Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy.

INTRODUCTION: Comparison data on management of device-related complications and their impact on patient outcome and healthcare utilization between subcutaneous implantable cardioverter-defibrillator (S-ICD) and transvenous ICD (TV-ICD) are lacking. We designed this prospective, multicentre, observational registry to compare the rate, nature, and impact of long-term device-related complications requiring surgical revision on patient outcome and healthcare utilization between patients undergoing S-ICD or TV-ICD implantation. METHODS AND RESULTS: A total of 1099 consecutive patients who underwent S-ICD or TV-ICD implantation were enrolled. Propensity matching for baseline characteristics yielded 169 matched pairs. Rate, nature, management, and impact on patient outcome of device-related complications were analyzed and compared between two groups. During a mean follow-up of 30 months, device-related complications requiring surgical revision were observed in 20 patients: 3 in S-ICD group (1.8%) and 17 in TV-ICD group (10.1%; p = .002). Compared with TV-ICD patients, S-ICD patients showed a significantly lower risk of lead-related complications (0% vs. 5.9%; p = .002) and a similar risk of pocket-related complications (0.6 vs. 2.4; p = .215) and device infection (0.6% vs. 1.2%; p = 1.000). Complications observed in S-ICD patients resulted in a significantly lower number of complications-related rehospitalizations (median 0 vs. 1; p = .013) and additional hospital treatment days (1.0 ± 1.0 vs. 6.5 ± 4.4 days; p = .048) compared with TV-ICD patients. CONCLUSIONS: Compared with TV-ICD, S-ICD is associated with a lower risk of complications, mainly due to a lower risk of lead-related complications. The management of S-ICD complications requires fewer and shorter rehospitalizations.

Management of patients explanted for implantable cardioverter defibrillator infections: Bridge therapy with external temporary ICD.

AIMS AND METHODS: In case of cardiacimplantable electronicdevice (CIED)-related infections, it is mandatory to completely remove the device and administer prolonged antibiotic therapy. The management of patients explanted for an implantable defibrillator (ICD) infection is complex especially in patients needing anti-bradycardia pacing or tachyarrhythmia protection. We tested the efficacy and safety of a conventional ICD externally connected to a transvenous dual-coil lead as bridging therapy before the reimplant, comparing outcomes with a historical cohort of patients (N = 113) treated with temporary transvenous pacing. We enrolled 18 patients explanted for ICD infection and needing prolonged antibiotic therapy in three high-volume Italian centers. They received an external ICD stand-by for a mean of 16.5 (4-30) days before the reimplant. RESULTS: No patient experienced malfunction of the system, with a significant reduction of this complication versus temporary transfemoral pacing (37%, p = .004). Post-procedural occurrence of other complications (infection, relevant local bleeding, ventricular tachycardia during insertion of the lead, cardiac perforation, and venous thromboembolism) was low and not different in the two groups. One patient experienced an electrical storm, effectively recognized by the external ICD and treated with anti-tachycardia pacings (ATPs) and shocks. CONCLUSIONS: An approach with an external ICD seems to be a safe and viable option as bridging therapy in patients requiring ICD explant for CIED infection.

A challenging pacemaker implantation in the presence of a giant right coronary aneurysm compressing the right atrium.

Giant coronary artery aneurysm is an uncommon disease, treated with surgical intervention or percutaneous coil embolization. A thrombosed aneurysm can cause extrinsic compression on the cardiac chambers, with potential hemodynamic effects and may cause problems when we need to implant a cardiac device. We present a case of difficult pacemaker implantation in a patient with 3 syncopes, first-degree AV block and complete left bundle branch block on electrocardiogram. The patient presented a giant aneurysm of the right coronary artery (85 x 90 mm), thrombosed, with right atrial compression. The pacemaker implantation was hampered by the difficulty of passing the lead through the compressed right atrium; indeed, only with simultaneous echocardiographic and fluoroscopic guidance, was it possible to complete the procedure. This case demonstrates the utility of echocardiogram, in particular settings, in cardiac stimulation procedures.

Takotsubo syndrome and pheochromocytoma: an insidious combination.

Pheochromocytoma is a rare adrenal tumor characterized by the secretion of catecholamines and vasoactive peptides. It can cause a catecholaminergic storm and lead to acute coronary syndromes. We present the case of a 53-year-old man, without any medical history, who arrived to the hospital following a spinal trauma due a fall. He presents back and retrosternal pain, with a clinical status of acute pulmonary edema, sinus tachycardia with left bundle branch block, left ventricular apical ballooning with depressed systolic function. Blood tests show a very important increase of Troponin and transaminases. A contrast chest-abdomen CT highlighted a right adrenal solid mass, with a diameter of 78mm, partial capsular laceration, compression of the inferior vena cava and the hepatic parenchyma. The clinical condition of the patient rapidly worsens from a respiratory and hemodynamic point of view, with cardiogenic shock, anuria and sepsis, refractory to all the medical treatments, until the patient died. The autopsy confirmed that the abdominal mass was a pheochromocytoma, broken after the trauma suffered. The resulting catecholaminergic storm caused a myocardial ischemia with Takotsubo syndrome, with cardiogenic shock. This unfortunate case confirms the pheochromocytoma as important risk factor for the onset of Takotsubo syndrome, and the how dramatic and severe a catecholaminergic storm can be.

External implantable defibrillator as a bridge to reimplant after explant for infection: Experience from two centers.

BACKGROUND: The management of patients explanted for implantable converter defibrillator (ICD) infections may be complex when anti-bradycardia pacing and tachyarrhythmia protection are needed. We aimed to test the efficacy and safety of a conventional ICD externally connected to a transvenous dual-coil lead as bridging therapy before the reimplantation. METHODS AND RESULTS: We enrolled seven patients explanted for ICD infections and needed prolonged antibiotic therapy in two high-volume hospitals in Italy and treated them with a passive-can external ICD for a mean of 13 (4-30) days before reimplant. One patient experienced an electrical storm, efficaciously recognized by the external ICD and treated with antitachycardia pacing and shocks. On-demand pacing was granted for all the patients. No device-related complications were reported. CONCLUSIONS: An external ICD seems safe and efficacious as a bridge to reimplant in patients explanted for ICD infections.

Feasibility of cathodic-anodal left ventricular stimulation for alternative multisite pacing.

BACKGROUND: Simultaneous cathodic-anodal capture by a bipole of a cardiac resynchronization therapy (CRT) left-ventricular (LV) catheter may depolarize a larger LV area than conventional multipoint pacing. We evaluated the feasibility of cathodic-anodal LV stimulation. METHODS: In 30 patients undergoing CRT with a quadripolar LV lead, we evaluated the cathodic and anodal capture threshold for each LV pole and compared QRS on electrocardiogram (ECG) during single-point cathodic biventricular stimulation (S-BS), multipoint BS (M-BS), and cathodic-anodal BS (CA-BS). RESULTS: Anodal capture was obtained by three poles in 23/30 patients, by two poles in five, and was not feasible in two. The mean single-point anodal threshold was 3.93 V versus single-point cathodic threshold of 1.95 V. On comparing ECGs, M-BS and CA-BS produced similar QRS wavefront activation in 90% of patients. CONCLUSIONS: CA-BS is feasible and may be used in LV pacing to achieve a different wavefront of electrical activation. Further prospective studies are needed in order to verify the clinical impact of this kind of stimulation.

Persistence of ICD indication at the time of replacement in patients with initial implant for primary prevention indication: Effect on subsequent ICD therapies.

BACKGROUND: Indication to implantable cardioverter defibrillator (ICD) for primary prevention of sudden death relies on left ventricular ejection fraction (LVEF). We measured the proportion of patients in whom indication to ICD persisted at the time of generator replacement (GR) and searched for predictors of appropriate therapies after GR. METHODS: We identified all consecutive patients who had received an ICD at our hospital, for LVEF ≤35% and no previous arrhythmias or unexplained syncope. Then, we included the 166 patients who outlived their first device and underwent GR. RESULTS: At the time of GR (mean follow-up 59 ± 20 months), ICD indication (i.e. LVEF ≤35% or previously treated ventricular arrhythmias) persisted in 114 (69%) patients. After GR, appropriate ICD therapies were delivered in 30 (26%) patients with persistent ICD indication and in 12 (23%) of the remaining patients (p = 0.656). Nonetheless, the annual rate of therapies was higher in the first group (1.08 versus 0.53 events/year; p < 0.001), as well as the rate of inappropriate therapies (0.03 versus 0 events/year; p = 0.031). The only independent predictor of appropriate ICD therapies after GR was the rate of shocks received before replacement (Hazard Ratio: 1.41; 95% confidence interval: 1.01-1.96; p = 0.041). CONCLUSION: In heart failure with reduced LVEF, ICD indication persisted at the time of GR in 69% of patients. However, even in the absence of persistent ICD indication at GR, the risk of recurrence of arrhythmic events was not null.

Ultrasound-guided Axillary Vein Puncture for Cardiac Device Implantation: A Safe and Effective Approach.

Ultrasound-guided axillary vein access is an effective alternative to conventional subclavian and cephalic access for cardiac implantable electronic device implantation. The aim of this study was to compare the safety, efficacy, and radiation exposure data of the ultrasound-guided axillary approach with other conventional access techniques. The study population included 130 consecutive patients, stratified as 65 (64% male; median age, 79 years) in the study group and 65 (66% male; median age, 81 years) in the control group. We performed a retrospective not-randomized analysis by comparing ultrasound-guided axillary vein puncture with subclavian and cephalic approaches in order to test the effect on X-ray exposure, total procedure time, and complications. Significant differences were observed in terms of radiation exposure, including fluoroscopy time (median, 95 s [study group] vs. 193 s [control group]; P < .001), air kerma (median, 29 mGy [study group] vs. 55.7 mGy [control group]; P < .001), and dose-area product (median, 8219 mGy·cm2 [study group] vs. 16736 mGy·cm2 [control group]; P < .001). The median procedure time was 45 min in the study group but 50 min in the control group (P < .05). Complications occurred in 6 control group patients (1 urticaria contrast medium-related, 3 pneumothorax, 2 subclavian artery puncture) and 2 study group patients (2 axillary artery puncture). We conclude that the ultrasound-guided axillary venous approach is a fast, feasible, and safe technique for cardiac lead implantation. It allows a significant reduction in fluoroscopy time without prolonging the procedural time. This approach offers direct visualization of the vessel during the puncture, so it can be useful in patients who cannot receive contrast medium, those who require "difficult" thoracic approaches (emphysema, too much or too little fat tissue), or those on anticoagulant therapy.

Impact on All-Cause and Cardiovascular Mortality of Cardiac Implantable Electronic Device Complications: Results From the POINTED Registry.

OBJECTIVES: This study aimed to determine how CIED-related complications affect all-cause and cardiovascular mortality over a long-term follow-up. BACKGROUND: Although complications related to implantable electronic device (CIED) implantation are steadily increasing in Europe, little is known about the impact of complications other than device infection on mortality. METHODS: The POINTED (Impact on Patient Outcome and health care utilization of cardiac ImplaNTable Electronic Device complications) registry was a prospective, multicenter, observational study designed to collect data on complications in patients undergoing de novo CIED implantation (NCT03612635). All consecutive patients were enrolled in 6 high-volume centers between January 2010 and December 2012 and followed up for at least 3 years. A complication was defined as any CIED-related adverse event requiring surgical revision after implantation. RESULTS: During follow-up (median 56.9 months), we observed 283 complications in 263 of 2811 consecutive patients (71 ± 14 years of age, 66.7% men). Early complications (≤30 days) were associated with significantly lower cumulative survival from cardiovascular death in comparison with late complications and with freedom from complications. On multivariate analysis, early complication, pneumothorax, and pocket hematoma were significantly associated with a higher risk of all-cause death, while device infection remained the only complication significantly associated with a higher risk of cardiovascular death. CONCLUSIONS: All CIED-related complications are associated with an increased risk of cardiovascular mortality, and early complications are associated with an increased risk of all-cause mortality. These data underline the importance of specific measures aimed at reducing CIED complications and improving their management.

Association between left atrial phasic conduit function and early atrial fibrillation recurrence in patients undergoing electrical cardioversion.

BACKGROUND: Diastolic dysfunction promotes atrial fibrillation (AF) inducing left atrial (LA) remodeling, with chamber dilation and fibrosis. Predominance of LA phasic conduit (LAC) function should reflect not only chamber alterations but also underlying left ventricular (LV) filling impairment. Thus, LAC was tested as possible predictor of early AF relapse after electrical cardioversion (EC). METHODS: 96 consecutive patients, who underwent EC for persistent non-valvular AF, were prospectively enrolled. Immediately after successful EC (3 h ± 15 min), an echocardiographic apical four-chamber view was acquired with transmitral velocities, annular tissue Doppler and simultaneous LV and LA three-dimensional full-volume datasets. Then, from LA-LV volumetric curves we computed LAC as: [(LV maximum - LV minimum) - (LA maximum - LA minimum) volume], expressed as % LV stroke volume. LA pump, immediately post-EC, was assumed and verified as being negligible. Sinus rhythm persistence at 1 month was checked with ECG-Holter monitoring. RESULTS: At 1 month 62 patients were in sinus rhythm and 34 in AF. AF patients presented pre-EC higher E/é values (p = 0.012), no major LA volume differences (p = NS), but a stiffer LV cavity (p = 0.012) for a comparable LV capacitance (p = 0.461). Conduit contributed more (p < 0.001) to LV stroke volume in AF subpopulation. Multiple regression revealed LAC as the most significant AF predictor (p = 0.013), even after correction for biometric characteristics and pharmacotherapy (p = 0.008). CONCLUSION: Our data suggest that LAC larger contribution to LV filling soon after EC reflects LA-LV stiffening, which skews atrioventricular interaction leading to AF perpetuation and makes conduit dominance a powerful predictor of early AF recurrence.