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Background: Small reference vessel diameters (RVDs) are a predictor of ischemic events after coronary stenting. Among patients at high bleeding risk (HBR) precluding long-term dual antiplatelet therapy (DAPT), those with small vessel disease (SVD) constitute an especially high-risk subgroup. Here, we evaluated the results of a durable-polymer, coronary zotarolimus-eluting stent (ZES) for the treatment of patients with SVD at HBR with 1-month DAPT. Methods: In the prospective, multicenter Onyx ONE (One-Month DAPT) Clear study, 1506 patients at HBR treated with a ZES that discontinued DAPT at 30 days were included. The clinical outcomes of patients undergoing treatment of lesions with an RVD of 2.5 mm (SVD group, as determined by the angiographic core laboratory) were compared with patients without SVD. The primary end point was the composite of cardiac death or myocardial infarction between 1 and 12 months. Results: Small vessel diameter treatment was performed in 489 (32.5%) patients. Patients with SVD were more likely to be women, have undergone a previous percutaneous intervention, and have multivessel coronary artery disease than patients without SVD. There were no significant differences in lesion, device, or procedural success between the groups. The Kaplan-Meier rate estimate of the primary end point was 8.5% and 6.8% in patients with SVD and those without SVD, respectively (P ¼ .425). No significant differences were found in any secondary end point. The Kaplan-Meier rate of stent thrombosis was 0.6% and 0.8% in patients with SVD and those without SVD, respectively (P ¼ .50). Conclusions: Among patients at HBR treated with a ZES and 1-month DAPT, those with SVD had favorable 12-month ischemic and bleeding outcomes, which were comparable with those of patients with larger caliber vessels.

OBJECTIVES To investigate whether age and valve size at implant contribute to outcomes after Melody transcatheter pulmonary valve replacement (TPVR). BACKGROUND Patient age and valve size at implant contribute to longevity of surgical pulmonary valves. METHODS All patients discharged with a Melody valve in the pulmonary position, as part of three prospective Melody valve multicenter studies, comprised the study cohort. Acute and time-related outcomes were analyzed according to age: children (≤12 years), adolescents (13-18 years), young adults (19-29 years), and older adults (≥30 years). RESULTS Successful Melody valve implantation occurred in 49 children, 107 adolescents, 96 young adults, and 57 older adults. Pediatric patients (≤18 years) were more likely to have TPVR for conduit stenosis than adults (62% vs. 44%); children had the smallest conduits. After TPVR, pediatric and adult patients had similar decreases in right ventricular (RV) size by MRI, but adults had improved percentage predicted peak VO2 (58% preimplant to 64% postimplant, p = .02) and FEV1 (69% pre to 71% post, p = .005). Younger age was associated with shorter freedom from RVOT dysfunction, reintervention, and explant. Children had the shortest freedom from endocarditis (p = .041), but all other groups had 5-year freedom from endocarditis of ≥90%. CONCLUSIONS Younger age was associated with shorter time to RVOT dysfunction, reintervention, and explant after Melody TPVR. Patients ≥13 years of age were at low risk for endocarditis and explant to 5 years. A better understanding of time-related outcomes by age will aid in the comparison of therapeutic options for TPVR candidates. CLINICAL TRIAL REGISTRATION https://clinicaltrials.gov/ct2/show/NCT00740870 (NCT00740870), https://clinicaltrials.gov/ct2/show/NCT01186692 (NCT01186692), and https://clinicaltrials.gov/ct2/show/NCT00688571 (NCT00688571).

OBJECTIVES To compare clinical outcomes in high bleeding risk (HBR) patients with and without complex percutaneous coronary intervention (PCI) treated with Resolute Onyx zotarolimus-eluting stents (ZES) after 1-month dual antiplatelet therapy (DAPT). BACKGROUND PCI with 1-month DAPT has been demonstrated to be safe in HBR patients treated with Resolute Onyx ZES. Whether these outcomes are consistent in patients with complex lesions is uncertain. METHODS Among HBR patients who were event-free 1��month after PCI with ZES and treated thereafter with single antiplatelet therapy (SAPT), the clinical outcomes between 1 month and 1 year were compared after complex PCI (3 vessels treated, ��� 3 lesions treated, total stent length > 60���mm, bifurcation with ��� 2 stents implanted, atherectomy, or left main, surgical bypass graft or chronic total occlusion PCI) versus noncomplex PCI. Propensity score adjustment was performed to adjust for baseline differences among complex and noncomplex patients. RESULTS Complex patients (N��=��401, 26.6% of total) had a higher prevalence of hyperlipidemia, diabetes mellitus and previous myocardial infarction (MI). Between 1 month and 1 year, rates of MI (7.1% vs. 4.0%, p��=��0.02) and cardiac death/MI (9.3% vs. 6.1%, p��=��0.04) were higher among complex versus noncomplex patients, although stent thrombosis rates were similar. After adjustment for baseline characteristics, differences in outcomes were no longer significant between groups. CONCLUSIONS Higher rates of ischemic outcomes in complex PCI patients were largely explained by baseline clinical differences, rather than lesion complexity, among HBR patients treated with 1-month DAPT following PCI with Resolute Onyx ZES.

Supplemental Digital Content is available in the text., Background: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. Methods: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. Results: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (P

OBJECTIVES This study describes procedural and 1-year outcomes of the 16 mm Melody PB1016 valve in patients with dysfunctional RVOT conduits. BACKGROUND The Melody PB1016 is a standard Melody valve produced from a 16 mm bovine jugular vein and is intended for deployment up to 20 mm. METHODS This is a prospective, non-randomized, multicenter study of the procedural and short-term outcomes of Melody PB1016 TPV replacement within dysfunctional RVOT conduits. Data from eight centers were included in the analysis. RESULTS During the study period, 39 patients underwent attempted Melody TPVR. Of the 39 patients, 30 underwent successful Melody TPVR. The majority of patients underwent placement of one or more stents prior to TPVR. There was a significant reduction in peak conduit pressure gradient following TPVR (38 mmHg vs. 11 mmHg, P

Objectives This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance. Background The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement. Methods Three sites participated in this first Food and Drug Administration–approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported. Results Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg). Conclusions In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.

High bleeding risk (HBR) patients undergoing percutaneous coronary intervention may require shorter durations of dual antiplatelet therapy (DAPT). The randomized Onyx ONE trial compared the Resolute Onyx zotarolimus-eluting stent with a polymer-free drug-coated stent in HBR patients with 1-month

Endocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves.The aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials.All patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator.A total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008).Endocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy. (Melody Transcatheter Pulmonary Valve [TPV] Study: Post Approval Study of the Original Investigational Device Exemption [IDE] Cohort; NCT00740870; Melody Transcatheter Pulmonary Valve Post-Approval Study; NCT01186692; and Melody Transcatheter Pulmonary Valve [TPV] Post-Market Surveillance Study; NCT00688571).

Stented bioprosthetic valves (BPVs) are commonly used for surgical pulmonary valve (PV) replacement in postoperative congenital heart disease, but develop structural failure in a time-related fashion. The Melody transcatheter PV (TPV) (Medtronic, Minneapolis, Minn) has been used to treat BPV dysfunction, but there have been few studies in this population.We performed a retrospective, multicenter study to evaluate Melody valve function in patients who underwent TPV replacement (TPVR) into a dysfunctional pulmonary BPV.One hundred patients who underwent TPVR at 10 centers between January 2010 and June 2015 were enrolled. The median patient age was 22 years (range, 5-79 years), and 32 patients were age18 years. The underlying diagnosis was tetralogy of Fallot in 80 patients, and moderate or severe pulmonary regurgitation (PR) was present in 84%. The TPV was implanted into various types of BPVs, with a median size of 23 mm (range, 19-33 mm). At hospital discharge, PR was mild or less in all but 1 patient, and the mean Doppler right ventricular outflow tract (RVOT) gradient was reduced from a mean of 29.3 ± 12.0 mm Hg to 16.2 ± 6.9 mm Hg (median, 29 mm Hg to 16 mm Hg; P .001). During follow-up (median, 12.4 months), no patients underwent reintervention on the TPV. Endocarditis was diagnosed in 1 patient who was managed medically without intervention. The mean RVOT gradient at the most recent follow-up was ≤35 mm Hg in all patients, and was similar to that at early postimplantation. PR was more than mild in only 1 patient. Hemodynamic outcomes did not differ between patients with small BPVs (≤23 mm) and those with large BPVs (≥25 mm).TPVR restores competence and relieves the obstruction of dysfunctional surgical BPVs, with excellent early results in both small and large BPVs, highlighting the potential for TPVR to extend the life of existing BPVs in adults and children. Collaboration between surgeons and cardiologists is important to determine the optimal lifetime management, combining surgical PV replacement and TPVR in this population.

Aims Percutaneous pulmonary valve implantation (PPVI) is used to treat patients with dysfunctional pulmonary valve conduits. Short- and longer-term results from multiple trials have outlined haemodynamic improvements. Our aim was to report the long-term results, including quality of life, from a multicentre trial in Europe and Canada. Methods and results From October 2007 to April 2009, 71 patients (24 female; median age 19.0 [IQR: 14.0 to 25.0] years) were enrolled in a prospective cohort study. PPVI was performed successfully in 63 patients. At five-year follow-up four patients had died. Moderate and severe pulmonary regurgitation were completely resolved in all except one patient, who needed re-PPVI. Outflow tract obstruction improved significantly from a mean pressure gradient of 37.7±12.1 mmHg before PPVI to 17.3±9.7 mmHg at five-year follow-up; however, 11 patients needed treatment for restenosis. The EQ-5D quality of life utility index and visual analogue scale scores were both significantly improved six months post PPVI and remained so at five years. Conclusions Five-year results following PPVI demonstrate resolved moderate or severe pulmonary regurgitation, improved right ventricular outflow tract obstruction, and improved quality of life.

This study sought to obtain in vivo data to confirm assumptions on device loading conditions and assess procedural feasibility, safety, and valve performance.The Harmony transcatheter pulmonary valve (Medtronic, Minneapolis, Minnesota) was designed for patients with severe pulmonary regurgitation who require pulmonary valve replacement.Three sites participated in this first Food and Drug Administration-approved early feasibility study using an innovative device design to accommodate the complex anatomy of the right ventricular outflow tract. Potentially eligible patients underwent review by a screening committee to determine implant eligibility. Six-month outcomes are reported.Between May 2013 and May 2015, 66 subjects were enrolled, and 21 were approved for implant and underwent catheterization; 20 were implanted. Catheterized patients had a median age of 25 years, were predominantly diagnosed with tetralogy of Fallot (95%), had severe pulmonary regurgitation (95%), and had trivial or mild stenosis. The device was delivered in the desired location in 19 of 20 (95%) patients. Proximal migration occurred in 1 patient during delivery system removal. Two devices were surgically explanted. Premature ventricular contractions related to the procedure were reported in 3 patients; 2 were resolved without treatment. One patient had ventricular arrhythmias that required treatment and later were resolved. At 1 month, echocardiography revealed none or trivial pulmonary regurgitation in all and a mean right ventricular outflow tract gradient of 16 ± 8 mm Hg (range 6 to 31 mm Hg).In this feasibility study of the Harmony transcatheter pulmonary valve device, there was high procedural success and safety, and favorable acute device performance.

The study aim was to compare the sizing characteristics and hemodynamics of the Medtronic Mosaic Ultra porcine and Carpentier-Edwards PERIMOUNT Magna bovine pericardial bioprosthetic stented aortic valves in relation to the patient's true aortic annulus size.In this prospective multicenter randomized study, data acquired perioperatively and at six months postoperatively were collected. Following aortic valve excision and debridement, the annulus was measured by blinded sizers prior to the randomization of 141 patients (Ultra, n=72; Magna, n=69).The median patient age was 75 years, and 89% of the patients had aortic stenosis. A good left ventricular function was present in 75% of patients, and the EuroSCORE-predicted mortality was 9%. Concomitant procedures (coronary artery bypass grafting, mitral/tricuspid repair, septal myectomy, modified Maze) were performed in 61% of patients. The in-hospital mortality was 3%, and at six months postoperatively 96% of the patients were NYHA class I or II, with no intergroup differences. The mean 'true aortic annulus' size was 23.0 +/- 1.4 mm for the Ultra valve, and 22.6 +/- 1.8 mm for the Magna valve (p = NS). The implanted labeled valve size wasor = 23 mm for 83% of Ultra valves, and for 52% of Magna valves (p0.01), and smaller than the measured true aortic diameter (44% Magna versus 33% Ultra). The mean echo gradients were lower with Magna valves (11 +/- 6 mmHg) than with Ultra (17 +/- 6 mmHg; p0.01), while the effective orifice area (EOA) was higher with Magna than with Ultra (1.6 +/- 0.4 versus 1.4 +/- 0.4 ; p0.01). Both groups showed a similar left ventricular mass regression (Ultra -48 +/- 83 g; Magna -42 +/- 70 g). Trivial to moderate regurgitation was noted in 24% of Ultra valves compared to 48% of Magna valves (p0.01).Selection of the Ultra bioprosthetic valve allowed the implantation of larger valve sizes. However, when compared to the 'true aortic annulus', the Magna was associated with lower transprosthetic gradients and larger EOAs. The longer term significance of these observations remains inconclusive in terms of bioprosthesis selection, however.

The Selection AFm Registry investigated the impact of pacemaker diagnostic data on the clinical management of patients with atrial arrhythmias, specifically atrial fibrillation (AF) through the use of advanced atrial arrhythmia monitoring features. Very few data on the clinical impact of such data has been reported in a real world setting.Patients with known or suspected AF with a Class I or Class II indication for a dual-chamber pacemaker received the Selection AFm pacemaker. These patients were prospectively followed at pacemaker follow-up visits, and data were collected on medications and device programming. Physicians identified which therapy changes were based upon the stored data within the pacemaker.Two hundred eighty-two patients were enrolled. A total of 119 patients had 311 changes made to either their medications or device programming after review of diagnostic pacemaker data. Changes involved rate and rhythm control, warfarin anticoagulation, and pacemaker programmed settings. Significantly, more changes were made in patients with documented atrial arrhythmias at follow-up.The atrial arrhythmia recording features were used by clinicians to guide therapy-related decisions in patients with paroxysmal AF. Such data represent an additional source of clinical information for AF disease management.

Aims The aim of the study was to prospectively examine the influence of structural heart disease (SHD) and sinus node dysfunction (SND) on the frequency and duration of atrial fibrillation (AF) episodes in patients with implanted pacemakers. Methods We examined episodes of AF in 207 patients (93 with SHD; 165 with SND) with known or suspected paroxysmal AF who underwent dual-chamber pacing. Results Seventy-one percent of all patients experienced at least one episode of AF during follow-up, with a mean burden of 3.3 ± 6.4 h/d (median, 0.2 hours) and a mean frequency of 11.7 ± 26.0 episodes per day (median, 1.4). The proportion of episodes longer than 6 hours was greater in patients with SHD when compared to patients without SHD. In a logistic regression model adjusted for SND, gender, and the 2-way interactions of SND, sex, and SHD, SHD was a significant factor ( P = .0188) with the odds ratio of having an episode longer than 6 hours 3.4 times higher for patients with SHD than for patients without SHD. Older patients with SHD had less frequent but longer episodes compared to younger patients. In patients without SHD, there was no comparable age difference. Burden, frequency, and average episode length were not influenced by the presence or absence of SND. Conclusions Patients with SHD have longer episodes of AF supporting the concept that SHD influences the underlying substrate to favor perpetuation.

The time to the first recurrence of atrial fibrillation (AF) and the AF burden have commonly been used as end points for AF therapy. We conducted a retrospective analysis of data from a large pacemaker registry to assess the relation between the time to the first recurrence and the AF burden. Although a statistical association exists, the small correlation coefficients limit the clinical value of the time to first recurrence as an indicator of AF burden. © 2006 Elsevier Inc. All rights reserved. (Am J Cardiol 2006;97:1343–1345)

Background Heart failure (HF) is a common medical problem with significant morbidity and mortality. Recently, device-based therapy, cardiac resynchronization therapy (CRT), implantable cardioverter-defibrillators (ICDs), and combined CRT and ICD have become established therapies in patients with HF receiving standard medical therapy. Contemporary implantable devices are able to continuously monitor, store, and display long-term diagnostic information. Daily diagnostic information includes intrathoracic impedance, patient activity, hours spent in atrial tachycardia/fibrillation, ventricular rate during atrial tachycardia/fibrillation, ventricular tachyarrhythmia episodes, ICD shocks, day and night heart rate, and heart rate variability. Methods PARTNERS HF is a prospective, nonrandomized, multicenter observational study. Patient data are collected at baseline and at 3, 6, 9, and 12 months. Our objectives are to assess the relationship between the (1) diagnostic data and HF-related events, (2) diagnostic data and HF-related health care utilizations, and (3) OptiVol (Medtronic, Inc, Minneapolis, MN) fluid monitoring diagnostic data and clinically relevant pulmonary congestion events in a subset of patients. The study has enrolled 1,024 patients with a commercially available combined CRT and ICD system at 100 sites in the United States. Participants will be followed for 1 year. Results Enrollment was completed in January 2007. Key baseline characteristics include the following: mean age of 68.4 ± 10.8 years, 32% female, 13% people of color, 64% with ischemic HF, and >80% of patients reported to be on recommended HF medications at enrollment. Conclusions The results of PARTNERS HF could help identify device diagnostic information that may provide an early recognition of impending HF-related events.

maximum inhibition when the SLV320 concentrations were greater than 10 ng/mL. SLV320 was well tolerated, no serious adverse events occurred. Conclusion: A1 adenosine antagonism might improve kidney function compared to furosemide while simultaneously promoting natriuresis and diuresis. Thus, SLV320 as an A1 adenosine receptor antagonist might be a new therapeutic strategy for the treatment of patients with heart failure.