Transfemoral transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis (AS). Although dual arterial access (DAA) is commonly used for catheter control and haemodynamic monitoring, single arterial access (SAA) has emerged as a minimalist strategy aimed at reducing procedural complexity and access-site complications. However, comparative outcome data remain limited. Four propensity score-matched observational studies comprising 540 patients (50.4

Relevant calcified coronary artery disease (CCAD) may be present in around 20% of patients undergoing percutaneous coronary interventions, and it is known to add procedural challenges and risks. Careful patient selection and specific expertise in multimodality imaging and plaque modification techniques are required to plan and adopt the most appropriate therapeutic strategy. This review aims to present the contemporary clinical approach and procedural planning for CCAD patients, describing the available tools and strategies in view of the most recent scientific evidence.

Since its inception, percutaneous coronary intervention (PCI) has relied upon vessel opacification with iodinated contrast to plan, guide, and assess the results of the procedure. Yet revisiting this fundamental concept is important in contemporary PCI practice, especially in patients with high-risk clinical or anatomical profiles. In addition to decreasing the probability of acute kidney injury during PCI, limiting the volume of iodinated contrast allows the operator to perform more thorough interventions by relying on intracoronary imaging and physiology, ultimately contributing to more complete revascularization and improving the efficacy and durability of the intervention. Ultra-low-contrast PCI (ULCPCI) may thus be useful in performing PCI not only in patients with chronic renal dysfunction but also in those with multivessel coronary artery disease, impaired left ventricular function, and many other scenarios. The aim of this review is to highlight contemporary PCI scenarios in which a ULCPCI approach may be beneficial. The authors provide a structured approach to address the challenges faced by operators in transitioning from conventional contrast-based interventions to ULCPCI, with practical solutions that are accessible to most interventionalists. The reader will learn that ULCPCI is feasible in contemporary practice as a result of technological innovation, the implementation of dedicated skills, and redefining the role of angiography as the cornerstone of contemporary PCI.

ImportanceThe differences between the use of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) in the long term are unknown.ObjectiveTo compare long-term outcomes of iFR- and FFR-based strategies to guide revascularization.Design, Setting, and ParticipantsThe DEFINE-FLAIR multicenter study randomized patients with coronary artery disease to use either iFR or FFR as a pressure index to guide revascularization. Patients from 5 continents with coronary artery disease and angiographically intermediate severity stenoses who underwent hemodynamic interrogation with pressure wires were included. These data were analyzed from March, 13, 2014, through April, 27, 2021.MAIN OUTCOME MEASURESFive-year major adverse cardiac events (MACE) (a composite of all-cause death, nonfatal myocardial infarction, and unplanned revascularization), as well as the individual components of the combined end point.ResultsAt 5 years of follow-up, no significant differences were found between the iFR (mean age [SD], 65.5 [10.8] years; 962 male [77.5%]) and FFR (mean age [SD], 65.2 [10.6] years; 929 male [74.3%]) groups in terms of MACE (21.1% vs 18.4%, respectively; hazard ratio [HR], 1.18; 95% CI, 0.99-1.42; P = .06). While all-cause death was higher among patients randomized to iFR, it was not driven by myocardial infarction (6.3% vs 6.2% in the FFR study arm; HR, 1.01; 95% CI, 0.74-1.38; P = .94) or unplanned revascularization (11.9% vs 12.2% in the FFR group; HR, 0.98; 95% CI, 0.78-1.23; P = .87). Furthermore, patients in whom revascularization was deferred on the basis of iFR or FFR had similar MACE in both study arms (17.9% in the iFR group vs 17.5% in the FFR group; HR, 1.03; 95% CI, 0.79-1.35; P = .80) with similar rates of the components of MACE, including all-cause death. On the contrary, in patients who underwent revascularization after physiologic interrogation, the incidence of MACE was higher in the iFR group (24.6%) compared with the FFR group (19.2%) (HR, 1.36; 95% CI, 1.07-1.72; P = .01).Conclusions and relevanceAt 5-year follow up, an iFR based–strategy was not statistically different than an FFR strategy to guide revascularization in terms of MACE, nonfatal myocardial infarction, and unplanned revascularization.Trial RegistrationClinicalTrials.gov Identifier: NCT02053038

New-generation single-layer polytetrafluorethylene (PTFE-) or polyurethane (PU-) covered stent (CS) for the treatment of coronary artery perforation (CAP) during PCI offer high procedural efficacy. To evaluate the comparative long-term safety and efficacy of both devices. This is a multicenter pooled analysis of individual data of patients with CAP undergoing implantation of single-layer PTFE-CS or PU-CS. Procedural endpoint was strategy success defined as successful placement of CS and sealing of perforation without surgical conversion. Clinical endpoints were mortality, myocardial infarction (MI), target vessel revascularization (TVR) and definite or probable stent thrombosis (def/prob ST) at 12 months. Seventy patients with CAP underwent implantation of two hundred eight CS, ninety-two PTFE-CS, and one hundred sixteen PU-CS. More than 1 stent was implanted in 13 patients (17.1

BACKGROUND The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital -level information on public vs private, urban vs rural, and TAVR volume was collected, as was country -level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central -South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low -volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central -South America, and Asia. National socioeconomic status, COVID-1 9 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises. (J Am Coll Cardiol Intv 2024;17:374-387) (c) 2024 by the American College of Cardiology Foundation.

Background: One of the most common complications post transcatheter aortic valve implantation (TAVI) is the development of heart block requiring permanent pacemaker implantation (PPM). The incidence of PPM in international registries ranges from 13% - 17.5%. Methods: The aim of this observational study was to report the PPM rate in the SHARE-TAVI registry and determine the clinical, electrocardiographic and procedural predictors of PPM as well as the effect of PPM on clinical outcomes. Results: Three hundred and fi ve subjects were analysed. The PPM rate was 9%. Third degree atrioventricular block at the time of implant was the most common indication for PPM. Self-expanding valves (PPM rate 14% vs. 6% for balloon-expandable valves, p=0.02) were correlated with the need for PPM. Baseline ECG predictors of PPM were axis deviation, QRS duration and conduction delay, most notably a pre-existing right bundle branch block (OR 15.88, p<0.01). PPM infl uenced functional class at 30 days, but not the need for repeat hospitalisation or mortality at 30-day and 1-year follow-up. Conclusions: A PPM rate lower than that reported in large international registries was found. Predictors of PPM and the infl uence of PPM on outcomes were similar to those reported in the international data.

AIM The aim was to assess the safety and efficacy of rotational atherectomy followed by drug-eluting balloon (DEB) in patients with a high risk of bleeding. METHODS A retrospective review was carried out of hospital records of consecutive patients who underwent the hybrid procedure. RESULTS The average age of the 23 patients was 74 years. Risk factors for bleeding included renal failure (35%), oral anticoagulation use (26%) and peptic ulcer disease (35%). All patients had procedural success. No bleeding was reported over the 24-month follow-up period. Dual antiplatelet therapy was stopped successfully in six patients (26%) at three months. Two patients had confirmed target-lesion failure (restenosis). Two patients died over the study period but the cause of death was not known to be cardiovascular disease related. CONCLUSIONS For patients at high risk of bleeding who require rotablation, the use of a drug-eluting balloon may be a safe, effective alternative.

Supplemental Digital Content is available in the text. Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. Results: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76–996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510–1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium–defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74–12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88–21.53; P<0.001) were both independently associated with repeat mitral valve replacement. Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

BACKGROUND:The PAST-PERF registry was initiated to collect data on the PK Papyrus covered stent, a second-generation device for the treatment of coronary artery perforations with enhanced mechanical properties, but with limited available data. METHODS:Patients treated for coronary artery perforations with the PK Papyrus stent at 14 international centers were retrospectively identified. The primary effectiveness outcome was successful sealing of the perforation. The primary safety outcome was a composite of all-cause mortality, definite or probable stent thrombosis, myocardial infarction and target lesion revascularization. RESULTS:Among the 94 included patients, 72.3% (68/94) had Ellis type III and cavity spilling perforations. Complete sealing was achieved in 93.6% (n = 88), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). Pericardiocentesis was required in 25.0% (n = 23), emergency cardiac surgery was needed in 7.6% (n = 7), acute stent thrombosis was observed in 1.1% (n = 1), and in-hospital mortality occurred in 11.7% (n = 11). The median follow-up duration was 283 (IQR:40;670) days. At 6 and 12 months, the incidence of the primary safety endpoint was 26.6% [95%CI:18.6;37.1] and 32.0% [95%CI:22.8;43.4], mortality 15.0% [95%CI:9.0;24.6] and 19.0% [95%CI:11.3;30.0], and target lesion revascularization 5.5% [95%CI:2.0;14.6] and 7.7% [95%CI:3.1;18.2]. Two definite stent thrombosis occurred, one during the procedure and one on post-procedure day 233. CONCLUSIONS:The registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. ANNOTATED TABLE OF CONTENT:The PAST-PERF registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. Specifically, complete sealing was achieved in 93.6% of patients (n = 88/94), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). The 12-month mortality was 19.0% [95%CI:11.3;30.0], the rate of target lesion revascularization was 7.7% [95%CI:3.1;18.2], and two definite stent thromboses occurred (one during procedure and one on post-procedure day 233).

Objectives This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions. Background In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift. Methods The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE) which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). The imaging efficacy endpoint was mean in-scaffold late lumen loss (LLL) evaluated by quantitative coronary angiography (QCA). Optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up. Results A total of 69 target lesions were identified in 64 enrolled patients (mean age 58.30 +/- 9.02 years). Of the treated lesions, 49 (71.01%) lesions were of type B2/C. Procedural and device success was achieved in 64 and 62 patients, respectively. At 2-year follow-up, MACE was reported in one patient (1.61%) in the form of ID-TLR. There was no case of MI, cardiac death or scaffold thrombosis through 2-year. In a subset of 32 patients, paired QCA showed mean in-scaffold LLL of 0.18 +/- 0.31 mm at 6-month follow-up. In a subset of 21 patients, OCT revealed 97.95 +/- 3.69% strut coverage with mean scaffold area of 7.56 +/- 1.79 mm(2) and no evidence of strut malapposition. Conclusions The clinical and imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions.

OBJECTIVES This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies. BACKGROUND An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. METHODS This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. RESULTS Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 +/- 0.51 vs. 0.43 +/- 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 +/- 0.09 vs. 0.91 +/- 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 +/- 0.09 vs. 0.85 +/- 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). CONCLUSIONS An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (C) 2019 by the American College of Cardiology Foundation.

Africa is witnessing an epidemic of cardiovascular disease (CVD), with staggering morbidity and mortality. The spectrum of CVD includes hypertension, rheumatic heart disease, cardiomyopathy, atherosclerotic disease, congenital heart disease and tuberculous pericarditis. Opportunities exist to alter the trajectory of CVD epidemiology but require committed policy makers, functional health systems and an engaged citizenry.

OBJECTIVES:A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses. BACKGROUND:Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis. METHODS:Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses). RESULTS:Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR. CONCLUSIONS:Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome.

The development of bioresorbable vascular scaffold (BRS) offers a new treatment strategy for coronary artery lesion by replacement of a permanent metallic scaffold with a temporary scaffold and eradicating a nidus for very late adverse events. The first-in-human MeRes-1 trial reported favorable

BACKGROUND Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06). CONCLUSIONS iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral. (c) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).