Minimalistic Approach for Transcatheter Aortic Valve Implantation (TAVI): Open Vascular Vs. Fully Percutaneous Approach.

BACKGROUND: Aortic stenosis (AS) is the most common valvular heart disease in elderly people. Transcatheter aortic valve implantation (TAVI) has emerged as a revolutionary treatment for elderly patients with symptomatic severe aortic stenosis. The authors present the first experiences with transcatheter aortic valve implantation treatment in Macedonia and compare their findings in regard to differences between open vascular vs. minimalistic transfemoral TAVI approach. METHODS: The procedure was performed in 54 patients with severe and symptomatic AS in the period from December 2014 until February 2018. All patients were deemed having high surgical risk or were denied surgery. Pre-procedural screening included detailed clinical and echocardiographic evaluation, coronary, peripheral and carotid angiography and computed tomography scan of the aortic root. A self-expandable aortic valve (Core Valve/Evolut R, Medtronic, USA) was implanted in all patients. RESULTS: Mean patient age was 75 ± 7.2 years, 28 (52%) were female, 26 patients (48%) male. All interventions were successfully performed through right transfemoral approach with 100% implantation success. Ancillary right radial and ulnar approach was used for correct valve positioning and control. 22(40%) cases were performed under general anesthesia and open vascular access to the femoral artery. All other 32(60%) cases were performed with minimalistic approach (local anaesthesia and analgosedation of the patients, access site was closed with closure devices). Patients in the minimalistic approach group were older, with more chronic conditions as anaemia, chronic kidney disease, poor mobility and peripheral vascular disease (p<0.0001). Also 4(12.5%) patients in the minimalistic group had bicuspid valve TAVI implantation (p<0.0001). Procedural time and contrast amount spent were shorter in this group with 97± 38 vs. 121± 38.3(p<0.0001) and 287± 122 vs. 330± 115 ml, while fluoroscopy time was similar in both groups. Immediate hemodynamic improvement was obtained in all patients. Echocardiographic peak gradient decreased from 85 ± 25 to 17 ± 8 mmHg (p < 0.001) and mean pressure gradient from 49 ± 26 to 8.3 ± 4.2 mmHg, (p < 0.001). Effective valve orifice area was 1.8±0.4 cm2 after intervention. None of the patients had significant aortic regurgitation after implantation. After intervention 7(12%) patients developed a permanent heart block and required implantation of a permanent pacemaker. There was a larger Hgb drop after intervention with open vs. minimalistic approach 1,9±0.9 vs. 0.7±0,2 g/dL (p<0.0001). 3 (13% vs.0%) patients from the open vascular access group had a major bleeding complication with 2 requiring transfusion after intervention (p<0.0001). Mortality was 5.5%, 2 with open-vascular and 1 with minimalistic approach. MACCE rate that included MI, Stroke, Major bleeding and Death rate, was recorded in 5(18%) patients with open vascular approach vs. 1(3.1%) in minimalistic approach (p<0.0001). Hospital discharge was 8.7±3.1 vs. 4±3.1 days respectively (p<0.0001). All TAVI patients with minimalistic approach were discharged the following day after intervention. All discharged patients had a good neurological condition, which was assessed based on the CPC-1 (Cerebra Performance Categories Scale). After median follow up of 26 months, the survival rate was 95% with clinical improvement in all patients. CONCLUSION: Percutaneous aortic valve implantation can be successfully conducted with high success rate and low rate of complications in patients with severe aortic stenosis. Using a less invasive approach with local anaesthesia and analgosedation is associated with shorter length of stay and a decrease in post-procedural complication rates and MACCE.

Benefit of routine preprocedural radial artery angiography in STEMI patients.

AIMS: To assess the benefit of routine preprocedural radial artery (RA) angiography in patients with ST segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: All consecutive STEMI patients, in the period from January 2010 until December 2016 were included in the study. Preprocedural radial artery angiography was performed in all patients since March 2011. We compared clinical and procedure characteristics, access site bleeding complications and failure of primary chosen TRA between two groups of STEMI patients before and after we started performing routine RA angiography. We compared 762 STEMI patients from 2010 until March 2011 and 4306 STEMI patients after March 2011 until December 2016. Mean age of patients was 60 ± 11 years with 73% males. The latter group had more elderly and obese patients (P < .0001 both). Prior percutaneous coronary interventions was present in 7% of patients and 0, 1% had prior coronary bypass surgery. Procedure duration (38 ± 16 vs. 32 ± 20 min) was significantly longer in the first group (P value < .0001), but contrast volume (120 ± 33 vs. 110 ± 35 ml), and fluoroscopy time (8.6 ± 6 vs. 8.7 ± 8 min) were similar in both groups. Access crossover from primary TRA was 4, 6% in the first group, with a significant decrease to 3, 1% in the second (P < .0001), after introducing preprocedural RA angiography. Access site bleeding complications were significantly higher in the first group 6.8% vs. 4.3% in the second (p < .0001). CONCLUSION: Routine preprocedural radial artery angiography in STEMI patients is associated with lower rate of access site bleeding complications and reduced overall procedural time and TRA crossover rate.

Transition Towards Transradial Approach Improves Outcomes of Acute Myocardial Infarction PCI.

INTRODUCTION AND AIM: Transradial (TRA) instead of transfemoral (TFA) approach strategy has been presented in research literature as superior access strategy especially for acute ST elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI). There is a paucity of registry-based data of outcomes from default TRA strategy compared to TFA. MATERIALS AND METHODS: All-comers STEMI PCI institutional Registry identified 1808 consecutive patients in time-frame of 40 months from 2007 to 2010, without making any exclusions. Moreover, we applied Propensity Score Matching (PSM) to replace randomization, address the potential confounding and selection bias. PSM derived 565 congruent pairs of patients from the groups. RESULTS: After 30 days the primary composite endpoint of major adverse cardiovascular events (MACE) was in favor of TRA 6.5% vs. 12.4% in TFA group, simultaneously secondary endpoints of death in TRA with rate of 4.8% and with rate of 10.1% in TFA. Moreover, the rate of major access related bleeding was 1.1% in TRA vs. 8.5% in TFA, in contrast the major non-access related bleeding was 1.8% and 2.4% respectively showed no significant difference. One year Kaplan Meier survival plots were in favor of TRA. CONCLUSIONS: Default transradial access strategy is associated with improved STEMI PCI outcomes.

Macedonia: coronary and structural heart interventions from 2010 to 2015.

The aim of this report is to describe invasive cardiology procedural practice in Macedonia during the period from 2010 to 2015. Details of all consecutive 39,899 patients who underwent cardiovascular, peripheral or structural heart procedures during the period from 2010 until 2015 were examined. Clinical and procedure characteristics, access site, procedural success and complications were analysed. The number of coronary angiographies increased from 5,540 in 2010 to 8,550 in 2015. Transfemoral access (TFA) was present in 4% of coronary angiographies in 2010 and had decreased to 1% in 2015. The number of primary percutaneous coronary interventions (PCI) for acute ST-segment elevation myocardial infarction increased from 763 to 1,175 and both chronic total occlusion and left main coronary artery interventions also increased over time. In 2015, the drug-eluting stent penetration rate was 65%. Structural heart interventions, including transcatheter aortic valve implantations (TAVI) were introduced in 2014 and 23 TAVI cases have since been performed. Transradial access was performed in 38,455 (96%) of all patients. Wrist access adoption in the majority of cardiovascular interventions is possible in all PCI centres in Europe if an appropriate national strategy is developed.

Transradial versus transfemoral access for female patients who underwent primary PCI in STEMI: Two years follow-up data from acute STEMI interventional registry.

BACKGROUND: Female patients possess a higher risk for poorer outcome in ST segment elevation myocardial infarction (STEMI). There is possibility that transradial access (TRA) for primary percutaneous coronary intervention (PPCI) could provide better outcome than transfemoral access (TFA) in female patients with STEMI. METHODS: From 2008 to 2010, 418 female patients (out of 1808 patients) underwent PPCI for acute STEMI. The registry recruited all-comers patients with acute STEMI. Cardiac mortality, major bleeding, and overall MACE rates (composite of death, stroke, re MI and target vessel revascularization-TVR) after 2years follow-up were compared between TRA and TFA. RESULTS: TRA for PPCI was performed in 261 patients and 157 underwent TFA PPCI. The 30-days, 1year mortality and 2year mortality rates were lower in TRA compared to TFA (6.9% vs.14.6%, p=0.012, 8.8% vs. 15.3%, p=0.045, and 9.2% vs. 16.6%, p=0.027respectively). After 2years follow-up, the overall MACE rates were similar (26.4% vs. 31.2%, p=0.336). The overall major bleeding and major vascular access site bleeding were more favorable for TRA than TFA (4.4 vs. 14%, p<0.001, and 2.7 vs. 10.8%, p<0.001, respectively). CONCLUSION: Transradial access for primary PCI in female patients provided better clinical outcomes with lower cardiac mortality and reduced major bleeding in comparison to TFA. There was no significant difference at 2years MACE between TRA and TFA.

Complete transitioning to the radial approach for primary percutaneous coronary intervention: a real-world single-center registry of 1808 consecutive patients with acute ST-elevation myocardial infarction.

OBJECTIVES: To compare the short- and long-term outcomes of transradial approach (TRA) versus transfemoral approach (TFA) for primary percutaneous coronary intervention (PPCI) during a complete institutional transition from TFA to TRA. METHODS AND RESULTS: An all-comer population of ST-elevation myocardial infarction (STEMI) patients (n=1808) who underwent PPCI using TRA (n=1162) and TFA (n=646) from October 2007 to December 2010 were enrolled. TRA was used in 25% of PPCIs by 2007 and in 96% of PPCIs in 2010. Primary endpoints were cardiovascular death and major adverse cardiac event (MACE), defined as a composite of death, stroke, reinfarction, and target vessel revascularization at 30 days and 1 year. At 30 days, TRA compared to TFA was associated with a significant reduction of cardiovascular mortality (5.2% vs 10.5%; P<.001), significant MACE reduction (7.3% vs 12.5%; P<.001), fewer access-site complications (0.9% vs 8.2%; P<.001), and lower TIMI major bleeding (1.1% vs 4.3%; P<.001). At 1 year, the cardiovascular mortality and MACE rates were also in favor of the TRA group (6.9% vs 11.5%; P<.001 and 11.6% vs 20.1%; P<.001), respectively. CONCLUSION: Complete transition from femoral access to a preferred radial access is safe and effective for STEMI patients undergoing PPCI, with a favorable effect on short- and long-term outcomes.

Transradial approach as first choice for stenting of chronic total occlusion of iliac and femoral superficial artery.

The transradial approach (TRA) for treatment of aortoiliac occlusive disease (AIOD) is nowdays a more common approach than several years ago. This is due to less post-procedural bleeding complications and its impact on mortality. The main reason for the growing interest in the TRA is because of the safety profile of this access. Peripheral arterial disease (PAD) is a growing phenomenon. It is a common circulatory problem in which narrowed arteries reduce blood flow to lower extremities due to atherosclerotic arterial lesions. According to the Trans Atlantic Inter-Society Consensus on the Management of Peripheral Arterial Disease (TASC II), an endovascular approach is recommended in type A and B lesions, and an open surgical approach for type C and D lesions. The aim of the study is to put the accent on the advantages of the transradial approach (TRA) versus the transfemoral approach (TFA), its safety and efficacy in treating peripheral arterial disease (PAD) even in type C and D lesions, in well and properly selected patients on whom it may be performed, and to evaluate the outcomes of transradial iliac stenting (TRAIS), attempting to increase the demand for the new devices and tools for its treatment. These improvements will exclude some disadvantages and limitations of TRA in the field of endovascular peripheral interventions (distance from the puncture site to the lesion location, bigger support, thinner devices). Despite difficult lesions, TASC C/D, the overall primary procedural and technical success rate was 100%. The ankle brachial index (ABI) significantly improved from a mean of 0.46 to 0.90 and 0.94 on the six months follow-up. Angiographic estimated residual stenosis was 0%. No minor or major complications (haematoma, distal emboli, vessel dissection, rupture, death) were documented. The primary patency rate was 100% for the iliac and for the SFA. The secondary patency rate after 6 months follow-up was also 100%. Transradial access might be recommended as the first-choice vascular access site for interventions on the iliac, and even proximal femoral territories. This technique is still limited by the lack of adequate equipment. This issue should be overcome in the future.

Investigation of SERPINE1 genetic polymorphism in Macedonian patients with occlusive artery disease and deep vein thrombosis.

BACKGROUND: Raised SERPINE1 plasma levels are related to a 1-bp guanine deletion/insertion (4G5G) polymorphism in the promoter of the SERPINE1 (plasminogen activator inhibitor 1 - PAI1) gene. Evidence suggested that the plasma levels of SERPINE1 modulate the risk of coronary artery disease; furthermore, that the 4G5G polymorphism affects the expression of the SERPINE1 gene. AIM: To analyse association of SERPINE1 polymorphism with occlusive artery disease (OAD) and deep venous thrombosis (DVT) in Macedonians in order to investigate its role as a part of candidate genes in different vascular diseases in Macedonians. METHODS: Investigated groups consisted of 82 healthy patients, 75 with OAD, and 66 with DVT. Blood samples were collected after written informed consent was obtained, and DNA was isolated from peripheral blood leukocytes. Identification of SERPINE1 polymorphism was done with CVD StripAssay (ViennaLab, Labordiagnostica GmbH, Austria). The population genetics analysis package, PyPop, was used for analysis of the SERPINE1 data. Pearson's P-values, crude odds ratio and Wald's 95% CI were calculated with Bonferroni corrected p value. RESULTS: The frequency of 4G allele for SERPINE1 was 0.538 for DVT, 0.555 for healthy participants, and 0.607 for OAD. The frequency of 5G allele for SERPINE1 was the smallest in patients with OAD (0.393) and was higher in healthy participants (0.445), and patients with DVT (0.462). Test of neutrality (Fnd) showed negative value, but was significantly different from 0 for SERPINE1 in healthy participants (p of F = 0.041) and in patients with DVT (p of F = 0.030). SERPINE1 genotypes in healthy participants and patients with OAD were not in Hardy Weinberg proportions (p = 0.019 and 0.001, respectively). No association between SERPINE1 polymorphisms and OAD or DVT was found. CONCLUSION: There is no significant relationship between SERPINE1 polymorphisms and occlusive artery disease or deep venous thrombosis in Macedonian population.

Association between 22 cytokine gene polymorphisms and dilated cardiomyopathy in Macedonian patients.

BACKGROUND: Inflammation is an important component in the pathogenesis of many cardiovascular diseases and one of the commonest mechanisms in cardiomyopathy. There have been several studies on the cytokine polymorphism and dilated cardiomyopathy (DCM), but the results obtained were contradictory. AIM: To examine a possible role of 22 cytokine gene polymorphisms in host susceptibility to or protection against DCM in Macedonians. METHODS: In this study 301 healthy unrelated individuals and 52 patients with DCM were studied. Cytokine genotyping was performed by PCR with sequence-specific priming (PCR-SSP) (Heidelberg kit). RESULTS: After the Bonferroni adjustment, the IL-4 -1098/T, IL-4 -1098/T:T, IL-4/TCC, and IL-4/TCC:TTC cytokine genes were positively associated with DCM, while a negative association was identified for IL-4 -1098/G, IL-4 -1098/G:T, IL-1B +3962/C:C, IL-4/GCC, and IL-4/GCC:TTC. CONCLUSIONS: These results suggest that some cytokine gene polymorphisms are significantly associated and affect host susceptibility/resistance to DCM in Macedonians.

Methylenetetrahydrofolate reductase (MTHFR-677 and MTHFR-1298) genotypes and haplotypes and plasma homocysteine levels in patients with occlusive artery disease and deep venous thrombosis.

The aim was to investigate different genotypes and haplotypes of methylenetetrahydrofolate reductase (MTHFR-677, -1298) and plasma concentration of total homocysteine (tHcy) in Macedonian patients with occlusive artery disease (OAD) and deep venous thrombosis (DVT). Investigated groups consists of 80 healthy, 74 patients with OAD, and 63 patients with DVT. Plasma tHcy was measured with Microplate Enzyme Immunoassay. Identification of MTHFR genotypes and haplotypes was done with CVD StripAssay. The probability level (P-value) was evaluated by the Student's t-test. Plasma concentration of tHcy in CC and CT genotypes of MTHFR C677T was significantly increased in patients with OAD and in patients with DVT. Plasma concentration of tHcy in AC genotype of MTHFR A1298C was increased in patients with OAD and in patients with DVT. Plasma concentration of tHcy was significantly increased in AA genotype of patients with OAD, but not in patients with DVT. We found a significant increase of plasma tHcy in patients with OAD in comparison with healthy respondents for normal:heterozygote (CC:AC), heterozygote:normal (CT:AA), and heterozygote:heterozygote (CT:AC) haplotypes. Plasma concentration of tHcy in patients with DVT in comparison with healthy respondents was significantly increased for normal:normal (CC:AA), normal heterozygote (CC:AC), and heterozygote:heterozygote (CT:AC) haplotypes. We conclude that MTHFR C677T and MTHFR A1289C genotypes and haplotypes are connected with tHcy plasma levels in Macedonian patients with OAD and DVT.

Association of methylenetetrahydrofolate reductase (MTHFR-677 and MTHFR-1298) genetic polymorphisms with occlusive artery disease and deep venous thrombosis in Macedonians.

AIM: To analyze the association of methylenetetrahydrofolate reductase polymorphisms (MTHFR-677 and MTHFR-1298) with occlusive artery disease and deep venous thrombosis in Macedonians. METHODS: We examined 83 healthy respondents, 76 patients with occlusive artery disease, and 67 patients with deep venous thrombosis. Blood samples were collected and DNA was isolated from peripheral blood leukocytes. Identification of MTHFR mutations was done with CVD StripAssay (ViennaLab, Labordiagnostika GmbH, Vienna, Austria) and the population genetics analysis package, PyPop, was used for the analysis. Pearson P values, crude odds ratio, and Wald's 95% confidence intervals were calculated. RESULTS: The frequency of C alleles of MTHFR-677 was 0.575 in patients with deep venous thrombosis, 0.612 in patients with occlusive artery disease, and 0.645 in healthy participants. The frequency of T allele of MTHFR-677 was lower in healthy participants (0.355) than in patients with occlusive artery disease (0.388) and deep venous thrombosis (0.425). The frequency of A allele for MTHFR-1298 was 0.729 in healthy participants, 0.770 in patients with occlusive artery disease, and 0.746 in patients with deep venous thrombosis. The frequency of C allele of MTHFR-1298 was 0.271 in healthy participants, 0.230 in patients with occlusive artery disease, and 0.425 in patients with deep venous thrombosis. No association of MTHFR-677 and MTHFR-1289 polymorphisms with occlusive artery disease and deep venous thrombosis was found, except for the protective effect of MTHFR/CA:CC diplotype for occlusive artery disease. CONCLUSION: We could not confirm a significant association of MTHFR-677 and MTHFR-1289 polymorphisms with occlusive artery disease or deep venous thrombosis in Macedonians, except for the protective effect of MTHFR/CA:CC diplotype against occlusive artery disease.