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Small vegetations (2.0 cm) associated with infected cardiac device leads can be managed percutaneously, whereas larger vegetations typically are removed via open heart surgery. Unfortunately, many patients with intracardiac vegetations are not candidates for open removal.The purpose of this study was to report our experience in the outcomes associated with the percutaneous management of large vegetations.Prospective data from January 2010 to August 2018 identified 826 patients with infections undergoing lead extraction. One hundred nineteen cases had vegetations measured in 2 dimensions (length and width) by transesophageal echocardiogram. Thirty-two patients had 3 characteristics: (1) at least 1 vegetation dimension ≥2.0 cm; (2) not a surgical candidate; and (3) had undergone transvenous lead extraction. The cohort was classified into 2 groups according to shape: (1) globular if the difference between dimensions was30% between dimensions; and (2) nonglobular if the difference was30%. The Fisher exact test and Pearson t test were used for analysis. P.05 was considered significant.Retrospective analysis of a single tertiary cardiac surgery center registry showed a significantly lower chance of being alive at discharge in patients with globular vegetations compared to patients with nonglobular vegetations (P = .002).Vegetation size is an important determinant of outcomes in patients who are not surgical candidates undergoing transvenous lead extraction. However, vegetation shape is also a relevant factor, as globular vegetations may predict a worse result compared to nonglobular vegetations.

Background Many clinicians use the strategy of prophylactically placing an endovascular balloon before transvenous lead extraction, yet there are no data regarding this practice. Objective This study assesses long-term outcomes of prophylactic placement of an endovascular balloon in the venae cavae of patients during transvenous lead extraction. Methods From April 1, 2016 to March 31, 2017 data were prospectively collected at 2 international cardiovascular centers on patients who had the balloon prophylactically placed in the venae cavae. Patients were monitored for a minimum of 3 months to capture any associated adverse events. Results Twenty-one patients had the balloon prophylactically placed in the venae cavae during lead extraction. Sixteen patients were male (76%); the mean age was 57.6 ± 18.7 years; and the mean body mass index was 26.1 ± 4.4 kg/m2. The mean lead dwell time was 11.2 ± 8.3 years, with an average of 2.2 ± 1.1 leads per case, and most indications for extraction were noninfectious (62%). Two minor complications (10%, pocket hematomas) and 1 major complication (5%, cardiac tamponade) occurred during the procedure. All cases (100%) were procedural successes, and all patients (100%) were discharged alive. On follow-up (6.8 ± 3.7 months), all patients were alive and reported no adverse events related to prophylactic balloon placement, such as pulmonary emboli or deep venous thrombi. Conclusion During the study period, we observed no acute or long-term adverse outcomes associated with prophylactic placement of an endovascular balloon in the venae cavae of patients undergoing transvenous lead extraction.

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Prevention of sudden cardiac arrest (SCA) after removal of an infected implantable cardioverter-defibrillator (ICD) is a challenging clinical dilemma. The cost-effectiveness of the wearable cardioverter-defibrillator (WCD) in this setting remains uncertain.The purpose of this study was to compare the cost-effectiveness of the WCD with discharge home, discharge to a skilled nursing facility, or inpatient monitoring for the prevention of SCA after infected ICD removal.A decision model was developed to compare the cost-effectiveness of use of the WCD to several different strategies for patients who undergo ICD removal. One-way and 2-way sensitivity analyses were performed to account for uncertainties.In the base-case analysis, the incremental cost-effectiveness of the WCD strategy was $20,300 per life-year (LY) or $26,436 per quality-adjusted life-year (QALY) compared to discharge home without a WCD. Discharge to a skilled nursing facility and in-hospital monitoring resulted in higher costs and worse clinical outcomes. The incremental cost-effectiveness ratio was as low as $15,392/QALY if the WCD successfully terminated 95% of SCA events and exceeded the $50,000/QALY willingness-to-pay threshold if the efficacy was69%.The WCD strategy remained cost-effective, assuming 5.6% 2-month SCA risk, as long as the time to reimplantation was at least 2 weeks.The WCD likely is cost-effective in protecting patients against SCA after infected ICD removal while waiting for ICD reimplantation compared to keeping patients in the hospital or discharging them home or to a skilled nursing facility.

In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial.Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited.We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers.Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P.0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs. 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%).Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

Background Limited venous access in certain patients increases the procedural risk and complexity of conventional transvenous pacemaker implantation. Objective The purpose of this study was to determine a minimally invasive epicardial approach using pericardial reflections for dual-chamber pacemaker implantation in patients with limited venous access. Methods Between June 2006 and November 2011, 15 patients underwent epicardial pacemaker implantation. Procedures were performed through a minimally invasive subxiphoid approach and pericardial window with subsequent fluoroscopy-assisted lead placement. Mean patient age was 46.4 ± 15.3 years (9 male [(60.0%], 6 female [40.0%]). The new surgical approach was used in patients determined to have limited venous access due to multiple abandoned leads in 5 (33.3%), venous occlusion in 3 (20.0%), intravascular retention of lead fragments from prior extraction in 3 (20.0%), tricuspid valve vegetation currently under treatment in 2 (13.3%), and unrepaired intracardiac defects in 2 (13.3%). Results All procedures were successful with no perioperative complications or early deaths. Mean operating time for isolated pacemaker implantation was 231.7 ± 33.5 minutes. Lead placement on the superior aspect of right atrium, through the transverse sinus, was possible in 12 patients. In the remaining 3 patients, the atrial lead was implanted on the left atrium through the oblique sinus, the postcaval recess, or the left pulmonary vein recess. None of the patients displayed pacing or sensing dysfunction, and all parameters remained stable throughout the follow-up period of 36.8 ± 25.1 months. Conclusion Epicardial pacemaker implantation through pericardial reflections is an effective alternative therapy for those patients requiring physiologic pacing in whom venous access is limited.

Background Superior vena cava (SVC) perforation is a rare but potentially fatal complication of transvenous lead removal. Objective The aim of this study was to evaluate the feasibility of hemodynamic stabilization using an occlusion balloon during SVC tear in a porcine model. Methods A surgically induced SVC perforation was created in Yorkshire cross swine (n = 7). Three animals were used to develop and test surgical repair methods. Four animals were used to evaluate hemodynamic, behavioral, and neurological effects up to 5 days after SVC tear and repair. An occlusion balloon (Bridge Occlusion Balloon, Spectranetics Corporation, Colorado Springs, CO) was percutaneously delivered through the femoral vein to the location of the injury and inflated. Once hemodynamic control was achieved, the perforation was surgically repaired. Results After SVC perforation and clamp release, the rate of blood loss was 7.0 ± 0.8 mL/s. Mean time from SVC tear to occlusion balloon deployment was 55 ± 12 seconds, during which mean arterial pressure decreased from 56 ± 2 to 25 ± 3 mm Hg and heart rate decreased from 76 ± 7 to 62 ± 7 beats/min. After the deployment of the occlusion balloon, the rate of blood loss decreased by 90%, to 0.7 ± 0.2 mL/s. The mean time of balloon occlusion of the SVC was 16 ± 4 minutes and hemodynamic measures returned to baseline levels during this time. Study animals experienced no major complications, demonstrated stable recovery, and exhibited normal neurological function at each postoperative assessment. Conclusion Endovascular temporary balloon occlusion may be a feasible option to reduce blood loss, maintain hemodynamic control, and provide a bridge to surgery after SVC injury.

Cleveland Clinic, Department of Cardiovascular Medicine, Cleveland, OH, Ohio State University, Division of ardiovascular Medicine, Columbus, OH, Broward General Medical Center, Fort Lauderdale, FL, University Hospital, ivision of Cardiovascular Medicine, Pisa, Italy, University of Miami, Cardiothoracic Surgery, Miami, FL, St. Thomas esearch Institute, University of Tennessee College of Medicine, Nashville, TN, Brigham and Women’s Hospital, Boston, A, **Baylor College of Medicine, Pediatrics and Texas Children’s Hospital, Houston, TX, Sahlgrenska University ospital, Gothenburg, Sweden, University of Medical Sciences, Poznan, Poland, Providence St. Joseph Medical enter, Burbank, CA, American Heart Association Representative.