Chronic performance of Riata 1580 and Endotak 0158 ICD leads: A single center 10-year experience.

BACKGROUND: The long-term performance of the Riata family of leads has recently come under increasing scrutiny. We aimed to determine the long-term performance of the Riata 1580 leads compared with Endotak 0158 leads. METHODS: All patients with Riata 1580 or Endotak 0158 leads implanted from 2003 to 2008 at the Heart Hospital, UCLH were analyzed. Significant electrical changes were as follows: threshold increase >1 V at a set pulse width between pacing checks, persistent R wave fall to <2 mV or reduction in R wave >50%, noise, pacing impedance change to <300 Ω or >1500 Ω, high voltage (HV) change to <20 Ω or >200 Ω, HV change ± 15 Ω, pacing impedance change >400 Ω over 12 months. RESULTS: 333 Riata and 356 Endotak leads were implanted. Median follow-up time + interquartile range were calculated, after exclusion of censored events including loss to follow-up: Riata 3652 + 655 days, Endotak 3730 + 810 days. A total of 51 (15.9%) Riata leads and 21 (6.3%) Endotak leads were affected. A greater risk of failure was found for the Riata lead compared with the Endotak lead (P = .0001). An additional time-dependent effect was found, with the Riata lead 1.9 times more likely to fail in the first 6 years following lead implantation and 5.3 times more likely to fail after 6 years. CONCLUSIONS: Riata leads have a higher risk of failure compared to Endotak leads over time. The importance of careful ongoing performance surveillance late in the leads' lifetime is reflected in this 10-year follow-up study.

Transseptal puncture performed with the new needle-free 'SafeSept' guidewire: a multicentre experience.

PURPOSE: Increasing numbers of transseptal punctures (TSP) are performed for different cardiac interventions, especially for left atrial (LA) ablation of atrial fibrillation (AF). Significant TSP-related complications may occur even by experienced operators. Any strategies to mitigate these should be adopted. Previous reports have confirmed the safety and efficacy of the first generation nitinol guidewire for TSP. The objective was to assess the safety and efficacy of a new nitinol 'needle free' SafeSept guidewire (NFSG) for TSP. The distal J-shaped tip (0.014 in.) of the NFSG is unchanged in design; however, the shaft is thicker (0.0315 in.) and stiffer. METHODS: This is a multicentre study evaluating TSP without a transseptal needle, using the NFSG via a standard transseptal sheath-dilator, in patients with an indication for TSP. RESULTS: A total of 145 consecutive unselected patients were studied. The mean patient age was 59 ± 15. Thirty-one (21.4%) were female and 43 (29.7%) had a previous procedure requiring TSP. The mean transverse LA diameter was 4.0 ± 0.8 cm. AF or LA tachycardia comprised the major indication for TSP (n = 115). Transesophageal echocardiography for direct guidance of TSP was utilised in cases performed under general anesthesia (n = 66, 45.5%). LA access by TSP using the NFSG was achieved successfully in 100% of cases after 1.6 ± 2.3 passes. There were no TSP or other major procedural complications. CONCLUSIONS: Use of the NFSG appears to be a safe and effective method in performing TSP. The major improvement in the design of the NFSG is that TSP can be performed without a transseptal needle and exchange for a standard guidewire is not required upon establishing LA access.

Gaining approval for clinical research.

Set-up and delivery of a clinical research project can be complicated and difficult. This article introduces the regulatory processes involved in gaining approval for clinical research and discusses the obstacles that may be encountered.

Long-Term Results of Triventricular Versus Biventricular Pacing in Heart Failure: A Propensity-Matched Comparison.

OBJECTIVES: The goal of this study was to assess the impact of triventricular pacing (Tri-V) on long-term survival. BACKGROUND: Biventricular pacing (Bi-V) is an important adjunctive treatment in advanced heart failure, but almost one-third of patients experience no improvement with this therapy and are labeled as nonresponders. Adding a third ventricular lead (Tri-V) has been shown to be feasible and provides favorable acute results when assessed by using echocardiographic, hemodynamic, and clinical endpoints. However, the long-term effects of Tri-V pacing and how it affects long-term survival remains unknown. METHODS: This single-center, propensity score-matched cohort study compared 34 patients with advanced heart failure who underwent implantation with Tri-V devices versus 34 control subjects treated with Bi-V pacing. Clinical outcomes during a median of 2,478 days (IQR: 1,183 to 3,214 days) were compared. RESULTS: Tri-V-treated patients compared with Bi-V-treated patients presented with a trend for shorter battery longevity (time to box change, 1,758 ± 360 days vs. 1,993 ± 408 days; p = 0.072). Incidence of lead dislodgement (Tri-V vs. Bi-V, 0.86 vs. 1.10 per 100 patient-years; p = 0.742), device-related infection (Tri-V vs. Bi-V, 1.83 vs. 1.76 per 100 patient-years; p = 0.996), and refractory phrenic nerve capture (Tri-V vs. Bi-V, 0.48 vs. 1.84 per 100 patient-years; p = 0.341) was comparable in the 2 groups. Episodes of ventricular arrhythmia requiring implantable cardioverter-defibrillator intervention occurred more frequently in the Bi-V group versus the Tri-V group (6.55 vs. 16.88 per 100 patient-years; adjusted hazard ratio: 0.31; 95% confidence interval: 0.14 to 0.66; p = 0.002). Lower all-cause mortality and heart transplant was observed in the Tri-V group compared with the Bi-V group (6.99 vs. 11.92 per 100 patient-years; adjusted hazard ratio: 0.44; 95% confidence interval: 0.23 to 0.85; p = 0.015). CONCLUSIONS: Tri-V displayed a similar safety profile compared with Bi-V and was associated with potential benefits regarding long-term survival and ventricular arrhythmia burden.

Cardiac resynchronisation therapy: a randomised trial of factory or echocardiographic settings for optimum response.

BACKGROUND: We aimed to assess whether echocardiographically-optimised atrioventricular (AV) and interventricular (VV) delay programming provided any additional benefit over standard settings following biventricular pacemaker implantation in patients with advanced heart failure. METHODS: Paired data were collected on 22 patients (aged 67.5 ± 8.3 years, 16 male) with refractory heart failure, NYHA class III/IV symptoms, sinus rhythm, LBBB and a broad QRS complex >120 ms. All patients underwent implantation of a biventricular pacemaker and were randomised to eight weeks of factory pacing mode (Mode 1) or echocardiographically-guided pacing mode (Mode 2), followed by eight weeks in the alternate mode, in a randomised blinded crossover design. RESULTS: Peak oxygen consumption, 6 min walk distance, NYHA class and quality of life scores improved after biventricular pacing, but no significant difference was found between the two modes, with the exception of peak oxygen consumption score (baseline: 14.8 ± 0.9, Mode 1: 14.6 ± 1.2, Mode 2: 16.1 ± 1.2 mL/kg/min), which was better in Mode 2 than Mode 1 (p 0.003). CONCLUSION: Transthoracic echocardiographic optimisation of AV and VV delays following biventricular pacing may offer additional clinical benefit in an unselected group of patients when compared with factory settings.