Impact of Prosthesis-Patient Mismatch on 1-Year Outcomes after Transcatheter Aortic Valve Implantation: Meta-analysis of 71,106 Patients.

OBJECTIVES: This study sought to evaluate the impact of prosthesis-patient mismatch (PPM) on the risk of early-term mortality after transcatheter aortic valve implantation (TAVI). METHODS: Databases (Medical Literature Analysis and Retrieval System Online [MEDLINE], Excerpta Medica dataBASE [EMBASE], Cochrane Controlled Trials Register [CENTRAL/CCTR], ClinicalTrials.gov, Scientific Electronic Library Online [SciELO], Latin American and Caribbean Literature on Health Sciences [LILACS], and Google Scholar) were searched for studies published until February 2019. PPM after TAVI was defined as moderate if the indexed effective orifice area (iEOA) was between 0.85 cm2/m2 and 0.65 cm2/m2 and as severe if iEOA ≤ 0.65 cm2/m2. RESULTS: The search yielded 1,092 studies for inclusion. Of these, 18 articles were analyzed, and their data extracted. The total number of patients included who underwent TAVI was 71,106. The incidence of PPM after TAVI was 36.3% (25,846 with PPM and 45,260 without PPM). One-year mortality was not increased in patients with any PPM (odds ratio [OR] 1.021, 95% confidence interval [CI] 0.979-1.065, P=0.338) neither in those with moderate PPM (OR 0.980, 95% CI 0.933-1.029, P=0.423). Severe PPM was separately associated with high risk (OR 1.109, 95% CI 1.041-1.181, P=0.001). CONCLUSION: The presence of severe PPM after TAVI increased early-term mortality. Although moderate PPM seemed harmless, the findings of this study cannot not rule out the possibility of it being detrimental, since there are other registries that did not address this issue yet.

Impact of prosthesis-patient mismatch on 1-year outcomes after transcatheter aortic valve implantation: meta-analysis of 71, 106 patients

Abstract Objectives: This study sought to evaluate the impact of prosthesis-patient mismatch (PPM) on the risk of early-term mortality after transcatheter aortic valve implantation (TAVI). Methods: Databases (Medical Literature Analysis and Retrieval System Online [MEDLINE], Excerpta Medica dataBASE [EMBASE], Cochrane Controlled Trials Register [CENTRAL/CCTR], ClinicalTrials.gov, Scientific Electronic Library Online [SciELO], Latin American and Caribbean Literature on Health Sciences [LILACS], and Google Scholar) were searched for studies published until February 2019. PPM after TAVI was defined as moderate if the indexed effective orifice area (iEOA) was between 0.85 cm2/m2 and 0.65 cm2/m2 and as severe if iEOA ≤ 0.65 cm2/m2. Results: The search yielded 1,092 studies for inclusion. Of these, 18 articles were analyzed, and their data extracted. The total number of patients included who underwent TAVI was 71,106. The incidence of PPM after TAVI was 36.3% (25,846 with PPM and 45,260 without PPM). One-year mortality was not increased in patients with any PPM (odds ratio [OR] 1.021, 95% confidence interval [CI] 0.979-1.065, P=0.338) neither in those with moderate PPM (OR 0.980, 95% CI 0.933-1.029, P=0.423). Severe PPM was separately associated with high risk (OR 1.109, 95% CI 1.041-1.181, P=0.001). Conclusion: The presence of severe PPM after TAVI increased early-term mortality. Although moderate PPM seemed harmless, the findings of this study cannot not rule out the possibility of it being detrimental, since there are other registries that did not address this issue yet.

Updated Meta-analysis on the Closure of Patent Foramen Ovale in Reduction of Stroke Rates: the DEFENSE-PFO Trial Does not Change the Scenario.

OBJECTIVE: We aimed to analyze whether patent foramen ovale (PFO) closure reduces the risk of stroke, assessing also some safety outcomes after the publication of a new trial. INTRODUCTION: The clinical benefit of closing a PFO has been an open question, so it is necessary to review the current state of published medical data in regards to this subject. METHODS: MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were used to search for randomized controlled trials (RCTs) that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Six studies fulfilled our eligibility criteria and included 3560 patients (1889 for PFO closure and 1671 for medical therapy. RESULTS: The risk ration (RR) for stroke in the "closure" group compared with the "medical therapy" showed a statistically significant difference between the groups, favouring the "closure" group (RR 0.366; 95%CI 0.171-0.782, P=0.010). There was no statistically significant difference between the groups regarding the safety outcomes, death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the "closure" group (RR 4.131; 95%CI 2.293-7.443, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke. CONCLUSION: This meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of hypertension, atrial septal aneurysm and effective closure. The publication of a new trial did not change the scenario in the medical literature.

Updated meta-analysis on the closure of patent foramen ovale in reduction of stroke rates: the defense-pfo trial does not change the scenario

Abstract Objective: We aimed to analyze whether patent foramen ovale (PFO) closure reduces the risk of stroke, assessing also some safety outcomes after the publication of a new trial. Introduction: The clinical benefit of closing a PFO has been an open question, so it is necessary to review the current state of published medical data in regards to this subject. Methods: MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were used to search for randomized controlled trials (RCTs) that reported any of the following outcomes: stroke, death, major bleeding or atrial fibrillation. Six studies fulfilled our eligibility criteria and included 3560 patients (1889 for PFO closure and 1671 for medical therapy. Results: The risk ration (RR) for stroke in the "closure" group compared with the "medical therapy" showed a statistically significant difference between the groups, favouring the "closure" group (RR 0.366; 95%CI 0.171-0.782, P=0.010). There was no statistically significant difference between the groups regarding the safety outcomes, death and major bleeding, but we observed an increase in the risk of atrial fibrillation in the "closure" group (RR 4.131; 95%CI 2.293-7.443, P<0.001). We also observed that the larger the proportion of effective closure, the lower the risk of stroke. Conclusion: This meta-analysis found that stroke rates are lower with percutaneously implanted device closure than with medical therapy alone, being these rates modulated by the rates of hypertension, atrial septal aneurysm and effective closure. The publication of a new trial did not change the scenario in the medical literature.