Determinants and long-term outcomes of largely uncovered struts in thin-struts drug-eluting stents assessed by optical coherence tomography.

BACKGROUND: Uncovered struts are a determinant of stent failure. The impact of plaque composition and procedural factors on the occurrence, evolution, and outcomes of uncovered struts in a high-risk setting has not been investigated. OBJECTIVE: To investigate the determinants and long-term clinical impact of largely uncovered struts (LUS) in thin-struts drug-eluting stents (DES) implanted in complex lesions by intracoronary optical coherence tomography (OCT). METHODS: Ninety patients with multivessel disease undergoing staged complete revascularization were randomly assigned to bioabsorbable or durable polymer DES. OCT were serially performed during the index procedure, at 3- and 18-month follow-up, and analyzed by an independent core lab. Struts were defined uncovered by OCT if no tissue was visible above the struts. LUS were defined as ≥30% of uncovered struts at 3-month follow-up. Clinical outcomes were the occurrence of target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up. RESULTS: LUS occurred in 31 patients (34.4%) regardless of stent platform. At 5 years, no differences were observed in the rate of TVF (12.7% vs. 13.4%; p = 0.91) and MACCE (23.9% vs. 24.9%; p = 0.88) between the two groups. At multivariate logistic regression, plaque rupture, mean lumen diameter, proximal reference vessel area, and maximum stent deployment pressure were independent predictors of LUS. CONCLUSIONS: LUS are a frequent finding in complex coronary lesions treated with thin-struts DES, especially in the presence of plaque rupture. However, in this study, no significant safety signal related to LUS emerged in long-term follow-up.

Effect of Respiratory Impairment on the Outcomes of Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction and Coronavirus Disease-2019 (COVID-19).

BACKGROUND: Coronavirus Disease-2019 (COVID-19) may impair outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The extent of this phenomenon and its mechanisms are unclear.Methods and Results:This study prospectively included 50 consecutive STEMI patients admitted to our center for primary percutaneous coronary intervention (PCI) at the peak of the Italian COVID-19 outbreak. At admission, a COVID-19 test was positive in 24 patients (48%), negative in 26 (52%). The primary endpoint was in-hospital all-cause mortality. Upon admission, COVID-19 subjects had lower PO2/FiO2 (169 [100-425] vs. 390 [302-477], P<0.01), more need for oxygen support (62.5% vs. 26.9%, P=0.02) and a higher rate of myocardial dysfunction (ejection fraction <30% in 45.8% vs. 19.2%, P=0.04). All patients underwent emergency angiography. In 12.5% of COVID-19 patients, no culprit lesions were detected, thus PCI was performed in 87.5% and 100% of COVID-19 positive and negative patients, respectively (P=0.10). Despite a higher rate of obstinate thrombosis in the COVID-19 group (47.6% vs. 11.5%, P<0.01), the PCI result was similar (TIMI 2-3 in 90.5% vs. 100%, P=0.19). In-hospital mortality was 41.7% and 3.8% in COVID-19 positive and negative patients, respectively (P<0.01). Respiratory failure was the leading cause of death (80%) in the COVID-19 group, frequently associated with severe myocardial dysfunction. CONCLUSIONS: In-hospital mortality of COVID-19 patients with STEMI remains high despite successful PCI, mainly due to coexisting severe respiratory failure. This may be a critical factor in patient management and treatment selection.

Trans-radial closure of coronary artery fistulae using Amplatzer vascular plug IV: A case series.

BACKGROUND: Trans-catheter closure of coronary artery fistulae (CAF) has become a successful alternative to cardiac surgery with excellent results and acceptable low rate of complications. Different techniques and devices are available to treat the extreme anatomical variability of CAF. AIM: We retrospectively describe our case series of five patients trans-radially treated using an Amplatzer vascular plug IV (AVP-IV) with telescoping catheter technique. RESULTS: Trans-radial closure of CAF using the "Child in Mother" technique with dedicated catheters to deliver the vascular plugs AVP-IV was successfully performed in all patients, in one case for a complex CAF, an hybrid step approach using coils and plugs was needed. CONCLUSIONS: Trans-radial closure of CAF using AVP-IV and a telescoping catheter appeared to be safe and feasible in our case series. A persistent closure of CAF was achieved in all patients at 2 year coronary angiography follow-up.

Autologous blood reinfusion during iatrogenic acute hemorrhagic cardiac tamponade: Safety and feasibility in a cohort of 30 patients.

BACKGROUND: Iatrogenic hemorrhagic pericardial tamponade (IHPT) represents a life-threating condition requiring emergency pericardiocentesis. In this clinical context, reinfusion of pericardial blood can stabilize the patient and sustain hemodynamic conditions. AIMS AND METHODS: We reviewed all cases of IHPT occurred at our hospital over a 10 years span. In all patient autologous blood reinfusion through a femoral vein was performed. RESULTS: In our clinical experience of 30 consecutive patients with hemorrhagic cardiac tamponade, this technique was successful to limit blood transfusions, to prevent further clinical worsening and bridge patients with intractable bleeding, to cardiac surgery. No major adverse reactions were directly related to blood autotransfusion. CONCLUSION: In the complex clinical scenario of acute tamponade occurring during catheter-based cardiac procedures, autotransfusion of pericardial blood through a femoral vein is safe and effective. It can be a useful trick up the sleeve of the interventional cardiologist.

Temporal course of vascular healing and neoatherosclerosis after implantation of durable- or biodegradable-polymer drug-eluting stents.

Aims: Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Whether biodegradable polymer (BP) may address these issues is uncertain. We compared in vivo vessel healing and NA of current generation BP- or DP-DES using serial optical coherence tomography (OCT) assessments. Methods and results: Ninety patients with multivessel coronary artery disease were randomized 1:1 to BP everolimus-eluting stents (EES, Synergy) or DP zotarolimus-eluting stents (ZES, Resolute Integrity). Co-primary endpoints were the maximum length of uncovered struts at 3 months (powered for non-inferiority) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority) as measured by OCT. The maximum length of uncovered struts at 3 months was 10 ± 8 mm in the BP-EES group and 11 ± 7 mm in the DP-ZES group (mean difference -1 mm; upper 97.5% confidence interval +2 mm; P = 0.05 for non-inferiority; P = 0.45 for superiority). The percentage of patients presenting with frames of NA at 18 months was low and similar between BP-EES and DP-ZES groups (11.6% vs. 15.9%; P = 0.56). There was no stent thrombosis in both groups at 24 months. Conclusion: BP-EES and DP-ZES showed a similar healing response at 3 months and a low incidence of NA at 18 months. Biocompatible polymers, regardless of whether they are durable or biodegradable, may favourably impact the long-term vascular response to current-generation DES.

Mechanism of luminal patency of the self-expanding Sideguard sidebranch stent: evaluation by intravascular ultrasound and optical coherence tomography.

BACKGROUND: The Cappella Sideguard (CS) sidebranch stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the sidebranch ostium designed to treat bifurcation lesions. OBJECTIVE: To evaluate the mechanism of long-term lumen patency of the novel, self-expanding CS sidebranch stent compared with a balloon-expandable stent in the main vessel. METHODS: We performed intravascular ultrasound postintervention and at follow-up in 24 CS stents and in 28 balloon-expandable drug-eluting stents deployed in the corresponding main vessel. Thirteen patients also had optical coherence tomography (OCT) at follow-up to evaluate neointimal hyperplasia and strut coverage. RESULTS: CS stent area at the sidebranch carina increased significantly from 3.8 ± 1.2 mm(2) postintervention to 4.6 ± 1.2 mm(2) at follow-up (P < 0.001), resulting in no change in lumen area (3.8 ± 1.2 mm(2) to 3.7 ± 1.2 mm(2) , P = 0.72) despite a neointimal area at follow-up of 0.9 ± 0.8 mm(2) . Volumetric changes were similar, and the distribution of neointimal hyperplasia peaked 1-2 mm distal to the carina. Change of lumen volume inversely correlated to the neointimal volume (R = -0.48, P < 0.001), but correlated positively to the change in stent volume (R = 0.52, P < 0.0001). By OCT, most CS struts were covered (100% [98.9, 100]) at the bifurcation site, whereas 61% of floating DES struts that crossed the sidebranch were covered by smooth tissue with a similar texture compared with neointima. CONCLUSION: Although neointimal hyperplasia accumulates within the CS stent mainly 1-2 mm distal to the carina, the self-expanding CS stent may be effective in maintaining an adequate patency in the sidebranch by continued stent expansion noted at follow-up.

Valve-in-valve transcatheter aortic valve implantation: The issues behind crossing a bioprosthesis.

Valve-in-valve transcatheter aortic valve implantation (ViV TAVI) is rapidly arising as a safe and effective alternative to redo-surgery in the treatment of bioprostheses deterioration. While scientific community is currently focusing its attention on the most common limitations related to this procedure, such as the risk of coronary obstruction and patient-prosthesis mismatch, data regarding the first step of a ViV TAVI, the crossing of a degenerated bioprosthesis, are still lacking. The aim of this review is to analyze the available information about bioprosthesis crossing, to show the inherent challenges encountered by interventional cardiologists during valve crossing and to describe the current strategies to perform a correct crossing.

Intravascular ultrasound comparison of the self-expanding Sideguard stent in the side branch versus a balloon-expandable stent in the main vessel to assess mechanisms of acute lumen gain in bifurcation lesions.

OBJECTIVES: We compared the mechanisms of lumen gain after Cappella Sideguard (CS) side branch (SB) bifurcation stent deployment versus a balloon-expandable stent in the corresponding main vessel (MV). BACKGROUND: The novel CS SB bifurcation stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the SB ostium. METHODS: In 28 bifurcation lesions, intravascular ultrasound imaging of both the SB and the MV was performed both pre- and postintervention; vessel and lumen areas were measured every 1 mm over a 5 mm segment beginning at the carina. RESULTS: Although minimum lumen area (MLA) within the distal 5 mm segment beginning at the carina increased from 2.8 ± 1.3 mm(2) to 3.8 ± 1.1 mm(2), P < 0.001, in the SB and from 3.4 ± 1.4 mm(2) to 6.0 ± 1.1 mm(2), P < 0.001, in the MV, stent expansion (minimum stent area/distal reference lumen area) was significantly less in the SB compared with the MV (77.8 ± 21.3% vs. 91.6 ± 18.4%, P = 0.02). Post stenting, the MLA site was located at the carina more frequently in the SB (85.7%) than in the MV (60.7%), P = 0.04. Plaque volume in the 5 mm proximal to carina in the MV tended to decrease, whereas plaque volume in the SB increased slightly with no change in overall plaque volume in the 5-mm-long segment distal to the carina in the MV, suggesting plaque shift from the proximal MV to the SB. CONCLUSIONS: Acute CS lumen gain is less than the lumen gain of a balloon-expandable stent in the MV because of less aggressive acute expansion and/or the plaque shift from the proximal MV to the SB.

Impact of different stent alloys on human vascular response to everolimus-eluting stent: an optical coherence tomography study: the OCTEVEREST.

BACKGROUND: New generation drug-eluting stents (DES) incorporate thinner struts and novel alloys to improve clinical performance. Nevertheless, the impact of novel stent materials and designs on human vascular response to DES remains elusive. We sought to evaluate the in-vivo coronary artery response to platinum-chromium (PtCr) versus cobalt-chromium (CoCr) stents featuring the same durable polymer and antiproliferative drug by optical coherence tomography (OCT). METHODS AND RESULTS: A total of 42 patients with de novo lesions in native coronary vessels was treated with PtCr-everolimus eluting stent (EES; n = 21) or CoCr-EES (n = 21). Angiography, intravascular ultrasound, and OCT were performed at the index procedure and 6-month follow-up. PtCr-EES and CoCr-EES had similar concentric expansion (stent eccentricity index; median 0.91 vs. 0.90, respectively, P = 0.47) and very low rate of strut malapposition (median 1.15 vs. 1.80%, P = 0.92) at post implantation. Proportion of struts embedded in tissue was lower in PtCr-EES compared to CoCr-EES (median 2.67 vs. 15.23%, P < 0.001). The primary prespecified end point, the percentage of uncovered struts per patient at 6 months follow-up, was 8.46% [interquartile range (IQR) = 3.05-17.26] in PtCr-EES and 5.88% (IQR = 1.35-13.27) in CoCr-EES (P = 0.36), whereas malapposed struts were observed in 0.00% (IQR = 0.00-0.25) versus 0.48% (IQR = 0.00-1.44), respectively, (P = 0.10). Strut-level neointimal thickness did not differ between the two platforms (median 0.09 vs. 0.08 mm, P = 0.49). CONCLUSIONS: Acute and mid-term responses to EES using PtCr or CoCr platforms were similar, with concentric stent expansion, low malapposition, similar strut coverage and limited amount of neointima. Conversely, at postprocedure, PtCr-EES had fewer embedded struts compared with CoCr-EES.

Radial artery: how many times?

BACKGROUND AND PURPOSE: Transradial approach for diagnostic and interventional procedures is becoming common practice. It has not been well determined how many times the same radial artery can be cannulated without complications. Aim of the study was to evaluate safety, feasibility and efficacy of repeat transradial procedures. METHODS: From May 1998 to March 2009 we studied 4818 consecutive patients (75.44% male; age 64.02 +/- 11.6 Years) via radial artery by a single experienced operator. RESULTS: A repeat transradial procedure through the same radial artery was performed in 670 patients: twice in 514 cases, three times in 119, four times in 25 patients, five times in 7 patients, six times in 3 patients and seven times in one patient. Repeat PCI was performed in 412 patients. 6F catheters were used in 98.11%. There was no significant difference in radial puncture success rate and vascular access time: puncture success rate was 99.23% in the initial procedure and 98.11% (5 puncture failure) in repeated transradial artery procedures, and vascular access time was 1.5 +/- 2.1 min at the initial procedure and 2.2 +/- 3.1 min at repeat (p = ns). CONCLUSIONS: Failure of repeat puncture may be due to thickening of the tunica intima resulting from sheath insertion injuries or because of periarterial fibrosis at the prior radial puncture site. We believe that repeated use of the same radial artery is effective in considering its high procedural success and low complication rates in majority of patients in the hands of experienced operators.

Safety and feasibility of selective angiography of left internal mammary artery grafts via right transradial approach.

BACKGROUND AND PURPOSE: Right transradial approach (TRA) for cardiovascular procedures is becoming common practice, but angiography and PCI of left mammary artery by-pass graft (LIMA) via the right radial artery is still technically challenging. Aim of the study was to evaluate the possibility to put a stable catheter in left mammary from right radial approach. METHODS: From June 2002 to March 2009, 246 consecutive patients (88% male; age 67.7 +/- 7.8 years) with previous CABG underwent LIMA graft angiography via right TRA by a single experienced operator. RESULTS: An adequate radial access was obtained in all patients. Selective angiography of LIMA was successfully performed in 218 patients (89.1%). In the remaining 28 (10.9%) the LIMA approach from right radial failed because of severe tortuosity of brachiocephalic trunk or severe calcified and tortuous left subclavian artery. 13 patients underwent PCI and stentingon mid-distal native LAD trough LIMA using 6FIM4 guiding catheter. No periprocedural cerebro-vascular complications, no vascular injury at the LIMA takeoff as a result of selective canulation, no injury of the left subclavian artery were observed CONCLUSIONS: In patients with previous CABG, the presence of LIMA grafts is not a limitation to successfully perform diagnostic and interventional procedures via the right radial approach with experienced operators.

Early Clinical Experience With Right and Left Distal Transradial Access in the Anatomical Snuffbox in 52 Consecutive Patients.

BACKGROUND: Distal transradial access in the anatomical snuffbox has advantages over standard access in terms of patient and operator comfort levels and risk of ischemia. Radial artery preservation could be a relevant issue in patients requiring multiple radial artery procedures and coronary bypass with the use of a radial graft. One relevant drawback is the challenging puncture of a small and weak artery, with a steeper learning curve. AIM: The study was aimed at proving feasibility and safety of right and left transradial access in the anatomical snuffbox. METHODS: All 52 consecutive patients assigned to only one operator program underwent diagnostic or procedural intervention through distal transradial access in the anatomical snuffbox. RESULTS: The overall feasibility was 90%, greater than expected in our early clinical experience, with 47 successful accesses out of 52 patients. Failures were due to proximal radial artery occlusion and hypoplastic/vasospastic distal radial artery. CONCLUSION: Distal transradial access in the anatomical snuffbox is an appealing and feasible option for both patients and operators. Further studies are needed to evaluate the clinical benefits conferred by this approach.

Bilateral Slender Transradial Aortic Balloon Valvuloplasty.

Percutaneous aortic balloon valvuloplasty as a bridge-to-decision strategy was performed in an 89-year-old woman with multiple comorbidities and cachexia. The patient did well; after 2 weeks, she was discharged home and referred for possible TAVR.

Transulnar recanalization of a chronic radial artery occlusion.

Trans-ulnar access is a viable alternative approach by experienced operators when the radial and femoral arteries cannot be accessed or used to preserve the contralateral radial artery as possible vascular graft for coronary bypass surgery, hemodynamic monitoring, or shunt creation for hemodialysis. We report a challenging case of ipsilateral trans-ulnar recanalization of a chronic radial artery occlusion, which allowed us to perform a complex trans-ulnar PCI.

How to perform distal anchoring technique by 6French radial approach in complex coronary procedures.

Despite remarkable advances in the interventional landscape, device delivery during percutaneous coronary intervention (PCI) can still present technical challenges especially when performed in complex anatomical settings and through radial approach. To overcome difficult coronary stent delivery, several strategies have been developed. A niche option in such complex cases is the anchoring balloon technique, which involves inflation of a balloon non-coaxially in a side branch or distally to the target lesion in a coaxial fashion, to facilitate stent delivery. However, the main limitation of this technique is the requirement of a large guide catheter (≥7French) which may preclude the use of radial approach. We describe, step-by-step, the distal anchoring ballooning technique performed by a 6Fr radial approach to overcome the stent delivery failure in complex anatomical scenarios and to safely and successfully carry out the PCI procedures.

Radiation Therapy-Induced Cardiovascular Disease Treated by a Percutaneous Approach.

We report the case of a 51-year-old woman, treated with radiotherapy at the age of two years, for a pulmonary sarcoma. Subsequently she developed severe aortic stenosis and bilateral ostial coronary artery disease, symptomatic for dyspnea (NYHA III functional class). Due to the prohibitive surgical risk, she underwent successful stenting in the right coronary artery and left main ostia with drug eluting stents and, afterwards, transcatheter aortic valve replacement with transfemoral implantation of a 23 mm Edwards SAPIEN XT valve. The percutaneous treatment was successful without complications and the patient is in NYHA II functional class at 2 years' follow-up, fully carrying out normal daily activities.

Through the drug-eluting stent labyrinth.

For interventional cardiologists restenosis has represented the main limit for the successful long-term treatment of coronary artery disease. The past 2 years witnessed the extraordinary results of drug-eluting stents (DES), putting this technique at the center stage. The safety and efficacy of sirolimus and paclitaxel-eluting stents have been proved in large prospective, multicenter, randomized trials (RAVEL, SIRIUS, TAXUS II). It is possible that the introduction of DES will lead to substantial changes in the therapeutic and/or the economic strategies of the treatment of ischemic coronary artery disease (increase in the complexity of patients treated, reduction in surgical indications, growing costs). Realizing the potential value of this technology will require the successful management of more complex coronary situations (for lesions and patients characteristics). Many extreme situations are still unexplored, although for some of them studies are currently in progress or already being planned.

Safety, feasibility and efficacy of transradial primary angioplasty in patients with acute myocardial infarction.

BACKGROUND: In recent years the transradial approach has been increasingly employed as an alternative approach to percutaneous coronary intervention. The aim of this study was to investigate the safety, feasibility and efficacy of transradial primary angioplasty. METHODS: We studied 726 patients (552 males, 174 females, mean age 61.5 +/- 12 years) with a diagnosis of acute myocardial infarction (< 12 hours after onset; Killip class 1-3) who underwent primary percutaneous coronary intervention. The transradial approach (group A) was used in 163 consecutive patients (126 males, 37 females, mean age 61.5 +/- 12 years) with a negative Allen test by a single experienced operator. The transfemoral approach (group B) was used for vascular access in the remaining patients (n = 563). RESULTS: No significant differences in baseline characteristics were observed between the two groups. The radial access was achieved in all patients of group A, but 9 who were switched to either left radial (n = 7) or right femoral approaches (n = 2). The time of radial artery cannulation was in all cases < 2 min. The cannulation time (from skin anesthesia to the time of arterial cannulation) and the total procedure time (from patient arrival at the catheterization room to the completion of the procedure) did not significantly differ between group A and group B (1.7 +/- 0.4 vs 1.6 +/- 0.6 min, p = 0.8; 62 +/- 23 vs 61 +/- 22 min, p = 0.7, respectively). In 71.1% of cases of group A, a single catheter (Sones type I or II) was employed for diagnostic angiography of the right and left coronary arteries and of the left ventricle. Only balloon angioplasty was performed in 6.1% of group A patients vs 9.9% of group B patients (p = NS). The primary success rate was identical: 96.9% in the radial and 95.5% in the femoral group. There were no major bleeding complications in group A as opposed to 7 (1.2%) in group B (p = 0.04). In the radial group patients during the 30-day follow-up period there was no forearm ischemia or loss of the radial pulse. The total length of hospitalization was slightly shorter in the radial group, although this difference was not statistically significant (5.9 +/- 2 vs 6.4 +/- 2.8 days, p = 0.1). CONCLUSIONS: Provided it is performed by experienced operators, the transradial approach can represent a safe and feasible method for performing primary angioplasty with similar results to those of the transfemoral approach.

Safety and feasibility of transradial coronary angioplasty in elderly patients.

BACKGROUND: The aim of this study was to assess the safety, feasibility and efficacy of transradial coronary angioplasty in elderly (> or = 70 years) vs younger patients (< 70 years). METHODS: We studied 1125 consecutive patients submitted to transradial coronary angioplasty by a single operator. An angiography of the arteries of the upper limbs was performed before and after the procedure. The presence of the radial pulse was assessed at 1 month of follow-up. RESULTS: At angiography, elderly patients (n = 323) were found to have a higher incidence of radial and brachiocephalic trunk anatomical tortuosity compared to younger subjects (35.3 vs 17.3%, p < 0.05; 10.5 vs 5.3%, p < 0.05, respectively). Radial access was successful in 98.8% of elderly and in 99% of younger patients (p = NS). The procedural success by radial access did not significantly differ between the two groups (97.5 vs 98.7%; p = NS). The cannulation time (from skin anesthesia to arterial cannulation) and the total procedure time (from patient arrival at the catheterization room to the completion of the procedure) were not significantly different between the two groups (1.5 +/- 0.8 vs 1.6 +/- 0.4 min, p = NS; 57 +/- 23 vs 56 +/- 12 min, p = NS, respectively). There were no access site bleeding complications in younger and only one (0.4%) such a complication in elderly patients. In all patients, there was no case of forearm ischemia and the incidence of asymptomatic loss of the radial pulse during the 30-day follow-up period was not different between the two groups (1.5 vs 1.4%, p = NS). CONCLUSIONS: Performed by experienced operators, transradial access constitutes a safe and feasible approach for coronary angioplasty in elderly patients. The results are similar to those observed in younger patients.