Impact of Contact Force on Pulsed Field Ablation Outcomes Using Focal Point Catheter.

BACKGROUND: Conventional focal radiofrequency catheters may be modified to enable multiple energy modalities (radiofrequency or pulsed field [PF]) with the benefit of contact force (CF) feedback, providing greater flexibility in the treatment of arrhythmias. Information on the impact of CF on lesion formation in PF ablations remains limited. METHODS: An in vivo study was performed with 8 swine using an investigational dual-energy CF focal catheter with local impedance. Experiment I: To evaluate atrial lesion formation, contiguity, and width, a point-by-point approach was used to create an intercaval line. The distance between the points was prespecified at 4±1 mm. Half of the line was created with radiofrequency energy, whereas the other half utilized PF (single 2.0 kV application with a proprietary waveform). Experiment II: To evaluate single application lesion dimensions with a proprietary waveform, discrete ventricular lesions were performed with PFA (single 2.0 kV application) with targeted levels of CF: low, 5 to 15 g; medium, 20 to 30 g; and high, 35 to 45 g. Following 1 week of survival, animals underwent endocardial/epicardial remapping, and euthanasia to enable histopathologic examination. RESULTS: Experiment I: Both energy modalities resulted in a complete intercaval line of transmural ablation. PF resulted in significantly wider lines than radiofrequency: minimum width, 14.9±2.3 versus 5.0±1.6 mm; maximum width, 21.8±3.4 versus 7.3±2.1 mm, respectively; P<0.01 for each. Histology confirmed transmural lesions with both modalities. Experiment II: With PF, lesion depth, width, and volume were larger with higher degrees of CF (depth: r=0.82, P<0.001; width: r=0.26, P=0.052; and volume: r=0.55, P<0.001), with depth increasing at a faster rate than width. The mean depths were as follows: low (n=17), 4.3±1.0 mm; medium (n=26), 6.4±1.2 mm; and high (n=14), 9.1±1.4 mm. CONCLUSIONS: Using the same focal point CF-sensing catheter, a novel PF ablation waveform with a single application resulted in transmural atrial lesions that were significantly wider than radiofrequency. Lesion depth showed a significant positive correlation with CF with depths of 6.4 mm at moderate CF.

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 .

Cardioneuroablation for the Treatment of Hypervagotonic Sinus Node Dysfunction.

Hypervagotonic sinus node dysfunction (SND) is a form of SND with sinus bradycardia caused by enhanced vagal tone. Indirect proof of hypervagotonia as the mechanism can be inferred from resolution of bradycardia following atropine infusion. In symptomatic patients, pacemaker implantation is recommended. We describe cardioneuroablation as a treatment for hypervagotonic SND.

Effects of Contact Force on Lesion Size During Pulsed Field Catheter Ablation: Histochemical Characterization of Ventricular Lesion Boundaries.

BACKGROUND: Effects of contact force (CF) on lesion formation during pulsed field ablation (PFA) have not been well validated. The purpose of this study was to determine the relationship between average CF and lesion size during PFA using a swine-beating heart model. METHODS: A 7F catheter with a 3.5-mm ablation electrode and CF sensor (TactiCath SE, Abbott) was connected to a PFA system (CENTAURI, Galvanize Therapeutics). In 5 closed-chest swine, biphasic PFA current was delivered between the ablation electrode and a skin patch at 40 separate sites in right ventricle (28 Amp) and 55 separate sites in left ventricle (35 Amp) with 4 different levels of CF: (1) low (CF range of 4-13 g; median, 9.5 g); (2) moderate (15-30 g; median, 21.5 g); (3) high (34-55 g; median, 40 g); and (4) no electrode contact, 2 mm away from the endocardium. Swine were sacrificed at 2 hours after ablation, and lesion size was measured using triphenyl tetrazolium chloride staining. In 1 additional swine, COX (cytochrome c oxidase) staining was performed to examine mitochondrial activity to delineate reversible and irreversible lesion boundaries. Histological examination was performed with hematoxylin and eosin and Masson trichrome staining. RESULTS: Ablation lesions were well demarcated with triphenyl tetrazolium chloride staining, showing (1) a dark central zone (contraction band necrosis and hemorrhage); (2) a pale zone (no mitochondrial activity and nuclear pyknosis, indicating apoptosis zone); and a hyperstained zone by triphenyl tetrazolium chloride and COX staining (unaffected normal myocardium with preserved mitochondrial activity, consistent with reversible zone). At constant PFA current intensity, lesion depth increased significantly with increasing CF. There were no detectable lesions resulting from ablation without electrode contact. CONCLUSIONS: Acute PFA ventricular lesions show irreversible and reversible lesion boundaries by triphenyl tetrazolium chloride staining. Electrode-tissue contact is required for effective lesion formation during PFA. At the same PFA dose, lesion depth increases significantly with increasing CF.

Same-day discharge after atrial fibrillation ablation.

Background: Atrial fibrillation (AF) catheter ablation has become an increasingly effective and safe strategy for the management of AF. With increased safety of catheter ablation, same-day discharge (SDD) is a potential way to minimize health care resource utilization and improve patient experience. Objective: To evaluate the safety and patient satisfaction of SDD after contemporary AF ablation. Methods: Consecutive patient undergoing AF ablation at our institution between 1/2020 and 10/2021 were enrolled in registry for clinical, quality, procedural and outcomes data. Patients were considered for SDD per physician discretion and patients' preference based upon clinical evaluation. Adjudicated ninety-day major complications, thirty-day adverse events, and thirty-day re-admissions were collected in a prospective registry for all patients. Results: A total of 2142 consecutive patients underwent elective AF ablation during the study period. After excluding cases with missing data, 1830 patients were included in the analysis. Of those, 350 (19 %) patients were discharged the same day (SDD group) and 1480 (81 %) stayed overnight. Patients in the SDD group compared to overnight stay group were younger, more likely to be male, White patients, lower CHA2DS2-VASc score and to be on lower rates of warfarin as an anticoagulation strategy. After propensity score matching, SDD was associated with lower rate of major complications and higher patient satisfaction. The majority of life-treating complications occurred interprocedurally or within 6 h of procedure termination. Conclusion: The present study demonstrated that SDD after contemporary AF ablation is feasible, safe and associated with higher patient satisfaction using a proposed SDD pathway and criteria.

Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life.

BACKGROUND: Atrial fibrillation (AF) risk increases with age. We aim to assess the efficacy and safety of catheter ablation in the older population. METHODS: All patients undergoing AF ablation (2013-2021) at our institution were enrolled in a prospectively maintained registry. The primary endpoint was AF recurrence. Patients were divided into 3 groups: non-elderly (< 65 years), elderly (65-75 years), and very elderly (> 75 years). Patient surveys at baseline and during follow-up were used to calculate quality of life (QoL) metrics: the AF severity score as well as the AF burden. RESULTS: A total of 7020 patients were included (42% non-elderly, 42% elderly, and 16% very elderly). Periprocedural major complications were low (< 1.5%) and similar in all groups besides pericardial effusion which was more frequent with older age and similar between the elderly and very elderly. At 3 years, AF recurrence for persistent AF (PersAF) was highest in the very elderly group (48%), followed by the elderly group (42%), and was the lowest in the non-elderly group (36%). In paroxysmal AF (PAF), there was no difference in AF recurrence between the elderly and non-elderly, while the very elderly remained associated with a significantly increased risk. Multivariable Cox analysis confirmed these findings (PersAF; elderly: HR = 1.23, P = 0.003; very elderly: HR = 1.44, P < 0.001) (PAF; elderly: HR = 1.04, P = 0.62; very elderly: HR = 1.30, P = 0.01). Catheter ablation resulted in a significant improvement in quality of life, irrespective of age group. CONCLUSION: Catheter ablation in elderly and very elderly patients is safe, efficacious, and associated with QoL benefits. Overall, major complications were minimal and did not differ significantly between age groups, with the exception of pericardial effusions which were higher in the elderly and very elderly compared to non-elderly adults. Very elderly patients had a higher rate of AF recurrence when compared with elderly or non-elderly patients. Nevertheless, ablation resulted in a remarkable improvement in QoL and a reduction of AF burden and AF symptoms with a similar magnitude, irrespective of age.

Ischemic or Coronary Evaluations in Patients With Monomorphic VT Electrical Storm Undergoing VT Ablation.

BACKGROUND: Monomorphic ventricular tachycardia (VT) electrical storm (ES) in patients with coronary artery disease is dependent on scarred myocardium. The role of routine ischemic or coronary evaluations before ablation in patients presenting with monomorphic VT storm, without acute coronary syndrome (ACS), remains unknown. OBJECTIVES: This study sought to assess the impact of ischemic or coronary evaluations on procedural outcomes and post-ablation mortality in monomorphic VT storm patients. METHODS: All patients undergoing VT ablation at the Cleveland Clinic from 2014 to 2020 after presenting with monomorphic VT storm were enrolled in a prospectively maintained registry. The associations among ischemic or coronary evaluations and short-term procedural efficacy, acute outcomes, and mortality during follow-up were assessed. RESULTS: A total of 97 consecutive patients with monomorphic VT storm in the absence of ACS underwent VT ablations. This cohort was characterized by severe LV systolic dysfunction (mean left ventricular ejection fraction 30.3%, 67% with known ischemic cardiomyopathy) with moderately severe heart failure (median NYHA functional class II); 45% of patients underwent ischemic or coronary evaluations via coronary angiography (10%), noninvasive myocardial perfusion (26%), or both (9%). The yield of these evaluations was low: No acute coronary occlusions were identified. There was no association between ischemic evaluation and acute ablation outcomes or mortality during follow-up. Similarly, in a secondary analysis, the yield of ischemic or coronary evaluations in patients with monomorphic VT storm and known coronary disease (regardless of ablation status) was found to be low. CONCLUSIONS: Ischemic evaluations in patients with monomorphic VT storm without ACS may not improve procedural outcomes or mortality after ablation.

Impact of obesity on catheter ablation of atrial fibrillation: Patient characteristics, procedural complications, outcomes, and quality of life.

INTRODUCTION: Obesity is a well-known risk factor for atrial fibrillation (AF). We aim to evaluate the effect of baseline obesity on procedural complications, AF recurrence, and symptoms following catheter ablation (CA). METHODS: All consecutive patients undergoing AF ablation (2013-2021) at our center were enrolled in a prospective registry. The study included all consecutive patients with available data on body mass index (BMI). Primary endpoint was AF recurrence based on electrocardiographic documentation. Patients were categorized into five groups according to their baseline BMI. Patients survey at baseline and at follow-up were used to calculate AF symptom severity score (AFSS) as well as AF burden (mean of AF duration score and AF frequency score; scale 0: no AF to 10: continuous and 9 frequencies/durations in between). Patients were scheduled for follow-up visits with 12-lead electrocardiogram at 3, 6, and 12 months after ablation, and every 6 months thereafter. RESULTS: A total of 5841 patients were included (17% normal weight, 34% overweight, 27% Class I, 13% Class II, and 9% Class III obesity). Major procedural complications were low (1.5%) among all BMI subgroups. At 3 years AF recurrence was the highest in Class III obesity patients (48%) followed by Class II (43%), whereas Class I, normal, and overweight had similar results with lower recurrence (35%). In multivariable analyses, Class III obesity (BMI ≥ 40) was independently associated with increased risk for AF recurrence (hazard ratio, 1.30; confidence interval, 1.06-1.60; p = .01), whereas other groups had similar risk in comparison to normal weight. Baseline AFSS was lowest in normal weight, and highest in Obesity-III, median (interquartile range) 10 (5-16) versus 15 (10-21). In all groups, CA resulted in a significant improvement in their AFSS with a similar magnitude among the groups. At follow-up, AF burden was minimal and did not differ significantly between the groups. CONCLUSION: AF ablation is safe with a low complication rate across all BMI groups. Morbid obesity (BMI ≥ 40) was significantly associated with reduced AF ablation success. However, ablation resulted in improvement in QoL including reduction of the AFSS, and AF burden regardless of BMI.

Performance of alert transmissions from cardiac implantable electronic devices to the CareLink network: A retrospective analysis.

Background: Remote monitoring of cardiac implantable electric devices improves patient outcomes and experiences. Alert-based systems notify physicians of clinical or device issues in near real-time, but their effectiveness is contingent upon device connectivity. Objective: To assess patient connectivity by analyzing alert transmission times from patient transceivers to the CareLink network. Methods: Alert transmissions were retrospectively gathered from a query of the United States de-identified Medtronic CareLink database. Alert transmission time was defined as the duration from alert occurrence to arrival at the CareLink network and was analyzed by device type, alert event, and alert type. Using data from previous studies, we computed the benefit of daily connectivity checks. Results: The mean alert transmission time was 14.8 hours (median = 6 hours), with 90.9% of alert transmissions received within 24 hours. Implantable pulse generators (17.0 ± 40.2 hours) and cardiac resynchronization therapy-pacemakers (17.2 ± 42.5 hours) had longer alert transmission times than implantable cardioverter-defibrillators (13.7 ± 29.5 hours) and cardiac resynchronization therapy-defibrillators (13.5 ± 30.2 hours), but the median time was 6 hours for all 4 device types. There were differences in alert times between specific alert events. Based on our data and previous studies, daily connectivity checks could improve daily alert transmission success by 8.5% but would require up to nearly 800 additional hours of staff time on any given day. Conclusion: Alert transmission performance from Medtronic devices was satisfactory, with some delays likely underscored by patient connectivity issues. Daily connectivity checks could provide some improvement in transmission success at the expense of increased clinic burden.

Catheter-Based Electroporation: A Novel Technique for Catheter Ablation of Cardiac Arrhythmias.

Catheter ablation of arrhythmias is now standard of care in invasive electrophysiology. Current ablation strategies are based on the use of thermal energy. With continuous efforts to optimize thermal energy delivery, effectiveness has greatly improved; however, safety concerns persist. This review focuses on a novel ablation technology, irreversible electroporation (IRE), also known as pulsed-field ablation which may be a safer alternative for arrhythmia management. Pulsed-field ablation is thought to be a nonthermal ablation that applies short-duration high-voltage electrical fields to ablate myocardial tissue with high selectivity and durability while sparing important neighboring structures such as the esophagus and phrenic nerves. There are multiple ongoing studies investigating the potential superior outcomes of IRE compared to radiofrequency ablation in treating patients with atrial and ventricular arrhythmias. In this review, we describe the current evidence of preclinical and clinical trials that have shown promising results of catheter-based IRE.

Left atrial volume by cardiac CTA prior to catheter ablation: comparison to echocardiography and association with recurrent atrial fibrillation.

OBJECTIVE: Left atrial volume index (LAVI) by echocardiography can be challenging and its accuracy is highly dependent on image quality. Cardiac computed tomography angiography (CTA) can overcome echocardiographic LAVI measurement challenges; however, data are limited. Therefore, we evaluated the reproducibility of LAVI by CTA, its correlation to echocardiography, and its association with recurrence of atrial fibrillation (AF) after pulmonary vein isolation (PVI) in this retrospective cohort study of patients who underwent CTA prior to PVI. LAVI was measured by CTA and echocardiography using the area length method. RESULTS: 74 patients had echocardiography and CTA within 6 months and were included in this study. The interobserver variability of LAVI measured by CTA was low (1.2%). CTA correlated with echocardiography but found larger LAVI values by a factor of 1.6. Also, LAVI cut off of ≥ 55 ml/m2 measured by CTA correlated with recurrent AF after PVI (adjusted Odds Ratio 3.47, p = 0.033).

Acute pericarditis after atrial fibrillation ablation: Incidence, characteristics, and risk factors.

Background: Little is known about the incidence and risk factors for the development of acute pericarditis after ablation for atrial fibrillation (AF). Objective: The purpose of this retrospective cohort study was to describe the occurrence of and associations with suspected acute pericarditis after AF ablation. Methods: All patients undergoing AF ablation in our center were enrolled in a prospectively maintained registry. Suspected acute pericarditis was defined as pericardial chest pain treated with disease specific anti-inflammatories within 3 months of AF ablation. Results: Among 2215 patients with AF ablations between January 1, 2018, and December 31, 2019, 226 (10.2%) had suspected acute pericarditis. Treatments included colchicine in 149 patients (65.9%), prednisone in 66 (29.2%), and high-dose ibuprofen in 43 (19.0%). Multiple anti-inflammatory therapies were used in 57 patients (25%). At baseline, a lower CHADS2VASc score and a higher body mass index were associated with pericarditis, whereas older patients were less likely to have pericarditis. With multivariable adjustment, age was associated with suspected acute pericarditis (odds ratio 0.95; 95% confidence interval 0.94-0.97; P <.0001). Among patients with suspected pericarditis, postprocedure pericardial effusion was present in 9.3% and pericarditis electrocardiographic changes in 19.5%. Conclusion: Suspected acute pericarditis is common after AF ablation and is associated with a younger age. Systematic assessments for acute pericarditis after AF ablation should be considered.

Preoperative Atrial Fibrillation and Cardiovascular Outcomes After Noncardiac Surgery.

BACKGROUND: The impact of pre-existing atrial fibrillation (AF) on outcomes after noncardiac surgery is not clear. OBJECTIVES: We aimed to study the impact of AF on the risk of adverse outcomes after noncardiac surgery in a nationwide cohort. METHODS: We identified Medicare beneficiaries admitted for noncardiac surgery from 2015 to 2019 and divided the study cohort into 2 groups: with and without AF. Noncardiac surgery was classified into vascular, thoracic, general, genitourinary, gynecological, orthopedics and neurosurgery, breast, head and neck, and transplant. We used propensity score matching on exact age, sex, race, urgency and type of surgery, revised cardiac risk index (RCRI) and CHA2DS2-VASc score, and tight caliper on other comorbidities. The study outcomes were 30-day mortality, stroke, myocardial infarction, and heart failure. We examined the incremental utility of AF in addition to RCRI to predict adverse events after noncardiac surgery. RESULTS: The study cohort included 8,635,758 patients who underwent noncardiac surgery (16.4% with AF). Patients with AF were older, more likely to be men, and had higher prevalence of comorbidities. After propensity score matching, AF was associated with higher risk of mortality (OR: 1.31; 95% CI: 1.30-1.32), heart failure (OR: 1.31; 95% CI: 1.30-1.33), and stroke (OR: 1.40; 95% CI: 1.37-1.43) and lower risk of myocardial infarction (OR: 0.81; 95% CI: 0.79-0.82). Results were consistent in subgroup analysis by sex, race, type of surgery, and all strata of RCRI and CHA2DS2-VASc score. AF improved the discriminative ability of RCRI (C-statistic 0.73 to 0.76). CONCLUSION: Pre-existing AF is independently associated with postoperative adverse outcomes after NCS.

Attenuated heart rate recovery is associated with higher arrhythmia recurrence and mortality following atrial fibrillation ablation.

AIMS: Heart rate recovery (HRR), the decrease in heart rate occurring immediately after exercise, is caused by the increase in vagal activity and sympathetic withdrawal occurring after exercise and is a powerful predictor of cardiovascular events and mortality. The extent to which it impacts outcomes of atrial fibrillation (AF) ablation has not previously been studied. The aim of this study is to investigate the association between attenuated HRR and outcomes following AF ablation. METHODS AND RESULTS: We studied 475 patients who underwent EST within 12 months of AF ablation. Patients were categorized into normal (>12 b.p.m.) and attenuated (≤12 b.p.m.) HRR groups. Our main outcomes of interest included arrhythmia recurrence and all-cause mortality. During a mean follow-up of 33 months, 43% of our study population experienced arrhythmia recurrence, 74% of those with an attenuated HRR, and 30% of those with a normal HRR (P < 0.0001). Death occurred in 9% of patients in the attenuated HRR group compared to 4% in the normal HRR cohort (P = 0.001). On multivariable models adjusting for cardiorespiratory fitness (CRF), medication use, left atrial size, ejection fraction, and renal function, attenuated HRR was predictive of increased arrhythmia recurrence (hazard ratio 2.54, 95% confidence interval 1.86-3.47, P < 0.0001). CONCLUSION: Heart rate recovery provides additional valuable prognostic information beyond CRF. An impaired HRR is associated with significantly higher rates of arrhythmia recurrence and death following AF ablation.

Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial.

BACKGROUND: The limited effectiveness of endocardial catheter ablation (CA) for persistent and long-standing persistent atrial fibrillation (AF) treatment led to the development of a minimally invasive epicardial/endocardial ablation approach (Hybrid Convergent) to achieve a more comprehensive lesion set with durable transmural lesions. The multicenter randomized controlled CONVERGE trial (Convergence of Epicardial and Endocardial Ablation for the Treatment of Symptomatic Persistent AF) evaluated the safety of Hybrid Convergent and compared its effectiveness to CA for persistent and long-standing persistent AF treatment. METHODS: One-hundred fifty-three patients were randomized 2:1 to Hybrid Convergent versus CA. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia absent new/increased dosage of previously failed/intolerant class I/III antiarrhythmic drugs through 12 months. Primary safety was major adverse events through 30 days. CONVERGE permitted left atrium size up to 6 cm and imposed no limits on AF duration, making it the only ablation trial to substantially include long-standing persistent-AF, that is, 42% patients with long-standing persistent-AF. RESULTS: Of 149 evaluable patients at 12 months, primary effectiveness was achieved in 67.7% (67/99) patients with Hybrid Convergent and 50.0% (25/50) with CA (P=0.036) on/off previously failed antiarrhythmic drugs and in 53.5% (53/99) versus 32.0% (16/50; P=0.0128) respectively off antiarrhythmic drugs. At 18 months using 7-day Holter, 74.0% (53/72) Hybrid Convergent and 55% (23/42) CA patients experienced ≥90% AF burden reduction. A total of 2.9% (3/102) patients had primary safety events within 7 days, and 4.9% (5/102) between 8 and 30 days postprocedure. No deaths, cardiac perforations, or atrioesophageal fistulas occurred. All but one primary safety event resolved. CONCLUSIONS: The Hybrid Convergent procedure has superior effectiveness compared to the CA for the treatment of persistent and long-standing persistent atrial fibrillation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01984346.

Pharmacologic and Nonpharmacologic Management of Atrial Fibrillation.

Atrial fibrillation (AF) is the most common arrhythmia and its management may be organized into risk stratification and/or treatment of heart failure, stroke prevention, and symptom control. At the core of symptom control, treatment is tailored to either allow AF continue with controlled heart rates, so-called rate control, versus restoring and maintaining sinus rhythm or rhythm control. Rate control strategies mainly use rate-modulating medications, whereas rhythm control treatment includes therapy aimed at restoring sinus rhythm, including pharmacologic and direct current cardioversion, as well as maintenance of sinus rhythm, including antiarrhythmic medications and ablation therapy.

Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.

BACKGROUND: A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to Food and Drug Administration (FDA) advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies the assessment of long-term mortality. OBJECTIVE: To test the association of FDA advisory status with long-term mortality. METHODS: The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between August 1996 and May 2004 who became subject to FDA advisories on ICD generators were identified. Mortality was determined by using the Social Security Death Index. RESULTS: In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were class I and 532 (32.3%) were class II. ICDs were explanted before advisory notifications in 14.0% of class I and 10.1% of class II advisories. Among ICDs under advisory, 28 (4.0%) advisory-related and 15 non-advisory- related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival rate was 65.6% overall, and 64.2, 61.1, and 69.3% in patients with no, class I, and class II advisories, respectively (P = .17). CONCLUSIONS: ICD advisories impacted 43% of the patients. Advisory-related malfunctions affected 4% within the combined advisory group. Based on a conservative management strategy, ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.