David L. Hayes

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons.

Sidney C. Smith, Jr, MD, FACC, FAHA, Chair Alice K. Jacobs, MD, FACC, FAHA, Vice-Chair Cynthia D. Adams, RN, PhD, FAHA[§][1] Jeffrey L. Anderson, MD, FACC, FAHA[§][1] Christopher E. Buller, MD, FACC Mark A. Creager, MD, FACC, FAHA Steven M. Ettinger, MD, FACC David P. Faxon, MD, FACC,

2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society.

Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons Andrew E. Epstein, MD, FACC, FAHA, FHRS, Chair ; John P. DiMarco, MD, PhD, FACC, FHRS; Kenneth A. Ellenbogen. MD, FACC, FAHA, FHRS; N.A. Mark Estes III, MD, FACC, FAHA, FHRS; Roger A.

ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: Summary Article

The current update of the ACC/AHA/NASPE Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices includes several significant changes in the recommendations and in the supporting narrative portion. In this summary, we list the updated recommendations along with the respective 1998 recommendations, each one accompanied by a brief comment outlining the rationale for the changes, additions, or deletions. All new or revised recommendations are listed in the second column and appear in boldface type. References that support either the 1998 recommendations that have not changed or the new or revised recommendations are noted in parentheses at the end of each recommendation. The reader is referred to the full-text version of the guidelines posted on the American College of Cardiology (ACC), American Heart Association (AHA), and North American Society for Pacing and Electrophysiology (NASPE) World Wide Web sites for a more detailed exposition of the rationale for these changes. In addition to the recommendation changes listed here, this update includes an expanded section on the selection of pacemakers and implantable cardioverter-defibrillators (ICDs) that reflects the technical advances that have taken place since 1998. A brief expanded summary of pacemaker follow-up procedures is also new to these guidelines. For both of these …

Mechanism of hemodynamic improvement by dual-chamber pacing for severe left ventricular dysfunction: An acute Doppler and catheterization hemodynamic study

OBJECTIVES This study was undertaken to determine the mechanism by which improvement in hemodynamic variables may occur with dual-chamber pacing in patients with severe left ventricular dysfunction. BACKGROUND Dual-chamber pacing has recently been proposed as a therapeutic alternative for the relief of symptoms in patients with dilated cardiomyopathy. METHODS Fifteen patients with severe left ventricular systolic dysfunction were studied acutely during atrioventricular (AV) sequential pacing at various AV intervals (60, 100, 120, 140, 180 and 240 ms) with use of combined Doppler velocity curves and pressures obtained by high fidelity manometer-tipped catheters and thermodilution cardiac output. RESULTS Neither cardiac output nor mean left atrial pressure was significantly different when hemodynamic variables in the baseline state were compared with those during AV sequential pacing at the various AV intervals in all patients. The patients were classified into two groups. In group I (eight patients with PR intervals > 200 ms on the rest 12-lead electrocardiogram), cardiac output was significantly increased when AV sequential pacing at the optimal AV interval to output was compared with that at the baseline state (3.0 +/- 1.0 vs. 3.9 +/- 0.43 liters/min, p = 0.005) because timing of mechanical atrial and ventricular synchrony was optimized. In addition, left ventricular end-diastolic pressure and duration of diastolic filling were increased, and diastolic mitral regurgitation was abolished. In group II (seven patients who had normal AV conduction at rest), cardiac output during AV pacing decreased from the baseline value without change in the diastolic filling period. CONCLUSIONS Dual-chamber pacing may improve acute hemodynamic variables in selected patients with dilated cardiomyopathy, mainly by optimization of the timing of mechanical atrial and ventricular synchrony. Reestablishment of the optimal diastolic filling period and abolition of diastolic mitral regurgitation may also contribute to hemodynamic improvement.

HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations

Developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association

ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities.

the American College of Cardiology Foundation Board of ssociation Science Advisory and Coordinating Committee, oard of Trustees in February 2008. iology Foundation, American Heart Association, and Heart s document be cited as follows: Epstein AE, DiMarco JP, I, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, y MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, CC/AHA/HRS 2008 guidelines for device-based therapy of report of the American College of Cardiology/American n Practice Guidelines (Writing Committee to Revise the deline Update for Implantation of Cardiac Pacemakers and oll Cardiol 2008;51:e1–62. This article h 2008 issue of H Copies: Thi College of C americanheart.o document, plea reprints@elsevie Permissions: tion of this doc College of Ca Society. Pleas elsevier.com. avid L. Hayes, MD, FACC, FAHA, FHRS* ark A. Hlatky, MD, FACC, FAHA . Kristin Newby, MD, FACC, FAHA ichard L. Page, MD, FACC, FAHA, FHRS ark H. Schoenfeld, MD, FACC, FAHA, FHRS ichael J. Silka, MD, FACC ynne Warner Stevenson, MD, FACC, FAHA‡ ichael O. Sweeney, MD, FACC*

Pacemaker Lead Extraction With the Laser Sheath: Results of the Pacing Lead Extraction With the Excimer Sheath (PLEXES) Trial

OBJECTIVES The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction. BACKGROUND Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments. METHODS A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS Complete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS). CONCLUSIONS Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks.

Long-Term Outcome After ICD and CRT Implantation and Influence of Remote Device Follow-Up: The ALTITUDE Survival Study

Background— Outcome data for patients receiving implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices treated outside of clinical trials are lacking. No clinical trial has evaluated mortality after device implantation or after shock therapy in large numbers of patients with implanted devices that regularly transmit device data over a network. Methods and Results— Survival status in patients implanted with ICD and CRT devices across the United States from a single manufacturer was assessed. Outcomes were compared between patients followed in device clinic settings and those who regularly transmit remote data collected from the device an average of 4 times monthly. Shock delivery and electrogram analysis could be ascertained from patients followed on the network, enabling survival after ICD shock to be evaluated. One- and 5-year survival rates in 185 778 patients after ICD implantation were 92% and 68% and were 88% and 54% for CRT-D device recipients. In 8228 patients implanted with CRT-only devices, survival was 82% and 48% at 1 and 5 years, respectively. For the 69 556 ICD and CRT-D patients receiving remote follow-up on the network, 1- and 5-year survival rates were higher compared with those in the 116 222 patients who received device follow-up in device clinics only (50% reduction; P<0.0001). There were no differences between patients followed on or off the remote network for the characteristics of age, gender, implanted device year or type, and economic or educational status. Shock therapy was associated with subsequent mortality risk for both ICD and CRT-D recipients. Conclusions— Survival after ICD and CRT-D implantation in patients treated in naturalistic practice compares favorably with survival rates observed in clinical trials. Remote follow-up of device data is associated with excellent survival, but arrhythmias that result in device therapy in this population are associated with a higher mortality risk compared with patients who do not require shock therapy.

Sustained Reverse Left Ventricular Structural Remodeling With Cardiac Resynchronization at One Year Is a Function of Etiology Quantitative Doppler Echocardiographic Evidence From the Multicenter InSync Randomized Clinical Evaluation (MIRACLE)

Background— Cardiac resynchronization therapy (CRT) is an effective therapy for patients with moderate to severe heart failure and prolonged QRS duration. The purpose of this study was to determine whether reverse left ventricular (LV) remodeling and symptomatic benefit from CRT were sustained at 12 months, and if so, in what proportion of patients this occurred. Methods and Results— Serial Doppler echocardiograms were obtained at baseline and 6 and 12 months after CRT in 228 patients enrolled in the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) trial. Measurements were made of LV end-diastolic (EDV) and end-systolic (ESV) volumes, ejection fraction, LV mass, severity of mitral regurgitation (MR), peak transmitral velocities during early (E wave) and late (A wave) diastolic filling, and myocardial performance index. At both 6 and 12 months, respectively, CRT was associated with reduced LV EDV (P<0.0001 and P=0.007) and LV ESV (P<0.0001 and P<0.0001), improved ejection fraction (P<0.0001 and P<0.0001), regression of LV mass (P=0.012 and P<0.0001), and reduced MR (P<0.0001 and P<0.0001). LV filling time, transmitral E/A ratio, and myocardial performance index all improved at 12 months compared with baseline (P<0.001, P=0.031, and P<0.0001). Reverse LV remodeling with CRT occurred in more patients at 6 than at 12 months (74% versus 60%, respectively; P<0.05) and was greater in patients with a nonischemic than an ischemic etiology. Conclusions— Reverse LV remodeling and symptom benefit with CRT are sustained at 12 months in patients with New York Heart Association class III/IV heart failure but occur to a lesser degree in patients with an ischemic versus a nonischemic etiology, most likely owing to the inexorable progression of ischemic disease.

Dual-Chamber Pacing for Hypertrophic Cardiomyopathy: A Randomized, Double-Blind, Crossover Trial

OBJECTIVES In a double-blind, randomized, crossover trial we sought to evaluate the effect of dual-chamber pacing in patients with severe symptoms of hypertrophic obstructive cardiomyopathy. BACKGROUND Recently, several cohort trials showed that implantation of a dual-chamber pacemaker in patients with severely symptomatic hypertrophic obstructive cardiomyopathy can relieve symptoms and decrease the severity of the left ventricular outflow tract gradient. However, the outcome of dual-chamber pacing has not been compared with that of standard therapy in a randomized, double-blind trial. METHODS Twenty-one patients with severely symptomatic hypertrophic obstructive cardiomyopathy were entered into this trial after baseline studies consisting of Minnesota quality-of-life assessment, two-dimensional and Doppler echocardiography and cardiopulmonary exercise tests. Nineteen patients completed the protocol and underwent double-blind randomization to either DDD pacing for 3 months followed by backup AAI pacing for 3 months, or the same study arms in reverse order. RESULTS Left ventricular outflow tract gradient decreased significantly to 55 +/- 38 mm Hg after DDD pacing compared with the baseline gradient of 76 +/- 61 mm Hg (p < 0.05) and the gradient of 83 +/- 59 mm Hg after AAI pacing (p < 0.05). Quality-of-life score and exercise duration were significantly improved from the baseline state after the DDD arm but were not significantly different between the DDD arm and the backup AAI arm. Peak oxygen consumption did not significantly differ among the three periods. Overall, 63% of patients had symptomatic improvement during the DDD arm, but 42% also had symptomatic improvement during the AAI backup arm. In addition, 31% had no change and 5% had deterioration of symptoms during the DDD pacing arm. CONCLUSIONS Dual-chamber pacing may relieve symptoms and decrease gradient in patients with hypertrophic obstructive cardiomyopathy. In some patients, however, symptoms do not change or even become worse with dual-chamber pacing. Subjective symptomatic improvement can also occur from implantation of the pacemaker without its hemodynamic benefit, suggesting the role of a placebo effect. Long-term follow-up of a large number of patients in randomized trials is necessary before dual-chamber pacing can be recommended for all patients with severely symptomatic hypertrophic obstructive cardiomyopathy.