Dataset Information

First-in-Man Surgical Extravascular-ICD Implantation: Suturing the Defibrillation Lead to the Heart Wall Post Device-Related Endocarditis.

ABSTRACT: We present the first worldwide case of a hybrid surgical-percutaneous procedure involving transvenous lead extraction, concomitant tricuspid valve repair, implantation of an atrioventricular (AV) leadless pacemaker, and extravascular implantable cardioverter-defibrillator placement with suturing of the defibrillation lead to the heart wall. Multiple interventions were necessary as a result of active endocarditis, congenital complete AV block, and ventricular arrhythmia secondary prevention.

SUBMITTER: Moltrasio M

PROVIDER: S-EPMC11328789 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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First-in-Man Surgical Extravascular-ICD Implantation: Suturing the Defibrillation Lead to the Heart Wall Post Device-Related Endocarditis.

Moltrasio Massimo M Biroli Matteo M Schiavone Marco M Naliato Moreno M Zanobini Marco M Tundo Fabrizio F Tondo Claudio C Curnis Antonio A

JACC. Case reports 20240807 15

We present the first worldwide case of a hybrid surgical-percutaneous procedure involving transvenous lead extraction, concomitant tricuspid valve repair, implantation of an atrioventricular (AV) leadless pacemaker, and extravascular implantable cardioverter-defibrillator placement with suturing of the defibrillation lead to the heart wall. Multiple interventions were necessary as a result of active endocarditis, congenital complete AV block, and ventricular arrhythmia secondary prevention. ...[more]

PMID: 39157554

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Project description:ImportanceLittle is known about the association between industry payments and medical device selection.ObjectiveTo examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D).Design, setting, and participantsIn this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated.ExposuresManufacturers' payments to physicians who performed an ICD or CRT-D implantation.Main outcomes and measuresThe primary outcome of the study was the manufacturer of the device used for the implantation.ResultsOver a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D.Conclusions and relevanceIn this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.

Project description:A 49-year-old man was admitted with symptomatic, sustained monomorphic ventricular tachycardia. He had a previous history of AMP-kinase disease associated with hypertrophic cardiomyopathy and complete heart block, and a pre-existing dual chamber pacemaker. He also had a mechanical tricuspid valve replacement and mitral valve replacement, for severe tricuspid regurgitation from right ventricle (RV) lead-induced injury to the tricuspid valve and a fibroblastoma on the mitral valve. His pre-existing RV lead was maintained between the prosthetic valve annulus and the native annulus. Inability to place an implantable cardioverter-defibrillator (ICD) in the RV due to the presence of a mechanical tricuspid valve replacement represented a rare but challenging clinical scenario. Surgical epicardial lead placement or the use of a subcutaneous ICD (S-ICD) were possible alternatives. Traditional ICD lead placement was favored because of the broad QRS from RV pacing meaning that use of the S-ICD was not possible due to failure of the electrocardiogram to lie within the bounds of the screening template, and the perceived high risk of repeat thoracotomy. We describe the technique for ICD lead placement in a mid-lateral cardiac venous branch of the coronary sinus with the ability to deliver anti-tachycardia pacing and cardiac resynchronization. To our knowledge this is the first report of an ICD in the mid-lateral cardiac vein, with cardiac resynchronization. <Learning objective: This case describes the technique for implantable cardioverter-defibrillator placement in the coronary sinus with biventricular pacing in a patient with a mechanical tricuspid and pre-existing right ventricular endocardial lead. This technique represents a viable alternative to repeat thoracotomy and surgical lead placement, where the risks of complication, prolonged hospital stay and lead failure are high. It also offers the ability to deliver anti-tachycardia pacing and cardiac resynchronization.>.

Dataset Information

First-in-Man Surgical Extravascular-ICD Implantation: Suturing the Defibrillation Lead to the Heart Wall Post Device-Related Endocarditis.

Publications

First-in-Man Surgical Extravascular-ICD Implantation: Suturing the Defibrillation Lead to the Heart Wall Post Device-Related Endocarditis.

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