I prefer the MitraClip in these cases: the 5-year COAPT data.

The COAPT 5-year data demonstrate that compared with medical treatment transcatheter edge-to-edge repair (TEER) with the MitraClip in symptomatic patients with Grade 3+/Grade 4+ secondary mitral regurgitation (SMR) reduced by nearly half the annualized hospitalization risk (33 vs. 57%), by almost 30% the death rate (57 vs. 67%) and achieved significant and durable SMR reduction in 95% of patients. Control patients who crossed over to TEER at 2 years had better prognosis, but nearly half of them died before reaching crossover eligibility. Death or hospitalization for heart failure (HHF) occurred in 73.6% of TEER patients and 91.5% of controls within 5 years, pointing to a need for further study to address left ventricle (LV) dysfunction, the underlying cause of patient's disease. MTRA-FR targeted SMR using the same device and did not improve the composite endpoint of all-cause mortality or HHF at 12 months. Possible reasons for the discrepancy include enrolment of patients with more severe MR and less-advanced LV disease (dilation/dysfunction), less-procedural complications, and higher success in reducing MR in COAPT compared with MITRA-FR. Thus, the ideal patient for MitraClip treatment would be one with severe MR, but with no too severe LV dilation/dysfunction, which is what differentiates COAPT patients from those in MITRA-FR.

Wire-based antegrade dissection re-entry technique for coronary chronic total occlusions percutaneous revascularization: Experience from the ERCTO Registry.

BACKGROUND: The recent development and widespread adoption of antegrade dissection re-entry (ADR) techniques have been underlined as one of the antegrade strategies in all worldwide CTO consensus documents. However, historical wire-based ADR experience has suffered from disappointing long-term outcomes. AIMS: Compare technical success, procedural success, and long-term outcome of patients who underwent wire-based ADR technique versus antegrade wiring (AW). METHODS: One thousand seven hundred and ten patients, from the prospective European Registry of Chronic Total Occlusions (ERCTO), underwent 1806 CTO procedures between January 2018 and December 2021, at 13 high-volume ADR centers. Among all 1806 lesions attempted by the antegrade approach, 72% were approached with AW techniques and 28% with wire-based ADR techniques. RESULTS: Technical and procedural success rates were lower in wire-based ADR than in AW (90.3% vs. 96.4%, p < 0.001; 87.7% vs. 95.4%, p < 0.001, respectively); however, wire-based ADR was used successfully more often in complex lesions as compared to AW (p = 0.017). Wire-based ADR was used in most cases (85%) after failure of AW or retrograde procedures. At a mean clinical follow-up of 21 ± 15 months, major adverse cardiac and cerebrovascular events (MACCEs) did not differ between AW and wire-based ADR (12% vs. 15.1%, p = 0.106); both AW and wire-based ADR procedures were associated with significant symptom improvements. CONCLUSIONS: As compared to AW, wire-based ADR is a reliable and effective strategy successfully used in more complex lesions and often after the failure of other techniques. At long-term follow-up, patient's MACCEs and symptoms improvement were similar in both antegrade techniques.

Transcatheter mitral valve replacement: there is still work to be done.

Transcatheter mitral valve replacement (TMVR) is a novel therapeutic option for patients with severe mitral regurgitation (MR) at high or prohibitive surgical risk. Most TMVR technologies under investigation use either a trans-apical or a trans-septal approach via dedicated multistep anchoring systems. Transcatheter mitral valve replacement offers several potential advantages over transcatheter repair, notably a greater and more sustained MR reduction. At the same time, significant engineering challenges and potential disadvantages must be acknowledged. Preclinical and clinical studies have shown promising results, demonstrating TMVR feasibility. Nevertheless, further development, testing, and trials are needed before considering TMVR as a definitive therapeutic option for MR in a wide range of anatomical scenarios.

Revival of a forgotten valve: use of the percutaneous clip for the treatment of tricuspid regurgitation.

Tricuspid regurgitation (TR) is common in patients with left-sided valvular heart disease and is independently associated with increased mortality and morbidity because it leads to right-sided heart failure and recurrent hospitalization. The prognostic benefit of isolated TR surgical repair or replacement is unclear and medical treatment of decompensated right heart failure alone does not prevent the progression of the disease. Recently, minimal invasive catheter-based techniques have emerged as a feasible and effective option for TR treatment in selected high-risk patients who would clinically benefit from tricuspid valve repair. We provide an overview of the current state of transcatheter TR treatment using the edge-to-edge technique.

Guiding Principles for Chronic Total Occlusion Percutaneous Coronary Intervention.

Outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have improved because of advancements in equipment and techniques. With global collaboration and knowledge sharing, we have identified 7 common principles that are widely accepted as best practices for CTO-PCI. 1. Ischemic symptom improvement is the primary indication for CTO-PCI. 2. Dual coronary angiography and in-depth and structured review of the angiogram (and, if available, coronary computed tomography angiography) are key for planning and safely performing CTO-PCI. 3. Use of a microcatheter is essential for optimal guidewire manipulation and exchanges. 4. Antegrade wiring, antegrade dissection and reentry, and the retrograde approach are all complementary and necessary crossing strategies. Antegrade wiring is the most common initial technique, whereas retrograde and antegrade dissection and reentry are often required for more complex CTOs. 5. If the initially selected crossing strategy fails, efficient change to an alternative crossing technique increases the likelihood of eventual PCI success, shortens procedure time, and lowers radiation and contrast use. 6. Specific CTO-PCI expertise and volume and the availability of specialized equipment will increase the likelihood of crossing success and facilitate prevention and management of complications, such as perforation. 7. Meticulous attention to lesion preparation and stenting technique, often requiring intracoronary imaging, is required to ensure optimum stent expansion and minimize the risk of short- and long-term adverse events. These principles have been widely adopted by experienced CTO-PCI operators and centers currently achieving high success and acceptable complication rates. Outcomes are less optimal at less experienced centers, highlighting the need for broader adoption of the aforementioned 7 guiding principles along with the development of additional simple and safe CTO crossing and revascularization strategies through ongoing research, education, and training.

Third- versus Second-Generation Stent Graft for Endovascular Aneurysm Repair: A Device-Specific Analysis.

PURPOSE: Our purpose is to analyze the outcomes of endovascular aneurysm repair (EVAR) in patients treated with Excluder endograft (W.L. Gore and Associate, Flagstaff, AZ), comparing second generation, featuring SIM-PULL delivery system (ExSP) and third generation, featuring C3 (ExC3), concerning intraprocedural data and long-term outcomes. METHODS: In our single-center, comparative study, we retrospectively analyzed all patients undergoing elective EVAR with Excluder from May 2008 to December 2015. This cohort was firstly divided according to the design of the endograft used, and then, two subgroups of complex procedures were identified according to International Standards. Preliminary end points were early- and mid-term outcomes. Primary end point was procedural data (i.e., procedural and fluoroscopy time, radiation dose (DAP), and contrast medium amount). RESULTS: The study included 64 patients (24 ExSP and 40 ExC3) with a mean follow-up of 31.6 ± 22.9 months. Patients in ExC3 group had significantly more risk factors (past or present history of smoking, P = 0.019), comorbidities (chronic heart failure and chronic kidney disease, both P = 0.032), as well as a more unfavorable anatomy (neck angulation, P = 0.035). Concerning preliminary outcome, no significant between-group difference was noted. As for intraoperative data, procedure duration was significantly shorter: 120 vs. 151 min (P = 0.002) in the overall population and 129 vs. 173 min (P = 0.004) in complex cases. A significant reduction was also found in fluoroscopy time and radiation exposure: 24,084 vs. 32,548 cGy/cm2 (P = 0.020) in the overall population and 26,770 vs. 41,104 cGy/cm2 (P = 0.003) in complex cases. No significant difference was found for contrast volume. CONCLUSIONS: The study shows that new C3 excluder enables to reduce radiation exposure and procedural time compared to the previous device. C3 excluder results are comparable to those of the previous device in spite of more comorbidities and complex anatomy of the treated patients. Further studies are needed to assess device performance on longer-term follow-up.

Carotid Artery Stenting With Proximal Embolic Protection via a Transradial or Transbrachial Approach: Pushing the Boundaries of the Technique While Maintaining Safety and Efficacy.

PURPOSE: To compare the feasibility and safety of proximal cerebral protection to a distal filter during carotid artery stenting (CAS) via a transbrachial (TB) or transradial (TR) approach. METHODS: Among 856 patients who underwent CAS between January 2007 and July 2015, 214 (25%) patients (mean age 72±8 years; 154 men) had the procedure via a TR (n=154) or TB (n=60) approach with either Mo.MA proximal protection (n=61) or distal filter protection (n=153). The Mo.MA group (mean age 73±7 years; 54 men) had significantly more men and more severe stenosis than the filter group (mean age 71±8 years; 100 men). Stent type and CAS technique were left to operator discretion. Heparin and a dedicated closure device or bivalirudin and manual compression were used in TR and TB accesses, respectively. Technical and procedure success, crossover to femoral artery, 30-day major adverse cardiovascular/cerebrovascular events (MACCE; death, all strokes, and myocardial infarction), vascular complications, and radiation exposure were compared between groups. RESULTS: Crossover to a femoral approach was required in 1/61 (1.6%) Mo.MA patient vs 11/153 (7.1%) filter patients mainly due to technical difficulty in engaging the target vessel. Five Mo.MA patients developed acute intolerance to proximal occlusion; 4 were successfully shifted to filter protection. A TR patient was shifted to filter because the Mo.MA system was too short. CAS was technically successful in the remaining 55 (90%) Mo.MA patients and 142 (93%) filter patients. The MACCE rate was 0% in the Mo.MA patients and 2.8% in the filter group (p=0.18). Radiation exposure was similar between groups. Major vascular complications occurred in 1/61 (1.6%) and in 3/153 (1.96%) patients in the Mo.MA and filter groups (p=0.18), respectively, and were confined to the TB approach in the early part of the learning curve. Chronic radial artery occlusion was detected by Doppler ultrasound in 2/30 (6.6%) Mo.MA patients and in 4/124 (3.2%) filter patients by clinical assessment (p=0.25) at 8.1±7.5-month follow-up. CONCLUSION: CAS with proximal protection via a TR or TB approach is a feasible, safe, and effective technique with a low rate of vascular complications.

Serial intravascular ultrasound analysis of complex bifurcation coronary lesions treated with the Tryton Bifurcation Stent in conjunction with an everolimus-eluting stent: IUVANT (Intravascular Ultrasound Evaluation of Tryton Stent) study.

OBJECTIVES: To characterize the treatment of complex bifurcation lesions (BL) with the Tryton Bifurcation Stent (TBS) paired with an everolimus-eluting stent (EES). BACKGROUND: Complex BL are associated with higher procedural complications and poorer long-term outcomes. The TBS is a dedicated side-branch (SB) stent designed to be used in conjunction with a standard drug-eluting stent. METHODS: Prospectively identified, consecutive patients underwent TBS+EES stenting of BL using a protocol which included TBS postdilation and simultaneous final kissing balloon inflations (FKBI). All lesions were systematically evaluated with coronary angiography and IVUS, obtained at procedure completion and at 9 months, and were assessed by independent core laboratories. RESULTS: Thirty-three BL were treated in 32 patients presenting primarily (87.5%) with stable angina and complex BL with angiographic apparent disease in the main vessel (MV) and SB in 87.9% and 75% by site and core evaluation, respectively. Procedural success was 100% and high postprocedure percent stent expansion (MV 96 [93, 109]%, SB 88 [77, 100]%, carina MV 135 [99, 166]%, carina SB 116 [91, 130]%) was demonstrated by IVUS. At 9-month angiographic follow-up (n = 28 patients), one MV in-segment restenosis and one SB in-stent restenosis were observed. SB in-stent late lumen loss was 0.41 ± 0.27 mm. IVUS assessment revealed the absence of stent recoil; percent carinal neointimal hyperplasia (NIH) was 1.8 [0.0,11.2]% in MV and 15.0 [6.7,23.5]% in SB, with NIH volume obstruction of 2.0 [0.7,4.3]% in MV and 14.2 [7.5,29.6]% in SB. CONCLUSIONS: Stenting of complex BL with the TBS+EES provides high acute success with sustained clinical, angiographic, and IVUS results at 9 months. These excellent results are likely due to the extent of stent expansion at the carina.

Noblestitch® system for PFO closure: A novel but judicious alternative to traditional devices-A case report.

Background: Percutaneous suture-mediated patent foramen ovale (PFO) closure has recently been used with the aim of avoiding double-disc nitinol device implantation. This novel technique has been carried out successfully in several centers offering PFO closure with an effective closure rate comparable to conventional double-disc devices. Case summary: A 50-year-old man, a pentathlon athlete, suffering from a previous left-sided ischemic stroke, underwent percutaneous closure of a permanent right-to-left shunt via PFO with a large fenestrated septum primum aneurysm at another institution. The NobleStitch® system was successfully implanted using local anesthesia and under angiographic-fluoroscopic monitoring. He was discharged home on aspirin 100 mg daily with a moderate residual shunt on contrast transthoracic echocardiography (cTTE) that persisted unaltered at subsequent controls. After 7 months, unable to resume sporting activity because of physical discomfort and dyspnea on exertion, the patient asked for a second opinion at our Heart and Brain clinic. Two-dimensional (2D) TTE showed septum primum laceration next to a radiopaque polypropylene knot with a moderate bidirectional shunt located at the fenestrated septum primum far from the PFO site. A catheter-based closure of the septal defect was therefore planned under local anesthesia and rotational intracardiac echo monitoring. An equally sized discs 28.5 mm × 28.5 mm Flex II UNI occluder (Occlutech GmbH, Jena, Germany) was successfully implanted across the atrial septal defect without complications. The patient was discharged in good clinical conditions; dual antiplatelet therapy (aspirin 100 mg/daily and clopidogrel 75 mg/daily) was recommended for 2 months and then single antiplatelet therapy (aspirin100 mg/daily) up to 6 months. Abolition of the residual shunt was confirmed at 1- and 6-month follow-up by contrast transcranial Doppler and 2D color Doppler cTTE. Discussion: Closing a PFO with a suture-base system, without leaving a device implant behind, may be a cutting-edge technology and potential alternative to traditional devices. Nevertheless, meticulous selection of the PFO anatomies by 2D TEE is key to a successful closure procedure in order to avoid complications that must be managed again with a second percutaneous procedure or by surgery.

The SALINE Technique for the Treatment of the No-Reflow Phenomenon during Percutaneous Coronary Intervention in STEMI.

BACKGROUND: Primary percutaneous coronary intervention (pPCI) performed for STEMI may be complicated by the "no-reflow" phenomenon. AIMS: A super-selective intracoronary injection of saline solution through a thrombus aspiration catheter (SALINE technique), was investigated for the treatment of no-reflow as compared with the standard care of therapy (SCT). METHODS: Among the 1471 patients with STEMI undergoing pPCI between May 2015 and June 2020, 168 patients developed no-reflow. Primary endpoints were the incidence of ST-segment resolution (STR) ≥ 70% at 90 min after PCI and the rate of flow restoration (TIMI flow grade 3 with an MBG > 1). The secondary endpoint was the incidence of major adverse cardiac and cerebrovascular events at 3 years follow-up. RESULTS: After propensity score matching analysis, patients treated with SALINE showed STR ≥ 70% in twelve out of the sixteen patients (75.0%), compared to only three patients out of the sixteen in the SCT control group (19.0%), (p < 0.004). SALINE was associated with a higher probability of final TIMI flow grade 3 with an MBG > 1, as shown in fourteen out of sixteen patients (87.5%), as compared to only seven out of sixteen patients in the SCT group (43.8%), (p < 0.03). MACCE at 3 years follow-up occurred in only one patient (6.3%) in the SALINE group, as compared to eight patients (50%) in the SCT group (p = 0.047). CONCLUSIONS: The SALINE technique showed to be a safe and effective strategy to reduce "no-reflow" in STEMI patients as assessed by significant STR, improvement of TIMI flow grade, and better 3-year outcomes.

Intravascular Lithotripsy in Calcified Coronary Lesions: A Single-Center Experience in "Real-World" Patients.

Objectives: This study aims to describe the outcome of intravascular lithotripsy (IVL) when used with different indications and to assess the short- and long-term outcomes of IVL-facilitated percutaneous coronary intervention (PCI). Background: Intravascular lithotripsy can improve the results of PCI of calcified coronary lesions with a low rate of periprocedural complications. Methods: A total of 105 consecutive patients with 110 calcified lesions underwent IVL. A total of 87 de novo lesions were treated by IVL with the following indications: 25 before attempting other balloon-based devices (primary IVL), 51 after the failure of non-compliant balloon dilatation (secondary IVL), and 11 after stent implantation because of stent under expansion (bailout IVL). In 23 lesions, IVL was used for the treatment of in-stent restenosis (ISR). Effectiveness (angiographic success) and safety [major adverse cardiovascular events (MACEs) and IVL-related procedural complications] endpoints were assessed. Results: Angiographic success was achieved in 84.6% of lesions. Early MACEs were periprocedural MI only, ranging from 6.7 to 20% depending on MI definition. The flow-limiting dissections rate was 2.7%. A total of five (4.5%) IVL balloons ruptured during treatment with subsequent vessel perforation in 1 case. MACEs at 12 months were 13.3%, with TLR occurring in 8 lesions (12% primary IVL, 0% secondary IVL, 0% bailout IVL, and 21.7% IVL for ISR, p = 0.002). Conclusion: Treatment of calcified coronary lesions with IVL in a "real-world" setting can be performed with high success, low rate of procedural complications, and an acceptable MACEs rate. Target lesion failure may be more frequent when IVL is performed for the treatment of ISR due to calcium-mediated stent under expansion.

Conduction disorders after transcatheter aortic valve implantation: A comparison between SAPIEN 3 and SAPIEN 3 Ultra balloon-expandable valves.

Background: Conduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve. Methods: We included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge. Results: No significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer's guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001). Conclusion: No significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.

The Role of Multimodality Imaging for Percutaneous Coronary Intervention in Patients With Chronic Total Occlusions.

Background: Percutaneous coronary intervention (PCI) of Chronic total occlusions (CTOs) has been traditionally considered a challenging procedure, with a lower success rate and a higher incidence of complications compared to non-CTO-PCI. An accurate and comprehensive evaluation of potential candidates for CTO-PCI is of great importance. Indeed, assessment of myocardial viability, left ventricular function, individual risk profile and coronary lesion complexity as well as detection of inducible ischemia are key information that should be integrated for a shared treatment decision and interventional strategy planning. In this regard, multimodality imaging can provide combined data that can be very useful for the decision-making algorithm and for planning percutaneous CTO recanalization. Aims: The purpose of this article is to appraise the value and limitations of several non-invasive imaging tools to provide relevant information about the anatomical characteristics and functional impact of CTOs that may be useful for the pre-procedural assessment and follow-up of candidates for CTO-PCI. They include echocardiography, coronary computed tomography angiography (CCTA), nuclear imaging, and cardiac magnetic resonance (CMR). As an example, CCTA can accurately delineate CTO location and length, distal coronary bed, vessel tortuosity and calcifications that can predict PCI success, whereas stress CMR, nuclear imaging and stress-CT can provide functional evaluation in terms of myocardial ischemia and viability and perfusion defect extension.

Sustained long-term benefit of patent foramen ovale closure on migraine.

OBJECTIVES: This single-center, observational, prospective study evaluated the impact of patent foramen ovale (PFO) closure on migraine attacks over time. BACKGROUND: PFO closure may reduce the frequency and severity of migraine headaches in patients with significant right-to-left shunts. METHODS: Between May 2000 and September 2009, 305 consecutive patients (mean age, 43 ± 12 years; 54.5% women) with a prior embolic cerebrovascular event underwent PFO closure with the Amplatzer PFO occluder for recurrence prevention. All patients had right-to-left shunts; the shunts were associated with migraine symptoms in 77 (25%), either alone (n = 64, 83%) or with aura (n = 13, 17%). Septal aneurysm was present in 15 (19.5%) migraine patients, and 43 (56%) had a previous transient brain ischemic attack. All migraine patients had a computed tomography scan or magnetic resonance imaging, indicating a previous brain ischemic lesion. All 305 patients underwent transthoracic echocardiography with clinical follow-up at 24 hr, at 3, 6, and 12 months, and then yearly. RESULTS: An acute migraine attack occurred 24-48 hr after PFO closure in 28 (36.4%) of 77 patients. There was a significant reduction (>50%) in the number and intensity of attacks in 46 (60.5%) of 77 patients at the 3-month follow-up. At the 12-month follow-up, migraine had ceased in 23 (46%) patients, and 20 (40%) had a reduction in the migraine recurrence rate and disabling symptoms. These results were maintained at follow-up (mean, 28 ± 27 months). There was overall improvement in migraine in 89% of the treated patients. CONCLUSIONS: Percutaneous PFO closure in migraineurs may provide beneficial mid-term and long-term results, with significant reduction in the intensity and frequency of headache symptoms.

Case Report: Key Role of the Impella Device to Achieve Complete Revascularization in a Patient With Complex Multivessel Disease and Severely Depressed Left Ventricular Function.

Background: Left ventricle (LV) assist devices may be required to stabilize hemodynamic status during complex, high-risk, and indicated procedures (CHIP). We present a case in which elective hemodynamic support with the Impella CP device was essential to achieve complete revascularization with PCI in a patient with complex multivessel disease and severely depressed LV function. Case Summary: A 45-year-old male with no previous history of cardiovascular disease presented to the emergency department for new onset exertional dyspnoea. Echocardiography showed severely depressed LV function (EF 27%) that was confirmed with cardiac magnetic resonance. Two chronic total occlusions (CTOs) of the proximal right coronary artery (RCA) and left circumflex coronary artery (LCx) were found at coronary angiography. After Heart Team evaluation, PCI with Impella hemodynamic support was planned. After crossing and predilating the CTO of the LCx, ventricular fibrillation (VF) occurred. No direct current (DC) shock was performed because the patient was conscious thanks to the support provided by the Impella pump. About 1 min later, spontaneous termination of VF occurred. Afterwards, the two CTOs were successfully treated with good result and no complications. Recovery of LV function was observed at discharge. At 9 months, the patient had no symptoms and echocardiography showed an EF of 60%. Discussion: In this complex high-risk patient, hemodynamic support was essential to allow successful PCI. It is remarkable that the patient remained conscious and hemodynamically stable during VF that spontaneously terminated after 1 min, likely because the Impella pump provided preserved coronary perfusion and LV unloading. This case confirms the pivotal role of Impella in supporting CHIP, particularly in patients with multivessel disease and depressed LV function.

Radiation Exposure for Percutaneous Interventions of Chronic Total Coronary Occlusions in a Multicenter Registry: The Influence of Operator Variability and Technical Set-up.

AIMS: Radiation exposure is a limiting factor for percutaneous coronary interventions (PCI) of chronic total coronary occlusion (CTO) lesions. This study was designed to analyze changes in patient radiation dose for CTO-PCI and parameters associated with radiation dose. METHODS AND RESULTS: We analyzed a cohort of 12,136 procedures performed by 23 operators between 2012 and 2017 from the European Registry of CTO-PCI. Radiation exposure was recorded as air kerma (AK) and dose area product (DAP). A dose rate index (DRI) was calculated as AK per fluoroscopy time to normalize for individual differences in fluoroscopy time. The lesion complexity increased from Japanese-CTO (J-CTO) score of 2.19 ± 1.44 to 2.46 ± 1.28, with an increase of retrograde procedures from 31.1% to 40.7%; still, procedural success improved from 87.7% to 92.1%. Fluoroscopy time remained similar, but AK decreased by 14.9%, from 2.35 Gy (interquartile range [IQR], 1.29-4.14 Gy) to 2.00 Gy (IQR, 1.08-3.45 Gy) and DAP decreased by 21.5%, from 130 Gy•cm² (IQR, 70-241 Gy•cm²) to 102 Gy•cm² (IQR, 58-184 Gy•cm²). Radiation exposure was determined by the lesion complexity (J-CTO score) and procedural complexity (antegrade or retrograde). DRI was determined by fluoroscopy frame rate and type of equipment used, but the major influence remained interoperator differences. CONCLUSIONS: Radiation exposure decreased during the observation period despite an increase in lesion and procedural complexity. While many operators already achieved a goal of low radiation exposure, there were considerable interoperator differences in radiation management, indicating further potential for improvement.

Global Chronic Total Occlusion Crossing Algorithm: JACC State-of-the-Art Review.

The authors developed a global chronic total occlusion crossing algorithm following 10 steps: 1) dual angiography; 2) careful angiographic review focusing on proximal cap morphology, occlusion segment, distal vessel quality, and collateral circulation; 3) approaching proximal cap ambiguity using intravascular ultrasound, retrograde, and move-the-cap techniques; 4) approaching poor distal vessel quality using the retrograde approach and bifurcation at the distal cap by use of a dual-lumen catheter and intravascular ultrasound; 5) feasibility of retrograde crossing through grafts and septal and epicardial collateral vessels; 6) antegrade wiring strategies; 7) retrograde approach; 8) changing strategy when failing to achieve progress; 9) considering performing an investment procedure if crossing attempts fail; and 10) stopping when reaching high radiation or contrast dose or in case of long procedural time, occurrence of a serious complication, operator and patient fatigue, or lack of expertise or equipment. This algorithm can improve outcomes and expand discussion, research, and collaboration.

Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting.

OBJECTIVES: The aim of this study was to randomly compare the double-layer Roadsaver stent (RS) (Terumo, Tokyo, Japan) with the single-layer Carotid Wallstent (CW) (Boston Scientific, Santa Clara, California) in association with either distal embolic protection with the FilterWire (FW) device (Boston Scientific) or proximal protection with the Mo.Ma Ultra device (Medtronic, Santa Rosa, California) in patients with lipid-rich carotid plaques. BACKGROUND: The role of both stent type and brain protection during carotid artery stenting (CAS) remains unsettled. METHODS: A total of 104 consecutive patients with carotid artery stenosis were randomized to CAS with FW + RS (group 1, n = 27), FW + CW (group 2, n = 25), Mo.Ma + RS (group 3, n = 27), or Mo.Ma + CW (group 4, n = 25). The primary endpoint was the number of microembolic signals (MES) on transcranial Doppler among groups in the following CAS steps: 1 and 2) target vessel access; 3) lesion wiring; 4) pre-dilation; 5) stent crossing; 6) stent deployment; 7) stent dilation; and 8) device retrieval and deflation. RESULTS: No significant differences in baseline characteristics were found among the 4 groups. Compared with the FW device, the Mo.Ma Ultra device significantly reduced mean MES count (p < 0.0001) during lesion crossing, stent crossing, stent deployment, and post-dilation. Compared with the CW, the RS significantly reduced MES count (p = 0.016) in steps 6 to 8, including spontaneous MES (29% of patients). The combination of Mo.Ma + RS performed significantly better than Mo.Ma + CW (p = 0.043). Clinical major adverse cardiac and cerebrovascular events occurred in 3 patients (p = 0.51). After CAS, peak systolic velocity significantly decreased in all patients. In-stent restenosis developed in 1 patient (0.98%) at 6-month follow-up. The RS was an independent predictor of external carotid artery patency over time. CONCLUSIONS: In patients with high-risk, lipid-rich plaque undergoing CAS, Mo.Ma + RS led to the lowest microembolic signals count. (Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection; NCT02915328).

Comparison of the Effectiveness of Percutaneous Intervention of the Left-Main Coronary Artery With Everolimus-Eluting Stents in Women -Vs- Men.

Everolimus-eluting stents are largely used for left main (LM) percutaneous coronary interventions (PCI). Long-term follow-up of patients who underwent LM PCI in a real world clinical setting, in particular women, have been scarcely reported. Consecutive patients who underwent unprotected LM PCI with EES at a single Institution from December 2006 to April 2016 were included. Main outcome assessed was the occurrence of major adverse cardiovascular events (MACE) as a composite of death, myocardial infarction or target lesion revascularization at follow-up. Overall, 589 patients (20.8% women) were included in the present analysis. Women were older, had lower body mass index and more frequently hypertensive compared with men. Main clinical presentation was stable coronary artery disease (CAD); unstable angina was more frequently observed in women compared with men, whereas ST-elevation myocardial infarction was less frequent. After 69.7 ± 28.3 months of follow-up, 47 patients overall experienced MACE (1.43 per 100*patients/year). MACE rate was higher in women compared with male patients, with a rate of 2.49 and 1.17 per 100*patients/year, respectively (p = 0.015). The difference was driven mainly by higher mortality in women (0.89 vs 0.15 per 100*patients/years, p = 0.002). At multivariable Cox regression, female gender was independently associated with an increased risk of MACE at follow-up (hazard ratio 2.21, 95% confidence interval 1.20 to 4.08, p = 0.011). In conclusion, EES can be safely and effectively adopted for LM PCI.

A Long-Term Single-Center Registry of 6893 Patients Undergoing Elective Percutaneous Coronary Intervention With the Xience Everolimus-Eluting Stent.

BACKGROUND: The safety and effectiveness of the everolimus-eluting stent (EES) have been previously demonstrated. AIMS: To assess very long-term performance and outcomes of the EES in a real-world population. METHODS: This single-center registry prospectively enrolled 6893 patients (mean age, 66 ± 9.7 years; 81.4% men) undergoing elective coronary intervention with the EES over a decade. Clinical follow-up (FU) was performed at 1 year and then yearly thereafter. RESULTS: Multiple risk factors were present in 34%. Stable angina was the main stenting indication (78.1%), followed by unstable angina (5.3%) and positive stress test (16.6%) for 1-vessel (44%) or 2/3-vessel disease (56%). Multiple stents (stent/patient ratio: 2.1 ± 0.8) in >1 vessel were implanted in 36.9% (mean stent length, 43 ± 31.3 mm). At 1 year, 80% of patients were on dual-antiplatelet therapy, while only 3% were on therapy at 2 years. A low 1-year major adverse cardiac event (MACE) rate of 5.0% was observed; stent thrombosis (ST) occurred in 19 patients (0.3%), with a prevalence of early (n = 9) over late (n = 4) and very late events (n = 6; 0.08%). Clinically driven target- lesion revascularization/target-vessel revascularization (TLR/TVR) occurred in 3.3% at 1-year follow-up. Long-term FU (3 years) completed in 6210 patients (90.0%) showed a MACE rate of 5.9%, while very long-term FU (>5 years and up to 10 years), available in 3550 out of 4635 exposed patients (76.6%), showed a MACE rate of 8.6%. Independent MACE predictors were stented segment length (odds ratio [OR], 2.1; 95% confidence interval [CI] 1.57-2.82), small vessel stenting (OR, 1.34; 95% CI, 1.08-1.68), and multivessel disease (2-vessel disease: OR, 1.59; 95% CI, 1.21-2.08; 3-vessel disease: OR, 2.26; 95% CI, 1.72-2.97). CONCLUSIONS: This large, prospective registry confirms the very long-term safety and efficacy of the EES in unselected real-world and complex coronary lesions.