Photoplethysmography using a smartphone application for assessment of ulnar artery patency: a randomized clinical trial.

BACKGROUND: Radial artery access is commonly performed for coronary angiography and invasive hemodynamic monitoring. Despite limitations in diagnostic accuracy, the modified Allen test (manual occlusion of radial and ulnar arteries followed by release of the latter and assessment of palmar blush) is used routinely to evaluate the collateral circulation to the hand and, therefore, to determine patient eligibility for radial artery access. We sought to evaluate whether a smartphone application may provide a superior alternative to the modified Allen test. METHODS: We compared the modified Allen test with a smartphone heart rate-monitoring application (photoplethysmography readings detected using a smartphone camera lens placed on the patient's index finger) in patients undergoing a planned cardiac catheterization. Test order was randomly assigned in a 1:1 fashion. All patients then underwent conventional plethysmography of the index finger, followed by Doppler ultrasonography of the radial and ulnar arteries (the diagnostic standard). The primary outcome was diagnostic accuracy of the heart rate-monitoring application. RESULTS: Among 438 patients who were included in the study, we found that the heart rate-monitoring application had a superior diagnostic accuracy compared with the modified Allen test (91.8% v. 81.7%, p = 0.002), attributable to its greater specificity (93.0% v. 82.8%, p = 0.001). We also found that this application had greater diagnostic accuracy for assessment of radial or ulnar artery patency in the ipsilateral and contralateral wrist (94.0% v. 84.0%, p < 0.001). INTERPRETATION: A smartphone application used at the bedside was diagnostically superior to traditional physical examination for confirming ulnar patency before radial artery access. This study highlights the potential for smartphone-based diagnostics to aid in clinical decision-making at the patient's bedside. Trial registration: Clinicaltrials.gov, no. NCT02519491.

Robotic technology in interventional cardiology: Current status and future perspectives.

Robotic technology has been utilized in cardiovascular medicine for over a decade, and over that period, its use has been expanded to percutaneous coronary and peripheral vascular interventions. The safety and feasibility of robotically assisted percutaneous cardiovascular interventions has been demonstrated in studies including simple to complex coronary lesions, and both iliac and femoropopliteal lesions. These reports have shown that robotically assisted PCI significantly reduces operator exposure to harmful ionizing radiation without a detrimental effect on procedural success or clinical efficacy. Additionally, the use of robotics has the intuitive benefit of alleviating the risk of orthopedic injuries faced by interventional operators. In addition to the interventional operator benefits, robotically assisted intervention has the potential for patient level benefit by allowing more accurate lesion length measurement, precise stent placement, and lower patient radiation exposure. However, further investigation is required to fully elucidate these potential benefits.

Does stent strut design impact clinical outcomes: comparative safety and efficacy of Endeavor Resolute versus Resolute Integrity zotarolimus-eluting stents.

UNLABELLED: Percutaneous coronary intervention is the most commonly performed method of revascularizing obstructive coronary artery disease. The impact of stent strut design on clinical outcomes remains unclear. The Endeavour Resolute (ER-ZES) and the Resolute Integrity (RI-ZES) zotarolimus-eluting stents utilize identical polymers and anti-proliferative agents, differing only in their respective strut design. This study assessed the comparative safety and efficacy of these two stents in unrestricted contemporary real-world practice. METHODS: A total of 542 patients were identified, corresponding to 340 ER-ZES and 480 RI-ZES. The primary endpoint was major adverse cardiac events (MACE) defined by a composite of death, nonfatal myocardial infarction and stroke. Secondary endpoints included post-procedural length of stay, in-stent restenosis, target lesion revascularization, target vessel revascularization, coronary artery bypass grafting and stent thrombosis. RESULTS: MACE occurred in 3.2% of the ER-ZES cohort and 5.0% of the RI-ZES cohort (p= 0.43). Adjusted analysis utilizing propensity score-adjusted odds ratio for MACE, was 1.37 (95% CI 0.46-4.07, p=0.57). The mortality rate (0.9% ER-ZES vs. 1.9% RI-ZES, p=0.59), non-fatal MI (2.3% ER-ZES vs. 3.1% RI-ZES, p=0.75) and stroke (0.0% ER-ZES vs. 0.3% RI-ZES, p=0.85) were not different. Additionally, there was no difference in any of secondary outcomes. CONCLUSIONS: The clinical performance and safety of both ER-ZES and RI-ZES were not statistically different, despite differences in stent strut design.

Granulocyte colony-stimulating factor therapy for stem cell mobilization following anterior wall myocardial infarction: the CAPITAL STEM MI randomized trial.

BACKGROUND: Small studies have yielded divergent results for administration of granulocyte colony-stimulating factor (G-CSF) after acute myocardial infarction. Adequately powered studies involving patients with at least moderate left ventricular dysfunction are lacking. METHODS: Patients with left ventricular ejection fraction less than 45% after anterior-wall myocardial infarction were treated with G-CSF (10 µg/kg daily for 4 days) or placebo. After initial randomization of 86 patients, 41 in the placebo group and 39 in the G-CSF group completed 6-month follow-up and underwent measurement of left ventricular ejection fraction by radionuclide angiography. RESULTS: Baseline and 6-week mean ejection fraction was similar for the G-CSF and placebo groups: 34.8% (95% confidence interval [CI] 32.6%-37.0%) v. 36.4% (95% CI 33.5%-39.2%) at baseline and 39.8% (95% CI 36.2%-43.4%) v. 43.1% (95% CI 39.2%-47.0%) at 6 weeks. However, G-CSF therapy was associated with a lower ejection fraction at 6 months relative to placebo (40.8% [95% CI 37.4%-44.2%] v. 46.0% [95% CI 42.7%-44.3%]). Both groups had improved left ventricular function, but change in left ventricular ejection fraction was lower in patients treated with G-CSF than in those who received placebo (5.7 [95% CI 3.4-8.1] percentage points v. 9.2 [95% CI 6.3-12.1] percentage points). One or more of a composite of several major adverse cardiac events occurred in 8 patients (19%) within each group, with similar rates of target-vessel revascularization. INTERPRETATION: In patients with moderate left ventricular dysfunction following anterior-wall infarction, G-CSF therapy was associated with a lower 6-month left ventricular ejection fraction but no increased risk of major adverse cardiac events. Future studies of G-CSF in patients with left ventricular dysfunction should be monitored closely for safety. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT00394498.

The role of vitamin D in chronic heart failure.

PURPOSE OF REVIEW: Despite advanced medical and device-based therapies, congestive heart failure (CHF) remains a major medical problem, associated with significant morbidity and mortality. Vitamin D deficiency is prevalent in CHF and is associated with poor outcomes. In this manuscript we review the evidence linking vitamin D deficiency and CHF and discuss potential mechanisms involved, as well the clinical data on vitamin D supplementation in CHF patients. RECENT FINDINGS: A clear relationship has been established between Vitamin D deficiency and increased mortality and morbidity in CHF. However, the mechanism involved is not clearly understood. Recent clinical and experimental evidence have identified the renin-angiotensin-aldosterone system and inflammatory cytokines as likely mediators that can lead to poor clinical outcomes via the cardiorenal syndrome. Clinical data on vitamin D supplementation also remain unestablished, with potential clinical benefits recently reported in patients with vitamin D deficiency. Nonetheless, large-scale randomized clinical trials are lacking. SUMMARY: Vitamin D is an emerging agent with tremendous potential and may represent a novel target for therapy in CHF. Further studies are needed to identify the mechanism(s) involved in the pathophysiology as well as to adequately examine the role of Vitamin D measurement and supplementation in patients with CHF.

The effect of statins on circulating endothelial progenitor cells in humans: a systematic review.

Numerous clinical trials have demonstrated early reductions in cardiovascular events occurring independently of the lipid-lowering effects of statins. These pleiotropic effects have been attributed to antiinflammatory properties, to atherosclerotic plaque stabilization, and more recently to mobilization of endothelial progenitor cells (EPCs). Our aim was to evaluate the evidence supporting statin-induced EPC mobilization in humans. We, therefore, performed a computerized literature search and systematic review of randomized trials to determine the effect of statin therapy and statin dosing on circulating EPC numbers. Our literature search identified 10 studies including 479 patients which met inclusion criteria with publication dates ranging from 2005 to 2011. Seven studies compared statin to nonstatin regimens whereas 3 studied low versus high-dose statin therapy. Reported increases in EPC number ranged from 25.8% to 223.5% with a median reported increase of 70.2% when compared to nonstatin regimens with 7 of 10 studies reporting significant increases. Considerable heterogeneity exists in regard to patient population, statin regimens, and the definition of an EPC within the identified studies. In conclusion, randomized studies in humans suggest that statin therapy mobilizes EPCs into the circulation. Larger randomized studies using uniform definitions are needed to definitively establish this effect.

Safety and Feasibility of a Novel, Second-Generation Robotic-Assisted System for Percutaneous Coronary Intervention: First-in-Human Report.

OBJECTIVES: The goal of this study is to evaluate the safety and efficacy of the second-generation robotic-assisted system CorPath GRX (Corindus) for percutaneous coronary intervention (PCI). BACKGROUND: The first-generation CorPath 200 robotic-assisted system for PCI is effective, but is limited by the lack of an active robotic guide-catheter control. The CorPath GRX device enables robotic guide-catheter manipulation, in addition to guidewire and balloon/stent delivery. However, there have been no clinical data reported with this device. METHODS: Consecutive patients with demonstrated obstructive coronary artery disease (>70% stenosis) and clinical indications for PCI were treated with the CorPath GRX system and enrolled in the study. The two co-primary endpoints were clinical procedural success (final TIMI 3 flow, and <30% residual stenosis without in-hospital major adverse cardiac event) and device technical success (robotic clinical procedural success without the need for unplanned manual assistance/conversion). RESULTS: The study enrolled 40 subjects (65.7 ± 11.9 years; 72.5% males; 54 lesions) with a high proportion of American College of Cardiology/American Heart Association type B2/C lesions (77.8%). Clinical procedural success and device technical success rates were 97.5% (n = 39 of 40) and 90.0% (n = 36 of 40), respectively. CONCLUSION: The second-generation CorPath GRX system for robotic-assisted PCI is safe and effective, and achieves high rates of clinical and technical success in a cohort of patients with complex coronary disease.

Robotically-assisted percutaneous coronary intervention: Reasons for partial manual assistance or manual conversion.

BACKGROUND: Robotically-assisted percutaneous coronary intervention (R-PCI) is feasible for simple coronary lesions. OBJECTIVES: To determine the frequency and reasons for partial manual assistance or manual conversion during R-PCI in clinical practice. METHODS: The CorPath 200 System (Corindus, Waltham, MA) enables the operator to sit in a radiation-shielded cockpit and remotely control intracoronary devices including guidewires, balloons, and stents. Consecutive R-PCI procedures performed over 18months were analyzed to identify reasons for planned or unplanned manual assistance or manual conversion, and categorized as due to 1) adverse event; 2) technical limitation of the robotic platform; or 3) limited guide catheter/wire support. RESULTS: During the study period, 108 R-PCI procedures (68.1±11.0years, 77.8% men, 69.4% elective PCI, 78.3% type B2/C lesions, and 50.3% left anterior descending/left main target lesion segment) were performed. High robotic technical success (91.7%) and clinical procedural success (99.1%) were achieved. Twenty procedures (18.5%) required either planned partial manual assistance (3.7%), unplanned partial manual assistance (7.4%), or manual conversion (7.4%). Among these procedures, manual assistance/conversion was required in 3 procedures for an adverse event (15%), 8 for technical limitation of the robotic platform (40%), and 9 for guide catheter/wire support issues (45%). CONCLUSIONS: High clinical success with R-PCI for a complex lesion cohort is possible with only occasional partial manual assistance or manual conversion. The majority of procedures requiring manual assistance/conversion were due to limited guide catheter/wire support or robotic platform limitations, rather than occurrence of adverse events.

A Bleeding Heart: Coronary-Cameral Fistula After Septal Myomectomy.

Coronary-cameral fistulas are relatively rare communications arising within the coronary vasculature entering into one of the four cardiac chambers. This case highlights a striking angiographic example of coronary-cameral fistula occurring after septal myomectomy, a complication occurring somewhat frequently with typical spontaneous resolution.

The Development of Robotic Technology in Cardiac and Vascular Interventions.

Robotic technology has been used in cardiovascular medicine for over a decade, and over that period its use has been expanded to interventional cardiology and percutaneous coronary and peripheral vascular interventions. The safety and feasibility of robotically assisted interventions has been demonstrated in multiple studies ranging from simple to complex coronary lesions, and in the treatment of iliofemoral and infrapopliteal disease. These studies have shown a reduction in operator exposure to harmful ionizing radiation, and the use of robotics has the intuitive benefit of alleviating the occupational hazard of operator orthopedic injuries. In addition to the interventional operator benefits, robotically assisted intervention has the potential to also be beneficial for patients by allowing more accurate lesion length measurement, stent placement, and patient radiation exposure; however, more investigation is required to elucidate these benefits fully.

Technique of delayed endovascular hemostatic closure for large bore vascular access site: A case series.

Large bore vascular access is becoming increasingly common for a range of interventional cardiovascular procedures. In the vast majority, percutaneous closure is preplanned and successfully achieved. However, for patients with percutaneous closure failure, or those requiring prolonged hemodynamic support, alternatives to percutaneous closure are required. Currently there are no approved vascular closure devices for delayed removal of large bore sheaths and therefore, manual hemostasis or surgical closure remains the only options. In this case series we present an endovascular approach to achieve delayed large bore vascular hemostasis, using either the contralateral femoral arterial access or radial arterial access.

Elevated Baseline Serum Fibrinogen: Effect on 2-Year Major Adverse Cardiovascular Events Following Percutaneous Coronary Intervention.

BACKGROUND: Elevated fibrinogen is associated with short-term major adverse cardiovascular events (MACE) after percutaneous coronary intervention, but the relation with late MACE is unknown. METHODS AND RESULTS: Baseline demographics and 2-year MACE were recorded among subjects undergoing nonemergent percutaneous coronary intervention. A total of 332 subjects (66.6±19.5 years, 69.9% male, 25.3% acute coronary syndrome) were enrolled. Two-year MACE (periprocedural myocardial infarction 9.0%, rehospitalization 6.3%, revascularization 12.7%, non-periprocedural myocardial infarction 4.5%, stent thrombosis 0.9%, stroke 1.8%, and death 0.6%) were associated with higher fibrinogen (352.8±123.4 mg/dL versus 301.6±110.8 mg/dL; P<0.001), longer total stent length (40.1±25.3 mm versus 32.1±19.3 mm; P=0.004), acute coronary syndrome indication (38.7% versus 17.8%; P<0.001), number of bare-metal stents (0.5±1.1 versus 0.2±0.5; P=0.002), and stent diameter ≤2.5 mm (55.8% versus 38.4%, P=0.003). No relation between platelet reactivity and 2-year MACE was observed. Fibrinogen ≥280 mg/dL (odds ratio [OR] 3.0, confidence interval [CI], 1.6-5.4, P<0.001), total stent length ≥32 mm (OR 2.2, CI, 1.3-3.8, P<0.001), acute coronary syndrome indication (OR 4.1, CI, 2.3-7.5, P<0.001), any bare-metal stents (OR 3.2, CI, 1.6-6.1, P<0.001), and stent diameter ≤2.5 mm (OR 2.0, CI, 1.2-3.5, P=0.010) were independently associated with 2-year MACE. Following a landmark analysis excluding periprocedural myocardial infarction, fibrinogen ≥280 mg/dL remained strongly associated with 2-year MACE (37.0% versus 17.4%, log-rank P<0.001). CONCLUSIONS: Elevated baseline fibrinogen level is associated with 2-year MACE after percutaneous coronary intervention. Acute coronary syndrome indication for percutaneous coronary intervention, total stent length implanted, and use of bare-metal stents or smaller-diameter stents are also independently associated with 2-year MACE, while measures of on-thienopyridine platelet reactivity are not.

Inappropriate ICD Shock From Perceived Ventricular Fibrillation During Balloon Manipulation at the Time of Percutaneous Coronary Intervention.

The authors demonstrate that device manipulation during percutaneous coronary intervention can result in "noise," which can be perceived as an arrhythmia resulting in an inappropriate shock. Although rare, this possibility should be considered when an operator encounters a difficult to traverse lesion in a patient with an ICD.

Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention).

OBJECTIVES: The aims of this study were to evaluate the feasibility and technical success of robotically assisted percutaneous coronary intervention (R-PCI) for the treatment of coronary artery disease (CAD) in clinical practice, especially in complex lesions, and to determine the safety and clinical success of R-PCI compared with manual percutaneous coronary intervention (M-PCI). BACKGROUND: R-PCI is safe and feasible for simple coronary lesions. The utility of R-PCI for complex coronary lesions is unknown. METHODS: All consecutive PCI procedures performed robotically (study group) or manually (control group) over 18 months were included. R-PCI technical success, defined as the completion of the procedure robotically or with partial manual assistance and without a major adverse cardiovascular event, was determined. Procedures ineligible for R-PCI (i.e., atherectomy, planned 2-stent strategy for bifurcation lesion, chronic total occlusion requiring hybrid approach) were excluded for analysis from the M-PCI group. Clinical success, defined as completion of the PCI procedure without a major adverse cardiovascular event, procedure time, stent use, and fluoroscopy time were compared between groups. RESULTS: A total of 315 patients (mean age 67.7 ± 11.8 years; 78% men) underwent 334 PCI procedures (108 R-PCIs, 157 lesions, 78.3% type B2/C; 226 M-PCIs, 336 lesions, 68.8% type B2/C). Technical success with R-PCI was 91.7% (rate of manual assistance 11.1%, rate of manual conversion 7.4%, rate of major adverse cardiovascular events 0.93%). Clinical success (99.1% with R-PCI vs. 99.1% with M-PCI; p = 1.00), stent use (stents per procedure 1.59 ± 0.79 with R-PCI vs. 1.54 ± 0.75 with M-PCI; p = 0.73), and fluoroscopy time (18.2 ± 10.4 min with R-PCI vs. 19.2 ± 11.4 min with M-PCI; p = 0.39) were similar between the groups, although procedure time was longer in the R-PCI group (44:30 ± 26:04 min:s vs. 36:34 ± 23:03 min:s; p = 0.002). Propensity-matched analysis confirmed that procedure time was longer in the robotic group (42:59 ± 26:14 min:s with R-PCI vs. 34:01 ± 17:14 min:s with M-PCI; p = 0.007), although clinical success remained similar (98.8% with R-PCI vs. 100% with M-PCI; p = 1.00). CONCLUSIONS: This study demonstrates the feasibility, safety, and high technical success of R-PCI for the treatment of complex coronary disease. Furthermore, comparable clinical outcomes, without an adverse effect on stent use or fluoroscopy time, were observed with R-PCI and M-PCI.

Robotics in percutaneous cardiovascular interventions.

INTRODUCTION: The fundamental technique of performing percutaneous cardiovascular (CV) interventions has remained unchanged and requires operators to wear heavy lead aprons to minimize exposure to ionizing radiation. Robotic technology is now being utilized in interventional cardiology partially as a direct result of the increasing appreciation of the long-term occupational hazards of the field. This review was undertaken to report the clinical outcomes of percutaneous robotic coronary and peripheral vascular interventions. Areas covered: A systematic literature review of percutaneous robotic CV interventions was undertaken. The safety and feasibility of percutaneous robotically-assisted CV interventions has been validated in simple to complex coronary disease, and iliofemoral disease. Studies have shown that robotically-assisted PCI significantly reduces operator exposure to harmful ionizing radiation without compromising procedural success or clinical efficacy. In addition to the operator benefits, robotically-assisted intervention has the potential for patient advantages by allowing more accurate lesion length measurement, precise stent placement and lower patient radiation exposure. However, further investigation is required to fully elucidate these potential benefits. Expert commentary: Incremental improvement in robotic technology and telecommunications would enable treatment of an even broader patient population, and potentially provide remote robotic PCI.

Progenitor Cells for Arterial Repair: Incremental Advancements towards Therapeutic Reality.

Coronary revascularization remains the standard treatment for obstructive coronary artery disease and can be accomplished by either percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery. Considerable advances have rendered PCI the most common form of revascularization and improved clinical outcomes. However, numerous challenges to modern PCI remain, namely, in-stent restenosis and stent thrombosis, underscoring the importance of understanding the vessel wall response to injury to identify targets for intervention. Among recent promising discoveries, endothelial progenitor cells (EPCs) have garnered considerable interest given an increasing appreciation of their role in vascular homeostasis and their ability to promote vascular repair after stent placement. Circulating EPC numbers have been inversely correlated with cardiovascular risk, while administration of EPCs in humans has demonstrated improved clinical outcomes. Despite these encouraging results, however, advancing EPCs as a therapeutic modality has been hampered by a fundamental roadblock: what constitutes an EPC? We review current definitions and sources of EPCs as well as the proposed mechanisms of EPC-mediated vascular repair. Additionally, we discuss the current state of EPCs as therapeutic agents, focusing on endogenous augmentation and transplantation.

A randomised study for optimising crossover from ticagrelor to clopidogrel in patients with acute coronary syndrome. The CAPITAL OPTI-CROSS Study.

Ticagrelor has been endorsed by guidelines as the P2Y12 inhibitor of choice in patients with acute coronary syndrome. Clinically, some patients on ticagrelor will require a switch to clopidogrel; however, the optimal strategy and pharmacodynamics effects of switching remain unknown. Patients with an indication to switch were randomly assigned to either a bolus arm (Clopidogrel 600 mg bolus followed by 75 mg daily, n=30) or a no-bolus arm (Clopidogrel 75 mg daily, n=30). Blood samples were collected at baseline, 12, 24, 48, 54, 60 and 72 hours (h) for assessment of platelet reactivity. The primary outcome was P2Y12 reactivity units (PRU) at 72 h. Secondary outcomes included: PRUs at each time point, incidence of high on-treatment platelet reactivity (HPR), major adverse cardiac events (MACE) and TIMI bleeding at 30 days. Serial PRUs increased after switching to clopidogrel in both groups. At 72 h, no difference in PRU was observed (165.8 ± 71.0 vs 184.1 ± 67.7, bolus vs no bolus, respectively, p=0.19). At 48 h the PRUs were significantly lower in the bolus arm (114 ± 73.1 vs 165.1 ± 70.5, respectively; p=0.0076) and at 72 h, there was a significant reduction in incidence of HPR (26.7 % vs 56.7 %, p=0.02). No differences in MACE or TIMI bleeding were observed. Although a bolus strategy was not associated with improved platelet inhibition at 72 h; at 48 h, platelet inhibition was superior with reduced incidence of HPR. Larger studies will be required to determine its clinical significance. Until then, decision for giving a bolus of clopidogrel at the time of a switch may in part be dependent on the indication for switching, especially if there are concerns for bleeding risk.

First Case of Robotic Percutaneous Vascular Intervention for Below-the-Knee Peripheral Arterial Disease.

Although the feasibility and safety of robotically assisted peripheral vascular intervention (PVI) for iliac and femoral peripheral arterial disease (PAD) have been demonstrated, robotic PVI for below-the-knee disease has never been reported. We present the first description of robotic PVI with the CorPath Vascular Robotic System (Corindus) for treating below-the-knee PAD. After contralateral sheath placement in the affected lower extremity, the entire procedure was performed robotically with remote control of the guidewire and angioplasty balloon. This feasibility report provides the opportunity to initiate further studies specifically focused on robotic PVI for below-the-knee PAD.

New developments in the clinical use of drug-coated balloon catheters in peripheral arterial disease.

Peripheral arterial disease (PAD) involving the lower extremity is a major source of morbidity and mortality. Clinical manifestations of PAD span the spectrum from lifestyle limiting claudication to ulceration and gangrene leading to amputation. Advancements including balloon angioplasty, self-expanding stents, drug-eluting stents, and atherectomy have resulted in high technical success rates for endovascular therapy in patients with PAD. However, these advances have been limited by somewhat high rates of clinical restenosis and clinically driven target lesion revascularization. The recent introduction of drug-coated balloon technology shows promise in limiting neointimal hyperplasia induced by vascular injury after endovascular therapies. This review summarizes the contemporary clinical data in the emerging area of drug-coated balloons.