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INTRODUCTION: Transvenous lead extraction (TLE) is generally considered a safe procedure, albeit not without risks. While gender-based disparities have been noted in short-term outcomes following TLE, a notable gap exists in understanding the long-term consequences of this procedure. The objective of this analysis was to investigate sex differences in both acute and long-term outcomes among patients who underwent TLE at a tertiary referral center. METHODS: In this retrospective cohort study, consecutive patients who underwent TLE between January 2014 and January 2016 were enrolled. The primary outcome comprised a composite of all-cause mortality and need for repeated TLE procedures. Secondary outcomes included fluoroscopy time, lead extraction techniques, success rates, and major and minor complications. Results were compared between female and male cohorts. RESULTS: The study population comprised 191 patients (median age, 70 years), 29 (15.2%) being women and 162 men (84.8%). Study groups had similar baseline characteristics. Complete procedural success was achieved in 189 out of 191 patients (99.0%), with no significant difference observed between the two groups (p = .17). No major complications were reported in the total cohort. However, there was a significantly higher incidence of minor complications in women compared to men (17.2% vs. 2.5%, p < .01). Following a median follow-up of 6.5 years, the incidence of the primary composite outcome occurred similarly between the study groups (log-rank p = .68). CONCLUSION: Women who underwent TLE exhibited a significantly higher incidence of minor acute intra- and peri-procedural complications than men. However, no differences in long-term outcomes between genders were observed.
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AIMS: Despite general agreement on the benefits of the Heart Team approach for patients with cardiac diseases, few data are available on its real impact on the decision-making process. The aim of the study is to define the evolution over time of the level of agreement with the systematic discussion of patients in the Heart Team and to evaluate the adherence to the Heart Team recommendations and the impact of the Heart Team on the clinical outcome of the patients. METHODS: In 2015--2016, an experienced cardiac surgeon and a cardiologist independently reviewed clinical data of a series of 100 patients (Group 1, G1) and subsequently for each patient recommended treatment (surgical, percutaneous, hybrid or medical therapy) or further diagnostic investigations. The next day, each case was discussed by the Hospital Heart Team. The Heart Team recommendation, the subsequent treatment received by the patient and the in-hospital outcome were recorded. The same study procedure was repeated in 2017 in a second (G2) and in 2018 in a third (G3) group, both of them including 100 patients. RESULTS: Complete agreement in treatment selection by the cardiac surgeon, cardiologist and the Heart Team was observed in 43% of cases in G1 and in 70% and 68% in G2 and G3, respectively (G1 vs. G2: P â<â0.001, G1 vs. G3: P â=â0.01, G2 vs. G3: P â=â0.30). Agreement was less frequent in patients with a higher risk profile and in patients with aortic valve stenosis. The Heart Team decision was implemented in 95% of cases with a 30-day mortality of 0.67%. CONCLUSION: Agreement in treatment selection among the cardiac surgeon, cardiologist and Heart Team appears to be low in the initial experience. Subsequently, it seems to steadily increase over time up to a limit, when it reaches a plateau of stable results. Heart Team clinical cases discussion, based on both guidelines and multidisciplinary experience, represents a key step in defining the best patient treatment pathway, potentially improving the decision-making process and clinical results.
Subject(s)
Aortic Valve Stenosis , Cardiovascular Diseases , Coronary Artery Disease , Humans , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/therapy , Precision Medicine , Coronary Artery Disease/surgery , Heart , Aortic Valve Stenosis/surgery , Treatment OutcomeABSTRACT
BACKGROUND: The increasing use of biological substitutes for surgical aortic valve replacement (AVR), has led to the development of new bioprostheses with improved hemodynamics and expected durability. METHODS: In this observational retrospective two-center cohort study, two innovative bioprostheses, INSPIRIS Resilia and AVALUS were analyzed. We analyzed early and 2.4-year follow-up results in terms of safety, clinical outcome and hemodynamic performance. RESULTS: From November 2017 to February 2021, 148 patients underwent AVR with INSPIRIS Resilia (N.=74) or AVALUS (N.=74) bioprosthesis. The 30-day and mid-term mortality was comparable (1% vs. 3%, P=0.1 and 7% vs. 4%, P=0.4, respectively). Valve-related mortality was observed in one AVALUS patient. Three (4%) patients of the AVALUS group developed prosthetic endocarditis and two of them died after reoperation. No other cases of prosthetic endocarditis were observed. No cases of structural valve degeneration or significant paravalvular leak were detected at follow-up. Median follow-up peak pressure gradient was 21 vs. 23 mmHg (P=0.4) and the mean pressure gradient was 12 vs. 13 mmHg (P=0.9) for Inspiris and AVALUS, respectively. The effective orifice area (EOA) and indexed EOA were 1.5 cm2 vs. 1.4 cm2 (P=0.4) and 0.8 vs. 0.7 cm2/m2 (P=0.5), respectively. Indexed left ventricular mass regression was -33 vs. -52 g/m2 for the Inspiris and AVALUS groups, respectively, (R2-adjusted =0.14; P<0.01). CONCLUSIONS: INSPIRIS Resilia and AVALUS bioprostheses were reliable with comparable results in safety, clinical outcome and hemodynamic performance. After statistical adjustment, AVALUS was associated with better left ventricular mass reduction. Long-term follow-up would provide definitive comparative results.
Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Endocarditis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Humans , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Retrospective Studies , Cohort Studies , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Hemodynamics , Prosthesis Design , Treatment OutcomeABSTRACT
INTRODUCTION: The prevalence and impact of pulmonary embolism (PE) in patients with lead-related infective endocarditis undergoing transvenous lead extraction (TLE) are unknown. METHODS: Twenty-five consecutive patients with vegetations ≥10 mm at transoesophageal echocardiography were prospectively studied. Contrast-enhanced chest computed tomography (CT) was performed before (pre-TLE) and after (post-TLE) the lead extraction procedure. RESULTS: Pre-TLE CT identified 18 patients (72%) with subclinical PE. The size of vegetations in patients with PE did not differ significantly from those without (median 20.0 mm [interquartile range: 13.0-30.0] vs. 14.0 mm [6.0-18.0], p = 0.116). Complete TLE success was achieved in all patients with 3 (2-3) leads extracted per procedure. There were no postprocedure complications related to the presence of PE and no differences in terms of fluoroscopy time and need for advanced tools. In the group of positive pre-TLE CT, post-TLE scan confirmed the presence of silent PE in 14 patients (78%). There were no patients with new PE formation. Large vegetations (≥20 mm) tended to increase the risk of post-TLE subclinical PE (odds ratio 5.99 [95% confidence interval (CI): 0.93-38.6], p = 0.059). During a median 19.4 months follow-up, no re-infection of the implanted system was reported. Survival rates in patients with and without post-TLE PE were similar (hazard ratio: 1.11 [95% CI: 0.18-6.67], p = 0.909). CONCLUSION: Subclinical PE detected by CT was common in patients undergoing TLE with lead-related infective endocarditis and vegetations but was not associated with the complexity of the procedure or adverse outcomes. TLE procedure seems safe and feasible even in patients with large vegetations.
Subject(s)
Defibrillators, Implantable , Endocarditis, Bacterial , Endocarditis , Pacemaker, Artificial , Prosthesis-Related Infections , Pulmonary Embolism , Defibrillators, Implantable/adverse effects , Device Removal/methods , Endocarditis/diagnostic imaging , Endocarditis/epidemiology , Endocarditis, Bacterial/diagnostic imaging , Endocarditis, Bacterial/epidemiology , Humans , Pacemaker, Artificial/adverse effects , Prevalence , Prosthesis-Related Infections/diagnostic imaging , Prosthesis-Related Infections/epidemiology , Prosthesis-Related Infections/etiology , Pulmonary Embolism/diagnostic imaging , Pulmonary Embolism/epidemiology , Pulmonary Embolism/therapy , Retrospective StudiesABSTRACT
AIMS: In this study, we aimed to compare the efficacy of single pulmonary vein isolation with the second-generation cryoballoon (CB-Adv) and predictors of atrial fibrillation recurrences in patients with paroxysmal (PAF) and persistent atrial fibrillation (PersAF). METHODS: Consecutive PAF and PersAF patients undergoing CB-Adv for the first time were enrolled. Patients were followed with in-clinic visits including Holter ECG. Atrial arrhythmic episodes symptomatic or documented lasting more than 30âs were considered as recurrences. RESULTS: A total of 96 consecutive patients [77 men (80%), mean age 57.4â±â9.9 years] were included in this analysis. About 56 (58%) patients had PAF and 40 had (42%) PersAF. The mean procedural and fluoroscopy times were 116â±â24 and 33â±â12âmin, respectively. Procedure-related complications occurred in four (4.2%) patients.At the 12-month follow-up, after a 3-month blanking period, freedom from recurrences was achieved in 59% [confidence interval (CI): 49-69%] of patients, 62% (CI: 48-75%) in PAF, and 54% (CI: 38-71%) in PersAF group. The difference was not statistically significant at the Kaplan-Meier survival analysis (Pâ=â0.242). Cardioversion to restore sinus rhythm was less frequently needed in PAF group [5% (CI: 1-15%) vs. 25% (CI: 13-41%), Pâ<â0.001]. Redo procedure was performed in 7% (CI: 3-15%) of patients. In the Cox regression analysis, early atrial-tachyarrhythmia recurrence was the only independent predictor of 1-year recurrence (hazard ratio 2.11, CI: 1.06-4.20, Pâ=â0.03). CONCLUSION: The success rate at 12 months after a single CB-Adv procedure was 62% in patients with PAF and 54% in study participants with PersAF. Early atrial-tachyarrhythmia recurrence appeared to be the only independent predictor of late atrial fibrillation recurrence.
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Atrial Fibrillation/therapy , Catheter Ablation/statistics & numerical data , Aged , Catheter Ablation/adverse effects , Catheter Ablation/methods , Female , Humans , Male , Middle Aged , Recurrence , Treatment OutcomeABSTRACT
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, Pâ=â0.01), and in ICD interventions in terms of both antitachycardia pacing (2 vs. 0, Pâ=â0.04) and shock delivery (2 vs. 0, Pâ=â0.02) after the addition of ranolazine. Moreover, fewer patients experienced episodes of nonsustained ventricular tachycardia (71 vs. 41%, Pâ=â0.04), ventricular tachycardia (76 vs. 24%, Pâ=â0.01), ICD antitachycardia pacing (47 vs. 18%, Pâ=â0.02), and ICD shocks (47 vs. 6%, Pâ=â0.03). 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.
Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Electric Countershock/instrumentation , Heart Failure/drug therapy , Ranolazine/therapeutic use , Tachycardia, Ventricular/drug therapy , Ventricular Fibrillation/drug therapy , Aged , Anti-Arrhythmia Agents/adverse effects , Defibrillators, Implantable , Disease Progression , Drug Resistance , Female , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Male , Middle Aged , Ranolazine/adverse effects , Recurrence , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/physiopathology , Time Factors , Treatment Outcome , Ventricular Fibrillation/diagnosis , Ventricular Fibrillation/physiopathologyABSTRACT
INTRODUCTION: 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. METHODS: Consecutive patients undergoing TLE between January 2014 and January 2016 were included in this analysis. The fluoroscopy time related to the leads removal was dichotomized as above or below its 90th percentile (PCTL). RESULTS: In total, 446 permanent leads were removed during 233 TLE procedures. Complete procedural success was achieved in 232 (99.1%) patients. The LED index resulted >10 in 83(35.6%) procedures. Among these cases, 20 had fluoroscopy time above the 90th PCTL (23.3 minutes) and were classified as true positive. Over the 150 procedures with LED score <10, 147 were classified as true negative, and only 3 resulted false negative. The sensitivity, the specificity, and the negative predictive value of the LED index in predicting complex cases resulted 86.9 (confidence interval [CI] 66.4-97.2)%, 70.0 (CI 63.3-76.1)%, and 98.0 (CI 94.3-99.6)%, respectively. The multivariate logistic regression analysis confirmed a 12% increased risk of high fluoroscopy for each additional point of the LED score (OR 1.12, CI 1.05-1.21, P = 0.001). CONCLUSION: The validation of the estimation model based on the LED index <10 confirmed its high efficacy in predicting simple TLE procedures.
Subject(s)
Defibrillators, Implantable/adverse effects , Device Removal/methods , Device Removal/standards , Equipment Failure , Femoral Vein/surgery , Aged , Female , Forecasting , Humans , Male , Middle AgedABSTRACT
An 84-year-old woman implanted with cardiac resynchronization therapy defibrillator underwent transvenous lead extraction 4 mo after the implant due to pocket infection. Atrial and right ventricular leads were easily extracted, while the attempt to remove the coronary sinus (CS) lead was unsuccessful. A few weeks later a new extraction procedure was performed in our center. A stepwise approach was used. Firstly, manual traction was unsuccessfully attempted, even with proper-sized locking stylet. Secondly, mechanical dilatation was used with a single inner sheath placed close to the CS ostium. Finally, a modified sub-selector sheath was successfully advanced over the electrode until it was free of the binding tissue. The post-extraction lead examination showed an unexpected fibrosis around the tip. No complications occurred during the postoperative course. Fibrous adhesions could be found in CS leads recently implanted requiring non-standard techniques for its transvenous extraction.
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INTRODUCTION: 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. METHODS AND RESULTS: We reported 12 cases of planned hybrid lead extraction; minithoracotomy and thoracoscopy were performed on 10 (83%) and 2 (17%) patients, respectively. A total of 25 leads out of 27 (median lead age 19 years) were successfully extracted with laser, mechanical or combined transvenous sheath. In 3 patients, the direct monitoring of vascular and myocardial integrity allowed for prompt treatment of potential vascular injury during the lead extraction maneuvers. Mean in-hospital stay was 4 ± 2 days. There were no major intraoperative complications and no deaths occurred after 30 days' follow-up. CONCLUSION: The hybrid approach, with minithoracotomy or thoracoscopy, is feasible and it might increase the safety in the most challenging TLE procedures: the minimally invasive surgical intervention allows for continuous monitoring of the critical cardiac structures and prompt treatment of potential complications.
Subject(s)
Cardiac Resynchronization Therapy Devices , Defibrillators, Implantable , Device Removal/methods , Pacemaker, Artificial , Thoracoscopy , Thoracotomy , Adult , Aged , Aged, 80 and over , Cardiologists , Device Removal/adverse effects , Electrophysiologic Techniques, Cardiac , Feasibility Studies , Female , Humans , Length of Stay , Male , Patient Care Team , Prosthesis Design , Prosthesis Failure , Risk Factors , Surgeons , Thoracoscopy/adverse effects , Thoracotomy/adverse effects , Time Factors , Treatment OutcomeABSTRACT
Cardiac resynchronization therapy (CRT) is an important tool for the treatment of patients with chronic heart failure, as it can correct the heterogeneity of regional left ventricular mechanical contraction, known as dyssynchrony. Although this therapy is strongly indicated in patients with both heart failure with left ventricular systolic dysfunction and wide Q-, R- and S-waves (QRS) on electrocardiogram, about one-third of these patients are non-responders. Since the degree of mechanical dyssynchrony can vary greatly, it is interesting to quantify dyssynchrony by means of imaging methods, such as echocardiography, which might be able to lead to a better selection of CRT candidates. This article will review the role of old and new echocardiographic techniques to predict CRT response.
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Cardiac Resynchronization Therapy Devices , Cardiac Resynchronization Therapy/methods , Echocardiography/instrumentation , Heart Diseases/diagnostic imaging , Heart Diseases/therapy , Heart Failure/therapy , HumansABSTRACT
BACKGROUND: Early postoperative data show that surgical ventricular reconstruction (SVR) induces reverse remodelling (RR) in dilated ischemic cardiomyopathy. The stability of these results at follow-up is debated. This retrospective study determined whether RR was stable at follow-up and the role, if any, of preoperative left ventricle volume and shape on SVR-induced changes. METHODS: The study group comprised 220 patients (age, 64 ± 9 years) with an echocardiography study at baseline, discharge, and at follow-up. RR was defined as a reduction of left ventricular end-systolic volume index (ESVI) at follow-up exceeding 15% vs baseline. RESULTS: Reverse remodelling occurred in 162 patients (74%); the ESVI at follow-up in the remaining 58 (26%) was equal to or greater than at baseline (no-RR). At baseline, the no-RR patients had lower volumes and higher ejection fraction; at the 1-week post-SVR evaluation, all patients reached significant ESV reduction, but at follow-up, the no-RR patients had dilated and showed significantly higher volumes and lower ejection fraction vs patients with RR. New York Heart Association class improved in both groups (2.6 ± 0.6 to 1.6 ± 0.5 and 2.5 ± 0.8 to 1.8 ± 0.7, respectively, p = 0.0001). Baseline ESVI less than 73 mL/m(2), apical axis less than 4.35 cm, and conicity index less than 0.759 were predictors of no-RR. CONCLUSIONS: A relatively small ESVI and a more physiologic apical shape (conical) are predictors of no-RR after SVR. Despite lack of RR, the ESV at follow-up is not severely enlarged, which explains the good survival rate in these patients.
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Heart Ventricles/pathology , Heart Ventricles/surgery , Ventricular Remodeling , Cardiac Surgical Procedures , Female , Follow-Up Studies , Humans , Male , Middle Aged , Organ Size , Retrospective StudiesABSTRACT
Congenital aortopulmonary window is a rare inborn cardiac malformation that should be surgically treated as soon as the diagnosis is made usually during infancy. We report a successful surgical treatment of a 23-year-old male patient with a big type III aortopulmonary window.