Contemporary Outcomes After Partial Resection of Infected Aortic Grafts.

INTRODUCTION: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. METHODS: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. RESULTS: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material.

Long-term survival following transvenous lead extraction: Importance of indication and comorbidities.

BACKGROUND: Long-term outcomes are poorly understood, and data in patients undergoing transvenous lead extraction (TLE) are lacking. OBJECTIVE: The purpose of this study was to evaluate factors influencing survival in patients undergoing TLE depending on extraction indication. METHODS: Clinical data from consecutive patients undergoing TLE in the reference center between 2000 and 2019 were prospectively collected. The total cohort was divided into groups depending on whether there was an infective or noninfective indication for TLE. We evaluated the association of demographic, clinical, and device-related and procedure-related factors on mortality. RESULTS: A total of 1151 patients were included. Mean follow-up was 66 months, and mortality was 34.2% (n = 392). Of these patients, 632 (54.9%) and 519 (45.1%) were for infective and noninfective indications, respectively. A higher proportion in the infection group died (38.6% vs 28.5%; P <.001). In the total cohort, multivariable analysis demonstrated increased mortality risk with age >75 years (hazard ratio [HR] 2.98; 95% confidence interval [CI] 2.35-3.78; P <.001), estimated glomerular filtration rate <60 mL/min/1.73 m2 (HR 1.67; 95% CI 1.31-2.13; P <.001), higher cumulative comorbidity (HR 1.17; 95% CI 1.09-1.26; P <.001), reduced risk per percentage increase in left ventricular ejection fraction (HR 0.98; 95% CI 0.97-0.99; P <.001), and near unity per year of additional lead dwell time (HR 0.98; 95% CI 0.96-1.00; P = .037). Kaplan-Meier survival curves demonstrated worse prognosis, with a higher number of leads extracted and increasing comorbidities. CONCLUSION: Long-term mortality for patients undergoing TLE remains high. Consensus guidelines recommend evaluating risk for major complications when determining whether to proceed with TLE. This study suggests also assessing longer-term outcomes when considering TLE in those with a high risk of medium- and long-term mortality, particularly for noninfective indications.

Management of Nellix migration and type Ia endoleak from proximal endovascular aneurysm sealing relining to late open conversion.

BACKGROUND: Despite promising early results, midterm failures of the Nellix endovascular aneurysm sealing (EVAS) system (Endologix Inc, Irvine, Calif) have been reported at higher than expected rates. The management of proximal endoleaks and migration differs from those after conventional endovascular aortic aneurysm repair (EVAR) owing to the peculiar design of the Nellix device. In the present study, we report a monocentric experience in the management of EVAS complications using various techniques. We also performed a comprehensive review of the relevant literature on both open surgical and endovascular management of proximal failure of EVAS from the MEDLINE database. METHODS: We retrospectively analyzed the reinterventions for type Ia endoleak and migration after elective infrarenal EVAS at our institution. We collected preoperative, intraoperative, and follow-up data. Open and endovascular techniques are described. Overall survival, aortic-related mortality, and the technical success rate (rate of exclusion of endoleaks) with endovascular techniques were the primary outcomes. RESULTS: We performed 101 infrarenal elective EVAS procedures from 2013 to 2018. Of the 101 patients, 20 (19.8%) had required reintervention for proximal sealing failure. The indications were type Ia (Is2, Is3) endoleak, migration >5 mm, sac expansion >5 mm, and secondary rupture. Of the 20 patients, 6 (30%) were treated with endovascular techniques-2 with a chimney Nellix-in-Nellix application and 4 with proximal relining with a covered stent. The remaining 14 patients (70%) were treated with late open conversion (OC). The average time from EVAS to reintervention was 36.1 months (range, 3-65 months). Six patients (30%) had undergone OC in an emergent setting because of secondary rupture. The technical success rate for the patients treated with endovascular reinterventions was 100%. The 30-day mortality was 20% (4 of 20), all emergent cases (four of six emergent repairs; 67%). The overall survival for the 20 patients was 75% (n = 15) at a mean follow-up of 15.1 months (range, 2-47 months). One patient had died after 7 months of non-aortic-related causes. CONCLUSIONS: The high reintervention rate of the Nellix graft mandates careful evaluation for its further use with the revised instructions for use, and it should not be used off-label. OC remains the strategy of choice when managing Nellix proximal sealing failures in fit patients. Chimney Nellix-in-Nellix application and transcatheter embolization are feasible alternative techniques. Proximal relining also appears to be an effective alternative to more complex interventions, although it requires further studies for validation.

A Canadian multicenter experience describing outcomes after endovascular abdominal aortic aneurysm repair stent graft explantation.

BACKGROUND: Most studies describing the outcomes after endovascular abdominal aortic aneurysm repair (EVAR) explantation have been from single, high-volume, centers. We performed a multicenter cross-Canadian study of outcomes after EVAR stent graft explantation. Our objectives were to describe the outcomes after late open conversion and EVAR graft explantation at various Canadian centers and the techniques and outcomes stratified by the indication for explant. METHODS: The Canadian Vascular Surgery Research Group performed a retrospective multicenter study of all cases of EVAR graft explantation at participating centers from 2003 to 2018. Data were collected using a standardized, secure, online platform (RedCap [Research Electronic Data Capture]). Univariate statistical analysis was used to compare the techniques and outcomes stratified the indication for graft explantation. RESULTS: Patient data from 111 EVAR explants collected from 13 participating centers were analyzed. The mean age at explantation was 74 years, the average aneurysm size was 7.5 cm, and 28% had had at least one instructions for use violation at EVAR. The average time between EVAR and explantation was 42.5 months. The most common indication for explantation was endoleak (n = 66; type Ia, 46; type Ib, 2; type II, 9; type III, 2; type V, 7), followed by infection in 20 patients; rupture in 18 patients (due to type Ia endoleak in 10 patients, type Ib in 1, type II in 1, type III in 2, and type V in 1), and graft thrombosis in 7 patients. The overall 30-day mortality was 11%, and 45% of the patients had experienced at least one major perioperative complication. Mortality was significantly greater for patients with rupture (33.3%) and those with infection (15%) compared with patients undergoing elective explantation for endoleak (4.5%; P = .003). The average center volume during the previous 15 years was 8 cases with a wide range (2-19 cases). A trend was seen toward greater mortality for patients treated at centers with fewer than eight cases compared with those with eight or more cases (19% vs 9%). However, the difference did not reach statistical significance (P = .23). Overall, 41% of patients had undergone at least one attempt at endovascular salvage before explantation, with the highest proportion among patients who had undergone EVAR explantation for endoleak (51%). Only 22% of patients with rupture had undergone an attempt at endovascular salvage before explantation. CONCLUSIONS: The performance of EVAR graft explantation has increasing in Canada. Patients who had undergone elective explantation for endoleak had lower mortality than those treated for either infection or rupture. Thus, patients with an indication for explanation should be offered surgery before symptoms or rupture has occurred. A trend was seen toward greater mortality for patients treated at centers with lower volumes.

Ongoing Risk of Ventricular Arrhythmias and All-Cause Mortality at Implantable Cardioverter Defibrillator Generator Change: A Systematic Review and Meta-Analysis.

[Figure: see text].

Management of Type IA Endoleak After EVAR by Explantation or Custom Made Fenestrated Endovascular Aortic Aneurysm Repair.

OBJECTIVE: Proximal type 1 endoleak after endovascular abdominal aortic aneurysmal repair (EVAR) remains challenging to solve with no existing consensus. This work aims to compare two different surgical strategies to remedy type IA endoleak: endograft explantation (EXP) and aortic reconstruction or relining by custom made fenestrated EVAR (F-EVAR). METHODS: A retrospective single centre analysis between 2009 and 2018 was conducted including patients treated for type IA endoleak after EVAR with either EXP or F-EVAR. The choice of surgical technique was based on morphological factors (F-EVAR eligibility), sac growth rate, emergency presentation and/or patient symptoms. Technical success, morbidity, secondary interventions, 30 day mortality, and long term survival according to Kaplan-Meier were determined for each group and compared. RESULTS: Fifty-nine patients (91% male, mean age 79 years) underwent either EXP (n = 26) or F-EVAR (n = 33) during the study period. The two groups were equivalent in terms of comorbidity and age at the time of procedure. The median time from initial EVAR was 60.4 months (34-85 months), with no difference between groups. The maximum aneurysm diameter was greater in the EXP group compared with the F-EVAR group, 86 mm (65-100) and 70 mm (60-80), respectively (p = .008). Thirty day secondary intervention (EXP: 11.5% vs. F-EVAR: 9.1%) and mortality (EXP: 3.8% vs. F-EVAR: 3.3%) rates did not differ between groups, while major adverse events at 30 days, defined by the current SVS guidelines, were lower in the F-EVAR group (2.4% vs. 13.6%; p = .016). One year survival rates were similar between the groups (EXP: 84.0% vs. F-EVAR: 86.6%). CONCLUSION: Open explantation and endovascular management with a fenestrated device for type IA endoleak after EVAR can be achieved in high volume centres with satisfactory results. F-EVAR is associated with decreased early morbidity. Open explantation is a relevant option because of acceptable outcomes and the limited applicability of F-EVAR.

Lessons Learned from Open Surgical Conversion after Failed Previous EVAR.

BACKGROUND: Delayed open conversion (OpC) after endovascular aortic aneurysm repair (EVAR) is becoming increasingly common worldwide. We reviewed our experience to characterize the perioperative spectrum of OpC repairs. MATERIALS AND METHODS: A retrospective analysis of a prospectively maintained institutional database to identify patients who underwent late OpC after failed EVAR was performed. Patient and aneurysm baseline characteristics, mechanism of failure, perioperative details, including type of repair/complications/survival, and late outcomes were examined. RESULTS: From January 2003 to January 2020, 38 male patients (mean age, 75 ± 7 years; range, 60-90) required late OpC. Interval time from initial EVAR to OpC was 63.6 ± 33.8 months (range, 17-120). Mean diameter of the aneurysms was 82.2 ± 22.1 mm before OpC compared with 62.9 ± 13 mm before endograft implantation. Mechanisms of failure were type Ia, Ib, II, and III endoleaks in 14 (36.8%), 9 (23.7%), 4 (10.5%), and 1 (2.6%) patient(s), respectively; infection in 3 (7.9%), leg ischemia in 2 (5.3%), and multiple causes in 5 (13.2%) patients. We observed 4 (10.5%) asymptomatic, 16 (42.1%) symptomatic, and 18 (47.3%) ruptured aneurysms. Four patients (10.5%) had stable contained ruptures, whereas the remaining 13 (34.2%) and 1 additional patient (2.6%) with aortoenteric fistula presented with hemorrhagic shock (class ≥II). Total endograft explantation, endograft preservation, or proximal/distal partial graft removal was performed in 16 (42.1%), 10 (26.3%), and 2 (5.2%)/9 (23.7%) of patients, respectively. Technical success was 100%, excluding an early postaortic clamping death. Overall, 30-day mortality was 21.1% (8 of 38) and significantly higher in patients with hemorrhagic shock or hemodynamic instability at presentation (P = 0.04 and P = 0.009, respectively) and in patients who had endografts with hooks/barbs or experiencing higher postoperative complication rate (P = 0.02 and P = 0.006, respectively). By definition, procedure success was 81.1%. Mean follow-up was 37.6 ± 39.8 months. By the end of the study, we recorded 11 deaths (2 were aneurysm related). CONCLUSIONS: Despite high technical success, OpC has a significant mortality in patients presenting with hemorrhagic shock and had active fixation endografts or experiencing high complication rate. Many other confounding factors may play a role.

Surgical explantation of transcatheter aortic bioprostheses: Results and clinical implications.

OBJECTIVE: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) and worldwide interest in its implantation, TAVR valve explantation has not been well described. METHODS: We retrospectively reviewed 1442 consecutive patients who underwent a TAVR procedure between 2011 and 2019, in which TAVR explantation was performed in 15 patients (1.0%). In addition, 2 patients from outside institutions also underwent TAVR explantation at our institution. We reviewed the clinical details of these 17 patients. RESULTS: The frequency of TAVR explant increased over time from 0 to 1 during the period from 2011 to 2015 to 6 in 2019. The mean age was 73.0 ± 9.3 years. The majority of patients (88.2%) were in New York Heart Association functional class IV heart failure. The Society of Thoracic Surgeons Predicted Risk of Mortality score was significantly higher at the time of explantation than at the time of the original TAVR (3.5% vs 9.9%; P < .001). The indication for explantation included structural valve degeneration (23.5%), severe paravalvular leak (41.2%), TAVR procedure-related complications (23.5%), endocarditis (5.9%), and bridge-to-definitive surgery (5.9%). Neoendothelialization of the TAVR valve into the aortic wall requiring intense aortic endarterectomy was noted in all 5 of the TAVR valves older than 1 year, in which 2 (40%) required unplanned aortic root repair. There were 2 (11.8%) in-hospital mortalities. CONCLUSIONS: Surgical TAVR valve explant is increasing and may become common in the near future. The clinical effects of explanting chronically implanted valves with the potential need for aortic repair is not negligible. These data should be used to more appropriately select TAVR candidates as TAVR practices expand into younger and lower risk patients.

First Result of a Tailored Progressive Multistep Approach for the Treatment of Aorto-esophageal Fistulae.

BACKGROUND: Aorto-esophageal fistulae (AEFs) are a rare but serious and life-threatening disease of the mediastinum. Especially, AEF in the presence of infected stent grafts, for example, after thoracic endovascular aortic repair (TEVAR) is only curable by a multistage interdisciplinary surgical approach. This study presents the results of our four-stage approach consisting of bridging TEVAR, esophagectomy, complete stent removal followed by total bovine tube aortic replacement (TBTAR), and finally esophageal reconstruction. METHODS: A case series of four patients from our department receiving a four-stage treatment of AEF is presented in this study. Retrospective database analysis focusing on overall survival, duration of intensive care unit and total hospital stay until discharge, complications, surgical time frame, and completion of chosen surgical treatment course was performed. RESULTS: Overall, four patients surgically treated for AEF since May 2015 were included. A 30-day mortality was 0%, and overall survival at 1 year was 75%. All patients survived more than 5 months and could be discharged after TEVAR and esophagectomy. TBTAR could be performed in two of four patients (50%). Esophageal reconstruction was completed in all patients. Average follow-up was 20.3 ± 1.7 months or until death. CONCLUSION: The acute management of AEF using this approach seems satisfactory, especially for reducing acute short-term mortality. Complete restoration of the circulatory system and digestive tract remains challenging and is associated with high morbidity. We support the application of bridging TEVAR with a staggered approach to further surgical treatment individually tailored to the patient.

Contemporary management and outcomes of complex vascular surgical groin wound infections.

OBJECTIVE: Vascular surgical groin wound infection (VS-GWI) has multiple causes and frequently is manifested as a limb- or life-threatening problem, resulting in significant morbidity and mortality. For patients undergoing operative extirpation, in situ repair, extra-anatomic bypass, or ligation can be used; however, limited data exist describing comparative results of the different operative choices or conduit subtypes. Therefore, we sought to describe our experience with management of VS-GWI and to detail outcomes of the different strategies. METHODS: Patients (2003-2017) undergoing surgical treatment of VS-GWI (Szilagyi grade III) secondary to primary infectious arteritis or infected pseudoaneurysm after percutaneous intervention as well as previous prosthetic graft placement were reviewed. The primary end point was major adverse limb events (MALEs; major amputation, graft occlusion, or unplanned reintervention). Secondary end points included 30-day mortality, wound healing, amputation-free survival (AFS), and all-cause mortality. Cox proportional hazards modeling was used to determine relative risk of end points; Kaplan-Meier methodology was employed to estimate freedom from outcomes. RESULTS: There were 149 patients (age, 65 ± 11 years; body mass index, 27 ± 6 kg/m2; 70% male; 32% diabetes) identified, of whom 120 (81%) had unilateral and 29 (19%) had bilateral VS-GWI. Indications included infected prosthetic bypass (88% [n = 131]; infrainguinal, 107; suprainguinal, 24) and primary infectious femoral artery complications (12% [n = 18]). A majority underwent single-stage operations (87% [n = 129]). In situ reconstruction occurred in 87% (n = 129); 9% (n = 13) underwent ligation, and 6% (n = 7) received extra-anatomic revascularization. Autogenous conduit was used most commonly (68% [n = 101/149]; 88% single stage), of which 81% (n = 80) were femoral vein. The remaining patients received cadaveric (15% [n = 23]; 87% single stage) or prosthetic (8% [n=12]; 67% single stage) grafts. Adjunctive myocutaneous flap was used in 37% (n = 54). Length of stay was 19 ± 15 days and 30-day mortality was 7% (n = 10), with no difference between conduit repair types. All femoral wounds healed (mean follow-up, 17 ± 11 months); however, 33% (n = 49) underwent reoperation (unplanned graft reintervention, 33%; graft occlusion, 16%; wound débridement, 15%; major amputation, 11%). Reinfection occurred in 17% (n = 27), with no difference between groups. MALE rate was 22% (n = 33; most were arterial reinterventions, 19%), with no difference in single-stage vs multistage, in situ vs extra-anatomic, or autogenous vs nonautogenous conduit strategies Predictors of MALE included younger age (hazard ratio [HR], 1.6 per decade; 95% confidence interval [CI], 1.1-2.5; P = .02) and lower body mass index (<25 kg/m2; HR, 1.6 per BMI category; 95% CI, 1.1-2.5; P = .02). Overall, 1- and 3-year freedom from MALE, AFS, and survival were as follows: MALE, 74% ± 5% and 63% ± 6%; AFS, 68% ± 4% and 58% ± 5%; survival, 78% ± 3% and 70% ± 4%. Autogenous conduit use was associated with better survival (HR, 0.5; 95% CI, 0.3-0.8; 1-year: 83% ± 4% vs nonautogenous, 78% ± 4%; 3-year: 68% ± 8% vs 53% ± 9%; log-rank, P = .006). CONCLUSIONS: An individualized approach to operative strategy and conduit choice leads to comparable outcomes in this challenging group of patients. VS-GWI can be safely managed with in situ, autogenous reconstruction in a majority of patients with acceptable mortality, excellent wound healing rates, and improved overall survival. However, a significant proportion of patients experience reinfection and MALEs, the preponderance of which are arterial reintervention, mandating need for close follow-up and graft surveillance.

The safety of bovine tissue arterial repair in removal of infected prosthetic hemodialysis grafts.

BACKGROUND: More than 400,000 Americans require dialysis, and many receive it via a prosthetic arteriovenous graft. Infection of these grafts is rare, but associated with significant morbidity and mortality. The gold standard is total graft excision with arteriotomy closure. This was previously done with autologous vein, but bovine tissue offers a reasonable alternative. The objective of this article is to evaluate a community hospital experience with bovine tissue arterial repair after total graft excision of infected prosthetic arteriovenous graft. METHODS: A retrospective review was performed of all cases of infected prosthetic arteriovenous graft removal with bovine tissue arterial repair was performed. Thirteen cases were identified. Presentation, location of graft, and causative organism were reviewed; outcomes including reoperation and mortality were recorded. RESULTS: Of the 13 patients, 12 (92%) had positive cultures of the graft, bloodstream, or wound. Methicillin-resistant Staphylococcus aureus was the most commonly isolated organism (54%). There were two unplanned reoperations including hematoma drainage and wound debridement within the first year. Over the 1-year follow-up period, 1 patient died for a mortality of 8%. There were no re-infections during follow-up. DISCUSSION: Prosthetic arteriovenous graft infection remains a difficult challenge and is associated with significant morbidity and mortality. It presents in a variety of ways, including within an old thrombosed graft. Over the last several years, the causative organism has increasingly become drug resistant. Treatment with total graft excision requires arteriotomy closure, and for this bovine tissue has been demonstrated to be a viable option.

Total Resection of Infected Peripheral Hemodialysis Grafts Has a Favorable Impact on Outcomes.

BACKGROUND: Surgical resection could be an eradication treatment for patients with infected hemodialysis arteriovenous grafts (AVGs). This study aimed to investigate the outcomes of 3 surgical methods, including total resection, subtotal resection, and revision. METHODS: The patients who underwent surgical excision of infected AVGs performed at a single center from August 2012 to March 2019 were retrospectively analyzed. The following 3 surgical methods were used in our study: revision, subtotal resection, and total resection. Patients' demographics, medical history, perioperative details, reconstruction time, and follow-up data were collected. The outcomes including perioperative complications (within 30 days), mortality, reinfection rate of AVGs, with new access reconstruction or not, and the outcomes between reconstruction and nonreconstruction in the follow-up period were evaluated. RESULTS: Forty-one patients had infected AVGs in our study. Patients' mean age was 62 years, and 65.9% of the patients were female. The mean duration from the time of diagnosis to the operation was 14.4 days. Signs and symptoms at presentation included fever (51.2 %), swelling (43.9%), pain (58.5%), erythematous change (92.7%), and more severe features, such as altered consciousness (14.6%) and hypotension (12.2%). The pathological changes in the infected grafts included bleeding (29.3%), pus formation (73.2%), pseudoaneurysm (26.8%), and graft exposure (17.1%). Wound and graft cultures revealed an infectious etiology with fungi (7.3%), Pseudomonas aeruginosa (12.2%), Enterococcus spp. (2.4%), and Staphylococcus spp. (58.5%), with methicillin-resistant Staphylococcus aureus accounting for only 7.3%. Total resection, subtotal resection, and revision surgery were performed in 17.1%, 63.4%, and 19.5% of patients, respectively. Seven patients with complications required reoperation (17.1%), and adhesion ileus and hospital-acquired pneumonia occurred in only 2.4% and 7.3% of patients, respectively. During follow-up, most patients (82.9%) had reconstruction of the peripheral hemodialysis access with mean time of 64.3 (range: 21-92) days; mean time of use of new access was 90.5 days; and mean time of removal of catheter was about 106.3 days. Mortality rates in patients without and with reconstructed AV access during follow-up were 50% and 18%, respectively (P < 0.004). Eight cases (19.5%) had recurrence of AV access infections during follow-up; of these, 2 had revision surgery and 6 had subtotal resection. However, no patient with total resection had recurrent infections. CONCLUSIONS: The total resection group had no recurrent infection compared to the subtotal and revision groups. In addition, patients with reconstruction of peripheral hemodialysis access had a low mortality rate during the follow-up period.

The effect of centre volume and procedure location on major complications and mortality from transvenous lead extraction: an ESC EHRA EORP European Lead Extraction ConTRolled ELECTRa registry subanalysis.

AIMS: Transvenous lead extraction (TLE) should ideally be undertaken by experienced operators in a setting that allows urgent surgical intervention. In this analysis of the ELECTRa registry, we sought to determine whether there was a significant difference in procedure complications and mortality depending on centre volume and extraction location. METHODS AND RESULTS: Analysis of the ESC EORP European Lead Extraction ConTRolled ELECTRa registry was conducted. Low-volume (LoV) centres were defined as <30 procedures/year, and high-volume (HiV) centres as ≥30 procedures/year. Three thousand, two hundred, and forty-nine patients underwent TLE by a primary operator cardiologist; 17.1% in LoV centres and 82.9% in HiV centres. Procedures performed by primary operator cardiologists in LoV centres were less likely to be successful (93.5% vs. 97.1%; P < 0.0001) and more likely to be complicated by procedure-related deaths (1.1% vs. 0.4%; P = 0.0417). Transvenous lead extraction undertaken by primary operator cardiologists in LoV centres were associated with increased procedure-related major complications including death (odds ratio 1.858, 95% confidence interval 1.007-3.427; P = 0.0475). Transvenous lead extraction locations varied; 52.0% operating room, 9.5% hybrid theatre and 38.5% catheterization laboratory. Rates of procedure-related major complications, including death occurring in a high-risk environment (combining operating room and hybrid theatre), were similar to those undertaken in the catheterization laboratory (1.7% vs. 1.6%; P = 0.9297). CONCLUSION: Primary operator cardiologists in LoV centres are more likely to have extractions complicated by procedure-related deaths. There was no significant difference in procedure complications between different extraction settings. These findings support the need for TLE to be performed in experienced centres with appropriate personnel present.

Predictors of short-term mortality in patients undergoing a successful uncomplicated extraction procedure.

BACKGROUND: The prognosis of patients with untreated cardiac implantable electronic device (CIED) infection is poor. Whether removal of all leads by a successful transvenous lead extraction (TLE) procedure changes the prognosis is unclear. OBJECTIVE: To identify predictors of mortality in patients with CIED infection despite successful TLE. METHODS: Retrospective single-center analysis of prospectively collected database from consecutive patients undergoing TLE at our center. Predictors for mortality were identified and a score predicting high mortality rate was calculated. RESULTS: A total of 371 consecutive patients underwent TLE, of whom 337 (90.8%) had complete hardware removal. Most were extracted due to infectious causes (81.3%). Approximately one-third (35%) died during a mean follow-up of 1056 ± 868 days. There was significantly higher mortality observed in the infectious group. Multivariate logistic regression models for infectious group only identified creatinine and albumin measurements as risk markers for 30 days mortality (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.19-2.38; P = .003 and OR, 0.4; 95% CI, 0.16-0.97; P = .039, respectively). A risk score was created based on cutoff values of creatinine ≥2md/dL (1 point) and albumin ≤3.5 g/dL (1 point). A value of 2 points predicted a 50% chance of 30-day mortality and a 75% chance of 1-year mortality (P < .0001 for both). CONCLUSIONS: Creatinine and albumin can be used as a combined risk score to successfully identify patients at risk of death despite undergoing a successful TLE procedure for infectious reasons. This score could help decision making when contemplating on conservative antibiotic treatment vs TLE.

Analysis of Outcomes in 8304 Patients Undergoing Lead Extraction for Infection.

Background Patients undergoing lead extraction for infected devices have worse outcomes compared with those with noninfected devices. We assessed predictors of in-hospital mortality and procedure-related major adverse events (MAEs) in a large cohort undergoing lead extraction. Methods and Results Deidentified hospital records procedure from 7 states between 1994 and 2013 were aggregated and International Classification of Disease, Ninth Revision (ICD-9) procedure codes were used to identify hospital records reporting lead extraction. MAEs included death, cardiac tamponade, hemothorax, and need for emergent cardiac surgery. Predictors of in-hospital MAEs for infected compared with noninfected leads were identified using multivariate regression. Associations between outcomes and specific microbe were also assessed. In total, 57 220 discharges specified lead extraction. Infected leads accounted for the minority of total lead extractions compared with fractured leads (16.1 versus 59.8%, 25.7% not reported). There were 3298 MAEs (5.8%) including 980 deaths (1.7%). Multivariate predictors of MAE included black race, atrial fibrillation, anemia, heart failure, and admission via either hospital transfer or emergency department versus home (all P<0.001). Infected leads were associated with an increased risk of death (4.6% versus 0.9%, P<0.001) compared with leads with fracture only. Among patients with microbial data, staphylococcal infection was most common, whereas streptococcal infection was associated with the worst outcomes. Conclusions Patients undergoing extraction of infected leads have higher in-hospital mortality and adverse events compared with noninfected leads. Streptococcus, anemia, and heart failure are predictors of adverse outcomes.

Reduced Number of Platelets During Intra-Aortic Balloon Pumping Counterpulsation Predicts Higher Cardiovascular Mortality After Device Removal in Association with Systemic Inflammation.

Thrombocytopenia is a frequent complication in patients requiring intra-aortic balloon pumping (IABP) counterpulsation. However, its prognostic impact has not been fully addressed. The objective of this study is to evaluate the impact of the change in the platelet number during IABP use on the prognosis after device removal.This is a retrospective observational study. Patients in the intensive cardiac care unit at three Juntendo University hospitals who underwent percutaneous implantation of IABP with or without veno-arterial extracorporeal membrane oxygenation (V-A ECMO), since 2012-2016, were enrolled in the study (n = 439). Patients who died during mechanical circulatory support (n = 47) were excluded. We evaluated the prognostic impact of the ratio of platelet reduction from the baseline (% PLT reduction) during IABP use on cardiovascular mortality after device removal.The median and the range of follow-up period were 298 days and 0-1,869 days, respectively. Unadjusted Kaplan-Meier analysis demonstrated that patients with a higher % PLT reduction had higher cardiovascular (CV) mortality. An adjusted Cox proportional hazard analysis demonstrated that a 10% higher % PLT reduction was associated with higher cardiovascular (CV) mortality (Hazard ratio: 1.3, 95% Confidence interval: 1.1-1.6, P < 0.001). Moreover, % PLT reduction and the maximum C-reactive protein (CRP) level during IABP use were positively correlated (r = 0.326, P < 0.001).The reduced number of platelets during IABP use was associated with an increased risk of CV mortality.

Transvenous management of cardiac implantable electronic device late lead perforation.

INTRODUCTION: Late lead perforation (LLP), defined as perforation ≥30 days from cardiac implantable electronic device implant, is a rare diagnosis and little data exist regarding management practices and outcomes. The purpose of this study was to evaluate the occurrence, safety, and efficacy of transvenous management of clinically significant LLP. METHODS: The electronic medical records of a single-center tertiary hospital were reviewed for all patients who were referred for LLP or its sequelae. RESULTS: Eleven consecutive patients were identified from October 2011 to December 2018 with clinically significant LLP. Patients most often presented with pericardial symptoms with the exception of one asymptomatic patient. The median time from lead implant to intervention for LLP was 246 days. Nine patients were managed with an initial transvenous approach, with one requiring sternotomy (lead 6.3 years old). Two patients had a surgical approach, one performed at an outside hospital with subsequent death and another had a mini-thoracotomy, but the lead was removed percutaneously with no surgical repair. In this small cohort, there was no association between the lead extending beyond the parietal pericardium and surgical repair (P = .99). CONCLUSION: Our single-center experience suggests that LLP can be initially managed with a cautious transvenous approach in most patients, but intraprocedural ultrasound for pericardial monitoring and a rescue plan with immediate surgical back up is mandatory.

Costs and complications associated with transvenous lead reoperation in cardiac implantable electronic devices.

BACKGROUND: Cardiac implantable electronic device transvenous (TV) lead reoperations are projected to increase, and robust economic data are needed to assess the resulting financial impact and the cost-effectiveness of prevention and treatment strategies. This study estimates Medicare costs, and describes patterns of complications, in patients who underwent TV lead reoperation. METHODS AND RESULTS: Medicare data (2010-2014) were used to identify patients who underwent TV lead reoperation. Cumulative costs to Medicare, and rates of infection and mechanical complications were calculated from 180 days before, to 180 days after, lead reoperation. Multivariate analysis was used to estimate adjusted costs, and to examine the impact of complications on medical resource use and costs. There were 1691 patients, 63.2% of whom underwent inpatient lead reoperation. Overall, the mean age was 78.2 years, 39.6% were female, and 92.3% were white. The mean cumulative cost was $36 199 (95% confidence interval [CI], $31 864-$40 535) for TV lead repositioning, $27 701 (95% CI, $19 869-$35 534) for repair, and $54 442 (95% CI, $51 651-$57 233) for removal. Underlying infection was associated with increased odds of inpatient reoperation and of lead removal, as well as longer length of stay and higher costs. CONCLUSIONS: The economic consequences of TV lead reoperation are substantial. Strategies aimed at reducing reoperation, particularly lead removal, are likely to result in considerable cost offsets.

Fluoroscopic removal of self-expandable metallic airway stent in patients with airway stenosis.

To study the safety and efficacy of fluoroscopic removal of self-expandable metallic stent for airway stenosis.We conducted a retrospective analysis of 67 consecutive patients, 39 male and 28 female, who underwent fluoroscopic stent removal from March 2011 to April 2017. The patients ranged in age from 12 to 85 years. Seventy-six airway stents were implanted, 70 covered stents and 6 bare stents, including 9 stents for second stent implantation after removal. All patients underwent chest computed tomography scans with/without bronchoscopy before stent removal. The indication of stent removal and postinterventional complications were analyzed retrospectively.Seventy-four of 76 airway stents were successfully removed, only 2 stent showed retained struts after removal, for a technical success rate of 97.4%. Two patients died of complications (1 hemorrhage and 1 respiratory failure), resulting in a clinical success rate of 94.7%. Five stents showed strut fracture and the remaining 71 stents were removed in 1 piece. Indications for stent removal include planned removal (n = 40), excessive granulation tissue (n = 15), intolerance of stenting (n = 6), inadequate expansion and deformation (n = 5), stent migration (n = 5), replacement of bare stent (n = 4), and strut fracture (n = 1). There were 17 complications of stent removal: death from massive bleeding (n = 1), restenosis requires stenting (n = 9), strut fracture or residue (n = 5), dyspnea requires mechanical ventilation (n = 2). The survival rates were 83.8%, 82.1%, and 82.1% for 0.5, 3, and 6 years.Fluoroscopic removal of airway stent is technically feasible and effective. Stents are recommended for removal within 3 months for treating airway stenosis.

Left Ventricular Assist Device Decommissioning Compared with Explantation for Ventricular Recovery: A Systematic Review.

Left ventricular assist device (LVAD) withdrawal with ventricular recovery represents the optimal outcome for patients previously implanted with an LVAD. The aim of this systematic review was to examine the patient outcomes of device withdrawal via minimally invasive pump decommissioning as compared with reoperation for pump explantation. An electronic search was performed to identify all studies in the English literature assessing LVAD withdrawal. All identified articles were systematically assessed for inclusion and exclusion criteria. Overall, 44 studies (85 patients) were included in the analysis, of whom 20% underwent decommissioning and 80% underwent explantation. The most commonly used LVAD types included the HeartMate II (decommissioning 23.5% vs. explantation 60.3%; p = 0.01) and HeartWare HVAD (decommissioning 76.5% vs. explantation 17.6%; p < 0.001). At median follow-up of 389 days, there were no significant differences in the incidence of cerebrovascular accidents (p = 0.88), infection (p = 0.75), and survival (p = 0.20). However, there was a trend toward a higher recurrence of heart failure in patients who underwent decommissioning as compared with explantation (decommissioning 15.4% vs. explantation 8.2%, cumulative hazard; p = 0.06). Decommissioning appears to be a feasible alternative to LVAD explantation in terms of overall patient outcomes.