Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia.

INTRODUCTION: Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width < 17 mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width < 17 mm. METHODS AND RESULTS: Thirty-two consecutive patients with a maximal LAA ostial width < 17 mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA2 DS2 -VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5 kg/m2 , and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6 mm (range 14-16) and 23.2 ± 4.5 mm (range 13-31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak > 5 mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure. CONCLUSIONS: LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width < 17 mm.

Association of Antitachycardia Pacing or Shocks With Survival in 69,000 Patients With an Implantable Defibrillator.

AIMS: Antitachycardia pacing (ATP) is an effective treatment for ventricular tachycardia (VT) and can reduce the frequency of shocks in patients with an implantable cardioverter defibrillator (ICD). The association between survival and ATP, as compared to a shock, has not been confirmed in a large patient population. This study aims to determine if patients with an ICD receiving ATP have lower mortality, as compared to those receiving shock. METHODS: Sixty-nine thousand three hundred and sixty-eight patients underwent ICD implantation between October 2008 and May 2013 and were enrolled in the remote monitoring network Merlin.net™ (St. Jude Medical, St. Paul, MN, USA). Patients were categorized into three groups based on the type of ICD therapy received during follow-up: no therapy (N = 47,927), ATP (N = 8,049), and shock (N = 13,392) groups. Survival was determined by linking implant records to the Social Security Death Index. RESULTS: The no therapy (hazard ratio [HR] 0.60, 95% confidence interval [CI] 0.56-0.64, P < 0.001) and ATP (HR 0.70, 95% CI 0.64-0.77, P < 0.001) groups were associated with a lower mortality risk than the shock group. These results were unaffected by age, gender, device type, atrial fibrillation (AF) burden, or ventricular rate. ATP was effective in 85% of episodes and ATP effectiveness was dependent on the ventricular rate. CONCLUSIONS: Mortality rates were higher in ICD patients who received only ATP compared to no therapy, but ICD patients who received a shock had higher mortality compared to both groups. Furthermore, the data suggest that age, gender, device type, AF burden, and rate of arrhythmia do not change the trend of higher mortality in patients receiving ICD shock compared to ATP alone.

Right Ventricular Pacing for Assessment of Cavo-Tricuspid Isthmus Block.

Background: Cavo-tricuspid isthmus (CTI) dependent atrial flutter is typically treated with cardiac ablation. Standard techniques to assess CTI block after ablation can be technically challenging. Right ventricular (RV) pacing may allow for another technique to assess CTI block after ablation. Objective: The purpose of this study was to evaluate RV pacing as a method to assess CTI block after ablation of CTI dependent atrial flutter, and define endpoints of ablation using this technique. Methods: 28 patients undergoing ablation of CTI dependent atrial flutter with intact ventriculoatrial (VA) conduction were prospectively enrolled in this study and underwent the RV pacing protocol, as well as standard coronary sinus (CS) pacing techniques to assess CTI block. Results: The mean trans-isthmus conduction interval during CS pacing (TICICS) at 600 and 400ms after CTI ablation was 168 +/- 9ms and 175 +/- 18ms, respectively. The mean trans-isthmus conduction interval during RV pacing (TICIRV) at 600ms and 400ms after CTI ablation was 109 +/- 5ms and 111 +/- 5ms, respectively. A TICIRV >100ms was associated with a successful outcome after CTI ablation. Conclusions: RV pacing may add incremental value in the assessment of CTI block in patients undergoing ablation of CTI dependent atrial flutter.

The relationship between defibrillation threshold and total mortality.

BACKGROUND: The relationship between the defibrillation threshold (DFT) and total mortality is unclear. METHODS: A university hospital prospectively maintained implantable defibrillator (ICD) database identified 508 patients who underwent ICD implantation and had DFT testing performed at implant. Patients were placed in one of three groups based on the implant DFT (high (≥20 J), moderate (19-11 J), or low DFT (≤10 J)). RESULTS: Sixty-seven patients had a high DFT, 216 had a moderate DFT, and 225 had a low DFT. The mean left ventricular ejection fraction (LVEF) was 0.25, 0.28, and 0.30 in the high, moderate, and low DFT groups, respectively, (p = 0.04). There were significantly more patients with a subcutaneous electrode in the high DFT group (p < 0.001), more patients taking amiodarone (p < 0.001), and more patients on oral anticoagulation (p = 0.04). There were a total of 140 deaths during the follow-up period (mean 3.2 ± 1.7 years). There were 24 deaths in the high DFT group (35.8%), 62 in the moderate DFT group (28.7%), and 54 in the low DFT group (24.0%) (p = 0.05). Implant DFT was a significant predictor of mortality (p = 0.01), as was age, LVEF (p < 0.001), CAD (p = 0.01), amiodarone use (p = 0.02), and hematoma at implant (p = 0.01). An elevated DFT was an independent predictor of mortality after controlling for all significant univariate variables (p = 0.004). CONCLUSIONS: A high-implant DFT predicts an adverse prognosis, even when an adequate ICD safety margin is present.

The role of ventricular tachycardia ablation in the reduction of implantable defibrillator shocks.

Frequent shocks from an implantable defibrillator (ICD) can have adverse cardiac affects and lead to increased pain, anxiety, and a decreased quality of life. Pharmacologic attempts and ICD reprogramming strategies aimed at reducing ICD shocks have modest results, with frequent discontinuation of medicines because of side effects. Ventricular tachycardia (VT) ablation is recommended in the treatment of patients with frequent ICD shocks caused by VT. VT ablation may also be considered in patients with an initial ICD shock and as prophylactic treatment in patients with a history of sustained VT who are undergoing ICD implant.

Cardiac resynchronization therapy in patients with minimally symptomatic heart failure.

Cardiac resynchronization therapy improves mortality and heart failure symptoms in patients with sinus rhythm, depressed left ventricular ejection fraction, a wide QRS complex and moderate-to-severe heart failure symptoms. The results of recent trials suggest that in similar patients with minimal heart failure symptoms cardiac resynchronization therapy is associated with left ventricular reverse remodeling, and may prevent the progression of heart failure.

Does the risk-benefit analysis favor the extraction of failed, sterile pacemaker and defibrillator leads?

Transvenous pacemaker and defibrillator (PM-D) lead failure is an important clinical problem. Lead extraction is routinely performed in patients with transvenous pacemaker and defibrillator (PM-D) infections. The management of sterile PM-D leads that have failed or are no longer required is less uniform. While extraction of excess or failed sterile PM-D leads is often advocated, the risk of lead extraction must be weighed against the risk of abandoning these leads. There are no randomized trials comparing lead extraction with abandoning sterile leads in this setting. What then are the data that are used to advocate the extraction of excess or failed, sterile chronically implanted PM-D leads, and are the data adequate to make this recommendation?

Characterization of the coronary sinus ostium by cardiac magnetic resonance imaging.

The diameter and the angle of the coronary sinus (CS) ostium was analyzed in 101 patients who underwent cardiac magnetic resonance imaging and had left ventricular ejection fractions < or =0.35 (n = 40) or > or =0.65 (n = 61). The angle of the CS ostium in patients with LVEFs < or =0.35 was less acute than in patients with LVEFs > or =0.65 (73 degrees +/- 12 degrees vs 65 degrees +/- 10 degrees, p <0.01). There was no statistically significant difference in the diameter of the CS ostium in patients with LVEFs < or =0.35 compared with those with LVEFs > or =0.65 (8 +/- 3 vs 8 +/- 2 mm, p = 0.5). The diameter and the angle of the CS ostium were not different when analyzed on the basis of the duration of the QRS complex, left atrial dimension, or left ventricular end-diastolic dimension. In conclusion, on the basis of cardiac magnetic resonance imaging data, the angle of the CS is less acute in patients with LVEFs < or =0.35 than in those with LVEFs > or =0.65.

One conversion of ventricular fibrillation is adequate for implantable cardioverter-defibrillator implant: an analysis from the Low Energy Safety Study (LESS).

OBJECTIVES: The purpose of this study was to analyze defibrillation conversion data from the Low Energy Safety Study (LESS) to determine how implant criteria that use fewer inductions of ventricular fibrillation (VF) correlate with outcome and, in particular, to assess the reliability of using a single VF induction and test shock at 14 J. BACKGROUND: A safety margin of 10 J has become standard for implantation of an implantable cardioverter-defibrillator (ICD), but the specifics and rigor of the implant test sequence are not standardized. METHODS: In LESS, 611 ICD recipients completed a rigorous VF induction test scheme that began at 14 J and continued until the energy that succeeded three times without a failure was determined (DFT++). The data were analyzed to determine how well the outcome of the first 14-J shock and various other combinations of first and/or second shocks predicted a rigorous gold standard of DFT++ < or =21 J (i.e., three successes at < or =21 J). RESULTS: The positive predictive accuracy for the 91% of patients in whom the first 14-J shock succeeded was virtually identical to the positive predictive accuracy for the commonly used criteria of two successes at < or =17 J (99.1% vs 99.0%, P = .69), and slightly higher than the positive predictive accuracy for two successes at < or =21 J (98.8%, P = .51). A single success at 17 J or 21 J had a somewhat lower positive predictive accuracy of 98.2% (P = .17). Eliminating VF induction testing would have resulted in a significantly lower positive predictive accuracy of 97.1% (P = .01). CONCLUSIONS: A single conversion success at 14 J on the first VF induction provides similar positive predictive accuracy as two successes at 17 J or 21 J. Using this criterion, 91% of patients meet implant criteria with a single induction of ventricular fibrillation.

Relationship between atrial tachyarrhythmias and symptoms.

OBJECTIVES: The purpose of this study was to correlate patient-reported symptoms of atrial fibrillation with the underlying rhythm. BACKGROUND: The reliability of patient-reported symptoms as a marker of atrial fibrillation recurrence has not been well studied. METHODS: This prospective multicenter trial correlated the recurrence of atrial tachyarrhythmias with symptoms in patients with a history of atrial fibrillation and a standard indication for permanent pacing. Pacemaker-detected atrial tachyarrhythmia events were correlated with symptoms. Patients logged symptomatic events into the device's memory via an external manual activator. Patients were followed for 12 months and were contacted weekly to ensure compliance with activator usage. Episodes were classified as symptomatic atrial tachyarrhythmia, asymptomatic atrial tachyarrhythmia, or symptomatic nonatrial tachyarrhythmia depending on concordance between patient symptoms and the rhythm. RESULTS: Forty-eight patients underwent implantation of a DDDRP pacemaker and were followed for 12 +/- 2 months. A median of 25.0 (4.0-55.8) symptomatic events attributed to atrial fibrillation. A median of 1.0 (0.0-10.0) symptomatic atrial tachyarrhythmia episodes were documented during follow-up. Symptoms related to atrial fibrillation were reported in 6% of atrial tachyarrhythmia episodes identified by the pacemaker. The probability that symptoms were associated with an atrial tachyarrhythmia (positive predictive value) was 17%. The ventricular rate between symptomatic and asymptomatic atrial tachyarrhythmia events was not significantly different. CONCLUSIONS: Among patients with symptomatic bradycardia and a history of atrial fibrillation, symptoms of atrial fibrillation often were not associated with documented atrial tachyarrhythmias, and more than 90% of atrial tachyarrhythmias were clinically silent.

Patient selection for cardiac resynchronization therapy: from the Council on Clinical Cardiology Subcommittee on Electrocardiography and Arrhythmias and the Quality of Care and Outcomes Research Interdisciplinary Working Group, in collaboration with the Heart Rhythm Society.

Cardiac resynchronization therapy (CRT) is a relatively new therapy for patients with symptomatic heart failure resulting from systolic dysfunction. CRT is achieved by simultaneously pacing both the left and right ventricles. Biventricular pacing resynchronizes the timing of global left ventricular depolarization and improves mechanical contractility and mitral regurgitation. Published clinical trials have demonstrated that CRT results in improved clinical status and lower mortality rate when selected patients with systolic ventricular dysfunction and heart failure are treated with CRT. This advisory identifies appropriate candidates for CRT on the basis of the inclusion criteria and results from the published clinical trials.