M. Alexander Otto

SAN FRANCISCO – Focal impulse and rotor modulation-guided ablation for persistent atrial fibrillation – either alone or in conjunction with other procedures – increased procedural times without improving outcomes, according to the first randomized trial to assess its utility.

In fact, enrollment in the rotor ablation-only (RA) arm was halted early for futility. “There was 100% recurrence” of atrial fibrillation (AF), said senior investigator Dr. Andrea Natale, executive medical director of the Texas Cardiac Arrhythmia Institute, Austin.

“I’m surprised it took this long for a randomized study, because this system has been around for 5 or 6 years,” noted Dr. Natale. “Our community should demand these sorts of studies earlier, because it’s not fair for patients to go on with a procedure for years that has not been proven to be effective.

Alex Otto/Frontline Medical News

“For us, unless there is a new version of rotor mapping that I feel is significantly different, this will be the end of rotor ablation in my lab with this system [the Topera Physiologic Rotor Mapping Solution],” Dr. Natale said at the annual scientific sessions of the Heart Rhythm Society.

In the study, his team randomized 29 patients to RA only, 42 to RA plus pulmonary vein antral isolation (PVAI), and 42 to PVAI plus posterior wall and nonpulmonary vein trigger ablation.

At about 1 year, four RA-only patients (14%), 22 RA plus PVAI patients (52%), and 32 patients in the PVAI plus trigger group (76%) were free of AF and atrial tachycardias without antiarrhythmic drugs (P < .0001).

Meanwhile, RA alone and RA plus PVAI cases took about 230 minutes, while the more effective PVAI plus trigger approach took about 130 minutes (P < .001).

There was “a very poor outcome with rotor-only ablation,” Dr. Natale said. “There isn’t a benefit either alone or as an add-on strategy, at least with this mapping software.”

Perhaps “people who think rotors don’t exist are right,” he added. On the other hand, maybe the basket mapping catheter doesn’t touch enough of the left atrium, or the software that makes sense of what the catheter detects needs to be improved, Dr. Natale noted.

All the patients were undergoing their first ablation. They were in their early 60s, on average, and most were men. The mean left atrium diameter was about 47 mm, and mean left ventricle ejection fraction about 55%. There were no statistically significant differences between the study arms, and no significant differences in outcomes between the 70% of patients with persistent AF and the 30% with long-standing persistent AF.

There was no industry funding for the work. Dr. Natale disclosed relationships with Biosense Webster, Boston Scientific, Janssen, Medtronic, and St. Jude Medical.

[email protected]

SAN FRANCISCO – Focal impulse and rotor modulation-guided ablation for persistent atrial fibrillation – either alone or in conjunction with other procedures – increased procedural times without improving outcomes, according to the first randomized trial to assess its utility.

In fact, enrollment in the rotor ablation-only (RA) arm was halted early for futility. “There was 100% recurrence” of atrial fibrillation (AF), said senior investigator Dr. Andrea Natale, executive medical director of the Texas Cardiac Arrhythmia Institute, Austin.

“I’m surprised it took this long for a randomized study, because this system has been around for 5 or 6 years,” noted Dr. Natale. “Our community should demand these sorts of studies earlier, because it’s not fair for patients to go on with a procedure for years that has not been proven to be effective.

Alex Otto/Frontline Medical News

“For us, unless there is a new version of rotor mapping that I feel is significantly different, this will be the end of rotor ablation in my lab with this system [the Topera Physiologic Rotor Mapping Solution],” Dr. Natale said at the annual scientific sessions of the Heart Rhythm Society.

In the study, his team randomized 29 patients to RA only, 42 to RA plus pulmonary vein antral isolation (PVAI), and 42 to PVAI plus posterior wall and nonpulmonary vein trigger ablation.

At about 1 year, four RA-only patients (14%), 22 RA plus PVAI patients (52%), and 32 patients in the PVAI plus trigger group (76%) were free of AF and atrial tachycardias without antiarrhythmic drugs (P < .0001).

Meanwhile, RA alone and RA plus PVAI cases took about 230 minutes, while the more effective PVAI plus trigger approach took about 130 minutes (P < .001).

There was “a very poor outcome with rotor-only ablation,” Dr. Natale said. “There isn’t a benefit either alone or as an add-on strategy, at least with this mapping software.”

Perhaps “people who think rotors don’t exist are right,” he added. On the other hand, maybe the basket mapping catheter doesn’t touch enough of the left atrium, or the software that makes sense of what the catheter detects needs to be improved, Dr. Natale noted.

All the patients were undergoing their first ablation. They were in their early 60s, on average, and most were men. The mean left atrium diameter was about 47 mm, and mean left ventricle ejection fraction about 55%. There were no statistically significant differences between the study arms, and no significant differences in outcomes between the 70% of patients with persistent AF and the 30% with long-standing persistent AF.

There was no industry funding for the work. Dr. Natale disclosed relationships with Biosense Webster, Boston Scientific, Janssen, Medtronic, and St. Jude Medical.

[email protected]

SAN FRANCISCO – Focal impulse and rotor modulation-guided ablation for persistent atrial fibrillation – either alone or in conjunction with other procedures – increased procedural times without improving outcomes, according to the first randomized trial to assess its utility.

In fact, enrollment in the rotor ablation-only (RA) arm was halted early for futility. “There was 100% recurrence” of atrial fibrillation (AF), said senior investigator Dr. Andrea Natale, executive medical director of the Texas Cardiac Arrhythmia Institute, Austin.

“I’m surprised it took this long for a randomized study, because this system has been around for 5 or 6 years,” noted Dr. Natale. “Our community should demand these sorts of studies earlier, because it’s not fair for patients to go on with a procedure for years that has not been proven to be effective.

Alex Otto/Frontline Medical News

“For us, unless there is a new version of rotor mapping that I feel is significantly different, this will be the end of rotor ablation in my lab with this system [the Topera Physiologic Rotor Mapping Solution],” Dr. Natale said at the annual scientific sessions of the Heart Rhythm Society.

In the study, his team randomized 29 patients to RA only, 42 to RA plus pulmonary vein antral isolation (PVAI), and 42 to PVAI plus posterior wall and nonpulmonary vein trigger ablation.

At about 1 year, four RA-only patients (14%), 22 RA plus PVAI patients (52%), and 32 patients in the PVAI plus trigger group (76%) were free of AF and atrial tachycardias without antiarrhythmic drugs (P < .0001).

Meanwhile, RA alone and RA plus PVAI cases took about 230 minutes, while the more effective PVAI plus trigger approach took about 130 minutes (P < .001).

There was “a very poor outcome with rotor-only ablation,” Dr. Natale said. “There isn’t a benefit either alone or as an add-on strategy, at least with this mapping software.”

Perhaps “people who think rotors don’t exist are right,” he added. On the other hand, maybe the basket mapping catheter doesn’t touch enough of the left atrium, or the software that makes sense of what the catheter detects needs to be improved, Dr. Natale noted.

All the patients were undergoing their first ablation. They were in their early 60s, on average, and most were men. The mean left atrium diameter was about 47 mm, and mean left ventricle ejection fraction about 55%. There were no statistically significant differences between the study arms, and no significant differences in outcomes between the 70% of patients with persistent AF and the 30% with long-standing persistent AF.

There was no industry funding for the work. Dr. Natale disclosed relationships with Biosense Webster, Boston Scientific, Janssen, Medtronic, and St. Jude Medical.

[email protected]

SAN FRANCISCO – Catheter ablation is a better option than antiarrhythmic drug escalation when patients with ventricular tachycardia (VT) fail standard first-line medical therapy, according to a 259-patient trial.

During a mean follow-up of 27.9 months, 59.1% (78) of patients randomized to ablation, but 68.5% (87) randomized to escalation, met the combined primary endpoint of death, ventricular tachycardia (VT) storm, or appropriate implantable cardioverter defibrillator shock (hazard ratio favoring ablation, 0.72; P = 0.04).

All the patients had ischemic cardiomyopathy secondary to myocardial infarct, as well as an implantable cardioverter defibrillator (ICD) and recurrent VT despite amiodarone in two-thirds and sotalol in the rest. “In this situation with the options we have available, catheter ablation is preferable,” lead investigator Dr. John Sapp, a cardiology professor at Dalhousie University in Halifax, N.S., said at the annual scientific sessions of the Heart Rhythm Society.

Guidelines already recommend ablation when antiarrhythmic drugs don’t do the job, but many clinicians opt for caution and escalate drug therapy instead; the two approaches have never been compared head to head. “This trial provides evidence that catheter ablation should be preferred over escalation of AAD [antiarrhythmic drug] therapy” to reduce “recurrent ventricular tachycardia,” Dr. Sapp and his colleagues concluded in their report, which was published online at the time of presentation (N Engl J Med. 2016 May 5. doi: 10.1056/NEJMoa1513614).

The benefit of ablation was seen only in patients on baseline amiodarone and was due entirely to fewer shocks and VT storms. There was no significant between-group difference in mortality, which was about 27% in both arms and mostly from cardiovascular causes. Dr. Sapp noted that the study wasn’t powered to detect a difference in mortality.

Three deaths were attributed to AAD in the escalation arm, two from pulmonary and one from hepatic complications. The authors didn’t attribute any deaths directly to ablation, but noted that there were two cardiac perforations and three cases of major bleeding in the ablation arm. Even so, treatment-related adverse events were significantly more common with escalation (51 vs. 22 in ablation patients) and occurred in more patients (39 and 20, respectively). VT that was undetectable by ICD persisted in 10.2% (13) of drug-escalated patient and 3% (4) of ablation patients.

In the patients randomly assigned to escalation, those on sotalol were switched to amiodarone 200 mg/day; amiodarone patients were either increased to more than 300 mg/day or, if already at that level, had mexiletine 600 mg/day added to their regimen.

The work was funded by the Canadian Institutes of Health Research, St. Jude Medical, and Biosense Webster. Dr. Sapp reported research grants from St. Jude, Biosense, Medtronic, and Philips.

[email protected]

SAN FRANCISCO – Catheter ablation is a better option than antiarrhythmic drug escalation when patients with ventricular tachycardia (VT) fail standard first-line medical therapy, according to a 259-patient trial.

During a mean follow-up of 27.9 months, 59.1% (78) of patients randomized to ablation, but 68.5% (87) randomized to escalation, met the combined primary endpoint of death, ventricular tachycardia (VT) storm, or appropriate implantable cardioverter defibrillator shock (hazard ratio favoring ablation, 0.72; P = 0.04).

All the patients had ischemic cardiomyopathy secondary to myocardial infarct, as well as an implantable cardioverter defibrillator (ICD) and recurrent VT despite amiodarone in two-thirds and sotalol in the rest. “In this situation with the options we have available, catheter ablation is preferable,” lead investigator Dr. John Sapp, a cardiology professor at Dalhousie University in Halifax, N.S., said at the annual scientific sessions of the Heart Rhythm Society.

Guidelines already recommend ablation when antiarrhythmic drugs don’t do the job, but many clinicians opt for caution and escalate drug therapy instead; the two approaches have never been compared head to head. “This trial provides evidence that catheter ablation should be preferred over escalation of AAD [antiarrhythmic drug] therapy” to reduce “recurrent ventricular tachycardia,” Dr. Sapp and his colleagues concluded in their report, which was published online at the time of presentation (N Engl J Med. 2016 May 5. doi: 10.1056/NEJMoa1513614).

The benefit of ablation was seen only in patients on baseline amiodarone and was due entirely to fewer shocks and VT storms. There was no significant between-group difference in mortality, which was about 27% in both arms and mostly from cardiovascular causes. Dr. Sapp noted that the study wasn’t powered to detect a difference in mortality.

Three deaths were attributed to AAD in the escalation arm, two from pulmonary and one from hepatic complications. The authors didn’t attribute any deaths directly to ablation, but noted that there were two cardiac perforations and three cases of major bleeding in the ablation arm. Even so, treatment-related adverse events were significantly more common with escalation (51 vs. 22 in ablation patients) and occurred in more patients (39 and 20, respectively). VT that was undetectable by ICD persisted in 10.2% (13) of drug-escalated patient and 3% (4) of ablation patients.

In the patients randomly assigned to escalation, those on sotalol were switched to amiodarone 200 mg/day; amiodarone patients were either increased to more than 300 mg/day or, if already at that level, had mexiletine 600 mg/day added to their regimen.

The work was funded by the Canadian Institutes of Health Research, St. Jude Medical, and Biosense Webster. Dr. Sapp reported research grants from St. Jude, Biosense, Medtronic, and Philips.

[email protected]

SAN FRANCISCO – Catheter ablation is a better option than antiarrhythmic drug escalation when patients with ventricular tachycardia (VT) fail standard first-line medical therapy, according to a 259-patient trial.

During a mean follow-up of 27.9 months, 59.1% (78) of patients randomized to ablation, but 68.5% (87) randomized to escalation, met the combined primary endpoint of death, ventricular tachycardia (VT) storm, or appropriate implantable cardioverter defibrillator shock (hazard ratio favoring ablation, 0.72; P = 0.04).

All the patients had ischemic cardiomyopathy secondary to myocardial infarct, as well as an implantable cardioverter defibrillator (ICD) and recurrent VT despite amiodarone in two-thirds and sotalol in the rest. “In this situation with the options we have available, catheter ablation is preferable,” lead investigator Dr. John Sapp, a cardiology professor at Dalhousie University in Halifax, N.S., said at the annual scientific sessions of the Heart Rhythm Society.

Guidelines already recommend ablation when antiarrhythmic drugs don’t do the job, but many clinicians opt for caution and escalate drug therapy instead; the two approaches have never been compared head to head. “This trial provides evidence that catheter ablation should be preferred over escalation of AAD [antiarrhythmic drug] therapy” to reduce “recurrent ventricular tachycardia,” Dr. Sapp and his colleagues concluded in their report, which was published online at the time of presentation (N Engl J Med. 2016 May 5. doi: 10.1056/NEJMoa1513614).

The benefit of ablation was seen only in patients on baseline amiodarone and was due entirely to fewer shocks and VT storms. There was no significant between-group difference in mortality, which was about 27% in both arms and mostly from cardiovascular causes. Dr. Sapp noted that the study wasn’t powered to detect a difference in mortality.

Three deaths were attributed to AAD in the escalation arm, two from pulmonary and one from hepatic complications. The authors didn’t attribute any deaths directly to ablation, but noted that there were two cardiac perforations and three cases of major bleeding in the ablation arm. Even so, treatment-related adverse events were significantly more common with escalation (51 vs. 22 in ablation patients) and occurred in more patients (39 and 20, respectively). VT that was undetectable by ICD persisted in 10.2% (13) of drug-escalated patient and 3% (4) of ablation patients.

In the patients randomly assigned to escalation, those on sotalol were switched to amiodarone 200 mg/day; amiodarone patients were either increased to more than 300 mg/day or, if already at that level, had mexiletine 600 mg/day added to their regimen.

The work was funded by the Canadian Institutes of Health Research, St. Jude Medical, and Biosense Webster. Dr. Sapp reported research grants from St. Jude, Biosense, Medtronic, and Philips.

[email protected]

LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.

With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.

Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.

At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.

“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.

“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.

“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.

Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.

The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.

There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.

The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.

The investigators had no relevant financial disclosures, and there was no outside funding for the work.

[email protected]

LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.

With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.

Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.

At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.

“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.

“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.

“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.

Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.

The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.

There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.

The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.

The investigators had no relevant financial disclosures, and there was no outside funding for the work.

[email protected]

LOS ANGELES – Fungi might play a far larger role in asthma and chronic sinusitis than previously thought, according to investigators at Baylor College of Medicine in Houston.

With the help of a special culturing technique to wash antifungal elements out of sputum samples, six or more fungal colony-forming units grew out of the sputum of 112 of 134 patients (83.5%) at the Houston Veterans Affairs Medical Center; about a third of the patients had asthma, a third had chronic sinusitis, and a third had both. Although Aspergillus and Candida species were common, more than 30 fungal species were identified. Only a handful of patients had positive results on IgE testing.

Of 62 patients treated with standard-dose voriconazole or terbinafine, sometimes for more than a year, 54 (87%) reported symptomatic benefit including 31 (50%) with decreased sputum production, 24 (39%) with improved breathing, 20 (32%) with less cough, and nine (14.5%) with less rescue inhaler use.

At Baylor, prescribing antifungals for patients with recalcitrant asthma and chronic sinusitis “has evolved into something we pretty much do all the time now regardless of sensitivity results. I’m pretty certain we are the only institution that does this,” said allergy and immunology fellow Dr. Evan Li.

“Fungi, we think, are important initiating factors in many cases of asthma. They set up chronic mucosal infection. Our [treatment] experience is extremely positive; it may be in the future that if you have significant asthma or sinusitis, you just go on an antifungal, but more research and clinical trials are needed,” said senior investigator Dr. David Corry, professor and chief of medical immunology, allergy, and rheumatology at Baylor.

“The standard culture techniques that have been used for 100 years are inadequate when it comes to culturing fungi from sputum, and why results almost invariably come back negative,” Dr. Corry said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The problem is that “almost everything in sputum” – eosinophils, macrophages, cytokines, and so on – “is designed to kill fungi.” Those elements have to be removed before plating. At Baylor, “we solubilize [sputum] with the reducing agent dithiothreitol, and vigorously stir the mixture to disperse the organisms and wash away the cellular elements and the other things.” The process leaves behind “a sandy material that’s basically fibrin clots mixed with a lot of fungal elements. You spread that on a plate, and it grows like wildfire,” he said.

“It’s easy to do, but time consuming. People are actually shipping their samples to us now from around the country, and we are happy to do those cultures,” Dr. Corry said. There’s no patent on the technique because “we want the community to use it. We want people to be helped,” he said.

Voriconazole seems to be the most effective option, and the team opts for it when possible, Dr. Corry noted. Terbinafine is the go-to drug for patients who can’t tolerate voriconazole. Fluconazole is sometimes added when monotherapy doesn’t seem to be doing the trick.

The work began as a search for household proteases. “One of our first discoveries was that” most are fungal. “The twist is that you are not inhaling the proteases, you are inhaling the fungus,” Dr. Corry said.

There have been both positive and negative results from the few prior investigations of antifungals for asthma. The team suspects that negative findings were a result of patients not being treated long enough, among other reasons.

The Baylor team is looking for funding for a prospective trial. The investigators hope to develop a protocol for diagnosis and treatment of fungal airway disease, but “there’s a lot of work that needs to get done,” Dr. Corry said.

The investigators had no relevant financial disclosures, and there was no outside funding for the work.

[email protected]

San Francisco – Routine ganglionic plexus ablation increases risk and offers no clinical benefit in patients undergoing thoracoscopic surgery for advanced atrial fibrillation, according to a randomized Dutch trial.

“Most surgeons who do epicardial ablation do GP [ganglionic plexus] ablation because of the assumption that they are doing something good; that assumption is wrong. GP ablation should not be performed in patients with advanced AF [atrial fibrillation],” said lead investigator Dr. Joris de Groot, a cardiologist at the University of Amsterdam.

Following pulmonary vein isolation (PVI), 117 patients were randomized to GP ablation, and 123 to no GP ablation. GP ablation eliminated 100% of evoked vagal responses; vagal responses remained intact in nearly all of the control subjects.

At 1 year, 70.9% in the GP group compared with 68.4% in control arm were free of recurrence (P = .7); there were no statistically significant differences when the analysis was limited to the 59% of patients who went into the trial with persistent AF or limited to the rest of the patients with paroxysmal AF. Recurrences constituted significantly more atrial tachycardia in the GP group than in the control group. Even after the researchers controlled for a wide variety of demographic, anatomical, and clinical variables, “GP ablation made no difference in atrial fibrillation recurrence at 1 year,” Dr. de Groot said at the annual scientific sessions of the Hearth Rhythm Society.

Meanwhile, major perioperative bleeding occurred in nine patients, all in the GP group, and one required a sternotomy for hemostatic control. Clinically relevant sinus node dysfunction occurred in 12 of the GP group, but only four control patients; six GP patients – but no one in the control arm – required subsequent pacemakers, three while in the hospital after surgery and three during follow-up. Almost 30 patients in each arm required cardioversion during the 3-month blanking period, and about 20 in each arm afterwards.

“The largest randomized study in thoracoscopic surgery for advanced AF to date demonstrates that GP ablation is associated with significantly more periprocedural major bleeding, sinus node dysfunction, and pacemaker implantation, but not with improved rhythm outcome,” the investigators concluded.

Procedure time was 185 +/– 54 minutes in the GP arm, and 168 +/– 54 minutes in the control arm (P = .015). In the GP group, four major GPs and the ligament of Marshall were ablated.

Patients were 60 years old, on average, and three-quarters were men. AF duration was a median of 4 years. Four patients had died at 1 year, all in the GP arm, but none related to the procedure. All antiarrhythmic drugs were stopped after the blanking period; any atrial arrhythmia lasting 30 seconds or longer thereafter was considered a recurrence.

Dr. de Groot disclosed payments for services from AtriCure, Daiichi, and St. Jude Medical and research funding from AtriCure and St. Jude.

[email protected]

San Francisco – Routine ganglionic plexus ablation increases risk and offers no clinical benefit in patients undergoing thoracoscopic surgery for advanced atrial fibrillation, according to a randomized Dutch trial.

“Most surgeons who do epicardial ablation do GP [ganglionic plexus] ablation because of the assumption that they are doing something good; that assumption is wrong. GP ablation should not be performed in patients with advanced AF [atrial fibrillation],” said lead investigator Dr. Joris de Groot, a cardiologist at the University of Amsterdam.

Following pulmonary vein isolation (PVI), 117 patients were randomized to GP ablation, and 123 to no GP ablation. GP ablation eliminated 100% of evoked vagal responses; vagal responses remained intact in nearly all of the control subjects.

At 1 year, 70.9% in the GP group compared with 68.4% in control arm were free of recurrence (P = .7); there were no statistically significant differences when the analysis was limited to the 59% of patients who went into the trial with persistent AF or limited to the rest of the patients with paroxysmal AF. Recurrences constituted significantly more atrial tachycardia in the GP group than in the control group. Even after the researchers controlled for a wide variety of demographic, anatomical, and clinical variables, “GP ablation made no difference in atrial fibrillation recurrence at 1 year,” Dr. de Groot said at the annual scientific sessions of the Hearth Rhythm Society.

Meanwhile, major perioperative bleeding occurred in nine patients, all in the GP group, and one required a sternotomy for hemostatic control. Clinically relevant sinus node dysfunction occurred in 12 of the GP group, but only four control patients; six GP patients – but no one in the control arm – required subsequent pacemakers, three while in the hospital after surgery and three during follow-up. Almost 30 patients in each arm required cardioversion during the 3-month blanking period, and about 20 in each arm afterwards.

“The largest randomized study in thoracoscopic surgery for advanced AF to date demonstrates that GP ablation is associated with significantly more periprocedural major bleeding, sinus node dysfunction, and pacemaker implantation, but not with improved rhythm outcome,” the investigators concluded.

Procedure time was 185 +/– 54 minutes in the GP arm, and 168 +/– 54 minutes in the control arm (P = .015). In the GP group, four major GPs and the ligament of Marshall were ablated.

Patients were 60 years old, on average, and three-quarters were men. AF duration was a median of 4 years. Four patients had died at 1 year, all in the GP arm, but none related to the procedure. All antiarrhythmic drugs were stopped after the blanking period; any atrial arrhythmia lasting 30 seconds or longer thereafter was considered a recurrence.

Dr. de Groot disclosed payments for services from AtriCure, Daiichi, and St. Jude Medical and research funding from AtriCure and St. Jude.

[email protected]

San Francisco – Routine ganglionic plexus ablation increases risk and offers no clinical benefit in patients undergoing thoracoscopic surgery for advanced atrial fibrillation, according to a randomized Dutch trial.

“Most surgeons who do epicardial ablation do GP [ganglionic plexus] ablation because of the assumption that they are doing something good; that assumption is wrong. GP ablation should not be performed in patients with advanced AF [atrial fibrillation],” said lead investigator Dr. Joris de Groot, a cardiologist at the University of Amsterdam.

Following pulmonary vein isolation (PVI), 117 patients were randomized to GP ablation, and 123 to no GP ablation. GP ablation eliminated 100% of evoked vagal responses; vagal responses remained intact in nearly all of the control subjects.

At 1 year, 70.9% in the GP group compared with 68.4% in control arm were free of recurrence (P = .7); there were no statistically significant differences when the analysis was limited to the 59% of patients who went into the trial with persistent AF or limited to the rest of the patients with paroxysmal AF. Recurrences constituted significantly more atrial tachycardia in the GP group than in the control group. Even after the researchers controlled for a wide variety of demographic, anatomical, and clinical variables, “GP ablation made no difference in atrial fibrillation recurrence at 1 year,” Dr. de Groot said at the annual scientific sessions of the Hearth Rhythm Society.

Meanwhile, major perioperative bleeding occurred in nine patients, all in the GP group, and one required a sternotomy for hemostatic control. Clinically relevant sinus node dysfunction occurred in 12 of the GP group, but only four control patients; six GP patients – but no one in the control arm – required subsequent pacemakers, three while in the hospital after surgery and three during follow-up. Almost 30 patients in each arm required cardioversion during the 3-month blanking period, and about 20 in each arm afterwards.

“The largest randomized study in thoracoscopic surgery for advanced AF to date demonstrates that GP ablation is associated with significantly more periprocedural major bleeding, sinus node dysfunction, and pacemaker implantation, but not with improved rhythm outcome,” the investigators concluded.

Procedure time was 185 +/– 54 minutes in the GP arm, and 168 +/– 54 minutes in the control arm (P = .015). In the GP group, four major GPs and the ligament of Marshall were ablated.

Patients were 60 years old, on average, and three-quarters were men. AF duration was a median of 4 years. Four patients had died at 1 year, all in the GP arm, but none related to the procedure. All antiarrhythmic drugs were stopped after the blanking period; any atrial arrhythmia lasting 30 seconds or longer thereafter was considered a recurrence.

Dr. de Groot disclosed payments for services from AtriCure, Daiichi, and St. Jude Medical and research funding from AtriCure and St. Jude.

[email protected]

SAN FRANCISCO – Repeat, invasive electrophysiology studies conducted 2 months after pulmonary vein isolation – regardless of symptoms and, if necessary, with repeat ablations – substantially reduce atrial fibrillation recurrence and improve quality of life at 1 year, according to an investigation conducted at the Liverpool (Eng.) Heart and Chest Hospital.

After initial pulmonary vein isolation (PVI), 40 patients with drug-refractory, paroxysmal atrial fibrillation (AF) were randomized to the repeat approach, and 40 others to the current standard of care (SC), meaning repeat PVI based on recurrent AF symptoms.

Pulmonary vein reconnections were found in 25 patients (63%) checked at 2 months, and all 25 had repeat PVIs without complications. Meanwhile, nine (23%) patients in the SC group had repeat PVIs for clinical recurrence at a mean of about 7 months.

At one year, 33 patients in the repeat group (82.5%), but only 23 in the SC group (57.5%), were free of atrial tachyarrhythmia (AT) (P = .03), and total group AT burden was lower (91 versus 127 days, P = .03). Quality of life scores on the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire were higher in the repeat study group, too (mean 92.2 versus 79.1 out of 126 points, P = .030).

“A strategy of early assessment with re-isolation of PV reconnections can be deployed safely and improves freedom from AT recurrence and quality of life compared with current standard care. While the gold standard remains durable PVI from the initial procedure, until rates of this can be substantially improved, early re-intervention could be considered as a reasonable strategy to improve outcomes,” the investigators concluded.

“If it was my dad and I was doing a PVI today, I’d say, ‘Dad, let’s bring you back and look at how you’re doing in 2 months,’” lead investigator Dr. Dhiraj Gupta said during an interview after his presentation at the Heart Rhythm Society annual meeting.

“We can’t really afford to do everybody twice, but this has certainly lowered our threshold for reintervention,” said Dr. Gupta, a cardiologist at the Liverpool hospital. “We used to try antiarrhythmic drugs” for recurrence; “we don’t do that anymore. We complete the job that [we] set out to do in the first place. Our threshold is any recurrence beyond 1 month. A surprising number of patients agree with this [recheck] strategy, which is one of the reasons we didn’t have a single drop out in this study. I tell them that it’s highly likely that some of the pulmonary veins I isolated for them are going to reconnect.”

Audience members were concerned that 15 patients in the study arm (38%) ended up having an invasive test they didn’t need. Dr. Gupta said it’s a “glass half full or half empty” situation. “I see it as half full. These repeat procedures are short, safe, and quick [about 80 minutes], and even shorter for those patients who don’t require pulmonary reisolation.” For those patients who do, only a few have symptoms; the rest would have had to wait for remergent symptoms to trigger a second procedure. “I believe that these repeat procedures have become so safe that the risk is more than made up” for by the benefits.

There were no complications with early reinterventions, and there were just two complications with the original PVI; one patient who ended up in the repeat group had a spontaneously resolving phrenic nerve palsy with the first procedure, and one SC patient had a transient ischemic attack. In short, “the complication rates for the two groups were identical,” Dr. Gupta said.

Patients were split about evenly between men and women in both study arms, and patients were in their early 60s, on average. The mean baseline AFEQT score was 46.8 points; 78% in the standard care group, but 55% in the early reintervention group, were on baseline anticoagulants.

All of the subjects were given portable ECG recorders after their initial PVIs, and told to take a daily 30-second recording, and to record if they felt any heart symptoms. They followed the instructions and made more than 32,000 recordings.

Every PVI patient at the Liverpool hospital now gets a recorder at discharge, and physicians there base early interventions on the results, whether or not patients are symptomatic. “We’ve bought lots of them, and tell patients to have a low threshold for recording. I believe 24-hours Holters are a bit outdated,” Dr. Gupta said.

All the PVIs in the study were contact-force guided and used wide area circumferential ablation with the help of 3-D mapping and automated lesion tagging. Entrance and exit block were demonstrated, and adenosine was administered to unmask dormant reconnections after a waiting period of at least 20 minutes. Antiarrhythmic drugs were stopped at 4 weeks.

Biosense Webster funded the work. Dr. Gupta is a speaker for and receives research and fellowship funding from the company.

[email protected]

SAN FRANCISCO – Repeat, invasive electrophysiology studies conducted 2 months after pulmonary vein isolation – regardless of symptoms and, if necessary, with repeat ablations – substantially reduce atrial fibrillation recurrence and improve quality of life at 1 year, according to an investigation conducted at the Liverpool (Eng.) Heart and Chest Hospital.

After initial pulmonary vein isolation (PVI), 40 patients with drug-refractory, paroxysmal atrial fibrillation (AF) were randomized to the repeat approach, and 40 others to the current standard of care (SC), meaning repeat PVI based on recurrent AF symptoms.

Pulmonary vein reconnections were found in 25 patients (63%) checked at 2 months, and all 25 had repeat PVIs without complications. Meanwhile, nine (23%) patients in the SC group had repeat PVIs for clinical recurrence at a mean of about 7 months.

At one year, 33 patients in the repeat group (82.5%), but only 23 in the SC group (57.5%), were free of atrial tachyarrhythmia (AT) (P = .03), and total group AT burden was lower (91 versus 127 days, P = .03). Quality of life scores on the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire were higher in the repeat study group, too (mean 92.2 versus 79.1 out of 126 points, P = .030).

“A strategy of early assessment with re-isolation of PV reconnections can be deployed safely and improves freedom from AT recurrence and quality of life compared with current standard care. While the gold standard remains durable PVI from the initial procedure, until rates of this can be substantially improved, early re-intervention could be considered as a reasonable strategy to improve outcomes,” the investigators concluded.

“If it was my dad and I was doing a PVI today, I’d say, ‘Dad, let’s bring you back and look at how you’re doing in 2 months,’” lead investigator Dr. Dhiraj Gupta said during an interview after his presentation at the Heart Rhythm Society annual meeting.

“We can’t really afford to do everybody twice, but this has certainly lowered our threshold for reintervention,” said Dr. Gupta, a cardiologist at the Liverpool hospital. “We used to try antiarrhythmic drugs” for recurrence; “we don’t do that anymore. We complete the job that [we] set out to do in the first place. Our threshold is any recurrence beyond 1 month. A surprising number of patients agree with this [recheck] strategy, which is one of the reasons we didn’t have a single drop out in this study. I tell them that it’s highly likely that some of the pulmonary veins I isolated for them are going to reconnect.”

Audience members were concerned that 15 patients in the study arm (38%) ended up having an invasive test they didn’t need. Dr. Gupta said it’s a “glass half full or half empty” situation. “I see it as half full. These repeat procedures are short, safe, and quick [about 80 minutes], and even shorter for those patients who don’t require pulmonary reisolation.” For those patients who do, only a few have symptoms; the rest would have had to wait for remergent symptoms to trigger a second procedure. “I believe that these repeat procedures have become so safe that the risk is more than made up” for by the benefits.

There were no complications with early reinterventions, and there were just two complications with the original PVI; one patient who ended up in the repeat group had a spontaneously resolving phrenic nerve palsy with the first procedure, and one SC patient had a transient ischemic attack. In short, “the complication rates for the two groups were identical,” Dr. Gupta said.

Patients were split about evenly between men and women in both study arms, and patients were in their early 60s, on average. The mean baseline AFEQT score was 46.8 points; 78% in the standard care group, but 55% in the early reintervention group, were on baseline anticoagulants.

All of the subjects were given portable ECG recorders after their initial PVIs, and told to take a daily 30-second recording, and to record if they felt any heart symptoms. They followed the instructions and made more than 32,000 recordings.

Every PVI patient at the Liverpool hospital now gets a recorder at discharge, and physicians there base early interventions on the results, whether or not patients are symptomatic. “We’ve bought lots of them, and tell patients to have a low threshold for recording. I believe 24-hours Holters are a bit outdated,” Dr. Gupta said.

All the PVIs in the study were contact-force guided and used wide area circumferential ablation with the help of 3-D mapping and automated lesion tagging. Entrance and exit block were demonstrated, and adenosine was administered to unmask dormant reconnections after a waiting period of at least 20 minutes. Antiarrhythmic drugs were stopped at 4 weeks.

Biosense Webster funded the work. Dr. Gupta is a speaker for and receives research and fellowship funding from the company.

[email protected]

SAN FRANCISCO – Repeat, invasive electrophysiology studies conducted 2 months after pulmonary vein isolation – regardless of symptoms and, if necessary, with repeat ablations – substantially reduce atrial fibrillation recurrence and improve quality of life at 1 year, according to an investigation conducted at the Liverpool (Eng.) Heart and Chest Hospital.

After initial pulmonary vein isolation (PVI), 40 patients with drug-refractory, paroxysmal atrial fibrillation (AF) were randomized to the repeat approach, and 40 others to the current standard of care (SC), meaning repeat PVI based on recurrent AF symptoms.

Pulmonary vein reconnections were found in 25 patients (63%) checked at 2 months, and all 25 had repeat PVIs without complications. Meanwhile, nine (23%) patients in the SC group had repeat PVIs for clinical recurrence at a mean of about 7 months.

At one year, 33 patients in the repeat group (82.5%), but only 23 in the SC group (57.5%), were free of atrial tachyarrhythmia (AT) (P = .03), and total group AT burden was lower (91 versus 127 days, P = .03). Quality of life scores on the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire were higher in the repeat study group, too (mean 92.2 versus 79.1 out of 126 points, P = .030).

“A strategy of early assessment with re-isolation of PV reconnections can be deployed safely and improves freedom from AT recurrence and quality of life compared with current standard care. While the gold standard remains durable PVI from the initial procedure, until rates of this can be substantially improved, early re-intervention could be considered as a reasonable strategy to improve outcomes,” the investigators concluded.

“If it was my dad and I was doing a PVI today, I’d say, ‘Dad, let’s bring you back and look at how you’re doing in 2 months,’” lead investigator Dr. Dhiraj Gupta said during an interview after his presentation at the Heart Rhythm Society annual meeting.

“We can’t really afford to do everybody twice, but this has certainly lowered our threshold for reintervention,” said Dr. Gupta, a cardiologist at the Liverpool hospital. “We used to try antiarrhythmic drugs” for recurrence; “we don’t do that anymore. We complete the job that [we] set out to do in the first place. Our threshold is any recurrence beyond 1 month. A surprising number of patients agree with this [recheck] strategy, which is one of the reasons we didn’t have a single drop out in this study. I tell them that it’s highly likely that some of the pulmonary veins I isolated for them are going to reconnect.”

Audience members were concerned that 15 patients in the study arm (38%) ended up having an invasive test they didn’t need. Dr. Gupta said it’s a “glass half full or half empty” situation. “I see it as half full. These repeat procedures are short, safe, and quick [about 80 minutes], and even shorter for those patients who don’t require pulmonary reisolation.” For those patients who do, only a few have symptoms; the rest would have had to wait for remergent symptoms to trigger a second procedure. “I believe that these repeat procedures have become so safe that the risk is more than made up” for by the benefits.

There were no complications with early reinterventions, and there were just two complications with the original PVI; one patient who ended up in the repeat group had a spontaneously resolving phrenic nerve palsy with the first procedure, and one SC patient had a transient ischemic attack. In short, “the complication rates for the two groups were identical,” Dr. Gupta said.

Patients were split about evenly between men and women in both study arms, and patients were in their early 60s, on average. The mean baseline AFEQT score was 46.8 points; 78% in the standard care group, but 55% in the early reintervention group, were on baseline anticoagulants.

All of the subjects were given portable ECG recorders after their initial PVIs, and told to take a daily 30-second recording, and to record if they felt any heart symptoms. They followed the instructions and made more than 32,000 recordings.

Every PVI patient at the Liverpool hospital now gets a recorder at discharge, and physicians there base early interventions on the results, whether or not patients are symptomatic. “We’ve bought lots of them, and tell patients to have a low threshold for recording. I believe 24-hours Holters are a bit outdated,” Dr. Gupta said.

All the PVIs in the study were contact-force guided and used wide area circumferential ablation with the help of 3-D mapping and automated lesion tagging. Entrance and exit block were demonstrated, and adenosine was administered to unmask dormant reconnections after a waiting period of at least 20 minutes. Antiarrhythmic drugs were stopped at 4 weeks.

Biosense Webster funded the work. Dr. Gupta is a speaker for and receives research and fellowship funding from the company.

[email protected]

SAN FRANCISCO – Lower doses and conservative applications eliminated phrenic nerve palsy with Medtronic’s Arctic Front Advance cryoballoon ablation catheter at the University of Florida, Gainesville.

Cardiologists there were accustomed to performing atrial fibrillation pulmonary vein isolation with the first-generation device – the Arctic Front – when they switched to the second-generation Advance catheter in 2012; they had 2 phrenic nerve palsies in the first 33 patients (6%), a doubling from the 2 cases in 74 patients (2.7%) with the first-generation device.

M. Alexander Otto/Frontline Medical News

The second-generation catheter is more powerful, with a cooling jet in the front of the balloon that delivers colder temperatures deeper into pulmonary veins. “We realized we needed to change the way we were using these catheters. You can use them safely, but you have to respect” their power, said lead investigator Dr. Robert Gibson.

“We reduced freezing times from 240 seconds to 180 seconds, and made that a hard rule. We limited the number of ablations” to two complete occlusions per vein, down from four to seven with the first-generation Arctic Front. “We also implemented a nadir cutoff to stop ablation when catheter temperatures fell below –55° C, and we tried to stay as proximal as possible to the pulmonary vein antra while still maintaining complete occlusion.” To help with that, cardiologists stopped using the 23-mm catheter, opting instead for the 28-mm catheter, Dr. Gibson said at the Heart Rhythm Society annual meeting.

Since making the changes, the team has performed 140 ablations, and there has not been a single phrenic nerve palsy. “We haven’t experienced a diaphragm paralysis” with the new approach. “We are very happy with these results. The changes make physiologic sense. You stay back; you use fewer freezes,” he said.

Phrenic nerve injury also decreased, from 3 cases in the first 33 second-generation patients (9%) to 9 in the 140 (6.4%) with the refined technique. Total phrenic nerve complications are now fewer in Gainesville than with the original, less powerful first-generation Arctic Front.

The team didn’t report ablation success with their new approach, but a 2015 review of Arctic Front Advance in more than 3,000 patients suggested long-term success with similar refinements (Heart Rhythm. 2015 Jul;12[7]:1658-66).

Patients in the University of Florida review were in their early 60s, on average, and about two-thirds were men. About 30% had prior ablations. Phrenic nerve injury was determined by continuous phrenic nerve stimulation and manual diaphragm palpation during cryoablation.

The investigators had no relevant financial disclosures. Medtronic helped with the statistical analysis.

[email protected]

SAN FRANCISCO – Lower doses and conservative applications eliminated phrenic nerve palsy with Medtronic’s Arctic Front Advance cryoballoon ablation catheter at the University of Florida, Gainesville.

Cardiologists there were accustomed to performing atrial fibrillation pulmonary vein isolation with the first-generation device – the Arctic Front – when they switched to the second-generation Advance catheter in 2012; they had 2 phrenic nerve palsies in the first 33 patients (6%), a doubling from the 2 cases in 74 patients (2.7%) with the first-generation device.

M. Alexander Otto/Frontline Medical News

The second-generation catheter is more powerful, with a cooling jet in the front of the balloon that delivers colder temperatures deeper into pulmonary veins. “We realized we needed to change the way we were using these catheters. You can use them safely, but you have to respect” their power, said lead investigator Dr. Robert Gibson.

“We reduced freezing times from 240 seconds to 180 seconds, and made that a hard rule. We limited the number of ablations” to two complete occlusions per vein, down from four to seven with the first-generation Arctic Front. “We also implemented a nadir cutoff to stop ablation when catheter temperatures fell below –55° C, and we tried to stay as proximal as possible to the pulmonary vein antra while still maintaining complete occlusion.” To help with that, cardiologists stopped using the 23-mm catheter, opting instead for the 28-mm catheter, Dr. Gibson said at the Heart Rhythm Society annual meeting.

Since making the changes, the team has performed 140 ablations, and there has not been a single phrenic nerve palsy. “We haven’t experienced a diaphragm paralysis” with the new approach. “We are very happy with these results. The changes make physiologic sense. You stay back; you use fewer freezes,” he said.

Phrenic nerve injury also decreased, from 3 cases in the first 33 second-generation patients (9%) to 9 in the 140 (6.4%) with the refined technique. Total phrenic nerve complications are now fewer in Gainesville than with the original, less powerful first-generation Arctic Front.

The team didn’t report ablation success with their new approach, but a 2015 review of Arctic Front Advance in more than 3,000 patients suggested long-term success with similar refinements (Heart Rhythm. 2015 Jul;12[7]:1658-66).

Patients in the University of Florida review were in their early 60s, on average, and about two-thirds were men. About 30% had prior ablations. Phrenic nerve injury was determined by continuous phrenic nerve stimulation and manual diaphragm palpation during cryoablation.

The investigators had no relevant financial disclosures. Medtronic helped with the statistical analysis.

[email protected]

SAN FRANCISCO – Lower doses and conservative applications eliminated phrenic nerve palsy with Medtronic’s Arctic Front Advance cryoballoon ablation catheter at the University of Florida, Gainesville.

Cardiologists there were accustomed to performing atrial fibrillation pulmonary vein isolation with the first-generation device – the Arctic Front – when they switched to the second-generation Advance catheter in 2012; they had 2 phrenic nerve palsies in the first 33 patients (6%), a doubling from the 2 cases in 74 patients (2.7%) with the first-generation device.

M. Alexander Otto/Frontline Medical News

The second-generation catheter is more powerful, with a cooling jet in the front of the balloon that delivers colder temperatures deeper into pulmonary veins. “We realized we needed to change the way we were using these catheters. You can use them safely, but you have to respect” their power, said lead investigator Dr. Robert Gibson.

“We reduced freezing times from 240 seconds to 180 seconds, and made that a hard rule. We limited the number of ablations” to two complete occlusions per vein, down from four to seven with the first-generation Arctic Front. “We also implemented a nadir cutoff to stop ablation when catheter temperatures fell below –55° C, and we tried to stay as proximal as possible to the pulmonary vein antra while still maintaining complete occlusion.” To help with that, cardiologists stopped using the 23-mm catheter, opting instead for the 28-mm catheter, Dr. Gibson said at the Heart Rhythm Society annual meeting.

Since making the changes, the team has performed 140 ablations, and there has not been a single phrenic nerve palsy. “We haven’t experienced a diaphragm paralysis” with the new approach. “We are very happy with these results. The changes make physiologic sense. You stay back; you use fewer freezes,” he said.

Phrenic nerve injury also decreased, from 3 cases in the first 33 second-generation patients (9%) to 9 in the 140 (6.4%) with the refined technique. Total phrenic nerve complications are now fewer in Gainesville than with the original, less powerful first-generation Arctic Front.

The team didn’t report ablation success with their new approach, but a 2015 review of Arctic Front Advance in more than 3,000 patients suggested long-term success with similar refinements (Heart Rhythm. 2015 Jul;12[7]:1658-66).

Patients in the University of Florida review were in their early 60s, on average, and about two-thirds were men. About 30% had prior ablations. Phrenic nerve injury was determined by continuous phrenic nerve stimulation and manual diaphragm palpation during cryoablation.

The investigators had no relevant financial disclosures. Medtronic helped with the statistical analysis.

[email protected]

San Francisco – Anticoagulation therapy is probably a good idea after ventricular tachycardia ablation in patients with risk factors or stroke, even if they don’t have atrial fibrillation, according to investigators from the University of Kansas Medical Center in Kansas City.

The advice comes from a review of 2,235 ventricular tachycardia (VT) ablation cases from the university and other members of the International VT Ablation Center Collaborative; about a quarter of the patients (604) were prescribed oral anticoagulation therapy at baseline and at discharge, nearly all for atrial fibrillation (AF) and most with warfarin. Over the next year, just 0.3% (2) had a subsequent thromboembolic complication, one of which was an ischemic stroke.

The remaining patients (1,631) did not have a diagnosis of AF and were not on anticoagulants at baseline or after discharge. They were more likely to have New York Heart Association class I or II heart failure and higher ejection fractions, and to otherwise be in better shape compared with the patients who received anticoagulation therapy. Even so, within a year, 1.3% (21) had a thromboembolic event, almost half of which were ischemic strokes, a substantial increase in relative risk (P = .05).

Maybe those patients had undiagnosed AF at baseline, or perhaps a clot formed over the ablation scar, Dr. Rizwan Afzal said at the annual scientific sessions of the Heart Rhythm Society. Regardless, “this observation has changed our practice. If VT ablation patients have low ejection fractions, if they’re elderly, or have other risk factors for stroke, we put them on blood thinners [afterward] “even if they don’t have atrial fibrillation. We are not sure how long they should be on anticoagulation [therapy] to counteract the increased risk of stroke,” but probably at least for a few weeks, he said.

Dr. Afzal and his colleagues generally opt for warfarin; the use is off label for newer oral anticoagulants, and a tough sell to insurance companies.

There were no predictors of increased thromboembolic risk in the group that was not on anticoagulation therapy. During follow-up, about 2.2% (13) of patients on anticoagulation therapy had bleeding complications, including one intracranial hemorrhage, compared with 2.5% (41) of the patients not treated with an anticoagulant; most of them were on aspirin after the procedure, and the rest were on dual antiplatelet therapy (P = .7), reported Dr. Afzal, a cardiology fellow at the University of Kansas.

The median age of the study patients was 65 years, and 87% were men. In the group on anticoagulation therapy, the mean baseline left ventricular ejection fraction was 31%; 35% had prior cardiac surgery, 29% were on cardiac resynchronization therapy, and 44% had NYHA class III or IV heart failure. The mean baseline ejection fraction among patients who were not on anticoagulation therapy was 35%; 29% had prior heart surgery, 24% were on CRT, and 32.5% had NYHA class III or IV heart failure.

There was no industry funding for the work, and the investigators had no disclosures.

[email protected]

San Francisco – Anticoagulation therapy is probably a good idea after ventricular tachycardia ablation in patients with risk factors or stroke, even if they don’t have atrial fibrillation, according to investigators from the University of Kansas Medical Center in Kansas City.

The advice comes from a review of 2,235 ventricular tachycardia (VT) ablation cases from the university and other members of the International VT Ablation Center Collaborative; about a quarter of the patients (604) were prescribed oral anticoagulation therapy at baseline and at discharge, nearly all for atrial fibrillation (AF) and most with warfarin. Over the next year, just 0.3% (2) had a subsequent thromboembolic complication, one of which was an ischemic stroke.

The remaining patients (1,631) did not have a diagnosis of AF and were not on anticoagulants at baseline or after discharge. They were more likely to have New York Heart Association class I or II heart failure and higher ejection fractions, and to otherwise be in better shape compared with the patients who received anticoagulation therapy. Even so, within a year, 1.3% (21) had a thromboembolic event, almost half of which were ischemic strokes, a substantial increase in relative risk (P = .05).

Maybe those patients had undiagnosed AF at baseline, or perhaps a clot formed over the ablation scar, Dr. Rizwan Afzal said at the annual scientific sessions of the Heart Rhythm Society. Regardless, “this observation has changed our practice. If VT ablation patients have low ejection fractions, if they’re elderly, or have other risk factors for stroke, we put them on blood thinners [afterward] “even if they don’t have atrial fibrillation. We are not sure how long they should be on anticoagulation [therapy] to counteract the increased risk of stroke,” but probably at least for a few weeks, he said.

Dr. Afzal and his colleagues generally opt for warfarin; the use is off label for newer oral anticoagulants, and a tough sell to insurance companies.

There were no predictors of increased thromboembolic risk in the group that was not on anticoagulation therapy. During follow-up, about 2.2% (13) of patients on anticoagulation therapy had bleeding complications, including one intracranial hemorrhage, compared with 2.5% (41) of the patients not treated with an anticoagulant; most of them were on aspirin after the procedure, and the rest were on dual antiplatelet therapy (P = .7), reported Dr. Afzal, a cardiology fellow at the University of Kansas.

The median age of the study patients was 65 years, and 87% were men. In the group on anticoagulation therapy, the mean baseline left ventricular ejection fraction was 31%; 35% had prior cardiac surgery, 29% were on cardiac resynchronization therapy, and 44% had NYHA class III or IV heart failure. The mean baseline ejection fraction among patients who were not on anticoagulation therapy was 35%; 29% had prior heart surgery, 24% were on CRT, and 32.5% had NYHA class III or IV heart failure.

There was no industry funding for the work, and the investigators had no disclosures.

[email protected]

San Francisco – Anticoagulation therapy is probably a good idea after ventricular tachycardia ablation in patients with risk factors or stroke, even if they don’t have atrial fibrillation, according to investigators from the University of Kansas Medical Center in Kansas City.

The advice comes from a review of 2,235 ventricular tachycardia (VT) ablation cases from the university and other members of the International VT Ablation Center Collaborative; about a quarter of the patients (604) were prescribed oral anticoagulation therapy at baseline and at discharge, nearly all for atrial fibrillation (AF) and most with warfarin. Over the next year, just 0.3% (2) had a subsequent thromboembolic complication, one of which was an ischemic stroke.

The remaining patients (1,631) did not have a diagnosis of AF and were not on anticoagulants at baseline or after discharge. They were more likely to have New York Heart Association class I or II heart failure and higher ejection fractions, and to otherwise be in better shape compared with the patients who received anticoagulation therapy. Even so, within a year, 1.3% (21) had a thromboembolic event, almost half of which were ischemic strokes, a substantial increase in relative risk (P = .05).

Maybe those patients had undiagnosed AF at baseline, or perhaps a clot formed over the ablation scar, Dr. Rizwan Afzal said at the annual scientific sessions of the Heart Rhythm Society. Regardless, “this observation has changed our practice. If VT ablation patients have low ejection fractions, if they’re elderly, or have other risk factors for stroke, we put them on blood thinners [afterward] “even if they don’t have atrial fibrillation. We are not sure how long they should be on anticoagulation [therapy] to counteract the increased risk of stroke,” but probably at least for a few weeks, he said.

Dr. Afzal and his colleagues generally opt for warfarin; the use is off label for newer oral anticoagulants, and a tough sell to insurance companies.

There were no predictors of increased thromboembolic risk in the group that was not on anticoagulation therapy. During follow-up, about 2.2% (13) of patients on anticoagulation therapy had bleeding complications, including one intracranial hemorrhage, compared with 2.5% (41) of the patients not treated with an anticoagulant; most of them were on aspirin after the procedure, and the rest were on dual antiplatelet therapy (P = .7), reported Dr. Afzal, a cardiology fellow at the University of Kansas.

The median age of the study patients was 65 years, and 87% were men. In the group on anticoagulation therapy, the mean baseline left ventricular ejection fraction was 31%; 35% had prior cardiac surgery, 29% were on cardiac resynchronization therapy, and 44% had NYHA class III or IV heart failure. The mean baseline ejection fraction among patients who were not on anticoagulation therapy was 35%; 29% had prior heart surgery, 24% were on CRT, and 32.5% had NYHA class III or IV heart failure.

There was no industry funding for the work, and the investigators had no disclosures.

[email protected]

VANCOUVER – In a study at New York University, it took 27 healthy, native English–speaking volunteers 42.8 seconds to complete the King-Devick concussion screening test, which is about average for nonconcussed subjects.

However, it took 27 other volunteers with English as a second language 54.4 seconds (P = .001). Had the test been given on the sidelines instead of in a laboratory, the extra 12 seconds might easily have been mistaken as a sign of serious concussion because concussions generally add about 5 seconds to the King-Devick score.

“A prolongation of 12 seconds in non-native English speakers has real clinical implications,” said lead investigator Katharine Dempsey, a medical student and member of the eye movement research team in the department of neurology at New York University.

King-Devick (KD) is an increasingly popular sideline screening tool used widely in professional sports. Subjects are timed on how long it takes to read out loud and in English three sets of 40 numbers, with each set progressively more difficult to read. It’s administered by flashcards or, as in the study, by computer screen.

All of the non-native speakers at NYU were largely proficient in English, but their native languages – 18 in total, most often Spanish or Chinese – were often dominant, meaning they were used at home and to work out mental arithmetic. Some subjects did not use Roman numerals or right-to-left reading in their native tongues.

KD instructions recommend testing subjects against their own preseason baseline scores; the NYU findings emphasize how important that is when subjects aren’t native English speakers. The investigators are concerned that when baseline scores are unavailable, non-native English speakers will be scored against reference ranges for native speakers.

“There’s incredible utility in using a sideline concussion screening test, but we definitely have to get out the message that the best practice is to take an athlete’s own preseason baseline. We have to be incredibly cautious when comparing test times of non-native English speakers to a normative database for native speakers,” Ms. Dempsey said at the annual meeting of the American Academy of Neurology.

The participants were in their early 30s, on average, and had no histories of concussion. The majority were women, and most were NYU employees or their friends.

The team also tracked eye movements during testing. Non-native speakers had more quick eye movement (149 vs. 135; P = .03), but also fixated longer on numbers before initiating eye movement (345.4 milliseconds vs. 288.0; P = .007). Lag time correlated with native language dominance and suggests longer processing time.

The next step is to test how well patients do with KD testing in their native language, Ms. Dempsey said.

Ms. Dempsey had no disclosures.

[email protected]

VANCOUVER – In a study at New York University, it took 27 healthy, native English–speaking volunteers 42.8 seconds to complete the King-Devick concussion screening test, which is about average for nonconcussed subjects.

However, it took 27 other volunteers with English as a second language 54.4 seconds (P = .001). Had the test been given on the sidelines instead of in a laboratory, the extra 12 seconds might easily have been mistaken as a sign of serious concussion because concussions generally add about 5 seconds to the King-Devick score.

“A prolongation of 12 seconds in non-native English speakers has real clinical implications,” said lead investigator Katharine Dempsey, a medical student and member of the eye movement research team in the department of neurology at New York University.

King-Devick (KD) is an increasingly popular sideline screening tool used widely in professional sports. Subjects are timed on how long it takes to read out loud and in English three sets of 40 numbers, with each set progressively more difficult to read. It’s administered by flashcards or, as in the study, by computer screen.

All of the non-native speakers at NYU were largely proficient in English, but their native languages – 18 in total, most often Spanish or Chinese – were often dominant, meaning they were used at home and to work out mental arithmetic. Some subjects did not use Roman numerals or right-to-left reading in their native tongues.

KD instructions recommend testing subjects against their own preseason baseline scores; the NYU findings emphasize how important that is when subjects aren’t native English speakers. The investigators are concerned that when baseline scores are unavailable, non-native English speakers will be scored against reference ranges for native speakers.

“There’s incredible utility in using a sideline concussion screening test, but we definitely have to get out the message that the best practice is to take an athlete’s own preseason baseline. We have to be incredibly cautious when comparing test times of non-native English speakers to a normative database for native speakers,” Ms. Dempsey said at the annual meeting of the American Academy of Neurology.

The participants were in their early 30s, on average, and had no histories of concussion. The majority were women, and most were NYU employees or their friends.

The team also tracked eye movements during testing. Non-native speakers had more quick eye movement (149 vs. 135; P = .03), but also fixated longer on numbers before initiating eye movement (345.4 milliseconds vs. 288.0; P = .007). Lag time correlated with native language dominance and suggests longer processing time.

The next step is to test how well patients do with KD testing in their native language, Ms. Dempsey said.

Ms. Dempsey had no disclosures.

[email protected]

VANCOUVER – In a study at New York University, it took 27 healthy, native English–speaking volunteers 42.8 seconds to complete the King-Devick concussion screening test, which is about average for nonconcussed subjects.

However, it took 27 other volunteers with English as a second language 54.4 seconds (P = .001). Had the test been given on the sidelines instead of in a laboratory, the extra 12 seconds might easily have been mistaken as a sign of serious concussion because concussions generally add about 5 seconds to the King-Devick score.

“A prolongation of 12 seconds in non-native English speakers has real clinical implications,” said lead investigator Katharine Dempsey, a medical student and member of the eye movement research team in the department of neurology at New York University.

King-Devick (KD) is an increasingly popular sideline screening tool used widely in professional sports. Subjects are timed on how long it takes to read out loud and in English three sets of 40 numbers, with each set progressively more difficult to read. It’s administered by flashcards or, as in the study, by computer screen.

All of the non-native speakers at NYU were largely proficient in English, but their native languages – 18 in total, most often Spanish or Chinese – were often dominant, meaning they were used at home and to work out mental arithmetic. Some subjects did not use Roman numerals or right-to-left reading in their native tongues.

KD instructions recommend testing subjects against their own preseason baseline scores; the NYU findings emphasize how important that is when subjects aren’t native English speakers. The investigators are concerned that when baseline scores are unavailable, non-native English speakers will be scored against reference ranges for native speakers.

“There’s incredible utility in using a sideline concussion screening test, but we definitely have to get out the message that the best practice is to take an athlete’s own preseason baseline. We have to be incredibly cautious when comparing test times of non-native English speakers to a normative database for native speakers,” Ms. Dempsey said at the annual meeting of the American Academy of Neurology.

The participants were in their early 30s, on average, and had no histories of concussion. The majority were women, and most were NYU employees or their friends.

The team also tracked eye movements during testing. Non-native speakers had more quick eye movement (149 vs. 135; P = .03), but also fixated longer on numbers before initiating eye movement (345.4 milliseconds vs. 288.0; P = .007). Lag time correlated with native language dominance and suggests longer processing time.

The next step is to test how well patients do with KD testing in their native language, Ms. Dempsey said.

Ms. Dempsey had no disclosures.

[email protected]