Israel Medical Association Journal

Background: Cardiac implantable electronic devices (CIEDs) are increasingly being used; thus, there is an increasing need for transvenous lead extraction (TLE).

Objectives: To summarize our experience with TLE at single referral center in northern Israel.

Methods: The study included all patients who underwent TLE at our center between 2019 and 2022, regardless of the indication.

Results: The cohort included 50 patients. The mean age was 69 ± 10.36 years; 78% were males. A total of 99 electrodes were targeted. The mean number of electrodes was 1.96 (range 1–4) per patient. The time between lead implantation and extraction ranged between 1.1 and 34 years with an average of 8.14 ± 5.71 years (median of 7.5 years). Complete lead removal was achieved in 98% of patients and in 98.99% of leads. The complete procedural success rate as well as the clinical procedural success rate was 96%. The procedural failure rate was 4% (1 patient died 2 days after the index procedure and 1 patient remained with large portion of lead). The indication for TLE was infection in 78% of the cohort group. Powered mechanical sheaths were used in 36 patients (72%), laser sheaths in 27 (54%), and a combination of laser and mechanical sheaths in 16 (32%).

Conclusions: The clinical and procedural success rates of TLE, primarily for CEID-related infection, were high. A combination of laser and mechanical sheaths was needed in one-third of patients.

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.

Despite recent advances in the pharmacological and endoscopic treatments for obesity, bariatric surgery is still considered one of the most effective and safe treatments for morbid obesity with over 250,000 bariatric procedures performed each year in the United States. While these procedures are considered safe, they are not free of complications. It has been reported that the primary short-term major complication after Roux-en-Y gastric bypass (RYGB), one-anastomosis (Mini) gastric bypass (OAGB), or sleeve gastrectomy (SG) is gastrointestinal leakage, with a reported leak rate of 0.1–8.3%, 0–5.1%, and 0–7%, respectively [1,2]. While the etiology of gastrointestinal leakage following bariatric procedure is multifactorial, including preoperative, intraoperative, and postoperative factors, a single factor can rarely be attributed to this misfortunate complication. We describe a case of a 30-year-old woman who presented on postoperative day (POD) 10 of a OAGB with a gastrointestinal leakage after treated with a high dose of oral misoprostol.

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: Falls are a common complication in persons with stroke (PwS). Reliable assessment of balance responses to unexpected loss of balance has the potential to identify risk for falls. 

Objectives: To examine inter-observer reliability of balance responses to unannounced surface perturbations in PwS and to explore the concurrent validity of a balance recovery assessment protocol.

Methods: Two observers evaluated balance recovery strategies and fall threshold (a fall into a harness system) in 15 PwS and 15 healthy adults who were exposed to forward, backward, right, and left unannounced surface translations in six increasing intensities while standing. 

Results: Observer agreement was 100% for the fall threshold. Kappa coefficients for step strategies were 0.960–0.988 in PwS and 0.886–0.938 in healthy adults, 0.905–0.988 for arm reactions in PwS and 0.754–0.926 in healthy adults. Significant correlations were found between fall threshold and Berg Balance Scale (r = 0.691), 6-minute walk test (r = 0.599), and fall efficacy scale-international (r= -0.581). 

Conclusions: A trained examiner can reliably classify reactive balance responses to surface perturbations. The high frequency of falls observed in PwS highlights the importance of assessing reactive balance responses to different directions and intensities of surface translations.

Background: Heart transplantation (HT) is the treatment of choice for patients with end-stage heart failure. The HT unit at the Sheba Medical Center is the largest of its kind in Israel.

Objectives: To evaluate the experience of HT at a single center, assess trends over 3 decades, and correlate with worldwide data.

Methods: Between 1990 and 2017, we reviewed all 285  adult HT patients. Patients were grouped by year of HT: 1990–1999 (decade 1), 2000–2009 (decade 2), and 2010–2017 (decade 3).

Results: The percentage of women undergoing HT has increased and etiology has shifted from ischemic to non-ischemic cardiomyopathy (10% vs. 25%, P = 0.033; 70% vs. 40% ischemic, for decades 1 vs. 3, respectively). Implantation of left ventricular assist device as a bridge to HT has increased. Metabolic profile has improved over the years with lower low-density lipoprotein, diabetes, and hypertension after HT (101 mg/dl, 27%, and 41% at decade 3, respectively). There has been a prominent change in immunosuppressive treatments, currently more than 90% are treated with tacrolimus, compared with 2.7% and 30.9% in decades 1 and 2, respectively (P < 0.001). Cardiac allograft vasculopathy (CAV) rates have declined significantly (47% vs. 17.5% for decades 1 and 2, P < 0.001) as have the combined endpoint of CAV/death. Similarly, the current incidence of acute rejections is significantly lower.

Conclusions: Our analysis of over 25 years of a single-center experience with HT shows encouraging improved results, which are in line with worldwide standards and experience.

Background: Postpericardiotomy syndrome (PPS) is characterized by pleuro-pericardial inflammation, which occurs in patients undergoing surgical procedures involving the pleura, pericardium, or both. The syndrome is considered to be immune mediated. However, its pathogenesis is not fully understood. It has previously been demonstrated that the Mediterranean Fever (MEFV) gene, which is associated with familial Mediterranean fever (FMF), has a role in the activation and expression of several inflammatory diseases.

Objectives: To investigate whether carriage of the MEFV mutation may precipitate PPS or affect its phenotype.

Methods: The study population included 45 patients who underwent cardiac surgery and developed PPS. The control group was comprised of 41 patients who did not develop PPS. Clinical and demographic data was collected. The severity of PPS was evaluated. Genetic analysis to determine the carriage of one the three most common MEFV gene mutations (M694V, V726A, E148Q) was performed. The carriage rate of MEFV mutations in patients with and without PPS was compared. Association between MEFV mutation carriage and severity of PPS was evaluated. 

Results: The rate of mutation carriage in the MEFV gene was similar in patients with and without PPS (15.6% in the study groups vs. 29.3% in the control group, P = 0.1937). The rate of mutation carriage in the MEFV gene was significantly lower among patients with severe PPS as compared to patients with mild-moderate PPS (4.8% vs. 25%, P < 0.05).

Conclusions: Carriage of mutations in the MEFV gene is not associated with development of PPS; however, it may affect PPS severity.

 

Background: Prolonged life expectancy has increased the number of elderly high risk patients referred for surgical aortic valve replacement (AVR). These referred high risk patients may benefit from sutureless bioprosthesis procedures which reduce mortality and morbidity.

Objectives: To present our initial experience with sutureless aortic bioprotheses, including clinical and echocardiographic results, in elderly high risk patients referred for AVR. 

Methods: Forty patients (15 males, mean age 78 ± 7 years) with symptomatic severe aortic stenosis underwent AVR with the 3F Enable™ or Perceval™ sutureless bioprosthesis during the period December 2012 to May 2014. Mean logistic EuroScore was 10 ± 3%. Echocardiography was performed preoperatively, intraoperatively, at discharge and at follow-up.

Results: There was no in-hospital mortality. Nine patients (22%) underwent minimally invasive AVR via a right anterior mini-thoracotomy and one patient via a J-incision. Four patients underwent concomitant coronary aortic bypass graft, two needed intraoperative repositioning of the valve, one underwent valve exchange due to inappropriate sizing, three (7.5%) had a perioperative stroke with complete resolution of neurologic symptoms, and one patient (2.5%) required permanent pacemaker implantation due to complete atrioventricular block. Mean preoperative and postoperative gradients were 44 ± 14 and 13 ± 5 mmHg, respectively. At follow-up, 82% of patients were in New York Heart Association functional class I and II.

Conclusions: Sutureless AVR can be used safely in elderly high risk patients with relatively low morbidity and mortality. The device can be safely implanted via a minimally invasive incision. Mid-term hemodynamic results are satisfactory, demonstrating significant clinical improvement.

 

Background: The rate of mitral bioprosthesis implantation in clinical practice is increasing. Transcatheter valve-in-valve implantation has been described for high risk patients requiring redo valve surgery. 

Objectives: To report our experience with transapical valve-in-valve implantation for failed mitral bioprosthesis.

Methods: Since 2010, 10 patients have undergone transapical valve-in-valve implantation for failed bioprosthesis in our center. Aortic valve-in-valve implantation was performed in one of them and mitral valve-in-valve implantation in nine. Mean age was 82 ± 4 years and 6 were female (67%). Mean time from original mitral valve (MV) replacement to valve-in-valve procedure was 10.5 ± 3.7 years. Follow-up was completed by all patients with a mean duration of 13 ± 12 months. 

Results: Preoperatively, all patients presented with significant mitral regurgitation; two with mitral stenosis due to structural valve failure. All nine patients underwent successful transapical valve-in-valve implantation with an Edwards Sapien™ balloon expandable valve. There was no in-hospital mortality. Mean and median hospital duration was 15 ± 18 and 7 days respectively. Valve implantation was successful in all patients and there were no major complications, except for major femoral access bleeding in one patient. At last follow-up, all patients were alive and in NYHA functional class I or II. Echocardiography follow-up demonstrated that mitral regurgitation was absent or trivial in seven patients and mild in two. At follow-up, peak and mean gradients changed from 26 ± 4 and 8 ± 2 at baseline to 16.7 ± 3 and 7.3 ± 1.5, respectively.

Conclusions: Transcatheter transapical mitral valve-in-valve implantation for failed bioprosthesis is feasible in selected high risk patients. Our early experience with this strategy is encouraging. Larger randomized trials with long-term clinical and echocardiographic follow-up are recommended.

 

Methods:  Between February 2004 and June 2012, 100 patients in our department suffering from aortic aneurysm with aortic valve regurgitation underwent elective aortic valve-sparing surgery. Of them, 30 had Marfan syndrome, were significantly younger (30 ± 13 vs. 53 ± 16 years), and had a higher percentage of root aneurysm, compared with ascending aorta aneurysm in their non-Marfan counterparts. We evaluated the safety, durability, clinical and echocardiographic mid-term results of these patients.

Results: While no early deaths were reported in either group, there were a few major early complications in both groups. At follow-up (ranging up to 8 years with a mean of 34 ± 26 months) there were no late deaths, and few major late complications in the Marfan group. Altogether, 96% and 78% of the patients were in New York Heart Association functional class I-II in the Marfan and non-Marfan groups respectively. None of the Marfan patients needed reoperation on the aortic valve. Freedom from recurrent aortic valve regurgitation > 3+ was 94% in the Marfan patients.

Conclusions: Aortic valve-sparing surgery in Marfan symdrome patients is safe and yields good mid-term clinical outcomes.

Background: Major changes in the evaluation and treatment of curable colorectal cancer (CRC) have emerged in the last two decades. These changes have led to better patient outcome over time.

Objectives: To evaluate the impact of these changes as reflected in the difference in long-term outcome of a consecutive group of recently laparoscopically operated curable CRC[1] patients and a consecutive group of patients operated 20 years earlier in the same department.

Methods: Data of the new group were taken from our prospectively collected data of patients who underwent elective laparoscopic surgery for CRC in recent years. Data regarding patients operated on 20 years ago were retrieved from previous prospectively collected data on the long-term survival of CRC patients operated in the same department.

Results: The recently operated group comprised 203 patients and the previous group 199 patients. Perioperative mortality was 0.5% in the new group versus 1.5% in the old group (not significant). There were more early-stage and more proximal tumors in the recently operated group. A Kaplan-Meier 5-year survival analysis revealed no difference between stage I patients of the two groups. However, there was a significant increase in 5-year survival in the new group for stage II (85% vs. 63%, P = 0.004) and for stage III patients (57% vs. 39%, P = 0.01). This trend was maintained after removing the rectal cancer patients from the calculated data.

Conclusions: We have demonstrated improved survival for stage II and III CRC patients over a 20-year period in the same medical center. This change most likely reflects advances both in imaging techniques leading to more accurate staging and in adjuvant treatments.

Background: Gunshot wounds impose a continuous burden on community and hospital resources. Gunshot injuries to the extremities might involve complex soft tissue, bone, vascular, musculotendinous, and nerve injuries. A precise knowledge of anatomy is needed to evaluate and treat those injuries.

Objectives: To review our experience with gunshot wounds to the extremities.

Methods: We retrospectively reviewed all cases of gunshot wounds to the limbs in a civilian setting treated in our institution during 2003–2005. Altogether, we evaluated 60 patients with 77 injuries.

Results: Of the 60 patients 36 had fractures, 75% of them in the lower extremity and 81% in long bones. The most common fixation modality used was external fixation (33%), followed by intramedullary nailing (25%). This relatively high percentage of fracture treated with external fixation may be attributed to the comminuted pattern of the fractures, the general status of the patient, or the local soft tissue problems encountered in gunshot wounds. About one-fifth of the fractures were treated by debridement only without hardware fixation. We treated 10 vascular injuries in 8 patients; 6 of them were injuries to the popliteal vessels. Fractures around the knee comprised the highest risk factor for vascular injuries, since 5 of the 12 fractures around the knee were associated with vascular injury requiring repair or reconstruction. There were 13 nerve injuries (16.8%), most of them of the deep peroneal nerve (38%). Only three patients had concomitant nerve and vascular injuries. The overall direct complication rate in our series was 20%.

Conclusions: Treating complex gunshot injuries requires a team approach, necessary for a favorable outcome. This team should be led by an orthopedic surgeon knowledgeable in the functional anatomy of the limbs.
 

Background: Prematurity remains the most significant cause of neonatal morbidity and mortality. Knowing which group of women is at risk for developing preterm labor will define a target population for better prenatal care and prevention modalities.

Objective: To examine whether preterm delivery rates are associated with ethnicity, age, parity, and style of living.

Methods: We conducted a longitudinal case series examining obstetric and demographic data of 17,493 deliveries that occurred between June 1994 and May 1999. All deliveries were performed in the obstetric department of HaEmek Medical Center (Afula, Israel), which serves as a referral center. The main outcome measures were preterm delivery, as related to the women's ethnicity, age parity, and style of living ± namely, town, village, or kibbutz.

Results: The overall preterm delivery rate was 8.5%. The preterm delivery rate in non-Jewish women (10.5%) was higher than in Jewish women (7.1%) (P < 0.00001). The preterm delivery rate in women younger than 20 or older than 40 (12.5%) was much higher than in women between the ages of 21 and 40 (8.0%) (P< 0.00001). Grand-multipara women (>8) had a higher preterm delivery rate (13.8%) than less parous women (8.5%) (P < 0.012). Style of living was also associated with the preterm delivery rate (P< 0.00001): kibbutz 5.5%, Jewish towns 7.8%, non-Jewish towns 8.7%, Jewish villages 6.7%, and non-Jewish villages 11.0%.

Conclusions: Style of living, ethnicity, age and parity are statistically significant risk factors for preterm delivery in our area. These factors provide a more definable target population for better prenatal care.
 

Background: Pregnant diabetic women are often subjected to frequent and prolonged hospitalizations to assure tight glycemic control, but in recent years attempts have been made at ambulatory control. The financial and social advantages of ambulatory management are obvious, but no report to date has prospectively compared its efficacy with that of hospitalization.

Objectives: To evaluate the efficacy and cost of ambulatory care as compared to repeated hospitalizations for management of diabetes in pregnancy.

Methods: We conducted an 8 year prospective controlled study that included 681 diabetic women, experiencing 801 singleton pregnancies, with commencement of therapy prior to 34 gestational weeks. During 1986–1989, 394 pregnancies (60 pre-gestational diabetes mellitus and 334 gestational diabetes mellitus) were managed by hospitalization, and for the period 1990–1993, 407 pregnancies (61 PGDM and 346 GDM) were managed ambulatorily. Glycemic control, maternal complications, perinatal mortality, neonatal morbidity and hospital cost were analyzed.

Results: There was no difference in metabolic control and pregnancy outcome in women with PGDM between the hospitalized and the ambulatory groups. Patients with GDM who were managed ambulatorily had significantly lower mean capillary glucose levels, later delivery and higher gestational age at induction of labor as compared to their hospitalized counterparts. In this group there were also lower rates of neonatal hyperbilirubinemia, phototherapy and intensive care unit admissions and stay. The saved hospital cost (in Israeli prices) in the ambulatory group was $6,000 and $15,000 per GDM and PGDM pregnancy, respectively.

Conclusions: Ambulatory care is as effective as hospitalization among PGDM patients and more effective among GDM patients with regard to glycemic control and neonatal morbidity. This is not only more convenient for the pregnant diabetic patient, but significantly reduces treatment costs.
 

Background: Concern about the side effects of allogeneic blood transfusion has led to an increased interest in methods of minimizing peri-operative transfusion. Technologies to minimize allogeneic transfusion include drugs such as aprotinin, desmopressin, tranexamic acid and erythropoietin, and techniques such as acute normovolemic hemodilution, cell salvage and autologous pre-donation.

Objective: To survey the current use in Israel of these seven technologies used to minimize allogeneic blood transfusion.

Methods: Our survey was conducted in 1996–97 in all hospitals in Israel with more than 50 beds and at least one of the following departments: cardiac or vascular surgery, orthopedics, or urology. All departments surveyed were asked: a) whether the technologies were currently being used or not, b) the degree of use, and c) the factors influencing their use and non-use. The survey was targeted at the heads of these departments.

Results: Pharmaceuticals to reduce allogeneic blood transfusion were used in a much higher proportion in cardiac surgery departments than in the other three departments. Pre-operative blood donation was used in few of the cardiac, urologic and vascular surgery departments compared to its moderate use in orthopedic departments. The use of acute normovolemic hemodilution was reported in a majority of the cardiac departments only. Moderate use of cell salvage was reported in all departments except urology where it was not used at all.

Conclusion: There is considerable practice variation in the use of technologies to minimize exposure to peri-operative allogeneic blood transfusion in Israel.