Recent clinical trials in valvular heart diseases.

PURPOSE OF REVIEW: In recent years, no other field of cardiology has experienced a greater influx of transformational therapeutic options as valvular heart disease. The present review discusses the landmark trials published in the last 18 months that have shaped the modern day management of valvular heart diseases. RECENT FINDINGS: There have been several landmark trials in recent years, which have expanded the indications for transcatheter aortic valve replacement to low-risk surgical patients and the use of MitraClip for patients with functional mitral regurgitation. Options for transcatheter management of right-sided valvular disease also continue to evolve, including promising results from early feasibility studies. SUMMARY: The development of novel transcatheter therapies for valvular heart disease has expanded the armamentarium of physicians treating patients with valvular heart disease. The present review will focus on the recent (within 2 years) trials in this field of interest.

Transcatheter aortic valve replacement versus surgical aortic valve replacement in low-surgical-risk patients: An updated meta-analysis.

OBJECTIVE: The purpose of this meta-analysis is to compare the safety and efficacy of transcatheter aortic-valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in low-surgical-risk patients. BACKGROUND: TAVR is proven to be safe and effective in patients with high- and intermediate-risk aortic stenosis. However, there is limited data on the safety and efficacy of TAVR in patients with low surgical risk. METHODS: We conducted an electronic database search of all published data for studies that compared TAVR to SAVR in low-surgical-risk patients (mean society for thoracic surgery [STS] score <4% and/or logistic EuroScore <10%) and reported on subsequent all-cause mortality, cardiac mortality, stroke rates, and other outcomes of interest. Event rates were compared with a forest plot of odds ratio using a random-effects model assuming interstudy heterogeneity. RESULTS: A total of seven studies (n = 6,293 patients; TAVR = 2,912; and SAVR = 3,381) were included in the final analysis. There was no significant difference between TAVR and SAVR in terms of all-cause mortality (OR 0.82; 95% CI 0.50-1.36, I2 = 51%), cardiac mortality (OR 0.57; 95% CI 0.32-1.02, I2 = 0%), new pacemaker implantation (OR = 3.11; 95% CI 0.58-16.60, I2 = 89%), moderate/severe paravalvular leak (PVL; OR 3.50; 95% CI 0.64-19.10, I2 = 54%) and rate of stroke (OR 0.63; 95% CI 0.34-1.15, I2 = 39%) at 1-year follow-up. TAVR was found to have a significantly lower incidence of atrial fibrillation (AF; OR 0.15, 95% CI 0.10-0.24, I2 = 38%) as compared to SAVR. CONCLUSION: The results of our meta-analysis demonstrate similar rates of all-cause mortality, cardiac mortality, and stroke at 1-year follow-up in patients undergoing TAVR and SAVR. TAVR is associated with a lower incidence of AF relative to SAVR. However, there was a significantly higher incidence of PVL with TAVR compared to SAVR.

Three to four years outcomes of the absorb bioresorbable vascular scaffold versus second-generation drug-eluting stent: A meta-analysis.

OBJECTIVE: This meta-analysis sought to evaluate the outcomes of absorb bioresorbable vascular scaffolds (BVS) compared with second-generation drug-eluting stents (DES) after 3 years, the approximate time of complete polymer bioresorption. BACKGROUND: BVS were found to be inferior to second-generation DES in early and mid-term outcomes with a higher rate of target vessel myocardial infarction (TV-MI) and device thrombosis (DT). Improper implantation techniques and incomplete bioresorption of the poly-l-lactide (PLLA) polymer were sighted as possible reasons. METHODS: We conducted an electronic database search for all randomized control trials that compared absorb BVS to second-generation DES and reported outcomes of interest after 3 years of absorb BVS implantation. Assuming interstudy heterogeneity, a random-effects analysis was conducted with odds ratio as the effect size of choice to compare the event rates between the two groups. RESULTS: A total of four studies (n = 3,245, BVS = 2075, DES = 1,170) were included in the final analysis. Pooled analysis revealed that there was no difference between absorb BVS and second-generation DES with respect to target lesion failure (TLF) (OR = 1.23, 95% CI = 0.73-2.07, p = 0.44), TV-MI (OR = 1.03, 95% CI = 0.42-2.53, p = 0.95), target lesion revascularization (TLR) (OR = 1.61, 95% CI = 0.77-3.33, p = 0.20) and definite/probable DT (OR = 0.71, 95% CI = 0.10-5.07, p = 0.74). Also, there was no difference in cardiac mortality (OR = 0.66, 95% CI = 0.22-1.94, p = 0.45). CONCLUSIONS: Between 3 and 4 years of follow-up, patients receiving absorb BVS did not have significantly different outcomes, in terms of TLF, TV-MI, TLR, DT, and cardiac mortality, compared to DES.

Left main percutaneous coronary intervention-Radial versus femoral access: A systematic analysis.

BACKGROUND: Debate still occurs of the benefits of transradial access (TRA) versus transfemoral access (TFA), especially for complex percutaneous coronary interventions. Recent data has shown equivalent efficacy and improved safety outcomes with TRA. OBJECTIVES: To systematically review and perform a meta-analysis comparing procedural characteristics and clinical outcomes of TRA versus TFA in patients who underwent percutaneous coronary intervention (PCI) for left main (LM) disease. METHODS: We conducted an electronic database search of all published data for studies that compared TRA with TFA in patients undergoing PCI of LM disease. Event rates were compared using the odds ratio (OR) as a measure of effect size. Random-effects models were used to account for interstudy heterogeneity. RESULTS: A total of 12 observational studies including 17,258 patients (TRA n = 7,971; TFA n = 9,287) were included. Compared to TFA, TRA was associated with a significant reduction in access site bleeding (OR = 0.11; 95% confidence interval [CI] = 0.04-0.26; I2 = 0%; p < .0001), major bleeding (OR = 0.44; 95% CI = 0.27-0.69; I2 = 0%; p = .0005) or any bleeding episode (OR = 0.43; 95% CI = 0.27-0.69; I2 = 12%; p = .0004). Rates of access site or vascular complications (OR = 0.26; 95% CI = 0.17-0.40; I2 = 0%; p < .00001) and in-hospital mortality (OR = 0.49; 95% CI = 0.31-0.79: I2 = 11%; p = .004) were also lower in the TRA group. There were no significant differences in procedural outcomes between TRA and TFA except for a significant reduction in the rate of long-term target vessel revascularization (TVR) in the TRA group (OR = 0.62; 95% CI = 0.41-0.94: I2 = 0%: p = .02). We further performed a subgroup analysis for unprotected left main PCI only, which showed a significant reduction in rates of any bleeding episode, lower access site or vascular complications, and in-hospital mortality with TRA as compared to TFA. CONCLUSION: Patients undergoing PCI for LM disease via TRA have with less bleeding, reduced access site or vascular complications, reduced in-hospital mortality, comparable procedural success, and possibly better long-term clinical efficacy when compared to those undergoing the procedure via TFA.

Comparison of single versus dual antiplatelet therapy after TAVR: A systematic review and meta-analysis.

OBJECTIVE: We aim to evaluate the efficacy of dual versus single anti-platelet therapy (SAPT) after TAVR through a systematic review and meta-analysis of published research. BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is a commonly practiced strategy after transcatheter aortic valve replacement (TAVR). However, there is lack of sufficient evidence supporting this approach. METHOD: We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials (RCT) and observational studies comparing DAPT with SAPT post TAVR. Event rates were compared using a forest plot of relative risk with 95% confidence intervals using a random-effects model assuming inter-study heterogeneity. RESULTS: A total of six studies (3 RCTs and 3 observational studies, n = 840) were included in the final analysis. Compared to SAPT, DAPT was associated with increased risk of significant bleeding (life threatening and major) [RR = 2.52 (95% CI 1.62-3.92, P < 0.0001)] with the number needed to harm for major or life-threatening bleeding calculated to be 10.4. There was no significant difference in the incidence of stroke [RR = 1.06 (95% CI, 0.43-2.60, P = 0.90)], spontaneous myocardial infarction [RR = 2.08 (95% CI, 0.56-7.70, P = 0.27)] and all-cause mortality [RR = 1.18 (95% CI, 0.68-2.05, P = 0.56] in the DAPT and SAPT groups. CONCLUSION: In this small meta-analysis of DAPT versus SAPT after TAVR, DAPT did not prevent stroke, myocardial infarction or death while the risk of bleeding was higher. Results from ongoing trials are awaited to determine the best anti-thrombotic approach after TAVR.

Percutaneous Mitral Valve Interventions and Heart Failure.

Mitral regurgitation (MR) is the most frequent Valvular Heart Disease (VHD) and is an important cause of heart failure. MR can be caused by primary valve abnormality (Degenerative MR/Primary MR) or it can be secondary to cardiomyopathy (Functional MR/Secondary MR). Medical management alleviates symptoms but does not alter the progression of the disease. Current guidelines recommend surgery for moderate-to-severe (Grade > 3) MR in patients with symptoms or evidence of left ventricular dysfunction. Despite current practice guidelines, the majority of patients with severe MR do not undergo surgery. The reasons include high surgical risk from advanced age or multiple comorbidities, and a lack of clear data supporting valve surgery for secondary MR with LV dysfunction. The recent emergence of percutaneous interventional approaches in treating MR has expanded therapeutic options for patients who are at high risk for conventional Mitral Valve (MV) surgery. In this chapter, we will review the novel advancements in the field of percutaneous MV interventions that could potentially become the standard of care for patients with MR and heart failure.

Effect of Alcohol Consumption on Cardiovascular Health.

PURPOSE OF REVIEW: This review aims to discuss the effect of alcohol consumption on various cardiovascular (CV) diseases and CV mortality. RECENT FINDINGS: Alcohol intake has consistently shown a J- or U-shaped relationship with several cardiovascular diseases. Light to moderate alcohol intake has been associated with lower risk of coronary artery disease, heart failure (HF), as well as CV mortality. On the other hand, heavy consumption has been associated with deleterious CV outcomes including increased mortality. However, the evidence is based from observational and population-based studies where risk of confounding cannot be excluded even after meticulous methodological approaches. This is compounded by conflicting data such as higher risk of certain CV diseases like HF in former drinkers compared to abstainers. Further, Mendelian randomization studies using genetic polymorphisms in enzymes have recently questioned the beneficial association of low-moderate drinking with CV system. There has been substantial and consistent evidence that light to moderate alcohol consumption have beneficial effect on overall cardiovascular profile and mortality. However, there are considerable limitations in the reported literature to determine a strong causality of a protective effect of moderate alcohol consumption by itself. Further robust studies or possibly a well-structured randomized controlled could bring an end to this debate.

Identification of essential surgical competencies to be imparted in urological residency: A survey-based study.

INTRODUCTION: There are variations in surgical procedures included in urology residency curricula across various programs. We conducted a survey of practicing urologists to determine which procedures are considered essential to a core urology residency curriculum. MATERIALS AND METHODS: A web-based survey was conducted between October 2016 and February 2017 using SurveyMonkey. The questionnaire, comprising a set of 5-questions, was sent to the members of the Urological Society of India. Respondents were requested to grade 37 of the most common urological procedures (competencies) into three groups. Group A, were those that the respondent believed were vital for the trainee to learn (must know). Group B, were those that the respondent thought were essential to acquire (good to know). Group C procedures were labeled as desirable to know by respondents. RESULTS: A total of 485 (15.75%) responses were received out of 3018 members contacted. 67% respondents were working in the private-sector. Out of the 37 listed procedures, 20 procedures received a median weightage of 1 indicating vital clinical competency for urology curriculum, 15 were identified as "essential to know" while two procedures were identified as "desirable to know." CONCLUSIONS: Twenty surgical procedures were identified as'must-know' for a urology trainee. The choice of procedures was not affected by the region of the responder or his practice type, suggesting a wide consensus.

Surgical Treatment of Ischemic Mitral Regurgitation: Valve Repair Versus Replacement.

PURPOSE OF REVIEW: Ischemic mitral regurgitation (MR), which occurs in about 20-30% patients with a prior myocardial infarction, is associated with worsening heart failure and an increase in cardiovascular mortality. It should be treated surgically if certain hemodynamic severity criteria are met and in patients who continue to experience symptoms of heart failure despite optimal medical therapy. However, current guidelines do not suggest which of the available approaches to mitral valve surgery-mitral valve (MV) repair or replacement (MVR) is superior for this indication. While MV repair is reported to confer improved survival, MVR may provide higher rates of freedom from recurrent MR. This article attempts to provide the reader with a comprehensive review and comparison of current techniques of mitral valve surgery in patients with severe ischemic MR. RECENT FINDINGS: The first randomized trial to compare MV repair versus MVR in patients with severe ischemic MR, the Cardiothoracic Surgical Trials Network (CTSN) trial, was recently concluded and reported no significant difference in the primary outcome of left ventricular end systolic volume index between the two approaches at either 1- or 2-year follow-ups. Data comparing approaches of MV repair and MVR for ischemic MR is largely limited to small, non-randomized retrospective trials. The only randomized trial data to examine this issue suggested no difference in mortality with either MVR or MV repair; however, MVR was shown to be consistently associated with higher rates of MR recurrence. Certain echocardiographic features have been reported to predict poor outcomes with MVR and may help refine the selection of the surgical approach in the individual patient.

Antithrombotic therapy before, during and after transcatheter aortic valve replacement (TAVR).

Transcatheter aortic valve replacement (TAVR) has been emerged as a promising alternative for the management of patients with severe AS who otherwise are deemed inappropriate candidates for surgery. Post procedural thromboembolic events and risk of bleeding continue to be a significant challenge in managing patients who underwent TAVR. This article systematically reviews the evidence, current guidelines and upcoming studies investigating antithrombotic therapy before, during and after TAVR.

Carcinoid Heart Disease without Liver Involvement Caused by a Primary Ovarian Carcinoid Tumour.

Carcinoid heart disease, caused by primary ovarian carcinoid tumour, is a rare form of valvular heart disease. This form of heart disease usually presents with symptoms of right-sided valvular dysfunction, ultimately leading to right-sided heart failure. This entity is unique as it develops in the absence of liver metastasis. We report a case of 75 year-old woman with primary ovarian carcinoid tumour who presented with symptoms of severe right-sided heart failure and successfully underwent pulmonic and tricuspid valve replacement along with a right ventricular (RV) outflow patch enlargement. This patient later underwent uneventful resection of the primary ovarian carcinoid tumour, with complete resolution of her symptoms.

Acute Coronary Syndrome in an Anomalous Left Main Coronary Artery.

Anomalous origin of the left main coronary artery (LMCA) from the right sinus of Valsalva (RSV) is a rare congenital anomaly that can cause myocardial ischemia, ventricular arrhythmia, and sudden cardiac death. We report the case of a 74-year-old male with a history of hyperlipidemia and hypertension who presented with non-ST elevation myocardial infarction (NSTEMI). On coronary angiogram, the patient was found to have LMCA originating from the RSV and a 90% stenosis of the left anterior descending (LAD) artery. The patient subsequently underwent computed tomography angiography (CTA) to assess the course of the LMCA, which was found to be intramyocardial with no compression. The echocardiogram reported a reduced ejection fraction (EF) of 40% and wall motion abnormalities in the anterior wall. The patient had a successful staged percutaneous coronary intervention (PCI). The patient on follow-up reported no symptoms and EF improved to 50%. Anomalous origin of the LMCA from the RSV is a rare but potentially life-threatening congenital anomaly. Once the course of the anomalous artery is established, immediate reperfusion using PCI is being increasingly used in place of surgical unroofing, noting a change in clinical practice. Further research is needed to determine the optimal treatment for this anomaly and to improve the long-term outcomes of affected individuals.

Intra-abdominal Pressure Measurement as a Predictor of Postoperative Wound Complications in Patients Undergoing Emergency Laparotomy: A Prospective Observational Study.

Introduction Elevated intra-abdominal pressure (IAP) hampers the effective functioning of intra- and extra-abdominal organs. Despite the abundance of knowledge, routine measurement of IAP still needs to be widely incorporated in managing at-risk patients. The present study intends to assess the need for IAP measurement on abdominal wound healing in emergency laparotomy patients. Methods This prospective study was carried out over 24 months in patients undergoing emergency laparotomy. The IAP was measured at admission, immediately after surgery, and during the early postoperative period at 6, 12, 24, 48, and 72 hours. The patients were evaluated for the development of wound-related complications over a follow-up period of three months post-operatively. Results Seventy-two patients were enrolled. At admission, 54 (75%) patients had intra-abdominal hypertension (IAH), of which three patients had evidence of abdominal compartment syndrome. Thirty-one (43%) patients developed postoperative wound infections. The overall incidence of wound infection was significantly higher in patients with IAH (54.3% vs. 24%, p-value = 0.04, Pearson's Chi-squared test). The frequency of wound dehiscence was greater (19.6 % vs. 4.3 %, p-value 0.14, Fischer's exact test) in patients with IAH. The median duration of hospital stay (13 vs. 8 days, p-value 0.02, Mann-Whitney U test) and healing time (30.5 vs. 18 days, p-value 0.02, Mann-Whitney U test) was significantly higher in patients with IAH. Conclusion Measurement of IAP is a relatively simple procedure that should be incorporated into the routine postoperative care of surgical patients. The presence of elevated IAP can identify the subset of patients at risk of increased postoperative wound complications.

Corrigendum: The safety and efficacy of balloon-expandable versus self-expanding trans-catheter aortic valve replacement in high-risk patients.

[This corrects the article DOI: 10.3389/fcvm.2023.1130354.].

The safety and efficacy of balloon-expandable versus self-expanding trans-catheter aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis.

Aim: Transfemoral Trans-catheter Aortic Valve Replacement (TF-TAVR) is a safe and effective therapy compared with surgical aortic valve replacement (SAVR) in patients across all risk profiles using balloon-expandable valves (BEV) and self-expanding valves (SEV). Our aim was to compare safety and efficacy of BEV vs. SEV in high-risk patients undergoing TF-TAVR. Methods and results: We searched PubMed, EMBASE, Clinicaltrials.gov, Scopus, and Web of sciences for studies on patients with severe aortic stenosis undergoing TAVR. Primary outcome was 30-day all-cause mortality. Secondary outcomes defined by Valve Academic Research Consortium 2 (VARC-2) criteria were also examined. Six studies with 2,935 patients (1,439 to BEV and 1,496 to SEV) were included. BEV was associated with lower risk of all-cause mortality (2.2% vs. 4.5%; RR: 0.51; 95% CI: 0.31-0.82; p < 0.006) and cardiovascular mortality [(2.5% vs. 4.3%; RR: 0.54; 95% CI: 0.32-0.90; p = 0.01) at 30 days compared with SEV. Implantation of more than one valve per procedure (0.78% vs. 5.11%; RR: 0.15; 95% CI: 0.07-0.31; p < 0.00001), and moderate/severe AR/PVL (2.5% vs. 9.01%; RR: 0.3; 95% CI: 0.17-0.48); p < 0.00001) were also lower in the BEV arm. Conclusion: BEV TAVR is associated with reduced all-cause mortality (High level of GRADE evidence), cardiovascular mortality (very low level) at 30 days compared with SEV TAVR in high surgical risk patients. Data are necessary to determine if the difference in outcomes persists in longer-term and if the same effects are seen in lower-risk patients. Systematic Review Registration: identifier, CRD42020181190.

Recurrent vesico-acetabulo-cutaneous fistula: lessons to be learnt.

A man in early 40s met with an accident with a complex pelvic fracture and extraperitoneal bladder injury and posterior urethral disruption 16 years ago. He additionally had left lumbar spinal segment mixed nerve injury, resulting in a foot drop. He underwent laparotomy and a diverting cystostomy at the time with a primary perineal urethroplasty a year later. He later developed pseudoarthrodesis of the hip joint, and poorly compliant bladder with complete block at bulbar urethra. A redo anastomotic urethroplasty was performed, hyperreflexive neurogenic bladder was managed with intravesical botox injections and underwent a hip replacement. Having defaulted botox injections, he developed a vesico-acetabulo-cutaneous fistula and the hip prosthesis was explanted. Later he underwent a ileal cystoplasty and a revision hip replacement. Ten years later, he presented with a recurrent fistula due to poor compliance with clean intermittent catheterisation. A challenging exploration with fistula excision was done with a primary bladder repair.

Operator Radiation Exposure During Transfemoral Transcatheter Aortic Valve Replacement.

Background: The level of radiation exposure received by operators performing transcatheter aortic valve replacement (TAVR) is not well investigated. The aim of this study is to measure the amount of radiation received by operators performing transfemoral TAVR and to identify various patient and procedural characteristics associated with increased radiation exposure. Methods: Primary (operator 1) and secondary (operator 2) operators' equivalent radiation doses in micro Sieverts (µSv) were calculated prospectively using real-time radiation dosimeters for a total of 140 consecutive transfemoral TAVRs. Corresponding eye and thorax radiation exposures between the operators were compared. Associations between various patient and procedural characteristics and the radiation exposure were tested using the t-test and Wilcoxon Mann-Whitney rank-sum test with Monte Carlo estimation. Multivariable regression analysis was also conducted. Results: Operator 1 had significantly higher cumulative equivalent radiation exposure than operator 2 (86 µSv vs 38 µSv, p-value: <0.0001) which was consistent at the level of the thorax (67 µSv vs 22 µSv, p-value: <0.0001), but not at the level of the eye (16.5 µSv vs 15 µSv, p-value: 0.30). On multivariable analysis, patient obesity and intraprocedural complications were associated with higher radiation exposure to both operators. Ad hoc percutaneous coronary intervention led to excessive radiation exposure to the secondary operator. Conclusions: Transfemoral TAVR is associated with a modest amount of radiation exposure to operators and is significantly higher for the primary operator than for the secondary operator.

Orbital atherectomy versus rotational atherectomy: A systematic review and meta-analysis.

BACKGROUND: Coronary artery calcification is associated with poor outcomes in patients undergoing percutaneous coronary intervention (PCI). Atheroablative techniques such as orbital atherectomy (OA) and rotational atherectomy (RA) are routinely utilized to treat these calcified lesions in order to optimize lesion preparation and facilitate stent delivery. OBJECTIVES: The purpose of this systematic review and meta-analysis is to compare the performance of OA versus RA in patients with calcified coronary artery disease (CAD) undergoing PCI. METHODS: We conducted an electronic database search of all published data for studies that compared OA versus RA in patients with calcified coronary artery disease undergoing PCI and reported on outcomes of interest. Event rates were compared using a forest plot of odds ratios using a random-effects model assuming interstudy heterogeneity. RESULTS: A total of five observational studies (total number of patients = 1872; OA = 535, RA = 1337) were included in the final analysis. On pooled analysis, OA compared to RA was associated with a significant reduction in fluoroscopy times (OR = -6.33; 95% CI = -9.90 to -2.76; p < .0005; I2 = 82). There was no difference between the two techniques in terms of contrast volume, coronary artery dissection, device induced arterial perforation, cardiac tamponade, slow flow/no reflow, periprocedural myocardial infarction (MI), in-hospital mortality, 30-day mortality, 30-day MI, 30-day target vessel revascularization (TVR), and 30-day major adverse cardiovascular events (MACE). CONCLUSION: Except for lower fluoroscopy time with OA, there are no significant differences between OA and RA in relation to procedural, periprocedural, and thirty day outcomes among patients with calcified CAD undergoing PCI.