Shortening of Palmaz Genesis XD stents by longitudinal compression in pediatric patients with pulmonary vein stenosis: Bench-testing and case series.

Webb MK, Justino H
The Palmaz Genesis XD stents (Cordis®, Cardinal Health, Dublin, OH) are an ideal option for stenting vessels in pediatric patients due to their ability to be re-dilated to large diameters to accompany children\'s somatic growth. Unfortunately, their length limits their utility for pulmonary vein stenting in small children, due to the risk of protrusion into the left atrium or into distal pulmonary vein branches. We describe a stent shortening technique by longitudinally compressing them prior to deployment, which may enhance their applicability in pediatric pulmonary vein stenosis.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 22 Oct 2021; epub ahead of print

Mobility aids predict mortality after transcatheter aortic valve implantation.

Amin R, Arunothayaraj S, Kirtchuk D, Williams T, ... Trivedi U, Hildick-Smith D
Background
Selection of appropriate patients for transcatheter aortic valve implantation (TAVI) can be challenging. Many factors can influence post-procedure outcomes. Traditional surgical scoring systems do not discriminate effectively. Medical parameters and functional indices can characterize mortality risk. Mobility is an important predictive functional index but is largely defined using subjective criteria.
Aim
To describe the relationship between mobility, objectively defined by the requirement for gait aids to ambulate, and all-cause 30-day and long-term mortality in patients undergoing TAVI.
Methods
Mobility aid use was assessed in 1444 consecutive patients undergoing TAVI in a single center. Patients were categorized into \"unaided,\" \"1-stick,\" and \"higher aid\" groups based on the Brighton Mobility Index. Mortality tracking was obtained via the NHS Spine Portal in February 2021.
Results
Patients were aged 82 (IQR 78-86). 66% of patients walked unaided, 26% walked with 1 stick, and 8% required more assistance (e.g., 2 sticks, a Rollator, a Zimmer frame, or a wheelchair). Overall 30-day mortality for the whole cohort was 3.5%; 1-year mortality was 12.2%. Mobility was a significant predictor of 30-day mortality (p = 0.025). Use of a higher aid was associated with a mortality odds ratio of 2.83 (95% CI: 1.39-5.74). Mobility was also a significant predictor of long-term mortality (p < 0.001). Odds ratios for 1-stick and higher aid groups were 1.45 (95% CI: 1.21-1.72) and 2.01 (95% CI: 1.55-2.60), respectively.
Conclusion
Objective assessment of mobility by gait aid use predicts both short and long-term survival in patients undergoing TAVI. Increased dependence on mobility aids is associated with a worse prognosis.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Oct 2021; epub ahead of print

Pulmonary percutaneous valve implantation in large native right ventricular outflow tract with 32 mm Myval transcatheter heart valve.

Rodríguez Ogando A, Ballesteros F, Martínez JLZ
Pulmonary percutaneous valve implantation (PPVI) is feasible with satisfactory mid-term results in patients with native right ventricular outflow tract (RVOT) and has been increasingly used instead of surgically implantable pulmonary valves. Creating a stable landing zone with a diameter less than the largest commercially available valve (previously available 29 mm and currently available 32 mm) is crucial for technical success of the procedure, limiting the number of suitable candidates for PPVI. We report the case of PPVI with a 32 mm Myval transcatheter heart valve in a patient with a large native RVOT (pre-stented with AndraStent XXL mounted on a 35 × 60 mm valve balloon catheter) lesion who had Tetralogy of Fallot surgically corrected. The post-procedural outcomes of this case were satisfactory with no complications reported during the hospital stay.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 20 Oct 2021; epub ahead of print

Outcomes of intravascular ultrasound versus optical coherence tomography guided percutaneous coronary angiography: A meta regression-based analysis.

Sattar Y, Abdul Razzack A, Kompella R, Alhajri N, ... Mamas MA, Alraies MC
Background
Studies comparing clinical outcomes with intravascular ultrasound (IVUS) versus optical coherence tomography (OCT) guidance for percutaneous coronary intervention (PCI) in patients presenting with coronary artery disease, including stable angina or acute coronary syndrome, are limited.
Methods
We performed a detailed search of electronic databases (PubMed, Embase, and Cochrane) for randomized controlled trials and observational studies that compared cardiovascular outcomes of IVUS versus OCT. Data were aggregated for the primary outcome measure using the random-effects model as pooled risk ratio (RR). The primary outcome of interest was major adverse cardiac events (MACE), cardiac mortality, and all-cause mortality. Secondary outcomes included myocardial infarction (MI), stent thrombosis (ST), target lesion revascularization (TLR), and stroke.
Results
A total of seven studies met the inclusion criteria, comprising 5917 patients (OCT n = 2075; IVUS n = 3842). OCT-PCI versus IVUS-guided PCI comparison yielded no statistically significant results for all the outcomes; MACE (RR 0.78; 95% confidence interval [CI], 0.57-1.09; p = 0.14), cardiac mortality (RR 0.97; 95% CI, 0.27-3.46; p = 0.96), all-cause mortality (RR 0.74; 95% CI, 0.39-1.39; p = 0.35), MI (RR 1.27; 95% CI, 0.52-3.07; p = 0.60), ST (RR 0.70; 95% CI, 0.13-3.61; p = 0.67), TLR (RR 1.09; 95% CI, 0.53-2.25; p = 0.81), and stroke (RR 2.32; 95% CI, 0.42-12.90; p = 0.34). Furthermore, there was no effect modification on meta-regression including demographics, comorbidities, lesion location, lesion length, and stent type.
Conclusions
In this meta-analysis, OCT-guided PCI was associated with no difference in clinical outcomes compared with IVUS-guided PCI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 19 Oct 2021; epub ahead of print

Integrated coronary disease burden and patterns to discriminate vessels benefiting from percutaneous coronary intervention.

Dai N, Zhang R, Hu N, Guan C, ... Xu B, Ge J
Objective
To evaluate the prognostic implications of atherosclerosis functional pattern on ischemia-causing vessels received percutaneous coronary intervention (PCI) or conservative treatment.
Background
Quantitative flow ratio (QFR)-derived pullback pressure gradient (PPG) index is recently proposed to characterize atherosclerosis functional pattern, but its prognostic value remains unclear.
Methods
QFR-derived PPG index was retrospectively calculated in patients from the PANDA III trial. Vessels with low or high PPG treated by PCI or not were compared for the risk of 2-year vessel-oriented composite outcome (VOCO), which was a composite of vessel-related ischemia-driven revascularization, vessel-related myocardial infarction, or cardiac death.
Results
A total of 1444 vessels were included while 94 (6.5%) VOCOs occurred within 2 years. Among physiologically ischemic vessels (QFR ≤ 0.80) treated by PCI, those with low PPG acquired higher VOCO risk than those with high PPG (8.4% vs. 3.8%; adjusted hazard ratio [HR] 2.13, 95% confidence interval [CI] 1.18 to 3.86), and a similar VOCO risk (8.4% vs. 7.8%; adjusted HR 1.11, 95%CI 0.70-1.78) compared to those treated by conservatively. After multiple adjustment, PPG index was an independent predictor for VOCO (HR 1.30, 95% CI 1.05-1.62). The addition of PPG to the model of clinical risk factors substantially improved the predictions of VOCO (C-index 0.67 vs. 0.62, net reclassification index 0.42).
Conclusions
PCI treatment was associated with improved outcomes in vessels with high PPG, but not for those with low PPG, which acquired similar risk of VOCO compared to vessels treated conservatively. QFR-derived PPG might assist the treatment strategy selection in ischemia-causing vessels.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Oct 2021; epub ahead of print

GORE® Cardioform ASD Occluder experience in transcatheter closure of \"complex\" atrial septal defects.

Santoro G, Cuman M, Pizzuto A, Haxhiademi D, ... Assanta N, Cantinotti M
Objective
To evaluate the GORE® Cardioform ASD Occluder (GCO) (WL Gore & Associates, Flagstaff, AZ) device for \"complex\" atrial septal defects (ASD) closure.
Background
Transcatheter ASD closure is still challenging in \"complex\" clinical/anatomic settings. This study evaluated the results of GCO in closure of \"complex\" ASD in a tertiary referral center.
Methods
Between January 2020 and March 2021, 72 patients with significant ASD were submitted to transcatheter closure with GCO at our Institution. Based on clinical/anatomic characteristics, they were classified as \"complex\" (n = 36, Group I) or \"simple\" (n = 36, Group II). We considered as \"complex\", defects with rim deficiency (< 5 mm) other than antero-superior, relatively large (diameter/patient weight > 1.2 or diameter/patient BSA > 20 mm/m² ) or within a multifenestrated septum. Procedure results and early outcome were compared between the groups.
Results
Absolute and relative ASD size (20 ± 4 vs. 15 ± 3 mm, p < 0.0001; 0.9 ± 0.3 vs. 0.4 ± 0.2 mm/kg, p < 0.0001; 23 ± 7 vs. 12 ± 5 mm/m² , p < 0.0001), QP/QS (2.0 ± 0.8 vs. 1.4 ± 0.3, p < 0.001), procedure and fluoroscopy times (73 ± 36 vs. 43 ± 21 min, p < 0.0001; 16 ± 9 vs. 9 ± 4 min, p < 0.0001, procedure feasibility (94.4 vs. 100%, p < 0.0001) and overall complication rate (13.9 vs. 0%, p < 0.0001) were significantly different between the groups. Successful closure of \"surgical\" ASDs was achieved in 92% of cases. Complete closure at last follow-up evaluation did not significantly differ between the groups (97.1 vs. 100%, p = NS), as was wireframe fractures rate (49.1% in the overall population), without clinical, EKG and echocardiographic consequences.
Conclusions
Percutaneous treatment with GCO device is effective and safe in high percentage of \"complex\" ASDs.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 14 Oct 2021; epub ahead of print

In vitro Doppler versus catheter transvalvular pressure gradients in balloon-expandable versus self-expanding transcatheter aortic valves.

Stanová V, Rieu R, Côté N, Salaun E, Rodés-Cabau J, Pibarot P
Objectives
The objective of this in vitro study was to compare Doppler versus catheter transvalvular pressure gradients (TPG) in third generations balloon-expandable (BE) versus self-expanding (SE) transcatheter heart valves (THV).
Background
TPG is a key parameter to assess and follow valve hemodynamic function following transcatheter aortic valve implantation (TAVI). It remains uncertain and debated whether, and to which extent, TPGs differ according to the type of THV, that is, BE versus SE and to the method used for TPG measurement, that is, Doppler echocardiography versus cardiac catheterization.
Methods
The CoreValve EVOLUT PRO 26 mm and the SAPIEN 3 23 mm THVs were tested in a left heart simulator using a 21 mm aortic annulus under following conditions: heart rate: 70 bpm, mean aortic pressure: 100 mmHg, stroke volume: 30, 70 and 100 ml. Mean TPGs were measured by continuous-wave Doppler and by micro-tip pressure catheters positioned in the left ventricle and at 50 mm downstream to the tip of the THV leaflets.
Results
Doppler TPGs (9.5 ± 3.9 mmHg) were on average 40.5 ± 13.9% higher (p < 0.001) than catheter TPGs (6.3 ± 3.4 mmHg). Both Doppler and catheter TPGs were lower (p = 0.003) in the SE versus BE THVs (Doppler: 8.7 ± 3.5 vs. 10.7 ± 4.6; catheter: 5.0 ± 1.7 mmHg vs. 7.1 ± 2.2). The Doppler versus catheter difference in TPG increased with the higher flow conditions. The Doppler versus catheter difference in TPG was similar in BE versus SE THVs (3.6 ± 1.1 vs. 3.7 ± 1.4 mmHg or 42 ± 9 vs. 47 ± 9%; p = 0.58) overall and in each flow conditions.
Conclusion
The Doppler TPGs are, on average, 40% higher than the catheter TPGs for both BE and SE THVs. The SE THV had lower Doppler and catheter TPGs compared to the BE THV, at normal and high flow states. The absolute and percent differences between Doppler versus catheter TPGs were similar in BE versus SE THVs.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 10 Oct 2021; epub ahead of print

Conventional versus modified delivery system technique in commissural alignment from the Evolut low-risk CT substudy.

Tang GHL, Sengupta A, Alexis SL, Zaid S, ... Kini A, Reardon MJ
Objectives
We assessed the impact of conventional delivery system (DS) insertion technique on \"Hat-marker\" orientation/commissural alignment in patients who underwent transcatheter aortic valve replacement (TAVR) in the Evolut Low Risk Trial CT substudy versus a modified technique.
Background
Unlike surgical aortic valve replacement, where alignment of the surgical valve commissures with native commissures can be achieved virtually 100% of the time, commissural alignment during TAVR is not achieved consistently. This may subsequently impact the feasibility of both coronary access and reintervention after TAVR.
Methods
\"Hat-marker\" orientations during deployment were characterized as outer curve (OC), center front (CF), inner curve, and center back. Severe commissure-to-CA overlap was 0-20°. \"Hat-marker\" orientations and CA overlap were compared to 240 patients from a single center using the modified 3-o\'clock flush port DS technique.
Results
In the CT substudy in which conventional DS insertion was performed (flush port at 12 o\'clock); 154/249 had both analyzable CT and procedural fluoroscopy to validate \"Hat-marker\" to C-tab/commissural orientation. On post-TAVR CT, Evolut valve commissural orientation and coronary artery (CA) ostia were identified. Compared to conventional DS technique in the CT substudy, the modified technique had higher rates of \"Hat-marker\" at OC/CF orientation, improved commissural alignment and reduced severe CA overlap; (left main, 14.2 vs. 27.9%; right coronary artery, 11.7 vs. 27.3% both, 5.0 vs. 13.6%; 1 or both CA, 20.8 vs. 41.6%, all p < 0.01).
Conclusions
The modified technique improved initial \"Hat-marker\" orientation during Evolut deployment and resulted in better commissural alignment and reduced CA overlap.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Oct 2021; epub ahead of print

Impact of diabetes mellitus on outcome after transcatheter aortic valve replacement: Identifying high-risk diabetic population from the OCEAN-TAVI registry.

Matsumoto S, Ohno Y, Miyamoto J, Ikari Y, ... Hayashida K, OCEAN-TAVI Investigators
Objectives
To identify the vulnerable diabetic cohort in patients undergoing transcatheter aortic valve replacement (TAVR).
Backgrounds
Considerable controversy remains about whether specific cohort exists in which presence of diabetes mellitus (DM) carries adverse risk of mortality after TAVR.
Methods
Of the 2588 patients who were enrolled in the OCEAN-TAVI registry, 2526 patients with glycohemoglobin data were analyzed. The individuals were divided into DM and non-DM groups according to previous medical history of DM or using diabetic medicine, and increased HbA1c values (≥6.5%) at baseline. The primary endpoint of this study was 2-year all-cause mortality after TAVR.
Results
The follow up rate of clinical outcome at 1-year was 2514/2526 (99.5%) and median follow-up period was 22.5 months. DM group had 699 (27.7%) patients, in which 153 (21.9%) was diagnosed by increased HbA1c levels without previous medical history of DM. Kaplan-Meier curve of 2-year all-cause mortality presented significant difference between patients with and without DM (p = 0.029). In addition, patients with low-density lipoprotein cholesterol (LDL-C) levels > 100 mg/dl and left ventricular ejection fraction (LVEF) < 40% had great risk of mortality after TAVR (LDL-C: hazard ratio [HR] 1.82, p < 0.001; LVEF: HR 2.61, p = 0.002, respectively).
Conclusions
Presence of DM was significantly associated with poor outcome after TAVR and adverse effect of DM was remarkable in patients with relatively higher LDL-C levels and reduced LVEF under 40%. These subtypes may need intensive control of cardiovascular risk factors, including DM, before and after TAVR.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Oct 2021; epub ahead of print

A new over-the-wire percutaneous mitral balloon valvuloplasty technique.

Weich H, van Veyeren LM
Objectives
To develop and evaluate a new over-the-wire technique for mitral valvuloplasty that is both technically easier and less costly.
Background
Rheumatic heart disease (RHD) and resultant mitral stenosis (MS) carries a significant burden of disease worldwide. The prevalence is however concentrated in lower income countries where the current gold standard for percutaneous mitral valvuloplasty (PMBV)-the Inoue technique, is not always available due to cost and technical complexity.
Methods
The development of an over-the-wire technique involving a steerable catheter to aid crossing of the valve and a dedicated TAVI wire is described. The procedure evolved over the initial eight cases and the final standardized procedure was performed in 16 cases. Clinical, echocardiographic and procedural outcomes are described in 16 consecutive cases performed at a single center.
Results
The procedure was performed with 88% procedural success and only one technical failure during the development phase. 2/24 patients had moderate mitral regurgitation (MR) afterwards but one had unfavorable anatomy and the other had pre-procedural moderate MR. The average procedural duration was 66 min, which was shortened significantly over time. No procedural deaths or conversion to open surgery at 1 year. Procedural cost was 44% lower than the Inoue technique.
Conclusion
We present favorable results of a new PMBV technique that is cheaper and technically easier in our opinion.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E610-E616

Initial experience with the fourth generation MitraClip™: Outcomes, procedural aspects, and considerations for device selection.

Garcia-Sayan E, Raghunathan D, Li FM, Dhoble A, ... Smalling RW, Mackensen GB
Objectives
We present our initial experience with the fourth-generation MitraClip™ (G4) system and propose preliminary criteria for device selection.
Background
The MitraClip™ G4 system recently underwent a \"controlled release\" for transcatheter edge-to-edge mitral valve repair. The four new devices include technical improvements such as controlled gripper actuation (independent leaflet capture) and continuous left atrial pressure monitoring. To date, a patient-specific device selection algorithm, and the technology\'s impact on procedural times and success, have not been described.
Methods
We present an initial multi-center experience and short-term outcomes with the new system, suggest procedural and imaging considerations, and propose initial guidance for device selection.
Results
Sixty-one procedures performed by three operators at two centers between November 2019 and May 2020 were analyzed. At 30-day follow-up, there were three deaths (4.9%), four neurological events (6.6%), and seven re-hospitalizations (11.5%). Fifty-nine patients achieved device and procedural success (96.7%), and there was one device-related technical issue (1.6%). Compared to the same operators utilizing the third generation MitraClip™, the G4 system resulted in a significant reduction in the median number of clips used per patient (1 IQR 1-2 vs. 2 IQR 1-3, p = .023) and a trend toward shorter device times.
Conclusion
Based on our initial experience, we found that the MitraClip™ G4 system is associated with high procedural success and fewer devices needed per procedure. The expanded device options may allow a more targeted approach to the myriad of pathologic presentations of mitral regurgitation. This early experience should provide a foundational opportunity for further refinement.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E626-E636

Successful radiofrequency perforation and balloon decompression of cor triatriatum sinister using novel technique, a case series.

Blais BA, Aboulhosn JA, Salem MM, Levi DS
Cor triatriatum sinister (CTS) is a rare congenital cardiac anomaly representing <0.1% of all congenital cardiac malformations. It is characterized by the presence of a left atrial (LA) membrane that leads to left ventricular inflow obstruction. Uncorrected, obstructed CTS may have significant sequelae such as pulmonary hypertension or arrhythmias. Transcatheter balloon decompression has been described as a successful alternative to surgical resection of the obstructing membrane. Our review of the literature revealed no reported cases utilizing radiofrequency (RF) energy to perforate the CTS membrane prior to balloon decompression. This manuscript describes two patients with CTS who were treated successfully with a transcatheter technique using RF energy to perforate the obstructing membrane prior to balloon angioplasty and decompression of the LA.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:810-814

Percutaneous mitral valve repair with MitraClip device in hemodynamically unstable patients: A systematic review.

Martinez-Gomez E, McInerney A, Tirado-Conte G, de Agustin JA, ... Macaya C, Nombela-Franco L
Background
Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip.
Methods
We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included.
Results
Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p < .001). The median weaning time from the procedure, to discontinuation of mechanical circulatory or respiratory support, was 2 days (IQR 1-4), with an in-hospital mortality and non-fatal complication rate of 12.6 and 9.1%, respectively. Kaplan-Meier curves estimated an overall mortality rate of 39.1% at 12-month follow-up, with persistent reduction in MR severity for survivors (Grade ≤ 2 in 81.3%) and one case of mitral valve reintervention.
Conclusions
Percutaneous mitral valve repair with MitraClip device is a technically feasible and potentially viable management option in high-risk patients with cardiogenic shock or refractory pulmonary edema and concomitant moderate-severe MR. Prospective trials are required to confirm these findings, and definitively determine the value of MitraClip in hemodynamically unstable patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E617-E625

The radioprotective effect of the Cathpax® AIR cabin during interventional cardiology procedures.

Gutierrez-Barrios A, Angulo-Pain E, Noval-Morillas I, Cañadas-Pruaño D, ... Calle-Perez G, Vázquez-García R
Background
The use of ionizing radiation during cardiac catheterization interventions adversely impacts the medical staff. Traditional radiation protection equipment is only partially effective. The Cathpax® radiation protection cabin (RPC) has proven 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 nonrandomized 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 the characteristics of patients and procedures, average contrast volume, air kerma (AK), dose area-product (DAP) and fluoroscopy time between both groups were apparent. In the 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.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E523-E530

A meta-analysis of transcarotid versus transfemoral transcatheter aortic valve replacement.

McGrath DP, Kawabori M, Wessler B, Chen FY, Zhan Y
Background
Carotid access has shown promise as an excellent delivery route for transcatheter aortic valve replacement (TAVR). We aimed to compare outcomes of transcarotid (TC) and transfemoral (TF) TAVR by conducting a search and analysis of the best evidence in the literature to shed light on its safety and effectiveness.
Methods
The PubMed/MEDLINE, Embase, and Cochrane library from inception to July 2020 were searched to identify articles reporting comparative data on TC versus TF approaches for TAVR. Patients\' baseline characteristics and clinical outcomes were extracted from the articles and pooled for analysis.
Results
Five studies, including a total of 2470 patients, were included in the study with 1859 patients in the TF group and 611 patients in the TC group. The TC group had higher prevalence of peripheral vascular disease, while the patients in the TF group was older. Meta-analysis revealed that there was no significant differences between the two groups with regard to 30-day mortality (p = 0.09), stroke (p = 0.28), new dialysis (p = 0.58), major bleeding (p = 0.69), or pacemaker implantation (p = 0.44). The TF group had a higher incidence of vascular complications (3.9% vs. 2.3%; OR 2.22; 95% CI [1.13, 4.38]; p = 0.02).
Conclusions
Compared with the TF approach, TC-TAVR is associated with comparable procedural and clinical outcomes. Our analysis found a lower rate of vascular complication in TC access compared with TF access. This supports consideration of such an alternative access when there are concerns over the feasibility of TF access.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:767-773

Bioprosthetic valve fracture: Predictors of outcome and follow-up. Results from a multicenter study.

Brinkmann C, Abdel-Wahab M, Bedogni F, Bhadra OD, ... Wolf A, Schofer J
Objectives
To evaluate outcome and its predictors of bioprosthetic valve fracture (BVF) in patients undergoing valve-in-valve transcatheter aortic valve replacement (VIV-TAVR).
Background
BVF is feasible and reduces transvalvular gradients in VIV-TAVR-procedures, but follow-up-data and information on factors influencing the outcome are missing.
Methods
The 81 cases of BVF-VIV-TAVR were collected from 14 international centers.
Results
Predominantly transcatheter heart valve (THV) was implanted first, followed by BVF. VARC-2 defined device success was 93%, most failures were attributed to residual high gradients. Mean gradients decreased from 37 ± 13 mmHg to 10.8 ± 5.9 mmHg (p < 0.001). BVF reduced the gradient by 16 mmHg. During follow-up (FU, 281 ± 164 days) mean gradient remained stable (10.8 ± 5.9 mmHg at discharge, 12.4 ± 6.3 mmHg at FU, p = ns). In-hospital major adverse events occurred in 3.7%. Event-free survival at 276 ± 237.6 days was 95.4%. The linear mixed model identified balloon-expandable valves (BEV), Mitroflow surgical valve, stenotic surgical bioprostheses and balloon only 1 mm larger than the true internal diameter of the surgical valve as predictors for higher gradients.
Conclusions
BVF is safe and can significantly reduce gradients, which remain stable at FU. BEV, Mitroflow surgical valve, stenotic bioprostheses and balloon larger than the true internal diameter of the surgical valve of only 1 mm are predictors for higher final gradients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:756-764

Early outcomes from the CLASP IID trial roll-in cohort for prohibitive risk patients with degenerative mitral regurgitation.

Lim DS, Smith RL, Zahr F, Dhoble A, ... Gillam L, CLASP IID Pivotal Trial Investigators
Objectives
We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site.
Background
The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site.
Methods
Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed.
Results
A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001).
Conclusions
Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E637-E646

External validation of the GRACE risk score 2.0 in the contemporary all-comers GLOBAL LEADERS trial.

Ono M, Kawashima H, Hara H, Gamal A, ... Onuma Y, Serruys PW
Objectives
This study aimed to assess the predictive ability of the Global Registry of Acute Coronary Events (GRACE) risk score 2.0 in contemporary acute coronary syndrome (ACS) patients, and its relation to antiplatelet strategies.
Background
The predictive value of the GRACE risk score in the contemporary ACS cohort and the appropriate antiplatelet regimen according to the risk remain unclear.
Methods
This is a subgroup analysis of the all-comers, randomized GLOBAL LEADERS trial, comparing ticagrelor monotherapy versus conventional dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The GRACE risk score 2.0 with 1-year mortality prediction was implemented. The randomized antiplatelet effect was assessed in predefined three GRACE risk-groups; low-risk (GRACE <109), moderate-risk (GRACE 109-140), and high-risk (GRACE >140).
Results
The GRACE risk score was available in 6,594 out of 7,487 ACS patients among whom 1,743, 2,823, and 2,028 patients were classified as low-risk, moderate-risk, and high-risk, respectively. At 1 year, all-cause mortality occurred in 120 patients (1.8%). The discrimination ability of the GRACE model was moderate (C-statistic = 0.742), whereas 1-year mortality risk was overestimated (mean predicted mortality rate: 3.9%; the Hosmer-Lemeshow chi-square: 21.47; p = 0.006). There were no significant interactions between the GRACE risk strata and effects of the ticagrelor monotherapy on ischemic or bleeding outcomes at 1 year compared to the reference strategy.
Conclusion
The GRACE risk score 2.0 is valuable in discriminating high risk ACS patients, however, the recalibration of the score is recommended for better risk stratification. There is no significant differences in efficacy and safety of ticagrelor monotherapy across the three GRACE risk strata.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E513-E522

The DISCO study-Does Interventionalists\' Sex impact Coronary Outcomes?

Yelavarthy P, Seth M, Pielsticker E, Grines CL, ... Sukul D, Gurm HS
Objectives
To examine the association of operator sex with appropriateness and outcomes of percutaneous coronary intervention (PCI).
Background
Recent studies suggest that physician sex may impact outcomes for specific patient cohorts. There are no data evaluating the impact of operator sex on PCI outcomes.
Methods
We studied the impact of operator sex on PCI outcome and appropriateness among all patients undergoing PCI between January 2010 and December 2017 at 48 non-federal hospitals in Michigan. We used logistic regression models to adjust for baseline risk among patients treated by male versus female operators in the primary analysis.
Results
During this time, 18 female interventionalists and 385 male interventionalists had performed at least one PCI. Female interventionalists performed 6362 (2.7%) of 239,420 cases. There were no differences in the odds of mortality (1.48% vs. 1.56%, adjusted OR [aOR] 1.138, 95% CI: 0.891-1.452), acute kidney injury (3.42% vs. 3.28%, aOR 1.027, 95% CI: 0.819-1.288), transfusion (2.59% vs. 2.85%, aOR 1.168, 95% CI: 0.980-1.390) or major bleeding (0.95% vs. 1.07%, aOR 1.083, 95% CI: 0.825-1.420) between patients treated by female versus male interventionalist. While the absolute differences were small, PCIs performed by female interventional cardiologists were more frequently rated as appropriate (86.64% vs. 84.45%, p-value <0.0001). Female interventional cardiologists more frequently prescribed guideline-directed medical therapy.
Conclusions
We found no significant differences in risk-adjusted in-hospital outcomes between PCIs performed by female versus male interventional cardiologists in Michigan. Female interventional cardiologists more frequently performed PCI rated as appropriate and had a higher likelihood of prescribing guideline-directed medical therapy.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E531-E539

Impact of sex on long-term cardiovascular outcomes of patients undergoing percutaneous coronary intervention for acute coronary syndromes.

Roumeliotis A, Claessen BE, Sartori S, Cao D, ... Dangas G, Mehran R
Background
Women with acute coronary syndrome (ACS) generally present with more comorbidities and experience worse clinical outcomes compared with males. However, it is unclear whether this represents genuine sex-related difference or stems from clinical, procedural and socioeconomic factors.
Methods
We analyzed consecutive patients undergoing percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina at a single tertiary-care center. Exclusion criteria were unknown sex, age < 18 years and PCI with bare metal stent or without stent placement. The study population was stratified according to sex. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of death, spontaneous myocardial infarction, or stroke at 1 year. Secondary endpoints were individual components of MACCE, target vessel revascularization (TVR) and clinically significant bleeding.
Results
Of the 7362 patients included, 5031 (68.3%) were men and 2331 (31.7%) women. Women were older and presented with a higher burden of comorbidities while men had more complex coronary anatomy. The incidence of 1 year MACCE was significantly higher among women (8.0% versus 5.6%; p < 0.01) compared to men. Women also experienced a higher rate of bleeding (2.3% vs. 1.4%; p = 0.02) while there were no differences between groups in terms of TVR (8.1% vs. 7.8%; p-value = 0.83). Differences in outcomes were attenuated after multivariable adjustment. Findings were consistent across ACS subgroups.
Conclusions
In a contemporary ACS population treated with drug-eluting stents, women experienced a higher crude rate of 1-year MACCE. This was no longer apparent after accounting for baseline imbalances.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E494-E500

Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document.

Berti S, Pastormerlo LE, Korsholm K, Saw J, ... Santoro G, Nielsen-Kudsk JE
Transcatheter left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Intraprocedural imaging is a crucial for a successful intervention, with transesophageal echocardiography (TEE) as the current gold standard. Since some important limitations may affect TEE use, intracardiac echocardiography (ICE) is increasingly used as an alternative to TEE for guiding LAAO. The lack of a standardized imaging protocol has slowed the adoption of ICE into clinical practice. On the basis of current research and expert consensus, this paper provides a protocol for ICE support of left atrial appendage occlusion.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:815-825

Feasibility of intravascular lithotripsy for calcific coronary lesions: A multi-institutional experience.

Iwańczyk S, Włodarczak A, Hiczkiewicz J, Faron W, ... Siniawski A, Lesiak M
Objective
We sought to determine the safety and performance of intravascular lithotripsy in the treatment of severe calcified atherosclerotic lesions.
Background
The modification of severe calcified atherosclerotic lesions with noncompliant or specialty balloons, as well as orbital or rotational atherectomy has limitations and may be ineffective, increasing the risk of periprocedural complications and worsening long-term results. Intravascular lithotripsy has recently been shown to be a safe and feasible alternative to the above methods.
Methods
All consecutive patients treated with Shockwave Medical Intravascular Lithotripsy (S-IVL) between May 2019 and June 2020 were included in current analysis. Device safety and efficacy were the critical endpoints of the study. The primary safety endpoint was 30-day major adverse cardiac events (MACE). In turn, device and clinical success were the primary performance endpoints.
Results
In total, 46 patients undergoing percutaneous coronary intervention were treated with S-IVL before stent deployment (65% male; age, 71 ± 7 years). Device success was achieved in 45 (97.8%) patients with reduction of diameter stenosis from 80% to 5.2% with an acute gain of 2.5 mm. Clinical success was demonstrated in 95.6% of cases. During the 30-day follow-up, one sudden death was recorded, regarded as probable subacute stent thrombosis. During 6-month follow up one target lesion and target vessel revascularizations occurred. The rate of MACE after 6 month was 6.2%.
Conclusions
S-IVL appears to be a safe and effective treatment modality in coronary calcium modification to optimize stent expansion. In selected cases this device obviates the need for more complex lesion preparation strategies such as atherectomy.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E540-E547

Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial appendage closure registry.

Teiger E, Thambo JB, Defaye P, Hermida JS, ... Le Corvoisier P, French national Left Atrial Appendage Closure registry (FLAAC) investigators
Objectives
The French left atrial appendage (LAA) closure registry (FLAAC) aimed to assess the safety and efficacy of LAA closure in daily practice.
Background
LAA closure has emerged as an alternative for preventing thromboembolic events (TE) in patients with non-valvular atrial fibrillation (NVAF). Clinical data in this field remains limited and few investigator-initiated, real-world registries have been reported.
Methods
This nationwide, prospective study was performed in 36 French centers. The primary endpoint was the TE rate after successful LAA closure.
Results
The FLAAC registry included 816 patients with a mean age of 75.5 ± 0.3 years, mean follow-up of 16.0 ± 0.3 months, high TE (CHA₂ DS₂ -VASc score: 4.6 ± 0.1) and bleeding risks (HAS-BLED score: 3.2 ± 0.05) and common contraindications to long-term anticoagulation (95.7%). Procedure or device-related serious adverse events occurred in 49 (6.0%) patients. The annual rate of ischemic stroke/systemic embolism was 3.3% (2.4-4.6). This suggests a relative 57% reduction compared to the risk of stroke in historical NVAF populations without antithrombotic therapy. By multivariate analysis, history of TE was the only factor associated with stroke/systemic embolism during follow-up (HR, 3.3 [1.58-6.89], p = 0.001). The annual mortality rate was 10.2% (8.4-12.3). Most of the deaths were due to comorbidities or underlying cardiovascular diseases and unrelated to the device or to TE.
Conclusions
Our study suggests that LAA closure can be an option in patients with NVAF. Long-term follow-up mortality was high, mostly due to comorbidities and underlying cardiovascular diseases, highlighting the importance of multidisciplinary management after LAA closure.
Registration
NCT02252861.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:788-799

Outcomes of bailout percutaneous ventricular assist device versus prophylactic strategy in patients undergoing nonemergent percutaneous coronary intervention.

O\'Neill BP, Grines C, Moses JW, Ohman EM, ... Medjamia AM, Mahmud E
Objectives
To compare in-hospital outcomes of bailout support to prophylactic support with percutaneous ventricular assist devices (pVAD) for high-risk nonemergent percutaneous coronary intervention (HRPCI).
Background
Prophylactic support with pVAD for a HRPCI is used in patients felt to be at risk for hemodynamic collapse during PCI. An alternative strategy of bailout pVAD support in the event of hemodynamic collapse is also entertained.
Methods
We compared the outcomes of patients entered in the cVAD database who underwent Impella Protected PCI (ProPCI group) with patients from the cVAD and USpella databases receiving bailout Impella support for hemodynamic collapse during HRPCI (Bailout group).
Results
A total of 1,028 patients supported with Impella pVAD were entered into the cVAD database as of July 2019 and were included in this analysis. Of those 971 were in the ProPCI group and 57 in the Bailout group. Patients in the Bailout group were more often female (50.9%vs. 27.2%, p = .0002) with higher median baseline left ventricular ejection fraction (LVEF) (40%vs. 30%, p < .0001) and with lower prevalence of both heart failure (42.1%vs. 56.9%, p = .0385) and left main disease (40.0%vs. 56.1%, p = .0250) compared to the ProPCI group. Unadjusted and adjusted in-hospital mortality was significantly higher in the Bailout group (49.1%vs. 4.3%, and 57.8%vs. 4.4%, p < .0001 for both).
Conclusions
In our study population, the bailout group was associated with significant increased mortality compared to ProPCI group. Female gender was more frequently observed in patients requiring bailout pVAD. Further investigation is warranted in order to generalize the findings of our study.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E501-E512

Hemolysis after transcatheter mitral valve replacement in degenerated bioprostheses, annuloplasty rings, and mitral annular calcification: Incidence, patient characteristics, and clinical outcomes.

El-Sabawi B, Guerrero ME, Eleid MF, Nkomo VT, Pislaru SV, Rihal CS
Objectives
To determine the incidence, characteristics, and outcomes of patients with hemolysis after transcatheter mitral valve replacement (TMVR).
Background
Hemolysis is an increasingly recognized complication of TMVR. Clinical outcomes and optimal management for patients with hemolysis after TMVR are unclear.
Methods
Patients that underwent mitral valve-in-valve (MViV), valve-in-ring (MViR), and valve-in-mitral annular calcification (ViMAC) at a single center were retrospectively assessed.
Results
A total of 101 patients had TMVR, including 69 with MViV, 14 with MViR, and 18 with ViMAC. ViMAC patients had an increased frequency of mild or greater paravalvular leak (PVL) (ViMAC, 72.2%; MViR, 14.3%; MViV, 13.0%; p < .001). Hemolysis occurred in eight patients and was more common after ViMAC (ViMAC, 33.3%; MViR, 7.1%; MViV, 1.5%; p < .001). This required transfusion in five (ViMAC, 4; MViV, 1) and was associated with acute kidney injury in five with ViMAC. Among the ViMAC patients, four had transcatheter re-intervention to treat hemolysis with resolution of anemia in three and mild residual anemia in one with persistent mild PVL. The two ViMAC patients without re-intervention had persistent anemia and died within 6 months. Both MViV and MViR patients with hemolysis did not have PVL but had turbulent flow from left ventricular outflow tract narrowing and their hemolysis was self-limited.
Conclusions
Hemolysis occurs with greater frequency and increased clinical severity after ViMAC as compared to MViV or MViR and is likely related to increased incidence of PVL. These findings demonstrate the need to investigate novel strategies that can reduce the burden of hemolysis with ViMAC.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:776-785

Improvement of symptoms and coronary perfusion gradient with mechanical left ventricular unloading in flow-limiting complex spontaneous coronary artery dissection, without revascularization.

Tarantini G, Fabris T, Rodinò G, Fraccaro C
Spontaneous coronary artery dissection (SCAD) can lead to acute coronary syndrome and sudden cardiac death, particularly in young women. Observational data show that, in SCAD patients, both percutaneous coronary intervention and coronary artery bypass grafting seem to be hampered by higher technical complexity, lower success rates, and worse outcomes. As spontaneous healing is a common occurrence, expert consensus advices medical management of the acute phase, when feasible. We present the case of a young woman with SCAD of left anterior descending artery causing myocardial infarction with ST-segment elevation. High-anatomical complexity and unstable conditions of the patient made both medical management and immediate revascularization unfeasible options. Therefore, we decided to implant a percutaneous off-loading mechanical support device to improve coronary perfusion pressure by unloading the left ventricle and preserve cardiac function, preventing worse complications of acute myocardial infarction. This strategy was successful in stabilizing the patient, until the definitive revascularization treatment became an option.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E581-E585

Percutaneous closure of a patent foramen ovale causing exercise hypoxemia: Case report and a review of the literature.

Punzengruber G, Kolb R, Meier B, Binder RK
Provoked exercise desaturation is a rare presentation of patent foramen ovale (PFO), when vigorous exercise leads to desaturation of arterial blood and subsequent dyspnea. We present a case of provoked exercise desaturation and curative percutaneous closure and review the literature. A 54-year-old male patient presented with shortness of breath during exercise in the pneumology outpatient department. During exercise spirometry, a relevant drop in arterial oxygen saturation and partial pressure of oxygen was observed and a right-left shunt suspected. In a transesophageal echocardiogram, a PFO was observed. Cardiac catheterization documented a right-left-shunt causing desaturation during exercise. Following percutaneous closure of the PFO, exercise induced desaturation was no longer detectable during exercise spirometry and there was considerable improvement in exercise capacity and subjective dyspnea. To sum up, provoked exercise desaturation is a rare but curable presentation of PFO. Percutaneous closure is a safe and effective way to treat this entity.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:733-737

Role of tenecteplase (rtPA) to re-establish flow in intraprocedural stent thrombosis in infants undergoing ductal stenting for duct-dependent pulmonary circulation-a case series.

Tan JWY, Alwi M, Siew ELL, Samion H
Ductal stenting in patients with duct-dependent pulmonary circulation has allowed growth of pulmonary arteries prior to definitive surgical procedures. Intraprocedural stent thrombosis (IPST) of the arterial duct is a life-threatening complication as it leads to total circulatory collapse. Previous reports have described use of tissue plasminogen activators in infants for less emergent settings. We report three infants with IPST and the use of tenecteplase to overcome this. Also discussed are the predisposing mechanisms in each scenario and a possibility of direct catheter-guided tenecteplase administration. Judicious use of tenecteplase can be life-saving and rapid access to this drug may obviate the need for emergency extracorporeal life support.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:738-742

Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy.

Boeder NF, Kastner J, Mehilli J, Münzel T, ... Nef HM, GABI-R Study Group
Aims
We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure.
Methods and results
A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT.
Conclusion
Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E555-E563

Safety and usefulness of a novel short track sliding balloon catheter.

Chung YH, Kim JS, Lee SY, Im E, ... Hong MK, Jang Y
Objectives
To evaluate the safety and technical utility of the short track sliding (STS) balloon catheter.
Background
An STS balloon catheter is designed to ensure a low profile at the shaft and perform distal anchoring using a single guidewire. However, its clinical practice with the STS balloon catheter has not been reported.
Methods
This prospective multi-center registry enrolled 100 patients with significant coronary artery disease who had undergone percutaneous coronary intervention using an STS balloon catheter at three hospitals in Korea from March 2019 to July 2020. Overall safety was assessed as any occurrences of device-related malfunction during the pre-dilation of the lesions. Its technical success rates of the kissing balloon technique or the distal anchoring technique using a single guidewire were also evaluated.
Results
Of the 118 lesions pre-dilated using the STS balloon, no significant complication was observed except for three significant coronary dissections, which were completely covered with stents. There was no incidence of balloon catheter malfunction, such as fracture, entrapment, or perforation. With 13 attempts of kissing ballooning techniques with the STS balloon with a 6F guiding catheter, all cases were successful. The distal anchoring techniques were attempted in 10 cases, the stent was successfully crossed to the target lesion in all 10 cases.
Conclusions
The novel STS balloon catheter can be safely applied in routine coronary intervention with minimal complications. In addition, this catheter could be useful for performing the kissing balloon technique with a small-caliber guiding catheter and distal anchoring technique with a single guidewire.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E548-E554

Everolimus eluting bioresorbable vascular scaffolds in patients with acute coronary syndromes: Two-year results from the German-Austrian ABSORB registry.

Tröbs M, Achenbach S, Nef HM, Gori T, ... Hamm CW, GABI-R Study Group
Objectives
To identify potential differences in 2-year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS).
Background
Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus-eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated.
Methods
German-Austrian ABSORB RegIstRy is a prospective all-comer multi-center observational study of consecutive patients who were considered for coronary revascularization with BVS. We compared 1499 patients with stable CAD to 1594 patients with ACS. Endpoints were major adverse cardiac events (MACE), TLF, and scaffold thrombosis.
Results
While single vessel disease was more prevalent in ACS (46% vs. 37%, p < 0.0001), lesion complexity (B2/C stenosis 37% vs. 36%, bifurcation 2.4% vs. 3.4%, p < 0.05), number of implanted scaffolds/patient (1.34 vs. 1.43), scaffold length (18 vs. 18 mm) or the rate of high pressure postdilatation (68% vs. 70%) did not differ between ACS and stable CAD. Two-year MACE rates were 11.6% in ACS and 11.4% in stable CAD, TLF occurred in 7.0% versus 7.4% and target vessel revascularization in 8.8 versus 10.2% (n.s. for all). Definite scaffold thrombosis rates were not significantly different (ACS 1.9% vs. stable CAD 2.1%).
Conclusion
Real-world 2-year event rates after coronary revascularization with BVS are not significantly different between individuals with ACS as compared to stable CAD.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E564-E570

In-hospital outcomes of endovascular versus surgical revascularization for chronic total occlusion in peripheral artery disease.

Zghouzi M, Moussa Pacha H, Ullah W, Sattar Y, ... Mamas MA, Alraies MC
Background
The outcome of endovascular intervention (EVI) compared vs. surgical revascularization in patients with peripheral artery disease (PAD) due to chronic total occlusion (CTO) is unknown.
Methods
Using the National Inpatient Sample database between 2007 and 2014, we identified all PAD patients with CTO who had limb revascularization. Multivariate analysis was performed to estimate the odds of in-hospital mortality and adverse outcomes between both groups.
Results
A total of 168,420 patients who had peripheral CTO and underwent limb revascularization were identified. 99,279 underwent EVI, and 69,141 underwent surgical revascularization. The patients who underwent EVI were younger, more likely to be women and African American, and less likely to be white (p < 0.001 for all). EVI was associated with lower in-hospital mortality (1.2% vs 1.7%, adjusted odds ratio [aOR]: 0.54; 95% confidence interval [CI] 0.50-0.59). The EVI group had higher vascular complications, major bleeding, acute kidney injury (AKI), and major amputation compared with surgical revascularization. A subgroup analysis on patients with critical limb ischemia showed lower mortality in the EVI group (1.4% vs. 1.9, aOR 0.56; 95% CI 0.50-0.63). Although there was no difference in the incidence of AKI or major amputation between the two groups, the EVI group had higher vascular complication rates and major bleeding events.
Conclusion
EVI in PAD with CTO is associated with lower in-hospital mortality, likely due to the procedure\'s less-invasive nature; however, it is associated with higher postprocedural complications likely due to the CTO\'s complexity.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E586-E593

Very late vasomotor responses and gene expression with bioresorbable scaffolds and metallic drug-eluting stents.

Koh JS, Gogas BD, Kumar S, Benham JJ, ... Jo H, Samady H
Objectives
To investigate the long-term vasomotor response and inflammatory changes in Absorb bioresorbable vascular scaffold (BVS) and metallic drug-eluting stent (DES) implanted artery.
Background
Clinical evidence has demonstrated that compared to DES, BVS is associated with higher rates of target lesion failure. However, it is not known whether the higher event rates observed with BVS are related to endothelial dysfunction or inflammation associated with polymer degradation.
Methods
Ten Absorb BVS and six Xience V DES were randomly implanted in the main coronaries of six nonatherosclerotic swine. At 4-years, vasomotor response was evaluated in vivo by quantitative coronary angiography response to intracoronary infusion of Ach and ex vivo by the biomechanical response to prostaglandin F2-α (PGF2-α), substance P and bradykinin and gene expression analysis.
Results
Absorb BVS implanted arteries showed significantly restored vasoconstrictive responses after Ach compared to in-stent Xience V. The contractility of Absorb BVS treated segments induced by PGF2-α was significantly greater compared to Xience V treated segments and endothelial-dependent vasorelaxation was greater with Absorb BVS compared to Xience V. Gene expression analyses indicated the pro-inflammatory lymphotoxin-beta receptor (LTβR) signaling pathway was significantly upregulated in arteries treated with a metallic stent compared to Absorb BVS treated arterial segments.
Conclusions
At 4 years, arteries treated with Absorb BVS compared with Xience V, demonstrate significantly greater restoration of vasomotor responses. Genetic analysis suggests mechanobiologic reparation of Absorb BVS treated arteries at 4 years as opposed to Xience V treated vessels.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:723-732

Predictors of prolonged guidewire manipulation time for native coronary chronic total occlusion percutaneous coronary intervention via primary antegrade approach.

Ochiumi Y, Yamamoto M, Tsuchikane E, Muramatsu T, ... Yoshikawa R, Otsuka T
Objectives
This study aimed to identify the predictive factors for the guidewire manipulation time (GWMT) of ≥20 and 30 min for chronic total occlusion-percutaneous coronary intervention (CTO-PCI) via the primary antegrade approach (PAA).
Background
Selection of primary retrograde approach (PRA) and the optimal timing to switch from antegrade to retrograde approach for coronary CTO-PCI is still debatable.
Methods
Using the Japanese CTO-PCI expert registry data, we selected and analyzed 4461 patients who underwent CTO-PCI via PAA alone. The considerable lesion/anatomical factors for GWMT ≥20 and 30 min were analyzed. The risks of prolonged GWMT ≥20 and 30 min were stratified as easy, intermediate, difficult, and very difficult according to the multivariate analysis.
Results
Nine lesion/anatomical characteristics (blunt stump, side branch at proximal cap, bifurcation at the exit point, calcification, tortuosity, occlusion length ≥ 20 mm, reattempt, nonleft anterior descending artery (nonleft anterior descending artery [LAD]), and tandem CTO) were independent predictors of GWMT ≥20 min (all p < 0.05). Excluding the nonLAD and tandem CTO, the same factors of GWMT ≥20 min correlated with GWMT ≥30 min (all p < 0.05). The distributions were increased in easy, intermediate, difficult, and very difficult subsets of GWMT ≥20 min (58.3%, 77.2%, 89.1%, and 100%) and GWMT ≥30 min (47.5%, 69.2%, 83.9%, and 100%).
Conclusions
These predictive factors of prolonged GWMT should be assessed before CTO-PCI via PAA and when considering an adequate timing to switch the retrograde or PRA if clinically available.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:E571-E580

Efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder.

Ben-Assa E, Herrero-Garibi J, Cruz-Gonzalez I, Elmariah S, ... Inglessis I, Palacios IF
Background
Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduces the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from large randomized trials.
Objectives
We compared the safety and efficacy of percutaneous PFO closure in patients with and without a hypercoagulable state.
Methods
Data from 800 consecutive patients undergoing percutaneous PFO closure in our medical center were analyzed. All patients were independently evaluated by specialists in neurology, cardiology, hematology, and vascular medicine. A post-procedural treatment of at least 3 months of anticoagulation was utilized in patients with thrombophilia. Follow-up events included death, recurrent neurological events, and the need for reintervention for significant residual shunt.
Results
A hypercoagulable state was found in 239 patients (29.9%). At median follow-up of 41.9 months, there were no differences in the frequencies of stroke or transient ischemic attack between patients with or without thrombophilia (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p = 0.35). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success, or complications between groups.
Conclusion
Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:800-807

Finding sideline benefits-Of pandemics and same-day-discharge following rotational atherectomy.

Hawamdeh H, Moliterno DJ
The occurrence of same-day discharge following elective rotational atherectomy cases in England and Wales during 2007-2014 increased from approximately 7 to 36%. High-volume centers and transradial approach were associated with more likelihood of same-day discharge. As compared with patients who stayed for overnight observation following elective rotational atherectomy, those discharged the same day as the procedure had a similar rate of 30-day mortality (0.35 and 0.50%, respectively; p = 0.409).

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 29 Sep 2021; 98:689-690

Percutaneous closure of a post-surgical ascending aortic pseudoaneurysm with an amplatzer septal occluder device and steerable guiding sheath.

McClure GR, Ratnayake G, Chan A, Gagnon J
Thoracic pseudoaneurysm in the ascending aorta is an uncommon condition associated with significant risk of morbidity and mortality. Treatment is recommended in all cases regardless of symptoms as the mortality rate if left untreated has been documented to be as high as 61%. The current standard of care for managing these lesions is open surgical repair. However, this is associated with significant morbidity. In-hospital mortality reported for patients undergoing surgical repair of an ascending aortic pseudoaneurysm ranges from 6.7% to 41%. When anatomically suitable, a less invasive approach using amplatzer vascular plug or septal occluder is an attractive approach. We present a case report of repair of a post-surgical ascending aortic false aneurysm using an amplatzer septal occluder with an Oscor ™ steerable guiding sheath; a novel approach to increase platform stability when engaging an aneurysm neck. Endovascular occluder deployment for closure of aortic false aneurysms remains a relatively novel technique. It is limited by the requirement to develop a stable endovascular platform to deliver the device and avoid system prolapse, particularly when accessing challenging lesions on the inner aortic curvature. We present the first case to utilize a steerable guiding sheath system to improve system stability and facilitate successful device delivery. Given the significant morbidity associated with open repair of these lesions we hope this will further expand the range of lesions viewed as appropriate for endovascular repair.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Sep 2021; epub ahead of print

Finding the optimal access for proximal upper limb artery (PULA) interventions: Lessons learned from the PULA multicenter registry.

Nardai S, Zafirovska B, Pataki Á, Nemes B, ... Merkely B, Ruzsa Z
Objective
The multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries.
Background
Little is known about the optimal vascular access for PULA interventions, despite the well-known technical complexity of these procedures.
Methods
We performed the retrospective analysis of consecutive patients treated for symptomatic steno-occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high-volume centers. Acute thrombotic occlusions were excluded from the study.
Results
Two hundred and seventy-two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient\'s characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255/272) versus 86.11% (93/108) p = 0.0230, while the procedure length 27 min (8; 133) versus 46 min (7; 140) p = 0.0001 and fluoroscopy times 439 s (92; 2993) versus 864 s (86; 4176) p = 0.0001 were higher in the occlusion group. The main adverse event rate was similarly low. Dual access was used more often to treat occlusions (60.19% (65/108) vs. 11.40% (31/272) p = 0.0001) without significantly increasing the complication rate. The safest access was ultrasound-guided distal radial artery puncture, significantly better than conventional radial access with 0% (0/31) versus 13.6% (18/131) p = 0.0253 complication.
Conclusions
The percutaneous revascularization of proximal upper limb arteries is a safe and effective. Dual access can be applied to increase treatment efficacy, without significantly compromising safety.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 28 Sep 2021; epub ahead of print

Optical coherence tomography, intravascular ultrasound or angiography guidance for distal left main coronary stenting. The ROCK cohort II study.

Cortese B, de la Torre Hernandez JM, Lanocha M, Ielasi A, ... Fineschi M, Burzotta F
Objectives
to test the safety and efficacy of intravascular imaging and specifically optical coherence tomography (OCT) as a diagnostic tool for left main angioplasty and analyze the mid-term outcome accordingly.
Background
Clinical data and international guidelines recommend the use of intravascular imaging ultrasound (IVUS) to guide left main (LM) angioplasty. Despite early experience using OCT in this setting is encouraging, the evidence supporting its use is still limited.
Methods
ROCK II is a multicenter, investigator-driven, retrospective European study to compare the performance of IVUS and OCT versus angiography in patients undergoing distal-LM stenting. The primary study endpoint was target-lesion failure (TLF) including cardiac death, target-vessel myocardial infarction and target-lesion revascularization. We designed this study hypothesizing the superiority of intravascular imaging over angiographic guidance alone, and the non-inferiority of OCT versus IVUS.
Results
A total of 730 patients, 377 with intravascular-imaging guidance (162 OCT, 215 IVUS) and 353 with angiographic guidance, were analyzed. The one-year rate of TLF was 21.2% with angiography and 12.7% with intravascular-imaging (p = 0.039), with no difference between OCT and IVUS (p = 0.26). Intravascular-imaging was predictor of freedom from TLF (HR 0.46; 95% CI 0.23-0.93: p = 0.03). Propensity-score matching identified three groups of 100 patients each with no significant differences in baseline characteristics. The one-year rate of TLF was 16% in the angiographic, 7% in the OCT and 6% in the IVUS group, respectively (p = 0.03 for IVUS or OCT vs. angiography). No between-group significant differences in the rate of individual components of TLF were found.
Conclusions
Intravascular imaging was superior to angiography for distal LM stenting, with no difference between OCT and IVUS.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Sep 2021; epub ahead of print

Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study.

Kandzari DE, Alaswad K, Jaffer FA, Brilakis E, ... Buller C, Karmpaliotis D
Background
Description of procedural outcomes using contemporary techniques that apply specialized coronary guidewires, microcatheters, and guide catheter extensions designed for chronic total occlusion (CTO) percutaneous revascularization is limited.
Methods
A prospective, multicenter, single-arm study was conducted to evaluate procedural and in-hospital outcomes among 150 patients undergoing attempted CTO revascularization utilizing specialized guidewires, microcatheters and guide extensions. The primary endpoint was defined as successful guidewire recanalization and absence of in-hospital cardiac death, myocardial infarction (MI), or repeat target lesion revascularization (major adverse cardiac events, MACE).
Results
The prevalence of diabetes was 32.7%; prior MI, 48.0%; and previous bypass surgery, 32.7%. Average (mean ± standard deviation) CTO length was 46.9 ± 20.5 mm, and mean J-CTO score was 1.9 ± 0.9. Combined radial and femoral arterial access was performed in 50.0% of cases. Device utilization included: support microcatheter, 100%; guide catheter extension, 64.0%; and mean number of study guidewires/procedure was 4.8 ± 2.6. Overall, procedural success was achieved in 75.3% of patients. The rate of successful guidewire recanalization was 94.7%, and in-hospital MACE was 19.3%. Achievement of TIMI grade 2 or 3 flow was observed in 93.3% of patients. Crossing strategies included antegrade (54.0%), retrograde (1.3%) and combined antegrade/retrograde techniques (44.7%). Clinically significant perforation resulting in hemodynamic instability and/or requiring intervention occurred in 16 (10.7%) patients.
Conclusions
In a multicenter, prospective registration study, favorable procedural success was achieved despite high lesion complexity using antegrade and retrograde guidewire maneuvers and with acceptable safety, yet with comparably higher risk than conventional non-CTO PCI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 27 Sep 2021; epub ahead of print

Development and validation of a predictive model for bleeding after peripheral vascular intervention: A report from the National Cardiovascular Data Registry Peripheral Vascular Interventions Registry.

Salisbury AC, Safley DM, Kennedy KF, Bhardwaj B, ... Attaran RR, Spertus JA
Objectives
To develop a model to predict risk of in-hospital bleeding following endovascular peripheral vascular intervention.
Background
Peri-procedural bleeding is a common, potentially preventable complication of catheter-based peripheral vascular procedures and is associated with increased mortality. We used the National Cardiovascular Data Registry (NCDR) Peripheral Vascular Interventions (PVI) Registry to develop a novel risk-prediction model to identify patients who may derive the greatest benefit from application of strategies to prevent bleeding.
Methods
We examined all patients undergoing lower extremity PVI at 76 NCDR PVI hospitals from 2014 to 2017. Patients with acute limb ischemia (n = 1600) were excluded. Major bleeding was defined as overt bleeding with a hemoglobin (Hb) drop of ≥ 3 g/dl, any Hb decline of ≥ 4 g/dl, or a blood transfusion in patients with pre-procedure Hb ≥ 8 g/dl. Hierarchical multivariable logistic regression was used to develop a risk model to predict major bleeding. Model validation was performed using 1000 bootstrapped replicates of the population after sampling with replacement.
Results
Among 25,382 eligible patients, 1017 (4.0%) developed major bleeding. Predictors of bleeding included age, female sex, critical limb ischemia, non-femoral access, prior heart failure, and pre-procedure hemoglobin. The model demonstrated good discrimination (optimism corrected c-statistic = 0.67), calibration (corrected slope = 0.98, intercept of -0.04) and range of predicted risk (1%-18%).
Conclusions
Post-procedural PVI bleeding risk can be predicted based upon pre- and peri-procedural patient characteristics. Further studies are needed to determine whether this model can be utilized to improve procedural safety through developing and targeting bleeding avoidance strategies.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 26 Sep 2021; epub ahead of print

Trends in utilization, outcomes, and readmissions after transcatheter mitral valve replacement.

Elbadawi A, Mahta D, Elgendy IY, Dang AT, ... Barker CM, Jneid H
Background
There is a paucity of real-world data regarding the temporal trends and outcomes of trans-septal transcatheter mitral valve replacement (TS-TMVR) in the United States (US).
Methods
We queried the Nationwide Readmissions Database (October 2015 to December 2018) for patients undergoing TS-TMVR procedures. We reported the temporal trends in the utilization, in-hospital outcomes and 30-day readmissions after TS-TMVR. The main study outcome was in-hospital mortality.
Results
There was an increase in the number of TS-TMVR procedures over time (48 in 2015 vs. 978 in 2018, P_trend  < 0.001), with a notable increase in the proportion of women (P_trend  = 0.04) and the prevalence of diabetes (P_trend  = 0.03). There was an increase in the number of centers performing TS-TMVR (21 in 2015 vs. 164 in 2018, P_trend  < 0.001). The overall in-hospital mortality was 7.2% with no change over time (6.3% in 2015 vs. to 5.2% in 2018, P_trend  = 0.67). There was no change in the frequency of in-hospital complications after TS-TMVR; however, the median length of stay has decreased over time. The overall 30-day readmission rate was 17.8%, with no change during the study years. The most frequent cause for 30-day readmission after TS-TMVR was acute heart failure followed by bleeding and infection-related complications. Prior coagulopathy and small-sized hospitals were independently associated with higher in-hospital mortality and 30-day readmissions.
Conclusion
This nationwide observational analysis of real-world data showed an increase in the number of TS-TMVR procedures over time, which is now performed at a greater number of centers. There was no change in the rate of in-hospital mortality, complications or 30-day readmissions; but a significant reduction in the length of hospital stay over time was noted. As the number of TS-TMVR continue to expand, these data provide a perspective on the early experience with this procedure.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 26 Sep 2021; epub ahead of print

The clinical impact of chronic liver disease in patients undergoing transcatheter and surgical aortic valve replacement: Systematic analysis of the 2011-2017 US hospital database.

Lee DU, Han J, Fan GH, Hastie DJ, ... Addonizio EA, Karagozian R
Objectives
In this study, we use a national database to evaluate post-transcatheter (TAVR)/surgical aortic valve replacement (SAVR) outcomes stratified using chronic liver disease (CLD).
Background
In patients undergoing TAVR and SAVR, the surgical risks should be optimized; this includes evaluating hepatic diseases that may pose an operative risk.
Methods
2011-2017 National Inpatient Sample was used to select in-hospital TAVR and SAVR cases, which were stratified according to CLD (cirrhosis, hepatitis B/C, alcoholic/fatty/nonspecific liver disease). The cases-controls were matched using propensity score matching and compared with various endpoints.
Result
After matching for demographics and comorbidities, for TAVR, 606 and 1818 were with or without CLD; for SAVR, 1353 and 4059 were with and without CLD. In TAVR, there was no differences in mortality (2.81% vs. 2.75% OR 1.02 95% CI 0.58-1.78) or length of stay (6.29 vs. 6.44d p = 0.29), and CLD-present patients had marginally increased costs ($228,415 vs. $226,682 p = 0.048). There were no differences in complications. In multivariate, there was no difference in mortality (aOR 1.02 95% CI 0.58-1.79). In SAVR, CLD patients had higher mortality (7.98% vs. 3.23% OR 2.60 95% CI 2.00-3.38), length of stay (13.3 vs. 11.3 days p < 0.001), and costs ($273,487 vs. $238,097 p < 0.001). CLD patients also had increased respiratory failure (9.02% vs. 7.19% OR 1.28 95% CI 1.03-1.59) and bleeding (8.43% vs. 6.33% OR 1.36 95% CI 1.08-1.71). In multivariate, CLD had higher mortality (aOR 2.60 95% CI 2.00-3.38).
Conclusion
CLD is associated with higher mortality and complications in patients undergoing SAVR; however, no correlation was found in patients undergoing TAVR.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 24 Sep 2021; epub ahead of print

Elective percutaneous coronary intervention performed during contrast-induced hypotension.

Soomro AY, Almaddah N, Lendel V, Agarwal SK, Uretsky BF
Objectives
To demonstrate the feasibility and safety of performing elective percutaneous coronary intervention (PCI) during contrast reaction producing severe hypotension.
Background
The development of profound hypotension due to a contrast reaction requires emergency treatment and usually signals procedure termination.
Methods and results
We report successful completion of planned PCI with blood pressure support with vasopressors during contrast-induced hypotension in nine procedures in three patients with previously known contrast reaction causing hypotension.
Conclusions
This case series provides support for the feasibility and safety of performing successful planned PCI under blood pressure support in patients with contrast reaction causing severe hypotension. A management approach for considering intervention in the setting of contrast-induced hypotension is provided.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 21 Sep 2021; epub ahead of print

The utility of geriatric nutritional risk index to predict outcomes in chronic limb-threatening ischemia.

Li J, Arora S, Ikeoka K, Smith J, ... Kashyap V, Shishehbor MH
Objectives
To assess geriatric nutritional risk index (GNRI) in patients with chronic limb-threatening ischemia (CLTI).
Background
The prevalence of CLTI continues to rise, with major amputation and mortality remaining prominent. Frailty is a vital risk factor for adverse outcomes in cardiovascular care. The GNRI is a nutrition-based surrogate for frailty that has been utilized in Southeast Asia to predict adverse events in CLTI. It has not yet been evaluated in a primarily Western population, nor in the context of wound healing.
Methods
Between 8August 2017 and April 2019, we identified patients undergoing endovascular interventions for CLTI at our institution, categorized into low GNRI (≤ 94, frail) versus normal GNRI (> 94, reference). We analyzed the risks of major adverse limb events (MALE), its individual components [mortality, major amputation, and target vessel revascularization (TVR)], amputation free survival (AFS), and wound healing using Kaplan-Meier and multivariate cox-proportional hazard regression analyses.
Results
A total of 255 patients were included in the analysis, with follow up of 14 ± 9.1 months. Lower GNRI was associated with higher cumulative event rates for MALE (71.0% vs. 43.3%, p <  0.001), mortality (34.3% vs. 15.2%, p < 0.001), major amputation (31.2% vs. 15.8%, p = 0.002), and freedom from AFS (56.0% vs. 28.2%, p < 0.001). There was a trend toward lower TVR and higher wound healing with higher GNRI score.
Conclusions
Our single-center, retrospective evaluation of GNRI (as a surrogate for frailty) correlated with increased risks of MALE, mortality, and major amputation. Future directions should focus not only on the recognition of these patients, but risk-factor modification to optimize long-term outcomes.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 18 Sep 2021; epub ahead of print

The hemodynamic spectrum of pulmonary vein stenosis from fibrosing mediastinitis.

Ingraham BS, Packer DL, Holmes DR, Reddy YNV
A 63-year-old man presented with hemoptysis and progressive dyspnea. His echocardiogram was concerning for pulmonary hypertension (PH) and CT chest showed fibrosing mediastinitis with possible cardiac involvement. Right heart catheterization revealed PH at rest and worsened with exercise. CT findings and simultaneous measurement of pulmonary capillary wedge pressure (PCWP), left atrial pressure, and left ventricular pressure helped diagnose pulmonary vein (PV) stenosis as the etiology of his PH. Both upper pulmonary veins were stented, and repeat exercise hemodynamic study revealed a substantial reduction in pulmonary arterial pressure with improvement in subjective dyspnea, cardiac output reserve, mechanical efficiency, and ventilatory efficiency. Repeat right upper PCWP normalized, consistent with resolution of the PV stenosis.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 17 Sep 2021; epub ahead of print

Initial in-human experience with the conveyor cardiovascular system for the delivery of large profile transcatheter valve devices.

O\'Neill BP, Wang DD, Caranasos TG, Chitwood WR, O\'Neill WW, Stack R
Objectives
To determine the safety and efficacy of the conveyor cardiovascular system (CCS) to facilitate the delivery of large profile transcatheter valve devices.
Background
Transcatheter valve devices rely on force provided by the operator to be delivered to their intended position. This delivery may be challenging in a variety of anatomic scenarios. The ability to provide steering from the tip of the device by forming an arterial venous loop may help overcome these challenges.
Methods
Between May, 2019 and October, 2020, five patients were recruited for delivery of transcatheter valve devices with the CCS. These patients were deemed by the operators to have challenging anatomy which could make conventional valve delivery difficult or impossible. These patients were recruited as part of an FDA approved early feasibility study or through an institutional review board approved compassionate use protocol.
Results
Three patients underwent transcatheter mitral valve replacement with a SAPIEN-3 valve. One patient each underwent transcatheter aortic valve (TAVR) implantation with a SAPIEN 3 and 1 patient underwent TAVR implantation with a Lotus valve. All patients underwent successful implantation of the valve and removal of the CCS and valve delivery systems. There was no more than trivial mitral regurgitation post procedure in any patient and there was no more than trivial paravavular leak. There were no major in-hospital complications.
Conclusions
The CCS facilitates the delivery of large profile transcatheter valve devices in challenging anatomic scenarios. Further studies are needed with additional valve technologies.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Sep 2021; epub ahead of print

Left femoral vein access for transcatheter mitral valve interventions in unfavorable interatrial septal anatomy.

Maisano F, Russo G, Tagliari AP, Gavazzoni M, Taramasso M
Optimal transseptal puncture (TSP) position on the interatrial septum as well as proper catheter direction and maneuverability in the left atrium (LA) are key elements for successful mitral valve (MV) interventions. TSP is usually performed from the right femoral vein being more comfortable for the operator and easier to reach the fossa ovalis. In the cases reported, TSP was performed from left femoral vein (LFV) to improve delivery system maneuverability and trajectory inside the LA in the context of MV repair with MitraClip. According to this early experience, LFV approach might be considered as first choice or as an alternative solution in patients in whom a higher position of the delivery system relative to the mitral annulus is needed.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Sep 2021; epub ahead of print

Redo-transcatheter aortic valve replacement with the supra-annular, self-expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry.

Attizzani GF, Dallan LAP, Forrest JK, Reardon MJ, ... Liu F, Pelletier M
Objectives
To assess the safety profile of redo-TAVR procedures from patients in the transcatheter valve therapy (TVT) Registry.
Background
The use of transcatheter aortic valves (TAV) to treat previously implanted failing TAVS (TAV-in-TAV) has been an increasingly important topic as indications for TAVR move to younger and lower-risk patients, but data on the safety and efficacy of redo-TAVR is limited.
Methods
Patients undergoing redo-TAVR procedures using the Evolut R, Evolut PRO or Evolut PRO+ valve in the TVT Registry between April 2015 and March 2020 were included. In-hospital, 30-day and 1-year outcomes were analyzed.
Results
Redo-TAVR was performed in 292 patients (213 patients received the Evolut R valve and 79 received the Evolut PRO or PRO+ valve). Device success was achieved in 94.5%. In-hospital mortality was 2.1%, stroke occurred in 2.7%, and 77.2% of patients were discharged home. There were no cases of coronary compression/obstruction or myocardial infarction that occurred in index hospitalization. Mean gradient at 30-days was 11.9 ± 6.9 mmHg, and 73.1% had none/trace total aortic regurgitation.
Conclusions
Results from the TVT Registry demonstrate good short-term outcomes after redo-TAVR with the supra-annular, self-expandable Evolut platform. Long-term follow-up is necessary to further expand understanding this complex scenario.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 16 Sep 2021; epub ahead of print

Trends in outcomes, cost, and readmissions of transcatheter edge to edge repair in the United States (2014-2018).

Alkhouli M, Sulaiman S, Osman M, El Shaer A, Mayahni AA, Kawsara A
Introduction
Despite the growth in transcatheter edge-to-edge repair (TEER) volume in the United States, data on the temporal changes in procedural outcomes are lacking.
Methods
We utilized the National Readmission Database to assess the annual changes in patient\'s characteristics, in-hospital outcomes, cost, and readmissions for patients who underwent TEER between January 1, 2014 and December 31, 2018. Outcomes of interest included mortality, major adverse cardiovascular events (MACE) and any adverse event (AE). We also assessed length of stay and cost.
Results
A total of 22,692 hospitalizations were included. The mean age increased from 75.2 ± 12.9 in 2014 to 78.1 ± 9.8 years in 2018. Changes in the prevalence of risk factors were heterogenous. The incidence of in-hospital mortality decreased from 4.0% in 2014 to 2.0% in 2018. Both MACE and any AE decreased significantly. Although the incidence of 30-day readmission remained stable, there was a trend towards a temporal increase in both 90-day and 180-day. The adjusted median length of stay of the index admission decreased by 50% and this trend was associated with a $2100 reduction in risk and inflation adjusted in-hospital cost, however, this reduction was offset by the increased total cost of readmissions within the first 6 months resulting in similar net-cost.
Conclusion
The volume of TEER has grown substantially between 2014 and 2018 coupled with a temporal improvement in in-hospital outcomes and reduction in cost and length of stay. Re-hospitalization rates after TEER remained steady at 30-day and trended towards worsening overtime at 90- and 180-days.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Sep 2021; epub ahead of print

The importance of proximal optimization technique with intravascular imaging guided for stenting unprotected left main distal bifurcation lesions: The Milan and New-Tokyo registry.

Watanabe Y, Mitomo S, Naganuma T, Chieffo A, ... Nakamura S, Colombo A
Objectives
This study evaluated the 5-years outcomes of intracoronary imaging-guided proximal optimization technique (POT) for percutaneous coronary intervention (PCI) in patients with unprotected left main distal bifurcation lesions (ULMD).
Background
The long-term effects of POT with intracoronary imaging guide in PCI for ULMD have been unclear.
Methods
Between January 2005 and December 2015, we identified 1832 consecutive patients who underwent DES implantation for ULM distal bifurcation lesions. Of them, 780 (56.1%) patients underwent POT with intravascular imaging guidance (optimal expansion group). Residual 611 (43.9%) patients did not undergo either POT or intravascular imaging or both (suboptimal expansion group). Analysis using propensity score adjustment was performed. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR), and myocardial infarction.
Results
TLF rate at 5 years was significantly lower in optimal expansion group than that in suboptimal expansion group [adjusted HR 0.65, 95% CI (0.48-0.87), p = 0.004]. Cardiac mortality was significantly lower in optimal expansion group than that in suboptimal expansion group [adjusted HR 0.46, 95% CI (0.27-0.79), p = 0.004]. The multivariable analysis identified POT with intravascular imaging guide [adjusted HR 0.65, 95% CI (0.48-0.87), p = 0.004] as an independent predictor of TLF.
Conclusions
Intravascular imaging guided POT was strongly associated with the reduced risk of TLF at 5 years after PCI for ULMD, mainly driven by reducing cardiac mortality.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 13 Sep 2021; epub ahead of print

Safety and efficacy of the polymer-free and polymer-coated drug-eluting stents in patients undergoing percutaneous coronary intervention.

Ullah W, Zghouzi M, Ahmad B, Suleiman AM, ... Mamas MA, Alraies MC
Introduction
The relative safety and efficacy of polymer-free (PF) versus polymer-coated (PC) drug-eluting stents (DES) in patients with angina or acute coronary syndrome (ACS) undergoing percutaneous coronary intervention has received limited study.
Method
Digital databases were queried to identify relevant studies. Major adverse cardiovascular events (MACE) and secondary outcomes were compared using a random effect model to calculate unadjusted odds ratios (OR).
Results
A total of 28 studies consisting of 23,198 patients were included in the final analysis. On pooled analysis, there was no significant difference in the odds of MACE (OR 0.98, 95% CI 0.91-1.08) and major bleeding (OR 0.87, 95% CI 0.61-1.24) between patients undergoing PF-DES versus PC-DES. Similarly, the odds of myocardial infarction, stroke, stent thrombosis, cardiovascular mortality and need for target vessel revascularization was similar between the two groups. PF-DES was favored due to significantly lower odds of non-cardiac death (OR 0.78, 95% CI 0.68-89) and all-cause mortality (OR 0.87, 95% CI 0.80-0.95), but had a higher need for target lesion revascularization (OR 1.2, 95% CI 1.02-1.42). A subgroup analysis based on follow up duration, clinical presentation, presence of diabetes and class of eluting drugs mirrored the net estimates for all outcomes with a few exceptions. A sensitivity and meta-regression analysis showed no influence of single-study and duration of antiplatelet therapy on pooled outcomes.
Conclusion
In patients presenting with angina or ACS, PF-DES might be favored due to lower all-cause mortality and equal risk of ischemic adverse cardiovascular and major bleeding events compared with PC-DES.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 11 Sep 2021; epub ahead of print

Surgical versus transcatheter aortic valve replacement in low-risk patients: A long-term propensity score-matched analysis.

Brízido C, Madeira M, Brito J, Madeira S, ... Neves JP, Mendes M
Background
Recent studies suggest the use of transcatheter aortic valve implantation (TAVI) as an alternative to surgical aortic valve replacement (SAVR) in lower risk populations, but real-world data are scarce.
Methods
Single-center retrospective study of patients undergoing SAVR (between June 2009 and July 2016, n = 682 patients) or TAVI (between June 2009 and July 2017, n = 400 patients). Low surgical risk was defined as EuroSCORE II (ES II) < 4% for single noncoronary artery bypass graft procedure. TAVI patients were propensity score-matched in a 1:1 ratio with SAVR patients, paired by age, New York Heart Association class, diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation, creatinine clearance, and left ventricular ejection fraction < 50%.
Results
A total of 158 patients (79 SAVR and 79 TAVI) were matched (mean age 79 ± 6 years, 79 men). TAVI patients had a higher incidence of permanent pacemaker implantation (0% vs. 19%, p < 0.001) and more than mild paravalvular leak (4% vs. 18%, p = 0.009), but comparable rates of stroke, major or life-threatening bleeding, emergent cardiac surgery, new-onset atrial fibrillation, and need for renal replacement therapy. Hospital length-of-stay and 30-day mortality were similar. At a median follow-up of 4.5 years (IQR 3.0-6.9), treatment strategy did not influence all-cause mortality (HR 1.19, 95% CI 0.77-1.83, log rank p = 0.43) nor rehospitalization (crude subdistribution HR 1.56, 95% CI 0.71-3.41, p = 0.26). ES II remained the only independent predictor of long-term all-cause mortality (adjusted HR 1.40, 95% CI 1.04-1.90, p = 0.029).
Conclusion
In this low surgical risk severe aortic stenosis population, we observed similar rates of 30-day and long-term all-cause mortality, despite higher rates of permanent pacemaker implantation and more than mild paravalvular leak in TAVI patients. The results of this small study suggest that both procedures are safe and effective in the short-term, while the Heart Team remains essential to assess both options on the long-term.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 09 Sep 2021; epub ahead of print

Prosthetic valve endocarditis after transcatheter aortic valve replacement in low-risk patients.

Medranda GA, Rogers T, Ali SW, Zhang C, ... Satler LF, Waksman R
Objectives
We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients.
Background
PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking.
Methods
We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee.
Results
We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care.
Conclusions
PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 09 Sep 2021; epub ahead of print

Exhaustion of coronary vasodilatory reserve in the resting state: Clinical characteristics and long-term outcomes after intervention.

Vallurupalli S, Salehi N, Agarwal S, Hasan R, ... Hakeem A, Uretsky BF
Objectives/background
Resting coronary blood flow approximates flow with maximal vasodilation in very severe coronary stenosis. We studied the incidence of exhausted vasodilatory reserve by FFR, its clinical characteristics and long-term prognosis after FFR guided percutaneous coronary intervention (PCI).
Methods
Consecutive patients undergoing FFR-guided PCI for coronary stenosis with reduced resting blood flow (baseline Pd/Pa < 0.8) were included. Basal maximal vasodilation (BMV) was defined as less than 5% difference between resting Pd/Pa and FFR, that is, FFR-baseline Pd/Pa < 0.05.
Results
Of 658 vessels that underwent FFR-guided PCI in 602 patients, 151 vessels had resting blood flow in the ischemic range (baseline Pd/Pa ≤ 0.8) and were included in the analysis. Of these, 28 lesions in 28 patients met criteria for BMV (4.25% of the entire registry and 18.5% of those with the reduced basal coronary flow). Stenosis severity was a significant predictor of the presence of BMV. In long term follow-up (median 106 ± 3.6 months), BMV was not associated with increased target vessel revascularization (TVR) or major adverse cardiac event compared to non-BMV(OR 1.9, 95% CI 0.7-4.8, p-value 0.2 and OR 1.3, 95% CI 0.75-2.5, p = 0.3, respectively).
Conclusion
Low baseline Pd/Pa that approximates fractional flow reserve (exhausted vasodilatory reserve) defines a subgroup of patients with severe coronary artery stenosis. Prognosis, when treated with PCI along with medical therapy, appears similar to those with intact vasodilatory reserve.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 08 Sep 2021; epub ahead of print

Association of peri-procedural myocardial infarction with mortality after stenting true coronary bifurcation lesions: A pooled individual participant data analysis from four randomized controlled trials.

Sheiban I, Ge Z, Kan J, Nie S, ... Chen SL, for DKCRUSH serial trials
Background
Five definitions of peri-procedural myocardial infarction (PMI) following percutaneous coronary intervention (PCI) are used in clinical trials; their clinical relevance in coronary bifurcation stenting remains unclear.
Objectives
To understand the correlation between PMI and mortality in bifurcation lesions from the DKCRUSH studies.
Methods
PMI was defined using serum creatine kinase-myocardial band (CK-MB) values within 48 h of PCI according to the SYNTAX, Fourth Universal Definition of MI (4th UDMI), ISCHEMIA, SCAI, and EXCEL definitions. Overall, 1300 patients with both CK and CK-MB measurements pre- and post-stenting were evaluated. The association of each PMI type and all-cause death or cardiac death at a median of 5.58 years of follow-up was analyzed using Cox regression.
Results
In total, 56 (4.3%) patients had PMI. According to SYNTAX, 4th UDMI or ISCHEMIA, SCAI, and EXCEL definitions, PMI occurred in 21 (1.6%), 56 (4.3%), 29 (2.2%), and 32 (2.5%) patients, respectively. All definitions were significantly correlated with unadjusted mortality at the end of follow-up but not at 30 days or 1-year after stenting. PMI using SYNTAX, SCAI, and EXCEL definitions rather than 4th UDMI definition was strongly associated with adjusted all-cause death. By adjusted analysis, PMI according to 4th UDMI, SCAI, and EXCEL definitions but not SYNTAX definition was positively correlated with cardiac death at a median of 5.58 years of follow-up. CK-MB ≥ 5 x UNL strongly enhanced the correlation of CK-MB values with mortality.
Conclusions
PMI rate varies with the definition following stenting for bifurcation lesions. PMI defined by SCAI and EXCEL definitions is strongly correlates with adjusted all-cause and cardiac death.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 06 Sep 2021; epub ahead of print

Long-term clinical outcomes after drug eluting stent implantation with and without stent overlap.

Coughlan JJ, Aytekin A, Koch T, Wiebe J, ... Kastrati A, Kufner S
Objective
The aim of this study was to investigate the impact of drug eluting stent (DES) overlap on clinical outcomes after percutaneous coronary intervention (PCI).
Background
While the use of overlapping bare metal stent has been associated with an increased risk of adverse clinical events, the long-term impact of DES overlap on clinical outcomes is not certain at present. Similarly, the effect of different DES generations and polymer types on DES overlap associated clinical outcomes has not previously been comprehensively elucidated.
Methods
We analyzed the angiographic and clinical outcomes of 5605 patients treated with DES in the setting of the ISAR-TEST 4 and ISAR-TEST 5 randomized control trials according to the presence or absence of stent overlap. The clinical endpoints assessed in this study were all-cause death, myocardial infarction (MI), target lesion revascularization (TLR), and definite or probable stent thrombosis at 10-years. We also compared rates of binary angiographic restenosis (BAR) at 6-8 months.
Results
At 10 years, all-cause mortality (Hazard ratios [HR] = 1.05 [0.95-1.16]; p = 0.348) did not differ between the stent overlap and no stent overlap groups. MI (8.4% vs. 5.2%; HR = 1.67 [1.35-2.07], p < 0.001) and TLR (23.7% vs. 16.3%; HR = 1.54 [1.36-1.74], p < 0.001) occurred more frequently in the stent overlap group. For MI, landmark analysis demonstrated that this increase in risk was primarily in the first 30 days post PCI. BAR at 6-8 months was also more frequent in the stent overlap group (16.0% vs. 10.3%; HR = 1.65 [1.41-1.92], p < 0.001).
Conclusion
DES overlap is associated with an increased risk of adverse clinical events post PCI.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Sep 2021; epub ahead of print

Restriction of congenital portosystemic shunt using the modified microvascular plug.

Rao S, Karuppasamy K, Radhakrishnan K, Fagan TE
Congenital portosystemic shunts (CPSS) may produce a variety of severe, clinically detrimental presentations. When indicated, closure is recommended; however, if the intrahepatic portal venous system (IPVS) is underdeveloped complete closure may not be possible and may result in severe acute portal hypertension. Staged restriction of CPSS flow by both surgical and complex transcatheter interventions has been successful in augmenting development of the IPVS such that complete occlusion of the CPSS can be performed. We report use of a modified microvascular plug to restrict CPSS flow with subsequent IPVS development and safe complete occlusion of CPSS.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 05 Sep 2021; epub ahead of print

Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database.

Case BC, Kumar S, Medranda GA, Yerasi C, ... Rogers T, Waksman R
Objectives
To analyze post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA).
Background
The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited.
Methods
Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports.
Results
Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication.
Conclusions
Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 03 Sep 2021; epub ahead of print

Impact of target vessel choice on outcomes following percutaneous coronary intervention in patients with a prior coronary artery bypass graft.

Beerkens FJ, Singh R, Cao D, Claessen BE, ... Mehran R, Kini A
Objectives
To evaluate and compare characteristics and clinical outcomes of percutaneous coronary intervention (PCI) among target vessel types in patients with a prior coronary artery bypass graft (CABG) surgery.
Background
Patients with a prior CABG often require repeat revascularization with PCI. Graft PCI has been associated with worse outcomes compared to native vessel PCI, yet the optimal PCI strategy in prior CABG patients remains unknown.
Methods
We stratified prior CABG patients who underwent PCI at a tertiary-care center between 2009 and 2017 by target vessel type: native vessel, venous graft, and arterial graft. The primary outcome of major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, stent thrombosis, or target vessel revascularization up to 1 year post-PCI.
Results
Prior CABG patients (n = 3983) represented 19.5% of all PCI interventions during the study period. PCI was most frequently performed on native vessels (n = 2928, 73.5%) followed by venous (n = 883, 22.2%) and arterial grafts (n = 172, 4.3%). Procedural success and complications were similar among the groups; however, slow- and no-reflow phenomenon was more common in venous graft PCI compared to native vessel PCI (OR 4.78; 95% CI 2.56-8.95; p < 0.001). At 1 year, there were no significant differences in MACE or in its individual components.
Conclusions
Target vessel choice did not appear to affect MACE at 1 year in a large cohort of patients with prior CABG undergoing PCI. Whether PCI of surgical grafts versus native arteries truly results in similar outcomes warrants further investigation in randomized controlled trials.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Sep 2021; epub ahead of print

Clinical outcomes according to lesion complexity in high bleeding risk patients treated with 1-month dual antiplatelet therapy following PCI: Analysis from the Onyx ONE clear study.

Kandzari DE, Kirtane AJ, Mehran R, Price MJ, ... Windecker S, Stone GW
Objectives
To compare clinical outcomes in high bleeding risk (HBR) patients with and without complex percutaneous coronary intervention (PCI) treated with Resolute Onyx zotarolimus-eluting stents (ZES) after 1-month dual antiplatelet therapy (DAPT).
Background
PCI with 1-month DAPT has been demonstrated to be safe in HBR patients treated with Resolute Onyx ZES. Whether these outcomes are consistent in patients with complex lesions is uncertain.
Methods
Among HBR patients who were event-free 1 month after PCI with ZES and treated thereafter with single antiplatelet therapy (SAPT), the clinical outcomes between 1 month and 1 year were compared after complex PCI (3 vessels treated, ≥ 3 lesions treated, total stent length > 60 mm, bifurcation with ≥ 2 stents implanted, atherectomy, or left main, surgical bypass graft or chronic total occlusion PCI) versus noncomplex PCI. Propensity score adjustment was performed to adjust for baseline differences among complex and noncomplex patients.
Results
Complex patients (N = 401, 26.6% of total) had a higher prevalence of hyperlipidemia, diabetes mellitus and previous myocardial infarction (MI). Between 1 month and 1 year, rates of MI (7.1% vs. 4.0%, p = 0.02) and cardiac death/MI (9.3% vs. 6.1%, p = 0.04) were higher among complex versus noncomplex patients, although stent thrombosis rates were similar. After adjustment for baseline characteristics, differences in outcomes were no longer significant between groups.
Conclusions
Higher rates of ischemic outcomes in complex PCI patients were largely explained by baseline clinical differences, rather than lesion complexity, among HBR patients treated with 1-month DAPT following PCI with Resolute Onyx ZES.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 02 Sep 2021; epub ahead of print

Blood pressure lowering with alcohol-mediated renal denervation using the Peregrine infusion Catheter is independent of injection site location.

Mahfoud F, Bertog S, Lauder L, Böhm M, ... Persu A, Sievert H
Objectives
The current analysis utilized core laboratory angiographic data from a prospective, single-arm, open-label, multi-center feasibility study to ascertain whether the location of alcohol infusion within main renal arteries during renal denervation (RDN) had an impact on the BP-lowering effect at 6 months.
Background
The influence of the location of alcohol infusion during RDN, within the main renal artery (proximal, middle, or distal), on the magnitude of the blood pressure (BP) lowering is unstudied.
Methods
The Peregrine Catheter was used to perform alcohol-mediated RDN with an infusion of 0.6 mL of alcohol per artery as the neurolytic agent in 90 main arteries and four accessory arteries of 45 patients with hypertension.
Results
No relationship between the site of alcohol infusion and change from baseline in both office systolic and 24-hour systolic ambulatory BP (ABP) at 6 months was observed. When analyzed at the artery level, the least squares (LS) mean changes ± SEM from baseline to 6 months post-procedure in 24-hour systolic ABP when analyzed by renal arterial location were -11.9 ± 2.4 mmHg (distal), -10 ± 1.6 mmHg (middle), and -10.6 ± 1.3 mmHg (proximal) (all p < 0.0001 for change from baseline within groups). The results were similar for office systolic BP. There was no difference between treated locations (proximal is reference).
Conclusion
In this post-hoc analysis, the location of alcohol infusion within the main renal artery using the Peregrine system, with alcohol as the neurolytic agent for chemical RDN, did not affect the magnitude of BP changes at 6 months.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 01 Sep 2021; epub ahead of print

Head to head comparison of quantitative flow ratio using 4-French and 6-French catheters versus fractional flow reserve.

Cuenin L, Honton B, Aminfar F, Meyer P, ... Maillard L, Adjedj J
Objectives
To validate QFR using 4-F diagnostic catheters compared to using 6-F guiding catheters, with conventional guidewire-based FFR as the reference standard, using independent core laboratory analysis.
Background
Quantitative Flow Ratio (QFR) allows Fractional Flow Reserve (FFR) calculation based on the coronary angiogram, using 5- or 6-French (F) catheters. However, the use of 4-F diagnostic catheters to perform coronary angiography is currently routine in some centers.
Methods
We included all consecutive patients with stable coronary artery disease and indicated for physiological assessment. QFR was performed using a 4-F diagnostic catheter, then QFR was performed using a 6-F guiding catheter while conventional FFR was measured using a pressure guidewire. Angiograms were sent to two separate core laboratories.
Results
One hundred lesions in 67 consecutive patients with QFR performed using 4-F and 6-F catheters, and with conventional FFR, were included. Pearson\'s correlation coefficient was for QFR 4-F vs. FFR 0.91 [0.87-0.94], for QFR 6-F vs. FFR 0.90 [0.86-0.94], and for QFR 4-F vs. QFR 6-F 0.93 [0.90-0.95]. Receiver-operator characteristic curves (ROC) comparing the ability to predict an FFR value above or below 0.80 with QFR 4-F and 6-F were generated. The area under the ROC curve (AUC) vs. FFR was 0.972 [0.95-0.99] for QFR 4-F and 0.970 [0.94-0.99] for QFR 6-F.
Conclusions
Our study demonstrated the feasibility of performing QFR analysis from angiograms obtained by 4-F catheters, and showed a good correlation with QFR performed using 6-F catheters as well as with conventional FFR performed using a pressure guidewire.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 31 Aug 2021; epub ahead of print

Comparing outcomes of general anesthesia and monitored anesthesia care during transcatheter aortic valve replacement: The Cleveland Clinic Foundation experience.

Sammour Y, Kerrigan J, Banerjee K, Gajulapalli RD, ... Skubas N, Kapadia S
Background
Monitored anesthesia care (MAC) has become more widely used during transcatheter aortic valve replacement (TAVR) to avoid the complications of general anesthesia (GA).
Methods
We included consecutive patients who underwent transfemoral-TAVR at our institution between January 2012 and April 2017. We compared outcomes with GA versus MAC.
Results
Of 998 patients, MAC was used in 43.9%. MAC was associated with shorter procedural time (96.9 ± 30.9 vs. 135 ± 64.6 mins; p < .001), fluoroscopy time (20.4 ± 8.9 vs. 29 ± 18.7 mins; p < .001), lower contrast volume (45.5 ± 27 vs. 60.4 ± 43 cc; p < .001), and decreased radiation exposure (12,869 ± 8,099 vs. 20,630 ± 16,276 cGy-cm² ; p < .001). Patients who underwent MAC had a briefer median (IQR) intensive care unit stay [23.3 (21-24) vs. 23.4 (20.8-26) hrs; p < .001], and hospital stay [2 (2, 3) vs. 3 (2-6) days; p < .001], and were more frequently discharged to home (93.4% vs. 82.9%; p < .001). MAC was associated with lower mortality at 30 days (0.5% vs. 2.9%; log-rank p = .012; adjHR 0.22, 95% CI 0.06-0.82; p = .024), but not at 1 year (11.7% vs. 14.6%; log-rank p = .157) or 3 years (36.8% vs. 38.4%; log-rank p = 0.433). There were no differences in major adverse cardiac and cerebrovascular events (MACCE) at either 30 days (4.6% vs. 9.3%; log-rank p = .14) or 1 year (21.1% vs. 21.5%; log-rank p = .653). Similar findings were seen among patients who received newer-generation SAPIEN-3 valves.
Conclusion
Utilizing MAC and omitting intraprocedural transesophageal echocardiography during TAVR seems to be more efficient without compromising safety. Better TAVR outcomes can be achieved with newer generation valves without needing GA.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E436-E443

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

Case BC, Kumar S, Yerasi C, Forrestal BJ, ... Rogers T, Waksman R
Objectives
We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott).
Background
Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited.
Methods
Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports.
Results
Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group.
Conclusions
Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:572-577

Plaster pipes and crystalized graphite: Open transventricular transcatheter aortic valve replacement for failed mechanical aortic valve prostheses in the porcelain aorta.

Yong MS, Camuglia AC, Cox SV, Cole CM
Patients with a true porcelain aorta and a failed mechanical aortic valve prosthesis have limited treatment options. Using a hybrid of an open trans-ventricular approach with peripheral cardiopulmonary bypass and integration of transcatheter techniques this challenge can be overcome. Trans-ventricular mechanical valve extraction (with transcatheter endovascular occlusion and cardioplegia) followed by direct ante-grade transcatheter heart valve implantation offers a potential solution to this conundrum. The procedure described is a novel technique that allows for the effective treatment of patients with failed mechanical surgical aortic valve prostheses in the setting of an inoperable porcelain aorta. In addition, a collaborative integrated multi-disciplinary heart team environment is required for the management of these complex patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E471-E474

Transcatheter pulmonary denervation in patients with left heart failure with reduced ejection fraction and combined precapillary and postcapillary pulmonary hypertension: A prospective single center experience.

Witkowski A, Szumowski Ł, Urbanek P, Jastrzębski J, ... Parulski A, Zieliński T
Objectives
The present study was a prospective, single-center, single-arm study to investigate the efficacy of transcatheter pulmonary artery denervation (TPADN) in patients with combined postcapillary and precapillary PH (Cpc-PH) associated with left heart failure with reduced ejection fraction (HF-rEF).
Background
Pulmonary hypertension (PH) in patients with left ventricular systolic dysfunction has a negative impact on outcome.
Methods
The combination of pulmonary artery systolic pressure (PAPs) ≥60 mmHg, transpulmonary pressure gradient (TPG) ≥12 mmHg, nonreversible mean PAP, and pulmonary vascular resistance (PVR) ≥3.5 Wood Units was considered as too high risk for heart transplantation (HTx). The clinical efficacy endpoint was an improvement in 6-min walking test and the hemodynamic endpoints were changes in PAPs, PVR, and TPG between baseline and 6 months. Circumferential radiofrequency applications were delivered around distal main, left and right pulmonary arteries. At each ablation point temperature was 45°C and energy 10 W.
Results
TPADN was performed in 10 patients. At 6-month in 5 patients we observed reduction in PAP, PVR, TPG, and DPG and then 1 had successful HTx, 2 are on HTx waiting list, 2 received LVADs, 2 patients did not improve, and 3 patients died.
Conclusions
TPADN may be beneficial in selected patients with HF-rEF and Cpc-PH.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:588-594

Effect of institutional transcatheter aortic valve replacement volume on mortality: A systematic review and meta-analysis.

Kir D, Shapero K, Chatterjee S, Grimshaw A, ... Goldsweig AM, Desai NR
Objective
We sought to conduct a systematic review and network meta-analysis to examine the association between institutional transcatheter aortic valve replacement (TAVR) volume and all-cause mortality.
Background
Since inception in 2011, there has been an exponential increase in the number of TAVR centers across the world. Multiple studies have questioned if a relationship exists between institutional TAVR volume and patient outcomes.
Methods
We performed a systematic literature search for relevant articles using a combination of free text terms in the title/abstract related to volume, TAVR, and patient outcomes. Two reviewers independently screened all titles/abstracts for eligibility based on pre-specified criteria. All-cause mortality data was pooled from eligible studies and centers were categorized as low-(30-50 cases), intermediate-, or high-volume (75-130 cases) based on their annual TAVR volumes.
Results
Our search yielded an initial list of 11,153 citations, 120 full text studies were reviewed and 7 studies met all inclusion and exclusion criteria, yielding a total of 1,93,498 TAVRs. Categorized according to center\'s annual volume; 25,062 TAVRs were performed in low-, 77,093 in intermediate- and 91,343 in high-volume centers. Network meta-analysis showed a relative reduction in mortality rates of 37%, 23% and 19%, for high volume versus low volume centers, high volume versus intermediate volume centers and intermediate versus low volume centers, respectively.
Conclusions
Existing research clearly shows an inverse relationship between annual TAVR procedural volume and all-cause mortality. We need to focus on development of strong referral networks and consolidation rather than expansion of existing TAVR centers to improve patient outcomes, while ensuring adequate access-to-care.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E453-E461

Tricuspid valve vegetation debulking using the AngioVac system.

Bangalore S, Alviar CL, Vlahakis S, Keller N
Tricuspid valve endocarditis with recurrent septic pulmonary emboli is an indication for surgery. We present the case of a 36-year old man with tricuspid valve endocarditis and septic pulmonary emboli with percutaneous extraction of the vegetation. We discuss the nuances of such an approach and the need for more evidence in the management of these complex patients.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E475-E477

In-hospital outcomes and usage of embolic protection devices in percutaneous coronary intervention for coronary artery bypass grafts: Insights from a Japanese nationwide registry.

Oba Y, Inohara T, Takahashi M, Fukutomi M, ... Ikari Y, Kario K
Objectives
We evaluated the in-hospital outcomes of percutaneous coronary intervention (PCI) for bypass graft vessels (GV-PCI) compared with those of PCI for native vessels (NV-PCI) using data from the Japanese nationwide coronary intervention registry.
Methods
We included PCI patients (N = 748,229) registered between January 2016 and December 2018 from 1,123 centers. We divided patients into three groups: GV-PCI (n = 2,745); NV-PCI with a prior coronary artery bypass graft (pCABG) (n = 23,932); and NV-PCI without pCABG (n = 721,552).
Results
GV-PCI implementation was low, and most cases of PCI in pCABG patients were performed in native vessels (89.7%) in contemporary Japanese practice. The risk profile of patients with pCABG was higher than that of those without pCABG. Consequently, GV-PCI patients had a significantly higher in-hospital mortality than NV-PCI patients without pCABG after adjusting for covariates (odds ratio [OR] 2.36, 95% confidence interval [CI] 1.66-3.36, p < .001). Of note, embolic protection devices (EPDs) were used in 18% (n = 383) of PCIs for saphenous vein grafts (SVG-PCI) with a significant variation in its use among institutions (number of PCI: hospitals that had never used an EPD vs. EPD used one or more times = 240 vs. 345, p < .001). The EPDs used in the SVG-PCI group had a significantly lower prevalence of the slow-flow phenomenon after adjusting for covariates (OR 0.45, 95% CI 0.21-0.91, p = .04).
Conclusion
GV-PCI is associated with an increased risk of in-hospital mortality. EDP use in SVG-PCI was associated with a low rate of the slow-flow phenomenon. The usage of EPDs during SVG-PCI is low, with a significant variation among institutions.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E356-E364

Computed tomography analysis of coronary ostia location following valve-in-valve transcatheter aortic valve replacement with the ACURATE neo valve: Implications for coronary access.

Khokhar AA, Laricchia A, Ponticelli F, Kim WK, ... Colombo A, Giannini F
Background
Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is an emerging alternative to re-do surgery. However, the challenge of coronary access (CA) following ViV-TAVR is a potential limitation as TAVR expands to younger lower-risk populations.
Objectives
Using post-implantation computed tomography (CT) scans to evaluate the geometrical relationship between coronary ostia and valve frame in patients undergoing ViV-TAVR with the ACURATE neo valve.
Methods
Post-implant CT scans of 18 out of 20 consecutive patients treated with the ACURATE neo valve were analyzed. Coronary ostia location in relation to the highest plane (HP) (highest point of the ACURATE neo or surgical valve) was determined. Ostia located below the highest plan were further subclassified according to the gap available between the transcatheter heart valve frame and ostium (transcatheter-to-coronary [TTC] distance). The impact implantation depth has on these geometrical relationships was evaluated.
Results
A total of 21 out of 36 coronary ostia (58%) were located below the level of the HP with the left coronary artery (36%) more likely to be affected than the right (22%). Further sub-classification of these ostia revealed a large (>6 mm), moderate (4-6 mm), and small (<4 mm) TTC distance in 57% (12/21), 38% (8/21), and in 6% (1/18) of cases, respectively. At an implantation depth <4 mm compared to >4 mm, all ostia were located below the HP with no difference in post-procedural mean gradients (14.5 mmHg ± 4.7 vs. 12.6 mmHg ± 5.8; p = .5, 95%CI 3.8-7.5).
Conclusions
CA following ACURATE neo implantation for ViV-TAVR could potentially be challenging in a significant proportion of patients and specific consideration should be given to the implantation depth.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:595-604

Interventional closure of aortomitral perforation after TAVR: A case report.

Petri N, Lengenfelder B, Voelker W, Nordbeck P
Despite TAVR emerging as the gold standard for a broad spectrum of patients, it is associated with serious complications. In this report we present a case, where a TAVR procedure led to a perforation at the aortomitral continuity, discuss the risk factors for the occurrence of perforations and how we decided to treat the patient.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E483-E485

Recapture failure in transcatheter aortic valve replacement with CoreValve Evolut R.

Ito N, Zen K, Kuwabara K, Matoba S
Self-expanding prostheses for transcatheter aortic valve replacement (TAVR), which can be recaptured, provide us the option of repositioning for a more accurate placement. We report a very rare case in which the recapture of CoreValve Evolut R (Medtronic, Minneapolis, Minnesota) to correct the implantation depth during the deployment could not be achieved. We planned TAVR with a 23 mm Evolut R prosthesis for a 92-year-old female with severe aortic stenosis and tightly bent thoracic aorta. During the first deployment attempt, the implantation depth was greater than we expected at 2/3 deployment. They tried to recapture and reposition the prosthesis, but the prosthesis was not re-sheathed into the capsule of the delivery system. The prosthesis could not be recaptured despite a repeat attempt, and they were forced to deploy the device as it was. The prosthesis was deployed very carefully and implanted successfully without a pop-up into the ascending aorta. At a later date, this situation was replicated in vitro and was found that the distal segment of the capsule became deformed, increasing the resistance to rotating the grip handle.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E486-E489

Trends and causes of readmission following peripheral vascular intervention in patients with peripheral vascular disease.

Moussa Pacha H, Mir T, Al-Khadra Y, Sattar Y, ... Hakim Z, Alraies MC
Objectives
To study the risk factors associated with 30-readmission postperipheral vascular intervention (PVI) in peripheral artery disease (PAD).
Background
There has been a paucity of data regarding the trend and predictors of PVI readmission.
Methods
We performed an observational cohort study of patients admitted with peripheral vascular disease for PVI using the NRD for the years 2010-2014. PVI was defined as angioplasty, atherectomy, and/or stenting of lower limb vessels.
Results
A total of 453,278 patients (30-day readmission n = 97,235). The mean age of study population was 68.6 ± 12.2 years and included 43.8% women. The 30-day readmission post-PVI was 21.5% (p = .034). Cardiovascular causes constitute 44% of readmission. Chronic limb ischemia and intermittent claudication were two most common cardiovascular causes constituting 11.7 and 4.9% cases of readmissions. Other cardiac causes of readmissions included heart failure (4.64%), dysrhythmias (1.4%), and acute myocardial infarction (1.7%). The high-risk factors for of all-cause 30-day readmission were hypertension, CLI, diabetes, renal failure, dyslipidemia, smoking, chronic pulmonary disease, and atrial fibrillation (p < .005). Length-of-stay was greater than 5 days for 56.2 and 75.4% paid by Medicare.
Conclusions
Our study shows an average yearly readmission rate of 21.5% post-PVI. Chronic comorbidities and prolonged hospitalization were associated with higher risk of readmission.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:540-548

Readmission following urgent transcatheter aortic valve implantation versus urgent balloon aortic valvuloplasty in patients with decompensated heart failure or cardiogenic shock.

Chakraborty S, Patel N, Bandyopadhyay D, Hajra A, ... Abbott JD, Naidu SS
Background
Urgent transcatheter aortic valve implantation (TAVI) is a feasible option for aortic stenosis (AS) patients with decompensated heart failure (HF) and cardiogenic shock (CS) as compared to the more traditional urgent balloon aortic valvuloplasty (BAV).
Objectives
We conducted a retrospective analysis to compare risk and cause of readmission in these two high-risk groups.
Methods
Nationwide Readmission Database (NRD) 2011-2014 was retrospectively analyzed to identify patients with AS having either urgent TAVI or urgent BAV using appropriate ICD-9 codes. Propensity scores were used to match patients with urgent TAVI as compared to patients with urgent BAV. Statistical analysis was performed using the Stata 15.1 software.
Results
We identified a weighted sample of 6,670 patients with urgent BAV and 6,964 patients with urgent TAVI. The all-cause 30- and 90-day readmission was lower in the urgent TAVI group compared to urgent BAV (15.4 vs. 22.5%, (aHR): 0.92 [0.90-0.95] p < .001). 30-day readmission due to CV cause and HF was also lower in the urgent TAVI group (aHR, 0.93: p < .001 and aHR, 0.98: p = .040, respectively). The 30-day gastrointestinal (GI) bleed readmission rate was three times higher in urgent TAVI group (aHR, 3.00:95% CI (1.23-7.33), p = .016), but was not statistically significant at 90-days. Cardiac causes of readmission were the predominant cause of readmission in both groups, but more pronounced in urgent BAV group (60.3 vs. 40.5%, p < .001).
Conclusion
Urgent TAVI appears beneficial in patients with AS and decompensated HF or CS driven by roughly 10 and 25% reductions in overall readmissions at 30 and 90 days, and marked reductions in reintervention, although offset partially by higher risk of readmission due to GI bleeding at 30 days.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:607-612

The validation of the dual antiplatelet therapy score in East Asians receiving percutaneous coronary intervention with exclusively second generation drug-eluting stents.

Kim M, Park KW, Lee HS, Ki YJ, ... Koo BK, Kim HS
Objectives
We investigated whether the dual antiplatelet therapy (DAPT) score (DS) predicts clinical outcome in an East-Asian population that received exclusively second generation drug-eluting stent (DES).
Backgrounds
It is uncertain whether the DS could adequately risk stratify patients exclusively receiving second generation DES.
Methods
From the Grand-DES registry, we evaluated patients who were treated with DAPT for at least 12 months and were event-free at 12 months after DES implantation. Patients were classified into two categories: high DS (≧2) (n = 3,157); and low DS (<2) (n = 5,226). The primary ischemic outcome was a composite of stent thrombosis and all myocardial infarction (MI), and the primary bleeding outcome was TIMI major or minor bleeding. A propensity score (PS)-matched analysis was done to correct for baseline differences between extended DAPT group and the conventional group.
Results
Among 8,383 subjects, the primary ischemic outcome occurred in 48 patients (0.6%) and the primary bleeding outcome in 49 patients (0.6%). High DS was associated with a higher incidence of ischemic events (ischemic outcome: 0.8% vs. 0.4%, for high vs. low DS, Log-rank p = .039), but not with any differences in bleeding events (Log-rank p = .734). In the PS-matched analysis, extended group was associated with lower risk of composite endpoint of MI, stent thrombosis, or cardiac death in only the high DS group (1.8% vs. 3.7%, Log-rank p = .004; hazard ratio 0.45, 95% confidence interval 0.27-0.76; p = .003 after adjustment).
Conclusions
The DS was an adequate risk stratifier for future ischemic events in East Asians receiving exclusively second generation DES.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E332-E341

Multicenter and all-comers validation of a score to select patients for manual thrombectomy, the DDTA score.

Cordero A, Cid-Alvarez B, Alegría E, Fernández-Cisnal A, ... Bertomeu-Gonzalez V, Ferreiro JL
Background
Routine manual thrombectomy (MT) is not recommended in primary percutaneous coronary intervention (P-PCI) but it is performed in many procedures. The objective of our study was validating the DDTA score, designed for selecting patients who benefit most from MT.
Methods
Observational and multicenter study of all consecutive patients undergoing P-PCI in five institutions. Results were compared with the design cohort and the performance of the DDTA was analyzed in all patients. Primary end-point of the analyses was TIMI 3 after MT; secondary endpoints were final TIMI 3, no-reflow incidence, in-hospital mortality and in-hospital major cardiovascular events (MACE). In-hospital prognosis was assessed by the Zwolle risk score.
Results
Three hundred forty patients were included in the validation cohort and no differences were observed as compared to the design cohort (618 patients) except for lower use of MT and higher IIb/IIIa inhibitors or drug-eluting stents. The probability of TIMI 3 after MT decreased as delay to P-PCI was higher. If DDTA score, MT was associated to TIMI 3 after MT (OR: 4.11) and final TIMI 3 (OR: 2.44). There was a linear and continuous relationship between DDTA score and all endpoints. DDTA score ≥ 4 was independently associated to lower no-reflow, in-hospital MACE or mortality. The lowest incidence of in-hospital mortality or MACE was in patients who had DDTA score ≥ 4 and Zwolle risk score 0-3.
Conclusions
MT is associated to higher rate of final TIMI3 in patients with the DDTA score ≥ 4. Patients with DDTA score ≥ 4 had lower no-reflow and in-hospital complications.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E342-E350

Changes in surgical revascularization strategy after fractional flow reserve.

Fournier S, Toth GG, De Bruyne B, Kala P, ... Pellicano M, Barbato E
Aims
In the randomized GRAFFITI trial, surgeons drew their strategy based on coronary angiography. When patients were randomized to fractional flow reserve (FFR)-guidance, surgeons were informed of the FFR values and asked to redraw their strategy. The aim of this study was to investigate the changes induced by FFR knowledge.
Methods and results
The intended and performed strategy (before and after FFR) were compared. Among 172 patients, 84 with 300 lesions were randomized to the FFR-guided group. The intended strategy was to bypass 236 stenoses:108 with a venous and 128 with an arterial graft. After disclosing FFR, a change in strategy occurred in 64 lesions (21.3%) of 48 (55%) patients. Among 64 lesions for which the intended strategy was medical therapy, 16 (25%) were bypassed after disclosing FFR. The number of procedures with >1 venous graft planned was significantly reduced from 37 to 27 patients (p = .031). The proportion of on-pump surgery was significantly reduced from 71 to 61 patients (p = .006). The rates of clinical events at 1 year were similar between patients with or without at least one change in strategy.
Discussion
FFR-guided CABG is associated with a simplified surgical procedure in 55% of the patients, with similar clinical outcomes.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E351-E355

Reduction of MANTA-associated vascular complications after implementation of key insights on failure mechanisms.

Moccetti F, Wolfrum M, Bossard M, Attinger-Toller A, ... Kobza R, Toggweiler S
Objectives
Report MANTA-associated vascular complications after implementation of key insights on failure mechanisms.
Background
The MANTA vascular closure device is utilized to close large-bore arterial access sites. We have previously identified and published the mechanisms and predictors of MANTA-associated vascular complications. We identified three distinct mechanisms leading to MANTA-associated vascular complications, predictors were a common femoral artery (CFA) diameter <6 mm and clinically established peripheral artery disease (PAD).
Methods
We compared 100 consecutive patients of the initial cohort (first n = 100) with consecutive patients in which the key insights acquired in the initial cohort were implemented (second n = 100).
Results
The initial cohort (n = 100 patients) had a MANTA-related vascular complication rate of 11% (7% major and 4% minor), and 14% MANTA-related bleeding complications. In a subsequent cohort of n = 100 patients, we applied the abovementioned findings: we did not use the MANTA device if the CFA was <6 mm and in patients with PAD. In addition, femoral puncture was ultrasound guided. This strategy led to a decline in MANTA-related vascular complication rates: 2% (1% major and 1% minor) p = .03, as well as a reduction in MANTA-related bleeding complications to 5% p = .01. To the best of our knowledge, this is the lowest rate of MANTA-related vascular complication reported thus far.
Conclusions
Our strategy achieves low MANTA-related vascular and bleeding complication rates. Careful and critical examination of complications can lead to rapid identification of complication mechanism and its predictors. In turn, rapid implementation of these insights can lead to a decline in complication rates.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E462-E465

Coronary sinus size and ischemia improvement after reducer implantation; \"one size to fit them all?\"

Tzanis G, Khokhar AA, Ponticelli F, Gallone G, ... Colombo A, Giannini F
Aim
Coronary sinus (CS) reducer implantation is associated with symptomatic relief of patients with refractory angina. However, 15% to 30% of the patients do not respond to this treatment. Aim if this study was to evaluate the effect of CS size in the effectiveness of the device.
Methods
Prior to device implantation and at 4-month resting ventricular function was assessed by stress cardiac magnetic resonance. Ischemia was assessed by the myocardial perfusion reserve index (MPRI).
Results
Fifteen patients (66 ± 10 years) underwent successful CS Reducer implantation, with improvements in angina class and exercise tolerance. Patients with a smaller CS size (<5.8 mm) presented a significantly higher percentage increase in MPRI (63 ± 51 vs 9 ± 30%, P = .03) and a higher reduction in left ventricle end-diastolic volumes.
Conclusions
Greater benefits, in terms of ischemia improvement, after CS Reducer implantation were seen in patients with smaller CS sizes, suggesting a potential mechanism underlying the observed rates of reducer non-responsiveness.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E365-E369

Future culprit detection based on angiography-derived FFR.

Pagnoni M, Meier D, Candreva A, Maillard L, ... Muller O, Fournier S
Objectives
We sought to characterize the hemodynamic impact of mild coronary artery disease (CAD) using quantitative flow ratio (QFR, an angiography-derived fractional flow reserve [FFR]) in a population of patients with only non-significant CAD at baseline that subsequently experienced a myocardial infarction (MI).
Background
The discriminatory value of FFR in patients with mild CAD remains imperfect.
Methods
We retrospectively included patients who underwent invasive coronary angiography for an MI, in whom another angiogram had been performed within the previous 5 years. Three-dimensional quantitative coronary angiography, QFR, and lesion length analysis were conducted on lesions responsible for the MI (future culprit lesions, [FCL]) as well as on control lesions (non-culprit lesions, [NCL]).
Results
Eighty-three FCL and 117 NCL were analyzed in 83 patients: FCL were more severe (median % diameter of stenosis [DS] 39.1% [29.8; 45.7] vs. 29.8% [25.0; 37.2], p < .001), had lower QFR values (0.94 [0.86; 0.98] vs. 0.98 [0.96; 1.00], p < .001) and tended to be longer (15.2 mm [10.0; 27.3] vs. 12.7 mm [9.3; 22.4], p = .070) than NCL. In lesions with an interval < 2 years between baseline angiography and MI, the difference in QFR was more pronounced compared to the lesions with a longer interval (FCL: 0.92 [0.85; 0.97] vs. NCL: 0.98 [0.94; 1.00], p < .001 and FCL: 0.96 [0.88; 1.00] vs. NCL: 0.98 [0.96;1.00], p = .006 respectively)
Conclusion:
Mild coronary stenoses that are subsequently responsible for an MI (FCL) exhibit a higher DS and lower QFR years before the event. Furthermore, FCL with a lower QFR at baseline appear to lead earlier to MI.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E388-E394

Impact of stent length and diameter on 10-year mortality in the SYNTAXES trial.

Hara H, Ono M, Kawashima H, Kogame N, ... Serruys PW, SYNTAX Extended Survival Investigators
Objectives
We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial.
Background
TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated.
Methods
Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients.
Results
TSL as a continuous variable was significantly associated with 10-year mortality (adjusted hazard ratio [HR], 1.05 [1.01-1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41-2.74]) or not- extensive stenting PCI (adjusted HR, 1.94 [1.36-2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85-1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23-2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19-2.53]). Patients treated with not-extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG.
Conclusions
Extensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E379-E387

New lesion after endovascular therapy of femoropopliteal lesions for intermittent claudication.

Katsuki T, Yamaji K, Soga Y, Iida O, ... Kawasaki D, Ando K
Background
Although the incidence of target lesion revascularization (TLR) was decreased in patients who underwent endovascular therapy (EVT) for femoropopliteal (FP) lesions, the clinical impact of newly developed lesions could not be disqualified in those patients.
Methods
Between January 2012 and December 2018, 911 patients with intermittent claudication (IC) who have not been previously treated for this condition underwent a successful EVT for de novo FP lesions in a multicenter registry (WATERMELON registry: neW lesion AfTer EndovasculaR therapy for interMittEnt cLaudicatiON).
Results
The mean follow-up duration was 3.5 ± 1.9 years. At 5 years, 53% patients underwent limb revascularization, (new lesion: 42% and TLR: 31%). We developed an ordinal risk score to predict the possibility of new lesion revascularization the following risk factors: body mass index (<23 kg/m² , 1 point), diabetes (2 points), hemodialysis (3 points), and atrial fibrillation (2 points). The patients were divided into three groups: low risk group (0-1 points: N = 283), intermediate risk group (2-3 points: N = 395), and high risk group (≥4 points: N = 233). The cumulative 5-year incidence of new lesion revascularization was 28% in the low risk group, 40% in the intermediate group, and 68% in the high risk group (p < 0.001).
Conclusion
within 5 years after the first EVT, more than half of the patients underwent limb revascularization. Of these patients, 42% underwent new lesion revascularization. Patients with a body mass index <23 kg/m² , diabetes, hemodialysis, and atrial fibrillation had increased risk for new lesion revascularization.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:E395-E402

Propensity-matched comparison of large-bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real-world experience.

Medranda GA, Case BC, Zhang C, Rappaport H, ... Rogers T, Waksman R
Objective
Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR).
Background
The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse.
Methods
This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality.
Results
We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p = 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p = .316), and no patients had major vascular complications.
Conclusions
In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:580-585

Anterior, posterior, or all-vessel infrapopliteal revascularization in patients with moderate-severe claudication: Insights from the LIBERTY 360 study.

Salahuddin T, Giannopoulos S, Adams G, Armstrong EJ
Background
Little data guides revascularization of infrapopliteal peripheral arterial disease (PAD) in patients with claudication. We assessed outcomes after infrapopliteal-only intervention for claudication in the LIBERTY 360 observational study.
Methods
In this post hoc analysis, LIBERTY 360 patients (N = 128) with claudication and isolated infrapopliteal disease undergoing endovascular revascularization were divided by territory into anterior-vessel, posterior-vessel, or all-vessel groups. Patients were followed for periprocedural, in-hospital, and long-term outcomes. Logistic regression for odds ratios, Cox proportional hazard models, ANOVA, and Kaplan-Meier estimates were utilized to compare outcomes.
Results
Patients underwent anterior (N = 37), posterior (N = 76), or all-vessel (N = 15) infrapopliteal revascularization. Initial procedural success was 86%, 86%, and 69% for anterior, posterior, and all-vessel groups, respectively. Each group had improvements in Rutherford classification (RC) from baseline to 2 years (mean RC change: -1.3, -1.5, and -1.5, respectively). Compared with all-vessel intervention, both anterior and posterior groups had lower rate of major adverse events (MAE) and target vessel revascularization (TVR) at 3 years (MAE: 12% and 15% in anterior and posterior groups, respectively compared with 51% in the all-vessel group; hazard ratios and 95% CIs 0.22 [0.06-0.74], p = .015; 0.24 [0.09-0.64], p = .004). Other outcomes were similar among the three groups. The anterior group showed more improvement in pain subdomain and total VascuQoL scores compared with posterior and all-vessel groups at 2 years (p = .016, p = .020 and p = .068, p = .009, respectively).
Conclusions
Both anterior or posterior revascularization have favorable outcomes and may be beneficial for improvement of symptoms in claudicants with isolated infrapopliteal PAD.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:559-569

Deformation and stenosis of the sinus-SuperFlex-DS stent after ductal stenting for the hybrid stage 1 procedure.

Hribernik I, Thomson J, Bentham J
We present five cases of sinus-SuperFlex-DS stent stenosis during early follow up that resulted in inadequate ductal patency and required urgent re-stenting with a balloon-expandable stent. This causes concern that these stents lack sufficient radial force against ductal constriction and if used need to be kept under close scrutiny.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:533-539

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

Rocha-Singh KJ, Sachar R, DeRubertis BG, Nolte-Ernsting CCA, ... Zeller T, REALITY Investigators
Background
Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation.
Objectives
Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD.
Methods
REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events.
Results
A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported.
Conclusions
Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:549-558

Cutting balloon angioplasty on branch pulmonary artery stenosis in pediatric patients.

Cobb H, Spray B, Daily J, Dossey A, Angtuaco MJ
Objectives
To identify medium-term results following cutting balloon angioplasty (CBA) for branch pulmonary artery stenosis (PAS) and predictors of successful intervention.
Background
CBA has emerged as a successful alternative therapy for PAS resistant to conventional balloon angioplasty techniques but there is little information on medium and long-term outcomes.
Methods
This is a descriptive, single center, retrospective chart review of pediatric patients who underwent CBA for PAS at Arkansas Children\'s Hospital between May 2005 and December 2020. We reviewed demographics, procedural specifics, and 30-day complications.
Results
Forty-four patients underwent pulmonary artery CBA on 114 pulmonary artery segments through 126 catheterization cases, totaling 148 CBA events. Thirty-three individual pulmonary arteries underwent repeat intervention. Average minimal luminal diameter increase from pre-CBA to end of follow-up was 57% (CI, 38%-75%). Absence of Tetralogy of Fallot with pulmonary atresia and major aortopulmonary collateral arteries (TOF/PA/MAPCAs) and the absence of Alagille Syndrome, Williams Syndrome, or Arterial Tortuosity Syndrome (ATS) were associated with increased odds of sustained success by 70% (CI, 0.11-0.79) and 91% (CI, 0.02-0.56), respectively. Increasing the cutting balloon diameter-to-minimal luminal diameter ratio by 0.5 increased odds of successful intervention by 2.37-fold (CI, 1.7-3.3). Seven patients had 30-day complications including one death.
Conclusions
In the longest follow-up to date of children and adolescents who underwent CBA for branch PAS, we found that there was moderate medium-term success. Additionally, absence of TOF/PA/MAPCAs, absence of Alagille Syndrome, Williams Syndrome, or ATS, and high cutting balloon diameter-to-minimal luminal diameter ratio are predictors of sustained results.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; 98:526-532

Coronary stent positioning under live IVUS guidance in low contrast percutaneous coronary interventions: The live IVUS stenting technique.

Lichaa H
In patients with renal insufficiency, advanced techniques have been described to achieve ultra-low contrast or zero contrast percutaneous coronary interventions (PCI). However, these techniques use intra-coronary imaging before stent placement to determine adequate landing zones, by correlating them with saved fluoroscopic landmarks. Still, this leaves the operator with a certain degree of uncertainty about the exact lesion coverage, which is checked with post-stent intra-coronary imaging. We hereby describe a novel technique which takes away the concern of uncertainty regarding stent-landing zones and allows for the highest amount of precision in stent positioning, arguably even better than with the use of angiography. This technique involves positioning coronary stents under the live guidance of an intravascular ultrasound (IVUS) catheter which is positioned simultaneously, side by side to a stent. This technique takes advantage of all the benefits of IVUS based PCI without losing the precision in stent positioning when compared to traditional angiography. It simplifies the application of low contrast PCI by the interventional cardiology community, while maintaining the confidence in precise stenting. It has also the potential to decrease the incidence of contrast-induced nephropathy, hence procedural morbidity, while allowing for optimal long-term image based PCI outcomes. Obviously, it applies to moderate or larger coronary segments, without significant tortuosity. It also comes at the expense of slightly larger guide catheters, which is compensated for by the use of thin walled sheaths or sheathless catheter systems. Finally, radial access is still applicable depending on radial artery size and available equipment.

© 2021 Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; epub ahead of print

Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium.

Wiebe J, Hofmann FJ, West N, Baumbach A, ... Nef HM, European ABSORB Consortium (EAC) investigators
Objectives
To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population.
Background
Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation.
Methods
The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics.
Results
A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST.
Conclusions
The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

© 2021 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Catheter Cardiovasc Interv: 30 Aug 2021; epub ahead of print