Manuel Cerini

Predicting the difficulty of a lead extraction procedure: the LED index.

Background According to recent surveys, many sites performing permanent lead extractions do not meet the minimum prerequisites concerning personnel training, procedures’ volume, or facility requirements. The current Heart Rhythm Society consensus on lead extractions suggests that patients should be referred to more experienced sites when a better outcome could be achieved. The purpose of this study was to develop a score aimed at predicting the difficulty of a lead extraction procedure through the analysis of a high-volume center database. This score could help to discriminate patients who should be sent to a referral site. Methods A total of 889 permanent leads were extracted from 469 patients. All procedures were performed from January 2009 to May 2012 by two expert electrophysiologists, at the University Hospital of Brescia. Factors influencing the difficulty of a procedure were assessed using a univariate and a multivariate logistic regression model. The fluoroscopy time of the procedure was taken as an index of difficulty. A Lead Extraction Difficulty (LED) score was defined, considering the strongest predictors. Results Overall, 873 of 889 (98.2%) leads were completely removed. Major complications were reported in one patient (0.2%) who manifested cardiac tamponade. Minor complications occurred in six (1.3%) patients. No deaths occurred. Median fluoroscopic time was 8.7 min (3.3–17.3). A procedure was classified as difficult when fluoroscopy time was more than 31.2 min [90th percentile (PCTL)]. At a univariate analysis, the number of extracted leads and years from implant were significantly associated with an increased risk of fluoroscopy time above 90th PCTL [odds ratio (OR) 1.51, 95% confidence interval (CI) 1.08–2.11, P = 0.01; and OR 1.19, 95% CI 1.12–1.25, P < 0.001, respectively). After adjusting for patient age and sex, and combining with other covariates potentially influencing the extraction procedure, a multivariate analysis confirmed a 71% increased risk of fluoroscopy time above 90th PCTL for each additional lead extracted (OR 1.71, 95% CI 1.06–2.77, P = 0.028) and a 23% increased risk for each year of lead age (OR 1.23, 95% CI 1.15–1.31, P < 0.001). Further nonindependent factors increasing the risk were the presence of active fixation leads and dual-coil implantable cardiac defibrillator leads. Conversely, vegetations significantly favored lead extraction. The LED score was defined as: number of extracted leads within a procedure + lead age (years from implant) + 1 if dual-coil – 1 if vegetation. The LED score independently predicted complex procedure (with fluoroscopic time >90th PCTL) both at univariate and multivariate analysis. A receiver-operating characteristic analysis showed an area under the curve of 0.81. A LED score greater than 10 could predict fluoroscopy time above 90th PCTL with a sensitivity of 78.3% and a specificity of 76.7%. Conclusion The LED score is easy to compute and potentially predicts fluoroscopy time above 90th PCTL with a relatively high accuracy.

Hybrid Minimally Invasive Approach for Transvenous Lead Extraction: A Feasible Technique in High-Risk Patients.

Despite the overall safety, transvenous lead extraction (TLE) remains a challenging procedure with inherent risks, where surgery can still be required in elective cases. In this study, we report our experience with a minimally invasive “hybrid” approach, defined as a procedure performed by an electrophysiologist with the support of a cardiac surgeon in the same operative session.

Predicting the difficulty of a transvenous lead extraction procedure: Validation of the LED index: BONTEMPI et al .

A lead extraction difficulty (LED) score was proposed to predict the difficult transvenous lead extraction (TLE) procedures, defined by means of the fluoroscopy time. The aim of this study was to validate the estimation model based on the LED index above 10 on an independent data set of TLE cases.

Active-fixation coronary sinus pacing lead extraction: a hybrid approach.

Cardiac resynchronization therapy (CRT) can be considered as the standard treatment for patients suffering from heart failure (NYHA III–IV), severely reduced left ventricular (LV) function, and wide QRS complexes. Over the past years, the lead systems used to stimulate the left ventricle have evolved technically from epicardial approaches to a transvenous access accompanied by a significant reduction of procedure-related complication rates [1]. However, even today, LV dislodgement rates ranging 5–10% and the instability of thresholds over time remain the greatest challenges with transvenous LV leads in CRT. Therefore, a special LV lead utilizing active fixation (the Attain StarFix® active fixation unipolar lead, Model 4195) was developed. At the target location, three lobes at the distal end of the lead can be deployed, which compress gently against the vein wall and thereby provide enhanced fixation of the LV lead [1]. This lead is safe and highly efficacious. It affords the physician more choices in lead placement location and has a remarkably low dislodgement rate [2,3]. We describe the case of a patient implanted in 2008 with a cardiac resynchronization therapy-defibrillator (CRT-D) device and an “active-fixation” coronary sinus lead (Attain StarFix®, Model 4195 Medtronic Inc., Minneapolis, MN, USA), who underwent transvenous lead

Jugular pacing lead extraction with laser sheath: a case report

Over the past 20 years, the number of patients with pacemakers (PM) or implantable cardioverter defibrillators has risen markedly; consequently, an increasing number of lead-removal procedures have become necessary. A 64-year-old woman presenting with an infected device pocket and positive bacterial cultures (Staphylococcus aureus) was admitted to our department for lead removal; in 1991, she underwent VVI PM implantation for atrioventricular II degree Mobitz 1 block, and a unipolar lead was introduced via the left jugular vein. The procedure was performed in our Electrophysiology Lab with a cardiac surgeon on standby, using an excimer laser system emitting the energy at the tip of a flexible, fibre-optic 12 F sheath, developed by Spectranetics, Inc., Colorado Springs, CO, USA.

The novel active fixation coronary sinus lead: efficacy and safety of transvenous extraction procedure.

AIMS Benefits of cardiac resynchronization therapy (CRT) are well known for heart failure; however, some patients might experience complications related to the coronary sinus (CS) lead (high pacing threshold, phrenic nerve stimulation, and dislodgment) with unfavourable impact on quality of life, costs, and management. Lead stability is one of the most common unmet needs for CRT procedures. METHODS AND RESULTS Recently, new model Medtronic 20066 Attain Stability(®) (Maastricht, The Netherlands) active fixation LV lead has been released, to overcome this issue. The lead has a small side helix of 0.20 mm (0.008 in.) that allows for secure placement of the lead within the vein at the desired location. We report our first experience with the extraction of this novel active fixation left ventricular lead. CONCLUSION In our case, to our knowledge the first reported in humans, the extraction of this new model of active fixation lead was proved to be a safe and effective procedure at 8 months after implantation. Indeed, under angiographic and fluoroscopic check, there was no documented dissection or damage to the CS during and after removal of the lead. The rotation manoeuvre was effective when combined with moderate traction of the lead itself.

Is it safe to allow patients with implantable cardioverter-defibrillators to drive? Learnings from a single center experience

Background Implantable cardioverter-defibrillator (ICD) implant indications have widened in recent years after the publication of the Multicenter Automatic Defibrillator Implantation Trial 2 and the Sudden Cardiac Death in Heart Failure Trial. On the contrary, guidelines on resumption of driving after ICD implant were published almost 10 years ago when the ICD implant rate was much lower and candidates were generally older. Aim of the study The overall objective of our study was to evaluate whether patients implanted with ICDs have higher risk than the general driving population. The specific aim of the study was to verify the rate of car accidents in patients implanted with an ICD, both for primary and secondary indication, and compare this with the rate of accidents in the general population. The primary end point of the study was the annual car accident rate; the secondary end point was to determine if there were subgroups of patients with a higher risk of car accidents. Methods All patients (612) followed up in our outpatient clinic were sent a questionnaire in which they were asked five questions regarding their driving habits before and after ICD implant and, specifically, whether they had been involved in a car accident after the implant. Results Two hundred eighty-six patients (47%) responded to the questionnaire. Seventy-one patients had never driven; two patients were forbidden to drive for professional reasons (one bus and one truck driver). Two hundred thirteen (74.5% of all responding) patients (201 men, mean age 62 ± 11 years) continued to drive after ICD implant. During the follow-up (1430 ± 920 days) 11 patients had been involved in car accidents and, importantly 10 out of 11 were innocent bystanders. Thus, in 996 patient-years, 11 events happened, yielding an annual event rate of 1.1% per patient-years (and only 0.1% in which the driver could had been responsible). Conclusion Car accidents are infrequent in patients implanted with an ICD, and – in any case – not more frequent than in the general population. The old guidelines need to be updated and specific restrictions on car driving in ICD patients need to be revised to reflect the current data.

Extraction of a coronary sinus lead: always so easy?

Lead extraction is a complex procedure associated with potential risks and requires considerable experience of the operator in the use of specific techniques and tools. With the exception of active fixation leads, the extraction procedure of coronary sinus leads is less complex and risky, in the absence of adhesions with other vascular leads. We report a difficult coronary sinus lead extraction, which required both superior (subclavian) and inferior (femoral) approaches and the use of multiple lead extraction tools. In order to perform a well tolerated and effective extraction procedure, well trained and experienced staff in a well equipped setting is, therefore, mandatory even for apparently simple cases.

Ranolazine therapy in drug-refractory ventricular arrhythmias

Aims Ranolazine is an antiischemic and antianginal agent, but experimental and preclinical data provided evidence of additional antiarrhythmic properties. The aim of this study was to evaluate the safety and efficacy of ranolazine in reducing episodes of ventricular arrhythmias in patients with recurrent antiarrhythmic drug-refractory ventricular arrhythmias or with chronic angina. Methods Seventeen implantable cardioverter defibrillator (ICD) recipients, who had experienced a worsening of their ventricular arrhythmia burden, and 12 ICD recipients with angina were enrolled. Patients were followed up for 6 months after the addition of ranolazine (postranolazine). Data were compared with before its administration (preranolazine). Results In the Arrhythmias group, a significant reduction was found in the median number of ventricular tachycardia episodes per patient (4 vs. 0, P = 0.01), and in ICD interventions in terms of both antitachycardia pacing (2 vs. 0, P = 0.04) and shock delivery (2 vs. 0, P = 0.02) after the addition of ranolazine. Moreover, fewer patients experienced episodes of nonsustained ventricular tachycardia (71 vs. 41%, P = 0.04), ventricular tachycardia (76 vs. 24%, P = 0.01), ICD antitachycardia pacing (47 vs. 18%, P = 0.02), and ICD shocks (47 vs. 6%, P = 0.03). In the Angina group, none of the patients developed major ventricular arrhythmias while on ranolazine treatment. No adverse effects were observed. Conclusion In this small study, ranolazine proved to be effective, well tolerated, and safe in reducing ventricular arrhythmia episodes and ICD interventions in patients with recurrent antiarrhythmic drug-refractory events. In addition, none of the patients with chronic angina developed major ventricular arrhythmias.

Can we implant left ventricle pacing lead in a patient with coronary sinus reducer

A 77-year-old man, who had a coronary sinus (CS) Reducer SystemTM (Neovasc, Canada) for refractory angina treatment implanted since 8 months, was referred for cardiac resynchronization therapy (CRT). The CS reducer is a stainless steel balloon-expandable hourglass-shaped stent, designed to create a focal narrowing leading to increased pressure in CS. The diameter of its mid portion is 3 mm (9F), and it can reach diameter of 7–13 mm (21–39F) at both ends. Recent studies have shown significant improvements in patients with refractory angina who were not candidates for revascularization [1, 2]. In order to position the left ventricular pacing lead, a CS angiography was performed showing the reducer system with a partial occlusion of the vessel lumen (Fig. 1A). A 5-Fr electrophysiology catheter was easily pushed through the reducer while the 9-Fr delivery sheath was stopped before the minimum diameter of the stent. A guidewire was inserted until the target postero-lateral vein and a 5-Fr quadripolar lead (QuartetTM LV, St Jude Medical, St Paul, MN, USA) was positioned using an over-the-wire approach (Fig. 1B). The CRT system implantation was completed successfully and a final angiography excluded the total occlusion of CS (Fig. 1C). To our knowledge, this is the first case of lead implantation in a patient with CS reducer, which could arise concerns considering the partial occlusion of the vessel. The procedure was feasible without any peculiar drawbacks as compared to a standard CRT implantation. No data are available on the long-term consequences of CS lead placement across this reducer system, including possibility of total occlusion or difficulty in lead extraction. Of note, in some anatomy of the CS branch, the insertion of the pacing lead may become more difficult due to lack of sufficient support from the sheath.