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To test whether a high defibrillation threshold (DFT) marks patients with poor outcomes which are improved when DFT is decreased by system modification (subcutaneous coil implant; SM).The electrical substrate generating fast ventricular arrhythmias may generate poor outcomes among patients treated with implantable cardioverter-defibrillators (ICDs), even when arrhythmias are treated successfully. Since patients with high DFTs have increased mortality, we contrasted survival among patients with high DFT treated with and without SM.We studied consecutive patients undergoing ICD implantation and DFT testing at Cleveland Clinic over a 14-year period. High DFT was defined as successful defibrillation by shock strength25 J or ≤10 J of maximal device output. Mortality was recorded using the Social Security Death Index. Survival was compared among those high DFT patients receiving SM versus the remainder.Out of 6353 patients tested, 191 (3%) had high DFT (32.1 ± 3.7 J) versus 13.9 ± 4.9 J in the remainder ("acceptable DFT," p .001). One hundred twenty-one high DFT patients (63%; 33.3 ± 3.4 J) underwent SM, which significantly decreased DFT (24.8 ± 5.9 J; p .001). Seventy patients (37%; 30.3 ± 3.3 J) did not undergo SM. During follow-up, 38% (2363/6162; 7.8 yrs) patients with acceptable DFT died versus 48% high DFT patients (91/191; 5.6 yrs.; p .001). Concomitantly, 48% patients with SM (58/121) died, as compared to 47% patients (33/70) without SM (p = .91); median follow-up 4.9 yrs).Patients with high DFT have a higher mortality than those with acceptable DFT. The additional subcutaneous coil implant decreases DFT to an acceptable range but does not appear to improve survival. The electrical substrate underlying high DFT appears to determine survival.

Introduction In patients with chronic systolic heart failure and frequent right ventricular pacing (RVP), upgrade to cardiac resynchronization therapy (CRT) has become common practice despite a lack of randomized clinical trials. We aimed to evaluate long term outcomes in patients upgraded to CRT from chronic RVP compared with de novo CRT implants. Methods and results We reviewed medical charts on consecutive patients with a left ventricular ejection fraction (LVEF) ≤ 35% and a QRSd ≥ 120 ms undergoing CRT. Survival free of left ventricular assist device (LVAD) and a heart transplant was compared amongst patients on the basis of pre-CRT QRS morphology. Improvement in LVEF was also compared across groups. A total of 1260 patients met inclusion criteria of whom 233 were upgraded from chronic RVP. Over a mean follow up 6.5 ± 4.0 years there were 821 endpoints (27 LVAD, 30 heart transplants, and 764 deaths). In a multivariate Cox regression model, upgraded patients had worse outcomes (HR 1.3(1.1-1.7) P = .007) compared with those with native LBBB and similar outcomes to patients with non-LBBB(HR 0.96(0.76-1.21) P = .7). The survival curve for chronic RVP parallels native LBBB for approximately 2.5 years before dropping sharply. Patients with chronic RVP derive similar improvements in LVEF compared with those with LBBB and superior improvements compared with those with non-LBBB. Conclusions Despite achieving similar levels of LVEF improvement, patients with systolic heart failure with chronic RVP undergoing upgrade to CRT have inferior long term outcomes compared with patients with native LBBB. Long term outcomes with CRT in patients with chronic RVP, RBBB, and IVCD are similar.

Background Limited medical options are available for rhythm control in patients with atrial fibrillation (AF) and hypertrophic cardiomyopathy (HCM). There are no published reports of dofetilide use in this population. Methods A retrospective chart review was conducted on 1,404 patients loaded on dofetilide for AF suppression at the Cleveland Clinic from 2008 to 2012, 25 of whom were found to have HCM. Results The HCM cohort was 32% female, 76% with persistent AF, mean age of 59 ± 10 years, and mean ejection fraction of 54 ± 9 %. Of the 25 patients, 21 were discharged on dofetilide, three discontinued during loading due to QTc prolongation, and one due to inefficacy. There were no adverse events during loading. Of those discharged on dofetilide, 11/21 (52%) were still on it at a median follow-up of 396 (198, 699) days at the time of the chart review. For those in whom it was discontinued, the median time on the drug was 301 (111, 738) days. Of the 10 patients who discontinued dofetilide during follow-up, six were due to inefficacy, one postablation, one postheart transplant, one due to death secondary to lung cancer, and one due to worsening edema. Conclusions Dofetilide was well tolerated in this group of patients with AF and HCM and it facilitated management of AF in 21/25 (84%) patients. Further research is needed to assess the safety and efficacy of dofetilide in order to develop evidence-based guidelines for the pharmacological management of AF in this population.

The AdaptResponse trial is designed to test the hypothesis that preferential adaptive left ventricular-only pacing with the AdaptivCRT® algorithm reduces the incidence of the combined endpoint of all-cause mortality and intervention for heart failure (HF) decompensation, compared with conventional cardiac resynchronization therapy (CRT), among patients with a CRT indication, left bundle branch block (LBBB) and normal atrioventricular (AV) conduction. The AdaptResponse study is a prospective, randomized, controlled, single-blinded, multicentre, clinical trial (ClinicalTrials.gov Identifier: NCT02205359), conducted at up to 200 centres worldwide. Following enrolment and baseline assessment, eligible subjects will be implanted with a CRT system containing the AdaptivCRT algorithm, and randomized in a 1:1 fashion to either a treatment ('AdaptivCRT') or control ('Conventional CRT') group. The study is designed to observe a primary endpoint in 1100 patients ('event-driven') and approximately 3000 patients will be randomized. The primary endpoint is the composite of all-cause mortality and intervention for HF decompensation; secondary endpoints include all-cause mortality, intervention for HF decompensation, clinical composite score (CCS) at 6 months, atrial fibrillation, quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), health outcome measured by the EQ-5D instrument, all-cause readmission after a HF admission, and cost-effectiveness. The AdaptResponse clinical trial is powered to assess clinical endpoints and is expected to provide definitive evidence on the incremental utility of AdaptivCRT-enhanced CRT systems.

BACKGROUND QRS duration (QRSd) may be impacted by both left ventricular (LV) dilatation and conduction delay. It is possible therefore that the same QRSd may portend significantly different amounts of LV activation delay in patients with small versus large left ventricles. We hypothesized that LV size modifies the effect of QRSd on predicting outcomes in patients undergoing CRT implant. METHODS We extracted data on consecutive patients presenting for initial CRT implant. In patients with a follow-up echocardiogram, response was defined as an absolute improvement in LV ejection fraction ≥5%. Multivariate models were created to determine if left ventricular end-diastolic diameter (LVEDD) modified the effect of QRSd on its association with both long-term survival free of left ventricular assist device (LVAD) and heart transplant and echocardiographic response. RESULTS 464 patients met inclusion criteria. At a mean follow-up of 4.9 ± 2.6 years, there were 210 deaths, 13 heart transplants, and 12 LVAD placements. There was a weak but significant correlation between baseline QRSd and LVEDD (Spearman's Rho 0.106, P < 0.001). In a multivariate analysis, there was no evidence of effect modification of LVEDD on QRSd (LVEDDi*QRS interaction term HR 1.0 [0.995-1.006], P = 0.94). Note that 305 patients had a follow-up echocardiogram, of whom 193 met the criteria for response. In a multivariate analysis, there was no evidence of effect modification of LVEDD on QRSd (LVEDDi*QRS interaction term odds ratio 0.998 (0.988-1.008), P = 0.65). CONCLUSION LV size does not modify the effect of QRSd and its association with outcomes following CRT. The correlation between LV size and QRSd in patients with a QRSd ≥ 120 ms is weak.

Reverse Remodeling Survival CRTBackground Multiple definitions of reverse ventricular remodeling (RVR) employing various changes in left ventricular end-systolic (LVESV) or diastolic volumes (LVEDVs) or left ventricular ejection fraction (LVEF) have been used in determining cardiac resynchronization therapy (CRT) response, making comparability across studies difficult. We compared different metrics to each other, and in combination, in terms of association with long-term outcomes. Methods We collected clinical and echocardiographic data on 436 patients undergoing CRT. LVEF was assessed via a combined volumetric and visual assessment. Volumes were manually traced. Using a nested multivariate model of a priori determined predictors of long-term survival free of left ventricular assist device (LVAD) or heart transplant, multiple definitions of RVR were added to the model individually to determine which provided the best model fit. Results Over a mean follow-up of 5.4 ± 2.3 years, there were 198 endpoints (10 LVADs, 15 heart transplants, and 173 deaths). When added to a nested model controlling for multiple potential confounders, all definitions of RVR were significantly associated with improved survival. Changes in LVEF and LVESV were superior to changes in LVEDV. A combination metric of an LVEF improvement ≥ 5% and LVESV reduction ≥ 10% was the best overall metric for model fit. Conclusions Changes in LVESV and LVEF are better predictors of long-term outcome following CRT compared to changes in LVEDV. Adding an assessment of LVEF to reduction in LVESV ≥ 10% provided the best overall definition for RVR in predicting CRT outcomes.

Background:We hypothesized that survival in implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients is predicted by baseline Heart Rate Score.Methods:Heart Rate Score is determined from the atrial paced and sensed histogram of a DDD ICD or CR

Background Unnecessary ventricular pacing from cardiac implantable electronic devices has been associated with long-term risks (heart failure, atrial fibrillation, and possibly stroke). Several device programming strategies are available to minimize ventricular pacing, each potentially associated with unintended consequences. Occasionally, the only effective means is to program to the AAI(R) pacing mode. However, in one manufacturer's implantable cardioverter defibrillators (ICDs), the AAI(R) mode has the potential risk of prolonged pacing cessation following a nonsustained ventricular tachycardia (NSVT). Method Patients with ICDs, managed through the Cleveland Clinic device clinic, follow the Heart Rhythm Society consensus document recommendations for device monitoring with remote interrogations (every three months) and yearly in-person evaluations. Clinically significant findings also trigger additional evaluations by the nurse and physician. Results Two patients having Boston Scientific ICDs (E110 Teligen 100; Boston Scientific Corp., Natick, MA, USA), had asystole and marked bradycardia following untreated NSVT. These pauses in pacing were due to use of the AAI(R) pacing mode. In order to enhance ventricular tachycardia detection, by design atrial pacing is disabled during, and for a time after, an episode of ventricular tachycardia when the device operates in the “ventricular tachycardia response” (VTR) phase. Thus, following spontaneous termination of the NSVT, no pacing occurred in these patients until the VTR period ended. Nonconventional programming was utilized to permit AAI(R) pacing while avoiding these asystolic and bradycardic events during VTR. Conclusions Unintended consequences can occur when complex VT detection parameters interact with specific pacing modes. At times, nonconventional programming can avoid these interactions while still achieving effective AAI(R) pacing.

Accelerated in vitro biostability studies are useful for making relativistic comparisons between materials. However, no in vitro study can completely replicate the complex biochemical and biomechanical environment that a material experiences in the human body. To overcome this limitation, three insulation materials [Optim™ insulation (OPT), Pellethane® 55D (P55D), and silicone elastomer] from cardiac leads that were clinically implanted for up to five years were characterized using visual inspection, SEM, ATR-FTIR, GPC, and tensile testing. Surface cracking was not observed in OPT or silicone samples. Shallow cracking was observed in 17/41 (41%) explanted P55D samples. ATR-FTIR indicated minor surface oxidation in some OPT and P55D samples. OPT molecular weight decreased modestly (∼20%) at 2-3 years before stabilizing at 4-5 years. OPT tensile strength decreased modestly (∼25%) at 2-3 years before stabilizing at 4-5 years. OPT elongation at 4-5 years was unchanged from controls. P55D had no significant changes in molecular weight or tensile properties. Overall, results for OPT and P55D were consistent with and limited to cosmetic surface oxidation. Silicone demonstrated excellent biostability with no identifiable degradation. This study of explanted cardiac leads revealed that OPT, P55D, and silicone elastomer demonstrate similar and excellent biostability through five years of implantation in human patients.

Background: Cardiac implantable electronic device (CIED) infection is a major complication that is associated with increased morbidity and mortality. Recent data suggested a relationship between the antiseptic agent used for skin preparation at time of CIED procedure and risk for infection. Methods: On April 30, 2011, we changed the antiseptic agent used for skin preparation at our tertiary care facility from chlorhexidine-alcohol to povidone-iodine for all CIED procedures. We retrospectively reviewed records of all patients who underwent CIED procedure 1 year before and after the change. CIED infection was defined as pocket or endovascular systemic infection that required removal within 1 year of the index procedure. We examined if the change affected the risk of CIED infection. Results: A total of 2,792 patients underwent 2,840 CIED procedures; 1,748 (61.5%) had implantable cardioverter defibrillator procedures and 1,092 (38.4%) had permanent pacemaker procedures. Chlorhexidine-alcohol agent was used in 1,450 (51.1%) procedures, and povidone-iodine agent was used in 1,390 (48.9%). After 1 year of follow-up, 31 patients (1.09%) developed CIED infection that required system removal. The 1-year infection rate was 1.1% among both antiseptic agent groups and there were no significant differences in the infection presentations among both groups (P = 0.950). Multivariate Cox proportional hazards regression model showed that risk factors for infection within 1 year included age, diabetes, and African American race. Conclusion: In one large cohort of patients undergoing CIED procedures, the antiseptic agent used for skin preparation (chlorhexidine-alcohol vs povidone-iodine) was not associated with increased risk of developing CIED infection. (PACE 2014; 00:1‐7) Cardiac implantable electronic device, pacemaker, defibrillator, infection, complication, outcome

Background Many patients eligible for cardiac resynchronization therapy (CRT) are over 80 years of age. Survival in this population and how it compares to the general octogenarian population has not been established. Methods We extracted clinical data on a cohort of 800 consecutive patients undergoing the new implantation of a CRT device between April 15, 2004 and August 6, 2007. Patients over age 80, with class III-IV New York Heart Association heart failure symptoms on optimal medical therapy undergoing initial CRT implantation, were included in the final cohort. Using the United States Social Security Period Life Table for 2006, fractional survival for octogenarians in the general population was calculated and matched to our cohort based on age and gender. A comparison was then made between octogenarians undergoing CRT compared to the general population. Results A total of 95 octogenarians who met inclusion criteria were identified, of whom 86.3% received a biventricular defibrillator and the remainder a biventricular pacemaker. Over a mean follow-up of 3.6 ± 1.5 years, there were 47 deaths (47.4%). The mean survival time was 4.1 years (95% CI 3.7–4.5), and survival at 2 years was 78.9%. Compared to the general octogenarian population, octogenarians receiving CRT had only modestly worse survival over the duration of follow-up with the survival curves diverging at 2 years of follow-up (P = 0.03). Conclusions Octogenarians with advanced heart failure have a reasonable mean survival time following CRT. All-cause mortality in this patient population is only modestly worse compared to the general octogenarian population. Therefore, in octogenarians deemed to be reasonable candidates, CRT should not be withheld based on age alone.

Prediction Rule to Identify Patients at High Risk for Early Demise Following CRT Background In patients with advanced heart failure, the decision of whether to pursue cardiac resynchronization therapy (CRT) or to proceed directly to advanced heart failure therapies can be challenging. We sought to create a prediction rule to identify patients with advanced systolic heart failure at heightened risk of rapid deterioration despite receiving CRT. Methods Clinical data were collected on consecutive patients with advanced heart failure presenting for a new CRT device at the Cleveland Clinic between February 12, 2002 and July 8, 2008. Early demise was defined as death, left ventricular assist device, or heart transplant within 6 months following CRT implant. Using a multivariate model, variables associated with early demise were identified and a prediction rule created. Results A total of 879 patients were included of whom 47 met criteria for early demise. Using forward stepwise regression followed by a bootstrapping analysis, the final model included: left ventricular end-diastolic diameter ≥6.5 cm (OR 3.23 [1.72–6.06 g], P < 0.001), the presence of a non-left bundle branch block (non-LBBB) morphology (OR 2.18 [1.18–4.04, P = 0.013]), creatinine ≥1.5 mg/dL (OR 2.98 [1.52–5.49], P < 0.001), and lack of or intolerance to β-blocker use (OR 2.80 [1.46–5.39], P = 0.002). The specificity for ≥2 and ≥3 risk factors was 72.6% and 94.6%, respectively. Conclusions Left ventricular dilatation, the presence of a non-LBBB morphology, renal dysfunction, and lack of or intolerance to β-blockers are associated with early demise following CRT. In patients with at least 3 of these factors, bypassing CRT with early adoption of advanced heart failure therapies may be considered given the high specificity for rapid decline.

Exercise-induced dyspnea is one of the most common symptoms that cause a patient to see a physician and a broad differential diagnosis is required. In this case report, we describe a patient with this complaint who had a left bundle branch block and preserved left ventricular function at rest. On stress echocardiography, she had significant exercise-induced left ventricular dysfunction and associated mitral regurgitation but a coronary angiogram demonstrated normal coronary arteries. Both of the echocardiographic findings, as well as her symptoms, improved with the placement of a bi-ventricular pacemaker. A brief review of the literature on cardiac resynchronization therapy for indications beyond the current guidelines is also provided.

Background Current implantable cardioverter defibrillators (ICDs) employ two or three low- and high-voltage lead connectors, adding complexity and bulk, sometimes resulting in incorrect connections and adverse events. The SJ4 study evaluates the performance of a novel integrated single-lead DF4 connection system by characterizing lead measurements, handling characteristics, and outcomes. Methods Patients with standard guidelines-based ICD indications were enrolled and implanted with a St. Jude Medical™ DF4 system (St. Jude Medical, Sylmar, CA, USA; right ventricular high-voltage DF4 lead models 7120Q, 7121Q, 7122Q, or 7170Q with compatible ICD). Device electrical measurements, handling characteristics, and any adverse events were collected at implant and during each scheduled 6-month follow-up. Results Among 1,701 patients (65 ± 13 years, 72% male, left ventricular ejection fraction 29 ± 12%) enrolled at 58 centers, there were 1,697 successful implants (99.8% implant success; ICD; n = 999, cardiac resynchronization therapy-defibrillator n = 698). Implanting physicians reported that implantation of the DF4 lead was normal or easier than normal in 94% of cases with successful implant. These patients have been followed for 1.7 ± 0.5 years with a maximum follow-up of 2.5 years. The complication rate was 0.017 per patient year of follow-up (95% confidence interval: 0.013–0.023), which included abnormal defibrillation impedance, elevated pacing thresholds, failure to detect ventricular tachycardia/ventricular fibrillation, lead dislodgement, lead fracture, loss of capture, and lead perforation. There were no set screw-related complications at implant or during follow-up. Conclusion The DF4 system overall performed very well with few complications at implant and in follow-up.

Introduction: Pacemakers and implantable cardioverter-defibrillators (ICDs) are vulnerable to inappropriate sensing of electromagnetic interference (EMI), such as from nerve conduction studies. We conducted a prospective study to assess the safety of repetitive nerve stimulation (RNS). Methods: Fourteen patients undergoing insertion of 10 ICDs and 4 pacemakers under general anesthesia received RNS of the median, axillary, and spinal accessory nerves at 2 HZ and 50 HZ. We recorded detection of EMI and whether or not this resulted in an arrhythmia diagnosis or change in pacing output. Results: EMI was visible in 2 ICDs, without spurious tachyarrhythmia detection. EMI was observed in 3 of the 4 pacemakers, which led to pacing inhibition and a pause in 2, both of which were programmed to a unipolar sensing configuration. Conclusions: RNS is safe in patients with ICDs. In pacemaker patients, RNS appears safe during bipolar sensing, but caution is recommended in pacemaker patients with unipolar sensing. Muscle Nerve 47: 840–844, 2013

Because there are many potential risks in the MR environment and reports of adverse incidents involving patients, equipment and personnel, the need for a guidance document on MR safe practices emerged. Initially published in 2002, the ACR MR Safe Practices Guidelines established de facto industry standards for safe and responsible practices in clinical and research MR environments. As the MR industry changes the document is reviewed, modified and updated. The most recent version will reflect these changes.

LV Lead Extraction and Reimplantation. Background: Early series of biventricular device removal have contained mostly younger cardiac venous (CV) left ventricular leads and few have reported on rates of successful reimplantation. Methods and Results: We performed a retrospective analysis of all patients referred to the Cleveland Clinic between February 2, 2001 and July 27, 2011 for removal of a biventricular device with a CV pacing lead for an infectious indication. A total of 173 patients were included. The median age of the CV leads was 22.3 months (interquartile range: 5.2–46.3 months). The complete procedural success rate for all leads was 97.7%, with the remaining 2.3% clinical successes. A total of 76.9% of CV leads were removed using simple traction alone with the remaining leads requiring the use of a laser-powered sheath. A total of 3.5% of leads required intervention (manual dissection or laser-powered dissection) within the coronary sinus (CS). Major complications occurred in 1.2% of patients. Minor complications occurred in 7.5% of patients, the majority of which were hematomas requiring drainage (6.9%). CV lead reimplantation was attempted in 107 patients of which 88 (82.8%) were successful. Conclusion: CV lead removal in patients with an infected biventricular device is associated with an extremely high procedural success rate and a low incidence of major complications. The use of a laser-powered sheath is necessary in roughly one-quarter of cases with a very small percentage requiring intervention within the CS. Reimplantation of CV leads is achievable in roughly 83% of patients, a figure lower than nationally quoted estimates for de novo implantations. (J Cardiovasc Electrophysiol, Vol. 23, pp. 1213–1216, November 2012)

Congest Heart Fail. 2011;17:248–254. ©2011 Wiley Periodicals, Inc. Clinical trial results support the hypothesis that implantable hemodynamic monitoring (IHM) systems may reduce hospitalizations among patients with chronic heart failure (HF). The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCE hf ) study was a prospective, randomized, multicenter, single-blinded trial that enrolled patients with New York Heart Association class II or III symptoms, an indication for an implantable cardioverter-defibrillator (ICD), and a previous HF hospitalization. A combination IHM-ICD was implanted and patients were randomly assigned to a treatment group in which hemodynamic information was used or a control group in which hemodynamic information was not available. Patients were followed for 12 months to evaluate the primary efficacy end point of HF hospitalizations, emergency department visits, or urgent clinic visits. The trial was designed to enroll 1300 patients, but stopped at 400 patients because of IHM lead failures experienced from previous trials. A total of 202 treatment patients and 198 controls were randomized for 12-month follow-up. The primary safety end point was met, but the rate of HF equivalents was not different between groups. REDUCE hf was unable to test clinical efficacy end points adequately. The device combining IHM-ICD technology was safe and functioned appropriately. Patients at high risk for decompensated HF have high baseline filling pressures and demonstrate consistent increases as the process of congestion worsens to the time of hospitalization.

Introduction: We investigated whether primary prevention implantable cardioverter defibrillator (ICD) patients with atrial arrhythmias are at higher risk for ICD shocks and mortality compared to patients without atrial arrhythmias in a subanalysis of the PREPARE study. Methods and Results: Details of the PREPARE study design and results have been previously reported. We now included 537 of the 700 patients enrolled in PREPARE. These patients had a dual or biventricular device and at least one device follow-up after implantation. Continuously collected device diagnostics data were used to classify patients into two groups during follow-up: with (n = 133) or without (n = 404) atrial tachycardia/atrial fibrillation (AT/AF). The primary outcomes were ICD shocks and mortality. Subjects were followed for a mean of 333 +/- 73 (range 5-365) days. During a follow-up of 1 year, ICD shocks occurred in 44 (8%) patients. Significantly, more patients with AT/AF received a shock (13.0% vs 6.9%, P = 0.03), with inappropriate shocks accounting for the majority of the difference (6.9% vs 2.6%, P = 0.02). There was no difference in prevalence of shocks between patients with and without a history of AF. Mortality was similar in patients with and without AT/AF, whether detected during the study or prior to the study. In addition, the 34 subjects with high average ventricular rate (>= 110 beats per minute) during AT/AF had a higher risk of an inappropriate shock (21.0% vs 2.1%, P

Background: QRS fragmentation (fQRS) has been shown to be a marker of scar in patients with left ventricular dysfunction. Whether fQRS is associated with progressive left ventricular remodeling and increased mortality in patients receiving cardiac resynchronization therapy (CRT) is unclear. Methods: We reviewed the preimplant and follow-up echocardiograms in 233 patients undergoing the new implantation of a CRT device between December 2001 and November 2006. Patients were included if they had a pre-CRT ECG with appropriate filter settings (filter 0.16–100 or 0.16–150 Hz, 25 mm/s, 10 mm/mV), a left ventricular ejection fraction (LVEF) ≤40%, and New York Heart Association class II–IV symptoms on standard medical therapy. The 12-lead electrocardiogram (ECG) was interpreted by two blinded reviewers for the presence of fQRS. Remodeling end points, including changes in LVEF and left ventricular end-diastolic (LVEDV) and systolic (LVESV) volumes, were compared between patients with and without contiguous fQRS, and an assessment of all-cause mortality was made. Results: Two hundred thirty-two patients met inclusion criteria, of which 50 demonstrated fQRS in contiguous leads. There was no difference in improvement in LVEF (%) (7.9 ± 12.9 vs 6.8 ± 11.0, P = 0.60) or reduction in LVEDV (mL) (−30.1 ± 57.2 vs −15.7 ± 47.6) or LVESV (mL) (−33.7 ± 58.1 vs −22.7 ± 50.6, P = 0.40) between patients with and without contiguous fQRS. At a mean follow-up of 4.4 ± 1.9 years, there were a total of 89 deaths, 22 (44.0%) in patients with contiguous fQRS and 67 (36.8%) without (log rank P = 0.31). Conclusions: QRS fragmentation is not a predictor of progressive ventricular remodeling or mortality in heart failure patients undergoing CRT. Ann Noninvasive Electrocardiol 2011;16(2):165–171

Background: The relationship between QRS narrowing and response to cardiac resynchronization therapy (CRT) has been controversial. Objective: We sought to analyze the relationship between QRS narrowing and reverse remodeling in patients undergoing CRT, taking into account potential confounders including pre-CRT QRS duration and underlying QRS morphology. Methods: We reviewed pre- and postimplant electrocardiograms and echocardiograms in a cohort of 233 patients undergoing the new implantation of a CRT device between December 2001 and September 2006. For inclusion in the final cohort, patients had New York Heart Association classes II–IV heart failure, left ventricular ejection fraction (LVEF) ≤ 40%, and QRS duration ≥120 ms. Response to CRT was defined as a reduction in left ventricular end-systolic volume (LVESV) of ≥10%. A multivariate model was constructed to determine the relationship between QRS change and response to CRT. Results: Patients with QRS narrowing had significantly greater reductions in left ventricular end-diastolic volume (LVEDV) (mL) (−26.5 ± 52.5 vs −4.8 ± 44.0, P = 0.002) and LVESV (mL) (−34.0 ± 55.5 vs −9.9 ± 45.8, P = 0.002) and improvement in LVEF (%) (8.9 ± 12.8 vs 4.5 ± 9.0, P = 0.007) than patients without narrowing. In univariate analysis, female gender (P = 0.0002), percent QRS narrowing from baseline (P = 0.008), lack of nitrate (P≤0.0001) and antiarrhythmic medication use (P = 0.01), lack of a nonspecific intraventricular conduction delay (=0.02), nonischemic cardiomyopathy (P = 0.003), and lower pre-CRT LVEDV (P = 0.006) and LVESV [P = 0.01]) were associated with responders. In a multivariate model, QRS narrowing, indexed to the baseline QRS duration, remained strongly associated with response (odds ratio 0.08 [0.01–0.56], P = 0.01). Conclusions: After adjusting for potential confounders, QRS narrowing, indexed to baseline QRS duration, is associated with enhanced reverse ventricular remodeling following CRT. (PACE 2011; 34:604–611)

Changes in intrathoracic impedance (Z) leading to crossing of a derived fluid index (FI) threshold has been associated with heart failure (HF) hospitalization. The authors developed a remote monitoring program as part of HF disease management and prospectively examined the feasibility and resource utilization of monitoring individuals with an implanted device capable of measuring Z. An HF nurse analyzed all transmitted data daily, as they were routinely uploaded as part of quarterly remote device monitoring, and called the patient if the FI crossed the threshold (arbitrarily defined at 60 Ω) to identify clinically relevant events (CREs) that occurred during this period (eg, worsening dyspnea or increase in edema or weight). A total of 400 uploads were completed during the 4-month study period. During this period, 34 patients (18%) had an FI threshold crossing, averaging 0.52 FI threshold crossings per patient-year. Thirty-two of 34 patients contacted by telephone (94%) with FI threshold crossing had evidence of CREs during this period. However, only 6 (18%) had HF hospitalizations, 19 (56%) had reported changes in HF therapy, and 13 (38%) reported drug and/or dietary plan nonadherence. The average data analysis time required was 30 min daily when focusing on those with FI threshold crossing, averaging 8 uploads for review per working day and 5 telephone follow-ups per week. Our pilot observations suggested that Internet-based remote monitoring of Z trends from existing device interrogation uploads is feasible as part of a daily routine of HF disease management.Congest Heart Fail. 2010;16:159–163. © 2010 Wiley Periodicals, Inc.

Introduction: In select patients with systolic heart failure, cardiac resynchronization therapy (CRT) has been shown to improve quality of life, exercise capacity, ejection fraction (EF), and survival. Little is known about the response to CRT in patients with right bundle branch block (RBBB) or non-specific intraventricular conduction delay (IVCD) compared with traditionally studied patients with left bundle branch block (LBBB). Methods: We assessed 542 consecutive patients presenting for the new implantation of a CRT device. Patients were placed into one of three groups based on the preimplantation electrocardiogram morphology: LBBB, RBBB, or IVCD. Patients with a narrow QRS or paced ventricular rhythm were excluded. The primary endpoint was long-term survival. Secondary endpoints were changes in EF, left ventricular end-diastolic and systolic diameter, mitral regurgitation, and New York Heart Association (NYHA) functional class. Results: Three hundred and thirty-five patients met inclusion criteria of which 204 had LBBB, 38 RBBB, and 93 IVCD. There were 32 deaths in the LBBB group, 10 in the RBBB, and 27 in the IVCD group over a mean follow up of 3.4 ± 1.2 years. In multivariate analysis, no mortality difference amongst the three groups was noted. Patients with LBBB had greater improvements in most echocardiographic endpoints and NYHA functional class than those with IVCD and RBBB. Conclusion: There is no difference in 3-year survival in patients undergoing CRT based on baseline native QRS morphology. Patients with RBBB and IVCD derive less reverse cardiac remodeling and symptomatic benefit from CRT compared with those with a native LBBB. (PACE 2010; 590–595)

Introduction: Around 30% of patients do not respond to cardiac resynchronization therapy (CRT). Nonischemic cardiomyopathy has been identified as an independent predictor of response to CRT, probably due to the absence of compact scar. Methods and results: The relationship between cardiac scar, ischemia, and hibernation (both at the left-ventricular pacing site and as a total burden) and response to CRT was studied in patients with ischemic cardiomyopathy using the perfusion-viability positron emission tomography (PET) test. Sixty-six patients with ischemic cardiomyopathy and traditional criteria for CRT were included. All patients underwent PET scan prior to CRT. Using PET, the amount and location of scarred, ischemic, and hibernating myocardium were characterized. No revascularization was indicated. Responders were defined by an improvement of left-ventricular ejection fraction (LVEF) ≥ 5% and/or New York Heart Association (NYHA) class ≥ 1 degree. During a mean follow-up of 26.2 ± 22.2 months, there was a significant improvement in NYHA class and reverse remodeling in patients with the LV lead inserted remotely from the scar. However, reverse remodeling of a similar degree was present also in patients with extensive scarring including the lateral wall. The presence of ischemia, hibernation, or nontransmural scar at the pacing-site did not significantly modify the outcome of CRT as compared with viable myocardium. There were only 38% of CRT-nonresponders. Neither the extent of scar, ischemia, hibernation, or viability predicted outcome or mortality. Twenty patients died during the follow-up, one patient underwent heart transplant. Conclusions: At follow-up, response to CRT is observed regardless of the presence of extensive scarring. Left ventricular (LV) pacing at sites with ischemia, hibernation, or nontransmural scar does not appear to modify the effect of CRT as compared to viable tissue.

Within the United States, the elderly population is projected to increase 126% by 2050, making those over the age of 65 the most rapidly growing segment in the population. Permanent pacemakers and defibrillators are important therapies with expanding indications for their use, and older persons constitute the majority of recipients of these devices. Recognizing complications associated with these cardiac devices is essential in caring for patients with them. Complications can be related to the implantation procedure and are most commonly lead dislodgement, pneumothorax, lead perforation, hematoma, and infection. Intrinsic device programming can also result in complications such as pacemaker syndrome, pacemaker-mediated tachycardia, and inappropriate shocks. Extrinsic factors, such as electromagnetic interference and physically manipulating the device, can also result in problems. Recent work suggests that older age, by itself, is not associated with a significant increase in the complication rates from these devices and should not preclude their use.

Objective: To determine if strategies used to safely scan nonpacemaker-dependent patients could be applied to facilitate safe MRI of pacemaker-dependent patients. Interventions: Ten pacemaker-dependent patients underwent a total of 11 MRI scans of the head and neck. Screening, reprogramming VOO or DOO at 60 ppm, and monitoring strategies were used to facilitate MRI. A transmit-receive coil was used and MRI pulse sequences were modified to limit the whole-body specific absorption rate (SAR). Results: All scans proceeded uneventfully. No difficulties in post-MRI telemetry or interrogation were seen and no post-MRI programming changes were noted. No patient experienced arrhythmia or symptoms during or immediately after MRI. Battery status remained unchanged. No patient experienced post-MRI change in sensing thresholds. Three patients showed no change in the atrial or ventricular pacing thresholds when the pre-MRI values were compared to the immediate post-MRI values and the 3-month follow-up values. All other patients showed a rise or fall of 0.5 V in their chamber threshold values when the pre-MRI, post-MRI, and 3-month follow-up values were compared. More patients showed a fall in their pacing thresholds than a rise post-MRI. Conclusion: While clearly a higher risk group, like nonpacemaker-dependent patients, MRI might be performed in pacemaker-dependent patients if appropriate pacemaker reprogramming, patient monitoring, and MRI scanning techniques are implemented.

Coronary Sinus Lead Position and Biventricular Pacing. Introduction: Biventricular pacing is an established treatment for congestive heart failure. Whether the anatomic location of the coronary sinus (CS) lead affects outcomes is unknown. The aim of this study was to evaluate the clinical response and mortality in patients who had transvenous CS leads placed in different anatomic branches for biventricular pacing. Methods and Results: We evaluated 233 consecutive patients with New York Heart Association (NYHA) class III-IV heart failure and ejection fraction

Introduction: The implantable cardioverter defibrillator (ICD) is commonly used to treat patients with documented sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). Arrhythmia recurrence rates in these patients are high, but which patients will receive a therapy and the forms of arrhythmia recurrence (VT or VF) are poorly understood. Methods and Results: The therapy delivered by the ICD was examined in 449 patients randomized to ICD therapy in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. Events triggering ICD shocks or antitachycardia pacing (ATP) were reviewed for arrhythmia diagnosis, clinical symptoms, activity at the onset of the arrhythmia, and appropriateness and results of therapy. Both shock and ATP therapies were frequent by 2 years, with 68% of patients receiving some therapy or having an arrhythmic death. An appropriate shock was delivered in 53% of patients, and ATP was delivered in 68% of patients who had ATP activated. The first arrhythmia treated in follow-up was diagnosed as VT (63%), VF (13%), supraventricular tachycardia (18%), unknown arrhythmia (3%), or due to ICD malfunction or inappropriate sensing (3%). Acceleration of an arrhythmia by the ICD occurred in 8% of patients who received any therapy. No physical activity consistently preceded arrhythmias, nor did any single clinical factor predict the symptoms of the arrhythmia. Conclusion: Delivery of ICD therapy in AVID patients was common, primarily due to VT. Inappropriate ICD therapy occurred frequently. Use of ICD therapy as a surrogate endpoint for death in clinical trials should be avoided. (J Cardiovasc Electrophysiol, Vol. 14, pp. 940-948, September 2003)

The North American Society of Pacing and Electrophysiology (NASPE) was established in recognition of the unique challenges that the management of patients with cardiac rhythm disorders present. As with other subspecialty fields within cardiology, the genesis of this specialty evolved from technological innovations and ensuing biomedical applications, which fueled the development of electrophysiological related interventions. The provision of services accompanying these technology-based interventions created an opportunity for health care professionals to specialize in the field of cardiac rhythm management. Known as Allied Professionals (APs), this diverse group of nurses, physician assistants, technologists, technicians, and engineers is dedicated to promoting excellence in the care of patients with cardiac rhythm disorders. The provision of safe, optimal care is contingent on the coordinated efforts of multiple disciplines, the acquisition of a defined specialized knowledge base, and the application of knowledge and skills in rendering patient care and technical support services. The Standards of Professional Practice for the Allied Professional in Pacing and Electrophysiology have been developed to articulate the scientific foundation, clinical skills, and technical knowledge requisite to provide and facilitate the provision of safe quality patient care. The Standards of Professional Practice address the scope of activities of the AP employed in the field of cardiac rhythm management. The first section, Core Knowledge and Skills, addresses essential areas of practice germane to the specialty to provide professional care and technical support services. Subsequent sections address knowledge requirements for specific technology-based interventions and therapies to patients undergoing invasive and noninvasive diagnostic, therapeutic

The laser sheath uses optical fibers, delivering pulsed ultraviolet excimer laser light, to vaporize fibrotic tissue binding intravenous cardiac leads to the vein or heart wall during lead extraction from the implant vein. The total investigational experience with laser sheaths is reported. During the period from October 1995 to December 1999, 2,561 pacing and defibrillator leads were treated in 1,684 patients at 89 sites in the United States with three sizes of laser sheath. Endpoints were complete removal of the lead, partial removal (leaving the tip behind), or failure (abandoning the lead, onset of complications, change to transfemoral or transatrial approach). Minimal follow-up at 30 days was recorded. Of the leads, 90% were completely removed, 3% were partially removed, and the balance were failures. Major perioperative complications (tamponade, hemothorax, pulmonary embolism, lead migration, and death) were observed in 1.9% of patients with in hospital death in 13 (0.8%). Minor complications were seen in an additional 1.4% of patients. Multivariate analysis showed that implant duration was the only preoperative independent predictor of failure; female sex was the only multivariate predictor of complications. Success and complications were not dependent on laser sheath size. At follow-up, various extraction related complications were observed in 2% of patients. The learning curve showed a trend toward fewer complications with experience. Lead extraction with the laser sheath can be safely practiced with high success rates. Success is independent of laser sheath size. Major complications can be expected in < 2% of patients, and occur more often during an investigator's early experience.

FREEDMAN, R.A., et al.: Assessment of Pacemaker Chronotropic Response: Implementation of the Wilkoff Mathematical Model. There are few practical guidelines for proper adjustment of rate responsive pacemaker sensor parameters. This study describes the application of the chronotropic assessment exercise protocol (CAEP) and the Wilkoff model of chronotropic response to assess the adjustment of pacemaker sensor parameters. In 31 patients implanted 1 month previously with a dual sensor pacemaker, pacemaker sensor parameters were adjusted to yield a peak sensor rate of 100 beats/min on a simple 6- minute walk (low intensity treadmill exercise [LITE] protocol); the maximum sensor rate was set to the age predicted maximum heart rate (220-age). The rate response behavior of the pacemaker was then assessed using the slope of metabolic-chronotropic relation (MCR) during CAEP exercise. After adjustments based on the LITE protocol, CAEP exercise yielded MCR slopes of 0.92 ± 0.25 for the entire study group, which compares well with the predicted normal slope of 1. However, 7 of the 31 patients had sensor MCR slopes during CAEP exercise that were 2 SD or more below expected. To test the sensitivity of this approach to suboptimal pacemaker programming or suboptimal exercise, simulations were performed with the maximum sensor rate programmed below age-predicted maximum heart rate or with exercise truncated before maximum exertion; with these conditions, MCR slopes were sharply lower for the entire group. The authors conclude that a simple treadmill walk (LITE) allowed for optimum programming of sensor parameters in most patients, but in a minority the chronotropic behavior was underresponsive. Failure to appropriately adjust pacemaker maximum sensor rate or failure to achieve peak exercise sharply limits the accuracy of this methodology.

Rehospitalization and Future Death.Introduction: It is generally considered that death is the only appropriate endpoint to evaluate interventions for preventing death; however, this belief may be based on the previous use of inappropriate or inadequate surrogates for death. The aim of this study was to evaluate whether rehospitalization following implementation of an intervention is a reasonable surrogate for death. Methods and Results: The time from discharge following intervention to rehospitalization was evaluated for 997 patients discharged after baseline hospitalization in the Antiarrhythmics Versus Implantable Defibrillators Trial. The relationship between rehospitalization for various reasons and subsequent death was compared in the two treatment arms to assess the adequacy of rehospitalization as a surrogate for death. Included were rehospitalization for: any reason, a cardiac problem, a noncardiac problem, new or worsened congestive heart failure (CHF), an acute coronary syndrome, and a cardiac procedure. For all of the reasons except cardiac procedure, rehospitalization was associated with a substantially increased hazard for subsequent death. Rehospitalization for new or worsened CHF was most closely (that is, temporally) related to subsequent death and was the only reason for rehospitalization, which fully explained the treatment effect of implantable cardiac defibrillators compared with antiarrhythmic drugs on death. Conclusion: Rehospitalization is a significant risk factor for subsequent death. However, only rehospitalization for new or worsened CHF appears to be a potential surrogate for death in the setting of antiarrhythmic interventions.

Several bipolar coaxial pacemaker leads, composed of an outer silicone rubber insulation and an inner polyether polyurethane (PEU) insulation, which were explanted due to clinical evidence of electrical dysfunction, were analyzed in this study. Optical microscopy (OM) and scanning electron microscopy (SEM) were used to determine the cause of failure. Attenuated total reflectance-Fourier transform infrared microscopy (ATR-FTIR) was used to analyze the PEU insulation for chemical degradation. In all leads, the silicone rubber outer insulation showed no signs of physical damage. Physical damage to the inner PEU insulation was the source of electrical dysfunction. Cracks through the PEU compromised the insulation between the inner and outer conductor coils in the lead. It was observed with SEM that these cracks originated on the outer surface of the inner insulation and progressed inward. ATR-FTIR analysis showed that the PEU had chemically degraded via oxidation of the ether soft segment. Furthermore, it was revealed that chemical degradation was more advanced on the outer surface of the PEU. It was hypothesized that hydrogen peroxide permeated through the outer silicone insulation and decomposed into hydroxyl radicals that caused the chemical degradation of PEU. The metal in the outer conductor coil catalyzed the decomposition of the hydrogen peroxide. Chemical degradation of the PEU could also have been catalyzed by metal ions created from the corrosion of the metal in the outer conductor coil by hydrogen peroxide. Physical damage probably occurred in regions of the leads that were subjected to a higher hydrogen peroxide concentration from inflammatory cells and high degrees and rates of strain due to intercorporeal movement, including, but not limited to, cardiac movement. Chemical degradation and physical damage probably had a synergistic affect on failure of the insulation, in that as chemical degradation proceeded, the polymer surface became brittle and more susceptible to physical damage. As physical damage proceeded, cracks propagated into the unaffected bulk, exposing it to oxidants.

Internal Defibrillation with Fully Discharging Capacitors. Introduction: The use of two independent, fully discharging capacitors for each phase of a biphasic defibrillation waveform may lead to the design of a simpler, smaller, internal defibrillator. The goal of this study was to determine the optimal combination of capacitor sizes for such a waveform. Methods and Results: Eight full-discharge (95/95% tilt), biphasic waveforms produced by several combinations of phase-1 capacitors (30, 60, and 90 μF) and phase-2 capacitors (1/3, 2/3, and 1.0 times the phase-1 capacitor) were tested and compared to a single-capacitor waveform (120 μF, 65/65% tilt) in a pig ventricular fibrillation model (n = 12, 23 ± 2 kg). In the full-discharge waveforms, phase-2 peak voltage was equal to phase-1 peak voltage. Shocks were delivered between a right ventricular lead and a left pectoral can electrode. E50s and V50s were determined using a ten-step Bayesian process. Full-discharge waveforms with phase-2 capacitors of ≥40 μF had the same E50 (6.7 ± 1.7 J to 7.3 ± 3.9 J) as the single-capacitor truncated waveform (7.3 ± 3.7 J), whereas waveforms with phase-2 capacitors of ≥60 μF had an extremely high E50 (14.5 ± 10.8 J or greater, P < 0.05). Moreover, of the former set of energy-efficient waveforms, those with phase-1 capacitors of ≥60 μF additionally exhibited V50s that were equivalent to the V50 of the single-capacitor waveform (344 ± 65 V to 407 ± 50 V vs 339 ± 83 V). Conclusion: Defibrillation efficacy can be maintained in a full-discharge, two-capacitor waveform with the proper choice of capacitors.

The procedure of lead removal has recently matured into a definable, teachable art with its own specific tools and techniques. It is now time to recognize and formalize the practice of lead removal according to the current methods of medicine and the health care industry. In addition, since at this time the only prospective scientific study of lead extraction is the PLEXES trial, we suggest that studies relating to the techniques of and indications for lead extraction be designed. Recommendations for a common set of definitions, for a framework of training and reviewing physicians in the art, for general methods of reimbursement, and for consistency among clinical trials have been made. Implementation of these recommendations will require additional effort and cooperation from practicing physicians, medical societies, hospital administrations, and industry.

Of the 400,000-500,000 permanent pacemaker leads implanted worldwide each year, around 10% may eventually fail or become infected, becoming potential candidates for removal. Intravascular techniques for removing problematic or infected leads evolved over a 5-year period (1989-1993). This article analyzes results from January 1994 through April 1996, a period during which techniques were fairly stable. Extraction of 3,540 leads from 2,338 patients was attempted at 226 centers. Indications were: infection (27%), nonfunctional or incompatible leads (25%), Accufix or Encore leads (46%), or other causes (2%). Patients were 64+/-17 years of age (range 5-96); 59% were men, 41% women. Leads were implanted 47+/-41 months (maximum 26 years), in the atrium (53%), ventricle (46%), or SVC (1%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, and/or transfemorally using snares, retrieval baskets, and sheaths. Complete removal was achieved for 93% of leads, partial for 5%, and 2% were not removed. Risk of incomplete or failed extraction increased with implant duration (P 300 cases), minor for 1.7%. Risk of complications increased with number of leads removed (P

The effects of extracorporeal shock wave lithotripsy (ESWL) were tested on four advanced generation implantable cardioverter-defibrillators (ICDs) in vitro and in vivo in two patients. During in vitro testing, advancement of nonsustained episode counters occurred in one device, and a set screw and power source cell loosened in another, which was connected to an external power source. No arrhythmias occurred during in vivo procedures, but programmed parameters were reset and elective replacement indicated after one procedure. ESWL can be performed safely in selected patients with ICDs, but testing should be performed afterwards to confirm satisfactory function and component continuity.

Biventricular Shocking Leads:Introduction: A single lead active can configuration has been widely used in patients with life-threatening ventricular arrhythmias. Occasionally, however, such a defibrillation lead configuration may not achieve adequate defibrillation threshold (DFT). The purpose of this study was to determine whether addition of a left ventricular (LV) lead can improve defibrillation efficacy. Methods and Results: Three transvenous defibrillation leads (8.3-French with a 5-cm long unipolar coil) were placed in the right ventricle (RV), LV, and superior vena cava (SVC), along with an active can (92 cm2) in the left subpectoral area. The DFT stored energy of seven combinations of these defibrillation leads were compared in a pig ventricular fibrillation model using a biphasic defibrillation waveform (125 μF, 6.5/3.5 msec). A biventricular leads active can configuration in which the RV and LV leads were of the same polarity reduced the DFT stored energy by approximately 35% when compared to a single RV lead active can configuration (9.6 ± 3.0 J vs 15.0 ± 7.2 J, respectively, P = 0.02). Moreover, adding a SVC lead further reduced the DFT energy (8.4 ± 3.3 J). Conclusion: A biventricular leads active can configuration can significantly improve defibrillation efficacy as compared to a single lead active can configuration. In such a defibrillation lead configuration, the polarity of RV and LV leads should be the same.

Use of IV (Conscious) Sedation/Analgesia by Nonanesthesia Personnel in Patients Undergoing Arrhythmia Specific Diagnostic, Therapeutic, and Surgical Procedures. This article is intended to inform practitioners, payers, and other interested parties of the opinion of the North American Society of Pacing and Electrophysiology (NASPE) concerning evolving areas of clinical practice or technologies or both, that are widely available or are new to the practice community. Expert consensus documents are so designated because the evidence base and experience with the technology or clinical practice are not yet sufficiently well developed, or rigorously controlled trials are not yet available that would support a more definitive statement. This article has been endorsed by the American College of Cardiology, October 1997.

The polarity of a monophasic and biphasic shocks have been reported to influence DFTs in some studies. The purpose of this study was to evaluate the effect of the first phase polarity on the DFT of a biphasic shock utilizing a nonthoracotomy "hot can" electrode configuration which had a 90-microF capacitance. We tested the hypothesis that anodal first phase was more effective than cathodal ones for defibrillation using biphasic shocks in ten anesthetized pigs weighing 38.9 +/- 3.9 kg. The lead system consisted of a right ventricular catheter electrode with a surface area of 2.7 cm2 and a left pectoral "hot can" electrode with 92.9 cm2 surface area. DFT was determined using a repeated "down-up" technique. A shock was tested 10 seconds after initiation of ventricular fibrillation. The mean delivered energy at DFT was 11.2 +/- 1.7 J when using the right ventricular apex electrode as the cathode and 11.3 +/- 1.2 J (P = NS) when using it as the anode. The peak voltage at DFT was also not significantly different (529.0 +/- 41.3 and 531.8 +/- 28.6 V, respectively). We concluded that the first phase polarity of a biphasic shock used with a nonthroracotomy "hot can" electrode configuration did not affect DFT.

“Parallel-Series” Biphasic Waveform. Introduction: A biphasic defibrillation waveform can achieve a large second phase leading-edge voltage by a “parallel-series” switching system. Recently, such a system using two 30-μF capacitances demonstrated better defibrillation threshold than standard waveforms available in current implantable devices. However, the optimized tilt of such a “parallel-series” system had not been defined. Methods and Results: Defibrillation thresholds were evaluated for five different biphasic “parallel-series” waveforms (60/15 μF) and a biphasic “parallel-parallel” waveform (60/60 μF) in 12 anesthetized pigs. The five “parallel-series” waveforms had first phase tilts of 40%, 50%, 60%, 70%, and 80% with second phase pulse width of 3 msec. The “parallel-parallel” waveform had first phase tilt of 50% with second phase pulse width of 3 msec. The defibrillation lead system comprised a left pectoral “hot can” electrode (cathode) and a right ventricular lead (anode). The stored energy at defibrillation threshold of the “parallel-series” waveform with first phase tilts of 40%, 50%, 60%, 70%, and 80% was 7.0 ± 2.1, 6.1 ± 2.8, 6.8 ± 2.8, 7.2 ± 2.9. and 8.4 ± 3.1 J, respectively. The stored energy of the “parallel-series” waveform with a 50% first phase tilt was 16% less than the nonswitching “parallel-parallel” waveform (7.3 ± 2.8 J, P = 0.006). Conclusions: A first phase tilt of 50% maximized defibrillation efficacy of biphasic waveforms implemented with a “parallel-series” switching system. This optimized “parallel-series” waveform was more efficient than the comparable “parallel-parallel” biphasic waveform having the same first phase capacitance and tilt.