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Background Pulmonary embolism (P.E.) is defined as an acute occlusion/subocclusion of pulmonary vascular vessels with a ranging clinical manifestation. A reperfusion therapy (preferably systemic thrombolysis) represents the first line therapy for high-risk patients. However, a percutaneous treatment option should be considered when thrombolysis is contraindicated or has failed. Case report A 73 y.o. male, a former smoker with history of hypertension and dyslipidemia, was admitted for hemorrhagic stroke and was subsequently treated by neuro-surgical treatment. 7 days after admission, a cardiac arrest with pulseless electrical activity occurred but return of spontaneous circulation was rapidly achieved. For persistent hypotension vasopressor therapy was started. As first diagnostic work up, an EKG was performed showing sinus tachycardia and new onset of right bundle branch block; the echocardiography revealed a right ventricle dilatation with signs of pressure overload. At the computed tomography angiography of the pulmonary circulation, multiple and bilateral filling defects finally confirmed the diagnosis of acute high-risk P.E.. Given the absolute contraindication for thrombolysis and the good neurological prognosis, a catheter-directed therapy (CDT) was indicated by a multidisciplinary team evaluation. In the cath-lab, the angiography of pulmonary artery confirmed the presence of an occluding embolus in the left lower lobe artery and of a sub-occluding clot in the basal right lower lobe. Multiple aspirations were performed using a Flow Triever (Inari Medical, Irvine, CA) 20 Fr device advanced in the left and right pulmonary artery; a 16 Fr device, adopting child-in-mother technique, was also used, finally removing a large amount of thrombotic material (Fig.1). Restoration of the distal vascular segment perfusion was confirmed by a repeated angiography (Fig.2) and by the reduction of the invasive mean pulmonary artery pressure from 35 mmHg (pre-procedure) to 22 mmHg (post-procedure) (Fig.3). After the procedure, a rapid de-escalation of intravenous vasopressors was performed and the patient was transferred to the Intensive Care Unit, in stable conditions. Finally, the patient was discharged 7 days later, with the resolution of the EKG and echocardiography alterations. Conclusions The Flow Triever device for the interventional treatment of P.E. is a CE approved aspiration system (3 sizes aspiration catheters) including 3 catheters with self-expanding nitinol for mechanical clot fragmentation. Evidence on the safety and efficacy of CDT is limited to observational single studies, a few small randomized trials and small single-arm cohort studies. Outcomes depend on the chosen technique, patient characteristics and local expertise. In particular, the FLARE study showed a significant Right/Left Ventricle ratio reduction after the use of a Flow Triever system while keeping a low rate of complications. The FLASH study is ongoing and the interim analysis showed encouraging results. However, randomized studies focusing on clinical outcomes and comparing CDT to conventional standard therapy (i.e. systemic thrombolysis for high-risk PE and anticoagulation for intermediate risk disease) are needed.

Effusive–constrictive pericarditis (ECP) is an uncommon diagnosis, frequently missed due to its heterogeneous presentation, but a potentially reversible cause of heart failure. A 62‐year‐old Caucasian male presented with remittent right heart failure and mild–moderate pericardial effusion. Following an initial diagnosis of idiopathic pericarditis, indomethacin was started, but the patient shortly relapsed, presenting with severe pericardial effusion and signs of cardiac tamponade, requiring pericardiocentesis. ECP was diagnosed on cardiac catheterization. Cardiac computed tomography showed non‐calcified, mildly thickened and inflamed parietal pericardium. Pericardiectomy was performed with symptoms remission. On histological examination of pericardium, chronic non‐necrotizing granulomatous inflammation was noted. Polymerase chain reaction assay was positive for non‐tuberculous mycobacteria. This case represents a rare finding of ECP with unusual presentation due to atypical mycobacteriosis in a non‐immunocompromised patient and in a non‐endemic area. Pericardiectomy can be an effective option in cases unresponsive to anti‐inflammatory treatment, even in the absence of significant pericardial thickening or calcification.

BackgroundThe impact of transcatheter aortic valve replacement (TAVR) leaflet design on long-term device performance is still unknown. This study sought to compare the clinical and hemodynamic outcomes of intra- (IA) versus supra-annular (SA) TAVR designs up-to 10-years following implantation.MethodsConsecutive patients with at least 5-years follow-up following TAVR for severe symptomatic aortic stenosis from June 2007 to December 2016 were included. Bioprosthetic valve failure (BVF) and hemodynamic valve deterioration (HVD) were defined according to VARC-3 updated definitions and estimated using cumulative incidence function to account for the competing risk of death.ResultsA total of 604 patients (82 years; 53% female) were analyzed and divided into IA (482) and SA (122) groups. Overall survival rates at 10-years were similar (IA 15%, 95%CI: 10–22; SA 11%, 95%CI: 6–20; p = 0.21). Compared to the SA TAVR, mean transaortic gradients were significantly higher and increased over time in the IA group. IA TAVRs showed higher 10-year cumulative incidences of BVF (IA 8% vs. SA 1%, p = 0.02) and severe HVD (IA 5% vs. SA 1%, p = 0.05). The occurrence of BVF and HVD in the IA group occurred primarily in the smallest TAVR devices (20–23-mm). After excluding these sizes, the cumulative incidences of BVF (IA 5% vs. SA 1%, p = 0.40) and severe HVD (IA 2% vs. SA 1%, p = 0.11) were similar.ConclusionIn this study, TAVR leaflet design had no impact on survival at 10-years. IA devices showed higher transaortic gradients and cumulative incidences of HVD and BVF predominantly occurring in the smallest valve sizes.

Background Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs). Objectives The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures. Methods Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs. Results A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups). Conclusions In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.

BackgroundsAmong vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population.MethodsPatients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated.ResultsEighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter ConclusionsIn a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.

Background: Coronary access (CA) after transcatheter aortic valve replacement (TAVR) with supra-annular transcatheter heart valves (THV) can be challenging. Specific Evolut R/Pro and Acurate Neo THVs orientations are associated with reduced neo-commissure overlap with coronary ostia, while SAPIEN 3 THV cannot be oriented. With the ALIGN-ACCESS study (TAVR With Commissural Alignment Followed by Coronary Access), we investigated the impact of commissural alignment on the feasibility of CA after TAVR. Methods: We performed coronary angiography after TAVR with intra-annular SAPIEN 3, supra-annular Evolut R/Pro, and Acurate Neo THVs in 206 patients. Evolut THVs were implanted aiming for commissure alignment. Alignment of Acurate Neo was retrospectively assessed in 36, intentionally attempted in 26 cases. The primary end point was the rate of unfeasible and nonselective CA after TAVR. Results: Thirty-eight percent of patients received SAPIEN 3, 31.1% Evolut Pro/R, 30.1% Acurate Neo THV. Final valve orientation was favorable to commissural alignment in 85.9% of Evolut and 69.4% of Acurate Neo cases (with intentional alignment successful in 88.5%). Selective CA was higher for SAPIEN 3 than for aligned and misaligned supra-annular THVs (95% versus 71% versus 46%, P P P =0.03), and THV–sinus of Valsalva relation (odds ratio, 1.06 [95% CI, 1.02–1.1]; P Conclusions: Commissural alignment improves the rate of selective CA after TAVR with supra-annular THVs. Nevertheless, aligned supra-annular THVs carry higher risk of unfeasible/nonselective CA than SAPIEN 3. Patients with a misaligned supra-annular THV, low sinus of Valsalva, and higher THV–sinus of Valsalva relation are at highest risk of impaired CA after TAVR.

ObjectivesTo assess the impact of conventional transcatheter heart valve (THV) commissural alignment techniques on THV/coronary overlap and coronary access (CA) after transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV).BackgroundSpecific Evolut Pro/Pro + and Acurate Neo2 THV orientations are associated with reduced neo-commissural overlap with coronary ostia in tricuspid aortic anatomy. Whether standard orientation techniques are effective also in the setting of BAV anatomy has not been studied.MethodsThe DA VINCI (Definition of trAnscatheter aortic Valve orIeNtation in biCuspId aortic valve) pilot study is a prospective registry enrolling consecutive patients with severe BAV stenosis undergoing TAVR with last generation supra-annular tall-frame THVs implanted with a cusp overlap view-based commissural alignment. Patients underwent pre- and post-TAVR computed tomography (CT) and coronary angiography. The study endpoint was the rate of favorable THV/coronary overlap, defined as an angle > 40° between the THV commissural post and coronary ostia. Other endpoints were the rates of successful THV alignment with respect to the raphe and of selective CA after TAVR. Moreover, different virtual THV alignment models were tested to identify which one would produce the lower degree of THV/coronary overlap.ResultsThirty-four patients with type 1 BAV with right-left raphe undergoing TAVR (23 with Evolut Pro/Pro + and 11 with Acurate Neo2) were included. At pre-TAVR CT, moderate/severe cusp asymmetry was found in 50% of patients, severe coronary ostia eccentricity was observed in 47.1% for the RCA vs. 8.8% for the LCA (P < 0.007). Correct TVH orientation was achieved in 29 cases. At post-TAVR CT, optimal THV alignment/mild misalignment to the raphe was observed in 86.2%, but a moderate/severe overlap with the coronaries was seen in 13.7% for the RCA and 44.8% for the LCA (P = 0.019). After TAVR, selective RCA cannulation was possible in 82.8% vs. 75.9% for the LCA (P = 0.74), while combined selective CA of both coronaries was possible in less than two-thirds of the patients. Virtual THV alignment in the coronary ostia overlap view assuming a hypothetical circular THV expansion would produce an optimal THV/coronary overlap in almost 90% of cases.ConclusionGiven cusp asymmetry and coronary ostia eccentricity of BAV combined with potential THV asymmetrical expansion, conventional commissural alignment techniques are associated with higher rates of THV misalignment and of moderate/severe neo-commissure overlap with the coronary ostia as compared to tricuspid aortic stenosis, resulting in lower rates of selective CA after TAVR. A modified THV orientation technique based on the coronary ostia overlap view might be preferable in BAV patients.

A 61-year-old man suffering from myasthenia gravis with predominant bulbar involvement since 10 months before admission, was diagnosed with thymoma in April 2021. He had no relevant comorbidities except for history of polymorphic ventricular ectopic beats. In this regard, in 2019 he had undergone transthoracic echocardiogram and coronary computed tomography angiography, which resulted both normal. After 1 month, due to poor response to standard medical therapy with prednisone and pyridostigmine and in preparation for thymectomy, an intravenous immunoglobulins (IVIG) treatment was prescribed leading to mild clinical improvement (Myasthenia Gravis Foundation of America Clinical Classification IIIA—MGFA). Two weeks later, the patient underwent robotic-assisted thoracoscopic thymectomy without complications. Pathological findings were consistent with type B1 Thymoma classified as Masaoka Stage IIB (TNM Stage pT1a). After discharge the patient complained a rapid worsening of neurological symptoms (MGFA IIIB) leading to an urgent hospitalization for Myasthenia Gravis exacerbation in the middle of June. On admission Intravenous Immunoglobulins (IVIG) treatment was immediately started. After administration of the second IVIG dose, he had a myasthenic crisis complicated by refractory heart failure with significant increase of cardiac troponin up to 5.768 ng/L, requiring invasive ventilation, inotropic support and urgent transfer to the Cardiac Intensive Care Unit (CICU). The 2D echo showed severe left ventricular systolic dysfunction (LVEF 20%) with diffuse hypokinesis. The patient underwent cardiac catheterization and coronary angiography that confirmed severe reduction of the LVEF (LVEF 23%) with embolic occlusion of the distal posterior descending coronary artery (PDA) without other significant coronary artery stenosis. An endomyocardial biopsy was performed, which revealed cardiomyocytes of normal dimensions with sporadic cytoplasmic vacuolization and excluded signs of inflammation, fibrosis, necrosis and viral myocarditis. The day after the patient completed IVIG treatment. During the following days, despite persistence of severe left ventricular systolic dysfunction, he was successfully weaned form inotropic and ventilatory support. At neurological evaluation he reported persistence of severe bulbar involvement with upper and lower limbs weakness. Five days later, the patient had a sudden cardiac arrest for pulseless electrical activity. Advanced cardiac life support requiring inotropes and invasive ventilation was performed for 28 min before returning to spontaneous circulation. The echocardiogram excluded pulmonary embolism and mechanical complications but showed severe left ventricular systolic dysfunction. A new coronary angiography showed clear coronary arteries including PDA. Because of severe haemodynamic compromise, an Impella CP device was implanted and set at maximum support level (P8 flow, >3 L/min). A neurological exam revealed no severe neurological sequelae. As a result of the long CPR the patient had a massive left haemothorax, initially treated with multiple blood transfusions and pleural drainage. Two days later, due to persistence of haemodynamic instability and active pleural bleeding with incessant severe anaemia the case underwent a Heart Team discussion where it was decided to escalate Impella CP device to Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) and then perform a video-assisted thoracoscopic evacuation of the haemothorax. Both procedures were carried out without complications. The patient had an immediate haemodynamic improvement which led to rapid weaning from inotropic support. Haemoglobin was stable. The 2D echo showed significant improvement of the LVEF (40%). After 3 days, given the persistence of haemodynamic stability, ECMO device was removed and invasive ventilation stopped shortly afterwards. Eleven days later, another 2D echo demonstrated complete recovery of left ventricular systolic function (LVEF 59%). Notwithstanding, the patient reported a progressive worsening of neurological symptoms with generalized myasthenia and severe bulbar involvement (MGFA IVB) along with episodes of respiratory muscle fatigue requiring non-invasive ventilation. For this reason, the patient was transferred to Subintensive Respiratory Unit and the case underwent a new multidisciplinary discussion involving neurologists, cardiologists and haematologists. Specialists agreed upon potential causal role of IVIG treatment in transient left ventricular dysfunction and considered re-administration absolutely contraindicated. Thus, they prescribed five plasmapheresis treatments and up-titration of corticosteroid therapy (methylprednisolone up to 60 mg od). An immediate and outstanding improvement of neurological symptoms was obtained (MGFA IIIA) and the patient was discharged from hospital 1 week later.

Objectives The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex. Background Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. Methods A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed. Results Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR. Conclusions Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure.

Background Transcatheter aortic valve replacement (TAVR)‐in‐TAVR is a possible treatment for transcatheter heart valve ( THV ) degeneration. However, the displaced leaflets of the first THV will create a risk plane ( RP ) under which the passage of a coronary catheter will be impossible. The aim of our study was to evaluate the potential risk of impaired coronary access ( CA ) after TAVR ‐in‐ TAVR . Methods and Results We prospectively performed coronary angiography after TAVR with different THV s in 137 consecutive patients, looking where the catheter crossed the valve frame. If coronary cannulation was achieved from below the RP , the distance between valve frame and aortic wall was measured by aortic angiography. CA after TAVR ‐in‐ TAVR was defined as feasible if the catheter passed above the RP , as theoretically feasible if passed under the RP with valve‐to‐aorta distance >2 mm, and as unfeasible if passed under the RP with valve‐to‐aorta distance ≤2 mm. Seventy‐two patients (53%) received a Sapien 3 THV, 26 (19%) received an Evolut Pro/R THV, and 39 (28%) received an Acurate Neo THV . CA after TAVR ‐in‐ TAVR was considered feasible in 40.9% (68.1%, 19.2%, and 5.1%, respectively; P P P =0.116). Independent predictors of impaired CA after TAVR ‐in‐ TAVR were female sex (odds ratio [OR], 3.99; 95% CI , 1.07–14.86; P =0.040), sinotubular junction diameter (OR, 0.62; 95% CI , 0.48–0.80; P THV (OR, 6.61; 95% CI , 1.98–22.03; P =0.002). Conclusions CA after TAVR ‐in‐ TAVR might be unfeasible in >30% of patients currently treated with TAVR . Patients with a small sinotubular junction and those who received a supra‐annular THV are at highest risk of potential CA impairment with TAVR ‐in‐ TAVR .

Aims Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. Methods and results A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7 ± 9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2–12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n = 523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n = 435, 43.2%), and other devices (n = 48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ≤ 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P = 0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02–1.13)], age [HR 1.21 (95% CI 1.01–1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11–1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis–patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31–14.39)], device malposition [SHR 3.75 (95% CI 1.36–10.35)], EBEV [SHR 3.34 (95% CI 1.26–8.85)], and age [SHR 0.59 (95% CI 0.44–0.78)]. Conclusions The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.

Left ventricular pseudoaneurysms (LVP) are rare but may arise after myocardial infarction, trauma or cardiac surgery, tending to expand and rupture over the time. We show the case of a 75-year-old patient with a recurrent giant ventricular pseudoaneurysm, who presented to the emergency department with sustained ventricular tachycardia. Pseudoaneurysmatic lesion was investigated through echocardiography, angiography and Cardiac Computed Tomography, in order to evaluate the size and spatial orientation of the pseudoaneurysm and to set a tailored treatment. At emergency department, sustained ventricular tachycardia may be the first and unique clinical presentation of ventricular pseudoaneurysm late recurrence, whose management requires a multimodality imaging approach to guide surgical correction.

BACKGROUND Previous implantation of a permanent pacemaker (PPM) is common among patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, onset of conduction disturbances needing new PPM implantation after TAVI is frequent. The interplay of pre-existing and new-PPM on mortality after TAVI remains controversial. METHODS We performed a systematic review and study-level meta-analysis on the influence of PPM on mortality after TAVI. Patients were divided into 3 groups: pre-existing PPM, new-PPM (implantation within 30 days after TAVI) and no-PPM (without PPM up to 30 days after TAVI). Outcomes were compared using pairwise and network meta-analysis. RESULTS A total of 28 studies including 40,016 subjects were eligible. Patients of the no-PPM group had a lower mortality outcome compared to the rest of the study population (relative risk [RR] 0.76, 95% confidence interval [CI] 0.68-0.85, P

Background: Data on transcatheter aortic valve replacement (TAVR) long-term clinical outcomes and hemodynamic performance of the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN XT (ES) (Edwards Lifesciences, Irvine, California, USA) transcatheter heart valves (THV) are limited. Therefore, this study aimed to compare long-term clinical outcome data and hemodynamic performance of TAVR with either CV or ES. Methods: We reviewed prospectively collected data of 171 patients treated with TAVR for severe aortic stenosis (AS) at our center between June 2007 and December 2010, with last follow-up contact in 2016. Results: Out of 171 patients treated with TAVR at our Institution, 87 received a CV and 84 an ES THV. Mean age was 81 [78–85] years, and mean Society of Thoracic Surgeons (STS) score was 7.5% [4.5–13.9%]. Hemodynamic success by Valve Academic Research Consortium (VARC) definition was 97.1%. Mean trans-prosthetic gradient remained low and stable during follow-up in both groups (at 5-year 9.2±6.4 versus 12.7±5.1 mmHg, P=0.10). Late prosthesis failure occurred in 4 cases (2.4%). Thirty-day mortality was 4.7%, and estimated survival rates by Kaplan-Meyer after 1, 5 and 8 years were 87.6%, 44.9%, and 24.5%, respectively, without difference between THV groups. Rates of cardiovascular death, stroke, myocardial infarction (MI) and congestive heart failure (CHF) were also similar with CV and ES at long-term follow-up. History of CHF, pre-existent severe mitral regurgitation, paravalvular leak grade ≥2+, and chronic obstructive pulmonary disease were independent predictors of late mortality at multivariate analysis. Conclusions: Clinical and hemodynamic outcomes of patients treated by self-expandable CV or balloon-expandable ES THV were favorable and similar throughout long-term follow-up, with a rate of prosthesis failure of less than 3%.

Background This single-center retrospective study assessed the variation of left ventricular ejection fraction (LVEF) after transapical transcatheter aortic valve implantation and its effect on survival. We also evaluated the effect of sheath diameter on LVEF. Methods We analyzed data of all consecutive patients who underwent transapical transcatheter aortic valve implantation with the Sapien (Edwards Lifesciences, Irvine, CA) device (and its evolutions) between 2009 and 2015. We analyzed the difference between preoperative LVEF and LVEF at discharge (ΔEF = LVEFpost-op – LVEFpre-op) and considered its interquartile range (±5%) as the cutoff. Patients were divided in three groups: (1) improved LVEF (ΔEF ≥ +5%); (2) unchanged LVEF (ΔEF –5% to +5%), and (3) worsened LVEF (ΔEF ≤ –5%). Survival was evaluated with Kaplan-Meier analysis, and logistic regression multivariable analysis was used to determine independent predictors of LVEF improvement. Results Data of 122 patients were analyzed. Patients in the three groups were distributed as follows: (group 1) 27 patients (22.1%), (group 2) 69 (56.6%), and (group 3) 26 (21.3%). The mean ΔEF was 12.7% ± 4.7% in group 1 and –10.8% ± 3.9% in group 3. The ΔEF was more likely to improve in patients with preoperative LVEF of less than 0.35 ( p = 0.014). There were no significant differences in survival ( p = 0.41), rehospitalization ( p = 0.472), and New York Heart Association Functional Classification ( p = 0.307) among the groups. The use of the smallest available sheath (18F) was not associated with a significant change of ΔEF. Conclusions LVEF worsened in a small number of patients after transapical transcatheter aortic valve implantation, but this change was not associated with worse postoperative outcomes. Patients with a low LVEF showed better improvement. The progressive reduction of sheath diameter does not have a significant effect on LVEF changes.

Background Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve replacement (TAVR) randomized trials. Methods With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker implantation, vascular complications and 1-year mortality. Results Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR = 1.13; 95% CI 0.88–1.46, p = 0.33) and 1-year mortality (OR = 1.02; 95% CI 0.77–1.37, p = 0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR = 2.35; 95% CI 1.30–4.23, p = 0.005), implantation of a second valve (OR = 2.06; 95% CI 1.31–3.25; p = 0.002), moderate/severe paravalvular leakage (PVL) (OR = 1.67; 95% CI 1.29–2.17; p = 0.0001) and device failure (OR = 1.26; 95% CI 1.02–1.56; p = 0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. Conclusions BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.

Objectives This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. Background Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. Methods S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient (≥30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth ≤20%. Results A total of 113 patients met inclusion criteria and were analyzed (76.5 ± 9.7 years of age, 65.8% male, STS score 8 ± 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 ± 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 ± 2.7% vs. 91.5 ± 3.5%; p = 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p Conclusions Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring.

Objectives The aims of this study were to assess the epidemiology of atrial fibrillation (AF) in patients treated with transcatheter aortic valve replacement (TAVR) and included in the large prospective SOURCE XT (SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) study and to evaluate their outcomes according to the presence of pre-existing or new-onset AF (NOAF) (defined as AF occurring within 30 days after TAVR). Background Data on the epidemiology and clinical impact of AF in patients undergoing TAVR are scant and limited to small retrospective studies. Methods The SOURCE XT study is a multicenter, prospective registry of consecutive patients treated with the SAPIEN XT valve at 99 sites in 17 countries. Follow-up was scheduled at discharge, 1 month, 1 year, and yearly thereafter. Patients (n = 2,706) were categorized according to the presence of pre-existing or NOAF. Results The prevalence of pre-existing AF was 35.6%, whereas NOAF occurred in 7.2% of patients. Both pre-existing AF and NOAF correlated with worse clinical outcomes compared with patients in sinus rhythm, including all-cause death, cardiac death, and bleeding events. NOAF was associated with higher rates of stroke at 2 years compared with sinus rhythm. Independent predictors of NOAF were age (hazard ratio: 1.1), New York Heart Association class III or IV (hazard ratio: 1.9), nontransfemoral access route (hazard ratio: 3), and balloon post-dilation (odds ratio: 1.6). No interaction was observed between any degree of post-implantation paravalvular leak and NOAF. Conclusions In the large dataset of the SOURCE XT registry, the presence of either pre-existing or NOAF increased all-cause and cardiac mortality and bleeding events. NOAF was associated with increased stroke rates at long-term follow-up.

Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI.From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up.transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirty-day cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney injury (AKI) rate was higher in the TA group (30.5% versus 11.2%; p0.001). Access-related complications were more frequent in the TF group (36.1% versus 11.4%; p0.001). Mean follow-up was 22.3 ± 17.8 months (range, 1-74 months). Overall survival rates at 1, 3, and 5 years were 85.5% ± 2.1%, 69.9% ± 3.2%, and 61% ± 4.3%, respectively. Independent predictors of all-cause mortality at follow-up were previous myocardial infarction (odds ratio [OR], 2.7), any grade of paravalvular leak (PVL) (OR, 2.5), and AKI (OR, 3.1). Mean gradient and effective orifice area at follow-up were 10.7 ± 12.0 mm Hg and 1.1 ± 0.9 cm(2)/m(2), respectively.Our data show that TAVI has good early and intermediate-term clinical and hemodynamic outcomes in high-risk or inoperable patients with severe symptomatic aortic valve stenosis. PVL of any grade has a significant impact on survival.

Aims: There are limited data on coronary obstruction following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The objectives of this study were to determine the incidence, predictors, and clinical outcomes of coronary obstruction in transcatheter ViV procedures. Methods and results: A total of 1612 aortic procedures from the Valve-in-Valve International Data (VIVID) Registry were evaluated. Data were subject to centralized blinded corelab computed tomography (CT) analysis in a subset of patients. The virtual transcatheter valve to coronary ostium distance (VTC) was determined. A total of 37 patients (2.3%) had clinically evident coronary obstruction. Baseline clinical characteristics in the coronary obstruction patients were similar to controls. Coronary obstruction was more common in stented bioprostheses with externally mounted leaflets or stentless bioprostheses than in stented with internally mounted leaflets bioprostheses (6.1% vs. 3.7% vs. 0.8%, respectively; P

BACKGROUND New-generation transcatheter heart valves have been developed to reduce complications of transcatheter aortic valve implantation (TAVI). With this study we sought to compare procedural and 30-day outcomes of the new-generation repositionable Boston Scientific Lotus (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) transcatheter heart valves. METHODS A total of 315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 included in two large Italian registries were considered for this analysis. After propensity matching, 93 matched pairs of patients were included. Outcomes were evaluated according to Valve Academic Research Consortium-2 definition at discharge and 30 days. RESULTS There were no differences in baseline characteristics, except for lower mean aortic gradient and larger mean aortic annulus in the ES3-treated patients. Valve Academic Research Consortium-2 defined device success was high and comparable between groups (97.8 for Lotus vs. 98.9% for ES3, P = 0.09). The frequency of moderate/severe paravalvular leak was low and similar for both devices (2.2 vs. 1.1%, P = 0.10). At 30 days, both groups showed low all-cause mortality (5.4 vs. 1.1%, P = 0.10) and rates of disabling stroke (3.2 vs. 1.1%, P = 0.31). New pacemaker implantation was more common after Lotus deployment (31.7 vs. 10.5%, P

Background In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease. Methods and results MATISSE is a retrospective, multicenter registry, which enrolled 151 patients treated with the device at 17 international centers. Primary study endpoint was the occurrence of major adverse cardiovascular events (MACE), a composite endpoint of cardiac death, target lesion revascularization (TLR) and target-vessel myocardial infarction, at 9 months clinical follow-up. Secondary endpoints included procedural success, the single determinants of MACE and stent thrombosis. Lesions were located in distal LM bifurcation in 84% of the patients. Procedural success was achieved in 150 patients. The average follow-up length was 348 ± 52 days. MACE occurred in 14 (9.3%) patients with 2 (1.3%) cardiac deaths. TLR occurred in 8 patients (5.3%). There were 2 cases of definite stent thrombosis, 1 acute and 1 very late. Conclusions A self-apposing stent, when used for LM PCI in a real world, high risk population, showed good immediate procedural results with low rates of adverse events at mid-term follow-up.

ObjectiveWe aimed to analyse the incidence of prosthesis–patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event.MethodsA total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls).ResultsModerate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta −0.023; 95% CI −0.032 to –0.014; PConclusionsSevere PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation.

The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.

Objectives To compare the outcomes of trans-subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI). Background A considerable proportion of patients undergoing TAVI are not eligible for transfemoral approach. To date, there are few data to guide the choice between alternative vascular access routes. Methods Among 874 consecutive patients who underwent TAVI, 202 procedures were performed through TA (n = 142, 70.3%) or TS (n = 60, 29.7%) access. Medtronic Corevalve (CV, Medtronic, Minneapolis, MN) was implanted in 17.3% of the patients, the Edwards-Sapien (ES, Edwards Lifesciences Inc., Irvine, CA) in 81.2% and other prostheses in 0.1%. In-hospital and long-term outcome were assessed using the Valve Academic Research Consortium (VARC)-2 definitions. Results Mean age was 82 ± 6 years, STS score 9.3 ± 7.9%. The 2 groups showed a relevant imbalance in baseline characteristics. In hospital mortality was 6.4% (1.7% TS vs. 8.4% TA, P = 0.06), stroke 2.0%, acute myocardial infarction 1.0%, acute kidney injury 39.4%, sepsis 4.0% with no significant differences between groups, while bleeding was more frequent in TA patients (53.5% vs. 11.7% TS, P < 0.001). One- and 2-year survival was 85.2% and 73.2% in TS patients, and 83.9% and 74.9% in TA patients (P = ns for both). Access site was not an independent predictor of mortality at multivariable analysis. Conclusion Transapical compared with trans-subclavian access for TAVI was associated with a nonsignificant trend to increased periprocedural events. However, 1- and 2-year survival appears similar. © 2015 Wiley Periodicals, Inc.

Background— Invasive physiological assessment of myocardial bridges (MBs) is largely unsettled. Unlike fractional flow reserve (FFR), instantaneous wave–free ratio (iFR) is a diastole-specific index. As such, its value might not be hampered by systolic pressure overshooting and negative systolic pressure gradient caused by the compression of the tunneled coronary artery. Methods and Results— We prospectively enrolled 20 patients with angina and/or positive noninvasive stress test, absence of significant coronary artery stenosis, and angiographic suspicion/evidence of MB in the left anterior descending artery. According to a prespecified protocol, all patients underwent functional intracoronary evaluation with FFR at rest and after dobutamine (up to 20 μg kg −1 min −1 ) and atropine (1 mg) intravenous infusion. iFR at baseline and dobutamine-induced hyperemic wave–free period pressure ratio were also recorded. FFR values ≤0.80 and iFR values ≤0.89 were considered indicative of hemodynamic significance of MB. At baseline, no MB was hemodynamically significant according to FFR, whereas iFR was below the cutoff value in all but 7 patients. During inotropic challenge, median FFR did not change significantly (0.87–0.86, P =0.59). Conclusions— Physiological evaluation of MBs with iFR seems to be more consistent with patients’ symptoms and noninvasive test results compared with FFR.

The aim of this study was to determine whether the association of small label size of the surgical valve with increased mortality after transcatheter valve-in-valve (ViV) implantation is, at least in part, related to pre-existing prosthesis-patient mismatch (PPM) (i.e., a bioprosthesis that is too small in relation to body size).Transcatheter ViV implantation is an alternative for the treatment of patients with degenerated bioprostheses. Small label size of the surgical valve has been associated with increased mortality after ViV implantation.Data from 1,168 patients included in the VIVID (Valve-in-Valve International Data) registry were analyzed. Pre-existing PPM of the surgical valve was determined using a reference value of effective orifice area for each given model and size of implanted prosthetic valve indexed for body surface area. Severe PPM was defined according to the criteria proposed by the Valve Academic Research Consortium 2: indexed effective orifice area 0.65 cmAmong the 1,168 patients included in the registry, 89 (7.6%) had pre-existing severe PPM. Patients with severe PPM had higher 30-day (10.3%, p = 0.01) and 1-year (unadjusted: 28.6%, p 0.001; adjusted: 19.3%, p = 0.03) mortality rates compared with patients with no severe PPM (4.3%, 11.9%, and 10.9%, respectively). After adjusting for surgical valve label size, Society of Thoracic Surgeons score, renal failure, diabetes, and stentless surgical valves, presence of pre-existing severe PPM was associated with increased risk for 1-year mortality (odds ratio: 1.88; 95% confidence interval: 1.07 to 3.28; p = 0.03). Patients with severe PPM also more frequently harbored high post-procedural gradients (mean gradient ≥20 mm Hg).Pre-existing PPM of the failed surgical valve is strongly and independently associated with increased risk for mortality following ViV implantation.

Background The fully retrievable and repositionable Lotus Valve System uses a unique mechanical expansion mechanism. Balloon aortic valvuloplasty (BAV) is recommended before valve deployment. There are no studies focusing on feasibility and efficacy of Lotus Valve implantation without previous BAV. Methods and results Thirty consecutive patients (63.3% female; mean age, 80±6.2years) underwent transcatheter aortic valve replacement (TAVR) with the Lotus Valve without preparatory BAV. Mean baseline aortic valve area was 0.41±0.14cm 2 /m 2 ; mean transvalvular gradient was 50.2±16.2mmHg. All patients were successfully implanted, with 96.6% device success (VARC-2 definition) and 0% intra-procedural mortality. Partial and full valve repositioning were performed in 11 (36.7%) and 2 (6.7%) cases, respectively. Mean 30-day transprosthetic gradient was 11.3±3.6mmHg, with an effective aortic orifice area of 1.0±0.2cm 2 /m 2 , and more than mild paravalvular leakage (PVL) in only one patient. At 30days, cardiac mortality was 3.3%, and 96.3% of subjects were NYHA Class I or II. The rate of life-threatening bleeding was 10%; one patient experienced disabling stroke. Ten patients underwent new pacemaker implantation (38%). Conclusions TAVR with the mechanically expandable Lotus Valve seems feasible without performing preparatory BAV. Valve hemodynamics at 30-days were favorable, and clinical outcomes were similar to studies employing routine preparatory BAV.

The use of transcatheter aortic valve replacement (TAVR) for high-risk patients with aortic stenosis has rapidly increased during the past years. Accordingly, more and more patients are referred for a follow-up echocardiographic study after TAVR. However, the echocardiographic evaluation of patients who underwent TAVR places specific demands on echocardiographers. Furthermore, TAVR may be associated with new types of complications, which are frequently unrecognized or underestimated due to lack of familiarity with the normal and pathological appearance of TAVR. Therefore, this review summarizes the echocardiographic parameters describing the structural and functional status of bioprostheses used in TAVR, procedures taking into account their peculiar hemodynamics. We also describe the strengths and the limitations of echocardiography and of other imaging modalities in detecting long-term complications of TAVR (eg, infective endocarditis, thrombosis). The aim of this review was to serve as a guide for a structured echocardiographic follow-up of TAVR patients, as well as for the echocardiographic diagnosis of the procedure-associated complications.

The impact of gender-related pathophysiologic features of severe aortic stenosis on transcatheter aortic valve implantation (TAVI) outcomes remains to be determined, as does the consistency of predictors of mortality between the genders. All consecutive patients who underwent TAVI at 6 institutions were enrolled in this study and stratified according to gender. Midterm all-cause mortality was the primary end point, with events at 30 days and at midterm as secondary end points. All events were adjudicated according to Valve Academic Research Consortium definitions. Eight hundred thirty-six patients were enrolled, 464 (55.5%) of whom were female. At midterm follow-up (median 365 days, interquartile range 100 to 516) women had similar rates of all-cause mortality compared with men (18.1% vs 22.6%, p = 0.11) and similar incidence of myocardial infarction and cerebrovascular accident. Gender did not affect mortality also on multivariate analysis. Among clinical and procedural features, glomerular filtration rate30 ml/min/1.73 m(2) (hazard ratio [HR] 2.55, 95% confidence interval [CI] 1.36 to 4.79) and systolic pulmonary arterial pressure50 mm Hg (HR 2.26, 95% CI 1.26 to 4.02) independently predicted mortality in women, while insulin-treated diabetes (HR 3.45, 95% CI 1.47 to 8.09), previous stroke (HR 3.42, 95% CI 1.43 to 8.18), and an ejection fraction30% (HR 3.82, 95% CI 1.41 to 10.37) were related to mortality in men. Postprocedural aortic regurgitation was independently related to midterm mortality in the 2 groups (HR 11.19, 95% CI 3.3 to 37.9). In conclusion, women and men had the same life expectancy after TAVI, but different predictors of adverse events stratified by gender were demonstrated. These findings underline the importance of a gender-tailored clinical risk assessment in TAVI patients.

Large thrombus burden (LTB) lesions in the context of primary percutaneous coronary intervention (p-PCI) have been related to unsuccessful angiographic reperfusion and unfavorable clinical outcomes. However, the hazard of LTB treatment on myocardial damage has not been evaluated. We investigated the impact of LTB on myocardial damage using contrast-enhanced cardiac magnetic resonance (CE-CMR) in the setting of p-PCI. In 327 patients, who underwent p-PCI without thrombus aspiration within 12 hours from symptom onset, we prospectively assessed the impact of LTB on infarct size and microvascular damage using CE-CMR. LTB was defined by the presence of Thrombolysis In Myocardial Infarction thrombus score ≥3 in patent infarct-related artery (IRA); or by "cut-off" occlusion pattern and/or large reference vessel diameter (≥3.5 mm) in occluded IRA. One hundred ninety-seven patients (60.2%) showed LTB and 130 (39.8%) did not. Distal embolization occurred in 18.8% patients with versus 6.9% without LTB (p = 0.003). At CE-CMR, patients with LTB had larger infarct size index (27.5 ± 11.1 vs 22.1 ± 17.5, p = 0.009) and more often transmural necrosis (70.5% vs 55.4%, p = 0.008) compared with patients without LTB. Excluding patients with distal embolization, patients with LTB still had larger necrosis. At multivariate analysis, occluded (IRA) at baseline, anterior infarction, and presence of LTB predicted transmural necrosis. In conclusion, LTB in the setting of p-PCI is related to larger myocardial damage as detected by CE-CMR, regardless of angiographic detectable distal embolization.

Coronary artery disease (CAD) negatively affects prognosis in patients undergoing surgical aortic valve replacement, being currently evaluated in the most common used risk score. Our meta-analysis aims to clarify the prognostic role of CAD on mid-term survival in patients undergoing TAVI.Studies reporting multivariate predictors of adverse outcomes in patients undergoing TAVI were systematically searched for and pooled, when appropriate, using a random-effect method. 960 citations were first screened and finally 7 studies (2472 patients) were included. Diagnosis of CAD was reported in 52%(42-65) of patients and 1169 Edwards SAPIEN and 1303 CoreValve prostheses were implanted. After a median follow up of 452 days (357-585) 24% of patients (19-33) died, and 23 (14-32) for cardiovascular death. At pooled analysis of multivariate approach, diagnosis of coronary artery disease did not increase risk of death (OR 1.0, 95% CI, confidence interval, 0.67-1.50 I(2) 0%).CAD does not affect mid-term TAVI outcome: this finding should be weighted to accurately evaluate risk and strategies for patients with severe aortic stenosis.

Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device.To investigate the feasibility, safety and effectiveness of the Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions.The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433).Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred.This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.

Background Gender-based differences in diabetic patients are understudied in the field of percutaneous coronary intervention (PCI) with drug-eluting stents. Methods Data were obtained from a multicenter registry of 2420 consecutive patients with diabetes mellitus (DM) who underwent PCI with paclitaxel- or sirolimus-eluting stents between 2003 and 2009. Among them, 679 (28.1%) women were compared to 1741 (71.9%) men in terms of clinical aspects and major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). Target vessel revascularization (TVR) and any revascularization were also reported. Results Women were less numerous, older, used more insulin and showed more tortuous coronary arteries, while men were more frequently smokers and received larger stents. At the median follow-up of 24.3months (interquartile range 12.3–39.7), MACE, TVR and any revascularization did not significantly differ between females and males (19.9% vs 18.7%, 12.2% vs 13.4%, 14.1% vs 15.1%, respectively). At multivariable analysis of the overall cohort, female gender was not a predictor of MACE (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.92–2.36, p=0.11), death (HR 1.04, 95% CI 0.84–1.24, p=0.86), MI (HR 1.48, 95% CI 0.92–2.36, p=0.11), and TLR (HR 1.14, 95% CI 0.85–1.52, p=0.38). Conclusion In this registry of diabetic patients treated by drug-eluting stents, women were less represented, older and needed more insulin compared to men who, on the other hand, received larger stents. Gender-related outcomes were similar and female sex did not predict MACE.

OBJECTIVE: Drug-eluting stents are more effective in reducing restenosis than bare-metal stents. Paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) are the most widely used first-generation drug-eluting stents, but long-term comparative data on these are scant. The aim of the present report is to investigate the 6-year clinical outcomes of PES versus SES in a matched cohort of single-center registry patients. MATERIALS AND METHODS: Data were obtained from the observational, monocentric registry of 632 consecutive patients who underwent percutaneous coronary intervention between September 2002 and September 2005 with PES or SES. We assessed the composite and separate occurrence of the major adverse cardiac events (MACE), including death, nonfatal myocardial infarction, and target lesion revascularization (TLR). RESULTS: After a propensity 1 : 1 matching analysis, baseline clinical, procedural, and angiographic characteristics were well balanced between the two groups. Throughout the 6 years of follow-up, there were no significant differences between PES and SES in terms of MACE (P=0.52), all-cause death (P=0.24), myocardial infarction (P=0.25), stent thrombosis (P=0.38), and TLR (P=0.68). The sensitivity analysis on the total unmatched population confirmed this result, the stent type not being predictive of MACE (PES vs. SES group, hazard ratio 0.97, 95% confidence interval 0.66-1.41, P=0.87) or TLR (PES vs. the SES group, hazard ratio 1.35, 95% confidence interval 0.69-2.64, P=0.38). CONCLUSION: In this 'real-life' registry, PES and SES showed a comparable safety and efficacy profile throughout the 6 years of follow-up. The increase in the rate of TLR was slow and comparable between the two groups, even though the 'late catch-up' phenomenon showed a different temporal pattern between PES and SES.

The presence of periprocedural conduction disorders (CDs) and the need for permanent pacemaker (PPM) after transcatheter aortic valve implantation (TAVI) are frequent findings in clinical practice. Notwithstanding, robust information on the prognostic and therapeutic implications of these complications are lacking. The newly occurrence of CD after TAVI seems related to the trauma of the conduction system during procedure. On the contrary, major predictors for PPM implantation after TAVI seem to be the use of CoreValve prosthesis (Medtronic, Minneapolis, MN) and the presence of CD before TAVI. An accurate pre-TAVI screening, careful valve implantation, as well as post-TAVI monitoring must be pursued to prevent avoidable PPM implantation. The aim of this report is to analyze the available data on this field and to propose some practical clinical tips to prevent or to manage these complications. © 2013 Wiley Periodicals, Inc.

This study sought to evaluate the prevalence and potential role of myocardial bridging in the pathogenesis of apical ballooning syndrome (ABS).ABS is characterized by reversible left ventricular dysfunction, frequently precipitated by a stressful event, but the pathogenesis remains still unclear.Forty-two consecutive patients (40 female, mean age 66 ± 7 years) with ABS underwent echocardiography, cardiac magnetic resonance, coronary angiography (CA) with intravascular ultrasound, and computed tomography angiography (CTA). Myocardial bridging was diagnosed by CA when a dynamic compression phenomenon was observed in the coronary artery and by CTA when a segment of coronary artery was completely (full encasement) or incompletely (partial encasement) surrounded by the myocardium. The prevalence of myocardial bridging detected by CTA and CA in ABS patients was compared with 401 controls without ABS who underwent both CTA and CA.Myocardial bridging by CTA was observed in 32 ABS patients (76%): 23 with partial encasement and 9 with full encasement. All myocardial bridging was located in the mid segment of the left anterior descending coronary artery (LAD) with a mean length of 17 ± 9 mm. CA revealed myocardial bridging in 17 subjects (40%) (9 with partial encasement and 8 with full encasement by CTA). All subjects in which dynamic compression was observed by CA showed myocardial bridging by CTA, while none of the subjects with negative findings for myocardial bridging by CTA revealed dynamic compression by CA. Compared with controls, ABS patients showed a significant higher prevalence of myocardial bridging in the LAD either by CA (40% vs. 8%; p0.001) or by CTA (76% vs. 31%; p0.001).Our study showed that myocardial bridging of the LAD is a frequent finding in ABS patients as revealed both by CA and, mostly, by CTA, suggesting a role of myocardial bridging as potential substrate in the pathogenesis of ABS.

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Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up.

BACKGROUND: Several factors have been identified as predictors of events after transcatheter aortic valve implantation (TAVI) but the impact of left ventricular ejection fraction (LVEF) and mean transaortic gradient (MTG) is controversial. This multicenter study aimed to clarify the prognostic role of low LVEF and low MTG after TAVI. METHODS: From 2007 to 2012, 764 consecutive patients with severe symptomatic aortic valve stenosis underwent TAVI at participating hospitals. Patients were divided according to LVEF and MTG into four groups. RESULTS: Sixty-four patients had LVEF 40% or less and MTG less than 40?mmHg, 76 had LVEF 40% or less and MTG at least 40?mmHg, 163 had LVEF more than 40% and MTG less than 40?mmHg, 461 had LVEF more than 40% and MTG at least 40?mmHg. Two-year mortality was significantly higher in patients with low LVEF and low MTG, whereas it was similar in patients with low LVEF and high MTG, high LVEF and low MTG, and high LVEF and high MTG (51.3 vs. 22.4 vs. 23.3. vs. 25.5%, respectively; P?=?0.001). These results were confirmed by multivariate analysis, as the combination of low LVEF and low MTG (both less than 40) was identified as the stronger mid-term mortality predictor (hazard ratio 2.4, confidence interval 95% 1.4–3.9; P?=?0.001). CONCLUSION: At least one parameter between LVEF or MTG over 40 predicts a good prognosis for TAVI patients at mid-term follow-up, whereas those with both left ventricular dysfunction and low mean aortic pressure gradient are at high risk of all-cause death after TAVI.

A 75-year-old man with symptomatic severe degeneration of aortic bioprosthesis and high surgical risk (STS score = 18) underwent transapical ‘valve-in-valve’ TAVI. The procedure was complicated by local bleeding and occlusion of distal left anterior descendent artery. A month later, the patient developed orthopnoea and dizziness. Due to the sequelae of previous surgery, only subcostal acoustic window was adequate for imaging. Two- and three-dimensional echocardiography (3DE) showed a large apical pseudoaneurysm (PsA) of the left ventricle ( Panel A , Supplementary material online, Video S1 ) with bidirectional flow ( Panel B , Supplementary material online, Video S2 ) and layered thrombus. Re-aligning the …

Background— Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV. Methods and Results— Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ≥20 mm Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P =0.03 and Sapien XT, 18.5% versus 43.5%; P =0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0–10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1–0.52; P =0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28–0.88; P =0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51–6.45; P =0.002). Conclusions— High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV.