Twelve-month clinical outcomes of "nano-crush technique" for the treatment of bifurcation lesions using ultra-thin (60 µm) sirolimus-eluting coronary stents.

BACKGROUND: Provisional stenting is preferred for bifurcation lesion; however, certain anatomical substrate does require two stents as a part of dedicated stent technique. Here, the present study evaluated outcomes of ultra-thin (60 µm) Supra family sirolimus-eluting stent (SES) (Sahajanand Medical Technologies Limited, Surat, India) for dedicated bifurcation lesions using nano-crush technique at 12 months angiographic follow-up. METHODS: This was prospective, single-center observational study which enrolled patients with de novo bifurcation lesion and underwent angioplasty with Supra family SES using nano-crush technique at a tertiary care center in India, between March-2017 and February-2019. Primary endpoint at 12 months was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included patient-oriented composite endpoint (POCE), all-cause death, any revascularization, clinically driven target vessel revascularization, stent thrombosis, periprocedural and spontaneous MI, and device failure. RESULTS: The study enrolled total 63 patients with a mean age of 62.5±4.9 years and had male dominance (89%). Left main (LM) bifurcation and non-LM bifurcation were observed in 21 (33%) and 42 (67%) patients, respectively. Total 50 (80%) patients had Medina class- 1,1,1. At 12 months, TLF occurred in 4 (6%) patients which included one cardiac death (1.5%), two (3.0%) TV-MI, and one CD-TLR (1.5%). POCE was observed in 6 (9.6%) patients. Stent failure was seen in 2 (3.1%) patient and one patient (1.5%) developed late stent thrombosis. Twelve months angiographic follow-up indicated intact stent patency in all other patients. On multivariate analysis, LM bifurcation, renal dysfunction, LM bifurcation with renal dysfunction, ejection fraction (<35%) and calcified lesion were found as predictors of TLF. CONCLUSIONS: Dedicated stenting with ultra-thin Supra family SES for complex bifurcation lesion using nano-crush technique reported acceptable clinical outcomes among real-world patients and can be performed safely with ease without any procedural complications.

Nano-crush technique in narrow-angle (<70°) bifurcation: bench test, CT reconstruction, fluid dynamics, and clinical outcomes.

BACKGROUND: Bifurcation stenting techniques are still refining and under testing. Nano-crush is a novel technique which allow minimum protrusion of side branch struts at the ostium. To demonstrate the efficacy of Nano-crush technique in narrow-angle bifurcation (<70°) using bench test model, 3D reconstruction of the stent structure, computational fluid dynamics study and a clinical follow-up. METHODS: This was a retrospective observational single-center study which included 40 patients who underwent angioplasty using Nano-crush technique for de-novo complex coronary bifurcation lesions with narrow bifurcation angle (<70°) between April-2016 to March-2019. The in-vitro bench test and computational fluid dynamics analysis were performed using a bifurcation model designed. The clinical primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization (TLR) at one-year angiographic follow-up. RESULTS: The reconstructed results of in-vitro bench test showed minimum length of stent struts moving away from the rounded side branch ostium. The mean age of patients was 62.8±7.98 years (32 male) and presented 100% procedural success. The mean bifurcation angle was 47.3±9.2°. The MACE was reported in four (10%) patients which included one (2.5%) death and three (7.5%) TLR at the mean follow-up of 35.54±12.31 months. No significant correlation between occurrence of MACE and gender, age, comorbidities and bifurcation angle was reported. CONCLUSIONS: The Nano-crush technique demonstrated least metal load around carina and abnormal flow dynamics in narrow angle (<70°) bifurcation lesions and also reported favorable long-term clinical outcomes.

Expert Opinion on P2Y12 Inhibitors Use in Management of Acute Coronary Syndromes: Focus on Ticagrelor.

Ticagrelor is a potent, oral P2Y12 inhibitor used as a part of dual antiplatelet therapy (DAPT) in acute coronary syndromes (ACS). New evidence has emerged for its use in ACS, which may be crucial for the Indian context. This brought together nearly 150 experts in ACS management across the country who reviewed the current evidence and discussed the same through a series of 10 meetings on an online platform. With all experts' agreement, the key expert opinions for the P2Y12 inhibitors use in ACS management were finalized. These include the following. In ACS patients aged <75 years, with diabetes, a history of stroke/transient ischemic attack, and chronic kidney disease, ticagrelor may be preferred over other P2Y12 inhibitors. It may also be preferred in the elderly above 75 years with clopidogrel is a suitable alternative in patients at high-risk of bleeding. Rates of stent thrombosis are lower with ticagrelor than clopidogrel. In patients managed with fibrinolysis, use ticagrelor after 48 hours if streptokinase was the fibrinolytic agent or it can be used after 12 to 24 hours if fibrin-specific fibrinolytic was used. Rates of major bleeding in patients treated with fibrinolysis are similar to clopidogrel. Prehospital administration may be preferred over in-hospital administration with expected bleeding rates similar to clopidogrel. Switching among P2Y12 inhibitors should be done with due consideration of their pharmacodynamics. At present, DAPT should be continued for 12 months with discontinuation after three to six months in patients with high bleeding risk. The use of low dose ticagrelor may be considered in cases with high-bleeding risk. DAPT or ticagrelor continuation beyond one year should be individualized considering ischemic and bleeding risks. Dyspnea is a common, mild, and transient and does not necessitate ticagrelor discontinuation. Severe dyspnea should be investigated thoroughly. In conclusion, ticagrelor (180 mg, 90 mg, and 60 mg doses), a potent antiplatelet is expected to reshape the antiplatelet use in the management of ACS.

Percutaneous coronary intervention of severely/moderately calcified coronary lesions using single-burr rotational atherectomy: A retrospective study.

OBJECTIVE: This study evaluates the safety and efficacy of percutaneous coronary intervention in moderately and severely calcified coronary lesions, which are either not crossed or dilated using a Scoreflex balloon at nominal pressure, using single-burr rotational atherectomy (burr-artery ratio, ≤0.6) followed by scoring balloon dilatation (balloon-artery ratio, 0.9). METHODS: We retrospectively identified 144 patients with severely and moderately calcified native coronary lesions, which were either not crossed or fully opened using an appropriately sized Scoreflex balloon at nominal pressure, from a tertiary care center in India. All patients underwent rotational atherectomy. The primary endpoint was angiographic and procedural success and in-hospital clinical outcomes. The secondary endpoint was the incidence of major adverse cardiac events (MACE) at one-year clinical follow-up. RESULTS: The mean age of the patients was 68.75±8.37 years, and 83.33% of them were over 60 years old. Moderate calcification was present in 21.53%, and the remaining 78.47% had severe calcification. Procedural success was achieved in 139 (96.52%) patients. In-hospital death was reported in four (2.77%) patients. Multiple regression analysis revealed that in severely calcified coronary lesions, burr rotation speed and heparin dose were significantly associated with in-hospital MACE occurrence (p=0.0337). CONCLUSION: A modified small-burr rotational atherectomy technique with scoring balloon angioplasty pre-dilatation is a safe and effective surgical procedure with favorable clinical outcomes for moderately and severely calcified coronary lesions.

Two chair test: a substitute of 6 min walk test appear cardiopulmonary reserve specific.

BACKGROUND: A simple and efficient exercise test possible in a small space is welcome to supplement 6 min walk test (6MWT) that demands a 100 feet corridor to perform. METHODS: The proposed two chair test (2CT) makes a person to sit and move five times between two chairs placed face to face at 5 feet apart and note the changes in pulse-rate (PR) and arterial oxygen saturation (SpO2) at every 10 s for 2 min after that. Comparison of the post-exercise measurements (PR and SpO2) with a repeat performance in same patients was done for reproducibility and doing the same after 6MWT and 2CT in another set of patients was meant for for acceptability. The statistical analysis was made on moment to moment change, mean maximal difference and mean cumulative difference for the measurements using p value, z-score, r value and principal component analysis (PCA). FINDINGS: A total of 40 and 60 volunteers were included for testing reproducibility and acceptability. On both the sets, the difference in most of comparisons between the measured variable (PR and SpO2) showed the p values remaining insignificant (>0.05), and z-score being <1 SD of the corresponding other and the correlation coefficients (r) remaining excellent (>0.9). Furthermore, the PCA shows complete overlapping. The post-exercise changes did not corelate the walking distance in 6MWT. INTERPRETATION: The proposed 2CT demands small space and appears reproducible and comparable with 6MWT in terms of its post-exercise impact on PR and SpO2. This novel test also appears more of cardiopulmonary reserve specific.

A novel “nano-crush” technique for the management of coronary bifurcation lesions: in vitro bench test analysis and preliminary report on real-world clinical evaluation in patients with one-year angiographic follow-up.

Aims: Although provisional stenting with a single drug-eluting stent has proven clinical efficacy in the treatment of bifurcation stenosis, some patients may require two stents. We propose a novel technique, called "nano-crush", which is easy to perform and can be used in all bifurcation angles. Methods and results: The feasibility of the nano-crush technique was confirmed in an in vitro bench test and intravascular ultrasound (IVUS) study. Subsequently, 42 patients with de novo coronary bifurcation stenosis were treated by this novel procedure using drug-eluting stents at our centre between January 2008 and December 2015. We experienced procedural success in all (100%) patients without any complications. The primary efficacy endpoint of the one-year incidence of major adverse cardiac events (MACE) was noted in three (7.14%) patients, comprising one case of cardiac death at nine months post procedure and two cases of repeat revascularisation due to in-stent restenosis. There were no cases of periprocedural myocardial infarction or stent thrombosis. Angiographic follow-up at one year indicated intact stent patency in the remaining patients. Conclusions: Initial experience with the nano-crush technique demonstrates that it can be performed easily without any procedural complications. Further, the angiographic and clinical follow-up indicates that the nano-crush technique is associated with acceptable clinical outcomes in a real-world scenario.

Angioplasty of unprotected left main coronary stenosis: Real world experience of a single-operator group from eastern India.

BACKGROUND: Coronary artery bypass graft surgery is the standard treatment of unprotected left main coronary stenosis (ULMCA). However, in the real world scenario, many of these patients are unfit for CABG or prefer angioplasty as an alternative when offered the choice. METHODS: A total of 86 clinically stable patients with ULMCA stenosis who were unfit or unwilling for CABG underwent PCI with DES at two tertiary care centers in Kolkata. Patients were followed up prospectively for a median of 34.6 months for major adverse cardiovascular events. Angiographic follow-up was done after 1 year of index procedure or earlier, if indicated. RESULTS: Fifty-five patients (64%) had distal left main stenosis. Two-stent technique was used in 19 patients (22%) and single-stent technique in 36 patients (42%) with distal left main lesion. Thirteen patients (15.1%) had left ventricular ejection fraction (LVEF) of ≤45%. There was no in-hospital death, MI, or stent thrombosis. During follow-up, major adverse cardiac event (MACE) occurred in 9 patients (10.5%). Our study revealed significantly greater MACE in patients with distal left main lesion with LVEF ≤45% (50% vs 6.38%, p=0.0002), high SYNTAX score (36.36% vs 6.82%, p=0.008), and diabetes (17.95% vs 0.00%, p=0.07). Overall, also patients with Diabetes, LVEF ≤ 45%, and SYNTAX score >32 had significantly higher MACE. Use of IC Stent, IVUS, or procedural strategy in distal lesion did not affect MACE. CONCLUSION: In selective patients with low-intermediate SYNTAX score and without diabetes and LV dysfunction, ULMCA PCI with DES is feasible.

Clopidogrel resistance: the way forward.

Clopidogrel, a second generation thienopyridine has been the mainstay of ACS (Acute Coronary Syndrome) treatment for more than a decade. Clopidogrel Resistance has been associated with increased mortality in ACS patients with an increase in number of Stent Thrombosis. This review article tries to find out the causes of Clopidogrel Resistance, the main factors involving it, Laboratory evaluation of Clopidogrel Resistance. The overall incidence of Clopidogrel Resistance across the Globe & India has also been considered. The article also discusses the clinical significance of Clopidogrel Resistance & its relationship with adverse cardiovascular events. This review ends with the probable solutions to Clopidogrel Resistance & the new generation of antiplatelets which can be used for the same.

Safety of Prasugrel in Indian patients - multicentric registry of 1000 cases.

BACKGROUND: Clopidogrel has been the only available antiplatelet drug used along with aspirin in patients of ACS. In recent years 2 new antiplatelet drugs (Prasugrel and Ticagrelor) have become available. Prasugrel in the dose of 10 mg OD has been found to be more efficacious but with increased risk of major bleeding. For this reason it has not gained widespread usage in ACS patients undergoing PCI. There are no systematic data on the use of Prasugrel in Indian population. METHOD: This is a prospective, multicentric, hospital registry of 1000 patients with ACS undergoing PCI who were administered Prasugrel. The primary safety endpoint of this study was major and minor bleeding while the efficacy endpoint is the composite of CV death, nonfatal MI, nonfatal stroke up to 30 days after PCI. Patients with high bleeding risk were excluded. RESULTS: Most patients (91%) received loading dose of Prasugrel along with the maintenance dose getting according to the defined protocol. Patients were followed up to 30 days post procedure. Primary efficacy end point was reached in 3 patients only with two of them dying due to possible stent thrombosis and the third requiring revascularization of the target vessel for stent thrombosis. One major and 19 minor bleeding complications were recorded, with access site bleeding in 0.7% & non-access site bleeding in 1.2% of the subjects. CONCLUSION: Prasugrel was found to be effective & not associated with a high incidence of bleeding in the high risk ACS patients when those at a high bleeding risk were excluded.

Impact of angiographic & procedural factors on the treatment of ostial LAD or LC(x) disease.

AIMS & OBJECTIVES: This study was designed to evaluate the impact of angiographic & procedural factors on MACE after DES deployment in ostial lesions of LAD & LC(x). PATIENTS, MATERIALS & METHODS: 65 patients with ostial disease of LAD or LC(x) underwent PCI using DES. In 56 patients the stent was placed perfectly at the ostium & in 9 patients the LMCA was covered as per protocol. Angiographically 48 patients had a bifurcation angle > 70 degrees whereas in 17 patients the angle was < 70 degrees. RESULT & ANALYSIS: Multivariate Regression Analysis was done. Mean age was 59 years & 77% were male patients. 69% were hypertensives & 52% diabetics. LAD was treated in 88%. 74% had bifurcation angle > 70 degrees. 26% presented with an angle < 70 degrees LMCA was covered during stent implantation in 12% of cases. Average follow up was 1.5 +/- 0.8 years. Overall MACE was 12%. Bifurcation angle > 70 degrees & use of Cypher stent remained significant in reduction of MACE (P < 0.05). Using Univariate analysis of 2 sample sets like cases with angle of separation > 70 degrees (n = 48) & with angle less than < 70 degrees (n = 17), it was found that covering LMCA was beneficial in cases with angle of separation < 70 degres (p-value and correlation coefficient nearer to statistical significance). CONCLUSION: Angiographic factors like bifurcation angle is important to formulate the strategy of stenting procedure in the ostial disease of LAD or LC(x) even with DES.

Importance of ischaemic time as a predictor of LV systolic function in Indians.

OBJECTIVE: Sucessful reperfusion therapy in AMI improves LV systolic function. Success in thrombolytic therapy is directly related to the ischaemic time. Our aim in the present study was to observe the importance of ischaemic time as a predictor of left ventricular systolic function in patients undergoing PPCI. In addition, the contribution of presentation delay in determining the ischaemic time in the Indian scenario was also observed. MATERIALS & METHODS: The present pilot study was carried out on 48 Indian patients (Male-40) of STEMI (Killip class I & II) undergoing primary PCI in last 2 yrs. Suggestive chest pain, ECG evidence of STEMI coming within 12 hrs were the inclusion criteria. Patients coming after 12 hours without ongoing chest pain, Killip class III & IV, the patients who were thrombolysed outside and the patients with prior PCland/or CABG were excluded from the study. Cardiac echodoppler study was done in every patient during followup at one month.Every patient received pre and peri procedural abciximab infusion and thrombosuction was done in all before deployment of BMS during the transfemoral primary PCI. RESULTS: Data analysis revealed mean age was 57.6 yrs, male preponderance (80%),diabetes (35%),hypertension (61%), Smoking (61%), average total ischaemic time 7.6 +/- 3.78 hours, average presentation delay 6.26 +/- 3.77 hrs, average door to balloon time 60 +/- 14 mins, SVD (69%), LAD involvement(60%). Multivariate regression analysis without considering any other factor showed predicted LV Systolic function one month post PPCI to be 74.08%. Mean LVEF: 58.2%. Most interesting observation is 0.63% reduction of predicted LVEF for each hour increment of ischaemic time. Also LAD occlusion is associated with 4.91% reduction of predicted LVEF compared to other vessel(s) involvement. All the 48 patients who underwent PPCI not only survived but also had good LV Systolic function one month post PPCI. CONCLUSION: Ischaemic time is an important predictor of LV Systolic function even after PPCI. lncrease in ischaemic time by one hour reduces predicted LVEF by 0.63%.Presentation delay is mostly responsible for total ischaemic time in India.

Thrombosuction with export aspiration catheter during PCI in acute MI.

The angiographic demonstration of thrombus laden LAD in a ventilated young man with IABP (to combat cardiogenic shock) demanded thrombosuction. Following thrombosuction no significant lesion was visible that could have mandated PTCA-Stenting. Follow-up coronary angiography in this hyperhomocysteinaemic young subject after one and a half month revealed normal coronaries. Thrombosuction alone unaccompanied by any other additional intervention is infrequently reported.

Revascularization of left main bifurcation lesions by "Mini-Crush technique" in a subject on haemodialysis.

A 75 old diabetic, hypertensive subject with chronic kidney disease stage V (on haemodialysis) had Acute Coronary Syndrome. Coronary angiography revealed bifurcation lesion of the distal Left Main Coronary Artery involving the origins of LAD & LCx, CABG was denied because of comorbidites, old age and unwillingness of the patient to face the risk of surgery. The LM bifurcation was treated in "Mini-Crush technique" resulting in TIMI-III flow and there was uneventful post-interventional recovery without MACE.