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Lead dwell time10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years.A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures.The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up.Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.

Purpose The aim of the present study was to evaluate the outcome of patients underwent subcutaneous implantable cardioverter defibrillator (S-ICD) implantation with the intermuscular (IM) two-incision technique during 3-year follow-up. Methods the study population consisted of 105 consecutive patients (79 male; median 50 [13–77] years) underwent S-ICD implantation with the IM two-incision technique. The composite primary end point of the study consisted of device-related complications and inappropriate shocks (IAS). Secondary end points included the individual components of the primary end point, death from any cause, appropriate therapy, major adverse cardiac events, hospitalization for heart failure, and heart transplantation. Results According to the PRAETORIAN score, the risk of conversion failure was classified as low in 99 patients (94.3%), intermediate in 6 (5.7%).Ventricular fibrillation was successfully converted at ≤65 J in 97.4% of patients. During a median follow-up of 39 (16–53) months, 10 patients (9.5%) experienced device-related complications, and 9 (8.5%) patients reported IAS. Lead-associated complications were the most common (5 patients, 4.7%), including 2 cases of lead failure (1.9%). Pocket complications were reported in 2 patients (1.9%). Extra-cardiac oversensing (3.8%) represented the leading cause of IAS. No T-wave oversensing episodes were recorded. Twelve patients (11.4%) experienced appropriate shocks. Eight patients (7.6%) died during follow-up. IAS or device-related complications did not impact on mortality. Conclusions The overall device-related complications and IAS rates over 3 years of follow-up were 9.5% and 8.5%, respectively. According to our findings, the IM two-incision technique allows for optimal positioning of the device achieving a low PRAETORIAN score with a high conversion rate. IM two-incision technique allows low incidence of pocket complications, shifting the type of complications towards lead-related complications, which represent the most common complications. The IM two-incision technique would not seem to impact the occurrence of IAS. Management of complications are safe without impact on the outcome.

A 50-year-old female with a history of bileaflet mitral valve prolapse (MVP) was admitted to our Department for persistent palpitation. Physical examination revealed a mid-systolic click, followed by a mid-to-late apical systolic murmur. The electrocardiogram showed sinus rhythm with negative T-waves in inferior leads and repetitive polymorphic premature ventricular contractions (PVCs) with a right bundle branch block pattern and superior axis morphology suggestive of a possible origin from the posterior papillary muscle. The echocardiography confirmed normal ventricular ejection fraction, bileaflet MVP with moderate regurgitation, systolic curling and mitral annulus disjunction. Exercise stress testing demonstrated an increase of polymorphic PVCs during maximum effort. The cardiac magnetic resonance showed an underlying late gadolinium enhancement at the level of the papillary muscles and in the inferobasal region. After a multidisciplinary evaluation, a transvenous implatable cardioverter defibrillator (ICD) was implanted for primary prevention without clear indications deriving from current guidelines. After eleven years, the patients experienced two appropriate shocks due to polymorfic ventricular tachycardia while she was sleeping. Furthermore, the patient underwent successful mechanical transvenous lead extraction and ICD re-implantation for lead failure. During this hospitalization a subsequent echocardiography detected severe ventricular dilatation with moderate systolic disfunction. Conclusion Our report demonstrated that MVP represents potentially cause of life-threatening ventricular arrhythmias and tachycardia induced cardiomyopathy. Beta-blockers are often inadequate in order to reduce PVCs burden. We need more arrhytmic predictors to assestment of sudden cardiac death risk and evaluate ICD for primary prevention. Obtain left ventricular function recovery is difficult and it requires a multidisciplinary approach. It will be important in the future to better define the role will play cathether ablation and mitral valve repair or replacement to prevent malignant arrhytmias.

Background The aim of the present study was to evaluate the outcome of patients underwent subcutaneous implantable cardioverter defibrillator (S-ICD) implantation with the intermuscular (IM) two-incision technique during 3-year follow-up. Methods the study population consisted of 105 consecutive patients (79 male; median 50 [13-77] years) underwent S-ICD implantation with the IM two-incision technique. Results according to the PRAETORIAN score, the risk of conversion failure was classified as low in 99 patients (94.3%), intermediate in 6 (5.7%). Ventricular fibrillation was successfully converted at ≤65 J in 97.4% of patients. During a median follow-up of 39 (16-53) months, 10 patients (9.5%) experienced device-related complications and 9 (8.5%) patients reported shocks (IAS). Lead-associated complications were the most common (3.8%), including 2 cases of lead failure (1.9%). Pocket complications were reported in 2 patients (1.9%). Extra-cardiac oversensing (3.8%) represented the leading cause of IAS. No T-wave oversensing episodes were recorded. Twelve patients (11.4%) experienced appropriate shocks. Eight patients (7.6%) died during follow-up. IAS or device-related complications did not impact on mortality (HR 0.5;95%CI 0-4.3;P=0.5; HR 0.7;95%CI 0.1-6.0;P=0.8, respectively). Conclusions according to our findings, the IM two-incision technique allows for optimal positioning of the device achieving a low PRAETORIAN score with a high conversion rate. IM two-incision technique allows low incidence of pocket complications, shifting the type of complications towards lead-related complications, which represent the most common complications. The IM two- incision technique would not seem to impact the occurrence of IAS. Management of complications are safe without impact on the outcome.

We report a case of a 77-years-old man admitted to our department because of facial plethora, prominent venous collateral over the anterior chest wall, marked swelling of the head and upper extremities. His medical history was notable diabetes, non-Hodgkin lymphoma (NHL), eradicated HCV, AV block, for which he underwent placement of a dual-chamber pacemaker 4 years earlier. A superior vena cava (SVC) syndrome lead-related was documented on angio-CT scan and phlebography. After a multidisciplinary team discussion, a treatment strategy was designed to consist of transvenous lead extraction, SVC reconstruction and epicardial pacing placement. At 5 months follow-up, he was completely relieved of symptoms. Conclusion Lead-associated SVC syndrome is a rare condition and there is no standard management protocol. Data are lacking and we need at least a registry to make the treatment homogeneous. In this specific patient, a hybrid procedure based on lead extraction and reconstruction of superior vena cava was safe and effective for the relief of symptoms and maintenance of SVC patency. Heparin alone will not lead to the resolution of the disease if the disease is at an advanced stage. Learning outcomes Patients with lead-induced superior vena cava syndrome often required a multidisciplinary approach. A hybrid procedure based on transvenous lead extraction and reconstruction of superior vena cava is safe and effective to achieve relief of symptoms, maintenance of SVC patency, and adequate pacing.

The aim of this monocentric experience was to evaluate the efficacy and safety of subcutaneous implantable cardioverter-defibrillators (S-ICDs) lead removal procedures. Background S-ICD represents a therapeutic option for patients at high-risk of sudden cardiac death, in whom pacing or cardiac resynchronization therapy is not required. Furthermore, S-ICD is a suitable alternative in patients who had underwent to transvenous lead extraction, expecially to limit lead-related complications of transvenous ICD. However, data are lacking about the safety and feasibility of S-ICD lead removal procedures. Methods We enrolled a population consisted of 11 consecutive patients requiring S-ICD lead removal between May 25, 2014, and June 26, 2022. The primary endpoint of the study was procedural success, defined as the removal of all the lead and lead material from the subcutaneous space. Secondary endpoints included procedural complications and the need for specific removal tools. Results S-ICD lead removal procedures were performed in 11 patients (mean age 47 ± 14, 82% men, 64% in primary prevention). Indications for S-ICD removal procedures were replace with inappropriate sensing (n=2), generator and lead infection (n= 3), pocket erosion (n=1), system malfunction (n=2), ineffective therapy (n=1) and, finally, heart transplantation (n=2). The median time from S-ICD lead implantation to S-ICD removal was 16 (6-38) months. The primary endpoint was achieved in 100% of the patients, without procedural failure. Simple traction of the S-ICD lead was successful in 8 patients (73%), whereas 3 patients (27%) required non-powered mechanical sheath to remove lead adhesions around the coil. No addictional incision were needed in order to lead removal. No procedure-related complications occurred. Patients with device infection underwent to S-ICD removal earlier than patients without (11 months [6.5 to 15.2 months ] vs 31 months [16.5 to 45.5 months]). Conclusions Although simple manual traction is effective in most patients, additional tools are required in few cases, raising the question, if also the S-ICD lead removal should performed in centers with lead extraction experience with available advanced tools.

Since 2003 a 73-year-old man was submitted to a pacemaker implantation because of atrio-ventricular block. After fourteen years, upgrading to CRT-D was made due to recovery for acute heart failure in a dilated cardiomyopathy with severe left ventricular systolic dysfunction. In 2019 and 2020 he presented pocket erosion therefore underwent to a submuscular reimplantation. After one year, he came to Arrhythmology outpatient appointment with inflammatory signs of the CRT-D pocket. The patient was started on Meropenem and Vancomicin. Transthoracic (TTE) and transesophageal echocardiogram didn't reveal any vegetation on valvular apparatus or on leads. The patient was submitted to transvenous lead extraction (TLE) with bidirectional rotational mechanical sheats and a epicardial lead on postero-lateral left ventricular wall was implanted. The post-procedural TTE showed a moderate to severe organic tricuspid valve regurgitation with annular dilatation despite the patient was asymptomatic. There weren't flail leaflets or tricuspid valve damage. The reimplantation of right atrial and ventricular leads was hindered by complex venous anatomy documented by intraprocedural phlebography. After Heart Team discussion, we agreed to tricuspid valve repair with annuloplasty ring and other two epicardial leads - right atrial and ventricular - was implanted. We achieve a successful result without complications. The patients was discharged without symptoms; the device interrogation showed good assessment of lead impedances, sensing thresholds, and capture thresholds. Conclusion The mechanisms of tricuspid valve regurgitation following TLE are complex. There isn't a standardized best practice to approach this phenomenon. It's important after TLE to assess tricuspid valve structure and function with TTE in order to understand the incidence of underlying potential mechanism and how to prevent it. Complex venous anatomy could direct the choice toward epicardial leads implantation.

We described the case of a 34 year-old young athlete who was referred to our Department because of palpitations and fatigue, arising after hard effort but also present at rest. Family history was unremarkable for sudden cardiac death or cardiomyopathies. Electrocardiography (ECG) evidenced multifocal premature ventricular contractions (PVCs): left bundle branch block (LBBB) morphology and superior/inferior axis; right bundle branch block (RBBB) morphology and undetermined axis. Cardiac MRI showed extensive mid wall and subepicardial late gadolinium enhancement in the postero-lateral left ventricular wall. We decided to perform electroanatomic mapping (EAM) because we didn't explain the origin of the PVCs with LBBB configuration. During EAM we found an area extending from the right ventricular outflow tract to the subtricuspidal lateral inferior wall which it had not described by cardiac MRI. In the low voltage areas, the electrograms inscribed by the catheter's electrodes was fractionated with different waveforms, a finding that corresponds to a deficiency of healthy myocardial tissue. We performed an endomyocardial biopsy in the interventricular septum close to the ventricular out flow tract. The histological examination of the biopsy samples showed fibro-fatty replacement. Therefore genetic testing revealed a pathogenic desmoplakin mutation. According to “Padua Criteria”, we made a diagnosis of biventricular arrhythmogenic cardiomyopathy. We finally implanted a transvenous cardioverter defibrillator. Conclusion Diagnosis of arrhythmogenic cardiomyopathy (ACM) is complex and requires the combination of multiple clinical, histological and genetic parameters. This clinical case demonstrated that ECG represent an essential tool in diagnostic work-up of the disease, and electroanatomic mapping is useful in selected cases for the documentation of the diagnosis of arrhytmogenic cardiomyopathy.

Background Subcutaneous implantable cardioverter defibrillator (S-ICD) is a suitable alternative for transvenous ICD (TV-ICD) patients who have undergone transvenous lead extraction (TLE). Limited data are available on the outcome of S-ICD patients implanted after TLE. We assessed the safety, efficacy and outcome of S-ICD implantation after TLE of TV-ICD. Methods The study population consisted of 36 consecutive patients with a median age of 52 (44-66) years who underwent S-ICD implantation after TLE of TV-ICD. Results and Conclusions Indications for TLE were: infection (63.4%) and lead malfunction (36.4%). During a median follow-up of 31 months, 3 patients (8.3%) experienced appropriate therapy and 7 patients (19.4%) experienced complications including inappropriate therapy (n=4;11.1%), pulse generator pocket erosion with no evidence of infection (n=2;5.5%) and ineffective therapy (n=1;2.7%).No pocket or systemic device-related infection, lead/hardware dysfunction were reported.Premature device explantation occurred in 4 patients (11%). Eight patients (22.2%) died during follow-up, six of them (75%) because of refractory heart failure (HF).There were no S-ICD-related deaths. Predictors of mortality included NYHA class ≥2 (HR 5.05;95% CI 1.00–26.38;p=0.04), hypertension (HR 22.72;95% CI 1.05–26.31;p=0.02), diabetes (HR 10.64;95% CI 2.05-55.60; p=0.001) and ischemic heart disease (HR 5.92;95% CI 1.17–30.30;p= 0.01). Our study provides evidences on the use of S-ICD as an ideal alternative after TV-ICD explantation for both infection and lead failure. Mortality of S-ICD patients who underwent TV-ICD explantation does not appear to be correlated with the presence of a prior infection, S-ICD therapy (appropriate or inappropriate), or S-ICD complications but rather to worsening of HF or other comorbidity.

Background Subcutaneous implantable cardioverter defibrillator (S-ICD) is a suitable alternative for transvenous ICD (TV-ICD) patients who have undergone transvenous lead extraction (TLE). Limited data are available on the outcome of S-ICD patients implanted after TLE. We assessed the safety, efficacy, and outcome of S-ICD implantation after TLE of TV-ICD. Methods The study population consisted of 36 consecutive patients with a median age of 52 (44–66) years who underwent S-ICD implantation after TLE of TV-ICD. Results Indications for TLE were infection (63.9%) and lead malfunction (36.1%). During a median follow-up of 31 months, 3 patients (8.3%) experienced appropriate therapy and 7 patients (19.4%) experienced complications including inappropriate therapy (n = 4; 11.1%), isolated pocket erosion (n = 2; 5.5%), and ineffective therapy (n = 1; 2.8%). No lead/hardware dysfunction was reported. Premature device explantation occurred in 4 patients (11%). Eight patients (22.2%) died during follow-up, six of them (75%) because of refractory heart failure (HF). There were no S-ICD-related deaths. Predictors of mortality included NYHA class ≥ 2 (HR 5.05; 95% CI 1.00–26.38; p = 0.04), hypertension (HR 22.72; 95% CI 1.05–26.31; p = 0.02), diabetes (HR 10.64; 95% CI 2.05–55.60; p = 0.001) and ischemic heart disease (HR 5.92; 95% CI 1.17–30.30; p = 0.01). Conclusion Our study provides evidences on the use of S-ICD as an alternative after TV-ICD explantation for both infection and lead failure. Mortality of S-ICD patients who underwent TV-ICD explantation does not appear to be correlated with the presence of a prior infection, S-ICD therapy (appropriate or inappropriate), or S-ICD complications but rather to worsening of HF or other comorbidities.