Andy Kaplan | University of Arizona College of Medicine- Phoenix (original) (raw)
Papers by Andy Kaplan
Journal of the American College of Cardiology, Feb 1, 1990
European Heart Journal
Background Cardiac resynchronization therapy (CRT) is guideline-recommended for the treatment of ... more Background Cardiac resynchronization therapy (CRT) is guideline-recommended for the treatment of symptomatic heart failure (HF) in patients (pts) with reduced LVEF and prolonged QRS. Clinical trials report Clinical Composite Score (CCS) response rates from 60 to 75%. However, patients with common comorbidities, such as atrial fibrillation, are often under-represented in clinical trials. The Strategic MAnagement to optimize response to cardiac Resynchronization Therapy (SMART) Registry (NCT03075215) was designed to examine outcomes in CRT patients in the real world. Methods The SMART Registry was a global, multicenter, prospective, clinical registry that enrolled subjects undergoing a de novo CRT-D implant or upgrade from pacemaker to CRT-D using a quadripolar LV lead. CCS was assessed at 12 months post-implant. Results For study design and CCS outcomes see Figure 1. CCS at 12 months showed that 58.8% of pts improved and 20.1% stabilized. Of the 21.1% of pts that worsened, 8.4% were ...
Journal of the American College of Cardiology, Feb 1, 1991
Journal of Cardiac Failure, Aug 1, 2006
Circulation, Oct 31, 2006
Europace, Sep 13, 2009
This retrospective analysis sought to develop and validate a model using the measured diagnostic ... more This retrospective analysis sought to develop and validate a model using the measured diagnostic variables in cardiac resynchronization therapy (CRT) devices to predict mortality. Methods and results Data used in this analysis came from two CRT studies: Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices (CRT RENEWAL) (n ¼ 436) and Heart Failure-Heart Rate Variability (HF-HRV) (n ¼ 838). Patients from CRT RENEWAL were used to create a model for risk of death using logistic regression and to create a scoring system that could be used to predict mortality. Results of both the logistic regression and the clinical risk score were validated in a cohort of patients from the HF-HRV study. Diagnostics significantly improved over time post-CRT implant (all P , 0.001) and were correlated with a trend of decreased risk of death. The regression model classified CRT RENEWAL patients into low (2.8%), moderate (6.9%), and high (13.8%) risk of death based on tertiles of their model predicted risk. The clinical risk score classified CRT RENEWAL patients into low (2.8%), moderate (10.1%), and high (13.4%) risk of death based on tertiles of their score. When both the regression model and the clinical risk score were applied to the HF-HRV study, each was able to classify patients into appropriate levels of risk. Conclusion Device diagnostics may be used to create models that predict the risk of death.
Pacing and Clinical Electrophysiology, 2007
Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart... more Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart failure (HF). Heart rate variability (HRV) is a prognostic marker of HF and mortality and is a sign of autonomic dysfunction. Acute improvements in measures of HRV have been demonstrated after CRT in small clinical studies. The purpose of the present study was to evaluate changes in HRV and patient outcomes over time and the relationship between these changes in a large generalized sample of patients who received CRT with defibrillator (CRT-D). Methods: The Heart Failure-Heart Rate Variability (HF-HRV) registry enrolled 1,421 patients who received a CRT-D device capable of measuring HRV.
Journal of the American College of Cardiology, Dec 1, 1992
Journal of the American College of Cardiology, 2009
The goal of this analysis was to determine the appropriate biventricular pacing target in patient... more The goal of this analysis was to determine the appropriate biventricular pacing target in patients with heart failure (HF). Background Cardiac resynchronization therapy (CRT) decreases the risk of death and HF hospitalization. However, the appropriate amount of biventricular pacing is ill-defined. Methods Mortality and HF hospitalization data from patients undergoing CRT in 2 trials (CRT RENEWAL [Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices] and REFLEx [ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study]; n ϭ 1,812) were analyzed in a post-hoc fashion. Subjects were grouped based on percent biventricular pacing quartiles with the use of Kaplan-Meier survival analysis.
Journal of Cardiac Failure, 2010
The American Journal of Cardiology, 2001
The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein I... more The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 1994;330:956-961. 2. The EPILOG Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. N Engl J Med 1997;336:1689-1696. 3. The CAPTURE investigators. Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE study. Lancet 1997;349:1429-1435. 4. The EPISTENT Investigators. Randomised placebo-controlled and balloonangioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade.
Journal of the American College of Cardiology, 2019
BACKGROUND Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration o... more BACKGROUND Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. OBJECTIVES This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. METHODS High-risk ACS subjects (N ¼ 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. RESULTS Safety was met with 96.7% freedom from system-related complications (n ¼ 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability ¼ 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). CONCLUSIONS The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events.
Pacing and Clinical Electrophysiology, 2007
Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart... more Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart failure (HF). Heart rate variability (HRV) is a prognostic marker of HF and mortality and is a sign of autonomic dysfunction. Acute improvements in measures of HRV have been demonstrated after CRT in small clinical studies. The purpose of the present study was to evaluate changes in HRV and patient outcomes over time and the relationship between these changes in a large generalized sample of patients who received CRT with defibrillator (CRT-D). Methods: The Heart Failure-Heart Rate Variability (HF-HRV) registry enrolled 1,421 patients who received a CRT-D device capable of measuring HRV.
Heart Rhythm, 2005
and ventricle (AVD) and between left (LV) and right ventricles (RV, VVD). The way VVD is defined ... more and ventricle (AVD) and between left (LV) and right ventricles (RV, VVD). The way VVD is defined differs per implantable device. We investigated if this affects improvement of pump function during BiV pacing. Methods: In 8 canine hearts with chronic LBBB, leading to 17Ϯ16% LV hypertrophy and 25Ϯ19% LV dilation, BiVS pacing was performed with a large number of combinations of AVDs and VVDs. Two commonly used methods to program VVDs are tested; BiVS1; programming an AVD with respect to the ventricle to be paced first and delaying stimulation of the other one and BiVS2; maintaining a fixed AVD for the LV while tuning the VVD with RV stimulation time. To combine the effects of AVD and VVD and intrinsic RV activation during LBBB we calculated an effective VVD (VVeff). VVeff was defined as the difference between time of LV stimulation and (a) time of intrinsic RV activation (RAVDintr) during LBBB or (b) RV stimulation, whichever occurred earlier. RAVDintr was determined during BiV0 pacing with incremental AVD, and defined as the AVD at which the shape of the QRS duration changed as a results of loss of full capture. Results: RAVDintr correlated linearly to PQ-time (rϭ0.84) and was 35Ϯ4 ms shorter than PQ-time. Maximal improvement of LVdPdtmax that could be achieved with BIVS pacing was 12.2Ϯ5.9%. The figure shows that LVdPdtmax depends on both AVD and VVD. Especially at long AVD BiVS1 leads to lower LVdP/dtmax values as large as 5% despite identical applied VVDs. LVdPdtmax had a unique relation with VVeff, independent from AVD and definition of VVD (rϭ0.91). Conclusion: definition of VVD is important for hemodynamic outcome, but use of VVeff avoids such confusion.
Journal of the American College of Cardiology, 2019
BACKGROUND Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes t... more BACKGROUND Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome. OBJECTIVES The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-segment shifts to reduce pre-hospital delay during ACS events. METHODS In the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) pivotal study, subjects at high risk for recurrent ACS events (n ¼ 907) were randomized to control (Alarms OFF) or treatment groups for 6 months, after which alarms were activated in all subjects (Alarms ON). Emergency department (ED) visits with standard-of-care cardiac test results were independently adjudicated as true-or false-positive ACS events. Alarm-to-door (A2D) and symptom-to-door (S2D) times were calculated for true-positive ACS ED visits triggered by 3 possible prompts: alarm only, alarms þ symptoms, or symptoms only. RESULTS The Alarms ON group showed reduced delays, with 55% (95% confidence interval [CI]: 46% to 63%) of ED visits for ACS events <2 h compared with 10% (95% CI: 2% to 27%) in the Alarms OFF group (p < 0.0001). Results were similar when restricted to myocardial infarction (MI) events. Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms ON subjects (p < 0.0089). Median A2D delay was 1.4 h for asymptomatic MI. Median S2D delay for symptoms-only MI (no alarm) in Alarms ON was 4.3 h. CONCLUSIONS Intracardiac monitoring with real-time alarms for ST-segment shift that exceeds a subject's selfnormative ischemia threshold level significantly reduced the proportion of pre-hospital delays >2 h for ACS events, including asymptomatic MI, compared with symptoms-only ED visits in Alarms OFF.
Circulation, Oct 31, 2006
American Heart Journal, 2008
Journal of the American College of Cardiology, 1990
Journal of the American College of Cardiology, Feb 1, 1990
European Heart Journal
Background Cardiac resynchronization therapy (CRT) is guideline-recommended for the treatment of ... more Background Cardiac resynchronization therapy (CRT) is guideline-recommended for the treatment of symptomatic heart failure (HF) in patients (pts) with reduced LVEF and prolonged QRS. Clinical trials report Clinical Composite Score (CCS) response rates from 60 to 75%. However, patients with common comorbidities, such as atrial fibrillation, are often under-represented in clinical trials. The Strategic MAnagement to optimize response to cardiac Resynchronization Therapy (SMART) Registry (NCT03075215) was designed to examine outcomes in CRT patients in the real world. Methods The SMART Registry was a global, multicenter, prospective, clinical registry that enrolled subjects undergoing a de novo CRT-D implant or upgrade from pacemaker to CRT-D using a quadripolar LV lead. CCS was assessed at 12 months post-implant. Results For study design and CCS outcomes see Figure 1. CCS at 12 months showed that 58.8% of pts improved and 20.1% stabilized. Of the 21.1% of pts that worsened, 8.4% were ...
Journal of the American College of Cardiology, Feb 1, 1991
Journal of Cardiac Failure, Aug 1, 2006
Circulation, Oct 31, 2006
Europace, Sep 13, 2009
This retrospective analysis sought to develop and validate a model using the measured diagnostic ... more This retrospective analysis sought to develop and validate a model using the measured diagnostic variables in cardiac resynchronization therapy (CRT) devices to predict mortality. Methods and results Data used in this analysis came from two CRT studies: Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices (CRT RENEWAL) (n ¼ 436) and Heart Failure-Heart Rate Variability (HF-HRV) (n ¼ 838). Patients from CRT RENEWAL were used to create a model for risk of death using logistic regression and to create a scoring system that could be used to predict mortality. Results of both the logistic regression and the clinical risk score were validated in a cohort of patients from the HF-HRV study. Diagnostics significantly improved over time post-CRT implant (all P , 0.001) and were correlated with a trend of decreased risk of death. The regression model classified CRT RENEWAL patients into low (2.8%), moderate (6.9%), and high (13.8%) risk of death based on tertiles of their model predicted risk. The clinical risk score classified CRT RENEWAL patients into low (2.8%), moderate (10.1%), and high (13.4%) risk of death based on tertiles of their score. When both the regression model and the clinical risk score were applied to the HF-HRV study, each was able to classify patients into appropriate levels of risk. Conclusion Device diagnostics may be used to create models that predict the risk of death.
Pacing and Clinical Electrophysiology, 2007
Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart... more Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart failure (HF). Heart rate variability (HRV) is a prognostic marker of HF and mortality and is a sign of autonomic dysfunction. Acute improvements in measures of HRV have been demonstrated after CRT in small clinical studies. The purpose of the present study was to evaluate changes in HRV and patient outcomes over time and the relationship between these changes in a large generalized sample of patients who received CRT with defibrillator (CRT-D). Methods: The Heart Failure-Heart Rate Variability (HF-HRV) registry enrolled 1,421 patients who received a CRT-D device capable of measuring HRV.
Journal of the American College of Cardiology, Dec 1, 1992
Journal of the American College of Cardiology, 2009
The goal of this analysis was to determine the appropriate biventricular pacing target in patient... more The goal of this analysis was to determine the appropriate biventricular pacing target in patients with heart failure (HF). Background Cardiac resynchronization therapy (CRT) decreases the risk of death and HF hospitalization. However, the appropriate amount of biventricular pacing is ill-defined. Methods Mortality and HF hospitalization data from patients undergoing CRT in 2 trials (CRT RENEWAL [Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices] and REFLEx [ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study]; n ϭ 1,812) were analyzed in a post-hoc fashion. Subjects were grouped based on percent biventricular pacing quartiles with the use of Kaplan-Meier survival analysis.
Journal of Cardiac Failure, 2010
The American Journal of Cardiology, 2001
The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein I... more The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 1994;330:956-961. 2. The EPILOG Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. N Engl J Med 1997;336:1689-1696. 3. The CAPTURE investigators. Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE study. Lancet 1997;349:1429-1435. 4. The EPISTENT Investigators. Randomised placebo-controlled and balloonangioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade.
Journal of the American College of Cardiology, 2019
BACKGROUND Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration o... more BACKGROUND Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. OBJECTIVES This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. METHODS High-risk ACS subjects (N ¼ 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. RESULTS Safety was met with 96.7% freedom from system-related complications (n ¼ 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability ¼ 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). CONCLUSIONS The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events.
Pacing and Clinical Electrophysiology, 2007
Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart... more Background: Cardiac resynchronization therapy (CRT) is a viable therapy in the treatment of heart failure (HF). Heart rate variability (HRV) is a prognostic marker of HF and mortality and is a sign of autonomic dysfunction. Acute improvements in measures of HRV have been demonstrated after CRT in small clinical studies. The purpose of the present study was to evaluate changes in HRV and patient outcomes over time and the relationship between these changes in a large generalized sample of patients who received CRT with defibrillator (CRT-D). Methods: The Heart Failure-Heart Rate Variability (HF-HRV) registry enrolled 1,421 patients who received a CRT-D device capable of measuring HRV.
Heart Rhythm, 2005
and ventricle (AVD) and between left (LV) and right ventricles (RV, VVD). The way VVD is defined ... more and ventricle (AVD) and between left (LV) and right ventricles (RV, VVD). The way VVD is defined differs per implantable device. We investigated if this affects improvement of pump function during BiV pacing. Methods: In 8 canine hearts with chronic LBBB, leading to 17Ϯ16% LV hypertrophy and 25Ϯ19% LV dilation, BiVS pacing was performed with a large number of combinations of AVDs and VVDs. Two commonly used methods to program VVDs are tested; BiVS1; programming an AVD with respect to the ventricle to be paced first and delaying stimulation of the other one and BiVS2; maintaining a fixed AVD for the LV while tuning the VVD with RV stimulation time. To combine the effects of AVD and VVD and intrinsic RV activation during LBBB we calculated an effective VVD (VVeff). VVeff was defined as the difference between time of LV stimulation and (a) time of intrinsic RV activation (RAVDintr) during LBBB or (b) RV stimulation, whichever occurred earlier. RAVDintr was determined during BiV0 pacing with incremental AVD, and defined as the AVD at which the shape of the QRS duration changed as a results of loss of full capture. Results: RAVDintr correlated linearly to PQ-time (rϭ0.84) and was 35Ϯ4 ms shorter than PQ-time. Maximal improvement of LVdPdtmax that could be achieved with BIVS pacing was 12.2Ϯ5.9%. The figure shows that LVdPdtmax depends on both AVD and VVD. Especially at long AVD BiVS1 leads to lower LVdP/dtmax values as large as 5% despite identical applied VVDs. LVdPdtmax had a unique relation with VVeff, independent from AVD and definition of VVD (rϭ0.91). Conclusion: definition of VVD is important for hemodynamic outcome, but use of VVeff avoids such confusion.
Journal of the American College of Cardiology, 2019
BACKGROUND Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes t... more BACKGROUND Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome. OBJECTIVES The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-segment shifts to reduce pre-hospital delay during ACS events. METHODS In the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) pivotal study, subjects at high risk for recurrent ACS events (n ¼ 907) were randomized to control (Alarms OFF) or treatment groups for 6 months, after which alarms were activated in all subjects (Alarms ON). Emergency department (ED) visits with standard-of-care cardiac test results were independently adjudicated as true-or false-positive ACS events. Alarm-to-door (A2D) and symptom-to-door (S2D) times were calculated for true-positive ACS ED visits triggered by 3 possible prompts: alarm only, alarms þ symptoms, or symptoms only. RESULTS The Alarms ON group showed reduced delays, with 55% (95% confidence interval [CI]: 46% to 63%) of ED visits for ACS events <2 h compared with 10% (95% CI: 2% to 27%) in the Alarms OFF group (p < 0.0001). Results were similar when restricted to myocardial infarction (MI) events. Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms ON subjects (p < 0.0089). Median A2D delay was 1.4 h for asymptomatic MI. Median S2D delay for symptoms-only MI (no alarm) in Alarms ON was 4.3 h. CONCLUSIONS Intracardiac monitoring with real-time alarms for ST-segment shift that exceeds a subject's selfnormative ischemia threshold level significantly reduced the proportion of pre-hospital delays >2 h for ACS events, including asymptomatic MI, compared with symptoms-only ED visits in Alarms OFF.
Circulation, Oct 31, 2006
American Heart Journal, 2008
Journal of the American College of Cardiology, 1990