Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study.

BACKGROUND: Transvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices. Mechanical TLE tools, including rotational sheaths, are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools. OBJECTIVE: To prospectively investigate the safety and effectiveness of mechanical TLE in real-world usage. METHODS: Patients were enrolled at 10 sites in the United States and Europe to evaluate the use of mechanical TLE devices. Clinical success, complete procedural success, and complications were evaluated through follow-up (median, 29 days). Patient data were source verified and complications were adjudicated by an independent clinical events committee (CEC). RESULTS: Between October 2018 and January 2020, mechanical TLE tools, including rotational sheaths, were used to extract 460 leads with a median indwell time of 7.4 years from 230 patients (mean age 64.3 ± 14.4 years). Noninfectious indications for TLE were more common than infectious indications (61.5% vs 38.5%, respectively). The extracted leads included 305 pacemaker leads (66.3%) and 155 implantable cardioverter-defibrillator leads (33.7%), including 85 leads with passive fixation (18.5%). A bidirectional rotational sheath was needed for 368 leads (88.0%). Clinical success was obtained in 98.7% of procedures; complete procedural success was achieved for 96.3% of leads. CEC-adjudicated device-related major complications occurred in 6 of 230 (2.6%) procedures. No isolated superior vena cava injury or procedural death occurred. CONCLUSION: This prospective clinical study demonstrates that use of mechanical TLE tools, especially bidirectional rotational sheaths, are effective and safe.

Speckle-tracking strain echocardiography for detecting cardiac dyssynchrony in a canine model of dyssynchrony and heart failure.

Multiple echocardiographic criteria have been proposed to diagnose mechanical dyssynchrony in patients with heart failure without being validated against a model of cardiac dyssynchrony with heart failure. This study examines which of these methods can detect dyssynchrony in a canine model. Adult mongrel dogs underwent His-bundle ablation and right-ventricular pacing for 4 wk at either 110 bpm to induce dyssynchrony without heart failure (D group, n = 12) or 170 bpm to induce dyssynchrony with heart failure (DHF group, n = 9). To induce heart failure with narrow QRS, atria were paced at 190 bpm for 4 wk (HF group, n = 8). Tissue Doppler imaging (TDI) and two-dimensional echocardiography were performed at baseline and at end of study. Standard deviation of time to peak systolic velocity (color-coded TDI), time to peak S wave on pulse-wave TDI, time to peak radial and circumferential strain by speckle-tracking analysis (E(rr) and E(cc), respectively), and septal-to-posterior wall motion delay on M mode were obtained. In D group, only E(rr) and E(cc) were increased by dyssynchrony. In contrast, all the echocardiographic parameters of dyssynchrony appeared significantly augmented in the DHF group. Receiver-operator curve analysis showed good sensitivity of E(rr) (90%) and E(cc) (100%) to detected dyssynchrony without heart failure and excellent sensitivity and specificity of E(rr) and E(cc) to detect dyssynchrony with heart failure. Radial strain by speckle tracking is more accurate than TDI velocity to detect cardiac dyssynchrony in a canine model of dyssynchrony with or without heart failure.

Cardiac resynchronization therapy.

Cardiac resynchronization therapy (CRT) addresses abnormal left ventricular (LV) activation that produces detrimental effects on cardiac systolic and diastolic function. CRT improves symptoms and ventricular performance, promotes reverse remodeling, and decreases mortality and hospitalization in patients with congestive heart failure (CHF). Atrial-synchronized biventricular stimulation reverses many of the temporal delays in mechanical activation associated with LV dysfunction and conduction system disease. The therapy evolved from anecdotal application through surgical implantation of LV pacing leads to transvenous delivery of LV pacing leads for use with dedicated CRT devices. The controlled clinical trials included specific patient groups, and provided data leading to widely adopted indications for the therapy. Current indications exclude the use of CRT in patients with permanent atrial fibrillation, although small series suggest a benefit of the therapy in these patients. The role of cardiac imaging with echocardiography to detect cardiac dyssynchrony promises to improve patient selection by not only excluding likely nonresponders, but also extending the therapy to those with dyssynchrony in the absence of QRS prolongation. Expanded indications under evaluation include the role of CRT in patients with mildly symptomatic CHF, mild to moderate LV dysfunction, dyssynchrony in the absence of QRS prolongation, and dyssynchrony induced by right ventricular pacing.

Vascular effects of sildenafil in hypertensive cardiac transplant recipients.

BACKGROUND: Sildenafil is commonly used in the treatment of erectile dysfunction in hypertensive male cardiac transplant recipients (CTR); however, little is known about the vascular effects of sildenafil in these patients. METHODS: Central and peripheral arterial blood pressure (BP), heart rate, and brachial artery reactivity were determined in 15 hypertensive male CTR before and after oral sildenafil (50 mg) administration. RESULTS: Sildenafil improved brachial and aortic systolic BP, pulse pressure, aortic augmentation index, left ventricular tension time index, travel time of the reflected aortic pressure wave, and brachial artery reactivity (P <.01 for each comparison). No patient became hypotensive with sildenafil despite continuation of usual antihypertensive medications. CONCLUSIONS: Sildenafil (50 mg) is well tolerated in hypertensive CTR and improves BP, aortic augmentation index, and endothelial function. By decreasing the amplitude of the reflected pressure wave and delaying its return to the heart, sildenafil reduces left ventricular afterload and systolic stress.

Amplitude and timing of central aortic pressure wave reflections in heart transplant recipients.

BACKGROUND: Hypertension (HTN) assessed by sphygmomanometer is a common finding in heart transplant recipients (HTR); however, little is known about the contribution of arterial wave reflection to central aortic pressure in these patients. The aim of this study was to measure the central aortic pressure wave in HTR on antihypertensive therapy and determine the effects of amplitude and timing of wave reflection on the various components of the wave. METHODS: A total of 53 stable adult HTR on antihypertensive medication underwent brachial artery blood pressure ([BP]; by sphygmomanometry) and central aortic pressure (by noninvasive radial artery applanation tonometry and use of a generalized transfer function) measurements at rest. Central aortic augmentation index (Ala), an indicator of arterial stiffness, was calculated from the aortic pressure waveform. Patients were divided into three groups (A, B, and C) based on the amplitude of AIa. RESULTS: Mean brachial BP was 136 +/- 15/84 +/- 9.4 mm Hg. Group A patients (n = 25) had a higher AIa (average 21% +/- 7.6%) than group B (n = 18, AIa = 6.5% +/- 3.0%, P < .001) or group C (n = 10, AIa = -8.7% +/- 8.1%, P < .001) patients. The amplitude of AIa was inversely related to the travel time (delta(t)p/2) of the reflected pressure wave from the periphery to the heart (r = -0.78, P < .001). Despite this clear stratification of patients by aortic pulse wave analysis, standard cuff pressure was similar among the groups. CONCLUSIONS: Noninvasive analysis of the central aortic PRESSURE wave identified a subgroup of hypertensive HTR with increased arterial stiffness, increased propagation of the reflected wave, and augmented aortic systolic and pulse pressure not identified with the sphygmomanometer.