ABSTRACT
INTRODUCTION: A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. METHODS AND RESULTS: Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. CONCLUSION: This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population.
Subject(s)
Arrhythmias, Cardiac/therapy , Cardiac Catheterization/methods , Pacemaker, Artificial , Patient Safety/statistics & numerical data , Prosthesis Design , Aged , Aged, 80 and over , Arrhythmias, Cardiac/diagnosis , Cardiac Pacing, Artificial/methods , Electrodes , Female , Follow-Up Studies , Humans , Male , Prospective Studies , Risk Assessment , Sampling Studies , Treatment OutcomeABSTRACT
AIMS: The authors tested the value of stress single-photon emission computed tomography (SPECT) imaging performed systematically for detecting angiographic restenosis in asymptomatic patients who underwent direct percutaneous coronary intervention (PCI) for acute ST segment elevation myocardial infarction (STEMI). Angiographic restenosis of the infarct-related artery after direct PCI for STEMI is often silent and the strategy for follow-up evaluation of asymptomatic patients remains debated. METHODS: A total of 149 patients successfully treated by direct PCI (96% stenting) for STEMI with no symptoms during the follow-up systematically underwent both rest thallium 201/stress Tc 99m setamibi myocardial perfusion imaging and coronary angiogram at 6 months. Patients were followed up for 2.5+/-0.5 years after 6 months control for cardiac events. RESULTS: In the 149 patients, the sensitivity, specificity, positive and negative predictive values and accuracy of SPECT imaging were 48, 61, 35, 72 and 57%, respectively, for detecting binary angiographic restenosis defined as > or =50% diameter stenosis. Whether stress testing was maximal or performed after withheld anti-ischemic drugs did not improve the results. Reversible ischemia at SPECT in the infarct territory did not predict long-term cardiac events. CONCLUSION: These data suggest a poor correlation between stress SPECT imaging and angiographic restenosis at 6 months in patients treated by direct PCI for STEMI who remain asymptomatic at follow-up. The long-term clinical prognostic value of SPECT reversible ischemia in the infarct territory appears also limited in this peculiar subset of patients. These findings should be taken into account in the strategy of the clinical follow-up of this population.
Subject(s)
Angioplasty, Balloon, Coronary/rehabilitation , Coronary Restenosis/diagnostic imaging , Myocardial Infarction/surgery , Tomography, Emission-Computed, Single-Photon , Aged , Exercise Test , Female , Follow-Up Studies , Humans , Male , Middle Aged , Myocardial Ischemia , Predictive Value of Tests , PrognosisABSTRACT
BACKGROUND: Biventricular pacing is useful for patients with congestive heart failure but has the disadvantage of being a long, user-dependent, highly technical procedure. OBJECTIVES: The purpose of this study was to simplify the procedure. The simplified technique consists of sinus (CS) venography prior to implantation, direct coronary access for the left ventricular (LV) lead without use of a left-heart delivery system, and triple-guide/one introducer cephalic vein access as the first approach in patients presenting in sinus rhythm. METHODS: A cephalic cutdown was performed, and a steerable hydrophilic guidewire was introduced in the cephalic vein. A 9Fr introducer was advanced over the guidewire, and two other guides were inserted through the introducer. This technique allowed for insertion of a right ventricular lead, an LV lead, and an atrial lead. RESULTS: One hundred three patients were evaluated from January 2002 to September 2004. Four implants failed (3.9%). The 7Fr LV lead was successfully placed in 99 of 103 patients (96.1%) directly via the 9Fr introducer, without use of a dedicated left-heart delivery system. The final position was lateral in 59 patients, posterolateral in 33, posterior in 4, and anterolateral in 3. Sixty patients were in sinus rhythm, 13 were in atrial fibrillation, and 26 had a previous pacemaker (n = 21) or defibrillator (n = 5). Triple cephalic vein access was possible in 48 of the patients in sinus rhythm (80%). Procedure parameters were as follows: LV threshold 0.9 +/- 0.7 V, LV wave amplitude 15 +/- 8 mV, LV impedance 790 +/- 232 Omega, skin-to-skin procedure time 76 +/- 33 minutes, and fluoroscopy time 23 +/- 19 minutes. Ten complications (10.1%) occurred: 7 lead dislodgments (3 within 48 hours and 4 within 6 months) requiring repositioning (7.1%), 1 subacute local infection requiring explantation (1%), 1 phrenic nerve stimulation (1%), and 1 pneumothorax (1%). The long-term success of biventricular pacing was 93.1%. CONCLUSIONS: This study demonstrates that cardiac resynchronization therapy implantation can be simplified with the combined use of a steerable hydrophilic guidewire, three guides, and one introducer via a right cephalic vein, without use of a left-heart delivery system. The triple cephalic vein approach yields an 80% implant success rate for patients in sinus rhythm. The long-term success of biventricular pacing was 93.1%.