One-year real-world outcomes for patients undergoing transcatheter mitral valve repair: the Gulf MTEER registry (GULF Mitral Transcatheter Edge to Edge Repair).

BACKGROUND: Severe mitral regurgitation (MR) with left ventricular dysfunction portends worse outcomes. Over the course of the last two decades, transcatheter repair of the mitral valve offered an alternative therapeutic modality for those deemed inoperable or high risk. Landmark studies such as the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation and Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation trials have shown conflicting results with respect to all-cause death and heart failure rehospitalisations. The Gulf Mitral Transcatheter Edge to Edge Repair registry (Gulf MTEER registry) is a regional registry that captured outcomes in those undergoing transcatheter repair of the mitral valve. The objectives of this study were to describe the baseline characteristics of patients undergoing transcatheter mitral valve repair in the Gulf region and estimate the cardiovascular effects of the mitral transcatheter therapies in routine practice. METHODS: The Gulf MTEER registry is an observational, multicentre, retrospective registry that enrolled all patients undergoing transcatheter repair of the mitral valve from four of the Gulf countries (Saudi Arabia, Kuwait, Bahrain, Oman) between 1 January 2017 and 31 December 2019. Baseline characteristics, echocardiographic parameters and immediate procedural success were reported. The primary outcome was a composite of death and rehospitalisations at 1 year. The secondary outcomes were the individual components of the composite endpoint; that is, death and rehospitalisations at 1 year as well as residual or recurrent MR or worsening New York Heart Association class and a need for repeat repair. RESULTS: A total of 176 patients were enrolled. Men constituted 56.3% of the total. At 1 year the primary outcome occurred in 21.1% (95% CI 15.6, 27.9). The secondary outcomes of death occurred in 5.4% (CI 2.9, 10.0) and rehospitalisations occurred in 16.9% (CI 11.9, 23.3). Univariate analysis revealed that the odds of having death or re-hospitalisation was two times higher if the effective regurgitant orifice (ERO) >40 mm2 irrespective of the therapy. CONCLUSIONS: The Gulf MTEER registry is the first registry in the Gulf region defining the patient population receiving MTEER therapies and evaluating 1-year outcomes. This is a low risk cohort with a high rate of immediate procedural success and low rate of all-cause death and rehospitalisations at 1 year. The odds of an event was two times higher if the ERO ≥40 mm2 with only a signal to higher odds for low left ventricular ejection fraction and larger end systolic dimension.

HAS-BLED Score for Prediction of Bleeding and Mortality After Transcatheter Aortic Valve Replacement

ABSTRACT Introduction: Bleeding after transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The predictive value of the HAS-BLED score in TAVR patients is still to be evaluated. We assessed the value of the HAS-BLED score to predict in-hospital bleeding and mortality after TAVR and the impact of diferent renal impairment definitions on the predictive value of the score system. Methods: We retrospectively included 574 patients who underwent TAVR at a single center. Study outcomes were 30-day mortality and the composite endpoint of major and life-threatening bleeding as defined by The Valve Academic Research Consortium-2. The predictive value of the HAS-BLED score was calculated and compared to a modified model. The performance of the score was compared using two definitions of renal impairment. Model discrimination was tested using C-statistic and the Net Reclassification Index. Results: Bleeding occurred in 78 patients (13.59%). HAS-BLED category 3 was a significant predictor of bleeding (OR: 1.99 ]1.18- 3.37], C-index: 0.56, P=0.01). C-index increased to 0.64 after adding body surface area and extracardiac arteriopathy to the model. The Net Reclassification Index showed an increase in the predic tive value of the model by 11.4% (P=0.002). The C-index increased to 0.61 using renal impairment definition based on creatinine clearance. Operative mortality was significantly associated with the HAS-BLED score (OR: 7.54 [95% CI: 2.73- 20.82], C-index: 0.73, P<0.001). Conclusion: The HAS-BLED score could be a good predictor of in-hospital mortality after TAVR. Its predictive value for bleeding was poor but improved by adding procedure-specific factors and using creatinine clearance to define renal impairment.

HAS-BLED Score for Prediction of Bleeding and Mortality After Transcatheter Aortic Valve Replacement.

INTRODUCTION: Bleeding after transcatheter aortic valve replacement (TAVR) is associated with increased mortality. The predictive value of the HAS-BLED score in TAVR patients is still to be evaluated. We assessed the value of the HAS-BLED score to predict in-hospital bleeding and mortality after TAVR and the impact of diferent renal impairment definitions on the predictive value of the score system. METHODS: We retrospectively included 574 patients who underwent TAVR at a single center. Study outcomes were 30-day mortality and the composite endpoint of major and life-threatening bleeding as defined by The Valve Academic Research Consortium-2. The predictive value of the HAS-BLED score was calculated and compared to a modified model. The performance of the score was compared using two definitions of renal impairment. Model discrimination was tested using C-statistic and the Net Reclassification Index. RESULTS: Bleeding occurred in 78 patients (13.59%). HAS-BLED category 3 was a significant predictor of bleeding (OR: 1.99 ]1.18- 3.37], C-index: 0.56, P=0.01). C-index increased to 0.64 after adding body surface area and extracardiac arteriopathy to the model. The Net Reclassification Index showed an increase in the predic tive value of the model by 11.4% (P=0.002). The C-index increased to 0.61 using renal impairment definition based on creatinine clearance. Operative mortality was significantly associated with the HAS-BLED score (OR: 7.54 [95% CI: 2.73- 20.82], C-index: 0.73, P<0.001). CONCLUSION: The HAS-BLED score could be a good predictor of in-hospital mortality after TAVR. Its predictive value for bleeding was poor but improved by adding procedure-specific factors and using creatinine clearance to define renal impairment.

One-Year Outcomes for Patients Undergoing Transcatheter Aortic Valve Replacement: The Gulf TAVR Registry.

BACKGROUND: The use of transcatheter aortic valve replacement (TAVR) is steadily increasing with TAVR procedures offered to patients across the entire spectrum of surgical risks. The Gulf TAVR registry captures the demographics of patients undergoing TAVR in the Gulf region, comorbidities that drive outcomes, procedural success, complications, and one-year outcomes of death or rehospitalization. METHODS: This is a retrospective cohort study for adult patients aged at least 18 years undergoing TAVR at eight centers in the Gulf region. The primary outcome was a composite of death or re-hospitalization at one-year. Secondary outcomes included the individual components of the composite, stroke, and myocardial infarction (MI). We used multivariable Cox regression to determine factors associated with the composite endpoint. RESULTS: A total of 795 patients (56% male) were included in the final analysis with a mean age of 74.6 (standard deviation (SD) 8.9) years, Society of Thoracic Surgeons Score (STS) Score 4.9 (4.2), ejection fraction of 53% (12.7%). Transfemoral approach was employed in over 95% (762/795). The primary outcomes rate was 12.8% (95% confidence interval [CI]: 10.6-15.4); secondary endpoints were death 5.4% (95% CI 4.0-7.2); stroke 0.8% (95% CI 0.3, 1.7), MI 0.8% (95% CI 0.4-1.9), rehospitalization: 9.3% (95% CI 7.5-11.5) of whom 71.6% were related to cardiovascular causes. 77% of the cardiovascular admissions were attributable to heart failure or the need for pacemaker implantation. Stage IV or V chronic kidney disease was significantly associated with the primary composite endpoint (Hazard Ratio: 2.49, [95% CI: 1.31, 4.73], p = 0.005). Although not significant, paravalvular leak and severe left ventricular dysfunction showed a 2-fold and 3-fold increased risk for the composite endpoint, respectively. CONCLUSIONS: The Gulf TAVR registry is the first of its kind in the region. It profiles an elderly population with a high procedural success rate and a low rate of complications. One-year outcomes were primarily driven by repeat hospitalization for heart failure and pacemaker implantation indicating a need to optimize heart failure management and improve algorithms for the detection of conduction abnormalities.

WIN Gulf TAVR Registry: Describing Sex Differences in Patient Characteristics, Prognosis, and Outcomes.

Background: Several international registries have examined outcomes in women undergoing transcatheter aortic valve replacement (TAVR). However, none of these studies included women from the Gulf region. The Women IN Gulf Transcatheter Aortic Valve Replacement (WIN Gulf TAVR) registry aimed to examine sex-based differences in patient characteristics and outcomes in patients undergoing TAVR in the region. Methods: This registry is a prespecified subanalysis of the main Gulf TAVR registry. Baseline characteristics, procedural details and success, and 1-year outcomes were recorded. The primary outcome consisted of a composite of all causes of death, myocardial infarction (MI), and rehospitalizations at 1 year. The secondary outcomes were a composite of the individual components of the primary composite. Results: A total of 347 women (44% of the Gulf TAVR registry) were included in the final analysis, with a mean age of 74.1 ± 9.1 years; mean ejection fraction of 56.20% ± 10.52%; and mean Society of Thoracic Surgeons score of 5.30 ± 4.35. The composite primary end point occurred in 12.4% (95% CI, 9.3-16.2). The individual components of the primary end point were as follows: death, 4.3% (95% CI, 2.6-7.0); MI, 1.1% (95% CI, 0.4-2.9); and rehospitalization, 9.8% (95% CI, 7.1-13.3), with 7.2% (95% CI, 4.9-10.4) related to cardiac causes. Conclusions: Women in the WIN Gulf TAVR registry had outcomes and baseline characteristics similar to men. Although higher rehospitalizations for cardiac causes and MI at 1 year in women were noted, the overall survival was better in women. These observations warrant a larger cohort to identify the drivers of events.

Outcomes After Transcatheter Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Diastolic Dysfunction.

OBJECTIVES: Left ventricular diastolic dysfunction (LVDD) in patients undergoing transcatheter aortic valve replacement (TAVR) is associated with poor outcomes; however, the effect of its severity is controversial. We sought to assess the impact of diastolic dysfunction on hospital outcomes and survival after TAVR and identify prognostic factors. METHODS: We included patients who underwent TAVR for severe aortic stenosis with preexisting LVDD from 2009 to 2018 (n = 325). Patients with prior mitral valve surgery (n = 4), atrial fibrillation (n = 39), missing or poor baseline diastolic dysfunction assessment (n = 36) were excluded. The primary endpoint was all-cause mortality. 246 patients were included in the study. RESULTS: The median age was 80 years (25th and 75th percentiles:75-86.7), 154 (62.6%) were males and the median EuroSCORE II was 4.3 (2.2-8). Patients with severe LVDD had significantly higher EuroSCORE, and lower ejection fraction (p < 0.001). There was no difference in post-TAVR new atrial fibrillation (p = 0.912), pacemaker insertion (p = 0.528), stroke (p = 0.76), or hospital mortality (p = 0.95). Patients with severe LVDD had longer hospital stay (p = 0.036). The grade of LVDD did not affect survival (log-rank = 0.145) nor major adverse cardiovascular events (log-rank = 0.97). Predictors of mortality were; low BMI (HR: 0.95 (0.91-0.99); p = 0.019), low sodium (0.93 (0.82-2.5); p = 0.021), previous PCI (HR: 1.6 (1.022-2.66); p = 0.04), E-peak (HR: 1.01 (1.002-1.019); p = 0.014) and implantation of more than one device (HR: 3.55 (1.22-10.31); p = 0.02). CONCLUSION: Transcatheter aortic valve replacement is feasible in patients with diastolic dysfunction, and the degree of diastolic dysfunction did not negatively affect the outcome. Long-term outcomes in those patients were affected by the preoperative clinical state and procedure-related factors.

Effect of COVID-19 Pandemic on the Cardiac Outpatients' Perception of Seeking Medical Advice.

OBJECTIVES: During this unprecedented time of COVID-19 pandemic, it was noticed a decline in cardiovascular cases presentation to the Emergency rooms in many countries, raising many speculations about the reasons and its ramifications. 1 - Identify the reasons during this pandemic that refrain patients from seeking medical care and its impact on stress level and medication adherence. 2 - Emphasize the new role of virtual medicine. METHODS: A quantitative descriptive cross-section survey study of 388 patients. It has been done in the cardiac outpatient department and conducted virtually through telemedicine. RESULTS: Despite this pandemic and its consensuses, the majority of cardiac outpatients will still seek medical advice in case of experiencing symptoms. Nevertheless, the fear of contracting COVID-19 infection, which can alter patient's decisions from visiting the emergency room and the increase in stress level during these challenging times, is genuine and no more an element of guessing. CONCLUSION: The majority of cardiac outpatients will wisely seek medical advice in case of serious cardiac symptoms and are adherent to their medications during this pandemic. Nevertheless, they face many concerns which need to implement a preventive and helping measures to fight the consensuses of COVID-19 such as, patient educations, establishing a hotline to all patients, telemedicine, new phone applications, and delivering medications to patients are essential in such circumstances to ensure continuity of care.

The trans-septal approach in transcatheter mitral valve-in-valve implantation for degenerative bioprosthesis.

BACKGROUND: Transcatheter Mitral Valve-in-Valve Implantation (TMViVI) has recently emerged as a novel therapy for degenerated mitral valve bioprosthesis. Re-operative mitral valve surgery is associated with a substantial risk of mortality and morbidity. The objective of this study was to describe the outcomes of transcatheter mitral valve-in-valve implantations in our cardiac center. METHODS: Twenty-two patients underwent the valve-in-valve procedure because of bioprosthesis degeneration from March 2017 to October 2018. Clinical, echocardiographic, procedural details and survival at follow up were assessed. RESULTS: Eight patients refused re-operative cardiac surgery while others were deemed a high risk for conventional re-operative sternotomy. All patients had TMViVI performed via a trans-septal approach, and the prosthesis was implanted successfully with immediate hemodynamic improvement in 20 patients. One patient had tamponade (4.55%), two had permanent pacemaker insertion (9.09%), two patients had a renal impairment (9.09%), and three patients had vascular complications (13.64%). There was one aborted procedure for the failure to cross the tissue valve with a transcatheter valve, and one patient was converted to an emergency mitral valve surgery. All patients were discharged in NYHA class I/II and NYHA class was markedly improved at one-year follow-up (p = 0.002). CONCLUSIONS: Trans-septal mitral valve-in-valve implantation can be performed safely for degenerative mitral valve bioprosthesis and with favorable early clinical and hemodynamic outcomes.

Prevalence and risk factors of clopidogrel non-response among Saudi patients undergoing coronary angiography.

OBJECTIVES: To estimate the prevalence of clopidogrel non-response and identify its risk factors among Saudi patients.  METHODS: This cross-sectional study was conducted at Prince Sultan Cardiac Center, Riyadh, Kingdom of Saudi Arabia between January and June 2013, to assess the degree of platelet inhibition using the VerifyNow assay (Accumetrics, San Diego, CA, USA) after receiving clopidogrel standard loading dose. Clopidogrel resistance was defined as ≤15% platelet inhibition or greater than 213 P2Y12 reaction units (PRU).  RESULTS: Three hundred and four patients were included in the study. The mean age was 60.3 ± 11.4 years, and 73% were males. Clopidogrel doses were 300 mg (57%), 600 mg (27%), and 75 mg (16%). All patients used aspirin (81 mg in 94%). Approximately 66% (200/304) showed in vitro clopidogrel non-response, 54% had low platelet inhibitions, and 61% had high post-loading PRU. Using multivariate regression analysis that included all significant characteristics; only diabetes (odds ratio [OR]: 2.36, 95% confidence interval [CI]: 1.30-4.27, p=0.005) and higher preloading PRU (OR: 2.39, 95% CI: 1.40-4.11, p=0.002) remained significantly associated with higher clopidogrel non-response while myocardial infarction (OR: 0.34, 95% CI: 0.15-0.81, p=0.014) remained significantly associated with lower clopidogrel non-response. The associations of morbid obesity and diuretics use with higher clopidogrel non-response were slightly attenuated.   CONCLUSION: Our findings indicate a high rate of clopidogrel in-vitro non-response among Saudi patients undergoing coronary angiography.

Predictors of radial artery size in patients undergoing cardiac catheterization: insights from the Good Radial Artery Size Prediction (GRASP) study.

BACKGROUND: Radial artery occlusion occurs after transradial cardiac catheterization or percutaneous coronary intervention. Although use of a sheath larger than the artery is a risk factor for radial artery occlusion, radial artery size is not routinely measured. We aimed to identify bedside predictors of radial artery diameter. METHODS: Using ultrasound, we prospectively measured radial, ulnar, and brachial artery diameters of 130 patients who presented for elective percutaneous coronary intervention or diagnostic angiography. Using prespecified candidate variables we used multivariable linear regression to identify predictors of radial artery diameter. RESULTS: Mean internal diameters of the right radial, ulnar, and brachial arteries were 2.44 ± 0.60, 2.14 ± 0.53, and 4.50 ± 0.88 mm, respectively. Results for the left arm were similar. The right radial artery was larger in men than in women (2.59 vs 1.91 mm; P < 0.001) and smaller in patients of South Asian descent (2.00 vs 2.52 mm; P < 0.001). Radial artery diameter correlated with wrist circumference (r(2) = 0.26; P < 0.001) and shoe size (r(2) = 0.25; P < 0.001) and weakly correlated with height (r(2) = 0.14; P < 0.001), weight (r(2) = 0.18; P < 0.001), body mass index (r(2) = 0.07; P = 0.002), and body surface area (r(2) = 0.22; P < 0.001). The independent predictors of a larger radial artery were wrist circumference (r(2) = 0.26; P < 0.001), male sex (r(2) = 0.06; P < 0.001), and non-South Asian ancestry (r(2) = 0.05; P = 0.006; final model r(2) = 0.37; P < 0.001). A risk score using these variables predicted radial artery diameter (c-statistic, 0.71). CONCLUSIONS: Wrist circumference, male sex, and non-South Asian ancestry are independent predictors of increased radial artery diameter. A risk score using these variables can identify patients with small radial arteries.

Efficacy of a single dose intravenous heparin in reducing sheath-thrombus formation during diagnostic angiography: A randomized controlled trial.

BACKGROUND: Femoral arterial sheath thrombosis and distal embolization are well-recognized complications of cardiac catheterization but the occlusion is extremely rare. Heparinized saline flushes are used during diagnostic coronary angiography to prevent thrombus formation within the sheath lumen. However, the use of prophylactic intravenous heparin following the femoral arterial sheath insertion is controversial. The aim of this study is to evaluate the effectiveness of 2000 units of intravenous heparin bolus in comparison to a saline placebo on the thrombus formation within the arterial sheath during the diagnostic coronary angiography. METHODS: Eligible patients were randomized to receive either a study drug or placebo at the time of femoral sheath insertion. The sheath was aspirated and flushed for any presence of thrombus after each catheter exchange and at the end of the procedure. Five milliliters of blood were extracted and visualized on clean gauze followed by a saline flush. The primary end-point was the effectiveness of the study drug on reducing the incidence of sheath-thrombus formation. RESULTS: Three hundred and twenty patients were randomized into two arms. Three hundred and four patients were analyzed: 147 patients in heparin arm and 157 patients in placebo arm after exclusion of 13 patients in heparin arm and three in placebo arm because of incomplete reports. The baseline characteristics were similar and sheath-thrombi formation was observed in 20% of the total cohort. Of the heparin arm, 12% (19 patients) developed sheath-thrombus formation, whereas 26% (42 patients) in the placebo arm, p-value = 0.002. An adjusted logistic regression model showed that the only predictor for the sheath-thrombus formation was the study drug (i.e. heparin). The odds ratio of developing a thrombus in the control arm was 2.5 (95% CI: 1.4-4.5, p = 0.003). There were no bleeding events observed. CONCLUSION: The risk of thrombus formation is significant and intravenous heparin significantly reduced thrombus formation during diagnostic coronary angiography, with no excess bleeding events.

Do We Need Premedication Before Coronary Angiography? A Controlled Clinical Trial.

BACKGROUND: Premedication with benzodiazepines has been thought to reduce patient anxiety, pain perception, and non-catheter-induced coronary spasms and may increase procedure-related complications. We used to routinely provide premedication with diazepam and chlorpheniramine before cardiac catheterization procedures. However the benefits of such a treatment are not well established here. Therefore, we designed this study to test whether the routine use of premedication during coronary angiography is needed. METHODS: A total of 200 consecutive patients scheduled to undergo either diagnostic or therapeutic coronary angiographic procedures were randomized to receive either premedication with diazepam (5 mg) and chlorpheniramine (4 mg) 60 minutes prior to their procedures (n = 100) or no premedication (n = 100). The administration of intravenous midazolam during the procedures was permitted at the operator's discretion. The primary endpoints were anxiety and pain perception during the procedure. RESULTS: A total of 200 patients with similar baseline characteristics were randomized into two groups. The first group received oral premedication with diazepam (5 mg) and chlorphenamine (4 mg) 60 minutes prior to their procedures, and the other group did not receive premedication. We observed no differences in periprocedural pain perception (31% in the premedicated group versus 29% in the non-premedicated group; P = 0.75) or anxiety (59% in the premedicated group versus 50% in the non-premedicated group; P = 0.2). Interestingly, local pain was more pronounced in the premedicated patients than in the non-premedicated patients (30% versus 16%, respectively; P = 0.018). There were no contrast-related reactions reported in either group. CONCLUSION: Treatment with oral diazepam and chlorphenamine prior to cardiac catheterization and percutaneous coronary intervention does not alter rates of anxiety, periprocedural pain.

Very delayed coronary stent fracture: A case report.

A stent fracture is an emerging complication of the coronary stents. There are numerous risk factors for stent fractures; which include forceful exaggerated motion in the atrioventricular groove seen in right coronary artery, long stent, an ostial lesion at the point of maximum curvature in a tortuous vessel, stent over-expansion, stent overlapping with different size stents, complex lesion after stenting of a totally occluded vessel, Cypher stent and a highly mobile segment causing high mechanical stress. Furthermore, chronic stretch at specific vessel sites as bends may lead to late occurrence of fracture. Here we report a case of 40-year-old male who had two overlapping Cypher stents (3.0 × 13 mm and 2.75 × 18 mm) deployed at mid left anterior descending artery 2 years earlier presented with progressive chest pain.

Lessons from the SYNTAX trial.

Despite the fact that CABG is the standard of care for patients with multivessel coronary arteries and/or left main stem stenosis, PCI has become a rival to CABG in patients with multivessel coronary artery disease or left main disease. However, the need for repeat revascularization, in-stent stenosis and thrombosis remain the achilis heal of PCI. SYNTAX trial randomized patients with left main disease and/or three-vessel disease to PCI with TAXus stent or CABG with the concept that PCI is not inferior to CABG. At 1 and 2 years follow up, MACCE was significantly increased in PCI patients mainly attributed to increased rate of repeat revascularization; however, stroke was significantly more with CABG. The composite safety endpoint of death/stroke/MI was comparable between the 2 groups. Therefore the criterion for non-inferiority was not met. What we learn from SYNTAX is that multi disciplinary team approach should be the standard of care when recommending treatment in more complex coronary artery disease. SYNTAX makes interventionists and surgeons come together, it may set the benchmark for MVD revascularization. PCI and CABG should be considered complementary rather than competitive revascularization strategies. There is no substitute for sound clinical judgment that takes into account the patient's overall clinical profile, functionality, co-morbidities, as well as the patient's coronary anatomy. The SYNTAX Score should be utilized to decide on treatment of patients with LM/MVD. Patients with low and intermediate score can be treated with PCI or CABG with equal results. Those with high score do better with CABG. SYNTAX trial showed that 66% of patients with 3VD or LMD are still best treated with CABG. In the remaining 1/3 of patients with low syntax score, PCI may be considered as an alternative to surgery. Finally, medical treatment should be optimized in patients going for CABG.