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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">&#40;A&#41; Two-year Kaplan-Meier survival curves of patients undergoing TAVI after BAV vs&#46; those maintained under medical therapy&#59; &#40;B&#41; two-year Kaplan-Meier survival curves of patients undergoing TAVI or SAVR after BAV vs&#46; those maintained under medical therapy&#46; BAV&#58; balloon aortic valvuloplasty&#59; SAVR&#58; surgical aortic valve replacement&#59; TAVI&#58; transcatheter aortic valve implantation&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Symptomatic severe aortic stenosis &#40;AS&#41; conveys a high risk of cardiovascular death and rehospitalization for heart failure with medical therapy alone&#46; Without treatment mean survival is only 1-3 years after symptom onset&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">1</span></a> Surgical aortic valve replacement &#40;SAVR&#41; is the gold standard for the treatment of severe AS&#46; However&#44; mainly due to the high prevalence of comorbidities&#44; up to one-quarter of patients do not undergo SAVR&#46;<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">2&#44;3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">For patients who are not suitable for surgical treatment&#44; balloon aortic valvuloplasty &#40;BAV&#41; was first proposed in 1986 by Alain Cribier as a useful&#44; low-risk&#44; palliative treatment for symptomatic relief&#46;<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">4&#44;5</span></a> Despite promising initial results &#40;reduction of maximum and mean aortic gradients and improvement in functional capacity&#41;&#44; its popularity waned&#44; due to the high rate of complications and early restenosis&#46; Moreover&#44; the long-term survival of these patients is low&#44; resembling the natural course of untreated severe AS&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">6</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The introduction of transcatheter aortic valve implantation &#40;TAVI&#41; has revived interest in BAV for clinically unstable patients as a bridge to definitive therapy &#40;TAVI or SAVR&#41; or as a destination therapy for palliative reasons&#46; Cohort B of the PARTNER trial showed that patients managed conservatively have significantly higher 12-month mortality compared to patients undergoing TAVI&#46; However&#44; only a small difference in six-month mortality was noted&#58; 22&#37; in the TAVI group vs&#46; 28&#37; in patients treated conservatively &#40;of whom 83&#37; underwent BAV&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">7</span></a> This good result in the first months supports BAV as a therapeutic bridge&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In the TAVI era&#44; BAV is often performed to facilitate percutaneous delivery of the prosthesis&#44; reduce paravalvular leaks and aid in ring size assessment&#46; The growing number of BAV procedures&#44; together with improvements in techniques and materials and use of vascular closure devices&#44; has led to a reduction in procedural complications&#46; While an older series had a 20&#37; complication rate and 8&#37; mortality&#44; a more recent study reported much lower rates of major complications and overall mortality &#40;6&#46;8&#37; and 2&#46;5&#37;&#44; respectively&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">8&#44;9</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The aim of this study was to analyze the current indications for BAV and to determine the success&#44; complication and survival rates after BAV of patients in a real-world setting&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Methods</span><p id="par0030" class="elsevierStylePara elsevierViewall">This was a retrospective single-center registry of patients undergoing BAV between January 2013 and January 2016&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Inclusion criteria</span><p id="par0035" class="elsevierStylePara elsevierViewall">All patients with symptomatic severe AS who underwent BAV were consecutively enrolled&#46; The center&#39;s heart team assessed the indication for BAV&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Procedural indications were classified as&#58; &#40;1&#41; bridge to recovery&#58; refractory cardiogenic shock&#44; pulmonary edema or congestive heart failure due to severe AS&#44; including patients under invasive mechanical ventilation&#59; &#40;2&#41; bridge to decision&#58; patients in whom it was judged that LV systolic function might recover and clinical condition improve via BAV&#44; enabling subsequent definitive treatment &#40;TAVI or SAVR&#41;&#59; and &#40;3&#41; bridge to non-cardiac surgery&#58; patients in whom urgent non-cardiac surgery was needed but had a prohibitive risk due to untreated severe AS&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Data collection</span><p id="par0045" class="elsevierStylePara elsevierViewall">Baseline clinical&#44; laboratory&#44; echocardiographic&#44; hemodynamic and procedural data were collected retrospectively through reviews of hospital records&#46; Follow-up was performed through hospital outpatient consultations or telephone interview&#46; Laboratory and echocardiographic assessment was repeated three to six months after the procedure&#46; Data on mortality were obtained from the National Patient Registry&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Procedure</span><p id="par0050" class="elsevierStylePara elsevierViewall">BAV was performed under conscious sedation&#44; with different balloon devices &#40;Nucleus<span class="elsevierStyleSup">&#174;</span> and Loma Vista Medical<span class="elsevierStyleSup">&#174;</span>&#41;&#44; by the standard retrograde technique and under rapid ventricular pacing&#46; Regarding balloon diameter &#40;which ranged from 20 to 25 mm&#41;&#44; the choice was made according to the individual patient&#39;s characteristics&#46; Some patients had already been assessed by cardiac computed tomography for TAVI&#44; and so these measurements were used&#46; In other cases&#44; aortic valve diameter was measured by a combination of transthoracic echocardiogram &#40;or&#44; in ventilated patients&#44; transesophageal echocardiogram&#41; and fluoroscopic angiogram during the procedure&#46; The access route was the right or left femoral artery &#40;arterial sheaths ranging from 11 to 12F&#41; and access site closure was performed in all cases using Perclose ProGlide&#8482; &#40;Abbott Vascular&#44; Abbott Park&#44; IL&#44; USA&#41; or Angio-Seal&#8482; STS &#40;St&#46; Jude Medical&#44; St&#46; Paul&#44; MN&#44; USA&#41; devices&#46; An unfractionated heparin bolus was administered after sheath insertion &#40;70-100 IU&#47;kg&#41;&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Study endpoints</span><p id="par0055" class="elsevierStylePara elsevierViewall">The primary endpoint was the incidence of all-cause death during long-term follow-up&#46; The secondary endpoint was the composite of cardiovascular or unknown cause death and rehospitalization due to heart failure&#44; stroke&#44; or myocardial infarction&#46; Serious adverse events were defined as stroke&#44; coronary occlusion or dissection&#44; moderate to severe aortic regurgitation&#44; tamponade&#44; permanent pacemaker requirement and vascular complication requiring intervention&#46; All events were retrospectively adjudicated according to the second Valve Academic Research Consortium &#40;VARC-2&#41; statement&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">10</span></a></p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Statistical analysis</span><p id="par0060" class="elsevierStylePara elsevierViewall">The statistical analysis was performed with IBM SPSS Statistics for Windows&#44; version 20&#46;0&#46; Continuous values are reported as mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>standard deviation or median &#40;interquartile range &#91;IQR&#93;&#41;&#44; and categorical data are reported as number and percentage&#46; The Wilcoxon test was used to compare two dependent nonparametric variables&#46; Kaplan-Meier survival analysis was performed&#46; Cox regression was used to identify independent predictors of mortality&#46;</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Results</span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Baseline characteristics and demographics</span><p id="par0065" class="elsevierStylePara elsevierViewall">Between January 2013 and January 2016&#44; 23 patients underwent standalone BAV procedures&#44; 56&#46;5&#37; male&#44; mean age 78&#177;7 years&#46; A total of 40 patients were included&#44; of whom 34&#46;8&#37; were in New York Heart Association functional class IV &#40;n&#61;8&#41;&#44; and the remainder were in class III&#46; Baseline pre-implantation characteristics are summarized in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46; The risk of mortality according to the Society of Thoracic Surgeons &#40;STS&#41; score was 12&#46;3&#177;10&#46;0&#37; &#40;with a risk of morbidity or mortality of 47&#46;0&#177;18&#46;8&#37;&#41;&#44; and mean EuroScore II was 11&#46;7&#177;6&#46;0&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">The main comorbidities were hypertension&#44; coronary artery disease &#40;CAD&#41;&#44; dyslipidemia&#44; atrial fibrillation &#40;AF&#41;&#44; diabetes&#44; chronic kidney disease &#40;CKD&#41; &#40;defined as Kidney Disease Outcomes Quality Initiative stage &#8804;3 &#91;creatinine clearance &#60;60 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#93;&#41;&#44; chronic obstructive pulmonary disease &#40;COPD&#41; and malignancy &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; A total of 26&#46;9&#37; of patients had previously undergone percutaneous coronary intervention &#40;PCI&#41; due to critical CAD&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Procedure details</span><p id="par0075" class="elsevierStylePara elsevierViewall">Indications for BAV were bridge to recovery &#40;n&#61;5&#41;&#44; including three patients under invasive mechanical ventilation&#59; bridge to non-cardiac surgery &#40;n&#61;8&#41;&#59; and bridge to decision &#40;n&#61;10&#41;&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The pre-procedure maximum and mean aortic gradients measured by transthoracic echocardiogram were 71&#46;7&#177;24 mmHg and 42&#46;9&#177;13&#46;3 mmHg&#44; respectively&#44; with aortic valve area of 0&#46;7&#177;0&#46;3 cm<span class="elsevierStyleSup">2</span> &#40;0&#46;4&#177;0&#46;1 cm<span class="elsevierStyleSup">2</span>&#47;m<span class="elsevierStyleSup">2</span>&#41;&#46; Mean left ventricular ejection fraction &#40;LVEF&#41; was 40&#46;2&#177;17&#46;4&#37;&#44; and mean pulmonary artery systolic pressure &#40;PASP&#41; was 53&#46;7&#177;13&#46;5 mmHg&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The procedure was performed under conscious sedation&#44; by femoral access&#44; with 11-12 F sheaths&#46; The Nucleus<span class="elsevierStyleSup">&#174;</span> balloon was used in the majority of cases &#40;n&#61;18&#59; 78&#46;3&#37;&#41;&#44; and the Loma Vista Medical<span class="elsevierStyleSup">&#174;</span> balloon in the remainder &#40;n&#61;5&#59; 21&#46;7&#37;&#41;&#44; with a mean balloon size of 20&#46;8&#177;1&#46;5 mm&#46; Two cases &#40;8&#46;9&#37;&#41; required two inflations&#46; Vascular closure devices were used in all patients&#59; the Perclose ProGlide&#8482; was used in 91&#46;3&#37; of cases and the Angio-Seal&#8482; STS in the remainder&#46; Mean procedure duration was 77&#46;0&#177;29&#46;3 min&#46; Mean fluoroscopy time was 16&#46;6&#177;7&#46;4 min&#44; with a fluoroscopic radiation dose of 59&#46;3&#177;28&#46;5 &#956;Gy&#47;cm<span class="elsevierStyleSup">2</span> and a contrast dose of 71&#46;1&#177;66&#46;3 ml&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Endpoints and outcomes</span><p id="par0090" class="elsevierStylePara elsevierViewall">The peak gradient assessed invasively during the procedure decreased from a median of 54&#46;0&#177;19&#46;0 mmHg to 28&#46;5&#177;13&#46;8 mmHg &#40;p&#61;0&#46;002&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46; Although without statistical significance&#44; there was a trend for reductions in N-terminal pro-B-type natriuretic peptide &#40;NT-proBNP&#41; and PASP and improvement in LVEF during follow-up &#40;NT-proBNP 4972&#177;15401 pg&#47;dl to 4654&#177;8009 pg&#47;dl&#44; p&#61;NS&#59; PASP 53&#177;18 mmHg to 39&#177;11 mmHg&#44; p&#61;NS&#59; LVEF 50&#177;33&#37; to 56&#177;30&#37;&#44; p&#61;NS&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">There were three serious adverse events in two patients&#46; One patient experienced an ischemic stroke and left lower limb ischemia requiring urgent surgery&#44; and another a femoral pseudoaneurysm requiring elective repair&#46; No other complications occurred&#44; including acute moderate or severe aortic regurgitation&#44; or need for urgent permanent pacemaker implantation&#44; SAVR or TAVI&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">All patients under invasive mechanical ventilation &#40;n&#61;3&#41; were extubated soon after the intervention and patients undergoing non-cardiac surgery had no major perioperative cardiovascular complications&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Mortality</span><p id="par0105" class="elsevierStylePara elsevierViewall">There was one BAV procedure-related death &#40;4&#46;3&#37;&#41; due to ischemic stroke and acute limb ischemia as procedural complications&#46; Another patient had a right coronary artery rupture during PCI&#44; and went into cardiogenic shock even after the rupture was resolved&#46; He underwent BAV immediately&#44; which resulted in some hemodynamic improvement&#44; but eventually died in refractory cardiogenic shock&#46; A third patient underwent a pre-TAVI left main PCI complicated by cardiogenic shock and BAV was performed successfully&#46; Nevertheless&#44; this patient also progressed to refractory cardiogenic shock and died&#46; Overall in-hospital mortality was thus 13&#46;0&#37; &#40;n&#61;3&#41;&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">During a mean follow-up of 258&#177;303 days&#44; 34&#46;8&#37; &#40;n&#61;8&#41; of the patients underwent TAVI &#40;mean time between BAV and TAVI 155&#46;0&#177;91&#46;3 days&#41; and 8&#46;7&#37; &#40;n&#61;2&#41; underwent SAVR&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">During follow-up&#44; thirteen patients &#40;56&#46;5&#37;&#41; died&#44; predominantly of non-cardiovascular causes &#40;n&#61;9&#44; 69&#46;2&#37;&#41;&#44; corresponding to the primary endpoint of all-cause death&#46; These patients died on average 5&#46;5 months after BAV &#40;range 0-15 months&#44; median three months&#41;&#46; Five patients &#40;21&#46;7&#37;&#41; reached the secondary endpoint&#58; four deaths of cardiovascular or unknown cause&#44; and one readmission due to heart failure during follow-up&#46; Readmission due to stroke or myocardial infarction did not occur&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">On Kaplan-Meier analysis&#44; mortality was significantly lower among patients undergoing TAVI or SAVR at one-year follow-up &#40;10&#46;0&#37; vs&#46; 61&#46;5&#37;&#59; p&#61;0&#46;005&#41; and at two-year follow-up &#40;20&#46;0&#37; vs&#46; 84&#46;6&#37;&#59; p&#61;0&#46;005&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>&#41;&#46; Only definitive treatment was a predictor of survival &#40;TAVI &#8211; hazard ratio &#91;HR&#93;&#58; 8&#46;5&#44; 95&#37; confidence interval &#91;CI&#93;&#58; 1&#46;1-69&#46;3&#44; p&#61;0&#46;05&#59; TAVI or SAVR &#8211; HR&#58; 7&#46;4&#44; 95&#37; CI&#58; 1&#46;5-37&#46;2&#44; p&#61;0&#46;02&#41;&#44; by Cox regression analysis&#46; Age&#44; left ventricular function&#44; comorbidities &#40;hypertension&#44; dyslipidemia&#44; diabetes&#44; CAD&#44; AF&#44; CKD&#44; malignancy&#44; CPOD&#44; liver disease&#41;&#44; BAV indication&#44; STS score and EuroScore II were not predictors of survival following BAV&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Discussion</span><p id="par0125" class="elsevierStylePara elsevierViewall">Although the number of procedures performed in our center was relatively low&#44; this study represents the largest sample of patients undergoing BAV published in Portugal&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">Patients with symptomatic severe AS and high surgical risk have seen an improvement in prognosis after the introduction and widespread use of TAVI&#46; The TAVI procedure was introduced in Portugal in 2007 and in our center in 2012&#44; and there is nationwide consensus regarding the use of this therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">11</span></a> By January 2016&#44; 155 valves had been implanted and 5&#46;2&#37; &#40;n&#61;8&#41; of patients had BAV before TAVI&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">As TAVI becomes more widely available&#44; decisions regarding extremely high-risk patients will become a challenge&#46; Similarly to other registries&#44; this procedure was most frequently performed as a bridge to TAVI or as definitive therapy&#46; A significant post-procedural reduction in aortic gradient was observed&#44; with an acceptable rate of periprocedural complications and mortality&#44; considering the high risk profile of this population&#44; and in agreement with previously published high-volume series&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">12&#44;13</span></a></p><p id="par0140" class="elsevierStylePara elsevierViewall">Long-term outcome in BAV patients bridged to TAVI or SAVR is superior to outcome in palliative use alone&#46;<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">13&#44;14</span></a> Moreover&#44; patients who were successfully bridged to TAVI or SAVR had similar survival rates to those who had undergone primary TAVI or SAVR&#59; however&#44; without further interventions&#44; the survival rate after BAV was similar to that of medical therapy alone&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">12&#44;13&#44;15</span></a> Our registry confirms the poor long-term prognosis for patients with symptomatic severe AS undergoing BAV alone&#44; with mortality of up to 55&#46;6&#37; at six months&#46; This observation is in agreement with previously reported rates&#46; Liberman et al&#46; found survival rates of 52&#37;&#44; 31&#37;&#44; and 18&#37; at one&#44; two&#44; and three years after BAV&#44; respectively&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">16</span></a> Otto et al&#46; reported 55&#37; survival at one year&#44; 35&#37; at two years&#44; and 23&#37; at three years&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">6</span></a> At one year&#44; most patients died for non-cardiac reasons&#44; due to the burden of comorbidities&#44; and all-cause death was significantly higher in patients who did not undergo TAVI or SAVR&#46; Of note&#44; 26&#46;1&#37; of patients had concomitant active malignancy&#46; Such patients are difficult to treat&#44; because of the inability to pursue therapy for either malignancy or severe AS&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">Subgroup analysis further corroborates the overall results&#44; as patient outcome is ultimately determined by definitive treatment for severe AS&#44; and not by the indication itself&#46; BAV can help in recovering from a critical condition or enabling the patient to undergo non-cardiac surgery&#44; so that TAVI or surgery can be performed in a more stable setting&#44; aiming for a better outcome&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Predictors of mortality in patients undergoing BAV have been previously reported&#44; including baseline functional status&#44; cardiac output&#44; renal function&#44; cachexia&#44; female gender&#44; left ventricular systolic function&#44; and mitral regurgitation&#46;<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">17&#44;18</span></a> In the present registry&#44; only the absence of definitive treatment predicted mortality&#44; which may be explained by the small population size and the high mortality rate&#46; Symptomatic severe AS was a major determinant of mortality by itself&#44; diluting the potential impact on mortality of other variables&#46;</p><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Practical recommendations</span><p id="par0155" class="elsevierStylePara elsevierViewall">In light of our results and the limited availability of TAVI &#40;since the prosthesis is not yet available off the shelf&#41;&#44; we believe BAV should primarily be used as a bridge to definitive therapy &#40;accepted or intended&#41;&#46; This includes &#40;1&#41; patients who require non-cardiac procedures such as surgery or treatment for infection or cancer&#44; &#40;2&#41; outpatients on a waiting list who are deteriorating clinically&#44; and &#40;3&#41; inpatients with acute heart failure due to AS refractory to medical therapy &#40;such as ventilated patients who cannot be weaned&#41;&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">We believe BAV primarily for palliative purposes is generally not a good option&#44; as these patients die shortly afterwards if no definitive treatment is undertaken&#44; and essentially exposes patients to a procedure that is prone to complications but with no impact on prognosis&#46; However&#44; in some cases the patient&#39;s prognosis may not be absolutely clear&#46; Thus&#44; an individualized&#44; multidisciplinary approach should be pursued&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">Regarding timing&#44; as our results and those of others clearly demonstrate&#44; BAV provides an effective yet short-lived improvement&#44; with a mean survival of 5&#46;5 months and many patients dying within only three months&#46; Thus&#44; definitive treatment should ideally be offered as soon as possible and no later than three months after BAV&#44; although we realize this may be difficult due to limited availability of prosthetic valves&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Study limitations</span><p id="par0170" class="elsevierStylePara elsevierViewall">Our study has limitations&#44; mainly related to its retrospective design&#44; and to the assessment of complications according to the VARC-2 definitions&#44; which have been described and updated specifically for TAVI patients&#46; Echocardiographic follow-up was performed at the discretion of the attending clinicians rather than routinely&#44; which may limit the value of comparisons of hemodynamic data from echocardiography&#46;</p></span></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Conclusions</span><p id="par0175" class="elsevierStylePara elsevierViewall">In the TAVI era&#44; BAV is a safe and effective procedure and should be considered for selected patients with severe AS and temporary contraindications to definitive therapy or as palliative therapy&#46; Given the limited availability of TAVI&#44; our data suggest that BAV should more often be considered in patients with high risk and temporary contraindications or who are on a waiting list for TAVI&#44; as it may lead to improvements in clinical condition and survival&#46; However&#44; long-term survival is poor after BAV alone&#44; so TAVI or SAVR should be performed during follow-up&#46; As TAVI develops and is performed more frequently&#44; we expect that the use of BAV will increase&#44; and will have an important role in the complex treatment algorithm for high-risk patients with severe AS&#46;</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Ethical disclosures</span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Protection of human and animal subjects</span><p id="par0180" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this study&#46;</p></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Confidentiality of data</span><p id="par0185" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols of their work center on the publication of patient data&#46;</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Right to privacy and informed consent</span><p id="par0190" class="elsevierStylePara elsevierViewall">The authors have obtained the written informed consent of the patients or subjects mentioned in the article&#46; The corresponding author is in possession of this document&#46;</p></span></span><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Funding</span><p id="par0195" class="elsevierStylePara elsevierViewall">No specific funding grants were used regarding this study&#46;</p></span><span id="sec0110" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0175">Conflicts of interest</span><p id="par0200" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Percutaneous balloon aortic valvuloplasty &#40;BAV&#41; has been limited by the risk of complications and restenosis&#46; However&#44; growing use of transcatheter aortic valve implantation &#40;TAVI&#41; has revived interest in this technique&#46; We analyzed the current indications for BAV and outcomes in a single center&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Acute results and long-term outcomes were analyzed in a retrospective single-center registry of patients undergoing BAV between January 2013 and January 2016&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Twenty-three patients underwent BAV&#44; 56&#46;5&#37; male&#44; mean age 78&#177;7 years&#46; Indications were severe aortic stenosis and decompensated heart failure &#40;n&#61;5&#41;&#44; urgent non-cardiac surgery &#40;n&#61;8&#41;&#44; or bridge to definitive treatment &#40;n&#61;10&#41;&#46; Peak invasive gradient decreased from a median of 54&#46;0&#177;19&#46;0 mmHg to 28&#46;5&#177;13&#46;8 mmHg &#40;p&#61;0&#46;002&#41;&#46; Complications included one ischemic stroke&#44; one lower limb ischemia and one femoral pseudoaneurysm requiring surgery&#46; During a mean follow-up of 11&#177;10 months&#44; eight patients underwent TAVI and two underwent surgical aortic valve replacement&#46; Thirteen patients died&#44; nine of non-cardiovascular causes&#46; On Kaplan-Meier analysis mortality was significantly lower among patients undergoing definitive treatment &#40;20&#46;0&#37; vs&#46; 84&#46;6&#37; at two-year follow-up&#59; p&#61;0&#46;005&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">BAV should be considered for selected patients with temporary contraindications to definitive therapy or as palliative therapy&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Introduction"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Methods"
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          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
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          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusion"
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        ]
      ]
      "pt" => array:3 [
        "titulo" => "Resumo"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introdu&#231;&#227;o</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">A implanta&#231;&#227;o de pr&#243;teses a&#243;rticas percut&#226;neas reavivou o interesse na valvuloplastia a&#243;rtica por bal&#227;o&#44; habitualmente limitada por complica&#231;&#245;es e restenose&#46; Analis&#225;mos as indica&#231;&#245;es e resultados desta t&#233;cnica&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Registo retrospetivo&#44; unic&#234;ntrico&#44; de doentes submetidos a valvuloplastia a&#243;rtica por bal&#227;o&#44; de janeiro de 2013 a janeiro de 2016&#46; Analisaram-se os resultados imediatos e a longo prazo&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Vinte e tr&#234;s doentes foram submetidos a valvuloplastia a&#243;rtica por bal&#227;o&#44; 56&#44;5&#37; homens&#44; idade m&#233;dia 78<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7 anos&#46; As indica&#231;&#245;es foram estenose a&#243;rtica grave com&#58; insufici&#234;ncia card&#237;aca descompensada &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>5&#41;&#59; cirurgia n&#227;o-card&#237;aca urgente &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>8&#41;&#59; ponte para terap&#234;utica definitiva &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>10&#41;&#46; O gradiente de pico invasivo reduziu-se de uma mediana de 54&#44;0 &#40;19&#44;0&#41; mmHg para 28&#44;5 &#40;13&#44;8&#41; mmHg &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;002&#41;&#46; Registaram-se um acidente vascular cerebral isqu&#233;mico&#44; uma isquemia aguda do membro inferior e um pseudoaneurisma femoral resolvidos cirurgicamente&#46; Durante um seguimento m&#233;dio de 11<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10 meses&#44; efetuaram-se oito implanta&#231;&#245;es percut&#226;neas de pr&#243;tese a&#243;rtica e duas substitui&#231;&#245;es cir&#250;rgicas&#46; Treze doentes morreram&#44; nove de causas n&#227;o-cardiovasculares&#46; Por an&#225;lise de sobreviv&#234;ncia de Kaplan-Meier&#44; a mortalidade foi menor nos doentes submetidos a tratamento definitivo &#40;20&#44;0 <span class="elsevierStyleItalic">versus</span> 84&#44;6&#37; a dois anos&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;005&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclus&#227;o</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">A valvuloplastia a&#243;rtica por bal&#227;o deve ser considerada em doentes selecionados com contraindica&#231;&#245;es tempor&#225;rias ao tratamento definitivo ou como terap&#234;utica paliativa&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Introdu&#231;&#227;o"
          ]
          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "M&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclus&#227;o"
          ]
        ]
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    ]
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          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Peak transaortic gradient assessed invasively pre- and post-transcatheter aortic valve implantation&#46;</p>"
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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">&#40;A&#41; Two-year Kaplan-Meier survival curves of patients undergoing TAVI after BAV vs&#46; those maintained under medical therapy&#59; &#40;B&#41; two-year Kaplan-Meier survival curves of patients undergoing TAVI or SAVR after BAV vs&#46; those maintained under medical therapy&#46; BAV&#58; balloon aortic valvuloplasty&#59; SAVR&#58; surgical aortic valve replacement&#59; TAVI&#58; transcatheter aortic valve implantation&#46;</p>"
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          "leyenda" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">AF&#58; atrial fibrillation&#59; CAD&#58; coronary artery disease&#59; CKD&#58; chronic kidney disease&#59; COPD&#58; chronic obstructive pulmonary disease&#59; NYHA&#58; New York Heart Association&#59; STS&#58; Society of Thoracic Surgeons&#46;</p>"
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                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Age&#44; years &#40;mean</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#177;</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">SD&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">78&#177;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">Male&#44; n &#40;&#37;&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">13 &#40;56&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">STS score &#40;mean</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#177;</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">SD&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">12&#46;3&#177;10&#46;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic">EuroScore II &#40;mean</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">&#177;</span><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">SD&#41;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">11&#46;7&#177;6&#46;0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">NYHA functional class</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>III &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">15 &#40;65&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>IV &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">8 &#40;34&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Comorbidities</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>CAD &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">12 &#40;52&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Hypertension &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">17 &#40;73&#46;9&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>AF &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">11 &#40;52&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Dyslipidemia &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">12 &#40;52&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Diabetes &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">10 &#40;43&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>CKD &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">10 &#40;43&#46;5&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>COPD &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">4 &#40;17&#46;4&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Malignancy &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">6 &#40;26&#46;1&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Liver disease &#40;n&#44; &#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">2 &#40;8&#46;8&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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        "descripcion" => array:1 [
          "en" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Characteristics of the study population&#46;</p>"
        ]
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    ]
    "bibliografia" => array:2 [
      "titulo" => "References"
      "seccion" => array:1 [
        0 => array:2 [
          "identificador" => "bibs0005"
          "bibliografiaReferencia" => array:18 [
            0 => array:3 [
              "identificador" => "bib0095"
              "etiqueta" => "1"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Aortic stenosis"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:2 [
                            0 => "J&#46; Ross"
                            1 => "E&#46; Braunwald"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:5 [
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                        "paginaInicial" => "12"
                        "paginaFinal" => "15"
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                    ]
                  ]
                ]
              ]
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            1 => array:3 [
              "identificador" => "bib0100"
              "etiqueta" => "2"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology &#40;ESC&#41;&#59; European Association for Cardio-Thoracic Surgery &#40;EACTS&#41;&#59; Guidelines on the management of valvular heart disease &#40;version 2012&#41;"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
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                            0 => "A&#46; Vahanian"
                            1 => "O&#46; Alfieri"
                            2 => "F&#46; Andreott"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1093/eurheartj/ehs109"
                      "Revista" => array:6 [
                        "tituloSerie" => "Eur Heart J"
                        "fecha" => "2012"
                        "volumen" => "33"
                        "paginaInicial" => "2451"
                        "paginaFinal" => "2496"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/22922415"
                            "web" => "Medline"
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            2 => array:3 [
              "identificador" => "bib0105"
              "etiqueta" => "3"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Valvular heart disease&#58; diagnosis and management"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:4 [
                            0 => "K&#46; Maganti"
                            1 => "V&#46;H&#46; Rigolin"
                            2 => "M&#46;E&#46; Sarano"
                            3 => "R&#46;O&#46; Bonow"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.4065/mcp.2009.0706"
                      "Revista" => array:6 [
                        "tituloSerie" => "Mayo Clin Proc"
                        "fecha" => "2010"
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                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/20435842"
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              ]
            ]
            3 => array:3 [
              "identificador" => "bib0110"
              "etiqueta" => "4"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
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                      "titulo" => "Percutaneous transluminal valvuloplasty of acquired aortic stenosis in elderly patients&#58; an alternative to valve replacement"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:3 [
                            0 => "A&#46; Cribier"
                            1 => "T&#46; Savin"
                            2 => "N&#46; Saoudi"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1016/S2215-0366(14)70220-2"
                      "Revista" => array:6 [
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                          0 => array:2 [
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                            "web" => "Medline"
                          ]
                        ]
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                    ]
                  ]
                ]
              ]
            ]
            4 => array:3 [
              "identificador" => "bib0115"
              "etiqueta" => "5"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Percutaneous transluminal balloon valvuloplasty of adult aortic stenosis&#58; report of 92 cases"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:3 [
                            0 => "A&#46; Cribier"
                            1 => "T&#46; Savin"
                            2 => "J&#46; Berland"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "J Am Coll Cardiol"
                        "fecha" => "1987"
                        "volumen" => "9"
                        "paginaInicial" => "381"
                        "paginaFinal" => "396"
                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/2948996"
                            "web" => "Medline"
                          ]
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                      ]
                    ]
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                ]
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            5 => array:3 [
              "identificador" => "bib0120"
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Original Article
Balloon aortic valvuloplasty in the transcatheter aortic valve implantation era: A single-center registry
Valvuloplastia aórtica por balão na era da implantação de válvula aórtica percutânea. Um registo unicêntrico
Ana Rita G. Franciscoa,
Corresponding author
ana.r.francisco@gmail.com

Corresponding author.
, Miguel Nobre Menezesa, Pedro Carrilho Ferreiraa, Cláudia Jorgea, Doroteia Silvab, Eduardo Infante de Oliveiraa, Fausto J. Pintoa, Pedro Canas da Silvaa
a Cardiology Department, Santa Maria University Hospital, CHLN, CAML, CCUL, Faculty of Medicine, University of Lisbon, Lisbon, Portugal
b Intensive Care Unit, Santa Maria University Hospital, CHLN, Lisbon, Portugal
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          "en" => "<p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">&#40;A&#41; Two-year Kaplan-Meier survival curves of patients undergoing TAVI after BAV vs&#46; those maintained under medical therapy&#59; &#40;B&#41; two-year Kaplan-Meier survival curves of patients undergoing TAVI or SAVR after BAV vs&#46; those maintained under medical therapy&#46; BAV&#58; balloon aortic valvuloplasty&#59; SAVR&#58; surgical aortic valve replacement&#59; TAVI&#58; transcatheter aortic valve implantation&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Symptomatic severe aortic stenosis &#40;AS&#41; conveys a high risk of cardiovascular death and rehospitalization for heart failure with medical therapy alone&#46; Without treatment mean survival is only 1-3 years after symptom onset&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">1</span></a> Surgical aortic valve replacement &#40;SAVR&#41; is the gold standard for the treatment of severe AS&#46; However&#44; mainly due to the high prevalence of comorbidities&#44; up to one-quarter of patients do not undergo SAVR&#46;<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">2&#44;3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">For patients who are not suitable for surgical treatment&#44; balloon aortic valvuloplasty &#40;BAV&#41; was first proposed in 1986 by Alain Cribier as a useful&#44; low-risk&#44; palliative treatment for symptomatic relief&#46;<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">4&#44;5</span></a> Despite promising initial results &#40;reduction of maximum and mean aortic gradients and improvement in functional capacity&#41;&#44; its popularity waned&#44; due to the high rate of complications and early restenosis&#46; Moreover&#44; the long-term survival of these patients is low&#44; resembling the natural course of untreated severe AS&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">6</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The introduction of transcatheter aortic valve implantation &#40;TAVI&#41; has revived interest in BAV for clinically unstable patients as a bridge to definitive therapy &#40;TAVI or SAVR&#41; or as a destination therapy for palliative reasons&#46; Cohort B of the PARTNER trial showed that patients managed conservatively have significantly higher 12-month mortality compared to patients undergoing TAVI&#46; However&#44; only a small difference in six-month mortality was noted&#58; 22&#37; in the TAVI group vs&#46; 28&#37; in patients treated conservatively &#40;of whom 83&#37; underwent BAV&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">7</span></a> This good result in the first months supports BAV as a therapeutic bridge&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">In the TAVI era&#44; BAV is often performed to facilitate percutaneous delivery of the prosthesis&#44; reduce paravalvular leaks and aid in ring size assessment&#46; The growing number of BAV procedures&#44; together with improvements in techniques and materials and use of vascular closure devices&#44; has led to a reduction in procedural complications&#46; While an older series had a 20&#37; complication rate and 8&#37; mortality&#44; a more recent study reported much lower rates of major complications and overall mortality &#40;6&#46;8&#37; and 2&#46;5&#37;&#44; respectively&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">8&#44;9</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The aim of this study was to analyze the current indications for BAV and to determine the success&#44; complication and survival rates after BAV of patients in a real-world setting&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Methods</span><p id="par0030" class="elsevierStylePara elsevierViewall">This was a retrospective single-center registry of patients undergoing BAV between January 2013 and January 2016&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Inclusion criteria</span><p id="par0035" class="elsevierStylePara elsevierViewall">All patients with symptomatic severe AS who underwent BAV were consecutively enrolled&#46; The center&#39;s heart team assessed the indication for BAV&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Procedural indications were classified as&#58; &#40;1&#41; bridge to recovery&#58; refractory cardiogenic shock&#44; pulmonary edema or congestive heart failure due to severe AS&#44; including patients under invasive mechanical ventilation&#59; &#40;2&#41; bridge to decision&#58; patients in whom it was judged that LV systolic function might recover and clinical condition improve via BAV&#44; enabling subsequent definitive treatment &#40;TAVI or SAVR&#41;&#59; and &#40;3&#41; bridge to non-cardiac surgery&#58; patients in whom urgent non-cardiac surgery was needed but had a prohibitive risk due to untreated severe AS&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Data collection</span><p id="par0045" class="elsevierStylePara elsevierViewall">Baseline clinical&#44; laboratory&#44; echocardiographic&#44; hemodynamic and procedural data were collected retrospectively through reviews of hospital records&#46; Follow-up was performed through hospital outpatient consultations or telephone interview&#46; Laboratory and echocardiographic assessment was repeated three to six months after the procedure&#46; Data on mortality were obtained from the National Patient Registry&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Procedure</span><p id="par0050" class="elsevierStylePara elsevierViewall">BAV was performed under conscious sedation&#44; with different balloon devices &#40;Nucleus<span class="elsevierStyleSup">&#174;</span> and Loma Vista Medical<span class="elsevierStyleSup">&#174;</span>&#41;&#44; by the standard retrograde technique and under rapid ventricular pacing&#46; Regarding balloon diameter &#40;which ranged from 20 to 25 mm&#41;&#44; the choice was made according to the individual patient&#39;s characteristics&#46; Some patients had already been assessed by cardiac computed tomography for TAVI&#44; and so these measurements were used&#46; In other cases&#44; aortic valve diameter was measured by a combination of transthoracic echocardiogram &#40;or&#44; in ventilated patients&#44; transesophageal echocardiogram&#41; and fluoroscopic angiogram during the procedure&#46; The access route was the right or left femoral artery &#40;arterial sheaths ranging from 11 to 12F&#41; and access site closure was performed in all cases using Perclose ProGlide&#8482; &#40;Abbott Vascular&#44; Abbott Park&#44; IL&#44; USA&#41; or Angio-Seal&#8482; STS &#40;St&#46; Jude Medical&#44; St&#46; Paul&#44; MN&#44; USA&#41; devices&#46; An unfractionated heparin bolus was administered after sheath insertion &#40;70-100 IU&#47;kg&#41;&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Study endpoints</span><p id="par0055" class="elsevierStylePara elsevierViewall">The primary endpoint was the incidence of all-cause death during long-term follow-up&#46; The secondary endpoint was the composite of cardiovascular or unknown cause death and rehospitalization due to heart failure&#44; stroke&#44; or myocardial infarction&#46; Serious adverse events were defined as stroke&#44; coronary occlusion or dissection&#44; moderate to severe aortic regurgitation&#44; tamponade&#44; permanent pacemaker requirement and vascular complication requiring intervention&#46; All events were retrospectively adjudicated according to the second Valve Academic Research Consortium &#40;VARC-2&#41; statement&#46;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">10</span></a></p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Statistical analysis</span><p id="par0060" class="elsevierStylePara elsevierViewall">The statistical analysis was performed with IBM SPSS Statistics for Windows&#44; version 20&#46;0&#46; Continuous values are reported as mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>standard deviation or median &#40;interquartile range &#91;IQR&#93;&#41;&#44; and categorical data are reported as number and percentage&#46; The Wilcoxon test was used to compare two dependent nonparametric variables&#46; Kaplan-Meier survival analysis was performed&#46; Cox regression was used to identify independent predictors of mortality&#46;</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Results</span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Baseline characteristics and demographics</span><p id="par0065" class="elsevierStylePara elsevierViewall">Between January 2013 and January 2016&#44; 23 patients underwent standalone BAV procedures&#44; 56&#46;5&#37; male&#44; mean age 78&#177;7 years&#46; A total of 40 patients were included&#44; of whom 34&#46;8&#37; were in New York Heart Association functional class IV &#40;n&#61;8&#41;&#44; and the remainder were in class III&#46; Baseline pre-implantation characteristics are summarized in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46; The risk of mortality according to the Society of Thoracic Surgeons &#40;STS&#41; score was 12&#46;3&#177;10&#46;0&#37; &#40;with a risk of morbidity or mortality of 47&#46;0&#177;18&#46;8&#37;&#41;&#44; and mean EuroScore II was 11&#46;7&#177;6&#46;0&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall">The main comorbidities were hypertension&#44; coronary artery disease &#40;CAD&#41;&#44; dyslipidemia&#44; atrial fibrillation &#40;AF&#41;&#44; diabetes&#44; chronic kidney disease &#40;CKD&#41; &#40;defined as Kidney Disease Outcomes Quality Initiative stage &#8804;3 &#91;creatinine clearance &#60;60 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#93;&#41;&#44; chronic obstructive pulmonary disease &#40;COPD&#41; and malignancy &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; A total of 26&#46;9&#37; of patients had previously undergone percutaneous coronary intervention &#40;PCI&#41; due to critical CAD&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Procedure details</span><p id="par0075" class="elsevierStylePara elsevierViewall">Indications for BAV were bridge to recovery &#40;n&#61;5&#41;&#44; including three patients under invasive mechanical ventilation&#59; bridge to non-cardiac surgery &#40;n&#61;8&#41;&#59; and bridge to decision &#40;n&#61;10&#41;&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The pre-procedure maximum and mean aortic gradients measured by transthoracic echocardiogram were 71&#46;7&#177;24 mmHg and 42&#46;9&#177;13&#46;3 mmHg&#44; respectively&#44; with aortic valve area of 0&#46;7&#177;0&#46;3 cm<span class="elsevierStyleSup">2</span> &#40;0&#46;4&#177;0&#46;1 cm<span class="elsevierStyleSup">2</span>&#47;m<span class="elsevierStyleSup">2</span>&#41;&#46; Mean left ventricular ejection fraction &#40;LVEF&#41; was 40&#46;2&#177;17&#46;4&#37;&#44; and mean pulmonary artery systolic pressure &#40;PASP&#41; was 53&#46;7&#177;13&#46;5 mmHg&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">The procedure was performed under conscious sedation&#44; by femoral access&#44; with 11-12 F sheaths&#46; The Nucleus<span class="elsevierStyleSup">&#174;</span> balloon was used in the majority of cases &#40;n&#61;18&#59; 78&#46;3&#37;&#41;&#44; and the Loma Vista Medical<span class="elsevierStyleSup">&#174;</span> balloon in the remainder &#40;n&#61;5&#59; 21&#46;7&#37;&#41;&#44; with a mean balloon size of 20&#46;8&#177;1&#46;5 mm&#46; Two cases &#40;8&#46;9&#37;&#41; required two inflations&#46; Vascular closure devices were used in all patients&#59; the Perclose ProGlide&#8482; was used in 91&#46;3&#37; of cases and the Angio-Seal&#8482; STS in the remainder&#46; Mean procedure duration was 77&#46;0&#177;29&#46;3 min&#46; Mean fluoroscopy time was 16&#46;6&#177;7&#46;4 min&#44; with a fluoroscopic radiation dose of 59&#46;3&#177;28&#46;5 &#956;Gy&#47;cm<span class="elsevierStyleSup">2</span> and a contrast dose of 71&#46;1&#177;66&#46;3 ml&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Endpoints and outcomes</span><p id="par0090" class="elsevierStylePara elsevierViewall">The peak gradient assessed invasively during the procedure decreased from a median of 54&#46;0&#177;19&#46;0 mmHg to 28&#46;5&#177;13&#46;8 mmHg &#40;p&#61;0&#46;002&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#41;&#46; Although without statistical significance&#44; there was a trend for reductions in N-terminal pro-B-type natriuretic peptide &#40;NT-proBNP&#41; and PASP and improvement in LVEF during follow-up &#40;NT-proBNP 4972&#177;15401 pg&#47;dl to 4654&#177;8009 pg&#47;dl&#44; p&#61;NS&#59; PASP 53&#177;18 mmHg to 39&#177;11 mmHg&#44; p&#61;NS&#59; LVEF 50&#177;33&#37; to 56&#177;30&#37;&#44; p&#61;NS&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">There were three serious adverse events in two patients&#46; One patient experienced an ischemic stroke and left lower limb ischemia requiring urgent surgery&#44; and another a femoral pseudoaneurysm requiring elective repair&#46; No other complications occurred&#44; including acute moderate or severe aortic regurgitation&#44; or need for urgent permanent pacemaker implantation&#44; SAVR or TAVI&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">All patients under invasive mechanical ventilation &#40;n&#61;3&#41; were extubated soon after the intervention and patients undergoing non-cardiac surgery had no major perioperative cardiovascular complications&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Mortality</span><p id="par0105" class="elsevierStylePara elsevierViewall">There was one BAV procedure-related death &#40;4&#46;3&#37;&#41; due to ischemic stroke and acute limb ischemia as procedural complications&#46; Another patient had a right coronary artery rupture during PCI&#44; and went into cardiogenic shock even after the rupture was resolved&#46; He underwent BAV immediately&#44; which resulted in some hemodynamic improvement&#44; but eventually died in refractory cardiogenic shock&#46; A third patient underwent a pre-TAVI left main PCI complicated by cardiogenic shock and BAV was performed successfully&#46; Nevertheless&#44; this patient also progressed to refractory cardiogenic shock and died&#46; Overall in-hospital mortality was thus 13&#46;0&#37; &#40;n&#61;3&#41;&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">During a mean follow-up of 258&#177;303 days&#44; 34&#46;8&#37; &#40;n&#61;8&#41; of the patients underwent TAVI &#40;mean time between BAV and TAVI 155&#46;0&#177;91&#46;3 days&#41; and 8&#46;7&#37; &#40;n&#61;2&#41; underwent SAVR&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">During follow-up&#44; thirteen patients &#40;56&#46;5&#37;&#41; died&#44; predominantly of non-cardiovascular causes &#40;n&#61;9&#44; 69&#46;2&#37;&#41;&#44; corresponding to the primary endpoint of all-cause death&#46; These patients died on average 5&#46;5 months after BAV &#40;range 0-15 months&#44; median three months&#41;&#46; Five patients &#40;21&#46;7&#37;&#41; reached the secondary endpoint&#58; four deaths of cardiovascular or unknown cause&#44; and one readmission due to heart failure during follow-up&#46; Readmission due to stroke or myocardial infarction did not occur&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">On Kaplan-Meier analysis&#44; mortality was significantly lower among patients undergoing TAVI or SAVR at one-year follow-up &#40;10&#46;0&#37; vs&#46; 61&#46;5&#37;&#59; p&#61;0&#46;005&#41; and at two-year follow-up &#40;20&#46;0&#37; vs&#46; 84&#46;6&#37;&#59; p&#61;0&#46;005&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Figure 2</a>&#41;&#46; Only definitive treatment was a predictor of survival &#40;TAVI &#8211; hazard ratio &#91;HR&#93;&#58; 8&#46;5&#44; 95&#37; confidence interval &#91;CI&#93;&#58; 1&#46;1-69&#46;3&#44; p&#61;0&#46;05&#59; TAVI or SAVR &#8211; HR&#58; 7&#46;4&#44; 95&#37; CI&#58; 1&#46;5-37&#46;2&#44; p&#61;0&#46;02&#41;&#44; by Cox regression analysis&#46; Age&#44; left ventricular function&#44; comorbidities &#40;hypertension&#44; dyslipidemia&#44; diabetes&#44; CAD&#44; AF&#44; CKD&#44; malignancy&#44; CPOD&#44; liver disease&#41;&#44; BAV indication&#44; STS score and EuroScore II were not predictors of survival following BAV&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Discussion</span><p id="par0125" class="elsevierStylePara elsevierViewall">Although the number of procedures performed in our center was relatively low&#44; this study represents the largest sample of patients undergoing BAV published in Portugal&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">Patients with symptomatic severe AS and high surgical risk have seen an improvement in prognosis after the introduction and widespread use of TAVI&#46; The TAVI procedure was introduced in Portugal in 2007 and in our center in 2012&#44; and there is nationwide consensus regarding the use of this therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">11</span></a> By January 2016&#44; 155 valves had been implanted and 5&#46;2&#37; &#40;n&#61;8&#41; of patients had BAV before TAVI&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">As TAVI becomes more widely available&#44; decisions regarding extremely high-risk patients will become a challenge&#46; Similarly to other registries&#44; this procedure was most frequently performed as a bridge to TAVI or as definitive therapy&#46; A significant post-procedural reduction in aortic gradient was observed&#44; with an acceptable rate of periprocedural complications and mortality&#44; considering the high risk profile of this population&#44; and in agreement with previously published high-volume series&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">12&#44;13</span></a></p><p id="par0140" class="elsevierStylePara elsevierViewall">Long-term outcome in BAV patients bridged to TAVI or SAVR is superior to outcome in palliative use alone&#46;<a class="elsevierStyleCrossRefs" href="#bib0155"><span class="elsevierStyleSup">13&#44;14</span></a> Moreover&#44; patients who were successfully bridged to TAVI or SAVR had similar survival rates to those who had undergone primary TAVI or SAVR&#59; however&#44; without further interventions&#44; the survival rate after BAV was similar to that of medical therapy alone&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">12&#44;13&#44;15</span></a> Our registry confirms the poor long-term prognosis for patients with symptomatic severe AS undergoing BAV alone&#44; with mortality of up to 55&#46;6&#37; at six months&#46; This observation is in agreement with previously reported rates&#46; Liberman et al&#46; found survival rates of 52&#37;&#44; 31&#37;&#44; and 18&#37; at one&#44; two&#44; and three years after BAV&#44; respectively&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">16</span></a> Otto et al&#46; reported 55&#37; survival at one year&#44; 35&#37; at two years&#44; and 23&#37; at three years&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">6</span></a> At one year&#44; most patients died for non-cardiac reasons&#44; due to the burden of comorbidities&#44; and all-cause death was significantly higher in patients who did not undergo TAVI or SAVR&#46; Of note&#44; 26&#46;1&#37; of patients had concomitant active malignancy&#46; Such patients are difficult to treat&#44; because of the inability to pursue therapy for either malignancy or severe AS&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">Subgroup analysis further corroborates the overall results&#44; as patient outcome is ultimately determined by definitive treatment for severe AS&#44; and not by the indication itself&#46; BAV can help in recovering from a critical condition or enabling the patient to undergo non-cardiac surgery&#44; so that TAVI or surgery can be performed in a more stable setting&#44; aiming for a better outcome&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Predictors of mortality in patients undergoing BAV have been previously reported&#44; including baseline functional status&#44; cardiac output&#44; renal function&#44; cachexia&#44; female gender&#44; left ventricular systolic function&#44; and mitral regurgitation&#46;<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">17&#44;18</span></a> In the present registry&#44; only the absence of definitive treatment predicted mortality&#44; which may be explained by the small population size and the high mortality rate&#46; Symptomatic severe AS was a major determinant of mortality by itself&#44; diluting the potential impact on mortality of other variables&#46;</p><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Practical recommendations</span><p id="par0155" class="elsevierStylePara elsevierViewall">In light of our results and the limited availability of TAVI &#40;since the prosthesis is not yet available off the shelf&#41;&#44; we believe BAV should primarily be used as a bridge to definitive therapy &#40;accepted or intended&#41;&#46; This includes &#40;1&#41; patients who require non-cardiac procedures such as surgery or treatment for infection or cancer&#44; &#40;2&#41; outpatients on a waiting list who are deteriorating clinically&#44; and &#40;3&#41; inpatients with acute heart failure due to AS refractory to medical therapy &#40;such as ventilated patients who cannot be weaned&#41;&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">We believe BAV primarily for palliative purposes is generally not a good option&#44; as these patients die shortly afterwards if no definitive treatment is undertaken&#44; and essentially exposes patients to a procedure that is prone to complications but with no impact on prognosis&#46; However&#44; in some cases the patient&#39;s prognosis may not be absolutely clear&#46; Thus&#44; an individualized&#44; multidisciplinary approach should be pursued&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">Regarding timing&#44; as our results and those of others clearly demonstrate&#44; BAV provides an effective yet short-lived improvement&#44; with a mean survival of 5&#46;5 months and many patients dying within only three months&#46; Thus&#44; definitive treatment should ideally be offered as soon as possible and no later than three months after BAV&#44; although we realize this may be difficult due to limited availability of prosthetic valves&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Study limitations</span><p id="par0170" class="elsevierStylePara elsevierViewall">Our study has limitations&#44; mainly related to its retrospective design&#44; and to the assessment of complications according to the VARC-2 definitions&#44; which have been described and updated specifically for TAVI patients&#46; Echocardiographic follow-up was performed at the discretion of the attending clinicians rather than routinely&#44; which may limit the value of comparisons of hemodynamic data from echocardiography&#46;</p></span></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Conclusions</span><p id="par0175" class="elsevierStylePara elsevierViewall">In the TAVI era&#44; BAV is a safe and effective procedure and should be considered for selected patients with severe AS and temporary contraindications to definitive therapy or as palliative therapy&#46; Given the limited availability of TAVI&#44; our data suggest that BAV should more often be considered in patients with high risk and temporary contraindications or who are on a waiting list for TAVI&#44; as it may lead to improvements in clinical condition and survival&#46; However&#44; long-term survival is poor after BAV alone&#44; so TAVI or SAVR should be performed during follow-up&#46; As TAVI develops and is performed more frequently&#44; we expect that the use of BAV will increase&#44; and will have an important role in the complex treatment algorithm for high-risk patients with severe AS&#46;</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Ethical disclosures</span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Protection of human and animal subjects</span><p id="par0180" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this study&#46;</p></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Confidentiality of data</span><p id="par0185" class="elsevierStylePara elsevierViewall">The authors declare that they have followed the protocols of their work center on the publication of patient data&#46;</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Right to privacy and informed consent</span><p id="par0190" class="elsevierStylePara elsevierViewall">The authors have obtained the written informed consent of the patients or subjects mentioned in the article&#46; The corresponding author is in possession of this document&#46;</p></span></span><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Funding</span><p id="par0195" class="elsevierStylePara elsevierViewall">No specific funding grants were used regarding this study&#46;</p></span><span id="sec0110" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0175">Conflicts of interest</span><p id="par0200" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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            0 => "Balloon aortic valvuloplasty"
            1 => "Severe aortic stenosis"
            2 => "Transcatheter aortic valve implantation"
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        1 => array:4 [
          "clase" => "abr"
          "titulo" => "Abbreviations"
          "identificador" => "xpalclavsec827756"
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            0 => "AF"
            1 => "AS"
            2 => "BAV"
            3 => "CAD"
            4 => "CKD"
            5 => "COPD"
            6 => "LVEF"
            7 => "NT-proBNP"
            8 => "PASP"
            9 => "PCI"
            10 => "SAVR"
            11 => "TAVI"
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          "palabras" => array:3 [
            0 => "Valvuloplastia a&#243;rtica por bal&#227;o"
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            2 => "Implanta&#231;&#227;o valvular a&#243;rtica percut&#226;nea"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Percutaneous balloon aortic valvuloplasty &#40;BAV&#41; has been limited by the risk of complications and restenosis&#46; However&#44; growing use of transcatheter aortic valve implantation &#40;TAVI&#41; has revived interest in this technique&#46; We analyzed the current indications for BAV and outcomes in a single center&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Acute results and long-term outcomes were analyzed in a retrospective single-center registry of patients undergoing BAV between January 2013 and January 2016&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Twenty-three patients underwent BAV&#44; 56&#46;5&#37; male&#44; mean age 78&#177;7 years&#46; Indications were severe aortic stenosis and decompensated heart failure &#40;n&#61;5&#41;&#44; urgent non-cardiac surgery &#40;n&#61;8&#41;&#44; or bridge to definitive treatment &#40;n&#61;10&#41;&#46; Peak invasive gradient decreased from a median of 54&#46;0&#177;19&#46;0 mmHg to 28&#46;5&#177;13&#46;8 mmHg &#40;p&#61;0&#46;002&#41;&#46; Complications included one ischemic stroke&#44; one lower limb ischemia and one femoral pseudoaneurysm requiring surgery&#46; During a mean follow-up of 11&#177;10 months&#44; eight patients underwent TAVI and two underwent surgical aortic valve replacement&#46; Thirteen patients died&#44; nine of non-cardiovascular causes&#46; On Kaplan-Meier analysis mortality was significantly lower among patients undergoing definitive treatment &#40;20&#46;0&#37; vs&#46; 84&#46;6&#37; at two-year follow-up&#59; p&#61;0&#46;005&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">BAV should be considered for selected patients with temporary contraindications to definitive therapy or as palliative therapy&#46;</p></span>"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introdu&#231;&#227;o</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">A implanta&#231;&#227;o de pr&#243;teses a&#243;rticas percut&#226;neas reavivou o interesse na valvuloplastia a&#243;rtica por bal&#227;o&#44; habitualmente limitada por complica&#231;&#245;es e restenose&#46; Analis&#225;mos as indica&#231;&#245;es e resultados desta t&#233;cnica&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Registo retrospetivo&#44; unic&#234;ntrico&#44; de doentes submetidos a valvuloplastia a&#243;rtica por bal&#227;o&#44; de janeiro de 2013 a janeiro de 2016&#46; Analisaram-se os resultados imediatos e a longo prazo&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Vinte e tr&#234;s doentes foram submetidos a valvuloplastia a&#243;rtica por bal&#227;o&#44; 56&#44;5&#37; homens&#44; idade m&#233;dia 78<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7 anos&#46; As indica&#231;&#245;es foram estenose a&#243;rtica grave com&#58; insufici&#234;ncia card&#237;aca descompensada &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>5&#41;&#59; cirurgia n&#227;o-card&#237;aca urgente &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>8&#41;&#59; ponte para terap&#234;utica definitiva &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>10&#41;&#46; O gradiente de pico invasivo reduziu-se de uma mediana de 54&#44;0 &#40;19&#44;0&#41; mmHg para 28&#44;5 &#40;13&#44;8&#41; mmHg &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;002&#41;&#46; Registaram-se um acidente vascular cerebral isqu&#233;mico&#44; uma isquemia aguda do membro inferior e um pseudoaneurisma femoral resolvidos cirurgicamente&#46; Durante um seguimento m&#233;dio de 11<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10 meses&#44; efetuaram-se oito implanta&#231;&#245;es percut&#226;neas de pr&#243;tese a&#243;rtica e duas substitui&#231;&#245;es cir&#250;rgicas&#46; Treze doentes morreram&#44; nove de causas n&#227;o-cardiovasculares&#46; Por an&#225;lise de sobreviv&#234;ncia de Kaplan-Meier&#44; a mortalidade foi menor nos doentes submetidos a tratamento definitivo &#40;20&#44;0 <span class="elsevierStyleItalic">versus</span> 84&#44;6&#37; a dois anos&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;005&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclus&#227;o</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">A valvuloplastia a&#243;rtica por bal&#227;o deve ser considerada em doentes selecionados com contraindica&#231;&#245;es tempor&#225;rias ao tratamento definitivo ou como terap&#234;utica paliativa&#46;</p></span>"
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          "leyenda" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">AF&#58; atrial fibrillation&#59; CAD&#58; coronary artery disease&#59; CKD&#58; chronic kidney disease&#59; COPD&#58; chronic obstructive pulmonary disease&#59; NYHA&#58; New York Heart Association&#59; STS&#58; Society of Thoracic Surgeons&#46;</p>"
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