Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%-100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%-100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%-99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%-99.0%)], without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.

BACKGROUND: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. METHODS: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; pnon-inferiority=0·034, psuperiority=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; pnon-inferiority=0·0058, psuperiority=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. INTERPRETATION: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. FUNDING: Abbott.

One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System.

Background: The FlexNav delivery system (DS) features a hydrophilic coating, stability layer, and integrated sheath to facilitate valve deployment in vessel diameters ≥5.0 mm. Methods: Data were pooled from 2 concurrent prospective, multicenter, premarket studies (PORTICO IDE [n = 147] and FlexNav EU CE Mark [n = 46]) to evaluate the safety and efficacy of the FlexNav DS to deliver the Portico valve in the Global FlexNav study. The primary end point was Valve Academic Research Consortium (VARC)-2 major vascular complication rate at 30 days. These outcomes were compared with those of the commercially available valve arm from the PORTICO IDE study. Results: The Global FlexNav study enrolled 193 high- or extreme-risk subjects for sugery. The mean age was 84.8 years, and 59.6% were women, with a mean Society of Thoracic Surgeons score of 5.2%. At 1 year, the rate of all-cause mortality was 5.2%, disabling stroke 2.1%, and mild or less paravalvular leak 99.4%. The mean aortic gradient was maintained at 7.4 ± 4.3 mm Hg through 1 year. At 1 year, 96.8% of subjects were classified as New York Heart Association class I or II. A pacemaker was implanted in 15.4% of subjects at 30 days and 18.4% at 1 year. The results of the Portico valve in the Global FlexNav study are comparable with the results from the commercially available valve arm in the PORTICO IDE study. Conclusion: The FlexNav DS was shown to be safe for the delivery of the Portico valve, which demonstrated sustained treatment benefits at 1 year with low rates of all-cause mortality or disabling stroke, improved heart failure symptoms, and excellent valve performance.

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).

Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System.

OBJECTIVES: The aim of this study was to characterize the safety profile of an intra-annular self-expanding valve with a next-generation low-profile delivery system (DS). BACKGROUND: Key design modifications to the FlexNav DS include the addition of a hydrophilic-coated, integrated sheath and stability layer to facilitate gradual, controlled deployment in vessels with diameter ≥5 mm. METHODS: Patients were pooled from 2 concurrent prospective, multicenter, single-arm studies (FlexNav DS arm of PORTICO IDE [Portico Re-Sheathable Transcatheter Aortic Valve System U.S. IDE Trial] [n = 134] and the FlexNav EU CE Mark Study [n = 46]) for the analysis. The primary endpoint was Valve Academic Research Consortium-2-defined major vascular complications at 30 days. Clinical outcomes and valve performance were assessed through 30 days by an independent clinical events committee and an echocardiography core laboratory, respectively. RESULTS: One hundred forty high-risk and 40 extreme-risk subjects enrolled between October 15, 2018, and December 10, 2019, from 28 sites in the United States, Australia, and Europe who underwent attempted transfemoral Portico valve implantation were included. The mean age was 85.1 ± 5.6 years, 60% were women, the mean Society of Thoracic Surgeons score was 5.3%, and 96.1% presented with ≥1 frailty factor. Technical device success was 96.7%. At 30 days, the rate of major vascular complications was 5.0%, with 4.4% of complications adjudicated as access site-related (3.3% transcatheter aortic valve replacement DS access site-related). Death (0.6%) and disabling stroke (1.1%) were rare. The rate of new permanent pacemaker implantation was 15.4%. Echocardiography revealed a mean gradient of 7.1 ± 3.2 mm Hg, mean valve area of 1.77 ± 0.41 cm2, and a 4.1% rate of moderate paravalvular leak at 30 days. CONCLUSIONS: Portico valve implantation with the FlexNav DS was associated with an excellent safety profile at 30 days.

Long-term clinical outcomes of real-world experience using sirolimus-eluting stents in saphenous vein graft disease.

OBJECTIVE: To evaluate the long-term clinical outcomes of patients undergoing percutaneous coronary intervention for saphenous vein graft (SVG) disease. Specifically, we compared clinical endpoints of patients who received sirolimus-eluting stents (SES) versus bare-metal stents (BMS) for SVG disease. BACKGROUND: A recent small randomized-controlled trial (RCT) reported increased mortality with the use of SES in SVG disease. METHODS: We retrospectively identified patients who underwent SES placement for a SVG lesion(s) at our institutions over a 4-year period. The procedural and medical records were reviewed to identify predetermined clinical outcomes. RESULTS: 318 patients who underwent SES placement for a SVG lesion were identified. 7 patients were lost to follow-up. 141/311 patients (45%) received SES, while 170/311 (55%) received BMS. At a mean follow-up of 34 months, there was a reduction in target lesion revascularization (TLR) (7% vs. 14%, P = 0.07) without an increased risk of mortality (6% vs. 12%, P = 0.06) in patients who received SES compared to patients who received BMS. When compared to the recent RCT's SES patients at long-term follow-up, our SES patients had significantly less mortality; rates of myocardial infarction, TLR, target vessel revascularization, and major adverse cardiac events; and were more likely to be taking dual antiplatelet and statin medications. CONCLUSION: Our results support that SES used in SVG lesions result in a reduction in TLR without an increased risk of mortality, and therefore may be an equally safe and feasible technique for revascularization with excellent long-term clinical outcomes. These patients may benefit from prolonged dual antiplatelet and statin medication regimens.

Percutaneous coronary intervention in patients with acute coronary syndrome: focus on bivalirudin.

Previously, indirect thrombin inhibitors such as unfractionated heparin or low-molecular-weight heparin were used as a standard anticoagulation during percutaneous coronary intervention to prevent procedural thrombotic complications but at a risk of hemorrhagic complications. More recently, bivalirudin, a member of the direct thrombin inhibitor class, has been shown to have 1) predictable pharmacokinetics, 2) ability to inhibit free- and clot-bound thrombin, 3) no properties of platelet activation, 4) avoidance of heparin-induced thrombocytopenia, and 5) a significant reduction of bleeding without a reduction in thrombotic or ischemic endpoints compared to heparin and glycoprotein IIbIIIa inhibitors when used in patients presenting with acute coronary syndrome who are planned for an invasive treatment strategy.

A new angle on the Angle of Louis.

Previous literature has stated that the center of the right atrium lies approximately 5 cm below the sternal angle regardless of body position. Our objective was to measure the distance from the Angle of Louis to various locations in the right atrium and determine whether these distances vary with patients' body habitus. The authors conducted a cross-sectional study with 52 consecutive patients who underwent computed tomography. The Angle of Louis was measured to various right atrial anatomic locations and was correlated with patients' body habitus characteristics. There was a positive correlation between patients' weight or body mass index and the distance of the Angle of Louis to right atrial locations. Therefore, using the traditional 5 cm in an obese patient can and usually will result in an underestimation of right atrial pressure. The authors suggest that in patients with body mass index > 35 kg/m2 (body surface area > 2.5 m2), a jugular venous column height at the clavicle is likely to indicate significantly elevated jugular venous pressure and should be considered abnormal. Therefore, further clinical assessment and subsequent therapeutic decisions of these morbidly obese patients with abnormal jugular venous pressures should be made accordingly.

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.

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.

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.

Late presentation of an anomalous origin of the left coronary artery from the pulmonary artery: case report and review.

Anomalous origin of the left coronary artery (LCA) from the pulmonary artery (ALCAPA) is a rare cause of ischemia, heart failure and/or sudden death. A premortem diagnosis beyond early childhood is exceedingly rare because over 90% of untreated infants die in the first 12 months of life. We present a case of an asymptomatic fourteen-year old male with ALCAPA diagnosed by multidetector computed tomography (MDCT) angiography, who was successfully treated by surgical coronary transfer of the ALCAPA with reimplantation of the LCA to the aortic root.

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.

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.