Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. OBJECTIVES: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. METHODS: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. RESULTS: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. CONCLUSIONS: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

A new intravascular ultrasound-guided stenting strategy compared with angiography on stent expansion and procedural outcomes in patients with positive lesion remodeling.

OBJECTIVES: We investigated the role of a new intravascular ultrasound (IVUS)-guided stenting strategy versus angiography on optimal stent expansion (OSE) and procedural outcomes in patients with positive lesion remodeling. BACKGROUND: There are no IVUS criteria on how to achieve OSE. METHODS: A total of 100 patients were assigned to a new IVUS-guided stenting strategy (IVUS group) versus angiography-guided stenting (Angio group). In the IVUS group, among patients with positive lesion remodeling, defined as a remodeling ratio (RR; lesion external elastic membrane (EEM) area/distal reference EEM area) >1.05, the stent was expanded with a balloon sized to the distal reference EEM diameter. In the Angio group, the stent was expanded by visual estimation. In both groups, IVUS was performed after postdilation. RESULTS: Minimum stent area (MSA) and stent volume index were significantly larger in the IVUS versus Angio group (7.1 ± 1.9 vs. 5.9 ± 1.5 mm2 , and 8.7 ± 2.1 vs. 7.5 ± 1.8 mm3 /mm, respectively; p < .01). The percentages of OSE, defined as an MSA ≥5.4 mm2 , MSA ≥90% of distal reference lumen area (DRLA), or MSA > DRLA, were significantly higher in the IVUS versus Angio group (80 vs. 56%, 78 vs. 54%, and 71 vs. 38%, respectively; p < .01). Stent underexpansion, malapposition, and residual reference segment stenosis were significantly higher in the Angio versus IVUS group (44 vs. 12%, 16 vs. 4%, and 12 vs. 0%, respectively; p < .05). In the IVUS group, owing to positive remodeling, there was no incidence of dissection or perforation. CONCLUSIONS: This new strategy of IVUS-guided stenting in patients with positive lesion remodeling, compared with angiography, significantly increased stent expansion and decreased stent underexpansion, malapposition, and residual reference segment stenosis with no complications.

Aortic Valve Stenosis Treatment Disparities in the Underserved: JACC Council Perspectives.

Underserved minorities make up a disproportionately small subset of patients in the United States undergoing transcatheter and surgical aortic valve replacement for aortic stenosis. The reasons for these treatment gaps include differences in disease prevalence and patient, health care system, and disease-related factors. This has major implications not only for minority patients, but also for other groups who face similar challenges in accessing state-of-the-art care for structural heart disease. The authors propose the following key strategies to address these treatment disparities: 1) implementation of measure-based quality improvement programs; 2) effective culturally competent communication and team-based care; 3) improving patient health care access, education, and effective diagnosis; and 4) changing the research paradigm that creates an innovation pipeline for patients. Only a concerted effort from all stakeholders will achieve equitable and broad application of this and other novel structural heart disease treatment modalities in the future.

Early Outcomes of Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification.

OBJECTIVES: The aim of this study was to examine 1-year outcomes of transseptal balloon-expandable transcatheter heart valve implantation in failed mitral bioprosthesis, ring annuloplasty, and mitral annular calcification (MAC). BACKGROUND: Immediate outcomes following transseptal mitral valve implantation in failed bioprostheses are favorable, but data on subsequent outcomes are lacking. METHODS: Percutaneous transseptal implantation of balloon-expandable transcatheter heart valves was performed in 87 patients with degenerated mitral bioprostheses (valve in valve [VIV]) (n = 60), previous ring annuloplasty (valve in ring) (n = 15), and severe MAC (valve in MAC) (n = 12). RESULTS: The mean Society of Thoracic Surgeons risk score was 13 ± 8%, and the mean age was 75 ± 11 years. Acute procedural success was achieved in 78 of 87 patients (90%) in the overall group and 58 of 60 (97%) in the VIV group, with a success rate of 20 of 27 (74%) in the valve in ring/valve in MAC group. Thirty-day survival free of death and cardiovascular surgery was 95% (95% confidence interval [CI]: 92% to 97%) in the VIV subgroup and 78% (95% CI: 70% to 86%) in the valve in ring/valve in MAC group (p = 0.008). One-year survival free of death and cardiovascular surgery was 86% (95% CI: 81% to 91%) in the VIV group compared with 68% (95% CI: 58% to 78%) (p = 0.008). At 1 year, 36 of 40 patients (90%) had New York Heart Association functional class I or II symptoms, no patients had more than mild residual mitral prosthetic or periprosthetic regurgitation, and the mean transvalvular gradient was 7 ± 3 mm Hg. CONCLUSIONS: One-year outcomes following successful transseptal balloon-expandable transcatheter heart valve implantation in high-risk patients with degenerated mitral bioprostheses are excellent, characterized by durable symptom relief and prosthesis function. Although mitral valve in ring and valve in MAC have higher operative morbidity and mortality, 1-year outcomes after an initially successful procedure are favorable in carefully selected patients.

Building Blocks of Structural Intervention: A Novel Modular Paradigm for Procedural Training.

Structural heart disease is a rapidly evolving field, and approaches to procedural training are not standardized. We describe a novel modular approach to procedural training that considers each procedure as a series of building blocks that may be taught and assessed separately. Ten key structural heart disease building blocks can be identified, which, when combined with the cognitive skills of structural intervention and device-specific training, allow appropriate planning and implementation of structural procedures. Structural procedures require careful navigation of the aorta, left atrium, and right heart, including detailed understanding of relational anatomy. Component blocks include large bore vascular access, navigation within the left atrium, occlusion, snaring, and 3-dimensional relational anatomy. These building blocks also provide the foundation for new procedures through innovative use of the skill sets and devices to approach new clinical problems. The addition of device-specific training may be provided via proctoring and industry support. Using this approach, competency in less common procedures may be achieved and maintained. We discuss each building block in detail, approaches specific to the structural heart disease patient, the need for cross-discipline training, and empirical recommendations for training using this approach. We postulate that this new paradigm may be the preferred approach for training and assessment of structural heart disease interventional skills.

Ticagrelor and Eptifibatide Bolus Versus Ticagrelor and Eptifibatide Bolus With 2-Hour Infusion in High-Risk Acute Coronary Syndromes Patients Undergoing Early Percutaneous Coronary Intervention.

BACKGROUND: In patients with non-ST-segment elevation acute coronary syndromes, inhibition of platelet aggregation (IPA) with a potent P2Y12 inhibitor, ticagrelor, was inferior to tirofiban infusion at 2 hours, indicating that glycoprotein IIb/IIIa inhibitors are still needed. Ticagrelor and eptifibatide bolus only may maximally inhibit platelet aggregation and decrease bleeding, but IPA with ticagrelor and eptifibatide bolus versus 2-hour infusion is unknown. METHODS AND RESULTS: A total of 70 P2Y12-naïve patients, with high-risk non-ST-segment elevation acute coronary syndromes, were randomized to ticagrelor and eptifibatide bolus (group 1) versus ticagrelor and eptifibatide bolus with 2-hour infusion (group 2). Levels of IPA with ADP, thrombin receptor-activating peptide, collagen, and high on-treatment platelet reactivity were measured by light transmission aggregometry at baseline and at 2, 6, and 24 hours after percutaneous coronary intervention in both groups. The primary end point, IPA with ADP 20 µmol/L at 2 hours, was 99.59±0.43% in group 1 versus 99.88±1.0% in group 2 (P<0.001 for noninferiority). High on-treatment platelet reactivity with ADP was zero at 2, 6, and 24 hours in both groups. IPA levels with ADP, thrombin receptor-activating peptide, and collagen were significantly higher at 2 and 6 hours than at 24 hours in both groups. Periprocedural myocardial infarction was not significantly different between the groups. Hemoglobin level was significantly less at 24 hours versus baseline in group 2 (13.35±1.8 versus 12.38±1.8 g/dL, respectively; P<0.01). CONCLUSIONS: Ticagrelor and eptifibatide bolus maximally inhibited platelet aggregation at 2 hours, which was associated with no significant hemoglobin drop after percutaneous coronary intervention. This obviates the need for eptifibatide 2-hour infusion and might decrease bleeding complications. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01919723.

Descending septal branch of right coronary artery: Rare, but important in hypertrophic cardiomyopathy.

A 54year old man with hypertrophic cardiomyopathy was evaluated for alcohol septal ablation. However there were no sizeable septal branches from the left anterior descending artery supplying the basal septum. He was found to have a rare variant, the descending septal branch from ostial right coronary artery and underwent ablation through the same. We describe our case and the relevant literature available for use of this anatomical variant in alcohol septal ablation.

Large-field intravascular ultrasound for annular sizing and predicting paravalvular regurgitation during TAVR: comparisons with multidetector computed tomography and transoesophageal echocardiography.

AIMS: The use of contrast media with multidetector computed tomography (MDCT) may induce acute kidney injury in patients with renal failure undergoing transcatheter aortic valve replacement (TAVR). We investigated the role of large-field intravascular ultrasound (IVUS) vs. MDCT and two-dimensional transoesophageal echocardiography (2D-TEE) for annular sizing and predicting paravalvular regurgitation (PVR) during TAVR. METHODS AND RESULTS: The aortic annulus was measured by large-field IVUS and 2D-TEE, and compared with MDCT in 50 patients undergoing TAVR. The IVUS and MDCT annular areas and diameters were not significantly different (446 ± 87 mm2 and 23.8 ± 84 mm vs. 466 ± 84 mm2 and 24 ± 2.1 mm, respectively; P > 0.05). IVUS and MDCT mean annular diameters were significantly greater than TEE diameter (23.8 ± 2.4 and 24 ± 2.1 vs. 22 ± 0.65 mm, respectively; P < 0.01). PVR ≥ Mild occurred in 13 patients (26%); 5 patients required post-dilation and 2 patients a second valve. Receiver operating characteristic analyses showed that transcatheter heart valve (THV) area - IVUS or MDCT areas equally predicted of ≥ mild PVR (areas under the curve [AUC] 0.79 and 0.81, respectively; P < 0.001), and were greater than THV diameter-TEE diameter (AUC 0.79 and 0.81 vs. 0.56, respectively; P < 0.05). CONCLUSIONS: The aortic annular measurements and predicting PVR by large field IVUS were not significantly different from those of MDCT, but were greater than those of TEE. Large filed IVUS can be reliably used in lieu of MDCT for annular sizing in patients with aortic stenosis and renal failure or suboptimal MDCT images.

Safety of hydrophilic guidewires used for side-branch protection during stenting and proximal optimization technique in coronary bifurcation lesions.

BACKGROUND AND PROPOSE: In coronary bifurcation lesions (CBL), hydrophilic guidewires used for side-branch (SB) protection can be withdrawn from underneath the stent easier than other wires. However, the safety of which has not been investigated. METHODS/MATERIALS: We performed scanning electron microscopic (SEM) examination of hydrophilic wires - the Whisper and Runthrough wires - used for SB protection during stenting and proximal optimization technique (POT) in 30 patients with CBL. The distal 15cm of the wire was examined every 1mm by SEM and 4500 segments were analyzed to investigate for wire fracture, polymer shearing (PS), and its correlations with post-stenting creatine kinase (CK)-MB release. RESULTS: SEM examination showed no evidence for wire fracture. The total area of PS and the largest defect on the wire were significantly larger with the Whisper wire versus the Runthrough wire (0.15±0.04mm2 vs. 0.026±0.01mm2 and 0.04±0.05mm2 vs. 0.01±0.01mm2; P<0.05, respectively). The total length of PS and the longest defect on the wire were significantly longer with the Whisper wire vs. the Runthrough wire (12.1±14.5mm vs. 2.7±3.0mm and 2.9±4.2mm vs. 1.0±1.2mm; P<0.05, respectively), but there were weak correlations between the extents of PS with CK-MB release. CONCLUSIONS: Hydrophilic guidewires may be safely used for SB protection during stenting and POT in CBLs. The extent of PS was significantly greater with the Whisper wire than with the Runthrough wire, but its correlation with post-stenting CK-MB release was weak.

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety.

OBJECTIVES: Introduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve). METHODS: From April 2007 to February 2012, 1100 patients, average age 85.0 ± 6.4 years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling. RESULTS: Mean procedure time decreased from 131 to 116 minutes within 30 cases (P = .06) and device success increased to 90% by case 45 (P = .0007). Within 30 days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (P âˆ¼ .08). Although longer procedure time was associated with more adverse events (P < .0001), these events were associated with change in patient risk profile, not the technical performance learning curve (P = .8). CONCLUSIONS: The learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex.

Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Ring Annuloplasty, and Severe Mitral Annular Calcification.

OBJECTIVES: This study sought to examine the feasibility, safety, and intermediate-term outcomes in patients undergoing percutaneous transvenous transcatheter mitral valve implantation in failed bioprosthesis, ring annuloplasty, and calcific mitral stenosis. BACKGROUND: Surgical mitral valve replacement in patients with previous surgery or severe mitral annular calcification (MAC) is often associated with high or prohibitive risk. METHODS: Percutaneous transfemoral antegrade transseptal implantation of Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California) was performed in 48 patients with degenerated mitral bioprosthesis (n = 33), previous ring annuloplasty (n = 9), and severe MAC (n = 6). RESULTS: The mean Society of Thoracic Surgeons risk score was 13.2 ± 7.4% with a mean age 76 ± 11 years. Acute procedural success was achieved in 42 of 48 patients (88%) in the overall group and 31 of 33 (94%) in the failed bioprosthetic mitral valve group and success rate of 11 of 15 (73%) in patients with failed annuloplasty rings and MAC. After successful procedure, no patients had > mild residual mitral prosthetic or periprosthetic regurgitation; mean transvalvular gradients were 6 ± 2.5 mm Hg. Thirty-day survival free of death and cardiovascular surgery was 85% in the overall group and 91% in the failed bioprosthetic mitral valve subgroup. CONCLUSIONS: Transfemoral percutaneous transvenous mitral valve implantation in high-risk patients with degenerated bioprosthesis is safe, effective, and associated with rapid improvement in hemodynamics, short length of stays, and improved functional status. Percutaneous mitral valve implantation in patients with failed annuloplasty rings and severe MAC is a promising therapy with significant short-term morbidity and mortality that requires further study.

Impact of Transcatheter Aortic Valve Replacement on Surgical Volumes and Outcomes in a Tertiary Academic Cardiac Surgical Practice.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) was FDA approved for the Sapien valve (Edwards Lifesciences) in the United States in November 2011. We sought to examine the impact of TAVR post-FDA approval on aortic valve surgery at our institution. STUDY DESIGN: Prospective data were collected on 573 consecutive patients that underwent surgical aortic valve replacement (SAVR) or TAVR with either the Sapien or Sapien XT from January 1, 2009 through December 31, 2014. RESULTS: Patients were divided into the following groups: SAVR before TAVR (n = 215), SAVR post TAVR (n = 163), and TAVR (n = 195). The 30-day mortality was not different among the 3 groups, but the mortality for the SAVR post TAVR group was better than the SAVR before TAVR group (p = 0.03). Postoperative hospital length of stay, ventilation hours, and atrial fibrillation were all decreased in the TAVR group. The number of isolated SAVRs increased after TAVR from 60 per year in group 1 to 67 per year in group 2. The total number of all isolated aortic valve procedures (SAVR + TAVR) increased from 60 per year to 177 per year. The TAVR group was divided into the following subgroups to examine the procedural learning curve: patients 1 to 50, patients 51 to 100, and patients 101 to 195. Mortality was higher in group 1 (8%) vs group 2 (0%) and group 3 (1%). CONCLUSIONS: Since initiation of the TAVR program at our institution, the total number of aortic valve procedures has increased. Transcatheter aortic valve replacement patients had more preoperative comorbidities, but no difference in postoperative morbidity or mortality and shorter length of stay. Transcatheter aortic valve replacement mortality has continued to improve since the inception of the program.

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

OBJECTIVES: 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). BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).

Simultaneous transcatheter pulmonary and tricuspid valve-in-valve implantation for the treatment of failing pulmonary and tricuspid bioprostheses.

We report a case of a patient with a history of bioprosthetic pulmonary and tricuspid valve replacement who developed significant stenosis and regurgitation of the bioprosthetic valves. Due to multiple comorbidities, he was deemed high risk for redo-valve replacement surgery. He subsequently underwent percutaneous transcatheter pulmonary and tricuspid valve-in-valve procedure at the same setting. This is the first of such that is reported in the literature. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

OBJECTIVES: To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: TF-TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown. METHODS: In the PARTNER-I trial, 1,521 patients underwent TF-TAVR from 4/2007-2/2012. Learning curve analysis of technical performance metrics was performed using institution-specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi-parametric and parametric mixed-effects models. RESULTS: As patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52-140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21-52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%. CONCLUSIONS: Technical performance learning curves exist for TF-TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late-entering institutions. Knowledge and experience accumulated by early TF-TAVR institutions were disseminated, shortening the learning curve of late-entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut-down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.

OBJECTIVES: To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve. BACKGROUND: TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes. METHODS: From 4/2007-2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay. RESULTS: Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6). CONCLUSIONS: By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

Emergent transcatheter mitral valve-in-valve implantation in a patient with cardiogenic shock secondary to a failed mitral bioprosthesis.

Transcatheter valve-in-valve (VIV) implantation is emerging as a therapeutic option for treatment of failed bioprosthesis in patients that are deemed high-risk or inoperable for redo-valve replacement. It can be carried out in suitable bioprosthetic valves in any position and usually performed as an elective or semi-elective procedure. Here, we report a case of emergent transcatheter VIV implantation in a failed mitral bioprosthesis in a critically ill patient with cardiogenic shock. We conclude that transcatheter VIV implantation may also be an option for critically ill patients with failing bioprosthesis. © 2015 Wiley Periodicals, Inc.

TAVR: Imaging Spectrum of Complications.

Transcatheter aortic valve replacement has recently become a suitable alternative for senile aortic stenosis in patients not suitable for surgery. With growing operative experience, appropriate patient selection, advances in imaging evaluation, and technical refinements, the outcomes have improved. Despite its less invasive nature, a unique set of complications and events are encountered during the transcatheter aortic valve replacement procedure and in the postoperative period. Knowledge of these complications, their prompt detection, and quick adequate treatment are critical in reducing the mortality and morbidity.