Predictors of the efficacy of His bundle pacing in patients with a prolonged PR interval: A stratified analysis of the HOPE-HF randomized controlled trial.

AIMS: The randomized, double-blind, placebo-controlled HOPE-HF trial assessed the benefit of atrio-ventricular (AV) delay optimization delivered using His bundle pacing. It recruited patients with left ventricular ejection fraction ≤40%, PR interval ≥200 ms, and baseline QRS ≤140 ms or right bundle branch block. Overall, there was no significant increase in peak oxygen uptake (VO2max) but there was significant improvement in heart failure specific quality of life. In this pre-specified secondary analysis, we evaluated the impact of baseline PR interval, echocardiographic E-A fusion, and the magnitude of acute high-precision haemodynamic response to pacing, on outcomes. METHODS AND RESULTS: All 167 randomized participants underwent measurement of PR interval, acute haemodynamic response at optimized AV delay, and assessment of presence of E-A fusion. We tested the impact of these baseline parameters using a Bayesian ordinal model on VO2max, quality of life and activity measures. There was strong evidence of a beneficial interaction between the baseline acute haemodynamic response and the blinded benefit of pacing for VO2 (Pr 99.9%), Minnesota Living With Heart Failure (MLWHF) (Pr 99.8%), MLWHF physical limitation score (Pr 98.9%), EQ-5D visual analogue scale (Pr 99.6%), and exercise time (Pr 99.4%). The baseline PR interval and the presence of baseline E-A fusion did not have this reliable ability to predict the clinical benefit of pacing over placebo across multiple endpoints. CONCLUSIONS: In the HOPE-HF trial, the acute haemodynamic response to pacing reliably identified patients who obtained clinical benefit. Patients with a long PR interval (≥200 ms) and left ventricular impairment who obtained acute haemodynamic improvement with AV-optimized His bundle pacing were likely to obtain clinical benefit, consistent across multiple endpoints. Importantly, this gradation can be reliably tested for before randomization, but does require high-precision AV-optimized haemodynamic assessment to be performed.

Effects of haemodynamically atrio-ventricular optimized His bundle pacing on heart failure symptoms and exercise capacity: the His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) randomized, double-blind, cross-over trial.

AIMS: Excessive prolongation of PR interval impairs coupling of atrio-ventricular (AV) contraction, which reduces left ventricular pre-load and stroke volume, and worsens symptoms. His bundle pacing allows AV delay shortening while maintaining normal ventricular activation. HOPE-HF evaluated whether AV optimized His pacing is preferable to no-pacing, in a double-blind cross-over fashion, in patients with heart failure, left ventricular ejection fraction (LVEF) ≤40%, PR interval ≥200 ms and either QRS ≤140 ms or right bundle branch block. METHODS AND RESULTS: Patients had atrial and His bundle leads implanted (and an implantable cardioverter-defibrillator lead if clinically indicated) and were randomized to 6 months of pacing and 6 months of no-pacing utilizing a cross-over design. The primary outcome was peak oxygen uptake during symptom-limited exercise. Quality of life, LVEF and patients' holistic symptomatic preference between arms were secondary outcomes. Overall, 167 patients were randomized: 90% men, 69 ± 10 years, QRS duration 124 ± 26 ms, PR interval 249 ± 59 ms, LVEF 33 ± 9%. Neither peak oxygen uptake (+0.25 ml/kg/min, 95% confidence interval [CI] -0.23 to +0.73, p = 0.3) nor LVEF (+0.5%, 95% CI -0.7 to 1.6, p = 0.4) changed with pacing but Minnesota Living with Heart Failure quality of life improved significantly (-3.7, 95% CI -7.1 to -0.3, p = 0.03). Seventy-six percent of patients preferred His bundle pacing-on and 24% pacing-off (p < 0.0001). CONCLUSION: His bundle pacing did not increase peak oxygen uptake but, under double-blind conditions, significantly improved quality of life and was symptomatically preferred by the clear majority of patients. Ventricular pacing delivered via the His bundle did not adversely impact ventricular function during the 6 months.

Residual Thyroid Tissue on Postoperative Diagnostic 131 I Radioactive Whole-Body Scan After Surgery in Differentiated Thyroid Cancer: A Tertiary Referral Centre Experience.

Residual thyroid tissue after total thyroidectomy in differentiated thyroid cancers is considered an independent risk factor for recurrence. Guidelines recommend following up patients after surgery with thyroglobulin (Tg), neck ultrasonography, and occasionally whole-body radioactive scan. However, the results of serum thyroglobulin and whole-body radioiodine scan are often discordant. The present study was undertaken to determine the levels of serum-stimulated thyroglobulin to complement the findings of residual thyroid tissue in the radioactive whole-body scan. One hundred twenty-six patients had undergone a radioiodine (131 I) whole-body scan (WBS) during the study duration, and 121 were available for analysis. The thyroglobulin level (measured by the CLIA method) was recorded at the time of these scans. The data was analysed to determine the level of stimulated thyroglobulin correlating with residual thyroid tissue, locoregional, and distant metastasis as assessed by WBS. The presence of residual thyroid tissue was noted in an overwhelmingly high 94% of cases. Twenty-four of the 28 patients with stimulated Tg < 2 ng/dl had residual thyroid tissue on a WBS. The discordancy rate (positive moderate - large WBS and negative serum thyroglobulin) of 64.28% was seen. Using ROC the serum thyroglobulin cut-offs levels for the loco-regional disease were found to be 27.705 ng/dl and 94.770 ng/dl for distant metastasis. The results highlight the fact that serum Tg levels cannot be used as an accurate predictor of the extent of the remnant thyroid tissue. Irrespective of the quality of surgery, which was analysed based on the centre and surgical specialty, over 90% of cases had residual thyroid tissue on WBS. The use of only stimulated Tg levels for follow-up may be inaccurate. Serum Tg is a useful test along with radioactive whole-body scans to distinguish local disease, loco-regional disease, and distant metastasis.

Prognostic Significance of Vocal Cord Mobility after Laryngeal Preservation Protocols in Locally Advanced Laryngopharyngeal Cancers: A Retrospective Analysis.

In the present study, we look at the prognostic implications of the recovery of vocal cord mobility after treatment in T3 laryngeal and hypopharyngeal cancers with fixed vocal cords. Patients with T3 laryngeal and hypopharyngeal carcinoma were considered for the study. All patients were treated with standard laryngeal preservation protocols as per treatment guidelines. Recovery of vocal cord functions was assessed with serial flexible laryngoscopic evaluation. Recovery of vocal cord mobility was compared with oncological outcomes. Twenty seven patients were available for final analysis. Cases, where vocal cords remained fixed or continued to have restricted mobility on follow up, were categorised as "unfavourable" and those with complete recovery of function as compared to pre treatment FOL as "Favourable". Thirteen (48%) patients did not regain complete mobility of vocal cords. Six patients from the 'unfavourable' group (46%) developed recurrence, whereas only one patient from the 'favourable' group (7%) had a recurrence (p = 0.03). The findings of the present study suggest that failure to regain complete vocal cord mobility after CTRT is a poor prognostic factor in T3 laryngeal and hypopharyngeal cancers.

Incidence of Micrometastasis and Isolated Tumour Cells in Clinicopathologically Node-Negative Head and Neck Squamous Cell Carcinoma.

INTRODUCTION: Occult neck node metastasis in head and neck squamous cell carcinoma (HNSCC) in the form of micrometastasis and isolated tumour cell (ITC) often goes unnoticed in the routine pathological examination. This limitation can be overcome by using serial sectioning and immunohistochemistry for detection of micrometastasis and ITC in clinically and pathologically node-negative neck. The primary objective was to determine the incidence of micrometastasis and ITC in the selective neck dissection specimen, whereas to determine the levels of lymph nodes involved, depending upon the site of primary tumour, was the secondary objective. MATERIALS AND METHODS: Lymph nodes from selective neck dissection specimen were subjected to serial sectioning and immunohistochemistry with pan-cytokeratin marker. Incidence of micrometastasis and ITC, site and stage of primary tumours and level of lymph nodes involved were determined. RESULTS: In total, 8.8% patients in the study got upstaged after serial sectioning and immunohistochemistry. Tongue and lower alveolar primaries showed the presence of micrometastasis and ITC in neck nodes. All the primary tumours were of pT1 stage. Level IB and II lymph nodes were primarily involved. CONCLUSION: Micrometastasis and isolated tumour cells are found in approximately 9% of cases of early-stage oral cavity squamous cell carcinoma. The predictive factors and clinical significance are still unknown. More prospective trials are required to solve this evolving aspect of HNSCC.

Modified facelift approach for posterior segmental mandibulectomy: a blend of oncology and cosmesis.

BACKGROUND: The approach to the mandible for segmental resection in malignant pathologies entails a lip-split, angle-split or visor flap incision with extension of the incision into the neck for performing neck dissection. The modified facelift approach with robot-assisted neck dissection can be used to achieve oncologically safe resections with good cosmesis. METHODS: Three patients meeting the inclusion criteria underwent the procedure at the Robotic facility of HCG Cancer Centre, Bangalore. RESULTS: The patients were analyzed on the basis of bone defect length, the margin status of primary, functional and aesthetic outcomes. One patient had wound dehiscence and needed secondary suturing. At 6 months, patients were satisfied with the aesthetic outcomes and functional results CONCLUSION: Modified facelift approach is a feasible procedure ensuring better cosmesis without compromising oncological outcomes.

Technique of flap elevation for robot assisted selective neck dissection via retroauricular approach: a surgeon's guide.

The retroauricular approach is being increasingly used in surgeries of head and neck in an attempt to avoid a disfiguring scar over the face or neck. The elevation of flap correctly is of paramount importance. The lateral to medial (vis-a vis posterior to anterior) approach can be challenging as the anatomical relations guiding the surgeon have a different orientation. The surgeons need to revisit the anatomy of the face and neck and identify reliable anatomical structures that will act as "new" landmarks to ensure proper dissection. 14 cases of robotic selective neck dissections and from January 2017 to January 2019 at Health Care Global Enterprises Ltd., Bangalore were included in the study. All the dissections were performed by a team of head and neck surgeon with experience in robotic surgery. In all the 14 cases, the step-wise surgical technique described was followed. One out of the 14 cases done had flap discolouration at the edge as it was thin. None of the patients had any wound dehiscence. This article tries to give a step to step description to enable the surgeon to raise the retroauricular flap safely and minimising the complications. Here, an attempt has been made to translate our experience to ensure standardisation of the technique with fewer complications.

Impaired Vestibular Function After Cochlear Implantation in Children: Role of Static Posturography.

To identify vestibular dysfunction in children after cochlear implant surgery and to study the utility of static posturography in evaluating vestibular function in children. A prospective study was carried out on 25 children between 2 and 7 years of age with sensorineural hearing loss with no overt vestibular dysfunction. All children underwent static posturography using Synapsis Posturographic System (SPS) software (Version 3.0, REV C) using a static platform with foam. The centre of pressure (COP) shift was recorded as statokinesiogram on the software and the mean vestibular, visual and somesthetic scores were obtained. Cochlear implantation (CI) surgery was done with insertion of Med-El Pulsar standard cochlear implant with 12 twin electrodes. Children were evaluated again after 4 weeks of CI surgery (2 weeks after switch on) with static posturography on the same SPS software. The scores obtained were compared with pre op value and data analyzed statistically by paired t tests on SPSS 18 software. The mean age was 4.6 years with range 2-7 years. All the children in the study were able to complete the test with no difficulty and the mean time required for each child was 10.2 min. The mean pre op somesthetic score was 95.16 (SD 1.52) and post op score was 94.06 (SD 1.79). The mean pre op visual score was 86.64 (SD 2.24) and post op score was 82.55 (2.89). The mean pre op vestibular score was 84.11 (SD 2.20) and post op score was 73.66 (SD 4.25). Correlation and statistical analysis of the pre and post values of each score revealed statistically significant reduction in vestibular scores post CI. The vestibular system is at high risk of injury leading to vestibular dysfunction in children during CI. Our study found the static posturography as a simple, fast and efficient tool to screen children for vestibular dysfunction post CI. Identifying the dysfunction early can help in initiating early rehabilitation measures.

Pacemaker leads and cardiac perforation.

This case series highlights the rare but potentially life threatening complication of ventricular perforation caused by pacemaker leads and discusses appropriate investigations and management strategies.

Drug and device therapy for patients with chronic heart failure.

Untreated heart failure is a terminal illness with a poor prognosis. ß-blockers are an established therapy used to reduce morbidity and mortality. Hypotension and bradycardia often hinder optimal ß-blocker administration in patients with chronic heart failure. The efficacy of cardiac resynchronization therapy (CRT) in affecting favorable cardiac remodeling and reducing mortality in heart failure patients with electrical dyssynchrony has been demonstrated in landmark trials only in patients receiving optimal medical therapy. This paper demonstrates the favorable effects of CRT on cardiac hemodynamics facilitating uptitration of ß-blocker therapy. It highlights the synergistic relationship of the two therapies and emphasizes the importance of optimizing medical therapy before and after CRT implantation.

Is the use of ABPM justified in patients on 1 or 2 antihypertensive medications?

We studied the utility of ABPM in patients with elevated clinic BP on 1-2 antihypertensive medications (group B, N=117), compared with those on no medications (group A, N=76) and on > or =3 medications (group C, N=110). 35% of patients in group B had adequately controlled 24-h BP based on ABPM, compared with 22.4% in group A (P=0.06) and 19.1% in group C (P=0.007). Antihypertensive treatment was not escalated in patients with adequately controlled BP. This suggests that ABPM has an important role in therapeutic decision-making for patients on 1-2 antihypertensive medications.