Network meta-analysis on patent foramen ovale: is a stroke or atrial fibrillation worse?

OBJECTIVE: Systematic reviews suggest that patent foramen ovale closure (PFOc) is performed percutaneously with low complication rates. We did a network meta-analysis (NMA) comparing devices for PFO closures, evaluating safety and efficacy of transcatheter PFOc in preventing neurological events in patients with stroke when compared with medical therapy (MT), and assessing risk of atrial fibrillation (AF). METHODS: We searched 3 databases (MEDLINE, EMBASE, CENTRAL/CCTR) identifying six randomized controlled trials from 2012 until December 2019. We performed a Bayesian NMA; number-needed-to-treat and number-needed-to-harm were derived by applying the estimated odds ratios (ORs). The likelihood of being helped or harmed (LHH) was evaluated to estimate the risk-effectiveness balance. RESULTS: The 3560 patients allocated to PFOc were less subject to a stroke than patients with MT. The overall ORs of PFOc versus MT were 0.41 with fixed-effects, and 0.22 with random-effects model. NMA proves that PFOc induces AF episodes significantly higher than MT, even when analysis is limited to only new episodes of "serious AF." LHH (0.68 fixed-effects, 0.79 random-effects) showed that strokes saved are less than cases of AFs added. By considering only serious AF, strokes saved are higher than serious AFs induced by the PFOc (LHH was 3.46 and 4.00 respectively). CONCLUSIONS: NMA supported PFOc in patients with cryptogenic stroke, confirming that devices are better than MT, but increase the risk of AF by over 2/4 times (serious or unserious AF). Considering serious AFs (real risky clinical condition), patients have more advantages in being treated, since LHH is ≥ 3-4.

The Closure of Patent Foramen Ovale in Preventing Subsequent Neurological Events: A Bayesian Network Meta-Analysis to Identify the Best Device.

BACKGROUND: Randomized-controlled trials (RCTs) reported a finding on the safety and efficacy of percutaneous patent foramen ovale (PFO) closure to prevent stroke recurrence. It showed that the Amplatzer (AMP) device appears to be superior to medical therapy (MT) in preventing strokes and episodes of atrial fibrillation (AF), than other devices. We performed a network meta-analysis (NMA) to evaluate the closure of PFO in preventing subsequent neurological events while investigating the results obtained by specific devices. METHODS: We searched 3 databases (MEDLINE, EMBASE, CENTRAL/CCTR) and identified 6 RCTs until March 2019. We performed an NMA and used pooled ORs. Analyses were done in NetMetaXL1.6-WinBUGS1.4. RESULTS: Six RCTs with 3,560 patients (mean age 45.2-46.2 years) were included in the present NMA. Depending on the device, 4 groups of patients were compared with MT: 1,889 patients undergoing PFO closure were significantly less likely to experience a stroke than 1,671 patients treated with MT (ORs 0.41; 95% Cr.I. 0.27-0.60 with fixed-effects model and ORs 0.22; 95% Cr.I. 0.05-0.70 with random-effects model). The patients with AMP showed a similar risk than those treated with Helex/Cardioform (HLX/CF) or with a group of 11 multiple devices. This suggests the equality between the 2 most currently used devices. When assessing TIA and, for the safety analysis, major bleeding, both models confirm no significant difference between any devices and MT. PFO closure increased the risk of new-onset AF: MT induces AF significantly less than all the devices. In favor of the AMP, there is a reduced number of cases of AF versus MT; however, no device superiority has been established in comparing HLX/CF and other devices in a random effect model. CONCLUSIONS: Our NMA provides evidence in favor of PFO closure with all the devices currently in use. We can conclude that these devices are better than MT, but not that 1 device is better than the rest in reducing stroke recurrences and AF episodes in the follow-up.

Efficacy and safety of catheter ablation versus antiarrhythmic drugs for atrial fibrillation: a meta-analysis of randomized trials.

BACKGROUND: Atrial fibrillation is the most common arrhythmia in clinical practice. Its treatment is still widely debated due to the large variety of therapeutic options. Radiofrequency catheter ablation (RFCA) around pulmonary vein ostia and in the left atrium has been proposed as a technique to cure atrial fibrillation and is now performed with increasing success worldwide. However, few randomized controlled trials (RCTs) are available. Some of these have been published recently and are not yet included in meta-analyses. OBJECTIVES: We conducted a meta-analysis to summarize the current evidence base for the efficacy and safety of RFCA in patients with atrial fibrillation. METHODS: We searched electronic databases for relevant RCTs comparing RFCA with antiarrhythmic drugs for the management of atrial fibrillation. Recurrence of any atrial tachyarrhythmia (including atrial fibrillation, atrial flutter and atrial tachycardia) and rate of complications and adverse events were the end-points of the analysis. The results are reported as relative risk and 95% confidence interval, calculated using RevMan 5. RESULTS: A total of eight RCTs were identified including 844 patients. Overall, 98 (23.2%) of 421 patients in the treatment group and 324 (76.6%) of 423 patients in the control group had atrial tachyarrhythmia recurrence. RFCA decreased atrial tachyarrhythmia recurrence by 71% (relative risk 0.29, 95% confidence interval 0.20-0.41, P < 0.00001, with random effects model). Fewer complications and adverse events were reported in the ablation group compared with the control group (relative risk 0.72, 95% confidence interval 0.40-1.30, P = 0.28, with random effects model). CONCLUSION: In selected patients with atrial fibrillation, RFCA is a relatively effective and well-tolerated procedure to cure atrial fibrillation. Even though the results of our systematic review favour ablation therapy, large, well-designed RCTs are needed to confirm the efficacy and safety of RFCA for the management of atrial fibrillation.

Long-term results of aortic valve replacement with Edwards Prima Plus stentless bioprosthesis: eleven years' follow up.

BACKGROUND AND AIM OF THE STUDY: The Edwards Lifesciences Prima Plus stentless valve (ELSV) is a bioprosthesis manufactured from a porcine aortic root. The study aim was to evaluate late clinical outcomes after aortic valve replacement (AVR) with ELSV implanted as a miniroot in patients with aortic valve disease. METHODS: Between 1993 and 2004, 318 patients (232 males, 86 females; mean age 69 +/- 9 years; range: 37-83 years) underwent AVR with the ELSV. Preoperatively, 102 patients (32%), 162 (51%) and 54 (17%) were in NYHA classes I/II, III and IV, respectively. Aortic stenosis, aortic regurgitation and combined lesions were present in 124 patients (39%), 114 (36%) and 41 (13%), respectively. Twenty patients (6%) were referred for an acute aortic dissection, 20 (6%) for an aortic root aneurysm, and 139 (44%) had an associated aneurysmal dilatation of the ascending aorta. The ascending aorta was replaced in 159 patients (50%); aortic arch replacement was required in 10 (3%). Coronary artery bypass graft was performed in 86 patients (27%). The follow up was based on clinical data. RESULTS: Operative mortality was 5% (n = 17). There were 49 late deaths (5.2%/pt-yr). Valve-related mortality occurred in 10 patients (1%/pt-yr). Actuarial survival at five and 10 years was 78% and 33%, respectively. Actuarial freedom from valve reoperation and structural valve deterioration at 10 years were 100% and 64%. Actuarial freedom from embolic events and endocarditis at 10 years were 84% and 81%, respectively. CONCLUSION: The ELSV, when implanted as a miniroot, provided good early and long-term results in terms of survival and freedom from major complications.

Suitability of stentless bioprostheses for combined replacement of the aortic valve and ascending aorta.

BACKGROUND: The Edwards Prima stentless valve (EPSV) is a bioprosthesis made of the porcine aortic root which, owing to its versatility, may be implanted with different techniques depending on the underlying disease. The aim of this study was to demonstrate the usefulness of the EPSV implanted as a miniroot in patients with disease of the aortic valve and ascending aorta. METHODS: Between January 1998 and July 2002, 91 patients (mean age 67 +/- 7 years) underwent combined replacement of the aortic valve and ascending aorta with an EPSV for aortic stenosis (n = 12), incompetence (n = 45) or mixed disease (n = 26); all had aneurysmal dilation of the ascending aorta and 8 had an acute aortic dissection. The EPSV was implanted using the miniroot (or inclusion) technique and by extending the aorta with a tubular graft; aortic arch replacement was required in 5 patients. Hospital survivors underwent clinical and echocardiographic follow-up at 6 and 12 months and yearly thereafter. RESULTS: The hospital mortality was 11% (10 patients). Causes of death included stroke (n = 3), septic shock (n = 3), myocardial infarction (n = 2), and low output syndrome (n = 2). The mean follow-up of the 81 discharged patients was 16 +/- 13 months and was 100% complete; there were 6 late deaths due to non-cardiac causes. All patients presented with clinical improvement (95% are in NYHA functional class I) with low transvalvular gradients and significant regression of left ventricular hypertrophy at two-dimensional echocardiography. CONCLUSIONS: The EPSV used as a miniroot has proved to be a valid option in patients requiring simultaneous replacement of the aortic valve and ascending aorta. Due to the limited information available on the long-term fate of the porcine aortic valve and root, the use of this device as a miniroot should presently be limited to elderly patients.

Predictors of right ventricular dysfunction in patients with coronary artery disease and reduced left ventricular ejection fraction.

BACKGROUND: The frequency and determinants of right ventricular (RV) dysfunction in patients with coronary artery disease (CAD) and reduced left ventricular (LV) function have not been thoroughly investigated. METHODS: The study population consists of 80 consecutive patients, invasively evaluated at our centre. Entry criteria were: LV ejection fraction < 45%; angiographic evidence of obstructive CAD; disease history of more than 3 months' duration. Exclusion criteria were: recent myocardial infarction and unstable angina. All patients underwent cardiac catheterization with coronary, LV and RV angiography. RV dysfunction was defined as a RV ejection fraction < 35%, which corresponds to the mean-three standard deviations of controls. RESULTS: Sixty-five patients (81%) had multi-vessel disease and 57 (71%) had a previous myocardial infarction. Mean LV ejection fraction was 31 +/- 8%. Mean RV ejection fraction was 46 +/- 11%. Right ventricular dysfunction was present in 14 patients (18%). An occluded proximal right coronary artery was associated with significantly lower RV ejection fraction (38 +/- 12% versus 47 +/- 10%; P = 0.009) but not LV ejection fraction (30 +/- 8% versus 32 +/- 9%; P = 0.444). However, at multivariate analysis, only pulmonary hypertension was an independent significant predictor of RV dysfunction (P < 0.001; OR: 1.13; CI: 1.06 -1.22). CONCLUSION: Right ventricular dysfunction in patients with chronic ischaemic LV dysfunction is detected in less than 20% of cases. Proximal right coronary artery occlusion is associated with a reduced RV ejection fraction. However, the role of right coronary artery disease is overwhelmed by the haemodynamic burden of pulmonary hypertension, which represents the only independent predictor of RV dysfunction in our population.