-
Cureus Dec 2023The optimal approach to deal with severe coronary artery calcification (CAC) in people with diabetes remains ill-defined. People with diabetes have a significant risk of... (Review)
Review
The optimal approach to deal with severe coronary artery calcification (CAC) in people with diabetes remains ill-defined. People with diabetes have a significant risk of developing severe vessel calcification and coronary artery disease (CAD). CAD is the leading cause of death in people with diabetes. Individuals with diabetes mainly present with severe multivessel stenosis, diffuse coronary calcification, and severe atherosclerosis, which are poor prognostic factors of revascularization procedures. Studies have shown that the revascularization of arteries in people with diabetes often results in worse outcomes than in people without diabetes. Coronary artery bypass grafting (CABG) has been recommended as the standard of care for people with DM and complex anatomic diseases, including left main CAD. However, percutaneous coronary intervention (PCI) is more acceptable to patients in clinical practice because of decreased trauma and rapid recovery. Severe CAC has traditionally been challenging for PCI and a frequent indication for surgical revascularization. This study aims to determine the effectiveness of orbital atherectomy (OA) in improving PCI outcomes in patients with diabetes and identify possible adverse effects that preclude its use. The study is reported according to PRISMA and analyzed according to Cochrane guidelines on synthesis without meta-analysis. A comprehensive literature search of EMBASE, Scopus, Web of Science, Cochrane Library, CINAHL, and MEDLINE was conducted for studies that utilized OA before PCI in people with diabetes. A reference list of the eligible articles was also screened. A narrative synthesis was done by representing the data on the effect direction plot, followed by vote counting. Eighteen studies were included in the analysis. Success rate/successful stent delivery was >90%, while freedom from angiographic complication and major adverse cardiovascular and cerebrovascular events (MACCE) were both >80% on the effect direction plot for people with diabetes and those without diabetes. People with diabetes had low event rates similar to those without diabetes. OA appears to be a viable treatment approach for people with diabetes. However, RCTs with a longer duration of follow-up are required to establish the appropriate treatment strategy for severe CAC in people with diabetes.
PubMed: 38186553
DOI: 10.7759/cureus.50153 -
BMC Cardiovascular Disorders Jan 2024Interventional cardiologists face challenges in managing chronic total occlusion (CTO) lesions, with conflicting results when comparing rotational atherectomy (RA) to... (Meta-Analysis)
Meta-Analysis Review
Safety and feasibility of rotational atherectomy (RA) versus conventional stenting in patients with chronic total occlusion (CTO) lesions: a systematic review and meta-analysis.
BACKGROUND AND AIM
Interventional cardiologists face challenges in managing chronic total occlusion (CTO) lesions, with conflicting results when comparing rotational atherectomy (RA) to conventional PCI. This meta-analysis aims to provide a critical evaluation of the safety and feasibility of RA in CTO lesions.
METHODS
PubMed, Scopus, Web of Science, Ovid, and Cochrane central library until April 2023 were searched for relevant studies. MACE was our primary outcomes, other outcomes were all cause of death, cardiac death, MI, and TVR. Also, we reported angiographic outcomes as technical success, procedural success, and procedural complications in a random effect model. The pooled data was analyzed using odds ratio (OR) with its 95% CI using STATA 17 MP.
RESULTS
Seven studies comprising 5494 patients with a mean follow-up of 43.1 months were included in this meta-analysis. Our pooled analysis showed that RA was comparable to PCI to decrease the incidence of MACE (OR = 0.98, 95% CI [0.74 to 1.3], p = 0.9). Moreover, there was no significant difference between RA and conventional PCI in terms of other clinical or angiographic outcomes.
CONCLUSION
Our study showed that RA had comparable clinical and angiographic outcomes as conventional PCI in CTO lesions, which offer interventional cardiologists an expanded perspective when addressing calcified lesions.
PROSPERO REGISTRATION
CRD42023417362.
Topics: Humans; Atherectomy, Coronary; Chronic Disease; Coronary Occlusion; Feasibility Studies; Percutaneous Coronary Intervention; Risk Factors; Treatment Outcome
PubMed: 38166554
DOI: 10.1186/s12872-023-03673-2 -
The American Journal of Cardiology Oct 2023Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose... (Meta-Analysis)
Meta-Analysis
Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose to stent thrombosis and in-stent restenosis. To date, SU with heavily CCP can be addressed using very high-/high-pressure noncompliant balloons, off-label rotational atherectomy/orbital atherectomy, excimer laser atherectomy, and intravascular lithotripsy (IVL). In this meta-analysis, we investigated the success rate of IVL for the treatment of SU because of CCP. Studies and case-based experiences reporting on the use of IVL strategy for treatment of SU were included. The primary end point was IVL strategy success, defined as the adequate expansion of the underexpanded stent. A metanalysis was performed for the main focuses to calculate the proportions of procedural success rates with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. This meta-analysis included 13 studies with 354 patients. The mean age was 71.3 years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2% to 82.4%) were male. The mean follow-up time was 2.6 months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4 mm (95% CI 3 to 3.8), and the post-IVL value was 6.9 mm (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in 7 studies, the pre-IVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). In conclusion, the "stent-through" IVL plaque modification technique is a safe tool to treat SU caused by CCP, with a high success rate and a very low incidence of complications.
Topics: Humans; Male; Aged; Female; Lithotripsy; Stents; Endovascular Procedures; Atherectomy; Atherectomy, Coronary; Constriction, Pathologic
PubMed: 37611414
DOI: 10.1016/j.amjcard.2023.07.144 -
European Heart Journal Mar 2023Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for... (Meta-Analysis)
Meta-Analysis
AIMS
Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy.
METHODS AND RESULTS
Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints.
CONCLUSION
Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.
Topics: Humans; Popliteal Artery; Vascular Patency; Peripheral Arterial Disease; Treatment Outcome; Femoral Artery; Angioplasty, Balloon; Risk Factors
PubMed: 36721954
DOI: 10.1093/eurheartj/ehac722 -
Frontiers in Cardiovascular Medicine 2022Endovascular treatment has become the first-line therapy for infrapopliteal artery occlusive disease (IPOD), while the optimal endovascular method remains to be...
BACKGROUND
Endovascular treatment has become the first-line therapy for infrapopliteal artery occlusive disease (IPOD), while the optimal endovascular method remains to be determined. We performed a network meta-analysis (NWM) of randomized controlled trials (RCTs) to simultaneously compare the outcomes of different endovascular modalities for IPOD.
METHODS AND RESULTS
The Pubmed, Embase, and Cochrane databases were used as data sources. The NWM approach used random-effects models based on the frequentist framework. In total, 22 eligible RCTs (44 study arms; 1,348 patients) involving nine endovascular modalities or combinations [balloon angioplasty (BA), drug-coated balloon (DCB), drug-eluting stent (DES), atherectomy device + BA (AD + BA), AD + DCB, balloon-expandable bare metal stent (BMS), self-expanding stent (SES), absorbable metal stents (AMS), and inorganics-coated stent (ICS)] were included. BA had a lower 12-month primary patency rate than DCB (RR 0.50, CI 0.27, 0.93) and AD + DCB (RR 0.34, CI 0.12, 0.93). AD + DCB decreased 6-month TLR compared with AMS (RR 0.15, CI 0.03, 0.90), and DES decreased it compared with BMS (RR 0.25, CI 0.09, 0.71). DCB had a lower 6-month TLR rate than AMS (RR 0.26, CI 0.08, 0.86) and BA (RR 0.51, CI 0.30, 0.89). BA had a higher 12-month TLR rate than DCB (RR 1.76, CI 1.07, 2.90). According to the value of the surface under the cumulative ranking curve (SUCRA), AD + DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 87.5) and 12 months (SURCA = 91). AD + BA was considered the best treatment in terms of 6-month TLR (SUCRA = 83.1), 12-month TLR (SURCA = 75.8), and 12-month all-cause mortality (SUCRA = 92.5). In terms of 12-month major amputation, DES was considered the best treatment (SUCRA = 78.6), while AD + DCB was considered the worst treatment (SUCRA = 28.8). Moreover, AD + BA always ranks higher than AD + DCB in the comparison including these two combinations. Subgroup analyses of modalities without stenting did not significantly change the primary outcomes.
CONCLUSION
ADs showed noteworthy advantages in multiple terms for IPOD except for 12-month major amputation. AD + BA may be a better method for IPOD than AD + DCB. The efficacy and safety of ADs are worthy of further investigation.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/prospero/], identifier [CRD42022331626].
PubMed: 36439998
DOI: 10.3389/fcvm.2022.993290 -
Frontiers in Cardiovascular Medicine 2022Severely calcified coronary lesions with reduced left ventricular (LV) function result in worse outcomes. Atherectomy is used in treating such lesions when technically...
Outcomes of atherectomy in treating severely calcified coronary lesions in patients with reduced left ventricular ejection fraction: A systematic review and meta-analysis.
BACKGROUND
Severely calcified coronary lesions with reduced left ventricular (LV) function result in worse outcomes. Atherectomy is used in treating such lesions when technically feasible. However, there is limited data examining the safety and efficacy of atherectomy without hemodynamic support in treating severely calcified coronary lesions in patients with reduced left ventricular ejection fraction (LVEF).
OBJECTIVE
To evaluate the clinical outcomes of atherectomy in patient with reduced LVEF.
METHODS
We searched PubMed, Cochrane CENTRAL Register and ClinicalTrials.gov (inception through July 21, 2021) for studies evaluating the outcomes of atherectomy in patients with severe LV dysfunction. We used random-effect model to calculate risk ratio (RR) with 95% confidence interval (CI). The endpoints were in-hospital and long term all-cause mortality, cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).
RESULTS
A total of 7 studies consisting of 2,238 unique patients were included in the analysis. The median follow-up duration was 22.4 months. The risk of in-hospital all-cause mortality using atherectomy in patients with severely reduced LVEF compared to the patients with moderate reduced or preserved LVEF was [2.4vs.0.5%; RR:5.28; 95%CI 1.65-16.84; = 0.005], the risk of long term all-cause mortality was [21 vs. 8.8%; RR of 2.84; 95% CI 1.16-6.95; = 0.02]. In-hospital TVR risk was 2.0 vs. 0.6% (RR: 4.15; 95% CI 4.15-15.67; = 0.04) and long-term TVR was [6.0 vs. 9.9%; RR of 0.75; 95% CI 0.39-1.42; = 0.37]. In-hospital MI was [7.1 vs. 5.4%; RR 1.63; 95% CI 0.91-2.93; = 0.10], long-term MI was [7.5 vs. 5.7; RR 1.74; 95%CI 0.95-3.18; = 0.07).
CONCLUSION
Our meta-analysis suggested that the patients with severely reduced LVEF when using atherectomy devices experienced higher risk of clinical outcomes in the terms of all-cause mortality and cardiac mortality. As we know that the patients with severely reduced LVEF are inherently at increased risk of adverse clinical outcomes, this information should be considered hypothesis generating and utilized while discussing the risks and benefits of atherectomy in such high risk patients. Future studies should focus on the comparison of outcomes of different atherectomy devices in such patients. Adjusting for the inherent mortality risk posed by left ventricular dysfunction may be a strategy while designing a study.
PubMed: 36204563
DOI: 10.3389/fcvm.2022.946027 -
Journal of Endovascular Therapy : An... Apr 2024Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore,... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore, different vessel preparation devices have been developed to contribute to better peri- and postprocedural outcomes. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug-coated balloon (DCB) angioplasty with POBA or DCB alone in infrapopliteal arterial disease.
METHODS
Medline, EMBASE, and Cochrane databases were searched for studies published between 2000 and 2022 assessing the value of adjunctive vessel preparation in infrapopliteal arterial disease. The primary outcomes were 12-month primary patency and limb salvage.
RESULTS
A total of 1685 patients with 1913 lesions were included in 11 POBA studies. Methodological quality was assessed as poor to moderate in these studies. Only 2 studies with 144 patients assessed vessel preparation in conjunction with DCB angioplasty. These randomized trials were assessed as high quality and found no significant benefit of adjunctive atherectomy to DCB angioplasty. The pooled Kaplan-Meier estimates of 12-month primary patency and limb salvage in the POBA studies were 67.8% and 80.9% for POBA, 62.1% and 86.4% for scoring balloons, 67.9% and 79.6% for mechanical atherectomy (MA), and 79.7% and 82.6% for laser atherectomy, respectively. Within the pooled data only scoring balloons and MA demonstrated significantly improved 12-month limb salvage compared to POBA.
CONCLUSIONS
Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and MA. However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.
CLINICAL IMPACT
Infrapopliteal arterial disease is associated with chronic limb-threatening ischemia (CLTI) and generally complex to treat due to small vessel diameter, long lesion length, multilevel disease and severe calcification. A wide range of vessel preparation devices have been developed to contribute to improved peri- and postprocedural outcomes in these complex lesions. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug coated balloon (DCB) angioplasty with POBA or DCB angioplasty alone in infrapopliteal arterial disease. Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and mechanical atherectomy (MA). However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.
Topics: Humans; Femoral Artery; Popliteal Artery; Peripheral Arterial Disease; Risk Factors; Treatment Outcome; Angioplasty, Balloon; Coated Materials, Biocompatible; Vascular Patency
PubMed: 36062761
DOI: 10.1177/15266028221120752 -
European Journal of Vascular and... Mar 2022Intravascular lithotripsy (IVL) is a novel technique for plaque modification during endovascular revascularisation for peripheral artery disease (PAD) with severe... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Intravascular lithotripsy (IVL) is a novel technique for plaque modification during endovascular revascularisation for peripheral artery disease (PAD) with severe calcification. The aim of this paper was to perform a systematic review and meta-analysis of contemporary data to elucidate the efficacy and safety of IVL in lower extremity PAD.
DATA SOURCES
A systematic literature search with pre-defined search terms was performed using PubMed, Web of Sciences, OvidSP, and EMBASE.
REVIEW METHODS
A meta-analysis was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Patient characteristics, lesion calcification, pre-IVL and post-IVL diameter stenosis, complications, and stent rates were evaluated.
RESULTS
Nine studies were included, encompassing a total of 681 patients (769 lesions) with IVL performed for PAD, of which 75.53% (95% confidence interval [CI] 66.08% - 83.03%) of the lesions were reported to have severe calcification. Comparison between pre-IVL and post-IVL diameter stenosis demonstrated a diameter stenosis reduction of 59.3% (95% CI 53.30% - 65.31%). Vascular complications were rare, with flow limiting or type D/E/F dissection occurring in only 1.25% (95% CI 0.60% - 2.61%) of cases. The overall pooled event rate for stent placement was 15.89% (95% CI 5.22% - 39.34%).
CONCLUSION
This meta-analysis supports IVL as an effective and safe approach for calcified plaque modification in lower extremity PAD, achieving a diameter stenosis reduction of 59.3% (95% CI 53.30% - 65.31%) with minimal vascular complications. Routine use of this device is not recommended; further high quality evidence is required to elucidate the efficacy of IVL with respect to different clinical characteristics such as lesion location and length, and in comparison with other treatment modalities such as atherectomy.
Topics: Humans; Lithotripsy; Lower Extremity; Peripheral Arterial Disease; Treatment Outcome; Vascular Calcification
PubMed: 34887206
DOI: 10.1016/j.ejvs.2021.10.035 -
Cardiovascular Revascularization... Jun 2022Rotational atherectomy (RA) plays a central role in the treatment of heavily calcified coronary artery lesions. Our aim was to compare periprocedural characteristics and... (Meta-Analysis)
Meta-Analysis
BACKGROUND/PURPOSE
Rotational atherectomy (RA) plays a central role in the treatment of heavily calcified coronary artery lesions. Our aim was to compare periprocedural characteristics and outcomes of planned (PA) vs. bailout (BA) rotational atherectomy.
METHODS
We conducted a systematic review and performed a meta-analysis on studies which compared PA vs. BA strategy.
RESULTS
Five studies fulfilled the inclusion criteria, pooling a total of 2120 patients. There was no difference in procedural success, PA vs. BA risk ratio (RR) 1.03 and 95% confidence interval (95% CI) 0.99-1.07. Compared to BA, PA was associated with a shorter procedural time [mean difference (MD) -25.88 min, 95% CI -35.55 to -16.22], less contrast volume (MD -43.71 ml, 95% CI -69.17 to -18.25), less coronary dissections (RR 0.50, 95% CI 0.26-0.99), fewer stents (MD -0.20, 95% CI -0.29 to -0.11), and a trend favouring less periprocedural myocardial infarctions (MI) (RR 0.77, 95% CI 0.54-1.11). There was no difference in major adverse cardiovascular events on follow-up (RR 1.04, 95% CI 0.62-1.74), death (RR 0.98, 95% CI 0.59-1.64), MI (RR 1.16, 95% CI 0.62-2.18), target vessel revascularization (RR 1.40, 95% CI 0.83 to 2.36), stroke (RR 1.50, 95% CI 0.46-4.86) or stent thrombosis (RR 0.82, 95% CI 0.06-10.74); all PA vs. BA comparisons.
CONCLUSIONS
Compared to bailout RA, planned RA resulted in significantly shorter procedural times, less contrast use, lesser dissection rates and fewer stents used. The bailout RA approach appears to enhance periprocedural risk, but there is no difference on mid-term outcomes.
Topics: Atherectomy, Coronary; Coronary Artery Disease; Humans; Myocardial Infarction; Retrospective Studies; Stents; Treatment Outcome; Vascular Calcification
PubMed: 34627732
DOI: 10.1016/j.carrev.2021.09.013 -
Journal of Vascular Surgery Feb 2022Atherectomy has become increasingly used as an endovascular treatment of lower extremity atherosclerotic disease in the United States. However, concerns and...
OBJECTIVE
Atherectomy has become increasingly used as an endovascular treatment of lower extremity atherosclerotic disease in the United States. However, concerns and controversies about its indications and outcomes exist. The goal of the present systematic review and meta-analysis was to investigate the outcomes and complications related to atherectomy to treat femoropopliteal atherosclerotic disease.
METHODS
A systematic review in accordance with the recommendations from the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement was performed. Four major scientific repositories (MEDLINE, Embase, the Cochrane Library, and Thompson Web of Sciences) were queried from their inception to April 5, 2020. We reviewed and entered the data in a dedicated dataset. The outcomes included the patency rates, clinical and hemodynamic improvement, and morbidity and mortality associated with atherectomy interventions.
RESULTS
Twenty-four studies encompassing 1900 patients met the inclusion criteria for the present study. Of the 1900 patients, 74.3% had presented with Rutherford class 1 to 3 and 25.7% presented with Rutherford class 4 to 6; 1445 patients had undergone atherectomy, and 455 patients had been treated without atherectomy. The atherectomy group had undergone directional atherectomy (n = 851), rotational atherectomy (n = 851), laser atherectomy (n = 201), and orbital atherectomy (n = 78). Most of these patients had also received adjunct treatments, which varied across the studies and included a combination of stenting, balloon angioplasty, or drug-coated balloon angioplasty. Technical success was achieved in 92.3% of the cases. Distal embolization, vessel perforation, and dissection occurred in 3.4%, 1.9%, and 4% of the cases, respectively. The initial patency was 95.4%. At the 12-month median follow-up, the primary patency was 72.6%. The ankle brachial index had improved from a preoperative mean of 0.6 to a postoperative mean of 0.84. The incidence of major amputation and mortality during the follow-up period was 2.2% and 3.4%, respectively.
CONCLUSIONS
The results from our review of the reported data suggest that femoropopliteal atherectomy can be completed safely, modestly improving the ankle brachial index and maintaining the 1-year patency in nearly three of four patients. However, these findings were based on heterogeneous studies that skewed the generalizable conclusions about atherectomy's efficacy. Atherectomy places a high cost burden on the healthcare system and is used in the United States at a higher rate than in other countries. Our review of the literature did not demonstrate clear atherectomy superiority to alternatives that would warrant the pervasive and increasing use of this costly technology. Future work should focus on developing high-quality randomized controlled trials to determine the specific patient and lesion characteristics for which atherectomy can add value.
Topics: Angioplasty, Balloon; Atherectomy; Atherosclerosis; Coated Materials, Biocompatible; Femoral Artery; Humans; Intermittent Claudication; Popliteal Artery; Stents; Vascular Patency
PubMed: 34303802
DOI: 10.1016/j.jvs.2021.07.106