BACKGROUNDThe extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODSWe conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system-or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the onesided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%.
Background: Impella CP support during Posterior Vein Isolation/Posterior Wall Isolation (PVI/PWI) in the setting of persistent cardiogenic shock from refractory atrial fibrillation with rapid ventricular response (AF/RVR), has not been reported in the literature to the best of our knowledge. Case: A 61-year-old male truck driver was admitted with acute HFrEF with AF/RVR 130-150. His EF was 20% with global hypokinesis. He was diuresed and cardioverted to sinus rhythm and had QTc of 532. He reverted to AF/RVR in less than 24 hours, requiring amiodarone drip. Shortly, amiodarone was discontinued because of intense anorexia, nausea, and vomiting. Class III and Class 1c agents were contraindicated due to prolonged QTc and cardiomyopathy. He developed cardiogenic shock, worsening cardiorenal syndrome, and shock liver requiring continuous renal replacement therapy (CRRT). Inotropes and vasopressors were contraindicated. AVN ablation was refused because he wanted to return to truck driving. EF dropped to 10%, and moderate RV dysfunction ensued. Right heart catheterization showed PASP 53, PADP 38, and PCWP 37 with RAP 28mmHg. Coronary angiogram was normal. An Impella device was inserted, and support was set to P6 with 3.4 L/min cardiac output. PVI with cryoablation, PWI, and anterior mitral isthmus ablation was successful. The adequacy of isolation was verified by demonstrating a complete exit block 30 mins after ablation. Normal sinus rhythm was restored after cardioversion. Echo 48 hours later revealed improvement in EF from 10% to 40% in sinus rhythm. Impella and CRRT were weaned. He was discharged on GDMT. Conclusion: There are no recommendations regarding PVI for AF/RVR on mechanical circulatory support (MCS). MCS assisted PVI/PWI may be the only resort to restore hemodynamic stability in cases where a pacemaker is not desirable. PVI/PWI is a lengthy procedure; the use of the Impella support for PVI/PWI in cardiogenic shock allows adequate time for exit block testing and PWI. The operator can do thorough mapping and ablation, knowing that the patient is receiving adjustable support based on hemodynamic demands. We had a good outcome; nevertheless, the potential pitfalls are unknown.
Background Impella support during Posterior Vein Isolation/Posterior Wall Isolation (PVI/PWI) in the setting of persistent cardiogenic shock due to refractory atrial fibrillation with rapid ventricular response (AF/RVR), to the best of our knowledge, has not been reported in the literature. Case A 61-year-old male trucker was admitted with acute HFrEF with AF/RVR 130 -150 bpm. EF was 20% with global hypokinesis. He was diuresed and cardioverted to sinus rhythm and a QTc of 532 msec. He reverted to AF/RVR in less than 24 hours and requiring amiodarone drip but was discontinued due to severe intolerance. Subsequently, he developed cardiogenic shock, worsening cardiorenal syndrome, and shock liver requiring continuous renal replacement therapy (CRRT) in the CCU. Inotropes and vasopressors were contraindicated. AV node ablation was refused because he wanted to return to truck driving. Right heart catheterization showed PASP 53, PADP 38, and PCWP 37 with RAP 28mmHg. Coronary angiogram was normal. An Impella device was inserted, with P6 support at 3.4 L/min cardiac output. PVI with cryoablation, PWI, and anterior mitral isthmus ablation was successful with RFA. There was a complete exit block 30 mins after ablation. Normal sinus rhythm was restored after cardioversion. Echocardiography 48 hours later revealed improvement in EF from 10% to 40% in sinus rhythm. Follow up six months in the clinic showed EF recovery to 62%. Conclusion This case report demonstrates that in patients with refractory atrial fibrillation causing cardiogenic shock, PVI/PWI, while on Impella support, could be a good treatment option.
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