Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), aiming to distinguish their respective leadless pacemaker offerings, presented new data last week in San Francisco at the Heart Rhythm Society’s annual meeting.
St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events.
“We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possible with the Nanostim leadless pacemaker,” lead investigator Dr. Vivek Reddy, of New York City’s Mount Sinai Hospital, said in prepared remarks.
Leadless II also compared a 718-patient Nanostim-implanted group with a cohort of 10,521 patients implanted with traditional transvenous pacers, using data from Truven MarketScan tracking of healthcare claims and Medicare supplemental insurance encounters.
Acute complications occurred in 5.8% of the Nanostim group, compared with 12.7% of patients in the traditional pacer arm. Mid-term complications in the 1st 2 years after implantation were 0.6% for the Nanostim arm and 5.4% for the TVP arm, the Leadless II data showed.
“Real-world claims data indicate higher-than-previously-reported rates of TVP complications with clear advantages for LCPs among infectious and lead-related events. LCPs and TVPs had similar rates of dislodgement and pericardial effusion,” according to the study.
“We are extremely pleased to see these three presentations provide additional insight into the potential benefits associated with the Nanostim leadless pacemaker,” said St. Jude’s chief medical officer, Dr. Mark Carlson. “The Nanostim leadless pacemaker has been available to patients in Europe since 2013 and we continue to work with the FDA to bring the Nanostim leadless pacemaker to the U.S. market to ensure broad patient access to this important therapy.”
St. Jude’s Twin Cities rival Medtronic touted an industry 1st at HRS 2016 – the ability of its Micra leadless pacer to measure patients’ movement using an accelerometer and calculate an appropriate pacing rate. A 20-patient study of stress test data at 3 and 6 months showed that “appropriate rate-responsive pacing is achievable with an entirely intra-cardiac accelerometer-based pacing system,” Medtronic said.
“Many patients with bradycardia require rate-responsive pacing so that their heart rates increase during exercise,” Dr. Razali Omar, of Malaysia’s National Heart Institute, said in prepared remarks. “Conventional pacemakers use various sensors outside the heart to detect patient activity, but even these sensors can have difficulty detecting moderate physical activity. As data presented today show, the Micra accurately responds to patients’ activity levels by adjusting therapy when needed using a sensor within the heart.”
Both Nanostim and Micra have won CE Mark approval in the European Union, but only Micra has won a nod from the FDA in the U.S. The 3rd player in the leadless pacing space, Boston Scientific (NYSE:BSX), is developing the Empower device to work alone or with its Emblem S-ICD pacer, which uses subcutaneous instead of transvenous leads.
Boston Scientific touts post-market data for S-ICD from Effortless study
Boston Scientific said post-market data from the Effortless registry study of the S-ICD confirmed the long-term safety and efficacy outlook on the device.
The 958-patient trial followed its subjects for 5 years, showing a complication rate of 0.3% at 30 days and 2.0% at 1 year. The device converted 97.4% of discrete arrhythmias, the company said. Follow-up at an average 3.1 years revealed showed that only 5 S-ICDs (0.5%) were explanted and replaced with anti-tachycardia pacers and just 1 (0.1%) was replaced with a pacer for treating bradycardia, Marlborough, Mass.-based Boston Scientific said. Read more
Medronic studies explore ‘extravascular’ leads
Medtronic said a pair of studies used a new method for placing implantable cardioverte defibrillators outside of the heart but under the ribcage.
The device used in a 16-patient feasibility study, which Fridley, Minn.-based Medtronic dubbed EV-ICD, used a Fast Patch Plus electrode made by former Medtronic subsidiary Physio Control and Medtronic’s Protecta ICD. The study showed successful defibrillation in 13 of 14 ventricular fibrillation episodes, with the lone failure coming from the high and lateral placement of the lead.
“These preliminary data demonstrate that substernal defibrillation is feasible and that successful defibrillation can be achieved with the shock energy available in current TV ICDs. This may open new alternatives to TV ICD therapy,” the study concluded.
In another study, the 24-patient Space trial, surgeons used Medtronic’s Marinr catheter to implant electrodes over the heart’s right ventricle. Seventeen patients had successful, consistent ventricular pacing capture in 1 or more 1 tested vectors.
“Preliminary data demonstrates that pacing is feasible from this novel extravascular substernal location. A bipolar substernal electrode configuration with wide electrode spacing has the potential to provide pacing in a future extravascular defibrillator,” the researchers found.
“The EV-ICD may be transformational for ICD therapy, with advancements for both patients and physicians,” cardiac rhythm & heart failure president Dr. John Liddicoat said in prepared remarks. “These feasibility study results are promising and have brought us one step closer to making this approach a reality for patients around the world at risk of sudden cardiac death.” Read more
EBR Systems’ WiSE comes through in Select-LV trial
A 39-patient safety & efficacy trial of the WiSE device made by EBR Systems, which uses a pacing electrode implanted in the wall of the left ventricle, showed an adverse event rate of 8.5% peri-operatively and 22% at 1 month. Bi-ventricular pacing was achieved in 97% at 1 month and 94% at 6 months. Ejection fraction scores rose by 5% or more in 63% of patients at 6 months, with a mean increase of 7.1±8.0%. The clinical composite score at 6 months showed that 28 patients (85%) improved, 3 (9%) remained unchanged, and 2 (6%) worsened.
“This multi-center experience has demonstrated the feasibility of direct, wireless endocardial LV pacing to achieve CRT in patients with a previous CRT failure or previously unsuitable for CRT,” the researchers found. Read more
St. Jude Medical’s newly approved Quadra multi-point pacing meets endpoints
St. Jude Medical said the MultiPoint pacing technology used with its Quadra Assura MP CRT-D and Quadra Allure MP CRT-P devices met its safetyt and efficacy endpoints.
The study, of more than 500 patients, showed a 93.2% rate of freedom from system-related complications, its primary safety endpoint.
“We know that up to one-third of patients do not respond to traditional cardiac resynchronization therapy. A growing body of clinical evidence, including data from this IDE study, shows that MultiPoint Pacing can enhance the response to CRT for heart failure patients whose devices are appropriately programmed,” Carlson said in prepared remarks. “We will continue to study and improve the response of cardiac resynchronization therapy and look forward to the results of our More CRT-MPP study that just completed enrollment.” Read more
AliveCor’s ECG app non-inferior to ambulatory monitor
A study comparing AliveCor‘s ECG monitor app with traditional ambulatory Holter monitoring showed that the AliveCor smartphone app was non-inferior to the ambulatory monitor.
“AliveCor provides a diagnostic yield comparable to an ambulatory event monitor. A smartphone-based ECG monitor can be used as a first approach for the diagnosis of palpitations,” the study found. Read more
Increased afib burden linked to higher ischemic stroke rate in iRhythm’s Zio monitor study
An increase in the burden of atrial fibrillation was associated with a higher risk for ischemic stroke or other thromboembolism in patients who are not on anti-coagulants in the Rhythm trial using the Zio cardiac monitor made by iRhythm. Read more
LivaNova’s Sonr hemodynamic monitor meets safety & efficaly endpoints in Respond-CRT trial
The 1,039-patient Respond-CRT study of the Sonr hemodynamic monitor made by LivaNova (NSDQ:LIVN) showed that patients were more likely to respond to cardiac resynchronization therapy when the Sonrtip lead was used.
The device measures patients’ cardiac muscle vibrations in real-time and uses the data to optimize CRT therapy. Respond-CRT showed a 75.0% increase in response rate for the Sonr cohort, compared with 70.4% for the control group. Sonr patients also showed a 35% reduction in hospitalizations related to heart failure. Read more
