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Background: Leadless pacemakers (LPs) can mitigate conventional pacemaker complications related to the transvenous leads and subcutaneous pocket surrounding the pulse generator. Although single-chamber leadless pacing has been established, multichamber pacing requires wireless bidirectional communication across multiple LPs to maintain synchrony. This preclinical study demonstrates the chronic performance of implant-to-implant (i2i) communication that achieves synchronous, dual-chamber pacing with 2 LPs. Methods: The i2i communication modality employs subthreshold electrical signals conducted between implanted LPs through the blood and myocardial tissue on a beat-by-beat basis. Right atrial and right ventricular LPs were implanted in 9 ovine subjects. The i2i transmission performance was evaluated 13 weeks after implant. Results: Right atrial and right ventricular LPs were implanted successfully and without complication in 9 ovine subjects. A total of 8715±457 right atrial-to-right ventricular and right ventricular-to-right atrial transmissions were sent per hour, with a success rate of 99.2±0.9%. Of periods with i2i communication failure when DDD pacing was not possible, 97.3±1.8% were resolved within 6 s. Conclusions: For the first time, synchronized, dual-chamber pacing has been demonstrated in a chronic preclinical feasibility study by 2 leadless pacemakers using beat-to-beat, wireless communication, achieving a success rate of 99.2%.

Background: The Nanostim {trade mark, serif} Leadless Cardiac Pacemaker (LCP) has been shown to be safe and effective in human clinical trials. Since there is little information on the effect of implant location on LCP performance, the aim of this study was to determine whether anatomic position affects the long-term pacing performance of the LCP. Methods: Patients who enrolled in the Leadless II IDE Clinical Trial and had finished 6 months follow up (n = 479) were selected for the study. The implanting investigators determined the LCP final position under fluoroscope, which was categorized into three groups: RV apex (RVA, n = 174), RV apical septum (RVAS, n = 101), and RV septum (RVS, n = 204) (Figure 1). Data on capture threshold (at a 0.4 ms pulse width), R-wave amplitude and impedance were analyzed at implant, hospital discharge and 2 weeks, 6 weeks, 3 months and 6 months post-implant. Results: At implant, the mean capture thresholds in the RVA, RVAS and RVS were 0.77 ± 0.45, 0.81 ± 0.61 and 0.78 ± 0.59 volts, respectively. R-wave amplitudes were 8.0 ± 3.0 mV, 7.7 ± 2.9 mV and 7.6 ± 2.9 mV, respectively. Impedance values were 727 ± 311, 765 ± 333, and 677 ± 227 respectively. There were no differences among the 3 implant locations in capture threshold or R-wave amplitudes at 6 months (P > 0.06); however, all 3 performance parameters significantly improved over time (P < 0.001). Conclusions: The LCP implant location does not affect capture thresholds or R-wave amplitudes at 6 months, and there is little effect on impedance. Although implant location does not appear to be a predictor of electrical performance, additional long-term data will help guide optimal implant location.

Leadless cardiac pacemakers (LCPs) aim to mitigate lead- and pocket-related complications seen with transvenous pacemakers (TVPs).The purpose of this study was to compare complications between the LCP cohort from the LEADLESS Pacemaker IDE Study (Leadless II) trial and a propensity score-matched real-world TVP cohort.The multicenter LEADLESS II trial evaluated the safety and efficacy of the Nanostim LCP (Abbott, Abbott Park, IL) using structured follow-up, with serious adverse device effects independently adjudicated. TVP data were obtained from Truven Health MarketScan claims databases for patients implanted with single-chamber TVPs between April 1, 2010 and March 31, 2014 and more than 1 year of preimplant enrollment data. Comorbidities and complications were identified via International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes. Short-term (≤1 months) and mid-term (1-18 months) complications were compared between the LCP cohort and a propensity score-matched subset of the TVP cohort.Among 718 patients with LCPs (mean age 75.6 ± 11.9 years; 62% men) and 1436 patients with TVPs (mean age 76.1 ± 12.3 years; 63% men), patients with LCPs experienced fewer complications (hazard ratio 0.44; 95% confidence interval 0.32-0.60; P .001), including short-term (5.8% vs 9.4%; P = .01) and mid-term (0.56% vs 4.9%; P.001) events. In the short-term time frame, patients with LCPs had more pericardial effusions (1.53% vs 0.35%; P = .005); similar rates of vascular events (1.11% vs 0.42%; P = .085), dislodgments (0.97% vs 1.39%; P = .54), and generator complications (0.70% vs 0.28%; P = .17); and no thoracic trauma compared to patients with TVPs (rate of thoracic trauma 3.27%). In short- and mid-term time frames, TVP events absent from the LCP group included lead-related, pocket-related, and infectious complications.Patients with LCPs experienced fewer overall short- and mid-term complications, including infectious and lead- and pocket-related events, but more pericardial effusions, which were uncommon but serious.

Background— The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). Methods and Results— This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were met: The 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock. Conclusions— The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01064076.

Background— This study aimed to determine whether QRS morphology identifies patients who benefit from cardiac resynchronization therapy with a defibrillator (CRT-D) and whether it influences the risk of primary and secondary end points in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) trial. Methods and Results— Baseline 12-lead ECGs were evaluated with regard to QRS morphology. Heart failure event or death was the primary end point of the trial. Death, heart failure event, ventricular tachycardia, and ventricular fibrillation were secondary end points. Among 1817 patients with available sinus rhythm ECGs at baseline, there were 1281 (70%) with left bundle-branch block (LBBB), 228 (13%) with right bundle-branch block, and 308 (17%) with nonspecific intraventricular conduction disturbances. The latter 2 groups were defined as non-LBBB groups. Hazard ratios for the primary end point for comparisons of CRT-D patients versus patients who only received an implantable cardioverter defibrillator (ICD) were significantly ( P P P =0.257). The risk of ventricular tachycardia, ventricular fibrillation, or death was decreased significantly in CRT-D patients with LBBB but not in non-LBBB patients. Echocardiographic parameters showed significantly ( P Conclusions— Heart failure patients with New York Heart Association class I or II and ejection fraction ≤30% and LBBB derive substantial clinical benefit from CRT-D: a reduction in heart failure progression and a reduction in the risk of ventricular tachyarrhythmias. No clinical benefit was observed in patients with a non-LBBB QRS pattern (right bundle-branch block or intraventricular conduction disturbances). Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00180271.

Background The intracoronary Doppler tipped guide wire has been shown to be highly accurate in the measurement of coronary flow velocity (CFV). Recent studies have indicated that blood flow velocity in the left anterior descending coronary artery (LAD) can be determined by transesophageal echocardiography (TEE). The purpose of this study was to compare flow velocity recordings and coronary flow reserve measurements in the LAD by TEE with those obtained by Doppler guide wire. Methods and Results The study population consisted of 14 patients with chest pain and normal coronary arteriograms. After routine coronary arteriography was performed, a 0.014-inch Doppler guide wire was advanced into the proximal part of the LAD. After baseline measurement of coronary flow velocity (CFV) was obtained, 140 μg/kg/min adenosine was administered intravenously for 3 minutes, and the flow velocity was recorded. TEE was performed within 24 hours of the cardiac catheterization. After baseline measurements of CFV in the LAD, heart rate, and blood pressure were obtained, 140 μg/kg/min adenosine was administered intravenously, and the CFV was recorded. Coronary flow reserve was calculated as the ratio of the peak diastolic CFV during adenosine infusion to the peak diastolic CFV at baseline. A good correlation was found (r = 0.91, p < 0.0001) between CFV by Doppler guide wire and that determined by TEE. A good correlation was also found between the coronary flow reserve assessed by Doppler guide wire and that determined by TEE (r = 0.92, p < 0.0001). Conclusion Our data indicate that CFV and coronary flow reserve in the LAD can be accurately measured by transesophageal echocardiography. (Am Heart J 1998;135:38-42.)