Updates on Patent Foramen Ovale (PFO) Closure.

PURPOSE OF REVIEW: Patent foramen ovale (PFO) has been previously linked to left circulation thromboembolism and stroke. This review article aims to discuss the latest evidence, updated societal guidelines, diagnostic algorithms and novel therapeutic devices for PFO closure. RECENT FINDINGS: PFO closure for cryptogenic stroke and systemic embolization is supported by a large body of evidence and has a strong societal recommendation. Limited data are available for platypnea-orthodeoxia syndrome, although closure appears to be beneficial. Current data do not support routine closure for migraines and decompression Illness. Development of heart-brain teams can improve identification of patients most likely to benefit from closure, utilizing a combination of imaging test and risk score algorithms. Multiple novel devices aiming at reducing complications and improving the long-term impact of current available devices are being evaluated. PFO closure has significantly progressed over the last years, with new data supporting its superiority in reducing risk of recurrent embolic stroke in patients with PFO-related stroke. Additional clinical data are required to provide further refinements on patient selection and guidance on treatment of specific subgroups.

Preclinical comparative assessment of a dedicated pediatric poly-L-lactic-acid-based bioresorbable scaffold with a low-profile bare metal stent.

BACKGROUND: Polymer-based bioresorbable scaffolds (PBBS) have been assessed for coronary revascularization with mixed outcomes. Few studies have targeted pediatric-specific scaffolds. We sought to assess safety, efficacy, and short-term performance of a dedicated drug-free PBBS pediatric scaffold compared to a standard low-profile bare metal stent (BMS) in central and peripheral arteries of weaned piglets. METHODS: Forty-two devices (22 Elixir poly-L-lactic-acid-based pediatric bioresorbable scaffolds [BRS] [6 × 18 mm] and 20 control BMS Cook Formula 418 [6 × 20 mm]) were implanted in the descending aorta and pulmonary arteries (PAs) of 14 female Yucatan piglets. Quantitative measurements were collected on the day of device deployment and 30 and 90 days postimplantation to compare device patency and integrity. RESULTS: The BRS has a comparable safety profile to the BMS in the acute setting. Late lumen loss (LLL) and percent diameter stenosis (%DS) were not significantly different between BRS and BMS in the PA at 30 days. LLL and %DS were greater for BRS versus BMS in the aorta at 30 days postimplantation (LLL difference: 0.96 ± 0.26; %DS difference: 16.15 ± 4.51; p < .05). At 90 days, %DS in the aortic BRS was less, and PA BRS LLL was also less than BMS. Histomorphometric data showed greater intimal proliferation and area stenosis in the BRS at all time points and in all vessels. CONCLUSIONS: A dedicated PBBS pediatric BRS has a favorable safety profile in the acute/subacute setting and demonstrates characteristics that are consistent with adult BRSs.

Impact of chronic thrombocytopenia on in-hospital outcomes and healthcare resource utilization after transcatheter aortic valve replacement.

BACKGROUND: There is little data on the impact of chronic thrombocytopenia (CTP) on outcomes after transcatheter aortic valve repair (TAVR). Most studies are from single centers and mostly focused on postprocedure thrombocytopenia. OBJECTIVES: This study sought to report on the impact of CTP (>1 year) on in-hospital outcomes and healthcare resource utilization after TAVR. METHODS: From the National Inpatient Sample (NIS) between 2012 and 2015, we identified patients with CTP who underwent TAVR. A 1:1 propensity-matched cohort was created to examine in-hospital outcomes in patients with and without CTP. The primary outcome was in-hospital mortality. Secondary outcomes included postprocedure complications, length of stay, total cost, and discharge disposition. RESULTS: A matched pair of 4,300 patients with and without CTP were identified. Patients with CTP had higher in-hospital mortality as compared to no CTP patients (6.0 vs. 3.3%, p-value .007), increased postprocedure hemorrhage, platelet and blood transfusion, vascular complications, postop sepsis, and acute kidney injury. With regards to resource utilization, CTP patients had a longer length of stay, higher total cost and were more likely to be discharged to a facility (34.1 vs. 27.6%) other than home (All, p-value <.001). Subanalysis, however, revealed this difference in resource utilization was seen when patients developed postprocedure complications. CONCLUSION: This study demonstrated higher risk of in-hospital mortality, perioperative complications, and healthcare resource utilization in patients with baseline CTP undergoing TAVR. Further studies are required to investigate ways to improve the management of these patients.

SCAI publications committee manual of standard operating procedures.

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. The Society for Cardiovascular Angiography and Interventions (SCAI) has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the society's education, advocacy, and quality improvement initiatives. The publications committee is charged with oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Left atrial appendage occlusion using a Watchman device in a transplanted heart with biatrial anastomosis.

A percutaneous left atrial appendage (LAA) occlusion using a Watchman device was performed in a patient with prior biatrial anastomosis orthotopic heart transplant (OHT). Due to the anatomical changes following biatrial anastomosis, transesophageal echocardiography (TEE) imaging and transseptal puncture become technically challenging. We describe how the standard LAA views on TEE were obtained for device sizing, and how the transseptal puncture was modified to cross the scarred septum. This case demonstrates that LAA occlusion using a Watchman device in biatrial anastomosis OHT is safe and can successfully be done.

Trends in complete heart block after transcatheter aortic valve replacement: A population based analysis.

OBJECTIVES: To define the national rate of complete heart block (CHB) after transcatheter aortic valve replacement (TAVR) and its impact on procedural mortality, overall cost, and length of hospital stay. BACKGROUND: CHB leading to permanent pacemaker (PPM) implantation is one of the most common complications post TAVR. National data on the temporal trend of CHB post TAVR are lacking. METHODS: We queried the 2012-2014 National Inpatient Sample databases to identify all patients who underwent TAVR. Patients with preoperative pacemakers or implantable cardioverter-defibrillators were excluded. Association between CHB and outcomes, and overall trends in rate of CHB, PPM implantation, and inpatient mortality were examined. RESULTS: Of 35,500 TAVR procedures, 3,675 (10.4%) had CHB. Overall, occurrence of CHB significantly increased from 8.4% in 2012 to 11.8% in 2014 (adjusted OR per year: 1.23; 95% confidence interval [CI]: 1.17-1.29, P trend <0.001). During the same period, PPM implantation increased from 9.5 to 13.7% (adjusted OR per year: 1.22; 95% CI: 1.16-1.28, P trend <0.001). Patients with CHB had higher odds of in-hospital mortality when compared to patients without CHB (5.9% vs. 4.2%, adjusted OR: 1.32; 95% CI: 1.12-1.56; p = 0.001). Moreover, CHB was also associated with longer length of stay (LOS) and higher hospitalization cost. CONCLUSIONS: There was a significant increase in rates of CHB and PPM implantation over the study period. Development of CHB was associated with increased in-hospital mortality, LOS, and hospitalization cost.

Safety and efficacy of transcatheter aortic valve replacement for native aortic valve regurgitation: A systematic review and meta-analysis.

OBJECTIVE: The objective of this study was to analyze the available literature on using transcatheter aortic valve replacement (TAVR) for native aortic regurgitation (AR). BACKGROUND: Surgical aortic valve replacement is the gold standard therapy for native AR. TAVR has emerged as an alternative approach in high-risk patients. METHODS: MEDLINE, Scopus, and Cochrane CENTRAL were searched for reports of at least 5 patients undergoing TAVR for native AR. Outcomes included 30-day mortality, myocardial infarction, stroke, major bleeding, postprocedural moderate to severe AR, and device success. Pooled estimates were calculated using a random-effects model. Subgroup analysis and a meta-regression were performed to study the effects of study level covariates on outcomes. RESULTS: Nineteen studies (n =998 patients) were included. The rate of procedural success per Valve Academic Research Consortium - 2 (VARC-2) criteria was 86.2% (78.8%-92.2%]. Thirty-day mortality was 11.9% (9.4%-14.7%). Subgroup analysis showed the use of new generation valves was associated with lower 30-day mortality (P = 0.02) and higher device success (P = 0.009) compared with early generation valves. There was no significant difference (P = 0.13) in the rate of 30-day mortality between patients receiving purpose-specific [8.2% (4.3%-13.1%); I2 = 0%] and nonpurpose specific valves [13.0% (8.2%-18.6%); I2 = 25%]. However, device success was higher (P = 0.02) in patients who received purpose-specific valves [96.3% (92.2%-98.9%); I2 = 0%] compared with nonpurpose specific valves [84.4% (75%-91.9%); I2 =46%]. CONCLUSION: TAVR for native AR is associated with acceptable procedural success but increased early mortality. However, the safety and the efficacy of the procedure increased with newer valves.

SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke: The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists.

Until recently, evidence to support Patent Foramen Ovale (PFO) closure for secondary prevention of recurrent stroke has been controversial. Publication of high-quality evidence from randomized clinical trials and the subsequent FDA approval of two devices for percutaneous PFO closure is expected to increase the volume of PFO closure procedures not only in the United States but worldwide. As this technology is disseminated broadly to the public, ensuring the safe and efficacious performance of PFO closure is essential to mitigate risk and avoid unnecessary procedures. This document, prepared by a multi-disciplinary writing group convened by the Society for Cardiovascular Angiography and Interventions and including representatives from the American Academy of Neurology, makes recommendations for institutional infrastructure and individual skills necessary to initiate and maintain an active PFO/stroke program, with emphasis on shared decision making and patient-centered care.

Transcatheter interventions in adults with congenital heart disease: Surveys from the Society for Cardiovascular Angiography and Interventions to identify current patterns of care and perception on training requirements.

BACKGROUND: Interventional catheterization is central to the care of Adults with Congenital Heart Disease (ACHD). Current standards for care provision and training in ACHD intervention are lacking. We sought to examine trends in current practice and training among interventionalists. METHODS: We analyzed the results of two separate international surveys in June 2016. One was sent to all active members from the Society of Cardiovascular Angiography and Interventions (SCAI) who self-identified Structural Heart Disease or Congenital Heart Disease as a practice area. The second survey was conducted through the Pediatric Interventional Early Career Society (PICES) aimed at pediatric and adult congenital interventionalists in their first seven years after training. The total survey sample sizes were 1,535 and 112, respectively. RESULTS: Response rates for the SCAI and PICES surveys were 15% (237/1,535) and 75% (84/112), respectively. Most respondents (74%) worked at institutions with pediatric and adult facilities in proximity (major medical centers). While 75% of SCAI respondents believed complex transcatheter procedures should be performed by ACHD-trained interventionalists or multidisciplinary teams, only 32% reported such care is being provided at the present time. Most pediatric and adult cardiologists surveyed (73%) do not believe current interventional fellowships provide adequate training for proficiency in ACHD interventions. CONCLUSIONS: ACHD management remains underdeveloped in relative terms, particularly in the United States. Significant gaps in interventional standards of practice and future training needs were recognized by this study. Our survey should serve as an impetus to establish training guidelines for physicians who seek to perform ACHD interventions.

Hybrid pulmonary artery plication followed by transcatheter pulmonary valve replacement: Comparison with surgical PVR.

Objective/Background Historically, the sole option for patients with a dysfunctional native right ventricular outflow tract (RVOT) requiring re-establishment of pulmonary competence has been surgical PVR. We sought to compare early outcomes of hybrid pulmonary valve replacement (PVR) combining surgical plication of the main pulmonary artery followed by transcatheter PVR, with a contemporary cohort of surgical PVR patients. Methods Retrospective chart analysis of all patients with a dilated native RVOT eligible for surgical PVR over 36 months was performed. The cohorts included patients with previous tetralogy of Fallot repair (n = 14), and previous intervention for congenital abnormality of the pulmonary valve (n = 7). Results Twenty-one patients with a dysfunctional native RVOT met criteria for PVR; 8 using the hybrid procedure (group 1: age, 31.5 +/- 17.4 years) and 13 with cardiopulmonary bypass (CPB) (group 2: age, 31 +/- 18.4 years). Valve delivery was successful in all patients with no procedural mortality. Group 1 had a lesser requirement for blood products (P =< 0.001) and a trend toward shorter hospital stay and higher post-operative hemoglobin. No patients in group 1 received inotropic support post-operatively compared to 54% of patients in group 2. Mean follow-up was 3.4 months for group 1 and 13.6 months for group 2 with the average peak gradient across the RVOT of 20.1 and 15.1 mm Hg respectively (P = 0.12), all with no more than mild PI. Conclusions Transcatheter hybrid PVR following RVOT plication provides a reasonable alternative to surgical PVR particularly in higher risk cohorts, reducing possible longer-term consequences of repeated runs of CPB. © 2016 Wiley Periodicals, Inc.

Platypnea-Orthodeoxia in Patients on Hemodialysis: A New Approach to Its Pathophysiology and Implications for Treatment.

Platypnea-orthodeoxia is a poorly understood clinical syndrome resulting in dyspnea and hypoxemia in the upright position, which diminishes with recumbency. Recognition of the disease is limited by its low prevalence and decreased awareness among clinicians. However, understanding the disease, its pathophysiology, its clinical presentation, and the possible therapeutic options is vital in the management of these patients. Here, we present 2 cases of platypnea- orthodeoxia where oxygen saturations worsened with hemodialysis. After highlighting the common features in the clinical pattern of each patient, we present a pressure-mediated pathophysiologic mechanism (in contrast to a previously reported morphologically based hypothesis) to explain the characteristic effects of hemodialysis on hypoxia in platypnea-orthodeoxia. We present a novel diagnostic approach using balloon occlusion testing when the diagnosis is unclear and illustrate how treatments can be tailored to the comorbidities of a specific patient.