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Objective Transcarotid access for transcatheter aortic valve replacement is emerging as an alternative to more traditional nonfemoral access options such as transapical or transaortic; however, comparative data are limited. The purpose of the study was to analyze outcomes after transcatheter aortic valve replacement using transcatheter compared with transthoracic (transapical/transaortic) access. Methods The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was queried for patients who underwent transcarotid, transapical, or transaortic transcatheter aortic valve replacement with the SAPIEN 3 (Edwards Lifesciences, Irvine, Calif) transcatheter heart valve between June 2015 and July 2019. Thirty-day unadjusted outcomes were evaluated, and propensity score matching and logistic regression were used to compare transcatheter access with transthoracic access. Results In the propensity-matched analysis, 667 transcarotid transcatheter aortic valve replacement procedures were compared with 1334 transthoracic procedures. Transcarotid transcatheter aortic valve replacement was associated with lower mortality (4.2% vs 7.7%, P = .004), less new-onset atrial fibrillation (2.2% vs 12.1%, P Conclusions Transcatheter aortic valve replacement using transcarotid access is associated with lower 30-day mortality, less atrial fibrillation, shorter intensive care unit and overall length of stay, fewer readmissions, greater improvement in Kansas City Cardiomyopathy Questionnaire scores, and no significant difference in stroke or major vascular complications compared with transthoracic access.

Objectives This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. Background Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. Methods The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. Results Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. Conclusions BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

Background: Bioprosthetic valve fracture (BVF) improves the hemodynamic results of valve-in-valve transcatheter aortic valve replacement (VIV TAVR) by facilitating optimal expansion of the transcat...

A 48-year-old woman presented with heart failure and bioprosthetic pulmonary valve regurgitation 2 years after pulmonary valve replacement. Intracardiac echocardiography demonstrated uniform thickening of a single prosthetic valve leaflet suggesting leaflet thrombosis rather than bioprosthetic valve degeneration. After 3 months of anticoagulation, valve regurgitation and symptoms improved. (Level of Difficulty: Intermediate.), Central Illustration

Background: Patient recovery following alternative-access transcatheter aortic valve replacement (TAVR) via transcarotid (TC) and transthoracic (TT; transapical or transaortic) access has not been ...

Degeneration of surgical bioprosthetic heart valves (BPVs) occurs in up to one third of surviving patients within a decade of implantation and is a common cause of cardiovascular morbidity. Valve-i...

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is approved by the FDA in patients at high surgical risk and increasingly utilized by heart teams as an alternative to reoperation for failing surgical tissue valves. Optimizing transcatheter heart valve (THV) expansion and decreasing the risk of patient-prosthesis mismatch are important concerns when performing VIV TAVR, particularly in small surgical valves. Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) are techniques to facilitate VIV TAVR in which a high-pressure inflation with a non-compliant balloon is performed to either fracture or stretch the surgical valve ring allowing for a more optimal expansion of the THV and reducing the potential for high residual transvalvular gradients. This article, along with the supplemental video, will provide a practical guide to performing BVF and BVR.

Objectives The aim of this study was to examine the relationship between chronic obstructive pulmonary disease (COPD) and outcomes after transcatheter mitral valve repair (TMVr) for severe secondary mitral regurgitation. Background TMVr with the MitraClip improves clinical and health-status outcomes in patients with heart failure and severe (3+ to 4+) secondary mitral regurgitation. Whether these benefits are modified by COPD is unknown. Methods COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) was an open-label, multicenter, randomized trial of TMVr plus guideline-directed medical therapy (GDMT) versus GDMT alone. Patients on corticosteroids or continuous oxygen were excluded. Multivariable models were used to examine the associations of COPD with mortality, heart failure hospitalization (HFH), and health status and to test whether COPD modified the benefit of TMVr compared with GDMT. Results Among 614 patients, 143 (23.2%) had COPD. Among patients treated with TMVr, unadjusted analyses demonstrated increased 2-year mortality in those with COPD (hazard ratio [HR]: 2.08; 95% confidence interval [CI]: 1.33 to 3.26), but this association was attenuated after risk adjustment (adjusted HR: 1.48; 95% CI: 0.87 to 2.52). Although TMVr led to reduced 2-year mortality among patients without COPD (adjusted HR: 0.47; 95% CI: 0.33 to 0.67), for patients with COPD, 2-year all-cause mortality was similar after TMVr versus GDMT alone (adjusted HR: 0.94; 95% CI: 0.54 to 1.65; pint = 0.04), findings that reflect offsetting effects on cardiovascular and noncardiovascular mortality. In contrast, TMVr reduced HFH (adjusted HR: 0.48 [95% CI: 0.28 to 0.83] vs. 0.46 [95% CI: 0.34 to 0.63]; pint = 0.89) and improved both generic and disease-specific health status to a similar extent compared with GDMT alone in patients with and without COPD (pint >0.30 for all scales). Conclusions In the COAPT trial, COPD was associated with attenuation of the survival benefit of TMVr versus GDMT compared with patients without COPD. However, the benefits of TMVr on both HFH and health status were similar regardless of COPD. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] [COAPT]; NCT01626079 )

Data regarding outcomes for patients with severe aortic stenosis (AS) with concomitant aortic insufficiency (AI), undergoing transcatheter aortic valve replacement (TAVR) are limited. This study aimed to analyze the prevalence of severe AS with concomitant AI among patients undergoing TAVR and outcomes of TAVR in this patient group.Using data from the STS/ACC-TVT Registry, we identified patients with severe AS with or without concomitant AI who underwent TAVR between 2011 and 2016. Patients were categorized based on the severity of pre-procedural AI. Multivariable proportional hazards regression models were used to examine all-cause mortality and heart failure (HF) hospitalization at 1-year. Among 54,535 patients undergoing TAVR, 42,568 (78.1%) had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P.001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P.001).Severe AS with concomitant AI is common among patients undergoing TAVR, and is associated with lower 1 year mortality and HF hospitalization. Future studies are warranted to better understand the mechanisms underlying this benefit.In this nationally representative analysis from the United States, 78.1% of patients undergoing TAVR had severe AS with concomitant AI. Device success was lower in patients with severe AS with concomitant AI as compared with isolated AS. The presence of baseline AI was associated with lower 1 year mortality (HR 0.94 per 1 grade increase in AI severity; 95% CI, 0.91-0.98, P.001) and HF hospitalization (HR 0.87 per 1 grade increase in AI severity; 95% CI, 0.84-0.91, P.001).

Background In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, transcatheter mitral valve repair (TMVr) with the MitraClip rapidly improved health status and reduced the long-term risks for death and heart failure (HF) hospitalization in patients with HF and severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT). Objectives The aim of this study was to examine if early health status changes were associated with long-term clinical outcomes in the COAPT population. Methods The association between change in health status (Kansas City Cardiomyopathy Questionnaire overall summary score [KCCQ-OS]) from baseline to 1 month and the composite rate of death or HF hospitalization between 1 month and 2 years in the COAPT trial were evaluated, and whether treatment (TMVr or GDMT alone) modified this association was tested. Results Among 551 patients with HF and severe secondary mitral regurgitation who were alive at 1 month, those randomized to TMVr were more likely than those randomized to GDMT alone to achieve a ≥10-point improvement in KCCQ-OS from baseline to 1 month (TMVr, 58%; GDMT alone, 26%). Early improvement in KCCQ-OS was inversely associated with the risk for death or HF hospitalization between 1 month and 2 years (p Conclusions In patients with HF and severe secondary mitral regurgitation, a short-term change in disease-specific health status was strongly associated with the subsequent long-term risk for death or HF hospitalization. These findings reinforce the prognostic utility of serial KCCQ-OS assessments to identify patients at risk for poor long-term clinical outcomes in this population. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial]; NCT01626079).

Background: Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is an effective treatment for high-risk patients with failed surgical bioprosthetic valves, but may be complicated by pa...

ObjectivesThis study aimed to compare short- and long-term outcomes following various alternative access routes for transcatheter aortic valve replacement (TAVR).MethodsThirty-four studies with a pooled sample size of 30,986 records were selected by searching PubMed and Cochrane library databases from inception through 11thJune 2021 for patients undergoing TAVR via 1 of 6 different access sites: Transfemoral (TF), Transaortic (TAO), Transapical (TA), Transcarotid (TC), Transaxillary/Subclavian (TSA), and Transcaval (TCV). Data extracted from these studies were used to conduct a frequentist network meta-analysis with a random-effects model using TF access as a reference group.ResultsCompared with TF, both TAO [RR 1.91, 95% CI (1.46–2.50)] and TA access [RR 2.12, 95%CI (1.84–2.46)] were associated with an increased risk of 30-day mortality. No significant difference was observed for stroke, myocardial infarction, major bleeding, conversion to open surgery, and major adverse cardiovascular or cerebrovascular events in the short-term (≤ 30 days). Major vascular complications were lower in TA [RR 0.43, (95% CI, 0.28-0.67)] and TC [RR 0.51, 95% CI (0.35-0.73)] access compared to TF. The 1-year mortality was higher in the TAO [RR of 1.35, (95% CI, 1.01–1.81)] and TA [RR 1.44, (95% CI, 1.14–1.81)] groups.ConclusionNon-thoracic alternative access site utilization for TAVR implantation (TC, TSA and TCV) is associated with similar outcomes to conventional TF access. Thoracic TAVR access (TAO and TA) is associated with increased short and long-term mortality.

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is currently indicated for the treatment of failed surgical tissue valves in patients determined to be at high surgical risk for re-operative surgical valve replacement. VIV TAVR, however, often results in suboptimal expansion of the transcatheter heart valve (THV) and can result in patient-prosthesis mismatch (PPM), particularly in small surgical valves. Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) can facilitate VIV TAVR by optimally expanding the THV and reducing the residual transvalvular gradient by utilizing a high-pressure inflation with a non-compliant balloon to either fracture or stretch the surgical valve ring, respectively. This article, along with the supplemental video, will provide patient selection, procedural planning and technical insights for performing BVF and BVR.

Purpose. Opioid-related adverse drug events (ORADEs) increase patient length of stay (LOS) and health care costs. However, ORADE rates may be underreported. This study attempts to understand the degree to which ORADEs are underreported in Medicare patients undergoing cardiac surgery. Materials and Methods. The Center for Medicare and Medicaid Services administrative claims database was used to identify ORADEs in 110 158 Medicare beneficiaries who underwent cardiac valve (n = 50 525) or coronary bypass (n = 59 633) surgery between April 2016 and March 2017. The International Classification of Disease (ICD)-10 codes specifically linked to ORADEs were used to identify an actual ORADE rate, while additional ICD codes, clinically associated with butas not specific to adverse drug events were analyzed as potential ORADEs. Length of stay (LOS) and hospital daily revenue were analyzed among patients with or without a potential ORADE. Results. Among patients undergoing valve or bypass surgery, the documented ORADE rate was 0.7% (743/110 158). However, potential ORADEs may have occurred in up to 32.4% (35 658/110 158) of patients. In patients with a potential ORADE, mean LOS was longer (11.4 vs 8.2 days; P < .0001) and mean Medicare revenue/day was lower ($4016 vs $4412; P < .0001). The mean net difference in revenue/day between patients with and without an ORADE varied between $231 and $1145, depending on the Diagnosis-Related Group analyzed. Conclusions. ORADEs are likely underreported following cardiac surgery. ORADEs can be associated with increased LOS and decreased hospital revenue. Understanding the incidence and economic impact of ORADEs may expedite changes to postoperative pain management. Adopting multimodal pain management strategies that reduce exposure to opioids may improve outcomes by reducing complications, side effects, and health care costs.

Objectives The aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair. Background Transcatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance. Methods MitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable. Results MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p Conclusions For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction.

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is a safe and effective method of treating patients with failed bioprosthetic surgical valves (BSVs) at high risk of reoperation. Ho...

OBJECTIVES We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site. BACKGROUND The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site. METHODS Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed. RESULTS A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p

Transcatheter mitral valve repair with MitraClip is a novel, intricate therapy for mitral regurgitation that improves survival and quality of life. Similar to other medical procedures, there is a relationship between procedural experience and clinical outcomes. MitraClip results and the efficiency and safety of the procedure all improved with increasing experience at both the institutional and operator level in two large studies from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry. Patient selection was also found to have a significant role in procedure success. The old adage of “See one, do one, teach one” does not necessarily apply to complex interventions, such as MitraClip, given that the learning curve does not appear to plateau even as operators approach a 150-case experience.

Transcatheter aortic valve implantation (TAVI) for isolated aortic regurgitation (AR) comprises

Background: Clinical trials have demonstrated health status benefit of transcatheter mitral valve repair (TMVr) with MitraClip in patients with mitral valve regurgitation. Real-world site-level variability in health status outcomes for TMVr, and factors associated with this variability, are unknown. Methods: All patients undergoing TMVr procedure with MitraClip between November 2013 and March 2019 in the Transcatheter Valve Therapy Registry were included. Health status was measured at baseline and 30 days with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) score. Site-level variability in 30-day change in KCCQ-OS was examined by calculating the median odds ratio from a hierarchical logistic regression model, with ≥20-point improvement as the dependent variable. To define the extent to which patient characteristics, procedural characteristics (residual mitral valve regurgitation, periprocedural bleeding), site volume, and patients’ baseline health status accounted for variability in outcomes, the proportion of variability ( R 2 ) explained by sequentially adding these variables to the model was quantified. Results: Across 339 sites, 12 415 patients (mean age 79.0±9.5 years, 46.1%. females, 89.5% White) completed baseline and 30-day health status assessments. Mean KCCQ-OS score was 43.0±24.4 at baseline and 67.0±24.9 at 30-day follow-up. Across sites, the proportion of patients achieving a ≥20-point improvement in KCCQ-OS ranged from 12.5% to 100% and the adjusted median odds ratio was 1.58 (95% CI, 1.46–1.69). The greatest contribution to the variability in health status outcomes was from patients’ baseline KCCQ-OS score ( R 2 =25%) with Conclusions: There is moderate variation across sites in their patients’ achievement of health status benefits from TMVr, with patient’s baseline health status accounting for the largest proportion of this variation. This underscores the importance of patient selection in supporting more consistent health status benefit from TMVr.

Introduction: Pulmonary hypertension (PH) was shown in multiple studies to be associated with an increased risk of mortality after transcatheter aortic valve replacement (TAVR). However, it is unclear if echocardiogram derived right ventricular systolic pressure (RVSP) is associated with health status outcomes in surviving patients after TAVR. We explored for an association between baseline RVSP and quality of life in patients before and after undergoing TAVR. Methods: We estimated RVSP by echocardiography using the modified Bernoulli equation in a single-center cohort of patients undergoing TAVR from 2012-2017 . Disease-specific health status was assessed at baseline and 1-month and 12-months after TAVR with the Kansas City Cardiomyopathy Questionnaire-Overall Summary Score (KCCQ-OS). We then explored the association between baseline RVSP and KCCQ-OS before and after TAVR using a linear mixed model with an interaction for time and baseline RVSP and adjusted for baseline mitral valve regurgitation and systolic blood pressure. Results: Among 485 patients who underwent TAVR (mean age 81.7±7.9 years, 54.8% men), baseline RVSP was 42±15 mmHg, and 73% had RVSP >34 mmHg. After TAVR, mean RVSP decreased to 37±13 mmHg at 1 month and 36±14 mmHg at 12 months. Baseline KCCQ-OS was 46±25 and improved to 66.9±23.6 at 1 month and 69.5± 22.6 at 12 months. In the linear mixed model, there was a significant cross-sectional association between baseline RVSP and baseline KCCQ-OS, with higher RVSP associated with worse health status. However, baseline RVSP was not significantly associated with KCCQ-OS at 1 month or 12 months (Figure). Conclusions: RVSP is not associated with worse health status after TAVR. This suggests that while patients with high RVSP are at an increased risk for mortality after TAVR, surviving patients appear to have similar health status as those with normal RVSP.

To review the current status and indications of transcatheter edge-to-edge mitral valve repair. Mitral regurgitation remains a common valvular disease and can be classified as degenerative (primary) or functional (secondary). Randomized controlled trials have shown that transcatheter edge-to-edge mitral valve repair with MitraClip is successful, safe, and effective in reducing mitral regurgitation. The US Food and Drug Administration approved MitraClip in 2013 for treatment of patients with primary mitral regurgitation at prohibitive surgical risk and in 2019 for secondary mitral regurgitation. Several MitraClip generations exist (NT/R, XT/R, NTW, and XTW) with unique features and considerations. Additional edge-to-edge repair, non-edge-to-edge repair, and transcatheter valve replacement systems are under investigation as stand-alone or adjunctive therapy for patients with mitral regurgitation. Mitral regurgitation remains a significant health burden and many patients are not suitable for surgical repair or replacement. Transcatheter mitral valve therapies can be considered in selected patients and are safe and effective. More research is needed to understand how to best select devices and patients and optimize outcomes.

Aims Bioprosthetic valve fracture (BVF) may improve transvalvular gradients and transcatheter heart valve (THV) expansion during VIV interventions. However, the optimal timing of BVF is unknown. We assessed the impact of timing of BVF (before versus after) for valve-in-valve (VIV) intervention, on hydrodynamic function and THV expansion. Methods and results Three THV designs were assessed, a 23 mm SAPIEN 3 (S3), small ACURATE neo (ACn) and 23 mm Evolut R, deployed into 21 mm Mitroflow bioprosthetic surgical valves. We evaluated each THV in three groups: 1) no BVF, 2) BVF before VIV, and 3) BVF after VIV. Hydrodynamic testing was performed using a pulse duplicator to ISO 5840:2013 standard. Transvalvular gradients were lower when BVF was performed after VIV for the S3 (no BVF 15.5 mmHg, BVF before VIV 8.0 mmHg, BVF after VIV 5.6 mmHg), and the ACn (no BVF 9.8 mmHg, BVF before VIV 8.4 mmHg, BVF after VIV 5.1 mmHg). Transvalvular gradients were similar for the Evolut R, irrespective of performance of BVF or timing of BVF. BVF performed after VIV resulted in better expansion in all three THV designs. The ACn and Evolut R samples all had a mild degree of pinwheeling, and BVF timing did not impact on pinwheeling severity. The S3 samples had severe pinwheeling with no BVF, and significant improvement in pinwheeling when BVF was performed after VIV. Conclusions BVF performed after VIV was associated with superior THV expansion in all three THV designs tested, with lower residual transvalvular gradients in the S3 and ACn THVs. The Evolut R had similar hydrodynamic performance irrespective of BVF timing. Timing of BVF has potential implications on THV function.

Valve-in-Valve Transcatheter aortic valve replacement (VIV TAVR) for treatment of failed bioprosthetic surgical valves has been shown to be a safe and effective alternative to reoperation for patie...

Objectives The aim of this study was to examine the independent impact of various care pathways, including those involving transradial intervention (TRI) and same-day discharge (SDD) after elective percutaneous coronary intervention (PCI), on hospital costs. Background PCI is associated with costs of $10 billion annually. Alternative payment models for PCI are being implemented, but few data exist on strategies to reduce costs. Various PCI care pathways, including TRI and SDD, exist, but their association with costs and outcomes is unknown. Methods In total, 279,987 PCI patients eligible for SDD in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims files were analyzed. Hospital costs in 2014 U.S. dollars were estimated using cost-to-charge ratios. Propensity scores for TRI and SDD, with propensity adjustment via inverse probability weighting, was performed. Results Of the 279,987 PCI procedures, TRI was used in 9.0% (13.5% of which were SDD), and SDD was used in 5.3% of cases (23.1% of which were TRI). TRI (vs. transfemoral intervention) was associated with lower adjusted costs of $916 (95% confidence interval [CI]: $778 to $1,035), as was SDD ($3,502; 95% CI: $3,486 to $3,902). The adjusted cost associated with TRI and SDD was $13,389 (95% CI: $13,161 to $13,607), while the cost associated with transfemoral intervention and non-same-day discharge was $17,076 (95% CI: $16,999 to $17,147), a difference of $3,689 (95% CI: $3,486 to $3,902; p Conclusions Among Medicare beneficiaries, TRI with SDD was independently associated with fewer complications and lower in-hospital costs. These findings have important implications for changing the current PCI care pathways to improve outcomes and reduce costs.

Objectives The aim of this study was to assess the association of baseline left ventricular diastolic dysfunction (LVDD) with health status outcomes of patients undergoing transcatheter aortic valve replacement (TAVR). Background Although LVDD in patients with aortic stenosis is associated with higher mortality after TAVR, it is unknown if it is also associated with health status recovery. Methods In a cohort of 304 patients with interpretable echocardiograms, undergoing TAVR, LVDD was categorized at baseline as absent (grade 0), mild (grade 1), moderate (grade 2), or severe (grade 3). Disease-specific health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at baseline and at 1-month and 12-month follow-up. Association of baseline LVDD with health status at baseline and follow-up after TAVR was assessed using a linear trend test, and association with health status recovery (change in KCCQ-OS) was examined using a linear mixed model adjusting for baseline KCCQ-OS. Results Twenty-four (7.9%), 54 (17.8%), 186 (61.2%), and 40 (13.2%) patients had LVDD grades of 0, 1, 2, and 3, respectively. Baseline KCCQ-OS was 61.3 ± 22.7, 51.0 ± 26.1, 44.7 ± 25.7, and 44.4 ± 21.9 (p = 0.004) in patients with LVDD grades of 0, 1,2 and 3. At 1 and 12 months after TAVR, LVDD was not associated with KCCQ-OS. Recovery in KCCQ-OS after TAVR was substantial and similar in patients across all severities of LVDD. Conclusions Although LVDD is associated with health status prior to TAVR, patients across all severities of LVDD have similar recovery in health status after TAVR.

Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset.The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr.TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables.All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (≤1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases.For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.

Background Smoking is a significant risk factor for aortic stenosis but its impact on clinical and health status outcomes after transcatheter aortic valve replacement ( TAVR ) has not been described. Methods and Results Patients (n=72 165) undergoing TAVR at 457 US sites in the STS/ ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between November 2011 and June 2016 were categorized at the time of TAVR as current/recent smokers versus prior/nonsmokers. A series of multivariable models examined the association between smoking status and outcomes, including 1‐year mortality, rehospitalization, mean gradient, and health status (measured by the 12‐item Kansas City Cardiomyopathy Questionnaire–Overall Summary Score [ KCCQ ‐ OS ]) and in‐hospital outcomes. A total of 4063 patients (5.6%) were smokers. Smokers presented for TAVR at a younger age (75 [68–81] years versus 83 [77–88] years) but with a greater burden of cardiovascular and lung disease. In adjusted models, smoking was associated with lower in‐hospital mortality (relative risk, 0.74; 95% CI , 0.62–0.89 [ P =0.001]) but not with in‐hospital stroke/transient ischemic attack or myocardial infarction. Smoking status had no association with postdischarge mortality, stroke, myocardial infarction, or heart failure (HF) but was associated with slightly lower 1‐year KCCQ ‐ OS scores (2.4‐point lower KCCQ ‐ OS ; 95% CI , −4.6 to −0.2 [ P =0.031]) and higher mean aortic valve gradients (11.1 versus 10.2 mm Hg, P Conclusions The current/recent smoking rate in US patients with TAVR is 5.6% and smokers present at a younger age for TAVR . Smoking was associated with lower in‐hospital but similar long‐term survival after TAVR , slightly worse long‐term health status, and marginally higher mean aortic valve gradients. Further research is needed to understand the effect of smoking cessation on outcomes.

Background: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. Methods and Results: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). Conclusions: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Sudden cardiac arrest is a major cause of death predominantly caused by ventricular tachyarrhythmia in patients with coronary artery disease. Despite advancements in resuscitation care, the rate of survival after cardiac arrest remains low. There is a growing body of observational data suggesting early coronary angiography reduces delay to revascularization and may improve outcomes. Most survivors present comatose, and neurologic outcome is uncertain; therefore it is often challenging to identify patients who will benefit from early coronary angiography. Several variables and risk scores that predict a favorable neurologic outcome have been identified. The rationale and current evidence for early angiography are reviewed, and a suggested approach to the selection of patients is presented.

Background: In inoperable patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) reduced mortality and hospitalization as compared with medical therapy. However, hospitalization rates after TAVR remain high, given the age and comorbidities of patients undergoing TAVR. Studies have thus far focused on rehospitalization after TAVR and have not examined the decline in hospitalizations achieved with TAVR. We sought to compare hospitalization rates in the 3 months before and after TAVR and further examine these changes in patients with and without LV dysfunction. Methods: We used the 2014 Nationwide Readmission Database (NRD) to identify patients who underwent TAVR between April and September, to allow for assessment of hospitalizations 3 months before and after TAVR. We compared hospitalization rates before and after TAVR using McNemar tests and also examined rates among patients with heart failure with reduced ejection fraction (HFrEF) and those without HFrEF. Results: Among 10416 who underwent TAVR between 4/1/14-9/30/14, mean age was 81.1 ± 8.4 years, 45.4% were men, mean number of chronic condition was 9.6 ± 3.1, and 40.6% had HFrEF. The rate of all-cause hospitalization in the 3 months before TAVR was 34.1%, which decreased to 25.5% in the 3 months after TAVR (p Conclusion: Although patients who are treated with TAVR have high rates of rehospitalization after the procedures, TAVR is associated with a reduction in all-cause hospitalization, which appears to be even more pronounced among patients with HFrEF. Further investigation is needed to better understand the patient factors associated with response to TAVR, in terms of hospitalization

Background: Drug-eluting stents reduce the risk of restenosis in patients undergoing percutaneous coronary intervention, but their use necessitates prolonged dual antiplatelet therapy, which increases costs and bleeding risk, and which may delay elective surgeries. While >80% of patients in the United States receive drug-eluting stents, less than a third report that their physicians discussed options with them. Methods and Results: An individualized shared decision-making (SDM) tool for stent selection was designed and implemented at 2 US hospitals. In the postimplementation phase, all patients received the SDM tool before their procedure, with or without decision coaching from a trained nurse. All patients were interviewed with respect to their knowledge of stents, their participation in SDM, and their stent preference. Between May 2014 and December 2016, 332 patients not receiving the SDM tool, 113 receiving the SDM tool with coaching, and 136 receiving the tool without coaching were interviewed. Patients receiving the SDM tool + coaching, as compared with usual care, demonstrated higher knowledge scores (mean difference +1.8; P P P Conclusions: An SDM tool for stent selection was associated with improvements in patient knowledge and SDM only when accompanied by decision coaching. However, the SDM tool (with or without coaching) had no impact on stent selection or concordance between patients’ stent preference and stent received, suggesting that physician-level barriers to SDM may exist. Clinical Trial Information URL: https://www.clinicaltrials.gov . Unique Identifier: NCT02046902.

Background Patients with diabetes mellitus (DM) experience higher rates of in-stent restenosis and greater benefit from drug-eluting stents implant at the time of percutaneous coronary intervention (PCI), necessitating prolonged dual anti-platelet therapy (DAPT). While DAPT reduces risk of ischemic events post-PCI, it also increases risk of bleeding. Whether bleeding rates differ among patients with and without DM, receiving long-term DAPT is unknown. Methods Among patients who underwent PCI and were maintained on DAPT for 1 year in a multicenter US registry, we assessed patient-reported bleeding over one year following PCI in patients with and without DM. Multivariable, hierarchical Poisson regression was used to evaluate the association of DM with bleeding during follow-up. Results Among 2334 PCI patients from 10 US hospitals (mean age 64, 54% ACS), 32.6% had DM. In unadjusted analyses, patients with DM had fewer bleeding events over the year following PCI (DM vs no DM: BARC=1: 78.0% vs 87.7%, P P = .33). Following adjustment, patients with (vs without DM) had a lower risk of BARC ≥1 bleeding during follow-up (relative risk [RR] 0.89, 95% CI 0.83–0.96). This decreased bleeding risk persisted after removing bruising from the endpoint definition. Conclusions In a real-world PCI registry, patients with DM experienced lower risk of bleeding risk on DAPT. As patients with DM also derive greater ischemic benefit from drug-eluting stents, which requires prolonged DAPT, our findings suggest that the balance between benefit and risk of this therapeutic approach may be even more favorable in patients with DM than previously considered.

Objectives To construct a model to predict long-term bleeding events following percutaneous coronary intervention (PCI). Background Treatment with dual antiplatelet therapy following PCI involves balancing the benefits of preventing ischemic events with the risks of bleeding. There are no models to predict long-term bleeding events after PCI. Methods We analyzed 1-year bleeding outcomes from 3,128 PCI procedures in the Patient Risk Information Services Manager (PRISM) observational study. Patient-reported bleeding events were categorized according to Bleeding Academic Research Consortium (BARC) definitions. Logistic regression analysis was used to develop a model predicting BARC ≥ 1 bleeding. Results BARC 0, 1, 2 or 3 bleeding was observed in 574 (18.4%); 2382 (76.2%); 114 (3.6%); and 58 (1.8%) patients, respectively. Compared to patients who had no bleeding, patients with BARC ≥ 1 bleeding were more often female (30 vs. 23%), Caucasian (94 vs. 83%), had a higher incidence of drug eluting stent (DES) implantation (83 vs. 76%) and warfarin therapy (7.4 vs. 3.9%), and a lower incidence of diabetes (31 vs. 45%; P-value

With the large number of late breaking clinical trials presented at major meetings, it is often difficult to stay current with advances in interventional cardiology. Therefore, the SCAI Publications Committee summarizes and provides editorial commentary on the most important structural heart and peripheral artery disease late-breaking trials from 2015. © 2016 Wiley Periodicals, Inc.

Vascular access for large endovascular devices has evolved as patients have become more complicated and device indications have expanded. As the benefits of catheter-based treatments for aortic aneurysm repair and aortic valve replacement become mainstream, there is a need to address difficult vascular access by developing not only smaller-diameter devices but also creative options for vascular access. We describe direct descending thoracic aortic access during endovascular aneurysm repair, transcatheter aortic valve replacement, and redo mesenteric revascularization in three patients who did not have traditional access options.

The primary objective of this study was to assess whether the topical administration of two neuroprotective drugs (brimonidine and somatostatin) could prevent or arrest retinal neurodysfunction in patients with type 2 diabetes. For this purpose, adults aged between 45 and 75 years with a diabetes duration ≥5 years and an Early Treatment of Diabetic Retinopathy Study (ETDRS) level of ≤35 were randomly assigned to one of three arms: placebo, somatostatin, or brimonidine. The primary outcome was the change in implicit time (IT) assessed by multifocal electroretinography between baseline and at the end of follow-up (96 weeks). There were 449 eligible patients allocated to brimonidine (n = 152), somatostatin (n = 145), or placebo (n = 152). When the primary end point was evaluated in the whole population, we did not find any neuroprotective effect of brimonidine or somatostatin. However, in the subset of patients (34.7%) with preexisting retinal neurodysfunction, IT worsened in the placebo group (P < 0.001) but remained unchanged in the brimonidine and somatostatin groups. In conclusion, the topical administration of the selected neuroprotective agents appears useful in preventing the worsening of preexisting retinal neurodysfunction. This finding points to screening retinal neurodysfunction as a critical issue to identify a subset of patients in whom neuroprotective treatment might be of benefit.

Objectives The authors assessed the effect of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) followed by bioprosthetic valve fracture (BVF), testing different transcatheter heart valve (THV) designs in an ex vivo bench study. Background Bioprosthetic valve fracture can be performed to improve residual transvalvular gradients following VIV TAVR. Methods The authors evaluated VIV TAVR and BVF with the SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) and ACURATE neo (Boston Scientific Corporation, Natick, Massachusetts) THVs. A 20-mm and 23-mm S3 were deployed in a 19-mm and 21-mm Mitroflow (Sorin Group USA, Arvada, Colorado), respectively. A small ACURATE neo was deployed in both sizes of Mitroflow tested. VIV TAVR samples underwent multimodality imaging, and hydrodynamic evaluation before and after BVF. Results A high implantation was required to enable full expansion of the upper crown of the ACURATE neo and allow optimal leaflet function. Marked underexpansion of the lower crown of the THV within the surgical valve was also observed. Before BVF, VIV TAVR in the 19-mm Mitroflow had high transvalvular gradients using either THV design (22.0 mm Hg S3, and 19.1 mm Hg ACURATE neo). After BVF, gradients improved and were similar for both THVs (14.2 mm Hg S3, and 13.8 mm Hg ACURATE neo). The effective orifice area increased with BVF from 1.2 to 1.6 cm2 with the S3 and from 1.4 to 1.6 cm2 with the ACURATE neo. Before BVF, VIV TAVR with the ACURATE neo in the 21-mm Mitroflow had lower gradients compared with S3 (11.3 mm Hg vs. 16 mm Hg). However, after BVF valve gradients were similar for both THVs (8.4 mm Hg ACURATE neo vs. 7.8 mm Hg S3). The effective orifice area increased from 1.5 to 2.1 cm2 with the S3 and from 1.8 to 2.2 cm2 with the ACURATE neo. Conclusions BVF performed after VIV TAVR results in improved residual gradients. Following BVF, residual gradients were similar irrespective of THV design. Use of a small ACURATE neo for VIV TAVR in small (≤21 mm) surgical valves may be associated with challenges in achieving optimum THV position and expansion. BVF could be considered in selected clinical cases.

Bioprosthetic valve fracture (BVF) improves the hemodynamic results of valve-in-valve transcatheter aortic valve replacement (VIV TAVR). However, long-term outcomes following BVF have not been reported. Data from 105 consecutive cases of BVF and VIV TAVR performed at 10 sites were analyzed.