Complication Rates Following Cerebral and Coronary Angiography: Nationwide Analysis 2008-2014.

Catheter-based angiography is an essential procedure for the diagnosis and treatment of vascular complications in patients. Since cerebral and coronary angiography are similar techniques that utilize the same access sites and general principles, the associated risks overlap and should be identified to help direct patient care. The purpose of this study was to determine complication rates in a combined cohort of cerebral and coronary angiography patients, as well as conduct a comparative analysis of coronary and cerebral angiography complications. The National Inpatient Sample was queried from 2008 to 2014 to identify patients who underwent coronary or cerebral angiography. After assessment of baseline characteristics, complication rates, and disposition in the combined cohort, propensity matching was utilized to create sub-cohorts of coronary and cerebral angiography patients based on demographics and comorbidities. Comparative analysis of procedural complications and disposition was then performed. A total of 3,763,651 hospitalizations were included in our study cohort (3,505,715 coronary angiographies and 257,936 cerebral angiographies). The median age was 62.9 years, with females being 46.42%. The most prevalent comorbidities in the overall cohort were hypertension (69.92%), coronary artery disease (69.48%), smoking (35.64%), and diabetes mellitus (35.13%). Propensity matching demonstrated that the cerebral angiography cohort had lower rates of acute and unspecified renal failure (5.4% vs 9.2%, OR 0.57, 95% CI, 0.53-0.61, P < 0.001), hemorrhage/hematoma formation (0.8% vs 1.3%, OR 0.63, 95% CI, 0.54-0.73, P < 0.001), and equivalent rates of retroperitoneum hematoma formation (0.03% vs 0.04%, OR 1.49, 95% CI, 0.76-2.90, P = 0.247) and arterial embolism/ thrombus formation (0.3% vs 0.3%, OR 1.01, 95% CI, 0.81-1.27, P = 0.900). Our study showed both cerebral and coronary angiography have generally low rates of procedural complications. Matched cohort analysis demonstrated that cerebral angiography patients are at no greater risk for complications than coronary angiography patients.

Myosin Inhibition in Patients With Obstructive Hypertrophic Cardiomyopathy Referred for Septal Reduction Therapy.

BACKGROUND: Septal reduction therapy (SRT), surgical myectomy or alcohol ablation, is recommended for obstructive hypertrophic cardiomyopathy (oHCM) patients with intractable symptoms despite maximal medical therapy, but is associated with morbidity and mortality. OBJECTIVES: This study sought to determine whether the oral myosin inhibitor mavacamten enables patients to improve sufficiently to no longer meet guideline criteria or choose to not undergo SRT. METHODS: Patients with left ventricular (LV) outflow tract (LVOT) gradient ≥50 mm Hg at rest/provocation who met guideline criteria for SRT were randomized, double blind, to mavacamten, 5 mg daily, or placebo, titrated up to 15 mg based on LVOT gradient and LV ejection fraction. The primary endpoint was the composite of the proportion of patients proceeding with SRT or who remained guideline-eligible after 16 weeks' treatment. RESULTS: One hundred and twelve oHCM patients were enrolled, mean age 60 ± 12 years, 51% men, 93% New York Heart Association (NYHA) functional class III/IV, with a mean post-exercise LVOT gradient of 84 ± 35.8 mm Hg. After 16 weeks, 43 of 56 placebo patients (76.8%) and 10 of 56 mavacamten patients (17.9%) met guideline criteria or underwent SRT, difference (58.9%; 95% CI: 44.0%-73.9%; P < 0.001). Hierarchical testing of secondary outcomes showed significant differences (P < 0.001) favoring mavacamten, mean differences in post-exercise peak LVOT gradient -37.2 mm Hg; ≥1 NYHA functional class improvement 41.1%; improvement in patient-reported outcome 9.4 points; and NT-proBNP and cardiac troponin I between-groups geometric mean ratio 0.33 and 0.53. CONCLUSIONS: In oHCM patients with intractable symptoms, mavacamten significantly reduced the fraction of patients meeting guideline criteria for SRT after 16 weeks. Long-term freedom from SRT remains to be determined. (A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy [VALOR-HCM]; NCT04349072).

Prevalence of comorbidities and symptoms stratified by severity of illness amongst adult patients with COVID-19: a systematic review.

Introduction: We performed a systematic review of comorbidities and symptoms of adult patients with coronavirus disease 2019 (COVID-19) to evaluate comorbidities, symptoms, and severity. Material and methods: We searched databases and extracted comorbidities and symptoms from the included studies. We stratified the similar signs and symptoms in groups and on the basis of severity and compared them with stratified analysis. Individual case reports and case series with < 5 patients were excluded. Results: A total of 163 studies with 43,187 patients were included. Mean age was 54.6 years. There were significantly fewer women in the study (43.9% vs. 56.1%, p < 0.0001). Prevalent cardiovascular comorbidities were hypertension (31.9%), obesity (27.9%), hyperlipidemia (26.4%), smoking (18.9%), diabetes mellitus (17.2%), atherosclerotic disease (9.2%) and arrhythmia (5.0%). The most frequently reported constitutional symptoms of COVID-19 were fever (73.9%), fatigue (33.4%), malaise (29.9%), myalgia and/or arthralgia (19.2%), generalized weakness (19.0%), and chills (11.3%). For the cardiovascular system, chest pain and/or tightness were most often reported (19.6%), followed by palpitations (5.2%). Hypertension and diabetes were common in severe disease. Obesity and congestive heart failure were not observed in any non-severe cases. Severe cases compared to non-severe cases more frequently had fever (87.8% vs. 58.5%, p < 0.001), shortness of breath (47.4% vs. 20.6%, p < 0.001), cough (66.8% vs. 62.9%, p < 0.001), sputum production (35.4% vs. 26.5%, p < 0.001) and rhinorrhea (32.2% vs. 7.3%, p < 0.001). Conclusions: Hypertension, diabetes, and atherosclerotic diseases are common comorbidities across the world, with obesity as the second most common in the US and more common in men.

Comparative Analysis of Patient Characteristics in Cardiogenic Shock Studies: Differences Between Trials and Registries.

OBJECTIVES: This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients. BACKGROUND: Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients. METHODS: We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries. RESULTS: We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P < 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P < 0.001), dyslipidemia (36.4% vs 53.6%, P < 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P < 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P < 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P < 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P < 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P < 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P < 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P < 0.001) and 30-day mortality (39.9% vs 45.9%, P < 0.001) were lower in RCT patients. CONCLUSIONS: RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality.

Utilization Rates of Diagnostic and Therapeutic Vascular Procedures Among Patients Undergoing Lower Extremity Amputations in a Rural Community Hospital: A Clinicopathological Correlation.

BACKGROUND: Significant geographical variations exist in amputation rates and utilization of diagnostic and therapeutic vascular procedures before lower extremity amputations in the United States. The purpose of this study was to evaluate the rates of diagnostic and therapeutic vascular procedures in the year prior to amputation in a contemporary population and correlate with pathological findings of the amputation specimens. METHODS: A retrospective analysis was conducted of non-traumatic amputations from 2011 to 2017 at a rural community hospital. We reviewed the proportion of patients undergoing diagnostic (ankle brachial index with duplex ultrasound, computerized tomography angiogram and invasive angiogram) and therapeutic (endovascular and surgical revascularization) vascular procedures in the year prior to amputation. Prevalence of tissue viability and osteomyelitis were evaluated in all amputated specimens and atherosclerotic vascular disease (ASVD) was evaluated in major amputations. We also analyzed primary amputation rates among different subgroups. RESULTS: 698 patients were included with 248 (36%) major amputations and 450 (64%) minor amputations. Any diagnostic procedure was performed in 59% of the major amputations and 49% of the minor amputations (P = 0.01). Any therapeutic revascularization procedure was performed in 34% of the major amputations and 28% of the minor amputations (P = 0.08). The pathology of major amputation specimens revealed severe ASVD in 57% and mild-moderate ASVD in 27% of specimens. Tissue viability was significantly higher in major amputations (90% vs 30%, P = 0.04) and osteomyelitis was significantly higher in minor amputations (50% vs 14%, P = 0.03). Primary amputations were performed in 66% of major amputations, 72% of minor amputations, 81% with mild to moderate ASVD and 54% with severe ASVD. CONCLUSION: Diagnostic and therapeutic vascular procedures appear under-utilized for patients undergoing lower extremity amputations at a rural community hospital. ASVD rates and tissue viability imply that revascularization could be of significant benefit to avoid major amputation.

Role of Advanced Testing: Invasive Hemodynamics, Endomyocardial Biopsy, and Cardiopulmonary Exercise Testing.

Hypertrophic cardiomyopathy affects 0.5% of the population. Advanced testing is considered, including cardiac catheterization, endomyocardial biopsy, and cardiopulmonary exercise testing. Right and left heart catheterization provides essential hemodynamic data, identifies patients who might benefit from septal reduction therapy, and assesses for comorbidities. Pathologic analysis reveals ventricular hypertrophy, myocardial disarray, and endocardial and interstitial fibrosis. Routine endomyocardial biopsy is not recommended unless other conditions that cause hypertrophy need to be ruled out. Cardiopulmonary exercise testing provides useful physiologic data, allows monitoring of the response to medication and surgical interventions, estimates prognosis, and guides referral for orthotopic heart transplantation.

Sex Differences in Outcomes Following Percutaneous Coronary Intervention According to Age.

BACKGROUND: Women <50 years of age with coronary artery disease may represent a group at higher risk for recurrent ischemic events after percutaneous coronary intervention (PCI); however, no long-term, multicenter outcomes assessment exists in this population. METHODS AND RESULTS: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated the association of sex and age on cardiovascular-related outcomes in 10,963 patients (3797 women, 394 <50 years) undergoing PCI and followed for 5 years. Death, myocardial infarction, coronary artery bypass graft surgery, and repeat PCI were primary outcomes comprising major adverse cardiovascular events. Although procedural success rates were similar by sex, the cumulative rate of major adverse cardiovascular events at 1 year was higher in young women (27.8 versus 19.9%; P=0.003), driven largely by higher rates of repeat revascularizations for target vessel or target lesion failure (coronary artery bypass graft surgery: 8.9% versus 3.9%, P<0.001, adjusted hazard ratio 2.4, 95% confidence interval 1.5-4.0; PCI: 19.0% versus 13.0%, P=0.005, adjusted hazard ratio 1.6, 95% confidence interval 1.2-2.2). At 5 years, young women remained at higher risk for repeat procedures (coronary artery bypass graft surgery: 10.7% versus 6.8%, P=0.04, adjusted hazard ratio 1.71, 95% confidence interval 1.01-2.88; repeat PCI [target vessel]: 19.7% versus 11.8%, P=0.002, adjusted hazard ratio 1.8, 95% confidence interval 1.24-2.82). Compared with older women, younger women remained at increased risk of major adverse cardiovascular events, whereas all outcome rates were similar in older women and men. CONCLUSIONS: Young women, despite having less severe angiographic coronary artery disease, have an increased risk of target vessel and target lesion failure. The causes of this difference deserve further investigation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00005677.

The impact of previous revascularization on clinical outcomes in patients undergoing primary percutaneous coronary intervention.

While the impact of prior coronary artery bypass graft surgery (CABG) on in-hospital outcomes in patients with ST-elevation myocardial infarction (STEMI) has been described, data are limited on patients with prior percutaneous coronary intervention (PCI) undergoing primary PCI in the setting of an STEMI. The aim of the present study was to assess the effect of previous revascularization on in-hospital outcomes in STEMI patients undergoing primary PCI. Between January 2004 and December 2007, a total of 1649 patients underwent primary PCI for STEMI at four New York State hospitals. Baseline clinical and angiographic characteristics and in-hospital outcomes were prospectively collected as part of the New York State PCI Reporting System (PCIRS). Patients with prior surgical or percutaneous coronary revascularization were compared to those without prior coronary revascularization. Of the 1649 patients presenting with STEMI, a total of 93 (5.6%) had prior CABG, 258 (15.7%) had prior PCI, and 1298 (78.7%) had no history of prior coronary revascularization. Patients with prior CABG were significantly older and had higher rates of peripheral vascular disease, diabetes mellitus, congestive heart failure, and prior stroke. Additionally, compared with those patients with a history of prior PCI as well as those without prior coronary revascularization, patients with previous CABG had more left main interventions (24% vs 2% and 2%; P<.001), but were less often treated with drug-eluting stents (47% vs 61% and 72%; P<.001). Despite a low incidence of adverse in-hospital events, prior CABG was associated with higher all-cause in-hospital mortality (6.5% vs 2.2%; P=.012), and as a result, higher overall MACE (6.5% vs 2.7%; P=.039). By multivariate analysis, prior CABG (odds ratio, 3.40; 95% confidence interval, 1.15-10.00) was independently associated with in-hospital mortality. In contrast, patients with prior PCI had similar rates of MACE (4.3% vs 2.7%; P=.18) and in-hospital mortality (3.1% vs 2.2%; P=.4) when compared to the de novo population. Patients with a prior history of CABG, but not prior PCI, undergoing primary PCI in the setting of STEMI have significantly worse in-hospital outcomes when compared with patients who had no prior history of coronary artery revascularization. Thus, only prior surgical - and not percutaneous - revascularization should be considered a significant risk factor in the setting of primary PCI.

Determinants of bare-metal stent use in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Bare-metal stent (BMS) use in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has been associated with higher rates of adverse cardiac events, including target lesion and target vessel revascularization. The purpose of the present study was to determine which clinical characteristics predict BMS use in patients with STEMI undergoing primary PCI. Data were prospectively collected from all patients who underwent primary PCI for STEMI between January 1, 2004 and December 31, 2007 at four New York State academic medical centers. Demographics, baseline medical history, procedural characteristics, and in-hospital outcomes were compared in patients receiving DESs versus BMSs. Of the 1394 patients studied, a total of 290 (20.8%) patients received a BMS while 1104 (79.2%) received a DES. Patients receiving a BMS were more likely to have higher rates of prior coronary artery bypass graft surgery, prior PCI, peripheral vascular disease, and diabetes mellitus, and were more likely to be Hispanic and uninsured. They were also more likely to present with stent thrombosis and worse left ventricular ejection fraction (LVEF). Patients receiving a BMS had significantly longer hospital length of stay and a trend toward higher all-cause in-hospital mortality. In multivariate analysis, independent predictors of BMS use included uninsured status (versus private insurance) (odds ratio [OR], 2.81; 95% confidence interval [CI], 1.70-4.67), peripheral vascular disease (OR, 1.96; 95% CI, 1.08- 3.56), and LVEF (OR, 0.98; 95% CI, 0.97-0.99). In conclusion, in this analysis of a contemporary cohort of patients undergoing primary PCI, lack of health insurance, peripheral vascular disease, and worse LVEF were independently associated with higher rates of BMS implantation in patients with STEMI undergoing primary PCI.

Impact of severity of renal dysfunction on determinants of in-hospital mortality among patients undergoing percutaneous coronary intervention.

BACKGROUND: Chronic kidney disease (CKD) is a known prognostic indicator of poor outcomes following percutaneous coronary intervention (PCI) for coronary artery disease. However, it is unclear whether other predictors of mortality differ among patients with varying degrees of renal impairment. Thus, we aimed to identify determinants of in-hospital mortality which are specific to patients with preserved renal function, moderate CKD, or end stage renal disease (ESRD) on dialysis, undergoing PCI. METHODS: The study population included 25,018 patients who underwent PCI between January 1, 2004, and December 31, 2007, at four New York State hospitals. The primary endpoint of the study was in-hospital mortality. RESULTS: A total of 474 (1.9%) patients had ESRD on dialysis, 6,596 (26.4%) had moderate CKD (GFR<60 ml/min/1.73 m(2) ), and 17,948 (71.7%) had preserved renal function (GFR>60 ml/min/1.73 m(2) ). Patients with ESRD and moderate CKD were older, more often male, and had higher rates of prior coronary revascularization, peripheral vascular disease, congestive heart failure, prior stroke, and diabetes than those with preserved function. All-cause in-hospital mortality rates were significantly higher in patients with ESRD and moderate CKD compared to patients with GFR >60 ml/min/1.73 m(2) (2.1% and 1.3%, respectively vs. 0.3%, p < 0.001). In multivariable analysis, ESRD (OR: 3.68, 95% CI 1.62-8.36) and moderate CKD (OR: 2.92, 95% CI 1.91-4.46) were independently associated with higher rates of in-hospital mortality. Independent predictors of mortality were markedly distinct in each group and included female gender and myocardial infarction within the past 72 hr in the ESRD group, versus left ventricular ejection fraction, peripheral vascular disease, congestive heart failure, emergency PCI, and absence of prior PCI in the moderate CKD group and age, prior bypass graft surgery, congestive heart failure, emergency PCI, and absence of prior myocardial infarction in patients with preserved renal function. CONCLUSIONS: Patients with moderate CKD or ESRD undergoing PCI have an approximately threefold increase in the risk of in-hospital mortality compared with patients with preserved renal function, with radically different mortality predictors existing for varying levels of renal function.

Risk of death and myocardial infarction in patients with peripheral arterial disease undergoing percutaneous coronary intervention (from the National Heart, Lung and Blood Institute Dynamic Registry).

Patients with peripheral arterial disease (PAD) undergoing percutaneous coronary intervention (PCI) are at high risk for adverse cardiovascular events. Trends over time in outcomes with advances in PCI and medical therapy are unknown. We evaluated 866 patients with PAD in the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry undergoing PCI according to treatment eras: the early bare metal stent (BMS) era (wave 1, 1997 to 1998, n = 180), the BMS era (waves 2 and 3, 1999 and 2001 to 2002, n = 339), and the drug-eluting stent (DES) era (waves 4 and 5, 2004 and 2006, n = 347). We compared in-hospital and 1-year outcomes by recruitment era. In-hospital coronary artery bypass graft surgery rates were significantly lower in the later eras (3.9%, 0.9%, and 0.6% for the early BMS, BMS, and DES eras, respectively, p for trend = 0.005), and an increasing percentage of patients were discharged on aspirin, ß blockers, statins, and thienopyridines (p for trend <0.001 for all comparisons). Cumulative 1-year event rates in patients with PAD in the early BMS era, BMS era, and DES era for death were 13.7%, 10.5%, and 9.8% (p for trend = 0.21), those for myocardial infarction (MI) were 9.8%, 8.8%, and 10.0% (p for trend = 0.95), and those for repeat revascularization were 26.8%, 21.0%, and 17.2% (p for trend = 0.008). The 1-year adjusted hazard ratios of adverse events in patients with PAD using the early BMS era as the reference were 0.84 for death in the BMS era (95% confidence interval [CI] 0.46 to 1.55, p = 0.58) and 1.35 in the DES era (95% CI 0.71 to 2.56, p = 0.36), 0.89 for MI in the BMS era (95% CI 0.48 to 1.66, p = 0.72) and 1.02 in the DES era (95% CI 0.55 to 1.87, p = 0.95), and 0.63 for repeat revascularization in the BMS era (95% CI 0.41 to 0.97, p = 0.04) and 0.46 in the DES era (95% CI 0.29 to 0.73, p = 0.001). In conclusion, despite significant improvements in medical therapy and a decrease in repeat revascularization over time, patients with PAD who undergo PCI have a persistent high rate of death and MI.

Alcohol septal ablation for symptomatic hypertrophic obstructive cardiomyopathy in patients with prior coronary revascularization.

Alcohol septal ablation has become an acceptable alternative to surgical myectomy in patients with hypertrophic obstructive cardiomyopathy who remain significantly symptomatic after optimized medical management and meet strict anatomic criteria. Given the prevalence of coronary artery disease and the variable phenotypic penetrance and age at first diagnosis of hypertrophic cardiomyopathy (HCM), patients may undergo coronary revascularization before a firm diagnosis of HCM is made. Patients with prior revascularization in the form of percutaneous coronary intervention or coronary artery bypass grafting pose unique challenges when contemplating and performing alcohol septal ablation. We present two cases of alcohol septal ablation after prior coronary revascularization, and discuss relevant concerns regarding patient selection, procedural technique and consequent durability of clinical outcome.