The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting.
Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide.
Boston Scientific, Abbott, Medtronic, Philips, and iRhythm unveiled advances that have the potential to revolutionize the field of cardiology and improve patient outcomes.
The cardiology devices showcased at the Heart Rhythm 2023 hold promise for the future of cardiovascular care. As these innovations continue to advance, they have the potential to significantly improve the lives of patients worldwide. Stay tuned as we delve deeper into the details of these groundbreaking technologies and their impact on the field of cardiology.
Here’s a roundup of Associate Editor Sean Whooley’s reporting on news out of Heart Rhythm 2023:
Philips AI for ventricular arrhythmias [Image courtesy of Philips]
The Aurora EV-ICD with the lead. [Image courtesy of Medtronic]
iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]
The Aveir single-chamber (VR) leadless pacemaker [Image courtesy of Abbott]
The PulseSelect for pulsed-field ablation. [Image courtesy of Medtronic
Boston Scientific’s Watchman FLX [Image from Boston Scientific]Click the + symbol to expand.
Philips (NYSE:PHG) presented data demonstrating how artificial intelligence (AI) can help predict life-threatening ventricular arrhythmias.
The study, “Near-Term Prediction of Life-Threatening Ventricular Arrhythmias using Artificial Intelligence-Enabled Single Lead Ambulatory ECG,” used an AI-based learning model. It successfully predicted sustained ventricular tachycardia (VT) over a two-week period when compared to ambulatory ECG data.
What were the researchers evaluating?
The AI-based learning model used a deep neural network and 115,505 ambulatory ECG recordings gathered from independent diagnostic testing facilities in five countries. The model then retrospectively validated the model using retrospective 14-day ambulatory ECG recordings from 2019 to 2023.
Researchers studied the algorithm’s ability to predict the risk of sustained VT (lasting longer than 30 seconds). The study evaluated a two-week period using data from the first 24 hours of monitoring.
Key findings
The model achieved a sensitivity of 83.3% and a specificity of 88.7% on its internal validation dataset. On the external validation dataset, sensitivity and specificity came in at 78.9% and 81.4%, respectively. The model correctly predicted VT occurrence in 88% of Holter users with rapid VT.
Philips said novel AI models “lay the foundation for a new approach to cardiac risk management.” The company believes it can apply across multiple care settings, helping to identify at-risk patients earlier.
Medtronic (NYSE:MDT) announced positive long-term follow-up results for its investigational implantable cardioverter defibrillator (ICD).
The medtech giant designed its extravascular (EV) ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. Medtronic’s first-of-its-kind implantable defibrillator aims to avoid certain risks of traditional, transvenous ICDs. It designed the system with a lead placed outside the heart and veins, under the sternum. Using a minimally invasive approach, the implant goes below the left armpit in the left mid-axillary region.
The ICD offers anti-tachycardia pacing (ATP) and pause prevention pacing.
What were the researchers evaluating?
Medtronic’s EV ICD pivotal study for safety and effectiveness followed 299 implanted patients through an average of 17.1 months. The company presented data as late-breaking science at Heart Rhythm 2023.
Key findings
An estimated 6.8% of patients experienced the appropriate therapy by 18 months. Nineteen patients experienced 80 spontaneous, appropriately treated arrhythmic episodes.
Medtronic said that of discrete episodes treated with shock, 21 of 21 were successfully terminated.
ATP successfully treated 35 of 52 episodes (67.3%). Patients avoided shocks in nearly half of all spontaneous episodes because of the availability of ATP, Medtronic said. Data built on the EV ICD’s previously reported defibrillation effectiveness results at implant (98.7%).
Medtronic observed a 91.9% rate of freedom from major EV ICD system- or procedure-related complications through 18 months. It observed the most common major complication, lead dislodgement (10 events in nine patients), at zero to 120 days post-implant. This predominantly relates to the lead-anchoring technique.
Inappropriate shocks occurred in 35 patients through all follow-ups, with a rate of 10.2% at one year. Medtronic previously reported exceeding its safety endpoint at six months.
The company also presented data leveraging EV ICD pivotal study device-detected episodes. This data demonstrated that the Medtronic proprietary algorithm designed to reduce inappropriate shocks successfully withheld inappropriate therapy caused by P-wave oversensing. It reduced inappropriate detection due to P-wave oversensing by 57%.
iRhythm (Nasdaq:IRTC) this week announced the presentation of four studies reinforcing evidence behind its long-term cardiac monitoring.
San Francisco-based iRhythm said data supports ambulatory cardiac monitoring of up to 14 days with the company’s Zio XT. It demonstrated increased diagnostic yield and improved diagnostic accuracy of ventricular arrhythmias across a variety of patient populations.
What were the researchers evaluating?
iRhythm’s EXAMINE-HCM study evaluated patients with hypertrophic cardiomyopathy (HCM).
Key findings
The study found that long-term monitoring of up to 14 days with Zio XT substantially improves the diagnostic yield of non-sustained ventricular tachycardia (NSVT).
Key findings included 48 hours of monitoring missing nearly two-thirds of patients with high-risk NSVT episodes. That may impact risk stratification and treatment.
iRhythm saw an 18% diagnostic yield for detecting NSVT in the first 48 hours. It saw 48% at 14 days, with 63% of initial NSVT episodes occurring after the first 48 hours.
The company observed 8% diagnostic yield for detecting high-risk NSVT episodes in the first 48 hours. That compared to 24% at 14 days, with 64% of initial high-risk NSVT runs occurring after the first 48 hours.
Abbott (NYSE:ABT) this week announced late-breaking results from a study of its Aveir dual-chamber (DR) i2i leadless pacemaker.
Aveir DR is the world’s first dual-chamber leadless pacemaker. It delivers electrical impulses directly to the heart muscle. This restores the normal heart rhythm. Unlike traditional pacemakers, the leadless devices go directly into the heart through a minimally invasive, catheter-based procedure. This eliminates the need for cardiac leads and a pulse generator under the skin.
What were the researchers evaluating?
The data came from the company’s large-scale FDA investigational device exemption (IDE) study of Aveir DR for safety and performance. Abbott said the data suggests Aveir DR could offer new benefits for those with slower-than-normal heart rhythms.
Key findings
In the study, physicians successfully implanted leadless pacemakers in the right atrium along with a leadless device in the right ventricle for the first time.
Abbott’s study analyzed primary safety and efficacy endpoints in the first 300 people enrolled. The study evaluated participants across 55 centers in the U.S., Canada and Europe through three months post-implant.
Results demonstrated a 98.3% implant success rate. The study achieved its safety endpoint evaluating freedom from device or procedure-related complications.
Abbott said more than 97% of people presented successful atrioventricular (AV) synchrony. This means the upper and lower chambers beat normally, despite different types of underlying slow heart rhythms. The average AV synchrony came in at 95% in each of the seven different posture and walking speeds. Abbott said this demonstrated that the system functions appropriately during everyday life activities.
Medtronic (NYSE:MDT) announced positive findings from a secondary analysis of the PULSED AF study for its pulsed-field ablation technology.
Related: What is pulsed-field ablation? Here’s what you need to know
The analysis demonstrated positive results for the PulseSelect system, including atrial arrhythmia (AA) burden reduction. This correlated to both improved quality of life and decreased healthcare utilization.
What were the researchers evaluating?
The PULSED AF trial evaluated the safety and effectiveness of PFA technology for atrial fibrillation (AFib) ablation.
Medtronic said the recurrence of known episodic AA depends on the monitoring strategy used. In PULSED AF, investigators calculated burden for every patient utilizing recording from trans-telephonic monitors (TTMs) and Holter monitoring. The study used an endpoint of AA burden, assessed by the greater amount of burden from Holter monitoring or TTMs.
Key findings
Findings demonstrated 87% of paroxysmal AFib and 82% of persistent AFib patients showed a post-ablation burden of less than 10%. The study observed zero burden in 69% and 62% of those cohorts, respectively.
Additionally, Medtronic reported on quality-of-life metrics based on the AF Effect On Quality-Of-Life Questionnaire (AFEQT). Results came at baseline and 12 months post-ablation. Paroxysmal AFib patients had AA burden of less than 10% associated with meaningful quality of life improvement. Persistent AFib patients undergoing pulsed-field ablation experienced quality of life improvement regardless of burden level.
Medtronic also said that its analysis evaluated the relationship between AA burden and AFib-related healthcare utilization. That includes repeat ablations, cardioversions and ER visits/hospitalizations that occurred following pulsed-field ablation treatment.
For both types of AFib patients, repeat ablations and cardioversion significantly increased with increasing AA burden.
Boston Scientific (NYSE:BSX) announced data supporting its pulsed-field ablation (PFA) and left atrial appendage closure (LAAC) systems.
Studies backed the company’s key electrophysiology and cardiac rhythm management therapies, plus the Watchman FLX device. In addition to the LAAC device, the Marlborough, Massachusetts-based company shared data on its Farapulse PFA system, POLARx cryoablation system and the Emblem MRI subcutaneous implantable defibrillator (S-ICD).
What were the researchers evaluating?
Farapulse: Boston Scientific presented real-world outcomes from the multicenter EU-PORIA registry for the Farapulse system. This registry demonstrated the safety, efficacy and learning curve characteristics of Farapulse. Data included favorable single procedure success rates, plus efficient procedure times in a broad patient population. The registry evaluated more than 1,200 patients with paroxysmal or persistent AFib across seven high-volume European centers.
PolarX: The prospective, nonrandomized, single-arm FROZEN-AF investigational device exemption (IDE) study evaluated the POLARx cryoablation system for safety and effectiveness in treating paroxysmal or intermittent AFib. It included an extension arm for the POLARx FIT cryoballoon catheter. This single device has capabilities for enabling 28mm and 31mm sizes. The extension arm sub-study also achieved its safety and effectiveness endpoints. That included 50 patients treated with at least one application of the 31mm cryoballoon set for 12-month follow-up. At the time of data release, patients underwent six of a total 12 months of follow-up.
Emblem MRI S-ICD: Boston Scientific also reported data from a secondary analysis of the investigator-sponsored, randomized ATLAS trial. It included 450 patients. The study evaluated the severity of tricuspid regurgitation at six months following the implantation of a transvenous implantable cardioverter-defibrillator (TV-ICD) versus the Emblem MRI S-ICD.
Watchman FLX: This study, out of the National Cardiovascular Data Registry (NCDR) LAAO Registry, provided insights into real-world treatment strategies with Watchman FLX. The first analysis assessed outcomes with different post-procedural antithrombotic therapies. Boston Scientific’s second analysis demonstrated that concomitant catheter ablation and LAAC with Watchman FLX proved safe. It demonstrated similar outcomes compared to device implantation alone.
Key findings
Farapulse:
- Boston Scientific reported a 74% rate of freedom from recurrence of AFib and atrial tachycardia. This was measured by the Kaplan-Meier estimate at a median follow-up of one year. Freedom from recurrence rate came in at 80% in patients with paroxysmal AFib and 66% in those with persistent AFib.
- The level of physician experience with AFib ablation did not impact procedure times or patient outcomes. Boston Scientific said this reinforces the procedural reproducibility of the Farapulse PFA system.
- Data demonstrated a predictable workflow with a median of 58 minutes within an interquartile range of 40 to 87 minutes.
- The study had a 1.7% major complication rate and 1.9% minor complication rate. It observed no reported esophageal damage or pulmonary vein stenosis, with a single case of sustained phrenic nerve palsy. That report came from the MANIFEST PF study.
PolarX:
- FROZEN-AF achieved its primary safety endpoint of composite acute and chronic primary safety events through 12 months. It observed an event-free rate of 96.3% at 12 months in the IDE trial and 100% at six months in the extension.
- Boston Scientific received no reports of moderate or severe pulmonary vein stenosis, persistent phrenic nerve palsy or esophageal fistulas in either patient cohort. Rate of freedom from documented atrial arrhythmias came in at 79.9% at 12 months in the IDE trial. It registered at 88% at six months in the extension.
Emblem MRI S-ICD:
- Data showed that at six months, patients in the TV-ICD group proved seven times more likely to present worsening tricuspid regurgitation.
- Of those with worsening tricuspid regurgitation, moderate or severe symptoms developed in 6.9% of TV-ICD patients. That compared to just 2.3% in the Boston Scientific S-ICD group.
- Meanwhile, data from the investigator-sponsored VTabl-SICD trial evaluated the safety and efficacy of a novel hybrid management strategy combining VT ablation with S-ICD implantation in patients who have scar-related VT. It evaluated 32 patients.
- Data suggested that the combination strategy proved superior to conventional IV-ICD implantation. This occurred in the secondary prevention of sudden cardiac death. Boston Scientific said the combination strategy significantly reduced the need to deliver ICD therapy. It also proved effective for avoiding untreated, symptomatic arrhythmias.
- At two years, the rate of delivery of any appropriate ICD therapy proved significantly lower in the VTabl-S-ICD group. No cases of untreated symptomatic VT or ventricular fibrillation appeared in the VTabl-S-ICD group.
Watchman FLX:
- The first analysis demonstrated that patients treated with direct oral anticoagulants (DOAC) alone had the lowest risk of major adverse events in comparison to other drug regimens following the implant.
- The second analysis demonstrated similar outcomes compared to device implantation alone.
- The company also said the latest preclinical data for the investigational Watchman FLX Pro device demonstrated that its new thromboresistant coating may further reduce the risk of device-related thrombus and result in faster and more uniform tissue coverage on the device at 45 days post-implant. The findings were also published in JACC Clinical Electrophysiology.