Impact of Cusp-Overlap View for TAVR with Self-Expandable Valves on 30-Day Conduction Disturbances.

METHODS AND RESULTS: We retrospectively compared 257 consecutive patients undergoing TAVR with self-expandable valves using either CON (n = 101) or COVL (n = 156) in four intermediate/low volume centers. There were no significant differences in baseline characteristics between the groups. The 30-day incidence of new-onset LBBB (12.9% vs. 5.8%; p=0.05) and PPMI rate (17.8% vs. 6.4%; p=0.004) was significantly lower when using the COVL implantation view. There was no difference between the CON and COVL groups in 30-day incidence of death (4.9% vs. 2.6%), any stroke (0% vs. 0.6%), and the need for surgical aortic valve replacement (0% for both groups). CONCLUSION: Using the COVL view for implantation, we achieved a significant reduction of the LBBB and PPMI rate after TAVR in comparison with the traditional CON view, without compromising the TAVR outcomes when using self-expandable prostheses.

Intravascular ultrasound for cardiac allograft vasculopathy detection.

Cardiac allograft vasculopathy (CAV) after heart transplantation is a fibro-proliferative process affecting coronary arteries of the graft in up to 46.8% of the cases during the first 10 years post-transplantation. It is one of the main causes of graft loss and death. Due to graft denervation, CAV causing ischemia is usually clinically silent until the disease is far advanced. In this study, we compared coronary angiography with intravascular ultrasound (IVUS) for CAV detection. OUTCOMES: A total of 114 patients with HTx who underwent coronary angiography and IVUS between March 2018 and March 2019 were included. Mean follow-up was 87 ± 61 month. Lesions documented by coronary angiography were found in only 27 (24%) of the 114 patients. IVUS revealed ISHLT CAV 0 in 87 patients (76.3%); ISHLT CAV1 in 15 (13,1%) and ISHLT CAV2 and CAV3 in 6 patients (5.2%) each. Among 328 IVUS images, maximum intimal thickness (MIT) >0.5 mm was obtained in 60 vessels (52%) with 24 patients having three-vessel and 19 two-vessel involvement. CONCLUSION: As an adjunct to conventional coronary angiography to detect angiographically silent CAV in heart transplant patients, IVUS is a reliable and safe technique with a low complication rate. Large multicenter studies are necessary to confirm these findings and the potential long-term clinical impact of early detection in clinically and angiographically silent phase.

Transradial Versus Transfemoral Carotid Artery Stenting: A 16-Year Single-Center Experience.

AIMS: Limited data exist on radial access in carotid artery stenting (CAS). This single-center study was performed to compare the outcome and complication rates of transradial (TR) and transfemoral (TF) CAS. METHODS AND RESULTS: The clinical and angiographic data of 775 consecutive patients with high risk for carotid endarterectomy, treated between 1999 and 2016 by CAS with cerebral protection, were evaluated. Patients were divided into 2 groups according to vascular access: TR (n = 101; 13%) and TF (n = 674). Primary combined end-point: in-hospital major adverse cardiac and cerebral events. Secondary end-points: angiographic outcome of the procedure and crossover rate to another puncture site. Angiographic success was achieved in all 775 patients, the crossover rate was 4.9% in the TR and 0% in the TF group (P < 0.05). TR was performed at the right side in 97% of cases. The incidence of in-hospital major adverse cardiac and cerebral events was 2% in the TR and 3.6% in the TF group (P = ns). CONCLUSIONS: The TR approach for CAS is safe and efficacious, with acceptable cross-over rate. In both groups, vascular complications rarely occurred.

Endovascular Repair of an Aortic Arch Aneurysm with Triple Chimney Stent Grafts: A Case Report.

The treatment of an aortic arch aneurysm in high-risk individuals poses a significant challenge. We present a surgical patient with a patent left internal mammary artery (LIMA) graft and a large aortic arch aneurysm who underwent aortic stent-graft implantation and complete endovascular branching to preserve the LIMA inflow, with successful exclusion of the aneurysm. A moderate flow, proximal type I endoleak was observed after deployment that disappeared at 2-year follow-up.

Transcatheter aortic valve implantation without balloon predilation: a single-center pilot experience.

AIM: To assess the results of transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve prosthesis (Medtronic, Minneapolis, MN), without balloon predilation, in high-risk patients with degenerated severe aortic stenosis. METHODS AND RESULTS: Fifty-one consecutive patients who underwent direct TAVI, 98% through a transfemoral approach. Patients were 79 ± 8 years of age, 74% in New York Heart Association classes III or IV and at high risk for surgical valve replacement (mean logistic EuroScore 20 ± 15). Mean aortic valve area was 0.7 ± 0.2 cm(2). Procedural success rate was 94.2%. In-hospital, there were 2 deaths, 1 minor stroke with minimal sequelae, and 14 (28%) pacemaker implantation. At 30 days, there was one additional stroke and no new deaths. The mean postprocedural transprosthetic gradient was 15 ± 5 mm Hg; periprosthetic severe regurgitation was absent and moderate in one case. After a median follow-up of 7 months, there were five additional deaths (two cardiac), while 84% of survivors were in New York Heart Association classes I or II. CONCLUSIONS: These results suggest that direct CoreValve implantation in patients with severe aortic stenosis is feasible and may lead to hemodynamic and clinical improvement in patients who are poor candidates for aortic valve surgery, pending confirmation in larger series with longer follow-up.

High-dose plasmid-mediated VEGF gene transfer is safe in patients with severe ischemic heart disease (Genesis-I). A phase I, open-label, two-year follow-up trial.

OBJECTIVES: We aimed to assess safety and, secondarily, the efficacy of intramyocardial high-dose plasmid-vascular endothelial growth factor (VEGF) 165 (pVEGF165) gene transfer in no-option patients with coronary artery disease (CAD). BACKGROUND: Controlled trials of pVEGF165 in CAD have shown little benefit. One possible reason is shortness of dosage. We have shown in large mammalian models of chronic myocardial ischemia and acute myocardial infarction that intramyocardial pVEGF165 at doses significantly higher than those used in recent phase II trials is safe and efficacious on myocardial perfusion, left ventricular function, and infarct size limitation. METHODS: Using an injection catheter, 10 patients with severe CAD not amenable for revascularization received 10 intramyocardial injections of 0.38 mg (total dose, 3.8 mg) pVEGF165 in zones exhibiting myocardial ischemia, as assessed by combined stress 99mTc-sestamibi single-photon emission computed tomography and stress echocardiography. RESULTS: No serious adverse events related to either VEGF or the injection procedure occurred over the 2-year follow-up. One patient suffered femoral artery thrombosis after a follow-up coronary angiography, successfully resolved with medical treatment. Six patients suffered uncomplicated coronary ischemic events during the second year follow-up. Angina functional class decreased from 2.6 ± 0.2 to 1.2 ± 0.3 (mean ± SEM, P < 0.05), quality of life increased from 56.9 ± 3.2 to 82.6 ± 2.4 (P < 0.05), the summed difference score of myocardial perfusion decreased from 13.4 ± 2 to 7.7 ± 1.8 (P < 0.04), and stress ejection fraction did not change (44.2 ± 3.6% to 47.8 ± 3.1%, P = NS). CONCLUSIONS: High-dose intramyocardial pVEGF165 is safe at 2 years follow-up in patients with severe CAD. The efficacy results observed must be taken cautiously given the uncontrolled, open-label study design.

Central-to-peripheral blood pressure amplification: role of the recording site, technology, analysis approach, and calibration scheme in invasive and non-invasive data agreement.

Background: Systolic blood pressure amplification (SBPA) and pulse pressure amplification (PPA) can independently predict cardiovascular damage and mortality. A wide range of methods are used for the non-invasive estimation of SBPA and PPA. The most accurate non-invasive method for obtaining SBPA and/or PPA remains unknown. Aim: This study aims to evaluate the agreement between the SBPA and PPA values that are invasively and non-invasively obtained using different (1) measurement sites (radial, brachial, carotid), (2) measuring techniques (tonometry, oscillometry/plethysmography, ultrasound), (3) pulse waveform analysis approaches, and (4) calibration methods [systo-diastolic vs. approaches using brachial diastolic and mean blood pressure (BP)], with the latter calculated using different equations or measured by oscillometry. Methods: Invasive aortic and brachial pressure (catheterism) and non-invasive aortic and peripheral (brachial, radial) BP were simultaneously obtained from 34 subjects using different methodologies, analysis methods, measuring sites, and calibration methods. SBPA and PPA were quantified. Concordance correlation and the Bland-Altman analysis were performed. Results: (1) In general, SBPA and PPA levels obtained with non-invasive approaches were not associated with those recorded invasively. (2) The different non-invasive approaches led to (extremely) dissimilar results. In general, non-invasive measurements underestimated SBPA and PPA; the higher the invasive SBPA (or PPA), the greater the underestimation. (3) None of the calibration schemes, which considered non-invasive brachial BP to estimate SBPA or PPA, were better than the others. (4) SBPA and PPA levels obtained from radial artery waveform analysis (tonometry) (5) and common carotid artery ultrasound recordings and brachial artery waveform analysis, respectively, minimized the mean errors. Conclusions: Overall, the findings showed that (i) SBPA and PPA indices are not "synonymous" and (ii) non-invasive approaches would fail to accurately determine invasive SBPA or PPA levels, regardless of the recording site, analysis, and calibration methods. Non-invasive measurements generally underestimated SBPA and PPA, and the higher the invasive SBPA or PPA, the higher the underestimation. There was not a calibration scheme better than the others. Consequently, our study emphasizes the strong need to be critical of measurement techniques, to have methodological transparency, and to have expert consensus for non-invasive assessment of SBPA and PPA.

Aortic systolic and pulse pressure invasively and non-invasively obtained: Comparative analysis of recording techniques, arterial sites of measurement, waveform analysis algorithms and calibration methods.

Background: The non-invasive estimation of aortic systolic (aoSBP) and pulse pressure (aoPP) is achieved by a great variety of devices, which differ markedly in the: 1) principles of recording (applied technology), 2) arterial recording site, 3) model and mathematical analysis applied to signals, and/or 4) calibration scheme. The most reliable non-invasive procedure to obtain aoSBP and aoPP is not well established. Aim: To evaluate the agreement between aoSBP and aoPP values invasively and non-invasively obtained using different: 1) recording techniques (tonometry, oscilometry/plethysmography, ultrasound), 2) recording sites [radial, brachial (BA) and carotid artery (CCA)], 3) waveform analysis algorithms (e.g., direct analysis of the CCA pulse waveform vs. peripheral waveform analysis using general transfer functions, N-point moving average filters, etc.), 4) calibration schemes (systolic-diastolic calibration vs. methods using BA diastolic and mean blood pressure (bMBP); the latter calculated using different equations vs. measured directly by oscillometry, and 5) different equations to estimate bMBP (i.e., using a form factor of 33% ("033"), 41.2% ("0412") or 33% corrected for heart rate ("033HR"). Methods: The invasive aortic (aoBP) and brachial pressure (bBP) (catheterization), and the non-invasive aoBP and bBP were simultaneously obtained in 34 subjects. Non-invasive aoBP levels were obtained using different techniques, analysis methods, recording sites, and calibration schemes. Results: 1) Overall, non-invasive approaches yielded lower aoSBP and aoPP levels than those recorded invasively. 2) aoSBP and aoPP determinations based on CCA recordings, followed by BA recordings, were those that yielded values closest to those recorded invasively. 3) The "033HR" and "0412" calibration schemes ensured the lowest mean error, and the "033" method determined aoBP levels furthest from those recorded invasively. 4) Most of the non-invasive approaches considered overestimated and underestimated aoSBP at low (i.e., 80 mmHg) and high (i.e., 180 mmHg) invasive aoSBP values, respectively. 5) The higher the invasively measured aoPP, the higher the level of underestimation provided by the non-invasive methods. Conclusion: The recording method and site, the mathematical method/model used to quantify aoSBP and aoPP, and to calibrate waveforms, are essential when estimating aoBP. Our study strongly emphasizes the need for methodological transparency and consensus for the non-invasive aoBP assessment.

Brachial Blood Pressure Invasively and Non-Invasively Obtained Using Oscillometry and Applanation Tonometry: Impact of Mean Blood Pressure Equations and Calibration Schemes on Agreement Levels.

The use of oscillometric methods to determine brachial blood pressure (bBP) can lead to a systematic underestimation of the invasively measured systolic (bSBP) and pulse (bPP) pressure levels, together with a significant overestimation of diastolic pressure (bDBP). Similarly, the agreement between brachial mean blood pressure (bMBP), invasively and non-invasively measured, can be affected by inaccurate estimations/assumptions. Despite several methodologies that can be applied to estimate bMBP non-invasively, there is no consensus on which approach leads to the most accurate estimation. Aims: to evaluate the association and agreement between: (1) non-invasive (oscillometry) and invasive bBP; (2) invasive bMBP, and bMBP (i) measured by oscillometry and (ii) calculated using six different equations; and (3) bSBP and bPP invasively and non-invasively obtained by applanation tonometry and employing different calibration methods. To this end, invasive aortic blood pressure and bBP (catheterization), and non-invasive bBP (oscillometry [Mobil-O-Graph] and brachial artery applanation tonometry [SphygmoCor]) were simultaneously obtained (34 subjects, 193 records). bMBP was calculated using different approaches. Results: (i) the agreement between invasive bBP and their respective non-invasive measurements (oscillometry) showed dependence on bBP levels (proportional error); (ii) among the different approaches used to obtain bMBP, the equation that includes a form factor equal to 33% (bMBP = bDBP + bPP/3) showed the best association with the invasive bMBP; (iii) the best approach to estimate invasive bSBP and bPP from tonometry recordings is based on the calibration scheme that employs oscillometric bMBP. On the contrary, the worst association between invasive and applanation tonometry-derived bBP levels was observed when the brachial pulse waveform was calibrated to bMBP quantified as bMBP = bDBP + bPP/3. Our study strongly emphasizes the need for methodological transparency and consensus for non-invasive bMBP assessment.

Fractional Flow Reserve Versus Instantaneous Wave-Free Ratio in Assessment of Lesion Hemodynamic Significance and Explanation of their Discrepancies. International, Multicenter and Prospective Trial: The FiGARO Study.

Background The FiGARO (FFR versus iFR in Assessment of Hemodynamic Lesion Significance, and an Explanation of Their Discrepancies) trial is a prospective registry searching for predictors of fractional flow reserve/instantaneous wave-free ratio (FFR/iFR) discrepancy. Methods and Results FFR/iFR were analyzed using a Verrata wire, and coronary flow reserve was analyzed using a Combomap machine (both Philips-Volcano). The risk polymorphisms for endothelial nitric oxide synthase and for heme oxygenase-1 were analyzed. In total, 1884 FFR/iFR measurements from 1564 patients were included. The FFR/iFR discrepancy occurred in 393 measurements (20.9%): FFRp (positive)/iFRn (negative) type (264 lesions, 14.0%) and FFRn/iFRp (129 lesions, 6.8%) type. Coronary flow reserve was measured in 343 lesions, correlating better with iFR (R=0.56, P<0.0001) than FFR (R=0.36, P<0.0001). The coronary flow reserve value in FFRp/iFRn lesions (2.24±0.7) was significantly higher compared with both FFRp/iFRp (1.39±0.36), and FFRn/iFRn lesions (1.8±0.64, P<0.0001). Multivariable logistic regression analysis confirmed (1) sex, age, and lesion location in the right coronary artery as predictors for FFRp/iFRn discrepancy; and (2) hemoglobin level, smoking, and renal insufficiency as predictors for FFRn/iFRp discrepancy. The FFRn/iFRp type of discrepancy was significantly more frequent in patients with both risk types of polymorphisms (endothelial nitric oxide synthaser+heme oxygenase-1r): 8 patients (24.2%) compared with FFRp/iFRn type of discrepancy: 2 patients (5.9%), P=0.03. Conclusions Predictors for FFRp/iFRn discrepancy were sex, age, and location in the right coronary artery. Predictors for FFRn/iFRp were hemoglobin level, smoking, and renal insufficiency. The risk type of polymorphism in endothelial nitric oxide synthase and heme oxygenase-1 genes was more frequently found in patients with FFRn/iFRp type of discrepancy. Registration URL: https://clinicaltrials.gov; Unique identifier: NCT03033810.

Usage patterns and 1-year outcomes with the TAXUS Liberté stent: results of the TAXUS OLYMPIA registry.

OBJECTIVES: The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberté paclitaxel-eluting stent in routine interventional cardiology practice. BACKGROUND: The thin-strut TAXUS Liberté stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria. METHODS: Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberté stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberté stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated. RESULTS: Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (>28 mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring >30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberté stent was 3.8% at 1 year. CONCLUSIONS: Low 1-year cardiac event rates were reported with TAXUS Liberté in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting.

[Treatment of compression of the left main coronary artery in patients with pulmonary hypertension]. / Tratamiento de la compresión del tronco de la arteria coronaria izquierda en pacientes con hipertensión pulmonar.

Chest pain is a frequent symptom in patients with pulmonary hypertension of any etiology. Its pathophysiology has not been clearly established, the proposed causes are ischemia due to increased right ventricle wall stress, transient increased pulmonary hypertension resulting in acute pulmonary artery dilatation and external compression of the left main coronary artery (LMCA) by a dilated pulmonary artery. We report and discuss here three cases where the association between chest pain and compression of the LMCA by a dilated pulmonary artery could be shown, and they were treated with coronary stenting.

Lifesaving kissing stent for pulmonary trunk stenosis due to primary angiosarcoma.

A 62-year-old diabetic female was referred to our institution with a 6-month history of pulmonary hypertension and worsening right-sided heart failure. Computed tomography of the chest and pulmonary angiogram revealed a pulmonary artery mass. Due to patient's frail state, palliative kissing stenting to both pulmonary arteries was performed with optimal angiographic results and overt clinical improvement. At 5 month follow-up, both stents were patent and adequate lung perfusion was observed bilaterally.

[Aortic valvular replacement by catheterism. Current state]. / Reemplazo valvular aórtico por cateterismo. Estado actual.

Severe aortic stenosis is a common disease whose prevalence is steadily growing with population ageing. Surgical aortic valve replacement (SAVR) has been the only effective alternative until the introduction of transcatheter aortic valve replacement (TAVR or TAVI). This procedure was initially used for non-surgical candidate patients where two randomized clinical trials and several registries showed superiority over conservative medical treatment. Furthermore, two additional clinical trials including high surgical risk patients proved the non-inferiority of TAVR versus surgical replacement. Similar findings regarding effectiveness were observed in other clinical trials including intermediate and low risk patients. Technical and procedural improvements, including learning curve and the current minimally invasive strategy have decreased periprocedural and mid-term complications such as those related with vascular access, stroke, the need for permanent pacemaker implantation and paravalvular leak. All things considered, durability is a pending question to establish which would be the role of TAVR in current and future practice.

La estenosis aórtica grave es una enfermedad común cuya prevalencia crece con el envejecimiento de la población. El reemplazo valvular aórtico quirúrgico (SAVR) ha sido la única alternativa efectiva hasta la aparición del reemplazo valvular aórtico por cateterismo (TAVR o TAVI). Este procedimiento se usó inicialmente para pacientes inoperables en quienes dos ensayos clínicos aleatorios y varios registros mostraron su superioridad sobre el tratamiento médico conservador. Dos ensayos clínicos adicionales en pacientes que, a pesar de ser considerados operables, tenían alto riesgo quirúrgico, demostraron la no inferioridad de TAVR versus reemplazo quirúrgico. Investigaciones posteriores probaron también su efectividad en pacientes de riesgo intermedio y bajo. Algunas complicaciones, como las relacionadas al acceso vascular, el accidente cerebro vascular, la necesidad de marcapasos definitivo y la regurgitación periprotésica, han ido disminuyendo con la mejoría de la tecnología, la curva de aprendizaje y la estrategia mínimamente invasiva actual. Queda pendiente determinar la durabilidad para establecer cuál será el papel de TAVR en la práctica clínica.

Central Blood Pressure Waves Assessment: A Validation Study of Non-invasive Aortic Pressure Measurement in Human Beings.

INTRODUCTION: Measurement of central (aortic) systolic blood pressure has been shown to provide reliable information to evaluate target organ damage. However, non-invasive central blood pressure measurement procedures are still under analysis. AIM: To compare human pressure waveforms invasively obtained in the aorta, with the corresponding waveforms non-invasively recorded using an oscillometric device (Mobil-O-Graph). METHODS: In this research were included 20 subjects in which invasive percutaneous coronary interventions were performed. They were 10 males (68 ± 12 y. o. , BMI: 27.4 ± 4.6 kg/m2) and 10 females (77 ± 8 y. o. , BMI: 28.5 ± 5.3 kg/m2). During the invasive aortic pressure recording, a synchronized non-invasive Mobil-O-Graph acquisition beat by beat and reconstructed central pressure wave was performed. Both, invasive and non-invasive pressure waves were digitized and stored for subsequent analysis and calculations. A computerized interpolation procedure was developed in our laboratory to compare these pressure waves. RESULTS: A significant correlation between Mobil-O-Graph central blood pressure measurements and the corresponding invasive values was found in males (r < 0.81; p < 0.01) and females (r < 0.93; p < 0.01). However, in both genders, the slope of the regression lines was lesser than 1 (males: y = 0.7354x + 18.998; females: y = 0.9835x + 2.8432). In the whole population (n = 20), a significant correlation between Mobil-O-Graph central blood pressure measurements and the corresponding invasive values was found (r < 0.89; p < 0.01) and the regression line was lesser than 1 (y = 0.9774x + 1.7603). CONCLUSIONS: In this research, a high correlation between invasive central blood pressure values and those measured with the Mobil-O-Graph device was found in males, females and the whole population. However, a sub estimation of Mobil-O-Graph central blood pressure values was observed.

Outcomes Following Transcatheter Aortic Valve Replacement for Degenerative Stentless Versus Stented Bioprostheses.

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.

Presencia de regurgitación moderada o grave luego del implante percutáneo de la válvula aórtica con la estrategia de "Cusp Overlap" / Presence of Moderate or Severe Regurgitation after Transcatheter Aortic Valve Implant with the Cusp Overlap Strategy

RESUMEN Objetivo : Analizar si la estrategia del implante alto usando superposición de las cúspides derechas e izquierdas (Cusp Overlap, COVL) en el implante percutáneo de la válvula aórtica (TAVI) se relaciona con menor incidencia de regurgitación paravalvular (RPV) moderada o grave, comparada con la estrategia convencional (CON). Material y métodos : Se analizaron 206 pacientes consecutivos que recibieron TAVI con válvulas autoexpandidles entre agosto de 2019 y mayo de 2022. Se utilizó una estrategia CON en 101 pacientes (49%) y COVL en 105 (51%). El Punto Final Primario (PFP) fue la presencia de regurgitación paravalvular moderada y grave a 30 días. Resultados : No hubo diferencia clínica entre los grupos en cuanto a la edad media, sexo ni comorbilidades; excepto una tendencia a más diabetes y angioplastia coronaria previa en el grupo COVL. El STS score fue mayor en el grupo de COVL (6,9 ± 2,2 vs. 5,8 ± 2,4 en CON, p = 0,01). A 30 días no hubo diferencia en el PFP (RPV moderada en 2% en CON, y 0,9% en COVL; ninguno presentó RPV grave). Tampoco hubo diferencia en mortalidad, infarto, oclusión coronaria, accidente cerebrovascular, sangrado mayor y complicación vascular. La necesidad de marcapasos definitivo fue menor con la estrategia de COVL (6,7% vs. 17,8%, p = 0,01) y un nuevo bloqueo de rama izquierda ocurrió en 5,7% vs. 12,9% (p = 0,07). Conclusiones : En esta serie de un solo centro, la estrategia del implante alto de la válvula aórtica percutánea usando la técnica de COVL no demostró diferencia en la presencia de regurgitaciones moderadas o graves comparada con la estrategia convencional, sin presentar diferencia en las complicaciones, y se asoció a una menor necesidad de marcapasos definitivo y a una tendencia de menos bloqueos de rama izquierda a 30 días.

ABSTRACT Objective : The aim of this study is to whether higher transcatheter aortic valve implantation (TAVI) with self-expandable valves using the right and left cusp overlap strategy (Cusp Overlap, COVL) is associated with a lower incidence of moderate or severe paravalvular regurgitation, compared with the conventional strategy (CON). Methods : A total of 206 consecutive patients undergoing TAVI with self-expandable valves between August 2019 and May 2022 were analyzed. The CON technique was used in the first 101 patients (49%) and COVL was used in 105 (51%). The primary endpoint (PEP) was the presence of moderate or severe paravalvular regurgitation at 30 days. Results : There were no clinical differences between the groups in terms of mean age, sex or comorbidities, except for a trend towards more patients with diabetes and previous percutaneous coronary intervention in the COVL group. The STS score was greater in the COVL group (6.9 ± 2.2 vs. 5.8 ± 2.4 in the CON group; p = 0.01). There was no difference in the PEP at 30 days with 2% incidence of moderate PVR in the CON group and 0.9% in the COVL group, and none of them presented severe PVR. There were no differences in mortality, myocardial infarction, coronary artery obstruction, stroke, major bleeding or vascular complications. The need for permanent pacemaker was lower with the COVL strategy (6.7% vs. 17.8%, p = 0.01) and a new left bundle branch block occurred in 5.7% vs. 12.9% (p = 0.07). Conclusions : In this single-center series, the strategy of high transcatheter aortic valve implantation using the COVL strategy showed no difference in the presence of moderate or severe regurgitation compared with the conventional strategy, with no differences in complications, and was associated with a lower need for definitive pacemaker and with a trend towards lower incidence of left bundle branch block at 30 days.

Long-term versus short-term clopidogrel therapy in patients undergoing coronary stenting (from the Randomized Argentine Clopidogrel Stent [RACS] trial).

The optimal duration of treatment with clopidogrel after percutaneous coronary intervention (PCI) with stent placement remains controversial. The Randomized Argentine Clopidogrel Stent (RACS) trial was a prospective, randomized, nonblinded study of 1,004 patients undergoing PCI who were randomized after successful bare metal stent placement to 30 versus 180 days of clopidogrel; all patients also received aspirin. Patients were eligible regardless of whether they had presented with ST-elevation myocardial infarction (MI), acute coronary syndrome, or stable angina. The primary end point was a composite of death, MI, and stroke at 180 days. Baseline clinical characteristics showed no differences between groups in terms of age, gender, history, risk factors, or incidence of diabetes; 72% presented with an acute coronary syndrome and 15% had MI as the indication for PCI. At hospital discharge and 30 days, when the 2 groups received the same treatment, there were no significant differences between groups in frequency of death, MI, or stroke. However, from 30 days to 6 months, patients assigned to 6 months of clopidogrel reached the primary end point of death, MI, and stroke less frequently (4.99% vs 1.74%, p = 0.010, relative risk decrease 65%). No significant between-group differences were found in frequency of total bleeding (0.64% vs 1.52%, p = 0.34) for the control and study groups. In conclusion, after successful placement of a bare metal stent in a coronary artery, patients treated with 6 months of clopidogrel showed a trend toward fewer adverse events compared with those treated for 30 days.

Protection of Distal Embolization in High-Risk Patients with Acute ST-Segment Elevation Myocardial Infarction (PREMIAR).

Distal embolization may decrease myocardial reperfusion after primary percutaneous coronary intervention (PCI). Nonetheless, results of previous trials assessing the role of distal protection during primary PCI have been controversial. The Protection of Distal Embolization in High-Risk Patients with Acute ST-Segment Elevation Myocardial Infarction Trial (PREMIAR) was a prospective, randomized, controlled study designed to evaluate the role of filter-based distal protection during PCI in patients with acute ST-segment elevation myocardial infarction at high risk of embolic events (including only baseline Thrombolysis In Myocardial Infarction grade 0 to 2 flow). The primary end point was continuous monitoring of ST-segment resolution. Secondary end points included core laboratory analysis of angiographic myocardial blush, ejection fraction measured by cardiac ultrasound, and adverse cardiac events at 6 months. From a total of 194 enrolled patients, 140 subjects were randomized to PCI with or without embolic protection, and 54 were included in a registry arm due to the presence of angiographic exclusion criteria. Baseline characteristics were comparable between arms. The rate of complete ST-segment resolution (>or=70%) at 60 minutes was similar in patients treated with or without distal protection (61.2% vs 60.3%, respectively, p = 0.85). Angiographic myocardial blush (67% vs 70.7%, p = 0.73), in-hospital ejection fraction (47.4 +/- 9.9% vs 45.3 +/- 7.3%, p = 0.29), and combined end point of death, heart failure, or reinfarction at 6 months (14.3% vs 15.7%, p = 0.81) were consistently achieved in a similar proportion in the 2 groups. In conclusion, the use of filter-based distal protection is safe and effectively retrieves debris; however, such use does not translate into an improvement of myocardial reperfusion, left ventricular performance, or clinical outcomes.

Percutaneous repair of left ventricular pseudoaneurysm after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) represents a viable therapeutic option in patients with severe symptomatic aortic valve stenosis. The development of a left ventricular pseudoaneurysm (LVP) represents an infrequent but potentially catastrophic complication after transapical TAVR. In this case report, we present a patient undergoing TAVR through subclavian access which had an LVP and underwent successful percutaneous closure.