Need For Post-dilation Research Articles

Optimal oversizing in transcatheter aortic valve replacement with the self-expanding Evolut valve system.

Valve oversizing has been associated with reduced paravalvular leaks (PVL) and valve migration risk. However, no optimal cut-off oversizing value has been defined for the Evolut system (Medtronic). The aim of this study was to assess the relationship between the degree of oversizing and moderate-to-severe PVL and determine the optimal oversizing cut-off value. We conducted a multicenter study that included 740 consecutive patients with multidetector computed tomography (CT) data. Valve size was selected according to manufacturer recommendations, with oversizing ranging from 10% to 30%. The primary endpoint was moderate-to-severe PVL. The median age was 84 years (79-87 years), with 58.4% women, and a median EuroSCORE II of 4.1% (2.4-7.3%). Moderate-to-severe PVL was observed in 7.0% of the patients. An inverse relationship was found between oversizing and both PVL (11.3%, 8.6%, 5.4%, and 2.7% for quartiles Q1 to Q4; P = .007) and the need for post-dilation (P = .016). The multivariable analysis showed an association between oversizing and PVL (OR: 0.915 for each 1%-increase, P = .002). The optimal oversizing cut-off value to predict PVL was 20%, and PVL was significantly higher in patients with oversizing less than 20% (10.5% vs.4.2%, P less than .001). There were no differences in major clinical events according to the degree of oversizing, and a higher oversizing did not translate into an increased risk of permanent pacemaker (18.4% vs18.3%, P = .976). In TAVR with the Evolut valve, a higher oversizing was associated with lower rates of moderate-to-severe PVL and a lower need for post-dilation, with no negative impact on procedural and early clinical outcomes. A 20% oversizing threshold could be suggested to reduce PVLs. Further prospective studies are warranted to validate optimal oversizing for this valve system.

Post-Dilatation of New-Generation Self-Expandable Transcatheter Aortic Valves Does Not Increase Atrioventricular Conduction Abnormalities.

The impact that post-dilatation has on the risk of experiencing conduction disorders after post-transcatheter aortic valve replacement with self-expanding valves (SE-TAVR) is unclear. We compared the rate of developing an atrioventricular (AV) high-grade conduction disorder and permanent pacemaker implantation (PPI) in post-TAVR patients undergoing post-dilatation. We enrolled patients with severe symptomatic calcified aortic stenosis (CAS) who were undergoing SE-TAVR between 1 January 2016, and 19 April 2019 at a single French center. Of the 532 patients treated with SE-TAVR, 417 subjects (78.4%) received Corevalve Evolute R and 115 subjects (21.6%) received the latest-generation Corevalve Evolute Pro valve. In total, 104/532 patients (19.5%; 21.6% with Evolute R vs. 12.2% with Evolute Pro, p = 0.024) required post-dilatation. Evolut R was associated with an increased risk of post-dilatation (odds ratio 2.1 (1.01-4.33, p = 0.046)). We did not observe any post-dilatation increases in AV or in intra- and interventricular conduction disorders. In total, 26.1% of participants needed PPI within the first 30 post-procedure days (p = 0.449). Post-dilatation was not associated with a higher PPI risk (subdistribution hazard ratio 1.033 (0.726-1.471); p = 0.857). No significant differences existed between the groups in terms of one-year mortality (10.3%; p = 0.507). Post-dilatation in SE-TAVR did not increase the rate of electrical conduction disorders and PPI in the early implantation phase. The latest generation of SE-TAVR valves was associated with less need for post-dilatation.

How to use the aortic valve calcium score to improve the results of transcatheter aortic valve implantation with a self-expanding prosthesis

In recent years, transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI) has become the preferred method for implanting TAVI prostheses. Appropriate patient selection is important to avoid suboptimal outcomes and associated complications. To evaluate whether aortic valve calcification measured with computed tomography predicts suboptimal results from direct TAVI with a self-expanding prosthesis. Single-centre retrospective analysis of patients who received a CoreValve™ prosthesis (Medtronic, Minneapolis, MN, USA) in a direct TAVI procedure between January 2018 and March 2019. Aortic valve calcification assessment (aortic valve calcium score, calcium volume and calcium mass) was calculated from the computed tomography scan before TAVI. Procedural characteristics, need for postdilation and complications were analysed. Of 168 included patients, 18 were postdilated. Aortic valve calcium score (4259 vs. 2578; P<0.001), calcium volume (1184 vs. 647mm3; P<0.001) and calcium mass (642 vs. 368mg; P<0.001) were higher in patients needing postdilation. Aortic valve calcium score (odds ratio 9.73; P=0.004), calcium volume (odds ratio 8.48; P=0.006) and calcium mass (odds ratio 6.21; P=0.006) were independent predictors of suboptimal direct TAVI outcomes. A high aortic valvular calcium score, assessed by computed tomography scan, is an independent predictor of suboptimal prosthesis implantation outcomes in direct TAVI.

Impact of Predilation During Transcatheter Aortic Valve Replacement: Insights From the PARTNER 3 Trial.

[Figure: see text].

Direct vs preimplantation balloon valvuloplasty in transcatheter aortic valve replacement-Systematic review and meta-analysis of randomized controlled trials and prospective-matched cohorts.

This systematic review and meta-analysis aimed to evaluate the efficacy and safety of direct vs preimplantation balloon valvuloplasty (predilatation) before transcatheter aortic valve replacement (TAVR). We performed a systematic literature search up until March 2020 from PubMed, SCOPUS, EuropePMC, Cochrane Central Database, ProQuest, and ClinicalTrials.gov. We included randomized controlled trial (RCT) and prospective-matched cohorts that compared direct TAVR and preimplantation balloon valvuloplasty before TAVR. The primary outcome was the device success as defined by Valve Academic Research Consortium 2. The secondary outcome was a patient-prosthesis mismatch, the need for balloon postdilatation, composite adverse events, and 1-year mortality. There were a total of 3078‬ patients from eight studies. This meta-analysis showed that direct TAVR has a similar device success rate (P = .63), the need for postdilatation (P = .82), and composite adverse events (P = .98) compared with preimplantation balloon valvuloplasty. Subgroup analysis for balloon-expandable valves showed lower need for balloon postdilatation (risk ratio [RR], 0.63 [0.47, 0.84]; P = .002; I2 , 0%) in direct TAVR group but higher incidence of acute kidney injury (RR, 3.23 [1.25, 8.40]; P = .02; I2 , 0%) and major/life-threatening bleeding (RR, 1.54 [1.17, 2.02]; P = .002; I2 , 0%). Subgroup analysis for the RCTs alone and RCTs + propensity-matched cohorts showed similar device success and composite adverse events in both groups. However, pooled RCTs showed a higher need for balloon postdilatation in direct TAVR (RR, 1.83 [1.03, 3.24]; P = .04; I2 , 0%). Direct TAVR has similar efficacy and safety to preimplantation balloon valvuloplasty. However, better-designed RCTs are required before drawing a definite conclusion.

Impact of Predilatation Prior to Transcatheter Aortic Valve Implantation With the Self-Expanding Acurate neo Device (from the Multicenter NEOPRO Registry)

Safety and feasibility of transfemoral Acurate neo implantation without systematic predilatation are not fully investigated. Our aim was to evaluate the use and impact of pre-implantation balloon aortic valvuloplasty (pre-BAV) before transcatheter aortic valve implantation (TAVI) with Acurate neo. The NEOPRO Registry retrospectively included 1,263 patients who underwent transfemoral TAVI with Acurate neo at 18 centers between January 2012 and March 2018. Information on pre-BAV was available for 1,262 patients (99.9%). Primary end points were pre-discharge moderate-to-severe paravalvular aortic regurgitation (PAR II+), 30-day new permanent pacemaker implantation, and 30-day all-cause mortality or stroke. A total of 1,262 patients who underwent TAVI with (n = 1,051) or without predilatation (n = 211) were included. A reduction in the pre-BAV rate was observed during the study period (from 95.7% in the first date quintile to 78.4% in the last date quintile). Patients who underwent pre-BAV had higher degrees of aortic valve (AV) and left ventricular outflow tract (LVOT) calcification. Primary endpoints were similar between pre-BAV and no pre-BAV groups (PAR II+ 5.5% vs 3.4%, p = 0.214; 30-day permanent pacemaker implantation 9.0% vs 8.0%, p = 0.660; 30-day death or stroke 4.9% vs 4.4%, p = 0.743). The need for postdilatation and other procedural outcomes were comparable between groups. Predilatation did not have a significant impact on primary endpoints across AV and LVOT calcification subgroups (subgroup analyses) and was not independently associated with primary endpoints (multivariate analyses). In conclusion, transfemoral Acurate neo implantation without predilatation appears to be feasible and safe, especially in patients with milder degrees of AV and LVOT calcification.

1336Outcome analysis of systolic or diastolic CT acquisition prior to transcatheter aortic valve replacement to estimate prothesis size

Abstract Background Computed tomography (CT) imaging is considered as standard of care for transcatheter aortic valve replacement (TAVR) prothesis sizing. ECG-triggered high-pitch helical CT data acquisition on dual-source CT systems is associated with less contrast volumes, but CT image reconstruction of the aortic valve is limited to a single time point within the cardiac cycle. Although systolic CT imaging of the aortic valve is recommended due to the changes in aortic annulus area during the cardiac cycle, this recommendation is not supported by clinical outcome data. Purpose The study aimed to assess the impact of systolic vs. diastolic CT imaging of the aortic annulus for TAVR sizing on patient outcomes in a large series of patients. Methods In the study CT images of 1346 patients undergoing TAVR at our centre from 2013–2016 were re-evaluated. Patients were stratified into two groups with 0–35% and 36–99% of the RR-interval as systolic and diastolic CT imaging. Outcomes according to VARC2-criteria at 30 days and long-term survival were analysed. Results CTs of 1135 out of 1346 patients were analysed retrospectively, 278 (24.5%) of which were acquired during systole and 859 (75.5%) during diastole. Mean age was 80.6±7.6 years and 52.2% were female. Mean follow-up, available for 83.4% of patients, was 2.1±0.8 years. No significant difference in baseline characteristics was observed across both groups. Aortic annular area measurements were significantly larger in systole (mean aortic anulus area: systole: 4.8±1.0 cm2; diastole: 4.5±1.0 cm2, p&lt;0.01), resulting in larger implanted valves. Balloon-expandable valves were used in 69.4% of patients; the need for post-dilation did not differ between both groups (systole 4.7%, and diastole 7.5%; p=0.13). There was no difference between groups concerning the combined endpoints for device success or early safety according to VARC2-criteria. Overall 30-day mortality was 3.4% (systole: 4.2% and diastole: 3.1%, p=0.35). Device failure occurred in 2.7% (systole: 2.9% and diastole: 2.7%, p=0.83). Permanent pacemaker implantation was required in 20.1% (systole: 18.7%, and diastole: 20.5%; p=0.55). Stroke rate at 30 days was 2.9%, n=33 and was similar in the two groups. The landmark analysis demonstrates the 30-day and 1-year mortality rates for both groups (Figure). Figure 1. Landmark analysis mortality Conclusion The current analysis does not suggest that systolic CT imaging for TAVR sizing is associated with improved early or late outcomes. Accordingly, full-cycle CT imaging which usually is associated with higher contrast volumes, should be avoided in this elderly population, which often presents with reduced kidney function.

Balloon Predilation in Transcatheter Aortic Valve Replacement with Self-expanding Valves

ABSTRACT Introduction: The utility of routine balloon predilation in transcatheter aortic valve replacement (TAVR) with self-expanding valves is not established. Clinical outcomes at 30 days and 1 year post TAVR, deploying the “no balloon predilation” strategy have not been systematically described. Methods: Between October 2011 and September 2016, all patients who underwent TAVR with self-expanding valves (CoreValve®, Medtronic, Inc., Minneapolis, MN, USA) were stratified into predilation and no predilation groups. Of the 564 patients in the study, predilation was performed in 410 (72.7%) patients. Results: The need for postdilation was less when predilation was performed (30.2%), compared with no predilation (39.0%; adjusted odds ratio [aOR]:0.741, 95% confidence interval [CI]: 0.493–1.114). “Clinically significant” paravalvular leak (PVL) was similar in the predilation (5.9%) and no predilation (6.8%) groups (aOR: 0.886, 95% CI: 0.398–1.971). Permanent pacemaker implantation was higher following predilation (25.1%), compared with no predilation (15.6%; aOR:3.086, 95% CI:1.413–6.738). There were no differences in 30-day myocardial infarction, or 30-day and 1-year stroke and death. When patients undergoing predilation were further stratified into conservative predilation (predilation balloon size ≤ minimum annulus diameter) and aggressive predilation (predilation balloon size > minimum annulus) groups, need for postdilation was lowest with aggressive predilation. PVL, 30-day and 1-year stroke rates were similar in the aggressive, conservative and no predilation groups. Conclusion: Balloon predilation in TAVR with a self-expanding prosthesis was associated with a significant decrease in the need for balloon postdilation, and a significant increase in the need for a permanent pacemaker. There was no difference in PVL, and 30-day and 1-year stroke and death rates between the two groups.

Accuracy of device landing zone calcium volume measurement with contrast-enhanced multidetector computed tomography

BackgroundThe extent of aortic valve calcification is an important determinant of procedural success in transcatheter aortic valve implantation (TAVI). We sought to validate device landing zone calcium volume (DLZ-CV) measurements on contrast-enhanced multidetector computed tomography (MDCT) with non-contrast-enhanced scans as reference. MethodsWe determined DLZ-CV in 141 patients undergoing transfemoral TAVI. Non-contrast-enhanced images were analyzed using a threshold of 130 HU as reference (DLZ-CV130). For contrast-enhanced scans, we applied various thresholds including 450 HU (DLZ-CV450), 850 HU (DLZ-CV850), mean aortic attenuation (AttenAo) + 2 SD (DLZ-CV2SD), AttenAo + 4 SD (DLZ-CV4SD), AttenAo + 4 SD + 5 mm3 volume filter (DLZ-CV4SD+), and based on visual estimation (DLZ-CVvis). We compared DLZ-CV values between patients with versus without paravalvular leak (PVL), and between patients with versus without post-dilatation stratified by the type of prosthesis. ResultsAll DLZ-CV measurements on contrast-enhanced scans significantly differed from DLZ-CV130 (p < 0.001 for all comparisons). The best approximation to DLZ-CV130 was achieved with DLZ-CV4SD+ (508 mm3 [332–772]; Pearson correlation: R = 0.87, p < 0.001; Bland-Altman: mean difference 1339 mm3 [limits of agreement 79;2600]). Moreover, DLZ-CV4SD+ allowed for discrimination of PVL ≥1° or the need for post-dilatation in patients receiving self-expanding prostheses. Procedural outcome using balloon-expandable prostheses was independent of DLZ-CV. ConclusionMeasurement of DLZ-CV using contrast-enhanced scans with unadjusted thresholds results in incorrect estimation of the calcium volume. The use of a scan-specific individual HU threshold including a volume filter (DLZ-CV4SD+) provides the best approximation to the reference and allows for discrimination of PVL ≥ 1° in patients receiving the Acurate neo prosthesis.

Aortic valve and left ventricular outflow tract calcium volume and distribution in transcatheter aortic valve replacement: Influence on the risk of significant paravalvular regurgitation

ObjectivesWe sought to determine the impact of aortic root calcium on the risk of significant paravalvular regurgitation (sPAR) in transcatheter aortic valve replacement (TAVR). MethodsIn 302 consecutive patients from 3 centers, aortic root calcium was quantified volumetrically on pre-TAVR multidetector computed tomography (MDCT) in three regions: 1) the aortic valve region, 2) the overall left ventricular outflow tract (LVOT) and 3) the upper LVOT. Transcathether heart valve (THV) oversizing was calculated as (THV nominal area/MDCT annular area−1) × 100. The study endpoint sPAR was a composite of post-dilatation (PD) and PAR > mild. ResultssPAR occurred in 15% (46/302) of patients. Upper LVOT calcium volume was more predictive of sPAR than overall LVOT calcium volume, with an area under the receiver operating curve (AUC) (95% confidence interval [CI]) of 0.80 (0.67–0.89) vs. 0.60 (0.51–0.70); p = 0.0001. The optimal cut-off calcium volume thresholds determined from receiver operating curves were 21 mm3 and 30 mm3 for upper LVOT and overall LVOT calcium, respectively. Upper LVOT calcium ≥ 21 mm3, but not overall LVOT calcium ≥ 30 mm3, independently predicted sPAR, odds ratio (95%CI): 9.5 (4.1–22.3) vs 1.6 (0.6–2.7). Upper LVOT calcium was more predictive of sPAR in patients with THV oversizing ≥ 13% compared to patients with THV oversizing <13%, AUC (95% CI): 0.83 (0.72–0.93) vs. 0.67 (0.51–0.74); p < 0.0001. ConclusionsUpper LVOT calcium predicts more-than-mild paravalvular regurgitation following TAVR or the need for postdilatation. Upper LVOT calcium is most predictive of paravalvular regurgitation in the event of THV oversizing ≥ 13%.

Transfemoral aortic valve implantation using a self-expanding transcatheter heart valve without pre-dilation

BackgroundThe aim of the present study was to investigate whether transfemoral implantation of the Acurate neo transcatheter heart valve without pre-dilation is feasible. MethodsBetween December 2014 and December 2016, 294 patients were treated with the Acurate neo prosthesis at our center. Of these, 72 cases were performed without pre-dilation. The decision to omit pre-dilation was at the discretion of the operator, preferably in the case of mild to moderate aortic valve calcification (AVC). Propensity matching (1:1) resulted in 48 cases in each group. Main outcomes of interest were device success according to VARC-2 criteria, residual aortic regurgitation (AR) ≥2°, and rate of post-dilation. ResultsMedian [IQR] age in patients without pre-dilation was 82.7years [78.6–85.6], STS score was 4.6% [3.4–6.1], and AVC-score was 1436AU [1043–1682] with mild and moderate AVC in 63.9% and 36.1% of cases, respectively. Device success was achieved in 94.4% of cases, post-dilation was necessary in 26.4%, and one (1.4%) patient had moderate AR. In the matched population, there were no differences regarding device success, rate of AR ≥2°, need for post-dilation, and post-procedural mean gradient, but the group without pre-dilation had shorter procedure (34.0min [27.0–38.8] vs. 43.0min [34.3–52.0]; p<0.001) and fluoroscopy times (7.4min [5.7–9.0] vs. 9.9min [7.9–13.5]; p<0.001). ConclusionIn select patients with mild to moderate AVC, transfemoral implantation of the Acurate neo without pre-dilation is feasible and safe. This allows for a straightforward procedure that may be performed without rapid pacing in the majority of cases.

Progression and Prognosis of Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation.

BackgroundThe impact of paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) remains uncertain.ObjectiveTo evaluate the impact of PVR on mortality and hospital readmission one year after TAVI.MethodsBetween January 2009 and June 2015, a total of 251 patients underwent TAVI with three different prostheses at two cardiology centers. Patients were assessed according to PVR severity after the procedure.ResultsPVR was classified as absent/trace or mild in 92.0% (n = 242) and moderate/severe in 7.1% (n = 18). The moderate/severe PVR group showed higher levels of aortic calcification (22% vs. 6%, p = 0.03), higher serum creatinine (1.5 ± 0.7 vs. 1.2 ± 0.4 mg/dL, p = 0.014), lower aortic valve area (0.6 ± 0.1 vs. 0.7 ± 0.2 cm2, p = 0.05), and lower left ventricular ejection fraction (49.2 ± 14.8% vs. 58.8 ± 12.1%, p = 0.009). Patients with moderate/severe PVR had more need for post-dilatation (p = 0.025) and use of larger-diameter balloons (p = 0.043). At one year, all-cause mortality was similar in both groups (16.7% vs. 12%, p = 0.08), as well as rehospitalization (11.1% vs. 7.3%, p = 0.915). PVR grade significantly reduced throughout the first year after the procedure (p < 0.01). The presence of moderate/severe PVR was not associated with higher one-year mortality rates (HR: 0.76, 95% CI: 0.27-2.13, p = 0.864), rehospitalization (HR: 1.08, 95% CI: 0.25-4.69, p=0.915), or composite outcome (HR: 0.77, 95% CI: 0.28-2.13, p = 0.613).ConclusionIn this sample, moderate/severe PVR was not a predictor of long-term mortality or rehospitalization. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0)

Sapien 3 versus Sapien XT prosthetic valves in transcatheter aortic valve implantation: A meta-analysis

ObjectivesThe S3 prosthetic valve was introduced to overcome several issues with its predecessor, the SXT, in transcatheter aortic valve implantation (TAVI), however, the clinical outcomes of this new model are not clearly defined. We performed a meta-analysis to compare the outcomes in Sapien 3 (S3) and Sapien XT (SXT) recipients. MethodsA literature search through PUBMED and EMBASE was conducted. Articles that included at least one of the clinical outcomes of interest were included in the meta-analysis: moderate to severe paravalvular regurgitation (PVR), permanent pacemaker implantation (PPI), major vascular complications (MVC), cerebrovascular events (stroke and transient ischemic attack) (CVE), failure rate of device implantation, life-threatening, disabling or major bleeding, need for post-dilation and early all-cause-mortality. ResultsA total of 9 observational cohort studies were included. S3 was implanted in 945 and SXT in 1553 patients. S3 was associated with a lower incidence of moderate to severe PVR (1.6% vs 6.9%, p<0.0001), lower MVC (5.1% vs 8.9%, p=0.01) and less serious bleeding (8.1% vs 15.2%, p=0.003) compared to the SXT. Device deployment failure rate was lower in the S3 (1.2% vs 5.9%, p=0.004) and the S3 required less post-dilation (16.9% vs 26.9%, p=0.05). Rates of CVE, perioperative mortality and PPI were similar between the two valves. ConclusionsImplantation of the S3 prosthetic valve results in lower rates of moderate to severe PVR, MVC, post-dilation and serious bleeding however it does not improve on the SXT in terms of CVE, PPI and early mortality.

Transfemoral valve-in-valve implantation for degenerated bioprosthetic aortic valves using the new balloon-expandable Edwards Sapien 3 valve.

Surgical aortic bioprosthetic valves deteriorate 10 to 20 years after operation. Valve-in-valve implantation with first generation transcatheter aortic valve implantation (TAVI) devices has shown to be feasible. We report a first case series with the new Edwards Sapien 3 valve for transfemoral aortic valve-in-valve implantation. Nine patients underwent valve-in-valve-TAVI with the Edward Sapien 3 valve. Seven patients presented with severe aortic stenosis and two patients with severe aortic insufficiency of surgical aortic bioprosthesis. Procedures were performed in local anaesthesia under fluoroscopic guidance with pre-procedural 256 multislice computed tomography for procedural planning. In all patients the Edwards Sapien 3 was successfully implanted decreasing the mean echocardiographic gradient from 42 ± 22mmHg to 18 ± 7mmHg (p < 0.01). Device success according to VARC 2 criteria was achieved in 8 out of 9 patients. There was no death, coronary obstruction, use of second valve or need for post-dilation. Furthermore there were no access-site complications, no minor or major bleedings or vascular injury. Two patients required pacemaker implantation within the first 7 days after valve-in-valve TAVI. Post-procedural echocardiography demonstrated no or trace aortic regurgitation. Early safety events within 30 days according to VARC-2 definition occurred in 1 patient. The Edwards Sapien 3 valve for treatment of failed surgical bioprostheses is feasible and is associated with no relevant post-procedural aortic regurgitation and a low risk of access site complications. © 2016 Wiley Periodicals, Inc.

Usefulness of Predilation Before Transcatheter Aortic Valve Implantation

Balloon predilation is historically considered a requirement before performing transcatheter aortic valve implantation (TAVI). As the procedure has evolved, it has been questioned whether it is actually needed, but data are lacking on mid-term outcomes. The aim of this study was to evaluate the effect of balloon predilation before TAVI. A total of 517 patients who underwent transfemoral TAVI from November 2007 to October 2015 were analyzed. The devices implanted included the Medtronic CoreValve (n= 216), Medtronic Evolut R (n= 30), Edwards SAPIEN XT (n= 210), and Edwards SAPIEN 3 (n= 61). Patients were divided into 2 groups depending on whether pre-implantation balloon aortic valvuloplasty (pre-BAV) was performed (n= 326) or not (n= 191). Major adverse cardiac and cerebrovascular events (MACCE) were primarily evaluated. Propensity score matching was used to adjust for differences in baseline characteristics and potential confounders (n= 113 pairs). In the overall cohort, patients without pre-BAV had a significantly higher MACCE rate at 30days, driven by a higher incidence of stroke (0.3% pre-BAV vs 3.7% no-pre-BAV, p <0.01). MACCE and mortality at 1year were, however, similar in both groups. Independent predictors of MACCE at 1year included serum creatinine, NYHA class 3 to 4, logistic European System for Cardiac Operative Risk Evaluation, and postdilation. Of note, the postdilation rate was higher in the no-pre-BAV group (21.5% pre-BAV vs 35.6% no-pre-BAV, p <0.001). After propensity score matching, there were no differences in MACCE between the 2 groups. In conclusion, this study showed that, in selected patients and with specific transcatheter valves, TAVI without pre-BAV appears to be associated with similar mid-term outcomes compared with TAVI with pre-BAV, but it may increase the need for postdilation.

Trends in Complications and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Experience From the PARTNER Continued Access Registry.

The aim of this study was to examine trends in the rates of complications and outcomes of patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR). It is unknown whether an evolution of case selection or accrual of case experience over time has resulted in a change in the rates of complications and outcomes of patients undergoing TF-TAVR. TF-TAVR patients enrolled in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial) nonrandomized continued access registry (N= 1,063, enrolled March 2011 to January 2012 after completion of the randomized trial) were divided into tertiles (T1 through T3) based on enrollment date. Patient characteristics and rates of adverse events were compared over time. There were no significant differences in sex, New York Heart Association functional classes III/IV, diabetes, coronary artery disease, previous revascularization, pulmonary hypertension, renal disease, or liver disease. There was an increase in mean age, but a decrease in porcelain aorta, chronic obstructive pulmonary disease (including oxygen-dependent chronic obstructive pulmonary disease), previous chest wall radiation, and a slight decrease in the median Society of Thoracic Surgeons Predicted Risk of Mortality score. There was a significant decline in the frequency of patients deemed "inoperable" (cohort B) and in need for post-dilation. Percutaneous access increased significantly. There were no differences in post-procedural stroke, major bleeding, major vascular complications, or the need for aortic valve reintervention over time. The incidence of moderate/severe paravalvular regurgitation declined significantly as did all-cause mortality at 1 and 2 years. A significant reduction in the incidence of moderate/severe paravalvular regurgitation as well as longer term all-cause mortality was observed over time. The cause of these reductions was likely multifactorial, including improved case selection and procedural techniques and increased site experience. (THE PARTNER TRIAL [Placement of AoRTic TraNscathetER Valve Trial]; NCT00530894).

What is better for predilatation in bioresorbable vascular scaffold implantation: a non-compliant or a compliant balloon?

Objective:The bioresorbable vascular scaffold system (BVS) is a fully absorbable vascular treatment system. In this study, we aimed to compare the periprocedural effectiveness and long term results of non-compliant balloon (NCB) and compliant balloon (CB) systems, which are used for predilatation before BVS implantation.Methods:One hundred forty-six BVS-treated lesions from 119 patients were retrospectively analyzed in the study. Patients with acute coronary syndrome, stable angina and silent ischemia were included in the study. Lesions and patients were categorized into the NCB and CB groups according to the type of balloon used for predilatation. NCB was implemented on 72 lesions (59 patients) and CB was implemented on 74 lesions (60 patients). The two groups were compared on terms of procedural features and both in-hospital and 1-year clinical follow-up results. Chi-square and independent sample t test were performed for statistical analysis.Results:There was no significant difference between the two groups in terms of patient characteristics and lesion properties. The number of postdilated lesions was significantly higher in the CB group. Procedure time, fluoroscopy time, and contrast volume were significantly lower in the NCB group. At follow-up, one patient had myocardial infarction in the CB group because of scaffold thrombosis and no mortality was observed.Conclusion:Predilatation with NCB before BVS implantation reduces the need for postdilatation. In addition, use of NCB reduces the procedure time, fluoroscopy time, and contrast volume but had no effect on 1 year clinical follow-up results compared with CB.

Comparison of Hemodynamic Performance of the Balloon-Expandable SAPIEN 3 Versus SAPIEN XT Transcatheter Valve

The SAPIEN 3 valve (S3V) is a new-generation transcatheter valve with enhanced anti-paravalvular leak properties, but no data comparing with earlier transcatheter valve systems are available. We aimed to compare the hemodynamic performance of the S3V and the SAPIEN XT valve (SXTV) in a case-matched study with echo core laboratory analysis. A total of 27 patients who underwent transcatheter aortic valve replacement (TAVR) with the S3V were matched for prosthesis size (26 mm), aortic annulus area, and mean diameter measured by computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 50 patients treated with the SXTV. The prosthesis size was determined by oversizing of 1% to 15% of annulus area. Doppler echocardiographic images collected at baseline and 1-month follow-up were analyzed in a central echocardiography core laboratory. The need for postdilation was higher in the SXTV group (20% vs 4%, p=0.047), and mean residual gradient and effective orifice area were similar in both groups (p>0.05). The incidence of paravalvular aortic regurgitation was greater with the SXTV (≥mild: 42%, moderate: 8%) than with the S3V (≥mild: 7%, moderate: 0%; p=0.002 for ≥mild vs SXTV). The implantation of an S3V was the only factor associated with trace or no paravalvular leak after TAVR (p=0.007). In conclusion, TAVR with the S3V was associated with a very low rate of paravalvular leaks and need for balloon postdilation, much lower than that observed with the earlier generation of balloon-expandable valve (SXTV). The confirmation of these results in a larger cohort of patients will represent a major step forward in using transcatheter valves for the treatment of aortic stenosis.

TCT-80: Amount of Aortic Valve Calcification Impairs Acute Procedural Result After Transcatheter Aortic Valve Implantation and Increases the Need for Postdilation

TCT-80: Amount of Aortic Valve Calcification Impairs Acute Procedural Result After Transcatheter Aortic Valve Implantation and Increases the Need for Postdilation

Stent Size Selection Using 64-Detector Coronary Computed Tomography Angiography: A Comparison to Invasive Coronary Angiography

Compare stent size selection using coronary computed tomography angiography (CCTA) to invasive coronary angiography (ICA). CCTA is increasingly performed before cardiac catheterization; however, the utility of incorporating these data into coronary interventions is unknown. Retrospective study of 18 consecutive patients with 24 coronary artery lesions evaluated with 64-detector CCTA followed by ICA and resulting stent placement. Two blinded interventional cardiologists independently reviewed designated arterial segments on both CCTA and ICA during different reading sessions and determined anticipated stent length and nominal diameter, maximum stenosis, the need for postdilation of either stent margin, and final proximal and distal stent diameters. There was strong correlation between CCTA and ICA in the anticipated stent length (r = 0.85, P < .001) and final stent diameter (proximal end r = 0.74, P < .001; distal end r = 0.63, P = .001). Anticipated stent length was longer with CCTA compared to ICA (27.0 +/- 16.0 vs. 21.8 +/- 13.3 mm; P = .006). The final stent diameters were larger with CCTA compared to ICA, both at the proximal end (3.6 +/- 0.5 vs. 3.1 +/- 0.5 mm; P < .001) and distal end (3.2 +/- 0.6 vs. 2.9 +/- 0.4 mm; P = .004). Using 64-detector CCTA, interventional cardiologists select longer stents with larger final stent diameters than with ICA. Further studies are needed to determine the clinical utility of incorporating CCTA, when available, in defining interventional strategy.