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 ◽  
...  

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

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
B Halliday ◽  
A Vazir ◽  
R Owen ◽  
J Gregson ◽  
R Wassall ◽  
...  

Abstract Introduction In TRED-HF, 40% of patients with recovered dilated cardiomyopathy (DCM) relapsed in the short-term during phased withdrawal of drug therapy. Non-invasive markers of relapse may be used to monitor patients who wish a trial of therapy withdrawal and provide insights into the pathophysiological drivers of relapse. Purpose To investigate the relationship between changes in heart rate (HR) and relapse amongst patients with recovered DCM undergoing therapy withdrawal in TRED-HF. Methods Patients with recovered DCM were randomised to phased withdrawal of therapy or to continue therapy for 6 months. After 6 months of continued therapy, those in the control arm underwent withdrawal of therapy in a single arm crossover phase. HR was measured at each study visit. Mean HR and 95% confidence intervals (CI) were calculated at baseline, 45 days after baseline, 45 days prior to the end of the study or relapse and at the end of the study or relapse. Patients were stratified by treatment arm and the occurrence of the primary relapse end-point. Heart rate at follow-up was compared amongst patients who had therapy withdrawn and relapsed versus those who had therapy withdrawn and did not. ANCOVA was used to adjust for differences in HR at baseline between the two groups. Results Of 51 patients randomised, 26 were assigned to continue therapy and 25 to withdraw therapy. In the randomised and cross-over phases, 20 patients met the primary relapse end-point; one patient withdrew from the study and one patient completed follow-up in the control arm but did not enter the cross-over phase. Mean HR (standard deviation) at baseline and follow-up for (i) patients in the control arm was 69.9 (9.8) & 65.9 (9.1) respectively; (ii) for those who had therapy withdrawn and did not relapse was 64.6 (10.7) & 74.7 (10.4) respectively; and (iii) for those who had therapy withdrawn and relapsed was 68.3 (11.3) & 86.1 (11.8) respectively [all beats per minute]. The mean change in HR between the penultimate visit and the final visit for those who had therapy withdrawn and did not relapse was −2.4 (9.7) compared to 3.1 (15.5) for those who relapsed. After adjusting for differences in HR at baseline, the mean difference in HR measured at follow-up between patients who underwent therapy withdrawal and did, and did not relapse was 10.4bpm (95% CI 4.0–16.8; p=0.002) (Figure 1 & Table 1). Conclusion(s) A larger increase in HR may be a simple and effective marker of relapse for patients with recovered DCM who have insisted on a trial of therapy withdrawal. Whether HR control is crucial to the maintenance of remission amongst patients with improved cardiac function, or is simply a marker of deteriorating cardiac function, warrants further investigation. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): British Heart Foundation


2021 ◽  
Vol 25 (1) ◽  
pp. 473-479
Author(s):  
Jagar Doski ◽  
Berivan Jamal

Background and objective: The accelerated protocol of Ponseti method was suggested to shorten the period of treatment of the conventional one for the cases of talipes equinovarus deformity. This study aimed to compare the accelerated protocol of Ponseti method in the treatment of clubfoot deformity with the conventional one. Methods: A prospective comparative study was conducted for infants less than six months with congenital talipes equinovarus deformity. The patients were randomized to either Group 1 (casts changed every week, conventional protocol of Ponseti method) or Group 2 (twice weekly, accelerated one). Pirani score was used to assess the severity of the deformity at presentation, at time of last cast removal, and at the last follow up visit (6th months). Results: The patients included were 48 cases with 79 feet. Group 1 (39 clubfeet) had a mean Pirani score of 5.6 (± 1.15) at presentation, which dropped to 0.47 (± 0.41) when the last cast was removed. In Group 2 (40 clubfeet), it dropped from 5.57 (± 0.83) to 0.77 (± 0.01). The result of each treatment protocol was significant, but the difference between them was not significant. Five cases (three patients aged more than three months) of Group 2 needed eight casts to reach an acceptable position of correction. The difference between the mean number of casts applied in Group 1 (5.09) and Group 2 (5.82) was statistically not significant. However, the difference between the mean number of days spent in the cast was significant. The complications occurred in 12 out of 79 feet, with no statistically significant difference between both groups. Conclusion: The accelerated protocol of Ponseti method for treating clubfoot deformity is as effective and as safe as the conventional one. It shortens the time required to complete the treatment program. Those who present lately (beyond the age of three months) may require an additional number of casts. Keywords: Clubfoot; Congenital talipes equinovarus; Ponseti; Accelerated; Cast.


2021 ◽  
Author(s):  
Aylin Karalezli ◽  
Sema Kaderli ◽  
Ahmet Kaderli ◽  
Cansu Kaya ◽  
Sabahattin Sul

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.


2022 ◽  
Vol 11 (2) ◽  
pp. 408
Author(s):  
Rony-Orijit Dey Hazra ◽  
Johanna Illner ◽  
Karol Szewczyk ◽  
Mara Warnhoff ◽  
Alexander Ellwein ◽  
...  

Introduction: The optimal treatment strategy for the proximal humeral fracture (PHF) remains controversial. The debate is centered around the correct treatment strategy in the elderly patient population. The present study investigated whether age predicts the functional outcome of locking plate osteosynthesis for this fracture entity. Methods: A consecutive series of patients with surgically treated displaced PHF between 01/2017 and 01/2018 was retrospectively analyzed. Patients were treated by locking plate osteosynthesis. The cohort was divided into two groups: Group 1 (≥65 years) and Group 2 (<65 years). At the follow-up examination, the SSV, CMS, ASES, and Oxford Shoulder Score (OS), as well as a radiological follow-up, was obtained. The quality of fracture reduction is evaluated according to Schnetzke et al. Results: Of the 95 patients, 79 were followed up (83.1%). Group 1 consists of 42 patients (age range: 65–89 years, FU: 25 months) and Group 2 of 37 patients (28–64 years, FU: 24 months). The clinical results showed no significant differences between both groups: SSV 73.4 ± 23.4% (Group 1) vs. 80.5 ± 189% (Group 2). CMS: 79.4 ± 21 vs. 81.9 ± 16, ASES: 77.2 ± 20.4 vs. 77.5 ± 23.1, OS: 39.5 ± 9.1 vs. 40.8 ± 8.2; OS: 39.5 ± 9.1 vs. 40.8 ± 8.2. In the radiological follow-up, fractures healed in all cases. Furthermore, the quality of fracture reduction in both groups is comparable without significant differences. The revision rate was 9.5% in Group 1 vs. 16.2% in Group 2. Discussion: Both age groups show comparable functional outcomes and complication rates. Thus, the locking plate osteosynthesis can be used irrespective of patient age; the treatment decision should instead be based on fracture morphology and individual patient factors.


Author(s):  
Claudio Furino ◽  
Alfredo Niro ◽  
Michele Reibaldi ◽  
Maria Oliva Grassi ◽  
Francesco Boscia ◽  
...  

Purpose: Different patterns of diabetic macular edema (DME) suggest different pathogenesis and drug response. We evaluated the outcomes after intravitreal dexamethasone (DEX) implant for DME with or without serous retinal detachment (SRD). Methods: In this retrospective study, 22 naïve patients (23 eyes) with DME who underwent a single DEX implant were evaluated. Based on the optical coherence tomographic pattern of DME, 12 eyes had a cystoid macular edema pattern (Group 1) and 11 eyes had an SRD pattern (Group 2). The best-corrected visual acuity (BCVA), central retinal thickness (СRТ), central retinal volume (CRV), SRD height (SRDh), and intraocular pressure (IOP) were recorded before and at two and four months after the treatment. Results: There were no significant differences between the groups regarding demographic, clinical data and outcomes at baseline. In Group 1, the CRT and CRV significantly decreased at two months (P = 0.002 and P = 0.01, respectively), while the BCVA significantly improved at four months (P = 0.03). In Group 2, the CRT and CRV significantly improved (P < 0.01 and P ≤ 0.01, respectively) during the follow-up period. At four months, both groups showed a recurrence of DME, Group 1 in particular (two-month CRT reduction, –149 ± 127 μm vs four-month CRT reduction, –72 ± 174 μm; P = 0.04). The mean reduction in CRV was significantly different at four months (Group 1, –0.49 ± 1.7 mm3 vs Group 2, –1.3 ± 1.3 mm3; P = 0.04). In Group 2, the SRDh significantly decreased at two (P = 0.01) and four months (P = 0.01). Four cases with elevated IOP were managed. Conclusion: DEX implants were found to be effective in different patterns of DME. The SRD pattern may predict a longer-lasting morphologic efficacy.


2021 ◽  
pp. 036354652110469
Author(s):  
Benjamin R. Saks ◽  
Vivian W. Ouyang ◽  
Elijah S. Domb ◽  
Andrew E. Jimenez ◽  
David R. Maldonado ◽  
...  

Background: Access to quality health care and treatment outcomes can be affected by patients’ socioeconomic status (SES). Purpose: To evaluate the effect of patient SES on patient-reported outcome measures (PROMs) after arthroscopic hip surgery. Study Design: Cohort study; Level of evidence, 3. Methods: Demographic, radiographic, and intraoperative data were prospectively collected and retrospectively reviewed on all patients who underwent hip arthroscopy for femoroacetabular impingement syndrome (FAIS) and labral tear between February 2008 and September 2017 at one institution. Patients were divided into 4 cohorts based on the Social Deprivation Index (SDI) of their zip code. SDI is a composite measure that quantifies the level of disadvantage in certain geographical areas. Patients had a minimum 2-year follow-up for the modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), International Hip Outcome Tool—12, and visual analog scale (VAS) for both pain and satisfaction. Rates of achieving the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) were calculated for the mHHS, NAHS, and VAS pain score. Rates of secondary surgery were also recorded. Results: A total of 680 hips (616 patients) were included. The mean follow-up time for the entire cohort was 30.25 months. Division of the cohort into quartiles based on the SDI national averages yielded 254 hips (37.4%) in group 1, 184 (27.1%) in group 2, 148 (21.8%) in group 3, and 94 (13.8%) in group 4. Group 1 contained the most affluent patients. There were significantly more men in group 4 than in group 2, and the mean body mass index was greater in group 4 than in groups 1 and 2. There were no differences in preoperative radiographic measurements, intraoperative findings, or rates of concomitant procedures performed. All preoperative and postoperative PROMs were similar between the groups, as well as in the rates of achieving the MCID or PASS. No differences in the rate of secondary surgeries were reported. Conclusion: Regardless of SES, patients were able to achieve significant improvements in several PROMs after hip arthroscopy for FAIS and labral tear at the minimum 2-year follow-up. Additionally, patients from all SES groups achieved clinically meaningful improvement at similar rates.


Author(s):  
A.P. Voznyuk ◽  
◽  
S.I. Anisimov ◽  
S.Y. Anisimova ◽  
L.L. Arutyunyan ◽  
...  

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.


2021 ◽  
Vol 17 (4) ◽  
pp. 311-320
Author(s):  
Pamela Wendel, MD ◽  
Danya DeMeo, BS ◽  
Madison R. Heath, BS ◽  
Alexandra T. Mackie, BA, PB-BS ◽  
Haoyan Zhong, MPA ◽  
...  

Objective: To determine the number of opioid pills remaining after pediatric ambulatory knee surgery to provide insight into how many pills are actually used. Design: Prospective observational cohort study. Participants who were expected to be prescribed 20 (Group 1) versus 40 (Group 2) opioid pills according to the institutional policy (based on the type of surgery) were studied. Patient’s reported pain, medication use, and number of opioid pills remaining at postoperative days (PODs) 7 and 14. Participants were not randomly assigned to groups and no intervention was applied.Setting: An urban tertiary care musculoskeletal institution.Participants: Sixty adolescents between the ages of 12 and 19 undergoing ambulatory knee surgery.Interventions: Observational study, no experimental study intervention.Main outcome measure: The total number of opioid pills remaining.Results: By POD7, more than 70 percent of patients had stopped taking their prescribed opioid medication mainly because their knee pain was tolerable either without the opioid or by using other medications. By POD14, the mean number of pills taken was 6.3 ± 5.3 for Group 1 and 18.4 ± 13.9 for Group 2. The mean number of unused opioids was 13.5 ± 7.2 for Group 1 and 17.9 ± 13.7 for Group 2. Conclusions: Even with prescribing practice guidelines in place, opioids may be overprescribed and could be given in a smaller quantity without affecting the quality of acute postoperative pain control in adolescents undergoing ambulatory knee surgery. However, one needs to consider that some patients may need a larger than average amount in order to be appropriately treated for their level of pain and thus prescription amounts—preferably after reevaluation—should be individualized.


2009 ◽  
Vol 19 (4) ◽  
pp. 535-543 ◽  
Author(s):  
Leopoldo Spadea ◽  
Massimo Saviano ◽  
Angela Di Gregorio ◽  
Domenico Di Lodovico ◽  
Fabio De Sanctis

Purpose To evaluate in a long-term period the effectiveness and safety of topographically guided two-step laser in situ keratomileusis (LASIK) and standard LASIK technique in the correction of refractive errors after successful penetrating keratoplasty (PKP) for keratoconus. Methods At least 2 years after PKP and 6 months after removal of all sutures, 15 eyes of 15 patients (Group 1; mean manifest refraction spherical equivalent (MRSE) −7.23 D ± 3.42 SD) were submitted to standard LASIK and 15 eyes of 15 patients (Group 2; mean MRSE −4.37 D ± 1.97 SD) to a topographically guided two-step LASIK procedure (first the flap and at least 2 weeks later the laser ablation). In all cases, a superior hinged corneal flap (160 μm/9.5 mm) was created. Results After a follow-up of 36 months, in Group 1 the mean uncorrected visual acuity (UCVA) was 0.51 logarithm of the minimum angle of resolution (logMAR) ± 0.41 SD and the mean best-corrected visual acuity (BCVA) was 0.03 logMAR ± 0.05 SD, with a mean MRSE of −1.57 D ± 2.65 SD. In Group 2, the mean UCVA was 0.28 logMAR ± 0.24 SD and the mean BCVA was 0.01 logMAR ± 0.03 SD, with a mean MRSE of −0.07 D ± 1.00 SD. In both groups, no complications were observed. Conclusions After a long follow-up period, both topographically guided two-step LASIK and standard LASIK could be considered effective and safe tools in the correction of refractive errors after successful PKP for keratoconus.


2013 ◽  
Vol 7 ◽  
pp. CMC.S12654 ◽  
Author(s):  
J. Meikle ◽  
A. Al-Sarraf ◽  
M. Li ◽  
K. Grierson ◽  
J. Frohlich

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.


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