A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT).

BACKGROUND: Arm restriction after cardiac implantable electronic device (CIED) placement is common practice despite minimal supporting evidence. Patients receive a range of restriction recommendations of variable durations with the goal of reducing complications such as wound dehiscence, infection, lead dislodgement, or hematoma formation. These movement limitations can lead to emotional stress and anxiety, complications such as frozen shoulder, and upper extremity venous thrombosis due to immobilization. There are no published clinical trials assessing the benefits and risks of arm restrictions post-CIED implant. OBJECTIVES: The randomized trial of lenient vs strict arm and activity instruction post-CIED surgery (LENIENT trial; NCT04915261) is a single center nonblinded randomized prospective study designed to evaluate lenient compared to restrictive post-CIED care instructions. We hypothesize that there will be no significant difference in complications between the arms. METHODS/DESIGN: All patients receiving a de novo CIED or those with upgrades and revisions requiring a new lead implant will be enrolled. Subjects are enrolled in a nonblinded randomized prospective trial with 6 randomly assigned 8-month periods, during which either a lenient or restrictive postoperative activity instructions will be given to all patients. Postoperative instructions are given at the time of discharge and further reinforced by recurrent interactive voice recognition (IVR) phone calls, text messages and emails. The requirement for individual consent has been waived. The primary end point is a composite of (1) lead dislodgement, (2) frozen shoulder, (3) upper extremity venous thrombosis, (4) clinically significant hematoma, and (5) infection occurring within 52 weeks of index surgery. The study is a noninferiority trial with a sample size of 1,250 per group. DISCUSSION: This is the first large randomized clinical trial designed to establish an evidence-based postoperative standard of care for patients undergoing CIED implantation. This will improve the quality of care provided to patients and help guide implanting physicians providing postoperative care instructions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04915261.

High-power, short-duration atrial fibrillation ablation compared with a conventional approach: Outcomes and reconnection patterns.

BACKGROUND: The effectiveness, safety, and pulmonary vein (PV) reconnection patterns of point-by-point high-power, short-duration (HPSD) ablation relative to conventional force-time integral (FTI)-guided strategies for atrial fibrillation (AF) ablation are unknown. OBJECTIVES: To compare 1-year freedom from atrial arrhythmia (AA), complication rates, procedural times, and PV reconnection patterns with HPSD AF AF ablation versus an FTI-guided low-power, long-duration (LPLD) strategy. METHODS: We compared consecutive patients undergoing a first ablation procedure for paroxysmal or persistent AF. The HPSD protocol utilized a power of 50 W and durations of 6-8 s posteriorly and 8-10 s anteriorly. The LPLD protocol was FTI-guided with a power of ≤25 W posteriorly (FTI ≥ 300g·s) and ≤35 W anteriorly (FTI ≥ 400g·s). RESULTS: In total, 214 patients were prospectively included (107 HPSD, 107 LPLD). Freedom from AA at 1 year was achieved in 79% in the HPSD group versus 73% in the LPLD group (p = .339; adjusted hazard ratio with HPSD, 0.67; 95% confidence interval, 0.36-1.23; p < .004 for non-inferiority). Procedure duration was shorter in the HPSD group (229 ± 60 vs. 309 ± 77 min; p < .005). Patients undergoing repeat ablation had a higher propensity for reconnection at the right PV carina in the HPSD group compared with the LPLD group (14/30 = 46.7% vs. 7/34 = 20.6%; p = .035). There were no differences in complication rates. CONCLUSION: HPSD AF ablation resulted in similar freedom from AAs at 1 year, shorter procedure times, and a similar safety profile when compared with an LPLD ablation strategy. Patients undergoing HPSD ablation required more applications at the right carina to achieve isolation, and had a significantly higher rate of right carinal reconnections at redo procedures.

Adherent skin barrier drape use is associated with a reduced risk of cardiac implantable device infection: Results from a prospective study of 14,225 procedures.

Background: Cardiac implantable electronic device (CIED) infection is a costly and highly morbid complication. Perioperative interventions, including the use of antibiotic pouches and intensified perioperative antibiotic regimens, have demonstrated marginal efficacy at reducing CIED infection. Additional research is needed to identify additional interventions to reduce infection risk. Objective: We sought to evaluate whether adherent skin barrier drape use is associated with a reduction in CIED infection. Methods: A prospective registry of all CIED implantation procedures was established at our institution in January 2007. The registry was established in collaboration with our hospital infection prevention team with a specific focus on prospectively identifying all potential CIED infections. All potential CIED infections were independently adjudicated by 2 physicians blinded to the use of an adherent skin barrier drape. Results: Over a 13-year period, 14,225 procedures were completed (mean age 72 ± 14 years; female 4,918 (35%); new implants 10,005 (70%); pulse generator changes 2585 (18%); upgrades 1635 (11%). Of those, 2469 procedures (17.4%) were performed using an adherent skin barrier drape. There were 103 adjudicated device infections (0.73%). The infection rate in patients in the barrier use groups was 8 of 2469 (0.32%) as compared with 95 of 11,756 (0.8%) in the nonuse group (P = .0084). In multivariable analysis, the use of an adherent skin barrier drape was independently associated with a reduction in infection (odds ratio 0.32; 95% confidence interval 0.154-0.665; P = .002). Conclusion: The use of an adherent skin barrier drape at the time of cardiac device surgery is associated with a lower risk of subsequent infection.

Do barrier dressings reduce cardiac implantable device infection: Protocol for a randomized controlled trial (BARRIER-PROTECT).

Background: Cardiac implantable electronic device (CIED) procedures can be associated with serious complications, including infection with significant mortality and morbidity, necessitating removal of the device and prolonged hospitalization. One potential pathophysiological mechanism is pocket contamination at the time of device implantation. Therefore, steps taken to prevent contamination at this stage can potentially reduce CIED infections.The barrier dressing, an adhesive material applied to the skin, has the potential to reduce the colonization of the surgical site with host flora that can predispose to infection. There are a limited number of randomized prospective studies on barrier dressing use during various surgeries, but it has never been systematically studied in CIED implantation. Objectives: Do Barrier Dressings Reduce Cardiac Implantable Device Infection? (BARRIER-PROTECT trial; NCT04591366) is a single-centre, prospective, double-armed, single-blinded, randomized controlled trial designed to evaluate the use of an intra-operative adhesive barrier dressing to reduce the risk of end-of-procedure pocket swab positivity. We hypothesize that adhesive draping during implant procedures will reduce the risk of contamination from the skin flora. Also, we aim to investigate if the end-of-procedure pocket swab culture positivity can be used as a potential surrogate marker of CIED infection. Methods and Design: Patients undergoing a second or later procedure on the same device pocket (pulse generator change, lead/pocket revision or upgrade) will be enrolled. Eligible and consenting patients will be equally randomized to the use of barrier dressing or not using an automated web-based system. Patients, but not the operator, will be blinded to the arm. The person performing the pocket swabs will also be blinded. The primary endpoint is the end-of-procedure pocket swab culture positivity. The main secondary endpoint is the CIED infection rate. Discussion: This is the first randomized controlled trial to assess the effectiveness of using a barrier adhesive draping on reducing the end-of-procedure pocket swab culture positivity. In this study, we are exploring a low-cost intervention that may significantly reduce CIED infection. Also, having a valid surrogate marker for CIED infection at the time of implant will facilitate design of future clinical trials.

Outcomes of a comprehensive strategy during repeat atrial fibrillation ablation.

BACKGROUND/PURPOSE: Atrial fibrillation (AF) recurs post-ablation in 30-40% of patients. The approach to a repeat ablation, beyond isolation of reconnected pulmonary veins (PVs), is not well established. We sought to prospectively assess outcomes and predictors of recurrence among consecutive patients who underwent repeat AF ablation with a standardized approach. METHODS: This was a single-center prospective study of consecutive patients who underwent repeat AF ablation. Our protocol consisted of six steps: PV re-isolation, ablation of left atrial low-voltage areas (LVAs), ablation of isoproterenol-induced non-PV triggers, electrophysiology study (EPS) and ablation of induced AVNRT/AVRT, ablation of induced clinical atrial flutters, and lastly empiric ablation as per operator discretion if no other ablation was performed. RESULTS: Among 725 AF ablations performed during the study period, 74 were repeat ablations. Of those undergoing repeat ablation, 53 (72%) had PV reconnection, 30 (41%) had LVAs, seven (10%) had non-PV triggers, five (7%) had AVNRT, and 15 (20%) had typical atrial flutter. Following repeat ablation, arrhythmia-free survival was 65% at 1 year. The absence of PV reconnection was the only factor independently associated with recurrence after repeat ablation (recurrence rate 71%, adjusted OR 7.91, 95% CI 2.31-27.16, p = 0.001). CONCLUSIONS: A comprehensive approach to repeat AF ablation including PV re-isolation, LVA ablation, non-PV trigger ablation, EPS, and flutter ablation was associated with a 65% 1-year arrhythmia-free survival. The absence of PV reconnection was the only independent predictor of arrhythmia recurrence. Further research is needed to identify therapies beyond PV isolation for patients undergoing repeat ablation.

The Wenckebach Phenomenon.

Medicine has many great pioneers, and in 1899, one such pioneer - Karel Frederik Wenckebach made a discovery which, even to this day, remains one of the fundamental concepts within electrophysiology. Since the Wenckebach Phenomenon was first described, the field of electrophysiology has developed at a rapid pace, allowing us to observe this behaviour, and its complexities, in many new ways. In a similar way, this chapter will illustrate Wenckebach behaviour across a spectrum of modalities from the 12 lead ECG, through to the intra-cardiac recordings from both electrophysiological studies and implantable cardiac devices. In doing so, we continue to shed light on the phenomenon first identified through Wenckebach's meticulous attention to detail some 120 years ago.

Catheter Ablation of Low-Voltage Areas for Persistent Atrial Fibrillation: Procedural Outcomes Using High-Density Voltage Mapping.

BACKGROUND: Several approaches have been proposed to address the challenge of catheter ablation of persistent atrial fibrillation (AF). However, the optimal ablation strategy is unknown. We sought to evaluate the efficacy of pulmonary vein isolation (PVI) plus low-voltage area (LVA) ablation using contemporary high-density mapping to identify LVA in patients with persistent AF. METHODS: Consecutive patients accepted for AF catheter ablation were studied. High-density bipolar voltage mapping data were acquired in sinus rhythm using multipolar catheters to detect LVA (defined as bipolar voltage < 0.5 mV). Semiautomated impedance-based software was used to ensure catheter contact during data collection. Patients underwent PVI + LVA ablation (if LVA present). RESULTS: A total of 145 patients were studied; 95 patients undergoing PVI + LVA ablation were compared with 50 controls treated with PVI only. Average age was 61 ± 10 years, and 80% were male. Baseline characteristics were comparable. Freedom from atrial tachycardia/AF at 18 months was 72% after PVI + LVA ablation vs 58% in controls (P = 0.022). Median procedure duration (273 [240, 342] vs 305 [262, 360] minutes; P = 0.019) and radiofrequency delivery (50 [43, 63] vs 55 [35, 68] minutes; P = 0.39) were longer in the PVI + LVA ablation group. Multivariable analysis showed that the ablation strategy (PVI + LVA) was the only independent predictor of freedom from atrial tachycardia/AF (hazard ratio, 0.53; 95% confidence interval, 0.29-0.96; P = 0.036). There were no adverse safety outcomes associated with LVA ablation. CONCLUSIONS: An individualized strategy of high-density mapping to assess the atrial substrate followed by PVI combined with LVA ablation is associated with improved outcomes. Adequately powered randomized clinical trials are needed to determine the role of PVI + LVA ablation for persistent AF.

High-power short-duration radiofrequency ablation of typical atrial flutter.

BACKGROUND: High-power short-duration (HPSD) ablation has been explored for pulmonary vein isolation. Early data suggest similar efficacy with shorter procedure times and perhaps greater safety. Data are lacking on the use of this ablation strategy for other arrhythmias. OBJECTIVE: The purpose of this study was to evaluate the safety, efficacy, and clinical outcomes of HPSD ablation in patients with typical atrial flutter compared to those undergoing ablation with conventional settings. METHODS: Consecutive patients undergoing cavotricuspid isthmus (CTI) ablation using standard power settings were compared to those performed after transitioning to HPSD ablation. Demographics, procedural details, and ablation outcomes were prospectively collected. The primary endpoint was duration of radiofrequency energy delivery. Secondary endpoints were radiation duration and analgesia requirements. RESULTS: A total of 114 consecutive subjects undergoing CTI ablation (57 standard power, 57 HPSD) were included. HPSD ablation and electroanatomic mapping/contact force (EAM/CF) use were associated with 66% (95% confidence interval [CI] 58%-73%) and 50% (95% CI 37%-60%) shorter ablation times compared to standard power and not using EAM/CF, respectively. Patients in the HPSD group required 50 mcg less fentanyl relative to the standard ablation arm after adjusting for sex, age, and comorbidities (P = .048). At a median follow-up of 6 months, 4 patients (7%) in the standard arm had recurrence of atrial flutter, compared to none in HPSD group (P = .057). CONCLUSION: HPSD is a safe and effective approach to CTI ablation. This strategy may reduce ablation time and analgesia requirements. Larger studies and longer follow-up are needed to further evaluate this strategy.

A focus on the human lens in vitro.

The lens is a unique organ in that it is avascular and non-innervated, obtaining all nutrients from the aqueous and vitreous humours that bathe the lens. All lenses attempt to achieve the same goal, namely to maintain transparency and focus light on to the retina. However, the mechanisms by which these processes are maintained, or disrupted leading to a loss of transparency, are likely to differ in some cases between animals and humans. To allow comparison to take place, human in vitro models have been developed, ranging from whole organ culture to the generation of human lens cell lines. All have their merits and limitations, but as a whole, they permit extensive studies of lens cell behaviour and function to be carried out. Together, these in vitro methods allow the biological events of the lens to be further understood. Moreover, they could help identify the mechanisms that give rise to cataract and posterior capsule opacification, a problem that occurs following surgery, providing therapeutic targets for their prevention.

Direct stenting is an independent predictor of improved survival in patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction.

AIMS: Randomised trials have shown that direct stenting (DS) is associated with improved markers of reperfusion during primary percutaneous coronary intervention (PPCI) for ST elevation myocardial infarction (STEMI). However, data evaluating its impact on long-term clinical outcomes are lacking. We set out to evaluate the effect of DS on mortality in a contemporary population of patients undergoing PPCI for STEMI. METHODS: Consecutive patients undergoing PPCI for STEMI at two high-volume UK heart attack centres between September 2008- December 2010 (n=1562) were included in the analysis. Local databases were analysed for patient demographics, as well as details on PPCI strategy, including use of DS versus predilatation (PD) followed by stenting, manual thrombus aspiration (MT) and glycoprotein IIb/IIIa inhibitors (GPIs). National databases were interrogated for in-hospital, 30-day and one-year mortality. To determine the impact of PPCI strategy on one-year survival, multivariate logistic analysis was performed. RESULTS: Altogether 489 patients underwent DS (31.3%) and 1073 (68.7%) received PD prior to stenting. Patients receiving DS had reduced mortality at 30 days (2.04 versus 4.66%, p=0.01) and one year (3.27 versus 8.48%, p=0.0001). After multivariate adjustment, PD remained an independent predictor of one-year mortality (odds ratio 2.42, 95% confidence interval 1.08-5.45, p=0.032) along with age, cardiogenic shock, number of diseased vessels, and left main or proximal left anterior descending artery intervention. However, neither GPI use nor MT improved survival in either univariate or multivariate analyses. CONCLUSIONS: In a contemporary, unselected population of patients undergoing PPCI for STEMI, DS - when compared with stenting after PD - is independently predictive of improved 30-day and one-year survival.