ST-segment elevation myocardial infarction: Management and association with prognosis during the COVID-19 pandemic in France.

BACKGROUND: Systems of care have been challenged to control progression of the COVID-19 pandemic. Whether this has been associated with delayed reperfusion and worse outcomes in French patients with ST-segment elevation myocardial infarction (STEMI) is unknown. AIM: To compare the rate of STEMI admissions, treatment delays, and outcomes between the first peak of the COVID-19 pandemic in France and the equivalent period in 2019. METHODS: In this nationwide French survey, data from consecutive STEMI patients from 65 centres referred for urgent revascularization between 1 March and 31 May 2020, and between 1 March and 31 May 2019, were analysed. The primary outcome was a composite of in-hospital death or non-fatal mechanical complications of acute myocardial infarction. RESULTS: A total of 6306 patients were included. During the pandemic peak, a 13.9±6.6% (P=0.003) decrease in STEMI admissions per week was observed. Delays between symptom onset and percutaneous coronary intervention were longer in 2020 versus 2019 (270 [interquartile range 150-705] vs 245 [140-646]min; P=0.013), driven by the increase in time from symptom onset to first medical contact (121 [60-360] vs 150 [62-420]min; P=0.002). During 2020, a greater number of mechanical complications was observed (0.9% vs 1.7%; P=0.029) leading to a significant difference in the primary outcome (112 patients [5.6%] in 2019 vs 129 [7.6%] in 2020; P=0.018). No significant difference was observed in rates of orotracheal intubation, in-hospital cardiac arrest, ventricular arrhythmias and cardiogenic shock. CONCLUSIONS: During the first peak of the COVID-19 pandemic in France, there was a decrease in STEMI admissions, associated with longer ischaemic time, exclusively driven by an increase in patient-related delays and an increase in mechanical complications. These findings suggest the need to encourage the population to seek medical help in case of symptoms.

Radiation Exposure for Percutaneous Interventions of Chronic Total Coronary Occlusions in a Multicenter Registry: The Influence of Operator Variability and Technical Set-up.

AIMS: Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose. METHODS AND RESULTS: We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 ± 1.44 to 2.46 ± 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy•cm² (IQR, 70-241 Gy•cm²) to 102 Gy•cm² (IQR, 58-184 Gy•cm²). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences. CONCLUSIONS: Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.

Impact of ß-blocker therapy on right ventricular function in heart failure patients with reduced ejection fraction. A prospective evaluation.

BACKGROUND: Beta-blocker (ß-blocker) therapy 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 ß-blockers are well described, their effects on right ventricular (RV) function have not been prospectively studied. OBJECTIVE: This prospective study aimed to (a) evaluate whether ß-blocker therapy impacts RV remodeling based on echo parameters and (b) determine the predictive echo factors of ß-blocker therapy response. METHODS: From September 2017 to September 2018, HF patients were prospectively enrolled using CIBIS criteria: Class II, III, or IV HF; left ventricular ejection fraction (LVEF) of ≤40%; hospitalized for HF within the previous 12 months. Echo evaluation was performed before initiating ß-blocker therapy and 3 months after optimal dose adjustment. Based on previous studies, patients with (absolute) LVEF ≥ 5% improvement were considered significant ß-blocker therapy responders. RESULTS: Overall, 40 patients (pts) completed the study, characterized as follows by age: 70 ± 10 years; gender: 10 women; cardiomyopathy etiology: idiopathic in 24 and ischemic in 16; NYHA Class: II in 22 and III in 10; LVEF: 32 ± 5%; and NTProBNP: 2665 ± 2400 pg/mL. The final population comprised 32 pts (79%), with eight (21%) excluded: two because of ß-blocker therapy intolerance, one lost to follow-up, and five withdrew from the study. Under ß-blocker therapy, several echo parameters significantly improved: LVEF from 31.7 ± 9 to 40.5 ± 9 (P < .0001); LV end-diastolic volume (EDV) from 154 ± 54 to 143 ± 45 mL (P = .06); LV end-systolic volume (ESV) from 107 ± 49 to 88 ± 37 mL (P = .0006); LV ES from 46 ± 11 to 64 ± 13 mL (P = .008); LV end-diastolic diameter (EDD) from 57 ± 9 to 54 ± 6 mm (P = .04); LV end-systolic diameter (ESD) from 48 ± 10 to 44 ± 7 mm (P = .007); and right ventricular systolic pressure (RV SP) from 39 ± 10 to 32 ± 8 mm Hg (P = .0001). Significant modifications were observed in terms of RV echo parameters: right ventricular (RV) size decreased from 30 ± 4 to 27 ± 5 mm (P = .03), while RV systolic function significantly improved based on tricuspid annular plane systolic excursion (TAPSE) (16.5 ± 4 vs. 19 ± 4 mm; 0.0006); DTI-derived tricuspid lateral annular systolic velocity wave (S') (10 ± 2 vs. 11.3 ± 3 cm/s; P = .03); and RIMP (Tei index) (0.5 ± 0.1 vs 0.46 ± 0.1; P = .04). RV 2D fractional area change (%) did not significantly differ despite a clear improvement tendency (35 ± 6 vs. 37 ± 4%; P = .1). No significant modifications were observed concerning LV diastolic parameters. Overall, ß-blocker echo responders (n = 23/32; 72%) exhibited the same left and right echo parameters. No echo variables predicted the ß-blocker response. CONCLUSIONS: In HFrEF pts, ß-blocker therapy significantly improves LV and RV systolic remodeling. Accordingly, ß-blocker therapy could be applied as soon as possible in HFrEF patients with right ventricular dysfunction so as to limit RV remodeling.

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.

Closed chest human aortic valve removal and replacement: Technical feasibility and one year follow-up.

BACKGROUND: Minimally invasive aortic valve replacement has so far required a minithoracotomy or a ministernotomy. We present here the first series of totally endoscopic aortic valve replacement (TEAVR). METHODS: Between June 2013 and April 2015, 14 consecutive patients (12 males, mean age=76 ± 5.4 years) with a mean EuroSCORE II of 2.72 ± 0.03% underwent TEAVR. A five trocar setting was used in all patients: after ablation of the native valve, a Nitinol stented sutureless 3f Enable Medtronic valve, compressed into the main working trocar, was introduced into the thorax and then expanded in the aortic root. RESULTS: Among the 14 patients, a thoracoscopic approach was successful in 13 (92.8%) and conversion into an open surgery using the right anterior minithoracotomy was necessary to close the aortotomy in one case. Mean cross-clamping and cardiopulmonary (CPB) times were 112 ± 18 and 161 ± 31 min, respectively. All patients left the surgical unit within 8 days after the operation without any paravalvular leakage. There was no paravalvular regurgitation, conductive block or any major adverse event at a mean follow-up of 10 ± 4 months (range 2-16). CONCLUSIONS: TEAVR is feasible and safe in a selected subset of patients. Closed chest surgery has the potential to become the future approach of the isolated aortic valve replacement in low risk patients but further technical refinement and larger studies are necessary to reduce operative durations and enhance reproducibility.

Sutureless aortic bioprosthesis valve implantation and bicuspid valve anatomy: an unsolved dilemma?

Interest is growing in the clinical use of sutureless (SU) valves. However, indications in some anatomical sub-settings, like bicuspid aortic valves (BAV), have been so far limited. We discuss herein our initial experience with the implantation of the 3f Enable SU bioprosthesis in patients with a BAV. Patients with a BAV were selected in our unit between March 2011 and September 2014 for a SU 3f Enable valve implantation. Twenty of the 198 patients who underwent a 3f Enable valve implantation in our unit had a BAV. Procedural success was 100 %, but reclamping was necessary in one (5 %) case. Median size of implanted bioprosthesis was 23 mm. After a mean follow-up of 13.8 ± 10.7 months, survival was 100 %. Two patients (10 %) showed an immediate grade 1 paravalvular leak (PVL) that progressed to grade 2 and 3+ (moderate/severe), respectively, during follow-up. Type of bicuspidy (Sievers classification) in these two patients was 0 and intraoperatively aortic annuli admitted the 25 mm calibrator. Among the 18 patients without PVL, no one had a type 0 large BAV. At 1 year, implantation of the 3f Enable SU bioprosthesis appears to be safe in patients with BAV type I and II, while in type 0 use of the SU valve seems to be safe only if the annular diameter is <25 mm. Larger studies are necessary to confirm our findings in order to clarify the indications for SU technology in the subset of bicuspid patients.

Sutureless 3F Enable Valve Replacement for Pure Aortic Regurgitation.

BACKGROUND AND AIM: We present our experience in the use of the sutureless valve in patients undergoing aortic valve replacement for pure aortic regurgitation. METHODS: Out of 167 patients who underwent sutureless aortic valve implantation with a Medtronic 3f Enable prosthesis in our unit between March 2011 and February 2014, 12 (7.1%) received a sutureless valve for pure aortic regurgitation. RESULTS: Mean age, logistic EuroSCORE, and left ventricular ejection fraction were 72 ± 5 years, 6.3 ± 2.9%, and 52.5 ± 15.3%, respectively. The sutureless valve could be successfully implanted in all cases; nine patients had a full sternotomy (associated coronary artery bypass graft in four cases and associated mitral surgery in five), one patient had a ministernotomy, and two had a thoracoscopic approach. Average cross-clamping and cardiopulmonary bypass times were 90 ± 30 and 127 ± 51 minutes, respectively. At the outpatient echocardiography, average mean gradient was 10.54 ± 4.99 mmHg and a grade I-II paravalvular leakage (PVL) was detected in the first patient of the cohort (ministernotomy approach). At a mean follow-up of 11.1 ± 5.5 months, average mean gradient was 9.75 ± 2.87 mmHg, no new PVL was detected, and the known PVL was stable. No pacemaker implantation was required. CONCLUSIONS: Implantation of the 3f Enable sutureless valve is technically possible with pure aortic regurgitation in selected patients. Multicenter investigations are necessary to assess the mid-term benefits of such a device in this subset of patients.

Endovascular repair of mitroaortic intervalvular fibrosa aneurysm after bentall surgery.

We report the first case of a successful transapical transcatheter treatment of a giant pseudoaneurysm originating from a rupture of the mitroaortic fibrosa that occurred 3 months after a Bentall procedure in a 81-year-old male patient. Because of the age of the patient and the location of the leak at the mitroaortic fibrosa, the risk of a conventional ascending aorta reoperation was considered too high, and a transcatheter approach was chosen. A transapical puncture was performed with a left minithoracotomy followed by a catheterization of the pseudoaneurysm neck and an 8-mm Amplatzer (St. Jude Medical, Saint Paul, MN, USA) device was delivered, resulting in a successful complete endovascular exclusion of the pseudo-aneurysmal sac.

Effect of coronary thrombus aspiration during primary percutaneous coronary intervention on one-year survival (from the FAST-MI 2010 registry).

Results from randomized trials evaluating thrombus aspiration (TA) in patients with ST-elevation myocardial infarction (STEMI) are conflicting. We assessed 1-year survival in STEMI patients participating in the French Registry of Acute ST-Elevation and non-ST-Elevation Myocardial Infarction (FAST-MI) 2010 according to the use of TA during primary percutaneous coronary intervention (PCI). FAST-MI 2010 is a nationwide French registry that included 4,169 patients with acute myocardial infarction at the end of 2010 in 213 centers. Of those, 2,087 patients had STEMI, of whom 1,538 had primary PCI, with TA used in 671 (44%). Patients with TA were younger (61 ± 13.5 vs 63 ± 14 years), with a similar risk score of the Global Registry of Acute Coronary Events (140 ± 31 vs 143 ± 34) and a shorter median time from symptom onset (245 vs 285 minutes); location of acute myocardial infarction, history of myocardial infarction, PCI, or coronary artery bypass surgery did not differ significantly. Thirty-day mortality was 2.1% versus 2.1% (adjusted p = 0.18), and the rate of 1-year survival was 95.5% versus 94.8%. Using fully adjusted Cox multivariate analysis, hazard ratio for 1-year death was 1.13 (95% confidence interval 0.66 to 1.94). After propensity score matching (480 patients per group), 1-year survival was also similar with both strategies. In a real-world setting of patients admitted with STEMI, the use of TA during primary PCI was not associated with improved 1-year survival.

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.

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.

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.

Return to work after acute ST-segment elevation myocardial infarction in the modern era of reperfusion by direct percutaneous coronary intervention.

BACKGROUND: Previous studies have evaluated return to work after acute ST-segment elevation myocardial infarction (STEMI) treated medically, after bypass surgery or after percutaneous coronary intervention (PCI) for stable coronary artery disease. However, there are few data regarding return to work after acute STEMI treated by direct PCI. AIMS: To analyse the factors influencing return to work after STEMI treated by direct PCI. METHODS: Two hundred consecutive patients who underwent direct PCI for acute STEMI and who were employed at the time of their STEMI were studied. Stents were used in 94% of patients and glycoprotein IIb/IIIa inhibitors in 77%. RESULTS: Among the 200 patients, 152 (76%) patients returned to work and 48 (24%) did not. Patients who did not return to work did not differ from those who returned to work in terms of time from onset of chest pain to PCI, STEMI location, left ventricular function, extent of vessel disease, PCI technique and success, completeness of revascularization, duration of hospital stay, intrahospital complications and performance of cardiac rehabilitation. Multivariable analysis showed that older age, daytime onset of chest pain, manual labour, rapid call-out of the emergency medical team, unmarried status and a limited number of risk factors were independent predictors of non-return to work. CONCLUSION: Age, sociopsychological and occupational factors appear to be the strongest predictors of return to work after STEMI treated by direct PCI. Clinical and procedural factors as well as cardiac rehabilitation appear to have no impact on return to work in this subset of patients.

Prevalence and risk factors related to infections of cardiac resynchronization therapy devices.

AIMS: Device-related infections (DRI) are not well understood in patients implanted with a cardiac resynchronization therapy (CRT) device. The aims of this study were: (i) to evaluate the prevalence of CRT DRI; (ii) to establish the factors predictive of CRT DRI. METHODS AND RESULTS: Between January 2001 and May 2007, CRT implantation was performed in 303 patients (247 men, 82%). The mean follow-up was 31 +/- 19 months. Population characteristics were a mean age of 70 +/- 10 years old; 56 female; aetiology includes (202 dilated and 101 ischaemic cardiomyopathy); NYHA class 3.2 +/- 0.3; LVEF (26 +/- 6%), and a QRS width of 171 +/- 31 ms. Thirteen patients developed a DRI: endocarditis in four, pocket erosion in three, pocket abscess in five, and septicaemia in one. The prevalence of DRI was 4.3%. By univariate analysis, predictive factors of DRI were: procedure time (skin to skin: median of 85 vs. 57.5 min; P = 0.03), re-intervention (54 vs. 6.5%; P < 0.0001), haematoma (31 vs. 8.6% P = 0.01), lead dislodgement (23 vs. 6.2%; P = 0.03), dialysis (23.1 vs. 1.72%; P = 0.003), and procedure type [CRT-ICD (8.6%) vs. CRT PM (1.6%) or system up-grade (1.5%); P = 0.03]. Significant correlations were found between re-intervention and lead dislodgement (r = 0.8; P < 0.001), haematoma (r = 0.2; P < 0.001). Four independent predictive factors of DRI were identified as procedure time (P = 0.002); dialysis (P = 0.0001); re-intervention (P = 0.006), and procedure type (CRT-ICD vs. other procedures; P = 0.01). CONCLUSION: This study found that the prevalence of CRT DRI is close to 4.3% at 2.6 years (1.7% per year incidence). Four independent predictive factors of infections were identified including re-intervention, procedure time, dialysis, and primo CRT-ICD implantation. These parameters should be part of the risk-benefit evaluation in patients selected for CRT implantation.

Radiofrequency catheter selection based on cavotricuspid angiography compared with a control group with an externally cooled-tip catheter: a randomized pilot study.

BACKGROUND: Radiofrequency ablation (RFA) of cavotricuspid isthmus (CTI)-dependent atrial flutter (AFL) can be performed using either externally cooled-tip RFA catheters or large-tip (8 mm) catheters. However, experimental and clinical studies suggest that the efficacy of both catheters may vary with CTI anatomy and catheters orientation. OBJECTIVES: The aim of this prospective study was to evaluate: a RFA catheter selection based on CTI angiography compared with a control group with an externally cooled-tip catheter together with the risk of an expensive crossover catheter in both groups. METHOD: Over a period of 16 months, 119 patients were included and randomized. RESULTS: When comparing the angiographic group (n = 56) and the externally cooled-tip RFA catheter group (n = 63), the duration of application time with a median of 7 min (interquartile range 4.5-11) versus a median of 10 min (interquartile range 6-20; P = 0.008) and the duration of X-ray exposure with a median of 7 min (interquartile range 4-10) versus a median of 10 min (interquartile range 5-15; P = 0.025) were significantly lower in the angiographic group versus externally cooled-tip catheter group. Furthermore, the number of catheters crossover was significantly higher in the angiographic group versus externally cooled-tip catheter group I (27% vs 7%; P = 0.007). CONCLUSIONS: This study shows that a strategy with a catheter selection based on a CTI angiographic evaluation is superior to an empirical use of an externally cooled-tip catheter during CTI RFA. Thus, angiographic isthmus evaluation predicts the effectiveness of a RFA catheter and the risk of an expensive catheter crossover.

A new approach of primary angioplasty for ST-elevation acute myocardial infarction based on minimalist immediate mechanical intervention.

OBJECTIVES: No reflow has been reported in 12-30% of the patients directly revascularized by angioplasty for acute ST elevation myocardial infarction with the highest incidence after primary stenting in patients with initial thrombolysis in myocardial infarction (TIMI) grade 0 flow. We hypothesized that a minimalist immediate mechanical intervention (MIMI) based on the use of very small size balloons to avoid both large dissection and distal embolization may be sufficient to restore flow in emergency and that recanalization may be sustained by maximized antithrombotic regimen (abcximab, clopidogrel, aspirin and heparin) allowing one to postpone stenting in better conditions. METHODS: MIMI was performed in 93 patients for ST elevation myocardial infarction with initial TIMI grade 0 flow. RESULTS: MIMI resulted in a TIMI grade 3 flow in 77/93 patients (83%). Immediate stenting was performed in the 16 patients with failed MIMI and resulted in a TIMI grade 3 flow in nine (56%). The residual stenosis after MIMI was 81+/-11% and ST segment resolution (> or =50%) at 1 h after reperfusion was obtained in 84%. Stenting was performed the following days in 52 patients with a post-stenting TIMI grade 3 flow in 50 (96%; 100% when stenting done beyond 24 h). No reocclusion occurred between MIMI and stenting. Among the 25 patients without stenting, six had mild stenosis at control angiogram and underwent medical treatment whereas 19 had multiple vessel disease and underwent bypass surgery. CONCLUSIONS: MIMI combined with maximized antithrombotic therapy results in immediate and sustained recanalization with a high rate of ST resolution in a majority of patients with ST elevation myocardial infarction. This approach allows one to postpone stenting in more stable conditions with a low rate of TIMI flow deterioration or to schedule more appropriate medical or surgical alternative management.

Clinical predictors of cardiac events in patients with isolated syncope and negative electrophysiologic study.

BACKGROUND: Patients with syncope or near syncope of unknown etiology represent a great challenge to cardiologists. An initial symptomatic episode triggers a series of diagnostic analysis which remain unsatisfactory when negative. More invasive tools such as electrophysiologic testing yield only partial answers to risk stratification while the complementary implantable holter diagnostics are not usually considered until a recurrent episode is documented. OBJECTIVE: This study targets predictors of significant cardiac rhythmic events in patients with a reported episode of syncope or near syncope presenting with negative diagnostics and electrophysiologic study results (EPS). A significant cardiac rhythmic event was defined as a combined end-point of (1) symptomatic AV block; (2) symptomatic conduction abnormalities requiring pacemaker therapy; (3) symptomatic sustained ventricular arrhythmia; and (4) sudden death. METHODS: All patients undergoing EPS after a first episode of syncope or presyncope between January 1997 and December 2001 were included for analysis. The study population consisted of 329 pts (42.6% women), 21 to 96 years old (mean 70+/-15 years) referred for an EP study for syncope or near syncope. RESULTS: Of the 329 patients who underwent EPS, 305 (92.7%) had follow-up data. The population, mean age 70 (+/- 15 years) and composed of 42% women, presented with hypertension (51.5%), diabetes mellitus (14.4%), hypercholesterolemia (30%), tobacco use (35%), a familial history of coronary heart disease (22%), history of stroke (4%), history of MI (12%), history of atrial fibrillation (10%), structural heart disease (17.4%), left ventricular ejection fraction 61 (+/- 11%) and ECG abnormalities (37%). These anomalies included right (RBBB) or left (LBBB) bundle branch blocks, left anterior fascicular block (LAFB), left posterior fascicular block (LPFB), bifascicular block (RBBB+LAFB) and traces of myocardial infarction. The mean follow-up was 31+/-20 months with 5% of patients recording significant cardiac rhythmic events (15/305): AV block requiring pacemaker therapy in 7 patients, sinus dysfunction in 4, sudden death in 3 and ventricular tachycardia in 1. Univariate analysis reveals structural heart disease, ECG abnormalities and LVEF associated with the risk of significant cardiac rhythmic events defined by the combined end-point. Multivariate analysis using a Cox model found that the only independent predictor of events was an ECG abnormality. The long-term risk of significant event in the subset with ECG abnormalities is of 10.6% (12/113). If unexplained syncope recurrence was included in the combined end-point, ECG abnormality and LVEF were both determinants with a 13.3% (15/113) risk of a arrhythmic events analysis in the subset of patients presenting with ECG abnormalities and Cox model found ECG abnormality as the only independent predictor of event. CONCLUSIONS: This study demonstrated that an ECG abnormality is the only predictive variable associated with a significant arrhythmic event in patients with a lone episode of syncope or near syncope and a negative EPS.

Long term prognosis of patients with myocardial infarction and normal coronary angiography: impact of inherited coagulation disorders.

The prognosis of patients with myocardial infarction (MI) and normal coronary arteries (NCA) in the presence of an inherited coagulation disorder is unknown. The purpose of this study was to compare the clinical thrombosis outcome of patients with (GpI) or without (GpII), inherited coagulation disorders, who suffered from an acute MI with NCA. Eighty two consecutive patients (mean age 49 +/- 15 years; 29 females) with MI, but NCA, were recruited. Twelve patients (15%) had an inherited coagulation disorder. GpI and GpII were statistically similar regarding age (45 +/- 11 vs 50 +/- 16 years-old), gender (33 vs. 36% female), tobacco consumption (50 vs. 53%), diabetes mellitus (8 vs. 10%), hypertension (25 vs. 17%), obesity (8.3 vs. 14%), family history of coronary heart disease (33 vs. 19%), hypercholesterolemia (50 vs. 21%; p =.08), left ventricular ejection fraction (58 +/- 13 vs. 61 +/- 13%) and spasm (8.3% vs. 17%). All patients were initially treated with antiplatelet agents with the exception of one (8%) in GpI, and 6 (9%) in GpII who were taking oral anticoagulant therapy (ns). The mean follow-up was 57 +/- 26 (range from 2-91 months). During the outcome, 12/78 (15.4%) thrombosis events occurred, including venous thrombosis or pulmonary embolism (1/12 vs. 1/66), reinfarction (2/12 vs. 4/66), and stroke (2/12 vs. 2/66), with two events in one patient (GpI). Kaplan-Meier event-free survival, with combined end-point, defined as venous thrombo-embolic event, reinfarction, or stroke differed between the two groups: 4/12 (33.3%) in GpI and 7/66 (10.6%) in Gp II (p <.02). Patients with MI, NCA and congenital coagulation disorder present a high risk of thrombosis recurrence under antiplatelet agent.