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Background: Atrial arrhythmias are common in patients with implantable cardioverter-defibrillator (ICD). External shocks and internal cardioversion through commanded ICD shock for electrical cardioversion are used for rhythm-control. However, there is a paucity of data on efficacy of external versus internal cardioversion and on the risk of lead and device malfunction. We hypothesized that external cardioversion is noninferior to internal cardioversion for safety, and superior for successful restoration of sinus rhythm. Methods: Consecutive patients with ICD undergoing elective cardioversion for atrial arrhythmias at 13 centers were randomized in 1:1 fashion to either internal or external cardioversion. The primary safety end point was a composite of surrogate events of lead or device malfunction. Conversion of atrial arrhythmia to sinus rhythm was the primary efficacy end point. Myocardial damage was studied by measuring troponin release in both groups. Results: N=230 patients were randomized. Shock efficacy was 93% in the external cardioversion group and 65% in the internal cardioversion group ( P Conclusions: This is the first randomized trial on external vs internal cardioversion in patients with ICDs. External cardioversion was superior for the restoration of sinus rhythm. The unmasking of silent lead malfunction in the internal cardioversion group suggests that an internal shock attempt may be reasonable in selected ICD patients presenting for electrical cardioversion. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03247738.

A 62-year-old woman presented to another hospital with a 36-hour history of uninterrupted, nonspecific chest pain. Her medical history included long-standing hypertension and diabetes mellitus for which she took metoprolol, perindopril, felodipine, metformin, and glimepiride. She had stopped smoking 10 years earlier, and did not drink alcohol or use illicit drugs. The ECG on the admission to the other hospital is shown in Figure 1. Laboratory results at the other hospital were all normal, with the exception of mild hyperglycemia; cardiac troponin I was also normal. Based on the ECG in Figure 1, the patient was transferred to our unit for emergency coronary angiography. Clinical examination on admission to our hospital was unremarkable. A repeated ECG on admission in our hospital is disclosed in Figure 2. Based on the history of uninterrupted chest pain in a patient with cardiovascular risk factors and the aspect of the ECG in Figure 1, the on-call cardiology team in our unit agreed with the indication for emergency coronary angiography. This, however, disclosed no significant coronary artery …

Leadless cardiac pacemaker (LCP) therapy has been established clinically as a feasible and safe alternative to conventional transvenous pacemaker therapy for patients with an indication for single-chamber right-ventricular pacing. 1-3 However, reports on loss of telemetry and pacing output due to abrupt battery failure called the safety of one of the two commercially available systems seriously into question. The initial battery advisory with the Nanostim™ LCP was issued by the manufacturer in October 2016, who instantly called a global stop to Nanostim™ implants. To this day, similar battery issues have not been described for the Micra™ transcatheter pacing system. Therefore, we thought to analyze the long-term pacemaker performance and rate of battery malfunction of the Nanostim™ LCP in our patient population.

Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure with reduced ejection fraction. Although these devices effectively improve survival, atrial and ventricular arrhythmias are common, predispose these patients to additional risk, and complicate patient management. However, there is no consensus on best practices for the medical management of these arrhythmias or on the optimal timing for procedural interventions in patients with refractory arrhythmias. Although the vast majority of these patients have preexisting cardiovascular implantable electronic devices or cardiac resynchronization therapy, given the natural history of heart failure, it is common practice to maintain cardiovascular implantable electronic device detection and therapies after LVAD implantation. Available data, however, are conflicting on the efficacy of and optimal device programming after LVAD implantation. Therefore, the primary objective of this scientific statement is to review the available evidence and to provide guidance on the management of atrial and ventricular arrhythmias in this unique patient population, as well as procedural interventions and cardiovascular implantable electronic device and cardiac resynchronization therapy programming strategies, on the basis of a comprehensive literature review by electrophysiologists, heart failure cardiologists, cardiac surgeons, and cardiovascular nurse specialists with expertise in managing these patients. The structure and design of commercially available LVADs are briefly reviewed, as well as clinical indications for device implantation. The relevant physiological effects of long-term exposure to continuous-flow circulatory support are highlighted, as well as the mechanisms and clinical significance of arrhythmias in the setting of LVAD support.

The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry.The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions.Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%).The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Background— The Coarctation of the Aorta Stent Trial (COAST) was designed to assess the safety and efficacy of the Cheatham Platinum stent when used in children and adults with native or recurrent coarctation. Acute outcomes have been reported. We report here follow-up to 2 years. Methods and Results— A total of 105 patients underwent attempted implantation, with 104 successes. There were no procedural deaths, serious adverse events, or surgical intervention. All patients experienced immediate reduction in upper- to lower-extremity blood pressure difference with sustained improvement to 2 years. Rates of hypertension and medication use decreased from baseline to 12 months and remained largely unchanged at 2 years. Six aortic aneurysms have been identified: 5 were successfully treated with covered stent placement, and 1 resolved without intervention. Stent fractures were noted in 2 patients at 1 year and 11 patients at 2 years, with evidence of fracture progression. To date, only larger stent diameter was associated with stent fracture. Twelve additional fractures have occurred after 2 years. No fracture has resulted in loss of stent integrity, stent embolization, aortic wall injury, or reobstruction. Nine reinterventions occurred in the first 2 years for stent redilation and address of aneurysms, and 10 additional reinterventions occurred after 2 years. Conclusions— The Cheatham Platinum stent is safe and associated with persistent relief of aortic obstruction. Stent fracture and progression of fracture occur but have not resulted in clinically important sequelae. Reintervention is common and related to early and late aortic wall injury and need for re-expansion of small-diameter stents. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00552812.

Background: The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (Abbott) is a centrifugal, fully magnetically levitated, continuous-flow blood pump engineered to enhance hemocompatibility and reduce shear stress on blood components. The MOMENTUM 3 trial (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) compares the HM3 LVAS with the HeartMate II (HMII) LVAS (Abbott) in advanced heart failure refractory to medical management, irrespective of therapeutic intention (bridge to transplant versus destination therapy). This investigation reported its primary outcome in the short-term cohort (n=294; 6-month follow-up), demonstrating superiority of the HM3 for the trial primary end point (survival free of a disabling stroke or reoperation to replace the pump for malfunction), driven by a reduced need for reoperations. The aim of this analysis was to evaluate the aggregate of hemocompatibility-related clinical adverse events (HRAEs) between the 2 LVAS. Methods: We conducted a secondary end point evaluation of HRAE (survival free of any nonsurgical bleeding, thromboembolic event, pump thrombosis, or neurological event) in the short-term cohort (as-treated cohort n=289) at 6 months. The net burden of HRAE was also assessed by using a previously described hemocompatibility score, which uses 4 escalating tiers of hierarchal severity to derive a total score for events encountered during the entire follow-up experience for each patient. Results: In 289 patients in the as-treated group (151 the HM3 and 138 the HMII), survival free of any HRAE was achieved in 69% of the HM3 group and in 55% of the HMII group (hazard ratio, 0.62; confidence interval, 0.42–0.91; P =0.012). Using the hemocompatibility score, the HM3 group demonstrated less pump thrombosis requiring reoperation (0 versus 36 points, P P =0.02), and fewer nondisabling strokes (6 versus 24 points, P =0.026) than the control HMII LVAS. The net hemocompatibility score in the HM3 in comparison with the HMII patients was 101 (0.67±1.50 points/patient) versus 137 (0.99±1.79 points/patient) (odds ratio, 0.64; confidence interval, 0.39–1.03; P =0.065). Conclusions: In this secondary analysis of the MOMENTUM 3 trial, the HM3 LVAS demonstrated greater freedom from HRAEs in comparison with the HMII LVAS at 6 months. Clinical Trial Registration: URL: http://clinicaltrials.gov . Unique identifier: NCT02224755.

Background— Several trials have demonstrated improved survival with implantable cardioverter-defibrillator (ICD) therapy. The cause and nature of death in the ICD population have been insufficiently investigated. The objective of this study was to analyze ICDs from deceased patients to assess the incidence of ventricular tachyarrhythmias, the occurrence of shocks, and possible device malfunction. Methods and Results— We prospectively analyzed intracardiac electrograms in 125 explanted ICDs. The incidence of ventricular tachyarrhythmia, including ventricular fibrillation, and shock treatment was assessed. Ventricular tachyarrhythmia occurred in 35% of the patients in the last hour of their lives; 24% had an arrhythmic storm, and 31% received shock treatment during the last 24 hours. Arrhythmic death was the primary cause of death in 13% of the patients, and the most common cause of death was congestive heart failure (37%). More than half of the patients (52%) had a do-not-resuscitate order, and 65% of them still had the ICD shock therapies activated 24 hours before death. Possible malfunctions of the ICD were found in 3% of all patients. Conclusions— More than one third of the patients had a ventricular tachyarrhythmia within the last hour of life. Cardiac death was the primary cause and heart failure the specific cause of death in the majority of the cases. Devices remained active in more than half of the patients with a do-not-resuscitate order; almost one fourth of these patients received at least 1 shock in the last 24 hours of life.

The overall risk of clinically significant adverse events related to EMI in recipients of CIEDs is very low. Therefore, no special precautions are needed when household appliances are used. Environmental and industrial sources of EMI are relatively safe when the exposure time is limited and distance from the CIEDs is maximized. The risk of EMI-induced events is highest within the hospital environment. Physician awareness of the possible interactions and methods to minimize them is warranted.

Implantable cardioverter defibrillators (ICDs) save lives in patients at risk for sudden death attributable to ventricular arrhythmias, pacemakers (PMs) have been improving symptoms in patients with bradyarrhythmias for decades, and, more recently, cardiac resynchronization devices have improved mortality, morbidity, and quality of life for patients with heart failure.1 However, these devices can also be life-changing for the patients receiving them. The need for long-term follow-up, concerns regarding malfunction, and lifestyle restrictions all affect patients with any implanted device. For patients with ICDs, receiving shocks, both appropriate and inappropriate, can impact quality of life (QOL). Lead or device malfunction can result in unnecessary shocks, and recalls can cause anxiety. Shocks at the end of life can be particularly devastating. However, with careful attention by the healthcare team, both shocks and their impact can be reduced. In addition to shocks, restrictions imposed by the ICD can also impact QOL. The possibility of syncopal arrhythmias and loss of control attributable to shocks, as well, has led to concerns regarding the safety of driving and of sports participation for some individuals, a further burden. Remote monitoring increases the ease of follow-up for patients and physicians and may improve timeliness of management. However, a consequence of remote follow-up has been a decrease in the amount of time electrophysiologists may spend face-to-face with patients, emphasizing the importance of communication between electrophysiologist and primary cardiologist. This article will review ways in which electrophysiologists, general cardiologists, and patients can work together to minimize the burdens that can accompany these devices, often weighing issues of patient QOL, safety, and autonomy. Studies of overall QOL for patients with ICDs have shown mixed results. Some studies have found no significant differences in overall QOL between ICD patients and other cardiac patients,2,3 PM patients, or the general population. …

Bioprosthetic valves are increasingly used in patients with aortic stenosis. Compared with mechanical valves, bioprosthetic valves are associated with a lower risk of thromboembolic events and do not require long-term anticoagulation.1,2 However, bioprosthetic valves have limited durability; the best current valves can be expected to degenerate within 10 to 20 years, resulting in stenosis or regurgitation. Surgical valve replacement is the current standard of care for these patients. However, reoperative morbidity and mortality risk is significant, not only because of the complexity of reoperation but also because many of these patients have comorbidities, particularly advanced age.1–5 Transcatheter heart valve (THV) implantation for native valve aortic stenosis has evolved as a viable, less invasive alternative to open heart surgery in selected patients.6 Recently, THV implantation within failed surgically implanted bioprostheses has proven feasible.7–10 Here, we review what is known of the potential and challenges of valve-in-valve (VinV) implantation in patients with failing surgical aortic bioprostheses. Bioprosthetic valves incorporate leaflets made from animal tissue. Xenografts are fashioned from porcine aortic valves, from more durable bovine pericardium, or rarely from porcine pericardium. Homografts are fashioned from human aortic valves. Tissue is generally preserved in glutaraldehyde, which cross-links collagen fibers, reducing antigenicity and in vivo enzymatic degradation.11 Various proprietary anticalcification treatments are commonly used. Surgical bioprostheses are commonly stratified into stented and stentless valves (Figure 1). Figure 1. Common bioprosthetic surgical valves. The Mosaic (Medtronic) valve could be implanted either intra-annularly or supra-annularly. ### Stented Bioprostheses Stented valves are usually constructed with bovine pericardium or whole porcine aortic valves attached to a support structure such as a stent or frame. Current bioprosthetic frames are composed of alloy or polymer materials that absorb some of the forces acting on the leaflets. The frame of the bioprosthesis is responsible …

Background— Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and congenital heart disease patients. Methods and Results— The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24-center international registry. Pediatric and congenital heart disease patients with ICD lead implantations from 2005 to 2010 were eligible. Study subjects comprised 878 ICD patients (44% congenital heart disease). Mean±SD age at implantation was 18.6±9.8 years. Of the 965 total leads, 54% were thin (≤7F), of which 57% were Fidelis, and 23% were coated with expanded polytetrafluoroethylene. There were 139 ICD lead failures (14%) in 132 patients (15%) at a mean lead age of 2.0±1.4 years, causing shocks in 53 patients (40%). Independent predictors of lead failure included younger implantation age and Fidelis leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implantation: 18 years ( P =0.015). The actuarial yearly failure rate was 2.3% for non-Fidelis and 9.1% for Fidelis leads. Extraction was performed on 143 leads (80% thin, 7% expanded polytetrafluoroethylene coated), with lead age as the only independent predictor for advanced extraction techniques. There were 6 major extraction complications (4%) but no procedural mortality. Conclusions— This study demonstrates that ICD leads in children and congenital heart disease patients have an age-related suboptimal performance, further compounded by a high failure rate of Fidelis leads. Advanced extraction techniques were common and correlated with older lead age. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00335036.

Background— In developing economies, there are patients in whom pacemaker implantation is delayed because they cannot afford one. Reused devices have been a solution. To address concerns about safety, a cohort of consecutive patients implanted with a reused pacemaker was compared with a control group. Methods and Results— A cohort of 603 consecutive patients from 2000 to 2010 was studied in an ambispective noninferiority study. The study group patients (n=307) received resterilized pacemakers, and the control group patients (n=296) received a new pacemaker. A combined end point of 3 major outcomes–unexpected battery depletion, infection, and device dysfunction–was analyzed. A total of 85 pacemakers had to be explanted, 31 in the control group (10.5%) and 54 in the study group (17.6%; relative risk, 1.68; 95% confidence interval, 1.1–2.5; P =0.02). Forty-three reached the primary end point, 16 in the control group (5.5%) and 27 in the study group (7.2%; relative risk, 1.3; 95% confidence interval, 0.70–2.45; P =0.794). In terms of individual outcomes, 5 new pacemakers (1.7%) and 11 resterilized pacemakers (3.6%) had unexpected battery depletion (relative risk, 2.12; 95% confidence interval, 0.75–6; P =0.116); 3.7% new pacemakers and 3.2% reused pacemakers had a procedure-related infection (relative risk, 0.87; 95% confidence interval, 0.38–2.03; P =0.46); and 1 pacemaker in the study group malfunctioned. Conclusions— Pacemaker reuse is feasible and safe and is a viable option for patient with bradyarrhythmias. Other than the expected shorter battery life, reuse of pacemaker generators is not inferior to the use of new devices.

Background— Using data from the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) study, we examined whether Fidelis lead failure was more common in patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (ICD-CRT) than in patients with an ICD only. Methods and Results— All cases of patients who had a right ventricular defibrillation lead revision in the RAFT study were adjudicated for the presence of lead fracture. Criteria for fracture were at least 2 of the following: (1) Impedance rise (>50% or >500 Ω in 1 week), (2) short interval count >10 times per day or 300 times per month, or (3) inappropriate shock caused by noise, verified by stored electrogram. A total of 1798 patients were enrolled into the RAFT study, with a mean follow-up of 40±20 months. There were 818 patients (45.5%) who received a Fidelis lead at the original implantation, 405 with an ICD only and 413 with an ICD-CRT. There were 47 confirmed defibrillation lead fractures; 45 were Fidelis leads (5.5% of Fidelis leads). The overall rate of fracture in the ICD group was 3.2% compared with 7.8% in the ICD-CRT group ( P =0.006; hazard ratio, 2.42; 95% confidence interval, 1.27–4.61). Significant correlates of lead fracture in this population were undergoing an ICD-CRT implantation and having ≥2 leads. Conclusions— In this analysis of the RAFT study, patients with an ICD-CRT were found to have a significantly higher fracture rate than patients with an ICD. This finding needs to be considered when these patients are assessed for possible lead revision at the time of an elective generator replacement.

Background— We report findings from optical coherence tomography (OCT) of in-stent neoatherosclerosis as a cause of drug-eluting stent (DES) failure. Methods and Results— Optical coherence tomography and grayscale and virtual histology intravascular ultrasound were performed in 50 patients (30 stable, 20 unstable angina) with 50 DES in-stent restenosis lesions and intimal hyperplasia >50% of stent area. Median follow-up time was 32.2 months. Overall, 26 lesions (52%) had at least 1 OCT-defined in-stent thin-cap fibroatheroma (TCFA)–containing neointima and 29 (58%) had at least 1 in-stent neointimal rupture. Patients presenting with unstable angina showed a thinner fibrous cap (55 μm [interquartile range 42 to 105 μm] versus 100 μm [interquartile range 60 to 205 μm], P =0.006) and higher incidence of OCT-defined TCFA-containing neointima (75% versus 37%, P =0.008), intimal rupture (75% versus 47%, P =0.044), thrombi (80% versus 43%, P =0.010), and red thrombi (30% versus 3%, P =0.012) than stable patients. Fibrous cap thickness negatively correlated with follow-up time ( r =−0.318, P =0.024). Compared with DES P =0.012) and red thrombi (27% versus 0%, P =0.007). Patients with unstable (versus stable) angina had an increasing number of unstable OCT findings including TCFA-containing neointima, neointima rupture, and thrombus ( P =0.027). The rate of agreement between grayscale intravascular ultrasound and OCT for detecting intimal rupture was 50% and for detecting thrombus was 44%. The agreement between virtual histology intravascular ultrasound and OCT for identifying TCFA-containing neointima was 78%. Conclusions— In-stent neoatherosclerosis may be an important mechanism of DES failure, especially late after implantation.

Background— Downloadable software upgrades are common in consumer electronics but not in implantable medical devices. Fractures of implantable cardioverter-defibrillator (ICD) leads present commonly as inappropriate shocks. A lead-integrity alert (LIA) designed to reduce inappropriate shocks is the first software download approved to enhance nominally functioning, previously implanted ICDs. Methods and Results— We performed a prospective study to determine whether an LIA could reduce inappropriate shocks. Patients were included if they had ICD lead fractures confirmed by analysis of explanted leads. The LIA group included the first 213 patients who met the inclusion criteria after the LIA was approved who had the LIA downloaded. The LIA is triggered either by high impedance or rapid oversensing. It responds by delaying detection of ventricular fibrillation and initiating a patient alert every 4 hours. The control group included the first 213 patients who did not have the LIA downloaded. They were monitored by conventional daily impedance measurements that respond with a daily alert. The LIA group had a 46% relative reduction (95% confidence interval 34% to 55%) in the percentage of patients with ≥1 inappropriate shock (LIA 38% versus control 70%, P P P Conclusions— A software download that upgrades previously implanted ICDs without surgical revision reduces inappropriate shocks caused by lead fractures.

Background— Defibrillator lead malfunction is a potential long-term complication in patients with an implantable cardioverter-defibrillator (ICD). The aim of this study was to determine the incidence and causes of lead malfunction necessitating surgical revision and to evaluate 2 approaches to treat lead malfunction. Methods and Results— We included 1317 consecutive patients with an ICD implanted at 3 European centers between 1993 and 2004. The types and causes of lead malfunction were recorded. If the integrity of the high-voltage part of the lead could be ascertained, an additional pace/sense lead was implanted. Otherwise, the patients received a new ICD lead. Of the 1317 patients, 38 experienced lead malfunction requiring surgical revision and 315 died during a median follow-up of 6.4 years. At 5 years, the cumulative incidence was 2.5% (95% confidence interval, 1.5 to 3.6). Lead malfunction resulted in inappropriate ICD therapies in 76% of the cases. Implantation of a pace/sense lead was feasible in 63%. Both lead revision strategies were similar with regard to lead malfunction recurrence ( P =0.8). However, the cumulative incidence of recurrence was high (20% at 5 years; 95% confidence interval, 1.7 to 37.7). Conclusions— ICD lead malfunction necessitating surgical revision becomes a clinically relevant problem in 2.5% of ICD recipients within 5 years. In selected cases, simple implantation of an additional pace/sense lead is feasible. Regardless of the chosen approach, the incidence of recurrent ICD lead-related problems after lead revision is 8-fold higher in this population.

Atherosclerosis in the form of peripheral arterial disease results in significant morbidity. Surgical treatment options for peripheral arterial disease include angioplasty, endarterectomy, and bypass grafting. For bypass grafting, vein remains the conduit of choice; however, poor quality and limited availability have led to the use of prosthetic materials. Unfortunately, because of a lack of endothelium and compliance mismatch, neointimal hyperplasia develops aggressively, resulting in high failure rates. To improve graft patency, investigators have developed surgical, chemical, and biological graft modifications. This review describes common prosthetic materials, as well as approaches currently in use and under investigation to modify and improve prosthetic conduits for bypass grafting in an effort to improve graft patency rates.

Background— The number of patients with longer follow-up after implantation of an implantable cardioverter-defibrillator is increasing continuously. Defibrillation lead failure is a typical long-term complication. Therefore, the long-term reliability of implantable cardioverter-defibrillator leads has become an increasing concern. The aim of the present study was to assess the annual rate of transvenous defibrillation lead defects related to follow-up time after lead implantation. Methods and Results— A total of 990 consecutive patients who underwent first implantation of an implantable cardioverter-defibrillator between 1992 and May 2005 were analyzed. Median follow-up time was 934 days (interquartile range, 368 to 1870). Overall, 148 defibrillation leads (15%) failed during the follow-up. The estimated lead survival rates at 5 and 8 years after implantation were 85% and 60%, respectively. The annual failure rate increased progressively with time after implantation and reached 20% in 10-year-old leads ( P P =0.06). The major lead complications were insulation defects (56%), lead fractures (12%), loss of ventricular capture (11%), abnormal lead impedance (10%), and sensing failure (10%). Conclusions— An increasing annual lead failure rate is noted primarily during long-term follow-up and reached 20% in 10-year-old leads. Patients with lead defects are younger and more often female.

Background— This randomized controlled trial evaluated clinical durability of Zilver PTX, a paclitaxel-coated drug-eluting stent (DES), for femoropopliteal artery lesions. Outcomes compare primary DES versus percutaneous transluminal angioplasty (PTA), overall DES (primary and provisional) versus standard care (PTA and provisional Zilver bare metal stent [BMS]), and provisional DES versus provisional BMS. Methods and Results— Patients with symptomatic femoropopliteal artery disease were randomly assigned to DES (n=236) or PTA (n=238). Approximately 91% had claudication; 9% had critical limb ischemia. Patients experiencing acute PTA failure underwent secondary randomization to provisional BMS (n=59) or DES (n=61). The 1-year primary end points of event-free survival and patency showed superiority of primary DES in comparison with PTA; these results were sustained through 5 years. Clinical benefit (freedom from persistent or worsening symptoms of ischemia; 79.8% versus 59.3%, P P P P =0.02), patency (72.4% versus 53.0%, P =0.03), and freedom from target lesion revascularization (84.9% versus 71.6%, P =0.06) with provisional DES were improved over provisional BMS. These results represent >40% relative risk reduction for restenosis and target lesion revascularization through 5 years for the overall DES in comparison with standard care and for provisional DES in comparison with provisional BMS. Conclusions— The 5-year results from this large study provide long-term information previously unavailable regarding endovascular treatment of femoropopliteal artery disease. The Zilver PTX DES provided sustained safety and clinical durability in comparison with standard endovascular treatments. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00120406.

Background— Delivery of inappropriate shocks caused by misdetection of supraventricular tachycardia (SVT) remains a substantial complication of implanted cardioverter/defibrillator (ICD) therapy. Whether use of optimally programmed dual-chamber ICDs lowers this risk compared with that in single-chamber ICDs is not clear. Methods and Results— Subjects with a clinical indication for ICD (n=400) at 27 participating centers received dual-chamber ICDs and were randomly assigned to strictly defined optimal single- or dual-chamber detection in a single-blind manner. Programming minimized ventricular pacing. The primary end point was the proportion of SVT episodes inappropriately detected from the time of programming until crossover or end of study. On a per-episode basis, 42% of the episodes in the single-chamber arm and 69% of the episodes in the dual-chamber arm were due to SVT. Mortality (3.5% in both groups) and early study withdrawal (14% single-chamber, 11% dual-chamber) were similar in both groups. The rate of inappropriate detection of SVT was 39.5% in the single-chamber detection arm compared with 30.9% in the dual-chamber arm. The odds of inappropriate detection were decreased by almost half with the use of the dual-chamber detection enhancements (odds ratio, 0.53; 95% confidence interval, 0.30 to 0.94; P =0.03). Conclusions— Dual-chamber ICDs, programmed to optimize detection enhancements and to minimize ventricular pacing, significantly decrease inappropriate detection.

Background— The optimal treatment for dysfunctional right ventricle–to–pulmonary artery (RV-PA) conduits is unknown. Limited follow-up data on stenting of RV-PA conduits have been reported. Methods and Results— Between 1990 and 2004, deployment of balloon-expandable bare stents was attempted in 242 obstructed RV-PA conduits in 221 patients (median age, 6.7 years). Acute hemodynamic changes after stenting included significantly decreased RV systolic pressure (89±18 to 65±20 mm Hg, P P 5 years), with younger age, homograft conduit, conduit diameter ≤10 mm, diagnosis other than tetralogy of Fallot, Genesis stent, higher prestent RV:aortic pressure ratio, and stent malposition associated with shorter freedom from surgery. Tricuspid regurgitation and RV function did not change between stent implantation and subsequent surgery. Conclusions— Conduit stenting is an effective interim treatment for RV-PA conduit obstruction and prolongs conduit lifespan in most patients. Stent fractures were common but not associated with significant complications or earlier conduit reoperation.

Background— Mitral annuloplasty is the most common surgical procedure performed for ischemic mitral regurgitation (MR). Surgical mitral annuloplasty is limited by morbidity, mortality, and MR recurrence. We evaluated the safety and feasibility of a transvenous catheter-delivered implantable device to provide a percutaneous alternative to surgical mitral annuloplasty. Methods and Results— Five patients with chronic ischemic MR underwent percutaneous transvenous implantation of an annuloplasty device in the coronary sinus. Implantation was successful in 4 patients. Baseline MR in the entire group was grade 3.0±0.7 and was reduced to grade 1.6±1.1 at the last postimplantation visit when the device was intact or the last postprocedural visit in the patient in whom the device was not successfully implanted. Separation of the bridge section of the device occurred in 3 of 4 implanted devices and was detected at 28 to 81 days after implantation. There were no postprocedural device-related complications. Conclusions— Percutaneous implantation of a device intended to remodel the mitral annulus is feasible. Initial experience suggests a possible favorable effect on MR. Percutaneous transvenous mitral annuloplasty warrants further evaluation as a less invasive alternative to surgical annuloplasty.

Background— Hemodialysis vascular access dysfunction is the single most important cause of morbidity in kidney hemodialysis patients. Failure of an arteriovenous polytetrafluoroethylene (PTFE) graft, the most common form of hemodialysis access, is primarily due to intimal hyperplasia and thrombosis at the venous anastomosis. Methods and Results— This study was aimed at evaluating the efficacy and safety of an adenoviral vector (Ad2/βARKct) encoding the carboxyl terminus of β-adrenergic receptor kinase (βARKct) in a pig model of arteriovenous PTFE graft failure. Transduction of the external jugular vein with Ad2/βARKct (5E9, 5E10, or 5E11 particles per vein) did not result in systemic toxicity, as measured by clinical and pathological assessments. Ad2/βARKct significantly reduced neointimal hyperplasia in the graft/vein anastomosis. It also improved the graft patency rate and angiographic score, as measured histologically and angiographically, compared with vehicle or empty viral vector controls. Conclusions— Our results suggest that local administration of adenoviral vectors encoding βARKct into the jugular vein represents a viable strategy to treat AV graft hemodialysis vascular access failure.

Background— Little is known about causes of intimal hyperplasia (IH) after sirolimus-eluting stent (SES) implantation. Methods and Results— Intravascular ultrasound was performed in 24 lesions with intra-SES restenosis and a comparison group of 25 nonrestenotic SESs. To assess stent strut distribution, the maximum interstrut angle was measured with a protractor centered on the stent, and the visible struts were counted and normalized for the number of stent cells. In SES restenosis patients, minimum lumen site was compared with image slices 2.5, 5.0, 7.5, and 10.0 mm proximal and distal to this site. The minimum lumen site had a smaller IVUS lumen area at follow-up (2.7±0.9 versus 6.2±1.9 mm 2 ; P P 2 ; P P P P P P P P P P Conclusions— The number and distribution of stent struts affect the amount of neointima after SES implantation.

Background— Because of risk of outlet strut fracture, prophylactic replacement should be considered for Björk-Shiley convexo-concave (BScc) valve recipients. We assessed the effects of epidemiological and decision-analytic guidelines on actual BScc valve replacement. Methods and Results— We performed a retrospective cohort study including all 2263 Dutch BScc patients with a mean follow-up of 11.3 years (range, 0 to 23 years). Outcomes were outlet strut fracture, mortality, and BScc valve replacement. For the surviving patients in 1992 (n=1330), we calculated the expected differences in life expectancy (LE) with and without BScc valve replacement according to decision guidelines developed in 1992. Differences in LE were compared with actual replacements. During 8 years of follow-up, there were 494 deaths (40%), and 11 patients had suffered outlet strut fracture. Of 1330 patients, 96 (10%) had undergone BScc valve replacement, particularly in years after introduction of initial and updated guidelines. One hundred seventeen patients (9%) had an estimated gain in LE after BScc valve replacement. These patients were more likely to undergo replacement than patients with an estimated loss of LE (hazard ratio, 6.6; 95% CI, 4.4 to 10; P Conclusions— Valve replacement for BScc heart valve patients was largely in concordance with guidelines in the Netherlands. Individualized guidelines that are based on high-quality epidemiological data and are updated and implemented rigorously can influence clinical practice in complex decision problems.

We report the case of a 20-year-old woman who had percutaneous closure of a patent ductus arteriosus (PDA) with a 17-mm Rashkind occluder when she was 4 years of age. A small residual shunt was noted on color-flow Doppler echocardiography immediately after the procedure and at 6-month follow-up. Because of the lack of hemodynamic complications, no additional intervention was performed. Sixteen years later, she presented with recurrent bilateral bronchopneumonia that required antibiotic treatment. Chest radiography during the third episode showed a right bronchopneumonia (Figure 1). At that time, new treatment with amoxicillin and clavulanic acid was given for 10 days, but fever persisted despite this course of antibiotics. Figure 1. Chest radiograph showed right upper lobe consolidation suggestive of infective bronchopneumonia (arrow). The Rashkind occluder device is visible in the duct area (dotted arrow). Results of the physical examination showed blood pressure of …

Background— Three trials demonstrated recently that a long detection window reduces implantable cardioverter-defibrillator (ICD) therapy in primary prevention patients. Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) was the only trial that enrolled both primary and secondary prevention patients. Methods and Results— Of the 1902 patients enrolled in the ADVANCE III trial, 477 received a defibrillator for secondary prevention; 248 patients were randomly assigned to a long detection setting (30 of 40 intervals) and 229 to the nominal setting (18 of 24 intervals) for ventricular arrhythmias with cycle length ≤320 ms. Eight-five percent of patients were men, with a mean age of 65±12 years, a previous history of ventricular fibrillation in 37% of the cases, and a mean ejection fraction of 38±13%. The ICD device mix was 37% single chamber, 47% dual chamber, and 16% triple chamber. Over a median period of 12 months, the long detection period was associated with a 25% reduction in the number of overall therapies (115.6 versus 86.8 per 100 patient-years; incidence rate ratio, 0.75; 95% confidence interval, 0.61–0.93; P =0.008) and a 34% reduction in the number of shocks (rate per 100 patient-years, 51.2 versus 38.1; incidence rate ratio, 0.66; 95% confidence interval, 0.48–0.89; P =0.007). Appropriate therapies (89.7 versus 67.7; incidence rate ratio, 0.77; 95% confidence interval, 0.60–0.97; P =0.029) and appropriate shocks (37.1 versus 28.1; incidence rate ratio, 0.64; 95% confidence interval, 0.45–0.93; P =0.018) were also reduced. Conclusions— ADVANCE III is the first randomized trial to assess a long detection window setting in ICDs in both primary and secondary prevention populations and demonstrates a reduction of overall therapies and shocks in the subgroup of secondary prevention patients. These data suggest that even the secondary prevention population may benefit from programming that combines a long detection period with antitachycardia pacing during charging. Clinical Trial Registration— URL: http://www/clinicaltrials.gov . Unique identifier: NCT00617175.

Case Presentation: A 56-year-old man with a history of ischemic cardiomyopathy and New York Heart Association functional class IV heart failure (HF) requiring intravenous inotropic therapy underwent uncomplicated implantation of a continuous-flow left ventricular assist device (LVAD) as bridge to heart transplantation (HT). The patient was weaned off inotropic support during the first week after surgery and had progressive improvement in functional status. He was discharged home on maintenance antithrombotic therapy with aspirin 325 mg once daily and warfarin targeted to an international normalized ratio of 2.0 to 3.0. Eight weeks after LVAD implantation, he developed progressive dyspnea on exertion, recurrent pedal edema, and a 7-pound weight gain. Physical examination revealed conjunctival pallor, a palpable carotid pulse, jugular venous pressure of 14 cm H2O, and 2+ pitting edema bilaterally. A rapid and targeted assessment of recurrent HF is essential in this LVAD patient because of multiple, potentially life-threatening causes that necessitate divergent treatments. The US Food and Drug Administration first approved implantable LVADs as a bridge to transplantation in 1994.1 Although HT remains the gold standard therapy for selected patients with end-stage HF, the stable donor base of

A 42-year-old man had undergone mitral valve (MV) replacement 12 years earlier with the use of a CarboMedics bileaflet mechanical prosthesis (Sorin Biomedica). On a routine visit, he was asymptomatic, and cardiac auscultation revealed closing and opening MV clicks. A transthoracic echocardiogram with the use of a 2-beat acquisition protocol showed normal excursion of both MV discs (Figure 1; Movie I in the online-only Data Supplement). Spectral Doppler of transmitral flow indicated normal peak gradients; however, abnormalities in the Doppler signal were intermittently noted. Whereas some cardiac cycles showed normal disc motion with near-simultaneous opening clicks, other cycles demonstrated a delay in 1 opening click or a single rather than dual opening clicks (Figure 2). The beats with a single opening click were associated with significant prolongation of the transmitral pressure half-time suggestive of obstruction to flow. The abnormalities on spectral Doppler prompted us to reimage the MV over several cardiac cycles. Intermittent delay in the opening of 1 disc with periodic disc entrapment in a closed position was noted (Figure 3;Movie II in the online-only Data Supplement). Interrogation with color Doppler showed intermittent …

Background —Atrial fibrillation (AF) is a common problem after CABG. Prevention with prophylactic drug therapy has had limited success, therefore alternative approaches are required. This study investigated the role of biatrial pacing compared with no pacing on AF incidence after isolated first-time CABG. Methods and Results —During surgery, temporary pacing leads were placed in the lateral wall of the right atrium and at the roof of the left atrium in Bachmann’s bundle to allow bipolar pacing and sensing at each site. After surgery, all patients were connected to an external pacemaker (Chorum ELA) that also acted as a Holter monitor. Patients were consecutively randomized to either 4 days of biatrial pacing at a base rate of 80 bpm or to no pacing (control group, base rate 30 bpm). End points included an episode of AF lasting >1 hour on pacemaker Holter, clinically detected AF, intensive care unit (ICU) and hospital stay, and postoperative complications. One hundred thirty patients were randomized. Biatrial pacing significantly reduced both monitored (13.8% versus 38.5%, P =0.001) and clinical (10.8% versus 33.8%, P =0.002) episodes of AF. Median ICU (19 versus 24 hours, P =NS) and mean hospital stay (7.7±6.9 versus 9.7±10, P =NS) did not significantly change. The number of postoperative complications was lower in the biatrial group (13 versus 35, P =0.001). Conclusions —Biatrial pacing after CABG significantly decreases the incidence of AF. This is associated with reduced postoperative complications and a trend toward reduced ICU and hospital stay.

Acute and subacute stent thromboses have existed since the first stent implantation procedures. Initially recognized as a complication of brachytherapy, late stent thrombosis has become a public health issue only during the current era of drug-eluting stent (DES) implantation, as evidenced by the March 8, 2007, issue of the New England Journal of Medicine , which includes 5 articles, 2 perspectives, and 1 editorial discussing late DES complications. Article p 2426 During every phase of percutaneous coronary intervention, intravascular ultrasound (IVUS) has provided important insights into the mechanisms of success and reasons for failure. In this issue of Circulation , Cook et al1 continue this tradition by reporting the IVUS findings in 13 patients who developed stent thrombosis >1 year after DES implantation. They concluded, “Incomplete stent apposition is highly prevalent in patients with very late stent thrombosis after DES implantation, suggesting a role in the pathogenesis of this adverse event.” Incomplete stent apposition (ISA), synonymous with stent malapposition, is a lack of contact between stent struts and the underlying vessel wall not overlying a side branch. ISA can be quantified by measuring the number of malapposed struts; the arc subtended by the malapposed struts; the distance between the malapposed struts and the vessel wall; and the area, length, and volume of the gap between the stent and vessel wall. ISA must be differentiated from and not confused with stent underexpansion. Stent expansion is the minimum stent area by itself or compared with a predefined reference. Although this distinction may seem obvious, ISA and stent underexpansion are used interchangeably by purported experts. Although the collaborative work of Nakamura and associates2 demonstrated an unexpectedly high percentage of IVUS-detected stent underexpansion and incomplete apposition after angiographically successful bare metal stent (BMS) implantations, no study has linked acute or subacute stent …

Multiple clinical trials have shown that a properly functioning implantable cardioverter-defibrillator (ICD) is capable of interrupting sudden death caused by ventricular tachyarrhythmias. Unfortunately, ICDs are complex medical devices, and they do not always perform as expected. For example, only 5% of ICD batteries last >7 years, and most dual-chamber ICD models must be replaced for battery depletion every 3 to 5 years.1 Normal battery depletion, however, is reliably predicted by routine follow-up methods before an ICD fails. In contrast, electronic malfunctions are unpredictable and may not be detected by standard follow-up techniques before an ICD is unable to deliver effective therapy. Thus, sudden cardiac arrest or death may be the first and only sign that an ICD has failed.2 Recently, we reported the death of a 21-year-old patient who received a Prizm 2 DR model 1861 ICD pulse generator (Guidant, Inc) in 2001 to prevent sudden cardiac death resulting from hypertrophic cardiomyopathy.3 In March 2005, this young man experienced a witnessed arrest and could not be resuscitated. His ICD was returned to Guidant, which found that the device had failed during the delivery of a shock. The cause of failure was massive electronic damage caused by electrical overstress that occurred when a short circuit developed between a high-voltage wire and a tube used to test the housing during manufacturing (see the Figure). At the time of our patient’s death, Guidant had knowledge of 25 similar Prizm 2 DR model 1861 failures in patients, 3 of whom had required rescue defibrillation. Indeed, Guidant had first observed this mode of failure 3 years earlier, in February 2002, when 2 returned Prizm 2 DR pulse generators exhibited the same short circuiting that caused our patient’s device to fail. Guidant was sufficiently concerned about these failures that manufacturing changes were made …

43-year—old man was admitted to the coronary care unit because of recurrent syncope. His medical history included pulmonic valve angioplasty at age 9 years, mechani-cal mitral valve replacement because of severe mitral regur-gitation caused by congenital atrioventricular canal, and pacemaker implantation because of complete atrioventricular block. On admission he was orthopneic, his blood pressure was 78/45 mmHg, and his pulse was 72 beats per minute, irregu -lar. On auscultation, lungs were clear and there were irregular cardiac sounds of mechanical mitral prosthesis. There were no signs of peripheral edema. ECG showed slow atrial fibrillation with intermittent ventricular pacing. International normalized ratio was in high therapeutic range, at 4.5. Echo examination showed intermittent opening of the mitral valve 1:2. This was confirmed by continuous wave Doppler, M-mode echo, and color M-mode echo (Figure) with mildly elevated gradient 20/8 mmHg. Cine fluoroscopy showed intermittent open -ing of the mitral prosthesis (online-only Data Supplement Movie I; Bjork -Shiley mono-leaflet tilting disk).The patient underwent surgery. Massive calcified pan-nus covered the valve and interfered with the opening of the prosthesis.Intermittent opening of prosthetic mitral valve is rare

A 62-year–old man presented with progressive exertional dyspnea and angina. His past medical history is notable for coronary artery disease, for which he underwent a coronary artery bypass graft surgery 8 years earlier. A few years afterward, he underwent aortic valve (AV) bypass (AVB) surgery for severe aortic stenosis (AS) using an apicoaortic conduit to the descending aorta consisting of a 16-mm connector and an 18-mm valved conduit (Hancock valve; Medtronic, Minneapolis, MN; Figures 1 and 2; online-only Data Supplement Movie I). After a period of initial improvement in symptoms, the patient developed progressive dyspnea and angina and was referred for additional cardiac workup. Figure 1. An ECG-gated thin-slice contrast-enhanced cardiac computed tomography scan showing a heavily calcified native aortic valve (AV), hypertrophied left ventricle (LV), and the apical LV insertion site of the apicoaortic valved conduit. Figure 2. A 3-dimensional cardiac computed tomography reconstruction image showing the apicoaortic valved conduit, extending from its apical insertion site into the left ventricle (LV) to its insertion site into the descending aorta. Arrow , Conduit valve. The patient underwent a bicycle ergometer test, which showed a diminished functional capacity and was stopped because of fatigue and a hypotensive response. He underwent a 2-dimensional transthoracic echocardiogram with gradual dobutamine infusion. He was found to have a heavily calcified AV (online-only Data Supplement Movie II) with a rest mean transvalvular gradient of 34 mm Hg and velocity of 3.5 m/s, which increased to 50 mm Hg and 4.8 m/s, respectively, at peak dobutamine dose (Figure 3). This corresponded with a …

Background This study examines the limitations and complex management problems associated with the use of tiered-therapy, implantable cardioverter-defibrillators (ICDs). Methods and Results The study group comprises the first 154 patients undergoing implantation of tiered-therapy ICDs at our institution. Pulse generators from three different manufacturers were used. In 39 patients, a complete nonthoracotomy lead system was used. The perioperative mortality was 1.3%. Of these 154 patients, 37% experienced late postoperative problems. Twenty-one patients required system revision within 36.5 months (mean, 8.57±11.3) of surgery. Reasons for revision were spurious shocks due to electrode fractures (3) or electrode adapter malfunction (2), inadequate signal from endocardial rate-sensing electrodes (3), superior vena cava or right ventricular coil migration (5), failure to correct tachyarrhythmias due to a postimplant rise in defibrillation threshold (5), or pulse generator failure (3). One of these patients required system removal for infection after revision of an endocardial lead. A further 32 patients received inappropriate shocks for atrial fibrillation with a rapid ventricular response or sinus tachycardia. Two of these patients also received shocks for ventricular tachycardia initiated by antitachycardia pacing triggered by atrial fibrillation. Ventricular pacing for bradycardia was associated with inappropriate shocks due to excessive autogain in 2 patients. Conclusions Despite the major diagnostic and therapeutic advantages of tiered-therapy ICDs, a significant proportion of patients continue to experience hardware-related complications or receive inappropriate shocks.

Background— Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. Methods and Results— The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. Conclusions— The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

Background— Repair of a dissected aorta involves reattaching the media with synthetic glue and/or reinforcement with nonbiodegradable felt. Late complications specific to each aspect of this procedure have been reported. We attempted to regenerate the media by using biodegradable felt. Methods and Results— We created a canine model of descending thoracic aortic dissection and compared 4 modes of aortic repair: biodegradable polyglycolic acid (PGA) felt in the media; PGA with basic fibroblast growth factor (bFGF) in the media; PGA with bFGF in the media plus external reinforcement with expanded polytetrafluoroethylene; and primary suture closure of the dissected lumen (control). Repaired aortic stumps were quantitatively tested for suture pull-out strength. Failure force improved 4-fold in all 3 medial reinforcement groups compared with controls. Additionally, animals were kept alive for histological examination and compliance testing 6 months after repair. Compliance of the aortic wall at the anastomotic sites was not essentially affected in the long term except in the group with concomitant external reinforcement (55.9±4.5% reduction; P Conclusions— Medial reinforcement provides sufficient augmented strength for aortic surgical repair. Medial regeneration using biodegradable felt as a scaffold preserves histological integrity and compliance in the canine dissected aorta.

Background— Stentless aortic bioprostheses were designed to provide enhanced hemodynamic performance and potentially greater longevity. The present report describes the outcomes of patients with the Freestyle stentless bioprosthesis followed for ≤18 years. Methods and Results— Between 1993 and 2011, 430 patients underwent primary aortic valve replacement with a Freestyle bioprosthesis in the subcoronary position. Mean age was 68.2±8.2 years. All of the clinical and echocardiographic data were collected prospectively. Mean overall follow-up was 9.1±4.4 years and was complete in all of the patients. In-hospital mortality was 3.5% (n=15). Overall, 10- and 15-year survival were 60.7% and 35.0%, respectively. Fifty-one patients required reoperation during follow-up, including 27 for structural valve deterioration (SVD). Overall, freedom from reoperation was 91.0% and 75.0% at 10 and 15 years, whereas freedom from reoperation for SVD was 95.9% and 82.3%, respectively. At 10 and 15 years, freedom from reoperation for SVD was 94.0% and 62.6% for patients P =0.002). The median time to explant for SVD was 10.7 years. SVD presented mostly as acute, severe aortic insufficiency attributed to leaflet tear (77.8%). The independent risk factors for reoperation for SVD were age P =0.001) and dyslipidemia ( P =0.02). Conclusions— Aortic valve replacement with the Freestyle bioprosthesis in a subcoronary position provides good long-term clinical and echocardiographic outcomes for patients >60 years of age. Severe aortic insufficiency with leaflet tear is the major mode of SVD leading to reoperation in these patients.