Non-surgical treatment of mild to moderate peri-implantitis with an oscillating chitosan brush or a titanium curette-12-month follow-up of a multicenter randomized clinical trial.

OBJECTIVES: To study clinical and radiographic outcomes after non-surgical treatment of peri-implantitis using either an oscillating chitosan brush (OCB) or titanium curette (TC) and to observe changes in clinical signs of inflammation after repeated treatment. METHODS: Thirty-nine patients with dental implants (n = 39) presented with radiographic bone level (RBL) of 2-4 mm, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm were randomly assigned to mechanical debridement with OCB (test) or TC (control). Treatment was performed at baseline and repeated at 3, 6, and 9 months in cases with > 1 implant site with BI ≥ 1 and PPD≥4 mm. Blinded examiners recorded PPD, BI, pus, and plaque. The radiographic bone level change between baseline and 12 months was calculated. A multistate model was used to calculate transitions of BI. RESULTS: Thirty-one patients completed the study. Both groups exhibited a significant reduction in PPD, BI, and pus at 12 months compared to baseline. Radiographic analysis showed stable mean RBL in both groups at 12 months. There was no statistically significant difference in any of the parameters between the groups. CONCLUSIONS: Within the limitations of this 12-month multicenter randomized clinical trial, non-surgical treatment of peri-implantitis with OCB or TC showed no statistically significant differences between the groups. Clinical improvements and, in some cases, disease resolution, was observed in both groups. However, persistent inflammation was a common finding which further puts emphasis on the need for further treatment.

Non-surgical treatment of mild to moderate peri-implantitis using an oscillating chitosan brush or a titanium curette-A randomized multicentre controlled clinical trial.

OBJECTIVES: This prospective, parallel-group, examiner-blinded, multicentre, randomized, controlled clinical trial aimed to assess the efficacy of an oscillating chitosan brush (OCB) versus titanium curettes (TC) on clinical parameters in the non-surgical treatment of peri-implantitis. MATERIAL AND METHODS: In five dental specialist clinics, 39 patients with one implant with mild to moderate peri-implantitis, defined as 2-4 mm radiographic reduced bone level, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm were randomly allocated to test and control groups, receiving OCB or TC debridement, respectively. Treatment was performed at baseline and three months. PPD, BI, and Plaque index (PI) were measured at six sites per implant and recorded by five blinded examiners at baseline, one, three, and six month(s). Pus was recorded as present/not present. Changes in PPD and BI were compared between groups and analysed using multilevel partial ordinal and linear regression. RESULTS: Thirty-eight patients completed the study. Both groups showed significant reductions in PPD and BI at six months compared with baseline (p < .05). There was no statistically significant difference in PPD and BI changes between the groups. Eradication of peri-implant disease as defined was observed in 9.5% of cases in the OCB group and 5.9% in the TC group. CONCLUSIONS: Within the limitations of this six-month multicentre clinical trial, non-surgical treatment of peri-implantitis with OCB and TC showed no difference between the interventions. Eradication of disease was not predictable for any of the groups.

A pilot study to investigate real-time digital alerting from wearable sensors in surgical patients.

BACKGROUND: Continuous vital sign monitoring may identify changes sooner than current standard monitoring. OBJECTIVE: To investigate if the use of real-time digital alerts sent to healthcare staff can improve the time taken to identify unwell patients and those with sepsis. DESIGN: A prospective cohort study design. SETTING: West Middlesex University Hospital, UK. PARTICIPANTS: Fifty acutely unwell surgical patients admitted to hospital. INTERVENTION: Patients wore a lightweight wearable sensor measuring heart rate (HR), respiratory rate (RR) and temperature every 2 min whilst standard intermittent ward monitoring of vital signs was performed by nurses. Digital alerts were sent to healthcare staff from the sensor to a smartphone device. All alerts were reviewed for recruited patients to identify the exact time on the sensor in which deterioration occurred. The time to acknowledgement was then reviewed for each action and an average time to acknowledgement calculated. RESULTS: There were 50 patients recruited in the pilot study, of which there were vital sign alerts in 18 patients (36%). The total number of vital sign alerts generated in these 18 patients was 51. Of these 51 alerts, there were 7 alerts for high HR (13.7%), 33 for RR (64.7%) and 11 for temperature (21.6%). Out of the 27 acknowledged alerts, there were 2 alerts for HR, 17 for RR and 8 for temperature. The average time to staff acknowledgement of the notification for all alerts was 154 min (2.6 h). There were some patients which had shown signs of deterioration in the cohort. The frequency of routine observation monitoring was increased in 2 cases, 3 patients were referred to a senior clinician and 2 patients were initiated on the sepsis pathway. CONCLUSION: This study demonstrates the evaluation of digital alerts to nurses in real time. Although not all alerts were acknowledged, deterioration on the ward observations was detected and actions were taken accordingly. Patients were started on the sepsis pathway and escalation to senior clinicians occurred. Further research is required to review why only some alerts were acknowledged and the effects of digital alerting on patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04638738.

Clinical impact of multi-parameter continuous non-invasive monitoring in hospital wards: a systematic review and meta-analysis.

OBJECTIVE: Delayed response to clinical deterioration as a result of intermittent vital sign monitoring is a cause of preventable morbidity and mortality. This review focuses on the clinical impact of multi-parameter continuous non-invasive monitoring of vital signs (CoNiM) in non-intensive care unit patients. DESIGN: Systematic review and meta-analysis of primary studies. Embase, MEDLINE, HMIC, PsycINFO and Cochrane were searched from April 1964 to 18 June 2019 with no language restriction. SETTING: The search was limited to hospitalised, non-intensive care unit adult patients who had two or more vital signs continuously monitored. PARTICIPANTS: All primary studies that evaluated the clinical impact of using multi-parameter CoNiM in adult hospital wards outside of the intensive care unit. MAIN OUTCOME MEASURES: Clinical impact of multi-parameter CoNiM. RESULTS: This systematic review identified 14 relevant studies from 3846 search results. Five studies were classified as Group A - associations found between measured vital signs and clinical parameters. Nine studies were classified as Group B - comparison between clinical outcomes of patients with and without multi-parameter CoNiM. Vital signs data from CoNiM were found to associate with type of presenting complaint, level of renal function and incidence of major clinical events. CoNiM also assisted in diagnosis by differentiating between patients with acute heart failure, stroke and sepsis (with sub-clustering of septic patients). In the meta-analysis, patients on multi-parameter CoNiM had a 39% decrease in risk of mortality (risk ratio [RR] 0.61; 95% confidence interval [95% CI] -0.39-0.95) when compared to patients with regular intermittent monitoring. There was a trend of reduced intensive care unit transfer (RR 0.86; 95% CI -0.67-1.11) and reduced rapid response team activation (RR 0.61; 95% CI 0.26-1.43). A trend towards reduced hospital length of stay was also found using weighted mean difference (WMD -3.32 days; 95% CI -8.82-2.19 days). CONCLUSION: There is evidence of clinical benefit in implementing CoNiM in non-intensive care unit patients. This review supports the use of multi-parameter CoNiM outside of intensive care unit with further large-scale RCTs required to further affirm clinical impact.

Hyperinsulinemia improves ischemic LV function in insulin resistant subjects.

BACKGROUND: Glucose is a more efficient substrate for ATP production than free fatty acid (FFA). Insulin resistance (IR) results in higher FFA concentrations and impaired myocardial glucose use, potentially worsening ischemia. We hypothesized that metabolic manipulation with a hyperinsulinemic euglycemic clamp (HEC) would affect a greater improvement in left ventricular (LV) performance during dobutamine stress echo (DSE) in subjects with IR. METHODS: 24 subjects with normal LV function and coronary disease (CAD) awaiting revascularization underwent 2 DSEs. Prior to one DSEs they underwent an HEC, where a primed infusion of insulin (rate 43 mU/m 2/min) was co-administered with 20% dextrose at variable rates to maintain euglycemia. At steady-state the DSE was performed and images of the LV were acquired with tissue Doppler at each stage for offline analysis. Segmental peak systolic velocities (Vs) were recorded, as well as LV ejection fraction (EF). Subjects were then divided into two groups based on their insulin sensitivity during the HEC. RESULTS: HEC changed the metabolic environment, suppressing FFAs and thereby increasing glucose use. This resulted in improved LV performance at peak stress, measured by EF (IS group mean difference 5.3 (95% CI 2.5-8) %, p = 0.002; IR group mean difference 8.7 (95% CI 5.8-11.6) %, p < 0.0001) and peak V s in ischemic segments (IS group mean improvement 0.7(95% CI 0.07-1.58) cm/s, p = 0.07; IR group mean improvement 1.0 (95% CI 0.54-1.5) cm/s, p < 0.0001) , that was greater in the subjects with IR. CONCLUSIONS: Increased myocardial glucose use induced by HEC improves LV function under stress in subjects with CAD and IR. Cardiac metabolic manipulation in subjects with IR is a promising target for future therapy.

Stunning and cumulative left ventricular dysfunction occurs late after coronary balloon occlusion in humans insights from simultaneous coronary and left ventricular hemodynamic assessment.

OBJECTIVES: We aimed to investigate whether left ventricular (LV) stunning could be detected late after coronary occlusion when coronary flow has normalized. BACKGROUND: Stunning and cumulative LV dysfunction after ischemia reperfusion has been clearly demonstrated in animal models but has been refuted in several angioplasty models in humans. However, these studies have assessed LV function early, during the reactive hyperemic phase, which might have augmented LV function. METHODS: We recruited 20 male subjects with single-vessel, type A coronary disease, and normal ventricular function. We simultaneously measured LV function with a conductance catheter and coronary flow velocity with a Combowire (Volcano Therapeutics, Inc., Rancho Cordova, California) at baseline (BL), for 30 s after a low-pressure coronary balloon occlusion for 1 min and again after 30 min, before a second balloon occlusion. RESULTS: Stunning was detected at 30 min after a 1-min balloon occlusion: stroke volume (ml) BL1: 88.4 (22.8) versus BL2: 79.4 (24.0), p = 0.04; tau (ms) BL1: 49.8 (9.0) versus BL2: 52.5 (8.9), p = 0.02, despite full recovery of coronary average peak velocity (p = 0.62). A second balloon occlusion caused cumulative LV dysfunction: stroke volume (ml) BO1: 77.3 (34.6) versus BO2 64.9 (22.9), p = 0.01. Reactive hyperemia significantly augmented early recovery systolic function: dP/dt max 30 s: +5.8% versus 30 min - 5.4%, p = 0.0009. CONCLUSIONS: Coronary occlusion for 1-min results in late stunning and cumulative LV dysfunction after 30 min. Reactive hyperemia augments stunned LV systolic function in early recovery.

Primary coronary microvascular dysfunction and poor coronary collaterals predict post-percutaneous coronary intervention cardiac necrosis.

BACKGROUND: An elevation in cardiac troponin-I (cTnI) after elective percutaneous coronary intervention (PCI) is because of cardiac necrosis and has prognostic implications. Primary microvascular dysfunction, evident before PCI, and paucity of coronary collaterals at baseline may influence cTnI. METHODS: We selected 22 patients awaiting elective PCI for a single-vessel, type-A coronary stenosis, with normal left ventricular function and a normal preprocedure cTnI. Intracoronary pressure and Doppler flow were measured during coronary balloon occlusion to derive microvascular resistance: Rp=[Pd(occl)-Pv]/APVoccl and collateral resistance: Rcoll=[Pa-Pd(occl)]/APVoccl, at each stage of PCI, where Pa is mean aortic pressure, Pv is central venous pressure, Pd(occl) is mean distal pressure, Rp is coronary microvascular resistance, Rcoll is coronary collateral resistance, and APVoccl is average peak velocity during coronary balloon occlusion. The resistance indices were compared with postprocedural cTnI levels measured at 24 h. RESULTS: There was a relationship between baseline Rp before PCI and elevated plasma cTnI levels at 24 h. Mean (SEM) Rp (mmHg/cm/s) increased for each cTnI tertile: T1 (mean cTnI 0.04 ng/ml): 1.3 (0.3), T2 (mean cTnI 0.13 ng/ml): 3.1 (0.4), and T3 (mean cTnI 2.5 ng/ml): 4.6 (0.7) (P=0.002). Baseline Rcoll (mmHg/cm/s) was similarly related to cTnI result and mean values showed an increasing trend: T1: 11.1 (1.9), T2: 14.5 (2.3), and T3: 19.5 (3.4) (P=0.12). Serial coronary balloon occlusions did not significantly alter Rp (P=0.82) or recruit coronary collaterals (P=0.69). CONCLUSION: Primary coronary microvascular dysfunction and poor collaterals at baseline are associated with post-PCI necrosis.

Remote ischaemic pre-conditioning does not attenuate ischaemic left ventricular dysfunction in humans.

AIMS: Remote ischaemic pre-conditioning (RIPC) reduces distant tissue ischaemia reperfusion injury. We tested the hypothesis that RIPC would protect the left ventricle (LV) from ischaemic dysfunction and stunning. METHODS AND RESULTS: Forty-two patients with single vessel coronary disease and normal LV function were prospectively recruited. Twenty patients had repeated conductance catheter assessment of LV function during serial coronary occlusions with/without RIPC and a further 22 patients underwent serial dobutamine stress echocardiography and tissue Doppler analysis with/without RIPC. Remote ischaemic pre-conditioning was induced by three 5 min inflations of a blood pressure cuff around the upper arm. RIPC did not diminish the degree of ischaemic LV dysfunction during coronary balloon occlusion (Tau, ms: 59.2 (2.8) vs. 62.8 (2.8), P = 0.15) and there was evidence of cumulative LV dysfunction despite RIPC [ejection fraction (EF), %: 54.3 (5.8) vs. 44.9 (3.7), P = 0.03]. Remote ischaemic pre-conditioning did not improve contractile recovery during reperfusion (EF, %: 51.7 (3.6) vs. 51.5 (5.7), P = 0.88 and Tau, ms: 55.6 (2.8) vs. 56.0 (2.0), P = 0.85). A neutral effect of RIPC on LV function was confirmed by tissue Doppler analysis of ischaemic segments at peak dobutamine (V(s), cm s(-1) control: 8.2 (0.4) vs. RIPC 8.1 (0.4), P = 0.43) and in recovery. CONCLUSION: RIPC does not attenuate ischaemic LV dysfunction in humans.

Cardiac Remote Ischemic Preconditioning in Coronary Stenting (CRISP Stent) Study: a prospective, randomized control trial.

BACKGROUND: Myocyte necrosis as a result of elective percutaneous coronary intervention (PCI) occurs in approximately one third of cases and is associated with subsequent cardiovascular events. This study assessed the ability of remote ischemic preconditioning (IPC) to attenuate cardiac troponin I (cTnI) release after elective PCI. METHODS AND RESULTS: Two hundred forty-two consecutive patients undergoing elective PCI with undetectable preprocedural cTnI were recruited. Subjects were randomized to receive remote IPC (induced by three 5-minute inflations of a blood pressure cuff to 200 mm Hg around the upper arm, followed by 5-minute intervals of reperfusion) or control (an uninflated cuff around the arm) before arrival in the catheter laboratory. The primary outcome was cTnI at 24 hours after PCI. Secondary outcomes included renal dysfunction and major adverse cardiac and cerebral event rate at 6 months. The median cTnI at 24 hours after PCI was lower in the remote IPC compared with the control group (0.06 versus 0.16 ng/mL; P=0.040). After remote IPC, cTnI was <0.04 ng/mL in 44 patients (42%) compared with 24 in the control group (24%; P=0.01). Subjects who received remote IPC experienced less chest discomfort (P=0.0006) and ECG ST-segment deviation (P=0.005) than control subjects. At 6 months, the major adverse cardiac and cerebral event rate was lower in the remote IPC group (4 versus 13 events; P=0.018). CONCLUSIONS: Remote IPC reduces ischemic chest discomfort during PCI, attenuates procedure-related cTnI release, and appears to reduce subsequent cardiovascular events.

Remote ischemic preconditioning stimulus does not reduce microvascular resistance or improve myocardial blood flow in patients undergoing elective percutaneous coronary intervention.

INTRODUCTION: Remote ischemic preconditioning (RIPC) may limit myocardial infarction by improving microvascular function and maintaining myocardial blood flow. We hypothesized that a RIPC stimulus would reduce coronary microvascular resistance and improve coronary blood flow during elective percutaneous coronary intervention (PCI). METHOD: We prospectively recruited 54 patients with multi-vessel disease (MVD = 32) or single vessel disease awaiting elective PCI. Patients with MVD had non-target vessel (NTV) index of micro-circulatory resistance (IMR) determined, before and after target vessel (TV) PCI (cardiac RIPC). The effect of arm RIPC on serial microvascular resistance (R(p)) was assessed in patients with single vessel disease. RESULTS: TV balloon occlusion did not alter the NTV IMR: 16.5 (12.4) baseline vs. 17.6 (11.6) post cardiac RIPC, P = 0.65 or hyperaemic transit time. Arm RIPC did not alter R( p) in patients with single vessel disease: Rp, mmHg.cm(-1).s( -1): 3.5 (1.9) baseline vs. 4.1 (3.0) post arm RIPC, P = 0.19 and coronary flow velocity remained constant. CONCLUSION: RIPC stimuli during elective PCI do not affect coronary microvascular resistance or coronary flow in humans.

Assessment of Myocardial Scar; Comparison Between F-FDG PET, CMR and Tc-Sestamibi.

OBJECTIVE: Patients with heart failure and ischaemic heart disease may obtain benefit from revascularisation if viable dysfunctional myocardium is present. Such patients have an increased operative risk, so it is important to ensure that viability is correctly identified. In this study, we have compared the utility of 3 imaging modalities to detect myocardial scar. DESIGN: Prospective, descriptive study. SETTING: Tertiary cardiac centre. PATIENTS: 35 patients (29 male, average age 70 years) with coronary artery disease and symptoms of heart failure (>NYHA class II). INTERVENTION: Assessment of myocardial scar by (99)Tc-Sestamibi (MIBI), (18)F-flurodeoxyglucose (FDG) and cardiac magnetic resonance (CMR). OUTCOME MEASURE: The presence or absence of scar using a 20-segment model. RESULTS: More segments were identified as nonviable scar using MIBI than with FDG or CMR. FDG identified the least number of scar segments per patient (7.4 +/- 4.8 with MIBI vs. 4.9 +/- 4.2 with FDG vs. 5.8 +/- 5.0 with CMR, p = 0.0001 by ANOVA). The strongest agreement between modalities was in the anterior wall with the weakest agreement in the inferior wall. Overall, the agreement between modalities was moderate to good. CONCLUSION: There is considerable variation amongst these 3 techniques in identifying scarred myocardium in patients with coronary disease and heart failure. MIBI and CMR identify more scar than FDG. We recommend that MIBI is not used as the sole imaging modality in patients undergoing assessment of myocardial viability.

A systematic approach to refractory angina.

PURPOSE OF REVIEW: Refractory angina pectoris is a common clinical condition associated with significant morbidity and mortality. This review aims to provide a systematic approach to the assessment and treatment of patients with this condition, focusing particularly on recent data. RECENT FINDINGS: Recent registry-based data have confirmed that a significant proportion of patients referred to cardiologists are suffering from refractory angina pectoris and that this is associated with poor quality of life and increased mortality. A number of novel antianginal drugs have been developed, although there has been little consensus on their use in the treatment of refractory angina. In addition, multiple interventional treatments are available but detailed evaluation is sparse. More recent studies have begun to address some of the major concerns associated with the use of these technologies, including the placebo effect. Studies comparing the different techniques are now beginning to emerge, allowing clinicians and patients to make informed choices. SUMMARY: A systematic approach is needed for the assessment and treatment of patients with refractory angina pectoris. Further research must include carefully designed randomized placebo-controlled trials to enable the role and application of the different techniques to be defined.

A study to assess changes in myocardial perfusion after treatment with spinal cord stimulation and percutaneous myocardial laser revascularisation; data from a randomised trial.

BACKGROUND: Spinal cord stimulation (SCS) and percutaneous myocardial laser revascularisation (PMR) are treatment modalities used to treat refractory angina pectoris, with the major aim of such treatment being the relief of disabling symptoms. This study compared the change in myocardial perfusion following SCS and PMR treatment. METHODS: Subjects with Canadian Cardiovascular Society class 3/4 angina and reversible perfusion defects as assessed by single-photon emission computed tomographic myocardial perfusion scintigraphy were randomised to SCS (34) or PMR (34). Twenty-eight subjects in each group underwent repeat myocardial perfusion imaging 12 months post intervention. Visual scoring of perfusion images was performed using a 20-segment model and a scale of 0 to 4. RESULTS: The mean (standard deviation) baseline summed rest score (SRS) and stress scores (SSS) were 4.6 (5.7) and 13.6 (9.0) in the PMR group and 6.1 (7.4) and 16.8 (11.6) in the SCS group. At 12 months, SRS was 5.5 (6.0) and SSS 15.3 (11.3) in the PMR group and 6.9 (8.2) and 15.1 (10.9) in the SCS group. There was no significant difference between the two treatment groups adjusted for baseline (p = 1.0 for SRS, p = 0.29 for SSS). CONCLUSION: There was no significant difference in myocardial perfusion one year post treatment with SCS or PMR.

Systolic and diastolic dyssynchrony are unaffected by revascularization of viable, dysfunctional myocardium.

BACKGROUND: There is little information about change in dyssynchrony with stress or after revascularization. METHODS: Subjects were recruited to this study if they were referred for revascularization of viable, dysfunctional myocardium. The inclusion criteria were ejection fraction of < or = 35%, sinus rhythm, and QRS duration < or = 120 msec. Tissue Doppler echocardiography with dobutamine stress was performed at baseline and 6 months after revascularization, and dyssynchrony indices (T-sd(c)) were calculated. RESULTS: A total of 25 patients completed a 6-month follow-up. The mean (standard deviation) resting systolic and diastolic T-sd(c) at baseline were 49.3 (18.2) msec and 41.0 (29.4) msec, respectively, with little change during dobutamine stress. After revascularization, there were no significant differences in mean T-sd(c) although there was a modest effect on systolic T-sd(c) at recovery (46.0 [23.1] msec baseline, 34.2 [20.1] msec follow-up, mean difference 11.8 msec, 95% confidence interval 0.3-23.4 msec, P = .046). CONCLUSION: Resting dyssynchrony in ischemic left ventricular dysfunction does not seem to be altered by dobutamine stress or revascularization.

An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial.

AIMS: Refractory angina pectoris leads to significant morbidity. Treatment options include percutaneous myocardial laser revascularization (PMR) and spinal cord stimulation (SCS). This study was designed to compare these two treatments. METHODS AND RESULTS: Subjects with Canadian Cardiovascular Society (CCS) class 3/4 angina and reversible perfusion defects were randomized to SCS (34) or PMR (34). The primary outcome was to compare exercise treadmill time on a modified Bruce protocol over 12 months. Thirty subjects in both groups completed 12-month follow-up. The mean total exercise time was 6.38 +/- 3.45 min in the SCS group and 7.41+/-3.68 min in the PMR group at baseline and 7.08 +/- 0.67 min in the SCS group and 7.12 +/-0.71 min in the PMR group at 12 months (95% confidence limits for the difference between the groups -1.02 to + 2.2 min, P = 0.466). There were no differences in angina-free exercise capacity, CCS class, and quality of life between treatments. SCS patients had more adverse events in the first 12 months, mainly angina or SCS system related (P = 0.001). CONCLUSION: There was little evidence of a difference in effectiveness between SCS and PMR in patients with refractory angina.