Self-expanding TAVI using the cusp overlap technique versus the traditional technique: electrocardiogram changes and 1-year cardiovascular outcomes.

INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using the cusp overlap technique (COT) has shown a lower pacemaker implantation rate at 30 days. The objective of this study was to compare electrocardiogram changes and clinical outcomes between COT and the traditional technique (TT) at 1 year of follow-up. METHODS: Observational, retrospective, nonrandomized study of consecutive patients undergoing TAVI between January 2015 and January 2021. Patients were matched using a propensity score and the TT was compared with COT. The primary endpoints were electrocardiogram changes and a combined endpoint including pacemaker implantation, hospitalization, or cardiovascular death at 1 year. RESULTS: We included 254 patients. After propensity score matching, 184 patients (92 per group) remained. There were no statistically significant differences in baseline characteristics. At 1 year, COT patients showed a significant reduction in new onset left bundle branch block (49% vs 27%, P=.002) and less P wave (13.1±21.0 msec vs 5.47±12.5 msec; P=.003) and QRS prolongation (29.77±27.0 msec vs 16.38±25.4 msec, P <.001). COT was associated with a significant reduction in the occurrence of the primary endpoint (SHR, 0.39 [IC95%, 0.21-0.76]; P=.005). CONCLUSIONS: At 1 year of follow-up, COT reduced the incidence of new onset left bundle branch block and diminished QRS and P wave widening compared with the TT. COT was also associated with a statistically significant reduction in the occurrence of the combined primary cardiovascular endpoint.

Impact of operators experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry.

BACKGROUND: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. METHODS: Prospective, multicenter, "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. RESULTS: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centers previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. CONCLUSIONS: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operators experience with its previous device iteration or the number of Watchman FLX devices implanted.

Early clinical outcomes after transaxillary versus transfemoral TAVI. Data from the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Transaxillary access (TXA) has become the most widely used alternative to transfemoral access (TFA) in patients undergoing transcatheter aortic valve implantation (TAVI). The aim of this study was to compare total in-hospital and 30-day mortality in patients included in the Spanish TAVI registry who were treated by TXA or TFA access. METHODS: We analyzed data from patients treated with TXA or TFA and who were included in the TAVI Spanish registry. In-hospital and 30-day events were defined according to the recommendations of the Valve Academic Research Consortium. The impact of the access route was evaluated by propensity score matching according to clinical and echocardiogram characteristics. RESULTS: A total of 6603 patients were included; 191 (2.9%) were treated via TXA and 6412 via TFA access. After adjustment (n=113 TXA group and n=3035 TFA group) device success was similar between the 2 groups (94%, TXA vs 95%, TFA; P=.95). However, compared with the TFA group, the TXA group showed a higher rate of acute myocardial infarction (OR, 5.3; 95%CI, 2.0-13.8); P=.001), renal complications (OR, 2.3; 95%CI, 1.3-4.1; P=.003), and pacemaker implantation (OR, 1.6; 95%CI, 1.01-2.6; P=.03). The TXA group also had higher in-hospital and 30-day mortality rates (OR, 2.2; 95%CI, 1.04-4.6; P=.039 and OR, 2.3; 95%CI, 1.2-4.5; P=.01, respectively). CONCLUSIONS: Compared with ATF, TXA is associated with higher total mortality, both in-hospital and at 30 days. Given these results, we believe that TXA should be considered only in those patients who are not suitable candidates for TFA.

The impact of waiting for intervention on costs and effectiveness: the case of transcatheter aortic valve replacement.

OBJECTIVES: The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis. METHODS: This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12 months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80 years old; other patient profiles were assessed in sensitivity analyses. RESULTS: As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently. CONCLUSIONS: A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3 months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

Anomalous right coronary artery origin with interarterial pathway-importance of morphological origin assessment and the role of percutaneous interventionism.

Anomalies in coronary arteries (CA) are an important issue in cardiology and cardiovascular surgery. Specifically the anomalous origin of the right coronary artery (RCA) is of special importance because it is the most frequent anomaly. Clinical practice guidelines recommend the revascularization treatment in cases of interarterial pathway and documented myocardial ischemia and when hypoplasia, compression or obstruction is evident. We report two different cases of patients with anomalous origin of RCA and associated interarterial pathway. With them we want to highlight the different presentation forms of these patients and the different diagnostic alternatives available in each of the steps. In the patient with anomalous origin of the RCA and associated interarterial pathway, the first step after establishing the diagnosis is to rule out the presence of inducible ischemia. In those patients in whom ischemia induction tests are negative, the second step is to adequately assess the interarterial pathway, in order to rule out obstructions or compressions that also justify revascularization. In those cases in which all the tests are negative, the current evidence does not recommend revascularization, but adequate periodic follow-up is recommended. For this reason, we believe that the stress echocardiogram and exercise perfusion scintigraphy (based on availability and experience in each center) are fundamental because of their high sensitivity and specificity. We would also like to highlight the role that percutaneous interventionism can play in this type of clinical cases. Especially with patients of high surgical risk and in whom the percutaneous approach is feasible.

Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: cost-utility and its determinants.

OBJECTIVE: To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement (SAVR) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk. METHODS: Patients were prospectively recruited in 6 Spanish hospitals and followed up over one year. We estimated adjusted incremental cost-effectiveness ratio (ICER) (Euros per quality-adjusted life-year [QALY] gained) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR. RESULTS: We analyzed data on 207 patients: 58, 87 and 62 in the Edwards SAPIEN (ES) TAVR, Medtronic-CoreValve (MC) TAVR and SAVR groups respectively. Average cost per patient of ES-TAVR was €8800 higher than SAVR and the gain in QALY was 0.036. The ICER was €148,525/QALY. The cost of MC-TAVR was €9729 higher than SAVR and the QALY difference was -0.011 (dominated). Results substantially changed in the following conditions: 1) in patients with high preoperative serum creatinine the ICERs were €18,302/QALY and €179,618/QALY for ES and MC-TAVR respectively; 2) a 30% reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to €32,955/QALY; and 3) imputing hospitalization costs from other European countries leads to TAVR being dominant. CONCLUSIONS: In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery, mainly because of the high cost of the valve compared to the cost of hospitalization. TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs.

Quantification of scientific output in cardiovascular medicine: a perspective based on global data.

AIMS: We sought to explore whether global and regional scientific output in cardiovascular medicine is associated with economic variables and follows the same trend as medicine and as science overall. METHODS AND RESULTS: We registered the number of documents, number of citations, citations per document and the h-index for the first 50 countries according to the h-index (a measure to evaluate both the productivity and impact of the publications) in cardiovascular medicine. Economic variables (gross domestic product [GDP] per capita, % expenditure of the GDP in research and development [R&D] and health) were obtained from the World Bank, the UNESCO, and the World Health Organization. In total, the scientific output in cardiology showed the same position as in medicine and science overall (mean difference vs. medicine -0.9±5.3º, p=0.25 vs. science -0.7±5.3º, p=0.39). We found significant correlations between the h-index and the % GDP expenditure in R&D (r=0.67, p<0.001), and the % GDP expenditure in health (r=0.71, p<0.0001). Overall, there was a 21.4% (interquartile range 3.7; 55.0) increase in the % GDP expenditure in R&D between 1996 and 2007. Emerging economies showed the larger growth in % GDP expenditure in health and R&D. CONCLUSIONS: The global situation of scientific output in cardiovascular medicine is highly polarised and closely related to economic indicators. Emergent economies, with higher rates of GDP growth and increasingly larger expenditures for R&D and healthcare, are expected to show a visible escalation in the scientific global picture in the near future.

Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks.

OBJECTIVES: The purpose of this study was to evaluate the feasibility and efficacy of the percutaneous device closure of a consecutive series of patients with periprosthetic paravalvular leaks referred to our structural heart disease center with congestive heart failure and hemolytic anemia. BACKGROUND: Clinically significant periprosthetic paravalvular leak is an uncommon but serious complication after surgical valve replacement. Percutaneous closure has been utilized as an alternative to surgical repair of this defect in high-risk surgical patients. METHODS: This is a retrospective review of 57 percutaneous paravalvular leak closures that were performed in 43 patients (67% male, mean age 69.4 ± 11.7 years) between April 2006 and September 2010. Integrated imaging modalities were used for the evaluation, planning, and guidance of the interventions. RESULTS: Closure was successful in 86% of leaks and in 86% of patients. Twenty-eight of 35 patients improved by at least 1 New York Heart Association functional class. The percentage of patients requiring blood transfusions and/or erythropoietin injections post-procedure decreased from 56% to 5%. Clinical success was achieved in 89% of the patients in whom procedure was successful. The survival rates for patients at 6, 12, and 18 months after paravalvular leak closures were 91.9%, 89.2%, and 86.5%, respectively. Freedom from cardiac-related death at 42 months post-procedure was 91.9%. CONCLUSIONS: Percutaneous closure of symptomatic paravalvular leaks, facilitated by integrated imaging modalities has a high rate of acute and long-term success and appears to be effective in managing symptoms of heart failure and hemolytic anemia.

A method for standardized computed tomography angiography-based measurement of aortic valvar structures.

AIMS: Reliable assessment of the aortic valvar apparatus (AVAp) is essential as it may facilitate consistent outcomes with percutaneous aortic valvar therapies. The commonly referenced aortic annulus is problematic since this measurement does not correspond to any actual anatomic structure. We aim to describe a reliable method of measuring relevant structures of the AVAp based on widely available computed tomography analyses. METHODS AND RESULTS: Retrospective analysis of computed tomograms of 75 patients with severe aortic stenosis (45 females, age 81.2 +/- 7.8 years). Curved multiplaner reconstruction technique was used to measure average diameters of the 'Aortic Leaflets Basal Attachment Plane' (ALBAP), sinuses of Valsalva (SV), sinutubular junction (STJ), ascending aorta (AA), and distance from coronary arteries to the base of the cusps. Angulation between the AA and the left ventricle (LV) was measured in one plane that included the LV inflow long axis and the maximum visualization of the aortic root. Inter-rater reliability and absolute agreement among three raters were evaluated. Intra-class correlation coefficients for ALBAP, SV, STJ, and AA diameters were 0.90, 0.99, 0.95, and 0.94, respectively (P < 0.001) with 95% limits of agreement of the observed differences falling in the less than 1 mm range. Intra-class correlation coefficients were 0.82 for the angle and 0.61 and 0.78 for distances to the right and left coronary arteries (P < 0.001). CONCLUSION: This method showed a high degree of inter-rater reliability and absolute agreement for AVAp diameters. Agreement was lower for AA-LV angle and distance to coronary artery measurements, emphasizing the need for software improvements and standardized image acquisition protocols.

Transcatheter aortic valve implantation.

In the 7 years since the first implant, more than 7000 transcatheter aortic valve implantations (TAVI) have been performed worldwide. This article describes the latest available information on this field and the upcoming technological expectations.

Insight into the dynamics of the coronary sinus/great cardiac vein and the mitral annulus: implications for percutaneous mitral annuloplasty techniques.

BACKGROUND: Implantation of devices into the coronary sinus (CS)/great cardiac vein (GCV) to reshape the mitral annulus (MA) is being investigated, despite these structures not being within the same plane and coronary arteries frequently traversing between them. Furthermore, dynamic changes in their relationship have never been studied. We analyzed the CS/GCV dimensions and its relationship with the MA and the coronary arteries. METHODS AND RESULTS: Of 390 consecutive computed tomography angiographies reviewed, 56 met the inclusion criteria. Mean age of the patients was 68.9 + or - 13.1 years (26.8% men). The dimensions of the CS/GCV and the distance between this structure and the MA were measured at 10 different spatial points along the CS/GCV trajectory and at 3 different time points along the cardiac cycle (phases 0%, 40%, and 75% of the RR interval) by using curved multiplanar reconstruction technique. The CS/GCV was larger in phase 40% than in phase 75% and was smallest in phase 0% (P<0.001). The distance between the CS/GCV and the MA was longest in phase 40% and shortest in phase 0% (P=0.013). The diameter of the MA was measured in oblique 2- and 4-chamber reconstructions, being largest in phase 0% and smallest in phase 40% (P=0.019). A coronary artery traversed between the CS/GCV and the MA in 85.7% of the patients. CONCLUSIONS: This study demonstrated dynamic changes in the relationship between the CS/GCV and the MA and also that coronary arteries frequently traverse between both structures. Whether these findings are of clinical relevance for patients undergoing percutaneous mitral annuloplasty needs to be prospectively evaluated.

[Percutaneous transcatheter valve therapy]. / Terapéutica valvular percutánea.

Aortic stenosis (AS) and mitral regurgitation (MR) are currently the commonest valvular pathologies in developed society. The current standard of treatment of severe AS and severe MR has been surgical aortic valve replacement (AVR) and mitral valve (MV) surgery. In 2002, the first human percutaneous AVR (PAVR) was performed and in 2005, results of percutaneous MV repair were also reported. The field of percutaneous transcatheter valve therapy is evolving very rapidly. There are 2 aortic percutaneous heart valves in clinical trials and several others with first-in-man data or in pre-clinical testing. Results seem promising and it appears that PAVR will most likely be a viable option for selected patients in a relatively short time. The future of AS treatment will evolve with the advent of devices which will be repositionable and retrievable, as well as integrating other materials engineered by nanotechnology and tissue engineering. There are several technologies being investigated in the field of MV repair, each attempting to mimic surgical technique. Compared with PAVR, percutaneous MV repair is a more complex process as many different pathological processes can result in MR. The current technologies will be suitable only for carefully selected patients with a specific etiology of MR. Most likely a combination of these technologies will be required for satisfactory MV repair although MV replacement may be what many of those patients require, and therefore percutaneous MV replacement will be an exciting alternative in the near future.