Impact of sacubitril/valsartan on echo parameters in heart failure patients with reduced ejection fraction a prospective evaluation.

BACKGROUND: Sacubitril/valsartan has been shown to improve mortality and reduce hospitalizations in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Although the physiological action mechanisms of sacubitril/valsartan are well described, its effects on left ventricular (LV) remodelling and other echocardiographic (echo) parameters have not been prospectively studied. OBJECTIVE: The aim of this prospective study was to: McMurray et al. (2012) [1] evaluate if sacubitril/valsartan impacts LV remodelling based on echo parameters; Ponikowski et al. (2016) [2] identify the predictive factors of sacubitril/valsartan response or intolerance. METHODS: From May 2017 to September 2018, 52 HF patients were prospectively enrolled using PARADIGM-HF criteria: Class II, III, or IV HF; ejection fraction (EF) of 40% or less; hospitalized for HF within the previous 12 months. Echo evaluation was performed before initiating sacubitril/valsartan and 3 months after optimal dose adjustment. Based on previous studies, patients with (absolute) improvement in left ventricular ejection fraction (LVEF) ≥ 5% were considered significant sacubitril/valsartan responders. RESULTS: The 52 patients completing the study were characterized by age: 70 ±â€¯10 years; gender: 11women; aetiology: idiopathic in 20 and ischaemic in 32; NYHA Class: II in 17 and III in 35; LVEF: 32 ±â€¯5%; NTProBNP: 1805 ±â€¯1914 pg/mL. The final population comprised 41 pts (79%), as 11 (21%) did not tolerate sacubitril/valsartan therapy. Under sacubitril/valsartan, several echo parameters significantly improved: LVEF from 32.6 ±â€¯5 to 36 ±â€¯6% (p < 0.0001); LVES volume from 117 ±â€¯40 to 108 ±â€¯46 mL (p = 0.0051); SEV from 59 ±â€¯12 to 64 ±â€¯13 (p = 0.0061); LVEDD from 60 ±â€¯4 to 57 ±â€¯5 mm (p = 0.0002); mean right ventricular systolic pressure (RVSP) from 39 ±â€¯10 to 32 ±â€¯8 (p = 0.0001). No significant modifications were observed concerning LV diastolic parameters or RV echo parameters. Sacubitril/valsartan echo responders (n = 18/41; 42%) had less severe LV remodelling, as shown by LVEDV: 144 ±â€¯37 vs. 193 ±â€¯47 mL, p = 0.0009; LVESV: 96 ±â€¯28 vs. 133 ±â€¯42 mL; p = 0.003; LVTDD: 61 ±â€¯4 vs. 57 ±â€¯5 mm; p = 0.02; significant mitral regurgitation: 6/18 (33%) vs. 16/23 (69%), p = 0.02; no diastolic LV or RV parameters impacted sacubitril/valsartan response. Predictors of sacubitril/valsartan intolerance were baseline creatinine level: 137 ±â€¯99 vs. 100 ±â€¯24, p = 0.03; LVEF: 29 ±â€¯6 vs. 33 ±â€¯5%; p = 0.04. CONCLUSIONS: In HFrEF patients, sacubitril/valsartan significantly improves LV systolic remodelling, without any significant effects on LV diastolic or RV systolic echo parameters. Sacubitril/valsartan responders exhibit both less severe LV remodelling and less significant mitral regurgitation. Accordingly, sacubitril/valsartan could be used as soon as possible in HFrEF patients in order to limit LV remodelling, while precluding non-response or intolerance.

Comparison of prevalence and management of left atrial appendage thrombi under old and new anticoagulants prior to left atrial catheter ablation.

BACKGROUND: The prevalence and management of left atrial appendage (LAA) thrombi associated with new anticoagulants remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to (1) compare the prevalence of LAA thrombi and/or severe LAA contrast under vitamin K antagonist (VKA) agents and novel oral anticoagulants (NOACs), (2) evaluate the rate of LAA thrombus resolution after anticoagulation modification, and (3) determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation. METHODS: Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included, and the prevalence of transesophageal echocardiography-detected thrombi was similar under NOACs (2.1%) and VKA agents (2.6%). RESULTS: Thrombus resolution was obtained in 50% of cases following anticoagulation modification. Through multivariate exact logistic regression analysis with relevant clinical and echocardiographic features, age (P<.001), LAA hypocontractility (P<.001), and left ventricular ejection fraction (P=.007) were found to be independently associated with the occurrence of LAA thrombus. The relevant factors independently associated with LAA thrombus or severe contrast were LAA hypocontractility (P<.001) and age (P<.001). CONCLUSIONS: The prevalence of transesophageal echocardiography-detected thrombi in patients referred for AFib ablation is similar under NOACs (2.1%) and VKA agents (2.6%). Under VKA therapy with 3-4 international normalized ratio, 50% of thrombi dissolved. Independent predictive factors of procedure contraindication included age, LAA hypocontractility, and left ventricular ejection fraction.

Substantial superiority of Niobe ES over Niobe II system in remote-controlled magnetic pulmonary vein isolation.

BACKGROUND: Catheter ablation of atrial fibrillation (AFib) primarily relies upon pulmonary vein isolation (PVI), but such procedures are associated with significant X-ray exposure. The newer Epoch system has been developed so as to enable more precise magnetic navigation whilst limiting X-ray exposure. OBJECTIVES: This study was aimed at quantifying both exposure time and X-ray reduction with the newer Epoch system compared to Niobe II during AFib ablation procedures. METHODS: From November 2011 to November 2013, our last 92 consecutive patients treated with the Niobe ES (Epoch Solution; 4th generation magnetic navigation technology) system were compared with the first 92 consecutive patients treated using the Niobe II system (3rd generation magnetic navigation technology) for symptomatic drug-refractory AFib. RESULTS: Mean patient age was 59±11years (20% female), and the study population was affected by either symptomatic paroxysmal (65.2%) or persistent (34.8%) AFib. Median procedure time was 2±0.5h and median total X-ray exposure 12.3±6.4min. Procedure time (1.9±0.4 vs. 2.7±1h, p<0.0001) and X-ray duration (12±4 vs. 15±7min, p=0.001) were significantly lower with Niobe ES than with the Niobe II system. X-ray ablation exposure time was also significantly lower with the Niobe ES system than with the Niobe II system (2.9±2 vs. 4±3.5min; p=0.01). Through multivariate analysis, the only predictive factors influencing both procedure duration and X-ray exposure were found to be the Niobe ES system use and LA size. CONCLUSIONS: Our study was the first to demonstrate that the new Niobe ES magnetic robotic system substantially reduced overall operating, fluoroscopy, and ablation times during AFib ablation procedure.

Transcatheter leadless cardiac pacing: The new alternative solution.

INTRODUCTION: A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. METHODS AND RESULTS: Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. CONCLUSION: This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population.

Robotic magnetic navigation for ablation of human arrhythmias.

Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation. As ongoing developments will likely improve results and procedure times, this technology will become one of the most modern technologies for treating arrhythmias. Based on the literature, this review summarizes the advantages and limitations of robotic magnetic navigation for ablation of human arrhythmias.

Preoperative skin antiseptics for prevention of cardiac implantable electronic device infections: a historical-controlled interventional trial comparing aqueous against alcoholic povidone-iodine solutions.

AIMS: Local skin antiseptic prevention against cardiac implantable electronic device (CIED) infections is not yet fully understood. This monocentre historical-controlled study sought to (i) conduct a prospective observational analysis comparing two antiseptic skin preparations over two similar consecutive periods of time, one conducted over a 1-year period using an aqueous povidone-iodine solution (Group I) and the other over the following with an alcoholic povidone-iodine solution (Group II); (ii) determine the predictive factors of CIED infection. METHODS AND RESULTS: Cardiac implantable electronic device implantation was performed in 1326 patients (pts). A total of 32 pts (2.4%) developed a CIED infection. Long-term follow-up (26 ± 3 months) revealed no significant difference between the groups: infections were observed in 14 of the 648 pts (2.2%) in Group I vs. 18 of the 678 pts (2.7%) in Group II (P = 0.9). Single- and multiple-variable logistic regression analyses were performed to identify risk factors; adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. The occurrence of infection was positively correlated with re-intervention (aOR, 7.16; 95% CI, 2.56-19.99; P < 0.0001), number of generator replacements, mean (aOR, 3.47; 95% CI, 2.22-5.44; P < 0.001), and haematoma (aOR, 48.4; 95% CI, 13.45-174.25; P < 0.0001). CONCLUSION: This study found that aqueous and alcoholic povidone-iodine solutions displayed similar antiseptic effects regarding CIED infection prevention. Independent predictive factors of CIED infection were re-intervention, haematoma, and number of generator replacements.

Remote-controlled magnetic pulmonary vein isolation combined with superior vena cava isolation for paroxysmal atrial fibrillation: a prospective randomized study.

BACKGROUND: Radiofrequency ablation (RFA) of paroxysmal atrial fibrillation (PAF) has focused on pulmonary vein isolation (PVI). However, despite initial positive results, significant recurrences have occurred, partly because of pulmonary vein (PV) reconnection or non-PV ectopic foci, including the superior vena cava (SVC). OBJECTIVES: This prospective, randomized study sought to investigate the efficacy of additional SVCI combined with PVI in symptomatic PAF patients referred for ablation. METHODS: From November 2011 to May 2013, RFA was performed remotely using a CARTO(®) 3 System in patients randomized to undergo PVI for symptomatic drug-refractory PAF, with (PVI+SVCI group) or without (PVI alone group) SVCI. PVI and SVCI were confirmed by spiral catheter recording during ablation. Procedural data, complications and freedom from atrial tachycardia (AT) and atrial fibrillation (AF) were assessed. RESULTS: Over an 18-month period, 100 consecutive patients (56±9years; 17 women) with symptomatic PAF were included in the study (PVI+SVCI, n=51; PVI, n=49); the CHA2DS2-VASc score was 0.9±1. Median duration of procedure (±interquartile), 2.5±1hours; total X-ray exposure, 13.3±8minutes; transseptal puncture and catheter positioning, 8±5minutes; left atrium electroanatomical reconstruction, 3±2minutes; and catheter ablation, 3.7±3minutes. After a median follow-up of 15±8months, and having undergone a single procedure, 84% of patients were symptom free, while 86% remained asymptomatic after undergoing two procedures. The cumulative risks of atrial arrhythmias (AT or AF) were interpreted using Kaplan-Meier curves and compared using the log-rank test. Long-term follow-up revealed no significant difference between groups, with atrial arrhythmias occurring in six (12%) patients in the PVI+SVCI group and nine (18%) patients in the PVI alone group (P=0.6). One transient phrenic nerve palsy and one phrenic nerve injury with partial recovery occurred in the PVI+SVCI group. CONCLUSIONS: SVCI combined with PVI did not reduce the risk of subsequent AF recurrence, and was responsible for two phrenic nerve injuries. Accordingly, the benefit-to-risk ratio argues against systematic SVCI.

Does a patent foramen ovale matter when using a remote-controlled magnetic system for pulmonary vein isolation?

BACKGROUND: Pulmonary vein isolation (PVI) takes longer when using a patent foramen ovale (PFO) compared with a transseptal puncture in paroxysmal atrial fibrillation (AF) with manual catheter ablation. To our knowledge, no data exist concerning the impact of a PFO on AF ablation procedure variables when using a remote magnetic navigation (RMN) system. AIM: To assess the impact of a PFO when using an RMN system in patients requiring AF ablation. METHODS: Between December 2011 and December 2012, catheter ablation was performed remotely using the CARTO(®) 3 system in 167 consecutive patients who underwent PVI for symptomatic drug-refractory AF. The radiofrequency generator was set to a fixed power ≤ 35 W. The primary endpoint was wide-area circumferential PVI confirmed by spiral catheter recording during ablation for all patients and including additional lesion lines (left atrial roof) or complex fractionated atrial electrograms for persistent AF. Secondary endpoints included procedural data. RESULTS: Mean age 58±10 years; 18% women; 107 (64%) patients with symptomatic paroxysmal AF; 60 (36%) with persistent AF; CHA2DS2-VASc score 1.2 ± 1. The PFO presence was evidenced in 49/167 (29.3%) patients during the procedure but in only 26/167 (16%) by transoesophageal echocardiography. Median procedure time 2.5 ± 1 hours; median total X-ray exposure time 14 ± 7 minutes; transseptal puncture and catheter positioning time 7.5 ± 5 minutes; left atrium electroanatomical reconstruction time 3 ± 2.3 minutes; catheter ablation time 3 ± 3 minutes. No procedure time or X-ray exposure differences were observed between patients with or without a PFO during magnetic navigation catheter ablation. X-ray exposure time was significantly reduced using a PFO compared with double transseptal puncture access. CONCLUSIONS: A PFO does not affect magnetic navigation during AF ablation; procedure times and X-ray exposure were similar. Septal catheter probing is mandatory to limit X-ray exposure and prevent potential complications.

Remote-controlled magnetic pulmonary vein isolation using a new three-dimensional non-fluoroscopic navigation system: a single-centre prospective study.

BACKGROUND: Catheter ablation of atrial fibrillation (AF) focuses on pulmonary vein isolation (PVI), but the procedure is associated with significant X-ray exposure. Few data exist concerning the combination of remote magnetic navigation (RMN) and a new three-dimensional non-fluoroscopic navigation system (Carto(®) 3), which facilitates precise catheter navigation and limits X-ray exposure. AIMS: To assess the efficacy and extent of fluoroscopic exposure associated with the combination of RMN and the Carto 3 system in patients requiring AF ablation. METHODS: Between January and September 2011, catheter ablation was performed remotely using the Carto 3 system in 81 consecutive patients who underwent PVI for symptomatic drug-refractory AF. The radiofrequency generator was set to a fixed power ≤ 35W. The primary endpoint was wide-area circumferential PVI confirmed by spiral catheter recording during ablation and including additional lesion lines (left atrial roof and coronary sinus defragmentation) or complex fractionated atrial electrograms for persistent AF. Secondary endpoints included procedural data, complications and freedom from atrial tachycardia (AT)/AF. RESULTS: Mean age was 60 ± 9 years; 20% were women; 73% had symptomatic paroxysmal AF; 27% had persistent AF. The CHA2DS2-VASc score was 1.2 ± 1. Median procedure time was 3.5 ± 1 hours; median total X-ray exposure time was 13 ± 7 minutes; transseptal puncture and catheter positioning took 8 ± 4 minutes, left atrium electroanatomical reconstruction 1 ± 4 minutes and catheter ablation 3.5 ± 5minutes. Recurrences were AT (n=3; 3.7%), paroxysmal AF (n=8; 9.9%) and persistent AF (n=4; 4.9%); redo ablation was performed in these 15 (19%) patients. After a median follow-up of 15 ± 6 months and a single procedure, 71% of patients were free of symptoms; 84% remained asymptomatic after two procedures. CONCLUSIONS: RMN with irrigated catheters combined with the Carto 3 system can be effectively performed in patients requiring AF ablation with minimal use of fluoroscopy, but larger randomized studies are warranted.

Focus on right ventricular outflow tract septal pacing.

Experimental and clinical studies have shown that right ventricular apical pacing may result in long-term deleterious effects on account of its negative impact on left ventricular remodeling through desynchronization. This risk appears more pronounced in patients with even moderate left ventricular dysfunction and generally occurs after at least 1 year of pacing. As right ventricular apical pacing may be associated with the development of organic mitral insufficiency, other sites that allow for more physiological stimulation, such as right ventricular outflow tract septal pacing, have been developed, with good feasibility and reproducibility. However, the prospective randomized studies and meta-analyses to date have only demonstrated a modest effect on ejection fraction in the medium term, without any significant effect on quality of life and morbimortality. However, the absence of a favorable effect for right ventricular outflow tract septal pacing compared with right ventricular apical pacing in terms of clinical manifestations and patient prognosis appears to be more associated with the designs of these studies, which were not homogeneous with regard to methodology used, judgment criteria, follow-up and, especially, statistical power. Two randomized prospective multicentre studies are currently ongoing in order to evaluate the favorable effect of infundibular septal pacing, when considering the indirect negative effects of right ventricular apical pacing as reported in the literature.

Clinical impact of the implantable loop recorder in patients with isolated syncope, bundle branch block and negative workup: a randomized multicentre prospective study.

BACKGROUND: Few studies have compared conventional testing with prolonged monitoring using an implantable loop recorder (ILR) following the first syncope episode in patients with bundle branch block (BBB) and negative workup. OBJECTIVES: To compare two syncope evaluation strategies-primary use of an ILR (Group 1) versus conventional testing (Group 2)-and to estimate the prevalence of significant arrhythmias in the ILR patient subset. METHODS: From January 2005 to December 2010, 78 patients admitted after one syncope episode were randomized to ILR (n=41) or conventional follow-up (n=37). Mean follow-up was 27 ± 12 months. RESULTS: Mean age was 76 ± 8 years and 30 patients were women (38.5%); 18 presented cardiomyopathy (23%) and 12 had a history of atrial fibrillation (15.4%). Mean left ventricular ejection fraction was 56.5 ± 11% and mean His-to-ventricle interval was 55 ± 6ms based on negative electrophysiological study (EPS). Electrocardiogram abnormalities involved: 34 left bundle branch blocks (BBBs); 11 right BBBs; and 33 bifascicular blocks. Overall, 21 patients (27%) developed significant arrhythmic events: ventricular tachycardia (n=1; 1.3%); sudden death (n=2; 2.6%); third-degree atrioventricular (AV) block (n=14; 18%); sick sinus syndrome (n=4; 5.1%). In 19 (24.4%) patients, relevant arrhythmias were detected, with a significant difference between the ILR group (n=15/41; 36.6%) and the conventional follow-up group (n=4/37; 10.8%) (P=0.02). Eighteen patients were implanted with pacemakers; one received an implantable defibrillator. No predictors of AV block were identified in the ILR group. CONCLUSIONS: In this randomized prospective study, the ILR strategy proved largely superior to conventional follow-up in detecting recurrent events, with a potential impact on therapeutic management. This observation highlights the usefulness of early monitoring in patients with BBB and negative EPS even after the first syncope episode but an empiric pacemaker strategy remains to be validated in this selected population.

Remote magnetic navigation and arrhythmia ablation.

Radiofrequency treatment is the first-choice treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared with antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications including tamponade. Given this context, robotic magnetic navigation is a technique well suited to the treatment of complex arrhythmias, on account of its efficacy and reliability, the significant reduction in X-ray exposure for both patient and operator, and the very low risk of perforation. As ongoing developments will likely improve results and procedure times, this technology will become one of the most advanced for treating arrhythmias.

A single-centre experience concerning the safety of Sprint Fidelis defibrillator lead extraction at the time of pulse generator replacement or in case of evidence of lead failure.

BACKGROUND: The reported failure rate of the Sprint Fidelis defibrillator lead (SFDL) has increased more than initially expected, with emerging evidence of accelerating fracture rates. Current consensus guidelines continue to discourage prophylactic lead extraction, citing major complication rates of 1.4-7.3%. Therefore, data relating to the risks of systematic SFDL extraction are lacking, with no methodical extraction protocol reported to date. Moreover, few statistical analyses have identified predictors of SFDL failure. OBJECTIVES: The aims of this single-centre study were: to examine the safety and feasibility of systematic SFDL extraction at the time of pulse generator replacement or in case of lead failure; and to identify predictors of SFDL failure. METHODS: Between January 2005 and October 2007, 218 consecutive patients underwent transvenous SFDL implantation in our centre. RESULTS: During a mean follow-up of 43 ± 15 months, SFDL extraction was performed in 49 patients (22.5%) for the following reasons: inappropriate shocks (n = 21; 9.6%), systematic extraction at time of pulse generator extraction (n = 23; 10.5%), high impedance (n = 3; 1.4%), high SFDL threshold (n = 1; 0.4%) and cardiac device-related infection (n = 1; 0.4%). No severe complications occurred, although two minor complications were reported (lead dislodgments). SFDL fracture was observed in 25 patients (11.5%; 3.2%/year incidence). The only predictor associated with SFDL fracture was the number of leads (P = 0.01). CONCLUSION: In our series, SFDL extraction at the time of pulse generator extraction or in case of evidence of lead failure was feasible and safe. Number of leads was identified as a new predictive factor for SFDL fracture.

Single-centre experience with an 8-mm tip catheter for radiofrequency catheter ablation of outflow tract ventricular ectopic beats.

BACKGROUND: Radiofrequency ablation (RFA) of outflow tract ventricular ectopic beats (OTVEBs) can be performed using a 4-mm or externally-cooled tip RFA catheter, but no data are available concerning the safety and efficacy of a large-tip (8-mm) catheter. AIMS: To evaluate the feasibility of using an 8-mm tip catheter in patients with OTVEBs. METHODS: In this prospective cohort study, the 8-mm tip catheter was tested in patients who were referred to our centre for RFA of symptomatic OTVEBs. RESULTS: The mean age of the 16 patients recruited between September 2008 and March 2010 was 53±18 years and 56.3% were male. Mean left ventricular ejection fraction was 62±9%, mean ventricular ectopic beat width was 144±21 ms, and all patients had left bundle branch block. Fourteen patients had inferior axis QRS morphology and two had superior. The main symptoms were palpitations and pre-syncope. RFA parameters were: procedure time 94±35 min; duration of application 11±10 min; impedance 81±12 Ω; temperature 50±5 °C; and power 46±17 W. RFA succeeded in 15 over 16 patients (93.8%); and recurrence was seen in one patient after a mean follow-up time of 11±6 months. No complications were noted. CONCLUSIONS: This preliminary study suggests that an 8-mm tip catheter may represent an alternative for RFA in patients with OTVEBs in whom a 4-mm tip was not successful. Larger randomized studies are therefore warranted.

Anatomical factors involved in difficult cardiac resynchronization therapy procedure: a non-invasive study using dual-source 64-multi-slice computed tomography.

AIMS: In cardiac resynchronization therapy (CRT) procedure, left ventricular (LV) lead implantation is time consuming. In this clinical setting, no study has investigated the impact of right atrium anatomical parameters on both CRT implantation procedure duration and X-ray exposure. Additionally, only few studies have examined the coronary sinus (CS) using dual-source 64-multi-slice computed tomography (DS 64-MSCT), and its impact on CRT procedure parameters has not yet been investigated. The aim of this prospective study was to identify local anatomical predictive factors of difficult CRT implantation procedure using DS 64-MSCT. METHODS AND RESULTS: Between January and July 2010, 50 consecutive patients underwent primo CRT implantation. The patient population had a mean age of 70 ± 10 years, and was 34% female, with New York Heart Association Class 3.2 ± 0.3 heart failure, left ventricle ejection fraction 30 ± 4%, and QRS width 157 ± 30 ms. Cardiac resynchronization therapy implantation was attempted in 50 patients, and first LV lead implantation was obtained in 49 of 50 patients (98% primary success). One implantation failed (2%) due to unsuccessful LV lead implant. Procedure parameters were as follows: LV threshold, 1.4 ± 0.8 V; LV wave amplitude, 17 ± 8 mV; LV impedance, 830 ± 240 Ω; median procedure time (skin to skin), 51 min (38 min); median fluoroscopy procedure time, 11.9 min (22 min); and median LV fluoroscopic time, 10.3 min (22 min). In 10 patients (20%), procedures were difficult requiring an implantation lasting ≥ 85 min. The only predictive factor for difficult CRT implantation was the insertion level of the CS ostium (CSO), evaluated by the distance between the CSO and the bottom floor of the right atrium (14.8 ± 4 vs. 9.5 ± 4; P= 0.01). Neither the right atrium dilation nor right ventricular dysfunction was associated with difficult CRT implantation procedures. CONCLUSIONS: Today, despite improvements in the materials used, problems still remain in the CRT procedure. In this clinical setting, the only predictive factor for very long CRT procedures is the CSO-level insertion (located high). This anatomical anomaly identified by DS 64-MSCT prior to surgery is responsible for 20% of difficult CRT device implantation procedures.

Predictive factors of difficult implantation procedure in cardiac resynchronization therapy.

AIMS: The usefulness of cardiac resynchronization therapy (CRT) in patients with congestive heart failure is offset by its long, user-dependent, and technical procedure. No studies have been published regarding factors related to CRT implantation procedure duration and X-ray exposure. Additionally, only a few studies have investigated the predictive factors of primary left ventricular (LV) lead implant failure. The aim of this prospective study was two-fold: (i) to evaluate the prevalence and predictive factors of prolonged CRT implantation procedure and (ii) to identify the predictive factors of primary LV lead implantation failure. METHODS AND RESULTS: Between November 2008 and September 2009, 128 consecutive patients underwent CRT implantation; of these, 22 patients (17.2%) were excluded because of CRT generator replacement. Population characteristics were a mean age of 69 +/- 10 years, 28.3% female, New York Heart Association class 3.2 +/- 0.3, LV ejection fraction (LVEF; 29 +/- 6%), and QRS width 146 +/- 23 ms. Cardiac resynchronization therapy implantation was attempted in 106 patients, and first LV lead implantation was obtained in 96 of 106 patients (90.5% primary success). Ten primary implantations failed (9.5%), due to unsuccessful LV lead implants. A second procedure was successfully attempted in six patients with a second more experienced operator (5.7%). Among the remaining four patients, one patient required a surgical epicardial LV lead implantation, and the implantation was not reattempted in the other three patients. The overall success rate of CRT system implantation was 96.2% (102 of 106 patients). Procedure parameters were as follows: LV threshold (1.4 +/- 0.9 V); LV wave amplitude (15 +/- 8 mV); LV impedance (874 +/- 215 ohm); median procedure time (skin to skin), 55 min (45-80); and median of procedure fluoroscopy time, 11 min (6.2-29). In 24 patients (22.6%), difficult procedures requiring >or=85 min of implantation duration occurred. By univariate analysis, predictive factors of difficult implantation were LV ejection fraction (25.6 +/- 6 vs. 30.2 +/- 8%; P = 0.02), LV end-diastolic diameter (72.4 +/- 11 vs. 66 +/- 11 mm; P = 0.01), LV end-systolic diameter (LVESD; 62 +/- 12 vs. 56 +/- 12 mm, P = 0.04), and the operator's experience (very experienced operator vs. less experienced operator, P = 0.006). By multivariate analysis, only primary LV lead implantation failure, LVESD, and operator's experience were independently associated with difficult procedures. In this patient subset with primary LV lead implant failure (n = 10), the only independent predictive factor was the LV end-systolic volume (P = 0.03). CONCLUSION: In this study, the rate of difficult CRT device implantation procedures approached 25%. Both the degree of LV dysfunction and the operator's experience were independent predictors of surgical difficulties. Left ventricular end-systolic volume was the only independent predictor of primary LV lead implant failure.