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Objective: Many patients undergoing transcatheter aortic valve implantation (TAVI) have a pre-existing, permanent pacemaker (PPM) or receive one as a consequence of the procedure. We hypothesised that chronic pacing may have adverse effects on TAVI outcomes.Methods and Results: Four groups of patients undergoing TAVI in the Placement of Aortic Transcatheter Valves (PARTNER) trial and registries were compared: prior PPM (n=586), new PPM (n=173), no PPM (n=1612), and left bundle branch block (LBBB)/no PPM (n=160). At 1 year, prior PPM, new PPM and LBBB/no PPM had higher all-cause mortality than no PPM (27.4%, 26.3%, 27.7% and 20.0%, p<0.05), and prior PPM or new PPM had higher rehospitalisation or mortality/rehospitalisation (p<0.04). By Cox regression analysis, new PPM (HR 1.38, 1.00 to 1.89, p=0.05) and prior PPM (HR 1.31, 1.08 to 1.60, p=0.006) were independently associated with 1-year mortality. Surviving prior PPM, new PPM and LBBB/no PPM patients had lower LVEF at 1 year relative to no PPM (50.5%, 55.4%, 48.9% and 57.6%, p<0.01). Prior PPM had worsened recovery of LVEF after TAVI (Δ=10.0 prior vs 19.7% no PPM for baseline LVEF <35%, p<0.0001; Δ=4.1 prior vs 7.4% no PPM for baseline LVEF 35-50%, p=0.006). Paced ECGs displayed a high prevalence of RV pacing (>88%).Conclusions: In the PARTNER trial, prior PPM, along with new PPM and chronic LBBB patients, had worsened clinical and echocardiographic outcomes relative to no PPM patients, and the presence of a PPM was independently associated with 1-year mortality. Ventricular dyssynchrony due to chronic RV pacing may be mechanistically responsible for these findings.Trial Registration Number: (ClinicalTrials.gov NCT00530894). [ABSTRACT FROM AUTHOR]

Objective: Pulmonary hypertension (PH) is associated with increased mortality after surgical or transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS), and when the pulmonary artery pressure is particularly elevated, there may be questions about the clinical benefit of TAVR. We aimed to identify clinical and haemodynamic factors associated with increased mortality after TAVR among those with moderate/severe PH. Methods: Among patients with symptomatic AS at high or prohibitive surgical risk receiving TAVR in the Placement of Aortic Transcatheter Valves (PARTNER) I randomised trial or registry, 2180 patients with an invasive measurement of mean pulmonary artery pressure (mPAP) recorded were included, and moderate/severe PH was defined as an mPAP ≥35 mm Hg. Results: Increasing severity of PH was associated with progressively worse 1-year all-cause mortality: none (n=785, 18.6%), mild (n=838, 22.7%) and moderate/severe (n=557, 25.0%) (p=0.01). The increased hazard of mortality associated with moderate/severe PH was observed in females, but not males (interaction p=0.03). In adjusted analyses, females with moderate/severe PH had an increased hazard of death at 1 year compared with females without PH (adjusted HR 2.14, 95% CI 1.44 to 3.18), whereas those with mild PH did not. Among males, there was no increased hazard of death associated with any severity of PH. In a multivariable Cox model of patients with moderate/severe PH, oxygen-dependent lung disease, inability to perform a 6 min walk, impaired renal function and lower aortic valve mean gradient were independently associated with increased 1-year mortality (p<0.05 for all), whereas several haemodynamic indices were not. A risk score, including these factors, was able to identify patients with a 15% vs 59% 1-year mortality. Conclusions: The relationship between moderate/severe PH and increased mortality after TAVR is altered by sex, and clinical factors appear to be more influential in stratifying risk than haemodynamic indices. These findings may have implications for the evaluation of and treatment decisions for patients referred for TAVR with significant PH. Trial Registration: NCT00530894. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. Background: The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. Methods: We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. Results: The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). Conclusions: The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; The Medtronic RESOLUTE US Clinical Trial (R-US); NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a ‘Real-World’ Patient Population [R-Int]; NCT00752128; RESOLUTE Japan–The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent [RJ]; NCT00927940). [Copyright &y& Elsevier]

Objectives: The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population. Background: The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety. Methods: The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores. Results: Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = −2.8%, upper 1-sided 95% confidence interval: −1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%. Conclusions: The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453) [Copyright &y& Elsevier]

Objectives: This study sought to evaluate the long-term safety of the zotarolimus-eluting stent (ZES) using a pooled analysis of pivotal trials. Background: Drug-eluting stents, compared with bare-metal stents (BMS), have reduced restenosis; however, individual trials of these stents have not had sufficient power to ascertain long-term safety. Methods: We combined patient level data from 6 prospective randomized single-arm multicenter trials involving 2,132 patients treated with ZES and 596 patients treated with a BMS control. The median follow-up was 4.1 years, with 5-year follow-up completed in 1,256 patients (97% of those eligible). The recommended minimum duration of dual antiplatelet therapy in these studies was 3 to 6 months regardless of stent type. An independent events committee adjudicated all events. The 2 treatment groups were compared after adjustment for between trial variation and for individual patient clinical and angiographic characteristics by propensity score. Results: The cumulative incidence of adverse events at 5 years for ZES and BMS were: death: 5.9% versus 7.6% (adjusted hazard ratio: 0.81, p = 0.34), cardiac death: 2.4 versus 3.7% (0.83, p = 0.57), myocardial infarction: 3.4 versus 4.8% (0.77, p = 0.37), target lesion revascularization: 7.0% vs. 16.5% (0.42, p < 0.001), stent thrombosis (definite or probable): 0.8 versus 1.7% (0.50, p = 0.21). After adjustment for variation in study and patient characteristics, there were no significant differences in stent thrombosis or the clinical safety event rates at 5 years between ZES and BMS. Conclusions: Over 5 years, there was no increased risk of death, myocardial infarction, or stent thrombosis, and there was a benefit of prevention of repeat revascularization procedures in ZES compared with BMS. (The ENDEAVOR Pharmacokinetic [PK] Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System [ENDEAVOR PK]; NCT00314275) (The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions [ENDEAVOR II]; NCT00614848) (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256) (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions [ENDEAVOR IV]; NCT00217269) [Copyright &y& Elsevier]

Drug-eluting stents, or intracoronary stents that combine the local delivery of antirestenotic pharmacologic therapies while maintaining the mechanical advantage of bare metal stents over balloon angioplasty alone, are a highly complex technology that have profoundly affected the practice of percutaneous coronary intervention over the last 5 years. These devices were designed specifically to treat the neointimal hyperplasia occurring after conventional bare metal stent placement, and have been remarkably successful in this regard. However, recent concerns have been raised regarding the long-term safety of these devices, particularly when used outside of the specific patient and lesion subsets studied in the pivotal randomized trials that led to device approval by regulatory bodies within the United States and abroad. This review aims to present a brief description of the sirolimus-eluting stent device platform and its mechanism of action, followed by an overview of current data regarding efficacy and safety regarding the clinical use of sirolimus-eluting stent technology. [ABSTRACT FROM AUTHOR]

Reviews the problems associated with the evaluation of new coronary devices, evaluation process progress and the role played by the database, New Approaches to Coronary Intervention (NACI) Registry in the United States. Components of an adequate device evaluation; Potential conflict of interest as an important part of new device evaluation; Financial responsibility issues.

Background: In patients with severe symptomatic aortic stenosis at low surgical risk, transfemoral transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve has been shown to reduce the composite of death, stroke, or rehospitalization at 2-year follow-up compared with surgical aortic valve replacement (SAVR). Whether TAVR is cost-effective compared with SAVR for low-risk patients remains uncertain. Methods: Between 2016 and 2017, 1000 low-risk patients with aortic stenosis were randomly assigned to TAVR with the SAPIEN 3 valve or SAVR in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). Of these patients, 929 underwent valve replacement, were enrolled in the United States, and were included in the economic substudy. Procedural costs were estimated using measured resource use. Other costs were determined by linkage with Medicare claims or by regression models when linkage was not feasible. Health utilities were estimated using the EuroQOL 5-item questionnaire. With the use of a Markov model informed by in-trial data, lifetime cost-effectiveness from the perspective of the US health care system was estimated in terms of cost per quality-adjusted life-year gained. Results: Although procedural costs were nearly $19 000 higher with TAVR, total index hospitalization costs were only $591 more with TAVR compared with SAVR. Follow-up costs were lower with TAVR such that TAVR led to 2-year cost savings of $2030/patient compared with SAVR (95% CI, –$6222 to $1816) and a gain of 0.05 quality-adjusted life-years (95% CI, –0.003 to 0.102). In our base-case analysis, TAVR was projected to be an economically dominant strategy with a 95% probability that the incremental cost-effectiveness ratio for TAVR would be <$50 000/quality-adjusted life-year gained (consistent with high economic value from a US health care perspective). These findings were sensitive to differences in long-term survival, however, such that a modest long-term survival advantage with SAVR would render SAVR cost-effective (although not cost saving) compared with TAVR. Conclusions: For patients with severe aortic stenosis and low surgical risk similar to those enrolled in the PARTNER 3 trial, transfemoral TAVR with the SAPIEN 3 valve is cost saving compared with SAVR at 2 years and is projected to be economically attractive in the long run as long as there are no substantial differences in late death between the 2 strategies. Long-term follow-up will be critical to ultimately determine the preferred treatment strategy for low-risk patients from both a clinical and economic perspective. [ABSTRACT FROM AUTHOR]

Background: Recent trends, including survival beyond 30 days, in aortic valve replacement (AVR) following the expansion of indications for transcatheter aortic valve replacement (TAVR) are not well-understood.Objectives: The authors sought to characterize the trends in characteristics and outcomes of patients undergoing AVR.Methods: The authors analyzed Medicare beneficiaries who underwent TAVR and SAVR in 2012 to 2019. They evaluated case volume, demographics, comorbidities, 1-year mortality, and discharge disposition. Cox proportional hazard models were used to assess the annual change in outcomes.Results: Per 100,000 beneficiary-years, AVR increased from 107 to 156, TAVR increased from 19 to 101, whereas SAVR declined from 88 to 54. The median [interquartile range] age remained similar from 77 [71-83] years to 78 [72-84] years for overall AVR, decreased from 84 [79-88] years to 81 [75-86] years for TAVR, and decreased from 76 [71-81] years to 72 [68-77] years for SAVR. For all AVR patients, the prevalence of comorbidities remained relatively stable. The 1-year mortality for all AVR decreased from 11.9% to 9.4%. Annual change in the adjusted odds of 1-year mortality was 0.93 (95% CI: 0.92-0.94) for TAVR and 0.98 (95% CI: 0.97-0.99) for SAVR, and 0.94 (95% CI: 0.93-0.95) for all AVR. Patients discharged to home after AVR increased from 24.2% to 54.7%, primarily driven by increasing home discharge after TAVR.Conclusions: The advent of TAVR has led to about a 60% increase in overall AVR in older adults. Improving outcomes in AVR as a whole following the advent of TAVR with increased access is a reassuring trend. [ABSTRACT FROM AUTHOR]

The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act. In response, a program of early feasibility studies (EFS) has been developed. One of the important issues has been the outmigration of the development and testing of medical devices from the United States. The EFS committee has developed and implemented processes to address issues to develop strategies for early treatment of these patient groups. Initial implementation of the U.S. Food and Drug Administration EFS program has been successful, but residual significant problems have hindered the opportunity to take full advantage of the program. These include delays in gaining Institutional Review Board approval, timeliness of budget and contractual negotiations, and lack of access to and enrollment of study subjects. This paper reviews improvements that have been made to the U.S. EFS ecosystem and outlines potential approaches to address remaining impediments to program success. [ABSTRACT FROM AUTHOR]

Background: Currently, there is a paucity of information on surgical explantation after transcatheter aortic valve replacement (TAVR).Objectives: The purpose of this study was to examine the incidence, patient characteristics, predictors, and outcomes of surgical explantation after TAVR using a population-based, nationally representative database.Methods: We analyzed the Medicare Provider profile to include all U.S. patients undergoing TAVR from 2012 to 2017. Time to surgical explant was calculated from the index TAVR discharge to surgical explantation. Post-operative survival was assessed using time-dependent Cox proportional hazard regression analysis and landmark analysis.Results: The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explant was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). Compared with the no-explant cohort, the explant cohort was significantly younger (mean age 73.7 years vs. 81.7 years), with a lower prevalence of heart failure (55.9% vs. 65.8%) but more likely a lower-risk profile cohort (15% vs. 2.4%; all p < 0.05). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (all p > 0.05). The time-dependent Cox regression analysis demonstrated a higher mortality in those with surgical explantation (hazard ratio: 4.03 vs. no-explant group; 95% confidence interval: 1.81 to 8.98). Indication, time-to-surgical-explant, and year of surgical explantation were not associated with worse post-explantation survival (all p > 0.05).Conclusions: The present study provides updated evidence on the incidence, timing, and outcomes of surgical explantation of a TAVR prosthesis. Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients. [ABSTRACT FROM AUTHOR]

Background: The effect of transcatheter aortic valve replacement (TAVR) on kidney function stage in patients with aortic stenosis remains poorly understood. We hypothesized that in some patients, TAVR results in improved kidney function by alleviating cardiorenal syndrome.Objectives: The purpose of this study was to assess change in chronic kidney disease (CKD) stage following TAVR, identify variables associated with pre- and post-TAVR estimated glomerular filtration rate (eGFR), and assess association of post-TAVR eGFR with mortality.Methods: Patients (n = 5,190) receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 1, 2, and PARTNER 2 S3 trials between April 2007 and October 2014 were included. Pre-TAVR and procedural variables associated with post-TAVR eGFR, change in CKD stage at ≤7 days post-TAVR, and association of post-TAVR eGFR on intermediate-term mortality were assessed.Results: At baseline, CKD stage ≥2 was present in 91% of patients. CKD stage either improved or was unchanged following TAVR in the majority of patients (77% stage 1, 90% stage 2, 89% stage 3A, 94% stage 3B, and 99% stage 4). Progression to CKD stage 5 occurred in 1 (0.035%) of 2,892 patients within 7 days post-TAVR. Of 3,546 patients in whom data were available, 70 (2.0%) underwent post-TAVR dialysis. Higher pre-TAVR eGFR and transfemoral approach were strongly associated with higher post-TAVR eGFR. Lower baseline and longitudinal post-TAVR eGFR were associated with lower intermediate-term survival.Conclusions: In patients with severe aortic stenosis undergoing TAVR, even with baseline impaired eGFR, CKD stage is more likely to stay the same or improve than worsen. Aortic stenosis may contribute to cardiorenal syndrome that improves with TAVR. [ABSTRACT FROM AUTHOR]

There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis. We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality. Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity. Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations. [ABSTRACT FROM AUTHOR]

Background: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFRangio) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFRangio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFRangio.Methods: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFRangio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFRangio for predicting pressure wire-derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity.Results: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFRangio values correlated well with FFR measurements ( r=0.80, P<0.001) and the Bland-Altman 95% confidence limits were between -0.14 and 0.12. The device success rate for FFRangio was 99%.Conclusions: FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR. FFRangio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes.Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262. [ABSTRACT FROM AUTHOR]

In the United States, the octogenarian population is projected to triple by 2050. With this aging population, the prevalence of valvular heart disease (VHD) is on the rise. The etiology, approach to treatment, and expected outcomes of VHD are different in the elderly compared with younger patients. Both stenotic and regurgitant lesions are associated with unfavorable outcomes if left untreated. Surgical mortality remains high due to multiple co-morbidities, and long-term survival benefit is dependent on many variables including valvular pathology. Quality of life is an important consideration in treatment decisions in this age group. Increasingly, octogenarian patients are receiving transcatheter therapies, with transcatheter aortic valve replacement having the greatest momentum. Numerous transcatheter devices for management of other valve lesions are currently in early clinical trials. This review will describe the epidemiology, etiology, diagnosis, and therapeutic options for VHD in the oldest old, with a focus on transcatheter technologies. [ABSTRACT FROM AUTHOR]

It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p = 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p = 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p = 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30 days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications. [ABSTRACT FROM AUTHOR]

The article presents a study which compares the risk of stent thrombosis between drug-eluting and bare-metal stents in the U.S. The study analyzes Food and Drug Administration (FDA)-approved stents such as cobalt-chromium everolimus-eluting stents (CoCr-EES), platinum-chromium EES (PtCr-EES) and phosphorylcholine-based zotarolimus-eluting stents (PC-ZES). It is found out that Co-Cr-EES shows that lowest rate of stent thrombosis after two years of implantation.

In-stent restenosis has become a significant clinical problem. In 1997 alone, it is estimated that up to 100,000 patients world-wide with in-stent restenosis were treated. Serial intravascular ultrasound (IVUS) analysis has shown that tubular-slotted stents almost never chronically recoil and that neointimal hyperplasia is responsible for in-stent restenosis. With the rapid recent explosion in stent use, information about in-stent restenosis has lagged behind, especially on the impact of new stent designs. For example, the true prevalence of in-stent restenosis (1) varies with the lesion and patient subset, being much higher in the "real world" than in the selected patients typically enrolled in many studies; and (2) depends on its definition (i.e., clinical vs angiographic, intralesion vs in-stent). "Conventional" catheter-based treatments have included percutaneous transluminal coronary angioplasty (PTCA), rotational atherectomy, excimer laser coronary angioplasty, directional coronary atherectomy, and additional stent implantation. Rates of recurrence with these approaches are not known and vary considerably among series; however, certain lesions seem likely to recur regardless of the treatment modality. Recently, brachytherapy has emerged as the most promising way to treat in-stent restenosis. [ABSTRACT FROM AUTHOR]

Background: Directional coronary atherectomy is a new technique of coronary revascularization by which atherosclerotic plaque is excised and retrieved from target lesions. With respect to the rate of restenosis and clinical outcomes, it is not known how this procedure compares with balloon angioplasty, which relies on dilation of the plaque and vessel wall. We compared the rate of restenosis after angioplasty with that after atherectomy. Methods: At 35 sites in the United States and Europe, 1012 patients were randomly assigned to either atherectomy (512 patients) or angioplasty (500 patients). The patients underwent coronary angiography at base line and again after six months; the paired angiograms were quantitatively assessed at one laboratory by investigators unaware of the treatment assignments. Results: Stenosis was reduced to 50 percent or less more often with atherectomy than with angioplasty (89 percent vs. 80 percent, P<0.001), and there was a greater immediate increase in vessel caliber (1.05 vs. 0.86 mm, P<0.001). This was accompanied by a higher rate of early complications (11 percent vs. 5 percent, P<0.001) and higher in-hospital costs ($11,904 vs. $10,637; P = 0.006). At six months, the rate of restenosis was 50 percent for atherectomy and 57 percent for angioplasty (P = 0.06). However, the probability of death or myocardial infarction within six months was higher in the atherectomy group (8.6 percent vs. 4.6 percent, P = 0.007). Conclusions: Removing coronary artery plaque with atherectomy led to a larger luminal diameter and a small reduction in angiographic restenosis, the latter being confined largely to the proximal left anterior descending coronary artery. However, atherectomy led to a higher rate of early complications, increased cost, and no apparent clinical benefit after six months of follow-up. (N Engl J Med 1993;329:221-7.) [ABSTRACT FROM AUTHOR]

Importance: Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated., Objective: To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR., Design, Setting, and Participants: This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024., Intervention: TAVR with or without CEP., Main Outcomes and Measures: The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes., Results: The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort., Conclusion and Relevance: The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy., Trial Registration: ClinicalTrials.gov Identifier: NCT04149535.

Background: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study., Methods: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year., Results: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients., Conclusions: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801., Competing Interests: Dr Malaisrie reports institutional research grants from Edwards Lifesciences, Medtronic, and Terumo Medical Corporation and consulting/speaker fees from Edwards Lifesciences, Terumo Medical Corporation, and Artivion; Dr Guerrero reports institutional research grants from Edwards Lifesciences; Dr Davidson reports institutional research grants from Edwards Lifesciences and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Williams reports institutional research grants from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific and consulting/speaker fees from Medtronic; Dr de Brito is a proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; Dr Shah reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Kaneko reports consulting/speaker fees from Edwards Lifesciences, Medtronic, and Abbott Vascular; Dr Poon reports institutional research grants from Edwards Lifesciences and consulting/speaker fees from Edwards Lifesciences and Anteris; Dr Yu is an employee of Edwards Lifesciences; Dr Pibarot reports institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; Dr Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation; Dr Blanke reports consulting/speaker fees from Edwards Lifesciences and LARALAB; Dr Leon reports institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; Dr Mack has served as trial coprimary investigator for Edwards Lifesciences and Abbott Vascular and has served as a study chair for Medtronic; Dr Zajarias reports consulting/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Background: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV)., Objectives: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV., Methods: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR., Results: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02)., Conclusions: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth., Competing Interests: Funding Support and Author Disclosures The PARTNER 2 trial was funded by Edwards Lifesciences. Dr R.T. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic and Philips Healthcare, Siemens Healthineers; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. P Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Dr George has received consulting fees from Edwards Lifesciences. Dr Zhao is an employee of Edwards Lifesciences. Dr Blanke has institutional core laboratory contracts with Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, PI Cardia, and Conformal; he is a Consultant for Edwards Lifesciences and Laralab Imaging. Dr Babaliaros has received consulting fees from Abbott and Edwards Lifesciences. Dr Szeto has received grant support from Edwards Lifesciences and Medtronic; and is a consultant for MicroInterventional Devices. Dr Makkar has received research support from Edwards Lifesciences and Abbott; and consultant fees/honoraria from Abbott, Cordis Corporation, and Medtronic. Dr Thourani serves on advisory boards for Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Webb is a consultant for Edwards Lifesciences. Michael Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (unpaid); has received institutional research grants from Abbott, Boston Scientific, and Medtronic; has been an unpaid advisor for Abbott, Boston Scientific, Sinomed, and Medtronic; and holds equity in Medinol. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Nazif has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Mitral regurgitation is the most common valvular disease and is estimated to affect over 5 million Americans. Real-world data collection contributes to safety and effectiveness evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, and clinical best practice research. We aimed to establish a minimum core data set in mitral interventions to promote efficient, reusable real-world data collection for all of these purposes. Two expert task forces separately evaluated and reconciled a list of candidate elements derived from: 1) 2 ongoing transcatheter mitral trials; and 2) a systemic literature review of high-impact mitral trials and U.S multicenter, multidevice registries. From 703 unique data elements considered, unanimous consensus agreement was achieved on 127 "core" data elements, with the most common reasons for exclusion from the minimum core data set being burden or difficulty in accurate assessment (41.2%), duplicative information (25.0%), and low likelihood of affecting outcomes (19.6%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established and implemented into the national Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapies Registry 127 interoperable, reusable core data elements to support more efficient, consistent, and informative transcatheter mitral device evidence for regulatory submissions, safety surveillance, best practice development, and hospital quality assessments., Competing Interests: Funding Support and Author Disclosures Dr Vemulapalli has received grants/contracts from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and SBIR), Food and Drug Administration (NEST cc), Abbott, Boston Scientific, and Cytokinetics; and is on the advisory board or is a consultant for Edwards Lifesciences, Medtronic, American College of Physicians, and Total CME. Ms Alu has received institutional research funding from Abbott and Edwards Lifesciences. Dr Shahim has received a research grant from the Stockholm county research council. Dr James has been a proctor for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Thourani has been an advisor for Abbott Vascular, ARtivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. Dr Carroll has received institutional grants for clinical trials from Edwards Lifesciences, Medtronic, and Abbott; and has been a consultant for Abbott. Dr Krucoff has received grants from Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical; and has been a consultant for Abbott Vascular, Boston Scientific, Medtronic, Mitre Medical, OrbusNeich, and 4C Medical., (Copyright © 2023 American College of Cardiology Foundation. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies. This article focuses on the early iterative steps required to optimize the process and achieve the goal of timely efficient innovation and device development in cardiovascular disease., (© 2022 Wiley Periodicals LLC.)

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; P <0.001), were more frequently women (45.9% versus 68.1%; P <0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P <0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; P <0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P <0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P <0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.

To highlight the trends of surgical (open) aortic valve replacement (SAVR) as well as to compare the outcome between transcatheter aortic valve replacement (TAVR) and SAVR in elderly dialysis patients. TAVR has evolved as an effective alternative to surgery (SAVR) for aortic stenosis. We identified dialysis-dependent patients who underwent SAVR or TAVR from 2000 to 2015 from the United States Renal Data System using ICD-9 codes. We defined high-risk surgical patients as age over 70 or older. The primary endpoint was survival at 3 years and we compared the outcome between SAVR and TAVR groups using inverse probability of treatment weighting (IPTW). A total of 4332 and 1280 dialysis patients underwent SAVR and TAVR, respectively, during the study period. Among SAVR cohort, 3312 patients underwent SAVR before June 2012 and 1020 after June 2012. In-hospital mortality was significantly worse before 2012 (14.6% vs. 11.3% after 2012, p = 0.007) as well as estimated 3-year mortality (69.1% vs. 60.3% after 2012, p < 0.001). After June 2012, the TAVR cohort was older and had more comorbidities including coronary artery disease and congestive heart failure compared to the SAVR cohort. After IPTW, in-hospital mortality was significantly lower after TAVR versus SAVR (odds ratio 0.38 [95% confidence interval [CI], 0.27-0.52], p < 0.001). However, TAVR had a significantly higher risk of 3-year mortality than SAVR (hazard ratio 1.24 [95% CI 1.1-1.39], p < 0.001). TAVR may be a reasonable and potentially preferable alternative to SAVR in the elderly dialysis population in the short-term period., (© 2022 Wiley Periodicals LLC.)

Background: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery., Methods: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes., Results: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted ( P <0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex., Conclusions: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

[Figure: see text].

Background Aortic stenosis is prevalent in end-stage renal disease. Transcatheter aortic valve replacement (TAVR) is a plausible alternative for surgical aortic valve replacement. However, little is known regarding long-term outcomes in patients with end-stage renal disease who undergo TAVR. Methods and Results We identified all patients with end-stage renal disease who underwent TAVR from 2011 through 2016 using the United States Renal Data System. The primary end point was 5-year mortality after TAVR. Factors associated with 1- and 5-year mortality were analyzed. A total of 3883 TAVRs were performed for patients with end-stage renal disease. Mortality was 5.8%, 43.7%, and 88.8% at 30 days, 1 year, and 5 years, respectively. Case volumes increased rapidly from 17 in 2011 to 1495 in 2016. Thirty-day mortality demonstrated a dramatic reduction from 11.1% in 2012 to 2.5% in 2016 ( P =0.01). Age 75 or older (hazard ratio [HR], 1.14; 95% CI, 1.05-1.23 [ P =0.002]), body mass index <25 (HR, 1.18; 95% CI, 1.08-1.28 [ P <0.001]), chronic obstructive pulmonary disease (HR, 1.25; 95% CI, 1.1-1.35 [ P <0.001]), diabetes mellitus as the cause of dialysis (HR, 1.22; 95% CI, 1.11-1.35 [ P <0.001]), hypertension as the cause of dialysis (HR, 1.17; 95% CI, 1.06-1.29 [ P =0.004]), and White race (HR, 1.17; 95% CI, 1.06-1.3 [ P =0.002]) were independently associated with 5-year mortality. Conclusions Short-term outcomes of TAVR in patients with end-stage renal disease have improved significantly. However, long-term mortality of patients on dialysis remains high.

Background: We evaluated whether there is equitable distribution across sexes of treatment and outcomes for aortic valve replacement (AVR), via surgical (SAVR) or transcatheter (TAVR) methods, in symptomatic severe aortic stenosis (ssAS) patients., Methods: Using de-identified data, we identified 43,822 patients with ssAS (2008-2016). Multivariate competing risk models were used to determine the likelihood of any AVR, while accounting for the competing risk of death. Association between sex and 1-year mortality, stratified by AVR status, was evaluated using multivariate Cox regression models with AVR as a time-dependent variable., Results: Among patients with ssAS, 20,986 (47.9%) were female. Females were older (median age 81 vs. 78, P<0.001), more likely to have body mass index <20 (8.5% vs. 3.5%), and home oxygen use (4.4% vs. 3.4%, P<0001 for all). Overall, 12,129 (27.7%) patients underwent AVR for ssAS. Females were less likely to undergo AVR compared with males (24.1% vs. 31.0%, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.77-0.83), but when treated, were more likely to undergo TAVR (37.9% vs. 30.9%, adjusted HR 1.21, 95% CI 1.15-1.27). Untreated females and males had similarly high rates of mortality at 1 year (31.1% vs. 31.3%, adjusted HR 0.98, 95% CI 0.94-1.03). Among those undergoing AVR, females had significantly higher mortality (10.2% vs. 9.4%, adjusted HR 1.24, 95% CI 1.10-1.41), driven by increased SAVR-associated mortality (9.0% vs. 7.6%, adjusted HR 1.43, 95% CI 1.21-1.69)., Conclusions: Treatment rates for ssAS patients remain suboptimal with disparities in female treatment., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background The impact of atrial fibrillation (AF) in intermediate surgical risk patients with severe aortic stenosis who undergo either transcatheter or surgical aortic valve replacement (AVR) is not well established. Methods and Results Data were assessed in 2663 patients from the PARTNER (Placement of Aortic Transcatheter Valve) 2A or S3i trials. Analyses grouped patients into 3 categories according to their baseline and discharge rhythms (ie, sinus rhythm [SR]/SR, SR/AF, or AF/AF). Among patients with transcatheter AVR (n=1867), 79.2% had SR/SR, 17.6% had AF/AF, and 3.2% had SR/AF. Among patients with surgical AVR (n=796), 71.7% had SR/SR, 14.1% had AF/AF, and 14.2% had SR/AF. Patients with transcatheter AVR in AF at discharge had increased 2-year mortality (SR/AF versus SR/SR; hazard ratio [HR], 2.73; 95% CI, 1.68-4.44; P <0.0001; AF/AF versus SR/SR; HR, 1.56; 95% CI, 1.16-2.09; P =0.003); patients with SR/AF also experienced increased 2-year mortality relative to patients with AF/AF (HR, 1.77; 95% CI, 1.04-3.00; P =0.03). For patients with surgicalAVR, the presence of AF at discharge was also associated with increased 2-year mortality (SR/AF versus SR/SR; HR, 1.93; 95% CI, 1.25-2.96; P =0.002; and AF/AF versus SR/SR; HR, 1.67; 95% CI, 1.06-2.63; P =0.027). Rehospitalization and persistent advanced heart failure symptoms were also more common among patients with transcatheter AVR and surgical AVR discharged in AF, and major bleeding was more common in the transcatheter AVR cohort. Conclusions The presence of AF at discharge in patients with intermediate surgical risk aortic stenosis was associated with worse outcomes-especially in patients with baseline SR-including increased all-cause mortality at 2-year follow-up. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01314313 and NCT03222128.

Importance: Bioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients., Objective: To assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement., Design, Setting, and Participants: In this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data., Exposures: Mitral valve-in-valve for degenerated bioprosthetic mitral valves., Main Outcomes and Measures: The primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance., Results: A total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg., Conclusions and Relevance: Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

Background: Surgical revascularization is associated with improved ventricular function and clinical outcomes among patients with ischemic cardiomyopathy. There are less extensive data on changes in ventricular function among patients with ischemic cardiomyopathy undergoing percutaneous coronary intervention (PCI). Accordingly, we sought to assess the extent and predictors of change in left ventricular ejection fraction (ΔLVEF) among patients undergoing hemodynamically-supported PCI., Methods: We assessed ΔLVEF following hemodynamically-supported PCI (with Impella or intra-aortic balloon counterpulsation) among patients enrolled in the PROTECT II trial and cVAD registry. The ΔLVEF was compared among patients with paired echocardiography at baseline and at least 30 days of follow-up. Independent correlates of ΔLVEF (modeled continuously and with an absolute ΔLVEF≥5%) were assessed using multivariable models., Results: Among the 689 patients with paired echocardiographic data included in the analysis, the mean LVEF improved from 24.8 ± 9.9% to 31.4 ± 13.3% after PCI, for a net increase of 6.5 ± 10.8% (p < .001). A total of 395 (57%) patients had ΔLVEF ≥ 5% following hemodynamically-supported PCI. The number of vessels treated was associated with ΔLVEF (ΔLVEF 5.5% with 1 vessel, 6.6% with 2 vessels, and 8.3% with 3 vessels, p for trend = .046). A lower baseline LVEF, absence of a history of congestive heart failure or aldosterone receptor antagonist use, and a greater number of vessels treated were independent correlates of LVEF improvement., Conclusions: Among patients with severe left ventricular systolic dysfunction and paired echocardiographic assessments, an improvement in LVEF was observed following hemodynamically-supported PCI., (© 2019 Wiley Periodicals, Inc.)

Background Aortic valve replacement (AVR) is a life-saving treatment for patients with symptomatic severe aortic valve stenosis. We sought to determine whether transcatheter AVR has resulted in a more equitable treatment rate by race in the United States. Methods and Results A total of 32 853 patients with symptomatic severe aortic valve stenosis were retrospectively identified via Optum's deidentified electronic health records database (2007-2017). AVR rates in non-Hispanic Black and White patients were assessed in the year after diagnosis. Multivariate Fine-Gray hazards models were used to evaluate the likelihood of AVR by race, with adjustment for patient factors and the managing cardiologist. Time-trend and 1-year symptomatic severe aortic valve stenosis survival analyses were also performed. From 2011 to 2016, the rate of AVR increased from 20.1% to 37.1%. Overall, Black individuals were less likely than Whites to receive AVR (22.9% versus 31.0%; unadjusted hazard ratio [HR], 0.70; 95% CI, 0.62-0.79; fully adjusted HR, 0.76; 95% CI, 0.67-0.85). Yet, during 2015 to 2016, AVR racial differences were attenuated (29.5% versus 35.2%; adjusted HR, 0.86; 95% CI, 0.74-1.02) because of greater uptake of transcatheter AVR in Blacks than Whites (53.4% of AVRs versus 47.3%; P =0.128). Untreated patients had significantly higher 1-year mortality than those treated (adjusted HR, 0.57; 95% CI, 0.53-0.61), which was consistent by race (interaction P value=0.52). Conclusions Although transcatheter AVR has increased the use of AVR in the United States, treatment rates remain low. Black patients with symptomatic severe aortic valve stenosis were less likely than White patients to receive AVR, yet these differences have recently narrowed.

Objectives: The aim of this study was to assess race-based differences in patients undergoing percutaneous coronary intervention from a large pooled database of randomized controlled trials., Background: Data on race-based outcomes after percutaneous coronary intervention are limited, deriving mainly from registries and single-center studies., Methods: Baseline characteristics and outcomes at 30 days, 1 year, and 5 years were assessed across different races, from an individual patient data pooled analysis from 10 randomized trials. Endpoints of interest included death, myocardial infarction, and major adverse cardiac events (defined as cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization). Multivariate Cox proportional hazards regression was performed to assess associations between race and outcomes, controlling for differences in 12 baseline covariates., Results: Among 22,638 patients, 20,585 (90.9%) were white, 918 (4.1%) were black, 404 (1.8%) were Asian, and 473 (2.1%) were Hispanic. Baseline and angiographic characteristics differed among groups. Five-year major adverse cardiac event rates were 18.8% in white patients (reference group), compared with 23.9% in black patients (p = 0.0009), 11.2% in Asian patients (p = 0.0007), and 21.5% in Hispanic patients (p = 0.07). Multivariate analysis demonstrated an independent association between black race and 5-year risk for major adverse cardiac events (hazard ratio: 1.28; 95% confidence interval: 1.05 to 1.57; p = 0.01)., Conclusions: In the present large-scale individual patient data pooled analysis, comorbidities were significantly more frequent in minority-group patients than in white patients enrolled in coronary stent randomized controlled trials. After accounting for these differences, black race was an independent predictor of worse outcomes, whereas Hispanic ethnicity and Asian race were not. Further research examining race-based outcomes after percutaneous coronary intervention is warranted to understand these differences., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction., Objectives: The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes., Methods: The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory., Results: The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04)., Conclusions: Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Due to perceived technical challenges, patients with previous surgical mitral valve repair or replacement (SMVR) have been excluded from most transcatheter aortic valve replacement (TAVR) trials. Our objective was to compare the 30-day and 1-year outcomes of TAVR for patients with and without prior SMVR., Methods: In a retrospective review of The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we compared 1097 patients with prior SMVR to 46,327 patients without prior SMVR who underwent TAVR between November 2011 and September 2015 at 394 US centers. Preoperative characteristics, procedural details, and clinical outcomes were analyzed., Results: Patients with previous SMVR were younger, more often female, and had higher STS predicted risk of mortality (8.6% vs 6.8%, P < .001). However, there was no difference in 30-day mortality (4.6% vs 5.5%, P = .293), myocardial infarction, stroke, reintervention, new dialysis, or readmission. Moderate/severe paravalvular leak at discharge was also similar (5.8% vs 4.9%, P = .343). At 1 year, morbidity was similar with slightly higher mortality among patients with prior SMVR (20% vs 17.5%, P = .087) that was significant after adjustment (hazard ratio 1.18, P = .043). The type of prior SMVR (repair, bioprosthetic replacement, or mechanical replacement) had no impact on 30-day or 1-year survival., Conclusions: Patients with prior SMVR undergoing TAVR had similar 30-day outcomes, slightly higher 1-year mortality, and no increase in early paravalvular leak compared with patients who did not have previous SMVR. Prior SMVR should not preclude TAVR for appropriately selected patients., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries., Background: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated., Methods: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut "Hat" marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation., Results: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut "Hat" at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut "Hat" at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases., Conclusions: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To assess the long-term safety and efficacy of the Resolute zotarolimus-eluting stent (R-ZES)., Background: The R-ZES has been associated with low rates of adverse events over short-intermediate term follow-up. However, reliable assessment of the safety and efficacy of any implanted device requires long-term evaluation., Methods: The RESOLUTE US trial was a prospective, observational study conducted at 116 U.S. sites and enrolled patients with de novo coronary lesions. Patients were followed clinically for 5 years with independent event adjudication and data monitoring., Results: A total of 1,402 patients (1,573 lesions) were enrolled; 34% had diabetes mellitus and 75% had ACC type B2/C lesions. The 5-year rate of target lesion failure (TLF) was 12.3%, target lesion revascularization was 6.5%, target vessel myocardial infarction was 3.2%, and cardiac death was 4.1%. Dual antiplatelet therapy usage was 94% at 1 year and 47% at 5 years, with a 0.1% and 0.5% respective incidence of definite or probable stent thrombosis. The 5-year rate of TLF was 16.9% among patients with diabetes mellitus and 14.7% in patients with at least one small (≤2.5 mm) vessel treated. Covariates independently associated with 5-year TLF in multivariable analysis included diabetes mellitus (odds ratio [OR] 1.89, p < .001), prior coronary artery bypass grafting (OR 2.28, p < .001), prior myocardial infarction (OR 1.85, p = .002), and smaller reference vessel diameter (OR 1.75, p = .004)., Conclusions: Results from the fully adjudicated and monitored RESOLUTE US trial demonstrate long-term 5-year safety and efficacy of the R-ZES stent among a relatively low-risk population of patients, including a 0.5% rate of stent thrombosis at 5 years., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to investigate whether therapeutic intravascular ultrasound pulmonary artery denervation (PDN) is safe and reduces pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension (PAH) on a minimum of dual oral therapy., Background: Early studies have suggested that PDN can reduce PVR in patients with PAH., Methods: TROPHY1 (Treatment of Pulmonary Hypertension 1) was a multicenter, international, open-label trial undertaken at 8 specialist centers. Patients 18 to 75 years of age with PAH were eligible if taking dual oral or triple nonparenteral therapy and not responsive to acute vasodilator testing. Eligible patients underwent PDN (TIVUS System). The primary safety endpoint was procedure-related adverse events at 30 days. Secondary endpoints included procedure-related adverse events, disease worsening and death to 12 months, and efficacy endpoints that included change in pulmonary hemodynamic status, 6-min walk distance, and quality of life from baseline to 4 or 6 months. Patients were to remain on disease-specific medication for the duration of the study., Results: Twenty-three patients underwent PDN, with no procedure-related serious adverse events reported. The reduction in PVR at 4- or 6-month follow-up was 94 ± 151 dyn·s·cm -5 (p = 0.001) or 17.8%, which was associated with a 42 ± 63 m (p = 0.02) increase in 6-min walk distance and a 671 ± 1,555 step (p = 0.04) increase in daily activity., Conclusions: In this multicenter early feasibility study, PDN with an intravascular ultrasound catheter was performed without procedure-related adverse events and was associated with a reduction in PVR and increases in 6-min walk distance and daily activity in patients with PAH on background dual or triple therapy., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Multisite procedure-based randomized trials may be confounded by performance variability and variability among sites. Therefore, we studied variability in mortality and stroke after patients were randomized to surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valves-2A (PARTNER-2A) randomized trial., Methods: Patients at intermediate risk for SAVR were randomized to SAVR (n = 1017) or TAVR (n = 1011) with a SAPIEN XT device (Edwards Lifesciences, Irvine, Calif) at 54 sites. Patients were followed to 2 years. A mixed-effect model quantified variability at intersite and intrasite levels., Results: There were 336 deaths (SAVR 170, TAVR 166) and 176 strokes (SAVR 85, TAVR 91). Intersite variability for mortality was similar across sites for SAVR (hazard ratios ranging from 0.52-1.93 among sites) and TAVR (hazard ratios ranging from 0.49-2.03), but intersite variability for stroke was greater for SAVR (hazard ratios ranging from 0.44-2.26) than for TAVR (no detectable variability). Case mix and lower site trial volume accounted for 37% of mortality intersite variability for SAVR and 73% for TAVR, but only 14% for stroke for SAVR. Intrasite mortality hazard ratios demonstrated all but 1 site's 95% confidence interval overlapped 1.0, indicating generally similar SAVR and TAVR mortalities within sites., Conclusions: Intersite variability was similar for mortality in SAVR and TAVR, but variability for stroke was greater for SAVR than for TAVR. Intrasite events were similar for both SAVR and TAVR. These findings suggest that in performance-based trials, site variability and its sources should be taken into account in analyzing and interpreting trial results., (Copyright © 2019. Published by Elsevier Inc.)

Background: High bleeding risk (HBR) patients undergoing percutaneous coronary intervention have been widely excluded from randomized device registration trials. The LF study (LEADERS FREE) reported superior outcomes of HBR patients receiving 30-day dual antiplatelet therapy after percutaneous coronary intervention with a polymer-free drug-coated stent (DCS). LFII was designed to assess the reproducibility and generalizability of the benefits of DCS observed in LF to inform the US Food and Drug Administration in a device registration decision., Methods: LFII was a single-arm study using HBR inclusion/exclusion criteria and 30-day dual antiplatelet therapy after percutaneous coronary intervention with DCS, identical to LF. The 365-day rates of the primary effectiveness (clinically indicated target lesion revascularization) and safety (composite cardiac death and myocardial infarction) end points were reported using a propensity-stratified analysis compared with the LF bare metal stent arm patients as controls., Results: A total of 1203 LFII patients were enrolled with an average 1.7 HBR criteria per patient, including 60.7% >75 years of age, 34.1% on anticoagulants, and 14.7% with renal failure. Propensity-adjusted 365-day clinically indicated target lesion revascularization was significantly lower with DCS (7.2% versus 9.2%; hazard ratio, 0.72 [95% CI, 0.52-0.98]; P =0.0338 for superiority), as was the primary safety (cardiac death and myocardial infarction) composite (9.3% versus 12.4%; hazard ratio, 0.72 [95% CI, 0.55-0.94]; P =0.0150 for superiority). Stent thrombosis rates were 2.0% DCS and 2.2% bare metal stent. Major bleeding at 1 year occurred in 7.2% DCS patients and 7.2% bare metal stent., Conclusions: LFII reproduces the results of the DCS arm of LF in an independent, predominantly North American cohort of HBR patients.

Objectives: This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead., Background: Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability., Methods: Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed., Results: The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment., Conclusion: The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to investigate bipolar radiofrequency renal denervation in patients with hypertension not receiving medications at baseline., Background: A blood pressure-reducing effect of renal denervation has been difficult to isolate in clinical investigations., Methods: REDUCE HTN: REINFORCE (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension) was a randomized, sham-controlled multicenter trial. Patients with office systolic blood pressure (SBP) of 150 to 180 mm Hg and average 24-h ambulatory SBP of 135 to 170 mm Hg after medication washout underwent bipolar radiofrequency renal denervation or a sham procedure. The planned outcome was 8-week change in 24-h ambulatory SBP. Enrollment was terminated for apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Safety assessments included all-cause death, renal failure, severe hypotension or syncope, hypertensive crisis, and renal artery stenosis., Results: Baseline 24-h blood pressure was 148.3 ± 10.9/85.7 ± 9.1 mm Hg for the denervation group (n = 34, mean age 58.5 ± 10.1 years, 47% women) and 149.1 ± 7.2/86.4 ± 9.8 mm Hg for the control group (n = 17, mean age 58.2 ± 9.8 years, 24% women). At 8 weeks, mean 24-h SBP reductions for the renal denervation and control groups were -5.3 mm Hg (95% confidence interval [CI]: -8.8 to -1.8 mm Hg) and -8.5 mm Hg (95% CI: -13.3 to -3.8 mm Hg), respectively (difference 3.3 mm Hg; 95% CI: -2.8 to 9.3 mm Hg; p = 0.30). Antihypertensive medications could then be added. By 6 months, decreases in SBP were greater for the denervation group, yielding between-group differences of -7.2 mm Hg (95% CI: -15.2 to 0.8 mm Hg; p = 0.08), -9.7 mm Hg (95% CI: -17.7 to -1.7 mm Hg; p = 0.02), and -11.4 mm Hg (95% CI: -19.2 to -3.7 mm Hg; p < 0.01) for 24-h, daytime ambulatory, and office measurements, respectively. Through 12 months, 1 patient (renal denervation group) had a hypertensive urgency requiring immediate management, and 1 experienced progression of renal artery stenosis., Conclusions: Future studies of radiofrequency renal denervation must anticipate delayed treatment effects. (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension [REDUCE HTN: REINFORCE]; NCT02392351)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Adjunctive coronary atherectomy (CA) can be utilized in treating severely calcified coronary lesions; however, the temporal trends, patient selection, and variation in use of CA have not been well described. We sought to assess the trends in usage, interhospital variability, and outcomes with CA among patients undergoing percutaneous coronary intervention (PCI)., Methods: All patients undergoing PCI in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009 to December 31, 2016 (N=3 864 377) were analyzed based on utilization of either rotational or orbital CA. Intervals using date of index CA grouped into 2009 Q3 to 2010, 2011 to 2012, 2013 to 2014, and 2015 to 2016 and hospital-level quartiles based on annual CA volumes were evaluated. The primary outcome measure was in-hospital major adverse cardiac events defined as a composite of all-cause mortality, periprocedural myocardial infarction, or stroke. Independent variables associated with outcomes were determined., Results: CA represented 1.7% (n=65 033) of the total PCI volume. Among hospitals performing PCI (n=1672), 577 (34.5%) did not perform any CA. Patients treated with CA were elderly, more often male, and had a history of diabetes, prior myocardial infarction, PCI, and coronary artery bypass grafting. The utilization of CA increased from 1.1% in Q3 2009 to 3.0% in Q4 of 2016 (5% quarterly increase in odds of CA; OR [95% CI], 1.05 [1.04-1.06], P <0.001). Among patients undergoing CA, there was a temporal decline in major adverse cardiac events (0.98 [0.97-0.99], P <0.001) and myocardial infarction (0.97 [0.96-0.98], P <0.001). In adjusted analyses, increasing hospital CA volume was associated with lower mortality (0.85 [0.76-0.96], P =0.01) and lower rates of PCI failure or complication requiring coronary artery bypass grafting (0.67 [0.56-0.79], P <0.001) but was associated with small increase in coronary perforation (1.18 [1.04-1.35], P <0.01)., Conclusions: Although CA is performed infrequently, its use has increased over time. After accounting for potential confounders, higher CA volume was associated with lower risk of major adverse events counterbalanced by small risk of coronary perforation.

Objectives: The aim of this study was to evaluate the incidence and outcomes of surgical bailout during transcatheter aortic valve replacement (TAVR)., Background: The incidence and outcomes of unplanned conversion to open heart surgery, or "surgical bailout," during TAVR are not well characterized., Methods: Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was analyzed with respect to whether surgical bailout was performed during the index TAVR procedure. A Cox proportional hazards models was used to evaluate 1-year mortality and major adverse cardiovascular events., Results: Between November 2011 and September 2015, a total of 47,546 patients underwent TAVR. Surgical bailout during TAVR was performed in 1.17% of the cases (n = 558); the most frequent indications were valve dislodgement (22%), ventricular rupture (19.9%), and aortic valve annular rupture (14.2%). The incidence of surgical bailout significantly decreased over time (first tertile 1.25%, second tertile 1.43%, third tertile 1.04%; p = 0.0088). The 30-day and 1-year incidence of major adverse cardiovascular events (54.6% vs. 7.4% [p < 0.0001] and 63.92% vs. 20.29% [p < 0.0001]) and all-cause mortality (50.00% vs. 4.98% [p < 0.0001] and 59.79% vs. 17.06% [p < 0.0001]) were significantly higher in those who underwent bailout. Independent predictors of surgical bailout included female sex, hemoglobin, left ventricular ejection fraction, nonelective cases, and nonfemoral access. Body surface area was the only independent predictor of survival after surgical bailout., Conclusions: In a large, nationally representative registry, the need for surgical bailout in patients undergoing TAVR is low, and its incidence has decreased over time. However, surgical bailout after TAVR is associated with poor outcomes, including 50% mortality at 30 days., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention., (© 2019 The Authors. The European Heart Journal is published on behalf of the European Society of Cardiology, Inc., by Oxford University Press. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is non-commercial, and no modifications or adaptations are made.)