Clinical and hemodynamic results after direct transcatheter aortic valve replacement versus pre-implantation balloon aortic valvuloplasty: A case-matched analysis.

OBJECTIVES: To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV). BACKGROUND: BAV was considered a mandatory previous step in TAVR procedures. METHODS: A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained. RESULTS: Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups. CONCLUSIONS: Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc.

Endoleak after Endovascular Abdominal Aortic Aneurysm Repair Treated by Bilateral Transradial Access: Case Report.

The treatment of endovascular leaks after endovascular abdominal aortic repair can be challenging, particularly in patients with a lack of vascular access. We describe the case of a critically ill elderly patient with an endoleak resulting from structural failure of an endograft years after endovascular abdominal aortic repair. The patient was treated with an aorto-uni-iliac endoprosthesis, but a few days later a new endoleak appeared and femoral or axillar access was not feasible. We successfully treated the endoleak using a novel technique via bilateral transradial access involving simultaneous insufflation of two peripheral low-profile balloons to achieve a diameter capable of improving the apposition of the stent graft. In selected cases, bilateral radial access allows procedures to be performed that would otherwise be impossible due to the inherent limitation in sheath size that can be used in the radial artery.

The Value of the SYNTAX Score II in Predicting Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

INTRODUCTION AND OBJECTIVES: The predictive value of the SYNTAX score (SS) for clinical outcomes after transcatheter aortic valve implantation (TAVI) is very limited and could potentially be improved by the combination of anatomic and clinical variables, the SS-II. We aimed to evaluate the value of the SS-II in predicting outcomes in patients undergoing TAVI. METHODS: A total of 402 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI were included. Preprocedural TAVI angiograms were reviewed and the SS-I and SS-II were calculated using the SS algorithms. Patients were stratified in 3 groups according to SS-II tertiles. The coprimary endpoints were all-cause death and major adverse cardiovascular events (MACE), a composite of all-cause death, cerebrovascular event, or myocardial infarction at 1 year. RESULTS: Increased SS-II was associated with higher 30-day mortality (P=.036) and major bleeding (P=.015). The 1-year risk of death and MACE was higher among patients in the 3rd SS-II tertile (HR, 2.60; P=.002 and HR, 2.66; P<.001) and was similar among patients in the 2nd tertile (HR, 1.27; P=.507 and HR, 1.05; P=.895) compared with patients in the 1st tertile. The highest SS-II tertile was an independent predictor of long-term mortality (P=.046) and MACE (P=.001). CONCLUSIONS: The SS-II seems more suited to predict clinical outcomes in patients undergoing TAVI than the SS-I. Increased SS-II was associated with poorer clinical outcomes at 1 and 4 years post-TAVI, independently of the presence of coronary artery disease.

Device specificity of vascular healing following implantation of bioresorbable vascular scaffolds and bioabsorbable polymer metallic drug-eluting stents in human coronary arteries: the ESTROFA OCT BVS vs. BP-DES study.

AIMS: We sought to compare vascular healing with bioresorbable everolimus-eluting vascular scaffolds (BVS) and drug-eluting stents with bioabsorbable polymers (BP-DES) at six and 12 months both implanted in the same patients. METHODS AND RESULTS: This was a multicentre and prospective study including patients with at least two comparable lesions to treat. In every patient both BVS and BP-DES (SYNERGY, Orsiro or BioMatrix Flex) were implanted by lesion randomisation. Patients included were evaluated with optical coherence tomography at six or 12 months (2:1). Finally, 68 patients had an examination at six months and 27 patients at 12 months. The rates of uncovered struts at six months were 1.7±3.2% for BVS and 5.3±5.6% for BP-DES (p=0.0001), and at 12 months 0.48±0.72% and 4.8±5%, respectively (p=0.001). Rates of strut malapposition were significantly lower with BVS. There was no significant intra-patient correlation with BP-DES/BVS for endpoints. Evaginations were more frequent and larger with BVS. Discontinuities in BVS were observed in 19.4% at six months and 14.3% at 12 months. CONCLUSIONS: Vascular healing with BVS and BP-DES could be more device-specific than patient-specific. At follow-up, BVS presented fewer uncovered or non-apposed struts than BP-DES but more frequent and larger evaginations. Discontinuities in BVS were relatively frequent at both time points.

State of Transcatheter Aortic Valve Implantation in Spain Versus Europe and Non-European Countries.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is now the standard treatment for severe aortic stenosis in high-risk symptomatic patients, and its indications are expanding to lower-risk patients. OBJECTIVES: The objective of this study was to analyze the state of TAVI in Spain vs other European and non-European countries. METHODS: Using an online questionnaire, we analyzed the routine practice of 250 TAVI centers worldwide. The questionnaire included 59 questions on patient selection, technical aspects of the procedure, and postprocedural management. The centers were divided into Spain (n = 41), rest of Europe (n = 105), and rest of the world (n = 104). RESULTS: The cumulative number of procedures (74; range, 40-122) and those performed in the last year (16.5; range, 15-29.5) in Spain, were significantly lower than the rest of Europe (P<.01) and the rest of the world (P<.01). The patient risk profile was higher, with an under-use of functional tests compared to the rest of the world. While the use of computed tomography to analyze the aortic annulus was lower in Spain (P<.001), general anesthesia and transesophageal echocardiography were more frequently used in Spain than in the rest of Europe (P<.001 for both). Dual-antiplatelet therapy is the most common post-TAVI antithrombotic therapy in the absence of an indication for anticoagulation, although its duration is longer in Spain (6 months) compared to European centers (3 months). CONCLUSIONS: Routine TAVI practice in Spain differed in some key aspects of preprocedural, intraprocedural, and postprocedural management. Future studies will help to unify strategies and assess their impact on clinical results.

Association of comorbid burden with clinical outcomes after transcatheter aortic valve implantation.

OBJECTIVES: To investigate the association of the CharlsonComorbidity Index (CCI) with clinical outcomes after transcatheter aortic valve implantation (TAVI). BACKGROUND: Patients undergoing TAVI have high comorbid burden; however, there is limited evidence of its impact on clinical outcomes. METHODS: Data from 1887 patients from the UK, Canada, Spain, Switzerland and Italy were collected between 2007 and 2016. The association of CCI with 30-day mortality, Valve Academic Research Consortium-2 (VARC-2) composite early safety, long-term survival and length of stay (LoS) was calculated using logistic regression and Cox proportional hazard models, as a whole cohort and at a country level, through a two-stage individual participant data (IPD) random effect meta-analysis. RESULTS: Most (60%) of patients had a CCI ≥3. A weak correlation was found between the total CCI and four different preoperative risks scores (ρ=0.16 to 0.29), and approximately 50% of patients classed as low risk from four risk prediction models still presented with a CCI ≥3. Per-unit increases in total CCI were not associated with increased odds of 30-day mortality (OR 1.09, 95% CI 0.96 to 1.24) or VARC-2 early safety (OR 1.04, 95% CI 0.96 to 1.14) but were associated with increased hazard of long-term mortality (HR 1.10, 95% CI 1.05 to 1.16). The two-stage IPD meta-analysis indicated that CCI was not associated with LoS (HR 0.97, 95% CI 0.93 to 1.02). CONCLUSION: In this multicentre international study, patients undergoing TAVI had significant comorbid burden. We found a weak correlation between the CCI and well-established preoperative risks scores. The CCI had a moderate association with long-term mortality up to 5 years post-TAVI.

Efficacy and safety of left atrial appendage closure versus medical treatment in atrial fibrillation: a network meta-analysis from randomised trials.

BACKGROUND: The effectiveness of vitamin K antagonist (VKA) versus placebo and antiplatelet therapy (APT) is well established for stroke prevention in atrial fibrillation (AF). Non-vitamin K antagonist oral anticoagulants (NOAC) are mostly superior to VKA in stroke and intracranial bleeding prevention. Recent randomised controlled trials (RCTs) suggested the non-inferiority of percutaneous left atrial appendage closure (LAAC) versus VKA. However, comparisons between LAAC versus placebo, APT or NOAC are lacking. The purpose of this network meta-analysis was to assess the efficacy and safety of LAAC compared with other strategies for stroke prevention in patients with AF. METHODS: We pooled together all RCTs comparing warfarin with placebo, APT or NOAC in patients with AF using meta-analysis guidelines. Two major trials of LAAC were also included and a network meta-analysis was performed to compare the impact of LAAC on mortality, stroke/systemic embolism (SE) and major bleeding in relation to medical treatment. RESULTS: The network meta-analysis included 19 RCTs with a total of 87 831 patients with AF receiving anticoagulants, APT, placebo or LAAC. Indirect comparison with network meta-analysis using warfarin as the common comparator revealed efficacy benefit favouring LAAC as compared with placebo (mortality: HR 0.38, 95% CI 0.22 to 0.67, p<0.001; stroke/SE: HR 0.24, 95% CI 0.11 to 0.52, p<0.001) and APT (mortality: HR 0.58, 95% CI 0.37 to 0.91, p=0.0018; stroke/SE: HR 0.44, 95% CI 0.23 to 0.86, p=0.017) and similar to NOAC (mortality: HR 0.76, 95% CI 0.50 to 1.16, p=0.211; stroke/SE: HR 1.01, 95% CI 0.53 to 1.92, p=0.969). LAAC showed comparable rates of major bleeding when compared with placebo (HR 2.33, 95% CI 0.67 to 8.09, p=0.183), APT (HR 0.75, 95% CI 0.30 to 1.88, p=0.542) and NOAC (HR 0.80, 95% CI 0.33 to 1.94, p=0.615). CONCLUSIONS: The findings of this meta-analysis suggest that LAAC is superior to placebo and APT, and comparable to NOAC for preventing mortality and stroke or SE, with similar bleeding risk in patients with non-valvular AF. However, these results should be interpreted with caution and more studies are needed to further substantiate this advantage, in view of the wide CIs with some variables in the current meta-analysis.

Incidence, Causes, and Impact of In-Hospital Infections After Transcatheter Aortic Valve Implantation.

In-hospital infections (IHI) are one of the most common and serious problems after invasive procedures. Transcatheter aortic valve implantation (TAVI) is an increasingly used alternative to surgery in patients with severe symptomatic aortic stenosis. The aim of this study was to determine the incidence, origin, risk factors, and clinical outcomes of IHI after TAVI. A total of 303 consecutive patients with severe aortic stenosis who underwent transfemoral TAVI were included and followed during a median time of 21 months. We examined the occurrence, types, origin, and timing of infections during hospital stay as well as short- and long-term clinical outcomes according to the occurrence of IHI. A total of 51 patients (17%; 62 infectious episodes) experienced IHI after TAVI. Respiratory and urinary tract infections were the most frequent type of infections (44% and 34%, respectively), followed by surgical site infection (8%) and bloodstream infection (5%). Positive cultures were obtained in 74% of the samples, of which 65% were gram-negative bacilli. Modifiable factors such as bleeding (p = 0.005) and length of coronary care unit stay (p <0.001) were independently associated with an increased infection risk. Patients with IHI had a longer hospital stay (14 vs 6 days, p <0.001), an increased mortality (hazard ratio 2.48, 95% CI 1.45 to 4.23) and readmission rate (hazard ratio 2.0, 95% CI 1.27 to 3.14) during the follow-up. In conclusion, IHI is a frequent complication after TAVI with a significant impact on short- and long-term clinical outcomes. The most important risk factors associated with the development of this complication were modifiable periprocedural aspects. These results underline the importance to implement specific preventive strategies to reduce in-hospital-acquired infections after TAVI.

Secondary forms of Takotsubo cardiomyopathy: A whole different prognosis.

BACKGROUND: Takotsubo syndrome (TKS) usually mimics an acute coronary syndrome. However, several clinical forms have been reported. Our aim was to assess if different stressful triggers had prognostic influence on TKS, and to establish a working classification. METHODS: We performed an analysis including patients with TKS between 2003-2013 from our prospective local database and the RETAKO National Registry, fulfilling Mayo criteria. Patients were divided in two groups regarding their potential triggers: (a) none/psychic stress as 'primary forms' and (b) physical factors (asthma, surgery, trauma, etc.) as 'secondary forms'. RESULTS: Finally, 328 patients were included, 90.2% women, with a mean age of 69.7 years. Patients were divided into primary TKS (n=265) and 63 secondary TKS groups. Age, gender, previous functional class and cardiovascular risk profile displayed no differences between groups before admission. However, primary-TKS patients suffered a main complaint of chest pain (89.4% vs 50.7%, p<0.0001) with frequent vegetative symptoms. Regarding treatment before admission, there were no differences either. During admission, differences were related to more intensive antithrombotic and anxiolytic drug use in the primary TKS group. Inotropic and mechanical ventilation use was higher in the secondary cohort. After discharge, a more frequent prescription of beta-blockers and statins in primary-TKS patients was seen. Secondary forms displayed more in-hospital stay and evolutive complications: death (hazard ratio (HR): 3.41; 95% confidence interval (CI): 1.14-10.16, p=0.02), combined event variable (MACE) (HR: 1.61; 95% CI: 1.01-2.6, p=0.04) and recurrences (HR: 1.85; 95% CI: 1.06-3.22, p=0.02). CONCLUSION: Secondary TKS could present or mark worse short and long-term prognoses in terms of mortality, recurrences and readmissions. We propose a simple working nomenclature for TKS.

Transient apical dyskinesia with a pacemaker: Electrocardiographic features.

Transient apical dyskinesia syndromes present features similar to acute coronary syndromes, but with normal coronary arteries and rapid complete resolution of wall motion alterations. We report the case of a 73-year-old woman who was admitted to hospital because of typical chest pain at rest after her brother's death. She had had a pacemaker implanted in 2001. Troponin levels were elevated and apical hypokinesia was shown by ventriculography and echocardiography, with normal coronary arteries. Evolving ECG alterations were observed in spite of the continued pacing rhythm. All these alterations were fully resolved after discharge. This case shows that, even in the presence of a pacemaker, evolving ECG alterations can be observed in Takotsubo syndrome.

Incidence, Causes, and Predictors of Early (≤30 Days) and Late Unplanned Hospital Readmissions After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to determine the incidence, causes, and predictors of unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR). BACKGROUND: Data regarding unplanned hospital readmissions after TAVR in a real-world all-comers population are scarce. METHODS: A total of 720 consecutive patients undergoing TAVR at 2 centers who survived the procedure, were included. Median follow-up was 23 months (interquartile range [IQR]: 12 to 39 months), available in 99.9% of the initial population. The occurrence, timing, and causes of hospital readmission within the first year post-TAVR were obtained in all cases. Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1 year post-TAVR, respectively. RESULTS: There were 506 unplanned readmissions in 316 patients (43.9%) within the first year post-TAVR (median time: 63 days; IQR: 19 to 158 days post-discharge). Of these, early readmission occurred in 105 patients (14.6%), and 118 patients (16.4%) had multiple (≥2) readmissions. Readmissions were due to noncardiac and cardiac causes in 59% and 41% of cases, respectively. Noncardiac readmissions included, in order of decreasing frequency, respiratory, infection, and bleeding events as the main causes, whereas heart failure and arrhythmias accounted for most cardiac readmissions. The predictors of early readmission were periprocedural major bleeding complications (p = 0.001), anemia (p = 0.019), lower left ventricular ejection fraction (p = 0.042), and the combined presence of antiplatelet and anticoagulation therapy at hospital discharge (p = 0.014). The predictors of late readmission were chronic obstructive pulmonary disease (p = 0.001), peripheral vascular disease (p = 0.023), chronic renal failure (p = 0.013), and atrial fibrillation (p = 0.012). Early readmission was an independent predictor of mortality during the follow-up period (hazard ratio: 1.56, 95% confidence interval: 1.02 to 2.39, p = 0.043). CONCLUSIONS: The readmission burden after TAVR in an all-comers population was high. Nearly one-fifth of the patients were readmitted early after hospital discharge, increasing the risk of mortality at follow-up. Reasons for readmission were split between noncardiac and cardiac causes, with respiratory causes and heart failure as the main diagnoses in each group, respectively. Whereas early readmissions were mainly related to periprocedural bleeding events, most late readmissions were secondary to baseline patient comorbidities. These results underscore the importance of and provide the basis for implementing specific preventive measures to reduce readmission rates after TAVR.

Bioresorbable stent restenosis: new devices, novel situations.

A 58-year-old man presented to our hospital with effort angina. Ten months prior, he was treated with a Bioresorbable vascular scaffold (BVS). During the current admission, an image angiographically compatible with in-BVS restenosis at the circumflex ostium with a radiolucent image in the ostial left anterior descending artery was shown. BVS failure is very infrequent and this is one of the first cases of BVS restenosis described. Thus, data on the best management option are scarce. We treated it like a drug-eluting stent restenosis, performing first an intracoronary optical coherence tomography scan in order to identify the left descending radiolucent image and to prepare the best treatment strategy.