Augmented trabeculectomy-outcomes of first hundred versus second hundred surgeries of a fellowship-trained glaucoma surgeon

2021 ◽  
pp. 112067212199827
Author(s):  
Pornjittra Rattanasirivilai ◽  
Zaria Christine Ali ◽  
Dawnn Ira Khoo ◽  
Vikas Shankar
Keyword(s):  
Statistical Difference ◽  
Secondary Outcome ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Patient Groups ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Purpose: We aim to compare the outcomes of trabeculectomy with mitomycin-C by a fellowship-trained glaucoma surgeon in the first hundred compared to second hundred surgeries. Patients and methods: Retrospective review of 200 consecutive surgeries from May 2015 to January 2017. Primary outcomes were intraocular pressure (IOP) control and use of IOP-lowering medications. Success between first hundred (Group 1) and second hundred (Group 2) patients were reported using World Glaucoma Association guidelines. Kaplan-Meier survival demonstrated complete success and qualified success. Secondary outcome measures were postoperative complications, bleb interventions and additional procedures. Results: We found no statistical difference between the first hundred and second hundred patient’s postoperative IOP at week 4 ( p = 0.17), 3 months ( p = 0.74), 6 months ( p = 0.46), 12 months ( p = 0.47), 18 months ( p = 0.13) or at final follow up ( p = 0.53). The mean final follow up period was 3.6 ± 0.7 years. Mean IOP reduction in Group 1 was from 27.1 ± 10.8 to 12.6 ± 7.1 ( p < 0.0001) and Group 2 from 22.8 ± 8.4 to 11.3 ± 4.2 ( p < 0.0001). Kaplan-Meier graphs showed no significant difference in complete success ( p = 0.0693) or qualified success ( p = 0.0866) between Group 1 and Group 2. Bleb interventions were not statistically significant between two groups. There was a significantly higher rate of complications with the first hundred patients ( p < 0.0001). Conclusion: Both first hundred and second hundred patient groups achieved statistically similar outcomes in long term IOP control. Significant reduction of complications was achieved in the second group of patients.

scholarly journals Comparison of Changes in Number of Hyperreflective Dots After İntravitreal Ranibizumab or Dexamethasone İmplant in Patients with Branch Retinal Vein Occlusion

2021 ◽  
Author(s):  
Aylin Karalezli ◽  
Sema Kaderli ◽  
Ahmet Kaderli ◽  
Cansu Kaya ◽  
Sabahattin Sul
Keyword(s):  
First Year ◽  
Intravitreal Ranibizumab ◽  
Retinal Layers ◽  
Vein Occlusion ◽  
Significant Difference ◽  
Group 3 ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Abstract Purpose: To compare the effect of intravitreal ranibizumab (IVR) or intravitreal dexamethasone implants (IVD) on regression of hyperreflective dots (HRDs) on optical coherence tomography (OCT) B-scan in patients with branch retinal vein occlusion (BRVO). Methods: 37 eyes of 37 patients with cystoid macular edema who received IVR or IVD and followed up for at least 12 months were included in this study. The patients were divided into three groups according to intravitreal treatment. Group 1 consisted of 12 eyes who received only IVD, group 2 consisted of 10 eyes who received only IVR on a pro re nata and group 3 consisted of 15 eyes who received both IVD and IVR. OCT parameters (CMT, number of HRDs, status of external limiting membrane (ELM) and ellipsoid zone (EZ)) and best-corrected visual acuity (BCVA) were compared between the groups over the follow-up time. HRDs were categorized as HRD in inner retinal layers (from the internal limiting membrane to the inner nuclear layer) or HRD in outer retinal layers (from the outer plexiform layer to the outer border of the photoreceptor layer).Results: There was no significant difference between groups in terms of BCVA, CMT, HRDs in the inner and the outer retinal layers at baseline visit. (p˃0.05 for all) Comparing the baseline values in all groups, a significant decrease was observed in CMT in the first year. (For group 1; p=0.013, group 2; p=0.010; group 3, p<0.001) The BCVA was significantly increased after 1 year in all groups. (p=0.001, p=0.006, p<0.001) The mean number of HRDs in inner and outer retinal layers were significantly decreased in group 1 and group 3. (For group 1; p<0.001, p=0.001, for group 3; p<0.001, p<0.001) However, there was no significant difference in terms of the mean number of HRDs in inner and outer retinal layers for group 2. (p=0.134, p=0.477) At the first year, the number of HRDs in inner and outer retinal layers was significantly lower in group 1 and group 3 than group 2. (For inner HRDs; group 1 vs. group 2 p=0.007, group 2 vs. group 3 p<0.001. For outer HRDs group 1 vs. group 2 p<0.001, group 2 vs. group 3 p<0.001.) The BCVA was higher in group 3 than group 2 at 1year. (p=0.048). There was no significant difference in terms of post-treatment CMT and the number of HRDs between group 1 and group3 in posthoc tests (p=0.621, p=0.876, and p=0.632).Conclusion: The reduction in HRDs at 12 months and better BCVA after IVD intimates that the HRDs should be considered as inflammatory markers in the follow-up of CME in BRVO. Thus, IVD injection could be more appropriate for patients with higher HRDs after BRVO.

Application of femtolaser-assisted phacoemulsification in combined pathology of cataract and glaucoma

2021 ◽  
pp. 18-21
Author(s):  
A.P. Voznyuk ◽  
◽  
S.I. Anisimov ◽  
S.Y. Anisimova ◽  
L.L. Arutyunyan ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Biomechanical Properties ◽  
Mean Values ◽  
Long Term Follow Up ◽  
The Mean ◽  
Group 2 ◽  
Observation Period ◽  
Group 1

Purpose. To evaluate the efficacy and safety of femtolaser-assisted phacoemulsification in glaucomatous eyes in the long-term follow-up. Materials and methods. A retrospective analysis of the results of the surgical treatment of patients with combined cataract and glaucoma pathology was analyzed. The patients were divided into groups depending on the method of surgical intervention: 1) phacoemulsification with femtolaser support (26 eyes, 23 patients); 2) phacoemulsification (36 eyes, 30 patients); Results. Before surgery, there were no statistically significant differences in IOP and corneal hysteresis (СН) between groups 1 and 2. The mean values of IOP cc, IOP g and СН of group 1 before surgery were 22.7±6.1 mm Hg, 20.9±6.9 mm Hg, 8.5±1.6 mm Hg; 2 group – 22.9±8.7 mm Hg, 21.6±8.9 mm Hg, 8.9±1.6 mm Hg respectively. Average values of IOP cc, IOP g and CН 5 years after the surgical treatment in group 1 were 15.3±1.2 mm Hg, 14.4±3.4 mm Hg, 9.6±4.2 mm Hg; in group 2 – 18.0±4.2 mm Hg, 16.1±4.2 mm Hg, 8.8±2.2 mm Hg respectively. In both groups, stabilization of IOP and CH indices was noted, which remained throughout the entire observation period, which shows the normalization of the biomechanical properties of the corneoscleral membrane of the eye in the long-term postoperative period. Conclusion. Femtolaser accompaniment of phacoemulsification is an effective and safe method of cataract surgery for combined pathology. Key words: femtolaser, cataract, glaucoma, phacoemulsification.

scholarly journals Exercise in a Healthy Heart Program: A Cohort Study

2013 ◽  
Vol 7 ◽  
pp. CMC.S12654 ◽  
Author(s):  
J. Meikle ◽  
A. Al-Sarraf ◽  
M. Li ◽  
K. Grierson ◽  
J. Frohlich
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Lipid Profile ◽  
Retrospective Chart Review ◽  
Secondary Outcome ◽  
The Mean ◽  
Group 2 ◽  
Prevention Clinic ◽  
Group 1

Objective To assess the effects of exercise on resting heart rate (RHR), weight, lipid profile, and blood pressure. We hypothesized that the participants who increased their physical activity would show improvement in their cardiovascular risk factors compared to those who did not. Design Retrospective chart review over the mean duration of 4.9 years of follow-up. Setting Healthy Heart Program Prevention Clinic at St. Paul's Hospital, Vancouver, British Columbia, Canada. Participants We reviewed 300 charts of patients randomly selected from those who attended the Prevention Clinic between 1984 and 2009. 248 (82.7%) patients were referred for primary prevention and 52 (17.3%) for secondary prevention. Primary and secondary outcome measures Weight, RHR, lipid profile, and blood pressure were recorded at the initial and last visit. Results During a mean of 4.9 years of follow-up, 55% of participants improved their exercise. The mean decrease in the RHR for these patients (group 1) was 5.9 beats per minute (bpm) versus the mean increase of 0.3 bpm for the “no change” group (group 2) ( P < 0.01). The mean net weight increase in group 1 was 0.06 kg/year versus 0.25 kg/year in group 2. Because of medications, all patients had a significant improvement in their lipid profiles. Furthermore, there was a statistically significant greater reduction in Framingham Risk Score (FRS) in group 1 versus group 2 (11.8% versus 15.1%, P < 0.01). Conclusion Participation in the program significantly reduces modifiable risk factors for cardiovascular disease. Improved exercise regimen results in lower RHR and greater reduction in FRS. However, even in a Prevention Program, despite strong advocacy of the importance of exercise, a significant percentage of participants does not improve their exercise habits.

scholarly journals Long-term Analysis of Surgically Induced Astigmatism after Combined Vitrectomy and Cataract Surgery versus Cataract Surgery Alone

2021 ◽  
Vol 62 (8) ◽  
pp. 1029-1035
Author(s):  
Zee Yoon Byun ◽  
Jung Hyun Lee ◽  
Sang-Mok Lee ◽  
Daniel Duck-Jin Hwang
Keyword(s):  
Cataract Surgery ◽  
Significant Difference ◽  
Induced Astigmatism ◽  
The Mean ◽  
Group 2 ◽  
23 Gauge ◽  
Surgically Induced ◽  
Sutureless Vitrectomy ◽  
Group 1

Purpose: To compare the long-term changes in surgically induced astigmatism (SIA) in patients who underwent 23-gauge sutureless vitrectomy and cataract surgery together with patients who underwent cataract surgery only.Methods: We retrospectively reviewed SIA changes for 1 year after surgery in patients who received only cataract surgery using phacoemulsification (group 1) and patients who underwent 23-gauge sutureless vitrectomy and cataract surgery together (group 2). Flat keratometry (K1), steep keratometry (K2), and astigmatism axis were measured with automatic keratometry before and after the surgery. Vector analysis was used to calculate SIA at 1, 3, 6, and 12 months postoperatively. We then examined whether the SIA values at each time point were different between the two groups.Results: A total of 86 eyes were included in this study (group 1, n = 45; group 2, n = 41). The mean SIA values calculated at 1, 3, 6, and 12 months after surgery in group 1 were 0.83 ± 0.37, 0.69 ± 0.39, 0.60 ± 0.33, and 0.59 ± 0.33, respectively. In group 2, the values were 0.82 ± 0.47, 0.69 ± 0.38, 0.62 ± 0.28, and 0.61 ± 0.30, respectively. Over time, SIA decreased in both groups (all p < 0.001). There was no significant difference in the mean SIA between the two groups at each follow-up time point after surgery (p = 0.296, p = 0.728, p = 0.361, and p = 0.356, respectively).Conclusions: When 23-gauge sutureless vitrectomy and cataract surgery were performed together, the astigmatism change caused by surgery did not show a significant difference compared with that of the group who received cataract surgery only. Thus, 23-gauge sutureless vitrectomy may not significantly affect corneal astigmatism.

scholarly journals Spectral-Domain Optical Coherence Tomography and Multifocal Electroretinography Results in the Long-Term Follow-Up of Glaucoma Patients

2020 ◽  
pp. 22-32
Author(s):  
Ersan Cetınkaya ◽  
Sibel Inan ◽  
Kenan Yıgıt ◽  
Mehmet Cem Sabaner ◽  
Ümit Übeyt Inan
Keyword(s):  
Primary Open Angle Glaucoma ◽  
Early Stage ◽  
Open Angle Glaucoma ◽  
Implicit Time ◽  
Significant Difference ◽  
Long Term Follow Up ◽  
Group 2 ◽  
Group 1

Objective: To investigate the changes in macular retinal layers and panretinal neuroretinal functions in the long-term follow-up of patients with primary open-angle glaucoma. Materials and Methods: Forty-one patients diagnosed with primary open-angle glaucoma were followed up for 12 months. According to their mean deviation (MD) values), the patients were put into two groups as Group 1 with early stage glaucoma (MD≥-6) and Group 2 with middle-advanced stage glaucoma (MD<-6). Optical coherence tomography (OCT) and multifocal electroretinography (mfERG) were performed at the baseline and at the sixth- and 12th-month evaluations. The OCT, retinal layer and mfERG findings were compared between the two groups. Results: There was no statistically significant difference between the groups in terms of gender and age In Group 2, the mean baseline macula Retina Nerve Fiber Layer, Ganglion Cell Layer and Inner Pleksiform Layer measurements were lower in each quadrant compared to Group 1. Concerning progression in OCT measurements, there was no significant difference between the two groups. However, it was noteworthy that in Group 2, there was a decrease especially in the first and second ring amplitudes of the P1 and N2 waves and prolongation of the implicit time. At the 12-month evaluation, there was prolongation of the implicit time of the N1 wave and a decrease in the P1 wave amplitude in Group 1. Conclusion: Retinal layers are affected in patients with intermediate and advanced stage glaucoma. In the follow-up of early stage glaucoma patients, mfERG measurements can show damage that may occur.

scholarly journals P1112COMPARISON OF EFFICACY BETWEEN MAINTENANCE HEMODIALYSIS AND THEIR COMBINATION WITH HEMOPERFUSION IN PATIENTS UNDERGOING CHRONIC HEMODIALYSIS TREATMENT

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Amela Beciragic ◽  
Alma Mutevelic-Turkovic ◽  
Badema Äœengiä† Roljiä† ◽  
Fahrudin Masnic ◽  
Aida Coric ◽  
...  
Keyword(s):  
Statistical Difference ◽  
Combined Treatment ◽  
Serum Levels ◽  
Uremic Toxins ◽  
Maintenance Hemodialysis ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background and Aims The occurance of mid- and longterm uremic complications is related to the low clearance rate of middle and large molecule uremic toxins when hemodialysis (HD) alone is adopted. As the uremic toxins and their corresponding biological effects become increasingly clear, blood purification treatment that aims to remove these toxins, has developed from a stage of life-sustaining to improving the quality of life. The objective of this study was to evaluated demographic, clinical and laboratory data in patients who underwent the combination of maintenance hemodialysis with hemoperfusion (HP) and in those who recieved HD alone and to investigate whether this combination could improve the clearance rate of middle and large molecule uremic toxins. Method A total of 26 patients, who underwent routine hemodialysis, were assessed in this study. Those patients were randomly divided into three groups: Group 1 (7 patients) received combined treatment of HD with HP biweekly (HD 2 times a week with HD+HP once a week), whereas Group 2 (10 patients) was given HD with high flux dialyzer and Group 3 (9 patients) was given HD with low flux dialyzer 3 times a week. This study was followed for 4 months. Before and after the observational period demographic and clinical data were taken from the medical history and blood samples were taken for hemoglobin (Hb), iron (Fe), total iron binding capacity (TIBC), albumin (Alb), calcium (Ca), phosphorus (P04) and parathyroid hormone (PTH). Results This study included 13 female and 13 male patients with a mean age of 41, 62 + 11.12 and a mean dialysis duration of 62, 78+53, 33 months. When it comes to baseline characteristics, patients of the group 3 were significantly older than patients in other groups (p=0.001). At the end of the four months observation period, the same difference according to age was noticed (p=0.01). Also, HD+HP group had significantly higher values of TIBC (p=0.006) and significantly lower serum levels of P04 (p=0.001). EPO doses were very similar in group 1 and 2, but in group 3 there were noticeably lower than in those two groups but without a significant difference. The serum levels of albumin were higher in group 3 compared to the other two groups but also without statistical difference. No statistical difference between groups after the follow up period was observed in terms of Hb, Fe, PTH, Ca, BMI, duration of dialysis treatment and vascular access. When groups are viewed individually, in the HD+HP group serum P04 levels were significantly lower after the 4 months off the follow up period than it was at the beginning (p=0.031) and also TIBC was significantly higher (p=0.018). In group 2 the values of TIBC were significantly lower after the follow up period than it was at the beginning (p=0.025). No significant difference was noticed in group 3 but serum PTH levels tends to decrease after 4 months compared to baseline measurement. Conclusion This combination treatment of HD with HP was superior to HD in reducing levels of phosphorus. These findings suggests a potential role of reducing the risk of cardiovascular events in this population especially when it is known that hyperphosphatemia has been pointed out as the primary culprit in the process of cardiovascular calcification. Also, patients who underwent the combined treatment showed higher values of TIBC but unfortunately no difference was noticed between Hb levels and EPO doses. These results eventually demonstrates their role in the improvement of renal disease anemia, which opens up the possibility of further research on a larger sample and over a longer period of time.

scholarly journals The Comparison of Results of Early and Late Rehabilitation Following Arthroscopic Bankart Repair with Knotless Anchor in Recurrent Traumatic Anterior Shoulder Dislocation

2014 ◽  
Vol 2 (11_suppl3) ◽  
pp. 2325967114S0012
Author(s):  
Harun Kütahya ◽  
Mustafa Yel ◽  
Onur Bilge ◽  
Ali Güleç ◽  
Burkay Kutluhan Kaçıra ◽  
...  
Keyword(s):  
Shoulder Dislocation ◽  
External Rotation ◽  
Bankart Repair ◽  
Knotless Anchor ◽  
Arthroscopic Bankart Repair ◽  
Significant Difference ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Objectives: The aim of this study was to compare the clinical and functional results of early and late rehabilitation of patients who had undergone arthroscopic Bankart repair with knotless anchor for recurrent shoulder dislocation and to define the most appropriate rehabilitation time and the effect of this on recurrence. Methods: 34 patients (32 male and 2 female) were included in this study. The patients were diagnosed with recurrent anterior shoulder dislocation with Bankart lesion in our institution. The exclusion criteria in this study were multi-directional shoulder instability, wide osseous Bankart lesion, wide Hill-Sachs lesion or rotator cuff tear. All patients underwent arthroscopic Bankart repair. Knotless anchor was used in all patients. The patients were grouped into 2 groups postoperatively according to the immobilization period and rehabilitation regimen. Both groups equally consisted of 17 patients. (Group 1; early rehabilitation group, Group 2; late rehabilitation group) All patients were examined retrospectively. Gender, age, dislocated side, dominant hand, recurrence, presence of additional pathologies, time of first and last dislocations preoperatively and numbers of dislocations were the demographic data recorded. At the final follow-up; the restriction in external rotation was measured by comparative goniometry and clinical evaluation was made using the Constant and Rowe scores. One-sample T-test, Mann-Whitney U Test, Crosstabs Chi Square Test and Shapiro-Wilk Tests used for statistical analysis. Results: The mean age of the patients in Group 1 was found to be 25.1 ± 6.5 ( 17-43) years and in Group 2, 30.8 ± 6.8 (21-46) years. After a mean follow-up period of 14.7 months, no patients in Group 1 experienced a recurrence, whereas in Group 2 over the mean follow-up period of 38.5 months, there was dislocation, following episodes of subluxation, in only 1 patient (5.8%). When the parameters of first dislocation, last dislocation and number of dislocations were evaluated separately in two groups, no statistical difference was observed between the groups in the relevant parameters (n.s.). A statistically significant difference was determined between the groups in respect to the restriction in external rotation (p<0.05). There was no statistically significant difference between the groups in respect to the Constant and Rowe scores (n.s.). Conclusion: The most important result of this study was that the early beginning of rehabilitation yielded less external rotation restriction than late beginning of rehabilitation. The absence of recurrence in the group of early beginning of rehabilitation reminds the question “does early rehabilitation reduce recurrence rates?” The findings in this study should be confirmed with further prospective, randomized and longer follow-up studies.

The effectiveness of different treatment methods in isolated telangiectasia and reticular vein treatment: A single-center prospective randomized study

2021 ◽  
pp. 026835552110307
Author(s):  
Ufuk Aydın ◽  
Mesut Engin ◽  
Tamer Türk ◽  
Yusuf Ata
Keyword(s):  
Medical Treatment ◽  
Randomized Study ◽  
Significant Difference ◽  
Patient Groups ◽  
Group 3 ◽  
The Mean ◽  
Group 2 ◽  
Reticular Veins ◽  
Group 1

Background There are opinions that telangiectasis and reticular veins are asymptomatic and constitute a cosmetic problem only. However, it has been proven that telangiectasis and reticular veins also affect the quality of life and are symptomatic. Methods Ninety consecutive female patients who were admitted to our outpatient clinic and did not have insufficiency in deep, superficial and perforating veins were included in this study. All participants were divided into three groups as the compression group (Group 1), medical treatment group (Group 2), and sclerotherapy group (Group 3). The initial complaint severities of all patients were noted. Except for patient compliance assessment, baseline, 1st month (T1), 3rd month (T2) and 6th month (T3) evaluation records were kept in all three groups. Results The study began with a total of 90 patients, 30 patients in each group. The mean ages of Groups 1, 2 and 3 were 39.73 ± 8.51 years, 39.30 ± 8.67 years, and 40.77 ± 9.45 years, respectively. The rates of decrease in pain, itching, restless leg, and muscle cramps were similar among the patient groups at all times (P > 0.05). The rate of reduction in swelling was similar between the groups at T1 and T2 (P > 0.05), while there was a significant difference between the groups at T3 (P = 0.009). The groups significantly differed in terms of appearance concern at all times (P = 0.002 for T1, P < 0.001 for T2 and T3). Conclusion We showed that symptoms such as swelling and heaviness in leg can be improved with medical treatment, but the patient's cosmetic satisfaction can increase with sclerotherapy.

Multilevel anterior cervical discectomy and fusion with and without rhBMP-2: a comparison of dysphagia rates and outcomes in 150 patients

2013 ◽  
Vol 18 (1) ◽  
pp. 43-49 ◽  
Author(s):  
Daniel C. Lu ◽  
Luis M. Tumialán ◽  
Dean Chou
Keyword(s):  
Group Versus ◽  
Anterior Cervical Discectomy ◽  
Bone Morphogenetic Protein 2 ◽  
Cervical Discectomy ◽  
Dysphagia Score ◽  
Significant Difference ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Object Reported complications of recombinant human bone morphogenetic protein–2 (rhBMP-2) use in anterior cervical discectomy and fusion (ACDF) cases include dysphagia and cervical swelling. However, dysphagia often occurs after multilevel ACDF procedures performed with allograft (without BMP) as well. To date, there has been no large study comparing the dysphagia rates of patients who have undergone multilevel ACDF using allograft spacers with those who underwent ACDF using polyetheretherketone (PEEK) cages filled with rhBMP2. The authors report one of the first such comparisons between these 2 patient cohorts. Methods The authors retrospectively reviewed 150 patient records. Group 1 (BMP group) consisted of 100 patients who underwent multilevel ACDF with PEEK cages filled with rhBMP-2 and instrumented with a cervical plate. Group 2 (allograft group) included a matched control cohort of 50 patients who underwent multilevel ACDF with allograft spacers and anterior plate fixation (without rhBMP-2). Patient demographics were not significantly different between the groups. Fusion was assessed by means of dynamic radiographs and/or CT at routine intervals. Complications, dysphagia incidence, standardized dysphagia score, Nurick grades, and fusion rates were assessed. Results The mean follow-up for the BMP group (Group 1) was 35 months while the mean follow-up for the allograft group (Group 2) was 25 months. There was a complication rate of 13% in the BMP group compared with 8% in the allograft group (p < 0.005). There was no significant difference in overall dysphagia incidence between the BMP group and the allograft group (40% vs 44%, respectively; p > 0.05). However, there was a significant difference in the severity of dysphagia (using the SWAL-QOL dysphagia scoring system) between the 2 groups: 0.757 for the BMP group versus 0.596 for the allograft group (p < 0.005). In subgroup analysis, the use of rhBMP-2 significantly increased the severity of dysphagia in patients undergoing 2-level ACDF (p < 0.005). However, the severity of dysphagia did not differ significantly between groups when 3- or 4-level ACDF cases were compared. There was no pseudarthrosis in Group 1 (the BMP group) compared with a 16% pseudarthrosis rate in Group 2 (the allograft group) (p < 0.05). There was a weak correlation between the total rhBMP-2 dose and the dysphagia score (Kendall tau rank correlation coefficient 0.166, p = 0.046). Conclusions The use of rhBMP-2 in patients undergoing 2-level ACDF significantly increases the severity of dysphagia (dysphagia score) without affecting the overall incidence of dysphagia. However, there is no statistically significant difference in the incidence or severity of dysphagia between patients undergoing 3-level or 4-level ACDF treated with PEEK/rhBMP-2 and those treated with only allograft. The use of rhBMP-2 appears to reduce the risk of pseudarthrosis. This benefit is most pronounced in patients who undergo 4-level ACDF and are smokers.

Creation of physiologic rhythm by closed loop stimulation in heart failure patients with severe chronotropic incompetence: worldwide first results of a pilot study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P.J Nordbeck ◽  
...  
Keyword(s):  
Heart Rate ◽  
Closed Loop ◽  
Funding Source ◽  
Chronotropic Incompetence ◽  
First Results ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Abstract Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. In HF patients with an implanted cardiac resynchronisation therapy (CRT) device and severe CI, the effect of rate adaptive pacing on patient outcomes is unclear. Closed loop stimulation (CLS) based on cardiac impedance measurement may be an optimal method of heart rate adaptation according to metabolic need in HF patients with severe CI. Purpose This is the first study evaluating the effect of CLS on the established prognostic parameters assessed by the cardio-pulmonary exercise (CPX) testing and on quality of life (QoL) of the patients. Methods A randomised, controlled, double-blind and crossover pilot study has been performed in CRT patients with severe CI defined as the inability to achieve 70% of the age-predicted maximum heart rate (APMHR). After baseline assessment, patients were randomised to either DDD-CLS pacing (group 1) or DDD pacing at 40 bpm (group 2) for a 1-month period, followed by crossover for another month. At baseline and at 1- and 2-month follow-ups, a CPX was performed and QoL was assessed using the EQ-5D-5L questionnaire. The main endpoints were the effect of CLS on ventilatory efficiency (VE) slope (evaluated by an independent CPX expert), the responder rate defined as an improvement (decrease) of the VE slope by at least 5%, percentage of maximal predicted heart rate reserve (HRR) achieved, and QoL. Results Of the 36 patients enrolled in the study, 20 fulfilled the criterion for severe CI and entered the study follow-up (mean age 68.9±7.4 years, 70% men, LVEF=41.8±9.3%, 40%/60% NYHA class II/III). Full baseline and follow-up datasets were obtained in 17 patients. The mean VE slope and HRR at baseline were 34.4±4.4 and 49.6±23.8%, respectively, in group 1 (n=7) and 34.5±12.2 and 54.2±16.1% in group 2 (n=10). After completing the 2-month CPX, the mean difference between DDD-CLS and DDD-40 modes was −2.4±8.3 (group 1) and −1.2±3.5 (group 2) for VE slope, and 17.1±15.5% (group 1) and 8.7±18.8% (group 2) for HRR. Altogether, VE slope improved by −1.8±2.95 (p=0.31) in DDD-CLS versus DDD-40, and HRR improved by 12.9±8.8% (p=0.01). The VE slope decreased by ≥5% in 47% of patients (“responders to CLS”). The mean difference in the QoL between DDD-CLS and DDD-40 was 0.16±0.25 in group 1 and −0.01±0.05 in group 2, resulting in an overall increase by 0.08±0.08 in the DDD-CLS mode (p=0.13). Conclusion First results of the evaluation of the effectiveness of CLS in CRT patients with severe CI revealed that CLS generated an overall positive effect on well-established surrogate parameters for prognosis. About one half of the patients showed CLS response in terms of improved VE slope. In addition, CLS improved quality of life. Further clinical research is needed to identify predictors that can increase the responder rate and to confirm improvement in clinical outcomes. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Biotronik SE & Co. KG

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