Economic Burden of Inpatient Care for Mitral Regurgitation in Maryland.

BACKGROUND: Mitral regurgitation (MR) is the most common valvular disease in the United States and increases the risk of death and hospitalization. The economic burden of MR in the United States is not known. METHODS AND RESULTS: We analyzed inpatient hospitalization data from the 1 221 173 Maryland residents who had any in-state admissions from October 1, 2015, to September 30, 2019. We assessed the total charges for patients without MR and for patients with MR who underwent medical management, transcatheter mitral valve repair or replacement, or surgical mitral valve repair or replacement. During the study period, 26 076 inpatients had a diagnosis of MR. Compared with patients without MR, these patients had more comorbidities and higher inpatient mortality. Patients with medically managed MR incurred average total charges of $23 575 per year; MR was associated with $10 559 more in charges per year and an incremental 3.1 more inpatient days per year as compared with patients without MR. Both surgical mitral valve repair or replacement and transcatheter mitral valve repair or replacement were associated with higher charges as compared with medical management during the year of intervention ($47 943 for surgical mitral valve repair or replacement and $63 108 for transcatheter mitral valve repair or replacement). Annual charges for both groups were significantly lower as compared with medical management in the second and third years postintervention. CONCLUSIONS: MR is associated with higher mortality and inpatient charges. Patients who undergo surgical or transcatheter intervention incur lower charges compared with medically managed MR patients in the years after the procedure.

Chronic migraine with aura as a neurologic manifestation of an atrial myxoma - A case report.

INTRODUCTION AND IMPORTANCE: Atrial myxomas account for more than half of all cardiac tumors. While the symptoms of these are many, the most prominent among them being migraines, heart failure, dyspnea, and chest pain thereby making a diagnosis all the more difficult. CASE PRESENTATION: A 53-year-old woman presented with a recent onset of headaches with aura. The latter was triggered by exercise and physical exertion. Taking Ibuprofen 800 mg three times daily provided relief to the patient. Headaches were associated with photophobia and nausea. CLINICAL DISCUSSION: The patient had the typical triad of symptoms, namely (i) obstructive (light headedness, near syncope, dyspnea, chest pain), (ii) embolic (transient ischemic attacks - TIA, peripheral arterial claudication), and (iii) constitutional (fever, malaise, weight loss). Cerebral infarction is the most frequent complication. The patient had multiple embolic acute and sub-acute infarcts. The aura and headaches were resolved following resection of the myxoma. CONCLUSION: Atrial myxomas must enter the differential diagnosis in the case of a patient presenting with migraines associated with aura. In particular, those whose headaches increase with physical exertion require further investigation.

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.

BACKGROUND: The Evolut Low Risk Trial (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients) showed that transcatheter aortic valve replacement (TAVR) with a supra-annular, self-expanding valve was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. This finding was based on a Bayesian analysis performed after 850 patients had reached 1 year of follow-up. OBJECTIVES: The goal of this study was to report the full 2-year clinical and echocardiographic outcomes for patients enrolled in the Evolut Low Risk Trial. METHODS: A total of 1,414 low-surgical risk patients with severe aortic stenosis were randomized to receive TAVR or surgical AVR. An independent clinical events committee adjudicated adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS: An attempted implant was performed in 730 TAVR and 684 surgical patients from March 2016 to May 2019. The Kaplan-Meier rates for the complete 2-year primary endpoint of death or disabling stroke were 4.3% in the TAVR group and 6.3% in the surgery group (P = 0.084). These rates were comparable to the interim Bayesian rates of 5.3% with TAVR and 6.7% with surgery (difference: -1.4%; 95% Bayesian credible interval: -4.9% to 2.1%). All-cause mortality rates were 3.5% vs 4.4% (P = 0.366), and disabling stroke rates were 1.5% vs 2.7% (P = 0.119), respectively. Between years 1 and 2, there was no convergence of the primary outcome curves. CONCLUSIONS: The complete 2-year follow-up from the Evolut Low Risk Trial found that TAVR is noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke, with event rates that were slightly better than those predicted by using the Bayesian analysis. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients [Evolut Low Risk Trial]; NCT02701283).

Frailty Among Older Adults With Acute Myocardial Infarction and Outcomes From Percutaneous Coronary Interventions.

Background Frailty is a predictor of adverse outcomes after acute myocardial infarction (AMI). Methods and Results We estimated the prevalence of frailty among adults age ≥75 years admitted with AMI and examined the relationship between frailty, interventions, and mortality. We used the Premier Healthcare Database to identify older adults with primary diagnoses of AMI. We classified individuals as frail or not using the validated Claims-based Frailty Index. We described patients' characteristics and receipt of percutaneous coronary intervention stratified by frailty status. The primary outcome was hospital mortality. From 2000 to 2016, we identified 469 390 encounters for older patients admitted with AMI. The median age was 82 years, 53% were women, and 75% were white. The prevalence of frailty was 19%. Frail patients were less likely to receive percutaneous coronary intervention than nonfrail (15% versus 33%, P<0.001) and much less likely to receive coronary artery bypass surgery (1% versus 9%, P<0.001). There were far fewer interventions in individuals over age 85 years. Frailty was associated with higher mortality during AMI admission (unadjusted odds ratio [OR] 1.43, CI 1.39-1.46). While there was a differential benefit of the interventions because of frailty, frail patients had reduced hospital mortality with percutaneous coronary intervention (frail: OR 0.59, CI 0.55-0.63; nonfrail: OR 0.49, CI 0.47-0.50, P for interaction <0.001) and with coronary artery bypass surgery (frail: OR 0.77, CI 0.65-0.93; nonfrail: OR 0.74, CI 0.71-0.77, P for interaction <0.001) relative to no intervention. Conclusions In the United States, frailty is common among older patients admitted with AMI. While these vulnerable patients are at an increased risk for mortality, judicial use of revascularization with percutaneous coronary intervention in frail older patients still confers immediate survival benefit.

Fentanyl Delays the Platelet Inhibition Effects of Oral Ticagrelor: Full Report of the PACIFY Randomized Clinical Trial.

Morphine delays oral P2Y12 platelet inhibitor absorption and is associated with adverse outcomes after myocardial infarction. Consequently, many physicians and first responders are now considering fentanyl as an alternative. We conducted a single-centre trial randomizing cardiac patients undergoing coronary angiography to intravenous fentanyl or not. All participants received local anaesthetic and intravenous midazolam. Those requiring percutaneous coronary intervention (PCI) with stenting received 180 mg oral ticagrelor intra-procedurally. The primary outcome was area under the ticagrelor plasma concentration-time curve (AUC0-24 hours). The secondary outcomes were platelet function assessed at 2 hours after loading, measured by P2Y12 reaction units (PRUs) and light transmission platelet aggregometry. Troponin-I was measured post-PCI using a high-sensitivity troponin-I assay (hs-TnI). All participants completed a survey of pain and anxiety. Of the 212 randomized, 70 patients required coronary stenting and were loaded with ticagrelor. Two participants in the no-fentanyl arm crossed over to receive fentanyl for pain. In as-treated analyses, ticagrelor concentrations were higher in the no-fentanyl arm (AUC0-24 hours 70% larger, p = 0.03). Platelets were more inhibited by 2 hours in the no-fentanyl arm (71 vs. 113 by PRU, p = 0.03, and 25% vs. 41% for adenosine diphosphate response by platelet aggregation, p < 0.01). Mean hs-TnI was higher with fentanyl at 2 hours post-PCI (11.9 vs. 7.0 ng/L, p = 0.04) with a rate of enzymatic myocardial infarction of 11% for fentanyl and 0% for no-fentanyl (p = 0.08). No statistical differences in self-reported pain or anxiety were found. In conclusion, fentanyl administration can impair ticagrelor absorption and delay platelet inhibition, resulting in mild excess of myocardial damage. This newly described drug interaction should be recognized by physicians and suggests that the interaction between opioids and oral P2Y12 platelet inhibitors is a drug class effect associated with all opioids. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02683707 (: NCT02683707).

Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States.

BACKGROUND: We examined the outcomes of older adults undergoing nontrans-femoral (non-TF) transcatheter aortic valve replacement (TAVR) procedures including trans-apical (TA), trans-aortic (TAo), trans-subclavian (TSub), and trans-carotid (TCa) techniques. METHODS AND RESULTS: This is an observational study of all consecutive older patients who underwent non-TF TAVR for symptomatic severe AS with Edwards Sapien (ES), Medtronic CoreValve, ES3 or Lotus Valve at three centers in France and the United States from 04/2008 to 02/2017. Baseline characteristics and clinical outcomes were defined according to VARC-2 criteria. Of 857 patients who received TAVR, 172 (20%) had an alternative access procedure. Of these, 45 (26%) were TA, 67 (39%) TAo, 17 (10%) TSub, and 43 (25%) TCa procedures. The preference for non-TF access site was different between the two countries (US: TA 39%, TAo 52%, TSub 9%; TCa 0% vs. France: TA 9%, TAo 23%, TSub 11%, and TCa 57%, P-value < .001). Most patients who underwent TAo TAVR were older women (median age: TA 82, TAo 84, TSub 81, TCa 81, P-value = 0.043; female gender: TA 32 (27%), TAo 30 (55%), TSub 10 (41%), TCa 27 (37%), P-value = .021). The predicted Society of Thoracic Surgery risk of mortality was similar among groups (TA 7%, TAo 7%, TSub 6%, TCa 7%, P-value= .738). No differences were observed in the frequency of para-valvular leak, intra-procedural bleeding, vascular complications, conversion to open-heart surgery, or development of acute kidney injury. The highest in-hospital mortality was observed in the TAo group (TA 2%, TAo 15%, TSub 0%, TCa 2%, P-value = .014). However, hospital length of stay, one-month, and one-year mortality were similar among non-TF techniques. CONCLUSION: Although regional differences exist in the choice of alternative access techniques, centers with high technical expertise can provide a safe alternative to traditional TF TAVR. TAo TAVR was associated with higher in-hospital mortality than other non-TF approaches, and this may have reflected patient rather than procedural factors. All alternative access techniques had similar mortality rates and clinical outcomes at one-year follow-up. Trans-carotid access is safe and feasible compared to other non-TF access techniques.

Complications After Self-expanding Transcatheter or Surgical Aortic Valve Replacement.

Procedural complications following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) are usually reported as retrospective analyses. We report the first comparison of complications following SAVR or self-expanding TAVR from a prospectively randomized study of high-risk SAVR patients. Three hundred ninety-five TAVR and 402 SAVR patients were prospectively enrolled and randomized 1:1 to TAVR with a CoreValve bioprosthesis or a surgical bioprosthetic valve. The rates of major procedural and vascular complications occurring (periprocedurally (0-3 days) and early (4-30 days)) were compared for TAVR vs SAVR patients. All-cause mortality, stroke, myocardial infarction, and major infection were similar in both periods post procedure. Within 0-3 days, the major vascular complication rate was significantly higher with TAVR (P = 0.003). Life-threatening or disabling bleeding (P < 0.001), encephalopathy (P = 0.02), atrial fibrillation (P < 0.001), and acute kidney injury (P < 0.001) were significantly higher with SAVR. Non-iliofemoral TAVR approaches had a higher incidence of major or life-threatening or disabling bleeding at 0-3days (P < 0.05). Procedural complications unique to TAVR included coronary occlusion 0.5% (2) and TAVR pop outs 2.8% (11) with no valve embolizations. Pop outs were similar between iliofemoral 2.8% (9/324) and non-iliofemoral approaches 3.0% (2/66). Procedural complications unique to SAVR included aortic dissection 0.8% (3/357) and injury to other heart structures 2.0% (7/357). The procedural complication profiles of TAVR and SAVR are unique. Intraoperative deaths were seen in TAVR only. Mortality at 3 and 30 days was similar. The higher incidence of some complications likely reflects the greater invasiveness of SAVR in this aged high-risk population.

Transcatheter or Surgical Aortic Valve Replacement in Patients With Prior Coronary Artery Bypass Grafting.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are treatment options for aortic stenosis in patients with prior coronary artery bypass graft surgery. We assessed the major clinical outcomes of such patients enrolled in the CoreValve High Risk (CHR) study. METHODS: Of the 795 CHR study patients, 226 had prior coronary artery bypass graft surgery; 115 underwent TAVR and 111 underwent SAVR. The primary endpoint was a comparison of all-cause mortality at 1 year. Important secondary clinical endpoints were assessed. RESULTS: At 1 year, all-cause mortality was 9.6% for TAVR versus 18.1% for SAVR (p = 0.06); cardiovascular mortality was 7.0% for TAVR versus 13.8% for SAVR (p = 0.09). A combination of The Society of Thoracic Surgeons risk score greater than 7 and age greater than 80 years was a significant predictor of mortality, with TAVR demonstrating a survival advantage (p = 0.03). No differences were seen for stroke. The SAVR group had longer intensive care unit and hospital stays, increased incidence of acute kidney injury, life-threatening or disabling bleeding, and major adverse cardiac and cerebrovascular events (p < 0.05). Pacemaker implantation and paravalvular regurgitation were greater with TAVR at all timepoints. CONCLUSIONS: For patients with prior coronary artery bypass graft surgery and aortic stenosis, TAVR offers a significant morbidity advantage and a strong trend toward improved survival over SAVR at 1 year.

2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement.

BACKGROUND: The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. OBJECTIVES: Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. METHODS: Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. RESULTS: A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). CONCLUSIONS: In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Bronchopulmonary fistula closure with an Amplatzer Multi-Fenestrated Septal Occluder.

Bronchopulmonary fistula, a communication between the bronchial airway and the pleural space, is associated with increased morbidity and mortality often requiring surgical therapy. A successful closure of a fistula from the posterior trachea to the right apical pleural space in a 60-year-old man with a history of Barrett's esophagus, esophagectomy, multiple pulmonary infections, and right upper lobectomy using an Amplatzer Multi-Fenestrated Septal Occluder via a transbronchial approach is reported.

Prospective motion correction of X-ray images for coronary interventions.

A method for prospective motion correction of X-ray imaging of the heart is presented. A 3D + t coronary model is reconstructed from a biplane coronary angiogram obtained during free breathing. The deformation field is parameterized by cardiac and respiratory phase, which enables the estimation of the state of the arteries at any phase of the cardiac-respiratory cycle. The motion of the three-dimensional (3-D) coronary model is projected onto the image planes and used to compute a dewarping function for motion correcting the images. The use of a 3-D coronary model facilitates motion correction of images acquired with the X-ray system at arbitrary orientations. The performance of the algorithm was measured by tracking the motion of selected left coronary landmarks using a template matching cross-correlation. In three patients, we motion corrected the same images used to construct their 3D + t coronary model. In this best case scenario, the algorithm reduced the motion of the landmarks by 84%-85%, from mean RMS displacements of 12.8-14.6 pixels to 2.1-2.2 pixels. Prospective motion correction was tested in five patients by building the coronary model from one dataset, and correcting a second dataset. The patient's cardiac and respiratory phase are monitored and used to calculate the appropriate correction parameters. The results showed a 48%-63% reduction in the motion of the landmarks, from a mean RMS displacement of 11.5-13.6 pixels to 4.4-7.1 pixels.