Long-term efficacy and safety of tailored immunosuppressive therapy in immune-mediated biopsy-proven myocarditis: A propensity-weighted study.

AIMS: Standardized immunosuppressive therapy (IS) had been previously investigated in biopsy-proven (BP) lymphocytic myocarditis with heart failure (HF). This study evaluated efficacy and safety of tailored IS in BP immune-mediated myocarditis, irrespective of histology and clinical presentation. METHODS AND RESULTS: Consecutive BP myocarditis patients treated with long-term tailored IS on top of optimal medical therapy (OMT), were compared with OMT non-IS controls using propensity-score weighting. The primary outcome was a composite of death or heart transplant, the secondary outcome was a composite of biventricular function, New York Heart Association (NYHA) class variation, and relapse. IS was managed by a multidisciplinary Cardioimmunology Team, involved a safety checklist and active patients' education. Ninety-one IS patients were compared with 267 non-IS patients. IS patients more frequently had systemic immune-mediated diseases (35% vs. 9.7%), lower baseline echocardiographic left ventricular ejection fraction (35% vs. 43%), lower right ventricular fractional area change (34% vs. 41%) and higher frequency of active lymphocytic, eosinophilic and giant cell myocarditis (71% vs. 58%, 12% vs. 1.1%, and 6.6% vs. 1.5%, respectively). At 5-year follow up, no difference was observed in the primary outcome (survival rate 93% in IS vs. 87% in non-IS), but IS patients had a higher relapse rate. Thus, IS patients, with a lower biventricular function and a higher risk profile at baseline, presented similar biventricular function and NYHA class to non-IS patients at follow-up. Minor adverse drug reactions occurred in 13% of patients, all resolved with therapy switch. CONCLUSIONS: Prolonged tailored IS is effective and safe in BP immune-mediated myocarditis irrespective of histology and clinical presentation.

A rare cause of effusive-constrictive pericarditis.

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.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Late recurrence of a giant left ventricular pseudoaneurysm: the importance of multimodality imaging approach.

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.

Transcatheter aortic valve replacement for bicuspid aortic valve stenosis with first- and new-generation bioprostheses: A systematic review and meta-analysis.

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.

Time course of the survival advantage of transcatheter over surgical aortic valve replacement: Interplay between sex and patient risk profile.

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.

[Percutaneous closure of a very large atrial septal defect: a case report and literature review]. / Chiusura percutanea di un difetto del setto interatriale molto ampio: caso clinico e revisione della letteratura.

Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASD) is the gold-standard treatment, because of a comparable efficacy and less complications than heart surgery. Nevertheless, percutaneous treatment of very large ASD is still considered a challenging procedure and is discouraged for diameters larger than 38 mm, especially when atrial septal rims are absent. These patients are characterized by more frequent complications when a percutaneous approach is attempted. Hence, the treatment of choice is still debated. We report the case of a 75-year-old Caucasian male, admitted for congestive heart failure secondary to a very large ASD. After accurate sizing with transesophageal echocardiography and sizing balloon, percutaneous closure with an Amplatzer Septal Occluder was successfully performed, using few simple tricks.

Unmasking Myocardial Bridge-Related Ischemia by Intracoronary Functional Evaluation.

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.

On-treatment platelet reactivity in peripheral and coronary blood in patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI).

Dual antiplatelet therapy is recommended in patients undergoing primary percutaneous coronary intervention (p-PCI) for ST-segment elevation myocardial infarction (STEMI). Pre-analytical variables may influence platelet function analysis results. Our aim was to evaluate the on-treatment platelet reactivity in peripheral artery vs coronary blood in patients with STEMI. We enrolled one hundred and nine patients who consecutively underwent p-PCI at Cardiology Unit of Padua University Hospital between June 2014 and June 2015. Before the procedure, all patients received intravenous aspirin 250 mg and either of the thienopyridines; clopidogrel 600 mg, prasugrel 60 mg or ticagrelor 180 mg. ASPI-test and ADP-test using multiple electrode aggregometry (MEA) were performed in samples collected from both a peripheral artery and the culprit coronary artery. 'Low responders' were patients with an ASPI-test or ADP-test value greater than or equal to a pre-established normal range. No significant differences were observed in ASPI-test values between peripheral (19 (median) [3-49 (10-90 percentiles)] U) vs coronary (12 [1-40] U, p = .06) blood and in ADP-test (40 [14-82] U vs 33 [7-79] U, p =.68) blood. In peripheral blood, fifteen (14%) patients were 'low aspirin' and forty-one (38%) 'low thienopyridines' responders. The prevalence of 'low clopidogrel' responders was higher (45%) than prasugrel (36%) and ticagrelor (33%). Similar results were observed in coronary blood. In patients undergoing p-PCI for STEMI, MEA platelet function observed in coronary arteries was consistent with peripheral artery blood's independently of the antiplatelet drug used. The clinical significance of peripheral and coronary on-aspirin/thienopyridines platelet reactivity needs further clarification.

Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve.

OBJECTIVE: We 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. METHODS: A 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). RESULTS: Moderate 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; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44). CONCLUSIONS: Severe 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.

Long-term outcomes and prosthesis performance after transcatheter aortic valve replacement: results of self-expandable and balloon-expandable transcatheter heart valves.

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 multivariable 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%.

TAVR with mechanically expandable prostheses: Is balloon aortic valvuloplasty really necessary?

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±0.14cm2/m2; 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±0.2cm2/m2, 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.

Impact of Changes in Left Ventricular Ejection Fraction on Survival After Transapical Aortic Valve Implantation.

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.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

OBJECTIVES: The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. METHODS: The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. RESULTS: Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). CONCLUSIONS: TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation.

BACKGROUND: 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. METHODS: 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. RESULTS: 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%; p < 0.001). Access-related complications were more frequent in the TF group (36.1% versus 11.4%; p < 0.001). 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. CONCLUSIONS: 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.

The impact of calcium volume and distribution in aortic root injury related to balloon-expandable transcatheter aortic valve replacement.

BACKGROUND: A detailed assessment of calcium within the aortic root may provide important additional information regarding the risk of aortic root injury during transcatheter heart valve replacement (TAVR). OBJECTIVE: We sought to delineate the effect of calcium volume and distribution on aortic root injury during TAVR. METHODS: Thirty-three patients experiencing aortic root injury during TAVR with a balloon-expandable valve were compared with a control group of 153 consecutive TAVR patients without aortic root injury (as assessed by post-TAVR multidetector CT). Using commercial software to analyze contrast-enhanced pre-TAVR CT scans, calcium volume was determined in 3 regions: (1) the overall left ventricular outflow tract (LVOT), extending 10 mm down from the aortic annulus plane; (2) the upper LVOT, extending 2 mm down from the annulus plane; and (3) the aortic valve region. RESULTS: Calcium volumes in the upper LVOT (median, 29 vs 0 mm(3); P < .0001) and overall LVOT (median, 74 vs 3 mm(3); P = .0001) were higher in patients who experienced aortic root injury compared with the control group. Calcium in the aortic valve region did not differ between groups. Upper LVOT calcium volume was more predictive of aortic root injury than overall LVOT calcium volume (area under receiver operating curve [AUC], 0.78; 95% confidence interval, 0.69-0.86 vs AUC, 0.71; 95% confidence interval, 0.62-0.82; P = .010). Upper LVOT calcium below the noncoronary cusp was significantly more predictive of aortic root injury compared to calcium underneath the right coronary cusp or the left coronary cusp (AUC, 0.81 vs 0.68 vs 0.64). Prosthesis oversizing >20% (likelihood ratio test, P = .028) and redilatation (likelihood ratio test, P = .015) improved prediction of aortic root injury by upper LVOT calcium volume. CONCLUSION: Calcification of the LVOT, especially in the upper LVOT, located below the noncoronary cusp and extending from the annular region, is predictive of aortic root injury during TAVR with a balloon-expandable valve.

Management and Long-Term Prognosis of Spontaneous Coronary Artery Dissection.

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.

Comparison of balloon-expandable versus self-expandable valves for transcatheter aortic valve implantation in patients with low-gradient severe aortic stenosis and preserved left ventricular ejection fraction.

A relevant proportion of patients, classified as severe aortic stenosis on the basis of valve area ≤1 cm(2), have a mean transvalvular gradient ≤40 mm Hg, despite a preserved left ventricular ejection fraction (LGSAS). We assessed the clinical and hemodynamic impact of transcatheter aortic valve implantation in patients with symptomatic LGSAS at high risk for surgery or inoperable, according to the type of percutaneous valve implanted. Ninety-five patients received an Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California) and 51 received a Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota). The hemodynamic performance of the 2 valves was similar in term of final transvalvular gradients (10 mm Hg, p = 0.069). Early mortality rate was 7% and was not different between the 2 valves (p = 0.73). During follow-up, cardiovascular mortality rate was similar between groups, and valve type was not a predictor of outcome (p = 0.72). Estimated survival by Kaplan-Meier at 2 years was 70%. At multivariate analysis, life-threatening or major bleeding, postprocedural aortic insufficiency, and acute kidney injury were the major predictors of an adverse outcome. In patients with LGSAS treated by transcatheter aortic valve implantation, the use of balloon-expandable versus self-expandable valves resulted in similar hemodynamic, early, and long-term clinical outcomes.