The study results could also be a boon for Redwood City, Calif.-based SentreHeart and its Lariat AAA closure device, which showed 96% complete LAA closure post-procedure and 98% complete closure at 1 year in study data presented at the HRS conference.
"It is feasible and effective at closing the LAA," Dr. Randall Lee of the University of California, San Francisco, told Heart Rhythm Daily. "This device can be considered a potential option for high-risk patients."
Topera Medical’s rotor-mapping draws buzz
Topera Medical unveiled the highly anticipated results of its Confirm study at the show, touting a 100% success rate for its RhythmView 3D mapping system.
A dozen doctors at 8 U.S. sites evaluated the RhythmView system in more than 30 patients with paroxysmal, persistent and long-standing persistent AF. The physicians were able to locate rotors or focal beats, helping in arrhythmia diagnosis and treatment planning.
"Every physician we spoke with was noticeably excited about Topera’s potential," Leerink Swann analysts wrote in a note to investors. "But all cited as well the need for a larger, randomized multi-center clinical trial to confirm the early experience. Our impression is such a trial will possibly get underway later this year."
One physician the analysts spoke with at the conference said that if Topera’s data can be replicated at other sites, it "would challenge 30 years of science" and be a real "game-changer."
"Rhythmia has an excellent new mapping system and catheter. Even if Topera is right, that is something that still has a role," another EP told the analysts. "It has very good resolution. And can generate a map in 5 minutes vs. 15-20 minutes for a comparable map with [Johnson & Johnson (NYSE:JNJ)]’s Carto."
"His physiologically-based ablation approach (identifying and targeting the mechanism of the arrhythmia using FIRM (Focal Impulse and Rotor Modulation) mapping), rather than a strictly anatomically approach) was intriguing," Fisher wrote. "I discussed the mapping system with other physicians who had used the system from U of Indiana and Ohio State and they shared similar excitement. The technique is not without its skeptics, however, but the initial reports from others with some limited experience suggested ‘it’s real’ and ‘doesn’t work on everybody but seeing persistent afib stop with ablation is pretty common.’"
Doc details DoJ probe into off-guideline ICD implantation
Dr. Suneet Mittal of Columbia University gave a presentation at HRS 2012 detailing his center’s experience weathering investigations by both the Centers for Medicare & Medicaid Services and the U.S. Justice Dept.
Surprisingly, the Justice Dept. investigators had more leeway than their CMS counterparts and proved to be somewhat flexible about what outside-the-guidelines uses of implantable cardiac defibrillators are permissible.