Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator
ABSTRACT BACKGROUND: Three incisions in the chest are necessary for the implantation of the entirely subcutaneous implantable defibrillator (S-ICD). The superior parasternal incision is a possible risk for infection and a potential source of discomfort. A less invasive alternative technique of implanting the S-ICD electrode avoids the superior parasternal incision: The two incision technique. OBJECTIVE: In this prospective cohort study, we sought to evaluate the safety and efficacy of the two incision technique for the implantation of the S-ICD. METHODS: Consecutive patients who received a S-ICD between October 2010 and December 2011 were implanted using the two incision technique, which positions the parasternal part of the S-ICD electrode using a standard 11 French peel-away sheath. All patients were routinely evaluated for at least one year for complications and device interrogation at the outpatient clinic. RESULTS: Thirty-nine patients (46% male, mean age 44±15 years) were implanted with a S-ICD using the two incision techniques. During a mean follow-up of 18 months (range 14-27) no dislocations were observed and there was no need for repositioning of either the ICD or the electrode. No serious infections occurred during follow-up except for two superficial wound infections of the pocket incision site. Device function was normal in all patients and no inappropriate sensing occurred related to the implantation technique. CONCLUSION: The two incision technique is a safe and efficacious alternative for S-ICD implantations and may help to reduce complications. The two incision technique offers physicians a less invasive and simplified implantation procedure of the S-ICD.
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ABSTRACT: OBJECTIVES: This study sought to collect data and evaluate the anecdotal use of transcatheter aortic valve implantation (TAVI) in pure native aortic valve regurgitation (NAVR) for patients who were deemed surgically inoperable. BACKGROUND: Data and experience with TAVI in the treatment of patients with pure severe NAVR are limited. METHODS: Data on baseline patient characteristics, device and procedure parameters, echocardiographic parameters, and outcomes up to July 2012 were collected retrospectively from 14 centers that have performed TAVI for NAVR. RESULTS: A total of 43 patients underwent TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) at 14 centers (mean age, 75.3 ± 8.8 years; 53% female; mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), 26.9 ± 17.9%; and mean Society of Thoracic Surgeons score, 10.2 ± 5.3%). All patients had severe NAVR on echocardiography without aortic stenosis and 17 patients (39.5%) had the degree of aortic valvular calcification documented on CT or echocardiography. Vascular access was transfemoral (n = 35), subclavian (n = 4), direct aortic (n = 3), and carotid (n = 1). Implantation of a TAVI was performed in 42 patients (97.7%), and 8 patients (18.6%) required a second valve during the index procedure for residual aortic regurgitation. In all patients requiring second valves, valvular calcification was absent (p = 0.014). Post-procedure aortic regurgitation grade I or lower was present in 34 patients (79.1%). At 30 days, the major stroke incidence was 4.7%, and the all-cause mortality rate was 9.3%. At 12 months, the all-cause mortality rate was 21.4% (6 of 28 patients). CONCLUSIONS: This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery, but the possibility of requiring 2 valves and leaving residual aortic regurgitation remain important considerations.Journal of the American College of Cardiology 02/2013; 61(15). DOI:10.1016/j.jacc.2013.01.018 · 15.34 Impact Factor
- Heart rhythm: the official journal of the Heart Rhythm Society 08/2013; 10(12). DOI:10.1016/j.hrthm.2013.08.008 · 4.92 Impact Factor
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ABSTRACT: To consider the case of need that underpinned the development of the subcutaneous implantable cardioverter-defibrillator (SICD), the preclinical and clinical data obtained so far, its current role and likely future. The data from prospective clinical evaluation of the device demonstrated safety and efficacy leading to Food and Drug Administration approval. This superseded earlier reports from Europe that raised some clinical concerns, previously anticipated through the introduction of new technology. Recent estimates indicate maybe 55% of patients in routine clinical practice needing an ICD are potentially suitable for a subcutaneous device. The SICD provides a useful alternative for high-energy (ICD) therapy in those deemed at risk and who need defibrillation and in whom there are no indications for cardiac resynchronization, bradycardia support or antitachycardia pacing. There is the possibility of both higher specificity and the avoidance of myo-cellular damage with shock delivery, and if these two aspects play out subcutaneous defibrillation could become an option of choice in many settings.Current opinion in cardiology 11/2013; DOI:10.1097/HCO.0000000000000031 · 2.59 Impact Factor