The First 4 Years of Postmarketing Safety Surveillance Related to the MitraClip Device: A United States Food and Drug Administration MAUDE Experience.

OBJECTIVE: The MitraClip (Abbott) is a commercially available device to perform percutaneous transcatheter mitral valve repair (TMVR) for patients with symptomatic mitral regurgitation (MR). Recent data support its role in appropriately selected patients with functional MR, and its use is poised to increase. However, limited safety data in "real-world" practice are available after market introduction. METHODS: We queried all available adverse event reports from the publicly available Manufacturer and User Facility Device Experience (MAUDE) database including "injuries" and "deaths" from October 2013 (date of Food and Drug Administration [FDA] premarket approval) to September 2017 using the following search limits: brand name ("MitraClip") and product code ("NKM," a unique FDA designation linked to MitraClip). RESULTS: During the first 4 years after FDA approval, MAUDE received 200 death reports and 1666 injury reports containing 2974 unique adverse events. Of all death reports, 21% described deaths occurring >1 year post MitraClip and 30% included limited details. The top three known causes of death included complications requiring rescue high-risk surgery, clip detachment or unsuccessful clip placement, and damage to the valvular apparatus. Similar non-fatal events were reported. Additional procedures or surgical intervention were required in 227 injury events (8%). CONCLUSIONS: While injuries reported to the FDA have steadily increased with more widespread use of TMVR, device- or procedure-related death reports have accrued more slowly, corroborating a potential institutional or operator learning curve with this device. However, in light of incomplete and poor data quality, higher-fidelity systems of postmarketing safety surveillance are needed in the evaluation of emerging devices.

Slit in the Coronaries: A Case of Spontaneous Coronary Artery Dissection.

Spontaneous coronary artery dissection (SCAD) is a noniatrogenic epicardial coronary artery dissection unrelated to an atherosclerotic disease process. SCAD is responsible for a small percentage of acute coronary syndrome (ACS) cases. The left anterior descending (LAD) artery is the most common artery affected in SCAD, although any coronary artery can be affected. We present an interesting case of SCAD presenting as an ST-elevation myocardial infarction complicated with dissection extending to the left main and distal LAD requiring emergent coronary artery bypass grafting. Our case emphasizes the importance of considering SCAD as a cause for ACS, especially in young patients with minimal atherosclerotic risk factors. Also, a very high recurrence rate demands strict follow-up and multidisciplinary decision making in the population impacted with this rare entity.

A Case of Left Ventricular Noncompaction Presenting as Atrial Fibrillation.

Ventricular noncompaction is a rare congenital cardiomyopathy resulting from failure in cardiac embryogenesis. Both left and right ventricular involvement has been reported in nature. We present a case of a 69-year-old male presenting with atrial fibrillation complicated with in-hospital cardiac arrest in the setting of left ventricular noncompaction (LVNC). Our case demonstrates the fatal nature of this disease entity thus demanding a high index of suspicion for early detection and treatment.

Sushruta: Father of plastic surgery in Benares.

Sushruta has been regarded as one of the pioneers of surgery. He performed procedures with crude surgical instruments that paved the path for today's operations. However, his existence is shrouded in myth and mystery. Sushruta belonged to a rich heritage of learned scholars and practiced and taught surgery at Benares University around 600BC. His work is assembled into a monumental thesis, possibly the first text book on surgery, the 'Sushruta Samhita' where he describes surgical instruments, procedures, illnesses, medicinal plants and preparation, dissection and the study of human anatomy, embryology and fractures. Sushruta is perhaps best known for the nasal reconstruction flap which is still used in different versions. For all his contributions, he has been aptly titled 'Father of Plastic Surgery'.

Mycobacterial chylous ascites: report of three cases and systematic review.

BACKGROUND: Chylous ascites is an uncommon presentation of mycobacterial infection. METHODS: We report three cases of tubercular chylous ascites, and in addition, we performed a systematic review of the published literature for the clinical presentation, treatment, and outcomes of mycobacterial chylous ascites. We followed the PRISMA guidelines for the systematic review. RESULTS: A total of 33 cases (including three of ours) were included. The mean age of the reported cases was 32.54 ± 17.56 years, and a male predominance (76%) was noted. The predominant clinical features were abdominal distension, abdominal pain, fever and loss of appetite and weight. Mycobacterium tuberculosis (MTB) and Mycobacterium avium-intracellulare (MAC) infection were responsible for 16 and 15 cases, respectively. All patients with MAC related chylous ascites had HIV infection. The mechanisms were related to lymph nodal enlargement, constrictive pericarditis and remote scrofuloderma. Overall, there was 29% mortality. Use of anti-mycobacterial therapy with use of total parenteral nutrition, octreotide and medium chain triglyceride-based diet resulted in improvement in the rest of the cases. The cause of death in our case was anti-tubercular therapy-induced hepatitis; three deaths were due to disseminated mycobacterial infection, one due to cardiopulmonary failure and unknown in four patients. CONCLUSION: Chylous ascites due to mycobacterial infection is uncommon and associated with poor outcome. However, early diagnosis and nutritional management along with antimycobacterial therapy can improve outcome.

Association Between Hypothyroidism and Takotsubo Cardiomyopathy: Analysis of Nationwide Inpatient Sample Database.

BACKGROUND: Takotsubo Cardiomyopathy (TC), also called transient left ventricular (LV) ballooning syndrome, resembles myocardial infarction and is characterized by LV dysfunction in the absence of coronary artery disease. Hypothesis described for TC has been an intense social stressor, pheochromocytoma, thyrotoxicosis among others. We performed this study to analyze the association of hypothyroidism with TC. METHODS: We queried the Nationwide Inpatient Sample which represents 20% of all the United States hospital data for our study. We identified TC and hypothyroidism through their respective ICD9. Codes for years 2006-2012. SAS 9.4 was used to perform a chi-square analysis to find any statistical significance and p < 0.05 used to determine statistical significance. Significant differences were identified using odds ratio (OR) estimates. RESULTS: A total of 19,713 cases with TC were identified of which 17,340 (87.96%) were females and 2,373 (12.04%) were males. 3,272 patients with TC had diagnosis of hypothyroidism. There is statistically significant evidence of an association between TC and hypothyroidism (OR 2.21 (95% CI: 2.11- 2.31); p<0.0001). There is evidence of increased statistical significance of females having TC 5.24 (95% CI: 4.96-5.53; (p<0.0001)) compared to males, with an increased statistically significance of females with hypothyroidism having TC, OR 6.65 (95% CI: 5.57-7.93; p< 0.001) compared to males. CONCLUSION: There is an increased association of hypothyroidism, especially hypothyroidism for females with TC.

Prevalence and Predictive Value of Microvascular Flow Abnormalities after Successful Contemporary Percutaneous Coronary Intervention in Acute ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Although microvascular flow abnormalities have been observed following epicardial recanalization in acute ST-segment elevation myocardial infarction (STEMI), the prevalence and severity of these abnormalities in the current era of rapid percutaneous coronary intervention (PCI) has not been evaluated. The objective of this study was to assess microvascular perfusion (MVP) following successful primary PCI in patients with STEMI and how it affects clinical outcome. METHODS: In this single-center, retrospective study, 170 patients who successfully underwent emergent PCI for STEMI were assessed using real-time myocardial contrast echocardiography using a continuous infusion of intravenous commercial microbubbles (3% Definity). Three patterns of myocardial contrast replenishment were observed following intermittent high-mechanical index impulses: infarct zone replenishment within 4 sec (normal MVP), delays in contrast replenishment but normal plateau intensity (delayed MVP [dMVP]), and both delays in replenishment and reduced plateau intensity (microvascular obstruction [MVO]). Changes in left ventricular ejection fraction at 6 months and clinical event rate at 12 months (death, recurrent infarction, need for defibrillator placement, or heart failure admission) were compared. RESULTS: Normal MVP was seen in 62 patients (36%), dMVP in 49 (29%), and MVO in 59 (35%). Left anterior descending coronary artery infarct location was the only parameter independently associated with dMVP or MVO, independent of age, cardiac risk factors, door-to-dilation time, pre-PCI Thrombolysis In Myocardial Infarction flow grade, and thrombus burden. A dMVP pattern had a similar reduction in left ventricular ejection fraction as MVO at hospital discharge but had recovery of left ventricular ejection fraction at 6 months and a greater than fourfold lower event rate than the MVO group (P < .001). CONCLUSIONS: MVO and dMVP are frequently seen following contemporary successful PCI for STEMI, especially following left anterior descending coronary artery infarction. Despite a similar area at risk, a dMVP pattern has better functional recovery and clinical outcome than MVO.

All that looks like "Brugada" is not "Brugada": Case series of Brugada phenocopy caused by hyponatremia.

Brugada syndrome (BS), a life-threatening channelopathy associated with reduced inward sodium current due to dysfunctional sodium channels, is characterized by ST-segment elevation with downsloping "coved type" (type 1) or "saddle back" (type 2) pattern in V1-V3 precordial chest leads (1, 2). Brugada phenocopy, a term describing conditions inducing Brugada-like pattern of electrocardiogram (EKG) manifestations in patients without true BS, is an emerging condition (3). We describe a case series of Brugada phenocopy with hyponatremia.

A Case of Isolated Right Ventricle Noncompaction with ST-Elevation Chest Leads.

Non-compaction of ventricular myocardium (NCVM) is a rare genetic disorder caused by intrauterine arrest of endomyocardial development. Left ventricle is the usual site of NCVM with very rare reports of isolated right ventricular non-compaction (IRVNC). We describe a case of asymptomatic IRVNC with unique EKG changes.

Demographic parameters related to 30-day readmission of patients with acute myocardial infarction: Analysis of 2,371,867 hospitalizations.

BACKGROUND: Acute myocardial infarction (AMI) is the most common cause of mortality in the USA as per the data released by the CDC. Short term hospital readmissions account for a significant portion of health care budget and much of the focus recently has been on reducing 30day readmission rate aimed to identify the demographics associated with readmissions from AMI and major causes of readmissions. METHODS: We queried the Nationwide Inpatient Sample which represents 20% of all the United States hospital data for our study. AMI was identified through ICD9 Clinical Classification Software Code 100 for readmissions secondary to AMI for years 2009-2013. Chi-square was used for statistical analysis. RESULTS: A total of 2,371,867 admissions were identified with AMI and 15.87% of these readmitted within 30days after index hospitalizations due to any cause. Patients with age greater than 65years, female gender, Medicare and Medicaid insurances, low median income for zip code and metropolitan areas were associated with high 30day readmission rate. The most common identified cause of readmission from 2009-2011 was coronary atherosclerosis (15%) and from 2012-2013 the cause identified was congestive heart failure (13.5%) (p<0.001). CONCLUSION: Aggressive medical management needs to be targeted at this demography of patients and prevent the most causes of readmissions to reduce the cost and morbidity of patients admitted with AMI.

Bitot's Spots: Look at the Gut.

Vitamin A deficiency (VAD) can cause a range of ocular manifestations, including night blindness, conjunctival and corneal xerosis and keratomalacia. It is an important cause of preventable blindness. Although usually a result of malnutrition, VAD can accompany malabsorption syndrome. We report a case of VAD as manifested by Bitot's spots and eventually diagnosed to have celiac disease. It is, therefore, important to consider gastrointestinal diseases causing malabsorption in the evaluation of VAD.