30-Day Clinical Outcomes of a Self-Expanding Transcatheter Aortic Valve: The International PORTICO NG Study.

BACKGROUND: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access. OBJECTIVES: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk. METHODS: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory. RESULTS: A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm2. CONCLUSIONS: The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis [PORTICO NG]; NCT04011722).

Lipotamous cardiac disorders: two unsual cases and a review of the literature.

Tumors involving the heart and surrounding cardiac structures may be benign or malignant and can be classified as primary versus secondary in etiology. Primary cardiac tumors are rare lesions and the vast majority of these are benign neoplasms. More commonly, masses that involve the cardiac structures are secondary in nature. The focus of this manuscript will be those cardiac lesions characterized by a predominance of fatty cells. We present two unusual cases of patients with lipomatous cardiac disorders with extreme imaging and review the current literature on this topic.

Femoral angiogram prior to arteriotomy closure device does not reduce vascular complications in patients undergoing cardiac catheterization.

OBJECTIVES: To compare the efficacy of achieving hemostasis without vascular access site complications (VCs) in patients who did not undergo femoral angiogram (FA) prior to arteriotomy closure device (ACD) placement. BACKGROUND: Following coronary angiogram/percutaneous coronary intervention (CA/PCI), VCs increase morbidity and mortality. Previous studies in which an FA was highly recommended but not mandatory suggest that a predictor of VC is ACD use. METHODS: We retrospectively identified consecutive patients who underwent CA/PCI and attempted ACD deployment at our institution over a three-year period. These patients' medical and procedural records, angiogram films, and subsequent hospitalization records were reviewed to identify predetermined clinical outcomes. RESULTS: One thousand four hundred and twenty-two patients underwent CA/PCI from the transfemoral approach with ACD deployment. Seven hundred and eight (49.8%) patients did not undergo FA prior to ACD deployment. The use of ACD without FA guidance was not associated with an increased rate of combined measured clinical end-point; immediate ACD failure; retroperitoneal bleed; TIMI minor bleed; infectious complications; need for surgical intervention; or mortality (5.3 vs. 4.9; 2.7% vs. 2.2%; 1.4% vs. 0.9%; 0.5% vs. 0.4%; 0% vs. 0%; 0.1% vs. 0.1%; 0% vs. 0%, respectively, P = NS). CONCLUSION: We found no evidence that performing an FA prior to ACD placement as recommended by the manufacturer had any influence on the clinical success rate of ACD placement or rates of VCs. Therefore, ACD use without FA guidance in patients undergoing CA/PCI is an equally safe and effective method in successfully obtaining hemostasis without an increased risk of VCs.

Ethanol septal ablation for refractory ventricular tachycardia.

It is not uncommon for patients with severe ischemic or nonischemic cardiomyopathy to have recurrent ventricular arrhythmias. Many of these arrhythmias remain asymptomatic and can be controlled with beta-blockers or amiodarone. However, for a subset of these patients, the arrhythmia is persistent and requires antitachycardic pacing, internal defibrillation, or radiofrequency ablation therapy. We present a patient with end-stage nonischemic cardiomyopathy and recurrent ventricular tachycardia (VT) who was listed for cardiac transplantation. His VT was not responsive to medical management, and standard endocardial or epicardial VT radiofrequency ablation (VTRFA) procedures. Therefore, this patient underwent successful ethanol septal ablation (ESA) to obliterate the source of arrhythmia. Five days after the ablation procedure, he underwent cardiac transplantation. Therefore, this case presents a rare opportunity to review the use of ESA for refractory VT and an excellent opportunity to review the acute pathologic and histologic changes induced by ESA.

Clinical experience with rotational atherectomy in patients with severe left ventricular dysfunction.

OBJECTIVE: To evaluate the safety and efficacy of rotational atherectomy (RA) in patients with severe left ventricular (LV) dysfunction. BACKGROUND: RA, using a rotating diamond-crystal burr, is most commonly used to open lesions with severe calcification or diffuse disease that may prove difficult to cross or dilate. However, RA generates microparticular debris that may attenuate the coronary microcirculation, inducing transient myocardial stunning and LV dysfunction. In fact, the manufacturer does not support RA use in patients with severe LV dysfunction. METHODS: We retrospectively identified patients with a LV ejection fraction < 30% who underwent RA in our institution over a 4-year period. The medical records were reviewed and risk factors for cardiac disease were recorded. The procedural reports and subsequent hospitalization records were reviewed to identify predetermined positive and negative outcomes. RESULTS: Twenty-three patients (17 males) who underwent RA with severe LV dysfunction (mean LVEF 21.3%) were identified. The majority of these patients had multivessel coronary artery disease, hypertension, hyperlipidemia and/or tobacco use. Also, a substantial subset had diabetes, renal insufficiency and or in-stent restenosis. RA was 100% successful in opening the lesions without any in-hospital procedure-related mortality. Three patients experienced periprocedural myocardial infarctions. One patient died from malignancy during hospitalization. There were no major adverse cardiac events at 30 days. CONCLUSION: The transient effect of RA on ventricular function did not adversely affect short-term outcomes in our study population. These results suggest that RA, when performed by experienced operators, is safe and feasible in patients with severe LV dysfunction.

A transfusion-related acute myocardial injury.

It is not uncommon for patients to have adverse reactions during or after blood transfusions, as they occur in 1%-6% of all blood transfusions. Although many of the reactions are clinically insignificant, a small subset of adverse reactions can lead to serious illness and even death. The authors describe a healthy young man who exhibited an acute pulmonary injury reaction to a blood product transfusion. However, he also suffered significant myocardial insult, as documented by decreased left ventricular ejection fraction and a significant rise in cardiac biomarkers. Based on current understanding of the pathophysiologic mechanisms in transfusion-related acute lung injury, the authors hypothesized that coronary endothelial injury may have caused microvascular ischemia or have induced acute myocarditis. Empiric treatment with steroids and a beta blocker resulted in improved left ventricular function in our patient.

Coronary artery perforation during percutaneous coronary intervention: incidence and outcomes in the new interventional era.

BACKGROUND: Coronary artery perforation (CP) is a serious complication of percutaneous coronary intervention (PCI). We sought to define the incidence and outcome of CP given the advance in interventional techniques, devices and use of glycoprotein inhibitors (GP IIb/IIIa). METHODS: We retrospectively reviewed the records of patients who underwent PCI at our institution over a four-year period. The incidence of CP was derived from patient records and then confirmed by reviewing the angiogram. Perforations were classified as Type 1, 2, or 3, as previously defined. RESULTS: A total of 4,886 patients underwent PCI. Atherectomy devices were used in 329 patients and GP IIb/IIIa in 2,200 patients. Twenty-five CP were identified (0.5% incidence). Six were Type 1 (24%), 10 were Type 2 (40%), and 9 were Type 3 (36%). 13/25 (52%) of the CP were Type C Lesions, and 12/25 (48%) occurred in calcified vessels. All Type 1 perforations were caused by coronary wires and 4/6 CP occurred with the use of hydrophilic and extra stiff wires. Type 2 perforations were caused by coronary wires in 8/10 CP, and by stent deployment in 2/10. Two patients with Type 2 CP sustained a non-ST-elevation myocardial infarction. Type 3 perforations were caused by stent placement in 4/9 CP, 2/9 by atherectomy devices, and 3/9 by coronary wires. Four patients with Type 3 CP underwent pericardial drainage, 5 patients had a myocardial infarction and 2 patients died. CONCLUSION: Type 1 and 2 perforations are predominately caused by hydrophilic and stiff wires and do not require pericardial drainage or surgical intervention. Type 3 perforations are more often associated with stent and device use. A majority of Type 3 perforations can be initially managed by percutaneous methods.

Noninfectious constrictive pericarditis in a heart transplant recipient.

Acute rejection, infection, and allograft coronary artery disease have been recognized as the major causes of postoperative morbidity and mortality in cardiac transplant patients. More recently, pericardial and mediastinal complications have been recognized as a more common complication than previously believed. We describe a case of a heart transplant recipient admitted for apparent congestive heart failure exacerbation who was unresponsive to standard medical management of congestive heart failure and rejection. After further invasive evaluation, it was discovered the patient's condition was attributable to posttransplantation constrictive pericarditis. It is appropriate to consider this diagnosis in any postcardiac surgery (especially heart transplant recipients) in patients presenting with congestive heart failure exacerbations refractory to usual medical management.