Background: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effecti... more Background: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. Methods: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 month...
The novel two‐lead cardiac resynchronization therapy (CRT)‐DX system utilizes a floating atrial d... more The novel two‐lead cardiac resynchronization therapy (CRT)‐DX system utilizes a floating atrial dipole on the implantable cardioverter‐defibrillator lead, and when implanted with a left ventricular (LV) lead, offers a two‐lead CRT system with AV synchrony. This study compared complication rates and CRT response among subjects implanted with a two‐lead CRT‐DX system to those subjects implanted with a standard three‐lead CRT‐D system.
BACKGROUND The subcutaneous implantable cardioverterdefibrillator (S-ICD) has shown favorable out... more BACKGROUND The subcutaneous implantable cardioverterdefibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations. OBJECTIVE The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) 35% (primary prevention 35%). METHODS Primary prevention 35% patients with no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable linear and logistic regression. RESULTS In 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included 3-incision technique, higher body mass index (BMI), performing defibrillation testing (DFT), imaging, younger age, black race, and European vs North American centers. Patients undergoing DFT (82%) were successfully converted (99.2%; 93.5% converting at 65 J). Higher BMI was predictive of failing DFT at 65 J. The rate of 30-day freedom Disclosures: Drs Lambiase, Dinerman, and Barr report no disclosures. Dr Boersma serves as a consultant and receives research grants from Boston Scientific and Medtronic. Dr El-Chami receives honoraria for Boston Scientific and Medtronic. Dr Bongiorni receives honoraria from Abbott Medical Italia S.p.a., Biotronik, Boston Scientific, and Medtronic. Dr Burke is a consultant and receives honoraria from Boston Scientific; receives research grants from Boston Scientific; and has equity in AtaCor Medical. Dr Knops reports honoraria for consulting and speaking, and research grants from Boston Scientific. Dr Aasbo reports Boston Scientific and Biotronik consulting fees. Dr Deharo receives research grants, travel grants, and honoraria for lectures/consulting from Medtronic, Boston Scientific, Abbott, Microport, and Biotronik. Dr Russo reports research grants from Boston Scientific, serves on steering Committees for Boston Scientific and Apple, and receives royalties from Up-to-Date. Dr Shaik receives honoraria for consulting, research, and speaking from Boston Scientific, Abbott, Biotronik, and Biosense Webster. Ms Appl, Mr Carter, Dr Brisben, and Dr Stein are all employees and shareholders of Boston Scientific. Dr Gold receives honoraria and research grants from Boston Scientific and Medtronic. Funding: The UNTOUCHED study was funded entirely by Boston Scientific Corporation.
The Journal of Innovations in Cardiac Rhythm Management, 2021
While previous generations of insertable cardiac monitors (ICMs) required a bedside monitor for r... more While previous generations of insertable cardiac monitors (ICMs) required a bedside monitor for remote monitoring (RM), the Confirm Rx™ ICM (Abbott, Chicago, IL, USA) utilizes Bluetooth®, Wi-Fi/cellular technology, and a smart device to connect to the RM system. We aimed to characterize compliance, connectivity, and event transmission timing with the Confirm Rx™ ICM RM system. The study cohort included American patients who received the Confirm Rx™ ICM with SharpSense™ technology within three months of release (May–July 2019). Compliance with RM was quantified as the proportion of patients registering the patient app on their smart device and transmitting at least once. Connectivity was measured as the median number of days between consecutive transmissions per patient. Event transmission time was measured from episode detection to availability on the Merlin.net™ RM system (Abbott). Time from transmission until review by a clinician was examined. Values for device connectivity, epis...
Reducing the form factor of an implantable cardiac monitor (ICM) may simplify device implant. Thi... more Reducing the form factor of an implantable cardiac monitor (ICM) may simplify device implant. This study evaluated R-wave sensing at a range of electrode distances and a preferred device implant location without mapping. Patients scheduled for a Medtronic Reveal® ICM implant (Medtronic Inc., Minneapolis, MN, USA) underwent a preimplant pocket recording using a diagnostic recording catheter. The ICM implant location was left to the discretion of the implanting physician, but a &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;recommended&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; position spanned the V2 -V3 electrocardiogram electrode location in an oblique 45° angle. R-wave amplitudes were analyzed from ICM follow-up. Seventeen of 41 subjects (15 male, age 57 ± 16 years) had the maximum surface-filtered R-wave at the recommended location. Fourteen patients underwent diagnostic recording across the range of electrode spacing. There was a strong correlation between the R-wave amplitude and electrode distance (r(2) = 0.97, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) with an increase of 29 μV per 2.5 mm. Comparing normalized R-wave distributions between the recommended ICM implant group (Group 1, n = 19) and the remaining patients (Group 2, n = 7), the proportion of ICM R-wave counts of amplitude 0.25-1.2 mV was higher (79% vs 46%, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05). Of 17 patients in Group 1 who had ≥ 1-month ICM follow-up (79 ± 45 days), no sensing-related false arrhythmia detection was found in 16 (93%) patients. The subcutaneous R-wave amplitude correlates with electrode spacing in the implant zone of ICM patients. Implant locations at the V2 -V3 position at a 45° angle offer an adequate R wave for sensing. Preimplant mapping to achieve acceptable R-wave amplitude may not be necessary.
Journal of the American College of Cardiology, 2012
The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran... more The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation.
In congestive heart failure (CHF), a low body temperature at hospital admission predicts in-hospi... more In congestive heart failure (CHF), a low body temperature at hospital admission predicts in-hospital mortality. We hypothesized that a postdischarge reduction in body temperature predicts early CHF rehospitalization and death. We reviewed the records of 198 patients discharged after CHF hospitalization. We categorized the patients as hypothermic or normothermic (cutoff point, 36.3 degrees C/97.4 degrees F) according to body temperature at discharge. We classified the 2 groups according to the direction of temperature change between discharge and the first follow-up visit: normothermic/non-decreasing temperature (N+), normothermic/decreasing temperature (N-), hypothermic/non-decreasing temperature (H+), and hypothermic/decreasing temperature (H-). Ninety-three patients (47%) had decreasing temperatures, and 105 patients (53%) had non-decreasing temperatures. Kaplan-Meier analysis revealed a significant intergroup difference in survival (P = .01) and rehospitalization time (P = .005). On logistic regression, a decreasing temperature was significantly associated with rehospitalization within 180 days (odds ratio, 4.01; 95% confidence interval, 1.63-10.02; P = .003). On Cox regression, the hazard ratios for death were 3.19 (P = .07), 6.49 (P = .004), and 5.17 (P = .07), for the N-, H+, and H- groups, respectively, versus the N+ group. For rehospitalization time, the hazard ratios were 7.02 (P = .01), 4.24 (P = .08), and 13.43 (P = .005) for the N-, H+, and H- groups, respectively, versus the N+ group. Decreasing body temperatures can predict readmission, decreased time to rehospitalization, and (in combination with hypothermia) decreased survival.
Background: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effecti... more Background: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. Methods: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 month...
The novel two‐lead cardiac resynchronization therapy (CRT)‐DX system utilizes a floating atrial d... more The novel two‐lead cardiac resynchronization therapy (CRT)‐DX system utilizes a floating atrial dipole on the implantable cardioverter‐defibrillator lead, and when implanted with a left ventricular (LV) lead, offers a two‐lead CRT system with AV synchrony. This study compared complication rates and CRT response among subjects implanted with a two‐lead CRT‐DX system to those subjects implanted with a standard three‐lead CRT‐D system.
BACKGROUND The subcutaneous implantable cardioverterdefibrillator (S-ICD) has shown favorable out... more BACKGROUND The subcutaneous implantable cardioverterdefibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations. OBJECTIVE The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) 35% (primary prevention 35%). METHODS Primary prevention 35% patients with no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable linear and logistic regression. RESULTS In 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included 3-incision technique, higher body mass index (BMI), performing defibrillation testing (DFT), imaging, younger age, black race, and European vs North American centers. Patients undergoing DFT (82%) were successfully converted (99.2%; 93.5% converting at 65 J). Higher BMI was predictive of failing DFT at 65 J. The rate of 30-day freedom Disclosures: Drs Lambiase, Dinerman, and Barr report no disclosures. Dr Boersma serves as a consultant and receives research grants from Boston Scientific and Medtronic. Dr El-Chami receives honoraria for Boston Scientific and Medtronic. Dr Bongiorni receives honoraria from Abbott Medical Italia S.p.a., Biotronik, Boston Scientific, and Medtronic. Dr Burke is a consultant and receives honoraria from Boston Scientific; receives research grants from Boston Scientific; and has equity in AtaCor Medical. Dr Knops reports honoraria for consulting and speaking, and research grants from Boston Scientific. Dr Aasbo reports Boston Scientific and Biotronik consulting fees. Dr Deharo receives research grants, travel grants, and honoraria for lectures/consulting from Medtronic, Boston Scientific, Abbott, Microport, and Biotronik. Dr Russo reports research grants from Boston Scientific, serves on steering Committees for Boston Scientific and Apple, and receives royalties from Up-to-Date. Dr Shaik receives honoraria for consulting, research, and speaking from Boston Scientific, Abbott, Biotronik, and Biosense Webster. Ms Appl, Mr Carter, Dr Brisben, and Dr Stein are all employees and shareholders of Boston Scientific. Dr Gold receives honoraria and research grants from Boston Scientific and Medtronic. Funding: The UNTOUCHED study was funded entirely by Boston Scientific Corporation.
The Journal of Innovations in Cardiac Rhythm Management, 2021
While previous generations of insertable cardiac monitors (ICMs) required a bedside monitor for r... more While previous generations of insertable cardiac monitors (ICMs) required a bedside monitor for remote monitoring (RM), the Confirm Rx™ ICM (Abbott, Chicago, IL, USA) utilizes Bluetooth®, Wi-Fi/cellular technology, and a smart device to connect to the RM system. We aimed to characterize compliance, connectivity, and event transmission timing with the Confirm Rx™ ICM RM system. The study cohort included American patients who received the Confirm Rx™ ICM with SharpSense™ technology within three months of release (May–July 2019). Compliance with RM was quantified as the proportion of patients registering the patient app on their smart device and transmitting at least once. Connectivity was measured as the median number of days between consecutive transmissions per patient. Event transmission time was measured from episode detection to availability on the Merlin.net™ RM system (Abbott). Time from transmission until review by a clinician was examined. Values for device connectivity, epis...
Reducing the form factor of an implantable cardiac monitor (ICM) may simplify device implant. Thi... more Reducing the form factor of an implantable cardiac monitor (ICM) may simplify device implant. This study evaluated R-wave sensing at a range of electrode distances and a preferred device implant location without mapping. Patients scheduled for a Medtronic Reveal® ICM implant (Medtronic Inc., Minneapolis, MN, USA) underwent a preimplant pocket recording using a diagnostic recording catheter. The ICM implant location was left to the discretion of the implanting physician, but a &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;recommended&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; position spanned the V2 -V3 electrocardiogram electrode location in an oblique 45° angle. R-wave amplitudes were analyzed from ICM follow-up. Seventeen of 41 subjects (15 male, age 57 ± 16 years) had the maximum surface-filtered R-wave at the recommended location. Fourteen patients underwent diagnostic recording across the range of electrode spacing. There was a strong correlation between the R-wave amplitude and electrode distance (r(2) = 0.97, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) with an increase of 29 μV per 2.5 mm. Comparing normalized R-wave distributions between the recommended ICM implant group (Group 1, n = 19) and the remaining patients (Group 2, n = 7), the proportion of ICM R-wave counts of amplitude 0.25-1.2 mV was higher (79% vs 46%, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05). Of 17 patients in Group 1 who had ≥ 1-month ICM follow-up (79 ± 45 days), no sensing-related false arrhythmia detection was found in 16 (93%) patients. The subcutaneous R-wave amplitude correlates with electrode spacing in the implant zone of ICM patients. Implant locations at the V2 -V3 position at a 45° angle offer an adequate R wave for sensing. Preimplant mapping to achieve acceptable R-wave amplitude may not be necessary.
Journal of the American College of Cardiology, 2012
The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran... more The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation.
In congestive heart failure (CHF), a low body temperature at hospital admission predicts in-hospi... more In congestive heart failure (CHF), a low body temperature at hospital admission predicts in-hospital mortality. We hypothesized that a postdischarge reduction in body temperature predicts early CHF rehospitalization and death. We reviewed the records of 198 patients discharged after CHF hospitalization. We categorized the patients as hypothermic or normothermic (cutoff point, 36.3 degrees C/97.4 degrees F) according to body temperature at discharge. We classified the 2 groups according to the direction of temperature change between discharge and the first follow-up visit: normothermic/non-decreasing temperature (N+), normothermic/decreasing temperature (N-), hypothermic/non-decreasing temperature (H+), and hypothermic/decreasing temperature (H-). Ninety-three patients (47%) had decreasing temperatures, and 105 patients (53%) had non-decreasing temperatures. Kaplan-Meier analysis revealed a significant intergroup difference in survival (P = .01) and rehospitalization time (P = .005). On logistic regression, a decreasing temperature was significantly associated with rehospitalization within 180 days (odds ratio, 4.01; 95% confidence interval, 1.63-10.02; P = .003). On Cox regression, the hazard ratios for death were 3.19 (P = .07), 6.49 (P = .004), and 5.17 (P = .07), for the N-, H+, and H- groups, respectively, versus the N+ group. For rehospitalization time, the hazard ratios were 7.02 (P = .01), 4.24 (P = .08), and 13.43 (P = .005) for the N-, H+, and H- groups, respectively, versus the N+ group. Decreasing body temperatures can predict readmission, decreased time to rehospitalization, and (in combination with hypothermia) decreased survival.
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