Procedural and long-term outcome among patients undergoing expedited trans-catheter aortic valve replacement.

OBJECTIVE: Patients with rapidly deteriorating clinical status due to severe aortic stenosis are often referred for expedited transcatheter aortic valve replacement (TAVR). Data regarding the outcome of such interventions is limited. We aimed to evaluate the outcome of patients undergoing expedited TAVR. DESIGN AND SETTING: Data were derived from the Israeli Multicenter Registry. SUBJECTS: Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N = 3140) and those who had an expedited TAVR (N = 142). Procedural and periprocedural complication rates were significantly higher among patients with an expedited indication for TAVR compared to those having an elective procedure: valve malposition 4.6% versus 0.6% (p < 0.001), procedural cardiopulmonary resuscitation 4.3% versus 1.0% (p = 0.007), postprocedure myocardial infarction 2.0% versus 0.4% (p = 0.002), and stage 3 acute kidney injury 3.0% versus 1.1%, (p < 0.001). Patients with expedited indication for TAVR had significantly higher in hospital mortality (5.6% vs. 1.4%, p = 0.003). Kaplan-Meier's survival analysis showed that patients undergoing expedited TAVR had higher 3-year mortality rates compared to patients undergoing an elective TAVR procedure (p < 0.001). Multivariate analysis found that patients with expedited indication had fourfolds increased risk of in-hospital mortality (odds ratio: 4.07, p = 0.001), and nearly twofolds increased risk of mortality at 3-year (hazard ratio: 1.69, p = 0.001) compared to those having an elective procedure. CONCLUSION: Patients with expedited indications for TAVR suffer from poor short- and long-term outcomes. It is important to characterize and identify these patients before the deterioration to perform TAVR in a fast-track pathway to minimize their procedural risk.

Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type.

BACKGROUND: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome. OBJECTIVES: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV. METHODS: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91]). RESULTS: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm2 vs 1.3 ± 0.8 cm2; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176). CONCLUSIONS: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR.

Impact of Valve Size on Paravalvular Leak and Valve Hemodynamics in Patients With Borderline Size Aortic Valve Annulus.

Background: Transcatheter heart valve (THV) selection for transcatheter aortic valve implantation (TAVI) is crucial to achieve procedural success. Borderline aortic annulus size (BAAS), which allows a choice between two consecutive valve sizes, is a common challenge during device selection. In the present study, we evaluated TAVI outcomes in patients with BAAS according to THV size selection. Methods: We performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multi-detector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multi-center TAVI registry. The aim was to evaluate outcomes of TAVI, mainly paravalvular leak (PVL) and valve hemodynamics, in patients with BAAS (based on MDCT) according to THV sizing selection in between 2 valve sizes. In addition, to investigate the benefit of shifting between different THV types (BE and SE) to avoid valve size selection in BAAS. Results: Out of 2,352 patients with MDCT measurements, 598 patients with BAAS as defined for at least one THV type were included in the study. In BAAS patients treated with SE-THV, larger THV selection was associated with lower rate of PVL, compared to smaller THV (45.3 vs. 64.5%; pv = 0.0038). Regarding BE-THV, larger valve selection was associated with lower post-procedural transvalvular gradients compared to smaller THV (mean gradient: 9.9 ± 3.7 vs. 12.5 ± 7.2 mmHg; p = 0.019). Of note, rates of mortality, left bundle branch block, permanent pacemaker implantation, stroke, annular rupture, and/or coronary occlusion did not differ between groups. Conclusion: BAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and optimized THV hemodynamics with no effect on procedural complications. Additionally, shift from borderline THV to non-borderline THV modified both THV hemodynamics and post-dilatation rates.

Mass to voltage ratio index predicts mortality following TAVI.

Transcatheter aortic valve implantation (TAVI) is commonly performed in elderly patients with aortic stenosis. Better methods of risk stratification are needed in this population with high morbidity. There is a relatively high incidence of cardiac amyloidosis in this population and high LV mass index (LVMI) to QRS voltage may help identify patients with worse prognosis following TAVI. This retrospective study enrolled consecutive patients who underwent TAVI in our institution between the years 2008-2019. Mass voltage ratio index (MVRi) was calculated as the ratio of LV mass index on echocardiogram to voltage using the Sokolow-Lyon criteria on 12 lead ECG performed within 3 months before the intervention. Two hundred and fifty-one patients (mean age 80.8 years, 49% men) were enrolled. One hundred and sixty-eight (67%) patients were alive at 3 years follow up. MVRi was a statistically significant predictor of 3 year mortality (p < 0.005). Patients were divided categorically into tertiles based on MVRi score; the "high" group had significantly higher 3-year mortality (p < 0.001). In the multivariate model only Euroscore (p < 0.009) and MVRi (p < 0.011; OR: 2.32; CI: 1.15-4.964) were statistically significant predictors of mortality. The "high" group had a significantly lower survival rate after 3 years follow up on Kaplan-Meier analysis (p < 0.001). Our findings suggest that MVRi is a strong, independent predictor of increased post-TAVI mortality. This may be a simple clinical tool to assist in the assessment of patients prior to before TAVI.

Increased Rate of New-onset Left Bundle Branch Block in Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation (From a National Registry).

There is a growing interest in transcutaneous aortic valve implantation (TAVI) therapy among patients with bicuspid severe aortic stenosis (BAV). Conduction disturbances remain a frequent complication of TAVI, and new-onset permanent LBBB (NOP-LBBB) post-TAVI may be a marker of worse outcomes. We aimed to evaluate the rate of NOP-LBBB following TAVI among patients with BAV as compared to tricuspid severe aortic stenosis (TAV). Patients enrolled in the multicenter (5 centers) Bicuspid AS TAVI Registry were reviewed and compared with patients with TAV. Patients with previous aortic valve replacement, other valve morphologies and those with preprocedural LBBB or pacemaker were excluded. NOP-LBBB was defined as LBBB first detected and persisting 30-days following TAVI. A total of 387 patients (66 with BAV, 321 with TAV), age 80.3 ± 7.3, 47% females were analyzed. The device success rates were 95% in both groups without any conversions to surgery. The rate of NOP-LBBB was significantly higher among patients with BAV versus TAV (29.2% vs 16.9%, p = 0.02). However, the rate of post procedural pacemaker implantation was similar (14.8% vs 12.5%; respectively, p = 0.62). In BAV and TAV groups, 1-year mortality (6.1% vs 7.2%; respectively, p = 0.75) and stroke rates (6.1% vs 3.5%; respectively, p = 0.30) were not significantly different. Multivariate analysis identified BAV as an independent predictor of NOP-LBBB (AdjOR = 2.7, 95%CI 1.3 to 5.4). Furthermore, BAV subtypes with raphe (type 1) were identified as independent predictors of NOP-LBBB (AdjOR = 3.2, 95%CI: 1.5 to 6.7). In conclusion, patients with BAV undergoing TAVI have greater risk for developing NOP-LBBB compared with patients with TAV and the presence of raphe was associated with increased risk of NOP-LBBB. The prognostic significance for this finding warrants further evaluation in future studies.

Limited flexibility in departure timing of migratory passerines at the East-Mediterranean flyway.

The rapid pace of current global warming lead to the advancement of spring migration in the majority of long-distance migratory bird species. While data on arrival timing to breeding grounds in Europe is plentiful, information from the African departure sites are scarce. Here we analysed changes in arrival timing at a stopover site in Israel and any links to Enhanced Vegetation Index (EVI) on the species-specific African non-breeding range in three migratory passerines between 2000-2017. Differences in wing length between early and late arriving individuals were also examined as a proxy for migration distance. We found that male redstart, but not females, advanced arrival to stopover site, but interestingly, not as a response to EVI phenology. Blackcap and barred warbler did not shift arrival timing significantly, although the arrival of blackcap was dependent on EVI. Barred warbler from the early arrival phase had longer wings, suggesting different populations. Our study further supports the existence species-specific migration decisions and inter-sexual differences, which may be triggered by both exogenous (local vegetation condition) and endogenous cues. Given rapid rate of changes in environmental conditions at higher latitudes, some migrants may experience difficulty in the race to match global changes to ensure their survival.

Prognostic implication of right ventricular dysfunction and tricuspid regurgitation following transcatheter aortic valve replacement.

OBJECTIVES: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are associated with adverse outcomes in severe aortic stenosis (AS) patients. Our aim was to evaluate the association between ≥moderate TR and RV dysfunction on long-term mortality following transcatheter aortic valve replacement (TAVR). METHODS: A retrospective analysis of the Israeli multicenter TAVR registry among 4,344 consecutive patients, with all-cause mortality as the main outcome measure. RESULTS: Echocardiographic assessment of TR grade and RV dysfunction was available for 3,733 and 1,850 patients, of whom ≥moderate TR and RV dysfunction was noted for 478(13%) and 78(4%), respectively. The mean follow-up time was 2.9 ± 2.3 years. In univariate models, ≥Moderate TR and ≥moderate RV dysfunction were associated with increased long-term mortality (HR 1.45, 95% CI 1.24-1.69, p < .001 and HR 1.73, 95% CI 1.21-2.47, p = 0.003, respectively). These finding did not remained significant after adjusting to echocardiographic parameters. A subset of patients with no improvement in RV function had the highest long-term mortality risk (HR 3.3, 95% CI 1.95-5.7, p < .001). CONCLUSION: When adjusted to multiple echocardiographic characteristics baseline ≥Moderate TR and ≥moderate RV dysfunction were not associated with long-term mortality following TAVR. Persistent RV dysfunction following TAVR was associated with the highest risk for mortality.

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

BACKGROUND: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions. OBJECTIVES: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs). METHODS: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year. RESULTS: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm2 vs. 1.37 ± 0.5 cm2; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003). CONCLUSIONS: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.

Acute kidney injury after MitraClip implantation in patients with severe mitral regurgitation.

INTRODUCTION: Percutaneous mitral valve repair (PMVR), such as MitraClip, is performed on high-risk patients and involves hemodynamic alternations that may cause acute kidney injury (AKI). We aimed to evaluate the incidence of AKI, predictors for developing AKI and the correlation with mortality after MitraClip. METHODS: We performed a retrospective analysis of collected data from patients who underwent PMVR in two tertiary medical centers in Israel to identify factors associated with AKI. RESULTS: The study population included 163 patients. The median age was 77 years; 60.7% of patients were male. The median eGFR significantly decreased post-procedure from 49 (35-72) to 47.8 (31-65.5) ml/min/1.73 m2 (p < .001). Forty-seven patients (29%) developed AKI. None of the patients who developed AKI required hemodialysis. Predictors of AKI included: baseline eGFR ≤30 ml/min/1.73 m2 , severity of residual MR, TMPG>5 mmHg, diuretic use, and re-do procedures. Among the patients who developed AKI there was an improvement in kidney function during follow-up, and creatinine levels significantly decreased from a peak mean creatinine of 179.5 (143-252) mmol/l to 136 (92-174) mmol/l (p < .001). However, 19% (9 out of 47) of patients experienced partial recovery and their creatinine level, when compared to their baseline, remained elevated. One-year survival showed a trend for increased mortality among patients who developed AKI (86.2% vs. 80.9%, p = .4), and patients who developed AKI that persisted had increased 1-year mortality compared with patients that had recovered their kidney function (86.8% vs. 55.6%, p = .01). CONCLUSION: The incidence of AKI after MitraClip is high. AKI is reversible in most patients; however, the persistence of kidney injury is associated with increased 1-year mortality.

Incidence and Predictors of Target Lesion Failure in Patients With Lesions in Small Vessels Undergoing PCI With Contemporary Drug-Eluting Stents: Insights From the BIONICS Study.

Treatment of lesions in small coronary vessels is associated with an increased risk of adverse cardiovascular events after percutaneous coronary intervention (PCI).We aimed to evaluate the outcomes of patients undergoing small-vessel PCI in the BIONICS trial and to identify predictors of stent failure. 1910 patients were randomized to treatment with the EluNIR™ ridaforolimus-eluting stent (RES) or Resolute™ zotarolimus-eluting stent (ZES). Small vessels were defined as reference vessel diameters (RVD) ≤2.5 mm. A Cox proportional hazards model was used to identify predictors of target lesion failure (TLF) through 2 years. Patients undergoing small vessel disease PCI had a higher frequency of diabetes, prior myocardial infarction (MI), and prior PCI. 2 year TLF was higher among patients with small vessels (9.7% vs. 5.9%, HR 1.7 [95% CI 1.22-2.37], p < 0.01), driven by increased rates of target vessel-MI and target lesion revascularization (TLR). Stent thrombosis at 2 years was higher among patients with small vessel disease (1.4% vs. 0.3%, HR 5.25 [95% CI 1.47-18.8], p < 0.01). 2 year TLF rates were similar in the RES and ZES patient groups (Pinteraction 0.86). In conclusion, patients undergoing PCI in small vessels have significantly worse outcomes despite the use of contemporary stents.

Short membranous septum length in bicuspid aortic valve stenosis increases the risk of conduction disturbances.

BACKGROUND: Distinct anatomical features predispose bicuspid AS patients to conduction disturbances after TAVR. This study sought to evaluate whether the incidence of permanent pacemaker implantation (PPMI) and left bundle branch block (LBBB) in patients with bicuspid aortic stenosis (AS) following transcatheter aortic valve replacement (TAVR) is related to an anatomical association between bicuspid AS and short membranous septal (MS) length. METHODS: Sixty-seven consecutive patients with bicuspid AS from a Bicuspid AS TAVR multicenter registry and 67 propensity-matched patients with tricuspid AS underwent computed tomography before TAVR. RESULTS: MS length was significantly shorter in bicuspid AS compared with tricuspid AS (6.2 ± 2.5 mm vs. 8.4 ± 2.7 mm, respectively; p < 0.001). In patients with bicuspid AS, MS length and aortic valve calcification were the most powerful pre-procedural independent predictors of PPMI or LBBB (odds ratio [OR]: 1.38, 95% confidence interval [CI]: 1.15 to 1.55, p = 0.003 and OR: 1.92, 95% CI: 1.1 to 3.34, p = 0.022, respectively). When taking into account pre- and post-procedural parameters, aortic valve calcification and the difference between MS length and implantation depth were the most powerful independent predictors of PPMI or LBBB in patients with bicuspid AS (OR: 1.82, 95%: 1.1 to 3.1, p = 0.027; OR: 1.25, 95% CI: 1.10 to 1.38, p = 0.003). CONCLUSION: MS length, which was significantly shorter in bicuspid AS compared with tricuspid AS, aortic valve calcification, and device implantation deeper than MS length predict PPMI or LBBB in bicuspid AS after TAVR.

Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study.

BACKGROUND: Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown. METHODS AND RESULTS: This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%, p < 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%, p = 0.03), target vessel MI (0% vs. 3.7%, p = 0.04), MACE (1.0% vs. 6.2%, p = 0.03) and TVF (1.0% vs. 6.9%, p = 0.02) were all significantly lower among Japanese patients. CONCLUSION: Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.

Predictors for permanent pacemaker implantation following transcatheter aortic valve implantation: trends over the past decade.

PURPOSE: This study sought to identify risk factors for permanent pacemaker implantation (PPMI) after Transcatheter aortic valve implantation (TAVI) and explain their trends over the last decade. TAVI is performed nowadays for severe aortic stenosis in more patients with lower surgical risk. While most TAVI complications have been reduced, PPMI remains common. METHODS: In this observational, retrospective cohort analysis, 338 TAVI patients treated between 2008 and 2017 were reviewed. Risk factors were compared between the early (2008-2013) and late years (2014-2017), and a multivariable logistic regression model was used. RESULTS: A decreasing trend in PPMI over time was observed (p for trend = 0.008), as was a lower rate of PPMI in the late period (19.3% vs. 31.7%, p = 0.009). Three variables were identified as independent risk factors for PPMI that also decreased significantly in the late period: valve implantation depth ≥ 8 mm (OR = 4.3, 95% CI 2.3-8.2, p < 0.001), use of self-expandable valves (OR = 2.8, 95% CI 1.4-5.5, p = 0.004), and patient risk assessed by EuroSCORE II (OR = 1.07, 95% CI 1.0-1.1, p = 0.034). Indications for PPMI were also shown to change over time, with an increase in the prevalence of complete AVB as the main indication for PPMI (p = 0.048), and a trend towards a decrease in LBBB alone (p = 0.061). CONCLUSIONS: The decrease in post-TAVI PPMI over the past decade is multifactorial and can be explained by (1) lower baseline patient surgical risk, (2) modified procedural variables including decreased implantation depth and increased use of balloon-expandable valves, and (3) refined indications for PPMI.

Pulmonary artery pressures and outcomes after MitraClip.

AIMS: We evaluated the impact of MitraClip on systolic pulmonary artery pressure (sPAP) and the effects of baseline sPAP on outcomes. METHODS AND RESULTS: In a cohort of patients who underwent MitraClip implantation, three groups were defined according to pre-procedure sPAP levels. Clinical and echocardiographic data were compared. The study included 177 patients: 59 had severe pulmonary hypertension (PHT), 96 had mild to moderate PHT, and 22 had no PHT. In patients with pre-existing severe PHT, sPAP was reduced from 70.8 ± 9.2 to 56.8 ± 13.7 mmHg (P < 0.001), sPAP remained unchanged in patients with mild to moderate PHT but was significantly increased from 30.8 ± 4.3 to 38.6 ± 8.3 mmHg in the no-PHT group (P < 0.001). Improvement of sPAP was observed in 77% of severe PHT group, while worsening of sPAP was more common among patients with no-PHT [57% compared with 33% among the mild to moderate PHT and 7% in the severe PHT group, respectively, (P < 0.001)]. One year survival was similar among the study groups. CONCLUSIONS: MitraClip decreases PHT among patients with severe PHT. A concerning finding is that most patients with no-PHT increase their sPAP.

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. OBJECTIVES: The authors sought to examine outcomes following redo-TAVR. METHODS: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. RESULTS: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis-regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. CONCLUSIONS: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

Outcomes of Patients With Coronary Arterial Bifurcation Narrowings Undergoing Provisional 1-Stent Treatment (from the BIONICS Trial).

Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (pinteraction = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.

Annular versus supra-annular sizing for transcatheter aortic valve replacement in bicuspid aortic valve disease.

BACKGROUND: CT measurement of supra-annular area (SA) has been proposed as an alternative to annular area (AA) for sizing of trancatheter valves in biscuspid aortic valves (BAV). This study examines the reproducibility of SA and AA measurements and their potential impact on downstream transcatheter heart valve sizing and clinical outcomes. METHODS: 44 consecutive patients (mean age: 73 ± 15 years, 57% male) undergoing CTA with subsequent SAPIEN 3 valve insertion for severe bicuspid aortic stenosis (AS) were included. AA was measured at the basal ring. SA was measured by generating a circle defined by the intercommisural distance. AA and SA were measured by 2 independent observers. Baseline characteristics, TAVR procedural data, and discharge echocardiography data were collected. RESULTS: The SA was significantly larger than the AA (562 ± 146mm2 vs. 518 ± 112mm2,p = 0.013). Interobserver agreement was high using both techniques (ICC AA = 0.98,p < 0.001; SA = 0.80,p < 0.001), but with narrower limits of agreement with AA measurements (mean difference (limits of agreement): AA = -3mm2 (22; 19), SA = -16mm2 (-92; 76)). AA-based device sizing demonstrated substantial agreement with final valve inserted (κ = 0.72,p < 0.001), while SA demonstrated fair agreement (κ = 0.40,p < 0.001). There was no difference in post TAVR gradients, paravalvular leakage or valve success between patients with concordant sizing between AA and SA, and those in whom SA would have suggested an alternate valve size. CONCLUSIONS: Supra-annular sizing is less reproducible than annular sizing, with no difference in procedural complication rates in patients in whom supra-annular sizing would have altered the device size used. These results suggest no role for supra-annular sizing in current clinical practice.

Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents: 2-Year Clinical Outcomes From the BIONICS and NIREUS Trials.

OBJECTIVES: This study sought to determine clinical outcomes between treatment groups over long-term follow-up. BACKGROUND: The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively. METHODS: Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization. RESULTS: A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39). CONCLUSIONS: In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.

Mid-term outcome in patients with bicuspid aortic valve stenosis following transcatheter aortic valve replacement with a current generation device: A multicenter study.

OBJECTIVES: To perform clinical and echocardiographic follow-up beyond 1 year in consecutive patients with severe bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with a current generation balloon-expandable valve. BACKGROUND: Treatment of bicuspid aortic valve disease with TAVR remains controversial and late follow-up data is still scarce. METHODS: We collected baseline characteristics, procedural data, 30-day and mid-term clinical follow-up findings from six centers in Europe and Canada from patients with bicuspid AS treated with TAVR using the SAPIEN 3 valve. RESULTS: Seventy-nine patients underwent TAVR. Mean age was 76 ± 9 years; median STS risk score for mortality was 3.8% (interquartile range 2.3-5.5%). Median follow-up was 390 days (interquartile range 138-739 days). Device success was achieved in 95% of patients. Postimplantation mean aortic gradient decreased from 50.2 ± 16.2 to 8.8 ± 4.4 mmHg and no patient had more than mild aortic regurgitation. At last follow-up, there was persistent good valve performance. At 30 days and 1 year, the rates of all-cause mortality were 3.8 and 7.7%, stroke 1.2 and 1.2%, and the rate of new pacemakers 18 and 18%. CONCLUSIONS: Our data confirm that treating patients with stenotic bicuspid aortic valves is safe, effective, and has favorable valve performance over time.

Transcatheter aortic valve-in-valve implantation for failed surgical bioprosthetic valves. A minimalist approach without contrast aortography or echocardiographic guidance.

OBJECTIVES: To demonstrate safety, feasibility and short-term clinical outcomes after transcatheter aortic valve-in-valve (ViV) implantation under local anesthesia without contrast aortography or echocardiographic guidance. BACKGROUND: Transcatheter ViV implantation is an emerging treatment modality for patients with degenerative surgical bioprostheses. Given the radiopaque properties of the surgical aortic valve (SAV) frame, ViV procedures can often be performed with fluoroscopic guidance alone. METHODS: ViV implantation was performed in 37 patients with SAV failure under local anesthesia without contrast aortography. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. RESULTS: Mean age was 74 ± 10 years and STS predicted risk of mortality was 5.6 ± 2.4%. Mean transaortic gradient decreased from 39.4 ± 15.5 mmHg to 13 ± 6.3 mmHg at discharge (p < .001), and 20 ± 7.5 mmHg at 30 days (p < .001 compared to baseline), aortic valve area increased from 0.9 ± 0.3 cm2 to 1.2 ± 0.4 cm2 at 30 days (p = .007). No patient had more than mild aortic regurgitation. Hospital discharge occurred at a median of 2.6 ± 4.4 days. At 30-day follow-up there were no deaths, myocardial infarctions, strokes, repeat hospital admissions for heart failure, or renal failure. One patient (2.7%) required a new pacemaker. 93% of the patients were in New York Heart Association functional class I or II. CONCLUSIONS: Transcatheter aortic ViV implantation for selected patients with degenerative surgical bioprostheses under local anesthesia without aortography or echocardiographic guidance is feasible and safe.