Rate, causes, and impact on patient outcome of implantable device complications requiring surgical revision: large population survey from two centres in Italy.

AIMS: The long-term impact of implantable device-related complications on the patient outcome has not been thoroughly evaluated. The aims of this retrospective, bi-centre study were to analyse the rate and nature of device-related complications requiring surgical revision in a large series of patients undergoing device implantation, elective generator replacement and pacing system upgrade and to systematically assess the impact of such complications on patient outcome and healthcare utilization. METHODS AND RESULTS: Data from 2671 consecutive procedures (1511 device implantations, 1034 elective generator replacements, and 126 pacing system upgrades) performed between January 2006 and March 2011 were retrospectively analysed. The outcome measures recorded were complication-related mortality, number of re-operations, need for complex surgical procedures, number of re-hospitalizations, and additional hospital treatment days. Over a median follow-up of 27 months, the overall rate of complications was 2.8% per procedure-year [9.5% in cardiac resynchronisation therapy (CRT) device implantation, 6.1% in pacing system upgrade, 3.5% in implantable cardioverter defibrillator implantation, 1.7% in pacemaker implantation, and 1.7% in generator replacement). The procedure with the highest risk of complications was CRT device implantation (odds ratio: 6.6; P < 0.001); these complications primarily involved coronary sinus lead dislodgement and device infection. Patients with complications had a significantly higher number of device-related hospitalizations (2.3 ± 0.6 vs. 1.0 ± 0.1; P < 0.001) and hospital treatment days (15.7 ± 25.1 vs. 3.6 ± 1.1; P < 0.001) than those without complications. Device infection was the complication with the greatest negative impact on patient outcome. CONCLUSION: Cardiac resynchronisation therapy implantation was the procedure with the highest risk of complications requiring surgical revision. Complications were associated with substantial clinical consequences and a significant increase in the number and length of hospitalizations.

Closed-loop cardiac pacing vs. conventional dual-chamber pacing with specialized sensing and pacing algorithms for syncope prevention in patients with refractory vasovagal syncope: results of a long-term follow-up.

AIMS: Closed-loop stimulation (CLS) pacing has shown greater efficacy in preventing the recurrence of vasovagal syncope (VVS) in patients with a cardioinhibitory response to head-up tilt test (HUTT) compared with conventional pacing. Moreover, there is no conclusive evidence to support the superiority of CLS over the conventional algorithms for syncope prevention. This study retrospectively evaluated the effectiveness of CLS pacing compared with dual-chamber pacing with conventional specialized sensing and pacing algorithms for syncope prevention in the prevention of syncope recurrence in patients with refractory VVS and a cardioinhibitory response to HUTT during a long-term follow-up. METHODS AND RESULTS: Forty-one patients (44% male, 53 ± 16 years) with recurrent, refractory VVS (26% with trauma) and a cardioinhibitory response to HUTT who had undergone pacemaker implantation were included in the analysis. Twenty-five patients received a dual-chamber CLS pacemaker (CLS group) and 16 patients received a dual-chamber pacemaker with conventional algorithms for syncope prevention (conventional pacing group): 9 patients with Medtronic rate drop response algorithm and 7 patients with Guidant-Boston Scientific sudden brady response algorithm. During the follow-up (mean 4.4 ± 3.0 years, interquartile range 2.2-7.4 years) one patient (4%) in the CLS group and six (38%) in the conventional pacing group had syncope recurrences (P= 0.016). The Kaplan-Meier actuarial estimate of first recurrence of syncope after 8 years was 4% in the CLS group and 40% in the conventional pacing group (P= 0.010). CONCLUSIONS: The results of this retrospective analysis show that, in order to prevent a recurrence of VVS in patients with a cardioinhibitory response to HUTT, dual-chamber CLS pacing was more effective than dual-chamber pacing with conventional algorithms for syncope prevention in preventing bradycardia-related syncope.

An atypical pseudoaneurysm as complication of prosthetic aortic-valve endocarditis.

Endocarditis of a prosthetic heart valve is a life-threatening condition that is associated with high morbidity and mortality. Perivalvular extension in infective endocarditis includes complications such as periannular or intramyocardial abscesses, pseudoaneurysms and fistulae. The incidence of perivalvular extension ranges from 10 to 30% in native valve endocarditis and 30 to 55% in prosthetic aortic-valve endocarditis. Herein, we describe a case of a 66-year-old man who presented endocarditis of a prosthetic aortic valve complicated by infective pseudoaneurysm with localization next to the right coronary sinus of Valsalva. Moreover, we underscore the importance of the diagnostic imaging tools options and surgical timing.

Predictive factors for pacemaker implantation in patients receiving an implantable loop recorder for syncope remained unexplained after an extensive cardiac and neurological workup.

BACKGROUND: Several previous implantable loop recorder (ILR) studies have shown bradyarrhythmic events requiring a pacemaker implantation in a significant proportion of patients with unexplained syncope (US). The aim of this observational, two-centre, study was to identify the predictive factors for pacemaker implantation in a population of patients receiving an ILR for US with suspected arrhythmic aetiology. METHODS: Fifty-six patients (mean age 68 years, 61% male) with a history of US and negative cardiac and neurological workup, who underwent ILR implantation, were enrolled. After the implantation, a follow-up visit was undertaken after symptomatic events or every 3 months in asymptomatic subjects. The end-point of the study was the detection of a bradyarrhythmia (with or without a syncopal recurrence) requiring pacemaker implantation. RESULTS: After a median ILR observation of 22 months, a clinically significant bradyarrhythmia was detected in 11 patients (20%), of which 9 cases related to syncopal relapses. In the multivariable analysis, three independent predictive factors for pacemaker implantation were identified: an age >75 years (odd ratio [OR]: 29.9; p=0.035); a history of trauma secondary to syncope (OR: 26.8; p=0.039); and the detection of periods of asymptomatic bradycardia, not sufficient to explain the mechanism of syncope, during conventional ECG monitoring (through 24 h Holter or in hospital telemetry), performed before ILR implantation (OR: 24.7; p=0.045). CONCLUSIONS: An advanced age, a history of trauma secondary to syncope, and the detection of periods of asymptomatic bradycardia during conventional ECG monitoring were independent predictive factors for bradyarrhythmias requiring pacemaker implantation in patients receiving an ILR for US.

[Implantable cardioverter-defibrillators: proposal of new criteria for the recognition of disability]. / Il defibrillatore automatico impiantabile: implicazioni per il riconoscimento di invalidità civile e proposta di aggiornamento medico-legale.

BACKGROUND: Indications to the implantable cardioverter-defibrillator (ICD) have been expanded in the last decade, including patients suffering from heart disease with or without functional disorders. Accordingly, the increasing number of patients with ICD is posing relevant legal implications. Currently, the Medical Committee that evaluates the legal criteria for disability is employing guidelines referring only to pacemaker devices and not to ICD. The aim of this study was to propose new indications for patients with ICD to replace the current criteria. METHODS: The study included 219 patients (83% male, mean age 63 years) with ICD who were administered an anonymous questionnaire to evaluate the presence of any disability. Most patients were suffering from ischemic or non-ischemic dilated heart disease (41% and 34%, respectively). Single- and dual-chamber ICD (72%) were more frequently implanted compared to biventricular ICD (28%). RESULTS: A higher percentage of disability was found in older patients (69 +/- 14 years) with ischemic heart disease (61%) and single- or dual-chamber ICD before ICD implantation. Conversely, a lower percentage of disability was found in younger patients (53 +/- 15 years), active workers (44%), without ischemic or non-ischemic dilated heart disease (36%), and with a lower number of biventricular ICD (22%) after ICD implantation. CONCLUSIONS: Overall, these data show that disability is currently recognized because of the presence of ICD rather than the underlying heart disease. We propose, therefore, new criteria that include the impact of the underlying heart disease for a better evaluation of disability in patients with ICD.

Sudden death due to atrial fibrillation in hypertrophic cardiomyopathy: a predictable event in a young patient.

This case refers to a 39-year-old woman with hypertrophic cardiomyopathy (HCM) and family history of sudden death (SD). In 1985, high rate atrial stimulation induced VF. In 1996 an ICD was implanted and she remained without arrhythmic events until November 2000 when the device reported one episode of atrial fibrillation degenerating into VF and terminated by the ICD. The VF induction mechanism recorded by the ICD was similar to that observed in 1985. The high incidence of atrial tachyarrhythmias in HCM renders cases like this at higher risk of SD. The predictive role of incremental atrial stimulation merits highlighting in future studies.