Israel Medical Association Journal

Background: Cardiac implantable electronic devices (CIEDs) with endocardial leads crossing the tricuspid valve can lead to or worsen tricuspid regurgitation (TR), causing substantial morbidity and mortality. Despite a recent randomized controlled study revealing a low short-term incidence of device-related TR (DRT) post-CIED implantation, uncertainties persist regarding the efficacy of intra-procedural 2-dimensional transthoracic echocardiography (2DTTE) in preventing long-term TR.

Objectives: To conduct a long-term follow-up study on patients with CIED implants based on a previous study conducted at our hospital.

Methods: In a retrospective study at Assuta Ashdod Medical Center (2018–2019), patients undergoing de-novo CIED implantation with (n=39, group 1) or without (n=51, group 2) intra-procedural 2DTTE were analyzed. Clinical, demographic, and long-term (> 1 year) echocardiographic data were collected and compared.

Results: The study included 90 patients (mean age 72.3 ± 11.0 years, 63% male, 23% ICD, 50% active leads, follow-up 32.8 ± 11 months). TR aggravation was found in 25% of patients (13 in group 1, 10 in group 2), with no statistical difference between groups. Multivariate analysis identified a history of atrial fibrillation (AF) as the sole significant factor in long-term TR deterioration (OR=3.44, 95%CI 1.13–10.43, P = 0.029). Other clinical, demographic, echocardiographic, and device-related factors did not significantly contribute to long-term DRT.

Conclusions: After one-year post-CIED implantation, the incidence of DRT significantly increases. Intra-procedural 2DTTE does not effectively reduce long-term DRT, suggesting that implantation-related mechanisms are less likely the primary cause. AF likely plays a major role in the pathogenesis of long-term TR in this subset post-CIED implantation.

Background: Cardiac implantable electronic devices (CIEDs) are associated with risks of device-related infections (DRI) impacting major adverse outcomes. Staphylococcus aureus (SA) is a leading cause of early pocket infection and bacteremia. While studies in other surgical contexts have suggested that nasal mupirocin treatment and chlorhexidine skin washing may reduce colonization and infection risk, limited data exist for CIED interventions.

Objectives: To assess the impact of SA decolonization on DRI rates.

Methods: We conducted a retrospective, single-center observational study on consecutive patients undergoing CIED interventions (March 2020–March 2022). All patients received pre-procedure antibiotics and chlorhexidine skin washing. Starting in March 2021, additional pre-treatment with mupirocin for SA decolonization was administered. DRI rates within 6 months post-implantation were compared between patients treated according to guidelines (Group 1) and those receiving mupirocin in addition to the recommended guidelines (Group 2).

Results: The study comprised 276 patients (age 77 ± 10 years; 60% male). DRI occurred in five patients (1.8%);80% underwent cardiac resynchronization therapy procedures. In Group 1 (n=177), four patients (2.2%) experienced DRI 11–48 days post-procedure; three with pocket infection (two with negative cultures and one with local Pseudomonas) and one with methicillin-sensitive SA endocarditis necessitating device extraction. In Group 2 (n=99), only one patient (1%) had DRI (Strep. dysgalactiae endocarditis) 135 days post-procedure (P = NS).

Conclusions: The routine decolonization of SA with mupirocin, in addition to guideline-directed protocols, did not significantly affect DRI rates. Larger prospective studies are needed to evaluate the preventive role of routine SA decolonization in CIED procedures.

Background: Long-term support with a HeartMate 3 (HM3) left ventricular assist device (LVAD) has improved outcomes of patients with end-stage heart failure. However, there is a paucity of data on the outcomes of patients who underwent concomitant cardiac surgical procedure (CCSP) during HM3-LVAD implantation.

Objectives: To assess our single-center experience with patients who underwent CCSP during the implantation of an HM3-LVAD.

Methods: From December 2016 until April 2022, 131 adult patients underwent HM3-LVAD implantation. A total of 23 patients underwent CCSP during the HM3-LVAD implantation+CCSP, and 108 underwent only HM3-LVAD implantation (HM3-only).

Results: The median age was 59 ± 11 years (range 54-67), 82% (n=108) were male, and 76% (n=100) were implanted as a bridge-to-transplant. The concomitant procedures performed during the implantation included 8 aortic valve repairs/replacements, 14 tricuspid valve repairs, 4 patent foramen ovales or atrial septal defect closures, and 3 other cardiac procedures. The mean cardiopulmonary bypass time was 113 ± 58 minutes for the HM3-only group and 155 ± 47 minutes for the HM3+CCSP group (P = 0.007). The mortality rates at 30 days, 6 months, and 12 months post-implantation were 2 (9%), 5 (22%), and 6 (26%) respectively for the HM3+CCSP group, and 7 (6%), 18 (17%), and 30 (28%) for the HM3-only group (P = 0.658, 0.554, and 1.000).

Conclusions: Our experience demonstrated no significant difference in the 30-day, 6-month, and 12-month mortality rates for patients who underwent a CCSP during HM3-LVAD implantation compared to patients who did not undergo CCSP during HM3-LVAD implantation.

Background: Unfractionated heparin is the preferred anticoagulant used during open heart surgeries, including left ventricular assist device (LVAD) implantation. In cases in which patients are heparin-induced thrombocytopenia positive (HIT+), the accepted practice has been to substitute heparin with bivalirudin. This practice may be associated with significant bleeding and adverse outcomes.

Objectives: To review our experience with HIT+ patients who were heparin-induced thrombocytopenia with thrombosis negative (HITT-) and who underwent HeartMate 3 LVAD implantation using heparin intraoperatively rather than bivalirudin.

Methods: From 2016 to 2022, 144 adult patients were implanted with HeartMate 3 LVAD at our center. Among them, 7 were detected as HIT+ but HITT- and therefore were prescribed intraoperatively with heparin and treated pre- and postoperatively with bivalirudin. We reviewed the preoperative, intraoperative, and postoperative characteristics as well as short-term mortality and the complication rates of these HIT+ patients.

Results: The median age of our cohort was 56 years (51–60), 71% were male (n=5), all were INTERMACS Level 1, and most were bridged to transplant (n=6, 86%). The 30-day mortality rate post-implantation was 0%. The average 24-hour chest drain postoperative output was 1502.86 ± 931.34 ml. There were no intraoperative pump thromboses, perioperative thromboses, cerebrovascular accidents, or gastrointestinal bleeding within the first 24 hours postoperative. One patient required a revision due to bleeding.

Conclusions: Intraoperative unfractionated heparin may be administered to patients who are HIT+ and HITT- while undergoing LVAD implantation. However, further investigation is required.

Background: Granulomatosis with polyangiitis (GPA) otologic manifestations include conductive and sensorineural hearing loss (HL). Vasculitis is assumed to be the primary cause of otologic manifestations. Deaf patients and patients with HL who do not benefit from hearing aids can benefit from cochlear implants (CI). There are currently no specific guidelines for treatment of patients with GPA suited for CI.

Objectives: To assess whether patients who are deaf due to GPA are good candidates for CI and if prior surgical or medical treatment of the inflammation are needed.

Methods: A case report is presented.

Results: A 71-year-old female patient with GPA and bilateral profound HL underwent CI. Prior to CI, preparation consisted of audiological evaluations by an otolaryngologist and a rheumatologist, followed by a course of prednisone and methotrexate for middle ear and nasal inflammations. CI was performed with no complications. The speech reception threshold and the monosyllabic word discrimination score after surgery were 25 dBHL and 75%, respectively.

Conclusions: Inflammation due to GPA can be controlled medically with immunosuppressive medications without subtotal petrosectomy, as in chronic suppurative otitis media. Satisfactory audiological results can be expected.

Background: Neutrophil-to-lymphocyte ratio (NLR) is a simple and cost-effective marker of inflammation. This marker has been shown to predict cardiac arrhythmias, progression of valvular heart disease, congestive heart failure decompensation, acute kidney injury, and mortality in cardiovascular patients. The pathologic process of aortic stenosis includes chronic inflammation of the valve and therefore biomarkers of inflammation might offer additive prognostic value.

Objectives: To evaluate NLR and its association with long term mortality in transcatheter aortic valve implantation (TAVI) patients.

Methods: We evaluated data of 1152 consecutive patient from the Tel Aviv Medical Center TAVI registry who underwent TAVI. Data included baseline clinical, demographic, and echocardiographic findings; procedural complications; and post-procedure mortality. Patients were compared by using the median NLR value (4.1) and evaluated for long-term mortality.

Results: Patients with NLR above the median had higher mortality rates (26.4% vs. 16.3%, P < 0.001) at 3 years post-procedure. A multivariable analysis found NLR to be an independent risk factor for mortality (hazard ratio = 1.47, 95% confidence interval 1.09–1.99, P = 0.013). In addition, high NLR was linked to complicationsduring and after the procedure.

Conclusion: NLR is an independent prognostic marker among TAVI patients. This marker may represent an increased inflammatory response and should be added to previous known prognostic factors.

Background: Endocardial leads of permanent pacemakers (PPM) and implantable defibrillators (ICD) across the tricuspid valve (TV) can lead to tricuspid regurgitation (TR) or can worsen existing TR with subsequent severe morbidity and mortality.

Objectives: To evaluate prospectively the efficacy of intraprocedural 2-dimentional-transthoracic echocardiography (2DTTE) in reducing/preventing lead-associated TR.

Methods: We conducted a prospective randomized controlled study comparing echocardiographic results in patients undergoing de-novo PPM/ICD implantation with intraprocedural echo-guided right ventricular (RV) lead placement (Group 1, n=56) versus non-echo guided implantation (Group 2, n=55). Lead position was changed if TR grade was more than baseline in Group 1. Cohort patients underwent 2DTTE at baseline and 3 and/or 6 months after implantation. Excluded were patients with baseline TR > moderate or baseline ≥ moderate RV dysfunction.

Results: The study comprised 111 patients (74.14 ± 11 years of age, 58.6% male, 19% ICD, 42% active leads). In 98 patients there was at least one follow-up echo. Two patients from Group 1 (3.6%) needed intraprocedural RV electrode repositioning. Four patients (3.5%, 2 from each group, all dual chamber PPM, 3 atrial fibrillation, 2 RV pacing > 40%, none with intraprocedural reposition) had TR deterioration during 6 months follow-up. One patient from Group 2 with baseline mild-moderate aortic regurgitation (AR) had worsening TR and AR within 3 months and underwent aortic valve replacement and TV repair.

Conclusions: The rate of mechanically induced lead-associated TR is low; thus, a routine intraprocedural 2DTTE does not have a significant role in reducing/preventing it

Background: Breast implant illness (BII) is a rising concern among many patients. Although not fully understood, a connection between silicone breast implants and systemic diseases may be present. This connection may influence the types of breast surgeries performed.

Objectives: To evaluate changing trends in breast surgeries in Israel over time, with regard to implantation, explantation, and implant exchange surgeries.

Methods: In this ecological study, we presented data from four private medical centers in Israel regarding the number of breast implant surgeries performed in the years 2018–2019. Data were collected bi-yearly. The types of surgeries included breast implantation, explantation, and breast implant exchange.

Results: When we summed and compared the yearly data, we saw that the number of implantations in 2018 was 2267 (80.1% of breast implant procedures that year), and 1929 (68.9%) in 2019. The number of implant exchanges in 2018 and 2019 was 482 (17.0%) and 608 (21.7%), respectively. In 2018, 80 (2.8%) explantations were performed and 262 (9.4%) in 2019.

Conclusions: There appears to be a trend in the rise of implant removal surgeries in addition to a decrease in breast implantations. One possible reason may be patient concerns of BII. Another reason may be the increased public interest and discussion about systemic effects of breast implants. More research is needed in this field to achieve better understanding of the phenomenon, the reasons behind it, and the possible solutions and ways of treatment

Background: Patients with right bundle branch block (RBBB) prior to transcatheter aortic valve implantation (TAVI) are at high risk for immediate post-procedural heart block and long-term mortality when discharged without a pacemaker.

Objectives: To test whether prophylactic permanent pacemaker implantation (PPI) is beneficial.

Methods: Of 795 consecutive patients who underwent TAVI, 90 patients had baseline RBBB. We compared characteristics and outcomes of the prophylactic PPI with post-TAVI PPI. Need for pacing was defined as  greater than 1% ventricular pacing.

Results: Forty patients with RBBB received a prophylactic PPI (group 1), and in 50 the decision was based on standard post-procedural indications (group 2). There were no significant differences in clinical baseline characteristics. One patient developed a tamponade after a PPI post-TAVI. A trend toward shorter hospitalization duration in group 1 patients was observed (P = 0.06). On long-term follow-up of 848 ± 56 days, no differences were found in overall survival (P = 0.77), the composite event-free survival of both mortality and hospitalizations (P = 0.66), or mortality and syncope (P = 0.65). On multivariate analysis, independent predictors of the need for pacing included baseline PR interval increase of 10ms (odds ratio [OR] 1.21 per 10 ms increment 95% confidence interval [95%CI] 1.02–1.44, P = 0.028), and the use of new generation valves (OR 3.92, 95%CI 1.23–12.46, P = 0.023).

Conclusions: In patients with baseline pre-TAVI RBBB, no outcome differences were found with prophylactic PPI. On multivariate analysis, predictors of the need for pacing included baseline long PR interval, and the use of newer generation valves.

Aortic stenosis (AS) is a common valvular pathology and is increasing in prevalence. Severe symptomatic AS is associated with serious outcomes if left untreated. Transcatheter aortic valve implantation (TAVI) is an innovative modality, which has revolutionized the treatment of AS. With growing experience and technological upgrades, TAVI has become a valid alternative to surgical valve replacement. However, TAVI is associates with increase non-negligible risks of mortality, stroke, physical disability, and healthcare expenditures. Furthermore, imaging modalities have shown new ischemic lesions in most patients following TAVI (silent strokes), which might be related to worse subsequent neurocognitive function. Embolic protective devices are emerging as a safe, technically feasible implements to reduce the burden of periprocedural thromboembolism, and have shown promising results of improved clinical outcomes.

Background: Access-site bleeding is a common complication of transfemoral transcatheter aortic valve implantation (TAVI). Percutaneous stent-graft implantation within the femoral artery may achieve hemostasis and avert the need for more invasive surgical vascular repair; however, failure to advance a guidewire antegradely via the injured vessel may preclude stent delivery. While retrograde stent-graft delivery from the distal vasculature may potentially enable percutaneous control of bleeding, this approach has not been reported.

Objectives: To assess the feasibility of a retrograde approach for stent-graft implantation in the treatment of access-site bleeding following transfemoral TAVI.

Methods: A prospective TAVI registry was analyzed. Of 349 patients who underwent TAVI, transfemoral access was used in 332 (95%). Access-site injury requiring stent-graft implantation occurred in 56 (17%). In four patients (7%), antegrade wiring across the site of vascular injury was not possible and a retrograde approach for stent delivery was used.

Results: Distal vascular access was achieved via the superficial femoral or profunda artery. Retrograde advancement of a polymer-coated 0.035” wire to the abdominal aorta, followed by stent-graft delivery to the common femoral artery, achieved hemostasis in all cases. During a median (interquartile range) follow-up period of 198 (618) days (range 46–2455) there were no deaths and no patient required additional vascular interventions.

Conclusions: A retrograde approach for stent-graft delivery is feasible and allows percutaneous treatment of a common femoral artery injury following TAVI in patients who are not suitable for the conventional antegrade approach.

Background: Pacemaker pocket early post-implantation inflammation (EPII) is defined as clinical signs of local erythema without any systemic signs of infection occurring early after implantation. Data on the best treatment regimen for apparent superficial EPII is scarce. 

Objectives: To investigate the prognostic value of medical treatment, rather than extraction surgery, in patients with EPII. 

Methods: Data from 6013 consecutive patients who underwent cardiac implantable electronic device (CIED) implantation or replacement from 2007–2015 were retrospectively analyzed; 40 (0.7%) presented with EPII. Our goal was the absence of major complications and to avoidance of extraction. 

Results: Patients with EPII were initially treated medically. Nineteen (47%) (group A) recovered with antibiotic treatment only. In the other 21 patients (53%) (group B), CIED extraction was performed. Group B had more major complications compared to group A (15 [71%] vs. 0 [0%], P < 0.001). The only significant difference in baseline characteristics was history of non-initial procedure. While 86% of group B patients had a previous non-initial procedure, only 53% of group A patients underwent previous replacement (P < 0.05). In multivariate analysis, previous non-initial procedure was the only predictor for need of extraction at 1 year, hazard ratio 3.5, 95% confidence interval 1.001–11.73, P < 0.05.

Conclusions: Conservative treatment in patients with EPII after non-initial procedure can lead to serious adverse events resulting in the need for extraction. Close follow-up and aggressive treatment should be considered early in the therapeutic course.

Background: Transcatheter tricuspid valve-in-valve implantation (TVIV) is an attractive yet under-explored alternative to redo valve surgery. 

Objectives: To report the multicenter TVIV experience in Israel.

Methods: We approached multiple centers and collected data regarding seven TVIV cases. 

Results: The study group comprised seven participants: five females and two males, with a mean age of 63 ± 12 years and EuroSCORE-II 13.6 ± 3.3%. Follow-up ranged from 3 to 21 months (mean 8 ± 6 months). All presented with advanced heart failure. The indication for valve intervention was a predominant tricuspid stenosis in three patients, significant tricuspid regurgitation in one and a mixture in three. Six procedures were conducted via a transfemoral approach and one by transatrial access. The Edwards SAPIENTM XT valve was used in four cases and the SAPIENTM 3 in three. Without pre-stenting/rapid pacing, all participants underwent successful valve implantation. Mean transvalvular gradient decreased from 11 ± 3 mmHg to 6 ± 3 mmHg (P = 0.003) and regurgitation decreased from moderate/severe (in four cases) to none/trace (in six of the seven cases). One patient remained severely symptomatic and died 3.5 months after the implantation. All others achieved a functional capacity improvement and amelioration of symptoms soon after the implantation, which persisted during follow-up. 

Conclusions: TVIV may be a safe and effective strategy to treat carefully selected patients with degenerated bioprosthetic tricuspid valve at high operative risk. 

 

Background: Syncope prognosis varies widely: 1 year mortality may range from 0% in the case of vasovagal events up to 30% in the presence of heart disease. 

Objectives: To assess the outcomes and prognosis of patients with implantable cardiac defibrillator (ICD) and indication of primary prevention and compare patients presenting with or without prior syncope.

Methods: We reviewed the charts of 75 patients who underwent ICD implantation with the indication of primary prevention and history of syncope and compared them to a control group of 80 patients without prior syncope. We assessed the number of ventricular tachycardia (VT), ventricular fibrillation (VF), shock, anti-tachycardia pacing (ATP), and death in each group during the follow-up.

Results: Mean follow-up was 893 days (810–976, 95% confidence interval) (no difference between groups). Patients with prior syncope had a higher ejection fraction (EF) (35.5 ± 12.6 vs. 31.4 ± 8.76, P = 0.02), more episodes of VT (21.3% vs. 3.8%, P = 0.001) and VF (8% vs. 0%, P = 0.01) and also received more electric shocks (18.7% vs. 3.8%, P = 0.004) and ATP (17.3% vs. 6.2%, P = 0.031). There were no differences in inappropriate shocks (6.7% vs. 5%, P = 0.74), in cardiovascular mortality (cumulative 5 year estimate 29.9% vs. 32.2% P = 0.97) and any death (cumulative 5 year estimate 38.1% vs. 48.9% P = 0.18) during the follow-up.

Conclusions: Syncopal patients before ICD implantation seem to have more episodes of VT/VF and shock or ATP. No mortality differences were observed