Introduction: Proper defect sizing and device size selection are imperative for ensuring successful clinical outcomes after transcatheter patent foramen ovale (PFO) closure. However, with current sizing techniques, residual shunting remains as high as 25% and is associated with an increased risk of recurrent neurologic events. Since 2017, we adopted a PFO sizing strategy based on right atrial (RA) tunnel “width” oversizing utilizing three-dimensional transesophageal echocardiography (3D-TEE). Hypothesis: We hypothesized that the PFO tunnel width at the RA opening and a cover index based on this dimension would predict residual shunting at long term follow-up. Methods: Sixty-four patients underwent transcatheter PFO closure (60 patients utilizing a 3D-TEE based oversizing strategy) at our institution between 2015 and 2022. PFO tunnel length, tunnel width at RA opening, and tunnel width at left atrial opening were determined by 3D-TEE either before or at the time of closure. We determined an absolute PFO “cover index” for each patient as follows: RA disc diameter - RA tunnel width. Receiver operating characteristic (ROC) curve analysis was used to determine the predictive ability of 3D-TEE derived PFO dimensions and the PFO cover index to predict residual shunting at follow-up. Results: Fifty-one of sixty-four patients had a long-term follow-up bubble study (mean follow-up time 8.0±3.7 months). Of the 47 patients closed utilizing a 3D-TEE based sizing strategy and with a follow-up bubble study, only 5 patients (10.6%) had residual shunting at follow-up. Of the three 3D-TEE based PFO dimensions, only the RA tunnel width was predictive of residual shunting at follow-up (AUC 0.84, p=0.004). A cutoff of 15.5 mm or greater for RA tunnel width had the best combination of sensitivity (86%) and specificity (73%). The PFO cover index was also strongly predictive of residual shunting at follow-up (AUC 0.87, p=0.002). A cutoff of 9.5 mm or less had the best combination of sensitivity (86%) and specificity (82%). Conclusions: A larger PFO tunnel width at the right atrial opening and a lower cover index based on this dimension predict residual shunting at follow-up. Our findings have important implications for improving sizing strategies for transcatheter PFO closure.
Purpose of review Although a patent foramen ovale (PFO) is an established risk factor for cryptogenic ischemic stroke, strategies for secondary prevention remain controversial. Increasing evidence over the past decade from well designed clinical trials supports transcatheter PFO closure for selected patients whose stroke was likely attributable to the PFO. However, patient selection using imaging findings, clinical scoring systems, and in some cases, thrombophilia testing, is crucial for determining patients most likely to benefit from closure, anticoagulation, or antiplatelet therapy. Recent findings Recent studies have found that patients with a high Risk of Paradoxical Embolism (RoPE) score and those with a thrombophilia benefit more from closure than medical therapy (including antiplatelet or anticoagulant therapy) alone. Meta-analyses have demonstrated an increased short-term risk of atrial fibrillation in closure patients, and that residual shunt after closure predicts stroke recurrence. Last, recent data have been inconclusive as to whether patients receiving medical therapy only benefit more from anticoagulation or antiplatelet therapy, so this remains an area of controversy. Summary Transcatheter PFO closure is an evidence-based, guideline-supported therapy for secondary stroke prevention in patients with a PFO and cryptogenic stroke. However, proper patient selection is critical to achieve benefit, and recent studies have helped clarify those patients most likely to benefit from closure.
The objective of this work was to investigate if central cardiac pressures are obtainable noninvasively using the subharmonic aided pressure estimation (SHAPE) technique with Definity (Lantheus Medical Imaging Inc, N Billerica, MA, USA) or Sonazoid (GE Healthcare, Oslo, Norway) microbubbles. Patients scheduled for a left and/or right heart catheterization procedure and providing written informed consent were included in IRB approved clinical trials (NCT03243942 for Definity; NCT03245255 for Sonazoid). A standard-of-care catheterization procedure was performed advancing clinically used pressure catheter into the left and/or right ventricles and/or the aorta. After pressure catheter placement, patients received an infusion of either Definity (56 patients; 2 vials in 50 mL of saline; infusion rate: 4-10 mL/min) or Sonazoid (60 patients; rate (mL/hour) = 0.18 mL/hour/kg x weight in kg co-infused with saline at 120 mL/hour). A customized interface on a SonixTablet scanner (BK Ultrasound, Peabody, MA, USA) was used to acquire SHAPE data synchronously with the pressure catheter data. Linear correlation between the SHAPE and pressure catheter data were computed using MATLAB (Mathworks, Natick, MA, USA). Central aortic pressures were estimated using cuff-based brachial pressure measurements with a SphygmoCor device (AtCor Medical Pty Ltd, West Ryde, NSW, Australia). Central aortic pressures and SHAPE data from the aorta were used to calculate a conversion factor (in mmHg/dB) for each patient to estimate pressures and determine errors associated with the SHAPE technique. Two adverse events were observed during Definity infusion; both were resolved. Errors between the pressure catheter and SHAPE derived mean diastolic pressures were less than 5 mmHg when using Definity microbubbles and greater than 5 mmHg when using Sonazoid microbubbles. These results indicate that SHAPE is a useful technique to noninvasively obtain central cardiac pressures.
Atrial fibrillation (AF) is considered the most common sustained arrhythmia resulting in significant morbidity, mortality, and cost. Management of AF includes rate control, prevention of thrombosis, and, in some patients, conversion and maintenance of normal sinus rhythm. Pharmacologic therapy is often used for maintenance of normal sinus rhythm. Current recommended antiarrhythmic drugs include dofetilide, propafenone, sotalol, and amiodarone. In March 2009 a new antiarrhythmic, dronedarone, was approved for use in patients with atrial fibrillation. The aim of this article is to review primary literature of currently available oral antiarrhythmic agents for efficacy, safety and place in therapy in the treatment of atrial fibrillation. Keywords: Antiarrhythmics, atrial fibrillation, rhythm, dronedarone, amiodarone, rate control, cardioversion, thrombosis, dofetilide, propafenone, sotalol, antiarrhythmic agents, Epidemiology, cardiac rhythm disturbances, tachyarrhythmia, electrophysiological remodeling, ventricles, atrial rate, mortality, sinus rhythm, Antithrombotic therapy, embolic stroke, hemodynamic compromise, NSR long-term, velocity, myocardial contractility, depolarization, potassium efflux, repolarization, affinity, proarrhythmia, heart failure, ventricular tachycardia, atria, Purkinje fibers, diarrhea, manifests, tinnitus, vomiting, coma, cardiorespiratory arrest, placebo, adrenergic-blockers, disopyramide's anticholinergic effects, ventricular systolic dysfunction, hypoglycemia, Flecainide, sodium channels, Efficacy, Cardiac Arrhythmia Suppression Trial (CAST), asymptomatic, myocardial infarction (MI), coronary artery disease/structural, dizziness, dyspnea, paroxysmal, hearts, spontaneous automaticity, bradycardia, bronchospasm, toxicity, Canadian Trial, hypersensitivity pneumonitis, Hypothyroidism, iodine, blindness, P-glycoprotein, beta-receptors, placebo group, ejection, morbidity, nausea, creatinine, amiodarone arm, monophasic action potentials, ventricular dysfunction, pacemaker
Although drug-eluting stents (DESs) have significantly reduced restenosis after percutaneous coronary intervention (PCI), repeat target vessel revascularization (TVR) after treatment with new-generation DES is approximately 10% at 2 years.1Silber S. Windecker S. Vranckx P. Serruys P. RESOLUTE All Comers Investigators. Unrestricted randomized use of two new generation drug-eluting stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial.Lancet. 2011; 377: 1241-1247Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar For patients who develop in-stent restenosis (ISR) after an initial DES procedure, current ACC/AHA/Society for Cardiovascular Angiography & Interventions revascularization guidelines give a class recommendation for use of a second DES during repeat PCI.2Lawton J.S. Tamis-Holland J.E. Bangalore S. et al.2021 ACC/AHA/SCAI guideline for coronary artery revascularization: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.J Am Coll Cardiol. 2022; 79: e21-e129Crossref PubMed Scopus (269) Google Scholar When an overlapped second DES is used to treat ISR, 10% to 20% of patients will subsequently develop recurrent restenosis, requiring a third TVR procedure.3Giustino G. Colombo A. Camaj A. et al.Coronary in-stent restenosis: JACC state-of-the-art review.J Am Coll Cardiol. 2022; 80: 348-372Crossref Scopus (20) Google Scholar,4Savage M.P. Fischman D.L. Resistant drug-eluting stent restenosis and resurrection of intracoronary brachytherapy: the Lazarus of contemporary coronary intervention.J Soc Cardiovasc Angiogr Interv. 2023; 2100566Google Scholar The outcome of performing further PCI after recurrent restenosis of DES is unclear because there is a paucity of studies on this patient cohort.4Savage M.P. Fischman D.L. Resistant drug-eluting stent restenosis and resurrection of intracoronary brachytherapy: the Lazarus of contemporary coronary intervention.J Soc Cardiovasc Angiogr Interv. 2023; 2100566Google Scholar, 5Theodoropoulos K. Mennuni M.G. Dangas G.D. et al.Resistant in-stent restenosis in the drug-eluting stent era.Catheter Cardiovasc Interv. 2016; 88: 777-785Crossref PubMed Scopus (0) Google Scholar, 6Kubo S. Kadota K. Otsuru S. et al.Optimal treatment of recurrent restenosis after drug-eluting stent implantation for in-stent restenosis lesions.EuroIntervention. 2013; 9: 788-796Crossref Scopus (22) Google Scholar The goal of this study was to evaluate longer-term outcomes of patients treated with repeated PCI for recurrent ISR after 2 DES procedures. This was a retrospective institutional review board–approved study of 44 consecutive patients who underwent a third PCI for recurrent ISR after 2 DES procedures on the same lesion. The primary outcome was freedom from a major adverse cardiac event (MACE) defined as death, myocardial infarction (MI), stroke, or TVR. The mean follow-up was 49 ± 13 months. Event-free survival was determined by a Kaplan-Meier analysis. A binary logistic regression analysis was performed to assess potential predictors of TVR at 3 years. The study population consisted of 29 men and 15 women, aged 66 ± 13 years. Diabetes was common (22/44, 50%), and 16 (36%) patients presented with chronic kidney disease. A history of tobacco use was also common, with 5 (11%) current and 27 (61%) former smokers. Most patients had underwent coronary artery bypass graft surgery (27, 61%) and presented with a history of MI (28, 64%). Clinical presentations of recurrent ISR prompting the third PCI were MI in 6 (13%), unstable angina in 22 (50%), stable angina in 14 (32%), and silent ischemia in 2 (5%). Interval between the last PCI and presentation was 30 ± 34 months. Target vessel was the left anterior descending artery in 11 (25%), left circumflex artery in 10 (23%), right coronary artery in 11 (25%), saphenous vein grafts in 11 (25%), and radial artery graft in 1 (2%). Mehran ISR classes included 22 (50%) focal, 12 (27%) diffuse, 4 (9%) proliferative, and 6 (14%) total occlusion. A third PCI was initially successful in all 44 patients. Treatment of recurrent ISR entailed additional DES in 31 (70%), bare metal stents in 3 (7%), atherectomy without stent placement in 4 (9%), and balloon angioplasty alone in 6 (14%). There were no major periprocedural complications. MACE-free survival and TVR-free survival are shown in Figure 1. TVR-free survival was 67.4% at 1 year, 34.8% at 3 years, and 27.8% at 5 years. MACE-free survival was 60.5% at 1 year, 23.1% at 3 years, and 19.2% at 5 years. Thus, within 3 years, 3 of the 4 patients experienced a MACE. A logistic regression analysis revealed no significant association of any clinical characteristic (such as age, sex, and diabetes) or use of additional DES with TVR at 3 years. Our findings are consistent with those in the study by Theodoropoulos et al5Theodoropoulos K. Mennuni M.G. Dangas G.D. et al.Resistant in-stent restenosis in the drug-eluting stent era.Catheter Cardiovasc Interv. 2016; 88: 777-785Crossref PubMed Scopus (0) Google Scholar who described “resistant” DES restenosis as recurrence of ISR after previous successful treatment of ISR. As in this study, there was a high prevalence of diabetes (62%). At 2 years, the rates of target lesion failure and MACE were 51% and 59%, respectively. The initial episode of DES restenosis was treated by a second DES in only 53%, with 21% involving new-generation DES; by contrast, all patients in this study presented with 2 overlapped DES layers, with new-generation DES in 55%. A limitation of this study is its size. However, the relatively small number of patients reflect that recurrent ISR after multilayered DES is an infrequent event. Based on the available data, it can be estimated that approximately 1% to 2% of patients undergoing PCI will develop resistant ISR.3Giustino G. Colombo A. Camaj A. et al.Coronary in-stent restenosis: JACC state-of-the-art review.J Am Coll Cardiol. 2022; 80: 348-372Crossref Scopus (20) Google Scholar, 4Savage M.P. Fischman D.L. Resistant drug-eluting stent restenosis and resurrection of intracoronary brachytherapy: the Lazarus of contemporary coronary intervention.J Soc Cardiovasc Angiogr Interv. 2023; 2100566Google Scholar, 5Theodoropoulos K. Mennuni M.G. Dangas G.D. et al.Resistant in-stent restenosis in the drug-eluting stent era.Catheter Cardiovasc Interv. 2016; 88: 777-785Crossref PubMed Scopus (0) Google Scholar Although uncommon, our findings highlight the difficult challenge presented by recurrent DES restenosis when it occurs. Another limitation is the lack of information on intravascular imaging. Owing to the retrospective design, there was no uniform protocol for intravascular imaging because it was performed at the operator’s discretion. In conclusion, patients undergoing a third PCI to treat recurrent restenosis after 2 layers of overlapped DES exhibit a poor prognosis. Most of the patients will experience a subsequent TVR or other MACE in <3 years. Further studies are needed to assess the role of alternative therapies, such as intravascular brachytherapy or drug-eluting balloons, in the management of this perplexing problem. The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. This research was supported partly by an unrestricted philanthropic grant from the Stanley and Arlene Ginsburg Family Foundation that had no involvement in this study.
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