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Cardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA).FDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations. Data extracted included deaths, major adverse clinical events (MACEs), and device and/or operator use problems.Between 2016 and July 2021, 563 perforations were reported within 30 days of implant and resulted in 150 deaths (27%), 499 cardiac tamponades (89%), 64 pericardial effusions (11%), and 146 patients (26%) required emergency surgery. Half of perforations were associated with 139 (25%) device problems, 78 (14%) operator use problems, and 62 (11%) combined device and operator use problems. Inadequate electrical measurements or difficult positioning were the most frequent device problems (n = 129); non-septal implants and perforation of other structures were the most frequent operator use problems (n = 69); a combined operator use and device problem resulted in 62 delivery system perforations. No device or operator use problem was identified for 282 perforations (50%), but they were associated with 78 deaths, 245 tamponades, and 57 emergency surgeries.The Micra perforations reported in MAUDE are often associated with death and major complications requiring emergency intervention. Device and use problems account for at least half of perforations. Studies are needed to identify who is at risk for a perforation and how MACE can be avoided or mitigated.

Leadless intracardiac pacemakers were developed to avoid the complications of transvenous pacing systems. The Medtronic Micra™ transcatheter pacemaker is one such system. We found an unexpected number of major adverse clinical events (MACE) in the Food and Drug Administration's Manufacturers and User Facility Device Experience (MAUDE) database associated with Micra implantation.The purpose of this study was to describe these MACE and compare them to implant procedure MACE in MAUDE for Medtronic CapSureFix™ active-fixation transvenous pacing leads.During January 2021, we queried the MAUDE database for reports of MACE for Micra pacemakers and CapSureFix leads using the simple search terms "death," "tamponade," and "perforation." Reports from 2016-2020 were included.The search identified 363 MACE for Micra and 960 MACE for CapSureFix leads, including 96 Micra deaths (26.4%) vs 23 CapSureFix deaths (2.4%) (P.001); 287 Micra tamponades (79.1%) vs 225 tamponades for CapSureFix (23.4%) (P.001); and 99 rescue thoracotomies for Micra (27.3%) vs 50 rescue thoracotomies for CapSureFix (5.2%) (P.001). More Micra patients required cardiopulmonary resuscitation (21.8% vs 1.1%) and suffered hypotension or shock (22.0% vs 5.8%) than CapSureFix recipients (P.001). Micra patients were more likely to survive a myocardial perforation or tear if they had surgical repair (P = .014).Micra leadless pacemaker implantation may be complicated by myocardial and vascular perforations and tears that result in cardiac tamponade and death. We estimate the incidence is low (1%). Rescue surgery to repair perforations may be lifesaving. MACE are significantly less for implantation of CapSureFix transvenous ventricular pacing leads.

Purpose We hypothesized that data in manufacturers’ product performance reports (PPRs) can provide clinically valuable ICD and cardiac resynchronization defibrillator (CRT-D) reliability and longevity information. Methods Data were obtained from 2019 PPRs. Kaplan-Meier (K-M) probabilities of freedom from malfunction, normal battery depletion (NBD), and NBD + malfunction were calculated for ICD and CRT-D pulse generators (PGs) with LiMnO2 or LiSVO/CFx batteries marketed in the USA from 2010 to 2019 and compared using the log-rank test. Malfunctions (MAL) included PGs that were found outside specifications. Results Study population included 1,149,803 ICD and CRT-D PGs: Abbott (ABT; 35.1%), Biotronik (BIO; 4.6%), Boston Scientific (BSC; 23.5%), and Medtronic (MDT; 36.9%). Significant differences in reliability (p < 0.001), defined by freedom from MAL, were found between manufacturers; the majority of 6808 MAL occurred in ABT devices (n = 4045; 59.4%), followed by BSC (n = 2384; 35.0%), MDT (n = 338;5.0%), and BIO (n = 41; 0.6%). Battery failure (n = 890; 57.9%) was the most common cause of MAL compromising therapy; analysis of unique ABT battery MAL–indicated problem appeared a year prior to advisory. Significant differences (p < 0.001) in battery longevity, as defined by freedom from NBD, were found between manufacturers. Overall performance (freedom from NBD + MAL) favored BSC for CRT-D PGs and MDT and BIO for ICDs. BSC subcutaneous ICD reliability was inferior to its transvenous ICD (p < 0.001). Conclusion PPRs contain valuable data that can be aggregated and analyzed to inform physicians. Differences in product reliability exist between manufacturers. Battery longevity has improved, but MAL have significantly impacted performance. PPR data may be useful for assessing product problems and new technology.

Although rare in the general population, genetic arrhythmia syndromes have a significant public health impact due to their contribution to the incidence of sudden cardiac death, particularly in children and young adults. When sudden cardiac death occurs in the absence of ischemic heart disease, a genetic cardiac condition may be suspected and clinical and genetic screening of family members is recommended. The Genetic Arrhythmia Center at the Minneapolis Heart Institute collaborates with local partners in the Sudden Cardiac Arrest network to connect patients and their family members with interdisciplinary care for diagnosis and treatment of these conditions. The most common conditions seen in the Genetic Arrhythmia Center include arrhythmogenic right ventricular cardiomyopathy, left ventricular noncompaction, long QT syndrome, and Brugada syndrome. In addition to providing clinical care and genetic testing and counseling services, the Genetic Arrhythmia Center is working to advance the scientific understanding of the clinical presentation and natural history of these rare conditions.

Implantable cardiac monitors (ICMs) are useful for long-term arrhythmia monitoring in patients with unexplained symptoms. Temporal trends in the use of ICMs in routine clinical practice, a...

Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is characterized by replacement of the myocardium with fibrous and fatty tissue that may lead to increased risk of ventricular arrhythmias and heart failure. Although left ventricular (LV) and biventricular involvement have been recognized with

Internal insulation breaches (IBR) may result in implantable cardioverter-defibrillator lead failure and adverse clinical events. Concerns exist that the Durata lead may be prone to IBR.The goals of this study were to assess Durata failures in the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and compare them to failures in MAUDE for Endotak Reliance and Sprint Quattro Secure (QS) leads.We searched the MAUDE database from 2008 to 2018 for IBR and other failure modes. Included were explanted leads whose manufacturers found an insulation or conductor defect not caused by extrinsic factors.The MAUDE search found 1011 qualifying leads. The cause of failure differed among leads (P.001). The primary cause of Durata failure was IBR (293 of 316 leads [93%]), with IBR accounting for 47% (137 of 293); few QS (9 of 523 [1.7%]) and no Endotak Reliance leads failed because of IBR (P.001). Durata IBR were responsible for 11 failures to treat ventricular tachycardia/ventricular fibrillation, and all were caused by high-voltage (HV) shorts between the proximal superior vena cava coil and a distal right ventricular coil cable (n = 10) or sensing conductor (n = 1); low values of HV impedance were found in these leads during defibrillation threshold testing (n = 3), after a shock or aborted shock (n = 7), and by an alert (n = 1). Inappropriate therapy was caused by 51 Durata IBR, but no QS IBR.Durata implantable cardioverter-defibrillator leads are susceptible to IBR that may result in failure to treat ventricular tachycardia/ventricular fibrillation or inappropriate therapy; such failures may occur without forewarning. HV testing of Durata leads may be indicated during pulse generator replacement or when an insulation defect is suspected.

Sudden cardiac death (SCD) often falls under the jurisdiction of the medical examiner (ME). A recent expert consensus statement recommends cardiac evaluation for all first degree blood relatives of an individual with SCD and supports the referral of these family members to a multidisciplinary inherited arrhythmia clinic; however, most MEs lack the appropriate clinical network for a specific referral and family members are often not followed up. In 2010, Minnesota MEs and cardiovascular pathologists began collaborating with a cardiology referral center specializing in familial cardiac conditions to form a regional Sudden Death Network (SDN). The cardiac pathologists and MEs have established protocols for appropriate specimen retention in accordance with the National Association of Medical Examiners position paper on postmortem deoxyribonucleic acid (DNA) collection and for referring families for clinical evaluation. The expertise of a genetic counselor has been essential to the evaluation of these families in coordinating appropriate genetic testing and assisting with the identification of at-risk family members in extended pedigrees. This SDN uses a multidisciplinary approach for referral of family members for screening and treatment of SCD risk and represents an important resource for MEs. Development of SDNs across the country would lead to a more uniform approach to SCD follow-up and a more efficient use of clinical resources. The ME's role is essential in consulting cardiac pathologists when needed, establishing the correct diagnosis, collecting and retaining appropriate specimens, and initiating the referral of at-risk family members to specialists.

A novel autosomal-dominant in-frame deletion resulting in a nonsense mutation in the desmoplakin (DSP) gene was identified in association with biventricular arrhythmogenic cardiomyopathy across three generations of a large Caucasian family. Mutations that disrupt the function and structure of desmosomal proteins, including desmoplakin, have been extensively linked to familial arrhythmogenic right ventricular cardiomyopathy (ARVC). Analysis of data from 51 individuals demonstrated the previously undescribed variant p.Cys81Stop (c.243_251delCTTGATGCG) in DSP segregates with a pathogenic phenotype exhibiting variable penetrance and expressivity. The mutation's pathogenicity was first established due to two sudden cardiac deaths (SCDs), each with a biventricular cardiomyopathy identified on autopsy. Of the individuals who underwent genetic screening, 27 of 51 were heterozygous for the DSP mutation (29 total with two obligate carriers). Six of these were subsequently diagnosed with arrhythmogenic cardiomyopathy. An additional nine family members have a conduction disorder and/or myocardial structural changes characteristic of an evolving condition. Previous reports from both human patients and mouse studies proposed DSP mutations with a premature stop codon impart mild to no clinical symptoms. Loss of expression from the abnormal allele via the nonsense-mediated mRNA decay pathway has been implicated to explain these findings. We identified an autosomal-dominant DSP nonsense mutation in a large family that led to SCD and phenotypic expression of arrhythmogenic cardiomyopathy involving both ventricles. This evidence demonstrates the pathogenic significance of this type of desmosomal mutation and provides insight into potential clinical manifestations.

Internal insulation breaches (IBR) in implantable cardioverter-defibrillator (ICD) leads may cause high-voltage short-circuiting (SHORT) and low-voltage noise/oversensing (NOS). SHORTs may compromise therapy delivery and NOS may case inappropriate antitachycardia pacing or shocks (IARx). Concerns

Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) is characterized by life-threatening ventricular arrhythmias and fibrous or fatty replacement of the myocardium, which can lead to congestive heart failure. Although there are recommendations based on high-risk characteristics, there

BACKGROUND: Post-operative atrial fibrillation (POAF) develops in approximately 30-40% of patients undergoing cardiovascular (CV) surgery and increases major adverse events, length of stay (LOS) and hospitalization costs. A standardized protocol may optimize POAF management and decrease LOS, hospital costs and adverse events including post-operative stroke. METHODS: In March 2013, an AF inpatient protocol was implemented in our CV surgery center’s post-operative care units. The protocol incorporates a consensus driven decision support algorithm based on blood pressure, heart rate and duration of AF to guide beta-blocker, antiarrhythmic and anticoagulation therapy recommendations in real-time. Using a shared electronic medical record we reviewed all coronary artery bypass graft (CABG) and valve surgery cases from March 1, 2013 to April 30, 2014 and compared LOS, intensive care unit (ICU) duration and post-operative stroke in POAF patients with and without the protocol. Based on actual CV surgery volume and average total variable cost per hospital day, we estimated the protocol’s impact post-implementation and at 50% annual use. RESULTS: Among 492 CABG and valve surgery cases, 176 (35.8%) developed POAF. Among patients with POAF, 55 (31.3%) used the AF protocol and 121 (68.7%) did not. In patients with POAF, median LOS was significantly shorter in cases with the protocol (6.9 [6.0, 9.1] days vs. 8.2 [6.1, 11.9] days; p=0.016). There was no difference in ICU duration or post-operative stroke (Table). Among 151 annual cases of POAF, average total variable cost was $2,374 per hospital day. Post-implementation, 71.5 hospital days and $169,741 have been saved. Achieving 50% protocol use, we estimate 98.0 hospital days and $232,652 could be saved annually. CONCLUSIONS: A standardized decision support protocol for POAF patients is associated with shorter LOS and provides a significant reduction in hospital days and total variable cost.

This study investigated the correlation between an elevated white blood cell (WBC) count as a marker of inflammation and the development of atrial fibrillation (AF) after cardiac surgery. WBC counts were prospectively followed in 181 consecutive patients who underwent coronary bypass or cardiac valve surgery to determine if a baseline or postoperative WBC count elevation is an independent predictor of postoperative AF.

With increasing utilization of new oral anticoagulants (NOACs), data are needed to guide therapy in patients anticipating procedures such as Cardiac Implantable Electronic Device (CIED) placement. There are limited data comparing outcomes with warfarin and NOACs apixaban, dabigatran, and rivaroxaban

Symptomatic atrial fibrillation (AF) is thought to occur in at least 20% of patients with hypertrophic cardiomyopathy (HCM), however, the burden and clinical significance created by asymptomatic and “silent” AF in HCM is unknown. Asymptomatic AF is often detected at routine device follow-up, and

A homeless man is poorly responsive, hypotensive, and febrile—and has a new heart murmur. What is the cause?

Hydroxymethylglutaryl coenzyme-A reductase inhibitors, or statins, have been shown to decrease mortality rates in patients who have coronary artery disease. It has been postulated that part of the mortality benefit conferred by statins is due to a decrease in ventricular arrhythmias. We assessed the effect of statin therapy on recurrent ventricular arrhythmias in 281 patients who developed coronary artery disease after implantable cardioverter-defibrillator placement. Statin therapy was associated with a significant decrease in the risk of ventricular arrhythmia that would require implantable cardioverter-defibrillator therapy.

This editorial refers to “Relationship between C-reactive protein concentrations during glucocorticoid therapy and recurrent atrial fibrillation”1 by J. Dernellis et al. on page 1100 Elevated C-reactive protein (CRP) levels are associated with numerous cardiovascular diseases, and have been shown to predict future cardiac events.1 Bruins and colleagues were the first to report an association between CRP elevation and the occurrence of atrial fibrillation (AF), in their case in the context of AF following cardiac surgery.2 They demonstrated that CRP levels peaked on the second post-operative day, and that increased levels of complement-CRP complexes peaked on the second or third post-operative day. The incidence of post-operative atrial arrhythmias similarly peaks at these times. AF following cardiac surgery affects 20–50% of all patients (depending on age and type of surgery), and CRP levels in this setting can increase more than 100-fold. In 2001, we reported that, apart from the surgical setting, low level CRP elevation was present in patients with paroxysmal atrial fibrillation and that these levels were even more elevated in patients with persistent AF. We concluded that CRP elevation may reflect the inflammatory processes that lead to structural remodelling of the atria, thus increasing the … *Correspondence to: David R. Van Wagonering, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. Tel.: +1-216-444-0820; fax: +1-216-444-9155 E-mail address: vanwagd{at}ccf.org