Complex robotic compared to manual coronary interventions: 6- and 12-month outcomes.

OBJECTIVES: To assess the long-term safety and efficacy of robotic percutaneous coronary revascularization for use in complex coronary lesions. BACKGROUND: Robotically assisted percutaneous coronary intervention (PCI) is safe and feasible in simple coronary lesions and has excellent short-term procedural and clinical outcomes for complex lesions; however, long-term safety and efficacy outcomes are unknown. METHODS: A total of 103 consecutive patients underwent a total of 108 robotic (R)-PCI procedures (age 68.1; 78.3% male) over 18 months, and 210 patients underwent a total of 226 manual (M)-PCI procedures (age 67.5; 78.1% male) during the same period. Patients were subsequently followed and both 6-month and 12-month major adverse cardiovascular events (MACE), comprised of any death, stroke, myocardial infarction, or target vessel revascularization, are reported and compared. RESULTS: There was no difference between the two groups with regard to overall MACE at 6 months (R-PCI 5.8% vs. M-PCI 3.3%, P = 0.51) or at 12 months (R-PCI 7.8% vs. M-PCI 8.1%, P = 0.92). There was no difference between the individual components of the primary combined endpoint at either time point. No access site complications occurred in either cohort that met BARC III or higher criteria. CONCLUSIONS: At the 6- and 12-month time points following R-PCI, no difference in clinical outcomes or safety measures was observed as compared to M-PCI.

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.

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.

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.

Fractured pericardial drain sheath: Removal technique.

Pericardiocentesis with drain placement provides relief of symptomatic pericardial tamponade. The use of a pericardial sheath preserves access to the pericardial space in the event a drain may need to be replaced or manipulated. Although rare, sheath fracture and migration into the pericardial space may be a complication of prolonged sheath maintenance. Prompt action may allow percutaneous retrieval of the foreign body and avoid the need for surgical exploration. We report a case of successful percutaneous retrieval of a fractured pericardial sheath. © 2015 Wiley Periodicals, Inc.

Invasive Cardiologists Are Exposed to Greater Left Sided Cranial Radiation: The BRAIN Study (Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures).

OBJECTIVES: This study sought to determine radiation exposure across the cranium of cardiologists and the protective ability of a nonlead, XPF (barium sulfate/bismuth oxide) layered cap (BLOXR, Salt Lake City, Utah) during fluoroscopically guided, invasive cardiovascular (CV) procedures. BACKGROUND: Cranial radiation exposure and potential for protection during contemporary invasive CV procedures is unclear. METHODS: Invasive cardiologists wore an XPF cap with radiation attenuation ability. Six dosimeters were fixed across the outside and inside of the cap (left, center, and right), and 3 dosimeters were placed outside the catheterization lab to measure ambient exposure. RESULTS: Seven cardiology fellows and 4 attending physicians (38.4 ± 7.2 years of age; all male) performed diagnostic and interventional CV procedures (n = 66.2 ± 27 cases/operator; fluoroscopy time: 14.9 ± 5.0 min). There was significantly greater total radiation exposure at the outside left and outside center (106.1 ± 33.6 mrad and 83.1 ± 18.9 mrad) versus outside right (50.2 ± 16.2 mrad; p < 0.001 for both) locations of the cranium. The XPF cap attenuated radiation exposure (42.3 ± 3.5 mrad, 42.0 ± 3.0 mrad, and 41.8 ± 2.9 mrad at the inside left, inside center, and inside right locations, respectively) to a level slightly higher than that of the ambient control (38.3 ± 1.2 mrad, p = 0.046). After subtracting ambient radiation, exposure at the outside left was 16 times higher than the inside left (p < 0.001) and 4.7 times higher than the outside right (p < 0.001). Exposure at the outside center location was 11 times higher than the inside center (p < 0.001), whereas no difference was observed on the right side. CONCLUSIONS: Radiation exposure to invasive cardiologists is significantly higher on the left and center compared with the right side of the cranium. Exposure may be reduced similar to an ambient control level by wearing a nonlead XPF cap. (Brain Radiation Exposure and Attenuation During Invasive Cardiology Procedures [BRAIN]; NCT01910272).

Renal frame count: a measure of renal flow that predicts success of renal artery stenting in hypertensive patients.

OBJECTIVES: Renal artery (RA) stenting can improve control of hypertension yet predicting clinical response remains difficult. We sought to determine the role of the renal frame count (RFC) (number of angiographic frames for contrast to reach distal renal parenchyma after initial RA opacification) as a predictor of improvement in blood pressure (BP) after RA stenting. METHODS: Renal flow was quantified in 68 consecutive patients (age 72.5 ± 9.1 years, 72% male) undergoing RA stenting for refractory hypertension (BP ≥ 140/90 mm Hg despite treatment with two or more antihypertensive medications) by measuring RFC pre-RA stenting. Significant renal artery stenosis (RAS) was defined as a stenosis ≥ 70% by visual estimation on angiography. Baseline and 6-month follow-up BP was recorded. Clinical response was defined by a drop in systolic blood pressure (SBP) >10 mm Hg on the same or fewer number of anti-hypertensive medications. RESULTS: Patients with RFC > 30 had SBP reduction (43.2 ± 25.7 mm Hg vs. 30.1 ± 31.3 mm Hg, P = 0.067), diastolic blood pressure reduction (9.1 ± 19.0 vs. -0.2 ± 13.4 mm Hg, P = 0.02), and mean arterial pressure reduction (23.8 ± 19.4 vs. 11.8 ± 16.1 mm Hg, P < 0.001) compared to patients with RFC ≤ 30. Furthermore, baseline RFC >30 was associated with a higher rate of clinical response to RA stenting (93.5% vs. 73%, P = 0.027). CONCLUSIONS: RFC can be used as a clinical predictor of response to RA stenting. RFC > 30 was associated with reduction in BP after RA stenting and was predictive of clinical response. RFC provides a useful intraprocedural tool in assessing the severity of RAS and predicts the likelihood of clinical response following RA stenting.

The potential effects of IGF-1 and GH on patients with chronic heart failure.

Heart failure (HF) is an important health concern with almost a quarter million deaths each year despite advances in medical therapy. Improvement of cardiac function has been shown to reduce morbidity and mortality in patients with HF. There has been recent interest in the growth hormone (GH) / insulin-like growth factor (IGF) pathway as a potential therapeutic target for patients with HF. Insulin-like growth factor 1 has been shown to augment cardiac function ex vivo and in animals. It was hypothesized that IGF-1/IGF-binding protein 3 levels might be able to provide prognostic benefits in patients with heart disease. Initial observational studies have shown significant benefits from GH supplementation including improved ejection fraction, increased exercise tolerance, and decreased New York Heart Association functional class. These results, however, were not replicated in randomized, controlled trials. Patients with advanced stages of HF might develop cachexia associated with a state of significant GH resistance. The lack of response to GH supplementation may be secondary to a deficiency in IGF-1, the effector hormone. Hypothetically, this group of patients could benefit from direct IGF-1 supplementation. Combined therapy with GH and IGF-1 is appealing; however, future trials in patients with advanced HF are warranted to prove this concept.

The effects of spirituality and religion on outcomes in patients with chronic heart failure.

Heart failure (HF) is a chronic progressive disease with marked morbidity and mortality. Patients enduring this condition suffer from fluctuations in symptom burden such as fatigue, shortness of breath, chest pain, sexual dysfunction, dramatic changes in body image and depression. As physicians, we often ask patients to trust in our ability to ameliorate their symptoms, but oftentimes we do not hold all of the answers, and our best efforts are only modestly effective. The suffering endured by these individuals and their families may even call into question one's faith in a higher power and portends to significant spiritual struggle. In the face of incurable and chronic physical conditions, it seems logical that patients would seek alternative or ancillary methods, notably spiritual ones, to improve their ability to deal with their condition. Although difficult to study, spirituality has been evaluated and deemed to have a beneficial effect on multiple measures including global quality of life, depression and medical compliance in the treatment of patients with HF. The model of HF treatment incorporates a multidisciplinary approach. This should involve coordination between primary care, cardiology, palliative care, nursing, patients and, importantly, individuals providing psychosocial as well as spiritual support. This review intends to outline the current understanding and necessity of spirituality's influence on those suffering from HF.

Comparison of long-term outcomes of drug-eluting stents and bare metal stents for saphenous vein graft stenosis.

OBJECTIVE: Our aim was to compare the long-term outcomes between drug-eluting stents and bare-metal stents for saphenous vein graft stenosis. BACKGROUND: The ideal type of stent to treat saphenous vein graft stenosis has not been clearly established. Short-term randomized controlled trial results comparing drug-eluting stents with bare-metal stents for saphenous vein graft stenosis are conflicting, intermediate-term retrospective studies and meta-analyses at two years suggest no difference in outcomes, and there are no long term follow-up studies. The need for long term follow-up data has become emerged with concern over late stent thrombosis. METHODS: 246 saphenous vein graft patients undergoing stenting from August 2002-December 2008 were studied. Overall survival and event-free survival were compared by Kaplan-Meier method. Hazard ratios (HR) were calculated by Cox-proportional hazards models. RESULTS: We treated 133 patients with DES (median follow-up four years) and 113 patients with BMS (median follow-up four years) for SVG stenosis. Overall survival (77.0% ± 3.9% vs. 70.6% ± 4.6%, log-rank P = 0.60) and MACE-free survival (57.5% ± 4.6% vs. 56.8% ± 4.9, log-rank P = 0.70) were not significantly different between the DES and BMS groups. Although BMS was associated with increased risk of target lesion revascularization (TLR) (freedom from TLR 85.2% ± 3.5% vs. 90.0% ± 3.0%, HR 2.07, 95% CI 0.97-4.42, log-rank P = 0.05), there was no significant difference in the freedom from myocardial infarction (86.7% ± 3.3% vs. 88.7% ± 3.2%, log-rank P = 0.39) or target vessel revascularization (77.1% ± 4.2% vs. 76.1% ± 4.2%, log-rank P = 0.33) between the two groups. CONCLUSIONS: Although mortality is not statistically different between DES and BMS for SVG stenosis, BMS is associated with increased risk of revascularization, thus suggesting the superiority of DES over BMS in the long term.

Testosterone therapy: treatment of metabolic disturbances in heart failure.

Heart failure (HF) is a complex progressive multisystem disease state with significant morbidity and mortality, which is not solely defined by pathology of the cardiovascular system but also is influenced by neurohormonal regulatory adjustments, peripheral cytokines, as well as hormonal and musculoskeletal dysfunction. Recent attention to the catabolic state found in patients with chronic heart failure has sparked interest in new potential targets for medical therapy. In particular, as many as 26% to 37% of men affected with HF have been found to be testosterone deficient. The severity of androgen deficiency has been shown to correlate with symptoms, functional class, and prognosis in patients with heart failure. Testosterone supplementation has been an accepted therapy in hypogonadal men with fatigue, muscle wasting, and sexual dysfunction for some time. Patients with severe HF show a similar constellation of symptoms and hypothetically would benefit from androgen replacement. Recent clinical studies have confirmed that functional, biochemical, and cardiopulmonary status in patients with HF have significant improvements when treated with testosterone supplementation. Symptomatic improvements may be obtainable in hypogonadal patients with HF who receive supplemental testosterone. This review seeks to outline the cardiovascular and peripheral effects of testosterone supplementation in patients with chronic HF.

Prognostic value of E/E' ratio in patients with unoperated severe aortic stenosis.

OBJECTIVES: The aim of this study was to evaluate the value of clinical and echo-Doppler parameters for the prognosis of unoperated severe aortic stenosis (AS). BACKGROUND: Approximately one-third of severe, symptomatic AS patients are denied surgery. Risk stratification of unoperated AS is important to determine eligibility for percutaneous aortic valve replacement, an evolving treatment option for AS patients deemed suboptimal for surgical aortic valve replacement. METHODS: We retrospectively compared clinical and echo-Doppler parameters between survivors and nonsurvivors of 125 patients with unoperated severe AS. RESULTS: The 1-year survival rate was 62.4%. In univariate analysis, survivors compared with nonsurvivors were younger (80.0 ± 10.9 years vs. 84.9 ± 11.1 years, p = 0.02), had a greater left ventricular ejection fraction (LVEF) (55 ± 15% vs. 50 ± 16%, p = 0.042), a higher left ventricular stroke volume (63 ± 19 ml vs. 56 ± 13 ml, p = 0.015), a lower E/E' ratio (12.19 ± 5.7 vs. 16.87 ± 7.43, p < 0.001), and a lower prevalence of E/E' > 15 (20% vs. 55%, p < 0.001). Symptomatic status was nonsignificantly different between survivors and nonsurvivors. In patients with an LVEF ≥ 50%, the subgroup with E/E' ≤ 15 and with E/E' > 15 had a 73.8% and 47.8% 1-year survival rate, respectively (p = 0.027). In the patients with an LVEF < 50%, the patients with E/E' ≤ 15 and those with E/E' > 15 demonstrated a 70.6% and 22.3% 1-year survival rate, respectively (p = 0.003). In multivariate analysis, significant predictors of mortality were E/E' > 15 and a combination of E/E' > 15 and B-type natriuretic peptide > 300 ng/ml: adjusted mortality risk 2.34 (95% confidence interval (CI) 1.27 to 4.33, p = 0.0072) and 2.59 (95% CI 1.21 to 5.55, p = 0.014), respectively. CONCLUSIONS: The E/E' ratio is the single most predictive clinical and echo-Doppler parameter in the assessment of overall prognosis in patients with unoperated severe AS. LVEF was a significant predictor of survival only in the univariate analysis. B-type natriuretic peptide alone was not a predictor of prognosis in the study population. However, the combination of E/E' and B-type natriuretic peptide is even more predictive of the 1-year prognosis.

Growth hormone and testosterone in heart failure therapy.

IMPORTANCE OF THE FIELD: Heart failure is a progressive disease affecting millions of people worldwide. The disease carries a significantly high morbidity and mortality risk. There are multiple pharmaceutical options to decrease this risk and prolong survival; however, despite optimization of medical management, several patients still await heart transplant, the only definitive cure for heart failure. To slow the progression of disease preventing need for transplantation, improve clinical symptoms, and improve heart failure outcomes, there is a persistent need to discover new therapeutic strategies. Of interest, low growth hormone and testosterone levels have been associated with a worsening degree of heart failure. Many studies have begun to show a clinical improvement in heart failure symptoms when these levels are corrected with hormonal therapy. These findings, although mixed, are promising and indicate that both testosterone and growth hormone therapy should be considered as adjunctive therapy in advanced heart failure patients. AREAS COVERED IN THIS REVIEW: This review discusses the physiology of both of these natural hormones, their therapeutic effects in heart failure and data from the published literature on studies using growth hormone or testosterone in patients with chronic heart failure. An extensive search of PubMed was conducted for topics on heart failure, growth hormone, insulin-like growth factor, testosterone, their physiology and pathophysiology, and trials in which they have been used as therapeutic interventions between 1989 and 2009. WHAT THE READER WILL GAIN: The reader will gain an understanding of the intricate balance of both of these hormones in the disease state of heart failure. In addition, the trials conducted using these hormones in pharmacotherapy for heart failure are discussed along with proposed theories for interstudy variability. TAKE HOME MESSAGE: Testosterone deficiency and growth hormone resistance are positively associated with a poor state of heart failure. Treatment of deficiency improves outcomes in heart failure; however, there is a significant paucity of data with regard to testosterone and heart failure as well as a significant amount of study variability with growth hormone and heart failure.

Medical management of hypertrophic cardiomyopathy.

Hypertrophic cardiomyopathy (HCM) is the most common genetically transmitted cardiomyopathy. The underlying cause of HCM has been attributed to a number of mutations within genes encoding primarily for sarcomeric proteins, which lead to a heterogeneous phenotype of left ventricular hypertrophy in the absence of other causes (eg, hypertension, aortic stenosis, or a discrete membranous subaortic stenosis). Symptoms may range from mild to severely limiting and consist of dyspnea and chest pain with exertion or at rest, syncope, or even sudden cardiac death (SCD). The majority of patients with HCM are treated medically. The primary aim of therapy is to reduce symptoms, but it should also address the risk of SCD. Throughout the years, numerous medical treatments have been used to achieve symptom control in these patients, and include medications such as ß-blockers, calcium channel blockers, amiodarone, disopyramide, and angiotensin receptor blockers. This review provides an overview of the current medical treatment of HCM.

Carcinoembryonic antigen and albumin predict survival in patients with advanced colon and rectal cancer.

HYPOTHESIS: Patients with stage IV colon or rectal cancer at initial diagnosis have characteristics that will predict subsequent survival time. DESIGN: Retrospective cohort study. SETTING: Urban county teaching hospital providing tertiary care. PATIENTS: Patients who came to the study institution with stage IV colon or rectal cancer between 1991-1999. MAIN OUTCOME MEASURE: Survival duration (days) after diagnosis. RESULTS: One hundred five patients were identified, with a median survival of 225 days (interquartile range, 72-688 days). Univariate analysis identified carcinoembryonic antigen (CEA) and albumin (ALB) as possible predictors for survival. Classification and regression tree analysis, a form of binary recursive partitioning, was used to identify optimal cut points for CEA (275 ng/mL) and ALB (2.7 g/dL) levels. Based on the cut points, patients were stratified into the following groups: (1) low CEA, high ALB; (2) low CEA, low ALB; (3) high CEA, high ALB; and (4) high CEA, low ALB. The median survival times for the first group and the fourth group were 287 days (interquartile range, 150-851 days) and 39 days (interquartile range, 14-168 days), respectively. A Kaplan-Meier analysis was performed, and a statistically significant difference was identified across all strata (P =.004). Additionally, groups 1 and 4 demonstrated the largest overall survival difference (P<.001). CONCLUSIONS: Patients with stage IV colon and rectal cancer with a CEA level greater than or equal to 275 ng/mL and an ALB level less than 2.7 g/dL had a significantly shorter survival time. Conversely, patients with an ALB level greater than or equal to 2.7 g/dL and a CEA level less than 275 ng/mL had a longer survival time.