Balloon pulmonary angioplasty in the current era of CTEPH treatment: How did we get here?

Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by persistent organized thromboembolic obstruction of the pulmonary arteries from incompletely resolved pulmonary embolism. The treatment of choice is pulmonary thromboendarterectomy (PTE) surgery and all patients should be evaluated for operability candidacy. Despite advancements in PTE technique allowing more segmental-subsegmental surgeries, up to a third of patients with CTEPH may still be considered inoperable. Over the past decade, there have been increasing treatment options for these inoperable CTEPH patients. Balloon pulmonary angioplasty (BPA) is a percutaneous-based interventional treatment option for select CTEPH cases. Early BPA experiences were plagued by high complication rates, but further refinements in technique and equipment pioneered by Japan led to the worldwide spread and adoption of BPA. Multiple centers have shown that patients experience significant improvements in hemodynamics, quality of life, exercise capacity, and survival with BPA treatment. There remain many questions on best practices, but BPA has evolved into a pivotal cornerstone of CTEPH treatment.

Percutaneous Interventional Therapy for Chronic Thromboembolic Pulmonary Hypertension.

Chronic thromboembolic pulmonary hypertension is a form of precapillary pulmonary hypertension resulting from the incomplete resolution of pulmonary thromboemboli and formation of chronic, fibrotic, flow-limiting obstructions within the pulmonary vasculature. The progression of chronic thromboembolic disease is associated with the development of pulmonary hypertension, right heart failure, and diminished patient function. Surgical pulmonary thromboendarterectomy to extract thromboembolic disease is curative and the primary treatment option for chronic thromboembolic pulmonary hypertension. For patients who are not surgical candidates, balloon pulmonary angioplasty (BPA) is a percutaneous treatment option that uses angioplasty techniques to dilate diseased pulmonary arteries, disrupt organized flow-limiting obstructions, revascularize underperfused lung regions, improve pulmonary vascular hemodynamics, and restore patient function. BPA has undergone refinement and worldwide adoption since its inception, leading to advancements in the equipment used, technical approach, and complication management for each procedure. The approach to modern BPA, its attendant complications, and contemporary treatment outcomes are discussed in this state-of-the-art review.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions (SCAI) 2021 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 annually for high-level field-wide discussions. The 2021 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. 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 dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

A case report of cardiogenic shock from takotsubo cardiomyopathy with left ventricular outflow tract obstruction: fundamental lessons in cardiac pathophysiology.

BACKGROUND: A subset of patients with takotsubo cardiomyopathy will develop significant dynamic left ventricular outflow tract (LVOT) obstruction leading to cardiogenic shock. However, traditional therapies for cardiogenic shock that focus on increased inotropy and afterload reduction can be detrimental in this situation. CASE SUMMARY: We describe a 71-year-old woman who presented to the emergency department with typical, substernal chest pain found to be hypotensive with ST-elevations in the lateral leads. Coronary angiography showed no significant coronary artery disease, but a left ventriculogram demonstrated takotsubo cardiomyopathy. Right heart catheterization revealed cardiogenic shock and elevated filling pressures. Haemodynamics and symptoms worsened with the initiation of dopamine and placement of intra-aortic balloon pump but improved with the initiation of phenylephrine. Follow-up echocardiogram demonstrated dynamic LVOT obstruction with concomitant severe mitral regurgitation (MR). The patient recovered in the intensive care unit for 5 days after successful weaning of phenylephrine and initiation of low-dose beta-blocker. Repeat echocardiogram 3 weeks later showed complete resolution of apical akinesis, LVOT obstruction, and MR. DISCUSSION: Elucidating whether dynamic LVOT obstruction is contributing to cardiogenic shock physiology is paramount since the management radically differs depending on the presence or absence of obstruction. Corrective therapy focuses on reducing the LVOT gradient and includes fluid administration to improve preload, beta-blocker therapy to increase diastolic filling time, and vasopressors to raise afterload.

Advances in balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

Balloon pulmonary angioplasty (BPA) is an emerging treatment option for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who have inoperable, segmental/subsegmental disease, or residual disease after pulmonary endarterectomy. In the past decade, advances in the techniques for BPA have led to better clinical outcomes with improvements in hemodynamics, pulmonary perfusion, exercise tolerance, functional capacity, and quality of life. We present the experience with BPA at our university, the largest CTEPH center in the world, followed by reviewing the published data regarding the efficacy and safety of BPA in patients with CTEPH. There is increasing evidence to support that the initial hemodynamic improvement is sustained for ≥3 years after the procedure. Although infrequent, complications observed with BPA are associated with pulmonary vascular injury or rarely reperfusion pulmonary edema. As the technique for percutaneous pulmonary artery revascularization has improved, the procedural risk and complications have continued to decrease. This promising technique continues to develop, and future research is required to demonstrate the long-term benefits of BPA, standardize the technique, and define a uniform institutional infrastructure for providing BPA as a part of the treatment of CTEPH.

Robotic Peripheral Vascular Intervention With Drug-Coated Balloons is Feasible and Reduces Operator Radiation Exposure: Results of the Robotic-Assisted Peripheral Intervention for Peripheral Artery Disease (RAPID) Study II.

BACKGROUND: A robotic-assisted platform (CorPath System; Corindus Vascular Robotics) is feasible for peripheral vascular intervention (PVI) for the treatment of femoropopliteal lesions. OBJECTIVES: This study was designed to determine the feasibility and safety of robotic PVI for treating femoropopliteal lesions with drug-coated balloon (DCB), and to evaluate the effect of robotic PVI on operator radiation exposure during robotic PVI. METHODS: This prospective, single-arm trial enrolled patients with symptomatic peripheral arterial disease affecting the femoropopliteal artery. The primary outcome measure was clinical success, defined as <50% residual stenosis and the absence of periprocedural device-related serious adverse events. Operator radiation exposure was compared between the robotic cockpit vs the tableside. RESULTS: This study enrolled 20 patients (age, 65.5 ± 9.9 years; 60% men), with the majority (75%) Rutherford category 3-4. A total of 24 lesions (lesion length, 49.8 ± 37.5 mm) were treated with DCB and 91.7% were located in the superficial femoral artery. Clinical success was 100% and provisional stenting was required in 1 lesion. Fluoroscopy time was 7.3 ± 3.3 minutes and operator radiation exposure was 1.9 ± 2.9 µSv, which was reduced by 96.9 ± 5.0% when compared with the table-side (control) dosimeter (P<.001). There were no adverse events associated with the use of the robotic system. CONCLUSIONS: These data demonstrate the safety and feasibility of using a robotic-assisted platform for treating femoropopliteal lesions with rapid-exchange interventional devices, and show 96.9% reduction in radiation exposure for the primary operator.

Cardiac procedural deferral during the coronavirus (COVID-19) pandemic.

We aimed to examine factors impacting variability in cardiac procedural deferral during the COVID-19 pandemic and assess cardiologists' perspectives regarding its implications. Unprecedented cardiac procedural deferral was implemented nationwide during the COVID-19 pandemic. A web-based survey was administered by Society for Cardiovascular Angiography and Interventions and the American College of Cardiology Interventional Council to cardiac catheterization laboratory (CCL) directors and interventional cardiologists across the United States during the COVID-19 pandemic. Among 414 total responses, 48 states and 360 unique cardiac catheterization laboratories were represented, with mean inpatient COVID-19 burden 16.4 ± 21.9%. There was a spectrum of deferral by procedure type, varying by both severity of COVID-19 burden and procedural urgency (p < .001). Percutaneous coronary intervention volumes dropped by 55% (p < .0001) and transcatheter aortic valve replacement volumes dropped by 64% (p = .004), with cardiologists reporting an increase in late presenting ST-elevation myocardial infarctions and deaths among patients waiting for transcatheter aortic valve replacement. Almost 1/3 of catheterization laboratories had at least one interventionalist testing positive for COVID-19. Salary reductions did not influence procedural deferral or speed of reinstituting normal volumes. Pandemic preparedness improved significantly over time, with the most pressing current problems focused on inadequate testing and staff health risks. During the COVID-19 pandemic, cardiac procedural deferrals were associated with procedural urgency and severity of hospital COVID-19 burden. Yet patients did not appear to be similarly influenced, with cardiologists reporting increases in late presenting ST-elevation myocardial infarctions independent of local COVID-19 burden. The safety and importance of seeking healthcare during this pandemic deserves emphasis.

Resource Utilization During Elective Robotic-Assisted Percutaneous Coronary Intervention.

OBJECTIVE: Robotic percutaneous coronary intervention (R-PCI) results in comparable outcomes to manual PCI in the treatment of obstructive coronary artery disease (CAD). The objective of this study is to evaluate the cost and resource utilization of R-PCI compared with manual PCI. METHODS: Consecutive patients with CAD undergoing elective R-PCI or manual PCI over an 18-month period by a single operator were included. Procedure-related costs and resource utilization were analyzed and propensity adjusted to account for differences in baseline demographic and lesion characteristics. RESULTS: A total of 164 patients (mean age, 68.9 ± 10.8 years; 81% men) underwent R-PCI (n = 56) or manual PCI (n = 108). The R-PCI group demonstrated higher Syntax scores (17.8 ± 12.9% vs 11.8 ± 7.7%; P<.01) and a greater proportion of type B2/C lesions (89.3% vs 69.4%; P<.01). R-PCI was associated with higher unadjusted costs of total hospitalization ($8219.90 ± 336.60 vs $7268.50 ± 220.10; P=.02) and direct supplies ($4711.10 ± 239.90 vs $3809.40 ± 166.80; P<.01). Following propensity-matched analysis, R-PCI was associated with higher direct supply costs alone, without a significant difference in total hospitalization or catheterization laboratory cost. Furthermore, R-PCI demonstrated similar fluoroscopy time, procedural time, and total number of stents, but with a lower volume of contrast (182.7 ± 8.9 mL vs 206.8 ± 9.0 mL; P=.04). CONCLUSIONS: Costs and resources associated with R-PCI are comparable with manual PCI, with an expected increase in direct supply costs attributed to single-use robotic components.

SCAI position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers.

The Centers for Medicare & Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed.

Planned Robotic Chronic Total Occlusion Percutaneous Coronary Intervention: Feasibility Report.

BACKGROUND: Complex robotic percutaneous coronary intervention (R-PCI) is technically possible and leads to clinically comparable outcomes compared with the manual approach. However, there are limited data on the feasibility of chronic total occlusion (CTO) revascularization via the R-PCI approach. METHODS: Ten consecutive patients undergoing R-PCI for a coronary CTO at a single tertiary academic center were analyzed. The PRECISION, PRECISION GRX, and PROGRESS CTO registries were utilized for data collection with regard to procedural/clinical details and results. RESULTS: Technical success, defined as successful CTO revascularization with full or partial robotic support, occurred in 7 of 10 patients. There were no periprocedural major adverse cardiac events. Average J-CTO score was 2; all procedures were performed from an antegrade approach. The time from robotic wire manipulation to completion of procedure regardless of method averaged 55.1 minutes; average fluoroscopy time was 29.9 minutes. CONCLUSIONS: CTO revascularization via a robotic approach is feasible. Technical success may be best predicted by those patients with low J-CTO scores and lesions amenable to antegrade wire escalation technique. Given the potential benefits to both operators and patients, further research is warranted.

Optimal Technique for Performing Invasive Pulmonary Angiography for Chronic Thromboembolic Pulmonary Disease.

High-quality invasive pulmonary angiography is invaluable for the evaluation of chronic pulmonary thromboembolic disease. Optimization of multiple technical factors enables optimal angiography, crucial for identifying both high-grade pulmonary thromboembolic disease warranting surgical resection, and surgically inaccessible disease for interventional and/or targeted medical therapy. Appropriate strategies to address the pitfalls encountered during angiography are highlighted. This manuscript provides detailed guidance in performing hemodynamic assessment and invasive pulmonary angiography for the evaluation of chronic thromboembolic pulmonary disease.

Robotic-Assisted Percutaneous Coronary Intervention: Concept, Data, and Clinical Application.

The occupational hazards for interventional cardiologists include the risk of cataracts, malignancy, and orthopedic injury. Robotic technology is now available with the introduction of platforms for performing percutaneous coronary and peripheral interventions. The original remote navigation system has evolved into the current CorPath robotic system, now approved for robotic-assisted cardiovascular interventions. The system removes the operator from the tableside and has been validated for safety, feasibility, and efficacy in coronary and peripheral vascular disease.

Complex robotic compared to manual coronary interventions: 6- and 12-month outcomes.

OBJECTIVES: To assess the long-term safety and efficacy of robotic percutaneous coronary revascularization for use in complex coronary lesions. BACKGROUND: Robotically assisted percutaneous coronary intervention (PCI) is safe and feasible in simple coronary lesions and has excellent short-term procedural and clinical outcomes for complex lesions; however, long-term safety and efficacy outcomes are unknown. METHODS: A total of 103 consecutive patients underwent a total of 108 robotic (R)-PCI procedures (age 68.1; 78.3% male) over 18 months, and 210 patients underwent a total of 226 manual (M)-PCI procedures (age 67.5; 78.1% male) during the same period. Patients were subsequently followed and both 6-month and 12-month major adverse cardiovascular events (MACE), comprised of any death, stroke, myocardial infarction, or target vessel revascularization, are reported and compared. RESULTS: There was no difference between the two groups with regard to overall MACE at 6 months (R-PCI 5.8% vs. M-PCI 3.3%, P = 0.51) or at 12 months (R-PCI 7.8% vs. M-PCI 8.1%, P = 0.92). There was no difference between the individual components of the primary combined endpoint at either time point. No access site complications occurred in either cohort that met BARC III or higher criteria. CONCLUSIONS: At the 6- and 12-month time points following R-PCI, no difference in clinical outcomes or safety measures was observed as compared to M-PCI.

Bacterial Contamination of Lead Aprons in a High-Volume Cardiac Catheterization Laboratory and Disinfection Using an Automated Ultraviolet-C Radiation System.

OBJECTIVES: Quantify and characterize bacterial contamination of lead aprons in a high-volume catheterization laboratory and evaluate the efficacy of decontamination using an ultraviolet-C (UV-C) radiation system. BACKGROUND: Bacterial contamination and ineffective disinfection of personal protective equipment in medical centers pose potential health risks to patients and medical staff. The contamination burden of lead aprons and a reliable disinfection strategy are unknown. METHODS: Ten routinely used, unsterilized lead aprons from a high-volume catheterization laboratory were studied. Standard and bacteria-resistant outer fabrics were included. Swabbings from four locations on each apron (inner thyroid collar, chest, waist, and bottom border) were obtained at baseline and after a 15-minute decontamination cycle using the UV-C based DCab System (Nosocom Solutions). Colony counts, speciation, and antibiotic resistance were obtained from aerobic and anaerobic cultures. RESULTS: Baseline cultures grew ≥1 colony from 25 of 40 samples (62.5%; 310 colonies; 0-100 colonies/sample; 16 organisms), mainly skin and mouth flora without antibiotic resistance. Baseline growth was greatest from the thyroid collar and similar between different fabrics. UV-C reduced subsequent growth (7.8 ± 23.8 colonies overall vs 0.1 ± 0.3 colonies overall; P<.001), with all four isolates considered contaminants of laboratory handling. Colony counts were reduced in thyroid collar, chest, waist, nylon fabric, polyurethane fabric, and alternative bacteria-resistant fabric subgroups (all P<.05). CONCLUSIONS: Routinely used lead aprons in a high-volume catheterization laboratory were contaminated by non-pathogenic skin and mouth flora located predominantly on the thyroid collar. Disinfection using an automated UV-C based system is highly effective across different apron surface locations and fabric types.

Chronic Thromboembolic Pulmonary Hypertension: Evolving Therapeutic Approaches for Operable and Inoperable Disease.

Chronic thromboembolic pulmonary hypertension (CTEPH), a rare consequence of an acute pulmonary embolism, is a disease that is underdiagnosed, and surgical pulmonary thromboendarterectomy (PTE) remains the preferred therapy. However, determination of operability is multifactorial and can be challenging. There is growing excitement for the percutaneous treatment of inoperable CTEPH with data from multiple centers around the world showing the clinical feasibility of balloon pulmonary angioplasty. Riociguat remains the only approved medical therapy for CTEPH patients deemed inoperable or with persistent pulmonary hypertension after PTE. We recommend that expert multidisciplinary CTEPH teams be developed at individual institutions. Additionally, optimal and standardized techniques for balloon pulmonary angioplasty need to be developed along with dedicated interventional equipment and appropriate training standards. In the meantime, the percutaneous revascularization option is appropriate for patients deemed inoperable in combination with targeted medical therapy, or those who have failed to benefit from surgery.

Safety and Feasibility of a Novel, Second-Generation Robotic-Assisted System for Percutaneous Coronary Intervention: First-in-Human Report.

OBJECTIVES: The goal of this study is to evaluate the safety and efficacy of the second-generation robotic-assisted system CorPath GRX (Corindus) for percutaneous coronary intervention (PCI). BACKGROUND: The first-generation CorPath 200 robotic-assisted system for PCI is effective, but is limited by the lack of an active robotic guide-catheter control. The CorPath GRX device enables robotic guide-catheter manipulation, in addition to guidewire and balloon/stent delivery. However, there have been no clinical data reported with this device. METHODS: Consecutive patients with demonstrated obstructive coronary artery disease (>70% stenosis) and clinical indications for PCI were treated with the CorPath GRX system and enrolled in the study. The two co-primary endpoints were clinical procedural success (final TIMI 3 flow, and <30% residual stenosis without in-hospital major adverse cardiac event) and device technical success (robotic clinical procedural success without the need for unplanned manual assistance/conversion). RESULTS: The study enrolled 40 subjects (65.7 ± 11.9 years; 72.5% males; 54 lesions) with a high proportion of American College of Cardiology/American Heart Association type B2/C lesions (77.8%). Clinical procedural success and device technical success rates were 97.5% (n = 39 of 40) and 90.0% (n = 36 of 40), respectively. CONCLUSION: The second-generation CorPath GRX system for robotic-assisted PCI is safe and effective, and achieves high rates of clinical and technical success in a cohort of patients with complex coronary disease.

Robotically-assisted percutaneous coronary intervention: Reasons for partial manual assistance or manual conversion.

BACKGROUND: Robotically-assisted percutaneous coronary intervention (R-PCI) is feasible for simple coronary lesions. OBJECTIVES: To determine the frequency and reasons for partial manual assistance or manual conversion during R-PCI in clinical practice. METHODS: The CorPath 200 System (Corindus, Waltham, MA) enables the operator to sit in a radiation-shielded cockpit and remotely control intracoronary devices including guidewires, balloons, and stents. Consecutive R-PCI procedures performed over 18months were analyzed to identify reasons for planned or unplanned manual assistance or manual conversion, and categorized as due to 1) adverse event; 2) technical limitation of the robotic platform; or 3) limited guide catheter/wire support. RESULTS: During the study period, 108 R-PCI procedures (68.1±11.0years, 77.8% men, 69.4% elective PCI, 78.3% type B2/C lesions, and 50.3% left anterior descending/left main target lesion segment) were performed. High robotic technical success (91.7%) and clinical procedural success (99.1%) were achieved. Twenty procedures (18.5%) required either planned partial manual assistance (3.7%), unplanned partial manual assistance (7.4%), or manual conversion (7.4%). Among these procedures, manual assistance/conversion was required in 3 procedures for an adverse event (15%), 8 for technical limitation of the robotic platform (40%), and 9 for guide catheter/wire support issues (45%). CONCLUSIONS: High clinical success with R-PCI for a complex lesion cohort is possible with only occasional partial manual assistance or manual conversion. The majority of procedures requiring manual assistance/conversion were due to limited guide catheter/wire support or robotic platform limitations, rather than occurrence of adverse events.

Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension.

Chronic thromboembolic pulmonary hypertension (CTEPH) is associated with several risk factors but is most frequently seen as a rare consequence of an acute pulmonary embolism. Surgical pulmonary thromboendarterectomy (PTE) is potentially curative for CTEPH with the best outcomes seen for the treatment of primarily proximal, accessible lobar or segmental disease. For surgically inoperable patients, percutaneous balloon pulmonary angioplasty (BPA) is feasible and has good short- to mid-term efficacy outcomes. This review focuses on the technique and outcomes associated with BPA which has emerged as a new therapeutic option for CTEPH.

A Bleeding Heart: Coronary-Cameral Fistula After Septal Myomectomy.

Coronary-cameral fistulas are relatively rare communications arising within the coronary vasculature entering into one of the four cardiac chambers. This case highlights a striking angiographic example of coronary-cameral fistula occurring after septal myomectomy, a complication occurring somewhat frequently with typical spontaneous resolution.