Transcatheter closure of patent foramen ovale (PFO) is a recommended stroke reduction option in patients ≤60 years of age with cryptogenic ischemic stroke, but data on clinical outcomes following PFO closure in patients >60 years of age are scarce. The aim of this real-world evidence study was to evaluate the clinical outcomes of PFO closure in patients >60 years of age in the United States. Medicare fee-for-service data from 2016 to 2022 were used to identify patients >60 years of age who were hospitalized with ischemic stroke and diagnosed with PFO or atrial septal defect and also had ≥6 months of prior fee-for-service coverage. Patients who were implanted with the Amplatzer or Talisman PFO occluder (device group) were identified by linkage to a manufacturer device-tracking database and were propensity score matched (1:4) to those who did not undergo device implantation (control group). Acute safety events through 30 days and recurrent ischemic stroke through 3 years were evaluated. A total of 20,999 Medicare beneficiaries (device group, n = 1,132; control group, n = 19,867) met the inclusion criteria. The matched cohort included 5,508 Medicare beneficiaries (device group, n = 1,132; control group, n = 4,376), with 45% women, a median age of 71 years (Q1-Q3: 67-75 years), and median follow-up of 2.58 years (Q1-Q3: 1.17-3.97 years). The risk for recurrent ischemic stroke was significantly lower in the device group (1.65 [95% CI: 1.18-2.13] events per 100 patient-years) than the control group (2.66 [95% CI: 2.33-3.00] events per 100 patient-years) (HR: 0.62; 95% CI: 0.44-0.88; P = 0.007). Rates of 30-day safety events were not different for death, but venous thromboembolism (1.86% vs 0.37%; P < 0.001) and atrial fibrillation or flutter (1.41% vs 0.64%; P = 0.01) were more common in the device group. In a real-world U.S. cohort of patients >60 years of age, PFO closure was associated with a reduced risk for recurrent ischemic stroke compared with medical therapy alone, while maintaining a clinically acceptable safety profile.
Background Transcatheter closure of patent foramen ovale (PFO) is a recommended stroke reduction option in patients ≤60 years of age with cryptogenic ischemic stroke, but data on clinical outcomes following PFO closure in patients >60 years of age are scarce. Objectives The aim of this real-world evidence study was to evaluate the clinical outcomes of PFO closure in patients >60 years of age in the United States. Methods Medicare fee-for-service data from 2016 to 2022 were used to identify patients >60 years of age who were hospitalized with ischemic stroke and diagnosed with PFO or atrial septal defect and also had ≥6 months of prior fee-for-service coverage. Patients who were implanted with the Amplatzer or Talisman PFO occluder (device group) were identified by linkage to a manufacturer device-tracking database and were propensity score matched (1:4) to those who did not undergo device implantation (control group). Acute safety events through 30 days and recurrent ischemic stroke through 3 years were evaluated. Results A total of 20,999 Medicare beneficiaries (device group, n = 1,132; control group, n = 19,867) met the inclusion criteria. The matched cohort included 5,508 Medicare beneficiaries (device group, n = 1,132; control group, n = 4,376), with 45% women, a median age of 71 years (Q1-Q3: 67-75 years), and median follow-up of 2.58 years (Q1-Q3: 1.17-3.97 years). The risk for recurrent ischemic stroke was significantly lower in the device group (1.65 [95% CI: 1.18-2.13] events per 100 patient-years) than the control group (2.66 [95% CI: 2.33-3.00] events per 100 patient-years) (HR: 0.62; 95% CI: 0.44-0.88; P = 0.007). Rates of 30-day safety events were not different for death, but venous thromboembolism (1.86% vs 0.37%; P < 0.001) and atrial fibrillation or flutter (1.41% vs 0.64%; P = 0.01) were more common in the device group. Conclusions In a real-world U.S. cohort of patients >60 years of age, PFO closure was associated with a reduced risk for recurrent ischemic stroke compared with medical therapy alone, while maintaining a clinically acceptable safety profile.
Mitral regurgitation (MR) is a complex valve lesion that can pose significant management challenges. This expert consensus decision pathway emphasizes that recognition of MR should prompt an assessment of its etiology, mechanism, and severity, as well as consideration of the indications for treatment. The document is a focused update of the 2017 ACC Expert Consensus Decision Pathway on the Management of Mitral Regurgitation, with some sections updated and others added in light of the publication of new trial data related to secondary MR, among other developments. A structured approach to evaluation based on clinical findings, accurate echocardiographic imaging, and, when necessary, adjunctive testing can help clarify decision making. Treatment goals include timely intervention by an experienced multidisciplinary heart team to prevent left ventricular dysfunction, heart failure, reduced quality of life, and premature death.
Transcatheter repair and replacement procedures have become an integral feature of the management of appropriately selected patients with valvular heart disease (VHD), thereby enabling the delivery of less-invasive treatments across a broad spectrum of conditions previously correctable only with open-heart surgery. Demonstration of the feasibility, effectiveness, and safety of transcatheter valve therapies in randomized controlled trials and large prospective registries has generated tremendous interest in these treatments and led to their widespread dissemination.
Transseptal puncture is increasingly utilized in electrophysiology and interventional cardiology. With a wide range of therapeutic indications, incidence of iatrogenic atrial septal defect (iASD) is likely to increase. However, the clinical and hemodynamic significance of iatrogenic atrial septal defect is not clear. We report a case of an 88year old woman with prior transcatheter aortic valve implantation and symptomatic severe degenerative mitral regurgitation. She developed persistent hypoxemia following MitraClip(®) procedure, requiring closure of iASD resulting in immediate recovery of hemodynamics. In here, we discuss the hemodynamic changes following percutaneous mitral valve repair and review the evidence supporting the closure of iatrogenic atrial septal defects.
Instantaneous Wave-free Ratio (iFR) is a novel technology for physiological assessment of severity of coronary stenosis that precludes the use of adenosine. Conversely, Fractional Flow Reserve (FFR), which is generally considered the reference standard, uses adenosine. We sought to evaluate the
BackgroundWhile percutaneous device closure (PDC) is a first‐line therapy for isolated muscular ventricular septal defects (mVSD), surgery is still the preferred approach for peri‐membranous ventricular septal defects (pmVSD).ObjectiveWe sought to compare the outcomes of percutaneous versus open surgical closure of pmVSDs.MethodsPubMed, Cochrane Library, and Web of Science databases were searched through October 15, 2014 for English language studies comparing outcomes of PDC with surgical closure of pmVSDs. Study quality, publication bias, and heterogeneity were assessed. A meta‐analysis of selected studies was performed using a random effects model. Comparison was done for early (<1 month) safety and efficacy outcomes.ResultsSeven studies with a total of 3,134 patients (PDC = 1,312, surgery = 1,822) were identified. Patients in the PDC group were older than those treated surgically (mean age 12.2 vs. 5.5 years, respectively). In six out of seven studies, the mean VSD size was found to be comparable between the treatment arms (PDC 4.9 mm vs. surgery 6.0 mm). Males represented 52% of patients in either group. Follow‐up ranged from 5 to 42 months. No significant differences were observed between PDC vs. surgery in terms of procedural success rate [relative risk (RR): 1.00, confidence interval (CI): 0.99–1.00; P = 0.67]. Combined safety end points for major complications (early death/reoperation/permanent pacemaker) were similar in both groups (RR: 0.55, CI: 0.23–1.35; P = 0.19) as were as other outcomes like post‐procedure significant residual shunt (RR: 0.69, CI: 0.29–1.68; P = 0.41), significant valvular (aortic/tricuspid) regurgitation (RR: 0.70, CI: 0.26–1.86; P = 0.47), and advanced heart block (RR: 0.99, CI: 0.46–2.14; P = 0.98). The need for blood transfusion (RR: 0.02, CI: 0.00–0.05; P < 0.001) and duration of hospital stay [standard mean difference (SMD) −2.17 days, CI: −3.12 to −1.23; P < 0.001] were significantly reduced in the PDC group.ConclusionPercutaneous closure of pmVSD when performed in a selected subgroup of patients is associated with similar procedural success rate without increased risk of significant valvular regurgitation or heart block when compared with surgical closure. © 2015 Wiley Periodicals, Inc.
“A compilation of the best medical evidence to date does not support use of the universal definition as the optimal criterion to identify clinically relevant post-percutaneous coronary intervention myocardial infarction events.”
Transradial access (TRA) offers advantages including decreased vascular complications, reduced length of hospital stay, and reduced cost. The size of the radial artery (RA) limits the equipment that can be used via TRA. Intra-arterial (IA) vasodilators prevent and treat RA spasm, yet are not uniformly used in TRA and their effect on the absolute size of the RA remains unknown.121 patients undergoing TRA for cardiac catheterization were included. 78 patients underwent RA angiography prior to administration of IA vasodilators (‘no vasodilator’ group), 43 patients underwent radial angiography after administration of an IA verapamil and nitroglycerin cocktail (‘vasodilator’ group). Quantitative angiography was used to compare the RA diameters.Clinical characteristics were similar between the groups, except that patients in the 'no vasodilator' cohort were taller (1.67 ± 0.1 m vs. 1.73 ± 0.1 m, p = 0.002), and heavier (84.9 ± 18.2 kg vs. 75 ± 17.1 kg, p = 0.003). In the 'vasodilator' group the proximal RA diameter was larger (2.29 ± 0.47 mm vs. 2.09 ± 0.41 mm, p = 0.02) as was the narrowest segment (1.83 ± 0.56 mm vs 1.39 ± 0.43, p < 0.0001) compared to the 'no vasodilator' group. At the RA origin, 79.4% of those in the 'vasodilator' group were larger than a 6 Fr guide catheter, compared to 51.4% in the 'no vasodilator’ group (p = 0.004). At the narrowest segment a higher percentage of RAs in the ‘vasodilator’ group were larger than a 5 Fr guide catheter (65.1% vs 26.9%, p < 0.001) and a 6 Fr catheter (34.9% vs 10.3%, p = 0.001).IA vasodilators increase pre-procedural RA diameter in patients undergoing cardiac catheterization via TRA. This increase in diameter has important implications for procedural planning.Boyer et al. performed a blinded controlled clinical trial investigating the effects of intra-arterial vasodilators on radial artery size and spasm during cardiac catheterization. The study demonstrates that intra-arterial vasodilators significantly increased the radial artery size throughout the entire course of the vessel and significantly decreased the amount of radial artery spasm. The authors conclude that these findings support the use of intra-arterial vasodilators during cardiac catheterization and have important implications for emerging technologies such as larger bore sheathless radial procedures.
Post-operative atrial fibrillation (POAF) after valve surgery is associated with increased morbidity and mortality. Risk factors identified in the past to predict POAF are of moderate accuracy. We performed a retrospective analysis of 139 patients undergoing aortic valve replacement for aortic stenosis. Post-operative AF occurred in 44% of the patients. In multivariate analysis only left atrial volume (LAV) index was a predictor of POAF. A LAV index of >46 cc/m2 predicted POAF with a sensitivity and specificity of 92% and 77%. We propose that LAV index can be used preoperatively to identify patients at risk for POAF to target preventive interventions. Background: Post-operative atrial fibrillation (POAF) is common after valve surgery and is associated with increased morbidity and mortality. Many of the previously identified predictors of POAF are of moderate accuracy. Left atrial volume (LAV) index has been proposed in the past as a predictor of POAF in patients undergoing cardiac surgery. In patients with aortic stenosis (AS), increased LAV is a marker of severity of stenosis. Hypothesis: Left atrial volume index is a very good predictor of POAF in patients undergoing aortic valve replacement (AVR) for AS. Methods: We performed a retrospective analysis of 139 consecutive patients with no previous atrial fibrillation (AF) undergoing AVR for AS in our center. Results: Post-operative AF occurred in 44% of patients. Patients with POAF had a longer hospital stay compared to patients without (12 vs 8 days; p < 0.001). In univariate analysis, age (p = 0.046), aortic valve area (p = 0.005) and LAV index (p < 0.001) were significant predictors of POAF. In multivariate analysis only LAV index (R2= 0.58; p < 0.001) predicted POAF. A LAV index > 46ml/m2 predicted POAF with a sensitivity and specificity of 92% and 77% respectively. Moreover, there was a significant increase in the incidence of POAF with increasing quartiles of LAV index, supporting causality. Conclusion: Left atrial volume index is an excellent predictor of POAF in patients undergoing AVR for AS. It can be used for selecting patients who are at a high risk for developing POAF to target preventive interventions.