Routine Pressure Wire Assessment Versus Conventional Angiography in the Management of Patients With Coronary Artery Disease: The RIPCORD 2 Trial.

BACKGROUND: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. METHODS: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non-ST-segment-elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. RESULTS: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3-5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613-£7015); and angiography+FFR, £4510 (£2721-£7415; P=0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60-87); and angiography+FFR, 75 (interquartile range, 60-90; P=0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR (P=0.64). CONCLUSIONS: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01070771.

Comparison of Sprint Fidelis and Riata defibrillator lead failure rates.

BACKGROUND/OBJECTIVES: Sprint Fidelis and Riata defibrillator leads are prone to early failure. Few data exist on the comparative failure rates and mortality related to lead failure. The aims of this study were to determine the failure rate of Sprint Fidelis and Riata leads, and to compare failure rates and mortality rates in both groups. METHODS: Patients implanted with Sprint Fidelis leads and Riata leads at a single centre were identified and in July 2012, records were reviewed to ascertain lead failures, deaths, and relationship to device/lead problems. RESULTS: 113 patients had Sprint Fidelis leads implanted between June 2005 and September 2007; Riata leads were implanted in 106 patients between January 2003 and February 2008. During 53.0 ± 22.3 months of follow-up there were 13 Sprint Fidelis lead failures (11.5%, 2.60% per year) and 25 deaths. Mean time to failure was 45.1 ± 15.5 months. In the Riata lead cohort there were 32 deaths, and 13 lead failures (11.3%, 2.71% per year) over 54.8 ± 26.3 months follow-up with a mean time to failure of 53.5 ± 24.5 months. There were no significant differences in the lead failure-free Kaplan-Meier survival curve (p=0.77), deaths overall (p=0.17), or deaths categorised as sudden/cause unknown (p=0.54). CONCLUSIONS: Sprint Fidelis and Riata leads have a significant but comparable failure rate at 2.60% per year and 2.71% per year of follow-up respectively. The number of deaths in both groups is similar and no deaths have been identified as being related to lead failure in either cohort.

Do implantable cardioverter defibrillators improve survival in patients with severe left ventricular systolic dysfunction after coronary artery bypass graft surgery?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether implantable cardioverter defibrillators (ICD) improve survival in patients with severe left ventricular systolic dysfunction (LVSD) after coronary artery bypass graft (CABG) surgery. ICDs are designed to terminate potentially fatal cardiac tachyarrhythmias. A right ventricular lead is mandatory for detection, pacing and defibrillation capabilities. Dual chamber ICDs have an additional right atrial lead and are used for patients with conventional atrioventricular pacing indications. More sophisticated, biventricular devices exist to provide cardiac resynchronisation therapy (CRT) in addition to defibrillation (CRT-D). ICDs have been extensively investigated in patients with LVSD post myocardial infarction and in patients with non-ischaemic cardiomyopathy for both secondary prevention (history of ventricular arrhythmias) and primary prevention (deemed high risk for ventricular arrhythmias). This best evidence topic aims to review the evidence and its applicability to patients post CABG. Nine hundred and sixteen papers were identified using the search method outlined. Eight randomised controlled trials, two meta-analyses, and one non-randomised trial, in addition to international guidelines presented the best evidence to answer the clinical question. The current evidence base and guidelines suggest that ICDs should be considered for all patients with LVSD [ejection fraction (EF) ≤30-40%] receiving optimal pharmacological management, who are ≥40 days post MI [four weeks for National Institute for Health and Clinical Excellence (NICE)] and in New York Heart Association (NYHA) class I-III. UK NICE guidelines require in addition; non-sustained ventricular tachycardia (NSVT) on a Holter monitor and inducible ventricular tachycardia at electrophysiological study for EF between 30 and 35%; or a QRS >120 ms if EF <30%. The North American guidelines recommend EF <30% as a threshold for those with NYHA class I symptoms. The evidence is applicable to patients post CABG, provided all the other criteria are met. European Society of Cardiology (ESC) guidelines recommend waiting at least three months (consensus opinion) after revascularisation prior to assessment for an ICD, to allow time for potential recovery of ventricular function.

In patients undergoing aortic valve replacement, what factors predict the requirement for permanent pacemaker implantation?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question was to determine what preoperative, perioperative and postoperative factors influence the requirement for permanent pacemaker (PPM) implantation postisolated aortic valve replacement (AVR). Transcatheter aortic valve intervention was not included in this analysis. Using the reported search method outlined below, 705 papers were found. No randomised controlled trials, meta-analyses or registries were identified. Seven single-centre retrospective observational studies represent the best evidence on the subject. The author, journal, date and country of publication, level of evidence, patient group studied, study type, outcomes and results were tabulated. The incidence of PPM implantation following AVR varied from 3.0% to 11.8% (mean 7.0%, median 7.2%). Current best available evidence suggests that baseline evidence of conducting system disease - first degree atrioventricular block (AVB), left anterior hemiblock, right bundle branch block (RBBB) or left bundle branch block (LBBB) is the most powerful independent predictor of PPM requirement following AVR. Other important predictors are surgery for aortic regurgitation, preoperative myocardial infarction and longer perioperative cardiopulmonary bypass time. No consistent postoperative factors were identified. The mean time to PPM implant postAVR ranged from 6 to 13 days in the four studies that reported it. Current European Society of Cardiology guidelines recommend a period of seven days of persistent AVB postsurgery prior to PPM implantation.

Postoperative permanent pacemaker implantation in patients undergoing trans-catheter aortic valve implantation: what is the incidence and are there any predicting factors?

A best evidence topic was written according to a structured protocol. The issue was to determine the incidence and predictors of postoperative permanent pacemaker (PPM) implantation in patients undergoing trans-catheter aortic valve implantation (TAVI) for symptomatic calcific aortic stenosis and to compare this to the known risks of this complication following surgical aortic valve replacement (AVR). Using the reported search method 3071 articles were identified, of which 94 were relevant to the procedure of TAVI and 14 were deemed to represent the best evidence. All 14 studies, including both multi-centre registries and single-centre retrospective case series containing ≥30 patients, reported incidence of postoperative PPM implantation. Five of these studies also assessed predictors of the need for postoperative PPM implantation. The author, journal, date and country of publication, study type, level of evidence, patient group, outcomes and results were tabulated for these studies. We conclude that the current best available evidence suggests that the mean incidence of PPM implantation following TAVI is 14.2% (range 0-34%, median 9.7%), although this appears higher with the CoreValve prosthesis (five studies, mean 20.8%, range 9.3-30.0%) than with the Edwards-Sapien prosthesis (six studies, mean 5.4%, range 0-10.1%). The mean incidences of PPM implantation overall and when using the CoreValve prosthesis are higher than the mean incidence of 7.0% (range 3-11.8%, median 7.2%) following conventional AVR and may be explained by distinct differences between the patient groups involved and the procedure performed. Indications for PPM implantation appear to occur early in the postoperative period following TAVI and there is little evidence of recovery following atrioventricular block (AVB). New onset persistent left bundle branch block is common following TAVI but the significance and follow-up required is unclear. Independent predictors of PPM requirement following TAVI include use of the CoreValve prosthesis and evidence of conduction system dysfunction, either pre-existing right bundle branch block or AVB at the time of TAVI. All patients should be made aware of the high risk of PPM implantation with TAVI.

Retrograde catheterisation vs. Doppler echocardiographic evaluation of aortic stenosis--a survey of contemporary UK practice.

UNLABELLED: Aortic stenosis (AS) is the most common indication for valve surgery. Recent data suggested an increased risk of cerebral emboli when the aortic valve is crossed to obtain 'pull-back' gradient. We conducted a large questionnaire based study to evaluate current practice in the assessment of aortic valve gradient amongst cardiologists and the preferences of cardiac surgeons in the UK. E-mail questionnaires were sent to 645 (72%) UK consultant cardiologists and to 198 (92%) UK consultant cardiac surgeons. 232 cardiologists and 52 cardiac surgeons responded. 53% of cardiologists routinely attempt to cross the valve in moderate AS while only 23% do so in severe AS. 38% of cardiologists in the age group '50+ years' cross the valve in severe AS compared to 13% in the age group '30-40 years'. Common reasons given for crossing a stenosed valve included 'to verify the echocardiographic gradient' (85%) and 'maintaining skill' (24%). 64% of cardiologists have changed their views on the necessity of crossing the valve in the last ten years. Although the majority appreciate the increased risk of crossing the valve only 18% of patients are consented differently if crossing the valve is planned. 26% of cardiac surgeons prefer the valve to be crossed to provide information on 'pull-back' gradient, 32% for LV function assessment and 14% to confirm MV competence. 92% would accept echocardiographic data alone if both the gradient and aortic valve area were available and considered correct. CONCLUSIONS: Our survey found that the practice of crossing the aortic valve has changed in the last 10 years and that younger consultant cardiologists are less likely to cross the aortic valve. Increasing confidence in echocardiographic data and potential complications of crossing the valve are implicated. 92% of cardiac surgeons do not require the valve to be crossed if the echo data is considered accurate.