Complex Percutaneous Intervention Research Articles

Abstract 15324: Biodegradable Polymer Ultrathin Sirolimus-Eluting Stent is Associated With Better Outcomes Compared With Polymer-Free Ultrathin Sirulimus-Eluting Stent in Complex Percutaneous Coronary Intervention: A Post Hoc Analysis of the HOST-IDEA Randomized Clinical Trial

Introduction: Third generation drug-eluting stents with ultrathin struts and advanced polymer technology have been introduced. However, their safety and efficacy have not been fully elucidated, particularly in complex percutaneous intervention (PCI). Aim To investigate the clinical outcomes of complex PCI using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. Methods: This study was a post-hoc analysis of the HOST-IDEA trial that randomly assigned 2,013 patients undergoing PCI with Orsiro or Coroflex ISAR into either 3-month dual antiplatelet therapy (DAPT) or 12-month DAPT arms from January 2016 to May 2021 at 37 centers in South Korea. We compared a 1:1 propensity score (PS)–matched cohort balanced by patient and procedural characteristics. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization at 1 year. Complex PCI was defined as any of the following features: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length ≥ 60 mm, left main PCI, or heavy calcification. Results: After PS matching, baseline patient and procedural characteristics were balanced between Coroflex ISAR and Orsiro groups (n=542 in each). Complex PCI was significantly associated with a higher rate of TLF compared with non-complex PCI (5.3% vs. 1.1%, hazard ratio (HR) 5.12 [95% confidence interval (CI) 2.21-11.86], P<0.001). Compared with the Coroflex ISAR SES, the better outcomes of TLF associated with the Orsiro SES was more pronounced in the complex PCI group (HR 0.14 [95% CI 0.03-0.60], P =0.008 in complex PCI; HR 0.99 [95% CI 0.25-3.98], P =0.993 in non-complex PCI; P for interaction 0.054). Conclusion In patients undergoing complex PCI with third-generation DES, the Orsiro SES was associated with significantly better outcomes in terms of TLF than the Coroflex ISAR SES.

Complex percutaneous intervention on pulmonary arteries in an adult patient with a corrected Taussig–Bing anomaly

Complex percutaneous intervention on pulmonary arteries in an adult patient with a corrected Taussig–Bing anomaly

The Role of the Percutaneous Impella Pump in Anesthesia and Intensive Care

The use of temporary mechanical circulatory support (tMCS) devices and in particular the increasing use of the Impella device family has gained significant interest over the last two decades. Nowadays, its use plays a well-established key role in both the treatment of cardiogenic shock, and as a preventive and protective therapeutic option during high-risk procedures in both cardiac surgery and cardiology, such as complex percutaneous interventions (protected PCI). Thus, it is not surprising that the Impella device is more and more present in the perioperative setting and especially in patients on intensive care units. Despite the numerous advantages such as cardiac resting and hemodynamic stabilization, potential adverse events exist, which may lead to severe, but preventable complications, so that adequate education, early recognition of such events and a subsequent adequate management are crucial in patients with tMCS. This article provides an overview especially for anesthesiologists and intensivists focusing on technical basics, indications and contraindications for its use with special focus on the intra- and postoperative management. Furthermore, troubleshooting for most common complications for patients on Impella support is provided.

Effective use of the cutting balloon technique for treatment of intramural hematoma complicating a complex percutaneous intervention in a patient with multivessel disease and severely decreased left ventricular ejection fraction.

Effective use of the cutting balloon technique for treatment of intramural hematoma complicating a complex percutaneous intervention in a patient with multivessel disease and severely decreased left ventricular ejection fraction.

Three years performance of Biodegradable Polymer Sirolimus Eluting Stent in all comer patients undergoing Percutaneous Coronary Intervention.

Introduction: Contemporary evidence suggest the comparable performance of biodegradable polymer sirolimus eluting stents (BPSES) with that of second generation durable polymer drug eluting stents. This study was done to evaluate the performance of BPSES in all comer patients undergoing percutaneous intervention (PCI) in real world setting over a period of three years. Materials & Methods: This was a prospective observational study, wherein all comer consecutive patients undergoing PCI with BPSES (Yukon Choice Elite stent by Translumina Therapeutics, India) were enrolled and followed up for 3 years. The study's primary endpoint was the Device Oriented Composite Endpoint (DOCE), which included cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR); the co-primary endpoint was the Patient-Oriented Composite Endpoint (POCE), which included all-cause mortality, any MI , and any repeat revascularization and the secondary endpoint was definite or probable stent thrombosis (DST & PST). Results: 301 patients with 502 lesions were treated with 485 BP-SES. Mean age of the study cohort was 61.6± 9.3 yrs and males were 79.1%. 18.6% patients were diabetic, 29.6% had ejection fraction less than 40% and 73.1% patients presented with acute coronary syndrome (ACS). Majority of the patient had triple vessel disease (TVD) (51.8%), multivessel PCI was done in 15.6% and complex PCI in 26.2% patients. A mean of 1.6 ±0.8 stents per patient with mean diameter 3.0 ± 0.3 mm and mean length of 27.2 ± 0.8 mm were placed. DOCE & POCE occurred in 7.9% (cardiac death-4.8%, TLR-2.6% & target vessel MI-0.4%) and 12.8% (All deaths-9.7%, any MI- 0.4% and any revascularisation-2.6%) patients respectively at three years follow-up. DST & PST rate was 0.9% and 0.4% respectively in the study cohort. All the cases of stent thrombosis occurred within 30 days. Kaplan Meier analysis revealed that diabetes mellitus, low ejection fraction (EF), acute coronary syndrome (ACS), long stents and complex intervention had no impact on occurrence of DOCE & POCE while using BP-SES in all-comer patient population. Conclusion: Present study showed favourable long term safety and efficacy profile of BP-SES for all-comer patients undergoing PCI.

Safety and efficacy of systematic lesion preparation with a novel generation scoring balloon in complex percutaneous interventions: results from a prospective registry.

Coronary lesions predilatation with semicompliant (SC) or non-compliant balloons (NC) may be insufficient to obtain an optimal stent expansion, which can lead to in-stent restenosis or thrombosis. Moreover, increasing evidence supporting an optimal lesion preparation is mandatory when drug coated balloons (DCB) are used. To this extent, more "aggressive tools" such as cutting/scoring balloons, atherectomy or lithotripsy may play an important role and improve outcomes. We enrolled 78 consecutive patients from March 2020 to October 2020 with calcific/fibrotic or ostially-located lesions, which were prepared using scoring balloons, in addition to SC/NC balloons and other plaque modification strategies. The final treatment consisted in either stent or DCB usage. The primary endpoint was the rate of clinically-driven target lesion revascularization. Secondary endpoints entailed the procedural success and the individual rates of major adverse cardiac events (MACE) at 12 months. Most of the patients had left main (LM) or ostial lesions, 65% of them being moderate/severely calcified, with further debulking strategies being required in 15 (19.2%) patients (rotational atherectomy, 3.8% or coronary intravascular lithotripsy, 15.3%). A high-rate of DCB usage was reported. Angiographic and procedural success was obtained in 77 and 76 patients, respectively. We encountered one vessel perforation, which was sealed with a covered stent, without consequence. During follo- up, we observed only 6 MACE, 6 target lesion revascularizations (TLR) and 2 cardiovascular deaths. Among patients with high complexity and calcific lesions, an optimal lesion preparation using a dedicated scoring balloon was associated with low clinical events at mid-term follow-up and may be considered to improve immediate procedural success rate.

Radioprotection during interventional cardiology procedures

Abstract Background The use of ionizing radiation during cardiac catheterization interventions adversely impacts both the patients and the medical staff. Traditional radiation protection equipment is only partially effective. The Cathpax® radiation protection cabin (RPC) has demonstrated to significantly reduce radiation exposure in electrophysiological and neuroradiology interventions. Our objective was to analyze whether the Cathpax® RPC reduces radiation dose in coronary and cardiac structural interventions in unselected real-world procedures. Methods and results In this non-randomized all-comers prospective study, 119 consecutive cardiac interventional procedures were alternatively divided into two groups: the RPC group (n=59) and the non-RPC group (n=60). No significant changes in patients and procedures characteristics, average contrast volume, air kerma (AK), dose area-product (PDA) and fluoroscopy time between both groups were apparent. In RPC group, the first operator relative radiation exposure was reduced by 78% at the chest and by 70% at the wrist. This effect was consistent during different types of procedures including complex percutaneous interventions and structural procedures. Conclusions Our study demonstrates, for the first time, that the Cathpax® cabin significantly and efficiently reduces relative operator radiation exposure during different types of interventional procedures, confirming its feasibility in a real-world setting. Funding Acknowledgement Type of funding sources: None.

The radioprotective effect of the cathpax air cabin during interventional cardiology procedures

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Hospital Puerta del Mar BACKGROUND The use of ionizing radiation during cardiac catheterization interventions adversely impacts both the patients and the medical staff. Traditional radiation protection equipment is only partially effective. The Cathpax® radiation protection cabin (RPC) has demonstrated to significantly reduce radiation exposure in electrophysiological and neuroradiology interventions. Our objective was to analyze whether the Cathpax® RPC reduces radiation dose in coronary and cardiac structural interventions in unselected real-world procedures. METHODS AND RESULTS In this non-randomized all-comers prospective study, 119 consecutive cardiac interventional procedures were alternatively divided into two groups: the RPC group (n = 59) and the non-RPC group (n = 60). No significant changes in patients and procedures characteristics, average contrast volume, air kerma (AK), dose area-product (PDA) and fluoroscopy time between both groups were apparent. In RPC group, the first operator relative radiation exposure was reduced by 78% at the chest and by 70% at the wrist. This effect was consistent during different types of procedures including complex percutaneous interventions and structural procedures. CONCLUSIONS Our study demonstrates, for the first time, that the Cathpax® cabin significantly and efficiently reduces relative operator radiation exposure during different types of interventional procedures, confirming its feasibility in a real-world setting. Table 3.Comparison of radiation exposureStructural (n = 12)Coronary (n = 107)pPrimary outcomesFirst operator relative exposure at chest*6.8 ± 33 ± 0.60.06First operator relative exposure at left wrist*19.3 ± 104 ± 1.50.01Secondary outcomesSecond operator relative exposure at chest*2.5 ± 1.21.2 ± 0.20.06First operator dose at chest (E in µSv)59.2 ± 4317.2 ± 50.08First operator dose at left wrist (E in µSv)134.1 ± 9623.4 ± 90.04Second operator dose at chest (E in µSv)19 ± 165.7 ± 20.1Patient exposure (DAP in mGy·cm2)62651 ± 2618059682 ± 142860.8Fluoroscopy time, min (±SD)24.2 ± 715.7 ± 40.2Abstract Figures 1 and 2

Hybrid Subxiphoid Perventricular Approach as an Alternative Access in Neonates and Small Children Undergoing Complex Congenital Heart Interventions.

The hybrid subxiphoid perventricular approach provides direct access through the heart and may alleviate the technical limitations of complex percutaneous interventions particularly in infants with low body weight. We present the outcomes from a tertiary cardiology center using this approach. We performed a retrospective review of all patients less than 15kg who underwent a hybrid perventricular approach via a small subxiphoid incision. Medical records were reviewed to obtain clinical, demographic and outcome data. Seventeen patients underwent 18 hybrid perventricular procedures using a subxiphoid approach. Median age at time of procedure was 4.6months (IQR = 1.6 to 18months) and median weight was 6.2 kgs (IQR = 3.4 to 8.6 kgs). Six patients underwent hybrid pulmonary valve replacement (PVR), 5 patients underwent pulmonary outflow stenting, and 5 infants underwent hybrid ventricular septal defect (VSD) device closure. One patient with a single ventricle who did not tolerate a percutaneous approach underwent left pulmonary artery (LPA) stenting for severe LPA coarctation with subsequent right ventricular outflow tract (RVOT) stenting. One further patient underwent implantation of a larger diameter stent for pulmonary artery bifurcation stenosis. Procedure success rate was 89% with two of the VSD cases reverted to open surgical repair. There were no intra-procedural complications; however, one patient died within 72h. Minor adverse events occurred in 2 patients including a wound infection in one patient with an immunodeficiency syndrome. Hybrid subxiphoid perventricular approach provides an excellent alternative access to the heart especially in low birth weight infants to prevent hemodynamic instability or in small children requiring large delivery sheaths.

Procedure for Changing an Impella Device While Maintaining Guide Wire Access: A Novel Technique

<strong>Highlights</strong> <p class="BodyA">We describe a novel technique to exchange an Impella over a guide-wire, preserving the arteriotomy access and to lower the risks of vascular complications. We describe this technique in the context of two interesting cases. The first case is of a young man with myocarditis and cardiogenic shock from a previously undiagnosed systemic lupus erythematous. The second case is of a woman with ST elevation myocardial infarction and cardiogenic shock requiring complex percutaneous intervention. The implantation of Impella CP served as circulatory support in these cases as myocardium recovered but was complicated by access site bleeding. We were able to remove the Impella device while maintaining the access sheath to allow for adequate hemostasis prior to sheath removal. We believe the readers of the journal will find these images and technique interesting and useful in their own practice. </p>

Guide extension catheter stepwise advancement facilitated by repeated distal balloon anchoring

Coronary stent delivery can be extremely challenging in tortuous and calcified lesions especially when radial approach is chosen. Guide extension catheter is a useful tool for overcoming the inherent difficulties arising by the use of radial access in complex percutaneous interventions. We describe a technique for guide extension catheter system advancement by presenting two cases. This was performed stepwise by repeated distal balloon anchoring in the coronary artery of interest.

Heart rate never lies: interventional cardiologist and Braude's quote revised

BackgroundInterventional cardiologists may be immune to stress, allowing them to perform complex percutaneous interventions under pressure.ObjectivesTo assess heart rate (HR) variations as a surrogate marker of stress of interventional cardiologists...

4 Complex PCI across the belfast trust over a 2 year period: Abstract 4 Table 1

Introduction It is well recognised that the prevalence of coronary artery disease and risk of myocardial infarction increases with age. An ageing population and increasing co-morbidity means that the frequency of complex percutaneous coronary intervention (PCI) is increasing. This is due to: Ageing population Surgical turn down for CABG Improvement in operator technique/equipment Evidence to support complex percutaneous intervention particularly in the elderly Methods The total number of PCI procedures performed within the Belfast trust (Belfast City Hospital and Royal Victoria Hospital) between 1st September 2012 and 31st August 2014 were collated from the local database. The indication (elective/ acute coronary syndrome/ST elevation MI) and complexity* of the procedure were recorded along with patient demographics including age, gender, ejection fraction and renal function. *The procedure was defined as complex if it involved at least one of the following: PCI of left main stem Use of high speed rotational atherectomy Chronic total occlusions 2 consultant operators. Results A total of 5356 PCI procedures were performed. 1209 procedures were complex. This represents 23% of the total number of procedures performed across the trust. 27% of PCI performed in patients over the age of 80 was complex. Obviously not all complex PCI performed involved only one criterion Below is a table showing the percentage breakdown of complex PCI. PCI for all acute coronary syndromes, Belfast City Hospital 909 procedures had indication as acute coronary syndrome 137 (15%) defined as complex Of the complex procedures 55 (40%) involved HSRA PCI for all acute coronary syndromes, Royal Victoria Hospital 1908 procedures had indication as acute coronary syndrome 184 (10%) defined as complex Of the complex procedures 67 (36%) involved HSRA PCI for ST elevation MI, Royal Victoria Hospital Within the ACS cohort: There were 973 PCI procedures with indication recorded as ST elevation MI 63 (6.5%) procedures were defined as complex 11 (1.3%) procedures involved HSRA Summary In the Belfast trust over a 2 year period there were 5356 PCI procedures: Average age was 66; average age complex PCI was 70 12% cases were patients over 80 23% of all cases were defined as complex 27% of cases in over 80s were complex 2817 procedures for ACS (53%) 11% of ACS cases were complex Conclusions Routine PCI is becoming increasingly complex with nearly 1 in 4 cases performed in the Belfast trust fulfilling complex criteria. Over 1 in 10 ACS cases were complex. Interventionalists should be proficient in HSRA use, invasive imaging modalities such as IVUS/OCT to define anatomy and left main PCI.

GuideLiner guide extension catheter for difficult coronary intervention: A large, single-centre case series

Background: The GuideLiner (Vascular Solutions, MN, USA) is a mother-and-child catheter enabling increased support for complex percutaneous interventions. There is limited published literature examining its use. Methods: A retrospective review of cases utilising GuideLiner from May 2011 to Feb 2015 was undertaken identifying 72 procedures in 70 patients. Data collected included demographics, presentation, access site, guide type and size, target vessel, lesion complexity, procedural success and complications. Results: All cases used a 5-in-6Fr GuideLiner, with 1 case also using a 7-in-8Fr. 55 (76.4%) were Type C lesions, and 8 (11.1%) were Type B2. 52 (80.6%) had femoral access. The median sheath size was 7Fr. Supportive guides were used in 61 cases (85%). 48 cases were mid or distal native vessel lesions (66.7%), with 2 (2.8%) saphenous vein grafts and 10 (13.9%) chronic total occlusions. GuideLiner success was reported in 61 (85%); final PCI success in 65 (90%). In 2 cases (2.8%) the GuideLiner could not pass into the artery. Complications occurred in 8 cases (11%): 6 (8.3%) cases of coronary dissection related to the guiding catheter or stent edge, 1 (1.4%) wire perforation, 1 (1.4%) acute stent thrombosis and 1 (1.4%) ventricular fibrillation. No complications related to GuideLiner use occurred. Discussion: GuideLiner use was predominantly for difficulty crossing tortuous and calcified lesions in distal vessels despite support of predominantly femoral access with appropriate guides. GuideLiner use was associated with a high proportion of procedural success in these difficult lesions, and provides a valuable adjunct to complex interventions.

Importance of a Patient Dosimetry and Clinical Follow-up Program in the Detection of Radiodermatitis After Long Percutaneous Coronary Interventions

Complex percutaneous interventions often require high radiation doses likely to produce skin radiation injuries. We assessed the methodology used to select patients with potential skin injuries in cardiac procedures and in need of clinical follow-up. We evaluated peak skin dose and clinical follow-up in a case of radiodermatitis produced during a total occlusion recanalization. This prospective study followed CIRSE and ACC/AHA/SCAI recommendations for patient radiation dose management in interventional procedures carried out in a university hospital with a workload of 4200 interventional cardiac procedures per year. Patient dose reports were automatically transferred to a central database. Patients exceeding trigger levels for air kerma area product (500 Gy cm(2)) and cumulative skin dose (5 Gy) were counseled and underwent follow-up for early detection of skin injuries, with dermatologic support. The Ethical Committee and the Quality Assurance and Radiation Safety Committee approved the program. During 2010, a total of 13 patients (3.0/1,000 that year) received dose values exceeding trigger levels in the cardiovascular institute. Only one patient, who had undergone two consecutive procedures resulting in 970 Gy cm(2) and 13.0 Gy as cumulative skin dose, showed signs of serious radiodermatitis that resolved in 3.7 months. The remaining patients did not manifest skin lesions during follow-up, and whenever patient examination was not feasible as part of the follow-up, neither patients nor families reported any skin injuries. Peak skin dose calculation and close clinical follow-up were feasible and appropriate, with a moderate additional workload for the staff and satisfaction for the patient.

Feasibility of complex coronary and peripheral interventions by trans‐radial approach using large sheaths

Trans-radial approach (TRA) reduces vascular access-site complications but has some technical limitations. Usually, TRA procedures are performed using 5 Fr or 6 Fr sheaths, whereas complex interventions requiring larger sheaths are approached by trans-femoral access. During 4 years, at two Institutions with high TRA use, we have attempted to perform selected complex coronary or peripheral interventions by TRA using sheaths larger than 6 Fr. Clinical and procedural data were prospectively collected. Attempt to place a 7 Fr or 8 Fr sheath (according to the planned strategy of the procedure) was performed after 5-6 Fr sheath insertion, administration of intra-arterial nitrates and radial artery angiography. Late (>3 months) patency of the radial artery was checked (by angiography in the case of repeated procedures or by palpation + reverse Allen test). We collected 60 patients in which TRA large sheath insertion was attempted. The large sheath (87% 7 Fr, 13% 8 Fr) was successfully placed in all cases. Most of the procedures were complex coronary interventions (bifurcated or highly thrombotic or calcific chronic total occlusive lesions), whereas 8.3% were carotid interventions. Procedural success rate was 98.3% (1 failure to reopen a chronic total occlusion). No access-site related complication occurred. In 57 (95%) patients, late radial artery patency was assessed and showed patency in 90% of the cases, the remaining patients having asymptomatic collateralized occlusion. In selected patients, complex percutaneous interventions requiring 7-8 Fr sheaths can be successfully performed by RA approach without access-site clinical consequences.

Effect of intra-aortic balloon pump support on microcirculation during high-risk percutaneous intervention

Intra-aortic balloon counter-pulsation (IABP) is recommended for hemodynamic support in cardiogenic shock. In addition, it can be applied during high-risk percutaneous interventions (PCI). While IABP support improves microflow in cardiogenic shock, its effect in hemodynamically stable patients is still unclear. We, therefore, sought to evaluate the effect of IABP treatment on microflow in hemodynamically stable patients undergoing elective high-risk PCI. In six patients with >50% left main stenosis, microflow was evaluated according to current guidelines, using side-stream dark-field microscopy, visualizing microcirculatory vessels without using fluorescent dyes. Microflow was analyzed separately for each vessel category (diameter: 10-25microm and 26-50microm), using a semiquantitative system (0= no flow; 1= intermittent flow; 2= sluggish flow; 3= continuous flow) by a trained investigator. Steady state recordings and additional recordings twenty seconds after discontinuation of the electively implanted IABP were acquired. Microflow in vessel categories 10-25microm and 26-50microm increased in this group of hemodynamically stable patients on use of IABP. Microflow decreased from 2.73 + or - 0.39 (p=0.052; 26-50microm: 2.88 + or - 0.20, p=0.008) to 2.22 + or - 0.23 (2.18 + or - 0.45) after stopping the IABP and increased to 2.90 + or - 0.14 (p=0.009; 2.85 + or - 0.28, p=0.009) after restart of the IABP. Circulatory support with IABP increases microcirculatory flow in the smallest vessels of the sublingual mucosa. Our data support the hypothesis that intra-aortic balloon counter-pulsation increases coronary and microvascular perfusion, thus, improving microcirculation even in hemodynamically stable patients. The use of IABP may increase safety of complex PCI and decrease the risk of deleterious complications.