Direct comparison of a novel antitachycardia pacing algorithm against present methods using virtual patient modeling.

BACKGROUND: Antitachycardia pacing (ATP) success rates as low as 50% for fast ventricular tachycardias (VTs) have been reported providing an opportunity for improved ATP to decrease shocks. OBJECTIVE: The purpose of this study was to determine how a new automated antitachycardia pacing (AATP) therapy would perform compared with traditional burst ATP using computer modeling to conduct a virtual study. METHODS: Virtual patient scenarios were constructed from magnetic resonance imaging and electrophysiological (EP) data. Cardiac EP simulation software (CARPEntry) was used to generate reentrant VT. Simulated VT exit sites were physician adjudicated against corresponding clinical 12-lead electrocardiograms. Burst ATP comprised 3 sequences of 8 pulses at 88% of VT cycle length, with each sequence decremented by 10 ms. AATP was limited to 3 sequences, with each sequence learning from the previous sequences. RESULTS: Two hundred fifty-nine unique ATP scenarios were generated from 7 unique scarred hearts. Burst ATP terminated 145 of 259 VTs (56%) and accelerated 2.0%. AATP terminated 189 of 259 VTs (73%) with the same acceleration rate. The 2 dominant ATP failure mechanisms were identified as (1) insufficient prematurity to close the excitable gap; and (2) failure to reach the critical isthmus of the VT. AATP reduced failures in these categories from 101 to 63 (44% reduction) without increasing acceleration. CONCLUSION: AATP successfully adapted ATP sequences to terminate VT episodes that burst ATP failed to terminate. AATP was successful with complex scar geometries and EP heterogeneity as seen in the real world.

Initial Clinical Experience With a New Automated Antitachycardia Pacing Algorithm: Feasibility and Safety in an Ambulatory Patient Cohort.

BACKGROUND: Antitachycardia pacing (ATP) in implantable cardioverter-defibrillators (ICD) decreases patient shock burden but has recognized limitations. A new automated ATP (AATP) based on electrophysiological first principles was designed. The study objective was to assess the feasibility and safety of AATP in ambulatory ICD patients. METHODS AND RESULTS: Enrolled patients had dual chamber or cardiac resynchronization therapy ICDs, history of ≥1 ICD-treated ventricular tachycardias (VT)/ventricular fibrillation episode, or a recorded, sustained monomorphic VT. Detection was set to ventricular fibrillation number of intervals to detect=24/32, VT number of intervals to detect≥16, and a fast VT zone of 240 to 320 ms. AATP prescribed the components and delivery of successive ATP sequences in real time, using the same settings for all patients. ICD datalogs were uploaded every ≈3 months, at unscheduled visits, exit, and death. Episodes and adverse events were adjudicated by separate committees. Results were adjusted (generalized estimating equations) for multiple episodes. AATP was downloaded into the ICDs of 144 patients (121 men), aged 67.4±11.9 years, left ventricular ejection fraction 33.1±13.6% (n=137), and treated 1626 episodes in 49 patients during 14.5±5.1 months of follow-up. Datalogs permitted adjudication of 702 episodes, including 669 sustained monomorphic VT, 20 polymorphic VT, 10 supraventricular tachycardia, and 3 malsensing episodes. AATP terminated 39 of 69 (59% adjusted) sustained monomorphic VT in the fast VT zone, 509 of 590 (85% adjusted) in the VT zone, and 6 of 10 in the ventricular fibrillation zone. No supraventricular tachycardias converted to VT or ventricular fibrillation. No anomalous AATP behavior was observed. CONCLUSIONS: The new AATP algorithm safely generated ATP sequences and controlled therapy progression in all zones without need for individualized programing.

Hemodynamic factors associated with acute decompensated heart failure: part 2--use in automated detection.

BACKGROUND: The purpose of this study was to develop an automated surveillance system, using pressure-based hemodynamic factors that would detect which patients were making the transition from compensated to decompensated heart failure before they developed worsening symptoms and required acute medical care. METHODS AND RESULTS: Intracardiac pressures in 274 patients with heart failure were measured using an implantable hemodynamic monitor (IHM) and were analyzed in a retrospective manner. An automated pressure change detection (PCD) algorithm was developed using the cumulative sum method. The performance characteristics of the PCD algorithm were defined in all patients who developed a heart failure-related event (HFRE); patients without HFRE served as controls. Optimal PCD threshold values were chosen using a receiver operator curve analysis. Each of the pressures measured with the IHM were evaluated using the PCD analysis. All had sensitivities ≥80% and false-positive rates <4.7/patient-year; however, estimated pulmonary artery diastolic pressure (ePAD) had the best performance. An ePAD based on the optimized PCD threshold of 6.0 yielded a sensitivity of 83% and a false-positive rate of 4.1/patient-year for detecting patients making the transition from compensated to decompensated heart failure. These performance characteristics were not significantly different for patients with an ejection fraction > vs. <50%, estimated glomerular filtration rate > vs. <60 mL/min/1.73 m(2), or age > vs. <60 years. CONCLUSIONS: The automated PCD algorithm had high sensitivity and acceptable false-positive rates in detecting the development of decompensated heart failure before the patient developed worsening symptoms and required acute medical care. These data support the development of a prospective study to examine the utility of adding an automated PCD algorithm to IHM-based management strategies to prevent decompensated heart failure.

Development of implantable devices for continuous ambulatory monitoring of central hemodynamic values in heart failure patients.

BACKGROUND: Care and management of patients with congestive heart failure (CHF) is a major health-care challenge. The value of acute hemodynamic data in assessing heart failure has been questioned in some studies, while more intensive hemodynamic monitoring has been reported to improve patient care in others. A series of patient studies are reported here that were conducted to identify device requirements and verify the feasibility of continuous hemodynamic monitoring in CHF patients and devices for remote transfer and use of these data. METHODS AND RESULTS: The results of four separate studies in 68 CHF patients who received systems for chronic hemodynamic monitoring between 1992 and the present are reviewed. One early study was with five patients followed for 7-16 months and another study was with nine patients followed for 4-22 months. A third study included 21 patients followed up to 39 months, and the fourth study included 32 patients implanted in 1998-99 with many of them still in follow-up. These studies support the technical feasibility of implanted devices and the external instrumentation required to transfer and manage the collected data. They also support the long-term stability and accuracy of these systems. Three additional acute studies conducted with 30 patients and chronic data from 53 of the 68 patients with the implanted systems are presented that support the feature included in the newer monitors--the ability to reliably estimate pulmonary artery diastolic pressures from the right ventricular pressure signal. CONCLUSIONS: Development of implantable technology to measure several hemodynamic variables in ambulatory CHF patients is feasible. External instrumentation needed to remotely acquire data from the implanted devices has been verified. The potential to eliminate the uncertainties associated with the use of acute, invasive hemodynamics and the ability to evaluate long-term ambulatory hemodynamic patterns is provided. These findings set the stage for determining the potential clinical value of these systems in impacting the care of chronic CHF patients.