The safety and feasibility of live-stream proctoring for CTO procedures.

OBJECTIVE: To assess the technical feasibility of a new method of educational training, based on audio-video (AV) communication between an interventional cardiologist and the cath lab staff members in one location and a remote expert proctor. METHODS: Overall, 9 patients underwent a percutaneous coronary intervention (PCI) targeting a chronic total occlusion (CTO) between June 2021 and January 2022 at a single Belgian center using the virtual proctoring approach. For this assessment, the strategic planning of the CTO PCI and all the decisions throughout the intervention were the responsibility of the proctor. The operator was guided via an AV link, by the proctor throughout the procedure. RESULTS: The operator performed each procedural step, guided by the remote proctor, who had continuous access to all relevant interventional details. No major adverse cardiac events (MACE) occurred during the index hospitalization or within 6 months follow-up. CONCLUSIONS: A new method of virtual proctoring based on live AV communication is feasible, even in the case of highly complex CTO PCI procedures. This strategy also appears safe and may provide the patient the benefit of incremental expertise. This approach is facilitated by advances in AV communication and allows physicians to share expertise irrespective of location. It could increase global interaction between colleagues and facilitate sharing of knowledge, which are both key aspects in the development of CTO PCI. This preliminary experience could serve as a basis for future large studies to study the potential role and benefits of virtual proctoring for complex CTO PCI procedures.

A new echocardiographic index to select patients for PFO suture-mediated percutaneous closure.

OBJECTIVES: To identify a simple echocardiographic predictor of procedural success to select patient for percutaneous suture-mediated patent fossa ovalis (PFO) closure. BACKGROUND: Percutaneous suture-mediated PFO closure has been shown as a safe and advantageous alternative to device-based PFO closure, yet its overall success is slightly lower in unselected patients. METHODS: Preprocedural transesophageal echocardiogram (TEE) of 302 patients (113 men, 45 ± 12 years) who underwent percutaneous suture-mediated PFO closure were reviewed. RESULTS: At echocardiographic follow-up (3-6 months), residual right-to-left shunt (RLS) ≥2 was found in 60 (19.9%) patients. At multivariable analysis, only two anatomical variables measured at preprocedural TEE were found as independent predictors of residual RLS ≥ 2 at follow-up: PFO maximum width (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.16-3.40, p = 0.02) and PFO minimal septa overlapping (OR 0.58, 95% CI 0.35-0.88, p = 0.02). An index based on the ratio of PFO maximum width to PFO minimum septal overlapping (W/SO) proved to be the most powerful predictor of RLS ≥ 2 at follow-up (OR 48.1, 95% CI 9.3-352.2, p < 0.01). The ROC curve for the W/SO ratio was found to have an AUC of 0.84 (95% CI 0.75-0.93) and a cut-off value of 0.61 yielding a sensitivity of 80% and specificity of 78% with a negative predictive value of 94%. A decision tree methodology's AUC was 0.75 (95% CI 0.67-0.83). CONCLUSIONS: The results of this study indicate that the ratio between the maximum amplitude of the PFO and the minimum overlap of the septa is the best predictive index of a favorable result by using one stitch only.

Radial artery occlusion after transradial procedures: impact on 1-year adverse events.

BACKGROUND: Radial artery occlusion after transradial procedures is a frequent iatrogenic thrombotic process. The impact on prognosis has not been investigated. This study sought to investigate whether radial artery occlusion is related to increased risk of major adverse cardiac and cerebrovascular events, defined as death, myocardial infarction, stroke and coronary revascularization. METHODS: Eight hundred thirty-seven consecutive patients who underwent a transradial coronary procedure had patency of radial artery checked at 24 hours. Radial artery occlusion occurred in 41 over 837 patients (4.8%); 764 (91.2%) were available for planned follow-up at 1 year and were included in the analysis. Event-free survival rate between patients with and without radial artery occlusion was calculated using Kaplan-Meier estimates, and Cox proportional-hazards models were used to identify independent risk factors. RESULTS: At a median 370-day follow-up (IQR: 366-375 days), adverse events occurred in 37 patients (4.8%), 2 in patients with radial artery occlusion and 35 in patients without. One-year survival rate was 94.9% vs. 95% (unadjusted HR=1.026, 95% CI: 0.24 to 4.6, P=0.9). After multivariable modeling, age and coronary artery disease extension was associated with increased risk of adverse events. CONCLUSIONS: Age and coronary artery disease extension were independent predictors of adverse events at follow-up. RAO had no prognostic impact.

Atrial function analysis after percutaneous umbrella device and suture-mediated patent fossa ovalis closure.

BACKGROUND: Atrial fibrillation is an undesirable event following percutaneous patent fossa ovalis (PFO) closure with metallic occluders, suggesting that implanting a rigid closure device could alter atrial function. Suture-mediated PFO closure is a new technique, achieving closure of the PFO by means of a simple suture. Aim of this study was to evaluate left atrial function after closure of PFO by direct suture and traditional occluders. METHODS: We studied 40 age and sex homogeneous patients, 20 undergoing PFO closure by device (OCL) and 20 by suturing (NS). Twenty healthy sex-age matched subjects made up the control group (CT). Left atrial function was evaluated by using volumetric and speckle-tracking analysis assessing the following parameters: total emptying fraction (EF), Expansion Index (EI), active emptying fraction (AEF), strain values of the reservoir (r-ED), conduit (cd-ED) and contraction phase (ct-ED). RESULTS: Compared to CT and NS, OCL patients had significantly worst indices of left atrial reservoir function (EF P=0.001, EI P=0.003, r-ED P<0.001), conduit function (cd-ED P=0.018) and contraction function (AEF P=0.010; ct-ED P<0.001). No significant differences were observed in left atrial function indices between CT and NS patients. CONCLUSIONS: Suture-mediated PFO closure does not alter left atrial function. Conversely, metallic occluder is associated with worse left atrium function. This detrimental effect on atrial function could favor the development of atrial arrhythmias.

Percutaneous suture-mediated patent foramen ovale closure: two-year clinical follow-up.

BACKGROUND: Percutaneous suture-mediated patent foramen ovale (PFO) closure has been recently introduced in clinical practice showing a favorable efficacy and safety profile in most PFO cases. The aim of this study was to assess the long-term outcomes of PFO closure by direct suture in a large consecutive series of patients. METHODS: We extracted all consecutive patients who underwent percutaneous closure of the PFO by suture technique (HeartStitch, Fountain Valley, CA, USA) from June 2016 with a follow-up of at least 2 years. After PFO closure, patients were followed-up clinically at 1, 6 and up to 12 months and microbubble transthoracic echocardiography (TTE) scheduled between 3 and 6 months, and at 12-month follow-up. After 12 months, patients were clinically checked every 6 months. RESULTS: As of September 1, 2020, 187 patients had undergone PFO closure with suture for at least two years and, of these, 181 (121 women and 60 men, mean age 45±13 years, range 15-75 years) had complete clinical and instrumental follow-up (97%). There were no peri-procedural complications. Mean follow-up was 1076±251 days (range 727-1574). At 12-month TTE, a significant residual atrial shunt was found in 39 patients (21%). At follow-up no recurrent thromboembolic or cerebral event occurred, no instrumental evidence of suture dehiscence detected and, 18 months after the procedure, one patient had an episode of transient atrial fibrillation lasting less than 24 hours and resolved spontaneously. CONCLUSIONS: Long-term follow-up data indicate that PFO closure by direct suturing is safe and effective. Two years after the procedure, there were no significant complications, no permanent arrhythmic complications and evidence of suture dehiscence.

International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study.

BACKGROUND: Distal radial access (DRA) has been proposed to improve procedure ergonomics and favor radial artery patency. Although promising data, nothing is known on evolving hand function after DRA. OBJECTIVES: This study sought to comprehensively evaluate hand function in patients undergoing DRA. METHODS: Real-world patients undergoing DRA undertook a thorough multimodality assessment of hand function implementing multidomain questionnaires (Disabilities of the Arm, Shoulder and Hand and Levine-Katz), and motor (pinch grip test) and sensory (Semmes-Weinstein monofilaments test) examinations of both hands. All assessments were performed at preprocedural baseline and planned at 1-, 6-, and 12-month follow-up (FU). Adverse clinical and procedural events were documented too. RESULTS: Data of 313 patients (220 men, age 66 ± 10 years) from 9 international centers were analyzed. The Disabilities of the Arm, Shoulder and Hand and the Levine-Katz scores slightly improved from baseline to FU (P = 0.008 and P = 0.029, respectively). Pinch strength mildly improved from baseline to FU (P < 0.001 for both the left and right hands). Similarly, touch pressure threshold appeared to faintly improve in both the left and right hands (P < 0.012 for all the sites). For both motor and sensory function tests, comparable findings were found for the DRA hand and the contralateral one, with no significant differences between them. Repeated assessment of all tests over all FU time points similarly showed lack of worsening hand function. Access-related adverse events included 19 harmless bleedings and 3 forearm radial artery and 3 distal radial artery occlusions. None affected hand function at FU. CONCLUSIONS: In a systematic multidimensional assessment, DRA was not associated with hand function impairment. Moreover, DRA emerges as a safe alternative vascular access.

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial.

BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.

Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study.

BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.

Reduction in emergency access for acute myocardial infarction during the COVID-19 pandemic: a survey from the greater area of Rome.

BACKGROUND: On March 9, 2020, the Italian government imposed a national lockdown to tackle the COronaVIrus Disease 19 (COVID-19) pandemic, including stay at home recommendations. The precise impact of COVID-19 scare and lockdown on emergency access for acute myocardial infarction (MI) is still subject to debate. METHODS: Data on all patients undergoing invasive coronary angiography at 9 hospitals in the greater area of Rome, Italy, between February 19, 2020 and March 29, 2020 were retrospectively collected. Incidence of ST-elevation MI (STEMI), and non-ST-elevation MI (NSTEMI), as well as corresponding percutaneous coronary intervention (PCI), was compared distinguishing two different 20-day time periods (before vs. on or after March 10, 2020). RESULTS: During the study period, 1068 patients underwent coronary angiography, 142 (13%) with STEMI and 169 (16%) with NSTEMI. The average daily number of STEMI decreased from 4.3 before the lockdown to 2.9 after the lockdown (P=0.021). Similarly, the average daily number of NSTEMI changed from 5.0 to 3.5 (P=0.028). The average daily number of primary PCI changed from 4.2 to 2.9 (P=0.030), while the average daily number of PCI for NSTEMI changed from 3.5 to 2.5 (P=0.087). For STEMI patients, the time from symptom onset to hospital arrival (onset-to-door time less than three hours) showed a significant increase after the lockdown (P=0.018), whereas door-to-balloon time did not change significantly from before to after the lockdown (P=0.609). CONCLUSIONS: The present study, originally reporting on the trends in STEMI and NSTEMI in the Rome area, highlights that significant decreases in the incidence of both acute coronary syndromes occurred between February 19, 2020 and March 29, 2020, together with increases in time from symptom onset to hospital arrival, luckily without changes in door-to-balloon time.

Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients.

OBJECTIVES: To compare incidence of forearm radial artery occlusion (RAO) and hemostasis characteristics between distal and conventional transradial approach (DRA and TRA, respectively). BACKGROUND: DRA has the potential advantage of reducing RAO. DRA effectively reduces time-to-hemostasis, however its role on preserving flow in the radial artery (PF) during hemostasis and consequent impact on RAO remains speculative. METHODS: Eight hundred thirty-seven patients with TRA were previously enrolled in a prospective registry investigating the relationship of residual anticoagulation and RAO. Three hundred twenty-six additional patients with DRA were added to the cohort and matched to the original cohort by propensity score. The composite end-point of RAO at forearm and distal site of puncture (dRAO) was evaluated as secondary end-point. RESULTS: RAO occurred in 4.8% (41 of 837) of patients undergoing TRA and in 0% (0 of 326) of those undergoing DRA (p < 0.0001). DRA was associated with higher percentage of PF (97.2% vs. 78.5% in TRA group, p < 0.0001) and reduced time-to-hemostasis (147 ± 99 min vs. 285 ± 138 min, p < 0.0001). After matching, hemostasis characteristics were still significant different (PF 95.7% vs. 90.1%, p = 0.023, and 190 ± 92 vs. 323 ± 162 min, p < 0.0001) with reduction in the incidence of RAO (0 of 213, 0% vs. 7 of 213, 3.3%, p = 0.0015). dRAO occurred in one case (0.3% and 0.5% after matching, p < 0.0001 and p = 0.032 compared to TRA). CONCLUSIONS: DRA was associated with lower rates of RAO compared to TRA. This effect is potentially explained by reduced time-to-hemostasis and maintained flow at the wrist during hemostasis.

Distal Radial Access: Consensus Report of the First Korea-Europe Transradial Intervention Meeting.

Among patients undergoing percutaneous coronary procedures, transradial access, compared with transfemoral access, is associated with a reduced risk for complications including mortality, especially in higher risk patients. However, transradial access is limited by radial artery occlusion (RAO) that despite being mostly asymptomatic because of the extensive anastomoses between the forearm arteries restricts future use of the same radial artery. Distal radial access (DRA) in the anatomic snuffbox or on the dorsum of the hand has recently gained global popularity as an alternative access route for vascular procedures. A strong anatomic and physiological rationale yields potential for significantly reduced risk for RAO and positive impact on procedural outcome for better patient care. Indeed, currently published studies buttress very low rates of RAO after DRA, hence supporting its development. The authors provide an analysis of the foundation of DRA, provide historical background, and offer a critical review of its current status and future directions. Also, given the limited evidence currently available to properly perform DRA in the real world, consensus opinion on what is considered optimal practice is also presented to supplement this document and enhance the implementation of DRA while minimizing its complications.

Predictors of Residual Right-to-Left Shunt After Percutaneous Suture-Mediated Patent Fossa Ovalis Closure.

OBJECTIVES: This study sought to assess patent fossa ovalis (PFO) anatomy by transesophageal echocardiography (TEE) in patients undergoing percutaneous suture-mediated PFO closure to identify predictors of post-procedural residual atrial right-to-left shunt (RLS). BACKGROUND: Percutaneous suture-mediated PFO closure has been proven to be a safe and effective technique in most PFO patients. METHODS: From June 2016 to October 2019, 247 consecutive patients underwent percutaneous suture-mediated PFO closure at our institution. Of them, 230 (46 ± 13 years of age, 146 women) had complete and technically evaluable pre-procedural TEE. The following parameters in short-axis view were assessed: presence and grade of spontaneous RLS, PFO length and width, presence of atrial septal aneurysm and its maximal bulge, and presence of an embryonic or fetal remnant (Chiari network or Eustachian valve). RESULTS: At the first follow-up transthoracic echocardiography performed between 3 and 6 months from the closure procedure, a residual RLS ≥2 grade was found in 37 (16%) patients. Grade of pre-procedural spontaneous RLS (hazard ratio: 1.99; 95% confidence interval: 1.14 to 3.48; p = 0.016) shunt and PFO width (hazard ratio: 2.52; 95% confidence interval: 1.85 to 3.43; p < 0.001) were both found to be significantly associated with significant residual RLS at multivariable analysis. The presence of atrial septal aneurysm and its maximal bulge and of congenital remnants was not associated with significant residual RLS. CONCLUSIONS: Percutaneous suture-mediated PFO closure is feasible in the majority of septal anatomies; however, PFO >5 mm in width and spontaneous large RLS are less likely to be closed with 1 stitch only.

Cryptogenic stroke over 60 years of age: should patent foramen ovale be closed?

Patent foramen ovale (PFO) is an anatomical communication between the left and the right atrium due to the lack of completed sealing of the fossa ovalis. Epidemiologic data, for the most part derived from young populations studies, suggested that PFO, allowing paradoxical embolization of thrombotic material from the venous to the arterial district, could play a significant role in the pathogenesis of cryptogenic ischaemic cerebral events. Recently, three randomized studies in patients ≤60 years of age demonstrated the superiority of percutaneous closure of PFO over medical antithrombotic treatment. Several studies, on the other hand, indicated that also in older patients with cryptogenic cerebral ischaemia, there was an higher prevalence of PFO in patients at low atherosclerosis and cardioembolic risk, and increased incidence of adverse cerebral events (mostly cryptogenic in patients treated medically, but likely due to a new cause in patients who had percutaneous closure of PFO). Advanced age is associated with more risk factors for deep vein thrombosis, and consequent paradoxical embolization through the PFO, so much so that careful consideration should be given to patients over the age of 60 years with cryptogenic stroke, as to not forgo the benefit of percutaneous closure of PFO, merely for anagraphic consideration. This consideration is particularly poignant in light of the more recent technical advances now available, such as direct percutaneous suture, mostly appealing for elderly patients, for its better tolerability and high safety both peri-procedural and during the follow-up, as well as the lack of necessity for antithrombotic treatment.

Modified percutaneous suture-mediated patent fossa ovalis closure for prevention of cerebral ischemic events.

Percutaneous suture-mediated transcatheter patent fossa ovalis (PFO) closure has been shown to be an effective and safe technique with self-evident advantages due to the lack of a permanent device heart implant. The success of this novel technique relies on an optimal catch of the interatrial septa, especially the septum primum which is floppier than the bulkier muscular septum secundum. We hypothesized that double suture of septum primum would further improve the efficacy of the procedure by increasing the surface contact between the septa when the septum primum is bent into the right atrium. We have provided proof of this concept by implementing a modified technique in two patients with PFO and cerebral ischemic events.